甘松新酮的稳定性研究

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pH至设定值,放置72 h,考察pH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pH在7~12范围内。

Objective: To investigate the stability of nardosinone and its ethanol solution and provide the reference for the research of standard substance. Methods: The solid nardosinone was placed under high temperature, high humidity and light conditions for 10 days, its content changes on the fifth and tenth days were respectively determined by HPLC;the pH values of the nardosinone solutions were adjusted to the setting pH with hydrochloric acid or sodium hydroxide, respectively, and the solutions were stored at room temperature for 72 h.The classical constant temperature method was applied to evaluate the stability of nardosinone solutions at room temperature and at 4 ℃. Results: The solid nardosinone was stable under the condition of high temperature(60 ℃)and high humidity, and was degraded to 92.19% under the condition of light.The nardosinone-ethanol solution was generally stable in alkaline condition and was rapidly degraded in acid and high temperature conditions.The higher the temperature was, the faster the degradation rate was.The validity duration(t₉₀)for the nardosinone solution was 73.18 h at room temperature and 1 621.22 h at 4 ℃. Conclusion:Nardosinone is sensitive to light and high temperature which should be kept out of light.In the extraction, separation and administration process, attention should be given to the control of temperature under 40 ℃ and solution within pH 7-12.

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