匹伐他汀钙配套杂质目录-2017
匹伐他汀钙片中潜在致突变杂质的检测方法[发明专利]
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(19)中华人民共和国国家知识产权局(12)发明专利申请(10)申请公布号 (43)申请公布日 (21)申请号 202010363066.2(22)申请日 2020.04.30(71)申请人 山东齐都药业有限公司地址 255400 山东省淄博市临淄区宏达路17号(72)发明人 王朋 马莹莹 胡中花 李梦琪 李颖 张晓 谢建卫 周玲玲 李晶玉 王君杰 王波 (74)专利代理机构 青岛发思特专利商标代理有限公司 37212代理人 耿霞(51)Int.Cl.G01N 30/02(2006.01)G01N 30/06(2006.01)G01N 30/34(2006.01)G01N 30/86(2006.01)(54)发明名称匹伐他汀钙片中潜在致突变杂质的检测方法(57)摘要本发明涉及药品质量检测领域，具体涉及一种匹伐他汀钙片中潜在致突变杂质的检测方法。
将待测样品采用溶剂溶解后，采用高效液相色谱法进行检测，色谱条件如下：流动相：有机酸盐缓冲液和乙腈；流速：1.0mL/min；柱温：25～40℃；色谱柱：用十八烷基硅烷键合硅胶为填充剂；进样体积：50μL；检测波长：270～280nm；洗脱方式：梯度洗脱；所述的潜在致突变杂质为杂质1和杂质2。
本发明所述的方法能够实现匹伐他汀钙、杂质1与杂质2三者的有效分离；同时避免匹伐他汀钙其他相关杂质对杂质1、杂质2检测的干扰，能够准确检测匹伐他汀钙片潜在致突变杂质1与杂质2的含量，有效监测匹伐他汀钙片药品质量，提高用药安全性。
权利要求书2页 说明书7页 附图2页CN 111505150 A 2020.08.07C N 111505150A1.一种匹伐他汀钙片中潜在致突变杂质的检测方法，其特征在于：将待测样品采用溶剂溶解后，采用高效液相色谱法进行检测，色谱条件如下：流动相：有机酸盐缓冲液和乙腈；流速：1.0mL/min；柱温：25～40℃；色谱柱：用十八烷基硅烷键合硅胶为填充剂；进样体积：50μL；检测波长：270～280nm；洗脱方式：梯度洗脱；其中，所述的潜在致突变杂质为杂质1和杂质2，杂质1的结构为：杂质2的结构为：2.根据权利要求1所述的匹伐他汀钙片中潜在致突变杂质的检测方法，其特征在于：所述的采用高效液相色谱法进行检测，采用反相高效液相色谱系统，梯度洗脱程序如下：3.根据权利要求1所述的匹伐他汀钙片中潜在致突变杂质的检测方法，其特征在于：所述的有机酸盐缓冲液为醋酸盐缓冲液，pH为3.4～3.6。
奥昔布宁杂质经验总结分享
10mg
Oxybutynin
25mg
5
10399-13-0 C15H20O3
研发申报
Impurity 1
50mg
100mg
湖北瑞诺医药---专注杂质对照品、标准品： ①布地奈德杂质 ②氟替卡松杂质 ③特布他林杂质 ④卡泊三醇杂质 ⑤托法替布杂质 q：300⑥伐地那非杂质 ⑦恩格列净杂质 ⑧卡托普利杂质 ⑨阿维巴坦杂质 ⑩孟鲁司特钠杂质 -8058⑪依折麦布杂质 ⑫普瑞巴林杂质 ⑬替卡格雷杂质 ⑭达比加群杂质 ⑮匹伐他汀钙杂质 -303 ⑯氟维司群杂质 ......等更多项目品种 并代理：CP/EP/USP/TRC/TLC/MC/LGC/RHINO 等品牌。
序号
名称
奥昔布宁杂质总结分享
CAS
分子式
规格 用途
10mg
Oxybutynin EP
2H35NO3
研发申报
Impurity A
50mg
100mg
结构式
Oxybutynin EP
2
14943-53-4
Impurity B
C22H25NO3
10mg 25mg 50mg 100mg
研发申报
10mg
Oxybutynin
25mg
3
1199574-70-3 C21H29NO3
研发申报
Impurity C
50mg
100mg
10mg
Oxybutynin 1215677-72-7 C23H33NO3. 25mg
4
研发申报
Impurity E (free base)
HCl
50mg
100mg
仿制药参比制剂目录(1-10批)
序号药品通用名称英文名称/商品名规格1-1盐酸胺碘酮片Amiodarone Hydrochloride Tablets/Cordarone0.2g 1-2阿卡波糖片Acarbose Tablets/Glucobay50mg 1-3尼莫地平片Nimodipine Tablets/Nimotop30mg1-4头孢呋辛酯片Cefuroxime Axetil Tablets/Ceftin按头孢呋辛(C16H16N4O8S)计0.125g1-5头孢呋辛酯片Cefuroxime Axetil Tablets/Zinacef按头孢呋辛(C16H16N4O8S)计0.25g1-6辛伐他汀片Simvastatin Tablets/Zocor10mg 1-7辛伐他汀片Simvastatin Tablets/Zocor20mg1-8盐酸氨溴索片Ambroxol Hydrochloride Tablets/Mucosolvan30mg1-9聚乙二醇4000散Macrogol 4000 powder/Forlax10g 1-10醋酸去氨加压素片Desmopressin Acetate Tablets/Minirin0.1mg1-11醋酸去氨加压素片Desmopressin Acetate Tablets/Minirin0.2mg 1-12富马酸比索洛尔片Bisoprolol Fumarate Tablets/ Concor 2.5mg 1-13富马酸比索洛尔片Bisoprolol Fumarate Tablets/ Concor5mg 1-14白消安片Busulfan Tablets/Myleran2mg 1-15富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel25mg 1-16富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel0.1g 1-17醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets/Provera0.1g 1-18醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets/Provera0.25g1-19阿莫西林克拉维酸钾片Amoxicillin and Clavulanate PotassiumTablets/Augmentin0.375g（C16H19N3O5S0.25g与C8H9NO50.125g）1-20阿莫西林克拉维酸钾片Amoxicillin and Clavulanate PotassiumTablets/Augmentin0.625g（C16H19N3O5S0.5g与C8H9NO50.125g）1-21阿莫西林克拉维酸钾片Amoxicillin and Clavulanate PotassiumTablets/Augmentin1g（C16H19N3O5S0.875g与C8H9NO50.125g）1-22格列美脲片Glimepiride Tablets/Amaryl1mg 1-23格列美脲片Glimepiride Tablets/Amaryl2mg 1-24环孢素软胶囊Ciclosporin Soft Capsules/Sandimmun Neoral10mg 1-25环孢素软胶囊Ciclosporin Soft Capsules/Sandimmun Neoral25mg 1-26环孢素软胶囊Ciclosporin Soft Capsules/Sandimmun Neoral50mg 1-27甲巯咪唑片Thiamazole Tablets/Thyrozol5mg 1-28硫酸氢氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets/Plavix75mg 1-29硝酸甘油舌下片Nitroglycerin Sublingual Tablets/ Nitrostat0.6mg 1-30克拉霉素片Clarithromycin Tablets/Klacid0.25g 1-31阿立哌唑片Aripiprazole Tablets/Abilify5mg 1-32阿立哌唑片Aripiprazole Tablets/Abilify10mg1-33阿立哌唑口崩片Aripiprazole Orally Disintegratingtablets/Abilify10mg1-34盐酸环丙沙星片Ciprofloxacin HydrochlorideTablets/Ciprobay0.25g(按C17H18FN3O3计)1-35盐酸环丙沙星片Ciprofloxacin HydrochlorideTablets/Ciprobay0.5g(按C17H18FN3O3计)1-36盐酸特拉唑嗪片Terazosin Hydrochloride Tablets/Hytrin2mg(按C19H25N5O4计)1-37吲达帕胺片Indapamide Tablets/Natrilix 2.5mg 1-38吲达帕胺缓释片Indapamide Sustained-release Tablets/Natrilix 1.5mg 1-39左甲状腺素钠片Levothyroxine Sodium Tablets/Euthyrox50μg 1-40佐匹克隆片Zopiclone Tablets/Imovane7.5mg1-41佐匹克隆片Zopiclone Tablets/Imovane 3.75mg1-42硫唑嘌呤片Azathioprine Tablets/Imuran50mg1-43奈韦拉平片Nevirapine Tablets/Viramune0.2g 