中药制剂银杏叶滴丸的安慰剂制备及模拟效果评价  

Preparation and simulation effect evaluation of placebos for Ginkgo Folium Dropping Pills

作　　者：孙明月[1] 陆芳[1] 赵阳[1] 柴露露 李庆娜[1] 张建兵 王青青 杨韬炜 高蕊[1] SUN Ming-yue;LU Fang;ZHAO Yang;CHAI Lu-lu;LI Qing-na;ZHANG Jian-bing;WANGQing-qing;YANG Tao-wei;GAO Rui(Xiyuan Hospital,Chinese Academy of Chinese Medical Sciences,Beijing 100091,China;Wanbangde Pharmaceutical Group Co.,Ltd.,Wenling 317599,China;Wanbangde Pharmaceutical Group Hangzhou Pharmaceutical Technology Co.,Ltd.,Hangzhou 310012,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]万邦德制药集团股份有限公司,浙江温岭317599 [3]万邦德制药集团杭州医药技术有限公司,浙江杭州310012

出　　处：《中草药》2019年第20期4884-4888,共5页Chinese Traditional and Herbal Drugs

基　　金：“十三五”国家重点研发计划项目(2017YFC1703703);国家“重大新药创制”项目(2017ZX09304003);中医药临床研究与培训国际合作基地(北京)项目(GZYYGJ2017010)

摘　　要：目的探索中药制剂银杏叶滴丸安慰剂的制备方法,并客观评价其模拟效果,为中药安慰剂的研制及评价方法提供参考。方法以银杏叶滴丸安慰剂制备为例,通过试验药物可能性、安慰剂与试验药的相似性评价、药物间的相似程度分析3种方法,从外观、颜色、气味和口味多个方面对其进行模拟效果评价。结果2种处方的安慰剂与银杏叶滴丸原药的相似度较高,在外观、颜色、气味和口味方面与原药基本一致,且处方2[苦味剂蔗糖八乙酸酯0.6 g,着色剂焦糖2.1g,填充剂聚维酮(PVP)K3013.3 g,水溶性基质聚乙二醇(PEG)400044.0 g,制1000丸]安慰剂的模拟效果较处方1(苦味剂蔗糖八乙酸酯1.2 g,着色剂焦糖2.1 g,填充剂PVP K3012.7 g,水溶性基质PEG 400044.0 g,制1000丸)更好。结论银杏叶滴丸安慰剂的研制填补了目前中药滴丸剂型安慰剂的空缺,本安慰剂能够满足随机对照临床试验对安慰剂的要求,为中药安慰剂的制备及模拟效果评价提供了可参考的方法及思路。Objective To explore the placebo-preparation method of Ginkgo Folium Dropping Pills(GFDP)and evaluate its simulation effect objectively,which could provide production and evaluation reference for Chinese materia medica(CMM)placebo.Methods Taking the placebo-preparation of GFDP as an example,the simulation effect was evaluated from aspects of appearance,color,smell,and taste.It employed three different approaches as possibility of experimental drug,similarity evaluation between placebo and experimental drug and the similarity analysis among the drugs.Results The two placebo-preparation prescriptions of GFDP have high similarity with the original drug in terms of appearance,color,smell,and taste.The simulation effect of No.2 placebo-prescription(0.6 g of sucrose octaacetate as bitter agent,2.1 g of caramel as colorant,13.3 g of PVP K30 as fillerz and 44.0 g of PEG 4000 as water-soluble bases to prepare 1000 pills)is better than No.1 placebo-prescription(1.2 g of sucrose octaacetate as bitter agent,2.1 g of caramel as colorant,12.7 g of PVP K30 as filler,and 44.0 g of PEG 4000 as water-soluble bases to prepare 1000 pills).Conclusion The placebo-preparation of GFDP conform to placebo requirements of randomized controlled trials.It fills the vacancy of dropping pills form placebo-preparation in CMM and provides method and idea for placebo-preparation and simulation-effect evaluation of CMM.

关 键 词：中药安慰剂 模拟效果 银杏叶滴丸 临床试验 可能性评价 相似性评价 相似程度分析 外观 颜色 气味 口味 随机对照 

分 类 号：R283.6[医药卫生—中药学]