In recent years, new preparations of traditional Chinese medicines (TCMs) have been developed, increasing the need for their clinical trials. Using placeboes rather than control drugs is increasingly popular in clinical trials of TCMs, as the therapeutic effects of the tested TCMs can be more properly judged. The basic attributes of TCM placeboes include similarity, safety, applicability and controllability. In particular, it is necessary to have similarities in appearance, color, smell and taste between the tested TCMs and placeboes. This is quite difficult for some TCMs due to their distinctive smell and taste. On the other hand, according to the TCM theory on homology of medicine and food, many foods also have certain bioactivities, potentially further complicating the selection of materials for TCM placeboes. In this review, firstly, studies on the special smell and taste of TCMs were introduced. Then, the preparation quality evaluation processes for TCM placeboes were summarized and discussed, based on the relevant literature published in recent years and the research results from our own lab. This review will facilitate the further research and development of TCM placeboes.

To evaluate the similarity of Huoling Shengji granule (HLG) and its placebo at both granules and solution status, the innovative methods that consist of intelligent sensory evaluation technologies and human sensory evaluation methods were developed based on critical quality attributes (CQAs) of granule. The CQAs for traditional Chinese medicine (TCM) placebo granule were mainly divided into three categories: formulation attributes, visual attributes, and attributes of taste and smell. In this investigation, the novel intelligent sensory evaluation technologies including the physical property testing apparatus, computer vision system, color card, and electronic tongue (E-tongue) were employed for characterization of CQAs of HLG and its placebo. Meanwhile, human sensory evaluation by test panels was used to description the HLG and its placebo in terms of appearance, color, taste, and smell. On that basis, the similarity of placebo to CQAs of HLG was assessed by calculating the angle cosine values. The intelligent and human sensory evaluation results showed that the similarity values of HLG and its placebo about the CQAs at granule and solution status were all close to 1, which means that the two preparations have high similarities. In this study, the established similarity evaluation methods based on the CQAs were convenient and reliable, which can be utilized to evaluate the similarity of TCM granule and their placebo at granule and solution status, and demonstrated to be well applied in placebo-controlled trials.

目的:以藿苓生肌颗粒安慰剂为例,以相似性、适用性、可控性和安全性为基本属性,对中药安慰剂的质量标准进行探讨.方法:在藿苓生肌颗粒质量标准的基础上,对其模拟制剂藿苓生肌颗粒安慰剂的质量标准进行研究.除相似性外,着重建立体现其他3个属性的质量控制项目.采用人工评价法建立安慰剂与受试制剂的相似性控制项;采用薄层色谱法对白术、茯苓和黄芪项目进行定性检查,采用HPLC法对马钱苷和淫羊藿苷进行限量测定,建立安慰剂的适用性和可控性控制项;通过对处方中材料成分的每日允许摄入量(ADI)数值统计,进行安慰剂的安全性评估.结果:通过人工评价打分的方法,计算得到藿苓生肌颗粒安慰剂与其受试制剂的相似度是0.9925;在薄层色谱中,藿苓生肌颗粒安慰剂与10％的受试制剂和受试制剂色谱无对应的斑点或者斑点更浅;在HPLC中,藿苓生肌颗粒安慰剂与10％的受试制剂相比含量更低;此外,食品添加剂的用量均在安全使用剂量范围内,在相似性、适用性、可控性和安全性四方面均符合安慰剂质量标准的要求.结论:以藿苓生肌颗粒安慰剂为例,探索建立中药安慰剂的质量标准的方法,为中药安慰剂行业标准的制定提供经验基础.

传统的中药质量评价和控制手段主要依靠感官评价,随着中药现代化的发展,中药质量评价理念和技术水平均在提升,感官评价作为一种中药质量评价的重要方式被重新重视,针对中药药效相关感官指标,主要介绍目前常用的测定方法和数据处理方法.测定方法包括化学定量测定、颜色评价、人工感官评价、动物偏好及动物评价实验、电子仿生设备评价等;感官信息的数据处理方法包括化学计量学分析、模糊数学处理、雷达图、风味轮和感官分级系统.

目的 制备薄荷-荆芥穗挥发油羟丙基-β-环糊精包合物.方法 以羟丙基-β-环糊精为包合材料,搅拌法制备包合物.在单因素试验基础上,以羟丙基-β-环糊精与挥发油比例、羟丙基-β-环糊精质量分数、包合温度为影响因素,含油率、包合率、收率的综合评分为评价指标,Box-Behnken响应面法优化包合工艺.结果 最佳条件为羟丙基-β-环糊精与挥发油比例11∶1,羟丙基-β-环糊精质量分数40％,包合温度47℃,包合时间1.5h,搅拌速度600r/min,综合评分为83.24.结论 该方法稳定可行,可用于制备薄荷-荆芥穗挥发油羟丙基-β-环糊精包合物.

Rhizoma Picrorhizae (RP) is a traditional Chinese medicine, which has always been used to treat many diseases like infantile epilepsy and malnutrition. In modern applications, it has been used to treat hepatitis B and various liver injuries with remarkable curative effects. So far, more than 90 chemical components have been reported in RP, mainly including iridoid glycosides, cucurbitacins, phenylethanoid glycosides, and phenolic glycosides. Among these, iridoid glycosides are the most important active ingredients, and about 30 such compounds have been isolated at present. In pharmacology, RP is beneficial to the choleresis, liver protection, anti‐inflammation, asthma relief, immune regulation, and protection of heart, brain, kidney, and other organs. There have been many investigations on this medicinal herb in recent years, and it has attracted much attention in the medicine domain. In this paper, through systematically consulting the relevant books and electronic databases, we analyzed, arranged, and summarized the available information on this herb to provide reference for its further research.