黄芩苷镁盐的稳定性研究  

Study on the Stability of Baicalin Magnesium Salt

作　　者：许海舰[1] 刘一鑫 王志轩[1] 宋鸿儒[2] 刘翠哲[1] 

机构地区：[1]承德医学院河北省中药研究与开发重点研究实验室,河北承德067000 [2]河北北方学院,河北张家口075061

出　　处：《中国药房》2017年第22期3076-3079,共4页China Pharmacy

基　　金：河北省自然科学基金资助项目(No.H2014406036);河北省教育厅高等学校科学技术研究重点项目(No.ZH2012050)

摘　　要：目的:研究黄芩苷镁盐的稳定性。方法:考察黄芩苷镁盐在高温(60℃)、高湿(相对湿度90%)、强光照(4 000 lx)及不同温度(20、37、50、60℃)、不同p H(6.80、5.70、4.60、4.30、3.90、3.60、3.20)条件下的稳定性,采用高效液相色谱法测定药物含量。结果:高湿试验表明黄芩苷镁盐在第5天的质量增加了(6.17±0.12)%,第10天质量增加了(6.92±0.05)%。高温、高湿和强光照试验中药物含量在第10天分别为(94.78±0.12)%、(94.79±0.20)%、(94.66±0.15)%(n=3)。在磷酸盐缓冲溶液(pH 6.80)中,仅当温度低于20℃时,黄芩苷镁盐稳定;在纯水(pH 6.76)中,37℃时黄芩苷镁盐稳定性良好。pH稳定性试验表明pH值为4.30时黄芩苷镁盐最稳定。结论:黄芩苷镁盐有一定程度的吸湿性,强光照对其稳定性的影响较高温与高湿更大,其在纯水中的稳定性优于在磷酸盐缓冲溶液中,且在弱酸性条件下较稳定。OBJECTIVE：To study the stability of baicalin magnesium salt. METHODS：The stability of baicalin magnesium salt at high temperature（60 ℃）,high humidity（90%）,strong illumination（4 000 lx）,different temperatures（20,37,50,60 ℃）and pHs（6.80,5.70,4.60,4.30,3.90,3.60,3.20） was investigated,and HPLC was used to detect the drug contents. RESULTS：High humidity test indicated that the quality of baicalin magnesium salt was increased by（6.17 ± 0.12）% in the 5th day and increased by（6.92±0.05）% in the 10 th day. Drug contents in the 10 th day were respectively（94.78±0.12）%,（94.79±0.20）%,（94.66±0.15）% in the high temperature,high humidity,strong illumination tests（n=3）. In phosphate buffer solution（p H 6.80）,baicalin magnesium salt was stable only when the temperature was below 20 ℃;and it was yet stable in pure water（pH 6.76）at37 ℃. pH stability test showed that the most stable pH was 4.30. CONCLUSIONS：Baicalin magnesium salt has hygroscopicity to some extent. Strong illumination affects the stability more seriously than high temperature and high humidity. The stability of baicalin magnesium salt in pure water is superior to in phosphate buffer solution,and the salt is stable in weak acid solution.

关 键 词：黄芩苷镁盐 高温 高湿 强光照 温度 PH 稳定性 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]