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目的 本文研究了D-氨基半乳糖盐酸盐溶液的化学稳定性,为该药物的制备、纯化以及实验动物肝细胞损伤模型用药提供必要的稳定性数据。方法 采用恒温加速实验,通过氨基半乳糖含量测定,研究不同pH条件下本品水溶液的稳定性,并与冰箱贮存样品比较。结果 实验表明,氨基半乳糖盐酸盐溶液pH值为3比较稳定,调pH值为7的本品水溶液不稳定,易分解,最多在5℃冰箱中保存5天。试样在加热情况下则迅速变色分解。结论 由于氨基己糖溶液多数不稳定,在各项操作中,应调节其盐酸盐水溶液的pH值小于7,中性试液只能在冰箱内短期保存。
Aim To study the chemical stability of D-galactosamine hydrochloride solution and provide the necessary stability data for the preparation, purification of the drug and the model of hepatocyte injury in experimental animals. Methods The constant temperature accelerated experiment was carried out to determine the stability of the aqueous solution under different pH conditions through the determination of the content of galactosamine and compare with the stored samples of refrigerators. Results The experiment shows that the pH value of amino galactose hydrochloride solution is relatively stable at pH = 7, the aqueous solution of this product is unstable, easily decomposed, and stored in the refrigerator at 5 ℃ for up to 5 days. The sample is quickly discolored under heating. Conclusions Since most of the hexosamine solution is unstable, the pH value of its aqueous hydrochloride solution should be adjusted to be less than 7 during each operation. The neutral solution should only be stored in the refrigerator for a short period of time.