复方甲酮栓的制备与质量控制

Preparation and Quality Control of Compound Jiatong Suppositories

目的:制备复方甲酮栓并建立其质量标准。方法:以甲硝唑和酮康唑为主药制备复方甲酮栓;采用双波长法测定复方甲酮栓中甲硝唑和酮康唑的含量。结果:所制栓剂的鉴别、检查等符合《中国药典》2010年版相关规定;甲硝唑和酮康唑检测浓度线性范围分别为0.60～1.40、0.40～1.20μg·mL-1(r=0.9999、0.9998);平均回收率分别为104.78%(RSD=0.14%)、101.77%(RSD=0.05%)。结论:本制剂制备工艺简便可行,质量稳定、可控。

OBJECTIVE： To prepare Compound jiatong suppositories,and to establish its quality standard.METHODS： Compound jiatong suppositories were prepared with metronidazole and ketoconazole as main components.Double wavelength coefficient method was used to determine the contents of metronidazole and ketoconazole.RESULTS： The identification and examination of preparation were in line with the standards stated in Chinese Pharmacopeia （2010 edition）.The linear ranges of metronidazole and ketoconazole were 0.60～1.40μg·mL-1 （r=0.999 9） and 0.40～1.20 μg·mL-1 （r=0.999 8）.The average recovery rates were 104.78% （RSD=0.14%） and 101.77%（RSD=0.05%）,respectively.CONCLUSION： The method is feasible and simple,and the quality of preparation is stable and controllable.