关于中药新药用饮片取样法的探讨

Discussion on sampling method of decoction pieces used as raw materials of new traditional Chinese medicine

从药材及饮片(植物药)的包件取样、包件内取样及试验样品制备等方面对《中国药典》(Chinese Pharmacopoeia,ChP)、《欧洲药典》(European Pharmacopoeia,EP)、《英国药典》(British Pharmacopoeia,BP)及《美国药典》(United States Pharmacopoeia,USP)进行对比,结合新药用饮片检验的要求,就中药新药用饮片取样法存在的问题进行探讨,并提出以下建议:(1)相关部门组织专家起草中药新药用饮片取样的指导原则或技术要求。(2)暂时参照EP、BP的取样法对中药新药用饮片进行研究,并关注饮片取样对检验结果的影响。(3)根据试验样品的特点研究确定其处理方法。如饮片的不同药用部位或位置的质量差异大,可采用分层抽样的方法,减少取样误差。(4)加强药材的源头管理,减少药材质量差异。(5)在新药用饮片的生产过程中采用混合步骤提高同批饮片的同质性。(6)在ChP“中药材及饮片取样办法”中增加:待检批次饮片应具有较好的同质性;有些样品或试验需要采用更严格的取样方法,包括更多取样包件数或包件内取样量;此外,可对包件内抽取的位置进行修订。

This paper compares Chinese Pharmacopoeia(ChP), European Pharmacopoeia(EP), British Pharmacopoeia(BP) and United States Pharmacopoeia(USP) from the aspects of container sampling, container internal sampling and test sample preparation of medical materials and decoction pieces(herbal drugs), and discusses the problems existing in the sampling method of decoction pieces used as raw materials of new traditional Chinese medicine in combination with the needs of the inspection of decoction pieces.Some suggestions are put forward as follows:(1) The relevant departments organize experts to draft the guideline or technical requirements for the sampling of decoction pieces used as raw materials of new traditional Chinese medicine.(2) The sampling method of EP, BP could be referred to study the decoction pieces temporarily. The effect of the sampling on the test results should be paid attention to.(3) Appropriate treatment methods should be determined according to the characteristics of test samples. If the quality of different parts or positions of the decoction pieces varies greatly, stratified sampling could be used to reduce sampling error.(4) The source management of the quality of medicinal materials should be strengthened to reduce the quality difference of medicinal materials.(5) The mixing step should be adopted to the production of decoction pieces to improve the homogeneity.(6) The following contents should be added to the “sampling method for Chinese medicinal materials and decoction pieces” in the ChP: The batch of decoction pieces being examined should be homogeneous;Some samples or tests may require more rigorous procedures involving more containers being sampled or more samples per container. In addition, the provisions on sampling location in packages need to be revised.