目的介绍生脉软胶囊质量标准研究的考察内容,试验方案及试验结果。方法主要考察其外观性状、鉴别反应、装量差异、崩解时限、含量测定等。对鉴别反应采用薄层色谱法,含量测定采用高效液相色谱法,通过对样品的考察,最后确定其质量标准草案。结果证明本试验采用的方法符合规定要求。结论可以应用此标准对本品进行质量控制。 Objective To introduce the study content, test plan and test result of Shengmai soft capsule quality standard. Methods The main study of its appearance and characteristics, identification of reactions, loading differences, disintegration time, content determination. The identification reaction using thin layer chromatography, determination of content using high performance liquid chromatography, through the inspection of the sample, and finally determine the draft quality standards. The results show that the method used in this test meets the requirements. Conclusion This standard can be used for quality control of this product.