Fasudil_Hydrochloride_HNMR_19812_MedChemExpress
盐酸二甲双胍质量标准(英国药典)
Metformin HydrochlorideC4H11N5·HCl 165.62Imidodicarbonimidic diamide,N,N-dimethyl-,monohydrochloride.1,1-Dimethylbiguanide monohydrochloride [1115-70-4].»Metformin Hydrochloride contains not less than 98.5percent and not more than 101.0percent of C4H11N5·HCl,calculated on the dried basis.USP Reference standards 〈11〉—USP Metformin Hydrochloride P Metformin Related Compound A RS.Identification—A:Infrared Absorption 〈197K〉.B:It meets the requirements of the tests for Chloride 〈191〉.Loss on drying 〈731〉—Dry it at 105for 5hours:it loses not more than 0.5%of its weight. Residue on ignition 〈281〉:not more than 0.1%.Heavy metals,Method I〈231〉:0.001%.Related compounds—Mobile phase—Prepare a solution in water,containing 17g of monobasic ammonium phosphate per L,adjust with phosphoric acid to a pHof 3.0,and mix.Standard solution—Prepare a solution of USP Metformin Related Compound A RSin water having a known concentration of about 0.2mg per mL.Transfer 1.0mLof this solution to a 200-mLvolumetric flask,dilute with Mobile phase to volume,and mix.[NOTE—Metformin related compound Ais 1-cyanoguanidine.]Test solution—Transfer about 500mg of Metformin Hydrochloride,accurately weighed,to a 100-mLvolumetric flask,dissolve in and dilute with Mobile phase to volume,and mix.Diluted test solution—Transfer 1.0mLof the Test solution to a 10-mLvolumetric flask,dilute with Mobile phase to volume,and mix.Transfer 1.0mLof this solution to a 100-mLvolumetric flask,dilute with Mobile phase to volume,and mix.Resolution solution—Transfer about 10mg of melamine to a 100-mLvolumetric flask,and dissolve in about 90mLof water.Add 5.0mLof the Test solution,dilute with water to volume,and mix.Transfer 1.0mLof this solution to a 50-mLvolumetric flask,dilute with Mobile phase to volume,and mix.Chromatographic system (see Chromatography 〈621〉)—The liquid chromatograph is equippedwith a 218-nm detector and a 4.6-mm ×25-cm column containing packing L9.The flow rate is about 1.0to 1.7mLper minute.Chromatograph the Resolution solution,and record the peak responses as directed for Procedure:the resolution,R,between melamine and metformin is not less than 10.Procedure—Separately inject equal volumes (about 20µL)of the Test solution,the Standard solution,and the Diluted test solution into the chromatograph,record the chromatograms for not less than twice the retention time of metformin,and measure the peak areas.The area of a peak corresponding to metformin related compound Ain the chromatogram of the Test solution is not greater than the area of the corresponding peak in the chromatogram of the Standard solution:not more than 0.02%of metformin related compound Ais found.The area of any other secondary peak in the chromatogram of the Test solution is not greater than the area of the major peak in the chromatogram of the Diluted test solution;and the sum of the areas of all secondary peaks in the chromatogram of the Test solution is not greater than five times the area of the major peak in the chromatogram of the Diluted test solution:not more than 0.1%of any other impurity is found;and not more than 0.5%of total impurities is found.Assay—[NOTE—To avoid overheating of the reaction medium,mix thoroughly throughout the titration,and stop the titration immediately after the endpoint has been reached.]Dissolve about 60mg of Metformin Hydrochloride,accurately weighed,in 4mLof anhydrous formic acid.Add 50mLof acetic anhydride.Titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction (see Titrimetry 〈541〉).Each mLof 0.1Nperchloric acid is equivalent to 8.28mg of C4H11N5·P28Auxiliary Information—Staff Liaison:Elena Gonikberg,Ph.D.,ScientistExpert Committee:(PA4)Pharmaceutical Analysis 4USP28–NF23Page 1231Pharmacopeial Forum:V olume No.29(6)Page 1925Phone Number:1-301-816-8251Metformin Hydrochloride(Ph Eur monograph 0931)C4H11N5,HCl 165.61115-70-4Ph EurDEFINITION1,1-Dimethylbiguanide hydrochloride.Content98.5 per cent to 101.0 per cent (dried substance).CHARACTERSAppearanceWhite crystals.SolubilityFreely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride.IDENTIFICATIONFirst identificationB, E.Second identificationA, C, D, E.A. Melting point (2.2.14): 222 C to 226 C.B. Infrared absorption spectrophotometry (2.2.24).Preparation. Discs of potassium chloride R.Comparison: Metformin hydrochloride CRS.C. Thin-layer chromatography (2.2.27).Test solution. Dissolve 20 mg of the substance to be examined in water R and dilute to 5 ml with the same solvent.Reference solution. Dissolve 20 mg of metformin hydrochloride CRS in water R and dilute to 5 ml with the same solvent.Plate. TLC silica gel G plate R.Mobile phase. Upper layer of a mixture of 10 volumes of glacial acetic acid R, 40 volumes of butanol R and 50 volumes of water R.Application. 5 µl.Development. Over a path of 15 cm.Drying. At 100C105 C for 15 min.Detection. Spray with a mixture of equal volumes of a 100 g/l solution of sodium nitroprusside R, a 100 g/l solution of potassium ferricyanide R and a 100 g/l solution of sodium hydroxide R, prepared 20 min before use.Results. The principal spot in the chromatogram obtained with the test solution is similar inposition, colour and size to the principal spot in the chromatogram obtained with the reference solution.D. Dissolve about 5 mg in water R and dilute to 100 ml with the same solvent. To 2 ml of the solution add 0.25 ml of strong sodium hydroxide solution R and 0.10 ml of a-naphthol solution R. Mix and allow to stand in iced water for 15 min. Add 0.5 ml of sodium hypobromite solution R and mix. A pink colour develops.E. It gives reaction (a) of chlorides (2.3.1).TESTSSolution SDissolve 2.0 g in water R and dilute to 20 ml with the same solvent.Appearance of solutionSolution S is clear (2.2.1) and colourless (2.2.2, Method II).Related substancesLiquid chromatography (2.2.29).Test solutionDissolve 0.50 g of the substance to be examined in the mobile phase and dilute to 100.0 ml with the mobile phase.Reference solution (a)Dissolve 20.0 mg of cyanoguanidine R in water R and dilute to 100.0 ml with the same solvent. Dilute 1.0 ml to 200.0 ml with the mobile phase.Reference solution (b)Dilute 1.0 ml of the test solution to 50.0 ml with the mobile phase. Dilute 1.0 ml of this solution to 20.0 ml with the mobile phase.Reference solution (c)Dissolve 10.0 mg of melamine R in about 90 ml of water R. Add 5.0 ml of the test solution and dilute to 100.0 ml with water R. Dilute 1.0 ml of this solution to 50.0 ml with the mobile phase.Column:size: l = 0.25 m, Ø = 4.6 mm,stationary phase: irregular, porous silica gel to which benzenesulphonic acid groups have been chemically bonded (10 µm),orsize: l = 0.11 m, Ø = 4.7 mm,stationary phase: regular, porous silica gel to which benzenesulphonic acid groups have been chemically bonded (5 µm).Mobile phase17 g/l solution of ammonium dihydrogen phosphate R adjusted to pH 3.0 with phosphoric acid R.Flow rate1 ml/min.DetectionSpectrophotometer at 218 nm.Injection20 µl.Run timeTwice the retention time of metformin hydrochloride.System suitabilityReference solution (c):resolution: minimum of 10 between the peaks due to melamine and to metformin hydrochloride.Limits:impurity A: not more than the area of the corresponding peak in the chromatogram obtained with reference solution (a) (0.02 per cent),any other impurity: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.1 per cent).Heavy metals (2.4.8)Maximum 10 ppm.12 ml of solution S complies with limit test A. Prepare the standard using lead standard solution (1 ppm Pb) R.Loss on drying (2.2.32)Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 100C105 C for 5 h. Sulphated ash (2.4.14)Maximum 0.1 per cent, determined on 1.0 g.ASSAYDissolve 0.100 g in 4 ml of anhydrous formic acid R. Add 80 ml of acetonitrile R. Carry out the titration immediately. