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LIQUID PREPARATION CONTAINING HUMAN URINARY TRYPSIN INHIBITOR AND ITS PRODUCTION

机译:包含人类尿胰蛋白酶抑制剂的液体制剂及其生产

摘要

PROBLEM TO BE SOLVED: To prepare the subject preparation excellent in stability in preservation by not allowing the preparation to include an acidic protease. ;SOLUTION: The objective preparation does not include an acidic protease. The objective preparation preferably has ≤0.01 ionic strength in terms of sodium chloride concentration and pH3-6. The objective preparation is obtained by heating a solution containing human urinary trypsin inhibitor therein to inactivate the before enzyme activities in the solution. The solution is treated by preferably raising the temperature to 60-100°C under pH5-7, lowering the pH, and heating for 1-30min. Further, the objective preparation can includes 0.01-1mg/mL disaccharides such as source, or a sugar alcohol such as mannitol. the preparation can be administered to a patient in a front of injections, eye lotions, nasal drops, etc.;COPYRIGHT: (C)1998,JPO
机译:解决的问题:通过不允许制剂包含酸性蛋白酶来制备保存稳定性优异的主题制剂。 ;解决方案:目标制剂不包含酸性蛋白酶。就氯化钠浓度和pH3-6而言,目标制剂优选具有≤0.01的离子强度。通过加热其中包含人尿胰蛋白酶抑制剂的溶液以使溶液中的酶活性失活来获得目标制剂。通过优选在pH5-7下将温度升高至60-100℃,降低pH并加热1-30min来处理溶液。此外,目标制剂可以包含0.01-1mg / mL的二糖如来源,或糖醇如甘露醇。该制剂可以在注射剂,眼药水,滴鼻剂等前给药于患者;版权所有:(C)1998,日本特许厅

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