海洋星虫多糖胶囊的稳定性研究
刘玉明++钱甜甜(等)[摘要] 目的 研究海洋星虫多糖胶囊的稳定性。 方法 按照《中国药典》2005年版二部附录原料药与药物制剂稳定性试验指导原则,以胶囊剂重点考察项目性状、鉴别、水分、崩解时限、微生物限度、含量测定为评价指标,进行加速试验和长期试验。 结果 三批样品经过6个月的加速试验和12个月的长期试验,各项指标均符合质量标准规定。 结论 海洋星虫多糖胶囊药物性质稳定。
[关键词] 海洋星虫多糖胶囊;稳定性;加速试验;长期试验
[中图分类号] R284 [文献标识码] A [文章编号] 1673-7210(2014)10(a)-0004-04
Investigation on stability of Sipunculus nudus Polysaccharide Capsules
LIU Yuming1 QIAN Tiantian1 JIANG Dingwen1 HE Ying1 SHEN Xianrong1 JIANG Shuqi2
1.Department of Radiation Protection Medicine, Naval Medical Research Institute, Shanghai 200433, China; 2.In-vitro Metabolism Laboratory of Traditional Chinese Medicine, Zhejiang Traditional Medicine University, Zhejiang Province, Hangzhou 310053, China
[Abstract] Objective To investigate the stability of Sipunculus nudus Polysaccharide Capsules. Methods According to the stability testing of pharmaceutical preparations and guiding principles in Appendix of Chinese Pharmacopeia (2005 edition, 2 volume), with the major investigation items of character, identification, moisture, disintegration time, microbial limit test, the content of polysaccharide as the evaluation indexes ......
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