| 溶菌酶的处方设计前稳定性研究 |
| 投稿时间：2009-10-10 修订日期：2009-11-30 点此下载全文 |
| 引用本文：周闺臣,刘青锋,鲁莹,钟延强.溶菌酶的处方设计前稳定性研究[J].药学实践杂志,2010,28(1):11~13,44 |
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| 中文摘要:目的考察pH值、温度、保护剂、有机溶剂对溶菌酶物理稳定性和生物活性的影响,为其缓释注射剂的处方学研究提供依据。方法以HPLC法测定溶液中溶菌酶的含量,以比浊法测定溶菌酶的生物活性。结果在pH4.0、pH10.0条件下溶菌酶的物理稳定性较好,pH4.0条件下溶菌酶可保持较高的生物活性,pH1.0的条件会完全破坏溶菌酶的溶菌活性;低温条件有利于保持溶菌酶的物理稳定性和生物活性;甘露醇对溶菌酶的稳定性具有先增强后减弱的作用;有机溶剂会严重破坏溶菌酶的物理稳定性,但仍保留着一部分溶菌活性。结论pH值、温度、保护剂、有机溶剂对溶菌酶的物理稳定性和生物活性具有明显影响。 |
| 中文关键词:溶菌酶 处方设计前工作 稳定性 |
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| Stability studies of lysozyme for preformulation |
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| Abstract:Objective To investigate the influence of pH value,temperature,protectant and organic solvent on the physical stability and biological activity of lysozyme.Methods The concentration of lysozyme was determined by HPLC and the biological activity of lysozyme was tested by turbidimetric method.Results Lysozyme was physically stable at pH4.0 and pH10.0.The biological activity of lysozyme was kept well at pH4.0 while it was totally destroyed at pH1.0.Low temperature tended to protect lysozyme from damage.Mannitol protected lysozyme at the beginning and then accelerated its destruction.Organic solvent seriously destroyed lysozyme while the biological activity of lysozyme remained to some degree.Conclusion The pH value,temperature,protectant and organic solvent can obviously influence the physical stability and biological activity of lysozyme. |
| keywords:lysozyme preformulation stability |
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