乙型肝炎病毒特异性转移因子的研究

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256±2 nm处,E260nm/E280nm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%～103.48%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.

Studies of Hepatitis B Virus-Specific Transfer Factor Preparation

To establish a new method for the preparation of hepatitis B virus-specific transfer factor preparation (HBV-STF)，and hence some available data for comparative study of clinical application are documented.HBV-STF was prepared with human placental from HBsAg female patients positive. The physical and chemical quality and its immunological properties of HBV-STF preparation were tested. Also preliminary clinical trial was used, demonstrates a consistency in quality among each batch. Results from bacteria culture，safety and pyrogen tests and acute toxicity in mice all satisfied with the requirements of the pharmacopoeia，indicating that the preparations were safe. The maximum absorption of ultraviolet spectra was at 256 ±2nm，The E260nm/E280nm is greater than 2.7，which is better than the internationally used criterion，i. e. E260nm/E280nm≥1.8. The preparations contained 17 kinds of amino acids. Effect of HBV-STF on activation of E receptors of human T lymphocytes shows the increasing rate ranging from 83.47% to 103.48%，HBV-STF can stimulate multiplication of T lympholeukcyte and inducing delayed allergy in mouse metatarsophalangeal skin by antigen specific skin test，indicating the preparations have strong immunological activities. Preliminary results from clinical trial also have obvious curative effect.The results showed that the HBV-STF preparation was a safe and high effective immuno-regulator for treating viral hepatitis B.