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

关键词:  中药制剂  洋葱伯克霍尔德氏菌  水活度  保济口服液  强力枇杷露

Key words:  traditional Chinese medicine preparation  Burkholderia cepacia  water activity  Baoji oral liquid  Qiangli loquat syrup

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，a_w），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a_w与微生物生长的关系，为应用a_w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a_w，通过水活度仪分别测定TSB、保济口服液和强力枇杷露的a_w，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a_w为0.98，保济口服液和强力枇杷露的a_w分别为0.99和0.93。高a_w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a_w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a_w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a_w可以有效降低其染菌风险。

Abstract:

OBJECTIVE To determine the lowest water activity(a_w) 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 a_w and the growth of Burkholderia cepacia, in order to provide a basis for the application of a_w to control microorganisms in the production of traditional Chinese medicine preparations. METHODS Adjusted the a_w of tryptic soy broth medium(TSB) with sodium chloride, and determined the a_w of TSB, Baoji oral liquid and Qiangli loquat syrup by determining instrument of a_w, 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 a_w 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 a_w could help the growth and reproduction of Burkholderia cepacia, while the growth and reproduction of Burkholderia cepacia in Qiangli loquat syrup with low a_w was inhibited. This result was consistent with USP <1112> “low a_w inhibits the growth of microorganisms in drugs”. CONCLUSION Reducing the a_w of traditional Chinese medicine in the production process can effectively reduce the risk of bacterial infection.