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).1 ml of 0.1 M perchloric acid is equivalent to 16.56 mg of C4H12ClN5.IMPURITIESQualified impuritiesA.Other detectable impuritiesB, C, D, E, F.A. cyanoguanidine,B. R = NH-C(=NH)-NH2: (4,6-diamino-1,3,5-triazin-2-yl)guanidine,C. R = N(CH3)2: N,N-dimethyl-1,3,5-triazine-2,4,6-triamine,D. R = NH2: 1,3,5-triazine-2,4,6-triamine (melamine),E. 1-methylbiguanide,F. CH3-NH-CH3: N-methylmethanamine.Ph EurAction and useHypoglycaemic.PreparationMetformin Tablets。
麦吉丽Mageline水氧润护系列好用么
大家都说这是个看脸的时代，但是大家有好好对待过自己的脸嘛。
就像女人三十那部电影里面说的，其实这个世界上没有丑女人只有懒女人。
其实大家只要注意保养自己的皮肤应该是不会丑的。
有很多女生会很纠结到底该怎么去选择护肤品呢，或者是哪个牌子的护肤品好呢？其实护肤这个东西都是因人而异的，每个人肤质不一样适合的护肤品也是不同的。
下面小编给大家推荐几款麦吉丽的护肤品，大部分都是值得回购的空瓶分享哦。
花漾活肤卸妆水温和洁净彩妆、污垢和老化的多余角质产品说明深层卸除眼部及脸部彩妆、污垢和老化的多余角质，收细毛孔，打开肌肤吸收通道，促进后续护肤养分吸收，蕴含植物萃取保湿成分，在清洁的同时不带走肌肤水分，让洗净的肌肤任有润泽，无黏腻感，温和不刺激，缔造清爽澄净的肌肤。
产品成分水、丁二醇、马齿苋（PORTULACA OLERACEA）提取物、PEG-12 甘油月桂酸酯、甘油月桂酸酯、仙人掌（OPUNTIA DILLENII）提取物、PEG-40氢化蓖麻油、尿囊素用法用量喷雾直接喷于面部或取适量于掌心，在脸部以螺旋状涂抹开，待卸妆水与彩妆及污垢充分融合后，用清水或温水充分清洗。
卸妆后，请务必使用洁面品清洁。
水养润护柔肤水舒缓保湿调理肌肤水油平衡产品说明蕴含蜗牛提取精华、酵母、透明质酸等多种成分，温和补水，帮助打开肌肤水通道，促进肌肤水循环，帮助改善肌肤干燥、脱屑、脆弱泛红、肤色暗沉等现象，舒缓保湿，调理肌肤水油平衡，令肌肤水润光采有活力。
产品成分水、甘油、丁二醇、透明质酸钠、蜗牛分泌物滤液、酵母菌发酵溶胞产物滤液、β-葡聚糖、甘油聚甲基丙烯酸酯、PVM/MA 共聚物、黄原胶、月见草（OENOTHERA BIENNIS）提取物、库拉索芦荟（ALOE BARBADENSIS）提取物等。
用法用量洁面后，以化妆棉沾取适量，轻轻拍打全脸及颈部直至吸收。
水养润护精华液补水保湿舒缓修护肌肤温和不刺激产品说明甄选多种植物、酵母及蜗牛提取精华等护肤成分，深层补水保湿，帮助改善肌肤干燥、脱屑、脆弱泛红、肤色暗沉等现象，淡化干纹、细纹，均匀肤色，重建肌肤皮脂膜,滋养修护肌肤，日复一日，肌肤绽放健康水润光泽，晶莹通透。
盐酸法舒地尔说明书
分类：化学药品类别：3.1【药品名称】通用名：盐酸法舒地尔注射液曾用名：商品名：英文名：Fasudil Hydrochloride Injection汉语拼音：Yansuan Fashudier Zhusheye剂型：注射剂【成分】化学名称：六氢—1—(5—磺酰基异喹啉)—1(H)—1，4—二氮杂卓盐酸盐。
化学结构式：分子式：C14H17N3O2S?HCl分子量：327.83【性状】本品为白色、类白色或微黄色的结晶性粉末。
无臭，味微苦。
有引湿性。
本品在水中极易溶，在甲醇中溶解，在乙醇中略溶，在氯仿中极微溶，在乙醚中几乎不溶。
【药理毒理】盐酸法舒地尔是一种蛋白激酶抑制剂即细胞内钙离子拮抗剂。
血管平滑肌的收缩是由于平滑肌细胞内Ca2+浓度显著增高激活了关键酶的缘故。
当CA2+ 达到一定浓度时，与CA2+结合蛋白钙调素结合，激活肌球蛋白轻链磷酸化酶，将肌球蛋白轻链磷酸化，引起肌肉收缩。
蛛网膜下腔出血时，血管中释放出的各种血管收缩物质参与血管痉挛，最终通过肌球蛋白轻链磷酸化造成血管收缩。
盐酸法舒地尔通过阻断血管收缩过程的最终阶段，肌球蛋白轻链磷酸化，来扩张血管，抑制血管痉挛。
急性毒性：小鼠、大鼠口服给药的LD50分别为：小鼠雄性为273.9 mg／kg；雌性为277.3 mg／kg；大鼠雄性为335 mg／kg；雌性为348 mg／kg。
小鼠静脉给药的LD50 为69.5mg／kg。
亚急性毒性：以大鼠、猴静脉内给药1个月，无毒性剂量为：大鼠12.5mg／kg，猴3.125mg／kg。
慢性毒性：以大鼠、猴静脉内给药6个月，无毒性剂量为：大鼠9mg／kg，猴3.125mg／kg。
致突变性实验：细菌回复突变实验及啮齿类动物微核试验均为阴性。
哺乳类细胞染色体试验证明在体内无致突变性。
生殖毒性试验：妊娠前及妊娠初期的大鼠及大鼠胎仔器官形成期生殖和发育的毒性研究，剂量分别为1.56，6.25，25和1.6，8.0，40mg/kg。
法舒地尔杂质种类整理列表
中文名称英文名称CAS规格用途结构式
盐酸法舒地尔Fasudil HCl105628-07-710mg-25mg-50mg-100mg
项目报批
纯度高于99.89%
法舒地尔二聚体Fasudil Dimer1337967-93-710mg-25mg-50mg-100mg
项目报批
纯度高于99.89%
法舒地尔吡啶N-氧化物三氟乙酸盐Fasudil Pyridine N-
Oxide TFA Salt
186544-56-910mg-25mg-50mg-100mg
项目报批
纯度高于99.89%
法舒地尔杂质 3Fasudil Impurity 3166895-80-310mg-25mg-50mg-100mg
项目报批
纯度高于99.89%
法舒地尔N-羟基杂
质Fasudil N-Hydroxy
Impurity
1350827-92-710mg-25mg-50mg-100mg
项目报批
纯度高于99.89%
武汉斯坦德供应各种杂质对照品:泊沙康唑杂质、替卡格雷杂质、索拉非尼杂质、索拉菲尼相关杂质、去氧肾上腺素杂质、维生素BI杂质、马来酸氯苯那敏杂质、瑞格列奈杂质等；并提供COA、NMR、HPLC、MS等图谱。
专注各种杂质对照品 代理中检所/EP/BP/USP/LGC/TRC/DR/TLC/MC/SIGMA/BACHEM/STD等品牌
法舒地尔杂质种类整理列表。
爱丽德洗发露成分表
爱丽德洗发露成分表1. 产品简介爱丽德洗发露是一款广受欢迎的洗发产品，被广大消费者认可为有效清洁头发并保护秀发健康的选择。
本文将对爱丽德洗发露的成分进行详细分析，以帮助读者更好地了解该产品。
2. 成分列表以下是爱丽德洗发露中的主要成分：• 2.1 透明质酸• 2.2 瓜尔胶• 2.3 茶多酚• 2.4 椰油酰胺丙基甜菜碱• 2.5 氨基酸• 2.6 阿魏酸3. 成分详解3.1 透明质酸透明质酸是一种天然存在于皮肤中的多糖，具有保湿和润滑的作用。
它能够吸引并锁住水分，使头发保持水润，减少干燥和毛躁，同时也能增加头发的光泽。
3.2 瓜尔胶瓜尔胶是一种植物胶，具有丰富的营养成分，如维生素和矿物质。
它能够形成保护膜，保护头发免受外界环境的损伤，同时还能够修复受损的发丝，使头发更加柔顺顺滑。
3.3 茶多酚茶多酚是一种具有抗氧化和抗炎作用的成分，被广泛应用于美容和护肤产品中。
在洗发产品中，茶多酚能够清洁头皮，减少头屑的产生，同时还能够促进头发生长，提高头发的密度和质量。
3.4 椰油酰胺丙基甜菜碱椰油酰胺丙基甜菜碱是一种表面活性剂，具有良好的起泡和清洁能力。
它能够去除头皮和头发上的污垢和油脂，使头发清爽干净，同时还能够改善发丝的柔软度和顺滑度。
3.5 氨基酸氨基酸是构成蛋白质的基本成分，对头发的生长和修复起着重要作用。
洗发产品中添加氨基酸能够为头发提供养分，修复受损的发丝，增强发质，减少断裂和分叉。
3.6 阿魏酸阿魏酸是一种具有温和护理作用的成分，能够调节头皮的油脂分泌，减少头皮屑的产生。
同时它还具有镇静和舒缓头皮的功效，缓解头皮不适和瘙痒。
4. 使用效果爱丽德洗发露中的成分经过精心配制，能够为头发提供全面的护理和保护。
使用爱丽德洗发露后，您可以期待以下效果：•头发清洁彻底，油脂、污垢和头屑得到有效去除。
•头发保持水润和滋养，减少干燥和毛躁问题。
•头发变得柔顺顺滑，易于梳理和造型。
•头皮舒缓，减少头屑产生，改善头皮状况。
beely芦荟胶
Beely芦荟胶
芦荟胶又叫万用胶,万能胶！因为它可以全面的修补肌肤,最主要的功效就是杀菌消炎，因为芦荟有修复再生，美容养颜，抗辐射，抗衰老，所以芦荟胶有很多意想不到的作用，平常的补水保湿，美白祛斑，修护皮肤等功效都有，是居家旅行必备之品！
芦荟胶使用方法：
一般一天1-2次，在乳液后使用，在使用芦荟胶后建议再涂一次乳液！修复痘痕印疤，轻度一般28天(2支左右)一个疗程，中重度2-3个疗程可以达到明显的全面效果。
富含天然芦荟原汁，有效锁住肌肤水分，达到深度保湿作用。
并能在皮肤上形成特有的透气性保护膜，使皮肤免受外界的干扰，促进皮肤新陈代谢，使皮肤自然、健康、美白。
产品成分：水、库拉索芦荟（ALOEBARBADENSIS）叶提取物、甘油、B-葡聚糖、双甘油、透明质酸钠、卡波姆、三乙醇胺、聚山梨醇酯-20、咪唑烷基脲、香精、食品绿（CI42053）。
适用肌肤：任何肤质
使用方法：洁肤后，取适量涂于面部或身体其他所需部位，轻轻按摩，直至完全吸收。
注意事项：请谨防入眼，如不慎入眼请立即用清水洗净。
使用后，请盖紧瓶盖。
用户评价：用的挺好的，凉凉的很舒服，水水的，有淡淡的味道，透明状。
涂上吸收很快，很好。
文章来源于beely芦荟胶:。
磺达肝癸钠原料药USP38标准
Chromatographic systemAdd the following:(See Chromatography 〈621〉, System Suitability .)Mode: LCDetector: UV 254 nmvFondaparinux SodiumColumn: 4.6-mm × 25-cm; packing L1Flow rate: 1mL/min Injection size: 25µLSystem suitabilitySamples: System suitability solution and Standard solutionSuitability requirementsResolution: NLT 3.6 between folic acid related com-pound A (calcium formyltetrahydrofolate) and folic acid, System suitability solutionRelative standard deviation: NMT 2.0%, Standard solution C 31H 43N 3O 49S 8Na 101728.08Analysisα-D -Glucopyranoside, methyl O -2-deoxy-6-O -sulfo-Samples: Standard solution and Sample solution 2-(sulfoamino)-α-D -glucopyranosyl-(1→4)-O -β-D -Calculate the percentage of the labeled amount ofglucopyranuronosyl-(1→4)-O -2-deoxy-3,6-di-O -sulfo-folic acid (C 19H 19N 7O 6) in the portion of Tablets taken:2-(sulfoamino)-α-D -glucopyranosyl-(1→4)-O -2-O -sulfo-α-L -Result = (r U /r S ) × (C S /C U ) × 100idopyranuronosyl-(1→4)-2-deoxy-2-(sulfoamino)-, 6-(hy-drogen sulfate), decasodium salt;r U= peak area of folic acid from the SampleMethyl O -2-deoxy-6-O -sulfo-2-(sulfoamino)-α-D -glucopyra-solutionnosyl-(1→4)-O -β-D -glucopyranuronosyl-(1→4)-O -2-deoxy-r S = peak area of folic acid from the Standard3,6-di-O -sulfo-2-(sulfoamino)-α-D -glucopyranosyl-(1→4)-O -solution2-O -sulfo-α-L -idopyranuronosyl-(1→4)-2-deoxy-6-O -sulfo-C S = concentration of USP Folic Acid RS in the2-(sulfoamino)-α-D -glucopyranoside, decasodium salt Standard solution (mg/mL)[114870-03-0].C U = nominal concentration of folic acid in theDEFINITIONSample solution (mg/mL)Fondaparinux Sodium is the sodium salt of a syntheticAcceptance criteria: 90.0%–115.0%sulfated pentasaccharide anticoagulant based on the anti-PERFORMANCE TESTS thrombin binding moiety of heparin. It is synthesized •D ISSOLUTION 〈711〉from a natural source of chirally pure sugars (mono- and Medium: Water; 500mL di-saccharides). A range of coupling, (de)protection and Apparatus 2: 50 rpm functionalization reactions leads to crude fondaparinux so-Time: 45 mindium, which is further purified to yield the drug sub-Standard solution: Solution having a known concentra-stance. Fondaparinux Sodium contains NLT 95.0% and tion of USP Folic Acid RS, corrected for water content,NMT 103.0% of fondaparinux sodium, calculated on the in Mediumanhydrous and solvent-free basis. Fondaparinux Sodium is Sample solution: Filtered portion of the solution under a white to off-white powder.test, suitably diluted with the Medium if necessary IDENTIFICATIONAnalysis•A . 