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目的:研究TSN在不同pH乙醇溶液和不同药用基质中的降解动力学特征,探求丹参酮IIA(TSN)在纳米载药和释药技术新剂型中的药物稳定性。方法:采用HPLC法检测溶解在不同pH乙醇溶液和不同药用基质中的TSN于不同时间的浓度,以剩余百分率(Cr)对时间(t)作图,分别按零级、一级和二级反应方程进行拟合并计算动力学参数。结果:室温条件下TSN在酸性和中性乙醇中稳定,随着pH值增加其稳定性逐渐下降,降解速率加快,除25℃的pH10~11呈一级动力学特征外,其余均符合二级动力学特征。结论:TSN在不同载体基质中的降解速率不同,并随温度升高降解速率呈不同程度加快,与其它载体基质相比较,中链甘油酸三酯(MCT)中的TSN在不同温度下均显示了较好的稳定性,可以将其作为TSN纳米制剂研究的首选辅料载体基质。
OBJECTIVE: To study the degradation kinetics of TSN in different pH ethanol solutions and different medicinal matrices, and to explore the drug stability of TSN in new drug delivery and drug release nano-formulations. Methods: The concentrations of TSN dissolved in different pH ethanol solutions and different medicinal matrices were measured by HPLC at different time intervals. The remaining percentage (Cr) was plotted against time (t) The reaction equations were fitted and kinetic parameters were calculated. Results: At room temperature, TSN was stable in acidic and neutral ethanol. With the increase of pH value, the stability of TSN was gradually decreased and the degradation rate was accelerated. Except for the first-order kinetics of pH10-11 at 25 ℃, Kinetic characteristics. CONCLUSIONS: The degradation rate of TSN in different carrier matrix is different, and the degradation rate of TSN is accelerated to different extents with the increase of temperature. Compared with other carrier matrix, the TSN of MCT shows at different temperatures The better stability can be used as TSN nano-preparation research materials preferred carrier substrate.