目的 探索建立眼疲寧合劑有效可控的微生物限度檢查方法。方法 選取不同陽(yáng)性菌種進(jìn)行方法學(xué)試驗(yàn)，并對(duì)本制劑進(jìn)行培養(yǎng)基稀釋法及薄膜過(guò)濾法兩種方法比較研究。結(jié)果 確立用枯草芽孢桿菌、金黃色葡萄球菌、銅綠假單胞菌、白色念珠菌及黑曲霉作為陽(yáng)性菌種進(jìn)行方法學(xué)試驗(yàn)；確立需氧菌檢查采取薄膜過(guò)濾法、霉菌酵母菌檢查采取培養(yǎng)基稀釋法，并驗(yàn)證了控制菌大腸埃希菌計(jì)數(shù)實(shí)驗(yàn)用培養(yǎng)基的量。結(jié)論 確立了眼疲寧合劑的微生物學(xué)檢查方法及質(zhì)量標(biāo)準(zhǔn)，可有效控制制劑的衛(wèi)生學(xué)質(zhì)量。

Objective The formulation has complex composition and the strong antibacterial activity, so its quite essential to establish the microbial limit test for Yanpining Liquid Preparations through the experiments. Methods we select different positive strains tested methodology and microbial limit tests were validated. comparative studies have been carried out between culture medium dilution method and membrane filtration. Results Experiments verified by Bacillus subtilis, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger as positive strains tested methodology and results show that the former method could be used for mold and yeast counting test; the latter could be used for total aerobic bacteria counting of the preparations; The amount of culture medium for Escherichia coli count experiment was verified. Conclusion Microbial limit tests has the good reference value and the confirmed experimental results could effectively control the hygiene quality of forYanpining Liquid Preparations.

全國(guó)中藥炮制技術(shù)湖南省中醫(yī)藥研究院附屬醫(yī)院傳承基地（2016年）；湖南省名老中醫(yī)藥專家黃柏良傳承工作室（2017年）