用于风湿病治疗的中药外用膏剂的应用现状及研究进展

Application Status and Research Progress of External Traditional Chinese Medicine Ointment for Rheumatism Treatment

由于疗效确切、药性稳定、不良反应率低,用于风湿病治疗的中药外用膏剂越来越受到国内外学者的关注。本文选择经国家食品药品监督管理总局(CFDA)批准上市并用于治疗风湿病的中药外用膏剂为研究对象,对其剂型、品种以及规格等方面进行梳理与分析;查阅近年来发表的中药外用膏剂研究的相关文献,对其制剂新技术应用、制剂处方研究、成型工艺研究、药效学与安全性研究等进行归纳、分析和总结;指出用于风湿病治疗的中药外用膏剂研究中存在的问题,如缺乏新型制剂,相关促透剂的促透物质基础、促透机制、促透规律研究较少,质量控制标准研究中检测指标的选择不够全面,药代动力学的定性、定量研究相对匮乏等。同时,提出应规范中药外用膏剂的剂型分类及规格描述,亦应积极引进中药智能化、缓控释、靶向制剂等新剂型;加强相关促透剂本身透皮行为的研究,并探讨促透剂自身成分透皮吸收与促透皮吸收的相关性;采用生物效应指标或化学与生物效应相结合的综合评价指标,借鉴中药多维谱效学的最新研究成果,从而建立符合现代透皮理念的科学检测指标及质量控制方法。

Due to the definite curative effect,stable drug properties and low incidence of adverse reactions,the external traditional Chinese medicine( TCM) ointment for rheumatism treatment has attracted more and more attention from scholars at home and abroad. Based on the external TCM ointment for the treatment of rheumatism approved by China Food and Drug Administration( CFDA),this paper would comb and analyze their dosage forms,varieties,specifications,etc. On the other hand,this article summarizes the application of the new formulation technology,prescription research,study on the forming process,pharmacodynamics and safety research,etc. The problems existing in this area were pointed out, such as lack of new preparations;less research on the penetration material basis,the penetration enhancing mechanism,and the penetration enhancing law;the selection of detection indicators of quality control standards is not comprehensive enough;qualitative and quantitative studies of pharmacokinetics are relatively scarce and so on. Meanwhile, proper measures and suggestions are put forward. Not only the formulation classification and specification description of external TCM ointment should be standardized,but also new dosage forms such as intelligentized,controlled release and targeted preparations of Chinese medicine should be actively introduced;the study of transdermal activity of transdermal enhancer itself should be strengthened,and investigating the correlation between the transdermal absorption of the agent itself and promoting transdermal absorption;the biological effect index or indicators that combine chemical and biological effects should be used, and learning from the latest research achievements of multidimensional spectroscopy of Chinese herbal medicine,thereby establishing scientific detection indicators and quality control methods that conform to modern transdermal concept.