国产地氯雷他定片的溶出曲线考察
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摘要
目的探讨国内地氯雷他定片与原研片剂体外溶出曲线的一致性。方法按2015年版《中国药典(四部)》通则0931溶出度与释放度测定法,采用自动溶出仪和高效液相色谱仪测定6种溶出介质下的溶出曲线;采用f_2因子法对溶出曲线的相似度进行评价。结果 0. 1 mol/L盐酸溶液中,受试片剂与原研片剂溶出行为相似;其余5种溶出介质下,部分厂家受试片剂与原研片剂的溶出行为有差异。结论原研片剂在6种溶出介质下的溶出行为不同,但更能评价出部分厂家地氯雷他定片与原研片剂溶出行为的差异。建议采取多条溶出曲线进行一致性评价,为国内企业加强工艺研究提供参考。
Objective To investigate the consistency of in vitro dissolution curves between domestic Loratadine Tablets and original tablets.Methods According to the dissolution and release assay in general principles 0931 of Chinese Pharmacopoeia( 2015 edition,Volume V),the 6 kinds of the dissolution curve in the dissolution medium were determined by automated dissolution apparatus and high performance liquid chromatograph( HPLC) spectrometer, the similarity of dissolution curves was evaluated by f_2 factor method. Results In 0. 1 mol/L HCL solution,the dissolution behavior of the tested tablets was similar to that of the original tablets. In the rest of the five kinds of dissolution medium,the test tablets from some manufacturers were different from the original tablets. Conclusion The dissolution behavior of the original tablets in 6 kinds of dissolution medium is different, but it can better evaluate the difference of dissolution behavior between Desloratadine Tablets from some manufacturers and the original tablets. It is suggested that several dissolution curves should be used for consistency evaluation,in order to provide reference for domestic enterprises to strengthen technological research.
Objective To investigate the consistency of in vitro dissolution curves between domestic Loratadine Tablets and original tablets.Methods According to the dissolution and release assay in general principles 0931 of Chinese Pharmacopoeia( 2015 edition,Volume V),the 6 kinds of the dissolution curve in the dissolution medium were determined by automated dissolution apparatus and high performance liquid chromatograph( HPLC) spectrometer, the similarity of dissolution curves was evaluated by f_2 factor method. Results In 0. 1 mol/L HCL solution,the dissolution behavior of the tested tablets was similar to that of the original tablets. In the rest of the five kinds of dissolution medium,the test tablets from some manufacturers were different from the original tablets. Conclusion The dissolution behavior of the original tablets in 6 kinds of dissolution medium is different, but it can better evaluate the difference of dissolution behavior between Desloratadine Tablets from some manufacturers and the original tablets. It is suggested that several dissolution curves should be used for consistency evaluation,in order to provide reference for domestic enterprises to strengthen technological research.
引文
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[16]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]周宏艳,王菁,罗斌.地氯雷他定片溶出曲线测定方法的建立[J].中国药业,2015,24(12):67-69.
[3]WS1-(X-401)-2004Z-2013,国家食品药品监督管理局国家药品标准[S].
[4]YBH05472004,国家食品药品监督管理局标准(试行)[S].
[5]YBH07352010,国家食品药品监督管理局标准[S].
[6]YBH10082004,国家食品药品监督管理局标准(试行)[S].
[7]YBH10082004-2015Z,国家食品药品监督管理局国家药品标准[S].
[8]谢沐风.简介日本“药品品质再评价”工程(溶出度研究系列一)[J].中国药品标准,2005,6(6):42.
[9]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.
[10]The United states Pharmacopieical Convention.USP 40-NF 35[M].Rockviue:The United States Pharmacopieial Convention,2017:3657.
[11]李美芳,蔡锦雄,陈承贵,等.国家评价性抽验地氯雷他定制剂质量分析[J].中国药物评价,2018,35(1):16-20.
[12]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.
[13]谢沐风.改善溶出度评价方法,提高固体药物制剂水平[J].中国医药工业杂志,2005,36(7):447-451.
[14]王诗红,黄斌,张辉煌,等.多条溶出曲线评价盐酸二甲双胍片的溶出行为[J].药学与临床研究,2016,24(1):26-28.
[15]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.
[16]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.