参比制剂第十批
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）。
注射剂原研参比制剂使用规范
注射剂参比制剂使用标准操作规程目的：建立注射剂参比制剂使用的标准操作规程，为质量研究人员进行参比制剂的质量研究工作提供参考。
范围：质量研究人员。
规程：一、参比制剂的选择首选原研厂家，或美国橙皮书、日本橙皮书公布的厂家，同剂型同规格不同时间段生产的（效期内前中后）三批样品。
二、参比制剂的购买与存储购买的参比制剂在核对无误后应建立台帐，置冷库（或按制剂标注的存储条件）保存，保管好说明书、外包装、标签和发票。
三、参比制剂的使用1、参比制剂的使用应填写领用记录。
2、参比制剂对比前检验（即0天检验）：取三批参比样品各1瓶，按以下项目顺序进行检验，直到1瓶参比制剂的内容物用完为止，每个项目在保证检验准确的条件下尽可能减少供试品用量：性状、有关物质、异构体（或光学异构体）、pH值、水分、溶液澄清度与颜色、含量、可见异物。
3、专属性研究（破坏试验）：取一批参比制剂2瓶，分别进行高温、光照、酸、碱、氧化破坏试验，与一批自研产品同步进行，对比参比制剂和自研产品各强制降解条件下产生的杂质数量、种类和含量是否一致。
4、影响因素试验：取一批参比制剂6瓶，分别于高温、高湿、光照条件下各放2瓶，于试验5天和10天每个分别取1瓶进行检测（按以下项目顺序进行检验，直到1瓶参比制剂的内容物用完为止，每个项目在保证检验准确的条件下尽可能减少供试品用量：性状、有关物质、异构体、pH值、水分、溶液澄清度与颜色、含量、可见异物），与一批自研产品同步进行，对比参比制剂和自研产品在影响因素条件下各项检测结果和变化趋势的异同，产生的杂质数量、种类和含量是否一致。
如果参比制剂比较昂贵，试验5天的点可以不做。
5、加速试验：取三批参比制剂各4瓶，分别置于加速试验条件下的稳定性试验箱中，于第1、2、3和6月分别取1瓶进行检测（按以下项目顺序进行检验，直到1瓶参比制剂的内容物用完为止，每个项目在保证检验准确的条件下尽可能减少供试品用量：性状、有关物质、异构体、pH值、水分、溶液澄清度与颜色、含量、可见异物），与三批自研产品同步进行，对比参比制剂和自研产品在加速条件下各项检测结果和变化趋势的异同，产生的杂质数量、种类和含量是否一致。
国家药监局发布停止生产销售使用含呋喃唑酮复方制剂的公告
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仿制药参比制剂目录(第二十批)
仿制药参比制剂目录（第二十批）
序号
药品通用名称
英文名称/商品名
规格
剂型
持证商
备注1
备注2
20-1
氨甲环酸片
Tranexamic Acid Tablets/Transamin
250mg
片剂
DAIICHI SANKYO CO.,LTD.（第一三共株式会社）
日本橙皮书
20-2
氨甲环酸片
Tranexamic Acid Tablets/Transamin
米非司酮片
Mifepristone Tablets/司米安
10mg
片剂
华润紫竹药业有限公司
国内特有规格
欧盟上市（上市国：意大利；产地：意大利）
20-4
甲硝唑片
Metronidazole Tablets/FLAGYL
0.2g
片剂
Winthrop Pharmaceuticals UK Limited/Zentiva/Aventis Pharma Limited/Sanofi
欧盟上市（上市国家：英国；产地：西班牙）
50mg
胶囊剂
辉瑞制药有限公司
原研地产化
20-8
甲磺酸倍他司汀片
Betahistine Mesilate Tablets/敏使朗
6mg
片剂
卫材（中国）药业有限公司
原研地产化
20-9
富马酸喹硫平片
Quetiapine Fumarate Tablets/思瑞康
25mg
片剂
阿斯利康制药有限公司
原研地产化
20-10
富马酸喹硫平片
Quetiapine Fumarate Tablets/思瑞康/Seroquel
国家药监局关于发布仿制药参比制剂目录（第七十一批）的通告
国家药监局关于发布仿制药参比制剂目录（第七十一
批）的通告
文章属性
•【制定机关】国家药品监督管理局
•【公布日期】2023.08.15
•【文号】国家药监局通告2023年第37号
•【施行日期】2023.08.15
•【效力等级】部门规范性文件
•【时效性】现行有效
•【主题分类】药政管理
正文
国家药监局通告
2023年第37号
关于发布仿制药参比制剂目录（第七十一批）的通告
经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第七十一批）。
特此通告。
附件：化学仿制药参比制剂目录（第七十一批）
国家药监局
2023年8月15日。
最新最全的289目录品种参比制剂基本情况表
0.2g
3-11
美国橙皮书
87
茶碱缓释片
片剂
0.1g
7-17
日本橙皮书
日本橙皮书收载名称：Theophylline Extended-release Tablets
7-18
日本橙皮书
7-19
日本橙皮书
7-20
美国橙皮书
美国橙皮书收载名称：Theophylline Extended-release Tablets
20mg
7-5
欧盟上市
上市国家：英国，上市名称：Omeprazole hard gastro-resistant capsules
60
呋喃妥因肠溶片
片剂
50mg
--
改剂型
企业可按“三改”技术指南进行研究和评估，选择参比制剂
61
吡嗪酰胺片
片剂
0.25g
--
