尼莫地平片抽验结果质量分析

Quality assessment on the inspection of Nimodipine tablets

目的通过对全国34个生产厂家的850批次尼莫地平片抽验结果的分析,考察国内市场上尼莫地平片的质量情况。方法采用中国药典2005版对本品进行全检,并参照日本在"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6个主要厂家尼莫地平片在水、pH 1.2人工胃液、pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液4种溶出介质中的体外溶出行为。结果经按中国药典2005版对全国850批样品检验,仅4批样品不合格,不合格率为0.47%,不合格项目为溶出度。同一批尼莫地平片在不同溶出介质中溶出差异很大;不同药厂尼莫地平片在同一溶出介质中溶出行为亦存在显著差异。结论尼莫地平片的生产工艺成熟,性质较稳定,总体质量情况较好,主要质量问题体现在体外溶出行为上。

Objective To evaluate the quality of Nimodipine tablets in domestic market by inspecting 850 samples from 34 manufacturers.Methods The general quality of all samples was detected by methods of Chp 2005.The dissolubility of the samples from 6 main manufacturers was tested in 4 media：water,pH 1.2 artificial gastric juice,pH 4.0 acetate buffer solution,and pH 6.8 phosphate buffer solution,as the project of drug quality re-evaluation in Japan.Results Based on the standards of Chp 2005,4 samples were unqualified（0.47%）.There was significant difference in dissolution both among the same samples in various media and among the samples from various manufactures in the same media.Conclusion The process technology for Nimodipine tablets is established,whose properties are stable,with satisfactory quality except the dissolution in vitro.