盐酸苯海拉明(溶出数据库)
日本药品体外溶出试验信息库 Microsoft Excel 工作表
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头孢特仑新戊酯 唑尼沙胺 醋酸可的松 头孢克肟 头孢妥仑匹酯 醋酸氟卡尼 醋酸甲羟孕酮 酒石酸美多洛尔 硝酸异山梨酯 醋酸氟氢可的松 醋酸美替诺龙 醋酸对氟米松 青霉胺 达那唑 噻洛芬酸 甲砜霉素 二硫化苯酰 丹曲洛林钠盐 硫普罗宁 硫利哒嗪 替硝唑 替米哌隆 Diphenylpyraline Chlorotheophyllinate 茶碱 替加氟 右旋糖酐硫酸钠硫 鞣酸苯海拉明 替诺昔康 地诺帕明 替普瑞酮 d-马来酸氯苯那敏 他扎司特 多卡巴胺 去氧氟尿苷 托西酸托舒沙星 甲磺司特 托拉塞米 地塞米松 曲尼司特 氨甲环酸 曲匹地尔 托西酸舒他西林 三唑仑 曲安奈德
17 18 19 20 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
丹曲林钠 硝苯地平 烟酰胺-盐酸罂粟碱 萘丁美酮 苯妥英·苯巴比妥 法莫替丁 黄素腺嘌呤二核苷酸钠 酚酞酸氯丙嗪 联苯酰苯酸氯哌斯汀 培哚普利特丁胺 倍他米松·右旋马来酸氯苯那 敏 盐酸二甲双胍 枸橼酸钾枸橼酸钠 L-羧甲司坦 阿卡波糖 阿昔洛韦 乙酰谷酰胺铝 茴三硫 氟喹酮 对氨基水杨酸钙铝 醋磺己脲 氨苄西林氯唑西林钠 三磷酸腺苷二钠 氨来呫诺 依替膦酸二钠 盐酸地拉卓 盐酸哌沙酯-L-谷氨酰胺 L-门冬氨酸钾 L-门冬氨酸钾镁 L-门冬氨酸钙 L-谷氨酰胺 抗坏血酸 谷丙甘氨酸 薁磺酸钠 复方谷氨酰胺 L-半胱氨酸 ε -氨基己酸颗粒 吡二丙胺 阿糖胞苷烷磷酯 扎托布洛芬 西诺沙星 地诺前列酮 齐多夫定 双嘧达莫
对照品批号
"品种编号","品种","规格(支)","","单价","申请数量","金额","备注" 171201,"吗啡","200mg","171201-200318","156.25 "171202,"盐酸地芬诺酯","50mg","171202-200303","37.50 "171203,"磷酸可待因","50mg","171203-200303","62.50 "171204,"枸椽酸芬太尼","200mg","171204-200303","106.25 " 171205,"福尔可定","100mg","171205-200303","106.25 "171206,"盐酸海洛因","20mg","171206-9710","250.00 ",,,"毒品分析用" 171207,"O6-单乙酰吗啡盐酸盐","20mg","171207-200310","175.00 ",,,"毒品分析用"171208,"O3-单乙酰吗啡氨基磺酸盐","20mg","171208-0106","175.00 ",,,"毒品分析用"171209,"乙酰可待因","20mg","171209-200305","175.00 ",,,"毒品分析用" 171210,"盐酸可卡因","100mg","171210-9201","37.50 ",,,"毒品分析用" 171211,"硫酸安非它明","50mg","171211-9301","62.50 ",,,"毒品分析用" 171212,"盐酸甲基安非它明","20mg","171212-9802","125.00 ",,,"毒品分析用"171213,"盐酸哌替啶","100mg","171213-200302","62.50 ",,,"毒品分析用" 171214,"盐酸罂粟碱","100mg","171214-9602","37.50 "171215,"咖啡因","100mg","171215-200305","87.50 "171216,"蒂巴因","100mg","171216-0102","62.50 "171217,"硝西泮","100mg","171217-200302","62.50 "171218,"阿普唑仑","100mg","171218-9702","62.50 "171219,"艾司唑仑","100mg","171219-0102","62.50 "171220,"巴比妥","100mg","171220-9201","37.50 "171221,"异戊巴比妥","100mg","171221-200302","62.50 "171222,"苯巴比妥","100mg","171222-200303","87.50 "171223,"司可巴比妥钠","100mg","171223-9201","37.50 "171224,"那可丁","100mg","171224-9902","37.50 "171225,"地西泮","100mg","171225-9601","87.50 "171227,"氯硝西泮","100mg","171227-200302","175.00 ""麻醉药对照品申请表""申请单位: 填表日期: 年月日""品种编号","品种","规格(支)","","单价","申请数量","金额","备注" 171228,"2-氨基-2'-氯-5-硝基二苯酮","100mg","171228-9701","37.50 " 171229,"奥沙西泮","100mg","171229-200302","175.00 "171230,"三唑仑","100mg","171230-9701","75.00 "171231,"盐酸爱康宁","20mg","171231-0104","175.00 "171232,"盐酸甲基爱康宁","20mg","171232-9902","175.00 "171233,"苯甲酰爱康宁","20mg","171233-0204","225.00 "171234,"大麻酚溶液 (1mg/ml)","0.3ml","171234-0207","100.00 " 171235,"大麻二酚溶液 (1mg/ml)","0.3ml","171235-9907","100.00 " 171237,"盐酸伪麻黄碱","100mg","171237-200103","87.50 "171238,"硫酸吗啡","100mg","1238-0103","106.25 "171239,"盐酸纳洛酮","50mg","171239-9701","250.00 "171240,"(-)-4,5-α-环氧基-3,14-二羟基吗啡喃-6-酮","20mg","1240-9701","106.25 "171241,"盐酸麻黄碱","100mg","171241-200102","87.50 "171242,"盐酸曲马多","100mg","171242-200302","87.50 "171243,"盐酸美沙酮","100mg","171243-200001","62.50 "171244,"盐酸丁丙诺啡","100mg","171244-200001","250.00 " 171245,"MDMA","20mg","171245-0101","212.50 ",,,"毒品分析用" 171246,"盐酸洛非西定","20mg","171246-200301","250.00 "171247,"盐酸甲基麻黄碱","100mg","171247-200301","87.50 " 171248,"氯氮卓","100mg","171247-200301","87.50 ""单位负责人(印章): 麻醉药品主管人(印章): 药品监督管理部门公章:" "注:1,申请数量栏请用大写,写成"计伍支"字样.不需要的品种写"零支",不要留空.填写完毕后请在所填数字上加盖公章."" 2,药品监督管理部门指单位所在地的药品监督管理部门."" 3,申请盐酸海洛因需经省药品监督管理局盖章."" 