摘要
目的:为制订简便、准确的归脾丸(浓缩丸)质量控制方法,对现行标准方法进行了简化与提高研究。方法:采用同一供试品溶液,在4块薄层板上鉴别了当归、木香、白术、甘草、龙眼肉、远志和党参。以乙腈-甲醇-0.1%磷酸(37∶18∶45)为流动相,采用高效液相法,测定了归脾丸中甘草酸的含量。结果:甘草酸的进样量在0.069 55～1.391μg与峰面积呈良好的线性关系(r=0.999 9),甘草酸的平均回收率为99.68%(n=9),RSD为1.65%。TLC鉴别阴性无干扰。结论:解决了原标准中甘草酸波峰包覆杂质峰的问题,提高了方法的准确性。所建质量控制方法简便、实用。
Objective： To establish a simple, rapid and accurate method for the quality control of Guipi Pills, the studies of improvemerit were proceeded for the original quality control method of Guipi Pills. Method： Angelicae Sinensis Radix, Aucklandiae Radix,Atractylodi. Macrocephalae Rhizoma, Glyvyrrbizae Radix et Rhizoma, Longan Arillus , Polygalae Radix and Codonopsis Radix were identified using a same sample solution at 4 thin-layer chromatographic plates by TLC. The content of glyeyrrhiszic acid in the Guipi Pills was detenninated using a mixture of aeetonitrile, methanol and 0. 1% phosphoric acid （37：18： 45） as the mobile phase by HPLC. Results： The methodological study showed that a good linear correlation existed in the range 0. 069 55-1. 391 ug （ r =0. 9999） of glycyrrhiszie acid . The average recovery of glycyrrhiszic acid was 99.68vh. and RSD was 1.65% （ n = 9）. The negative sample has not interference on TLC identification. Conclusion： The question of glycyrrhiszie acid peak included impurity peak in original standard was solved, the accuracy of method was greatly improved. The new quality standard of Guipi Pills is simple and usable.
出处
《中国药品标准》
CAS
2012年第6期413-418,共6页
Drug Standards of China