1-44米索前列醇片Misoprostol Tablets/Cytotec0.2mg1-45马来酸依那普利片Enalapril Maleate Tablets/Renitec5mg 1-46马来酸依那普利片Enalapril Maleate Tablets/Renitec10mg1-47拉米夫定片Lamivudine Tablets/Epivir(3TC)0.15g 1-48拉米夫定片Lamivudine Tablets/Epivir(3TC)0.3g 1-49拉米夫定片Lamivudine Tablets/Epivir-HBV0.1g 1-50氯雷他定片Loratadine Tablets/Clarityne10mg 1-51氯雷他定胶囊Loratadine Capsules/Claritin10mg2-1盐酸胺碘酮片Amiodarone Hydrochloride Tablets/Ancaron0.1g 2-2阿卡波糖片Acarbose Tablets/Glucobay0.1g2-3头孢呋辛酯片Cefuroxime Axetil Tablets/Ceftin按头孢呋辛(C16H16N4O8S)计0.5g2-4头孢呋辛酯干混悬剂Cefuroxime Axetil for Suspension/Zinnat按头孢呋辛(C16H16N4O8S)计0.125g2-5辛伐他汀片Simvastatin Tablets/Zocor5mg 2-6辛伐他汀片Simvastatin Tablets/Zocor40mg2-7盐酸氨溴索片Ambroxol Hydrochloride Tablets/Mucosolvan60mg2-8盐酸氨溴索缓释胶囊Ambroxol Hydrochloride Sustained-releaseCapsules/Mucosolvan75mg2-9富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel0.2g 2-10富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel0.3g 2-11富马酸喹硫平片Quetiapine Fumarate Tablets/Seroquel50mg 2-12醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets/Provera10mg 2-13醋酸甲羟孕酮片Medroxyprogesterone Acetate Tablets/Farlutal0.5g2-14阿莫西林克拉维酸钾干混悬剂Amoxicillin and Clavulanate Potassium forSuspension/Augmentin0.15625g（C16H19N3O5S0.125g与C8H9NO50.03125g）2-15阿莫西林克拉维酸钾干混悬剂Amoxicillin and Clavulanate Potassium forSuspension/Augmentin0.3125g（C16H19N3O5S0.25g与C8H9NO50.0625g）2-16阿莫西林克拉维酸钾干混悬剂Amoxicillin and Clavulanate Potassium forSuspension/Augmentin0.2285g（C16H19N3O5S0.2g与C8H9NO50.0285g）2-17硫酸氢氯吡格雷片Clopidogrel Hydrogen Sulphate Tablets/Plavix300mg2-18克拉霉素缓释片Clarithromycin Sustained-releaseTablets/Klacid SR0.5g2-19克拉霉素干混悬剂Clarithromycin for Suspension/Klacid0.125g 2-20克拉霉素干混悬剂Clarithromycin for Suspension/Klacid0.25g 2-21阿立哌唑片Aripiprazole Tablets/Abilify15mg2-22盐酸特拉唑嗪片Terazosin Hydrochloride Tablets/Hytrin1mg(按C19H25N5O4计)2-23盐酸特拉唑嗪片Terazosin Hydrochloride Tablets/Hytrin5mg(按C19H25N5O4计)2-24盐酸特拉唑嗪胶囊Terazosin Hydrochloride Capsule/TerazosinHydrochloride1mg(按C19H25N5O4计)2-25盐酸特拉唑嗪胶囊Terazosin Hydrochloride Capsule/TerazosinHydrochloride2mg(按C19H25N5O4计)2-26左甲状腺素钠片Levothyroxine Sodium Tablets/Euthyrox25μg2-27左甲状腺素钠片Levothyroxine Sodium Tablets/Euthyrox100μg 2-28右佐匹克隆片Eszopiclone Tablets/ Lunesta3mg 2-29右佐匹克隆片Eszopiclone Tablets/ Lunesta2mg 2-30右佐匹克隆片Eszopiclone Tablets/ Lunesta1mg 2-31马来酸依那普利片Enalapril Maleate Tablets/Vasotec 2.5mg2-32氯雷他定咀嚼片Loratadine Chewable Tablets/Children'sClaritin5mg2-33氯雷他定口崩片Loratadine Orally Disintegrating Tablets/Claritin Reditabs10mg3-1氟康唑片Fluconazole Tablets/Diflucan50mg 3-2氟康唑片Fluconazole Tablets/Diflucan0.1g3-3氟康唑胶囊Fluconazole Capsules/Triflucan50mg 3-4氟康唑胶囊Fluconazole Capsules/Triflucan0.1g3-5盐酸克林霉素胶囊Clindamycin Hydrochloride Capsules/CleocinHydrochloride按克林霉素（C18H33ClN2O5S）计0.15g3-6苯磺酸氨氯地平片Amlodipine BesilateTablets/Norvasc按氨氯地平（C20H25ClN2O5）计5mg3-7格列吡嗪片Glipizide Tablets/Glucotrol5mg3-8布洛芬片IbuprofenTablets/Brufen0.1g 3-9布洛芬片IbuprofenTablets/Motrin IB0.2g 3-10布洛芬颗粒Ibuprofen Granules/Brufen20%1g 3-11布洛芬胶囊Ibuprofen Capsules/Ibuprofen0.2g3-12硫酸氢氯吡格雷片Clopidogrel Bisulfate Tablets/Plavix25mg（按C16H16ClNO2S计）3-13阿司匹林肠溶片Aspirin Enteric-coated Tablets/Aspirin0.3g 3-14阿司匹林片Aspirin Tablets/Aspirin0.3g 3-15阿司匹林片Aspirin Tablets/Aspirin0.5g3-16阿莫西林片Amoxicillin Tablets/Sawacillin0.25g（按C16H19N3O5S计）3-17阿莫西林胶囊Amoxicillin Capsules/Amoxil0.25g（按C16H19N3O5S计）3-18阿替洛尔片Atenolol Tablets/Tenormin25mg 3-19阿替洛尔片Atenolol Tablets/Tenormin50mg 3-20卡马西平片Carbamazepine Tablets/Tegretol0.1g 3-21卡马西平片Carbamazepine Tablets/Tegretol0.2g 3-22阿法骨化醇片Alfacalcidol Tablets/Bon-One0.25μg 3-23阿法骨化醇片Alfacalcidol Tablets/Bon-One0.5μg3-24阿法骨化醇软胶囊Alfacalcidol Soft Capsules/Etalpha0.25μg 3-25阿法骨化醇软胶囊Alfacalcidol Soft Capsules/One-Alpha0.5μg 3-26阿奇霉素片Azithromycin Tablets/Azitromycin 250 TEVA0.25g3-27阿奇霉素胶囊Azithromycin Capsules/Sumamed0.25g 4-1氟康唑片Fluconazole Tablets/Diflucan0.15g4-2氟康唑胶囊Fluconazole Capsules/Triflucan0.15g4-3盐酸克林霉素胶囊Clindamycin Hydrochloride Capsules/CleocinHydrochloride按克林霉素(C18H33ClN2O5S)计75mg4-4盐酸克林霉素胶囊Clindamycin Hydrochloride Capsules/CleocinHydrochloride按克林霉素(C18H33ClN2O5S)计0.3g4-5盐酸克林霉素棕榈酸酯颗粒Clindamycin Palmitate HydrochlorideGranules/Cleocin按克林霉素(C18H33ClN2O5S)计75mg/5ml4-6苯磺酸氨氯地平片Amlodipine BesilateTablets/Norvasc按氨氯地平(C20H25ClN2O5)计2.5mg4-7苯磺酸氨氯地平片Amlodipine BesilateTablets/Norvasc按氨氯地平(C20H25ClN2O5)计10mg4-8苯磺酸氨氯地平胶囊Amlodipine