胃肠舒片的质量标准  

Study on Quality Standard of Weichangshu Pills

作　　者：王纪彩[1] 刘德胜[2] 栾海云[2] 张晓帆[2] 刘孟安[2] 

机构地区：[1]滨州医学院,2007级药学班山东烟台264003 [2]滨州医学院药学院

出　　处：《中国药师》2012年第10期1396-1398,共3页China Pharmacist

基　　金：山东省高等学校教学改革研究项目(编号:2009402);山东省高校科技计划项目(编号:J10LF73)

摘　　要：目的:建立胃肠舒片的质量标准。方法:采用TLC法对制剂中组成药味大黄、枳壳、甘草进行鉴别;用HPLC法测定胃肠舒片中柚皮苷的含量,使用Thermo BDS色谱柱(250 mm×4.6 mm,5μm),流动相:乙腈-水溶液(17∶83);检测波长:230nm;流速:1.0 ml·min-1;柱温:室温;进样量:20μl。结果:TLC法能对制剂中的大黄、枳壳、甘草进行专属性定性鉴别;高效液相色谱法中柚皮苷对照品在125.00～4000.00 ng·ml-1浓度范围内线性关系良好(r=0.999 3),回收率为98.49%(RSD=1.39%,n=6)。结论:该质量控制方法简便、可靠、准确,可用于胃肠舒片的质量控制。Objective: To develop a method for the quality control of Weichangshu pills.Method: Rheum palmatum L.,Citrus aurantium L.and Radix Glycyrrhiza.were identified by TLC.HPLC using a Thermo BDS column(250 mm×4.6 mm,5 μm) was applied in the determination of naringin with the mobile phase of acetonitrile-water(17∶ 83),the flow rate of 1.0 ml·min-1,the detection wavelength of 230 nm,the column temperature of room temperature and the injection volume of 20 μl.Result: The chromatographic spots were identified without interference of the negative control.Naringin had a good linearity within the range of 125.00-4000.00 ng·ml-1(r=0.999 3) with the average recovery of 98.49%(RSD=1.39%,n=6).Conclusion: The method is sensitive,accurate and rapid,and the standard can be used in the quality control of Weichangshu pills.

关 键 词：胃肠舒片 薄层色谱 高效液相色谱 质量标准 

分 类 号：TQ460.72[医药卫生—药物分析学]