促性腺激素释放激素Buserelin稳定性的研究

Study on the Stability of the API Buserelin

目的:研究Buserelin原料药的性质在温度、湿度、光线等条件的影响下随时间变化的规律,为该原料药的生产、包装、储存、运输及有效期的制定提供依据。方法:根据中国药典2005版二部附录XIX C药物稳定性试验指导原则及化学药物稳定性研究技术指导原则进行强光照射、高温(60℃、40℃)、高湿(RH92.5%±5%、RH75%±5%)影响因素试验,加速试验(40℃±2℃、RH75%±5%;25℃±2℃、RH60%±10%);按Buserelin原料药标准规定的质量指标及相关的检验方法对产品在试验条件下的主要质量指标进行检测。结果:强光照射、高温、高湿等影响因素对Buserelin的稳定性有明显影响,故应密封、于干燥、阴凉处保存。在加速试验中,Buserelin原料药的各项质量指标发生了小的变化,但均在质量标准规定的范围内。结论:强光照射、高温、高湿等影响因素对Buserelin的稳定性有明显影响,应在阴凉干燥处避光密封保存和运输。加速试验结果证明:在此条件下,它的各项质量指标变化均在质量标准范围内,符合Buserelin原料药质量标准规定的要求;故将其保质期暂定为两年。

Objective： To study the influence of temperature, humidity and light on the quality ofAPI buserelin with time change, and to make the basis of the formulation for this bulk drugs＇ production, the packaging, storage, transportation and the term of validity. Methods： According to the XIX C medicine stability test guiding principle and chemistry medicine stability technical guidance principle in the appendix of Chinese pharmacopoeia 2005 edition,the hard light, high temperature （60℃, 40℃）, high humidity （RH92.5%±5%, RH75%±5%） influence factor experiment and the acceleration test （40℃±2℃, RH75%±5%; 25℃±2℃, RH60%±10%） were tested. Based on the prescribed standards for Buserelin API quality indicators and related test method for products, the main qualitative index un- der experimental condition was detected. Results： Hard light, high temperature, high humidity and other factors had significantly affect on the stability of Buserelin, so it should be sealed in a dry, cool place. In the acceleration test, the API Buserelin＇s each qualitative index had little change, but still in the scope of quality standards. Conclusion： Hard light, high temperature, high humidity and other factors had r significantly affect on the stability of Buserelin, so it should be sealed and transported in a dry, cool and dark condition. The acceleration test results showed that the API Buserelin＇s each qualitative index was in the scope of quality specification stipulation under this condi- tion, and it met the quality specification stipulation requirement for API Buserelin; Therefore the guarantee period was tentatively sched- uled for two-year.