Objective: To explore the minimum effective inhibitory concentration of bacteriostatic agent in the prescription of human interferon α1b spray, and to determine the reasonable dosage of bacteriostatic agent. Methods: Biological activity detection method was used to screen bacteriostatic agents in the prescription of human interferon α1b spray preparation, determine bacteriostatic agents. The bacteriostatic efficacy was determined according to the bacteriostatic efficacy test method of general principles 1121 of the Chinese Pharmacopoeia 2020 edition to determine the minimum effective bacteriostatic concentration of bacteriostatic agents. Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger were used as test strains to test the applicability of colony counting method. The dose screening test of bacteriostatic agent was designed to investigate the bacteriostatic effect of bacteriostatic agent with different concentrations on four kinds of experimental bacteria, and the reasonable dosage of bacteriostatic agent was selected. Results: Benzalkonium bromide was screened out as the bacteriostatic agent in the prescription of human interferon α1b spray. When the concentration of Benzalkonium bromide was 0.05-0.1 mg·mL-1, its bacteriostatic efficacy against Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger met the grade A criteria. Conclusion: The minimum effective bacteriostatic concentration of benzalkonium bromide in the prescription of human interferon α1b spray is determined to be 0.05 mg·mL-1.
LIU Lin-lin, DONG Li-zi, CUI Yue, ZHU Qiu-mei, SU Chang, ZHANG Yu, LIU Jing-hui
. Study on the screening and bacteriostatic efficacy of bacteriostatic agent in human interferon α1b spray*[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(2)
: 359
-367
.
DOI: 10.16155/j.0254-1793.2024.02.20
[1] 中华人民共和国药典2020年版. 四部[S]. 2020:8, 354, 176, 160
ChP 2020. Vol Ⅳ[S]. 2020:8, 354, 176
[2] 潘学田. 中国医院制剂规范[M]. 第2版. 北京:中国医药科技出版社,1995:20
PAN XT.Pharmaceutics Regulates of Hospitals in China[M]. 2nd Ed.Beijing:China Medical Science and Technology Press,1995: 20
[3] 郑俊民.药用辅料手册[M]. 第四版.北京:化学工业出版社,2005:60
ZHENG JM. The Handbook of Pharmaceutical Excipients[M]. 4th Ed.Beijing:Chemical Industry Press,2005:60
[4] RAYMOND CR, PAUL JS, MARIAN EQ. Handbook of Pharmaceutical Excipients[M]. 6th Ed. London: Pharmaceutical Press and American Pharmacists Association, 2009: 56
[5] 熊家娟.药品中防腐剂的抗菌效力测定与评价[J]. 中国药事,2005,19(10):592
XIONY JJ. Evaluation and testing of antimicrobial preservatives in drug[J]. Chin Pharm Aff,2005,19(10):592
[6] 李宁,陈松杰.聚季铵盐-1和苯扎氯铵在眼用制剂中的应用研究进展[J]. 今日药学,2015,25(2):140
LI N, CHEN SJ. Progress in the application of polyquaternary ammonium salt-1 and benzalkonium chloride in ophthalmic preparations[J]. Pharm Today, 2015, 25(2):140
[7] 李珏,王知坚,项露婷,等.苄达赖氨酸滴眼液中抑菌剂的检测与评价[J]. 药物分析杂志,2015,35(5):884
LI J, WANG ZJ, XIANG LT, et al. Evaluation and testing of antimicrobial preservatives in bendazac lysine eye drops[J]. Chin J Pharm Anal, 2015, 35(5):884
[8] 肖璜,杨美琴,王似锦,等.国产滴眼液中常用抑菌剂的应用分析与评价[J]. 药学研究,2017,36(9):519
XIAO H, YANG MQ, WANG SJ, et al. Analysis and evaluation of bacteriostatic agent appliacation in domestic eye drops[J]. J Pharm Res, 2017, 36(9):519
[9] 牛振东,江志杰,张光华, 等.用微生物挑战性试验考察化妆品防腐剂效果[J]. 日用化学品科学,2012,35(3):36
NIU ZD, JIANG ZJ, ZHANG GH, et al. Evaluation of the effect of preservatives in cosmetic with microbial challenge test[J]. Deterg Cosmet, 2012, 35(3):36
[10] 朱荣峰,陈伟盛,简敏骞,等.阿昔洛韦滴眼液中苯扎溴铵含量的合理性探讨[J]. 中国药品标准,2015,16(6):420
ZHU RF, CHEN WS, JIAN MQ, et al. Exploration of rational benzalkonium bromide contents in acyclovir eye drops[J]. Drug Stand China, 2015, 16(6):420
[11] 肖璜,林吉恒,陈万胜,等.氯霉素滴眼液处方中尼铂金乙酯含量合理性探讨[J]. 中国药师,2014,17(5):785
XIAO H, LIN JH, CHEN WS, et al. Expolration of rational ethylparaben contents in chloramphenicol eye drop[J]. China Pharm,2014,17(5):785
[12] 林吉恒,肖璜,陈万胜,等.氯霉素滴眼液处方中硫柳汞含量的合理性分析[J]. 中国药师,2014,17(10):1687
LIN JH, XIAO H, CHEN WS, et al. Analysis of rational thiomersal contents in chloramphenicol eye drop[J]. China Pharm, 2014, 17(10):1687
[13] 罗庆进,陈吉祥,李素琴,等.一种不含抑菌剂的氧氟沙星滴眼液及其制备工艺:中国,CN105232452A[P]. 2015-10
LUO QJ, CHEN JX, LI SQ, et al. An Ofloxacin Eye Drop without Antimicrobial Agent and Its Preparation Technology:China, CN105232452A[P]. 2015-10
[14] CHA SH, LEE JS, OUM BS, et al. Corneal epithelial cellular dysfunction from benzalkonium chloride (BAC) in vitro[J]. Clin Exp Ophthalmol, 2004, 32(2): 180
[15] PELLINEN P, HUHTALA A, TOLONEN A, et al. The eytotoxic effects of preserved and preservative-free prostaglandin analogs on human coreal and conjunctival epithelium in vitro and the distribution of benzalkonium chloride homologs in ocular surface tissues in vivo[J]. Curr Eye Res, 2012, 37(2):145
[16] 张超,赛景影,张晓天,等.一次性氧氟沙星滴眼液抑菌效力的检测及其结果评价[J]. 吉林大学学报(医学版),2014,40(1):113
ZHANG C, SAI JY, ZHANG XT, et al. Detection of bacteriostatic effect and evaluation of disposable ofloxactin eye drops[J]. J Jilin Univ(Med Ed), 2014, 40(1):113
[17] 朱世真,王丽芳,王尊文,等. 常用滴眼剂抑菌效力的考察[J]. 中国药品标准,2016,17(2):95
ZHU SZ, WANG LF, WANG ZW, et al. Investigation on bacteriostatic efficacy of common eye drops[J]. Drug Stand China, 2016, 17(2):95
