CN110075062A - 一种肾病用氨基酸注射液 - Google Patents
一种肾病用氨基酸注射液 Download PDFInfo
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
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- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
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Abstract
一种肾病用氨基酸注射液，加入肾功能衰竭时需求增大的酪氨酸、色氨酸，以及有效促进尿素循环、抑制血氨浓度上升的精氨酸等9种非必需氨基酸，EAA/NEAA比合理，临床效果确切，副作用少，具有肾用氨基酸制剂的维持肾功能的效果以及尿毒症改善效果，而且从末梢静脉或中心静脉寄给还获得显著的营养改善效果。
Description
技术领域
本发明涉及氨基酸注射液制备方法，特别是一种肾病用氨基酸注射液。
背景技术
我国在80年代就开发出了肾病用氨基酸注射液，这些注射液主要是根据Giordano提出的“必需氨基酸疗法”来加以组方的，其中只含有8种必需氨基酸以及组氨酸，临床上仅用于慢性肾功能衰竭患者临床症状改善。
近年来，大量的临床研究对肾功能衰竭的病情以及营养支持疗法有了新的见解，随着TPN疗法普及，对慢性肾功能衰竭患者施行TPN，NPC/N设定在300～400左右；但是TPN时使用单纯的必需氨基酸制剂可导致血氨浓度上升、血浆氨基酸谱紊乱等问题，局限了单纯的必需氨基酸制剂的配方。
随着TPN“全合一”技术的开展，施行TPN时用Nephamine作为氮源加入，TPN时非蛋白热量/氨保持在300以上，Nephamine的组方是依据在低蛋白饮食的基础上，补充必需氨基酸，增加体内蛋白质合成，使慢性肾衰病人营养不良状况得以改善；经多年的临床应用，肾用氨基酸注射液的作用机理得到临床医师的认可，复方氨基酸注射液的成功开发将会给临床上提供更多更好的选择。
发明内容
为了克服现有技术的上述缺点，本发明的目的是提供加入了肾功能衰竭时需求量增大的非必需氨基酸的一种肾病用氨基酸注射液。
本发明解决其技术问题所采用的技术方案是：一种肾病用氨基酸注射液，每1000ml注射液中含有：
作为本发明的进一步改进：还包括加入醋酸和磷酸调节pH值，所述氨基酸注射液pH值为5～7。
作为本发明的进一步改进：所述氨基酸注射液的必需氨基酸和非必需氨基酸比即EAA/NEAA比为3.21。
作为本发明的进一步改进：包括以下制备工艺：
(1)用注射用水冲洗所有生产设备；
(2)注入注射液总体积75～90％的注射用水；
(3)通入氮气，氧气浓度降低至0.8～1.4ppm时，依次加入L-精氨酸、L-组氨酸、L-半胱氨酸，搅拌溶解；
(4)加入亚硫酸氢钠，再加入其余氨基酸原料，搅拌至溶解；
(5)补充注射用水到注射液总体积，搅拌均匀；
(6)加入1:1的醋酸和磷酸调节pH值，并测量注射液pH值；
(7)充氮灌装灭菌得成品。
作为本发明的进一步改进：上述步骤(3)中对配制罐先抽真空至真空度60～85％，再通入氮气至大气压。
作为本发明的进一步改进：所述氨基酸注射液制备完成后检测质量标准，包括pH值、透光率、亚硫酸氢钠含量、渗透压摩尔浓度、异常毒性、细菌内毒素、无菌。
与现有技术相比，本发明的有益效果是：
(1)加入肾功能衰竭时需求增大的酪氨酸、色氨酸，以及有效促进尿素循环、抑制血氨浓度上升的精氨酸等9种非必需氨基酸，进行氨基酸补充，NPC/N由以往的500～1000降到300～400，提高给与的总氨量；
(2)确定了必需氨基酸与非必需氨基酸的适当比率(E/N)，比标准复方氨基酸注射液9AA更适合肾功能衰竭患者；
(3)减少了以往肾用必需氨基酸制剂使用时血药浓度容易上升的赖氨酸、蛋氨酸、苯丙氨酸、苏氨酸以及组氨酸的处方量。
