中药制剂四草通脉胶囊安慰剂制备方法及效果评价

目的：建立制备中药制剂四草通脉胶囊安慰剂的方法,为中药临床试验中安慰剂的制备提供参考。方法：以四草通脉胶囊安慰剂的研制为例,对安慰剂的气味和外观分别通过评价打分及电子鼻进行考察。结果：四草通脉胶囊安慰剂与原药粉末的外观、颜色基本达到一致,口味也基本一致。但气味仍稍有差异。模拟临床试验表明安慰剂不易破盲。结论：该安慰剂已能够满足中药临床试验的需要,但在制备技术上仍有提高的空间。

Preparation and Efficacy Evaluation of the Placebos of Sicao Tongmai Capsules

ABSTRACT Objective: To prepare the placebos of Sicao Tongmai capsules to provide the reference for the placebo preparation in clinical trials of traditional Chinese medicines. Methods: Taking the placebo preparation of Sicao Tongmai capsules as the example, the appearance, color and smell of the placebo were assessed by the scoring method and an electronic nose. Results: The appearance, color and taste of the placebo were in line with those of the drug powder, while there was difference in smell. The simulated clinical experiments showed that the placebo was difficult to be unblinded.Conclusion:The placebo can be used in TCM clinical trials, however, the production technology should be further improved and modified.