复方黄槐片质量标准的提高  

Quality Standard Improvement for Compound Huanghuai Tablets

作　　者：李俊[1] 王冬[1] 张丽梅[1] 褚阳[1] 彭程[1] 刘久红[2] 郭研[1] 

机构地区：[1]北京军区北戴河疗养院,河北秦皇岛066001 [2]解放军第252医院

出　　处：《中国药师》2017年第12期2251-2254,共4页China Pharmacist

基　　金：军队医疗机构制剂标准提高科研专项课题重点项目(编号:14ZJZ13)

摘　　要：目的:提高并完善复方黄槐片的质量标准。方法:采用TLC法对制剂中槐米、黄芩、赤芍、大黄、白茅根、鸡血藤、薏苡仁、夏枯草等8味药材进行定性鉴别;采用HPLC法测定芦丁的含量:色谱柱为DIKMASpursil C18柱(250 mm×4.6 mm,5μm),以甲醇-0.2%磷酸(45∶55)为流动相;检测波长为350 nm;柱温为25℃;流速为1.0 ml·min^(-1),进样量为20μl。结果:TLC鉴别斑点清晰,阴性对照无干扰;芦丁在0.011 6~0.185 9 mg·ml^(-1)的浓度范围内有良好的线性关系(r=0.999 9),平均回收率为98.93%(RSD=1.14%,n=6)。结论:提高后的质量标准具有操作简单、专属性强、重复性好的特点,可用于该制剂的质量控制。Objective： To improve the quality standard for compound Huanghuai tablets. Methods： The main components of the preparation including Flos Sophorae Immaturus, Radix Seutellariae Baicalensis, Radix Paeoniae Rubra, Radix et Rhizoma Rhei Palmati, Rhizoma Imperatae, Caulis Spatholobi, Semen Coicis and Spica Prunellae Vulgaris were identified by TLC qualitatively. The content of rutin in Flos Sophorae Immaturus was determined by HPLC. A DIKMA Spursil C18 （250 mm ×4.6 mm, 5 μm） column was used with methanol-0.2% phosphoric acid solution （45： 55） as the mobile phase. The flow rate was 1.0 ml·min^-1, the detection wave-length was set at 350 nm, the column temperature was maintained at 25℃, and the injection volume was 20μl. Results： The spots in TLC were clear without any interference. The calibration curve was linear within the range of 0.011 6-0. 185 9 mg·ml^-1 （r = 0.999 9） for turin. The average recovery was 98.93 % （RSD = 1.14%, n = 6）. Conclusion： The improved quality standard is simple, specific and reproducible, which can be used for the quality control of compound Huanghuai tablets.

关 键 词：复方黄槐片 质量标准 薄层色谱法 高效液相色谱法 芦丁 

分 类 号：TQ460.72[医药卫生—药物分析学]