复方角菜酸酯乳膏中抑菌剂效力测试

目的: 探索复方角菜酸酯乳膏中抑菌剂的合理添加剂量。方法: 对不同浓度抑菌剂的抑菌效果进行考察,筛选出抑菌剂的合理添加量。选择有代表性的挑战微生物加入供试品中进行挑战试验,测试微生物在不同时间段的存活情况。结果: 0.10%羟苯甲酯与0.05%山梨酸复合使用对铜绿假单胞菌、大肠埃希菌、金黄色葡萄球菌、白色念珠菌和黑曲霉5种代表试验菌均有良好的抑制作用,为最低有效剂量。结论: 0.10%羟苯甲酯与0.05%山梨酸复合使用可作为复方角菜酸酯乳膏的抑菌剂,且抑菌效力安全有效。

Objective: To investigate the reasonable concentration of antimicrobial preservatives added to compound carraghenates cream. Methods: The antimicrobial effectiveness of antimicrobial preservatives at different ratios was tested to screen the reasonable concentration of antimicrobial preservatives to be added.Representative challenging microorganisms were selected to add into the test samples, then the viable microorganisms in different time periods were tested. Results: The growth of five kinds of representative test microorganisms(Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Candida albicans and Aspergillus niger)was inhibited effectively by compound carraghenates cream composed of 0.10% methylparaben and 0.05% sorbic acid which was the minimum effective dosage. Conclusion: 0.10% methylparaben and 0.05% sorbic acid can be used as the antimicrobial preservatives for compound carraghenates cream which is safe and effective.

[1] JIANG ZJ(江志杰), GAO C(高春).Sodium hyaluronate eye drops inhibitory effectiveness evaluation(玻璃酸钠滴眼液抑菌效力的评价)[J].Chin J Mod Appl Pharm(中国现代应用药学), 2013, 30(7):788
[2] DING B(丁勃), XU XJ(徐晓洁), XIE YC(谢元超).Studies on antimicrobial effectiveness of hydrobromate galanthamine oral solution(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].Chin J Pharm Anal(药物分析杂志), 2011, 31(12):2312
[3] ZHANG SL(张世磊), BAI RW(白若琬), LI J(李津), et al.Determination of preservative effect on naphazoline hydrochloride and chlorphenamine maleate and vitamin B₁₂ eye drops(萘敏维滴眼液的抑菌效力测定)[J].Food Drug(食品与药品), 2011, 13(1):42
[4] ZHOU J(周晶), DAI FR(戴发荣), LI YJ(李拥军).Simultaneous determination of nipagin and nipasol in food with gas spectrometry(食品中对羟基苯甲酸甲酯和对羟基苯甲酸丙酯的气相色谱同时测定法)[J].Occup Health(职业与健康), 2005, 21(1):41
[5] ZHENG JM(郑俊民).The Handbook of Pharmaceutical Excipients(药用辅料手册)[K].4th ed(第四版).Beijing(北京):Chemical Industry Press(化学工业出版社), 2005
[6] ChP 2010.Vol Ⅰ(中国药典2010年版.一部)[S].2010:Appendix(附录)ⅩⅧ D
[7] USP 36-NF 31[S].2013:2242
[8] US Food and Drug Administration.Inactive Ingredient Search for Approved Drug Products[EB/OL].2001-02-20[2013-9-16].http://www.drugfuture.com/fda/IIG_query.aspx
[9] ChP 2010.The Second Supplement(2010年版中国药典.第二增补本)[S].2013:Appendix(附录)ⅩⅨ N
[10] ChP 2010.Vol Ⅱ(中国药典2010年版.二部)[S].2010:215
[11] NIU ZD(牛振东), JIANG ZJ(江志杰), ZHANG GH(张光华), et al.Evaluation of the effect of preservatives in cosmetic with microbial challenge test(用微生物挑战性试验考察化妆品防腐剂效果)[J].Deterg Cosmet(日用化学品科学), 2012, 35(3):36
[12] SUTTON SV, PORTER D.Development of the antimicrobial effectiveness test as USP chapter(51)[J].PDA J Pharm Sci Technol, 2002, 56(6):300