《中国药典》2020年版一部含乌头碱制剂质量控制探讨

为了较全面了解《中国药典》2020年版一部收载含乌头碱制剂的质量控制情况,本文以制剂的鉴别、检查和含量测定项目为依据,结合用法和用量项目,对87种制剂的含乌头碱饮片质控情况进行整理和分析。结果显示,大多数制剂的含乌头碱饮片质量控制很不完善,相关项目指标和内容建议在新版药典中修订,以便规范控制制剂质量,保证药品安全有效。

Discussion on the quality control of preparations containing aconitine in the Chinese Pharmacopoeia 2020 (Volume I)

In order to fully understand the quality control of preparations containing aconitine in the Chinese Pharmacopoeia 2020 (Volume I), this paper, based on the items of identification, inspection and content determination of preparations, combined with the items of usage and dosage, organizes and analyzes the quality control of 87 preparations containing aconitine. The results showed that the quality control of the prepared slices containing aconitine in most preparations was not perfect, and the indexes and contents of related items were suggested to be revised in the new edition of the Pharmacopoeia in order to standardize the quality control of preparations and ensure the safety and effectiveness of drugs.