CN1480134A - 氨基酸碘组合物及其制备方法和应用 - Google Patents
氨基酸碘组合物及其制备方法和应用 Download PDFInfo
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- CN1480134A CN1480134A CNA03139874XA CN03139874A CN1480134A CN 1480134 A CN1480134 A CN 1480134A CN A03139874X A CNA03139874X A CN A03139874XA CN 03139874 A CN03139874 A CN 03139874A CN 1480134 A CN1480134 A CN 1480134A
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- Prior art keywords
- amino acid
- iodine
- preparation
- methionine
- composition
- Prior art date
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Abstract
本发明涉及一种氨基酸碘组合物及其制备方法和应用,该组合物由作为活性成分的氨基酸碘、载体及辅料组成,其重量百分比组成如下:氨基酸碘0.1-90%,载体和辅料为余量。其制备方法包括:氨基酸碘溶于溶剂和/或助溶剂,再加入其它载体和/或辅料,经混制、精制、均质、造型,包装而成;制备温度20-110℃,制备压力1-10MPa。该组合物可用于制备防治包括艾滋病,SARS病,对虾白斑综合症,桃拉病毒病,草鱼出血病,口腔炎,咽炎,阴道炎,肿瘤,家禽的消化道病,滴虫病,球虫病,人类的消化道病患或碘缺乏症病害的药物。
Description
技术领域
本发明涉及一种新颖的氨基酸碘组合物。本发明还涉及该氨基酸碘组合物的制备方法。本发明还涉及该氨基酸碘组合物在制药领域中的应用。
背景技术
碘是必需的营养素之一,碘酊作为消毒杀菌剂已有164年的历史。碘化油作为诊断用药和补碘剂已载入中华人民共和国药典(2000版二部,961页)。聚乙烯吡咯烷酮碘(简称PVP-I),作为消毒防腐药也已载入中华人民共和国药典(2000版二部,996页)。碘酊和碘化油稳定性比较差,聚乙烯吡咯烷酮碘中的PVP不适合口服。
本发明是曾雄飞有关氨基酸氨基羧基络合碘,称作氨基酸碘络合物,中国专利申请号CN01114666.4,国际申请号PCT/CN01/01490,相关发明的改进,涉及其制剂、制备方法和在制药领域中的用途。
发明内容
本发明的目的在于针对现有技术的不足,提供一种稳定的氨基酸碘组合物。
本发明目的还在于提供所述氨基酸碘组合物的制备方法。
本发明目的还在于提供氨基酸碘组合物氨基酸碘组合物在制药中的应用。
本发明的氨基酸碘组合物,由作为活性成分的氨基酸碘、载体及辅料组成,其重量百分比组成如下:氨基酸碘0.1-90%,载体和辅料为余量。
氨基酸碘是氨基酸的氨基羧基络合碘,络合剂是简单氨基酸和/或多肽。
氨基酸碘是氨基酸的非离子态的氨基络合碘,络合剂是简单氨基酸和/或多肽。
载体和辅料是无机溶剂和/或有机溶剂,无机溶剂是水、盐酸、硫酸、磷酸其中一种或一种以上的混合物;有机溶剂是乙醇、乙二醇、丙三醇、乙酸、丙酸、丁酸、乳酸、二甲基亚砜、二甲基砜、苯甲醇其中一种或一种以上的混合物。
