治疗用Na^(131)I胶囊的研制及其动物实验

Preparation and Animal Experiments of Na^(131)I Therapeutic Capsule

本工作进行了治疗用 Na131I胶囊的研制及其性能评价。首先通过对失去不同结晶水及不同直径的 Na2 HPO4 · 12 H2 O吸附条件的研究得出 :失结晶水越多 ,吸附量越大 ;晶体颗粒越小 ,吸附量越大。 50 0 mg直径小于 0 .135mm的无水 Na2 HPO4 在 0号胶囊中可吸附 2 70 μL 0 .0 5mol/ L Na OH溶液。吸附剂中加入 1%的 Vc,可减少 131I的损失。胶囊的完全崩解时间为 5min,在 30 d内 2 0个样品的放射性都在平均值的 96.5%～ 10 3.5% ;样品的放射化学纯度 >95% ,核纯度 >99% ,均匀度和稳定性良好。动物实验结果表明 ,该胶囊无异常毒性 ;家兔甲状腺对治疗剂量的 Na131I胶囊和 Na131I液体在各时相的摄取率无差异。

The preparation and property of Na 131 I therapeutic capsules are studied. The adsorption of different particle size Na 2HPO 4 with different crystallized water is investigated The results indicate that the more the crystallized water, the less the adsorption; the small the particle size, the more the adsorption. The adsorbent amount of >110 mesh 500 mg anhydrous Na 2HPO 4 in No.0 capsule is 270 μL 0.05 mol/L NaOH solution. In order to prevent the volatility of radioiodide, 1% Vc should be included in adsorbent. The disintegrated time of capsule is 5 min. The radiochemical purity and nuclear purity of Na 131 I therapeutic capsule are over 95% and 99% respectively within 30 days after preparation. At the same time, the radioactivity of 20 capsules is in the range of 96.5%～103.5%. The animal experiments show that there is not extraordinary toxicity with Na 131 I therapeutic capsule, and no difference between Na 131 I therapeutic capsule and Na 131 I solution in rabbits thyroid uptake within 24 h.