注射用丹参多酚酸盐与21种临床常用药品配伍稳定性研究
注射用丹参多酚酸与12种常用注射剂的配伍稳定性
注射用丹参多酚酸与12种常用注射剂的配伍稳定性周岩;李德坤;周大铮;杨悦武;鞠爱春;叶正良【期刊名称】《中成药》【年(卷),期】2018(040)002【摘要】考察注射用丹参多酚酸与12种临床常用注射剂的配伍稳定性.方法模拟注射用丹参多酚酸和各注射剂临床使用剂量,紫外分光光度法、HPLC法考察配伍后溶液的理化指标及酚酸类成分含有量的变化情况.结果碳酸氢钠注射液与注射用丹参多酚酸接触后,颜色和pH值发生明显变化;盐酸普罗帕酮注射液、盐酸左氧氟沙星与注射用丹参多酚酸接触后立刻产生沉淀,紫外图谱和指纹图谱发生明显变化;盐酸法舒地尔注射液与注射用丹参多酚酸接触后立刻产生沉淀,紫外图谱发生明显改变;氨茶碱和二羟丙茶碱注射液不溶性微粒书超标和指纹图谱发生明显变化.结论注射用丹参多酚酸在与盐酸普罗帕酮注射液、氨茶碱注射液、二羟丙茶碱注射液、盐酸法舒地尔注射液、碳酸氢钠注射液和盐酸左氧氟沙星氯化钠注射液配伍使用时可能会对药物疗效和安全性产生隐患,应予以特别注意.【总页数】5页(P494-498)【作者】周岩;李德坤;周大铮;杨悦武;鞠爱春;叶正良【作者单位】天津医科大学药学院,天津300402;天津天士力之骄药业有限公司,天津300070;天津市中药注射剂安全性评价企业重点实验室,天津300070;天津天士力之骄药业有限公司,天津300070;天津市中药注射剂安全性评价企业重点实验室,天津300070;天津天士力之骄药业有限公司,天津300070;天津市中药注射剂安全性评价企业重点实验室,天津300070;天津天士力之骄药业有限公司,天津300070;天津市中药注射剂安全性评价企业重点实验室,天津300070;天津天士力之骄药业有限公司,天津300070;天津市中药注射剂安全性评价企业重点实验室,天津300070;天津天士力之骄药业有限公司,天津300070;天津市中药注射剂安全性评价企业重点实验室,天津300070【正文语种】中文【中图分类】R969.1【相关文献】1.3种常用中药注射剂配伍不同溶媒的稳定性考察 [J], 时扣荣;王卓;陈伟成;顾伟鹰2.注射用丹参多酚酸与8种常用溶剂的配伍稳定性考察 [J], 周岩;李德坤;周大铮;杨悦武;鞠爱春;王晓毅;叶正良3.注射用丹参多酚酸盐与21种临床常用药品配伍稳定性研究 [J], 任贤;谢楠;徐向阳;宣利江4.注射用卡络磺钠与3种注射剂及5种常用输液的配伍稳定性 [J], 陈丽;刘放5.注射用奥美拉唑钠与20种常用中药注射剂配伍稳定性研究 [J], 冯霞;余利军;邓国祥;刘悦;张惠霞;李茂星;李靖因版权原因，仅展示原文概要，查看原文内容请购买。
注射用丹参多酚酸盐成品输液的稳定性
注射用丹参多酚酸盐成品输液的稳定性吴妍;耿魁魁;史天陆;刘圣【摘要】Objective To research the quality and stability of finished Salvianolate transfusion .Methods The content of active ingre-dients,appearance,pH value and insoluble particles of 3 clinical commonly used products of Salvianolate within 8 hours were measured under the room temperature (25 ℃) and refrigeration (4 ℃),respectively.Results When Salvianolate and insulin were mixed in 5%glucose injection,the content of Salvianolic acid B dropped more than 10% in 2 h at room temperature (25 ℃) or in refrigerator (4 ℃),the pH value of the solution was higher than 6,the number of insoluble particles with diameters greater than 10 μm and 25 μm were more than 25 /mL and3/mL,respectively.When Salvianolate was diluted by 5% glucose injection or 0.9% sodium chloride injec-tion,the solution remained stable for 8 hours under room temperature .Under refrigeration condition,the insoluble particles in the fin-ished product infusion after diluted with 0.9% sodium chloride injection did not meet regulation criteria within 6 hours,and the insolu-ble particles in the finished product infusion after diluted with 5% glucose injection did not meet regulation criteria within 2 hours. Conclusions Salvianolate should not be mixed with insulin due to the incompatibility .Under refrigeration condition,the solution dilu-ted by 0.9% sodium chloride injection should not be kept for more than 6 hours and the solution diluted by 5% glucose injection should not be kept for morethan 2 hours.