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自从医药品的微生物的污染成为GMP的一个课题而提出以来,对于非无菌制剂的各剂型制订微生物标准的要求与日俱增。医药品的微生物污染,如同瑞典等外国的病例那样不仅对患者引起新的感染症,而且亦影响医药品本身的质量。尤其发现致癌性的霉菌毒素—黄曲霉毒素(aflatoxin)以来,因霉菌引起的污染就成为引人注意的问题了。以动植物为原料的生药材,因属天然产物容易发霉,故在日本药局方生药总则中规定“生药材要力求清除来自于霉菌、昆虫以及其他动物的污损物或混合物及其他异物,且须讲求清洁卫生”。以确保医药品制剂的质量和安全的角度出发,作者等对市场饮片药材的霉菌及菌毒(mycotoxin)污染情况进行了调查,现将结果报告如下。
Since microbial contamination of pharmaceuticals has been proposed as a subject of GMP, the requirement for the establishment of microbiological standards for each formulation of non-sterile preparations is increasing. Microbiological contamination of pharmaceuticals, like foreign cases such as Sweden, not only causes new infections to patients, but also affects the quality of pharmaceuticals themselves. In particular, since the discovery of the carcinogenic mycotoxin aflatoxin, the contamination caused by mold has become an issue of concern. Raw materials that use animals and plants as raw materials, because natural products are prone to mildew, it is stipulated in the General Regulations of the Japanese Pharmacopoeia that “biological medicinal materials should seek to remove contaminants or mixtures and other foreign materials from molds, insects and other animals, And it must pay attention to cleanliness." To ensure the quality and safety of pharmaceutical preparations, the authors investigated the mycotoxin contamination of the marketed herbal medicines and reported the results as follows.