13C NMR S PECTRUMSamples: Standard solution and Sample solutionNMR reference: Dissolve in 1mL of deuterium oxide Proceed as directed in the Assay , making any necessary 20mg of (2,2,3,3-(d4)-3-(trimethylsilyl)propionic acid modifications.sodium salt (TSP), enriched to 98% deuterated or Calculate the percentage of the labeled amount of equivalent, as a chemical shift reference.folic acid (C 19H 19N 7O 6) dissolved:Standard solution: NLT 40mg/mL of USPResult = (r U /r S ) × (C S × D × V /L ) × 100Fondaparinux Sodium Identification RS in deuterium oxider U= peak area of folic acid from the SampleSample solution: NLT 40mg/mL of Fondaparinux So-solutiondium in deuterium oxide r S = peak area of folic acid from the StandardInstrumental conditionssolution(See Nuclear Magnetic Resonance 〈761〉.)C S = concentration of USP Folic Acid RS in theMode: NMR, pulsed (Fourier transform)Standard solution (mg/mL)Frequency: NLT 100MHz (for 13C)D = dilution factor for the Sample solution Temperature: 40°V = volume of Medium , 500mL System suitabilityL = label claim (mg/Tablet)Sample: Standard solutionTolerances: NLT 75% (Q ) of the labeled amount of folic Using a pulsed (Fourier transform) NMR spectrometer acid (C 19H 19N 7O 6) is dissolved.operating at NLT 100MHz for 13C, acquire a free in-•U NIFORMITY OF D OSAGE U NITS 〈905〉: Meet the duction decay (FID) using a 90° pulse and a 5-s delay.requirements Record the 13C NMR spectra of the NMR reference at 40°, and set the trimethylsilyl resonance to 0.0ppm.ADDITIONAL REQUIREMENTSCollect the 13C NMR spectrum with a spectral window •P ACKAGING AND S TORAGE : Preserve in well-closed of at least 235 to −10ppm with spinning at 20 Hz,containers.using line broadening of NLT 1. The number of tran-•USP R EFERENCE S TANDARDS 〈11〉sients should be adjusted until the signal-to-noise ratio USP Folic Acid RSof the signal for the C-1 in the β-D -glucopyra-USP Folic Acid Related Compound A RS nosyluronic acid ring of fondaparinux sodium in the Calcium formyltetrahydrofolate.Standard solution meets the suitability requirements.The Standard solution shall be run at least daily when the Sample solution is being run. The chemical shift forthe C-1 resonance of the β-D-glucopyranosyluronic Standard solution: 5.0mg/mL of USP Fondaparinux acid ring of fondaparinux sodium in the Standard solu-Sodium for Assay RS in water. Prepare in duplicate.tion should be observed at 103.9 ± 0.1ppm. Record Sensitivity check solution: 0.01mg/mL of USPthe 13C NMR spectrum of the Sample solution at 40°Fondaparinux Sodium for Assay RS in water from the using the same conditions.Standard solutionSuitability requirements Sample solution: 5.0mg/mL of fondaparinux sodium Number of transients: The signal-to-noise of the β-D-in water. Prepare in at least duplicate.glucopyranosyluronic acid ring of fondaparinux so-Blank: Waterdium in the Standard solution is at least 20/1 in the Chromatographic systemregion near 103.9ppm.(See Chromatography 〈621〉, System Suitability.)Chemical shift: The trimethylsilyl resonance for the Mode: LCNMR reference should be set to 0.0ppm, which acts Detector: UV 210 nmas an external calibration for all samples.Column: 4-mm × 25-cm; packing L46Chemical shifts for system suitability: The O-methyl Column temperature: 25°and two carbonyl carbons of fondaparinux sodium Flow rate: 1.0mL/minshould be observed at 58.2, 176.7, and 178.0ppm,Injection volume: 100µLall ± 0.3ppm, respectively, in the Standard solution.System suitabilityAnalysis Samples:System suitability solution, Standard solution, Sample:Sample solution Sensitivity check solution, and BlankAcceptance criteria: Resonances for fondaparinux so-Inject the Blank in duplicate, the Sensitivity check solu-dium should be observed at 58.2, 59.5, 60.5, 60.8,tion, and the System suitability solution. Inject the Stan-68.9, 69.2, 69.6, 98.9, 100.4, 101.1, 102.4, 103.9,dard solution at least six times consecutively.176.7, and 178.0ppm. The chemical shifts of these sig-Suitability requirementsnals do not differ by more than ±0.3ppm. Other sig-Specificity and baseline driftnals of variable heights and chemical shifts, attributable The chromatogram of the second Blank injection to fondaparinux sodium, may be seen between shows a baseline drift between 0.00 and 0.02 AU58.0–80.5ppm and 98.7–104.5ppm.over 30 min. If necessary, adjust the DMSO content •B. C HROMATOGRAPHIC I DENTITY of the Mobile phase until an acceptable baseline is Analysis: Proceed as directed in the Assay.achieved.Acceptance criteria: The retention time of the major The chromatogram of the second Blank injection does peak of the Sample solution corresponds to ±5% of that not contain peaks between 3.00 and 30.00 min.of the Standard solution.Signal-to-noise ratio: NLT 10 for the fondaparinux •C. S ODIUM D ETERMINATION peak in the chromatogram of the Sensitivity check Analysis: Proceed as directed in Sodium Determination.solutionAcceptance criteria: It meets the requirements.Chromatogram similarity: The chromatogram of theSystem suitability solution corresponds to that of the ASSAY chromatogram provided with USP Fondaparinux So-•P ROCEDURE dium System Suitability Mixture A RS.5 mM phosphate solution: Dissolve 0.210g of mono-Relative standard deviation: For six consecutive in-basic sodium phosphate dihydrate and 0.650g of diba-jections of the Standard solution, the calculated % sic sodium phosphate dihydrate in water, and dilute RSD of the area of the fondaparinux peak is NMT with water to 1000mL. pH of solution is approximately 2.0%. The retention time of the fondaparinux peak7.3.should be ±5% of the mean value. The calculated %Solution A: 15±10 ppm dimethylsulfoxide (DMSO) in RSD of the response factors for all replicate injections5 mM phosphate solution (1 in 67000, v/v). Filter before of the Standard solution is NMT 2.0%. The calculateduse.% RSD of the pooled response factors for all injec-Solution B: 2.0 M sodium chloride solution with 5 mM tions of the Standard solution is NMT 2.0%. The % phosphate solution RSD of the mean response factors for each duplicate Mobile phase: See Table 1.Standard solution is NMT 2.0%.