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Comparison of quality and stability study of different prescription process of Nicergoline for Injection
Pages: 338-341
Year: Issue:  6
Journal: Qilu Pharmaceutical Affairs

Keyword:  尼麦角林稳定性水分有关物质;
Abstract: 目的 确定影响注射用尼麦角林质量及稳定性的因素,为本品处方工艺及质量控制提供依据.方法 采用不同处方、冻干工艺制备样品,进行不同温度下稳定性考察,以有关物质为指标,评价不同温度对产品稳定性的影响.结果 产品处方、水分及温度均会对注射用尼麦角林的稳定性造成影响.结论 水分和温度是影响注射用尼麦角林质量稳定性的主要因素,处方差异对稳定性的影响较小.
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