匹伐他汀钙配套杂质目录-2017

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匹伐他汀钙片中潜在致突变杂质的检测方法[发明专利]

(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

匹伐他汀钙杂质总结分享序号名称cas分子式规格用途结构式3r5rpitavastatincalciumsalt254452965c25h23fno4ca10mg25mg50mg100mg研发申报defluoropitavastatincalciumsalt1258947306c25h24no4ca10mg25mg50mg100mg研发申报3s5spitavastatincalciumsalt254452921c25h23fno4ca10mg25mg50mg100mg研发申报3s5rpitavastatincalciumsalt254452885c25h23fno4ca10mg25mg50mg100mg研发申报zpitavastatincalciumsalt1159588212c25h23fno4ca10mg25mg50mg100mg研发申报湖北瑞诺医药专注杂质对照品标准品维格列汀杂质硼替佐米杂质拉米夫定杂质阿格列汀杂质己酮可可碱杂质300克拉霉素杂质波舒替尼杂质氨氯地平杂质阿齐沙坦杂质舒更葡糖钠杂质8058普拉克索杂质瑞戈非尼杂质莫西沙星杂质美罗培南杂质303奥氮平杂质
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

匹伐他汀钙片溶出度一致性评价研究

第 44 卷第 4 期2021 年 4 月名於，{I Drug Evaluation Research Vol. 44 No. 4 April 2021•751 •匹伐他汀钙片溶出度一致性评价研究张莉，高扬，李浩然，张志清‘河北医科大学第二医院药学部，河北石家庄050000摘要：目的建立匹伐他汀钙片溶出度测定方法，评价国内仿制药与原研药溶出曲线的相似性。

方法建立高效液相色谱（H P L C)法测定匹伐他汀钙片含量，并进行专属性、回收率、精密度、重复性、稳定性等方法学考察。

以原研药为参比制剂，采用桨法，转速50r/min，测定仿制药与原研药在4种不同p H溶出介质（p H 1.2盐酸溶液、p H4.5醋酸盐缓冲液、p H 6.8磷酸盐缓冲液、水）中的溶出度，绘制溶出曲线，采用相似因子（/2)法分析溶出曲线相似性。

结果色谱条件为：色谱柱0丨3111〇1^1(^丨8(25〇111111父4.6 111〇1，5哗），醋酸盐缓冲液（冰醋酸500叫、醋酸铵140.6 11^，加水至1000 〇11-)-乙腈（15:85)为流动相，波长244n m。

方法学验证结果均符合检测要求。

其中3家仿制药与原研药溶出行为基本一致，另外1家仿制药在水和p H 4.5醋酸盐缓冲液中均与原研药溶出曲线不相似。

结论大部分厂家仿制药体外溶出与原研药一致。

所建H P L C法适用于匹伐他汀钙片的浓度测定，可为今后匹伐他汀钙片溶出度一致性评价提供参考。

关键词：匹伐他汀钙片；高效液相色谱法；溶出曲线；一致性评价中图分类号：R927 文献标志码：A文章编号：1674-6376 (2021) 04-0751-05D O I：10.7501/j.issn. 1674-6376.2021.04.011Evaluation of dissolution consistency of pivastatin calcium tabletsZHANG Li,GAO Yang,LI Haoran,ZHANG ZhiqingDepartment of Pharmacy, the Second Hospital of Hebei Medical University, Shijiazhuang 050000, ChinaAbstact: Objective To establish a method for determination of dissolution curve of pivastatin calcium tablets, and evaluate the similarity of dissolution curve of domestic generic drugs and the original drugs. Methods The concentrations of samples were detected by HPLC. The specificity, recovery, precision, repeatability, stability and other methodological studies were carried out. The paddle method was using for the dissolution process. The rotation speed of paddle was 50 r/min. To determine the dissolution profiles of generic pivastatin calcium tablets and the original product in four dissolution mediums (the p H 1.2 hydrochloric acid solution, the p H 4.5 acetate buffer solution, the p H 6.8 phosphate buffer solution and water). The f2 factor method was used for analyze the similarity of dissolution curves. Results A Diamonsil C,gcolumn (250 m m x 4.6 m m, 5 |xm) was used. Mobile phase consisted of a mixture of acetate buffer(acetic acid 500 and a m m o n i u m acetate 140.6 m g were added to 1000 m L water)-acetonitrile(15: 85), and U V detection wavelength was 244 nm. The results of methodology validation met the detection requirements. The dissolution profile of three generic tablet were similar to the original tablet in the four dissolution media. The dissolution of the other company's products was inconformity to the innovater drug in the water dissolution media and p H 4.5 acetate buffer solution. Conclusion The in vitro dissolution of some generic drugs was significantly different from the original drug. The H P L C method be appropriate for the determination of the concentration of pivastatin calcium tablets, which can provide a reference for further consistency evaluation of pivastatin calcium tablets.K ey words: pivastatin calcium tablets; HPLC; dissolution profiles; consistency evaluation匹伐他汀（pitavastatin)为HMG-CoA还原酶抑低效果，用于治疗动脉粥样硬化、高胆固醇血症和制剂，对低密度脂蛋白胆固醇（LDL-C)有显著的降家族性高胆固醇血症[“2]。

