CN108272819A - 一种门冬氨酸钾复方电解质注射液及其制备方法 - Google Patents
一种门冬氨酸钾复方电解质注射液及其制备方法 Download PDFInfo
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- CN108272819A CN108272819A CN201810216510.0A CN201810216510A CN108272819A CN 108272819 A CN108272819 A CN 108272819A CN 201810216510 A CN201810216510 A CN 201810216510A CN 108272819 A CN108272819 A CN 108272819A
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Abstract
本发明提供了一种门冬氨酸钾复方电解质注射液及其制备方法,该注射液以1000mL计,包括以下组分,各组分的重量表示如下:氯化钠3~15g;门冬氨酸钾0.1~2.0g;氯化镁0.05~1.0g;醋酸钠0.2~5.0g;葡萄糖酸钙0.2~3.0g;枸橼酸钠0.2~3.0g;木糖醇10~200g;余量为水。该产品为全静脉营养注射液,可同时为机体提供多种电解质和糖类,能达到补充机体体液、维持水和电解质平衡、提供能量的目的。并且不依赖胰岛素代谢,非常适合糖尿病患者和肝病患者使用;代谢稳定,特别适合创伤及手术病人使用,促进手术、创伤患者的伤口愈合、提高免疫功能。
Description
技术领域
本发明属于药物制剂领域,具体涉及一种门冬氨酸钾复方电解质注射液及其制备方法。
背景技术
水、电解质代谢紊乱在临床上十分常见。许多器官系统的疾病,一些全身性的病理过程,如肝硬化、糖尿病、肺心病、烧烫伤及手术后等,都可以引起或伴有水、电解质代谢紊乱;外界环境的某些变化,某些医源性因素如药物使用不当,也常会导致水、电解质代谢紊乱。如果得不到及时的纠正,水、电解质代谢紊乱本身又会导致全身各器官系统特别是心血管系统、神经系统的生理功能和机体的物质代谢发生相应的障碍,严重时常可导致死亡。因此,水、电解质代谢紊乱的问题,是医学科学中极为重要的问题之一,受到了医学科学工作者的普遍重视。
目前临床常用的补充和调节水、电解质平衡的药物有生理盐水、林格液、乳酸钠林格液、5%葡萄糖生理盐水溶液及5%葡萄糖乳酸钠林格溶液和醋酸林格液等,而这些药物中补充钾的药为氯化钾,氯化钾在补充钾离子的同时,也使氯离子浓度升高,大量补充时可引起高氯性代谢性酸中毒,在临床应用上受到一定限制。
发明内容
本发明旨在解决上面描述的问题。本发明提供一种门冬氨酸钾复方电解质注射液,该产品为全静脉营养注射液,可同时为机体提供多种电解质和糖类,能达到补充机体体液、维持水和电解质平衡、提供能量的目的。并且不依赖胰岛素代谢,非常适合糖尿病患者和肝病患者使用;代谢稳定,特别适合创伤及手术病人使用,促进手术、创伤患者的伤口愈合、提高免疫功能。
本发明提供一种门冬氨酸钾复方电解质注射液,以1000mL计,包括以下组分,各组分的重量表示如下:
其中,包括以下组分,各组分的重量表示如下:
其中,包括以下组分,各组分的重量表示如下:
其中,所述复方注射液pH为4.0~8.0。
根据本发明的另一方面,提供一种门冬氨酸钾复方电解质注射液的制备方法,包括以下步骤:
(1)浓配:将氯化钠、门冬氨酸钾、氯化镁、醋酸钠、葡萄糖酸钙、枸橼酸钠和木糖醇按预定比例置于浓配罐中,按注射用水总量的40%-80%,泵入注射用水,循环20min-40min;
(2)除热原:向浓配罐中加入活性炭,循环20min-40min,过滤除炭,得到浓配液;
(3)稀配:将浓配液泵入稀配罐中,注射用水补至总量,循环20min-40min,过滤得到滤液。
其中,在所述步骤(3)后还包括以下步骤:
(4)灌装:将滤液灌装至输液袋;
(5)灭菌。
其中,所述步骤(2)中的活性炭为注射用活性炭,其用量为所述注射液体积的0.05~0.5%(g/ml)。
其中,所述步骤(2)中过滤使用的滤膜孔径为0.45um。