4,以上对照品不邮寄,请派人带此表来取.""2004年标准品目录""2004年药品检验用标准品,对照品,标准试剂征订单""序号","品种编号","名称","类别","用途","","规格","单价","申请量","金额","备注"1,100001,"醋酸甲羟孕酮","对照品","含量测定","100001-9503","50mg","100.00 "2,100002,"安乃近","对照品","检查","0002-9504","500mg","12.50 "3,100003,"(+)2-氨基丁醇","对照品","检查","0003-200303","100mg","37.50 "4,100004,"苯丙酸诺龙","对照品","含量测定","0004-8102","50mg","100.00 "5,100005,"苯丁酸氮芥","对照品","含量测定","0005-9402","50mg","100.00 "6,100006,"苯甲酸雌二醇","对照品","含量测定","0006-9703","100mg","125.00 "7,100008,"丙酸睾酮","对照品","含量测定","0008-9404","50mg","62.50 " 8,100010,"醋酸氟氢松","对照品","含量测定","0010-0206","50mg","187.50 "9,100011,"醋酸氯地孕酮","对照品","鉴别","0011-8501","50mg","12.50 " 10,100012,"醋酸泼尼松","对照品","含量测定","10012-0105","100mg","62.50 "11,100013,"醋酸氢化可的松","对照品","含量测定","10013-0106","50mg","100.00 "12,100015,"地高辛","对照品","含量测定","10015-0208","30mg","125.00 " 13,100016,"地塞米松磷酸钠","对照品","含量测定","10016-0011","100mg","125.00 "14,100017,"对氨基苯甲酸","对照品","检查","10017-0107","50mg","25.00 "15,100018,"对乙酰氨基酚","对照品","检查","10018-0107","1000mg","62.50 "16,100021,"泛影酸","对照品","鉴别","0021-8102","200mg","12.50 "17,100022,"甘罗溴铵","对照品","含量测定","0022-9302","100mg","100.00 "18,100023,"谷氨酸","对照品","鉴别","0023-8601","50mg","12.50 "19,100024,"磺胺","对照品","检查","0024-8702","50mg","12.50 "20,100025,"磺胺甲恶唑","对照品","含量测定","0025-9503","50mg","100.00 "21,100026,"磺胺嘧啶","对照品","含量测定","0026-8601","50mg","100.00 " 22,100027,"黄体酮","对照品","含量测定","100027-200301","50mg","100.00 "23,100028,"炔诺孕酮","对照品","含量测定","0028-9907","100mg","62.50 " 24,100029,"甲萘醌","对照品","含量测定","100029-200009","50mg","62.50 "25,100030,"甲巯咪唑","对照品","检查","0030-9703","100mg","25.00 " 26,100031,"甲氧苄啶","对照品","含量测定","0031-200304","50mg","100.00 "27,100032,"己酸羟孕酮","对照品","含量测定","0032-8501","50mg","100.00 "28,100033,"己烯雌酚","对照品","含量测定","0033-9805","50mg","100.00 " 29,100034,"枸橼酸氯米芬","对照品","含量测定","0034-9702","50mg","100.00 "30,100035,"甲磺酸双氢麦角毒碱","对照品","含量测定","0035-9701","50mg","100.00 "31,100037,"克霉唑","对照品","鉴别","10037-200306","200mg","62.50 " 32,100038,"邻甲苯磺酰胺","对照品","检查","0038-9802","50mg","12.50 " 33,100039,"6-巯基嘌呤","对照品","检查","0039-9601","50mg","37.50 " 34,100040,"硫酸阿托品(毒)","对照品","含量测定","0040-9109","50mg","100.00 ""2004年药品检验用标准品,对照品,标准试剂征订单""序号","品种编号","名称","类别","用途","","规格","单价","申请量","金额","备注"35,100041,"利血平","对照品","含量测定","10041-0210","100mg","187.50 " 36,100042,"2-氯-4-硝基苯胺","对照品","检查","10042-0002","50mg","25.00 "37,100043,"氯普噻吨","对照品","检查","0043-9701","50mg","25.00 "38,100045,"咪唑","对照品","检查","0045-9903","50mg","12.50 "39,100046,"吡喹酮","对照品","含量测定","100046-200304","50mg","125.00 "40,100047,"马来酸氯苯那敏","对照品","鉴别","100047-200305","50mg","125.00 "41,100049,"氢溴酸东莨菪碱 (毒)","对照品","含量测定","0049-200308"," 50mg","100.00 "42,100050,"氢溴酸加兰他敏","对照品","检查","0050-7801","50mg","12.50 "43,100052,"炔雌醇","对照品","含量测定","100052-200308","50mg","250.00 "44,100053,"炔诺酮","对照品","含量测定","0053-200204","50mg","250.00 " 45,100054,"4-N-去甲基安乃近","对照品","检查","0054-9503","500mg","12.50 "46,100055,"曲安萘德","对照品","含量测定","100055-200302","50mg","125.00 "47,100056,"去乙酰毛花甙(毒)","对照品","含量测定","0056-9302","50mg","100.00 "48,100058,"乳糖","对照品","含量测定","0058-9501","200mg","100.00 " 49,100060,"酞丁安","对照品","含量测定","100060-200302","50mg","125.00 "50,100061,"VD3","对照品","含量测定","10061-0206","50mg","62.50 "51,100062,"VE","对照品","含量测定","10062-0007","160mg","62.50 "52,100063,"戊酸雌二醇","对照品","含量测定","0063-9503","100mg","125.00 "53,100065,"盐酸胺碘酮","对照品","含量测定","100065-200304","200mg","125.00 "54,100066,"盐酸苯海拉明","对照品","含量测定","0066-9705","200mg","100.00 "55,100067,"盐酸苯海索","对照品","含量测定","0067-7801","1000mg","100.00 "56,100068,"盐酸多沙普仑","对照品","含量测定","0068-9701","50mg","100.00 "57,100069,"盐酸多塞平","对照品","检查","0069-9702","50mg","62.50 " 58,100070,"盐酸多巴胺","对照品","含量测定","0070-9404","200mg","50.00 "59,100071,"盐酸可乐定","对照品","含量测定","0071-9905","100mg","100.00 "60,100072,"盐酸克仑特罗","对照品","含量测定","0072-8501","50mg","100.00 "61,100073,"盐酸芬氟拉明","对照品","含量测定","10073-0002","100mg","62.50 "62,100075,"荧光母素","对照品","检查","0075-7902","100mg","12.50 " 63,100076,"左炔诺孕酮","对照品","含量测定","0076-8801","50mg","100.00 "64,100077,"胆红素","对照品","含量测定","10077-0301","50mg","125.00 " 65,100078,"胆酸","对照品","含量测定","10078-0013","500mg","25.00 " 66,100080,"芦丁","对照品","含量测定","100080-200306","200mg","125.00 "67,100082,"葡萄糖酸钙","对照品","检查","0082-9701","50mg","25.00 " 68,100083,"匹莫林","对照品","检查","0083-9501","50mg","25.00 ""2004年药品检验用标准品,对照品,标准试剂征订单""序号","品种编号","名称","类别","用途","批号","规格","单价","申请量","金额","备注"69,100084,"酒石酸美托洛尔","对照品","含量测定","10084-0101","50mg","37.50 "70,100085,"氟哌利多","对照品","含量测定","0085-9701","50mg","100.00 " 71,100086,"硝基呋喃丙烯酸","对照品","检查","0086-8302","100mg","12.50 "72,100088,"克罗米通","对照品","含量测定","0088-9801","100mg","100.00 "73,100089,"双羟萘酸噻嘧啶","对照品","含量测定","100089-200301","50mng","100.00 "74,100090,"双羟萘酸","对照品","含量测定","100090-200301","50mg","100.00 "75,100091,"酚酞","对照品","含量测定","0091-9601","100mg","100.00 " 76,100093,"香草醛","对照品","熔点测定用","0093-8403","每套10个品种,1g/支.","375.00 ",,,"成套发放,不零售.",100094,"乙酰苯胺","对照品","熔点测定用","0094-0204",100095,"非那西丁","对照品","熔点测定用","0095-8904",100096,"磺胺","对照品","熔点测定用","0096-9404",100097,"茴香酸","对照品","熔点测定用","0097-9402",100098,"磺胺二甲嘧啶 ","对照品","熔点测定用","0098-8303",100099,"双氰胺","对照品","熔点测定用","0099-8403",100100,"糖精","对照品","熔点测定用","0100-8403",100101,"咖啡因","对照品","熔点测定用","0101-8403",100102,"酚酞","对照品","熔点测定用","0102-9404"77,100103,"水杨酸片","对照品","溶出度校正片","10103-200208","7片/包","37.50 "78,100105,"氨基己酸","对照品","鉴别","0105-9902","50mg","12.50 "79,100106,"水杨酸","对照品","含量测定","0106-9702","100mg","37.50 " 80,100107,"溴甲阿托品","对照品","鉴别","0107-9501","50mg","12.50 " 81,100109,"α-甲基吡啶","对照品","含量测定","10109-0201","50mg","37.50 "82,100110,"甲磺酸酚妥拉明","对照品","含量均匀度","0110-9501","50mg","100.00 "83,100111,"盐酸萘甲唑林","对照品","含量测定","10111-0103","100mg","62.50 "84,100113,"阿司匹林","对照品","含量测定","10113-200302","300mg","37.50 "85,100114,"氨苯砜","对照品","检查","0114-9101","50mg","37.50 "86,100115,"烟酰胺","对照品","含量测定","10115-0001","50mg","62.50 " 87,100116,"盐酸吡哆辛","对照品","含量测定","0116-9801","50mg","100.00 "88,100117,"阿替洛尔","对照品","含量测定","0117-9903","50mg","37.50 "89,100118,"倍他米松","对照品","含量测定","0118-9502","50mg","62.50 " 90,100119,"丙酸倍氯米松","对照品","含量测定","0119-9802","50mg","125.00 "91,100121,"茶碱","对照品","检查","100121-199903","50mg","100.00 " 92,100122,"醋酸地塞米松","对照品","含量测定","100122-200304","50mg","250.00 "93,100123,"醋酸可的松","对照品","含量测定","100123-200303","50mg","125.00 ""2004年药品检验用标准品,对照品,标准试剂征订单""序号","品种编号","名称","类别","用途","","规格","单价","申请量","金额","备注"94,100124,"醋酸泼尼松龙","对照品","含量测定","100124-200303","50mg","125.00 "95,100125,"醋酸曲安奈德","对照品","含量测定","10125-0103","50mg","125.00 "96,100126,"达那唑","对照品","含量测定","0126-9101","50mg","100.00 " 97,100127,"胆石酸","对照品","检查","0127-9701","50mg","25.00 "98,100128,"地蒽酚","对照品","含量测定","10128-0201","50mg","62.50 " 99,100129,"地塞米松","对照品","含量测定","100129-200303","50mg","187.50 "100,100130,"丁溴东莨菪碱","对照品","含量测定","0130-9501","50mg","62.50 "101,100131,"对甲苯磺酰胺","对照品","检查","0131-9501","50mg","25.00 " 102,100132,"对羟基苯乙酰胺","对照品","检查","0132-9702","50mg","25.00 "103,100133,"奋乃静","对照品","含量测定","0133-9601","50mg","100.00 " 104,100134,"酚磺乙胺","对照品","含量测定","0134-9302","50mg","100.00 "105,100135,"格列本脲","对照品","含量测定","10135-0103","50mg","100.00 "106,100136,"10%A晶型甲苯咪唑","对照品","检查","0136-9301","50mg","62.50 "107,100138,"甲氨蝶呤","对照品","含量测定","0138-9702","50mg","100.00 "108,100139,"甲苯咪唑 ","对照品","鉴别","0139-9702","50mg","25.00 " 109,100140,"6-甲氧基-2-萘乙酮","对照品","检查","100140-200303","50mg","62.50 "110,100141,"N-甲基哌嗪","对照品","检查","0141-9301","50mg","12.50 " 111,100142,"卡马西平","对照品","含量测定","0142-9503","50mg","37.50 " 112,100143,"硫喷妥","对照品","含量测定","0143-9101","50mg","100.00 " 113,100144,"磷酸咯萘啶","对照品","含量测定","10144-0001","50mg","125.00 "114,100145,"苯丙氨酯","对照品","含量测定","0145-9501","50mg","125.00 "115,100146,"哈西奈德","对照品","含量测定","0146-9502","50mg","62.50 " 116,100147,"氯化胆碱","对照品","检查","100147-200302","50mg","100.00 "117,100148,"氯化琥珀胆碱","对照品","检查","0148-9301","50mg","12.50 " 118,100149,"4-[2-(5-氯-2-甲氧基苯甲酰胺)-乙基]-苯磺酰胺","对照品","检查","10149-0202","50mg","125.00 "119,100150,"4-[2-(5-氯-2-甲氧基苯甲酰胺)-乙基]-苯磺酰胺基-甲酸乙酯","对照品","检查","10150-0202","50mg","125.00 "120,100151,"吡哌酸","对照品","检查","0151-9202","50mg","25.00 "121,100152,"氢化可的松","对照品","含量测定","0152-0206","50mg","100.00 "122,100153,"泼尼松龙","对照品","含量测定","0153-9302","50mg","50.00 " 123,100154,"肾上腺素","对照品","含量测定","100154-200301","50mg","125.00 "124,100155,"维生素D2","对照品",,"10155-0004","50mg","62.50 "125,100156,"维生素K1","对照品","含量测定","10156-0003","50mg","62.50 "126,100157,"硝酸毛果芸香碱(毒)","对照品","含量测定","10157-0201","50mg","62.50 ""2004年药品检验用标准品,对照品,标准试剂征订单""序号","品种编号","名称","类别","用途","","规格","单价","申请量","金额","备注"127,100158,"西咪替丁","对照品","鉴别","0158-9303","50mg","25.00 " 128,100160,"盐酸丙咪嗪","对照品","检查","0160-9602","50mg","12.50 " 129,100161,"盐酸地尔硫 ","对照品",,"10161-0102","100mg","37.50 " 130,100163,"盐酸雷尼替丁","对照品","含量测定","10163-0004","50mg","37.50 "131,100165,"盐酸乙胺丁醇","对照品","检查","10165-0103","50mg","25.00 "132,100167,"盐酸左旋咪唑","对照品","检查","0167-9202","50mg","18.75 " 133,100168,"盐酸奈福泮","对照品","含量测定","10168-0101","50mg","37.50 "134,100169,"重酒石酸去甲肾上腺素","对照品","含量测定","0169-9505","100mg","100.00 "135,100170,"左旋多巴","对照品","含量测定","0170-9302","50mg","100.00 "136,100171,"醋酸甲地孕酮","对照品","含量测定","10171-0103","50mg","37.50 "137,100172,"甲睾酮","对照品","含量测定","0172-9702","50mg","50.00 " 138,100173,"布美他尼","对照品","检查","0173-9301","50mg","25.00 " 139,100174,"氨甲环酸","对照品","检查","0174-9501","50mg","25.00 " 140,100175,"胡椒乙腈","对照品","检查","10175-0201","50mg","37.50 " 141,100176,"丙谷胺","对照品","检查","10176-0003","50mg","25.00 " 142,100177,"吡罗昔康","对照品","检查","0177-9802","50mg","25.00 "143,100179,"布洛芬","对照品","含量测定","0179-9702","50mg","37.50 " 144,100180,"倍他米松磷酸钠","对照品","含量测定","0180-9401","50mg","125.00 "145,100181,"比沙可啶","对照品","鉴别","0181-9501","50mg","12.50 " 146,100182,"雌二醇","对照品","含量测定","10182-0103","50mg","125.00 " 147,100183,"醋酸氯己定","对照品","含量测定","0183-9902","50mg","100.00 "148,100184,"双氢青蒿素","对照品","检查","100184-200302","50mg","125.00 "149,100185,"莪术醇","对照品","含量测定","100185-200305","200mg","250.00 "150,100186,"2,6-二甲基酚","对照品","检查","10186-0201","50mg","37.50 "151,100188,"环戊噻嗪","对照品","含量测定","0188-9701","50mg","100.00 "152,100189,"甲基多巴","对照品","含量测定","0189-9501","50mg","62.50 " 153,100190,"甲芬那酸","对照品","检查","0190-9501","50mg","18.75 " 154,100191,"甲硝唑","对照品","含量测定","100191-200305","200mg","125.00 "155,100192,"联苯双酯","对照品","含量测定","0192-9501","50mg","100.00 "156,100193,"螺内酯","对照品","检查","0193-9601","50mg","37.50 "157,100194,"碘化钾","对照品","含量测定","10194-0001","50mg","62.50 " 158,100195,"氯噻酮","对照品","含量测定","0195-9701","50mg","37.50 " 159,100196,"邻位甲酚","对照品","含量测定","0196-200302","1000mg","100.00 "160,100197,"硫唑嘌呤","对照品","检查","0197-9601","50mg","25.00 " "2004年药品检验用标准品,对照品,标准试剂征订单""序号","品种编号","名称","类别","用途","","规格","单价","申请量","金额","备注"161,100198,"萘普生","对照品","含量测定","10198-0002","50mg","62.50 " 162,100199,"泼尼松","对照品","含量测定","0199-9401","50mg","62.50 " 163,100200,"青蒿琥酯","对照品","检查","0200-0202","50mg","62.50 " 164,100201,"氢溴酸右美沙芬","对照品","检查","0201-9901","50mg","25.00 "165,100203,"舒必利","对照品","含量测定","0203-9702","100mg","50.00 " 166,100204,"沙丁胺醇","对照品","含量测定","0204-9701","50mg","37.50 " 167,100206,"双氰胺","对照品","检查","0206-200302","50mg","37.50 " 168,100208,"水杨酸镁","对照品","含量测定","10208-0102","50mg","37.50 "169,100209,"司坦唑醇","对照品","含量测定","0209-9401","50mg","50.00 " 170,100211,"辛可尼丁","对照品","检查","0211-9601","50mg","12.50 " 171,100212,"溴甲贝那替嗪","对照品","检查","0212-9701","50mg","25.00 " 172,100213,"硝酸咪康唑","对照品","含量测定","0213-9903","100mg","62.50 "173,100214,"硝酸益康唑","对照品","含量测定","0214-9802","100mg","50.00 "174,100216,"盐酸安他唑啉","对照品","含量测定","0216-9701","50mg","100.00 "175,100217,"盐酸苯丙醇胺","对照品","含量测定","100217-200303","200mg","125.00 "176,100218,"盐酸美西律","对照品","含量测定","0218-9601","50mg","100.00 "177,100219,"盐酸酚苄明","对照品","含量测定","0219-9902","50mg","100.00 "178,100220,"盐酸氯丙那林","对照品","含量测定","0220-9401","50mg","100.00 "179,100221,"氢醌","对照品","检查","100221-200301","50mg","100.00 " 180,100222,"盐酸罗通定","对照品","鉴别","0222-9401","50mg","62.50 " 181,100223,"盐酸维拉帕米","对照品","含量测定","0223-9601","50mg","100.00 "182,100224,"异维A酸","对照品","含量测定","10224-0202","50mg","125.00 "183,100225,"贝诺酯","对照品","含量测定","0225-9601","50mg","100.00 " 184,100226,"半乳糖","对照品","含量测定","0226-0103","50mg","100.00 " 185,100228,"醋酸甲萘氢醌","对照品","含量测定","0228-9802","50mg","100.00 "186,100229,"富马酸氯马斯汀","对照品","检查鉴别","0229-9601","50mg","62.50 "187,100230,"富马酸酮替芬","对照品","含量测定","0230-9501","50mg","100.00 "188,100231,"果糖","对照品","含量测定","100231-200304","50mg","100.00 "189,100232,"环吡酮胺","对照品","鉴别","100232-200305","50mg","125.00 "190,100233,"环己胺","对照品",,"100233-200301","50mg","125.00 "191,100235,"己内酰胺","对照品","检查","0235-9701","50mg","25.00 " 192,100236,"硝酸甘油","对照品","含量测定","0236-0201","2mg/ml","37.50 "193,100237,"磷酸苯丙哌啉","对照品","含量测定","0237-9701","50mg","37.50 "194,100238,"米诺地尔","对照品","含量测定","0238-9701","50mg","37.50 " "2004年药品检验用标准品,对照品,标准试剂征订单""序号","品种编号","名称","类别","用途","","规格","单价","申请量","金额","备注"195,100241,"羟甲香豆素","对照品","含量测定","0241-9902","100mg","100.00 "196,100244,"双嘧达莫","对照品","检查","0244-9701","50mg","25.00 "。
药物分析练习题B 答案
药物分析练习题B 答案一、名词解释1.精密称定：指称取重量应准确至所取重量的千分之一。
2.标准品系指用于生物检定，抗生素或生化药品中含量或效价测定的标准物质，按效价单位（或ug）计，以国际标准品进行标定。
3.一般鉴别试验：一般鉴别试验是依据某一类药物的化学结构或理化性质的特征，通过化学反应来鉴别药物的真伪。
4.定量限：指样品中被测物能被定量测定的最低量，其测定结果应具有一定的准确度和精密度。
5.特殊杂质：指在特定药物的生产和贮藏过程中引入的杂质。
二、填空题1.药典中规定的杂质检查项目，是指该药品在生产和贮藏中可能含有并需要控制的杂质。
2.古蔡氏检砷法的原理为金属锌与酸作用产生H2 ,与药物中微量砷盐反应生成具挥发性的AsH3 ,遇溴化汞试纸，产生黄色至棕色的砷斑，与一定量标准砷溶液产生的砷斑比较，判断药物中砷盐的含量。
3.巴比妥类药物的母核为1,3-二酰亚胺结构，为环状的丙二酰脲结构。
巴比妥类药物常为白色结晶或结晶性粉末，环状结构与碱共热时，可发生水解开环。
巴比妥类药物本身不溶于水，易溶于乙醇等有机溶剂，其钠盐易溶于水而不溶于有机溶剂。
4.对乙酰氨基酚含有酚羟基，与三氯化铁发生呈色反应，可与利多卡因和醋氨苯砜区别。
5.铈量法测定氯丙嗪含量时，当氯丙嗪失去1 个电子显红色，失去2 个电子红色消褪。
6.绿奎宁反应为喹啉类衍生物的特征反应，在酸性水溶液中，滴加微过量的溴水或氯水，再加入过量的氨水，应显绿色。
7.甾体激素类药物分子结构中存在�6�2 1,3 -4-酮基和苯环共轭系统，在紫外光区有特征吸收。
8.链霉素的结构是由一分子链霉胍和一分子链霉双糖胺结合而成的碱性苷。
9.四环素类抗生素在酸性溶液中会发生差向异构化，当pH 小于2 或pH 大于6 时差向异构化速度减小。
10.中国药典的主要内容由凡例、正文、附录和索引四部分组成。
三、选择题1.杂质限量是指药物中所含杂质的最大允许量2.药物的中金属检查中（第一法），溶液的酸碱度通常是弱酸性3.药物氯化物检查中所用的酸是稀硝酸4.药物杂质限量检查的结果是1.0ppm，表示药物所含杂质的重量是药物本身重量的百万分之一5.药物中氯化物检查的意义可以考核生产工艺是否正常和反映药物的纯度水平6.砷盐检查中，为了除去供试品中可能含有的微量硫化物的影响，在导气管中需填装蘸有下列溶液的药棉醋酸铅7.微孔滤膜法是用来检查重金属8.古蔡法检查砷盐中Zn和HCl的作用是D.生成新生台H2↑9.干燥失重主要是检查药物中A.水分及其他挥发性成分10.检查维生素C中重金属：取样2.0g，规定含重金属不得过百万分之十，应吸取标准铅溶液（每1ml=0.01mg的Pb）多少ml C. 2.0ml11.两步滴定法测定阿司匹林的含量时，每1ml氢氧化钠溶液（0.1mol/L）相当于阿司匹林（分子量=180.16）的量是E.18.02mg12.阿司匹林片剂的含量测定采用两步滴定法是因为A.片剂中有酸性稳定剂和分解产物13.阿司匹林的酸碱滴定中，要求采用中性乙醇做溶剂，所谓“中性”是指A.对所用指示剂显中性14.盐酸丁卡因与硝酸作用形成B.N-亚硝基化合物15.药物分子中具有下列哪一基团才能在酸性溶液中直接用亚硝酸钠液滴定C.芳伯氨基16.不能直接与三氯化铁试液反应的药物是D阿司匹林17.苯巴比妥在吡啶溶液中与铜离子作用，生成的络合物颜色为 B.紫色18.哪个药物与吡啶—硫酸酮作用，生成绿色配位化合物E.硫喷妥钠19.银量法测定苯巴比妥的含量，现版中国药典采用什么方法指示终点 E电位滴定法20.能使碘试液褪色的药物是B司可巴比妥四、简答题1.简述维生素C 的主要化学性质。
