复方奥硝唑栓剂的制备及质量控制

Preparation and quality management of compound ornidazole suppository

目的研究复方奥硝唑栓剂的制备及质量控制标准。方法以半合成脂肪酸甘油酯为基质,用熔融法制备,采用紫外分光光度法测定其含量,并对其进行稳定性和局部刺激性试验。结果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。结论本品应在凉暗处保存。

OBJECTIVE The paper was studied on the production and quality management of compound ornidazole suppository. METHODS Take semi-composed fatty glyceride as the ground substance, use melting method to produce it and ultraviolet spectrophotomery method to assess its content, and carry out tests on its stability and partial thrill. RESULTS The production of this suppository was technically simple,and its quality was good and stable,and the method of quality management was convenient accurate and precise. CONCLUSION This product needs to be stored in cool and dark areas.