马蔺子素的降解机制及其稳定性的影响因素

Study on the factors influencing stability of irisquinone and its degradation mechanism

目的:考察马蔺子素的降解规律及其稳定性的影响因素。方法:加速试验法考察马蔺子素在热、光照和不同pH催化下的降解规律,应用化学动力学原理计算药物的相关参数t1/2和(pH)m。同时,研究抗氧剂及羟丙基-β-CD对药物热和光敏性的影响。结果:马蔺子素水溶液的半衰期仅为15d,溶液最稳定的(pH)m6.5。联合应用0.1%的亚硫酸氢钠和0.2%维生素C作抗氧剂可提高药物的稳定性,且马蔺子素:羟丙基-β-CD摩尔比为1:2时有最强的抗光性。结论:抗氧化剂和羟丙基-β-环糊精可增强马蔺子素的稳定性。

OBJECtIVE To study degradation mechanism relating to the stability of irisquinone influenced by light, hot and pH. METHODS Accelerated testing was conducted to study the stability. The correlation parameters, t1/2, were calculated by drug chemical degradation kinetics function. RESULTS Irisquinone was instable to the light, hot and pH. t1/2 of irisquinone solution was 15 days under room temperature, and the （pH）m was about 6. 5. 0. 1% sodium bisulphite and 0. 2% vitamin C were useful antioxidants. Irisquinone： hydroxypropyl-β-cyxlodextrin 1：2 mol ratio had the most strength anti-photosensitivity. CONCLUSION The antioxidant and hydroxypropyl-β-cyclodextrin are effective to enhance the stability of irisquinoe.