黄芩苷镁盐的稳定性研究

摘要

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(4000 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 in-creased by(6.92±0.05)% in the 10th day. Drug contents in the 10th 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(pH 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)at 37 ℃. 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 ba-icalin magnesium salt in pure water is superior to in phosphate buffer solution,and the salt is stable in weak acid solution.%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(4000 lx)及不同温度(20、37、50、60℃)、不同pH(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.