活血通脉胶囊制备工艺及质量标准研究

Study on Preparation and Quality Standards of Huoxuetongmai Capsules

目的探讨活血通脉胶囊的制备工艺及质量标准。方法采用显微镜观察与TLC法对活血通脉胶囊进行定性鉴别,用凝血酶滴定法测定活血通脉胶囊的含量。在高温、高湿、强光3个影响因素下,从性状、水分、崩解时限、含量等方面考察活血通脉胶囊的稳定性。结果该产品每1g含抗凝血酶活性不低于16.0U,在高温、高湿、强光条件下,稳定性良好。结论制备工艺合理,检测方法可用于活血通脉胶囊的质量控制。

Objective To establish the preparing technique and the quality standards of Huoxuetongmai capsules. Methods The huoxuetongmai capsules was identified by microscope observation and TLC. The activity of Huoxuetongmai capsules was determined by anti- thrombin titration. The stability of the finished preparation was determined under strong- illumination, high-temperature, high- moisture by character, moisture content, disintegrate time- limit, activity and so on. Results The activity of anti-thrombin per gram powder in Huoxuetongmai capsules was more than 16. 0 U. The finished preparation was stable in quality under strong- illumination, high- temperature and high- moisture. Conclusion The preparation technique of this product is reasonable, and its method of quality control is accurate. Its stability is good. The detecting method can be used for the quality control of Huoxuetongmai capsules.