减味锡类散栓剂质量标准研究  

Studies on Quality Control Standard of Modified Xileisan Suppository

作　　者：丁晓瑜[1] 陈钧[1] 刘一丹[1] 郭丹钊[1,2] 杨学娟[1] 

机构地区：[1]江苏大学药学院,江苏镇江212313 [2]河南科技学院生科院,河南新乡453003

出　　处：《中国实验方剂学杂志》2011年第17期97-99,共3页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：目的:建立减味锡类散栓剂的质量标准。方法:采用TLC法对制剂中的青黛、牛黄、冰片进行定性鉴别。用HPLC对制剂中的靛玉红进行含量测定。色谱柱为SinoChrom ODS-AP C18(4.6 mm×250 mm,5μm),流动相为甲醇-1%醋酸水溶液(81∶19),流速0.8 mL.min-1,检测波长288 nm,柱温为室温。结果:定性鉴别薄层色谱特征明显。靛玉红在0.2～10.8mg.L-1线性关系良好(r=0.999 5),平均回收率为100.95%(RSD 1.12%,n=6)。结论:该方法简单、准确、重复性好,可作为减味锡类散栓的质量控制方法。Objective：To eatablish the quality standard of modified xileisan suppository.Method： Indigo Naturalis,Calculus Bovis,and borneol in this preparation were identified by TLC.The content of indirubin in Modified Xileisan Suppository was determined by HPLC which was performed on a Sino Chrom ODS-AP C18（4.6 mm×250 mm,5 μm） column with a mobile phase of methanol-1% acetic acid solution（81：19） at a flaw rate of 0.8 mL·min-1.The UV detection wavelength was 288 nm,and the column temperature was room temperature.Result： Characteristics of identification were very obviously.The linear ranged from 0.2 mg·L-1 to 10.8 mg·L-1（r=0.999 5） and the average recovery was 100.95%（RSD 1.12%,n=6）.Conclusion： The method is simple,accurate,good reproducibility,and can be used as quality control for Modified Xileisan Suppository.

关 键 词：减味锡类散栓剂 质量标准 薄层色谱 高效液相色谱 靛玉红 

分 类 号：R284.1[医药卫生—中药学]