近年来，中药制剂安慰剂制备和评价的基本原则已被明确提出和应用实践，包括安全性、相似性、适用性和可控性4个基本属性，及模拟制剂和临床试验药物制剂的双重身份。在此基础上，随着安慰剂在临床应用愈加广泛、品质要求逐步提高，相似性作为确保临床试验盲法实施的关键属性，愈发受到重视。除了模拟关键质量属性（critical quality attributes，CQAs）及选择合适的感官参数表征方法外，一些新的思路和设计被提出，用以进一步提升中药制剂安慰剂与其模拟对象的相似性。以模拟难度最大的剂型——中药颗粒安慰剂为例，限定安慰剂处方为纯辅料，以确保临床试验盲法为关键目标，提出了基于CQAs提取和有效模拟的中药颗粒安慰剂制备策略，包括对关键感官参数随时间变化规律的模拟，及探索安慰剂处方中关键原料感官性质在制剂制备过程中的传递规律，并对气味模拟策略和新的评价技术提出展望，为中药颗粒安慰剂的品质提升和临床应用提供参考。

In recent years, the basic principles for the preparation and evaluation of traditional Chinese medicine (TCM) placebos have been established and implemented, including the four basic attributes of safety, similarity, applicability and controllability, as well as the dual identity as simulated preparations and clinical trial preparations. On this basis, with the increasing clinical applications of placebo and the gradual improvement of quality requirements, similarity as the most critical attribute to ensure the implementation of clinical trial blinding, has gained increasing attention. In addition to clarifying the critical quality attributes (CQAs) of the simulation and selecting appropriate sensory parameter characterization methods, some new ideas and designs have been proposed to further enhance the similarity between TCM placebos and their simulated objects. This study focuses on TCM granules, the dosage form most challenging to simulate, where placebo formulations are typically limited to pure excipients to maintain clinical blinding. The placebo preparation strategy of TCM granules based on the extraction and effective simulation of CQAs is proposed. It also includes the simulation of the change rule of key sensory parameters with time and the exploration of the transfer rule of the sensory properties of key raw materials in the placebo prescription in the preparation process. The odor simulation strategy and new evaluation technology are proposed, aiming to provide reference for the quality improvement and clinical application of TCM granule placebo.

R28

上海市卫健委临床研究专项资助项目（201940296，202140347）；上海中医药慢性病防治与健康服务省部共建协同创新中心（A1-U24-308-01）；上海市科技计划项目“上海市健康辨识与评估重点实验室”（21DZ2271000）