真方白丸胶囊质量标准研究

Study on Quality Standard of Zhenfangbaiwan Capsule

目的采用多指标综合评价的方法,为真方白丸胶囊提供质量控制的方法和依据。方法采用薄层色谱法(TLC)对制剂中的天麻、枳壳进行定性研究;采用高效液相色谱法(HPLC)测定真方白丸胶囊中天麻素的含量;采用紫外分光光度法测定真方白丸胶囊中总胆酸的含量。结果薄层色谱斑点清晰,阴性对照无干扰,天麻素在0. 13～2. 60μg(r=0. 9999),鹅去氧胆酸在0～0. 167μg(r=0. 9999)范围内线性关系良好,平均回收率分别为99. 98%,99. 57%,RSD分别为0. 202%(n=9)、2. 890%(n=6)。结论该方法简便、灵敏度高、重复性好,能用于该制剂的质量控制。

Objective:To provide quality control methods and basis for Zhenfangbaiwan capsule by means of multi-index comprehensive evaluation.Methods:TLC was used to qualitatively study the gastrodia elata and clam shells.The content of gastrodin in Zhenfangbaiwan capsule was determined by high performance liquid chromatography(HPLC).The spectrophotometric method was used to determine the content of total bile acid in Zhenfangbaiwan capsule.Results:The TLC spots were clear and the negative control had no interference.The gastrodin had a good linear relation in the range of 0.13~2.60μg(r=0.9999),and the chenodeoxycholic acid was in the range of 0~0.167μg(r=0.9999).The average recovery rates were 99.98%and 99.57%respectively,and the RSD was 0.202%(n=9)and 2.890%(n=6),respectively.Conclusion:This method is simple,sensitive and reproducible,and can be used for quality control of the preparation of the capsule.