一叶抗流感胶囊安慰剂的制备及效果评价

Preparation method and effect evaluation of Yiye Anti-influenza Capsule Placebo

目的建立制备中药制剂一叶抗流感胶囊安慰剂的方法,为中药临床试验中安慰剂的制备提供参考。方法以一叶抗流感胶囊安慰剂的研制为例,对其外观、颜色及气味分别通过评价打分进行考察。结果一叶抗流感胶囊安慰剂与原药粉末的外观、颜色基本达到一致,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。

Objective To establish a method for preparing placebo of Yiye Anti-influenza Capsule, which is a traditional Chinese medicine preparation, so as to provide reference for the preparation of placebo in clinical trials of traditional Chinese medicine.Methods Taking the preparation of Yiye Anti-influenza capsule placebo as an example, the appearance, color and smell of Yiye Anti-influenza capsule were evaluated and scored. Results The appearance and color of Yiye Anti-influenza capsule placebo and the original powder were basically the same, but the odor was still slightly different. The simulated clinical trial showed that the placebo was not easy to break the blindness. Conclusions The placebo can meet the needs of clinical trials of traditional Chinese medicine, but there is still room for improvement in preparation technology.