%目的考察注射用丹参多酚酸盐成品输液稳定性.方法分别考察室温(25℃)和冷藏(4℃)条件下,注射用丹参多酚酸盐的3种临床常用成品输液在0~8 h间的有效成分的含量、输液外观、pH值及不溶性微粒的数量的变化.结果注射用丹参多酚酸盐与胰岛素在5%葡萄糖注射液中混合调配后,无论在室温或冷藏条件下,2 h内成品输液丹酚酸B含量下降均超过10%,溶液pH值超过6,≥10μm不溶性微粒的数量超过25个/毫升,≥25μm不溶性微粒的数量超过3个/毫升.使用5%葡萄糖注射液和0.9%氯化钠注射液稀释的成品输液,室温保存8 h稳定.然而,在冷藏条件下,0.9%氯化钠注射液稀释后的成品输液6 h内不溶性微粒数超出规定范围,而5%葡萄糖注射液稀释后的成品输液2 h内不溶性微粒的数量超出规定范围.结论注射用丹参多酚酸盐不宜与胰岛素配伍使用.在冷藏条件下,建议采用0.9%氯化钠注射液稀释后的成品输液保存不得超过6 h,采用5%葡萄糖注射液稀释后的成品输液保存不得超过2 h.【期刊名称】《安徽医药》【年(卷),期】2018(022)006【总页数】4页(P1203-1206)【关键词】丹参酚;药物稳定性;药物配伍禁忌【作者】吴妍;耿魁魁;史天陆;刘圣【作者单位】安徽省立医院药剂科,安徽合肥 230001;安徽省立医院药剂科,安徽合肥 230001;安徽省立医院药剂科,安徽合肥 230001;安徽省立医院药剂科,安徽合肥 230001【正文语种】中文注射用丹参多酚酸盐由中药丹参提取，其主要活性成分为水溶性化合物丹参乙酸镁[1-2]。
注射用丹参多酚酸盐产品及研究简介(省区经理综合版)20111014
有效成分的含量，是疗效的物质基础！
丹参酚酸B（MLB）含量是传统丹参制剂的数百倍！
超高效液相色谱 (UPLC) Accuricy系统检测6种不同成分的含量
（ND表示未检测到） 李耿，史载祥，杨洪军，杜金行(全国中西医结合心血管病中心 / 中国中医科学院中药研究所)
《丹参类注射剂中主要成分含量的比较分析》，中国药房，20(3):207-209,2009
2011年度“国家技术发明奖” 二等奖
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用法用量 与 注意事项
产品规格：单瓶 200mg /100mg /50mg （三种）
用法用量： 静脉滴注。一次200mg，用5%葡萄糖注射液或0.9%氯化钠注射液 250～500 ml溶解后使用。一日1次。疗程14天。 • 给药期间，如滴速过快，可能 发生头胀痛、头晕、头昏，在 停药后即可消失。建议：减少 输液量、放慢滴速。 • • • 有出血倾向者慎用。 孕妇、哺乳期妇女慎用。 还原性极强，避免与其他药物 联用。顺序给药需冲洗管道， 并间隔至少15分钟。
gbACT(秒)
gbACT 的正常范围 119－195秒
1mg/ml 0.01mg/ml 0.5mg/ml 0.005mg/ml 1.5mg/ml 2mg/ml
血药浓度
200mg/天，单次静脉滴注最高 血药浓度0.01mg/ml
丹参多酚酸盐在大剂量下能够使影响ＡＣＴ，说明它干预了凝血瀑布。（史旭波等，待发表）
大便隐血1例阳性：胃溃疡患者，有手术史，86岁，长期使用阿司匹林。 提示该药对于有明确出血倾向者慎用
安全性：在推荐剂量下不会增加出血的危险性
出血风险评估：玻璃珠激活全血凝固时间 (gbACT) Glass bead active clotting time (gbACT)
丹参注射液与临床常用输液配伍的稳定性研究
DOI:10.16662/ki.1674-0742.2021.22.001丹参注射液与临床常用输液配伍的稳定性研究陈虹1,郭昌贵1,合雄1,赖芸1,韩惟芳1,孙荣飞2,戴宇婷21.云南省昭通市中医医院,云南昭通657000;2.云南省昭通市食品药品检验所,云南昭通657000[摘要]目的探讨丹参注射液与临床常用输液0.9%氯化钠注射液(0.9%NS),5%葡萄糖注射液(5%GS),10%葡萄糖注射液(10%GS),葡萄糖氯化钠注射液(GNS),转化糖注射液及果糖注射液配伍后的稳定性。
方法按说明书中推荐剂量,将丹参注射液与常用溶媒配置的成品输液,在光照与遮光的环境下,分别置于常温(10~30℃)、高温(35~37℃)、低温(4~8℃)下,考察成品输液8h 内配伍溶液的外观、pH、不溶性微粒及主要有效成分的含量变化情况。
结果丹参注射液与6种溶媒配伍后的成品输液外观、pH 均无明显改变(RSD≤1%)。
