吡哌酸片的溶出曲线考察
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摘要
目的:建立吡哌酸片溶出度曲线的测定方法,以评价该制剂的质量。方法:用4条溶出曲线分别测定国内吡哌酸片与国外厂家吡哌酸片的溶出状况,并利用相似因子评价溶出曲线的相似性,并确定有区分力的溶出度检测方法。结果:国内一家企业产品与国外厂家吡哌酸片的溶出曲线相似,其余企业产品与其相比溶出行为有一定差异。结论:新建方法适用于吡哌酸片的溶出曲线测定,可以为吡哌酸片的质量评价提供试验依据。
Objective: To establish a new method for the dissolution curve determination of pipemidic acid tablets,so as to evaluate the drug quality. Methods: In four dissolution media,the dissolution behaviors of domestic and foreign preparations of pipemidic acid tablets were detected,and the consistency of dissolution curves was evaluated by calculating the similarity factor( f_2). The dissolution test method with discriminatory power was established finally. Results: The products from one domestic pharmaceutical company were in line with the foreign tablets in the dissolution curve similarities,while the other samples showed differences from the foreign preparations. Conclusion: The new dissolution method is suitable for the dissolution curve determination of pipemidic acid tablets,which provides reference for the further quality consistency evaluation.
Objective: To establish a new method for the dissolution curve determination of pipemidic acid tablets,so as to evaluate the drug quality. Methods: In four dissolution media,the dissolution behaviors of domestic and foreign preparations of pipemidic acid tablets were detected,and the consistency of dissolution curves was evaluated by calculating the similarity factor( f_2). The dissolution test method with discriminatory power was established finally. Results: The products from one domestic pharmaceutical company were in line with the foreign tablets in the dissolution curve similarities,while the other samples showed differences from the foreign preparations. Conclusion: The new dissolution method is suitable for the dissolution curve determination of pipemidic acid tablets,which provides reference for the further quality consistency evaluation.
引文
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2 Shen LL,Mitscher LA,Sharma PN,et al.Mechanism of inhibition of DNA gyrase by quinolone antibacterials:a cooperative drug-DNAbinding model[J].Biochemistry,1989,28(9):3886-3894
3张启明,谢沐风,宁保明.采用多条溶出曲线评价口服固体制剂的内在质量[J].中国医药工业杂志,2009,40(12):946-950
4中国药典[S].2015年版.二部.473
5日本厚生省医药安全局.日本医疗用医药品品质情报[EB/OL].(2010-01-27)[2018-05-10]http://www.cde.org.cn/recommend.do?method=view&id=403
6陈学敏,钱春梅.吡哌酸的溶解度及增溶[J].西北药学杂志,1990,5(3):28-30
7原国家食品药品监督管理总局药品审评中心.普通口服固体制剂溶出曲线测定与比较指导原则[EB/OL].(2016-03-18)[2018-05-11]http://www.cde.org.cn/news.do?method=large Info&id=314185
8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):308-311
9谢沐风.具有区分力的溶出曲线[J].中国医药工业杂志,2014,45(7):687-689
10牛剑钊,林兰,张启明.美国和日本溶出曲线相似性判定方法介绍[J].中国药物评价,2013,30(2):67-69
2 Shen LL,Mitscher LA,Sharma PN,et al.Mechanism of inhibition of DNA gyrase by quinolone antibacterials:a cooperative drug-DNAbinding model[J].Biochemistry,1989,28(9):3886-3894
3张启明,谢沐风,宁保明.采用多条溶出曲线评价口服固体制剂的内在质量[J].中国医药工业杂志,2009,40(12):946-950
4中国药典[S].2015年版.二部.473
5日本厚生省医药安全局.日本医疗用医药品品质情报[EB/OL].(2010-01-27)[2018-05-10]http://www.cde.org.cn/recommend.do?method=view&id=403
6陈学敏,钱春梅.吡哌酸的溶解度及增溶[J].西北药学杂志,1990,5(3):28-30
7原国家食品药品监督管理总局药品审评中心.普通口服固体制剂溶出曲线测定与比较指导原则[EB/OL].(2016-03-18)[2018-05-11]http://www.cde.org.cn/news.do?method=large Info&id=314185
8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):308-311
9谢沐风.具有区分力的溶出曲线[J].中国医药工业杂志,2014,45(7):687-689
10牛剑钊,林兰,张启明.美国和日本溶出曲线相似性判定方法介绍[J].中国药物评价,2013,30(2):67-69