塞克硝唑栓的研制和质量控制

Preparation and Quality Control of Secnidazole Suppository

目的建立塞克硝唑栓的制备方法及质量控制标准。方法筛选基质，确定栓剂中的主要成分和基质的组成与比例，并采用高效液相色谱法测定栓剂中塞克硝唑的含量.结果以塞克硝唑为主药，使用水溶性基质制备栓剂；塞克硝唑浓度在0．1～60μg·mL^-1内呈良好的线性关系（r=0．9999），平均回收率为98．93％，RSD为1．7％。结论该制剂制备工艺简单，质量稳定质量控制方法简便、准确、精密度好。

OBJECTIVE To develop the preparation technique of compound secnidazole suppository and to establish its quality control method. METHODS The proper base material was picked out. The proportion of the base material and the main ingredients in suppository were defined. The content of secnidazole was determined by HPLC method. RESULTS The suppository was prepared with secnidazole as the main ingredient,and water-soluble base PEG as materials. The linear range of secnidazole was 0. 1 - 60 μg · mL^- 1 （r =0. 999 9 ） and the average recovery rate of secnidazole was 98.93 % （ RSD = 1.7% ）. CONCLUSION The preparation is simple in preparation technique and stable in quality. The quality control method is convenient, accurate and precise.