文档介绍：排石Ⅰ号颗粒剂质量标准研究
作者:农英高, 莫海玲, 于灿华
【摘要】目的研究排石I号颗粒的质量控制标准。方法采用薄层色谱法对制剂中广金钱草、泽泻进行定性鉴别,采用高效液相色谱法测定排石I号颗粒中的绿原酸的含量。结果金钱草、泽泻的薄层色谱鉴别专属性强; 32~ 20 mg/ml 范围内呈良好的线性关系,r= 8。%,RSD =% (n=6)。结论该方法简便、灵敏、准确、重现性好,可作为排石I号颗粒剂的质量控制标准。
【关键词】排石I号颗粒; 金钱草; 泽泻; 绿原酸; 薄层色谱; 高效液相色谱
Abstract:ObjectiveTo establish the quality standards of Paishiyihao identification of Herba Desmodii Styracifolii, Rhzoma Alismatis were carried out by TLC. The content of chlorogenic acid was determined by HPLC. ResultsHerba Desmodii Styracifolii, Rhzoma Alismatis could be detected by TLC. A good linearity of chlorogenic acid was in the range of 32~ 20 mg/ml (r= 8) and the average recovery of Chloro
genic acid was % ,RSD was % (n=5).ConclusionThis method is simple,sensitive, accurate and with good reproducibility and can be used for the quality control of Paishiyihao Granule.
Key words:Paishiyihao Granule; Herba Desmodii Styracifolii; Rhzoma Alismatis; Chlorogenic acid; TLC; HPLC
排石汤Ⅰ号是来源于临床经验方的我院自制制剂,由广金钱草、海金沙、泽泻、车前草、石韦等6味药材组成,具有清湿热、利尿、排石的功效。临床上主要用于尿路结石、肾盂肾炎和胆囊炎等,疗效显著。为了方便临床应用,将其开发为便于携带和服用的颗粒剂。为了控制该制剂的质量,保证临床用药安全有效,通过实验研究及参考文献,我们对方中的君药广金钱草、泽泻用薄层色谱法鉴别,并采用高效液相色谱法测定石韦中的绿原酸含量,本方法简便可行,准确可靠,能有效控制制剂质量。
1 仪器与试药
仪器美国BECKMAN公司高效液相色谱仪,166紫外检测仪,125泵;电子天平(BP211D,Sartorius,德国);美国BECKMAN DU640型紫外分光光度仪;德国Elma D
78224型超声仪。
试药绿原酸对照品购自中