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目的:分析国内奥美拉唑肠溶胶囊质量,以不断提高奥美拉唑肠溶胶囊生产企业工艺水平。方法:对国内获得奥美拉唑肠溶胶囊生产资格的86家药品生产企业(共99个批准文号)进行质量抽检;分析指标参照奥美拉唑肠溶胶囊国内统一检验标准即《中国药典》2010年版第一增补本。结果:共抽取290个批次样品,涉及48家企业,共49个批准文号,占总范围企业百分比为55.8%,占总批准文号比例为49.5%。所抽取290个批次样品中,合格率为98.3%,不合格5个批次,其中性状不合格1个批次、释放度不合格3个批次、耐酸力不合格1个批次。5个批次不合格产品分别取样自江苏、吉林、湖南、河南及云南5个省份。仓库期保存34个批次均抽检合格,货架期保存256个批次抽检合格率为97.7%。结论:参照现行检验标准,奥美拉唑肠溶胶囊整体合格率较为理想,但仍需在产品性状、释放度及耐酸力等方面进行质量提高,进一步改善生产工艺。
OBJECTIVE: To analyze the quality of omeprazole enteric-coated capsules in China so as to continuously improve the technological level of omeprazole enteric-coated capsules manufacturers. Methods: Quality sampling was conducted on 86 pharmaceutical manufacturers (totaling 99 approval numbers) of omeprazole enteric-coated capsules in China. The analysis indexes refer to the domestic uniform test standard of omeprazole enteric-coated capsules, ie, "Chinese Pharmacopoeia 2010 edition of the first supplement. Results: A total of 290 batches of samples were collected involving 48 companies with a total of 49 approval numbers, accounting for 55.8% of the total business scope and 49.5% of the total approval number. Of the 290 batches of samples taken, the pass rate was 98.3%, 5 batches failed, of which 1 trait was unqualified, 3 batches were unqualified, and 1 batch was unqualified for acid resistance. Five batches of substandard products were sampled from Jiangsu, Jilin, Hunan, Henan and Yunnan provinces. 34 batches of the warehouse were preserved sampling inspection, shelf life of 256 batches sampling pass rate was 97.7%. Conclusion: According to the current test standards, the overall pass rate of omeprazole enteric-coated capsules is ideal, but the product quality, release and acid resistance still need to be improved to further improve the production process.