大陸抗生素製劑之安全性評估   全文下載

Safety Assessment of Antibiotics Manufactured in Mainland China

依據1998年中國大陸衛生部公佈之第一季藥品質量抽樣檢驗結果顯示：100件被公佈為劣藥之藥品中，抗生素製劑被列為劣藥者就有28件，佔全部劣藥之28%。為了確保國人用藥安全及配合行政院「加強消費者藥物食品檢驗及資訊服務」行政革新方案之實施，六年來持續對大陸抗生素之安全性進行試驗評估，以了解大陸製造之抗生素製劑是否有產生急性毒性反應之慮，作為其產品品質之評估。於八十七年度間委託民間學術團體赴大陸共價購23件大陸產抗生素，除其中2件製劑已超過有效期限外，最終完成21件製劑之檢驗。本實驗中急性毒性之試驗係依據中華藥典、美國藥典(USP XXI)、日本抗生素物質醫療藥品基準解說、中華人民共和國藥典、經濟合作及發展組織（Organization for Economic Cooperation, OECD）之相關規定進行，將抗生素製劑以藥典或公定書中規定之溶媒配製成規定濃度之檢液後，依單一劑量以小白鼠進行急性毒性試驗，將抗生素溶液以尾靜脈注射法（6件檢體）、口服灌餵法（14件檢體）或皮下注射法（l件檢體）投與動物之後，連續觀察14天，每天記錄動物體重之變化，並觀察有無震顫、抽慉、嗜眠、流涎、排液或死亡等中毒症狀。實驗結果顯示投與21件大陸抗生素製劑之所有小白鼠生長皆正常，製劑應不具急性毒性。"

According to a test report of drug sampling during the at first stage in 1998 by the Department in Health of Mainland China(PRC), results showed that 28% (28 cases) of antibiotics assessed in 100 drug samples was inferior. To verify the drug safety and the compliance with the policy of the ROC government, we have continuously evaluated for six years the safety of antibiotics manufactured in Mainland China. We conducting acute toxicity tests to determine the safety and quality of these products. Several commercial organizations purchased for us in 1998 23 cases of antibiotic samples from Mainland China. Two case, of antibiotic samples exceeded the valid period of expiration. The remaining 21 cases were evaluated using acute toxicity tests on mice in accordance with the guidelines of Chinese Pharmacopoeia IV, US Pharmacopoeia XX I, Minimum Requirements for Antibiotic Product (MRAP, Japan), Mainland China Pharmacopoeia (1990) and Organization for Economic Cooperation (OECD). The results showed that all of the antibiotic samples from Mainland China passed acute toxicity testing administered by systemic injection (6 cases), oral administration (14 cases), and subcutaneous injection (1 case). All tested mice showed normal growth patterns. The results support the conclusion that all antibiotics sampled & tested were qualified and safe.