盐酸苯海拉明工艺规程
盐酸苯海拉明工艺规程1.引言1.1 概述盐酸苯海拉明是一种重要的有机合成中间体，在医药和化工领域具有广泛的应用。
本文旨在探讨盐酸苯海拉明的工艺规程，以期通过对生产流程、原料准备、反应条件控制等方面的介绍，为盐酸苯海拉明的制备提供指导和参考。
盐酸苯海拉明的工艺流程是一系列复杂的化学反应，需要精确的控制条件和高质量的原料。
通过本文的研究，可以更好地了解盐酸苯海拉明的制备过程，并提供一些改善和优化的建议。
在本文中，我们将首先介绍盐酸苯海拉明工艺规程的概述，包括其基本原理和应用领域。
然后，我们将详细介绍文章的结构和内容安排，以便读者能够更好地理解和阅读本文。
本文的目的在于提供一个全面而详尽的盐酸苯海拉明工艺规程，以指导和帮助从业人员正确地进行盐酸苯海拉明的制备工作。
通过本文的研究成果，我们希望能够为相关领域的研究和实践者提供有价值的参考和指导，并为今后的研究和发展提供新的思路和方向。
在接下来的章节中，我们将详细介绍盐酸苯海拉明的工艺流程，包括原料准备、反应条件控制等方面的内容。
我们将详细描述每个环节的操作步骤和注意事项，以确保生产过程的安全和高效。
同时，我们还将探讨盐酸苯海拉明的工艺优势以及相关的质量控制措施，以确保产品的优质和稳定性。
最后，我们将对盐酸苯海拉明的工艺规程进行总结，并展望未来的发展方向和挑战。
我们将提出一些可能的改进和创新方案，以期为盐酸苯海拉明的制备和应用带来更大的发展潜力。
总之，本文的概述部分为读者提供了对盐酸苯海拉明工艺规程的整体了解，并介绍了本文的结构和内容安排。
接下来的章节中，我们将对工艺流程、原料准备、反应条件控制等方面进行详细的介绍和讨论。
通过本文的研究，我们希望为相关领域的从业人员提供有用的信息和指导，推动盐酸苯海拉明的制备技术的进一步发展和应用。
1.2文章结构1.2 文章结构本文将按照以下结构进行叙述和讨论盐酸苯海拉明的工艺规程：1. 引言：在引言部分，将对盐酸苯海拉明进行概述，介绍其重要性和应用领域。
中检院国家药品标准物质目录
中检院国家药品标准物质目录第 1 页，共 52 页第 2 页，共 52 页第 3 页，共 52 页第 4 页，共 52 页第 5 页，共 52 页第 6 页，共 52 页第 7 页，共 52 页第 8 页，共 52 页第 9 页，共 52 页第 10 页，共 52 页第 11 页，共 52 页第 12 页，共 52 页第 13 页，共 52 页第 14 页，共 52 页第 15 页，共 52 页第 16 页，共 52 页第 17 页，共 52 页第 18 页，共 52 页第 19 页，共 52 页第 20 页，共 52 页第 21 页，共 52 页第 22 页，共 52 页第 23 页，共 52 页第 24 页，共 52 页第 25 页，共 52 页第 26 页，共 52 页第 27 页，共 52 页第 28 页，共 52 页第 29 页，共 52 页第 30 页，共 52 页第 31 页，共 52 页第 32 页，共 52 页第 33 页，共 52 页第 34 页，共 52 页第 35 页，共 52 页第 36 页，共 52 页第 37 页，共 52 页第 38 页，共 52 页第 39 页，共 52 页第 40 页，共 52 页第 41 页，共 52 页第 42 页，共 52 页第 43 页，共 52 页第 44 页，共 52 页第 45 页，共 52 页第 46 页，共 52 页第 47 页，共 52 页第 48 页，共 52 页第 49 页，共 52 页第 50 页，共 52 页。
盐酸苯海拉明缓释片的制备
盐酸苯海拉明缓释片的制备刘欣洋;董锐;于洋懿;葛冰;胡湘婷;韩翠艳(指导)【期刊名称】《中国高新科技》【年(卷),期】2024()2【摘要】目的 :制备24h缓释的盐酸苯海拉明缓释片。
方法 :建立盐酸苯海拉明紫外分光光度法的含量测定方法;以片剂成型情况确定制备工艺;以释放度为评价指标,筛选盐酸苯海拉明缓释片的骨架材料,确定处方;根据优选的处方工艺制备盐酸苯海拉明缓释片,考察其质量。
结果 :紫外分光光度法:在纯化水中的标准曲线:y=0.0015x+0.015,r=0.9998,线性范围:130.5~451.7μg/mL;在模拟胃液中的标准曲线:y=0.0016x-0.0074,r=0.9993,线性范围:130.5~401.5μg/mL;在模拟小肠液中的标准曲线:y=0.0016x-0.0041,r=0.9991,线性范围:130.4~401.5μg/mL;在模拟结肠液中的标准曲线:y=0.0016x-0.0179,r=0.9991,线性范围:150.5~401.5μg/mL。
精密度和回收率符合规定。
优选的处方工艺为:盐酸苯海拉明75mg、乙基纤维素360mg、滑石粉15mg,粉末直接压片,压力70N。
通过优选的处方及制备工艺制备的盐酸苯海拉明缓释片,片剂表面光滑整洁,片重差异及在不同释放介质中的释放度均在80%以上。
结论 :以乙基纤维素为骨架材料制备的不溶性盐酸苯海拉明骨架片,可缓慢释放24h,制备工艺简单,造价成本低。
【总页数】4页(P113-116)【作者】刘欣洋;董锐;于洋懿;葛冰;胡湘婷;韩翠艳(指导)【作者单位】齐齐哈尔医学院药学院【正文语种】中文【中图分类】R969【相关文献】1.盐酸苯海拉明口崩片制备工艺探讨2.复方盐酸苯海拉明凝胶的制备与质量控制3.盐酸苯海拉明凝胶的制备及质量控制4.盐酸苯海拉明口崩片的制备工艺及质量控制研究5.盐酸苯海拉明糖浆的制备及质量控制因版权原因，仅展示原文概要，查看原文内容请购买。
羟丙甲纤维素的概况
完善与改进各个单元操作方面。一般都用棉绒为原料，用
50%的氢氧化钠水溶液进行碱性处理，得到纤维素钠盐，在
进行羟丙基化和甲基化操作。最近常用的羟丙基化试剂是氧
化丙烯，而在70年代也有用丙醇作羟丙基化试剂的报道。甲
基化试剂一般都采用氯甲烷，在早期也有用溴甲烷、硫酸二
甲酯的报道。
评价：HPMC性能的指标是甲基取代度，醚化效率，聚
8、HPMC随甲氧基含量减少、凝胶点升高、水溶解度下降，表 面活性也下降。
2、用途 ①建筑工业 ②化学工业 ③化妆品业 ④食品工业 ⑤医药工业 ⑥器窑行业 ⑦其他行业
①建筑工业 1、水泥砂浆：提高水泥－砂的分散性，大幅度改善砂浆的可塑性和 保水性，对防止裂纹有效果，可增强水泥强度。 2、瓷砖水泥：提高压制瓷砖砂浆的可塑性、保水性、提高瓷砖的胶 接力，防止粉化。 3、石棉等耐火材料的涂复：作为悬浮安剂，流动性改善剂，还提高 对基底的胶接力。 4、石膏混凝浆料：改善保水性和加工性，提高对基底的胶粘力。 5、接缝水泥：添加于石膏板用的接缝水泥中，改善流动性和保水性 。 6、乳胶油灰：改善以树脂乳胶为基础油灰的流动性和保水性。 7、灰泥：作为代替天然物的浆糊，能改善保水性，提高同基底的胶 接力。 8、涂料：作为乳胶涂料的增塑剂，对改善涂料及腻子粉的操作性 能和流动性的改善有作用。 9、喷涂涂料：对防止水泥系或乳胶系喷涂只得料填料下沉和改善 流动性及喷束图形有良好效果。 10、水泥、石膏二次制品：作为水泥－石棉系等水硬性物质的压出 成型粘结剂使用，提高流动性，能得到均一的成型品。 11、纤维壁：由于抗酶抗细菌作用，作为砂壁的粘合剂是有效的。
②化学工业
1、氯乙烯、亚乙烯基的聚合：作为聚合时悬安定剂 ，分散剂，可以同乙烯醇（PVA ）羟丙基纤维素（ HPC）并用，能控制粒形和粒子的分布。
盐酸苯海拉明147-24-0
7.3 特定用途
无数据资料
8 接触控制/个体防护
8.1 暴露控制
适当的技术控制 无数据资料 人身保护设备 眼/面保护 无数据资料 皮肤保护 无数据资料 身体保护 无数据资料 呼吸系统防护 如须暴露于有害环境中,请使用P5型(美国)或P1型(欧盟英国143)防微粒呼吸器。如需更高级别防护,请 使用OV/AG/P型(美国)或ABEK-P2型(欧盟英国143)防毒罐。呼吸器使用经过测试并通过政府标准如 NIOSH（US）或CEN（EU）的呼吸器和零件。.
2.1 GHS分类
根据全球化学品统一分类和标签制度（GHS）的规定，不是危险物质或混合物。
2.2 GHS 标记要素，包括预防性的陈述
2.3 其它危害物
-无
3 成分/组成信息