Besilate Capsules/Amlor按氨氯地平(C20H25ClN2O5)计5mg4-9格列吡嗪片Glipizide Tablets/Mindiab 2.5mg 4-10格列吡嗪控释片Glipizide Controlled Tablets/Glucotrol XL5mg4-11利培酮口崩片Risperidone Orally DisintegratingTablets/Risperdal0.5mg4-12利培酮口崩片Risperidone Orally DisintegratingTablets/Risperdal1mg4-13利培酮口崩片Risperidone Orally DisintegratingTablets/Risperdal2mg4-14布洛芬片IbuprofenTablets/Ibuprofen0.4g4-15布洛芬咀嚼片 Ibuprofen Chewable Tablets/Children'sMotrin50mg4-16布洛芬软胶囊Ibuprofen Soft Capsules/Advil0.2g4-17布洛芬口崩片Ibuprofen Orally Disintegrating Tablets/Nurofen0.1g4-18布洛芬口崩片Ibuprofen Orally DisintegratingTablets/Nurofen0.2g4-19阿司匹林缓释胶囊Aspirin Sustained-Release Capsules/Durlaza162.5mg 4-20阿司匹林肠溶片Aspirin Enteric-Coated Tablets/Bayaspirin0.1g4-21阿莫西林胶囊Amoxicillin Capsules/Amoxil0.5g（按C16H19N3O5S计）4-22阿莫西林咀嚼片Amoxicillin Chewable Tablets/Amoxicillin0.125g（按C16H19N3O5S计）4-23阿莫西林咀嚼片Amoxicillin Chewable Tablets/Amoxicillin0.25g（按C16H19N3O5S计）4-24阿莫西林干混悬剂Amoxicillin for Suspension/Clamoxyl250mg/5ml（按C16H19N3O5S计）4-25阿莫西林干混悬剂Amoxicillin for Suspension/Clamoxyl125mg/5ml（按C16H19N3O5S计）4-26阿替洛尔片Atenolol Tablets/Tenormin0.1g4-27瑞舒伐他汀钙片Rosuvastatin Calcium Tables/Crestor5mg（按C22H27FN3O6S)计）4-28瑞舒伐他汀钙片Rosuvastatin Calcium Tables/Crestor10mg（按C22H27FN3O6S)计）4-29瑞舒伐他汀钙片Rosuvastatin Calcium Tables/Crestor20mg（按C22H27FN3O6S)计）4-30卡马西平缓释片Carbamazepine Sustained-releaseTablets/Tegretol-XR0.2g4-31阿奇霉素片Azithromycin Tablets/Sumamed0.125g 4-32阿奇霉素片Azithromycin Tablets/Sumamed0.5g4-33阿奇霉素干混悬剂Azithromycin for Suspension/Sumamed100mg/5ml5-1艾司唑仑片Estazolam Tablets/EURODIN1mg5-2艾司唑仑片Estazolam Tablets/EURODIN2mg5-3氨茶碱片Aminophylline Tablets/Neophyllin 0.1g（按C2H8N2（C7H8N4O2）2·2H2O计）5-4丙硫氧嘧啶片Propylthiouracil Tablets/Propylthiouracil50mg 5-5醋酸甲地孕酮片Megestrol Acetate Tablets/Megace0.16g 5-6地高辛片Digoxin Tablets/Lanoxin0.25mg5-7多潘立酮片Domperidone Tablets/Motilium10mg5-8奋乃静片Perphenazine Tablets/PERPHENAZINE2mg 5-9奋乃静片Perphenazine Tablets/PERPHENAZINE4mg5-10复方地芬诺酯片Compound Diphenoxylate HydrochlorideTablets/Lomotil盐酸地芬诺酯2.5mg，硫酸阿托品25μg5-11格列本脲片Glibenclamide Tablets/Daonil 2.5mg5-12枸橼酸他莫昔芬片Tamoxifen Citrate Tablets/Nolvadex 10mg（按他莫昔芬计）5-13红霉素肠溶胶囊Erythromycin Enteric Capsules/ERYC 0.25g（25万单位）5-14红霉素肠溶片Erythromycin Enteric-coated Tablets/ERY-TAB0.25g（25万单位）5-15琥珀酸亚铁片Ferrous Succinate Tablets/INOFER0.1g5-16华法林钠片Warfarin Sodium Tablets/Coumadin 2.5mg 5-17华法林钠片Warfarin Sodium Tablets/Coumadin5mg 5-18己烯雌酚片Diethylstilbestrol Tablets /DISTILBENE1mg5-19卡托普利片Captopril Tablets/CAPTORIL 12.5mg 5-20卡托普利片Captopril Tablets/CAPTORIL 25mg 5-21利培酮片Risperidone Tablets/Risperdal1mg 5-22利培酮片Risperidone Tablets/Risperdal2mg5-23柳氮磺吡啶肠溶片Sulfasalazine Enteric-coatedTablets/Azulfidine0.25g5-24马来酸多潘立酮片Domperidone Maleate Tablets/Motilium10mg（按C22H24ClN5O2计）5-25麦角胺咖啡因片Ergotamine and CaffeineTablets/CAFERGOT酒石酸麦角胺1mg，无水咖啡因100mg5-26蒙脱石散Montmorillonite Powder/SMECTA3g 5-27米非司酮片Mifepristone Tablets/Mifegyne0.2g5-28诺氟沙星片Norfloxacin Tablets/BACCIDAL0.1g 5-29氢化可的松片Hydrocortisone Tablets/Cortef10mg 5-30氢化可的松片Hydrocortisone Tablets/Cortef20mg 5-31舒必利片Sulpiride Tablets/Abilit0.1g 5-32舒必利片Sulpiride Tablets/Abilit50mg 5-33替加氟胶囊Tegafur Capsules/Futraful0.2g5-34替硝唑片Tinidazole Tablets/Fasigyn0.5g 5-35硝酸异山梨酯片Isosorbide Dinitrate Tablets/ISORDIL5mg5-36盐酸地尔硫䓬片Diltiazem Hydrochloride Tablets/HERBESSER 30mg 5-37盐酸二甲双胍片Metformin Hydrochloride Tablets/Glycoran 0.25g 5-38盐酸二甲双胍片Metformin Hydrochloride Tablets/Glucophage0.5g 5-39盐酸雷尼替丁胶囊Ranitidine Hydrochloride Capsules ／RANITIDINE HYDROCHLORIDE 0.15g （按C 13H 22N 403S 计）5-40盐酸雷尼替丁片Ranitidine Hydrochloride Tablets ／Zantac 0.15g （按C 13H 22N 403S 计）5-41盐酸美西律片Mexiletine Hydrochloride Tablets/MexiletineHydrochloride50mg 5-42盐酸美西律片Mexiletine Hydrochloride Tablets/MexiletineHydrochloride0.1g 5-43盐酸帕罗西汀片Paroxetine Hydrochloride/Paxil 20mg （按C 19H 20FNO 3计）5-44盐酸乙胺丁醇片Ethambutol Hydrochloride Tables/Ebutol0.25g 5-45异烟肼片Isoniazid Tablets/Isoniazid 0.3g 5-46异烟肼片Isoniazid Tablets/Isoniazid0.1g 5-47盐酸普萘洛尔片Propranolol Hydrochloride Tablets/Inderal10mg 5-48丙硫氧嘧啶片Propylthiouracil Tablets/PROPYL-THYRACIL 0.1g 5-49磷酸氯喹片Chloroquine Phosphate Tablets/Resochin0.25g （按氯喹C 18H 26ClN 3计155mg ）6-1草酸艾司西酞普兰片Escitalopram Oxalate Tablets/Lexapro 5mg(按C 20H 21FN 2O 计)6-2草酸艾司西酞普兰片Escitalopram Oxalate Tablets/Lexapro 10mg(按C 20H 21FN 