[N OTE—Make adjustments to Solution A as necessary,Analysisand degas the Mobile phase and the sample before Samples:Standard solution and Sample solutionuse. Dissolved gas in the injected solution may lead to Inject the Standard solution at least six times consecu-baseline interference. Degassing of the Mobile phase is tively and the Sample solution in duplicate. Record the critical to obtain a suitable signal-to-noise ratio and chromatograms and measure the retention times and higher sensitivity. An eluant generator1 installed be-areas for the major peaks (excluding peaks before 3.00 tween the injector and the column may reduce the and after 30.00 min).baseline interference.]For each injection of the Standard solution, calculate aresponse factor (F R):Table 1F R = (C S/r S)Time Solution A Solution B(min)(%)(%)C S= concentration of fondaparinux sodium in the05050Standard solution (mg/mL)r S= peak response of fondaparinux sodium from 55050the Standard solution25595Calculate the mean response factor (F M) for each 30595duplicate injection, and determine the % RSD for the 355050peak areas of fondaparinux sodium (rS) for six 505050consecutive injections of the Standard solution.Using the mean response factor, calculate the System suitability solution: 5.0mg/mL of USP percentage of fondaparinux in the portion of sample Fondaparinux Sodium System Suitability Mixture A RS taken:1One suitable eluant generator is Dionex DEGAS EG40/50 (12×17 cm, thick-ness 2.2cm).Result (% w/w) = (F M× r U×D× 100)/WF M= mean response factor for each duplicateChromatographic systeminjection(See Chromatography 〈621〉, System Suitability .) r U = peak response of fondaparinux sodium in theMode: LCSample solutionDetector: Conductivity (range 200 µS, suppressor cur-D = dilution factor for the sample (mL)rent 300mA)W = weight of fondaparinux sodium taken toColumn: 4.6-mm × 5-cm; packing L23, coupled with a prepare the Sample solution (mg)neutralization micromembrane suppressor 2Acceptance criteria: 95.0%–103.0% on an anhydrous Regenerating solvent for the suppressor: Ultrapuri-and solvent-free basisfied water in a counter current direction Column temperature: Ambient OTHER COMPONENTS Flow rate: 1.0mL/min •S ODIUM D ETERMINATIONInjection volume: 50µL (See Spectrophotometry and Light-Scattering 〈851〉.)Run time: 24 min 2% Nitric acid solution: 21mL nitric acid diluted with System suitabilitywater to 1000mLSamples: Calibration standard solutions and Resolution Sodium solution: 1000ppm sodium in 2% Nitric acid solutionsolutionSuitability requirementsStandard solutions: Prepare Standard solutions contain-Resolution: NLT 2 between the chloride and nitrite ing 20, 30, 40, 50, and 60ppm of sodium ion from the ion peaks, Resolution solutionSodium solution , diluting with 2% Nitric acid solution .Response stability: ±5% between injections of 5ppm Sample solution: 0.3mg/mL of Fondaparinux Sodium of each of the Calibration standard solutions before in 2% Nitric acid solutionand after the Sample solutionAnalysis: Concomitantly determine the absorbances of Relative standard deviation: NMT 3% for NLT 5 in-the Sample solution and Standard solutions at 330.2 nm jections of 5-ppm Calibration standard solutions by using a sodium hollow-cathode lamp and anAnalysisair–acetylene flame. Using the absorbances of the Stan-Sample: Sample solutiondard solutions , determine the sodium content in the [N OTE —Regenerate the anion-exchange column for 15Sample solution after appropriate blank correction.min with 0.1 M sodium hydroxide after each injection Acceptance criteria: 11.5%–15.0% on the anhydrous of fondaparinux sample, followed by equilibration with and solvent-free basis Mobile phase for 21 min.]Inject 50µL of each of the Calibration standard solutions IMPURITIESand 50µL of the Sample solution in triplicate. The peak •F REE S ULFATE AND R ESIDUAL C HLORIDE D ETERMINATIONarea responses for the chloride and sulfate ion peaks in Mobile phase: 3 mM carbonate solution containing the chromatograms obtained with the Calibration stan-0.106g of sodium carbonate and 0.168g of sodium dard solutions show two peaks corresponding respec-hydrogen carbonate in 1000mL of watertively to chloride ions at a retention time of approxi-Standard solution 1: Dissolve 164.9mg of sodium mately 3.6 min and to sulfate ions at a retention time chloride in 80mL of water, and dilute with water to of approximately 14.1 min. The Calibration standard 100.0mL.solutions and the corresponding standard concentra-Standard solution 2: Dissolve 147.9mg of anhydrous tions are used to construct five-point calibration curves sodium sulfate in 80mL of water, and dilute with water for both chloride and sulfate ions. The concentrations to 100.0mL.of sulfate and chloride ions in the Sample solutions are Standard solution 3: Dilute 1.0mL of Standard solution calculated using the standard curves.1 with water to 100.0mL.Calculations: Calculate the free sulfate and residual Standard solution 4: Dilute 1.0mL of Standard solution chloride ion contents in % w/w of fondaparinux so-2 with water to 100.0mL.dium in the solution to be examined:Calibration standard solutions: Using appropriate volumes of the Standard solutions , prepare calibration Result = C S × F × (1/C U ) × 100standards as shown in Table 2.C S= concentration of the ion calculated from thequadratic calibration equation (µg/mL)Table 2F = conversion factor (µg/mL to mg/mL)Volume of Volume of C U = concentration of Fondaparinux Sodium in theSulfate Chloride Sample solution (mg/mL)Concentra-Solution Solution Final VolumeReport the average of the triplicate determinations.tion (mL)(mL)(mL)Acceptance criteria: NMT 0.30% free sulfate; NMT 5.0, Standard 10.0, Standard 0.5 ppm SO 4−21.0% chloride /1 ppm Cl −solution 4solution 3100.0•O RGANIC I MPURITIES0.50, Standard 0.50, Standard Analysis: Proceed as directed in the Assay .2.5 ppm SO 4−2/2.5 ppm Cl −solution 2solution 1200.0Samples: System suitability solution , Standard solution ,Sensitivity check solution , Sample solution , and Blank 0.50, Standard 0.50, Standard 5.0 ppm SO 4−2Calculate the percentage of each individual impurity in /5.0 ppm Cl −solution 2solution 1100.0the portion of Fondaparinux Sodium taken:20.0 ppm 2.0, Standard 2.0, Standard SO 4−2/20 ppmResult (% area/area) = [r U /(r S + r T )] × 100Cl −solution 2solution 1100.050.0 ppm r U= peak response of each impurity from the5.0, Standard 5.0, Standard SO 4−2/50 ppmSample solutionCl −solution 2solution 1100.0r S = peak response of fondaparinux sodium fromthe Sample solutionResolution solution: Dissolve 150mg of sodium nitrite r T= sum of all peak responses for impurities fromin 100.0mL of water. Combine 2.0mL of this solution the Sample solutionand 2.0mL of Standard solution 1 in 80mL of water,and dilute with water to 100.0mL.2One suitable suppressor is Dionex ASRS 300 4mm.Sample solution: 3mg/mL of Fondaparinux Sodium in waterThe total impurities content (% area/area) is the sum of Table 4all mean unrounded contents of an individual impurityHold Time that are NLT 0.200%.Initial at Final Acceptance criteria: See Table 3.Tempera-Temperature Final Tempera-ture Ramp Temperature tureTable 3(°)(°/min)(°) (min)40—4020Relative Acceptance40102400Retention Criteria,Name Time NMT (%)240—2405 Impurity peak A a0.930.8 (a/a)Carrier gas: Helium with a linear velocity ofImpurity peak B a 1.2b0.6 (a/a)20–30cm/sAny unspecified im-Injection type: Split ratio, 1:7—purity0.3Head space autosamplerTotal impurities—NMT 2.0%Sample equilibration temperature: 80°a Impurity peak A contains two structures: Methyl (2-deoxy-2-sodium Sample equilibration time: 60 minsulfoamino-6-O-sodium sulfonato-α-D-glucopyranosyl)-(1→4)-(sodium β-D-Transfer line temperature: 110°glucopyranosyluronate)-(1→4)-(2-deoxy-2-sodium sulfoamino-3,6-di-O-so-System suitabilitydium sulfonato-α-D-glucopyranosyl)-(1→4)-(sodium 2,3-di-O-sodiumsulfonato-α-L-idopyranosyluronate)-2-deoxy-2-sodium sulfoamino-6-O-sodi-Samples:Standard solution 2 (A and B) and Blankum sulfonato-α-D-glucopyranoside; and Methyl (2-deoxy-2-formylamino-6-Assay a water Blank followed by six consecutive samples O-sodium sulfonato-α-D-glucopyranosyl)-(1→4)-(sodium-β-D-glucopyra-of Standard solution 