愈伤灵胶囊初步稳定性考察 |
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引用本文: | 张倩瑶,解春文,于秀丽.愈伤灵胶囊初步稳定性考察[J].中国医药技术经济与管理,2009,3(12):55-59. |
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作者姓名: | 张倩瑶 解春文 于秀丽 |
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作者单位: | [1]中国医药科技成果转化中心,北京100009 [2]山东达因海洋生物制药股份有限公司,山东威海264300 |
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摘 要: | 目的研究影响因素试验(强光照射、高温、高湿)、加速试验、长期使用中愈伤灵胶囊的外观性状、浸出物及含量变化,初步考察其稳定性。方法利用高效液相色谱法,通过与对照品比较,观察变化的情况。结果本品的外观性状、浸出物及含量在高温、高湿度、强光照射试验、六个月恒温加速试验及常温考察中均未发生变化,各项指标均符合规定。
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关 键 词: | 愈伤灵胶囊 高效液相色谱 稳定性 |
Preliminary study on the stability of Yushangling capsulest. |
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Institution: | ZHANG Qianyao,XIE Chunwen, YU Xiuli, (China Pharmaceutical Technology Transfer Cenrer, Beijing 100009,China,2, Shan Dong Dyne Pharmaceutical Co.Ltd, Weihai 264300, China.) |
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Abstract: | To study stability of Yushangling capsules under the infuence of stress testing,accelerated testing and long-term testing.Method:By observing change of yushangling capsules compared with control sample by HPLC.The separation was performed on Hypersil BDS C18 (4.6mm × 250mm, 5 μm) with mobile phase of acetonitrile-0.05% phosphoric acid(25:75) and a flow rate of 1.0ml/min at 30℃ with the UV detection at 203 nm.Results: Yushangling capsules was relatively stable due to light,temperature ,humidity,accelerated testing and long-term testing. |
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Keywords: | Yushangling Capsules HPLC Stability |
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