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目的：研究葡萄糖酸镁口服液的制备工艺及其内在质量。方法：依据药物溶解度和临床治疗需要，筛选设计了处方，确定药物浓度。同时对附加剂，溶剂温度，消毒灭菌温度，时间和稳定性等进行了考察。结果：实验结果表明处方中药物浓度以１０ ％ 无水品计算投料，加入适量甜叶菊甙矫味，以８０ ℃左右热蒸馏水直接溶解制备，成品以１００ ℃３０ ｍｉｎ 消毒灭菌。经４０ ℃相对湿度７５ ％ 条件下加速试验３ 个月，质量稳定。结论：该产品处方和工艺设计合理，操作简便，质量稳定，临床补镁有效率达１００ ％ 。
Objective: To study the preparation process and its intrinsic quality of magnesium gluconate oral solution. Methods: Based on the drug solubility and clinical treatment needs, the prescription was designed and the drug concentration was determined. At the same time, the additives, solvent temperature, sterilization temperature, time and stability were investigated. Results: The experimental results showed that the concentration of drug in the prescription was calculated with 10% anhydrous product, adding proper amount of steviol glycoside and prepared by dissolving with hot distilled water at about 80 ℃. The finished product was sterilized at 100 ℃ for 30 min. After 40 ℃ relative humidity 75% accelerated test 3 months, the quality is stable. Conclusion: The product prescription and process design is reasonable, easy to operate, stable quality, clinical efficiency of magnesium up to 100%.