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目的:筛选复方小儿桑菊薄荷合剂防腐剂的种类及浓度,提高复方小儿桑菊薄荷合剂质量。方法:在复方小儿桑菊薄荷合剂中分别加入0.01%和0.02%羟苯乙酯,0.01%醋酸氯已定,0.02%醋酸氯已定丙二醇溶液,0.02%醋酸氯已定甘油溶液,0.01%和0.02%苯扎溴铵,0.03%、0.05%苯甲酸,0.01%和0.02%氯化苯甲烃铵置于室温观察溶解情况,并在不同留样期进行微生物限度检查。结果:除0.01%、0.02%和0.05%羟苯乙酯,0.01%醋酸氯已定,0.02%醋酸氯已定丙二醇溶液,0.02%醋酸氯已定甘油溶液,有结晶析出,其余防腐剂均在复方小儿桑菊薄荷合剂中溶解完全;含有0.01%和0.02%苯扎溴铵,0.03%和0.05%苯甲酸,0.01%和0.02%氯化苯甲烃铵的样品放置12个月,微生物限度均符合规定。结论:可选用0.03%苯甲酸,0.01%氯化苯甲烃铵为复方小儿桑菊薄荷合剂的防腐剂。
OBJECTIVE: To screen the types and concentrations of preservatives in compound pediatric Sangju mint mixture and improve the quality of Compound Sang Ju mentap mixture. Methods: The compound pediatric Sang Ju menthol mixture were added 0.01% and0.02% of the hydroxybenzene ethyl ester, 0.01% of chlorine acetate has been set, 0.02% of chlorine acetic acid fixed propylene glycol solution, 0.02% 0.02% benzalkonium bromide, 0.03%, 0.05% benzoic acid, 0.01% and 0.02% benzalkonium chloride were dissolved in the room temperature to observe the situation, and in different sample retention period microbial limit check. Results: In addition to 0.01%, 0.02% and 0.05% of the hydroxybenzoate, 0.01% of the chlorine has been set, 0.02% of chlorine has been set propylene glycol solution, 0.02% acetic acid has been given glycerol solution, crystallization, the remaining preservatives are Compound pediatric Sang Ju mentap mixture was completely dissolved; samples containing 0.01% and 0.02% benzalkonium bromide, 0.03% and 0.05% benzoic acid, 0.01% and 0.02% benzalkonium chloride were allowed to stand for 12 months with both microbial limits Compliance. Conclusion: 0.03% benzoic acid and 0.01% benzalkonium chloride can be used as antiseptics for Compound Sanguill Mint mixture.