利胆片中黄芩苷的含量测定及其质量评价

Content Determination and Quality Evaluation of Baicalin in Cholagogic Tablet

目的:建立利胆片中黄芩苷的含量测定方法,并评价不同厂家利胆片的质量。方法:采用高效液相色谱法测定利胆片中黄芩苷的含量;对不同厂家以及同一厂家不同批次利胆片中黄芩苷的含量进行对比,并且对黄芩苷含量分布区域进行比较,拟订黄芩苷的控制指标并进行质量评价。结果:黄芩苷检测质量浓度在0.00214～0.05340mg/mL范围内与峰面积积分值呈良好的线性关系(r=0.9999);平均加样回收率为100.33%,RSD=1.09%(n=6)。53批利胆片的黄芩苷含量最大值为每片1.14mg,最小值只有每片0.29mg,各厂家平均值最高的为每片1.04mg,最低的只有每片0.30mg。结论:有必要增加黄芩苷含量控制标准,可考虑规定利胆片每片含黄芩苷不得少于0.59mg,以保障该药成品的质量和效果稳定。

OBJECTIVE： To develop the method for content determination of baicalin in Cholagogic tablet, and to evaluate the quality of them from different manufacturers for consideration. METHODS： The content of baicalin in Cholagogic tablet was de- termined by HPLC. The contents of baicalin in Cholagogic tablet from different manufactures or different batches of the tablet from same manufactures were analyzed comparatively; the distribution area of baicalin content were also compared, and the quality control index of baicalin were determined to evaluate the qualities of them. RESULTS： The linear range of baicalin were 0.002 14-0.053 40 mg/mL （r=0.999 9） with an average recovery of 100.33% （RSD=1.09%, n=6）. For the content of baicalin in 53 batches, the maximum was 1.14 mg per tablet, and the minimum was 0.29 mg per tablet. The maximal average value was 1.04 mg per tablet, and the minimal average value was 0.30 mg per tablet. CONCLUSION： It is necessary to add the control index of the content of baicalin. It should be considered that the content of baicalin is no less than 0.59 mg per tablet in order to guarantee the quality and effect of the product.