CN108721596B - 一种复方氨基酸维生素注射液及其应用 - Google Patents
一种复方氨基酸维生素注射液及其应用 Download PDFInfo
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Abstract
本发明公开一种复方氨基酸维生素注射液及其应用,每1000ml中含:L‑亮氨酸:5‑40g、L‑异亮氨酸:2‑30g、L‑缬氨酸:2‑30g、L‑丙氨酰‑L‑谷氨酰胺:5‑90g、L‑苏氨酸:1‑5g、L‑赖氨酸:1‑10g、L‑蛋氨酸:1‑12g、L‑苯丙氨酸:1‑10g、L‑色氨酸:0.5‑8g、L‑精氨酸:2‑30g、L‑组氨酸:1‑10g、维生素B6:1‑100mg、维生素B1:0‑50mg、维生素B12:0‑100μg。本发明针对人体围手术麻醉期应激、免疫、代谢等的变化,以创新性配方因应加速康复外科理念,起到抑制分解代谢、促进合成代谢,产热保温,改善机体物质能量代谢和免疫功能,加速康复的目的。
Description
技术领域
本发明涉及生物医药技术领域,具体地说,是一种复方氨基酸维生素注射液及其应用。
背景技术
既往,围术期仅在术后7-10天病人仍无法有效进食才考虑给予病人输注葡萄糖之外的能量物质(氨基酸、脂肪),发明人在2003年即开展手术麻醉期间输注复方氨基酸注射液,之后研究了多种配方氨基酸的临床效应,发现:手术麻醉期间合适地输注复方氨基酸注射液可以抑制骨骼肌蛋白分解、促进其合成,抑制脂肪动员、改善手术麻醉引起的低温,纠正负氮平衡,并且无明显副作用,不损害肝肾功能,且能安全用于糖尿病病人等。但目前市售氨基酸注射液并不针对此类围手术麻醉期(术前、术中、术后早期)病人,不能适应此类病人物质能量代谢的需求。因此,通过多年研究,并因应当前加速康复外科(enhancedrecovery after surgery,ERAS)理念,我们研发了复方氨基酸维生素注射液,其中含有特异的氨基酸成分、配比,并加入B族维生素以促进氨基酸的利用。
氨基酸是组成蛋白质的基本单位。复方氨基酸注射液作为一种静脉注射营养剂,广泛用于营养支持治疗,通用名为复方氨基酸注射液(15HBC)的氨基酸复方注射液,其配方为每1000ml含有异亮氨酸7.66g、缬氨酸8.86g、亮氨酸酸4.00g、赖氨酸4.10g(醋酸赖氨酸5.80g)、精氨酸5.80g、组氨酸1.60g、甲硫氨酸2.50g、丝氨酸3.30g、苯丙氨酸3.20g、脯氨酸6.30g、苏氨酸2.00g、甘氨酸3.30g、色氨酸0.90g、L-盐酸半胱氨酸<0.20g。通用名为复方氨基酸注射液(18AA-II)的氨基酸复方注射液,其配方为每250ml含有亮氨酸1.98g、异亮氨酸1.43g、缬氨酸1.83g、丙氨酸4.08g、苏氨酸1.43g、醋酸赖氨酸3.18g、蛋氨酸1.43g、苯丙氨酸1.98g、色氨酸0.48g、精氨酸2.80g、组氨酸1.70g、门冬氨酸0.83g、胱氨酸0.05g、谷氨酸1.43g、甘氨酸1.98g、脯氨酸1.70g、丝氨酸1.13g、酪氨酸0.08g。中国专利2012105433005,采用乳酸作为pH调节剂,降低高温灭菌后注射液降压物质。中国专利2014102294531公开一种复方氨基酸注射液(17AA-I)的药物组合物,用于蛋白质摄入不足、吸收障碍等氨基酸不能满足机体代谢需要的病人,改善手术后病人的营养状况、以及代谢性酸中毒等的预防或治疗,每1000ml中含有主药组份:L-异亮氨酸0.696-1.05克;L-亮氨酸0.94-1.42克;L-赖氨酸1.11-1.68克,或L-醋酸赖氨酸1.57-2.36克;L-甲硫氨酸或甲硫氨酸0.896-1.35克;L-苯丙氨酸0.82-1.24克;L-苏氨酸0.896-1.35克;L-色氨酸0.34-0.52克;L-精氨酸2.315-3.48克,或L-醋酸精氨酸3.11-4.61克;L-缬氨酸0.76-1.14克;甘氨酸2.58-3.88克;L-组氨酸0.58-0.88克;L-酪氨酸0.13-0.20克;L-丙氨酸4.26-6.40克;L-脯氨酸2.32-3.48克;L-丝氨酸2.32-3.48克;N-乙酰-L-半胱氨酸0.17-0.27克;L-谷氨酸1.82-2.74克;山梨醇或木糖醇或甘露醇或葡萄糖或果糖或其中一种或数种45-55克。现有技术中,关于本发明针对围手术麻醉期的物质能量代谢特点、利用率高的复方氨基酸维生素注射液,目前还未见报道。