2(A), followed by a single injection nosyluronate)-(1→4)-(2-deoxy-2-sodium sulfoamino-3,6-di-O-sodiumof Standard solution 2(B).sulfonato-α-D-glucopyranosyl)-(1→4)-(sodium 2-O-sodium sulfonato-α-L-idopyranosyluronate)-2-deoxy-2-sodium sulfoamino-6-O-sodium sulfonato-Suitability requirementsα-D-glucopyranoside.Blank: The chromatogram of the water Blank should b Impurity peak B can appear as a complex set of peaks and not fully not present a peak corresponding to ethanol or resolved. In such a case, the integration should be performed such that all pyridine.such peaks are combined.Signal-to-noise ratio: NLT 40 of the pyridine peak in •P YRIDINE AND E THANOL D ETERMINATION the chromatogram of Standard solution 2(A) (See Residual Solvents 〈467〉.)Relative standard deviation: NMT 5% for the aver-Pyridine standard solution: In a 100-mL volumetric age areas of the chromatographic peaks for ethanol flask containing about 20mL of water, transfer 101.8µL and pyridine in six consecutive assaysof pyridine accurately. Dilute with water to 100mL.AnalysisInternal standard solution: 500-µg/mL solution of Samples:Internal standard solution, Standard solution 1-butanol in water2(A), and Sample solutionStandard solution 1: In a 100-mL volumetric flask con-Calculations: Calculate the ethanol and pyridine con-taining about 20mL of water, transfer accurately tent in ppm (µg/g) in the portion of Fondaparinux So-1.27mL of ethanol and 1.0mL of Pyridine standard so-dium taken:lution. Dilute with water to 100.0mL.Standard solution 2:Standard solution 1 and water Result = C S× (R U/R S) × (V/M) ×D(1:100). Prepare in duplicate (A and B).C S= concentration of Standard solution 2 (µg/mL)Sample stock solution: 10mg/mL of Fondaparinux So-R U= peak response ratio of solvent “s” in the dium in water in triplicateSample solution to solvent “s” in the Internal Sample solution: 2mg/mL of Fondaparinux Sodium instandard solutionwater from the Sample stock solutionR S= peak response ratio of solvent “s” in Standard Blank: Watersolution 2 to solvent “s” in the Internal Sample preparation: For the Blank, transfer 5.0mL ofstandard solutionwater and 5g of potassium carbonate to an appropriateV= volume of solution used to prepare the Sample headspace vial, apply stopper, cap, and mix. For sam-solution (mL)ples and standards, add 5.0mL of the Sample solutionM= mass of sample dissolved to prepare the or Standard solution 2 with 5g of potassium carbonateSample solution (g)and 0.1mL of the Internal standard solution to an ap-D= dilution factor of the Sample solution propriate headspace vial, apply stopper, cap, and mix.The average of three independent assays constitutes Chromatographic systemthe results.(See Chromatography 〈621〉, System Suitability.)Acceptance criteria: NMT 5×104 ppm for ethanol and Mode: GC with headspace sampler50ppm for pyridineDetector: Flame ionizationColumn: 0.32-mm × 30-m fused silica, 1.8-µm filmSPECIFIC TESTSthickness; support G43•B ACTERIAL E NDOTOXINS T EST〈85〉: It contains NMT 25 TemperaturesUSP Endotoxin Units/mg.[N OTE—At initial temperature NLT 3 min between•P H 〈791〉: 6.0–8.0, in a solution, at 20°–25° (2.5% w/v) injections.]•M ICROBIAL E NUMERATION T ESTS〈61〉: NMT 350 cfu/g Injector: 140°•W ATER D ETERMINATION, Method Ic〈921〉: It contains NMT Detector: 250°20.0% (w/w).Column: See Table 4.ADDITIONAL REQUIREMENTS•P ACKAGING AND S TORAGE: Preserve in tight containers,and store at or below 25° in a dry environment.•L ABELING: Label to indicate mass of active drug substanceper container.•USP R EFERENCE S TANDARDS〈11〉Blank: WaterUSP Endotoxin RS Chromatographic systemUSP Fondaparinux Sodium for Assay RS(See Chromatography 〈621〉, System Suitability.)USP Fondaparinux Sodium Identification RS Mode: LCUSP Fondaparinux Sodium System Suitability Mixture A Detector: UV 210 nmRS v USP38Column: 4-mm × 25-cm; packing L46Column temperature: 25°Flow rate: 1.0mL/minInjection volume: 100µLSystem suitabilitySamples:System suitability solution, Standard solution, Add the following:Sensitivity check solution, and BlankInject the Blank in duplicate, the Sensitivity check solu-tion, and the System suitability solution. Inject thev Fondaparinux Sodium Injection Standard solution at least six times consecutively.Suitability requirementsDEFINITION Specificity and baseline drift: The chromatogram of Fondaparinux Sodium Injection is a sterile solution of a second Blank injection shows a baseline drift be-Fondaparinux Sodium in Water for Injection with sodium tween 0.00 and 0.02 AU over 30 min. If necessary, chloride added for isotonicity. It is a clear, colorless to adjust the DMSO content of the Mobile phase until an slightly yellow solution.acceptable baseline is achieved. The chromatogramof a second Blank injection does not contain peaks IDENTIFICATION between 3.00 and 30.00 min.•A. The retention time of the major peak of the Sample Chromatogram similarity: The chromatogram of the solution corresponds to that of the Standard solution, as System suitability solution corresponds to that of the obtained in the Assay.reference chromatogram provided with USP•B. I DENTIFICATION T ESTS—G ENERAL, Chloride 〈191〉: Pro-Fondaparinux Sodium System Suitability Mixture B ceed as directed in the chapter. Meets the requirements RS.of the Chloride and Sulfate 〈221〉 test.Signal-to-noise ratio: NLT 10 for the fondaparinuxpeak in the chromatogram of the Sensitivity check ASSAY solution•P ROCEDURE Resolution: NLT 1.2 between fondaparinux related5 mM phosphate solution: 0.210g of monobasic so-compound C and fondaparinux related compound D,dium phosphate dihydrate and 0.650g of dibasic so-System suitability solution; NLT 1.1 betweendium phosphate dihydrate. Dissolve in and dilute with fondaparinux related compound F and fondaparinux water to 1000mL. pH is approximately 7.3.related compound G (see Table 2), System suitability Solution A: 15±10 ppm of dimethylsulfoxide (DMSO)solutionin 5 mM phosphate solution (1 in 67000, v/v)Standard agreement: The difference in the mean re-Solution B: 2.0 M sodium chloride solution in 5 mM sponse factors for each Standard solution is NMT phosphate solution 2.0%.Mobile phase: See Table 1. [N OTE—Make adjustments Relative standard deviation: For six consecutive in-to Solution A as necessary, and degas the Mobile phase jections of the Standard solution the calculated % RSD before use. Dissolved gas in the injected solution may of the area of the fondaparinux peak is NMT 2.0%.lead to baseline interference. Degassing of the Mobile The retention time of the fondaparinux peak should phase is critical to obtain a suitable signal-to-noise ratio be ±5% of the mean value. The calculated % RSD of and higher sensitivity. An eluant generator1 installed be-the response factors for six consecutive injections of tween the injector and the column may reduce the the Standard solution is NMT 2.0%. The calculated % baseline interference.]RSD of the pooled response factors for all injectionsof the Standard solution is NMT 2.0%. The % RSD of Table 1the mean response factors for the duplicate prepara-tions of the duplicate Standard solutions is NMT Time Solution A Solution B2.0%.