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该文建立高效凝胶渗透色谱法 (HPGPC) ,明胶比浊法 ,氧瓶燃烧法三种分析方法考察海洋硫酸多糖药物几丁糖酯的稳定性 ,采用这三种方法分别考察几丁糖酯原料药在高温、高湿、强光照射及加速条件下分子量及分布宽度、样品中硫酸根含量及样品含量的变化情况。结果表明 :三种方法均适用于几丁糖酯的稳定性考察 ,几丁糖酯在上述影响因素条件下稳定性良好
In this paper, the stability of chitosan esters of marine sulphuric acid polysaccharides was investigated by high performance gel permeation chromatography (HPGPC), gelatin nephelometry and oxygen bottle combustion methods. Chitosan esters were investigated using these three methods. The changes of the molecular weight and distribution width, the content of sulfate in the sample and the content of the sample in the raw material drug under high temperature, high humidity, strong light irradiation and acceleration conditions. The results showed that: The three methods are all suitable for the stability of chitosan esters. Chitosan esters have good stability under the above factors.