其中,所述步骤(3)中过滤使用的滤膜孔径为0.22um。
其中,所述步骤(5)的灭菌方式为湿热灭菌;灭菌条件为115℃灭菌30min或121℃灭菌15min。
本发明的门冬氨酸钾复方电解质注射液包括氯化钠3~15g,优选的,为5~10g,更进一步优选的,为6.372g;包括氯化镁0.05~1.0g,优选的,为0.05~0.35g,更进一步优选的,为0.204g;镁离子是生成糖原及高能磷酸酯不可缺少的物质,采用该重量份的氯化镁可以增强门冬氨酸钾盐的治疗作用,使治疗效果最佳。
醋酸钠0.2~5.0g,优选的,为1.5~3.5g,更进一步优选的,为2.052g由于传统电解质输液中氯离子浓度偏高,大量输注时可能引起代谢性酸中毒,本配方中降低氯化钠用量,加入醋酸钠,醋酸代谢速度快,且在肝脏以外的肾脏、肌肉等器官均可代谢,即使体外循环时也极少蓄积。选用该重量份的醋酸钠,使输液组成更接近细胞外液,输入体内可使水和电解质平衡,且可以扩张血容量,有效地维持酸碱平衡。
同时,在配方中添加葡萄糖酸钙0.2~3.0g,优选的,为0.2~1.0g,更进一步优选的,为0.588g;用葡萄糖酸钙代替氯化钙,可以降低处方中氯离子的水平,更接近于血中各离子的组成,同时避免了氯离子水平过高而造成的代谢性酸中毒。并且该重量份的葡萄糖酸钙可以保证既补充了钙离子,同时糖尿病人使用时,血糖水平不受影响。镁、钠和钙是细胞内重要的阳离子,在多种酶反应和肌肉收缩过程中扮演着重要的角色,细胞内外钾离子、钙离子、钠离子、镁离子浓度的比例影响心肌收缩性,本发明经过大量实验得出了以上几种离子的最佳配比;不仅添加的钠、钙、镁离子其摩尔浓度均与人体细胞外液中离子浓度一致,可以在输注时迅速补充机体体液;并且,在输注时,保证心脏、肝脏等器官的稳定性。
门冬氨酸钾是一种电解质补充药,与氯化钾相比有很多优势:(1)不升高氯离子浓度;(2)门冬氨酸是体内草酰乙酸的前体,在三羧酸循环中起重要作用。同时,门冬氨酸也参加鸟氨酸循环,促进氨和二氧化碳的代谢,使之生成尿素,降低血中氨和二氧化碳的含量。门冬氨酸与细胞有很强的亲和力,可作为钾、镁离子进入细胞的载体,使钾离子重返细胞内,促进细胞除极化和细胞代谢,维持其正常功能。门冬氨酸钾0.1~2.0g,优选的,0.5~1.0g,更进一步优选的,为0.7252g。选用该比例范围的门冬氨酸钾,即保证注射液中钾离子的摩尔浓度与人体细胞外液中离子浓度一致,同时由于门冬氨酸与细胞有很强的亲和力,可作为钾离子进入细胞的载体,使钾离子重返细胞内,促进细胞除极化和细胞代谢,维持其正常功能,并对细胞凋亡有保护作用。
枸橼酸钠含量为每1000mL注射液0.2~3.0g,优选的,为0.2~1.0g,更进一步优选的,为0.672g。采用以上重量份的枸橼酸钠替代了氯化钠,与特定比例的醋酸钠组合,缓冲作用更强,不增加肝脏代谢负担,并且不干扰机体组织代谢的监测;同时,该比例范围注射液的钠离子的摩尔浓度与人体细胞外液中离子浓度一致,可以大量、快速输注。
木糖醇适用于糖尿病患者的热量补充木糖醇是一种有甜味的结晶性白色粉末,是一种集甜味剂、营养剂、治疗剂等功能于一体的五碳糖醇,广泛存在于苔藓、海藻、酵母及许多果实、果浆、蔬菜、树木、稻草、玉米芯等植物中,但其含量很低。1955年,Toster在研究特发性戊糖尿症(Pentosuria)的过程中发现木糖醇在人体代谢中是一种正常的中间体,具有十分重要的生理学、生物学作用。
商品木糖醇甜度和发热量与蔗糖相近,甜度比例为1:1.25。因其是人体糖类代谢的正常中间体所以被人体摄入后不需要胰岛素促进,不会造成血糖的急剧变化,因而是糖尿病患者临床食品中良好的蔗糖代用品;它能够明显降低转氨酶,并对于血酮体有特殊的降酮作用,促进肝糖元的增加,是良好的护肝药物。
我们在处方中加入木糖醇,组成一种全静脉营养注射液,可同时为机体提供多种电解质和糖类,能达到补充机体体液、维持水和电解质平衡、提供能量的目的。并且不依赖胰岛素代谢,非常适合糖尿病患者和肝病患者使用,制剂浓度有5%、10%、20%和50%。代谢稳定,特别适合创伤及手术病人使用。本发明的注射液中含有木糖醇10~200g,优选的,为10~40g,更进一步优选的,为10g。木糖醇可为糖尿病人提供能量,本处方的木糖醇浓度范围是针对需要补充热量又需要补充电解质溶液的病理情况的特定范围。
