氯氮平片仿制药与原研药溶出度一致性评价研究

Study on Consistency Evaluation of the Dissolution of Generic and Original Preparations of Clozapine Tablet

关键词:  氯氮平片  溶出度  溶出曲线  一致性评价  相似因子

Key words:  clozapine tablet  dissolution  dissolution curve  consistency evaluation  similarity factor

摘要:

目的 建立氯氮平片溶出度曲线测定方法，评价国内9家仿制药产品与原研药品溶出曲线的相似性。方法 用pH 1.0溶液、pH 4.0缓冲液、pH 6.8缓冲液和含0.2%SDS水溶液4种溶出介质，分别考察氯氮平片仿制药与原研片的溶出状况，并通过计算相似因子（f₂）评价溶出曲线的相似性。结果 国内2家制药公司产品与原研片在4种溶出介质中的溶出曲线均相似，其余企业产品与原研片相比溶出行为均不一致。结论 该方法适用于氯氮平片的溶出曲线测定，可为氯氮平片质量一致性评价提供参考。

Abstract:

OBJECTIVE To establish a new method for the dissolution curve determination of clozapine tablet, and evaluate the comparability of dissolution curve of 9 domestic generic tablets and the original tablet. METHODS With the dissolutive medium of hydrochloric acid solution (pH 1.0), acetate buffer (pH 4.0), phosphate buffer (pH 6.8) and water (0.2% SDS), the dissolution behaviors of generic and original preparations of clozapine were detected, and the dissolution curves of consistency were evaluated by calculating the similarity factor(f₂). RESULTS The two domestic pharmaceutical company products were all in line with the original tablet in the dissolution curve similarities of four media, compared to the other samples showing difference from original preparation. CONCLUSION The new dissolution method is suitable for dissolution curve determination of clozapine tablet, making reference for further quality consistency evaluation.