基于水活度的2种中药制剂洋葱伯克霍尔德氏菌的控制研究

    Study on the Control of Burkholderia Cepacia in Two Traditional Chinese Medicine Preparations Based on Water Activity

    • 摘要: 目的 测定洋葱伯克霍尔德氏菌生长所需的最低水活度(water activity,aw),考察洋葱伯克霍尔德氏菌在保济口服液和强力枇杷露中的生长情况,探讨aw与微生物生长的关系,为应用aw控制中药制剂生产过程中的微生物提供依据。方法 利用氯化钠调节胰酪大豆胨液体培养基(TSB)的aw,通过水活度仪分别测定TSB、保济口服液和强力枇杷露的aw,在分别接种洋葱伯克霍尔德氏菌后置35℃培养,采用平皿法在规定的时间点进行计数,并绘制生长速率曲线。结果 洋葱伯克霍尔德氏菌的最低生长aw为0.98,保济口服液和强力枇杷露的aw分别为0.99和0.93。高aw的保济口服液有助于洋葱伯克霍尔德氏菌的生长繁殖,而低aw的强力枇杷露中洋葱伯克霍尔德氏菌的生长繁殖受到抑制。该结果与美国药典(USP)<1112>“低aw会抑制药物中微生物的生长”相一致。结论 在生产过程中适当降低中药制剂的aw可以有效降低其染菌风险。

       

      Abstract: OBJECTIVE To determine the lowest water activity(aw) required for the growth of Burkholderia cepacia, and to observe the growth situation of Burkholderia cepacia in Baoji oral liquid and Qiangli loquat syrup, also to explore the relationship between aw and the growth of Burkholderia cepacia, in order to provide a basis for the application of aw to control microorganisms in the production of traditional Chinese medicine preparations. METHODS Adjusted the aw of tryptic soy broth medium(TSB) with sodium chloride, and determined the aw of TSB, Baoji oral liquid and Qiangli loquat syrup by determining instrument of aw, respectively. Then incubated at 35 ℃ after inoculated Burkholderia cepacia, used the pour ptates for enumeration tests at the setting times, and draw the Burkholderia cepacia growth rate curve. RESULTS The lowest aw of Burkholderia cepacia was 0.98, that of Baoji oral liquid and Qiangli loquat syrup was 0.99 and 0.93, respectively. Baoji oral liquid with high aw could help the growth and reproduction of Burkholderia cepacia, while the growth and reproduction of Burkholderia cepacia in Qiangli loquat syrup with low aw was inhibited. This result was consistent with USP <1112> “low aw inhibits the growth of microorganisms in drugs”. CONCLUSION Reducing the aw of traditional Chinese medicine in the production process can effectively reduce the risk of bacterial infection.

       

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