本发明的门冬氨酸钾复方电解质注射液的制备方法,主要包括:
(1)浓配:将氯化钠、门冬氨酸钾、氯化镁、醋酸钠、葡萄糖酸钙、枸橼酸钠和木糖醇按预定比例置于浓配罐中,按注射用水总量的40%-80%,泵入注射用水,循环20min-40min;
(2)除热原:向浓配罐中加入注射液的0.05~0.5%(g/ml)的活性炭,循环20min-40min,过滤除炭,得到浓配液;过滤使用的滤膜孔径为0.45um;
(3)稀配:将浓配液泵入稀配罐中,注射用水补至总量,循环20min-40min,过滤得到滤液;过滤使用的滤膜孔径为0.22um;
(4)灌装:将滤液灌装至多层共挤输液袋;每袋装量为500ml或250ml;
(5)灭菌,灭菌方式一般采用湿热灭菌;灭菌条件为115℃灭菌30min或121℃灭菌15min。注射液常用灭菌条件,输液袋首选115℃、30min水浴灭菌。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合本发明的实施例,对本发明的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。需要说明的是,在不冲突的情况下,本申请中的实施例及实施例中的特征可以相互任意组合。
本发明的门冬氨酸钾复方电解质注射液,以1000mL计,包括氯化钠3~15g;门冬氨酸钾0.1~2.0g;氯化镁0.05~1.0g;醋酸钠0.2~5.0g;葡萄糖酸钙0.2~3.0g;枸橼酸钠0.2~3.0g;木糖醇10~200g;余量为水。
优选的,氯化钠5~10g;门冬氨酸钾0.5~1.0g;氯化镁0.05~0.35g;醋酸钠1.5~3.5g;葡萄糖酸钙0.2~1.0g;枸橼酸钠0.2~1.0g;木糖醇10~40g;余量为水。
进一步优选的,氯化钠6.372g;门冬氨酸钾0.7252g;氯化镁0.204g;醋酸钠2.052g;葡萄糖酸钙0.588g;枸橼酸钠0.672g;木糖醇10g;余量为水。
制备方法:将氯化钠、门冬氨酸钾、氯化镁、醋酸钠、葡萄糖酸钙、枸橼酸钠和木糖醇按预定比例置于浓配罐中,按注射用水总量的40%-80%,泵入注射用水,循环20min-40min;向浓配罐中加入注射液的0.05~0.5%(g/ml)的注射用活性炭,循环20min-40min,0.45um孔径滤膜过滤除炭,得到浓配液;将浓配液泵入稀配罐中,注射用水补至总量,循环20min-40min,0.22um孔径滤膜过滤得到滤液;将滤液灌装至500ml或250ml多层共挤输液袋;采用湿热灭菌。灭菌条件为115℃灭菌30min或121℃灭菌15min,即得产品。
下面列出本发明门冬氨酸钾复方电解质注射液及其制备方法的具体实施例:
实施例
实施例1
处方组成:
制备方法:
(1)浓配:将氯化钠、门冬氨酸钾、氯化镁、醋酸钠、葡萄糖酸钙、枸橼酸钠和木糖醇按预定比例置于浓配罐中,加入按注射用水总量60%的注射用水,调节pH值7.2,循环20min;
(2)除热原:按0.5%g/ml加入注射用活性炭,循环20min,0.45um孔径滤膜过滤除炭;
(3)稀配:将浓配液泵入配液罐中,加注射用水至全量,循环40min,0.22um孔径滤膜过滤得到滤液;
(4)灌装:灌装入多层共挤输液袋中,每袋装量为500ml或250ml;
(5)灭菌:灌装后,115℃灭菌30min,即得产品。
实施例2
处方组成:
制备方法:
(1)浓配:将氯化钠、门冬氨酸钾、氯化镁、醋酸钠、葡萄糖酸钙、枸橼酸钠和木糖醇按预定比例置于浓配罐中,加入按注射用水总量80%的注射用水,调节pH值6.7,循环30min;
(2)除热原:按0.2%g/ml加入注射用活性炭,循环25min,0.45um孔径滤膜过滤除炭;
(3)稀配:将浓配液泵入配液罐中,加注射用水至全量,循环30min,0.22um孔径滤膜过滤得到滤液;
(4)灌装:灌装入多层共挤输液袋中,每袋装量为500ml或250ml;
(5)灭菌:灌装后,121℃灭菌30min,即得产品。
实施例3
处方组成:
制备方法:
(1)浓配:将氯化钠、门冬氨酸钾、氯化镁、醋酸钠、葡萄糖酸钙、枸橼酸钠和木糖醇按预定比例置于浓配罐中,加入按注射用水总量40%的注射用水,调节pH值4.3,循环40min;
