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2.1 g，填充剂聚维酮（PVP）K30 13.3 g，水溶性基质聚乙二醇（PEG）4000 44.0 g，制1 000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 K30 12.7 g，水溶性基质PEG 4000 44.0 g，制1 000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 1 000 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 1 000 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.

“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）