发明内容
本发明针对围手术麻醉期病人特点,因应加速康复外科理念,研发一种复方氨基酸维生素注射液,用于抑制分解代谢、促进合成代谢,并产热保温,改善机体物质能量代谢和免疫功能,加速病人康复。
本发明的第二个目的是,提供如上所述复方氨基酸维生素注射液的用途。
为实现上述第一个目的,本发明采取的技术方案是:
一种复方氨基酸维生素注射液,所述注射液每1000ml中含有主药组份为:
L-亮氨酸:5-40g、
L-异亮氨酸:2-30g、
L-缬氨酸:2-30g、
L-丙氨酰-L-谷氨酰胺:5-90g、
L-苏氨酸:1-5g、
L-赖氨酸(醋酸盐):1-10g、
L-蛋氨酸:1-12g、
L-苯丙氨酸:1-10g、
L-色氨酸:0.5-8g、
L-精氨酸:2-30g、
L-组氨酸:1-10g、
维生素B6:1-100mg、
维生素B1:0-50mg、
维生素B12:0-100μg。
作为本发明的一个优选实施方案,所述注射液每1000ml中含有主药组份为:L-亮氨酸:20.6g、
L-异亮氨酸:12.2g、
L-缬氨酸:15.2g、
L-丙氨酰-L-谷氨酰胺:25g、
L-苏氨酸:2g、
L-赖氨酸(醋酸盐):3.8g、
L-蛋氨酸:3g、
L-苯丙氨酸:2.8g、
L-色氨酸:1g、
L-精氨酸:12g、
L-组氨酸:2.4g、
维生素B6:10mg、
维生素B1:0mg、
维生素B12:0μg。
作为本发明的一个优选实施方案,所述注射液每1000ml中还含有亚硫酸氢钠0.3-0.8g。
作为本发明的一个优选实施方案,所述注射液每1000ml中还含有亚硫酸氢钠0.5g。
作为本发明的一个优选实施方案,所述注射液中还含有80mmol/L以下Na+。
作为本发明的一个优选实施方案,所述注射液中还含有80mmol/L以下Cl-。
作为本发明的一个优选实施方案,所述注射液采用冰醋酸调节pH值至5.5-7.0。
为实现上述第二个目的,本发明采取的技术方案是:
如上任一所述复方氨基酸维生素注射液在制备药物中的应用,所述药物针对围手术麻醉期(术前、术中、术后早期)的病人,用于抑制分解代谢、促进合成代谢,并产热保温,改善机体物质能量代谢和免疫功能,加速病人康复。
本发明优点在于:
1、本发明的复方氨基酸维生素注射液针对围手术麻醉期病人能量代谢特点,设计具有特异氨基酸组分、配比,并加入B族维生素,各组分综合作用,具有显著的抑制分解代谢、促进合成代谢、产热保温、改善机体物质能量代谢和免疫功能的功效,加速术后病人康复。
2、本发明的复方氨基酸维生素注射液符合围手术麻醉期病人物质能量代谢特点,利用率高,临床疗效好。
3、加速康复外科(ERAS)快速发展,术前、术中、术后加强营养理念已得到公认。既往概念--围术期仅在术后7-10天病人仍无法有效进食才考虑给予输注葡萄糖之外的能量物质(氨基酸、脂肪),已被摒弃。本发明可用于手术麻醉期间、术后病人以及术前高代谢病人。
4、本发明安全高效,可于术前、术中、术后全程使用。
5、迄今还没有专门用于围手术麻醉期营养的补液,市售氨基酸注射液均无此特异针对性。
6、本发明参照人体围手术麻醉期应激、免疫、代谢等的变化,以创新性配方因应加速康复外科理念,起到抑制分解代谢、促进合成代谢,产热保温,改善机体物质能量代谢和免疫功能,加速康复的目的。a)支链氨基酸是必需氨基酸,通过多种途径参与糖、脂肪、蛋白质代谢和能量平衡,且可以改善氨基酸代谢紊乱。围手术麻醉期分解入血的氨基酸中谷氨酰胺和丙氨酸占比70%左右,且支链氨基酸参与从头合成谷氨酰胺和丙氨酸,如补充不足则严重影响蛋白质合成代谢。b)B族维生素直接参与物质能量代谢,其中维生素B6参与氨基酸代谢的转氨基、脱羧、侧链裂解、脱水及转硫化等,补充则能促进氨基酸的利用。
c)精氨酸有较好的节氮作用和增强免疫作用。d)注射液中其他组分氨基酸起到平衡和补充作用。
