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盐酸四环素是临床上常用的广谱抗生素,但在生产和贮存过程中易产生杂质,如4-差向四环素(4-ETC),4-差向脱水四环素(4-EATC),金霉素(CTC)等。这些杂质的结构和理化性质与四环素十分相似,但生物效价与毒性却不同,这些杂质体内吸收慢,血中浓度低,且毒性大。国内外药典均规定杂质限度,多采用薄层色谱法,高效液相色谱法测定4-差向脱水四环素。本文作者参考文献,对天美制药公司出口的三批四环素原料检验时,发现该原料中的最多杂质并不是4-差向脱水四环素,经薄层,液相与紫外联用,确认是4-差向四环素(4-ETC)。本文将报道盐酸四环素及4-差向四
Tetracycline hydrochloride is a broad-spectrum antibiotic commonly used clinically, but it is easy to produce impurities such as 4-ETC, 4-EATC, Chlortetracycline CTC) and so on. The structure and physico-chemical properties of these impurities are very similar to that of tetracycline, but their biological potency and toxicity are different. These impurities absorb slowly in vivo, have low blood concentrations, and are highly toxic. Pharmacopoeia both at home and abroad are provided for impurity limits, and more by thin-layer chromatography, high performance liquid chromatography determination of 4- dehydration tetracycline. The author of the reference, the day of the United States exported three batches of tetracycline testing of raw materials and found that most of the impurities in the raw material is not 4-epichlorohydrin dehydration, TLC, liquid and UV combined to confirm the 4-poor Tetracycline (4-ETC). This article reports tetracycline hydrochloride and 4-epi-4