| 尚悦,马仕洪,张启明,杨昭鹏.科学监管方法之湿热灭菌药品参数放行探索研究[J].中国药事,2022,36(5):497-502 |
| 科学监管方法之湿热灭菌药品参数放行探索研究 |
| Study on Parametric Release of Moist-heat Sterilized Drugs by Scientific Supervision Methods |
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| DOI：10.16153/j.1002-7777.2022.05.003 |
| 中文关键词: 湿热灭菌 参数放行 药典 无菌药品 |
| 英文关键词: moist-heat sterilization parametric release pharmacopoeia aseptic drugs |
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| 中文摘要: |
| 通过研究国内外法规文献，结合我国湿热灭菌无菌药品生产实际情况，分析我国目前行业及法规现状，并在生产企业范围进行调研，最后对我国试行参数放行提出建议。使未来《中华人民共和国药典》中湿热灭菌产品参数放行的内容能够与国际上其他通用标准初步接轨，并为国内无菌药品等生产企业的无菌保障工作起到切实可行的指导作用。 |
| 英文摘要: |
| Through the study of domestic and foreign laws, regulations and literature and combined with the actual production situation of drug products terminally sterilized by moist heat in China, the present situation of the industry, laws and regulations in China was analyzed. After the scope of manufacturers was investigated, suggestions were put forward for the trial parametric release in China so that the parts about the parameter release of drug products terminally sterilized by moist heat in Chinese Pharmacopoeia could be preliminarily in line with other general international standards in the future. This paper will serve a practical guideline for domestic aseptic drug manufacturers in their aseptic guarantee work. |
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