清宫寿桃丸临床安慰剂的制作工艺摸索研究

Study on the manufacturing technology of clinical placebo of Qinggong Shoutao pills

目的:建立清宫寿桃丸临床安慰剂工艺制备方法。方法:通过对清宫寿桃丸安慰剂中黄豆粉淀粉比例(A)、黏合剂用量(B)、色素加入量(C)和药粉加入量(D)4个因素进行正交试验,以外观、直径、重量、颜色、气味为指标与清宫寿桃丸进行比较。结果:清宫寿桃丸安慰剂最佳工艺组分组合为A2B2C3D3,即黄豆粉与淀粉比为0.8∶1;黏合剂比例为65%,焦糖色素加入量为2%,药粉加入量为3%,清宫寿桃丸安慰剂与清宫寿桃丸在外观、直径、重量、颜色、气味方面比较基本一致。结论:清宫寿桃丸安慰剂成品符合临床试验要求,可有效实施盲法,保证清宫寿桃丸上市后再评价的临床试验顺利开展。

Objective:To establish a preparation method for the clinical placebos of Qinggong Shoutao pills.Methods:The orthogonal experiments were carried out to investigate the four factors in the preparation process of the clinical placebos of Qinggong Shoutao pills,including the ratio of soybean powder to starch(A),the amount of adhesive(B),the amount of caramel pigment(C)and the amount of drug powder(D).The appearance,diameter,weight,color and smell of the clinical placebos were compared with those of qinggong Shoutao pills.Results:The optimal combination was A2 B2 C3 D3,that is,the ratio of soybean flour to starch was 0.8∶1,and the amount of binder,caramel pigment and drug powder was 65%,2%and 3%,respectively.The placebo pills were basically similar with qinggong Shoutao pills in appearance,diameter,weight,color and smell.Conclusion:The finished product of placebos for Qinggong Shoutao pills meets the requirements of clinical trials,which can effectively implement the blind method,and ensure the smooth development of clinical trials for the re-evaluation after the marketing of Qinggong Shoutao pills.