具体实施方式
下面结合具体实施方式,进一步阐述本发明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明记载的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等价形式同样落于本申请所附权利要求书所限定的范围。
实施例1复方氨基酸维生素注射液(一)
复方氨基酸维生素注射液(每1000ml)包括:L-亮氨酸:20.6g、L-异亮氨酸:12.2g、L-缬氨酸:15.2g、L-丙氨酰-L-谷氨酰胺:25g、L-苏氨酸:2g、L-赖氨酸(醋酸盐):3.8g、L-蛋氨酸:3g、L-苯丙氨酸:2.8g、L-色氨酸:1g、L-精氨酸:12g、L-组氨酸:2.4g、维生素B6:10mg、亚硫酸氢钠0.5g,采用冰醋酸调节pH值至5.5-6.5,添加注射用水至总量1000ml。使用方法:术中按照4-8kJ·kg-1·h-1经静脉输注,术后按照每天1.2-2.0g/kg经静脉输注。
实施例2复方氨基酸维生素注射液(二)
L-亮氨酸:40g、L-异亮氨酸:30g、L-缬氨酸:30g、L-丙氨酰-L-谷氨酰胺:10g、L-苏氨酸:5g、L-赖氨酸(醋酸盐):5g、L-蛋氨酸:2g、L-苯丙氨酸:3g、L-色氨酸:0.5g、L-精氨酸:5g、L-组氨酸:1g、维生素B6:1mg、维生素B1:1mg、维生素B12:100μg、亚硫酸氢钠0.3g、Na+10mmol/L、Cl-10mmol/L,采用冰醋酸调节pH值至5.5-7.0,添加注射用水至总量1000ml。使用方法:术中按照4-8kJ·kg-1·h-1经静脉输注,术后按照每天1.2-2.0g/kg经静脉输注。
实施例3复方氨基酸维生素注射液(三)
L-亮氨酸:5g、L-异亮氨酸:2g、L-缬氨酸:2g、L-丙氨酰-L-谷氨酰胺:5g、L-苏氨酸:1g、L-赖氨酸(醋酸盐):1g、L-蛋氨酸:1g、L-苯丙氨酸:1g、L-色氨酸:8g、L-精氨酸:30g、L-组氨酸:10g、维生素B6:8mg、维生素B1:10mg、维生素B12:100μg、亚硫酸氢钠0.8g、Na+80mmol/L、Cl-80mmol/L,采用冰醋酸调节pH值至5.5-7.0,添加注射用水至总量1000ml。使用方法:术中按照4-8kJ·kg-1·h-1经静脉输注,术后按照每天1.2-2.0g/kg经静脉输注。
实施例4复方氨基酸维生素注射液(四)
L-亮氨酸:5g、L-异亮氨酸:10g、L-缬氨酸:2g、L-丙氨酰-L-谷氨酰胺:90g、L-苏氨酸:1g、L-赖氨酸(醋酸盐):10g、L-蛋氨酸:1g、L-苯丙氨酸:10g、L-色氨酸:0.5g、L-精氨酸:30g、L-组氨酸:1g、维生素B6:100mg、维生素B1:50mg、维生素B12:100μg、亚硫酸氢钠0.3g、Na+80mmol/L、Cl-80mmol/L,采用冰醋酸调节pH值至5.5-7.0,添加注射用水至总量1000ml。使用方法:术中按照4-8kJ·kg-1·h-1经静脉输注,术后按照每天1.2-2.0g/kg经静脉输注。
实施例5复方氨基酸维生素注射液(五)
L-亮氨酸:40g、L-异亮氨酸:2g、L-缬氨酸:30g、L-丙氨酰-L-谷氨酰胺:5g、L-苏氨酸:5g、L-赖氨酸(醋酸盐):1g、L-蛋氨酸:12g、L-苯丙氨酸:1g、L-色氨酸:8g、L-精氨酸:2g、L-组氨酸:10g、维生素B6:10mg、维生素B1:10mg、维生素B12:100μg、亚硫酸氢钠0.8g、Na+10mmol/L、Cl-10mmol/L,采用冰醋酸调节pH值至5.5-7.0,添加注射用水至总量1000ml。使用方法:术中按照4-8kJ·kg-1·h-1经静脉输注,术后按照每天1.2-2.0g/kg经静脉输注。
实施例6复方氨基酸维生素注射液(六)