3.1 物质
分子式 - C17H22ClNO 分子量 - 291.82
4 急救措施
4.1 必要的急救措施描述
一般的建议 仅供科研用途，不作为药物、家庭备用药或其它用途。 如果吸入 请教医生。向到现场的医生出示此安全技术说明书。 在皮肤接触的情况下 如果吸入,请将患者移到新鲜空气处。如呼吸停止，进行人工呼吸。请教医生。 在眼睛接触的情况下 用肥皂和大量的水冲洗。请教医生。 如果误服 谨慎起见用水冲洗眼睛。
吸入 吸入可能有害。 可能引起呼吸道刺激。 吞咽 吞咽有害。 皮肤 通过皮肤吸收可能有害。 可能引起皮肤刺激。 眼睛 可能引起眼睛刺激。 接触后的征兆和症状 无数据资料 附加说明 KR7000000
12 生态学资料
12.1 毒性
无数据资料
12.2 持久存留性和降解性
无数据资料
12.3 生物积累的潜在可能性
盐酸苯海拉明原研晶型
盐酸苯海拉明原研晶型盐酸苯海拉明（Hydrochloride of Phenylpiracetam）是一种晶型，它具有许多重要的应用和研究价值。
本文将从以下几个方面对盐酸苯海拉明原研晶型进行介绍。
盐酸苯海拉明是一种白色结晶体，具有良好的稳定性和溶解性。
它可以在常温下稳定保存，并且可以在水中迅速溶解，便于制备和使用。
这使得盐酸苯海拉明在医药领域中应用广泛。
盐酸苯海拉明具有多种药理作用。
研究表明，它可以增强大脑的认知功能和记忆能力，改善学习和记忆能力。
此外，它还具有抗疲劳和抗抑郁的作用，可以提高身体的适应能力和抵抗力。
这些作用使得盐酸苯海拉明在治疗认知障碍、神经衰弱和抑郁症等疾病方面具有潜在的价值。
盐酸苯海拉明的研究晶型对其性质和应用有着重要的影响。
研究发现，盐酸苯海拉明晶型的结构与其溶解性和稳定性密切相关。
通过研究晶型，可以优化盐酸苯海拉明的制备工艺和质量控制，提高其药效和稳定性，从而更好地满足临床需求。
盐酸苯海拉明的晶型也对其溶解度和生物利用度的研究具有重要意义。
研究发现，不同晶型的盐酸苯海拉明在体内的溶解度和吸收速度有所不同，这对于药物的吸收和代谢有着重要的影响。
通过研究晶型，可以优化盐酸苯海拉明的药物给药途径和剂型设计，提高其生物利用度和治疗效果。
盐酸苯海拉明原研晶型具有重要的应用和研究价值。
通过对其晶型的研究，可以优化其制备工艺和质量控制，提高其药效和稳定性；同时，还可以优化药物给药途径和剂型设计，提高其生物利用度和治疗效果。
我们相信，在未来的研究中，盐酸苯海拉明晶型的研究将会取得更多的突破和进展，为临床治疗和科学研究提供更好的支持和指导。
一致性评价重磅参考资料：(USP1092)溶出度试验的开发和验证
一致性评价重磅参考资料：（USP1092）溶出度试验的开发和验证2015-12-25刘建华医药信息新药开发译者：刘建华国药集团工业有限公司前言目的：溶出度试验的开发和验证（1092）目的是为溶出度的测定提供了全面的开发和验证的方法以及相应的分析技术。
本指导原则贯穿溶出度测定的全部过程，并对方法验证提供了指导和验证标准。
同时它还涉及对普通制剂和缓释制剂产生的数据和接受标准进行说明。
范围：本指导原则讨论了溶出度试验的开发和验证，重点是固体口服剂型。
所提出的概念也可能适用于其他剂型和给药途径。
对于一些不同于USP章节中的设备和程序均已给出合适的解释。
本指导原则的基本框架如下：1.前期评估（对产品开发以及溶出度方法开发的前期研究评估）1.1滤膜相容性研究（Performing Filter Compatibility）1.2原料药在不同溶媒中溶解度和稳定性的测定1.3选择溶出介质和体积1.4选择溶出设备（桨法和篮法以及其他方法）2.方法开发2.1脱气2.2沉降2.3搅拌2.4研究设计2.4.1取样时间点2.4.2观察2.4.3取样2.4.4清洗2.5数据处理2.6溶出度试验的评估3.分析整理3.1样品的处理3.2过滤3.3离心3.4分析过程3.5光谱分析3.6HPLC分析4.程序化4.1溶出介质的准备4.2样品的选择和取样时间的设计4.3取样和过滤4.4清洗4.5使用软件和计算机处理结果4.6找出需要验证的存在偏差的过程5.验证5.1专属性/安慰剂的干扰5.2线性和范围5.3准确度/回收率5.4精密度试验5.4.1重复性试验5.4.2中间精密度试验5.4.3重现性试验5.5耐用性试验5.6对照品和供试品的稳定性试验5.7程序化验证6.接受标准6.1普通速释制剂6.2缓释制剂6.3控释制剂6.4多重溶出度试验6.5溶出度结果的解释6.5.1普通速释制剂6.5.2缓释制剂6.5.3控释制剂7.参考文献1. 前期评估（对产品发展以及溶出度方法开发的前期研究评估）在方法开发之前，对用以评价剂型的溶出行为的滤膜、溶出介质、介质体积和溶出设备进行筛选是非常重要的。
仿制药一致性评价
仿制药一致性评价一：背景信息1) 2016年2月6日，国务院颁布了国办发【2016】8号文件“国务院办公厅关于开展仿制药质量和疗效一致性评价的意见”，随后国家又在短时间内连续颁布了一系列关于仿制药一致性评价工作的相关文件和指南，真正拉开了仿制药产品质量和疗效一致性评价工作的序幕。
2) 根据国家仿制药一致性评价政策和时限要求，289种基本药物要求在2018年底完成评价，其他仿制药产品若能成为“首名”或“前三名”，对市场和经济意义重大。
否则，则存在较大风险失去市场甚至文号不保。
二：认识与建议虽然国家提出了明确的时间要求和评价原则，但当前的法规并不具体，企业左右为难。
公司基于长期从事药政法规研究的工作经验，我们对本轮要求的认识如下：1) 不等不靠、主动研究。
2) 要充分重视对产品的信息回顾与整理，重视仿制药评价的整体策划，为开展研究工作打基础。
3) 重视药学研究。
仿制药研究的重点是药学部分，也是国家评价仿制药质量的重要内容，CMC是重中之重，必须先行。
4) 时间紧迫仿制药一致性评价，尤其是基本药物的评价看起来还有2年多时间，实际分解后留给企业的时间已经非常紧张，即使一切顺利也需要20-25个月。
5) 逐步开展，分段进行。
仿制药一致性评价是一个综合工程，链条长，费用高。
尤其是早年完成注册的产品，注册研究与申报资料更加薄弱，适合先初步摸索产品质量现状再进行系统深入的研究。
6) 仿制药一致性评价应分为四个阶段开展三：优势与业绩仿制药一致性评价工作是一个系统工程，需要完整的服务链条和资源配置，包括CMC研发实验室、动物GLP实验室、BE临床实验基地、生化分析实验室和注册服务团队，以及良好的公共资源，并且各个环节都要有经验丰富的技术团队与完善的质量管理体系，要经得起注册现场核查与临床现场核查。
1) 咨询拥有的优势包括以下几方面：✔建立了高水平配置的国家级CMC研发实验室，拥有专业的研发人员和十多年药品研发经验，为中国三大医药技术研究成果转化平台之一，国家基本药物标准溶出度曲线制作承担单位之一；✔合作动物GLP实验室，比格犬等大动物试验不是问题；✔集团内拥有BE临床试验基地与通过FDA审计的生化分析实验室（海口、长春、南京3个BE基地），BE试验优先快速安排；✔18年丰富经验的注册团队，轻松化解技术难题。
一致性评价之体外溶出试验——溶出数据库
一致性评价之体外溶出试验——溶出数据库溶出度试验是评价口服固体制剂内在质量的一种重要手段，旨在保证不同生产企业生产的同一药品的口服固体制剂具有相同的品质和疗效。
按照《总局关于发布化学药品仿制药口服固体制剂质量和疗效一致性评价申报资料要求(试行)的通告》(2016年第120号)，溶出曲线相似性评价研究资料是申报的必备材料之一。
参比制剂的溶出曲线和溶出条件是开展体外溶出度试验的首要条件。
一致性评价的三个重要节点，图片出自中国产业信息网药渡数据——溶出数据库包括四个子库，分别为美国FDA溶出库、日本溶出库、BCS分类-WHO数据库和BCS分类-US数据库。
溶出数据库目前已收录了超过3000条数据，其中包括美国FDA溶出数据约1270条，日本溶出数据约1260条、WHO的BCS分类数据库约120条和美国的BCS分类数据约380条。
1.FDA溶出库本数据库涵盖了FDA官网公布的所有溶出数据，根据官网不定期更新，并可支持8种关键词检索，包括药物名称、剂型、溶出介质、容积、USP溶出方法、转速、推荐采样时间和更新日期等。
本数据库也可通过药渡数据一键搜索访问，支持该药物的中英文名、商品名或者别名检索。
