摘要
目的:建立中药制剂补肺活血胶囊安慰剂的制备方法,并评价安慰剂与真药的相似性,为中药制剂安慰剂的制备提供参考。方法:通过筛选安慰剂的基质、香精、色素,探索并获得补肺活血胶囊安慰剂制备的处方和工艺,然后经过生产验证,最终评价安慰剂与真药的相似性。结果:通过二次制粒后填充胶囊制得补肺活血胶囊模拟剂,安慰剂与真药的相似性大于90%,不易被研究者和受试者识别,能够最大限度地防止双盲、安慰剂对照的临床试验中出现偏倚和破盲,从而保证临床试验的质量。结论:制得的补肺活血安慰剂具有实用性,可以作为临床研究的对照药物。
Objective:To establish the preparation method of Bufei Huoxue capsule placebo and evaluate the similarity between placebo and real medicine,so as to provide reference for the preparation of placebo.Methods:The prescription and preparation process of placebo were explored and obtained through screening the matrix,essence and pigment,then verified by production,and finally the similarity between the placebo and the real drug was evaluated.Results:The similarity between the placebo and the real drug was greater than 90%,and the mimic was not easy to be identified by researchers and subjects.It could prevent bias and unblinding in double-blind,placebo-controlled clinical trials to the maximum extent,so as to ensure the quality of clinical trials.Conclusion:The prepared Bufei Huoxue placebo is practical and can be used as a control drug in clinical research.
作者
耿婉丽
杨东鑫
周红秋
欧娥
关敏怡
曾令杰
宫俊
Geng Wanli;Yang Dongxin;Zhou Hongqiu;Ou E;Guan Minyi;Zeng Lingjie;Gong Jun(Central Laboratory,Yunfu People's Hospital,Yunfu 527300,China;Guangdong Leiyunshang Pharmaceutical Co.,Ltd.,Yunfu 527300,China;School of Life Sciences,Sun Yat-Sen University,Guangzhou 510000,China;School of Pharmacy,Guangdong Pharmaceutical University,Guangzhou 510006,China)
出处
《亚太传统医药》
2023年第12期57-60,共4页
Asia-Pacific Traditional Medicine
基金
云浮市中医药(南药)创新团队项目(TP20210003)
广东省医学科学技术研究基金项目(B2023357)。
关键词
补肺活血胶囊
安慰剂
制备
评价
Bufei Huoxue Capsule
Placebo
Preparation
Evaluation
