心脉佳Ⅰ胶囊的质量标准研究

Study on quality standard of Xinmaijia Ⅰ capsule

目的对中药新药心脉佳I胶囊的质量标准进行研究,为其质量标准的制定提供依据。方法采用薄层色谱法对制剂中白藜芦醇、丹参酮IIA和葛根素进行定性鉴别,并检查其性状、崩解时限、装量差异、水分等项目,采用高效液相色谱法测定丹参酮IIA的含量。结果白藜芦醇、丹参酮IIA和葛根素薄层色谱斑点清晰,阴性对照无干扰。3批心脉佳I胶囊的装量差异符合药典要求,平均崩解时间为(12.28±5.37)min,平均水分含量为(2.60±0.26)%。丹参酮IIA每粒平均含量为(6.75±0.33)mg。结论本研究所建立的方法灵敏、简便、准确、重复性好,可作为心脉佳I胶囊的质量控制标准。

Objective To study the quality standard of Xinmaijia I capsule,and provide the basis for the formulation of its quality standard. Methods The thin layer chromatography（ TLC） was applied to identify the properties,disintegration time limited,content uniformity and moisture content of resveratrol,tanshinone IIA and puerarin. The high performance liquid chromatography（ HPLC） was used to detecte the content of tanshinone IIA. Results Resveratrol,tanshinone IIA and puerarin could be detected by TLC with clear spots and the negative sample without interference. The three batches samples were in good agreement with the requirements of content uniformity,and the average disintegration time was（ 12. 28 ± 5. 37） min,the average moisture content was（ 2. 60 ± 0. 26） %. The average content of tanshinone IIA was（ 6. 75 ± 0. 33） mg per capsule.Conclusion The methods established in this study are sensitive,simple,accurate and with good reproducibility,which can be used for the quality control of Xinmaijia I capsule.