四環素類抗生素對照標準品效價測定

A POTENCY TEST OF TETRACYCLINE SECONDARY STANDARDS

本組第一年試辦藥物對照標準品之製備，針對常用抗生素Tetracycline HCI，Oxytetracycline HCI及Doxycycline HC1加以測定。依據CFR 1981記載之Microbiological Turbidimefric Method，一級標準品使用Tetracycline HCI（USP 990 ug／mg），Oxytetracycline HCI（USP 953 ug／mg），Doxycycline Hyclate（USP 865 ug／mg），測試的高純度原料向具代表性之廠商洽贈或購買，為Tetracycline HCI Lederle；Oxytetracycline HCI，Pfizer；Doxycycline HCI，Pfizer。結果發現三種抗生素原料對各該標準品之含量百分率為Tetracycline HCI 99.79 ％，Oxytetrcycline HCI為98.11 ％，Doxycycline HCI 98.26 ％，效價依次為988 g／mg，935 g／m，850 g／m。目前國內尚未有藥物對照標準品的製備與供應，且為配合政府推行GMP制度，加強輔導國內業者藥品之檢驗及品質管制，本組嘗試製備，供應國內各家廠商，使其取得藥物對照標準品迅速、方便又經濟，便利GMP制度的推行。 According to the process stated in the 'CFR Microbiological turbidimetric Method, 1981', the highly purified and frequently used antibiotic raw materials, such as Tetracycline HCI, Oxytetracycline HCI, and Doxycycline HCI were assayed against USP Reference Standards respectively as secondary standards and planned to supply domestic pharmaceutical makers for the basis of quality control. The results showed that Tetracycline HCI is 988 ug/mg, Oxytetracycline HCI is 935 ug/ mg, and Doxycycline HCl is 850 ug/mg.