消瘀痛胶囊的制备及血竭素的含量测定

Preparation of Xiaoyutong Capsule and Determination of Blood Stasis

目的:介绍消瘀痛胶囊的制备工艺,并建立其处方中血竭素的含量测定方法,为其质量内控评价方法提供科学依据。方法:采用HPLC对胶囊中的血竭素进行定量分析,色谱柱为Kromasil 100-5-C18(4.6mm×250mm,5μm),柱温:40℃;流动相为乙腈-0.05mol/L磷酸二氢钠溶液(36∶64),流速:1.0mL·min^-1,检测波长:440nm。结果:血竭素高氯酸盐在50.3~1006μg/mL范围内线性关系良好(r=0.9998),重复性、精密度、稳定性试验结果的RSD<5%,加样回收率的平均值为99.45%,RSD<2%。结论:制备工艺简便,所建立的定量鉴别方法可作为评价消瘀痛胶囊剂的内在质量依据。

Objective: This paper introduces the preparation process of Xiaoyutong Capsule and establishes a method for determining the content of hemoglobin in its prescription, which provides a scientific basis for its quality internal control evaluation method. Methods: The hemoglobin in the capsule was quantitatively analyzed by HPLC, and the column was Kromasil 100-5-C18(4.6mm×250mm,5μm), column temperature: 40°C;mobile phase is acetonitrile - 0.05mol/L sodium dihydrogen phosphate solution (36∶64), flow rate: 1.0mL· min^-1, detection wavelength: 440nm.Results: The internal linear relationship was good (r=0.9998), the RSD of the repeatability and stability test results were all <5%, the average of the recovery of the sample was 99.45%, and the RSD was <2%. Conclusion: The preparation process is simple, and the established qualitative and quantitative identification method can be used as the basis for evaluating the intrinsic quality of Xiaoyutong capsule.