长效复方磺胺间甲氧嘧啶注射液稳定性试验

长效复方磺胺间甲氧嘧啶注射液稳定性试验(8200字)
摘  要：长效复方磺胺间甲氧嘧啶注射液稳定性试验是考察该兽药在温度、湿度、光线的影响下随时间变化的规律，为生产、包装、贮存、运输条件提供科学依据，同时通过试验建立该药品的有效期。稳定性研究是兽药质量控制研究的主要内容之一，与兽药质量研究和质量标准的建立紧密相关。本文进行了光照试验和加速试验，对供试品的外观、PH值、含量变化等项目进行考察，运用永停滴定法和紫外分光光度计法测定主要成分的含量。光照试验结果得出其应该在遮光、密闭常温下保存较好。加速试验结果得出其稳定性较好，该药的制备处方组成、工艺设计比较合理，参照相关数据分析可预测产品的有效期为两年。
关键词：稳定性试验；紫外分光光度法；长效复方磺胺间甲氧嘧啶注射液
 
Stability Testing Of Long-effect Compound Sulfamonomethoxine Injection
Abstract: Stability testing of long-effect compound sulfamonomethoxine injection is in examining the veterinary drug in temperature, humidity, light under the influence law of change over time. Its purpose is to veterinary drugs production, packaging industries, transportation condition, and providing science basis for its clinical application. Stability studies is veterinary medicine quality control is one of the main contents, and veterinary drug quality research and the establishment of quality standard of closely related. This article has conducted the illumination test and accelerate test, to the test product appearance, PH value, content change and other project investigated, and using ever stop titration and Ultraviolet Spectrophotometry Method for determining the content of main component. Light test results that its should be in room temperature preservation shading, airtight good. Acceleration test results that its stability is better, the preparation of the drug prescription component, process design is reasonable. Consult relevant data analysis can predict product will be valid for two years.
Key words: Stability Testing; Ultraviolet Spectrophotometry Method; Long-effect Compound Sulfamonome-thoxine Injection.
 

目    录
摘要………………………………………………………………………………………1
关键字…………………………………………………………………………………1
1  前言………………………………………………………………………………………2
1.1  长效复方磺胺间甲氧嘧啶注射液概述…………………………………………2
1.2  兽用化学药物稳定性概述………………………………………………………2
1.3  研究思路与方法…………………………………………………………………4
2  材料与方法………………………………………………………………………………5
2.1 仪器及试剂………………………………………………………………………5
2.2 澄明度测定………………………………………………………………………5
2.3 PH值测定…………………………………………………………………………5
2.4永停滴定法………………………………………………………………………5
2.5紫外分光光度法…………………………………………………………………5
3  试验结果及分析…………………………………………………………………………6
3.1光照试验结果及分析………………………………………………………………6
3.2 加速试验结果及分析……………………………………………………………9
4  结论……………………………………………………………………………………11
5  讨论……………………………………………………………………………………11
参考文献……………………………………………………………………………………12
致谢………………………………………………………………………………………13