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制备一种乙型肝炎病毒特异性转移因子制剂 (HBV STF) ,为临床应用提供有价值的实验依据。从人HBsAg阳性胎盘中制备了HBV STF ,并对其理化性质、免疫学活性进行了检测和初步的临床试用。每批样品经无菌试验、热原质检查、动物安全性试验等均符合药典要求。本品最大紫外吸收光谱在 2 5 6± 2nm处 ,E2 60nm/E2 80nm比值大于 2 7。其水解氨基酸含 17种。对人T淋巴细胞E受体的激活试验结果显示 ,HBV STF的Ea RFc平均增高率在 83 47%～ 10 3 48%之间 ,抗原特异性皮肤试验表明HBV STF能刺激小鼠体内T淋巴细胞增殖 ,诱导小鼠跖趾部皮肤的迟发性变态反应。对HBV STF的初步临床试用也取得明显效果 ,显示HBV STF是一种可用于治疗乙肝的安全、有效的免疫调节剂
Preparation of a hepatitis B virus-specific transfer factor preparation (HBV STF), provide valuable experimental evidence for clinical application. HBV STF was prepared from human HBsAg positive placenta, and its physical and chemical properties, immunological activity were tested and preliminary clinical trial. Each batch of samples by sterility test, pyrogen test, animal safety tests are in line with Pharmacopoeia requirements. The maximum UV absorption spectrum of this product at 25 6 ± 2 nm Department, E2 60nm / E2 80nm ratio greater than 27. Its hydrolyzed amino acids contain 17 kinds. The activation of human T lymphocyte E receptor showed that the average increase rate of Ea RFc in HBV STF ranged from 83 47% to 103 48%. Antigen-specific skin tests showed that HBV STF could stimulate T lymphocytes in mice Proliferation, induced delayed metamorphosis in metatarsophalangeal skin of mice. The initial clinical trial of HBV STF also achieved significant results, indicating that HBV STF is a safe and effective immunomodulator for the treatment of hepatitis B