匹伐他汀钙联合谷维素对32例高胆固醇血症患者血脂水平的影响

匹伐他汀钙联合谷维素对32例高胆固醇血症患者血脂水平的影响韦涛【摘要】目的:探讨匹伐他汀钙联合谷维素对高胆固醇血症患者血脂水平的影响.方法:选取64例原发性高胆固醇血症患者随机分为对照组和研究组各32例,对照组患者给予匹伐他汀钙治疗,研究组给予匹伐他汀钙联合谷维素治疗.治疗前后检测两组患者血脂指标,评估两组患者的临床疗效,并观察两组患者治疗过程中不良反应的发生情况.结果:两组患者治疗后TG、TC和LDL-C水平均明显降低,HDL-C水平明显升高;研究组患者治疗后的TG、TC和LDL-C水平均明显低于对照组(P＜0.05);研究组患者治疗后的HDL-C水平明显高于对照组(P＜0.05).研究组患者治疗的总有效率明显高于对照组(P＜0.05).两组患者的不良反应发生率比较无明显统计学差异.结论:匹伐他汀钙联合谷维素可有效改善高胆固醇血症患者的血脂水平,且不良反应少.【期刊名称】《上海医药》【年(卷),期】2017(038)011【总页数】4页(P20-22,47)【关键词】匹伐他汀钙;谷维素;高胆固醇血症;血脂【作者】韦涛【作者单位】连山壮族瑶族自治县人民医院内科清远513200【正文语种】中文【中图分类】R541.4;R282.71高胆固醇血症是临床上常见的内分泌疾病之一，为高脂血症的其中一种类型，主要表现为血清总胆固醇（total cholesterol, TC）和低密度脂蛋白胆固醇（low density lipoprotein cholesterol, LDL-C）水平的异常升高[1]。

近年来，随着人们生活水平的提高及饮食方式和习惯的转变，高胆固醇血症的发病率呈逐年上升的趋势，已引起人们的普遍关注。

研究表明[2]，高胆固醇血症是诱发动脉粥样硬化和冠心病的重要危险因素。

因此，给予高胆固醇血症患者积极有效的治疗，对降低患者心血管不良事件发生风险有着重要的意义。

他汀类药物是目前临床上常用的调脂药物，但不同种类的他汀药物，其调脂效果不一[3]。

匹伐他汀钙原料药的性状研究

基）．３一喹啉基］．３，５．二羟基．６．庚酸｝单钙盐，系日本化学工业株式会社与兴和株式会社共同开发的第三代他汀类药物［ｆ】，匹伐他汀对ＨＭＧ．ＣｏＡ还原酶抑制作用强，呈肝细胞
表１溶解度测定结果（温度：２５。Ｇ）
２方法与结果
临床研究用药品质量标准中的检查项中。在实验所用的８种２．１外观、色泽、嗅本品为白色或类白色无定形粉末，无嗅，对光不稳溶剂中氯仿，ｎｏ．１ｍｏｌ／ＬＨＣ１是最合适的溶剂。下一步将对本
选择性，同时具有作用时间长、耐受性好、安全性高等特点，被制药界誉为 “ 超级他汀 ”口］。通过查阅相关文献，发现匹伐他汀钙与同类药品相比具有如下特点［３－５］：①在降低低密度脂蛋白（ＬＤＬ —ｃ）的同时，还可显著升高高密度脂蛋白（ＨＤＬ—Ｃ）。② 对遗传性高血脂症以及伴有糖尿病的高脂血症有显著疗效。③很少通过细胞色素Ｐ４５０途径代谢，因而不像其他他汀类药物那样易受可改变细胞色素Ｐ４５０活性药物的影响。由于具备上述优点，匹伐他汀钙
被药学界颇为看好，对匹伐他汀钙的相关研究就相当的有
意义。
１仪器和试药
通过上述溶解度试验，可见本品在氯仿，０．１ｍｏｌ／ＬＨＣ１

