当归补血微丸的制备及其质量控制

Preparation and Quality Control of Danggui Buxue Pellets

目的制备当归补血微丸并建立其质量控制方法。方法以挤出滚圆法制备当归补血微丸,考察微丸的粉体学性质和溶散时限,并采用高效液相色谱法测定微丸中阿魏酸的含量。结果所制微丸圆整度、流动性好,溶散时限合格。阿魏酸进样量在0.03438μg^1.146μg范围内线性关系良好(r=0.9998),平均回收率为97.0%(RSD=0.664%)。结论该制剂制备方法可行;所建立的含量测定方法准确、灵敏、稳定性好,可用于该制剂的质量控制。

OBJECTIVE：To prepare traditional Chinese medicine formula danggui buxue pellets by extrusion- spheronization and to establish its quality control method.METHODS： Danggui buxue pellets were prepared by extrusion - spheronization pelletizer.The micromeritic properties of pellets and its dissolution time limit were determined, the content of ferulic acid in pellets was detected by HPLC. RESULTS： Danggui buxue pellets by extrusion- spheronization were all spheral with smooth surface, good in flowability and qualified in dissolution time limit. The linearity of ferulic acid was in the range of 0.03 438μg～ 1.146μg（ r=0.9 998）, and the average recovery was 97.0% （RSD = 0.664% ） .CONCLUSION： The method is feasible; The determination is accurate,sensitive, stable,and suitable for the quality control of danggui buxue pellets.