中药制剂肾八味胶囊的安慰剂制备及评价研究

Preparation and Evaluation of Placebos for Shenbawei Capsules

目的:建立中药制剂肾八味胶囊安慰剂的制备方法,并客观评价其模拟效果,为中药临床试验中安慰剂的研制提供参考。方法:以肾八味胶囊安慰剂地研制为例,采用盲法,从外观、色泽、气味等多个方面对其进行模拟效果评价打分。结果:肾八味胶囊安慰剂与原药粉末的外观、色泽、气味基本一致,模拟临床试验表明此安慰剂不易破盲。结论:该安慰剂能够满足肾八味胶囊临床试验课题的研究需要。

To establish the preparation method of the placebos for Shenbawei capsules and objectively evaluate the simulation effects. Methods： Using the placebos for Shenbawei capsules as the example, a blind trial was used to assess and score the appearance, color and smell of the placebos. Results： The placebos were basically the same in the appearance, color and taste with the testing drugs. The results of the clinical trial simulation showed that the placebos were difficult to be unblinded. Conclusion： The placebos can be Used in the clinical trial for Shenbawei capsules.