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甲哌力复霉素(利福平)生产上采用正丁醇转晶工艺,成品中残留一定量的溶媒。残留溶媒的存在不仅影响药品有效期限,而且在临床上长时间服用易导致慢性中毒。因此控制成品中溶媒残留量的限度很有必要。据资料介绍:甲哌力复霉素样品经处理后以正丙醇为内标,在102硅烷化担体,PEG12M固定液的柱上分离测定正丁醇残留量。我们认为该法在柱和内标的选择、出峰时间和定量方法上还有探讨的余地。本文提出的测定方法是选用测定甲哌力复霉素半合成原料侧链的类似柱子,以仲丁醇为内标,近似峰高法定量得到较为满意的结果。它具有操作简单,快速、定量准确、计算方便的特点,有一定实用意义。
Methotrexate rifamycine (rifampicin) production of n-butanol crystallization process, a certain amount of residual solvent in the finished product. The presence of residual solvent not only affects the expiration date of the drug, but also can lead to chronic poisoning when taken for a long time in clinic. Therefore, it is necessary to control the limit of solvent residue in the finished product. According to the introduction of the data, after the treatment of mequindox methyl in metronidazole, n-propanol was used as the internal standard and the n-butanol residual amount was determined on the column of 102 silanol carrier and PEG12M fixative. We think there is still room for discussion of the method in terms of column and internal standard selection, timing and method of quantitation. The determination method proposed in this paper is to select the similar column for the determination of side chain of mequindox in the semisynthetic raw materials, and to use sec-butanol as the internal standard, the approximate peak height method is used to obtain the more satisfactory results. It has a simple, fast, accurate quantitative, easy to calculate features, have some practical significance.