2O 计)6-3草酸艾司西酞普兰片Escitalopram Oxalate Tablets/Lexapro20mg(按C 20H 21FN 2O 计)6-4多潘立酮口崩片Domperidone Orally DisintegratingTablets/Motilium 10mg 6-5恩替卡韦片Entecavir Tablets /BARACLUDE 0.5mg 6-6恩替卡韦片Entecavir Tablets /BARACLUDE 1mg 6-7红霉素肠溶片Erythromycin Enteric-coated Tablets/ERY-TAB 0.5g （50万单位）6-8甲磺酸倍他司汀片Betahistine Mesilate Tablets/Merislon6mg 6-9利培酮片Risperidone Tablets/Risperdal 3mg 6-10磷酸奥司他韦胶囊Oseltamivir Phosphate Capsules/ Tamiflu75mg （按C 16H 28N 2O 4计）6-11硫酸氨基葡萄糖胶囊Glucosamine Sulfate Capsules/Viartril-S0.25g(以硫酸氨基葡萄糖计)6-12硫酸羟氯喹片 Hydroxychloroquine Sulfate Tablets/Plaquenil0.2g 6-13匹伐他汀钙片Pitavastatin CalciumTablets /Livalo Kowa1mg 6-14匹伐他汀钙片Pitavastatin CalciumTablets /Livalo Kowa2mg6-15氢溴酸西酞普兰片Citalopram Hydrobromide Tablets/Cipramil20mg(按C20H21FN2O计)6-16头孢地尼胶囊Cefdinir Capsules/Cefzon0.1g 6-17缬沙坦胶囊Valsartan Capsules/DIOVAN40mg 6-18缬沙坦胶囊Valsartan Capsules/DIOVAN0.16g6-19缬沙坦片Valsartan Tablets/DIOVAN0.16g 6-20缬沙坦片Valsartan Tablets/DIOVAN80mg 6-21缬沙坦片Valsartan Tablets/DIOVAN40mg 6-22盐酸乙胺丁醇片Ethambutol Hydrochloride Tablets/Myambutol0.4g6-23盐酸地尔硫䓬片Diltiazem Hydrochloride Tablets/HERBESSER60mg6-24盐酸二甲双胍缓释片Metformin Hydrochloride Sustained-releaseTablets/GLUCOPHAGE XR0.5g6-25盐酸二甲双胍片Metformin Hydrochloride Tablets/Glucophage0.85g6-26盐酸雷尼替丁片Ranitidine Hydrochloride Tablets／Zantac75mg（按C13H22N403S计）6-27盐酸美西律胶囊Mexiletine Hydrochloride Capsules/Mexitil50mg 6-28盐酸美西律胶囊Mexiletine Hydrochloride Capsules/Mexitil0.1g6-29盐酸特比萘芬片Terbinafine Hydrochloride Tablets/Lamisil0.125g（按C21H25N计）6-30盐酸特比萘芬片Terbinafine Hydrochloride Tablets/Lamisil0.25g（按C21H25N计）6-31盐酸西替利嗪口崩片Cetirizine Hydrochloride Orally DisintegratingTablets/Zyrtec Allergy10mg6-32盐酸西替利嗪片Cetirizine Hydrochloride Tablets/Zyrtec10mg 6-33盐酸左西替利嗪片Levocetirizine Hydrochloride Tablets/Xyzal5mg6-34硬脂酸红霉素片Erythromycin Stearate Tablets/ERYTHROCINSTEARATE0.25g（按C37H67NO13计，25万单位）6-35阿司匹林肠溶胶囊Aspirin Enteric Capsules/Astrix0.1g 7-1阿普唑仑片Alprazolam Tablets/Solanax0.4mg7-2阿昔洛韦胶囊Aciclovir Capsules/Zovirax0.2g7-3阿昔洛韦片Aciclovir Tablets/Zovirax0.2g 7-4氨苯砜片Dapsone Tablets /--0.1g7-5奥美拉唑肠溶胶囊Omeprazole Enteric Capsules/Losec20mg 7-6奥美拉唑肠溶胶囊Omeprazole Enteric Capsules/Losec10mg7-7奥美拉唑肠溶片Omeprazole Enteric-coated Tablets/Omepral20mg 7-8奥美拉唑肠溶片Omeprazole Enteric-coated Tablets/Omepral10mg7-9苯巴比妥片Phenobarbital Tablets/Luminaletten15mg 7-10苯巴比妥片Phenobarbital Tablets/Phenobal30mg 7-11苯巴比妥片Phenobarbital Tablets/Luminal0.1g 7-12苯妥英钠片Phenytoin Sodium Tablets50mg 7-13苯妥英钠片Phenytoin Sodium Tablets0.1g 7-14别嘌醇片Allopurinol Tablets/Zyloprim0.1g7-15丙戊酸钠片Sodium Valproate Tablets/Depakene0.1g 7-16丙戊酸钠片Sodium Valproate Tablets/Depakene0.2g7-17茶碱缓释片Theophylline Sustained-releaseTablets/Theolong0.1g（按C7H8N4O2计）7-18茶碱缓释片Theophylline Sustained-releaseTablets/THEODUR0.1g（按C7H8N4O2计）7-19茶碱缓释片Theophylline Sustained-releaseTablets/UNICON0.1g（按C7H8N4O2计）7-20茶碱缓释片Theophylline Sustained-releaseTablets/THEOPHYLLINE0.1g（按C7H8N4O2计）7-21地红霉素肠溶片Dirithromycin Enteric CoatedTablets/Dynabac0.25g7-22地塞米松片Dexamethasone Tablets/DEXAMETHASONE0.75mg 7-23地西泮片Diazepam Tablets/VALIUM5mg7-24对乙酰氨基酚片Paracetamol Tablets/Panadol Original Tablets0.5g 7-25对乙酰氨基酚片Paracetamol Tablets/Panadol Advance Tablets0.5g7-26法莫替丁片Famotidine Tablets/Gaster20mg 7-27呋塞米片Furosemide Tablets/LASIX20mg 7-28氟哌啶醇片Haloperidol Tablets/HALOPERIDOL2mg7-29复方磺胺甲噁唑片Compound SulfamethoxazoleTablets/BACTRIM磺胺甲噁唑0.4g，甲氧苄啶80mg7-30复方左炔诺孕酮片Compound LevonorgestrelTablets/Microgynon 30左炔诺孕酮0.15mg，炔雌醇0.03mg7-31磺胺嘧啶片Sulfadiazine Tablets0.5g 7-32甲氨蝶呤片Methotrexate Tablets/METHOTREXATE 2.5mg7-33甲硝唑片Metronidazole Tablets/FLAGYL0.2g 7-34酒石酸美托洛尔片Metoprolol Tartrate Tablets/Seloken50mg7-35劳拉西泮片Lorazepam Tablets/Ativan1mg 7-36劳拉西泮片Lorazepam Tablets/Ativan0.5mg7-37利福平胶囊Rifampicin Capsules/RIFADIN0.3g 7-38利福平胶囊Rifampicin Capsules/RIFADIN0.15g7-39硫酸吗啡缓释片Morphine Sulphate Sustained-release Tablets/--10mg7-40硫酸吗啡缓释片Morphine Sulphate Sustained-release Tablets/--30mg7-41硫酸吗啡缓释片Morphine Sulphate Sustained-release Tablets/--60mg25mg Clozapine Tablets/Clozaril氯氮平片7-427-43氯氮平片Clozapine Tablets/Leponex 50mg7-44氯化钾颗粒Potassium Chloride Granules/PotassiumChloride20MEQ(相当于1.5g 氯化钾)7-45氯硝西泮片Clonazepam Tablets/Klonopin 2mg 7-46氯硝西泮片Clonazepam Tablets/Klonopin 0.5mg 7-47马来酸氯苯那敏片Chlorphenamine Maleate Tablets/Chlor-Tripolon 4mg7-48尼群地平片Nitrendipine