普瑞巴林口服溶液抑菌效力研究与抑菌剂浓度筛选

目的：探索普瑞巴林口服溶液中抑菌剂的合理添加浓度。方法：按照：《中华人民共和国药典》（简称《中国药典》）2015年版通则1121抑菌效力检查法，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，对3批同时含有2种抑菌剂（羟苯甲酯和羟苯丙酯）的普瑞巴林口服溶液进行抑菌效力测定。结果：含有羟苯甲酯0.2%、羟苯丙酯0.03%和含有羟苯甲酯0.13%、羟苯丙酯0.02%的2批普瑞巴林口服溶液对5株试验菌的抑菌效力均达到《中国药典》2015年版抑菌效力检查法的规定，但含有羟苯甲酯0.05%、羟苯丙酯0.01%的普瑞巴林口服溶液对金黄色葡萄球菌、大肠埃希菌和白色念珠菌的抑菌效力达不到《中国药典》2015年版的要求。结论：0.13%~0.2%羟苯甲酯和0.02%~0.03%羟苯丙酯可作为普瑞巴林口服溶液抑菌剂的添加浓度。

Objective: To explore the reasonable concentration of antimicrobial preservative in pregabalin oral solution. Methods: Staphyococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candia albicans and Aspergillus niger were used as the test strains, the antimicrobial effectiveness of three batches of pregabalin oral solution containing two species of antimicrobial preservative (hydroxybenzyl esters and hydroxyphenyl ester) were determined according to the method of antimicrobial effectiveness test of General Regulation 1121 of Chinese Pharmacopoeia (i.e. ChP) 2015 edition. Results: The antimicrobial effectiveness of one batch of pregabalin oral solution containing 0.2% hydroxybenzyl ester and 0.03% hydroxyphenyl ester and one batch of pregabalin oral solution containing 0.13% hydroxybenzyl ester and 0.02% hydroxyphenyl ester against the five test strains met the requirements of the antimicrobial effectiveness test of ChP (2015 edition). However, the antimicrobial effectiveness of one pregabalin oral solution containing 0.05% hydroxybenzyl ester and 0.01% hydroxyphenyl ester against Staphylococcus aureus, Escherichia coli and Candia albicans did not meet the requirements of the antimicrobial effectiveness test of ChP (2015 edition). Conclusion: 0.13% to 0.2% hydroxybenzyl ester together with 0.02% to 0.03% hydroxyphenyl ester can be used as the additive concentration of antimicrobial preservative for pregabalin oral solution.

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