复方甲硝唑分散片的制备及质量控制  

Preparation and Quality Control of Compound Metronidazole Dispersible Tablet

作　　者：潘康锁 王成龙 刘一霖[1] 孙腾飞[1] 李华日[1] 孙睿[1] 万金霞[1] 李引乾[1] 

机构地区：[1]西北农林科技大学动物医学院,陕西杨凌712100 [2]陕西省动物疫病预防控制中心,陕西西安710016 [3]河南省新乡市畜牧局,河南新乡453000

出　　处：《动物医学进展》2014年第6期65-70,共6页Progress In Veterinary Medicine

基　　金：西北农林科技大学大学生科技创新项目(1201210712038)

摘　　要：以甲硝唑和盐酸土霉素为主药,选择合适的辅料制备分散片,以制备出适应于兽医临床应用的复方甲硝唑分散片。用正交试验筛选处方,并进行制粒粒度的选择;复方甲硝唑分散片的质量检查包括性状检查、重量差异检查、硬度检查、pH检查、崩解时限检查和分散均匀度检查;紫外分光光度法对甲硝唑和盐酸土霉素有效含量进行考察,计算其回收率和精密度。结果显示,最优处方甲硝唑含量为200g/kg,盐酸土霉素为100g/kg,羧甲基淀粉钠为150g/kg,淀粉为250g/kg,微晶纤维为250g/kg,蔗糖等50g/kg,复方甲硝唑分散片质量检查结果符合中国药典对片剂的质量要求;紫外分光光度法对甲硝唑和盐酸土霉素测定,其结果回收率高,精密度好。制备的复方甲硝唑分散片具有崩解速度快、服用方便、制备工艺简单、稳定性和顺应好的优点,可试用于兽医临床。In order to prepare compound metronidazole dispersible tablets,metronidazole and oxytetracy-cline hydrochloride were used as the main drugs,and appropriate auxiliary materials were selected to make dispersible tablets in this experiment.Orthogonal experiment was used to screen prescription of the drug and conduct the selection of the granulation size.The quality inspection of dispersible tablets of the com-pound metronidazole included the check of character,the weight difference,the hardness,pH,disintegra-tion time and uniform dispersion.The dispersible tablets of compound metronidazole were prepared and the contents of metronidazole and oxytetracycline hydrochloride were determined by UV spectrophotome-try.The results showed that metronidazole accounted for 200 g/kg,oxytetracycline hydrochloride accoun-ted for 100 g/kg,CMS-Na accounted for 150 g/kg,starch is accounted for 250 g/kg MCC is accounted for 250 g/kg and sucrose accounted for 50 g/kg.The contents of metronidazole and oxytetracycline hydrochlo-ride were determined by UV spectrophotometry,and the recovery rate was high and the precision was good.The result of the quality inspection of dispersible tablets was accord with the request of the tablet in China Drug Standard.Compound metronidazole dispersible tablets had fast disintegration speed,convenient use,simple preparation process,high stability and good compliance and then can be used for veterinary clinic.

关 键 词：甲硝唑 盐酸土霉素 正交试验 双波长法 

分 类 号：S859.53[农业科学—临床兽医学]