医院多规药品目录

110
骨肽
粉针25mg
25
伏立康唑
注射剂0.1g
氨溴索
胶囊30mg
骨肽
注射剂50mg
伏立康唑
注射剂0.2g
69
氨溴索
注射液15mg
111
妥布霉素
滴眼液5ml
26
恩替卡韦
片剂0.5mg
氨溴索
注射液30mg
妥布霉素
眼膏3g
恩替卡韦
胶囊0.5mg
70
沙丁胺醇
吸入溶液剂2ml
112
妥布霉素地塞米松
滴眼液5ml
脑安滴丸
50mg/丸
急支
颗粒4g
4
肝苏
颗粒3g/袋
肝苏
胶囊0.42g/粒
肝苏
分散片0.5g/片
硫普罗宁
粉针0.2g
克林霉素磷酸酯
注射剂4ml:0.6g
65
维生素C
注射剂0.5g
107
小儿复方氨基酸
注射剂 20ml
22
左氧氟沙星
注射剂0.5g
维生素C
注射剂1.0g
小儿复方氨基酸
注射剂 100ml
左氧氟沙星
注射剂0.3g
66
曲克芦丁脑蛋白水解物
注射剂2ml
108
脂肪乳（中链及长链复合剂）
乳剂100ml
阿奇霉素
片剂0.25g
63
叶酸
片剂0.4mg
5%葡萄糖氯化钠
注射剂 250ml
20
克拉霉素
软胶囊 0.125g
叶酸
片剂5mg
5%葡萄糖氯化钠
注射剂 500ml
克拉霉素
缓释片剂0.5g
64

匹伐他汀钙片

匹伐他汀钙片【药品名称】通用名称：匹伐他汀钙片商品名称：匹伐他汀钙片(冠爽)英文名称：Pitavastatin Calcium Tablets拼音全码：PiFaTaTingGaiPian(GuanShuang)【主要成份】匹伐他汀钙。

【成份】分子量：C50H46CaF2N2O8【性状】类白色片，除去包衣后为类白色。

【适应症/功能主治】主要用于高胆固醇血症和家族性高胆固醇血症。

【规格型号】 2mg*7s【用法用量】通常成人每次1～2mg匹伐他汀钙，每天1次，饭后口服。

根据年龄、病情可以酌情增减药量，低密度脂蛋白值下降不明显时，可以考虑增加药量，每天的最大用药量为4mg。

注意：1、肝脏障碍患者首次服药剂量由1mg/天开始，每天最大药量为2mg。

2、由于随着给药量增加，可能会出现横纹肌溶解症，因此在增大给药量时，要注意观察CK值是否上升，尿中是否出现肌球素，肌肉痛或乏力感等横纹肌溶解的前期症状。

【不良反应】临床试验受试者886人中有197人(2.2%)现不良反应。

自觉和他觉症状共有50人v.6%)主要有腹痛、药疹、倦殆感、麻木、瘙痒等症状。

与临床检查值相关的异常有167人(18.8%)主要是γ-GTP 上升、CK(CPK)上升、血清ALT(GPT)上升、血清AST(GOT)上升等。

1、重大的不良反应(1)纹肌溶解症(现频率不明)易引起肌肉痛、乏力、检查发现CK(CPK)上升，血和尿中的肌红蛋白上升等为特征的横纹肌溶解症，并伴随有急性肾功能损害，因此，在出现上述这些症状时，立即停止了给药。

(2)(现频率不明)由于会引起肌病，因此，当出现全身的肌肉痛、肌肉压痛以及显著的CK(CPK)上升时，停止了给药。

(3)功能损害(现频率不明)黄疸(现频率不明)由于会引起伴有AST(GOT)、ALT(GPT)显著上升的肝功能损害、黄疸，因此需进行定期的肝功能检查，发现异常时立即停止给药。

