一种重组人甲状旁腺激素(1-84)药物组合物及其制备方法

Medicinal composition of recombinant human parathormone(1-84) and its preparing process

Abstract

The invention relates to a method for preparing recombined parathormone (1-84) drug composite, which comprises parathormone (1-84), shaping agent, and some fixity buffer for adjusting the pH value in acceptable range, protecting agent for protecting the activity of protein, and germ-free water, while the active component is parathormone. And the preparation method comprises that preparing mother solution, recombining the parathormone (1-84) mixture, making volume constant and freezing or the like. The water content of invention is lower than 3%, and the storage time of active component can reach 30 months at 2-8Deg. C, with prolonged storage time on drug purity.
本发明公开了一种重组人甲状旁腺激素(1-84)药物组合物及其制备方法,该组合物由医学有效剂量的人甲状旁腺激素(1-84)、赋形剂、其量足够调节制剂的pH值使其保持在生理可接受范围之内的不挥发性缓冲剂、用于保护蛋白活性的保护剂,以及无菌水,活性成分为重组人甲状旁腺激素;制备方法包括配置母液、重组人甲状旁腺激素(1-84)混合液、定容、冻干等步骤,采用本发明方法制备的重组人甲状旁腺激素(1-84)药物组合物含水量不超过3%,在2℃-8℃的条件下,其活性成份的保存期可达到30个月,药物的纯度的保藏期也相应延长。

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    CN-103301058-ASeptember 18, 2013深圳翰宇药业股份有限公司一种特立帕肽注射用组合物及其制备方法和制剂