5-氨基水杨酸栓的制备及质量标准

Preparation and quality control of 5-aminosalicylic acid suppositories

目的 研制以 5 氨基水杨酸为主药的栓剂。方法 拟定处方组成与制备工艺 ,用高效液相色谱法测定含量 ,并进行稳定性试验。结果 处方设计合理 ,制备工艺可行 ,5 氨基水杨酸测定的标准曲线为A =- 1770 2 +2 2 2 786 9C ,r=0 9999,平均回收率 99 10 % ,RSD =0 73%。结论 该栓剂处方合理 ,质量控制方法可靠。

Objective To prepare 5-aminosalicylic acid suppositories and establish standard for quality control. Methods The composition of recipe and manufacturing technique were designed. The content of 5-aminosalicylic acid in preparation was determined by HPLC and its stability tests were carried out. Results The designation of the recipe was reasonable and manufacturing technique was feasible. The recovery of the assay was 99.10%. The stability tests of preparation showed no remarkable change. Conclusion The preparation is rational in formula and method of quality control is suitable.