摘要:
目的:比较不同药厂生产的非洛地平片的体外溶出情况,为临床用药提供参考。方法:参照日本在"药品品质再评价"拟定流程中对溶出度试验条件的规定,分别考察不同药厂非洛地平片在水、pH1.2人工胃液、pH4.0醋酸盐缓冲液、pH6.8磷酸盐缓冲液4种溶出介质中的体外溶出行为,溶出方法采用浆法,转速为50 r/min,同时和中国药典2005年版规定的非洛地平片溶出方法进行比较。结果:按照中国药典方法进行溶出时,4家药厂的非洛地平片在30 min内溶出均超过80%;在其他介质中溶出时,4个药厂中只有1家药厂的产品能够在6 h溶出超过90%,另外教家药厂产品均不太满意。结论:同一批非洛地平片在不同溶出介质中溶出差异很大;不同药厂非洛地平片的质量水平存在显著性差异,临床用药时应加以注意。
Abstract:
Objective :To compare the dissolution in vitro of felodipine tablets of four pharmaceutical factories so as to make a reference to clinical application of felodipine tablets. Methods :The dissolubility of felodipine tablets of four pharmaceutical factories was inspected in the following 5 mediums:water,pH 1.2 artificial gastric juice,pH 4.0 acetate buffer solution,pH 6.8 phosphate buffer solution(the above 4 mediums were used according to the project of drug quality's re-evaluation in Japan)and the mediums that used in ChP 2005.The dissolution tests were proceeded using paddle method at 50 r/min. Results :The cumulative dissolution of all felodipine tablets in 30 min was over 80% when the mediums regulated in ChP 2005 was used.However,when the mediums that regulated in the project of drug quality's re-evaluation in Japan were used,only the products of one manufacture could dissolved over 90% in 6h. Conclusion :The dissolution of the same batch of felodipine tablets in different mediums verifies obviously.There are significant difference among the quality of the felodipine tablets of different pharmaceutical factories,which should be given attention to in clinical application.
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