基于《中华人民共和国药典》探讨含毒性中药饮片的中成药现状与思考

Current Situation,Problems and Solutions of Chinese Patent Medicines Containing Toxic Chinese Traditional Medicine Decoction Pieces Based on Pharmacopoeia of The People's Republic of China

目的针对中药临床不良反应/事件报告逐年增多现象,提出可行建议。方法以《中华人民共和国药典》(简称《中国药典》)2020年版一部中含毒性中药饮片的中成药为范例,研究分析含毒性中药饮片的中成药分布现状、存在问题,并注重对儿童可用药进行归纳分析。结果《中国药典》中收录毒性中药饮片616种。含毒性中药饮片的中成药共514种,涵盖19种剂型,病种分布以肺系疾病、心脑疾病、经络肢体病证为主。其中成人专用药401种、儿童专用药37种、共用药76种。113种儿童可用含毒性中药饮片的中成药中毒性中药饮片使用频率最高的为朱砂、苦杏仁、雄黄,剂型多为丸剂、片剂、颗粒剂,病种分布以肺系疾病、心脑疾病、脾胃疾病为主。其中明确年龄分段品种33个,未明确年龄分段品种80个;有18个品种毒性饮片的日使用剂量超过《中国药典》的规定范围。结论研究发现含毒性中药饮片的中成药中存在用药安全风险、说明书欠规范(如功能主治欠完善、注意事项标注不明等)、年龄分段不清、剂型欠合理等问题。建议加强中药监管,完善药品说明书,改良制剂,开展中药新药研发。该研究可以为开展含毒性中药饮片的中成药规范管理和临床应用提供数据参考,并为中药新药研发提出建议。

Objective To put forward feasible suggestions for the increasing reports of adverse reaction/events in Traditional Chinese Medicine.Methods Taking the Chinese patent medicines in decoction pieces of toxic Chinese traditional medicines in the first edition of Pharmacopoeia of the People's Republic of China(2020)as an example,the current situation and existing problems of drug use of Chinese patent medicines in decoction pieces of toxic Chinese traditional medicines were studied and analyzed,with emphasis on medicines available for children.Results A total of 616 toxic Chinese herbal medicine decoction pieces were included in the Pharmacopoeia of the People's Republic of China(Chinese Pharmacopoeia).There were 514 Chinese patent medicines containing toxic Chinese herbal medicines,covering 19 dosage forms,and the related diseases were mainly pulmonary diseases,cardiac and cerebral diseases and meridian and limb diseases.Among them,there were 401 adult-specific drugs,37 children-specific drugs and 76 common drugs.113 Chinese patent medicines containing toxic Chinese medicines decoction pieces available for children were used most frequently for cinnabaris,armeniacae semen amarum and realgar.The dosage forms were mostly pills,tablets and granules,with the related diseases were mainly the pulmonary diseases,heart and brain diseases and spleen and stomach diseases.There were 80 kinds of unspecified age-segmented varieties and 33 kinds of explicit age-segmented varieties.The daily use doses of 18 Chinese patent medicines containing toxic Chinese medicines decoction pieces available for children exceeded the range specified in the Chinese Pharmacopoeia.Conclusion The study has found that there are problems of safety risks,lack of standardization of instructions(e.g.lack of perfect function and treatment,unclear labeling of precautions,etc.),unclear age segmentation and unreasonable dosage forms in Chinese patent medicines containing toxic Chinese medicine.It is recommended to strengthen the regulation of TCM,improve the drug instructions and formulations and carry out research and development of new TCM drugs.This study can provide data reference for carrying out the standardized management and clinical application of Chinese patent medicines containing toxic Chinese medicine beverages and make suggestions for the research and development of new Chinese medicines.