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人白细胞干扰素是用健康人白细胞经病毒诱导后所产生的一种蛋白质制剂,具有广泛抗病毒繁殖,抑制肿瘤细胞生长和调节机体免疫状态等功能。自1961年Gresser发现人白细胞经诱导后能产生高效价的干扰素以来,人白细胞干扰素发展很快。国外最早是芬兰,后来是美国、英国、法国、日本、瑞士、西德、苏联和南斯拉夫等国进行了大量生产,并提供临床使用,取得了较好的治疗效果。国内虽有单位已批量生产,但远不能满足临床需要,为此我们进行了试制,产品经中国药品生物制品检定所检定,达到部颁质量标准并获得了卫生部颁发的生产批准文号。 人白细胞干扰素制备的工艺流程 健康人白细胞→氯化氨破坏红细胞→病毒诱导→离心除去细胞→pH2.0杀灭病毒→pH7.0→残毒试验合格→澄清和除菌过滤→冻干→成品检定合格。
Human leukocyte interferon is produced by a healthy human leukocyte virus after a protein preparation, with a wide range of anti-virus reproduction, inhibition of tumor cell growth and regulation of immune status and other functions. Since 1961 Gresser has discovered that human leukocytes can produce high titer of interferon after induction, human leukocyte interferon develops rapidly. The earliest foreign countries were Finland, and later the United States, Britain, France, Japan, Switzerland, West Germany, the Soviet Union and Yugoslavia and other countries conducted mass production, and provide clinical use, and achieved good results. Although the domestic units have been mass-produced, but can not meet the clinical needs far, for which we conducted trial production of products by the China Pharmaceutical and Biological Products accreditation, ministerial standards to the quality standards and access to the Ministry of Health issued a production approval number. Human leukocyte interferon preparation process Healthy white blood cells → ammonium chloride destruction of red blood cells → virus induced → centrifugation to remove cells → pH2.0 kill virus → pH7.0 → residue test pass → clarification and sterilization filtration → lyophilized → finished Qualified.