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目的:制定香黄养心胶囊制剂工艺并建立质量标准控制方法。方法:根据处方药味各成分性质建立可行稳定的生产工艺,采用薄层色谱法建立主要组成药味人工牛黄、大黄、当归、枳壳、五味子的鉴别方法,以空白对照法进行专属性研究。结果:所制定的生产工艺稳定、鉴别方法专属性强,说明该工艺和鉴别方法方便合理、简便可行,重现性良好,可作为该产品的生产和质量控制方法。
OBJECTIVE: To develop the preparation technology of Xianghuang Yangxin Capsule and to establish the quality standard control method. Methods: A feasible and stable production process was established according to the properties of prescription ingredients. The identification method of the main constituents of artificial bezoar, rhubarb, Chinese angelica root, Fructus Aurantii and Schisandra chinensis was established by TLC, and the specificity was studied by the blank control method. Results: The established production process is stable and the identification method is highly specific. It shows that the process and identification method are convenient and reasonable, simple and feasible, reproducible and can be used as the production and quality control methods of the product.