医学CMC对照翻译

KE6 工艺/溶解、酶解

KE6-process/dissolution and enzymolysis

(1)溶解：称取适量的粗品肝素,搅拌溶解,控制料液浓度15%,料液温度57-65℃。

(1) Dissolution: Weigh the appropriate amount ofcrude heparin, stir to dissolve, control the liquidconcentration-to-15% and-the liquid-temperature-at-57-65℃.

(2)酶解：溶解完成后，用20%氢氧化钠调 pH至 8.0±0.5。按 5gAlcalase@酶/kg 粗品肝素计算、称取酶,用纯化水按酶:水=1:10 (w/v)充分溶解称取的酶。控制料液温度57-65℃,将酶加至料液中。加入酶开始计时,间隔搅拌4~5小时,反应过程中控制料液温度57~65℃, pH在8.0±0.5.

(2)·Enzymolysis: After dissolution, adjust-pH·to·8.0· ±·0.5·with 20% sodium·hydroxide.·Calculate and weigh enzyme as-5-g ofAlcalase® enzyme/kg ofcrude heparin, and-fully dissolve-enzyme in-the purifiedwater-at-a-ratio-of-enzyme: water-=1:10-(w/v).-Control-the-liquid-temperature-at-57-65℃, and-add-the enzyme to the liquid. Start to count when adding the enzyme, stirat certain interval for4-5 h, control the liquid-at-57-65℃ and the-pH-to-8.0·±·0.5-duringthe reaction process.

(3)加热处理:酶解完成,加入料液体积2%的氯化钠,快速将料液温度升到90±5℃,保温20-30分钟，然后降温至 60℃以下。

(3) Heating treatment: After enzymolysis, add 2% sodium chloride-to the liquid, quickly raise the liquidtemperature to-90·±·5℃,hold for 20-30 min, and then cool down to below 60℃.