对新鱼腥草素钠注射液稳定性与质量标准可控性的探讨  

Study on the Stability and Quality Standard Controllability of Sodium New Houttuyfonate Injection

作　　者：曾茂法[1] 张学斌[1] 屈晓萍[1] 

机构地区：[1]浙江省台州市药品检验所,台州市318000

出　　处：《中国药品标准》2006年第4期21-23,共3页Drug Standards of China

摘　　要：目的对新鱼腥草素钠注射液质量标准可控性与稳定性进行研究。方法采用化学鉴别、紫外吸收光谱与高效液相色谱法对四个不同厂家生产的4批样品进行定性、定量分析。结果用HPLC法测定,其中3批未检出新鱼腥草素钠成份,1批含量仅为10.3%,4批样品均全部或部分分解。结论新鱼腥草素钠注射液不稳定,法定标准不能控制药品质量,这一剂型存在的合理性急需重新论证。Objective;To study the stability and quality standard controllability of Sodium New Houttuyfonate Injection. Methods,The four samples from different manufacturers were analyzed qualitatively and quantitatively by means of chemical identification,UV and HPLC. Results：Through HPLC determination,no Sodium New Houttuyfonate were detected in three batches of samples,the content of the other one was 10.3% ,the four samples were all or partially decomposed. Conclusion.Sodium New Houttuyfonate Injection is not stable. The official standard can not control the quality of the drug. The rationality of this dosage form need to validate again.

关 键 词：新鱼腥草素钠注射液 稳定性 质量标准可控性 

分 类 号：R725.622.5[医药卫生—儿科]