安慰劑對照試驗(yàn)是新藥研發(fā)最常用的臨床隨機(jī)對照試驗(yàn)方法之一，但目前中成藥安慰劑的制備存在諸多困難，其難點(diǎn)在于中藥復(fù)方成分復(fù)雜且中藥"氣味、味道、顏色"較化學(xué)藥、藥用輔料及食品更為突出獨(dú)特，而用于模擬味道和氣味的輔料種類較少，且尚無完善的"氣味、味道、顏色"模擬輔料的統(tǒng)計(jì)與歸納，因此模擬難度較大。針對中成藥安慰劑制備難點(diǎn)，整理歸納出可用于模擬"氣味、味道、顏色"的食品添加劑、食品或藥食兩用物質(zhì)及香料等輔料，并對現(xiàn)有的制備和評價方法進(jìn)行總結(jié)，以期為中成藥安慰劑的輔料、制備、評價方法等研究提供參考。

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.

國家自然科學(xué)基金資助項(xiàng)目（81774452，81001646）；河南省衛(wèi)生健康中青年學(xué)科帶頭人專項(xiàng)（HNSWJW-2020014）；河南省中醫(yī)科學(xué)研究基地專項(xiàng)（2021JDZY036）；國家中醫(yī)藥管理局青年岐黃學(xué)者培養(yǎng)項(xiàng)目（國中醫(yī)藥人教函［2022］256號）