CAJ | 학술논문

我国药品微生物污染的调查数据比较少，但细菌污染仍居首位，中药制剂在生产过程中由于污染微生物，造成了非常严重的不良后果和无法挽回的损失。本文根据国内相关文献资料，进行整理归纳，探讨控制中药制剂生产中污染微生物的方法。中药制剂生产中的微生物污染途径有生产人员、空气、原料、生产厂房、水、设备，生产中要加强对污染途径的控制，以提高产品质量。
아국약품미생물오염적조사수거비교소，단세균오염잉거수위，중약제제재생산과정중유우오염미생물，조성료비상엄중적불량후과화무법만회적손실。본문근거국내상관문헌자료，진행정리귀납，탐토공제중약제제생산중오염미생물적방법。중약제제생산중적미생물오염도경유생산인원、공기、원료、생산엄방、수、설비，생산중요가강대오염도경적공제，이제고산품질량。
The data on microbial contamination of drugs in our country is not adequate, but the bacterial contamination is the leading factor. The serious consequence and the irredeemable loss have been reported due to the microbial contamination during the production of traditional Chinese medicine (TCM) preparations. In this paper, the data concerning this issue were collected and analyzed on the basis of the evidence available in the domestic literature to explore the methods for microbial contamination controls during the production of TCM preparations. The results showed that the routes associated with microbial contamination in TCM preparation production included personnel, air, raw materials, workshop, water and equipment, which indicated that the contamination routes in TCM preparation productions should be strictly controlled to improve the product quality.