20mL 丹参注射液与100mL 5%GS 配伍的高浓度成品输液及与250mL 5%GNS、0.9%NS、转化糖注射液配伍的常规浓度成品输液,不溶性微粒超出药典(2015版)标准,时间、温度对不溶性微粒的影响差异有统计学意义(P<0.01或P<0.05);且低温与高温、低温与常温条件下的不溶性微粒数有差异,差异有统计学意义(P<0.01或P<0.05),高浓度成品输液在高温8h 时原儿茶醛含量最大下降约14%,丹参素钠含量变化<2.5%,在其余溶媒中丹参素钠、原儿茶醛含量较稳定,含量变化不超过2.7%。
结论丹参注射液与溶媒配伍的成品输液浓度较高时,温度、光照和时间对其质量有一定影响,应尽量避免在高温和阳光直射的环境中输注,且应在6h 内使用。
非病情必须,不推荐大剂量、高浓度输注该品的成品输液。
[关键词]丹参注射液;临床常用输液;配伍;稳定性;温度;光照;遮光[中图分类号]R942[文献标识码]A[文章编号]1674-0742(2021)08(a)-0001-06Study on the Stability of the Compatibility of Danshen Injection with Common Clinical InfusionCHEN Hong 1,GUO Changgui 1,HE xiong 1,LAI Yun 1,HAN Weifang 1,SUN Rongfei 2,DAI Yuting21.Zhaotong Hospital of Traditional Chinese Medicine,Zhaotong,Yunnan Province,657000China;2.Food and DrugInspection Institute of Zhaotong City,Zhaotong,Yunnan Province,657000China[Abstract]Objective To explore Danshen injection and common clinical infusion 0.9%sodium chloride injection (0.9%NS),5%glucose injection (5%GS),10%glucose injection (10%GS),glucose sodium chloride injection (GNS),the stabilityof the compatibility of invert sugar injection and fructose injection.Methods According to the recommended dosage in theinstructions,the finished product of Danshen injection and common solvents were infused under light and shadingenvironment,respectively,at room temperature (10-30℃),high temperature (35-37℃),and low temperature (4-8℃),the appearance,pH,insoluble particles and the content of the main active ingredients of the compatible solution of the finished infusion solution within 8h were investigated.Results There was no significant change in appearance and pH of the finished product infusion after Danshen injection and 6kinds of solvents (RSD ≤1%).The high -concentration finished infusion of 20mL Danshen injection compatible with 100mL 5%GS and the regular -concentration finished infusion compatible with 250mL 5%GNS,0.9%NS,and invert sugar injection.Insoluble particles exceed the standards of the Pharmacopoeia(2015edition).There were statistically significant differences in the effects of time and temperature oninsoluble particles(P<0.01or P<0.05);and the differences in the number of insoluble particles between low temperature and high temperature,low temperature and normal temperature was statistically significant (P<0.01or P <0.05).Protocatechuic aldehyde content of high-concentration finished infusion solution at high temperature for 8h will decrease by about 14%,and the content of danshensu sodium will change