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转移因子(Transfer Factor 简称 TF)为由淋巴细胞中提取的含有多核苷酸、多肽的小分子活性物质,它能将细胞免疫力转移给受体,促使受体淋巴细胞致敏,增加机体的免疫力,抗御致病原,从而对免疫性缺陷和免疫功能低下的患者发生效能。对某些抗生素难以控制的病毒性、霉菌性细胞内感染所引起的疾病有一定疗效,对类风湿性关节炎、支气管哮喘、系统性红斑狼疮有显著疗效,对肿瘤患者有缓解、辅助性治疗作用,为一安全可靠的细胞免疫增强剂。目前国内外临床应用的 TF 大多取自人体血液的白细胞或制备血浆时所分离的白细胞,由于原料来源缺乏,影响临床的广泛使用。本院李洗等自1977年以人体脾脏为原料,用超滤法分离提取 TF 的研究获得成功。在此基础上放大批量生产,制订了工艺规程,改进了操作,制订“人脾转移因子注射液”的质量标准。现对 TF 注射液生产中若干质量控制问题探讨如下。
Transfer factor (TF) is a small molecule active substance containing polynucleotides and peptides extracted from lymphocytes. It can transfer cellular immunity to receptors, sensitize recipient lymphocytes and increase body immunity Force against pathogenic pathogens, thereby effecting immune deficiency and immunocompromised patients. Some of the antibiotics is difficult to control the viral, fungal infection caused by the disease have a certain effect on rheumatoid arthritis, bronchial asthma, systemic lupus erythematosus have a significant effect on cancer patients with relief, adjuvant therapy Role for a safe and reliable cellular immune enhancer. At present, most clinical applications of TF at home and abroad are derived from white blood cells of human blood or leucocytes isolated during the preparation of plasma. Due to the lack of sources of raw materials, the widespread use of TF is affected. Our hospital Lee washing since 1977 to human spleen as raw material, ultrafiltration separation and extraction of TF was successful. On this basis, amplification of mass production, the development of the process rules and improve the operation, the development of “human spleen transfer factor injection” quality standards. Now the production of TF injection in a number of quality control issues are discussed below.