普瑞巴林口服溶液抑菌效力研究与抑菌剂浓度筛选
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摘要
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.
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.
引文
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[2]陈宝泉,李彩文,史艳萍,等.普瑞巴林的药理作用及临床评价[J].中国新药与临床杂志,2010,29(1):11CHEN BQ,LI CW,SHI YP,et al.Pharmacology and clinical evaluation of pregabalin[J].Chin J New Drugs Clin Rem,2010,29(1):11
[3]中华人民共和国药典2015年版.四部[S].2015:151ChP 2015.VolⅣ[S].2015:151
[4]杨寿清.新型高效低毒食品防腐剂-对羟基苯甲酸酯钠[J].饮料工业,2003,6(6):17YANG SQ.New high efficiency and low toxic food preservativesodium p-hydroxybenzoate[J].Bever Ind,2003,6(6):17
[5]陈国安,杨凯,彭昌亚,等.新型食品防腐剂-尼泊金酯[J].中国调味品,2003(3):31CHEN GA,YANG K,PENG CY,et al.A new-type food preservative-Nipagin[J].China Condiment,2003(3):31
[6]张宗舟,薛林贵,陈志梅.不同防腐剂复配的抑菌效果研究[J].中国酿造,2010(11):26ZHANG ZZ,XUE LG,CHEN ZM.Inhibitory effect of the combined preservatives[J].China Brewing,2010(11):26
[7]丁勃,徐晓洁,谢元超.氢溴酸加兰他敏口服液添加抑菌剂筛选与抑菌效力研究[J].药物分析杂志,2011,31(12):2312DING B,XU XJ,XIE YC.Studies on antimicrobial effectiveness of hydrobromate galanthamine oral solution[J].Chin J Pharm Anal,2011,31(12):2312
[8]刘广桢,沈振,任丽宏,等.苯酚滴耳液抑菌效力测定和评价[J].中国现代应用药学,2016,33(5):645LIU GZ,SHEN Z,REN LH,et al.Determination and evaluation of antimicrobial effectiveness of phenol ear drops[J].Chin J Mod Appl Pharm,2016,33(5):645
[9]李中东,张云轩,郭燕萍,等.羟苯酯类防腐剂的不良反应[J].中国药物警戒,2012,9(5):303LI ZD,ZHANG YX,GUO YP,et al.Adverse drug reactions induced by parabens used as preservatives[J].Chin J Pharmacovigil,2012,9(5):303
[10]林日高,林捷,周爱梅,等.对羟基苯甲酸酯类钠盐的抑菌作用及其稳定性研究[J].中国食品添加剂,2002(3):19LIN RG,LIN J,ZHOU AM,et al.The bacteriostasis and the stability of sodium p-hydroxytudies on tbenzoate[J].China Food Add,2002(3):19
[11]郑萍,丁培,武利平,等.对羟基苯甲酸酯类防腐剂的抑菌效果评价[J].中国卫生检验杂志,2015,25(10):1540ZHENG P,DING P,WU LP,et al.Evaluation of p-hydroxybenzoate preservatives’s antibacterial effect[J].Chin J Health Lab Technol,2015,25(10):1540
[12]钱木水,叶兴法,倪赤杭.液体制剂中防腐剂选用的体会[J].海峡药学,2009,21(3):32QIAN MS,YE XF,NI CH.Experience in the selection of preservatives in liquid preparation[J].Strait Pharm J,2009,21(3):32