疏可眠胶囊质量标准研究

Study on Quality Standards for Shukemian Capsules

目的 :制订疏可眠胶囊质量标准。方法 :采用薄层色谱法对制剂中的夏枯草、五味子、合欢花进行定性鉴别 ;采用高效液相色谱法对制剂中的芍药甙进行了含量测定。结果 :疏可眠胶囊中芍药甙含量约为 3 .5 9mg/粒 ;平均回收率为 10 0 .6 6 % ,RSD =3.35 %。结论 :方法简便 ,专属性强 ,重复性好 。

Objective: To establish the quality standards for Shukemian capsules. Methods: Spica prunellae, Fructus Schisandrae and Flos Albiziae were identified by TLC, and paeoniflorin was determined by HPLC. Results: Paeoniflorin content in Shukemian Capsules was about 3.59 mg/capsule. The average recovery was 100.66% and RSD was 3.35%. Conclusion: These methods are simple with strong specificity and good reproducibility, and can be used as the quality control of this preparatiion.