复方茜草秦艽颗粒质量标准的研究  

Quality Standards for Fufangqinjiao Granules

作　　者：陈玉敏[1] 曹红[1] 水彩红[1] 单婷婷[1] 胡丹[1] 邵千 

机构地区：[1]总后勤部卫生部药品仪器检验所,北京100166

出　　处：《解放军药学学报》2016年第3期230-232,共3页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：全军制剂标准提高科研专项重点课题;No.13ZJZ16

摘　　要：目的建立复方茜草秦艽颗粒质量标准,使该药品质量可控。方法采用HPLC法对制剂中的茜草进行定性鉴别,色谱柱:Kromasil 100-5C18(250 mm×4.6 mm,5μm);流动相:甲醇-水(80∶20);检测波长:250 nm;流速:1.0ml·min^(-1)。用TLC法对制剂中的秦艽、甘草进行定性鉴别,HPLC法测定制剂中龙胆苦苷的含量。色谱柱:Kromasil 100-5C18(250 mm×4.6 mm,5μm);流动相:甲醇-水(20∶80);检测波长:273 nm;流速:1.0 ml·min^(-1)。结果龙胆苦苷的加样回收率平均为99.30%,RSD为0.95%(n=6)。TLC、HPLC鉴别阴性无干扰。结论试验结果表明,该方法重复性良好,方便控制该制剂的质量。Objective To establish a method for content determination of Fufangqiancaoqinjiao granules. Methods Rubiae radix et rhizome, Forsythiae Fructus, Glycyrrhizae Radix et rhizome were identified by TLC. Macrophyllae Radix was identified by HPLC. Kromasil 100-5C18 （250 mm × 4.6 mm, 5 μm）column was used as the stationary phase, methanol-water acid solution （80： 20） as the mobile phase, with the detection wavelength at 250 nm and the flow rate at 1.0 ml .min-1. The content of Gentianae in this preparation was determinated by HPLC. Kromasil 100-5C18（250 mm × 4. 6 mm,5 μm）column was used as the stationary phase, methanol-water acid solution （20： 80） as the mobile phase, with the detection wavelength at 273 nm and the flow rate at 1.0 ml .min- Results The mean recovery of Gentianae in Fufangqiancaoqinjiao granules was 99.30% （ RSD = 0.95%, n = 6 ）. The negative sample didn＇t interfere with the identification of TLC or HPLC. Conclusion The results show that this method is reliable and accurate.

关 键 词：复方茜草秦艽颗粒 龙胆苦苷 茜草 秦艽 甘草 TLC HPLC 

分 类 号：R927.2[医药卫生—药学]