L-亮氨酸:30g、L-异亮氨酸:20g、L-缬氨酸:20g、L-丙氨酰-L-谷氨酰胺:40g、L-苏氨酸:4g、L-赖氨酸(醋酸盐):8g、L-蛋氨酸:10g、L-苯丙氨酸:8g、L-色氨酸:6g、L-精氨酸:20g、L-组氨酸:8g、维生素B6:2mg、维生素B1:4mg、维生素B12:40μg、亚硫酸氢钠0.6g、Na+60mmol/L、Cl-60mmol/L,采用冰醋酸调节pH值至5.5-7.0,添加注射用水至总量1000ml。使用方法:术中按照4-8kJ·kg-1·h-1经静脉输注,术后按照每天1.2-2.0g/kg经静脉输注。
效果说明
围手术麻醉期病人机体能量储备物质(糖原、蛋白质、脂肪)均被动员,以提供底物用于能量供给、组织修复、合成新蛋白等,且持续至康复期,致使机体分解代谢旺盛,骨骼肌消瘦,尿氮增加,产生负氮平衡,机体炎症和免疫反应易失衡。另外,由于中枢和外周胰岛素抵抗,以及脂肪分解产生游离脂肪酸、酮体等,蛋白质(氨基酸)是围手术麻醉期安全有效的物质能量供给物质。支链氨基酸是必需氨基酸,通过多种途径参与糖、脂肪、蛋白质代谢和能量平衡,且可以改善氨基酸代谢紊乱。围手术麻醉期分解入血的氨基酸中谷氨酰胺和丙氨酸占比70%左右,且支链氨基酸参与从头合成谷氨酰胺和丙氨酸,如补充不足则严重影响蛋白质合成代谢。B族维生素直接参与物质能量代谢,其中维生素B6参与氨基酸代谢的转氨基、脱羧、侧链裂解、脱水及转硫化等,补充则能促进氨基酸的利用。精氨酸有较好的节氮作用和增强免疫作用。本发明的复方氨基酸维生素注射液针对围手术期麻醉病人能量代谢需求,设计具有特异氨基酸组分、配比,并加入B族维生素,各组分综合作用,具有显著的抑制分解代谢、促进合成代谢、产热保温、改善机体物质能量代谢和免疫功能的功效,加速术后病人康复。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员,在不脱离本发明方法的前提下,还可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。
Claims (8)
1.一种复方氨基酸维生素注射液,其特征在于,所述注射液每1000ml 中的主药组份为:
L-亮氨酸:5-40g、
L-异亮氨酸:2-30g、
L-缬氨酸:2-30g、
L-丙氨酰-L-谷氨酰胺:5-90g、
L-苏氨酸:1-5g、
L-赖氨酸:1-10g、
L-蛋氨酸:1-12g、
L-苯丙氨酸:1-10g、
L-色氨酸:0 .5-8g、
L-精氨酸:2-30g、
L-组氨酸:1-10g、
维生素 B6:1-100mg、
维生素 B1:0-50mg、
维生素 B12:0-100μg。
2.根据权利要求 1 所述复方氨基酸维生素注射液,其特征在于,所述注射液每1000ml 中的主药组份为:
L- 亮氨酸:20 .6g、
L-异亮氨酸:12 .2g、
L-缬氨酸:15 .2g、
L-丙氨酰-L-谷氨酰胺:25g、
L-苏氨酸:2g、
L-赖氨酸:3 .8g、
L-蛋氨酸:3g、
L-苯丙氨酸:2 .8g、
L-色氨酸:1g、
L-精氨酸:12g、
L-组氨酸:2 .4g、
维生素 B6:10mg、
维生素 B1:0mg、
维生素 B12:0μg。
3.根据权利要求 1 或 2 任一所述复方氨基酸维生素注射液,其特征在于,所述注射液每 1000ml 中还含有亚硫酸氢钠 0 .3-0 .8g。
4.根据权利要求 1 或 2 任一所述复方氨基酸维生素注射液,其特征在于,所述注射液每 1000ml 中还含有亚硫酸氢钠 0 .5g。
5.根据权利要求 1 或 2 任一所述复方氨基酸维生素注射液,其特征在于,所述注射液中还含有 80mmol/L 以下 Na+。
6.根据权利要求 1 或 2 任一所述复方氨基酸维生素注射液,其特征在于,所述注射液中还含有 80mmol/L 以下 Cl-。
7.根据权利要求 1 或 2 任一所述复方氨基酸维生素注射液,其特征在于,所述注射液采用冰醋酸调节 pH 值至 5 .5-7 .0。
8.权利要求 1或2 任一所述复方氨基酸维生素注射液在制备药物中的应用,其特征在于,所述药物针对围手术麻醉期的病人,用于抑制分解代谢、促进合成代谢,并产热保温,改善机体物质能量代谢和免疫功能,加速病人康复。
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