less than 2.5%.In other solvents,the content of danshensu sodium andprotocatechuic aldehyde was relatively stable.The change did not exceed 2.7%.Conclusion When the concentration of the infusion of the finished product of Danshen injection and solvent is high,temperature,light and time have certain effects onits quality.It should be avoided in the environment of high temperature and direct sunlight,and should be used within 6h.It is not necessary for the condition,and it is not recommended to inject the finished infusion of this product in large doses and high concentrations.[Keywords]Dansheninjection;Commonclinicalinfusion;Compatibility;Stability;Temperature;Light;Shading[基金项目]云南省科技厅应用基础研究-中医联合专项(面上)项目(2017FF116(-050))。
注射用丹参多酚酸盐与21种临床常用药品配伍稳定性研究
注射用丹参多酚酸盐与21种临床常用药品配伍稳定性研究任贤;谢楠;徐向阳;宣利江【摘要】目的考察注射用丹参多酚酸盐与21种临床常用药品配伍后的稳定性.方法模拟临床用药,将注射用丹参多酚酸盐200mg分别与临床21种常用药品,用0.9%氯化钠注射液250 mL或5%葡萄糖注射液稀释配伍,观察溶液外观,测定配伍后4 h 内pH、不溶性微粒和含量的变化.结果注射用丹参多酚酸盐与维生素C注射液、黄芪注射液、单硝酸异山梨酯注射液、盐酸川芎嗪注射液、地塞米松磷酸钠注射液配伍使用时pH超出注射用丹参多酚酸盐厂家质量标准;与香丹注射液配伍在0.9%氯化钠注射液为溶刺的情况下,含量在1 h后下降.注射用丹参多酚酸盐与其他15种临床常用药品配伍,0～4 h内外观、pH、不溶性微粒、含量测定方面均符合规定.结论注射用丹参多酚酸盐与所选15种,临床常用药品配伍在4 h内基本稳定.但基于中药注射液成分的复杂性,建议临床上单独使用.%Objective To investigate the stability of Salvianolate for Injection after the compatibility with 21 clinical drugs. Methods By simulating clinical medication, 200 mg Salvianolate for Injection was compatible with 21 kinds of drugs commonly used in clinic, and 250 mL 0. 9% sodium chloride injection or 5% glucose injection as solvent to observe the appearance, pH, insoluble particles and content detected within 4 h in the mixed solution. Results In the compatibility of Salvianolate for Injection with Vitamin C Injection, Astragalus Injection, Isosorbide Mononitrate Injection, Ligustrazine Hydrochloride Injection and Dexamethasone Sodium Phosphate Injection, the pH value exceeded the quality standard of the manufactories. In its compatibility with Xiangdan Injection in 0. 9% Sodium Chloride Injection as solvent, the content wasdecreased after 1 h. In its compatibility with other 15 kinds of clinically commonly used drugs, the inner appearance, pH, insoluble particles and content determination within 4 h were all accorded with the standard for quality control of Salvianolate for Injection. Conclusion The compatibility Salvianolate for Injection with 15 kinds of drugs commonly used in clinic is stable within 4 h. But based on the complex composition of traditional Chinese medicine injections, it is recommended to be used alone in clinic.