大陸抗生素 安全性之調查評估急性毒性試驗——第三報

EVALUATION OF THE SAFETY OF SEVERAL ANTIBIOTICS MANUFACTURED IN MAINLAND CHINA--THE THIRD REPORT ACUTE TOXICITY TEST

自從大陸探親政策開放後，兩岸接觸頻繁，使得大陸藥品有機會經由各種管道流入國內，為了解大陸抗生素醫藥品質，提供民眾知的權力，乃奉行政院衛生署之指示，辦理有關大陸抗生素之安全性調查評估，且委託各大藥廠及民間相關團體前往大陸各省價購抗生素檢體25件。本實驗之急性毒性試驗方法及試驗濃度係依據美國藥典第21版、中華人民共和國藥典1990年第二版、日本抗生物質基準解說1982年、1990年及中華藥典第三版等基準，進行其急性毒性之安全性調查評估，進行試驗的方法有三種，第一種為尾靜脈注射法，測試之抗生素有18件，第二種為經口灌餵法，測試之抗生素有5件，第三種為皮下注射法，測試之抗生素有2件，本實驗結果均顯示此25種大陸抗生素皆不具急性毒性反應。雖然本次實驗樣品之安全性檢驗結果都符合規定，但並不代表所有流入國內使用之大陸抗生素都符合安全性檢驗，故目前除了仍透過各種管道自不同省分收集抗生素檢體進行試驗外，並希望能找出更周詳的檢驗系統。

Peoples of Taiwan and Mainland China have frequently communicated with each other over the last few years. Many different kinds of drugs manufactured in Mainland China have been transported to Taiwan through different routes. In order to assess the quality of several Chinese antibiotics, this laboratory has carried out the safety evaluation of such products as a mission assigned by the Department of Health. Twenty-five antibiotics manufactured by different companies in Mainland China were collected to serve as samples for the safety test. The methods of acute toxicity test adopted for the analysis are those referred to the methods section found and described in 'Chinese Pharma-copoeia (R.O.C.)'; 'US Pharmacopoeia'; 'Requirements for Antibiotic Products of Japan' and 'Chinese Pharmacopoeia (Mainland China)'. There are three different methods conducted in mice: tail vein injection, oral administation and subcutaneous injection. The results show all antibiotics tested were non-acutly toxic. The package and labeling of these antibiotics are substandard. The wax seal around the cap vials is out of date. The content of the containers is easily contaminated. A more systematic survey of the different categories of antibiotics produced in Mainland China is necessary to maintain high quality standards of antibiotic manufacture and distribution .