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我院制剂室新购置一不锈钢配料桶,在配制乳酸环丙沙星注射液中发现。在中间品测定合格,灌装灭菌后颜色加深,特别是前后几瓶颜色加深明显,呈深黄色。经吸收度测定,其吸收度明显大于《中国药典》中的规定值。经观察发现,新购置的新桶表面光泽性较差,特别是药液流出口有较明显的锈迹,我们认为造成药液颜色加深的原因可能与铁离子有关。为了探讨铁离子对乳酸环丙沙星注射液颜色的影响,特做如下试验,为制剂生产和质量控制提供参考。1仪器与试药(53WB)微机型数显紫外分光光度计(上海光学仪器厂);乳酸环丙沙星(天津中央制药厂);注射用氯化钠(河北
Our hospital preparation room newly purchased a stainless steel bucket, in the preparation of ciprofloxacin lactate injection found. Measured in the intermediate product, after filling color deepened sterilization, especially before and after a few bottles of color deepened significantly, dark yellow. Absorbance determination, the absorption was significantly greater than the “Chinese Pharmacopoeia” in the provisions of value. The observation found that the newly purchased new barrel surface gloss is poor, especially at the liquid outlet there is more obvious rust, we believe that the color of the liquid medicine may deepen the reason may be related to iron ions. In order to investigate the effect of iron ion on the color of ciprofloxacin lactate injection, the following special test is made to provide a reference for preparation production and quality control. 1 instrument and reagent (53WB) microcomputer digital UV spectrophotometer (Shanghai Optical Instrument Factory); ciprofloxacin lactate (Tianjin Central Pharmaceutical Factory); sodium chloride for injection (Hebei