国产盐酸贝那普利片质量评价
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摘要
目的:评价国产盐酸贝那普利片的质量现状。方法:采用法定标准方法和探索性研究对盐酸贝那普利片进行相关测定。结果:93批样品依据法定标准检验合格率为100%。不同生产企业产品之间有关物质和溶出度存在差异。结论:目前国内生产的盐酸贝那普利片产品质量符合法定标准,但探索性研究提示部分生产企业的生产工艺值得改进,改善制剂的溶出行为,减少有关物质的总杂质量。
Objective: To evaluate the quality condition of domestic benazepril hydrochloride tablets. Methods: Statutory methods and exploratory research methods were used to test the samples. Results: 100% of 93 batches met the requirement of current statutory standards. Related substances and dissolution data of benazepril hydrochloride tablets were different between different manufacturers. Conclusion: The quality of domestic benazepril hydrochloride tablets met the requirement of statutory standards currently. However,exploratory research suggests that some of the manufacturers should better the processing technique in order to improve the dissolution behavior and reduce total impurities.
Objective: To evaluate the quality condition of domestic benazepril hydrochloride tablets. Methods: Statutory methods and exploratory research methods were used to test the samples. Results: 100% of 93 batches met the requirement of current statutory standards. Related substances and dissolution data of benazepril hydrochloride tablets were different between different manufacturers. Conclusion: The quality of domestic benazepril hydrochloride tablets met the requirement of statutory standards currently. However,exploratory research suggests that some of the manufacturers should better the processing technique in order to improve the dissolution behavior and reduce total impurities.
引文
[1] Liu XP,Pang YJ,Zhu WW,et al. Benazepril,an angiotensin-converting enayme inhibitor,alleviates renal injury in spontaneously hyperitensive rats by inhibiting advanced glycation end-product-mediated pathways[J]. Clin Expe Pharmacol P,2009,36:287-296.
[2] Hisashi M,Hidekazu K,Toshifumi W,et al. Evaluation of the clinical efficacy of Benazepril in the treatment of chronic renal insufficiency in cats[J].J Vet Intern Med,2006,20:1074-1079.
[3] Sent U,Gossl R,Elliott J,et al. Comparison of efficacy oflong-termoral treatment with telmisartan and benazepril in cats with chronic kidney disease[J]. J Vet Intern Med,2015,29(6):1479-1487.
[4]王晓华,何杏容.金水宝联合贝那普利治疗糖尿病肾病蛋白尿的临床效果分析[J].中国医院用药评价与分析,2015,15(7):857-859.
[5]冯迎九.盐酸贝那普利治疗糖尿病肾病110例[J].中国药业,2012,21(19):66.
[6]国家食品药品临督管理局国家药品标准[S]. WS1-(X-347)-2003Z.
[7]国家食品药品临督管理局国家药品标准[S]. YBH01662005.
[8]国家食品药品临督管理局国家药品标准[S]. YBH13652004.
[9]国家食品药品临督管理局国家药品标准[S]. YBH10332005.
[10]国家食品药品临督管理局国家药品标准(试行)[S]. YBH05862004.
[11]谢沐风.如何科学、客观地制定溶出度试验质量标准[J].中国医药工业杂志,2012,43(3):A23-A32.
[12]美国药典[S]. USP41-NF36,462-463.
[13]谢沐风.溶出曲线相似性的评价方法[J].中国医药工业杂志,2009,40(4):308-310
[14]贾文君,仝立卿.盐酸西替利嗪片仿制药与原研药的溶出度一致性评价[J].中国药物评价,2017,34(6):410-413.
[15]米楠,马超,房思萌,等.伊潘立酮片溶出度一致性评价研究[J].药物评价研究,2017,40(2):164-168.
[2] Hisashi M,Hidekazu K,Toshifumi W,et al. Evaluation of the clinical efficacy of Benazepril in the treatment of chronic renal insufficiency in cats[J].J Vet Intern Med,2006,20:1074-1079.
[3] Sent U,Gossl R,Elliott J,et al. Comparison of efficacy oflong-termoral treatment with telmisartan and benazepril in cats with chronic kidney disease[J]. J Vet Intern Med,2015,29(6):1479-1487.
[4]王晓华,何杏容.金水宝联合贝那普利治疗糖尿病肾病蛋白尿的临床效果分析[J].中国医院用药评价与分析,2015,15(7):857-859.
[5]冯迎九.盐酸贝那普利治疗糖尿病肾病110例[J].中国药业,2012,21(19):66.
[6]国家食品药品临督管理局国家药品标准[S]. WS1-(X-347)-2003Z.
[7]国家食品药品临督管理局国家药品标准[S]. YBH01662005.
[8]国家食品药品临督管理局国家药品标准[S]. YBH13652004.
[9]国家食品药品临督管理局国家药品标准[S]. YBH10332005.
[10]国家食品药品临督管理局国家药品标准(试行)[S]. YBH05862004.
[11]谢沐风.如何科学、客观地制定溶出度试验质量标准[J].中国医药工业杂志,2012,43(3):A23-A32.
[12]美国药典[S]. USP41-NF36,462-463.
[13]谢沐风.溶出曲线相似性的评价方法[J].中国医药工业杂志,2009,40(4):308-310
[14]贾文君,仝立卿.盐酸西替利嗪片仿制药与原研药的溶出度一致性评价[J].中国药物评价,2017,34(6):410-413.
[15]米楠,马超,房思萌,等.伊潘立酮片溶出度一致性评价研究[J].药物评价研究,2017,40(2):164-168.