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注射用盐酸四环素的某些批号产品,注射后出现发冷、发抖,高热等反应,甚至有死亡病例。本文报道用凝胶渗透法从注射用盐酸四环素中分离出大分子杂质。检查了这些杂质的某些性质。以鲎试验和兔法检查内毒素及豚鼠法检查致敏性杂质并比较临床有反应批号与正常批号间差异。 一、大分子杂质的分离 据报道四环素类抗生素可以使鲎变形细胞溶解物与内毒素不发生反应。为此必须将制剂中的四环素分离除去,然后才能采用鲎试验法检查内毒素。取一定量四环素,无菌无热原双蒸水溶解,经葡聚糖凝胶G—25(100～200目)柱,无菌无热原双蒸水淋洗,收集含大分子杂质流出液,减压浓缩至一定浓度供检测用。
Some of the batch products of tetracycline hydrochloride for injection have chills, tremors, fever and other reactions after injection, and even deaths. This paper reports the separation of macromolecular impurities from tetracycline hydrochloride for injection by gel permeation. Some properties of these impurities were examined. To 鲎 test and rabbit law check endotoxin and guinea pig method to detect allergenic impurities and compare the clinical response batch number and the normal batch number difference. First, the separation of macromolecular impurities It is reported tetracycline antibiotics can 鲎 deformable cell lysate and endotoxin does not react. For this purpose, the tetracycline in the preparation must be separated and removed before the endotoxin test can be performed using the 鲎 test. Take a certain amount of tetracycline, sterile pyrogen-free double distilled water dissolved by Sephadex G-25 (100 ~ 200 mesh) column, sterile pyrogen-free double distilled water leaching, collecting macromolecular impurities containing effluent , Concentrated under reduced pressure to a certain concentration for testing purposes.