| 王似锦,马仕洪.《中国药典》2020年版中生物指示剂相关指导原则的标准建立与研究[J].中国药事,2021,35(5):530-535 |
| 《中国药典》2020年版中生物指示剂相关指导原则的标准建立与研究 |
| Standard Establishment and Research on the Guidelines Related to Biological Indicators in Chinese Pharmacopoeia (2020 Edition) |
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| DOI：10.16153/j.1002-7777.2021.05.006 |
| 中文关键词: 中国药典 生物指示剂 质量控制 |
| 英文关键词: Chinese pharmacopeia biological indicators quality control |
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| 中文摘要: |
| 生物指示剂是药品灭菌工艺监控、确认和验证的关键物质。《中国药典》2020年版增订了通则 9207灭菌用生物指示剂指导原则和通则9208生物指示剂耐受性检查法指导原则，进一步规范了生物指示剂的定义、特点、质量和应用等，并且增加了总芽孢计数、D值测定、存活时间和杀灭时间的确认等质量控制方法。新增订的指导原则弥补了《中国药典》在生物指示剂方面的不足，规范了灭菌生物指示剂的质量控制，以及药品灭菌工艺的研究与开发，有助于进一步提高我国的药品质量与安全。 |
| 英文摘要: |
| Biological indicators are the key substance in the monitoring, confirmation and verification of drug sterilization process. Two guidelines for biological indicators, 9207 guidelines for biological indicators of sterilization and 9208 guidelines for resistance tests of biological indicators were added to Chinese Pharmacopoeia (2020 edition). The definition, characteristics, quality and application of BIs were further standardized. More quality control methods, including total viable spore count, D value, and confirmation of survival time and kill time were added, too. The newly revised guidelines make up for the deficiency of biological indicators in Chinese Pharmacopoeia and standardize the quality control of sterilization biological indicators and the research and development of drug sterilization technology as well, which is helpful to further improving the quality and safety of drugs in China. |
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