复方桔梗麻黄碱糖浆(Ⅱ)的微生物污染状况分析及抑菌剂效力考察

甘永琦, 农浚, 朱荣, 孙煜, 朱斌

中国药学杂志 ›› 2018, Vol. 53 ›› Issue (11) : 925-930.

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中国药学杂志 ›› 2018, Vol. 53 ›› Issue (11) : 925-930. DOI: 10.11669/cpj.2018.11.014
·论著·

复方桔梗麻黄碱糖浆(Ⅱ)的微生物污染状况分析及抑菌剂效力考察

  • 甘永琦, 农浚, 朱荣, 孙煜, 朱斌*
作者信息 +

Analysis of Microbial Contamination and Investigation on Bacteriostatic Efficacy of Compound Balloonflowers and Ephedrine Syrup(Ⅱ)

  • GAN Yong-qi, NONG Jun, ZHU Rong, SUN Yu, ZHU Bin*
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摘要

目的 考察分析复方桔梗麻黄碱糖浆(Ⅱ)的微生物污染状况及抑菌剂(苯甲酸)的抑菌效力。方法 测定复方桔梗麻黄碱糖浆(Ⅱ)中抑菌剂含量采用C18色谱柱进行梯度洗脱,流动相为醋酸铵溶液和甲醇,检测波长:255 nm。抑菌效力及微生物限度等;通过VITEK2 Campact、MALDI-TOF-MS和16S rRNA测序技术鉴定污染菌,并对同一企业样品中的污染菌株进行同源性比对分析。结果 1家生产企业产品抑菌剂效力无法达到2015年版《中国药典》的要求,样品存在微生物超标及污染不均匀情况;部分企业产品抑菌剂使用量不合理。结论 生产企业应严格控制抑菌剂的使用量和生产工艺的稳定性,加强监测各生产环节的灭菌效果,提高产品质量。

Abstract

OBJECTIVE To analyze the microbial contamination and investigate the bacteriostatic efficacy of compound balloonflowers and ephedrine syrup(Ⅱ). METHODS The compound balloonflowers and ephedrine syrup(Ⅱ) was analyzed for the bacteriostatic efficacy, content of bacteriostatic agent and C18 column was adopted with gradient elution. The mobile phase consisted of 0.02 mol·L-1 ammonium acetate solution and methanol. The detective wavelength was set at 255 nm. The contaminating bacteria detected in the samples were identified by VITEK2 Campact, MALDI-TOF-MS and 16S rRNA sequencing, and homology analysis was conducted for the contaminating bacteria in the samples from the same enterprise. RESULTS The bacteriostatic efficacy of the products of one enterprise did not meet the requirements of Chinese Pharmacopoeia(2015 edition). There were excessive and uneven contamination of microorganisms in the samples. The dosages of bacteriostatic agents in some enterprises did not conform to the standard requirements. CONCLUSION Production enterprises should strictly control the dosages of bacteriostatic agents and the stability of the production process, and strengthen the monitoring of the sterilization effect of the whole production process to improve product quality.

关键词

复方桔梗麻黄碱糖浆(Ⅱ) / 肠膜明串珠菌 / 微生物鉴定 / 同源性分析 / 抑菌效力

Key words

compound balloonflowers and ephedrine syrup(Ⅱ) / Leuconostoc mesenteroides / microbiological identification / homology analysis / bacteriostatic efficacy

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导出引用
甘永琦, 农浚, 朱荣, 孙煜, 朱斌. 复方桔梗麻黄碱糖浆(Ⅱ)的微生物污染状况分析及抑菌剂效力考察[J]. 中国药学杂志, 2018, 53(11): 925-930 https://doi.org/10.11669/cpj.2018.11.014
GAN Yong-qi, NONG Jun, ZHU Rong, SUN Yu, ZHU Bin. Analysis of Microbial Contamination and Investigation on Bacteriostatic Efficacy of Compound Balloonflowers and Ephedrine Syrup(Ⅱ)[J]. Chinese Pharmaceutical Journal, 2018, 53(11): 925-930 https://doi.org/10.11669/cpj.2018.11.014
中图分类号: R284   

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基金

广西食品药品监督管理局2017年食品药品安全科研项目资助(药品口服溶液剂中抑菌剂处方合理性评价研究)
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