Objective: To establish a microbiological limit test method for tacrolimus raw materials, and investigate the microbiological limit of tacrolimus using a combination of test methods. Methods: 5 standard bacterial strain preparations were selected for the suitability test [1], while conventional method, culture medium dilution method, extraction method and membrane filtration method were used to prepare test solutions in determing the suitability of microbiological counting methods for Tacrolimus. Escherichia coli preparation was used to prepare a test solution in the control bacteria test for Tacrolimus. Results: The recovery ratios of Tacrolimus total aerobic bacteria, mold and yeast were between 0.5-2, and the control bacteria was undetected, which met the requirements of the pharmacopoeia. Conclusion: Tacrolimus has strong antibacterial activity against strains used in suitability test and control bacteria test. Culture medium dilution method, extraction method and membrane filtration method can be combined in addition with the sterile surfactant [2] to remove its antibacterial activity in determing the microbiological limit of Tacrolimus.[2]
[1] 中华人民共和国药典2015年版. 四部[S]. 2015:114 ChP 2015. Vol Ⅳ[S]. 2015:114
[2]
邵敏,赵然,周鹤峰. 霉菌检测培养基改良实验研究[J]. 食品工业科技,2010, 31(2):331 SHAO M,ZHAO R,ZHOU HF. Study
on the improvement of medium for mold inspection[J]. Sci Technol Food
Ind,2010,20(2):331
[3] 落合武德,矶野可一,张之荫. 新型免疫抑制剂FK506[J]. 国外医药·抗生素分册, 1991,
12(3):225 LUO HWD, JI YKY, ZHANG ZY. A new type immunosuppressive agent
FK506[J]. World Notes Antibiot,1991, 12(3):225
[4] KINO T, HATANAKA H,
HASHIMOTO M, et al. FK506, a novel immunosuppressant isolated from a
treptomyces, I. Fementation,isolation,and physico -chemical and biological
characteristic.[J]. J Antibiot,1987,40(9):1249
[5] 王意如. 免疫抑制剂研究新进展[J].
中国新药杂志, 2002, 11(7):512 WANG YR. Recent advances in immunosuppressive drugs[J].
Chin J New Drugs,2002, 11(7):512
[6] DENYER SP,HODGES NA,GORMAN SP.
司书毅,洪斌,余利岩译. 药物微生物学. 第七版[M]. 北京:化学工业出版社,2007:39 DENYER SP, HODGES NA, GORMAN SP.
Translated by SI SY, HONG B, YU LY. Drug Microbiology. 7th Ed[M].
Beijing:Chemical Industry Press,2007:39
[7] 周剑. 李霞.
药品微生物限度检查法中几种样品前处理方法的可行性研究[J]. 中国药房,2012, 23(33):273 ZHOU J,LI X. Feasibility of
pretreatment methods of samples in the microbial limit test[J]. China
Pharm,2012, 23(33):273
[8] BAIRD RM,HODGES NA,DENEY SP. Handbook of
Microbiological Quality Control[M]. Boca Raton:Chemical Rubber Company
Press,2000:97
[9] 马群飞. GB 4789.15-2016《食品安全国家标准-食品微生物学检验霉菌和酵母计数》标准解读[J].
中国卫生标准管理,2018, 9(5):1 MA QF. Interpretation for GB 4789.15-2016 national food
safety standard-food microbiological examination-enumeration of moulds and
yeasts[J]. China Health Stand Manage,2018, 9(5):1
[10] 贾俊涛,梁成珠,马维兴.
食品微生物检测工作指南[M]. 北京:中国质检出版社/中国标准出版社, 2012:211 JIA JT, LIANG CZ, MA WX. Guidelines
for Food Microbiological Testing[M]. Beijing:China Quality and Standards
Publishing, 2012:211
[11] 吴美华. 对中国药典微生物限度霉菌和指示菌检查的探索[J]. 海峡药学, 2005, 17(2):81
WU MH. A study on the examination of microbial limit mould and indicator
bacteria in Chinese Pharmacopoeia[J]. Strait Pharm J, 2005, 17(2):81
[12]
周玉庭,任佳丽,张紫莺. 粮食中霉菌污染检测方法现状及发展趋势[J]. 食品安全质量检测学报, 2016, 7(1):244 ZHOU YT,REN
JL,ZHANG ZY. Current situation and development trends of detection methods for
mold contamination in grains[J]. J Food Saf Qual,2016, 7(1):244
