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目的:探索天然产物标准样品的长期稳定性和加速稳定性之间的关系,为标准样品的有效期确定提供必要的技术支撑。方法:在研制5个国家标准样品(肉桂醛、樱花素、长梗冬青苷、水苏糖和β-谷甾醇)的过程中,将置于0~8℃条件下的样品,分别于第0,1,2,3,6,9,12,18,24个月测定各标准样品的纯度,进行长期稳定性检验。将置于温度(40±2)℃和相对湿度(75±5)%条件下的样品,分别于第0,1,2,3,6个月时测定各标准样品的纯度,进行加速稳定性检验。结果:统计分析的结果显示,长期稳定性检验和加速稳定性检验的稳定性均良好,二者之间无显著性差异。结论:天然产物标准样品24个月的有效期可通过6个月的加速稳定性检验进行预判。
Objective: To explore the relationship between long-term stability and accelerated stability of natural product standard samples and to provide the necessary technical support for the determination of the expiration date of standard samples. Methods: During the development of five national standard samples (cinnamaldehyde, safflower, long stem glycosides, stachyose and β-sitosterol), the samples which were placed at 0 ~ , 1,2,3,6,9,12,18,24 months to determine the purity of each standard sample for long-term stability test. The samples which were placed in the temperature (40 ± 2) ℃ and the relative humidity (75 ± 5)% were measured for the purity of each standard sample at 0, 1, 2, 3 and 6 months to accelerate the stability test. Results: The results of statistical analysis show that the stability of the long-term stability test and accelerated stability test are both good, with no significant difference between the two. CONCLUSIONS: The 24-month validity period of a natural product standard sample can be predicted by a 6-month accelerated stability test.