(min)(%)(%)Analysis05050Samples:Standard solution and Sample solution55050Inject the Standard solution at least six times consecu-25595tively. Inject duplicate preparations of the Sample solu-tion. Record the chromatograms, and measure the re-30595tention times and areas for the major peaks (excluding 355050peaks before 3.00 and after 30.00 min).505050Calculations: For each injection of the Standard solu-tion calculate a response factor (F R): System suitability solution: 5.0mg/mL of USPFondaparinux Sodium System Suitability Mixture B RSF R = (C S/r S)Standard solution: 5.0mg/mL of USP FondaparinuxSodium for Assay RS in water. Prepare in duplicate.C S= concentration of fondaparinux sodium in theSensitivity check solution: 0.01mg/mL of USPStandard solution (mg/mL) Fondaparinux Sodium for Assay RS in water from ther S= peak response of fondaparinux sodium from Standard solutionthe Standard solution Sample solution: Transfer the contents of prefilled sy-Relative retention times (RRT) are calculated by ringes to a suitable container, and mix well. Dilute withdividing the retention time of the peak by the water, if needed, to obtain a 5.0-mg/mL solution ofretention time of fondaparinux established by the fondaparinux sodium.Standard solution. Using the mean response factor1One suitable eluant generator is Dionex DEGAS EG40/50 (12×17 cm, thick-(F M), calculate the concentration (mg/mL) ofness 2.2cm).。
编码产品名称硫氢化钠
五、消防措施 适当的灭火剂：可用雾状水、干粉、泡沫等灭火。 化学品产生的具体危险：在高温高热下燃烧分解，释放出有毒气体。 消防人员的特殊防护行动：消防人员必须配戴空气呼吸器、消防衣及防护手套，根据着火原 因选择适当灭火剂，在安全距离以外的上风向灭火。
六、意外释放措施 人身防范、保护设备和应急程序：建议应急处理人员戴正压式呼吸器，穿防毒工作服。不 要直接接触泄漏物。 环境防范措施：隔离泄漏污染区，限制出入。 抑制和清洁的方法和材料：小量泄漏：避免扬尘，用洁净的铲子收集于干燥、洁净、有盖的 容器中，转移至安全场所。切勿使产品进入下水道等限制性区域。大量泄漏：用塑料布、帆 布覆盖。使用无火花工具收集回收或运至废物处理场所处置。
十四、运输信息 联合国编号：2949。 联合国正式运输名称：氢硫化钠，含结晶水不低于 25%。 运输危险分类：8。 包装类别（如果适用）：II。 环境危险：/ 用户的特殊防范措施：/
十五、管理信息 国内化学品安全管理法规：本化学品安全数据单遵照了以下相关国家标准：GB 16483-2008、 GB 13690-2009、GB 6944-2012、GB/T 15098-2008、GB 18218-2009、GB 15258-2009、GB 190-2009、GB 191-2009、GB 12268-2008、GA 57-1993、GBZ 2-2007 以及相关法规：《铁路 危险货物运输管理规则》、《危险化学品安全管理条例》。
九物理及化学性质外观物理状态颜色等气味气味阈值ph熔点凝固点初始沸点和沸腾范围闪点蒸发速率易燃性固体气体上下易燃极限或爆炸极限蒸气压力蒸气密度相对密度可溶性分配系数
编 码： 产品名称：硫氢化钠
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可能腐蚀金属。吞咽会中毒。皮肤接触致命。造成严重皮肤灼伤和眼损伤。对水生生物有毒。
428.3液体制剂的常用附加剂
⑥ 其他防腐剂
1. 20%的乙醇 2. 30%以上甘油的均有防腐作用。 3. 0.05%薄菏油 4. 0.01%的桂皮醛 5. 0.01%~0.05%的桉叶油（eucalyptus oil）等也有一定防
腐作用。
（五）矫味剂
内服液体制剂应味道可口，外观良好，使患者 尤其是儿童乐于服用。 1. 甜味剂 2. 芳香剂 3. 胶浆剂 4. 泡腾剂
（1） 形成可溶性分子络合物
例如 碘在水中的溶解度为1︰2950，而在10%碘化钾溶液中可制成含碘
5%的水溶液，碘化钾为助溶剂。 药典上收载的复方碘溶液就是利用碘化钾与碘形成分子络合物而增
加碘在水中的溶解度。
I2 + KI → KI3 = K+ + I3-
（2） 形成复盐
例如 茶碱在水中溶解度为1∶120 用乙二胺为助溶剂形成氨茶碱，其溶解度为1∶5。
其防腐作用是靠未解离的分子，而其离子无作用。因此，溶液 的pH值影响苯甲酸的防腐力。苯甲酸pKa=4.2，故溶液的pH值 在4以下抑菌效果好，溶液pH值超过5时解离度增大，防腐能力 降低，用量应增加至不少于0.5%。
苯甲酸钠在水中溶解度为55%，在乙醇中微溶（1：80），常用 量为0.1%~0.25%。
环境、操作室、用具设备、人员、操作过程等 （2）严格控制原辅料质量 （3）添加防腐剂：羟苯酯类（尼泊金），苯甲酸，山梨酸，苯扎
溴铵（新洁尔灭），邻苯基苯酚（0.2%以下，水果蔬菜保鲜）
① 对羟基苯甲酸酯类
羟基苯甲酸酯类(parabens) 又称尼泊金类。对羟基苯甲酸酯类有 甲酯、乙酯、丙酯和丁酯，是一类优良的防腐剂，无毒、无味、 无嗅、不挥发、化学性质稳定。
使用最多的是酯类。 香精又称调合香料，其组成包括： 天然香料、人工合成香料及一定量的溶剂，如苹果香精、桔
月桂基二甲基铵羟丙基水解角蛋白 -回复
月桂基二甲基铵羟丙基水解角蛋白-回复[月桂基二甲基铵羟丙基水解角蛋白]，也称为Lauryl Dimethylamino Hydroxypropyl Hydrolyzed Collagen，是一种用于个人护理产品的活性成分。
它广泛应用于洗发水、护发素、洗面奶、沐浴露等产品中，具有清洁、保湿和修护肌肤和头发的功效。
月桂基二甲基铵羟丙基水解角蛋白主要由几个部分组成。
首先是月桂基二甲基铵，它是一种表面活性剂，能够起到清洁和去污的作用。
它具有良好的起泡性能，能够有效地去除头发和皮肤上的污垢和油脂。
其次是羟丙基水解角蛋白，它是一种来源于动物骨骼和皮肤的蛋白质。
经过水解处理后，蛋白质分子变得较小，更容易被吸收和利用。
羟丙基水解角蛋白具有良好的保湿和修护作用，能够滋养和改善肌肤和头发的质地。
洗发水是使用月桂基二甲基铵羟丙基水解角蛋白的一个常见例子。
当我们使用洗发水时，月桂基二甲基铵羟丙基水解角蛋白可以迅速起泡，并将其中的清洁和去污成分输送到头皮和头发上。
月桂基二甲基铵羟丙基水解角蛋白能够去除头皮屑和多余的油脂，使头发清爽洁净。
同时，羟丙基水解角蛋白的保湿作用能够滋润头发，防止其变干和易断裂。
此外，月桂基二甲基铵羟丙基水解角蛋白中的修护成分能够修复受损的头发纤维，使头发更加健康和有光泽。
护面产品中使用月桂基二甲基铵羟丙基水解角蛋白也能带来一系列好处。
洗面奶中的月桂基二甲基铵羟丙基水解角蛋白能够温和清洁面部皮肤，并保持其天然的水油平衡。
此外，羟丙基水解角蛋白的保湿作用能够滋润皮肤，减少水分流失，使肌肤更加柔软和有弹性。
月桂基二甲基铵羟丙基水解角蛋白中的修护成分还能修复肌肤受损的组织，减少细纹和皱纹的出现。
因此，使用含有月桂基二甲基铵羟丙基水解角蛋白的洗面奶可以让肌肤更健康和年轻。
沐浴露中的月桂基二甲基铵羟丙基水解角蛋白也能为身体肌肤带来好处。
月桂基二甲基铵羟丙基水解角蛋白可以迅速起泡，并将其中的清洁成分输送到全身皮肤上。
迷迭香酸对过氧化氢处理下的皮肤黑色素瘤的抗氧化作用(原文翻译)
迷迭香酸（罗丹酚酸）对H2O2处理过的皮肤黑色素瘤细胞的抗氧化作用Sun Mi Yoo1 and Jeong Ran Kang2*1.韩国光州500-741号东冈大学美容系2.韩国首尔143-701号建国大学生物工程系2009.2.6收到 2009.4.17接收本学科旨在检测迷迭香酸对人工孵育的皮肤黑色素瘤细胞在ROS下的抗氧化作用。
通过XTT比色法，以细胞毒性和抗氧化作用来分析细胞粘附活性，DPPH自由基清除活性以及H2O2处理1-10h和未经处理的两种情况下乳酸脱氢酶的活性。
用20-110 μM 的H2O2处理皮肤黑色素瘤细胞5-7h后，细胞活性的降低呈剂量和时间依赖性。
通过XTT比色法测得H2O2的半抑制浓度（IC50 ）为90μM。
同时H2O2增强了LDH细胞的剂量依赖性。
用50-90μM的H2O2处理8h后测得LDH50为60 μM H2O2。
迷迭香酸能增强细胞活性和DPPH自由基清除活性，降低乳酸盐脱氢酶的活性。
细胞的H2O2处理证实了对人工孵育的皮肤黑色素瘤细胞的强抗氧化作用。
通过H2O2的处理，迷迭香酸能在细胞内能增强细胞活性和DPPH 自由基清除活性，降低乳酸盐脱氢酶的活性。
这被认为是迷迭香酸对ROS（ROS）如H2O2的抗氧化作用。
Key words：DPPH-radical scavenging, LDH, rosmarinic acid, XTT assay关键字：DPPH自由基清除活性，乳酸脱氢酶，迷迭香酸，XTT比色法据研究发现，ROS通过氧化应激对细胞的损伤和一些脑部疾病比如帕金森症或心脏疾病例如心肌梗塞之间有很大的关联[Difazio et al., 1992; Delanty and Dichter, 1998].尤其是研究人员认为ROS是皮肤老化的一个主要的因素后，一直试图从ROS方面研究衰老。
[Yokozawa et al., 1998].据研究表明，ROS的氧化应激会通过萎缩细胞引起各种疾病，例如超氧自由基、H2O2（H2O2）或羟基自由基的巯基蛋白反应中断酶的活性，破坏脱氧RMA（DNA）或RMA（RNA），诱导细胞膜脂质过氧化。
优色林尿素洗发水成分表
优色林尿素洗发水成分表介绍优色林尿素洗发水是一款备受欢迎的洗发产品。
它采用了尿素成分，具有深层清洁、滋养头发和头皮的效果。
本文将详细介绍优色林尿素洗发水的成分表及其功效。
成分表以下是优色林尿素洗发水的主要成分表：1.水：作为溶剂，使其他成分能够充分溶解并发挥作用。
ureth-5 Carboxylic Acid：起到温和清洁的作用，避免对头皮造成刺激。
3.Cocamidopropyl Betaine：能够在洗发过程中产生丰富的泡沫，有效去除头皮和头发上的油脂和污垢。
4.Glycerin：具有保湿能力，能够为头皮和头发提供足够的水分。
5.Urea：尿素是优色林尿素洗发水的关键成分，能够深层清洁头皮和头发，去除多余的油脂、角质和污垢。
6.Sodium Chloride：增加洗发水的粘度，使其更容易使用和涂抹。
7.Fragrance：添加了香味，为用户带来清新愉悦的洗发体验。
成分功效解析Laureth-5 Carboxylic AcidLaureth-5 Carboxylic Acid是一种温和的清洁剂，能够有效去除头皮和头发上的污垢，同时又不会对头皮造成刺激和干燥。
Cocamidopropyl BetaineCocamidopropyl Betaine是一种有效的洗净剂，能够产生丰富的泡沫，帮助去除多余的油脂和污垢。
它还具有保湿的作用，可以使头发更加柔软和滋润。
GlycerinGlycerin是一种天然的保湿剂，能够为头皮和头发提供足够的水分。
它有助于减少头皮的干燥和瘙痒，使头发更加柔软、顺滑。
UreaUrea是优色林尿素洗发水的关键成分，它具有深层清洁头皮和头发的功能。
Urea能够渗透到头皮深层，去除多余的油脂、角质和污垢，并提供保湿效果。
它还能平衡头皮的pH值，减少头皮屑和瘙痒的问题。
使用方法为了达到最佳效果，您可以按照以下步骤正确使用优色林尿素洗发水：1.将头发彻底湿润。
2.取适量洗发水倒在手掌中。
盐酸依匹斯汀滴眼液(来源于FDA)英文
Page 3ELESTAT™(epinastine HCl ophthalmic solution) 0.05%SterileDESCRIPTIONELESTAT™(epinastine HCl ophthalmic solution) 0.05% is a clear, colorless, sterile isotonicsolution containing epinastine HCl, an antihistamine and an inhibitor of histamine release fromthe mast cell for topical administration to the eyes.Epinastine HCl is represented by the following structural formula:C16H15N3 •HCl Mol. Wt. 285.78Chemical Name: 3-Amino-9, 13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochlorideEach mL contains: Active: Epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine0.044% (0.44mg/mL); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetatedisodium; purified water; sodium chloride; sodium phosphate, monobasic; and sodiumhydroxide and/or hydrochloric acid (to adjust the pH). ELESTAT™has a pH of approximately7 and an osmolality range of 250 to 310 mOsm/kg.CLINICAL PHARMACOLOGYEpinastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release ofhistamine from the mast cell. Epinastine is selective for the histamineH1-receptor and hasaffinity for the histamine H2 receptor. Epinastine also possesses affinity for the α1-, α2-, and 5-HT2 –receptors. Epinastine does not penetrate the blood/brain barrier and, therefore, is notexpected to induce side effects of the central nervous system.Fourteen subjects, with allergic conjunctivitis, received one drop of ELESTAT ™in each eyetwice daily for seven days. On day seven average maximum epinastine plasma concentrations of0.04 ±0.014 ng/ml were reached after about two hours indicating low systemic exposure. Whilethese concentrations represented an increase over those seen following a single dose, the day 1NDA 21-565Page 4and day 