改规格
企业可按“三改”技术指南进行研究和评估，选择参比制剂
50
氢氯噻嗪片
片剂
10mg
--
改规格
企业可按“三改”技术指南进行研究和评估，选择参比制剂
25mg
7-51
欧盟上市
上市国家：德国；产地：德国
51
阿替洛尔片
片剂
12.5mg
--
改规格
企业可按“三改”技术指南进行研究和评估，选择参比制剂
25mg
3-18
美国橙皮书
50mg
3-19
美国橙皮书
52
酚酞片
片剂
50mg
62
克拉霉素胶囊
胶囊
0.125g
--
国家药监局关于发布仿制药参比制剂目录（第八十批）的通告
国家药监局关于发布仿制药参比制剂目录（第八十
批）的通告
文章属性
•【制定机关】国家药品监督管理局
•【公布日期】2024.05.13
•【文号】国家药监局通告2024年第19号
•【施行日期】2024.05.13
•【效力等级】部门规范性文件
•【时效性】现行有效
•【主题分类】药政管理
正文
国家药监局通告
2024年第19号
关于发布仿制药参比制剂目录（第八十批）的通告经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第八十批）。
特此通告。
附件：化学仿制药参比制剂目录（第八十批）
国家药监局
2024年5月13日。
2022仿制药参比制剂目录第五十批
Novartis Pharmac50-7
复方硫酸钠片
Sodium sulfate, magnesium sulfate, and potassium chloride Tablets
每片含硫酸钠1.479g，硫酸镁0.225g，氯化钾0.188g
3mg
エーザイ株式会社
未进口原研药品
日本上市
50-18
盐酸多奈哌齐口服凝胶
Donepezil Hydrochloride Oral Jelly/Aricept
5mg
エーザイ株式会社
未进口原研药品
日本上市
50-19
盐酸多奈哌齐口服凝胶
Donepezil Hydrochloride Oral Jelly/Aricept
未进口原研药品
欧盟上市
50-14
马来酸甲麦角新碱注射液
Methylergonovine Maleate Injection/ Methergin
1ml:0.2mg
Novartis Pharma GmbH
未进口原研药品
欧盟上市
50-15
昂丹司琼口崩片
Ondansetron Orally Disintegrating Tablets
Vernakalant Hydrochloride for Injection/Brinavess
25ml:500mg
Correvioe
未进口原研药品
欧盟上市
50-12
盐酸维纳卡兰注射液
Vernakalant Hydrochloride for Injection/Brinavess
10ml:200mg
30mg
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仿制药参比制剂目录（第十批）
序号
药品通用名称
英文名称/商品名
规格
剂型
持证商
备注1
备注2
10-1
阿司匹林双嘧
达莫缓释胶囊
Aspirin and
Dipyridamole Sustained-release Capsules/ Aggrenox
阿司匹林
25mg与双嘧
达莫200mg
胶囊剂（缓
释胶囊）
Boehringer Ingelheim Pharma GmbH&Co.KG
Hydrochlorid e Tablets
10-6
氨酚双氢可待
因片
Paracetamol and
Dihydrocodeine Tartrate Tablets/Co-dydramol
对乙酰氨基
酚500mg；酒 石酸双氢可 待因10mg
片剂
Actavis UK Limited
欧盟上市（上市
国家：英国；产
每片含对乙 酰氨基酚
330mg，维生
素C 200mg
片剂（泡腾
片）
UPSA SAS
欧盟上市（上市
国家：法国；产
地：法国）
持证商为Bristol-Myer s Squibb，
S.A.的产品
亦可
10-28
多索茶碱颗粒
Doxofylline Granules /ANSIMAR
0.2g
颗粒剂
ABC FARMACEUTICI S.P.A.
Olmesartan
Medoxomil Tablets/BENICAR
40mg
片剂
DAIICHI SANKYO INC
美国橙皮书
10-13
奥沙拉秦钠胶
囊
Olsalazine Sodium
Capsules/DIPENTUM
0.25g
胶囊剂
Mylan SPECIALTY LP
美国橙皮书
10-14
奥沙西泮片
Oxazepam
Tablets/Sobril
15mg
片剂
Pfizer AB
欧盟上市（上市
国家：瑞典；产
地：意大利）
10-15
巴氯芬片
Baclofen
Tablets/Lioresal
10mg
片剂
Novartis Pharma
Schweiz AG
原研进口
10-16
苯甲酸利扎曲
普坦片
Rizatriptan Benzoate
地：英国）
序号
药品通用名称
英文名称/商品名
规格
剂型
持证商
备注1
备注2
10-7
氨磺必利片
Amisulpride
Tablets/Solian
50mg
片剂
SANOFI
欧盟上市（上市
国家：英国；产
地：法国）
持证商为
Aventis
Pharma
Limited的产
品亦可
10-8
氨磺必利片
Amisulpride
Tablets/Solian
0.3g
片剂
Gilead Sciences Inc.
