国产与原研盐酸氯哌丁片体外溶出曲线初步研究

Preliminary Study on Dissolution Curves in Vitro of Home-made and Original Patented Cloperastine Hydrochloride Tablets

目的初步比较国产盐酸氯哌丁片与原研药在4种溶出介质中溶出曲线的相似性,为仿制药的质量一致性评价及标准修订提供参考。方法以p H 1. 2盐酸溶液、p H 4. 0磷酸氢二钠-枸橼酸缓冲液、p H 6. 8磷酸盐缓冲液和水为溶出介质,分别测定其溶出曲线,并采用AV法来考察其相似性。结果在4种溶出介质中,国产仿制药与原研制剂的AV值均大于15. 0。结论国产与原研盐酸氯哌丁片在4种溶出介质中的溶出行为不相似,提示国产仿制药在处方或工艺上亟须改进。

OBJECTIVE To compare the similarity of the dissolution curves of cloperastine hydroehloride tablets in four kinds of dissolution media to provide reference for evaluating the consistency of the quality of domestic generics and revising the drug standards. METHODS The dissolution curves of home-made and original patented cloperastine hydrochloride tablets in hydrochloric acid solu- tion （ pH 1.2 ） , disodium hydrogen phosphate and citric acid buffer solution （ pH 4. 0） , phosphate buffer solution （ pH 6. 8 ） and water were determined and the similarity was evaluated according to the AV values. RESULTS In the four kinds of media, the AV values were more than 15.0. CONCLUSION The dissolution behaviors of home-made and original patented cloperastine hydrochloride tablets in the four kinds of media are dissimilar, which indicates that the domestic generics urgently need to be improved in the prescription or the manufacturing process.