【期刊名称】《中国药业》【年(卷),期】2012(021)002【总页数】4页(P22-25)【关键词】注射用丹参多酚酸盐;药物配伍;稳定性【作者】任贤;谢楠;徐向阳;宣利江【作者单位】上海绿谷制药有限公司,上海,201203;上海绿谷制药有限公司,上海,201203;上海绿谷制药有限公司,上海,201203;中国科学院上海药物研究所,上海,201203【正文语种】中文【中图分类】R959.2;R285.6注射用丹参多酚酸盐是由中药丹参提取精制的多酚酸盐类化合物制备而成[1－2]，主要成分丹参乙酸镁是丹参中最重要的有效活性部分，可通过多种机制和途径发挥其保护心血管系统的作用[3－4]。
注射用丹参多酚酸盐联合常规西药治疗急性脑梗死有效性和安全性的
王诗颖*，方海姬，谷娜,靳秋霞，郭胜才?（中国人民解放军联勤保障部队第903医院药剂科，浙江杭州 310013）中图分类 R932文献标志码 A
DOI 10. 14009/j.—/. 1672-2124. 2019. 07. 029
Systematic Evaluation on Efficacy and Safety of Salvianolate Injection Combined with Conventional Western Medicinc in the Treatmect of Accte Ceredral Infarction WANG Shiying,FANG Haiji,GU Na,JIN Qiuxia,GUO Shengcai (Dept, of Pharmacy, the 903 Hospital of the Chinese Peopled Liberation Army Joint Logstics Support Forca,Zhejiang Hangzhou 310013, China)
ABSTRACT OBJECTINE : To systematicaHy evaluMe the efficacy and safety of salvianolate injection cambined with c*onventiona western medicine in the treatment of acute c*erebra infarction. METHODS: CNKI, China Medical Information Resourca System, Wanfang datt base and PubMed were retteved to callect the randomized controlled triy (RCT) of salvianolate injection combined with canventional western medicine in the treatment of acute cerebral infaetion ( the controO group was treated with conventional western medicine, and the observation group received salvianOate injection on the basis of the cantroO group) , the retmeval time was from 2000 te 2017. Methodolooical quality of the included literature was assessed by using tlie Cochrane systematia evaluation method, and meta-analysit was performed using the RevMan 5. 2 softwae. RESULTS: A total of 14 literature were included. Meta-analysie showed that the total effective rate ( RR = 1. 29,95% CI = 1. 19-1.41, !<0. 000 1 ) , neurological impairment score ( MD = -3.84,95% CA= -4. 73-2.95, ! < 0. 000 01) , daily living ability ( MD = 12. 88, 95% CC = 8. 66-17.10, !< 0. 000 01) , and C-reactive protein levvC ( MD = - 2. 81,95% CC = - 5. 29-- 0. 34, ! = 0. 03 ) and dll hemodynamia indexes ( !<0. 