摘要
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 of magnesium gluconate oral solution and control its quality.METHODS:The formulation and drug concentration was confirmed according to the drug solubility and clinical effect.At same time,correctant,water temperature,sterile temperature and time,stability had been tested.RESULTS:Weigh 10 g of anhydrous magnesium gluconate,dissolve in 80 ml of hot purified water,add stevioside and hot purified water to make 100 ml.The preparation was sterilized at 100℃ for 30 minutes. The stability test showed that the preparation be stable under temperature 40℃ and relative humidity 75%.CONCLUSIONS:This formulation is rational.The product is stable.The clinical supplement magnesium total effective rate was 100%.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
1999年第7期394-396,共3页
Chinese Journal of Hospital Pharmacy