7 Area Under the Curve (AUC) values were unchanged indicating that there is noincrease in systemic absorption with multiple dosing. Epinastine is 64% bound to plasmaproteins. The total systemic clearance is approximately 56 L/hr and the terminal plasmaelimination half-life is about 12 hours. Epinastine is mainly excreted unchanged. About 55% ofan intravenous dose is recovered unchanged in the urine with about 30% in feces. Less than10% is metabolized. The renal elimination is mainly via active tubular secretion.Clinical studies: Epinastine HCl 0.05% has been shown to be significantly superior to vehiclefor improving ocular itching in patients with allergic conjunctivitis in clinical studies using twodifferent models: (1) conjunctival antigen challenge (CAC) where patients were dosed and thenreceived antigen instilled into the inferior conjunctival fornix; and (2) environmental fieldstudies where patients were dosed and evaluated during allergy season in their natural habitat.Results demonstrated a rapid onset of action for epinastine HCl 0.05% within 3 to 5 minutesafter conjunctival antigen challenge. Duration of effect was shown to be 8 hours, making a twicedaily regimen suitable. This dosing regimen was shown to be safe and effective for up to 8weeks, without evidence of tachyphylaxis.INDICATIONS AND USAGEELESTAT™ophthalmic solution is indicated for the prevention of itching associatedwith allergic conjunctivitis.CONTRAINDICATIONSELESTAT™ophthalmic solution is contraindicated in those patients who have shownhypersensitivity to epinastine or to any of the other ingredients.WARNINGSELESTAT™is for topical ophthalmic use only and not for injection or oral use. PRECAUTIONSInformation for Patients: Patients should be advised not to wear a contact lens if their eye isred. ELESTAT™should not be used to treat contact lens related irritation. The preservative inELESTAT™, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lensesshould be removed prior to instillation of ELESTAT™and may be reinserted after 10 minutesfollowing its administration.Patients should be instructed to avoid allowing the tip of the dispensing container to contactthe eye, surrounding structures, fingers, or any other surface in order to avoid contaminationof the solution by common bacteria known to cause ocular infections. Serious damage to theeye and subsequent loss of vision may result from using contaminated solutions.Bottle should be kept tightly closed when not in use.NDA 21-565Page 5Carcinogenesis, Mutagenesis, Impairment of Fertility:In 18-month or 2-year dietary carcinogenicity studies in mice or rats, respectively,epinastine was not carcinogenic at doses up to 40 mg/kg [approximately30,000times higher than the maximum recommended ocular human dose of 0.0014 mg/kg/day (MROHD) on a mg/kg basis, assuming 100% absorption in humans andanimals].Epinastine in newly synthesized batches was negative for mutagenicity in the Ames/Salmonella assay and in vitro chromosome aberration assay using humanlymphocytes. Positive results were seen with early batches of epinastine in two in vitrochromosomal aberration studies conducted in 1980s with human peripheral lymphocytesand with V79 cells, respectively. Epinastine was negative in the in vivo clastogenicitystudies, including the mouse micronucleus assay and chromosome aberration assay inChinese hamsters. Epinastine was also negative in the cell transformation assay usingSyrian hamster embryo cells, V79/HGPRT mammalian cell point mutation assay, and invivo/in vitro unscheduled DNA synthesis assay using rat primary hepatocytes. Epinastine had no effect on fertility of male rats. Decreased fertility in female rats wasobserved at an oral dose up to approximately 90,000 times the MROHD. Pregnancy: Teratogenic Effects: Pregnancy Category CIn an embryofetal developmental study in pregnant rats, maternal toxicity with noembryofetal effects was observed at an oral dose that was approximately150,000 timesthe MROHD. Total resorptions and abortion were observed in an embryofetal study inpregnant rabbits at an oral dose that was approximately 55,000 times the MROHD. Inboth studies, no drug-induced teratogenic effects were noted.Epinastine reduced pup body weight gain following an oral dose to pregnant rats that wasapproximately 90,000 times the MROHD.There are, however, no adequate and well-controlled studies in pregnant women.Because animal reproduction studies are not always predictive of human response,ELESTAT™ophthalmic solution should be used during pregnancy only if the potentialbenefit justifies the potential risk to the fetus.Nursing Mothers: A study in lactating rats revealed excretion of epinastine in the breastmilk. It is not known whether this drug is excreted in human milk. Because many drugsare excreted in human milk, caution should be exercised when ELESTAT™ophthalmicsolution is administered to a nursing woman.Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 yearshave not been established.NDA 21-565Page 6Geriatric Use: No overall differences in safety or effectiveness have been observedbetween elderly and younger patients.ADVERSE REACTIONSThe most frequently reported ocular adverse events occurring in approximately 1 –10% ofpatients were burning sensation in the eye, folliculosis, hyperemia, and pruritus.The most frequently reported non-ocular adverse events were infection (cold symptoms andupper respiratory infections) seen in approximately 10% of patients, and headache, rhinitis,sinusitis, increased cough, and pharyngitis seen in approximately 1 - 3% of patients.Some of these events were similar to the underlying disease being studied. DOSAGE AND ADMINISTRATIONThe recommended dosage is one drop in each eye twice a day.Treatment should be continued throughout the period of exposure (i.e., until the pollenseason is over or until exposure to the offending allergen is terminated), even whensymptoms are absent.HOW SUPPLIEDELESTAT™(epinastine HCl ophthalmic solution) 0.05% is supplied sterile in opaque whiteLDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps asfollows:5 mL in 8 mL bottle NDC XXXX-XXXX-XX10 mL in 15 mL bottle NDC XXXX-XXXX-XXStorage: Store at 15-25ºC (59-77ºF). Keep bottle tightly closed and out of the reach ofchildren.Rx OnlyOctober 2003© 2002 Allergan, Inc.Irvine, CA 92612, U.S.A. 9343X®™Marks owned by Allergan, Inc. Part No., Copy Code。
氢溴酸达非那新
适应证
氢溴酸达非那新用于膀胱过度刺激引起的尿频、尿急、尿失禁。
禁忌证
1.对氢溴酸达非那新及其中成分过敏者禁用。 2.尿潴留、胃潴留及未控制的闭角型青光眼患者禁用。 3.重度肝功能损害患者不推荐使用。
注意事项
1.由于尿潴留的可能，有明显膀胱尿道阻塞症状的患者使用时应谨慎。 2.氢溴酸达非那新具有抗胆碱作用，能降低胃肠道动力，胃肠道阻塞性疾病患者有胃潴留的可能，使用时应 谨慎。严重便秘、溃疡性结肠炎和重症肌无力患者慎用。 3.已控制的闭角型青光眼患者慎用。 4.氢溴酸达非那新生殖毒性分级为C，只有当对母体的益处高于对胎儿的危险时方可用于孕妇。 5.氢溴酸达非那新可经大鼠乳汁分泌，尚不知氢溴酸达非那新是否经人乳汁分泌，哺乳期妇女应慎用。
用法用量
口服，推荐剂量为7.5mg，1次/d，整片服下，不得嚼碎、掰开或压碎，可单服或与食物同服。根据个人临床 反应，剂量可增至15mg。中度肝功能损伤患者及与CYP3A4抑制剂（如酮康唑、伊曲康唑、利托那韦、奈非那韦、 克拉霉素、奈法唑酮）同服时，剂量不得超过7.5mg。
药物相互作用
1.氢溴酸达非那新主要经CYP2D6和CYP3A4代谢，CYP3A4抑制剂（酮康唑、伊曲康唑、利托那韦、奈非那韦、 克拉霉素、奈法唑酮）可使氢溴酸达非那新代谢减少，日剂量不应超过7.5mg。
尿失禁治疗药物是一个潜力巨大但尚未完全开发的市场，临床特征均是在24h内需要小便数不少于十次。据 世界卫生组织(WHO)有关人员估计，全球约有10%～15%中年人(50岁以下)和40%～70%老年人不同程度地受到此病 困扰。膀胱过动症一般没有神经源性损伤或疾病，可由膀胱的快速充盈、体位改变、甚至行走、咳嗽诱发。估计 全世界约有4～5亿名尿失禁患者，女性的发生率为男性的2倍。男性的发生率随着年龄的增长而升高，是一种常 见和令人痛苦的疾病。（另有一组数据估计世界7个主要国家受影响的人群达1.54亿，其中0.73亿人被分类为明 显尿失禁症。）。
Fasudil_Hydrochloride_DataSheet_MedChemExpress
