刍议《中华人民共和国药典》中药材项下的含量测定

A rustic opinion on the content determination of traditional Chinese medicine in Chinese Pharmacopoeia

通过对1953年版至2020年版《中华人民共和国药典》中中药材项下的含量测定的指标成分数量进行分析,统计中药含量测定在建国以来的历版药典的变化趋势,结果为:《中华人民共和国药典》收载的含量检测项下一个指标的中药材所占比例越来越高,两个指标的中药材从1990年版开始所占比例也是越来越高。随着科学技术的广泛运用,中药中被发现的化学成分越来越多,出现多个指标的含量检测的中药数量将会越来越多。中药质量的控制,我们肯定以代表成分作为其质量控制在一定范围内的积极作用,也要考虑在中医药理论指导下,综合权衡中药基原、种植/养殖、采收、加工、炮制、剂型、临床配伍和使用以及其不同药用部位都可影响到中药临床的安全性和有效性。在中药传承创新发展过程中,需做到充分尊重中医药理论体系的指导,以切合中医药特色的中医药思维对中药质量进行控制和管理,建立符合中药特点的质量管理标准,发挥中医药的特色和优势。

Through the analysis of the quantity of index components of content determination of traditional Chinese medicine in Chinese Pharmacopoeia from 1953 to 2020,the change trend of content determination of traditional Chinese medicine in the previous editions of Chinese Pharmacopoeia was counted since the founding of the People's Republic of China.The results showed that the proportion of traditional Chinese medicine with one index of content determination in Chinese Pharmacopoeia was increasing,and the proportion of traditional Chinese medicine with two indexes was also higher and higher since the 1990 edition.With the wide application of science and technology,increasing chemical components have been found in traditional Chinese medicine,the number of traditional Chinese medicine with multiple indexes of content determination will increase.For the quality control of traditional Chinese medicine,we must take the representative components as the positive role of their quality control in a certain range,and should also consider that under the guidance of traditional Chinese medicine theory,traditional Chinese medicine origin,planting/breeding,harvesting,processing,preparation,dosage form,clinical compatibility and use,and different medicinal parts all can affect the clinical safety and effectiveness of traditional Chinese medicine.In the process of inheritance,innovation and development of traditional Chinese medicine,it is necessary to fully respect the guidance of traditional Chinese medicine theoretical system,in order to correspond with traditional Chinese medicine thinking with traditional Chinese medicine characteristics to control and manage the quality of traditional Chinese medicine,establish quality management standards in line with traditional Chinese medicine characteristics,and give full play to the characteristics and advantages of traditional Chinese medicine.