摘要
目的:研究人参皂苷Rh2静脉注射亚微乳(Rh2-SME)的化学稳定性,并预测其有效期。方法:采用高效液相色谱法测定乳剂中人参皂苷Rh2的含量,分别采用威布尔分布拟合法和经典恒温法处理恒温加速试验数据来预测其有效期,通过对长期试验数据进行统计分析估算其有效期。结果:威布尔分布拟合法预测的有效期与长期试验数据经统计分析估算的有效期较为接近,分别为29.58个月和30.44个月,经典恒温法预测的有效期为40.94个月,与长期试验结果有较大的误差。结论:威布尔分布拟合法与经典恒温法相比,更加适合微粒分散体系Rh2-SME化学稳定性的预测。
Objective：To investigate the chemical stability of intravenous ginsenoside Rh2 submicro-emulsion and to predict its expiry term.Methods：The content of the drug in intravenous ginsenoside Rh2 submicro-emulsion was determined by high performance liquid chromatography.Isothermal test-weibull distribution method, class isothermal method and long-term storage test were used to estimate the chemical stability of intravenous ginsenoside Rh2 submicro-emulsion,respectively.Results：The emulsion was stable during 18 months long-term storage test at 25℃.The expiry term predicted by weibull distribution method,class isothermal method and long-term storage test were 29.58 months,40.94 months and. 30.44 months,respectively.Conclusion：Compared with class isothermal method,weibull distribution method is more suitable for the chemical stability prediction of intravenous ginsenoside Rh2 submicro-emulsion.
出处
《亚太传统医药》
2010年第3期4-6,共3页
Asia-Pacific Traditional Medicine