05 ) in the obserwtion group were significantly betee than those in the controO group, and the dmferencec were statistically significant. There were no severe adverse drug reactione in both groups and the safety wae highee. CONCUSIONS: Based on the cuirent clinical eyinenco, the eCOcacy of salvianolate injection combined with conentionl western medicine in Wv treatment of acute carebral infarction is signifmantly better than conyentionl western medicine alone, which can reduca the recent morbidity rate and has highee safety. Due to the smaH numbee and low quality of the literature included in this study, the above conclusions stiH need to be further verified by more larae samples, multi-centee clinical randomized, doublcblind controlled tWIs with long follow-up time. KEYWORDS Salvianolate; Acute cerebral infaretjon ； Meta-analysis; Systematic review
注射用丹参多酚酸与8种常用溶剂的配伍稳定性考察
注射用丹参多酚酸与8种常用溶剂的配伍稳定性考察周岩;李德坤;周大铮;杨悦武;鞠爱春;王晓毅;叶正良【期刊名称】《中国药房》【年(卷),期】2017(028)017【摘要】OBJECTIVE:To investigate the compatibility stability of Salvianolic acid for injection (SAFI) combined with 8 kinds of common solvents. METHODS:Referring to package inserts,SAFI was collected and combined with 0.9% Sodium chlo-ride injection,5% Glucose injection,10% Glucose injection,Compound sodium chloride injection,Mannitol injection,Glycerol fructose and sodium chloride injection,Sodium lactate Ringer's injection,Glucose and sodium chloride injection,250 mL each re-spectively,and then sealed in the dark at the room temperature. The appearance of mixtures were observed,pH value,the number of insoluble particles,maximal absorption wavelength and maximal absorbance were detected,and the contents of salvianolic acid B,rosmarinic acid,lithospermic acid and salvianolic acid Y in mixtures were determined by HPLC at0,1,2,4,8 h after mix-ing. RESULTS:Under above condition,no obvious change was found in appearance or pH values of the mixtures within 8 h. Maxi-mal absorption wavelength ranged 284.5-286.0 nm. After mixed with Mannitol injection,the number of particles≥10μm(1-8 h af-ter mixing)and particles ≥25 μm(4-8 h after mixing)exceeded the scope of Chinese Pharmacopoeia(2015 edition);the maxi-mal absorbance changedsignificantly(RSD=9.17%,n=5);the relative content of salvianolic acidB,rosmarinic acid,lithosper-mic acid and salvianolic acid Y decreased by more than 10%(RSD=14.65%,6.45%,8.97%,12.49%,n=5);after mixed with Sodium lactate Ringer's injection,the relative content of rosmarinic acid and