轻燕减肥胶囊质量标准研究

STUDY ON QUALITY STANDARDS OF QINGYAN OBESITY ATTENUATION CAPSULE

目的 :制定轻燕减肥胶囊的质量标准。方法 :采用薄层色谱法对防己、大黄、陈皮进行定性鉴别 ;并建立粉防己碱含量的检测方法 ,采用薄层扫描法测定。层析条件 :硅胶G薄层板 ,氯仿 丙酮 甲醇 (6∶1∶1)为展开剂 ,稀碘化铋钾为显色剂 ,双波长反射法锯齿扫描 ,λS =4 .95nm ,λR =6 0 0nm ,SX =3。结果 :粉防己碱的量在 0 .5～ 3.2 μg范围内具有良好的线性关系 ,r =0 .9999,平均回收率为 95.1% ,RSD =2 .2 2 %。结论 :方法简便 ,专属性及重现性强 ,结果准确 ,可作为该制剂的质量标准。

Objective:To establish the quality standards of Qingyan obesity attenuation capsule.Method:The TCL method was used to identified Radix Stephaniae Tetrandrae,Radix et Rhizoma Rhei and Pericarpium Citri Reticulatae in the Qingyan obesity attenuation capsule.The quantity determination of tetrandrine was also established by TLC method.chromatography conditions were as follows:silica gel G plate,developer solution:chloroform acetone methanol(6∶1∶1),color developing agent:bismuth Potassium iodide,dual wavelength,reflection,zigzag scanning method.λ s=4.95nm,λ R=600nm,S X=3. Result:Calibration graph was linear in the range of 0.5～3.2μg,r=0.999 9;the average recovery of tetrandrine was 95.1%,RSD=2.22%(n=5).Conclusion:These methods are simple,accurate and repeatable,so can be used as quality standards of this preparation.