CN117731590A - 尿酸氧化酶复合制剂及其制备方法 - Google Patents
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Abstract
本发明涉及一种尿酸氧化酶复合制剂及其制备方法,属于生物医药技术领域。解决了现有技术中尿酸氧化酶复合制剂的活性和稳定性不易保持的技术问题。本发明的尿酸氧化酶复合制剂,以重量份计,包括:1‑2份尿酸氧化酶、1‑3份氯化镁、0.5‑1份维生素B6、2‑4份丙氨酸、0.5‑2份甘露醇、1‑3份L—半胱氨酸、20‑30份磷酸钠缓冲液。本发明的尿酸氧化酶复合制剂酶活性好,稳定性好,澄明度好,可以通过皮下、静脉或肌肉注射进入人体或动物体内发挥作用。
Description
技术领域
本发明属于生物医药技术领域,具体涉及一种尿酸氧化酶复合制剂及其制备方法。
背景技术
痛风是嘌呤代谢紊乱、尿酸排泄减少而致的血尿酸水平升高,尿酸晶体在关节、软骨和肾脏等沉积所致的一种代谢性疾病。主要表现为反复发作性关节红、肿、热、痛与功能障碍,甚至出现关节畸形。
高尿酸血症不仅是痛风的直接诱因,还与代谢综合征、2型糖尿病、高血压、心血管疾病、慢性肾病等密切相关。目前临床上用于抗高尿酸血症的药物主要有黄嘌呤氧化酶抑制剂、尿酸盐阴离子转运蛋白抑制剂和尿酸氧化酶。
尿酸氧化酶分为重组型氧化酶、非重组型氧化酶,重组型尿酸氧化酶可以帮助快速降低尿酸,加速痛风石溶解,有效控制痛风发作、降低血尿酸。在临床上,常用的含有重组型尿酸氧化酶的药物包括拉布立酶、普瑞凯希。这些药物的作用是通过提供额外的尿酸氧化酶,增加尿酸的代谢和降解速度,以降低血液中尿酸的浓度。此类含有尿酸氧化酶类药物通常与其他药物一起使用,如抑制尿酸生成的药物。但尿酸氧化酶作为一种蛋白质,其制剂中,尿酸氧化酶的活性和稳定性都不易保持。
发明内容
本发明为解决现有技术中尿酸氧化酶复合制剂的活性和稳定性不易保持的技术问题,提供一种尿酸氧化酶复合制剂及其制备方法。
本发明解决上述技术问题采取的技术方案如下。
本发明的尿酸氧化酶复合制剂,以重量份计,包括:
优选的是,包括:
优选的是,所述磷酸钠缓冲液的浓度为8mM-10mM,pH值在7.5至8.5之间。
本发明的尿酸氧化酶复合制剂的制备方法,步骤如下:
先按组成及重量份称取各组分,然后混合均匀,得到尿酸氧化酶复合制剂。
优选的是,混合均匀的方式为搅拌混合均匀。
与现有技术相比,本发明的有益效果为:
本发明的尿酸氧化酶复合制剂酶活性好,稳定性好,澄明度好,可以通过皮下、静脉或肌肉注射进入人体或动物体内发挥作用。
具体实施方式
为了进一步理解本发明,下面对本发明优选实施方案进行描述,但是应当理解,这些描述只是为进一步说明本发明的特征和优点,而不是对本发明权利要求的限制。
本发明的尿酸氧化酶复合制剂,以重量份计,包括:1-2份尿酸氧化酶、1-3份氯化镁、0.5-1份维生素B6、2-4份丙氨酸、0.5-2份甘露醇、1-3份L—半胱氨酸、20-30份磷酸钠缓冲液。
上述技术方案中,优选,包括:1.5份尿酸氧化酶、2份氯化镁、1份维生素B6、3份丙氨酸、1份甘露醇、2份L—半胱氨酸、25份磷酸钠缓冲液。
上述技术方案中,优选磷酸钠缓冲液的浓度为8mM-10mM,pH值在7.5至8.5之间。
本发明的尿酸氧化酶复合制剂的制备方法,步骤如下:
先按组成及重量份称取各组分,然后混合均匀,得到尿酸氧化酶复合制剂。
本发明中,混合均匀的方式为搅拌混合均匀,需要说明的是,本领域其他能够实现混合均匀的方式亦可。
在本发明中所使用的术语,一般具有本领域普通技术人员通常理解的含义,除非另有说明。
为了使本领域的技术人员更好地理解本发明的技术方案,下面将结合实施例对本发明作进一步的详细介绍。
在以下实施例中,未详细描述的各种过程和方法是本领域中公知的常规方法。下述实施例中所用的材料、试剂、装置、仪器、设备等,如无特殊说明,均可从商业途径获得。
实施例1
尿酸氧化酶复合制剂,以重量份计,包括:
实施例2
尿酸氧化酶复合制剂,以重量份计,包括:
实施例3
尿酸氧化酶复合制剂,以重量份计,包括:
实施例4
尿酸氧化酶复合制剂,以重量份计,包括:
对实施例1-4的尿酸氧化酶复合制剂的澄清度、酶活性和稳定性进行检测,结果如表1所示。
表1实施例1-4的尿酸氧化酶复合制剂的澄清度、酶活性和稳定性
尿酸氧化酶活性分析方法如下:用文献报道的方法(Legoux R.et al.,J.Biol.Chem.,1992,267,(12),8565-8570)分析酶活性,3ml缓冲液体系(TEA buffer,7.5g三乙醇胺;0.38g EDTA)中含尿酸0.18μmol,pH8.9,30℃保温,检测波长292nm,每分钟将1μmol尿酸氧化为尿囊酸所需的酶量为一个酶活性单位。
显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施例的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有实施例予以穷举。而由此所引申出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (5)
1.尿酸氧化酶复合制剂,其特征在于,以重量份计,包括:
2.根据权利要求1所述的尿酸氧化酶复合制剂,其特征在于,包括:
3.根据权利要求1所述的尿酸氧化酶复合制剂,其特征在于,所述磷酸钠缓冲液的浓度为8mM-10mM,pH值在7.5至8.5之间。
4.根据权利要求1-3任何一项所述的尿酸氧化酶复合制剂的制备方法,其特征在于,步骤如下:
先按组成及重量份称取各组分,然后混合均匀,得到尿酸氧化酶复合制剂。
5.根据权利要求4所述的尿酸氧化酶复合制剂的制备方法,其特征在于,混合均匀的方式为搅拌混合均匀。
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