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作 者:夏天瑶[1] 程晓耕[1] 白春杰[1] 崔岩[1] 丰沧玉[1] 杨琳[1]
机构地区:[1]长春生物制品研究所生化制品室,长春130062
出 处:《中国生物制品学杂志》2007年第10期746-749,共4页Chinese Journal of Biologicals
摘 要:目的制备缓释胸腺肽口服片剂,并探讨其生物学活性及对小鼠免疫功能的影响。方法采用常规方法制备缓释胸腺肽片剂。以E-玫瑰花环试验及淋巴细胞转化试验,评价其生物学活性;免疫小鼠,以乳酸脱氢酶释放法检测小鼠NK细胞活性;巨噬细胞吞噬功能试验检测小鼠腹腔巨噬细胞的吞噬率;流式细胞仪检测T淋巴细胞亚群。结果所制备的缓释胸腺肽口服片剂,各项质量检测指标均达到《中国药典》三部(2005版)要求,其释药过程无突释和释药峰。缓释片剂组的E-玫瑰花结形成率及淋巴细胞转化率明显高于空白基质片组,且差异有显著意义;NK细胞活性、巨噬细胞吞噬率及CD3^+、CD4^+、CD4^+/CD8^+比值与空白基质片组相比,差异均有显著意义。结论缓释胸腺肽口服片剂具有良好的生物学活性,并对小鼠免疫调节功能有明显的增强作用。Objective To prepare oral control-released thymopoietin (TP)tablet and explore its bioactivity as well as its effect on the immune function of mice. Methods Prepare oral control-released TP tablet by routine method and evaluate its bioactivity by E rosette test and lymphocyte transformation test. Immunize mice with the prepared tablet and determine NK cell activity by lactic dehy- drogenase release test, the percentage of phagocytosis of macrophages in abdominal cavity by macrophage phagocytosis test, and the T lymphocyte subgroups by flow cytometer. Results All the quality control indexes of prepared control-released TP tablet met the re- quirements in Chinese Pharmacopoeia ( Volume Ⅲ ,2005). No burst release or release peak was observed during release of the tablet. The E rosette formation rate, lymphocyte transformation rate, NK ceil activity, percentage of phagocytosis of macrophages, CD3^+ and CD4^+ ceil counts as well as CD4^+/CD8^+ ratio of mice immunized with the prepared tablet were significantly higher.than those of blank control (matrix). Conclusion The prepared oral control-released TP table showed good bioactivity and enhanced the immunoregulatory function of mice significantly.
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