脾康灵胶囊质量标准研究

Study on quality Standards for Pi kang-ling capsules

目的建立脾康灵的质量标准。方法采用薄层色谱法对陈皮、肉桂进行定性鉴别;采用高效液相色谱法对肉桂的桂皮醛进行含量测定,色谱柱为Diamonsil C18(250mm×4.6mm,5μm),流动相为乙腈-水溶液(35∶65),检测波长为290nm。结果薄层色谱能检出陈皮、肉桂;桂皮醛线性关系良好(r=0.9998),平均回收率为98.27%,RSD=1.81%。结论陈皮、肉桂鉴别方法简便、快速,重现性好;高效液相色谱法测定桂皮醛含量准确、快速。

OBJECTIVE To study and establish the quality standards for Pi kang-ling capsules. METHODS TLC method was used to identify the drugs of Tangerine Peel and Cortex Cinnamomi. HPLC method was used to determinate the contents of Trans-Cinnamaldehyde. The HPLC condition of Trans-Cinnamaldehyde was as fol- lows： column was Diamonsil Cl8 （250mm × 4.6mm, 5μm）, the mobile phase consisted of acetonitrile-water（35： 65）, the UV detection wavelength was at 290nm. RESULTS The Tangerine Peel and Cortex Cinnamomi can be identified by TLC method;The calibration curve of Trans-Cinnamaldehyde was linear （r = 0.9998）. The average recovery was 98.27 96 with RSD of 1.81%. CONCLUSION The TLC method is exclusive, reprodueibl and suitable for the identity of Tangerine Peel and Cortex Cinnamomi. The HPLC method is exclusive, quickly and quality suitable.