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目的:考察甘松新酮及其溶液的稳定性,为对照品研制提供参考。方法:将甘松新酮固体放置高温、高湿以及光照条件下10 d,分别于第5天和第10天用HPLC法测定其含量变化;在室温下将甘松新酮乙醇溶液分别用氢氧化钠溶液或盐酸调节p H至设定值,放置72 h,考察p H对其醇溶液稳定性的影响;采用经典恒温法预测甘松新酮醇溶液在室温下和4℃条件下的稳定性。结果:甘松新酮固体在高温(60℃)以及高湿条件下稳定,在10 d内光照条件下降解到92.19%;甘松新酮乙醇溶液在碱性环境下基本稳定,在酸性以及高温环境中则迅速降解,且温度越高,降解速率越快;甘松新酮醇溶液在室温下的有效期(t90)为73.18 h,4℃下为1 621.22 h。结论:甘松新酮对光以及高温敏感,应避光保存;在提取分离以及给药过程中应注意控制温度低于40℃以及溶液p H在7~12范围内。
OBJECTIVE: To investigate the stability of Ganoderma lucidum ketone and its solution, provide a reference for the development of reference substance. Methods: Ganoderma lucidum ketone solid was placed under high temperature, high humidity and light conditions for 10 d, respectively, on the 5th and 10th days by HPLC determination of its content changes; at room temperature, the Gan Song Ketone ethanol solution with sodium hydroxide solution or Hydrochloric acid was used to adjust p H to the set value for 72 h, and the effect of p H on the stability of the alcohol solution was investigated. The stability of the solution of ginsenoside at room temperature and 4 ℃ was predicted by the classical thermostat method. Results: Ganssanone was stable at high temperature (60 ℃) and high humidity, and degraded to 92.19% in 10 days. The ethanol solution of Ganssongnone was stable in alkaline environment and rapidly in acid and high temperature Degradation, and the higher the temperature, the faster the degradation rate; Ganoderma lucidum alcohol solution at room temperature, the effective period (t90) 73.18 h, 4 ℃ to 1621.22 h. Conclusion: Gangesong ketone is sensitive to light and high temperature and should be stored in the dark. During the process of extraction, separation and dosing, the control temperature should be below 40 ℃ and the pH of solution should be within 7 ~ 12.