双盲临床试验中中药颗粒安慰剂的制备及评价  

Preparation and Evaluation of TCM Granules Placebo Used in Double-blind Clinical Trials

作　　者：闫晓楠 张红茹 YAN Xiao-nan;ZHANG Hong-ru(Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;R&D Center of Tianjin Zhongxin Pharmaceutical Group Co.,Ltd.,Tianjin Key Laboratory of Traditional Chinese Medicine Quality Control,Tianjin 30045,China)

机构地区：[1]天津中医药大学,天津301617 [2]天津中新药业集团股份有限公司研究院分公司天津市中药质量控制重点实验室,天津300193

出　　处：《食品与药品》2020年第2期108-111,共4页Food and Drug

摘　　要：目的研究双盲临床试验中药颗粒安慰剂的制备工艺,并进行人工评价。方法采用药用辅料及食品为主要原料,以外观、气味、口味及颜色与治疗药物的相似程度为指标,考察安慰剂制备工艺,并采取人工打分的方法进行评价。结果统计分析结果表明安慰剂与原治疗药评分差异无统计学意义(P>0.05)。结论该安慰剂能满足临床试验的需要,但评价方法仍需改进。Objective To study the preparation technology of placebo used in double-blind clinical trials of traditional Chinese medicine granules and evaluate it by manual scoring.Methods Taking the similarity to therapeutic drug in appearance,smell,taste and color as indexes,the preparation technology of the placebo was investigated using pharmaceutical excipients and foods as raw materials,and the placebo was evaluated by manual scoring.Results The results of statistical analysis showed that there was no significant difference between the the scores of the placebo and therapeutic drug(P>0.05).Conclusion The placebo can be used in clinical trials.However,the evaluation method should be further improved.

关 键 词：中药颗粒安慰剂 临床试验 制备工艺 评价方法 

分 类 号：R943[医药卫生—药剂学]