两种中药注射剂稳定性实验观察  

Stability of Two Kinds of Injection of Traditional Chinese Medicine

作　　者：黄江虹[1] 

机构地区：[1]广东省中医院,广东广州510120

出　　处：《时珍国医国药》2007年第6期1413-1415,共3页Lishizhen Medicine and Materia Medica Research

摘　　要：目的观察两种中药注射剂的稳定性,为中药注射剂的质量监测提供操作简便,行之有效的科学依据。方法通过简单、有效的留样观察法对高丽参注射液,益气固肾注射液的有关检测项目(性状?澄明度?热原?相对密度?pH值?无菌检查)其稳定性进行为期一年半的定期检测观察。结果一年半的检测期内,两种注射剂的各项检测数据标示均符合相关标准。结论为了提高中药注射剂在临床使用上的安全性,必须定期检测其相关的检测项目,制定安全系数较大的使用有效期。Objective To observe the stability of two kinds of injection of traditional Chinese medicine, and offer the easy and effective scientific method to the quality charge of the injection of traditional Chinese medicine. Methods Observe the stability of some interrelated tested program （such as properties, clear level, antigen of heat, relative density, pH, test without pathogen/ bacteria, and so on） of the injection of Gaolishen and the injection of Yiqigushen in one and a half years, with the easy and effective method of retaining and observing the sample . Results During the testing period of one and a half years, all kinds of testing digit of the two kinds of injection were according to the related standard. Conclusion In order to improve the safety of the injection of traditional Chinese medicine in clinic, we must check some i rlterrelated tested program regularly, and lay down a using allotted time with much more coefficient of safety.

关 键 词：中药注射剂 稳定性 有效期 

分 类 号：R285.5[医药卫生—中药学]