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血卟啉注射液无菌控制
引用本文:周健,李中全.血卟啉注射液无菌控制[J].四川理工学院学报(自然科学版),2004,17(2):34-38.
作者姓名:周健  李中全
作者单位:1. 四川理工学院生物工程系,四川,自贡,643000
2. 重庆市华鼎现代生物制药有限责任公司,重庆,401320
摘    要:血卟啉是用氯化血红素经过化学半合成而得的多种卟啉类的混合物,主要成分是血卟啉、卟啉聚合体、羟乙基-乙烯基次卟啉及少量原卟啉。血卟啉注射液就是血卟啉的无菌水溶液。文章通过对血卟啉注射液的工艺流程以及检验过程的监控和检验,确认控制血卟啉注射液无菌的步骤和要点。证明以无菌灌装方式生产的血卟啉注射液无菌质量符合国家标准要求,并确保患者用药安全。

关 键 词:血卟啉注射液  无菌  环境监控
文章编号:1008-438X(2004)02-0034-05
修稿时间:2003年6月26日

Asepsis Control of Iniection Hematoporphvrin
ZHOU Jian ,LI Zhong-quan.Asepsis Control of Iniection Hematoporphvrin[J].Journal of Sichuan University of Science & Engineering:Natural Science Editton,2004,17(2):34-38.
Authors:ZHOU Jian  LI Zhong-quan
Institution:ZHOU Jian 1,LI Zhong-quan 2
Abstract:Hematoporphyin quinoline is an undergo half chemical formatting,got many kinds of porphying mixtures used by chlorination heamachrome. Major elements of injection hematoporphyrin is hematoporphyrin, porphyrinpolymer injection hematoporphyrin the second base of hydroxyl- hematoporphyrin quinoline once of vinyl and a small amount of original hematoporphyrin quinoline. Hematoporphyrinactual injection is an asepsis liquor of hematoporphyrin. Through control and inspection of the technological process and examining the course of the injection hematoporphyrin confirm controlling injection hematoporphyrin procedure and main point without fungus prove that injection hematoporphyrin which is poured into producing injection by a way of asepsis fungus quality accord with national standard request, and can guarantee securities that patients use the medicine.
Keywords:injection hematoporphyrin  asepsis  environment-control  
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