lithospermic acid changed greatly (RSD=14.57%, 7.28%,n=5);after mixed with 5% Glucose injection(4-8 h after mixing)and Glycerol fructose and sodium chloride injection(8 h after mixing),the relative content of rosmarinic acid were less than 90%(RSD=6.30%,4.86%,n=5);and the number of particles ≥25μm exceeded the scope of phamcopoeia after mixing with Glycerol fructose and sodium injection(0 h). The number of insoluble particles in other mixtures were in line with the standard of pharmacopoeia;maximal absorbance had no significantchange(RSD<5%,n=5),and the relative content change of analytes were all less than 10%. CONCLUSIONS:Clinical appli-cation of SAFI combined with Mannitol injection,Sodium lactate Ringe's injection and Glycerol fructose and sodium injecrion should be avoided. After mixed with 5% Glucose injection,SAFI should be used within 4 h. SAFI can be compatible with0.9%Sodium chloride injection,10% Glucose injection,Compound sodium chloride injection and Glucose and sodium chloride injec-tion.%目的:考察注射用丹参多酚酸与8种临床常用溶剂的配伍稳定性.方法:参照药品说明书,取注射用丹参多酚酸适量,分别与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液、复方氯化钠注射液、甘露醇注射液、甘油果糖氯化钠注射液、乳酸钠林格注射液、葡萄糖氯化钠注射液各250 mL配伍.在室温避光条件下,分别于配伍后0、1、2、4、8 h观察各配伍液的外观,检测其pH、不溶性微粒数、最大吸收波长和最大吸收度,并采用高效液相色谱法测定各配伍液中丹酚酸B、迷迭香酸、紫草酸和丹酚酸Y的含量.结果:在上述条件下,各配伍液在8 h内外观和pH均无明显变化,最大吸收波长为284.5~286.0 nm.与甘露醇注射液配伍后,配伍液中粒径≥10μm的微粒数(配伍后1~8 h)和≥25μm的微粒数(配伍后4~8 h)均超出2015年版《中国药典》规定范围,最大吸收度变化明显(RSD=9.17%,n=5),且丹酚酸B、迷迭香酸、紫草酸和丹酚酸Y相对百分含量的降幅均超过了10%(RSD分别为14.65%、6.45%、8.97%、12.49%,n=5);与乳酸钠林格注射液配伍后,配伍液中迷迭香酸和紫草酸的相对百分含量变化较大(RSD分别为14.57%、7.28%,n=5);与5%葡萄糖注射液配伍后4~8 h、与甘油果糖氯化钠注射液配伍后8 h,配伍液中迷迭香酸的相对百分含量均低于90%(RSD分别为6.30%、4.86%,n=5);与甘油果糖氯化钠注射液配伍后0 h,配伍液中粒径≥25μm的微粒数超出药典标准;其他配伍液中不溶性微粒数均符合药典标准,最大吸收度变化不大(RSD<5%,n=5),且各待测物相对百分含量的变化均未超过10%.结论:临床应避免注射用丹参多酚酸与甘露醇注射液、乳酸钠林格注射液和甘油果糖氯化钠注射液配伍使用;与5%葡萄糖注射液配伍后应在4 h内使用;可与0.9%氯化钠注射液、10%葡萄糖注射液、复方氯化钠注射液、葡萄糖氯化钠注射液配伍使用.【总页数】7页(P2350-2356)【作者】周岩;李德坤;周大铮;杨悦武;鞠爱春;王晓毅;叶正良【作者单位】天津医科大学药学院,天津300070;天津天士力之骄药业有限公司,天津 300402;天津市中药注射剂安全性评价企业重点实验室,天津 300402;天津天士力之骄药业有限公司,天津 300402;天津市中药注射剂安全性评价企业重点实验室,天津 300402;天津天士力之骄药业有限公司,天津 300402;天津市中药注射剂安全性评价企业重点实验室,天津 300402;天津天士力之骄药业有限公司,天津 300402;天津市中药注射剂安全性评价企业重点实验室,天津 300402;天津天士力之骄药业有限公司,天津 300402;天津市中药注射剂安全性评价企业重点实验室,天津300402;天津天士力集团研究院创新研究中心,天津 300402;天津天士力之骄药业有限公司,天津 300402;天津市中药注射剂安全性评价企业重点实验室,天津300402【正文语种】中文【中图分类】R969.3【相关文献】1.注射用丹参多酚酸与12种常用注射剂的配伍稳定性 [J], 周岩;李德坤;周大铮;杨悦武;鞠爱春;叶正良2.注射用乌司他丁与2种常用溶剂在输液泵中的配伍稳定性考察 [J], 林淑瑜;甘惠贞;李玉堂;潘丹婷;陈志民3.注射用丹参多酚酸盐与21种临床常用药品配伍稳定性研究 [J], 任贤;谢楠;徐向阳;宣利江4.不同溶剂与奥美拉唑钠配伍稳定性考察 [J], 薛建辉5.注射用盐酸万古霉素与三种常用电解质注射液的配伍稳定性考察 [J], 刘钢;秦侃;袁杰;吴文华因版权原因，仅展示原文概要，查看原文内容请购买。
