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目的对纯阳正气胶囊的质量标准进行完善。方法采用TLC法对茯苓、白术、苍术、广藿香进行定性鉴别;采用HPLC法同时测定橙皮苷与桂皮醛含量,Agilent TC-C18(4.6 mm×150 mm,5μm)色谱柱;以水(A)和乙腈(B)为流动相,梯度洗脱,流速1.0 ml·min-1,柱温30℃,检测波长290 nm。结果 TLC法鉴别专属性强,分离度好;HPLC法同时测定橙皮苷与桂皮醛含量,两者分别在2.115~33.84μg·ml-1(r=0.9998)、12.30~196.80μg·ml-1(r=0.9997)范围内线性关系、色谱峰分离度、稳定性均良好,平均回收率分别为101.02%、98.46%,RSD分别为1.97%、1.76%。结论 TLC、HPLC方法的定性定量鉴别可作为中药复方纯阳正气胶囊的质量标准的参考。
Objective To improve the quality standard of Chunyang Zhengqi Capsule. Methods The TLC and TLC methods were used for the qualitative identification of Poria cocos, Atractylodes macrocephala, Atractylodes macrocephala and Patchouli. The contents of hesperidin and cinnamic aldehyde were determined by HPLC. The chromatographic column was Agilent TC-C18 (4.6 mm × 150 mm, A) and acetonitrile (B) were used as the mobile phase. The gradient elution was carried out at a flow rate of 1.0 ml · min-1. The column temperature was 30 ℃ and the detection wavelength was 290 nm. Results The HPLC method was simple and specific. The HPLC method was used to determine the contents of hesperidin and cinnamic aldehyde at the same time. The contents of hesperidin and cinnamic aldehyde were between 2.115 and 33.84μg · ml-1 (r = 0.9998) and 12.30 ~ 196.80μg · ml-1 (r = 0.9997). The average recoveries were 101.02% and 98.46%, respectively. The RSDs were 1.97% and 1.76%, respectively. Conclusion Qualitative and quantitative identification by TLC and HPLC methods can be used as reference for the quality standard of Chunyang Zhengqi Capsule.