(2)除热原:按0.1%g/ml加入注射用活性炭,循环30min,0.45um孔径滤膜过滤除炭;
(3)稀配:将浓配液泵入配液罐中,加注射用水至全量,循环30min,0.22um孔径滤膜过滤得到滤液;
(4)灌装:灌装入多层共挤输液袋中,每袋装量为500ml或250ml;
(5)灭菌:灌装后,121℃灭菌15min,即得产品。
本发明的门冬氨酸钾复方电解质注射液的组分和重量还可以用表格表示,如表1。(以1000mL计)
表1
测试例
表2示出了实施例4-9的检测指标情况。
表2
由表2可以看出,注射液成品的各项含量均在95%-105%之间,有关物质均小于0.1%,且处方间差异不大,适用于临床输液要求。在临床使用过程中,检测到输液后血液的pH值均在7.34-7.38之间,血浆中碳酸氢根浓度大于23mmol/L,可以有效避免代谢性酸中毒。同时,检测病人血液中的血糖值水平并未有明显增高。
综上,本发明的门冬氨酸钾复方电解质注射液,该产品为全静脉营养注射液,可同时为机体提供多种电解质和糖类,能达到补充机体体液、维持水和电解质平衡、提供能量的目的。并且不依赖胰岛素代谢,非常适合糖尿病患者和肝病患者使用;代谢稳定,特别适合创伤及手术病人使用。
最后应说明的是:在本文中,术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含,从而使得包含一系列要素的过程、方法、物品或者设备不仅包括那些要素,而且还包括没有明确列出的其他要素,或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下,由语句“包括一个…”限定的要素,并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。
以上实施例仅用以说明本发明的技术方案,而非对其限制。尽管参照前述实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的精神和范围。
Claims (10)
1.一种门冬氨酸钾复方电解质注射液,其特征在于,以1000mL计,包括以下组分,各组分的重量表示如下:
2.如权利要求1所述的门冬氨酸钾复方电解质注射液,以1000mL计,其特征在于,包括以下组分,各组分的重量表示如下:
3.如权利要求1所述的门冬氨酸钾复方电解质注射液,以1000mL计,其特征在于,包括以下组分,各组分的重量表示如下:
4.如权利要求1-3中任一项所述的门冬氨酸钾复方电解质注射液,其特征在于,所述复方注射液pH为4.0~8.0。
5.一种根据权利要求1-4中任一项所述的门冬氨酸钾复方电解质注射液的制备方法,其特征在于,包括以下步骤:
(1)浓配:将氯化钠、门冬氨酸钾、氯化镁、醋酸钠、葡萄糖酸钙、枸橼酸钠和木糖醇按预定比例置于浓配罐中,按注射用水总量的40%-80%,泵入注射用水,循环20min-40min;
(2)除热原:向浓配罐中加入活性炭,循环20min-40min,过滤除炭,得到浓配液;
(3)稀配:将浓配液泵入稀配罐中,注射用水补至总量,循环20min-40min,过滤得到滤液。
6.如权利要求5所述的门冬氨酸钾复方电解质注射液的制备方法,其特征在于,在所述步骤(3)后还包括以下步骤:
(4)灌装:将滤液灌装至输液袋;
(5)灭菌。
7.如权利要求5所述的门冬氨酸钾复方电解质注射液的制备方法,其特征在于,所述步骤(2)中的活性炭为注射用活性炭,其用量为所述注射液体积的0.05~0.5%(g/ml)。
8.如权利要求5所述的门冬氨酸钾复方电解质注射液的制备方法,其特征在于,所述步骤(2)中过滤使用的滤膜孔径为0.45um。
9.如权利要求5所述的门冬氨酸钾复方电解质注射液的制备方法,其特征在于,所述步骤(3)中过滤使用的滤膜孔径为0.22um。
10.如权利要求6所述的门冬氨酸钾复方电解质注射液的制备方法,其特征在于,所述步骤(5)的灭菌方式为湿热灭菌;灭菌条件为115℃灭菌30min或121℃灭菌15min。
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