摘要
目的:测定nodosin在水中的平衡溶解度,考察其水溶液的稳定性,为药物剂型的研发奠定基础。方法:采用高效液相色谱法测定nodosin的含量,测定25℃水溶液中nodosin平衡溶解度;采用经典恒温法预测nodosin水溶液在室温(25℃)和4℃条件下的稳定性;在室温下,考察pH值对nodosin水溶液稳定性的影响。结果:25℃下nodosin在水中的平衡溶解度为38.33mg/L,nodosin水溶液在室温下有效期(t90)为190.22h;在4℃下t90为2299.37h。nodosin降解的pH-速率曲线呈V型,pH值在5～7范围内,药物比较稳定。结论:nodosin的水溶性较差,水溶液不稳定,其降解反应速度受溶液的pH值影响,属于酸碱专属催化反应。
OBJECTIVE： To determine the equilibrium solubility of nodosin in water and investigate the stability of the nodosin solution to lay a foundation for dosage forms R＆D. METHODS： HPLC was adopted to determine the content and the equilibrium solubility of nodosin at 25℃ ; the stability of nodosin solution was evaluated by the constant temperature method at room tempera- ture （25 ℃ ） and 4 ℃; the effect of pH on the stability of nodosin solution was investigated at room temperature. RESULTS： The equilibrium solubility of nodosin in water was 38.33 mg/L at 25 ℃. The t90 of nodosin solution was 190.22 h and 2299.37 h at room temperature and 4 ℃. The pH-rate profile of nodosin was V -shaped, nodosin was stable when the pH of solution was between 5 and 7. CONCLUSION： The water-solubility of nodosin is poor and it is not stable in aqueous solution. The pH-dependent degrada- tion of nodosin solution confirms to specific acid-base catalysis reaction.
出处
《中国药房》
CAS
CSCD
2013年第7期603-605,共3页
China Pharmacy
基金
河南省科技发展计划项目资助(No.102102310011)
