目的 探索瓜薤滴丸安慰剂的制备方法，评价其效果。方法 采用单因素试验筛选瓜薤滴丸安慰剂的处方中基质、填充剂、着色剂、矫味剂、包衣溶剂，确定最佳处方和生产工艺。对安慰剂的外观、气味、颜色、口味4个方面进行评价，采用人工打分的方法进行安慰剂模拟效果评价。结果 瓜薤滴丸安慰剂的最佳处方为：聚乙二醇4000 70 g、聚乙二醇6000 59.5 g、聚山梨酯80 3.5 g、焦糖10 g、牛奶巧克力棕1.2 g、蔗糖八醋酸酯4 g、可溶性淀粉51.8 g，制成1 000丸瓜薤滴丸，共200 g。安慰剂与试验药在外观、气味、颜色和口味基本一致。结论 瓜薤滴丸安慰剂能够满足实验的需求，可为中药特色的临床安慰剂的制备提供参考。

Objective To explore the preparation method of Guaxie Dropping Pill placebo and evaluate its effect. Methods The single factor test was used to screen the matrix, fillers, colorants, flavors, and coating solvents in the prescription of Guaxie Dropping Pills to establish the best prescription and production process. The appearance, smell, color, and taste of the preparation were evaluated, and the artificial scoring method was used to evaluate the placebo simulation effect. Results The best placebo prescription for Guaxie Dropping Pills is: polyethylene glycol 4000 70 g, polyethylene glycol 6000 59.5 g, polysorbate 80 3.5 g, caramel 10 g, milk chocolate brown 1.2 g, sucrose octaacetate 4 g, and soluble starch51.8 g. Guaxie Dropping Pills placebo of 1 000 pills were obtained with a total weight of 200 g. The appearance, smell, color, and taste of placebo were basically the same as those of Guaxie Dropping Pills test drug. Conclusion The placebo of Guaxie Dropping Pill can meet the needs of this study, and can provide a reference for the preparation of clinical placebo with characteristics of traditional Chinese medicine.

R944

国家科技重大专项重大新药创制项目（2018ZX09301-011-001）