目的 探索瓜薤滴丸安慰劑的制備方法，評價其效果。方法 采用單因素試驗篩選瓜薤滴丸安慰劑的處方中基質(zhì)、填充劑、著色劑、矯味劑、包衣溶劑，確定最佳處方和生產(chǎn)工藝。對安慰劑的外觀、氣味、顏色、口味4個方面進行評價，采用人工打分的方法進行安慰劑模擬效果評價。結(jié)果 瓜薤滴丸安慰劑的最佳處方為：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。安慰劑與試驗藥在外觀、氣味、顏色和口味基本一致。結(jié)論 瓜薤滴丸安慰劑能夠滿足實驗的需求，可為中藥特色的臨床安慰劑的制備提供參考。

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

國家科技重大專項重大新藥創(chuàng)制項目（2018ZX09301-011-001）