Tablets/Bayotensin mite 10mg 7-49齐多夫定胶囊Zidovudine Capsules/Retrovir0.1g 7-50齐多夫定片Zidovudine Tablets/--0.3g 7-52秋水仙碱片Colchicine Tablets/Colchicine 0.5mg 7-53巯嘌呤片Mercaptopurine Tablets/Purinethol 50mg 7-54双氯芬酸钠肠溶片Diclofenac Sodium Enteric-coatedTablets/Voltaren 25mg7-55双氯芬酸钠缓释胶囊Diclofenac Sodium Sustained Release Capsules/Diclofenac-Actavis 100 mgRetardkapseln 0.1g7-56双氯芬酸钠缓释胶囊Diclofenac Sodium Sustained ReleaseCapsules/Diclomax Retard 0.1g7-57双氯芬酸钠缓释片Diclofenac Sodium Sustained ReleaseTablets/Voltaren 0.1g7-58双氯芬酸钠缓释片Diclofenac Sodium Sustained ReleaseTablets/Voltarene LP 0.1g7-59双氯芬酸钠缓释片Diclofenac Sodium Sustained ReleaseTablets/--0.1g 7-60双嘧达莫片Dipyridamole Tablets/Persantin 25mg 7-61司他夫定胶囊Stavudine Capsules/Zerit15mg25mg25mg Clozapine Tablets/Clozaril Hydrochlorothiazide Tablets/Esidrix 氯氮平片氢氯噻嗪片7-427-517-62司他夫定胶囊Stavudine Capsules/Zerit20mg 7-63司他夫定胶囊Stavudine Capsules/Zerit40mg 7-64碳酸锂片Lithium Carbonate Tablets/TERALITHE0.25g7-65头孢氨苄胶囊Cefalexin Capsules / Keflex0.25g（按C16H17N3O4S计）7-66头孢氨苄胶囊Cefalexin Capsules / Sencephalin0.125g（按C16H17N3O4S计）7-67头孢氨苄片Cefalexin Tablets / Keflex0.25g（按C16H17N3O4S计）7-68硝苯地平缓释片Nifedipine Sustained-release Tablets/Adalatretard20mg7-69硝苯地平缓释片Nifedipine Sustained-release Tablets/Adalat-L20mg7-70缬沙坦胶囊Valsartan Capsules/DIOVAN80mg7-71熊去氧胆酸片Ursodeoxycholic Acid Tablets/URSO50mg 7-72溴吡斯的明片Pyridostigmine Bromide Tablets/Mestinon60mg 7-73盐酸阿米替林片Amitriptyline Hydrochloride Tablets/--25mg7-74盐酸昂丹司琼片Ondansetron Hydrochloride Tablets/Zofran4mg（按C18H19N3O计）7-75盐酸昂丹司琼片Ondansetron Hydrochloride Tablets/Zofran8mg（按C18H19N3O计）7-76盐酸苯海拉明片Diphenhydramine Hydrochloride Tablets/Benadryl25mg7-77盐酸地芬尼多片Difenidol Hydrochloride Tablets/Cephadol25mg7-78盐酸多塞平片Doxepin Hydrochloride Tablets/SINEQUAN25mg（按C19H21NO计）7-79盐酸多西环素片Doxycycline Hyclate Tablets/Vibramycin0.1g(按C22H24N2O8计)7-80盐酸多西环素片Doxycycline Hyclate Tablets/Vibramycin50mg(按C22H24N2O8计)7-81盐酸氟桂利嗪片Flunarizine Hydrochloride Tablets/Sibelium5mg（按C26H26F2N2计）7-82盐酸金刚烷胺片Amantadine HydrochlorideTablets/AMANTADINE HYDROCHLORIDE0.1g7-83盐酸氯丙嗪片Chlorpromazine HydrochlorideTablets/Largactil25mg 7-84盐酸氯米帕明片Clomipramine HydrochlorideTablets/Anafranil 10mg 7-85盐酸氯米帕明片Clomipramine Hydrochloride Tablets/Anafranil25mg 7-86盐酸普罗帕酮片Propafenone Hydrochloride Tablets/Pronon100mg Verapamil Hydrochloride Tablets/Isoptin mite 7-88盐酸溴己新片Bromhexine Hydrochloride Tablets/Bisolvon8mg7-89盐酸异丙嗪片Promethazine HydrochlorideTablets/Phenergan25mg7-90叶酸片Folic Acid Tablets/SPECIAFOLDINE 5mg7-91依非韦伦片Efavirenz Tablets/ Stocrin 50mg 7-92依非韦伦片Efavirenz Tablets/ Stocrin 0.2g 7-93依非韦伦片Efavirenz Tablets/ Stocrin 0.6g 7-95盐酸苯海索片Trihexyphenidyl Hydrochloride Tablets/Trihexyphenidyl Hydrochloride2mg 7-96卡托普利片Captopril Tablets/Capoten 25mg 7-97阿奇霉素片Azithromycin Tablets/Zithromax 0.25g 8-1阿折地平片Azelnidipine Tablets/Calblock 8mg 8-2阿折地平片Azelnidipine Tablets/Calblock 16mg 8-3阿苯达唑片Albendazole Tablets/Zentel 0.4g 8-4阿德福韦酯片Adefovir Dipivoxil Tablets/Hepsera 10mg 8-5阿仑膦酸钠片Alendronate Sodium Tablets/Fosamax 10mg （按C 4H 13NO 7P 2计）8-6阿仑膦酸钠片Alendronate Sodium Tablets/Fosamax70mg （按C 4H 13NO 7P 2计）8-7阿仑膦酸钠维D 3片Alendronate Sodium and Vitamin D3 Tablets/--阿仑膦酸钠（以C 4H 13NO 7P 2计）70mg 和维生素D 32800IU40mg0.25g Acetazolamide Tablets/Diamox 盐酸维拉帕米片乙酰唑胺片7-877-948-8阿莫西林舒巴坦匹酯片Amoxicillin and Sulbactam PivoxilTablets/Trifamox IBL0.5g(C16H19N3O5S0.25g与C8H11NO5S 0.25g)8-9阿那曲唑片Anastrozole Tablets/Arimidex1mg8-10阿托伐他汀钙片Atorvastatin Calcium Tablets/Lipitor10mg（按C33H35FN2O5计）8-11阿托伐他汀钙片Atorvastatin Calcium Tablets/Lipitor20mg（按C33H35FN2O5计）8-12阿托伐他汀钙片Atorvastatin Calcium Tablets/Lipitor40mg（按C33H35FN2O5计）8-13阿维A胶囊Acitretin Capsules/Neotigason10mg8-14阿昔洛韦分散片Aciclovir Dispersible Tablets/Zovirax0.2g8-15阿昔洛韦片Aciclovir Tablets/Zovirax0.4g 8-16阿昔莫司胶囊Acipimox Capsules/Olbetam0.25g8-17氨酪酸片Aminobutyric Acid Tablets/GAMMALON0.25g8-18奥氮平片Olanzapine Tablets/ Zyprexa 2.5mg 8-19奥氮平片Olanzapine Tablets/ Zyprexa5mg 8-20奥氮平片Olanzapine Tablets/ Zyprexa10mg 8-21奥利司他胶囊Orlistat Capsules/Alli60mg 8-22奥利司他胶囊Orlistat Capsules/Xenical0.12g8-23奥美拉唑肠溶胶囊Omeprazole Enteric Capsules/Losec40mg8-24奥美拉唑镁肠溶片Omeprazole Magnesium Enteric-coatedTablets/ LOSEC MUPS20mg（按C17H19N3O3S计）8-25奥美拉唑镁肠溶片Omeprazole Magnesium Enteric-coatedTablets/ LOSEC MUPS10mg（按C17H19N3O3S计）8-26奥沙普秦片Oxaprozin Tablets/Alvo0.2g 