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由于灭菌制剂(尤其中草药注射剂)生产流程长,暴露时间久,注射用溶剂、配制容器、原料等,均易被微生物污染,可导致注射液热原不合格。我院灭菌制剂室曾于1986年夏季发生过二批注射液热原不合格,我们根据文献介绍的几种方法,对我院二批热原不合格的注射液采用了活性炭——白陶土—碱式氯化铝分步吸附法进行了处理,取得了满意效果,现介绍如下。方法与结果一、材料与方法 1.材料 (1) 20％甘露醇注射液 250ml轧铝盖,处理前批号860625,本院制剂室生产 (2) 鲎试剂厦门鲎试剂厂,0.5ml/
As the sterilization preparation (especially Chinese herbal medicine injection) long production process, exposure time, injection solvent, preparation of containers, raw materials, etc., are susceptible to microbial contamination, can lead to unqualified injection pyrogen. Sterilization preparation room in our hospital had occurred in the summer of 1986, two batches of injection pyrogen failed, according to several methods described in the literature, our hospital two batches of pyrogen unqualified injection using activated carbon - clay - Alkali aluminum chloride step adsorption was processed, and achieved satisfactory results, are presented below. Methods and Results 1. Materials and Methods 1. Materials (1) 250ml aluminum cap with 20% mannitol injection, batch No. 860625 before treatment, and (2)