维地西林涂剂的制备及质量控制  

Preparation and Quality Control of Verdicyclime Paint

作　　者：常明泉[1] 余学英[1] 王正军[1] 聂小雪[1] 

机构地区：[1]湖北医药学院附属太和医院,湖北十堰442000

出　　处：《儿科药学杂志》2012年第11期37-39,共3页Journal of Pediatric Pharmacy

摘　　要：目的:建立维地西林涂剂的制备工艺及质量控制方法。方法:以研磨法制备维地西林涂剂,采用高效液相色谱法测定含量。色谱柱为C18柱,流动相0.05 mol/L磷酸二氢钾溶液-乙腈(97.5∶2.5),流速1 mL/min,检测波长254 nm。结果:所制维地西林涂剂为黄色混悬液,其主药阿莫西林在0.05～0.45 mg/mL范围内与峰面积呈良好的线性关系,线性方程为A=44.5799C+0.188(r=0.999 9),平均回收率为98.7%,RSD为1.18%。结论:研磨法制备维地西林涂剂工艺可行,高效液相色谱法用于维地西林涂剂中阿莫西林含量的测定,方法简便,结果重现性好,适用于该制剂的质量控制。Objective： To prepare verdicyclime paint and establish the preparation and quality control procedures. Methods： erdieyline paint with grinding was prepared and the high performance liquid chromatography was chose to determine amoxicillin content, with C is column and potassium dihydrogen phosphate-aeetonitrile （97.5 ： 2.5 ） of 0.05 mol/L as the mobile phase. The flow rate was 1 mL/min and detection wavelength was 254 nm. Results： The verdieyline paint was yellow suspension, amoxicillin showed a good linear relation in a range of 0. 05 -0.45 mg/mL, the curve equation was A =44. 5799C＋0. 188, r = 0. 9999, the average recovery was 98.7% and RSD was 1.18%. Conclusions： Preparation of verdicyclime with grinding is a feasible method and the quality control is easy, simple and reproducible to apply the high performance liquid chromatography in the determination of amoxicillin content in verdicyline.

关 键 词：维地西林涂剂 质量控制 阿莫西林 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]