8-27苯溴马隆片Benzbromarone Tablets/Urinorm50mg 8-28比卡鲁胺片Bicalutamide Tablets/Casodex50mg8-29吡格列酮二甲双胍片Pioglitazone Hydrochloride and MetforminHydrochloride Tablets /Actoplus Met每片含盐酸吡格列酮（以吡格列酮计）15mg，盐酸二甲双胍0.5g8-30吡嘧司特钾片Pemirolast Potassium Tablets/Alegysal5mg 8-31吡嘧司特钾片Pemirolast Potassium Tablets/Alegysal10mg 8-32吡嗪酰胺片Pyrazinamide Tablets0.5g 8-33茶苯海明片Dimenhydrinate Tablets/Dramamine50mg8-34茶碱缓释胶囊Theophylline Sustained-release Capsules/Slo-bid 50mg （按C 7H 8N 4O 2计）8-35茶碱缓释胶囊Theophylline Sustained-release Capsules/Slo-bid0.1g （按C 7H 8N 4O 2计）8-36茶碱缓释胶囊Theophylline Sustained-releaseCapsules/THEO-240.1g （按C 7H 8N 4O 2计）8-37茶碱缓释胶囊Theophylline Sustained-release Capsules/Slo-bid0.2g （按C 7H 8N 4O 2计）8-38达沙替尼片Dasatinib Tablets/Sprycel 20mg 8-39达沙替尼片Dasatinib Tablets/Sprycel 50mg 8-40达沙替尼片Dasatinib Tablets/Sprycel 70mg 8-41地氯雷他定片Desloratadine Tablets/AERIUS 5mg 8-42碘化钾片Potassium Iodide tablets/IOSAT0.13g 8-43丁二磺酸腺苷蛋氨酸肠溶片Ademetionine 1,4 - Butanedisulfonate EntericCoated Tablets/Transmetil 0.5g8-44对乙酰氨基酚泡腾片Paracetamol Effervescent Tablets/PanadolActiFast Soluble Tablets0.5g 8-45厄贝沙坦片Irbesartan Tablets /APROVEL 0.3g 8-46厄贝沙坦片Irbesartan Tablets /APROVEL 0.15g 8-47厄贝沙坦片Irbesartan Tablets /APROVEL 75mg 8-48厄贝沙坦氢氯噻嗪片Irbesartan and HydrochlorothiazideTablets/COAPROVEL每片含厄贝沙坦0.15g ，氢氯噻嗪12.5mg 8-49厄多司坦胶囊Erdosteine Capsules/--0.3g8-52法罗培南钠片Faropenem Sodium Tablets/Farom 150mg8-53法罗培南钠片Faropenem Sodium Tablets/Farom 200mg 8-54法莫替丁咀嚼片Famotidine Chewable Tablets/Pepcid AC20mg 8-55法莫替丁片Famotidine Tablets/Gaster 10mg 8-56法莫替丁散Famotidine Powder/Gaster2%1g 8-57非洛地平缓释片Felodipine Sustained- Release Tablets/Plendil5mg每片含盐酸二甲双胍0.25g 与格列吡嗪2.5mg 每片含盐酸二甲双胍0.5g 与格列吡嗪2.5mg Metformin Hydrochloride and GlipizideTablets/--Metformin Hydrochloride and GlipizideTablets/--二甲双胍格列吡嗪片二甲双胍格列吡嗪片8-508-518-58非洛地平片Felodipine Tablets/Splendil 2.5mg 8-59非洛地平片Felodipine Tablets/Splendil5mg 8-60伏格列波糖片Voglibose Tablets/BASEN0.3mg 8-61伏格列波糖片Voglibose Tablets/BASEN0.2mg8-62氟哌噻吨美利曲辛片Flupentixol and Melitracen Tablets/Deanxit氟哌噻吨0.5mg，美利曲辛10mg8-63福多司坦片Fudosteine Tablets/Cleanal0.2g 8-64福辛普利钠片Fosinopril Sodium Tablets/ MONOPRIL10mg8-65富马酸卢帕他定片Rupatadine Fumarate Tablets/Rupafin10mg（按C26H26ClN3）8-66格列喹酮片Gliquidone Tablets/Glurenorm30mg8-67环酯红霉素片Erythromycin cyclocarbonateTablets/Davercin0.25g8-68黄体酮软胶囊Progesterone Soft Capsules/Utrogestan0.1g 8-69吉非罗齐胶囊Gemfibrozil Capsules/Lopid0.3g 8-70吉非替尼片Gefitinib Tablets /IRESSA0.25g8-71己酮可可碱缓释片Pentoxifylline Sustained-releaseTablets/Trental400mg8-72甲磺酸多沙唑嗪缓释片Doxazosin Mesylate Extended ReleaseTablets/CARDURA XL4mg（以C23H25N5O5计）8-73甲磺酸多沙唑嗪片Doxazosin Mesylate Tablets/CARDURA4mg（以C23H25N5O5计）8-74甲磺酸多沙唑嗪片Doxazosin Mesylate Tablets/CARDURA2mg（以C23H25N5O5计）8-75甲磺酸多沙唑嗪片Doxazosin Mesylate Tablets/CARDURA1mg（以C23H25N5O5计）8-76甲磺酸伊马替尼胶囊Imatinib Mesylate Capsules/ Glivec0.1g(按C29H31N7O计)8-77甲磺酸伊马替尼片Imatinib Mesylate Tablets/ Glivec 0.1g(按C29H31N7O计)8-78甲泼尼龙片Methylprednisolone Tablets/MEDROL4mg 8-79甲硝唑片Metronidazole Tablets/FLAGYL0.25g8-80酒石酸美托洛尔片Metoprolol Tartrate Tablets/Seloken0.1g8-81卡培他滨片Capecitabine Tablets/Xeloda0.5g 8-82卡培他滨片Capecitabine Tablets/Xeloda0.15g 8-83坎地沙坦酯片Candesartan Cilexetil Tablets/Blopress4mg 8-84坎地沙坦酯片Candesartan Cilexetil Tablets/Blopress8mg 8-85坎地沙坦酯片Candesartan Cilexetil Tablets/Blopress12mg 8-86坎地沙坦酯片Candesartan Cilexetil Tablets/Atacand16mg 8-87来曲唑片Letrozole Tablets/Femara 2.5mg8-88利巴韦林片Ribavirin Tablets/Copegus0.2g8-89氯氮平口崩片Clozapine Orally Disintegrating Tablets/Fazaclo ODT25mg8-90氯氮平口崩片Clozapine Orally Disintegrating Tablets/Fazaclo ODT100mg8-91氯沙坦钾片Losartan Potassium Tablets/Cozaar50mg 8-92氯沙坦钾片Losartan Potassium Tablets/--0.1g 8-93马来酸氟吡汀胶囊Flupirtine Maleate Capsules/Katadolon0.1g8-94门冬氨酸钾片Potassium Aspartate Tablets/ASPARAPotassium0.3g8-95孟鲁司特钠咀嚼片Montelukast Sodium ChewableTablets/Singulair5mg8-96孟鲁司特钠片Montelukast Sodium Tablets/Singulair10mg 8-97米氮平片Mirtazapine Tablets/Remeron15mg 8-98米氮平片Mirtazapine Tablets/Remeron30mg 8-99米格列醇片Miglitol Tablets/Glyset25mg 8-100米格列醇片Miglitol Tablets/Glyset50mg 8-101米格列醇片Miglitol Tablets/Glyset100mg 8-102米格列奈钙片Mitiglinide Calcium Tablets/GLUFAST5mg 8-103米格列奈钙片Mitiglinide Calcium Tablets/GLUFAST10mg 8-104那格列奈片Nateglinide Tablets/STARLIX0.12g 8-105那格列奈片Nateglinide Tablets/STARLIX60mg8-107普瑞巴林胶囊Pregabalin