抑瘤肽注射液的研制及其抑瘤作用研究

目的研制抑瘤肽注射液。方法采用生化方法从乳猪肝中提取可溶性胶原，经胃蛋白酶水解后制成抑瘤肽注射液，同时拟订质量标准并进行检验；观察抑瘤肽注射液对荷瘤昆明小鼠HepA肝瘤和S180纤维肉瘤及小鼠体内肝癌H22移植瘤的影响。结果抑瘤肽注射液生产工艺路线合理，质量达到拟订标准。抑瘤肽注射液能明显抑制HepA肝瘤生长，25，50，100，200mg／（kg·d）的抑制率分别为43．26％，55．06％，74、71％，40．47％；对于荷瘤小鼠S180纤维肉瘤，25，50，100mg／（kg·d）的抑制率分别为53．87％，76．53％，58．20％，而阿霉素阳性对照组2mg／（kg·d）]的抑制率为62．41％；对小鼠体内肝癌H22移植瘤生长的抑制呈剂量相关性，50，100，200mg／（kg·d）的抑制率分别为48．1％，60.0％，74、8％，而卡铂阳性对照组20mg／（kg·d）]的抑制率为63．7％。结论制备出的抑瘤肽注射液合格，且适合于大规模生产，能明显地抑制荷瘤小鼠肿瘤的生长。

Preparation of Tumor- inhibiting Polypeptides for Injection and Its Inhibitive Effect on Tumor Growth

Objective To study the preparation of tumor inhibiting polypeptides for injection （TIPI）. Methods The dissolvable collagen was extracted from the suckling pig liver by the biochemical approach, TIPI was prepared by the pepsin hydrolysis. The product was checked on the drafting quality criteria. The effect of TIPI on the HepA hepatoma, H22 hepatoma and S180 fibrosarcoma were investigated. Results The product＇s quality reached the drafting quality criteria showed that the production technological line of TIPI was suitable. The results showed that TIPI could apparently inhibit the growth of HepA hepatoma in the tumor-bearing mice with the inhibitory rate of 43.26%, 55.06%,74.71%,40.47% from the doses of 25, 50, 100, 200 mg/（kg· d） TIPI; and inhibit the growth of S180 fibrosarcoma with the inhibitory rate of 53.87%,76. 53%,58.20% from the respective doses of 50, 100,200mg/（kg· d） TIPI, the relative inhibitory rate of the positive adriamycin 2 mg/（kg· d）] control was 62.41%;TIPI could apparently inhibit the growth of H22 hepatoma transplanted in the mice in a dose dependant way with the inhibitory rate of 48.1%, 60.0%, 74.8% from the respective doses of 50, 100, 200 mg/（kg· d） TIPI, and the relative inhibitory rate of the positive adriamycin 20mg/（kg· d）] control was 63.7%. Conclusion TIPI produced by the biochemical approach is qualified for injection and a large scale production, TIPI can apparently inhibit the growth of tumor transplanted in the mice.