基于SPSS的枳壳微生物污染状况差异分析

Difference Analysis of Fructus Aurantii Microbial Pollution Status Based on SPSS

目的研究枳壳药材及饮片微生物负载水平并对其产地、炮制方法进行相关性分析。方法参照《中国药典》2020年版,对枳壳药材及饮片共78批样品进行微生物限度检查,通过SPSS软件对产地、炮制方法进行多重比较分析。结果36批枳壳药材中,有9批江西药材需氧菌总数超过10^(5)cfu/g;1批四川药材、3批云南药材、1批陕西药材、1批河南药材霉菌和酵母菌总数超过10^(3) cfu/g。42批枳壳饮片中,有4批江西产未炒饮片的需氧菌总数超过10^(5)cfu/g。炮制方法是影响枳壳需氧菌、霉菌和酵母菌、耐热菌的影响因素,不同产地间的枳壳霉菌和酵母菌总数差异明显。结论饮片经过炒制等热加工,能有效降低其微生物负载,对于中药材微生物控制具有重要意义。发酵饮片发酵过程可能存在大量的细菌繁殖从而抑制了甚至灭活了霉菌和酵母菌。微生物限度检查结果超出药典标准的药材及饮片,提示质量风险,需加强管理控制。

Objective To study the microbial load levels of fructus aurantii and decoction pieces and analyze the correlation between their origin and processing methods.Methods According to Chinese Pharmacopoeia(2020 edition),78 batches of fructus aurantii and decoction pieces were examined by microbial limit test,and the origin and processing methods were compared by SPSS software.Results 36 batches of fructus aurantii,the total amount of aerobic bacteria in 3 batches of Jiangxi exceeded 10^(5)cfu/g.The total number of molds and yeasts in 1 batch of Sichuan,3 batches of Yunnan,1 batch of Shaanxi,and 1 batch of Henan exceeded 10^(3)cfu/g.42 batches of decoction pieces,4 batches produced in Jiangxi had a total aerobic bacterial exceeded 10^(5)cfu/g.The processing methods were the influencing factors of aerobic bacteria,mold and yeast,thermostable bacteria in fructus aurantii,and the total number of mold and yeast in fructus aurantii from different producing areas was significantly different.Conclusion The microbiological load of decoction pieces can be reduced effectively after hot processing such as roasting,which is of great significance for microbiological control of Chinese medicinal materials.During the fermentation of fermented slices,there may be a large number of bacterial reproduction,which inhibits or even inactivates mold and yeast.The results of microbiological limit test exceeded the pharmacopoeia standards of medicinal materials and decoction pieces,indicating quality risks,need to strengthen management control.