| 于丹,李静,余立,韩颖,尚悦,徐昕怡,张军,史莹莹.国内外主流药典中可见异物检查方法的比较与分析[J].中国药事,2024,38(7):784-795 |
| 国内外主流药典中可见异物检查方法的比较与分析 |
| Comparison and Analysis of Visible Particle Inspection Methods in Domesticand International Pharmacopeias |
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| DOI：10.16153/j.1002-7777.2024.07.009 |
| 中文关键词: 可见异物 人工灯检法 检查人员 检验操作方法 判定标准 |
| 英文关键词: visible particles manual visual inspection inspector inspection procedure judgment standards |
| 基金项目:中国医药质量管理协会《疫苗注射剂可见异物研究》 |
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| 中文摘要: |
| 目的：探析国内外各主流药典中可见异物检查的分析方法，为《中国药典》中可见异物检查法的升版提出一些思路和建议。方法：通过查阅国内外各主流药典，分别从可见异物的定义、人工灯检法、可见异物的判定标准等方面进行分析比对，总结国内外各主流药典的异同点。结果：各主流药典对可见异物的定义、判定标准等方面均存在差异，对于人工灯检法的检验人员、光源、光照强度、检查数量的要求以及具体的操作方法等均有不同，各主流药典均有所长及所短，检验参数相辅相成，并相互制约。结论：建议《中国药典》结合各主流药典的优缺点和中国企业的现状，对可见异物检查法的内容进行完善，从而更好地保证药品的质量以及人民的用药安全。 |
| 英文摘要: |
| Objective: This article aims to study the analysis methods of visible particles test in the majorPharmacopeias worldwide and to provide some suggestions and ideas for the upgrade of the visible particles testin the Chinese Pharmacopeia. Methods: Through reviewing the major Pharmacopeias worldwide, the defi nition ofvisible particles, the manual visual inspection, and the judgment standards of visible particles were analyzed andcompared, and the similarities and diff erences of the major Pharmacopeias worldwide were summarized. Results:The Pharmacopeias worldwide were differences in the definition and judgment standard of visible particles,and there were diff erences in the requirements for detecting personnel, light sources, light intensity, inspectionquantity, and specifi c operation methods of manual visual inspection. Diff erent Pharmacopeias showed certainstrengths and weaknesses, and the detection parameters were both complementary and constrained. Conclusion:It is suggested that the Chinese Pharmacopoeia should combine the advantages and disadvantages of majorPharmacopeias worldwide, meanwhile, based on the current situation of Chinese enterprises, to further improve the content of the visible particles test and ensure the quality of drugs and the safety of people's medication. |
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