Capsules/Lyrica25mg 8-108普瑞巴林胶囊Pregabalin Capsules/Lyrica75mg 8-109普瑞巴林胶囊Pregabalin Capsules/Lyrica0.1g8-110羟苯磺酸钙胶囊Calcium Dobesilate Capsules/Doxium0.5g（按C12H10CaO10S2•H2O计）5mgNitrendipine Tablets/Baylotensin 尼群地平片8-1068-112炔雌醇环丙孕酮片Ethinylestradiol and Cyproterone AcetateTablets/Diane-35醋酸环丙孕酮2mg ，炔雌醇0.035mg8-113瑞巴派特片Rebamipide Tablets/Mucosta 0.1g 8-114沙格列汀片Saxagliptin Tablets/Onglyza2.5mg 8-115双氯芬酸钠肠溶缓释胶囊Diclofenac Sodium Enteric-coated SustainedRelease Capsules/Difene0.1g8-116双氯芬酸钠肠溶片Diclofenac Sodium Enteric-coatedTablets/Voltaren 50mg 8-117双氯芬酸钠片Diclofenac Sodium Tablets/Voltaren25mg 8-118司他夫定散Stavudine Powder/Zerit 1mg/1ml 8-119他克莫司胶囊Tacrolimus Capsules/ Prograf 5mg 8-120他克莫司胶囊Tacrolimus Capsules/ Prograf 1mg 8-121他克莫司胶囊Tacrolimus Capsules/ Prograf 0.5mg 8-122碳酸锂片Lithium Carbonate Tablets/LIMAS 0.1g 8-123替米沙坦片Telmisartan Tablets/Micardis 80mg 8-124替米沙坦片Telmisartan Tablets/Micardis 40mg 8-125替米沙坦片Telmisartan Tablets/Micardis 20mg 8-126替莫唑胺胶囊Temozolomide Capsules/TEMODAR5mg 8-127替莫唑胺胶囊Temozolomide Capsules/--20mg 8-128替莫唑胺胶囊Temozolomide Capsules/--0.1g 8-129头孢氨苄胶囊Cefalexin Capsules / Keflex0.5g （按C 16H 17N 3O 4S 计）8-130头孢氨苄片Cefalexin Tablets / Keflex0.5g （按C 16H 17N 3O 4S 计）8-131头孢克肟干混悬剂Cefixime for Suspension/Suprax100mg/5ml （按C 16H 15N 5O 7S 2计）8-132头孢克肟干混悬剂Cefixime for Suspension/Suprax200mg/5ml （按C 16H 15N 5O 7S 2计）8-133头孢克肟胶囊Cefixime Capsules/Cefspan50mg （按C 16H 15N 5O 7S 2计）50mg Hydrochlorothiazide Tablets/HYDROCHLOROTHIAZIDE 氢氯噻嗪片8-1118-134头孢克肟胶囊Cefixime Capsules/Cefspan C16H15N5O7S2计）8-135头孢克肟咀嚼片Cefixime Chewable Tablets/Suprax0.1g（按C16H15N5O7S2计）8-136头孢克肟片Cefixime Tablets/Suprax0.2g（按C16H15N5O7S2计）8-137头孢羟氨苄胶囊Cefadroxil Capsules / Cefadroxil0.5g（按C16H17N3O5S计）8-138托西酸舒他西林片Sultamicillin Tosilate Tablets/Unasyn0.375g（以C25H30N4O9S2计）8-139维生素E烟酸酯胶囊Vitamin E Nicotinicate Capsules/JuvelaN0.1g8-140乌苯美司胶囊Ubenimex Capsules/Bestatin10mg 8-141乌苯美司胶囊Ubenimex Capsules/Bestatin30mg 8-142西咪替丁片Cimetidine Tablets/TAGAMET HB0.2g 8-143西咪替丁片Cimetidine Tablets/Tagamet0.4g 8-144西咪替丁片Cimetidine Tablets/--0.8g8-145硝苯地平缓释片Nifedipine Sustained-release Tablets/Adalatretard10mg8-146硝苯地平缓释片Nifedipine Sustained-release Tablets/Adalat-L10mg 8-147硝苯地平控释片Nifedipine Controlled-release Tablets/Adalat30mg8-148硝苯地平软胶囊Nifedipine Soft Capsules/Adalat5mg8-149硝苯地平软胶囊Nifedipine Soft Capsules/Adalat10mg 8-150熊去氧胆酸片Ursodeoxycholic Acid Tablets/URSO 2500.25g 8-151盐酸阿比多尔胶囊Arbidol Hydrochloride Capsules/Арбидол0.1g8-152盐酸安非他酮缓释片Bupropion Hydrochloride Sustained-releaseTablets/Wellbutrin SR0.15g8-153盐酸安非他酮片Bupropion Hydrochloride Tablets/--0.1g 8-154盐酸安非他酮片Bupropion Hydrochloride Tablets/--75mg 8-155盐酸奥洛他定片Olopatadine Hydrochloride Tablets/Allelock5mg8-156盐酸吡格列酮口崩片Pioglitazone Hydrochloride OrallyDisintegrating Tablets/ACTOS OD15mg（按C19H20N2O3S计）。
立他司特杂质经验总结分享
立他司特杂质总结分享
序号
名称
CAS
分子式
规格
用途
结构式
1
Lifitegrast Impurity 1
2295862-29-0
C30H26Cl2N2
O7S
10mg 25mg 50mg 100mg
研发申报
2
Lifitegrast Impurity 2
1194550-67-8
C36H30Cl2N2
O7S
10mg 25mg 50mg 100mg
研发申报
3
Lifitegrast Impurity 3
2271299-08-0
C29H24Cl2N2
O7S
10mg 25mg 50mg 100mg
研发申报
4
Lifitegrast Impurity 42049127-88
-8C17H19NO4S
HCl
10mg 25mg 50mg 100mg
研发申报
5
Lifitegrast Impurity 5
1270093-99-6C10H13NO4S
10mg 25mg 50mg 100mg
研发申报
湖北瑞诺医药---专注杂质对照品、标准品：①布地奈德杂质②氟替卡松杂质③特布他林杂质④卡泊三醇杂质⑤托法替布杂质q：300-
⑥伐地那非杂质⑦恩格列净杂质⑧卡托普利杂质⑨阿维巴坦杂质⑩孟鲁司特钠杂质-8058-⑪依折麦布杂质⑫普瑞巴林杂质
⑬替卡格雷杂质
⑭达比加群杂质
⑮匹伐他汀钙杂质
-303
⑯氟维司群杂质......等更多项目品种
并代理：CP/EP/USP/TRC/TLC/MC/LGC/RHINO 等品牌。
匹伐他汀钙ppt课件
PROVE-IT – Atv
IDEAL-Atv
AFCAPS - Pl
一级预防
5
AFCAPS - Rx
MEGA-Pl WOSCOPS - Rx
MEGA-Rx ASCOT-PL ASCOT - Rx
0
40 (1.0)
60 (1.6)
80 (2.1)
100 (2.6)
120 (3.1)
140 (3.6)
160 (4.1)
何振山 教授
14
方案设计
给药10mg/日
阿托伐他汀钙+试验模拟片
对照组(n=160)
筛选期 安慰剂 导入期
随机 分组
12周 多中心双盲双模拟 平行对照
匹伐他汀钙片+对照模拟片
给药1mg/日 给药2mg/日
试验组(n=160) 指标检查点 15
匹伐他汀临床结果——显著降低LDL-C
❖ 1mg匹伐他汀钙使用4周后，可降低LDL-C 27.81%；使用剂量增加到 2mg后，12周时可降低LDL-C 33.95%。
16
匹伐他汀临床结果 ——降低动脉硬化指数优于阿托伐他汀
❖ 1mg匹伐他汀钙使用4周后，可降低动脉硬化指数23.44%；使用剂量 增加到2mg后，12周时可降低LDL-C 26.36%。
17
匹伐他汀临床结果——显著升高HDL-C
❖ 1mg匹伐他汀钙使用4周后，可使HDL-C基线在1.2~1.5mmol/L患者升 高3%；使用剂量增加到2mg后，8周时可升高11.28% （p<0.01）
匹伐他汀钙原料
绝对无 水无氧 环境
-80℃低 温环境
8
双鹤匹伐他汀钙合成方法优势
❖ 控制产品中对映异构体杂质限量达到无法检出的极低水平； ❖ 控制产品中两个非对映异构体杂质限量达到0.1%的极低水平；
匹伐他汀钙杂质总结分享
序号
名称
匹伐他汀钙杂质总结分享
CAS
分子式
规格 用途
10mg
(3R,5R)-Pitav
2
25mg
1
astatin
254452-96-5 C25H23FNO4.
