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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 establish the preparation technology and quality control method of Viti Xilin coating agent. Methods: Vitexilin coating agent was prepared by grinding method, and the content was determined by high performance liquid chromatography. The column was C18 with a mobile phase of 0.05 mol / L potassium dihydrogen phosphate - acetonitrile (97.5: 2.5) at a flow rate of 1 mL / min and a detection wavelength of 254 nm. Results: The prepared Vildicilin lotion was a yellow suspension. The main drug amoxicillin showed a good linear relationship with the peak area in the range of 0.05-0.45 mg / mL. The linear equation was A = 44.5799C + 0.188 (r = 0.999 9) with an average recovery of 98.7% and RSD of 1.18%. Conclusion: The preparation of Viti Xilin coating by grinding method is feasible and the HPLC method is suitable for the determination of amoxicillin in the preparation of Vedicilin. The method is simple, the method has good reproducibility and is suitable for the quality control of the preparation.