基于速释透皮给药系统的中药复方制剂外用透皮剂型加工工艺研究  

Study on the Processing Technology of Transdermal Preparation of Chinese Herbal Compound Preparation Based on Rapid Release Transdermal Delivery System

作　　者：汪杰[1] 黄祖光[1] 陈焕擂 刘楚楚 WANG Jie;HUANG Zu-gunag;CHEN Huan-lei;LIU Chu-chu(Sanya Traditional Chinese Medicine Hospital,Sanya 572000,China;Department of Chinese Medicine,Guangzhou University of Chinese Medicine,Guangzhou 510006,China)

机构地区：[1]三亚市中医院,海南三亚572000 [2]广州中医药大学中药分析教研室,广东广州510006

出　　处：《中药材》2017年第12期2913-2916,共4页Journal of Chinese Medicinal Materials

基　　金：三亚市专项科研试制项目(2015KS18)

摘　　要：目的:探讨基于速释透皮给药系统的中药复方制剂外用透皮剂型加工工艺。方法:以凝胶剂、巴布剂、涂膜剂三种药物作为研究对象,将药物分为对照组和速释组。结合中药复方特点,在中医药传统"内病外治"理论指导下,加入"速释"机制,对中药复方制剂外用透皮剂型加工工艺进行分析。结果:速释组凝胶剂、巴布剂、涂膜剂三种药物使用时给药次数少于对照组(P<0.05);速释组给药时间长于对照组(P<0.05);速释组药物达到峰值所需时间短于对照组(P<0.05);速释组凝胶剂、巴布剂、涂膜剂临床试验恶心呕吐、腹泻、过敏等不良反应发生率均低于对照组(P<0.05);速释组测试后血浆黏度、全血低切黏度、全血中切黏度、全血高切黏度、红细胞压积、血浆纤维蛋白原及血小板聚集率均低于对照组(P<0.05)。结论:基于速释透皮给药系统的中药复方制剂外用透皮剂型能改善目前中药透皮制剂的整体质量,可避免肝脏的首过效应及胃肠道的破坏,提高疗效。Objective：To investigate the processing technique of transdermal preparation of Chinese herbal compound preparation based on transdermal delivery system. Methods ： Three kinds of drugs as Gel agent, Babu agent and Coating agent were divided into control group and quick release group. Combined with traditional Chinese medicine compound characteristics under the guidance of the traditional Chinese medicine theory＂ disease outside the rule＂, adding ＂quick release＂ mechanism,to analyze the processing technology of transdermal formulation of Chinese herbal compound preparation. Results ： Three kinds of drug for quick release Gel agent, Babu agent, Coating agent of use administration times were less than that of the control group（ P〈0. 05） ;and quick release delivery time were longer than the control group（P〈0.05） ;quick release drug groups reached the peak time were shorter than the control group（ P〈0. 05） ;quick release group Gel agent, Babu agent, Coating agent clinical trials of nausea and vomiting, diarrhea, allergies, and other adverse reaction rates were lower than control group （P〈0. 05 ） ;after testing, the plasma viscosity, whole blood low shear and middle shear viscosity, whole blood high shear viscosity, hematocrit, plasma fibrinogen the original and platelet aggregation rate of quick release groups were lower than control group（P〈0. 05）. Conclusion ：Traditional Chinese medicine compound preparation topical formulations based on scalp quick release transdermal delivery system can improve the overall quality of transdermal formulation, and avoid the first pass effect of the liver and gastrointestinal damage, to improve the curative effect.

关 键 词：速释透皮给药系统 中药复方制剂 外用透皮剂型 加工工艺 

分 类 号：R283.6[医药卫生—中药学]