溶媒结晶法两性霉素B稳定性考察
Chinese Journal of Antibiotics（2008）
Abstract
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、两性霉索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.
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Key words
Amphotericin B,Injection,Solvent crystallization,Stability
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