【禁忌】 1、对本药所含成分有过敏史者2、严重的肝功能障碍或胆管闭塞患者(些患者服用本药，血药浓度会上升，出现不良反应的几率会比较大，而且可能会加重肝脏病变)。

国家药品集中采购目录第一、二、三批带量目录

0.15g*10片/板/盒 0.5g*12片/板/盒 0.15g*12片/板*1板/盒 0.5g*12片/板*1板/盒 0.5g*10片/板*1板/盒 25mg*21片/板*4板/盒 25mg*100片/瓶 25mg*20片/板*5板/盒 25mg*100片/瓶 25mg*100片/瓶 25mg*100片/瓶 25mg*100片/瓶
盐酸莫西沙星氯化钠注射液
50
盐酸莫西沙星氯化钠注射液
51
左氧氟沙星滴眼液
左氧氟沙星滴眼液
52
盐酸环丙沙星片
盐酸环丙沙星片
头孢地尼胶囊
头孢地尼胶囊
头孢地尼胶囊
53
头孢地尼分散片
头孢地尼分散片
头孢地尼胶囊
头孢克洛胶囊
头孢克洛胶囊
54
头孢克洛胶囊
头孢克洛胶囊
头孢克洛胶囊
克拉霉素片
克拉霉素片
55
克拉霉素片
0.5g*60片/瓶 0.5g*10片/板*3板/盒 0.5g*10片/板*3板/盒 0.5g*12片/板*3板/盒
0.5g*60片/盒 0.5g*60片/瓶
0.25g*21片/板*4板/小盒 0.25g*100片/瓶/盒 0.25g*60片/瓶 0.5g*6*10片/板/盒
0.25g*10片/板*10板/盒 0.25g*100片/瓶
31
塞来昔布胶囊
31
塞来昔布胶囊
32
盐酸舍曲林片
盐酸舍曲林片
盐酸坦索罗辛缓释胶囊
盐酸坦索罗辛缓释胶囊
33
盐酸坦索罗辛缓释胶囊
盐酸坦索罗辛缓释胶囊
碳酸氢钠片
碳酸氢钠片
34
碳酸氢钠片
碳酸氢钠片
替格瑞洛片
替格瑞洛片

国家基本医疗保险、工伤保险和生育保险药品目录(2017年版)

XA10BB
磺酰脲类衍生物甲甲甲
乙乙乙乙 XA10BD XA10BF
★（113） 115 116 ★（116）
格列吡嗪格列喹酮格列齐特格列齐特Ⅱ
XA10BG
XA10BH
XA10BX
XA10X XA11 维生素类
口服复方降糖药 α -葡萄糖苷酶抑制剂甲 117 乙 118 乙 119 噻唑啉二酮类乙 120 乙 121 二肽基肽酶-4（DPP-4）抑制剂乙 122 乙 123 乙 124 乙 125 乙 126 其他降血糖药乙 127 乙 128 乙 129 其他的糖尿病用药乙 130 甲甲甲甲甲甲甲乙乙乙乙乙乙乙乙乙乙乙乙乙乙乙乙乙 131 132 133 134 135 ★（135） 136 137 138 139 ★（139） 140 141 142 ★（131） ★（132） ★（133） ★（134） ★（136） 143 144 145 ★（145） 146
国家基本医疗保险、工伤保险和生育保险药品目录（2
一、西药部分
药品分药品分类类代码
XA XA01 消化道和代谢方面的药物口腔科制剂甲乙乙乙乙乙 XA02 XA02A 治疗胃酸相关类疾病的药物抗酸药甲 7 甲 8 甲 9 甲 10 甲 11 乙 12 乙 ★（10）乙 13 乙 14 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 甲 ★（15）甲 16 甲 ★（16）质子泵抑制剂甲 17 乙乙乙乙乙乙乙乙乙 XA02BD XA02BX 18 ★（18） 19 ★（17） 20 ★（20） 21 22 ★（22）大黄碳酸氢钠小儿大黄碳酸氢钠复方氢氧化铝枸橼酸铋钾碳酸氢钠复方铝酸铋枸橼酸铋钾胶体果胶铋铝碳酸镁 1 2 3 4 5 6 复方硼砂糠甾醇克霉唑氯己定替硝唑西吡氯铵

匹伐他汀钙配套杂质目录-2017

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
2835770匹伐他汀钙中间体n4的杂质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2环丙基44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e32环丙基4苯基3喹啉2丙烯醛无氟n9暂无cas匹伐他汀钙中间体n9的无氟杂质e72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2环丙基4苯基3溴甲基喹啉无氟n61暂无cas线中间体n61的无氟杂质溴化三苯基2环丙基4苯基3甲基喹啉鏻无氟n63暂无cas间体n63的无氟杂质4r6s61e2环丙基4苯基3喹啉基乙烯基22二甲基13二氧六环4乙酸叔丁酯无氟匹伐1暂无cas中间体4r6s61e2环丙基44氟苯基3喹啉基乙烯基22二甲基13二氧六环4乙酸叔丁酯杂质3r5s6e72环丙基4苯基3喹啉基35二羟基6庚酸叔丁酯无氟匹伐2暂无cas中间体3r5s6e72环丙基44氟苯基3喹啉基35二羟基6庚酸叔丁酯杂质
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