中成药安慰剂辅料、制备与评价的研究进展

安慰剂对照试验是新药研发最常用的临床随机对照试验方法之一,但目前中成药安慰剂的制备存在诸多困难,其难点在于中药复方成分复杂且中药"气味、味道、颜色"较化学药、药用辅料及食品更为突出独特,而用于模拟味道和气味的辅料种类较少,且尚无完善的"气味、味道、颜色"模拟辅料的统计与归纳,因此模拟难度较大。针对中成药安慰剂制备难点,整理归纳出可用于模拟"气味、味道、颜色"的食品添加剂、食品或药食两用物质及香料等辅料,并对现有的制备和评价方法进行总结,以期为中成药安慰剂的辅料、制备、评价方法等研究提供参考。

Research progress on excipient, preparation and evaluation of Chinese patent medicine placebo

Placebo-controlled trial is one of the most commonly used clinical randomized controlled trial methods in new drug development. However, there are many difficulties in the preparation of Chinese patent medicine placebo. The difficulty is that the composition of Chinese medicine compound is complex and the smell, taste and color of Chinese medicine are more prominent and unique than chemical medicine, pharmaceutical excipient and food. However, there are few types of excipient used to simulate taste and odor, and there is no perfect statistics and induction of odor, taste and color simulation excipient, so the simulation is difficult. In view of the difficulties in the preparation of Chinese patent medicine placebo, food additives, food or drug-food dual-use substance, spices and other excipient that can be used to simulate odor, taste and color were summarized, and the existing preparation and evaluation methods were summarized, in order to provide reference for the research on excipient, preparation and evaluation methods of Chinese patent medicine placebo.