具体实施方式
现结合实施例对本发明进一步说明：
一种肾病用氨基酸注射液，每1000ml注射液中含有：
制备该氨基酸注射液包括以下制备工艺：
(1)用注射用水冲洗所有生产设备；
(2)注入注射液总体积75～90％的注射用水；
(3)通入氮气，氧气浓度降低至0.8～1.4ppm时，依次加入L-精氨酸、L-组氨酸、L-半胱氨酸，搅拌溶解；
(4)加入亚硫酸氢钠，再加入其余氨基酸原料，搅拌至溶解；
(5)补充注射用水到注射液总体积，搅拌均匀；
(6)加入1:1的醋酸和磷酸调节pH值，并测量注射液pH值；
(7)充氮灌装灭菌得成品。
实施案例一：
按照下表称量各氨基酸原料：
(1)用注射用水淋洗所有生产设备；
(2)注入注射用水8L；
(3)配制罐抽真空至真空度70％，用经0.22μm孔径过滤的氮气通入配制罐至大气压；
(4)待氧气浓度降低至0.8～1.4ppm，保持注射用水水温在70℃，依次加入L-精氨酸、L-组氨酸、L-半胱氨酸，搅拌溶解；
(5)保持通入氮气，降温至45℃，加入亚硫酸氢钠，再加入其余氨基酸原料，搅拌至溶解；
(6)补充注射用水到注射液总体积为10L，保持搅拌；
(7)加入1:1的醋酸和磷酸调节pH值至5～7；
(8)充氮灌装灭菌。
实施案例二：
按照下表称量各氨基酸原料：
(1)用注射用水淋洗所有生产设备；
(2)注入注射用水10.5L；
(3)配制罐抽真空至真空度80％，用经0.22μm孔径过滤的氮气通入配制罐至大气压；
(4)待氧气浓度降低至0.8～1.4ppm，保持注射用水水温在70℃，依次加入L-精氨酸、L-组氨酸、L-半胱氨酸，搅拌溶解；
(5)保持通入氮气，降温至40℃，加入亚硫酸氢钠，再加入其余氨基酸原料，搅拌至溶解；
(6)补充注射用水到注射液总体积为15L，保持搅拌；
(7)加入1:1的醋酸和磷酸调节pH值至5～7；
(8)充氮灌装灭菌。
实施案例三：
按照下表称量各氨基酸原料：
(1)用注射用水淋洗所有生产设备；
(2)注入注射用水42.5L；
(3)配制罐抽真空至真空度85％，用经0.22μm孔径过滤的氮气通入配制罐至大气压；
(4)待氧气浓度降低至0.8～1.4ppm，保持注射用水水温在70℃，依次加入L-精氨酸、L-组氨酸、L-半胱氨酸，搅拌溶解；
(5)保持通入氮气，降温至42℃，加入亚硫酸氢钠，再加入其余氨基酸原料，搅拌至溶解；
(6)补充注射用水到注射液总体积为50L，保持搅拌；
(7)加入1:1的醋酸和磷酸调节pH值至5～7；
(8)充氮灌装灭菌。
综上所述，本领域的普通技术人员阅读本发明文件后，根据本发明的技术方案和技术构思无需创造性脑力劳动而作出其他各种相应的变换方案，均属于本发明所保护的范围。
Claims (5)
1.一种肾病用氨基酸注射液，其特征在于，每1000ml注射液中含有：
其余为注射用水。
2.根据权利要求1所述的一种肾病用氨基酸注射液，其特征在于，还包括加入醋酸和磷酸调节pH值。
3.根据权利要求1所述的一种肾病用氨基酸注射液，其特征在于，所述氨基酸注射液pH值为5～7。
4.根据权利要求1所述的一种肾病用氨基酸注射液，其特征在于，所述氨基酸注射液的必需氨基酸和非必需氨基酸比即EAA/NEAA比为3.21。
5.根据权利要求1所述的一种肾病用氨基酸注射液，其特征在于，包括以下制备工艺：
(1)用注射用水冲洗所有生产设备；
(2)注入注射液总体积75～90％的注射用水；
(3)通入氮气，氧气浓度降低至0.8～1.4ppm时，依次加入L-精氨酸、L-组氨酸、L-半胱氨酸，搅拌溶解；
(4)加入亚硫酸氢钠，再加入其余氨基酸原料，搅拌至溶解；
(5)补充注射用水到注射液总体积，搅拌均匀；
(6)加入1:1的醋酸和磷酸调节pH值，并测量注射液pH值；
(7)充氮灌装灭菌得成品。
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