研发申报
50mg
Calcium Salt
Ca
100mg
结构式
10mg
Defluoro
2
25mg
2 Pitavastatin 1258947-30-6 C25H24NO4.
研发申报
50mg
Calcium Salt源自Ca100mg10mg
匹伐他汀钙
结 论
匹伐他汀钙片2mg/d口服可以明显降低LDL-C 、TC、甘油三酯，其降脂幅度 与10mg/d阿托伐他汀钙片相当。 匹伐他汀钙片1mg/d组与阿托伐他汀钙片10mg/d组降低动脉硬化指数幅度相 当，匹伐他汀钙片2mg/d降低动脉硬化指数幅度大于阿托伐他汀钙片10mg/d 组。 匹伐他汀钙片2mg/d口服的安全性与10mg/d阿托伐他汀钙片相当，匹伐他汀 钙片组CK升高发生率低于阿托伐他汀钙片组。
4S - Pl
25
LDL降低值
4S - Rx
二级预防
20
事件率降低值
15
LIPID - Pl
10
CARE - Pl LIPID - Rx CARE - Rx IDEAL-Sim HPS - Pl HPS - Rx TNT – Atv10 PROVE-IT - Pra TNT – Atv80 IDEAL-Atv PROVE-IT – Atv AFCAPS - Pl AFCAPS - Rx ASCOT - Rx 40 (1.0) 60 (1.6) 80 (2.1) 100 (2.6) ASCOT-PL 120 (3.1)
匹伐他汀临床结果
——降低动脉硬化指数优于阿托伐他汀
1mg匹伐他汀钙使用4周后，可降低动脉硬化指数23.44%；使用剂量 增加到2mg后，12周时可降低LDL-C 26.36%。
匹伐他汀临床结果——显著升高HDL-C
1mg匹伐他汀钙使用4周后，可使HDL-C基线在1.2~1.5mmol/L患者升 高3%；使用剂量增加到2mg后，8周时可升高11.28% （p<0.01）
活性成分：本品活性成份为匹伐他汀钙，其化学名称为 (+)-双 {(3R,5S,6E)-7-[2-环丙基-4-(4-氟苯基)-3–喹啉基]-3,5-二羟基-6-庚酸} 单钙盐。 性状：本品为白色薄膜衣片，除去薄膜衣后显白色或类白色。 规格： （1）1mg （2）2mg 用法用量：
2017版国家医保药品目录完整版
甲
11 碳酸氢钠
乙
12 复方铝酸铋
乙 ★（10） 枸橼酸铋钾
乙
13 胶体果胶铋
乙
14 铝碳酸镁
治疗消化性溃疡病和胃食道反流病的药物
H2-受体拮抗剂
甲
15 法莫替丁
甲 ★（15） 法莫替丁
甲
16 雷尼替丁
甲 ★（16） 雷尼替丁
质子泵抑制剂
甲
17 奥美拉唑
乙
18 埃索美拉唑（艾司奥美拉唑）
乙 ★（18） 埃索美拉唑（艾司奥美拉唑）
XA10AD XA10AE XA10B XA10BA XA10BB
XA10BF
XA10BG
药品分类代码
XA10BH
XA10BX
甲
103 动物源中效胰岛素
乙
104 人中效胰岛素
胰岛素及其类似物，预混
甲
105 动物源预混胰岛素
甲
106 普通胰岛素预混
乙
107 胰岛素类似物预混
胰岛素及其类似物，长效
甲
108 动物源长效胰岛素
乙
19 艾普拉唑
乙 ★（17） 奥美拉唑
乙
20 兰索拉唑
乙 ★（20） 兰索拉唑
乙
21 雷贝拉唑
乙
22 泮托拉唑
乙 ★（22） 泮托拉唑
其他治疗消化性溃疡病和胃食道反流病的药物
乙
23 吉法酯
乙
24 硫糖铝
XA03 XA03A
乙 ★（24） 硫糖铝
乙
25 瑞巴派特
乙
26 替普瑞酮
治疗功能性胃肠道疾病的药物
甲
172 双嘧达莫
乙 ★（171） 阿司匹林
乙
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杂质名称
Cas
隶属关系
图谱
匹伐他汀钙对映体
Cas：254452-88-5
匹伐他汀钙
有
匹伐他汀钙非对映体一
Cas：254452-96-5
匹伐他汀钙
有
匹伐他汀钙非对映体二cas：254452-92-1
匹伐他汀钙
有
匹伐他汀钙消旋体
暂无cas
匹伐他汀钙
无
匹伐他汀钙内酯
Cas：141750-63-2
匹伐他汀钙
有
无氟匹伐他汀钙cas1258947-30-6
匹伐他汀钙杂质
有
（E）-7-[2-环丙基-4-（4-氟苯基）-3-喹啉基]-5-羟基-3-氧代-6-庚酸钠
暂无cas
匹伐他汀钙中间体N10水解产物的钠盐杂质
氢谱
2-氨基-二苯甲酮（无氟N4）
cas：2835-77-0
匹伐他汀钙中间体
N4的杂质
氢谱
无
（3R,5S,6E)-7-[2-环丙基-4-苯基-3-喹啉-基]-3,5-二羟基-6-庚酸叔丁酯（无氟匹伐-2）暂无cas
匹伐他汀钙主侧链路线中间体
（3R,5S,6E)-7-[2-环丙基-4-（4-氟苯基）-3-喹啉-基]-3,5-二羟基-6-庚酸叔丁酯杂质
氢谱
2-环丙基-4-苯基-3-喹啉甲醇（无氟N6）暂无cas
匹伐他汀钙中间体N6无氟杂质
氢谱
2-环丙基-4-苯基喹啉-3-甲醛（无氟N7）暂无cas
匹伐他汀钙中间体N7的无氟杂质
氢谱
2-环丙基-4-（4-氟苯基）喹啉-3-二乙基缩醛暂时cas
匹伐他汀钙中间体N7的无氟杂质
氢谱
(E)-3-[2-环丙基-4-苯基-3-喹啉-2-丙烯醛（无氟N9）暂无cas
（无氟N6-3）暂无cas
匹伐他汀钙主侧链路线中间体N6-3的无氟杂质
无
(4R,6S)-6-[[(1E)-2-环丙基-4-苯基-3-喹啉基]乙烯基]-2,2-二甲基-1,3-二氧六环-4-乙酸叔丁酯(无氟匹伐-1)
暂无cas
匹伐他汀钙主侧链路线中间体(4R,6S)-6-[[(1E)-2-环丙基-4-（4-氟苯基-3-喹啉基]乙烯基]-2,2-二甲基-1,3-二氧六环-4-乙酸叔丁酯杂质
匹伐他汀钙中间体N9的无氟杂质
氢谱
（E)-7-（2-环丙基-4-苯基-3-喹啉基）-5-羟基-3-氧代-6-庚烯酸乙酯（无氟10）暂无cas
匹伐他汀钙中间体N10无氟杂质
氢谱
2-环丙基-4-苯基-3-Fra bibliotek甲基喹啉（无氟N6-1）暂无cas
匹伐他汀钙主侧链路线中间体N6-1的无氟杂质
无
溴化三苯基（2-环丙基-4-苯基-3-甲基喹啉）鏻