论文部分内容阅读
一、前言 在四环素(TC)生产过程中,形成一定量的脱水四环素(ATC)、4—差向脱水四环素(EATC)及4—差向四环素(ETC),这些杂质带入成品四环素中。在成品四环素保存过程中,可见到药品外观颜色逐渐加深,其中所含的ATC、EATC及ETC等杂质的含量亦随之增加。从而导致药品质量的下降、抗菌活性降低,毒副作用显著增加 为了控制药品质量,国内外药典都对四环素中的杂质含量,作了具体规定,英国药典1973版规定:四环素盐酸盐中,ATC<0.5％,EATC<0.5％,ETC<4.0％。美国药典20版规定:四环素碱、四环素盐酸盐和四环素磷酸盐复合物中,EATC的含量都不超过2.0％。中国药典1977版则规定:四环素盐酸盐中,ETC<4.0％。 英国药典和中国药典对四环素中杂质含量的测定方法,都采用板层限度法,不能测出准确杂质含量数据。美国药典则采用光密度法(简称USP法),只测定四环素中ATC
I. INTRODUCTION A certain amount of dehydrated tetracycline (ATC), 4-epi-dehydrotetracycline (EATC) and 4-epi-tetracycline (ETC) are formed in tetracycline (TC) production and these impurities are introduced into the finished tetracycline. In the finished product tetracycline preservation process, we can see the gradual deepening of the appearance of the drug color, which contains ATC, EATC and ETC impurity content also increased. Resulting in the decline in the quality of medicines, antibacterial activity decreased, significantly increased side effects In order to control the quality of medicines, both at home and abroad, the content of tetracycline in the impurities, made specific provisions of the British Pharmacopoeia 1973 version: tetracycline hydrochloride, ATC < 0.5%, EATC <0.5%, ETC <4.0%. The United States Pharmacopoeia 20 edition states: Tetracycline, tetracycline hydrochloride and tetracycline phosphate complexes, EATC content of not more than 2.0%. Chinese Pharmacopoeia 1977 edition provides: tetracycline hydrochloride, ETC <4.0%. British Pharmacopoeia and Chinese Pharmacopoeia tetracycline in the determination of impurity content, using plate limit method, can not be accurately measured impurity content data. The United States Pharmacopoeia using optical density method (referred to as the USP method), only tetracycline ATC