丹参注射液与临床常用注射液配伍的稳定性
丹参注射液与临床常用注射液配伍的稳定性
马媛媛;李雪宁
【期刊名称】《中成药》
【年(卷),期】2013(035)004
【摘要】目的通过与临床常用注射液组成配伍溶液,考察丹参注射液的配伍稳定性.方法模拟临床用药方法,配制丹参注射液与各类药物的配伍溶液;采用HPLC法测定配伍后丹参注射液各成分的量变化情况,同时考察配伍溶液的外观、pH值和不溶性微粒的变化情况.结果室温状态下各配伍溶液的外观、pH值稳定性、不溶性微粒和丹参中各组分的量均无明显变化.结论丹参注射液分别与盐酸川芎嗪注射液、血塞通注射液、葛根素注射液、维生素C注射液、维生素B6注射液、脉络宁注射液、西咪替丁注射液和盐酸倍他司汀注射液配伍后6 h内稳定,可安全用于临床.【总页数】4页(P705-708)
【作者】马媛媛;李雪宁
【作者单位】复旦大学附属中山医院,药物临床试验机构,上海,200032
【正文语种】中文
【相关文献】
1.丹参注射液与黄芪注射液在5%葡萄糖注射液中的配伍稳定性观察 [J], 王文彤;袁立友
2.复方丹参注射液与临床常用溶媒配伍的稳定性 [J], 应群芳;徐冬
3.复方丹参注射液临床常用配伍分析与安全应用 [J], 黄剑臻
4.西咪替丁注射液与丹参注射液配伍在不同时段的稳定性 [J], 李燕灵;林夏飞
5.丹参注射液与临床常用输液配伍的稳定性研究 [J], 陈虹;郭昌贵;合雄;赖芸;韩惟芳;孙荣飞;戴宇婷
因版权原因，仅展示原文概要，查看原文内容请购买。
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・
药物研究 ・
中ｌ 虱茄
Ｃ ｉ ｎａ ａ ｍ ａｃ ｕ ｉ口 ｒ ｅ ｔｃ
２１ ０ ２年 １月 ２ ０日 第 ２ ｌ卷第 ２期
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Ｄｒｇ ／ｅ ／ｉ ＃ ｎ ｕ ｄ ｎｉｃ ｏ ｆｏ
注射用丹参多酚酸盐与 ２ １种临床常用药品配伍稳定性研究 木
盐与 所 选 ｌ 临床 常 用 药品 配伍 在 ４ｈ内基 本 稳 定 。 基 于 中药 注射 液 成 分 的 复 杂性 ， 议 临 床上 单独 使 用 。 ５种 但 建 关键词 ： 注射 用 丹 参 多 酚 酸 盐 ； 药物 配伍 ； 定性 稳 中图 分 类 号 ： ９ ９ ２ Ｒ ８ ． Ｒ ５ ． ；２５６ 文献 标 识 码 ： Ａ 文章 编 号 ：０ ６—４３ （０ ２ ０ １０ ９ １ ２ １ ）２—０ ２ ０ ０ ２— ４
任 贤 谢 ， 楠 徐 向阳 宣利江 ， ，
２ １０ ） ０ ２ ３ （ ．上 海绿谷 制 药有 限公 司 ， 海 １ 上 ２ １０ ； ２ ０ ２ ３ ．中国科 学 院上海 药物研 究所 ， 上海
摘要 ： 目的 考察注射 用丹参 多酚酸盐与 ２ 种临床常用药品配伍后 的稳 定性 。 １ 方法 模拟临床用药 ， 注射用丹参 多酚酸盐 ２ ０ｍｇ 将 ０ 分别与 临床 ２ 种常 用药品 ， ０ ９ １ 用 ． ％氯化钠 注射液 ２０ｍ ５ Ｌ或 ５ 葡萄糖注射 液稀释 配伍 ， ％ 观察溶液外观 ， 测定配伍后 ４ｈ内ｐ 不溶性微粒和含 Ｈ、 量的 变化。 结果 注射用丹参 多酚酸盐与维生素 ｃ注射 液、 黄芪注射液、 单硝酸异 山梨酯 注伍使用时 ｐ Ｈ超 出注射用丹参多酚酸 盐厂 家质量标准； 与香丹注射液 配伍在 ０ ９ ． ％氯化钠 注射液为溶剂的情 况下， 量在 ｌ 含 ｈ后下降。 注射用丹参多酚 酸盐与其他 ｌ ５种临床 常用药品 配伍 ， ４ｈ内外观、Ｈ、 ０— ｐ 不溶性微粒、 含量测定方面均符合规定。 结论 注射 用丹参 多酚酸
２ Ｓ ａｇ ａ ｎｔｕｅｏ ｔ ｉ ｄ ａ ｈｎｓ Ａ ａ ｅ ｙ ｏ ｃ ｎｅ ｈ ｎ ｈ ｉＣ ｉｎ ． ｈ ｎｈ ｉＩｓｔｔ ｆ Ｍａｅ ａ Ｍｅｉ ，Ｃ ｉ ｅ ｃｄｍ ｆ Ｓｉ ｃ ，Ｓａ ｇ ａ， ｈａ ｉ ｒｌ ｃ ｅ ｅ ｓ
２ １０ ） ０２３
Ａ ｓ ａ ｔ Ｏｂ ｅｔ ｅ Ｔ ｎ ｅｔ ａ ｈ ｔ ｉｔ ｏ ａ ｉｎｌｔ ｆｒ Ｉｊｃ ｏ ｆ ｒ ｔ ｏ ｐ ｔ ｉｔ ｗ ｔ １ ｌ ｉ ｒｇ ． ｔｏ ｓ Ｂ ｂ ｔ ｃ： ｊｃｉ ｏ ｉ ｓ ｇ ｔ ｔｅ ｓ ｂｌｙ ｆ Ｓ ｌ ａ ｏ ｅ ｏ ｎｅｔ ｎ ａ ｅ ｈ ｃｍ ａ ｂｌｙ ｉ ２ ｃ ｎｃ ｄｕ ｓ Ｍｅｈ ｄ ｙ ｒ ｖ ｖ ｉ ｅ ａ ｉ ｖ ａ ｉ ｔ ｅ ｉ ｉ ｈ ｉ ａ ｌ ｓ ｕａ ｎ ｌ ｉ ｌｍ ｄｃｔ ｎ ２ ０ｍ ａ ｉ ｏ ｔ ｆｒＩｊｃ ｏ ａ ｏ ｐ ｔ ｌ ｗｔ ｋｎ ｓ ｏ ｒｇ ｏ ｍ ｎｙ ｕ ｅ ｎ ｃ ｎｃ ａ ｄ ２ ０ｍＬ ｉ ｌ ｉｇ ｃ ｎ ａ ｅ ｉ ｉ ， ０ ｇ Ｓ ｖａ ｌ ｅ ｏ ｎｅｔ ｎ ｗ ｓ ｃ ｍ ａ ｂ ｉ ２ ｉｄ ｆｄｕ ｓ ｃ ｍ ｏ ｌ ｓｄ ｉ ｌ ｉ ｎ ５ ｍ ｔ ｉｃ ａｏ ｌ ｎ ａ ｉ ｉｅ ｈ １ ｉ ，