国家评价性抽验复方胃蛋白酶颗粒质量分析

Quality Analysis of Compound Pepsin Granules Selected from National Evaluation Sampling Test

目的:评价复方胃蛋白酶颗粒质量现状及存在的问题,为国家药品标准的建立和修订提供更加科学的依据,同时为行政监管提供有力保障。方法:对国家评价性抽验的265批复方胃蛋白酶颗粒进行全项检验,并对检验结果进行统计分析。结果:按照标准检验,有2批次样品不合格,总体不合格率为0.8%。不合格项目均为胃蛋白酶效价。按照探索性研究方法检验,发现维生素B1含量及均匀度不合格、加速试验中部分企业胃蛋白酶活性下降幅度较高等问题。结论:复方胃蛋白酶颗粒的现行质量标准不能满足质量控制的要求,仍需进一步充实和完善。

Objective: To evaluate the quality and existing problems of compound pepsin granules, lay a more scientific basis for the establishment and revision of national drug standards and provide a strong guarantee for administrative supervision. Methods: 265 batches of compound pepsin granules by national sampling evaluation were tested in every respect and the test results were statistically analyzed. Results: According to the standard inspection, two batches of samples were unqualified, and the overall unqualified rate was 0.8%. The unqualified items were pepsin titers. By using the exploratory research method, we identified the problems that the content and evenness of vitamin B1 are not up to standard and that the pepsin activity of some enterprises in the accelerated test decreased to a higher extent. Conclusion: The current quality standard of compound pepsin granules can not meet the requirements of quality control and needs to be further enriched and improved.