硫酸镁甘油溶液质量标准提高研究

目的:提高硫酸镁甘油溶液的质量及其控制标准。方法:针对本品原处方中不含防腐剂且质量标准无甘油鉴别项进行改进。通过微生物限度检查筛选硫酸镁甘油溶液防腐剂的种类及浓度(苯甲酸0.03%、0.08%,羟苯乙酯0.01%、0.03%,苯扎溴铵0.01%、0.02%,醋酸氯己定0.001%、0.000 1%);采用化学法鉴别甘油。结果:除在冷处苯甲酸(0.08%)和羟苯乙酯(0.03%)有结晶析出外,其余各浓度防腐剂均在硫酸镁甘油溶液中无明显变化;含有苯甲酸(0.03%)、苯扎溴铵(0.01%、0.02%)、醋酸氯己定(0.001%)的样品放置15 d内微生物限度检查符合规定;综合考虑后优选0.03%苯甲酸为硫酸镁甘油溶液的防腐剂。新处方甘油鉴别呈正反应。结论:建议硫酸镁甘油溶液的处方中增加0.03%苯甲酸为防腐剂,质量控制标准中增加甘油鉴别项。

Study on Enhancing Quality Standards of Magnesium Sulfate Glycerin Solution

OBJECTIVE： To improve the quality and its control standards of Magnesium sulfate glycerin solution. METHODS： The quality standards were improved in terms of free of preservatives in the formulation and no glycerol identification in previous standard. The microbial limit test was conducted to select the type and concentration of antiseptic agents for Magnesium sulfate glycerin solution （benzoic acid 0.03%, 0.08% ; ethylparaben 0.01%, 0.03% ; benzalkonium bromide 0.01%, 0.02% ; chlorhexidine acetate 0.001%, 0.000 1% ）. Chemical method was used to identify glycerin. RESULTS： Except crystal separated out from benzoic acid （0.08%） and ethylparaben （0.03%） under cold condition, other antiseptic agents had no obvious change in magnesium sulfate glycerin solution. The microbial limit test of samples containing benzoic acid （0.03%）, benzalkonium bromide （0.01%, 0.02% ） and chlorhexidine acetate （0.001% ） were in line with the standard of microbial limit test after 15 days. After overall consideration, 0.03% benzoic acid was the best choice as antiseptic agents for Magnesium sulfate glycerin solution. The identification of glycerin was positive chemical reaction. CONCLUSIONS： It is suggested to add 0.03% benzoic acid as antiseptic agents into Magnesium sulfate glycerin solution, and the item of glycerol identification should be included in standard.