兽用速效感冒注射液质量标准的研究

RESEARCH ON THE QUALITY STANTARD OF QUICK-ACTING COLD INJECTION

本研究按照农业部《新兽药及兽药新制剂管理办法》的有关要求，除制定出该注射液各药含量及其限度、性状、pH值检查、贮藏条件和有效期等项质量标准外，尚确立了腐植酸显色反应和沉淀反应的鉴别项目，筛选出分光光度法作为控制该注射液色泽的检查指标，并从复方注射液中定量测定出挥发油的含量。该质量标准经四川省兽药监察所检测验证，认为标准先进，方法可行。从而为该注射剂批量生产和质量控制奠定了重要基础。

According to 'the Management Measures of New Veterinary Medicaments and New Formulations'of the Agricultural Department,this research set up the quality standare of the injection, such as the concentrations of all components and their limits,apperences,pH value,storage couditions and expirations date.The color display and precipitation reactions of humic acid were also set to be a judgement item.Spectrophotometer was chosen to inspect the color of the injection.The concentration of volatile oil was determined,too.This standard was proved,by Sichuan Supervision Institute of Vetrinary Medicament, to be practical,and as a result,laid a foundation for the large-seale production and quality control of the injection.