溶媒结晶法两性霉素B稳定性考察

Study on the stability of amphotericin B from solvent crystallization

采用溶媒结晶法生产的注射级两性霉素B在高温、高湿及光照条件下放置10d，温度25℃、相对湿度（RH）60％条件下放置6个月和2℃～8℃条件下放置36个月，分别取样考察其外观、两性霉素A、干燥失重、生物效价、含量及相关物质。结果表明，本品对强光、高温不稳定，加速及长期试验稳定性较好。

To study on the stability of injectable amphotericin B from menstruum after placing under the following conditions： high temperature, high humidity, and light for 10 days, RH 60% at 25℃ for 6 months, and at 2℃-8℃ for 36 months. Experimental parameters include the appearance, the degradation product amphotericin A, loss on drying, microbial assays, composition and relative substances. Results indicated that amphotericin B for injection is unstable to light and high temperature, while stable in ordinary storage condition.