Inhibitors, Agonists, Screening Libraries Data SheetBIOLOGICAL ACTIVITY:Fasudil (Hydrochloride) is a potent inhibitor of ROCK–II , PKA , PKG , PKC , and MLCK with K I of 0.33 μM, 1.6 μM, 1.6 μM, 3.3 μM and 36μM, respectively.IC50 & Target: Ki: 0.33 μM (ROCK–II), 1.6 μM (PKA), 1.6 μM (PKG), 3.3 μM (PKC), 36 μM (MLCK)In Vitro: Fasudil (Hydrochloride) has vasodilatory action and occupies the adenine pocket of the ATP–binding site of the enzyme [1].Fasudil is a class of calcium antagonists. Fasudil produces a competitive inhibition of the Ca 2+–induced contraction of thedepolarized rabbit aorta. Fasudil is able to inhibit contractile responses to KCl, phenylephnne (PHE) and prostaglandin (PG) F2a [2].Fasudil also exhibits vasodilator actions by inhibition of 5–hydroxytryptamine, noradrenaline, histamine, angiotensin, and dopamine induced spiral strips contraction [3]. Fasudil induces disorganization of actin stress fiber and cell migration inhibition [4]. Fasudil inhibits hepatic stellate cells spreading, the formation of stress fibers, and expression of α–SMA with concomitant suppression of cell growth, but does not induce apoptosis. Fasudil suppresses the LPA–induced phosphorylation of ERK1/2, JNK and p38 MAPK [5]. In Vivo: Fasudil (30 μg) produces an approximate 50% increase in CBF via intra–coronary injection to dogs. Fasudil (0.01, 0.03, 0.1and 0.3 mg/kg, bolus, i.v.) dose–dependently decreases MBP and increases HR, VBF, CBF, RBF, and FBF. A total dose of 1.0 ng/mL Fasudil increases cardiac output. The infusion of Fasudil i.v. produces a significant fall in MBP, left ventricular systolic pressure and total peripheral resistance with an increase in HR and cardiac output, but without significant changes in right atrial pressure, dP/dt or left ventricular minute work in dogs [3]. Fasudil administration displays protectable effects on cardiovascular disease and reduces the activation of JNK and attenuates mitochondrial–nuclear translocation of AIF under ischemic injury [6]. The oral administration of Fasudil (a dosage of 100 mg/kg/day) significantly reduces incidence and mean maximum clinical score of EAE in SJL/J miceimmunized with PLP p139–151. Treatment of mice with Fasudil suppresses the proliferative response of splenocytes to the antigen.Oral administration of Fasudil decreases inflammation, demyelination, axonal loss and APP positivein spinal cord of Fasudil–treated mice [7].PROTOCOL (Extracted from published papers and Only for reference)Kinase Assay:[1]Cyclic AMP–dependent protein kinase activity is assayed in a reaction mixture containing, in a final volume of 0.2mL, 50 mM Tris–HCl (pH 7.0), 10 mM magnesium acetate, 2 mM EGTA, 1 μM cyclic AMP or absence of cyclic AMP, 3.3 to 20 μM [r–32P] ATP (4×105 c.p.m.), 0.5 μg of the enzyme, 100 μg of histone H2B and compound. The mixture is incubated at 30°C for 5 min. The reaction is terminated by adding 1mL of ice–cold 20% trichloroacetic acid after adding 500 μg of bovine serum albumin as a carrierprotein. The sample is centrifuged at 3000 r.p.m. for 15min, the pellet is resuspended in ice–cold 10% trichloro–acetic acid solution and the centrifugation–resuspension cycle is repeated three times. The final pellet is dissolved in 1 mL of 1 N NaOH and radioactivity is measured with a liquid scintillation counter.Product Name:Fasudil (Hydrochloride)Cat. No.:HY-10341CAS No.:105628-07-7Molecular Formula:C 14H 18ClN 3O 2S Molecular Weight:327.83Target:ROCK; ROCK; ROCK; PKC; PKC; Autophagy Pathway:TGF–beta/Smad; Stem Cell/Wnt; Cell Cycle/DNA Damage;TGF–beta/Smad; Epigenetics; Autophagy Solubility:DMSO: ≥ 31 mg/mLReferences:[1]. Ono–Saito N, et al. H–series protein kinase inhibitors and potential clinical applications. Pharmacol Ther. 1999 May–Jun;82(2–3):123–31.[2]. Asano T, et al. Mechanism of action of a novel antivasospasm drug, HA1077. J Pharmacol Exp Ther. 1987 Jun;241(3):1033–40.[3]. Asano T, et al. Vasodilator actions of HA1077 in vitro and in vivo putatively mediated by the inhibition of protein kinase. Br J Pharmacol. 1989 Dec;98(4):1091–100.[4]. Negoro N, et al. The kinase inhibitor fasudil (HA–1077) reduces intimal hyperplasia through inhibiting migration and enhancing cell loss of vascular smooth muscle cells. Biochem Biophys Res Commun. 1999 Aug 19;262(1):211–5.[5]. Fukushima M, et al. Fasudil hydrochloride hydrate, a Rho–kinase (ROCK) inhibitor, suppresses collagen production and enhances collagenase activity in hepatic stellate cells. Liver Int. 2005 Aug;25(4):829–38.[6]. Zhang J, et al. Inhibition of the activity of Rho–kinase reduces cardiomyocyte apoptosis in heart ischemia/reperfusion via suppressing JNK–mediated AIF translocation. Clin Chim Acta. 2009 Mar;401(1–2):76–80.[7]. Sun X, et al. The selective Rho–kinase inhibitor Fasudil is protective and therapeutic in experimental autoimmune encephalomyelitis. J Neuroimmunol. 2006 Nov;180(1–2):126–34.Caution: Product has not been fully validated for medical applications. For research use only.Tel: 609-228-6898 Fax: 609-228-5909 E-mail: tech@Address: 1 Deer Park Dr, Suite Q, Monmouth Junction, NJ 08852, USA。
法舒地尔杂质谱
37
8-异喹啉磺酸乙酯
现货
38
4392-52-3
现货
39
1,3-二溴丙烷
现货
40
8-异喹啉二聚体
现货
41
5-异喹啉磺酸氮氧化物
现货
42
1，3-丙二胺
现货
43
现货
44
现货
45
现货
46
现货
47
现货
48
现货
49
现货
50
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51
52
湖南增达生物科技有限公司是国内研究法舒地尔药物杂质最全，杂质谱最多的企业，具有大量库存。同时具有1000多个现货药物杂质库存。
分子式：C4H17N3O2·HCl
分子量：327.83
结构式：
编号
名称
结构分子式、量
货期
FSDR-1
FasudilDimer
CAS:1337967-93-7
C25H22N4O4S2 482.58
现货
FSDR-2
Fasudil Impurity 1
C15H19ClN2O2S 326.84
现货
FSDR-3
CAS:1350827-92-7
C37H39N7O7S3 789.94
现货
FSDR-6
Fasudil Pyridine N-Oxide TFA Salt
CAS:186544-56-9(Free Amine
C37H39N7O7S3 789.94
现货
FSDR-7
现货
FSDR-9
1,4-bis(phenylsulfonyl)-1,4-diazepane
现货
22
7-位异喹啉磺酸
米诺迪尔
【商品名】：达霏欣 英文名：Minoxidil Solution
【汉语拼音】：Minuodi￠ er Rongye
【本品主要成分是】6-(1-哌啶基)-2,-4-嘧啶二胺,3-氧化物。
【其结构式为】：
分子式C9H15N5O
分子量 209.25
【性状】本品为无色或淡黄色的澄明液体
【不良反应】：本品临床上常见的不良反应是头皮的轻度皮炎。
偶有报道使用本品后可有下列不良反应，但其与使用的因果关系尚不明确。这些不良反应包括刺激性皮炎(红肿、皮屑和灼痛)，非特异性过敏反应，风团、过敏性鼻炎、面部肿胀、过敏、气短、头痛、神经炎、头晕、晕厥、眩晕、水肿、胸痛、血压变化、心悸和脉搏频率变化。
【适应症】：本品用于治疗男性型秃发及斑秃。
【用法用量】： 局部外用，每次1ml（含米诺地尔20mg），涂于头部患处，从患处的中心开始涂抹，并用手按摩3-5分钟。不管患处的大小如何，均使用该剂量。每天的总用量不得超过2ml。使用本品后，应清洗双手。
本品必须在医务人员的指导下使用，不能将本品涂于身体的其他区域；本品应在头发和头皮完全干燥时使用。
【关于长期用药】：有些人对米诺地尔有误解，认为米诺地尔在使用一段时间后就无效了，其实米诺地尔一般会在一年左右的时间内帮助补给萎缩的毛囊再次长出较粗的头发。在一年以后，它仍会继续帮助头发维持在生长期间，使新生的头发拥有更长的生长期。这也就是说米诺地尔的最佳效果一般是在一年左右达到顶峰（大部分情况下是在6-8个月），过了这个周期以后，米诺地尔对头发就是一个维持的状况，不会持续再让头发变多，但可以使用头发维持在一个较稳定的状态。
意外使用本品会导致严重的不良反应。应将本品放置在远离小孩能拿到的地方。
二甲双胍格列吡嗪片有效性与安全性评价
实验结果
3、非房室模型解析 采用统计矩的原理对体内血药浓度时曲线进 行非模型化解析，结果如表5，6所示，将两 制剂因素间各个非房室模型药动学参数进行 方差分析，结果表明：试验制剂与参比制剂 相比，两制剂得的体内平均滞留时间十分相 似，无显著性差异(P>0.1)，说明二者具有
实验结果
4、相对生物利用度计算
实验方法
3、给药方案 3只Beagle犬采用双周期交叉试验，一组服用对照制剂5mg x l片， 一组服用实验制5mg x l粒，一周后进行交叉试验。采血时间均为： 0、1、2、3、4、5、6、8、10、12、16、24、36、48h。 分别取后肢静脉血2.5mL，于肝素化试管中，离心，分离血浆。血 浆预处理后，进HPLC分析，将所得的二甲双胍格列吡嗪与蔡普生 钠的色谱峰面积比值代入标准曲线，计算血药浓度值。
目录
二、有效性评价
1、类似2型糖尿病的动物模型的建立方法 2、二甲双胍格列吡嗪片在Beagle犬体内的药动 学研究 3、临床研究
类似2型糖尿病的动物模型的建立方法：
1、实验性肥胖及糖尿病大鼠模型 2、肥胖性胰岛素抵抗MSG动物模型 3、自发性乙型糖尿病动物
有五类动物，分别为：肥胖小鼠；糖尿病小鼠；KK小鼠（轻度肥胖型 糖尿病动物）；NZO小鼠（表现为超体重、轻度高血糖及高胰岛素水平，早 期有胰岛素抵抗）；Zucker fa/fa 大鼠（常染色体隐形基因的名称为fa） 。
糖尿病现状
盐酸二甲双胍和格列吡嗪是两种使用广泛、疗效好的口服降糖药，两 者联合用药，具有协同降糖作用。二甲双胍格列吡嗪片适用于患有高 血糖症而又不能单纯依赖食物和运动获得满意治疗的2型糖尿病人的初 步治疗；还适用于经食物、运动和单用磺酰脲类或二甲双胍初步治疗 均不能取得血糖过多适当控制的2 型糖尿病人的二线治疗。