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碳酸氢钠注射液是电解质与酸硷平衡药,用于酸中毒,也用于治疗早期脑血栓症。碳酸氢钠水溶液久贮易变质。加热则分解,放出二氧化碳,变成碳酸钠,硷度升高。给制剂带来了若干困难,生产和贮存过程中常存在澄明度不合乎要求的现象。为了满足临床要求,解决生产中存在的问题,我们对原料,玻璃容器,附加剂及工艺等对碳酸氢钠注射液的稳定性的影响进行了探讨,实验方法与结果如下:
Sodium bicarbonate injection is an electrolyte and acid-base balance medicine, used for acidosis, but also for the treatment of early cerebral thrombosis. Sodium bicarbonate aqueous solution for a long time easy to degenerate. Heat is decomposed, emit carbon dioxide, into sodium carbonate, alkalinity increased. The preparation has brought a number of difficulties, production and storage process often exist in the unacceptable degree of clarity of the phenomenon. In order to meet the clinical requirements and solve the problems in production, we discussed the influence of raw materials, glass containers, additives and process on the stability of sodium bicarbonate injection. The experimental methods and results are as follows: