苦豆子总碱温度敏感型凝胶的质量控制和稳定性研究  

Quality control and stability study of total alkaloid of Sophora alopecuroides thermo-sensitive gel

作　　者：张建萍[1] 魏玉辉[1] 张建强[1] 武新安[1] 

机构地区：[1]兰州大学第一医院药剂科,甘肃兰州730000

出　　处：《中国医院药学杂志》2016年第8期632-635,共4页Chinese Journal of Hospital Pharmacy

基　　金：甘肃省科技厅支撑计划(编号:1011FKCA123)

摘　　要：目的:建立苦豆子总碱温度敏感型凝胶的质量控制以及其稳定性研究。方法:采用TLC鉴别苦豆子总碱,HPLC测定槐定碱含量,以性状、颜色、pH值、胶凝温度和槐定碱含量为指标,通过离心试验、耐热耐寒试验和长期稳定性试验考察凝胶的稳定性。结果:HPLC法测定槐定碱在9.06~580μg·mL^(-1)的质量浓度范围内线性关系良好;凝胶剂在常温下为均匀、淡黄色澄明液体,在33℃左右变为凝胶状;贮存6个月后性状、颜色、pH值、胶凝温度和槐定碱含量均未发生明显变化。结论:该制剂在室温储存质量稳定,建立的质量标准可用于控制凝胶的质量。OBJECTIVE To establish a method for quality control of total alkaloid of Sophora alopecuroides thermo-sensitive gel,and study its stability.METHODS TLC was used for identification of total alkaloid of Sophora alopecuroides.Sophoridine was determined by RP-HPLC.Stability of sample was studied by centrifugation,anti-heat test,anti-cold test and longterm test.RESULTS The linear range was 9.06-580μg·mL^-1 for sophoridine.The gel was light yellow and homogenous liquid at room temperature,coagulated approximately at 33 ℃.Appearance,color,pH,gelation temperature and sophoridine content were not changed obviously during 6 months.CONCLUSION The gel is stable at room temperature and controllable in quality.

关 键 词：苦豆子总碱 温度敏感型凝胶 质量标准 稳定性 

分 类 号：R927[医药卫生—药学]