奥美拉唑肠溶胶囊释放度考察及对异常结果的调查研究

Study on the Release Rate and the Abnormal Result of Omeprazole Entericcoated Capsules

目的:对不同厂家不同批次奥美拉唑肠溶胶囊释放度结果进行分析,为其质量控制提供依据。方法:测定16个生产企业51批奥美拉唑肠溶胶囊的释放度,进行统计学分析,并对出现异常结果的检品进行了研究探讨。结果与结论:51批奥美拉唑肠溶胶囊释放度全部符合药典规定,但批间均一性较差,1批出现异常情况,研究发现化学试剂盐酸对个别批次的检品释放度影响较大。

Objective： To discuss the release rate of Omeprazole Enteric-coated capsules from different manufacturers and batches, so as to provide references for quality control. Methods： We determined the release rate of Omeprazole Enteric-coated Capsules in 51 batches from 16 manufacturers, then made statistical analysis and discussed the abnormal result. Results and Conclusion： The 51 batches of Omeprazole Entericcoated capsules release rate all meet the requirement of pharmacopoeia, but inter batch uniformity was poor, and abnormal results were found in one batch. The study found that the chemical reagent hydrochloric acid had great effect on the release rate of individual batches of samples.