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Pharmacy Information 2023
对《中国药典》2020年版四部通则微生物限度标准相关术语的探讨
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Abstract:
《中国药典》2020年版四部通则微生物限度标准中药材原粉、脏器提取物有关术语概念不够清晰,标准执行者容易产生分歧,本文就该问题展开讨论,并提出相关建议。本文的目的是希望药典标准及相关操作规范在起草过程中能更加明确相关术语的概念,并完善相应的内容,使标准更加完善。
The concept of relevant terms of microbiological limit standard of the original powder of Chinese medicinal materials and the extract of organs in Chinese Pharmacopoeia 2020 edition Vol. Ⅳ are not clear enough, and the standard implementers are likely to have disagreements. This paper discusses the problem and gives relevant suggestions. The purpose of this paper is to hope that in the drafting process of pharmacopoeia standards and relevant operating codes, the concept of relevant terms can be more clearly defined, and the corresponding content can be improved to make the standards more perfect.
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