2020年版《中国药典》收载的含麝香、牛黄中药制剂的质量标准探讨

Discussion on Quality Standards of Traditional Chinese Medicine Preparations Containing Moschus or Bovis Calculus in 2020 Edition of Chinese Pharmacopoeia

作为名贵中药材,麝香、牛黄常用于急重症患者的救治,但因二者来源稀缺、价格昂贵,野生动物资源急需保护,天然麝香和牛黄已经无法满足制剂生产的需要,人工麝香、人工牛黄、体外培育牛黄等代用品的使用在一定程度上缓解了原药材紧张的问题,目前已被广泛用于中药制剂的生产和使用。2020年版《中华人民共和国药典》(以下简称《中国药典》)共收载了75个中药制剂含有麝香,95个制剂含有牛黄,但在这134个中药制剂的质量标准中,对天然药材与其代用品的区别并不十分明显,部分质量控制项目较为简单。笔者通过梳理2020年版《中国药典》(一部)所载含麝香、牛黄的中药制剂的质量标准情况,包括制剂中麝香或牛黄的类型、入药形式、处方用量、每日(次)最大服用量及质量控制项目等,探讨含麝香、牛黄的中药制剂质量标准的合理性,并在规范麝香和牛黄的使用类型、结合现代研究成果和先进技术完善中药制剂中麝香、牛黄的质量控制项目等方面给出建议,以期能够科学认识、评价含有麝香和牛黄的中药制剂,并为此类中药制剂的质量标准提高提供参考。

As precious Chinese medicinal materials,Moschus and Bovis Calculus are often used in the treatment of acute and severe patients.However,due to their scarce sources and high prices,wild animal resources are in urgent need of protection,natural Moschus and Bovis Calculus can no longer meet the needs of preparation production.The use of substitutes such as Moschus Artifactus,Bovis Calculus Artifactus and Bovis Calculus Sativus has alleviated the shortage of original medicinal materials to some extent,and has been widely used in the production and use of traditional Chinese medicine(TCM)preparations.According to statistics,the 2020 edition of Chinese Pharmacopoeia contains 75 TCM preparations containing Moschus and 95 preparations containing Bovis Calculus,but in the quality standards of these 134 TCM preparations,the difference between natural medicinal materials and their substitutes is not very obvious,and some quality control projects are relatively simple.Based on this,the author intends to sort out the quality standards of TCM preparations containing Moschus or Bovis Calculus in the 2020 edition of Chinese Pharmacopoeia(volume Ⅰ),including the type,drug form,prescription dosage,maximum daily(time)dosage and the quality control items of Moschus and Bovis Calculus in the preparation,in order to explore the rationality of the quality standard of TCM preparations containing Moschus or Bovis Calculus,and to give some suggestions on standardizing the use types of Moschus and Bovis Calculus,improving the quality control items of Moschus and Bovis Calculus in TCM preparations combining modern research achievements and advanced technology.