本数据库检索结果包括药物名称、剂型、USP溶出方法、转速(RPMs)、溶出介质、容积(mL)、推荐采样时间(minutes)和更新日期，其中可根据需要按照药物名称首字母排序或更新日期早晚调整结果显示顺序。
图中字体为蓝色的药物名称，点击后可进一步查看完整的溶出信息。
本文以Calcifediol为例，点击黄色圆框内的“Calcifediol”，跳转到黄色箭头所示窗口，该窗口可以完整展示列表页未展示完全的内容。
2.日本溶出库本数据库涵盖了日本橙皮书官网所有药物的溶出数据，每月更新一次，并可提供活性成分(日文/英文)、参比制剂(全部/是/否)、溶出试验(全部/是/否)和药品品质情报(全部/是/否)等关键词检索。
本数据库可提供日英文活性成分名、参比制剂、溶出试验和药品品质情报集等信息，可根据需要按照日英文活性成分名调整显示顺序。
盐酸苯海拉明片的说明书
盐酸苯海拉明片的说明书皮肤病已经成为现在很普遍的一种疾病，而且种类也很多，像牛皮廯，白癜风，皮肤病疱疹等。
面对各种各样的皮肤病，患者应该怎样治疗呢?盐酸苯海拉明片是现在治疗皮肤病效果相当不错的一种药物，受到很多患者的信任，下边我们就详细了解一下。
【药品名称】通用名称：盐酸苯海拉明片商品名称：盐酸苯海拉明片拼音全码：YanSuanBenHaiLaMingPian【主要成份】本品含盐酸苯海拉明(C17H21NOHCl)应为标示量的93.0％～107.0 ％。
化学名：N，N-二甲基-2-(二苯基甲氧基)乙胺盐酸盐。
分子式：C17H21NOHCl分子量：291.82【性状】本品为糖衣片，除去糖衣后显白色。
【适应症/功能主治】用于皮肤黏膜的过敏，如荨麻疹、过敏性鼻炎、皮肤瘙痒症、药疹，对虫咬症和接触性皮炎也有效。
亦可用于预防和治疗晕动病。
【规格型号】25mg*100s【用法用量】口服。
成人一次1片，一日2-3次。
用于防治晕动病时，宜在旅行前1～2小时，最少30分钟前服用。
【不良反应】剂量过度的表现有心绞痛、心律失常、心悸、腹泻、呕吐、震颤、兴奋、头痛、不安、失眠、多汗、潮红、体重减轻、骨骼肌痉挛等，通常在减少用量或停药数日后，上述表现消失。
【禁忌】重症肌无力、闭角型青光眼、前列腺肥大者禁用。
对本品及赋形剂过敏者禁用。
新生儿、早产儿禁用。
【注意事项】1.幽门十二指肠梗阻、消化性溃疡所致幽门狭窄、膀胱颈狭窄、甲状腺功能亢进、心血管病、高血压以及下呼吸道感染（包括哮喘）者不宜用本品；2.对其他乙醇胺类高度过敏者，对本品也可能过敏；3.应用本药后避免驾驶车辆、高空作业或操作机器；4.肾功能衰竭时，给药的间隔时间应延长；5.本品的镇吐作用可给某些疾病的诊断造成困难。
【儿童用药】尚不明确。
【老年患者用药】尚不明确。
【孕妇及哺乳期妇女用药】尚不明确。
【药物相互作用】1.本品可短暂影响巴比妥类药和磺胺醋酰钠等的吸收；2.和对氨基水杨酸钠同用可降低后者血药浓度；3.可增强中枢神经抑制药的作用。
SOP-QC 盐酸苯海拉明检验操作规程
盐酸苯海拉明检验操作规程1. 目的建立盐酸苯海拉明检验标准操作规程，使盐酸苯海拉明检验操作规范化。
2. 范围适用于盐酸苯海拉明的质量检验。
3. 术语或定义3.1 GMP：药品生产质量管理规范(Good Manufacturing Practice)的英文简称。
3.2 SMP：标准管理程序（Standard Management Procedure），用于指导工作的管理类文件。
3.3 SOP：标准操作程序（Standard Operating Procedure），用于指导如何完成一项工作的文件。
4. 职责质量控制部对本规程的实施负责。
5. 程序5.1 检验依据5.1.1《中国药典》2020年版二部（1199页）。
5.1.2 盐酸苯海拉明质量标准（质量标准编号：）5.1.3。
《中国药典》2020年版四部。
、1.【性状】1.1本品为白色结晶性粉末；无臭。
本品在水中极易溶解，在乙醇或三氯甲烷中易溶，在丙酮中略溶，在乙醚中极微溶解。
1.2熔点依熔点测定法检验操作规程进行测定。
本品的熔点应为167～171℃。
2.【鉴别】2.1鉴别⑴取本品5mg，加硫酸一滴，初显黄色，随即变成橙红色；滴加水，即成白色乳浊液。
2.2鉴别⑵2.2.1仪器与用具电子天平（感量0.1mg）、紫外-可见分光光度计量瓶（100ml）2.2.2操作方法取本品50mg，加0.01mol/L盐酸溶液溶解并稀释至100ml（每1ml中约含0.5mg盐酸苯海拉明），照紫外-可见分光光度法检验操作规程测定，供试品溶液在253nm与258nm的波长处有最大吸收。
2.3鉴别⑶2.3.1仪器与用具红外分光光度计、压片机、玛瑙研钵2.3.2操作方法取供试品1mg，置入玛瑙研钵研细，再取氯化钾粉(约200mg)，在玛瑙研钵中充分研磨混匀，移置于直径13mm的压模中，使铺布均匀，加压至20MPa，约60秒取出。
将供试片置于仪器的样品光路中，进行光谱扫描。
供试品的红外光吸收图谱应与对照的图谱（光谱集365图）一致。
第二节苯乙胺类药物的分析一基本结构与典型药物
4. 溶解性 游离碱难溶于水，易 溶于有机溶剂，其盐可溶于水
5. 取代基：具芳伯氨基的盐酸克 仑特罗可用重氮化—偶合反应鉴别、 亚硝酸钠滴定法测定含量。
二、鉴别试验
（一）三氯化铁反应 在 碱 性 溶 液 中 与 三 价 Fe 成紫或紫红。
（二）与甲醛—硫酸反应 (氧化?)成醌式有色物（P156）
（五）HPLC法 茶苯海明片 离子抑制色谱法
内标法定量
例1. 氨基醚衍生物类药物的鉴别反应 是（ABCD）
A. 硫酸呈色反应 B. 水解反应 C. 与硝酸银反应 D. 吸收光谱法 E. 三氯化铁反应
例2. 盐酸苯海拉明的含量测定可用 （CDE）
A. 电泳法 B. X—射线衍射法 C. 非水溶液滴定法 D. 酸性染料比色法 E. 阴离子表面活性剂滴定法
检查方法 比较法（含量测定法） 检查原理 利用酮体在310nm波长
处有最大吸收，而药物本身在 此波长处几乎没有吸收，规定 一定浓度溶液在310nm波长处的 吸收度限制酮体的量。
（二）有关物质检查 盐酸去氧肾上腺素、硫酸沙丁胺
醇等药物中的有关杂质进行检查。 检查方法：TLC中高低浓度对比法。 配制两种浓度，稀的作对照，杂质斑 点不得更深。两液相差100-200倍。
例3. 阴离子表面活性剂滴定法的终点 指示原理是（B）
A. 碱性药物和滴定剂反应，所生 成的配位化合物溶于有机溶剂而显色
B. 滴定剂和碱性染料反应，所生 成的配位化合物溶于有机溶剂而显色
碱滴定。所列14种药物中有11中采用 此法。
1 重酒石酸去甲肾上腺素的测定 0.2g加冰醋酸10ml，微温溶解，
加结晶紫指示剂一滴，高氯酸滴定至 溶液显蓝绿。空白实验校正。1ml高 氯酸滴定液（0。1mol/l）相当于31。 93mg。
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【盐酸苯海拉明】
日文名：塩酸ジフェンヒドラミン
结构式：
（ジフェンヒドラミン塩酸塩）
英文名：Diphenhydramine Hydrochloride
解离常数（25℃）：pKa = 8.6（针对叔氨基、采用滴定法测定）
在各溶出介质中的溶解度（37℃）：pH1.2：1.0g/ml以上pH4.0：1.0g/ml以上
pH 6.8：1.0g/ml以上水：1.0g/ml以上
在各溶出介质中的稳定性：
水：未测定。
在各pH值溶出介质中：在酸性溶出介质中缓慢降解。
光：缓慢降解。
《四条标准溶出曲线》
溶出度试验条件：桨板法/50转、溶出介质中不添加表面活性剂。
< 10mg规格片剂（A型）>
< 10mg规格片剂（B型）>
《质量标准》
取本品，照溶出度测定法（桨板法），以水900ml为溶出介质，转速为每分钟50转，依法操作，经30分钟时，取溶液适量，弃去至少10ml初滤液，取续滤液作为供试品溶液。
另精密称取经105℃干燥3小时的对照品22mg，置100ml量瓶中，加水溶解并稀释至刻度，摇匀，精密量取5ml，置100ml量瓶中，加水稀释至刻度，摇匀，作为对照品溶液。
取上述两种溶液照紫外-可见分光光度法，在220nm的波长处测定吸光度，计算出每片溶出量，限度为标示量的75%，应符合规定。