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盐酸四环素在生产及精制过程中采用多种有机溶媒为溶剂,如甲醇、丙酮、正丁醇等,一般常用丙酮、正丁醇。盐酸四环素是一种广谱抗生素,广泛应用于临床,服用或注射剂量较大,疗程长,因而易导致慢性中毒,故有必要控制其中有机溶媒的残留量。 目前对于盐酸四环素中溶媒残留量,没有一个现成的测定方法及规定的限度,为此,总结出一种有效地、准确地测定有机溶媒残留量的方法及制订出残留量的限度范围很有必要,本文介绍气相色谱法,以正丙醇为内标物测定丙酮、正丁醇的残留量。本测定方法灵敏度、选择性均较高,操作快速,样品用量省,对多批样品的测定优越性尤为明显。
Hydrochloride tetracycline in the production and refining process using a variety of organic solvents as solvents, such as methanol, acetone, n-butanol, etc., commonly used acetone, n-butanol. Tetracycline hydrochloride is a broad-spectrum antibiotics, widely used in clinical, taking or injection of a larger dose, long course of treatment, and thus easily lead to chronic poisoning, it is necessary to control the organic solvent residues. At present, there is no ready-made determination method and limits for the solvent residue in tetracycline hydrochloride. Therefore, it is necessary to summarize an effective and accurate method for determining the residual amount of organic solvent and to formulate the limit range of the residual amount This article describes the gas chromatography, n-propanol as the internal standard determination of acetone, n-butanol residues. The method has the advantages of high sensitivity and selectivity, rapid operation, less amount of sample used, and obvious superiority to the determination of multiple batches of samples.