摘要
目的通过建立盐酸氨溴索口服溶液的抑菌效力检测方法,探索确定盐酸氨溴索口服溶液抑菌剂的合理添加量。方法依据《中国药典》2020年版四部(通则1121),以金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、白色念珠菌和黑曲霉为试验菌株,确定菌落计数方法,建立该样品的抑菌效力检查法,并对添加不同浓度抑菌剂(0.03%、0.04%、0.05%、0.06%、0.07%、0.08%)的盐酸氨溴索口服溶液进行抑菌效力测定。结果添加苯甲酸浓度为0.05%、0.06%、0.07%、0.08%均通过抑菌效力挑战试验,添加苯甲酸浓度为0.03%的盐酸氨溴索口服溶液对金黄色葡萄球菌、大肠埃希菌和黑曲霉的抑菌效力达不到药典要求,添加苯甲酸浓度为0.04%的盐酸氨溴索口服溶液对大肠埃希菌和金黄色葡萄球菌的抑菌效力达不到要求。结论0.05%苯甲酸可作为盐酸氨溴索口服溶液抑菌剂的最低添加浓度。
OBJECTIVE To establish a method for measuring the bacteriostatic efficacy of ambroxol hydrochloride oral solution,to explore the reasonable dose of bacteriostatic preservative in ambroxol hydrochloride oral solution.METHODS According to the general rule 1121 of the fourth part of CH.P(2020),the colony counting method was used with Staphylococcus aureus,Pseudomonas aeruginosa,Escherichia coli,Candida albicans,and Aspergillus niger as test strains.The method for bacteriostatic efficacy test of the samples was established.Then the bacteriostatic efficacy of ambroxol hydrochloride oral solution with different benzoic acid content(0.03%,0.04%,0.05%,0.06%,0.07%,and 0.08%)was tested.RESULTS Ambroxol hydrochloride oral solution containing 0.05%,0.06%,0.07%,and 0.08%benzoic acid passed the bacteriostatic effectiveness test.However,the bacteriostatic effectiveness of ambroxol hydrochloride oral solution containing 0.03%benzoic acid against Staphylococcus aureus,Escherichia coli,and Aspergillus niger did not meet the requirements.And the bacteriostatic effectiveness of ambroxol hydrochloride oral solution containing 0.04%benzoic acid against Staphylococcus aureus and Escherichia coli did not meet the requirements.CONCLUSION Benzoic acid 0.05%can be used as optimal concentration of bacteriostatic agent in ambroxol hydrochloride oral solution.
作者
吕杨兰
陈静
Lü Yang-lan;CHEN Jing(Sanming Inspection and Testing Center,Sanming 365000,China)
出处
《海峡药学》
2022年第9期72-75,共4页
Strait Pharmaceutical Journal
关键词
盐酸氨溴索口服溶液
抑菌剂
抑菌效力
苯甲酸
Ambroxol hydrochloride oral solution
Bacteriostat
Bacteriostatic efficacy
Benzoic acid
