2020版《中国药典》42种有毒中药外用特点分析

External Use Characteristics of 42 Toxic Chinese Medicinals in Chinese Pharmacopoeia(2020)

目的:总结有毒中药的外用方法及特点,明确有毒中药外用的安全剂量范围,规范有毒中药的外用,缩短治疗周期,减少毒性反应的发生,为临床使用有毒中药提供理论数据支撑。方法:筛选有毒中药临床外用研究文献,归纳有毒中药主治疾病,使用剂量,赋型方法及剂型,治疗周期,禁忌不良反应和解救措施。结果:42种有毒中药外用以膏剂为主,且以陈醋、蜂蜜和姜汁为主要的赋型剂,治疗频次多数为每日一次,治疗周期以两周至三周为主。临床上使用较多的有毒中药如甘遂、(制)天南星、硫黄、制川乌、白附子、木鳖子、芫花及制草乌等均高于药典中的安全内服剂量,朱砂外用剂量可达到10 g。多数的有毒中药在出现不良反应时,以胃肠道反应为主,伴随有头晕、冷汗、恶心等症状;轻粉、狼毒外用时易出现皮疹等不良反应;金钱白花蛇、蟾酥等动物来源中药则易引起神经系统的不良反应,应慎用。结论:有毒中药外用势必较内服安全,通过数据分析阐明了有毒中药在临床应用的特点及方法,明确了有毒中药在临床外用方面的安全剂量范围,基于临床用药的安全性和治疗的高效性来考虑,有毒中药外用的发展前景很好且研究空间巨大。

Objective:This study aims to summarize the methods and characteristics of external use of toxic Chinese medicinals,clarify the safe dose range of them,and standardize the external use,so as to shorten the treatment cycle and reduce the occurrence of toxic reactions.Thereby,this study is expected to serve as a reference for clinical use of toxic Chinese medicinals.Methods:Articles on clinical external use of toxic Chinese medicinals were retrieved,and the main indications,doses,shaping methods and dosage forms,treatment cycle,contraindications,adverse reactions,and solutions were summarized.Results:A total of 42 toxic Chinese medicinals for external use are applied in the form of paste,and mature vinegar,honey,and ginger juice are the main excipients.They are generally applied once a day for 2~3 weeks.The doses of the common toxic Chinese medicinals such as Gansui(甘遂),Zhitiannanxing(制天南星),Liuhuang(硫黄),Zhichuanwu(制川乌),Baifuzi(白附子),Mubiezi(木鳖子),Yuanhua(芫花),Zhicaowu(制草乌),are all higher than the safe oral doses in Chinese Pharmacopoeia,and the external dose of Zhusha(朱砂)is up to 10 g.The adverse reactions generally occur in gastrointestinal tract,accompanied by dizziness,cold sweating,and nausea.In the external application,Qingfen(轻粉)and Langdu(狼毒)induce rash and other adverse reactions.Chansu(蟾酥),Jinqianbaihuashe(金钱白花蛇),and other animal medicinals cause adverse reactions in the nervous system,which should be used with caution.Conclusion:The external use of toxic Chinese medicinals is bound to be safer than the internal use.Through data analysis,this paper expounds the characteristics and methods of clinical application of toxic Chinese medicinals,and defines the safe dose range of toxic Chinese medicinals for clinical external use.In view of the safety and the efficiency in the treatment,external use of toxic Chinese medicinals has good prospect and should be further studied.