原研进口
10-46
富马酸酮替芬
胶囊
Ketotifen Fumarate Capsules/Zaditen
1mg （按
C19H19NOS计）
胶囊剂
Sun Pharmaceutical Industries Limited
规格
剂型
持证商
备注1
备注2
10-18
吡罗昔康胶囊
Piroxicam Capsules /FELDENE
10mg
胶囊剂
PFIZER LABORATORIES DIV PFIZER INC
美国橙皮书
10-19
吡罗昔康胶囊
Piroxicam Capsules /FELDENE
20mg
胶囊剂
PFIZER LABORATORIES DIV PFIZER INC
欧盟上市（上市
国家：意大利；
产地：意大利）
10-29
泛昔洛韦片
Famciclovir
Tablets/Famvir
0.125g
片剂
Novartis
Pharmaceuticals UK Limited
欧盟上市（产地：
西班牙）
10-30
泛昔洛韦片
Famciclovir
Tablets/Famvir
0.25g
Dohme Limited
原研进口
序号
药品通用名称
英文名称/商品名
规格
剂型
持证商
备注1
备注2
10-37
非诺贝特胶囊
Fenofibrate
Capsules/Lipanthyl
0.2g
胶囊剂
Abbott Laboratories
Limit ED
nd Caffeine Tablets/Hedex Extra
0.2g
片剂
SANOFI-AVENTIS FRANCE
原研进口
10-9
奥卡西平片
Oxcarbazepine
Tablets/Trileptal
0.3g
片剂
Novartis Pharma
Schweiz AG
原研进口
10-10
奥美拉唑碳酸
氢钠胶囊
Omeprazole and Sodium Bicarbonate Capsules/ZEGERID
德国上市名 称：
Isosorbidmon onitrat
Retardtablett en
10-24
单硝酸异山梨
酯缓释片
Isosorbide
Mononitrate Sustained-release Tablets/Imdur
60mg
片剂（缓释
片）
AstraZeneca UK Limited
欧盟上市（上市
Tablets/Maxalt
5mg（以
C15H19N5计）
片剂
MERCK AND CO INC
美国橙皮书
10-17
比沙可啶肠溶
片
Bisacodyl
Enteric-coated
Tablets/--
5mg
片剂（肠溶
片）
Boehringer Ingelheim France
原研进口
序号
药品通用名称
英文名称/商品名
欧盟上市（上市 国:德国；产地： 德国）
10-2
艾司奥美拉唑
镁肠溶片
Esomeprazole
Magnesium Enteric-coated Tablets/NEXIUM
20mg
片剂（肠溶
片）
AstraZeneca AB
原研进口
10-3
艾司奥美拉唑
镁肠溶片
Esomeprazole
Magnesium Enteric-coated Tablets/NEXIUM
丹麦上市名称：Felodipin
Depottablette
r
10-35
非那雄胺片
Finasteride
Tablets/PROPECIA
1mg
片剂
MSD PHARMA (SINGAPORE)PTE.L TD.
原研进口
10-36
非那雄胺片
Finasteride
Tablets/PROSCAR
5mg
片剂
Merck Sharp&
欧盟上市（上市
国家：英国）
英国上市名
称：
Felodipine Prolonged-rel ease Tablets
10-34
非洛地平缓释
片
Felodipine
Sustained-release Tablets/Plendil
5mg
片剂（缓释
片）
AstraZeneca A/S
欧盟上市（上市
国家：丹麦）
序号
药品通用名称
英文名称/商品名
规格
剂型
持证商
备注1
备注2
10-23
单硝酸异山梨
酯缓释片
Isosorbide Mononitrate Sustained-release Tablets/Ismo retard
40mg
片剂（缓释
片）
Riemser Pharma GmbH
欧盟上市（上市
国家：德国；产
地：西班牙）
40mg
片剂（肠溶
片）
AstraZeneca AB
原研进口
序号
药品通用名称
英文名称/商品名
规格
剂型
持证商
备注1
备注2
10-4
氨苄西林胶囊
Ampicillin Capsules/AMPICILLI N TRIHYDRATE
500mg（以
C16H19N3O4S计）
胶囊剂
DAVA Pharmaceuticals INC
美国橙皮书
10-26
单硝酸异山梨
酯片
Isosorbide
Mononitrate Tablets
/Monoket
20mg
片剂
KREMERS URBAN PHARMACEUTICA LS INC
美国橙皮书
序号
药品通用名称
英文名称/商品名
规格
剂型
持证商
备注1
备注2
10-27