| 张乃斌,李春焕,薛维丽,张迅杰,由鹏飞.国家评价性抽验复方胃蛋白酶颗粒质量分析[J].中国药事,2022,36(1):45-55 |
| 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 |
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| DOI：10.16153/j.1002-7777.2022.01.007 |
| 中文关键词: 复方胃蛋白酶颗粒 国家评价性抽验 质量分析 药品监管 质量标准提高 |
| 英文关键词: compound pepsin granules national evaluation sampling test quality analysis drug administration improvement of quality standards |
| 基金项目: |
| 作者 | 单位 | | 张乃斌 | 山东省食品药品检验研究院,山东省仿制药一致性评价工程技术研究中心,济南 250000 | | 李春焕 | 山东省食品药品检验研究院,山东省仿制药一致性评价工程技术研究中心,济南 250000 | | 薛维丽 | 山东省食品药品检验研究院,山东省仿制药一致性评价工程技术研究中心,济南 250000 | | 张迅杰 | 山东省食品药品检验研究院,山东省仿制药一致性评价工程技术研究中心,济南 250000 | | 由鹏飞 | 山东省食品药品检验研究院,山东省仿制药一致性评价工程技术研究中心,济南 250000 |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
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