载体和辅料是阳离子表面活性剂、阴离子表面活性剂、两性离子表面活性剂或非离子表面活性剂;阳离子表面活性剂是烯酰胺乙基型烯基咪唑啉季铵化物、阳离子蛋白肽、十八烷基胺醋酸盐或油酸三异丙醇胺酯;阴离子表面活性剂是烷基酚聚氧乙烯醚磷酸酯、磺基琥珀酸酯4910或多元醇磷酸酯;两性离子表面活性剂是烷基酰胺丙基甜菜碱、氨基酸类咪唑啉表面剂或氯化羟基磷酸酯十二叔胺酯铵;非离子表面活性剂是AEO-8、聚氧乙烯壬基酚醚、聚氧乙烯月桂酸酯、斯盘60、斯盘80、吐温60、或吐温80。
载体和辅料是包括营养素类、无机盐、螯合盐、脂类、调味剂类、增香剂类、乳化增稠剂类、被膜剂类其中一种或一种以上的食品添加剂,营养素类是蛋氨酸、赖氨酸、精氨酸或甘氨酸;维生素类是维生素B1、维生素B2或肌醇;无机盐、螯合盐类是葡糖酸锌,葡糖酸亚铁,葡糖酸钙,氨基酸锌,氨基酸铜,氨基酸锰,氨基酸亚铁或氨基酸硒;脂类是油脂、大豆磷脂、卵磷脂、神经节苷脂或胆酸羊毛脂;分散剂是聚乙二醇;调味剂类是核糖核苷酸钙或甘草甜素;增香剂类是肉桂油、柠檬油、苯甲醇、尼泊金乙酯、苯氧乙醇、冰片或薄荷油;乳化增稠剂类是羟丙基纤维素、海藻酸、甲壳质、酪蛋白或明胶;被膜剂是蜂蜡、聚乙烯醇或石蜡油。
载体和辅料还包括食品和/或合成药物,食品是蜂蜜、白糖、红塘、蛋黄粉、蛋白粉、鱼精粉、海藻粉或海带粉;解热镇痛药是阿司匹林、萘普生或芬布芬;抗虫药是青蒿素或甲消唑;抗真菌药是酮康唑或咪康唑;抗过敏药类是氢化可的松、去氢可的松、苯海拉明或扑尔敏。
组成氨基酸碘组合物的络合剂为简单氨基酸和/或多肽,简单氨基酸是丙氨酸、精氨酸、天冬酰胺、天冬氨酸、胱氨酸、谷氨酰胺、谷氨酸、甘氨酸、组氨酸、异亮氨酸、亮氨酸、赖氨酸、甲硫氨酸、苯丙氨酸、脯氨酸、丝氨酸、苏氨酸、色氨酸、酪氨酸、或缬氨酸;多肽是由不同氨基酸残基组成的,所含氨基酸是脯氨酸、甘氨酸、天冬氨酸、精氨酸、赖氨酸、蛋氨酸、酪氨酸、谷酰氨酸、胱氨酸或组氨酸;多肽是甘精促皮质肽,丝赖促皮质肽,胸腺肽或HR多肽。所述的络合剂蛋氨酸和碘络合而成的氨基羧基络合碘,具有如下化学结构:
制备所述的氨基酸碘组合物的方法包括:氨基酸碘溶于溶剂和/或助溶剂,再加入其它载体和/或辅料,经混制、精制、均质、造型,包装而成;制备温度20-110℃,制备压力1-10MPa。
所述的氨基酸碘组合物在制备防治病害的药物中的应用,这些病害是艾滋病,SARS病,对虾白斑综合症,桃拉病毒病,草鱼出血病,口腔炎,咽炎,阴道炎,肿瘤,家禽的消化道病,滴虫病,球虫病,人类的消化道病患或碘缺乏症。
本发明是以氨基酸碘络合物为原料药,加入载体和辅料,制成可供外用的组合物(药剂),和/或口服的组合物(药剂),或注射组合物(剂)。载体和辅料可以是溶剂,表面活性剂,和/或食品添加剂,或其它有助于方便应用和/或增效的天然、合成的物质,如营养素,食品,和/或其它活性物质。
所述的氨基酸碘,如前述专利申请,是以碘分子为配位中心,络合剂氨基酸的氨基和羧基为络合位点,通过络合反应制成。络合剂可以是同种和/或不同种的氨基酸,和/或多肽,称作氨基酸氨基羧基碘,简称氨基酸碘。在氨基酸碘分子中,简单氨基酸分子对碘分子的克分子比例为20~2∶1。
所述的氨基酸碘,也可以是以碘分子为配位中心,络合剂氨基酸的氨基为络合位点,通过络合反应制成,络合剂可以是同种和/或不同种的氨基酸,和/或多肽,特称非离子氨基酸氨基碘。在非离子氨基酸氨基碘分子中,简单氨基酸分子对碘分子的克分子比例为1∶1至20∶1。
所述的碘可以是一般的碘分子,也可以是其放射性同位素。
作为活性物质的氨基酸碘,用AA表示氨基酸,I2表示碘分子,其络合位点是氨基和羧基时,反应通式为:
(I)其络合位点是氨基时,反应通式为:
(II)
以L-蛋氨酸(L-Met)为络合剂,制成蛋氨酸氨基羧基络合碘(METHIONINE AMINO-CARBOXYLIODINE COMPLEX),其反应式为:
所有其它的氨基酸或肽的氨基羧基络合碘,均具有类似于式(III)蛋氨酸碘那样的化学结构。表1是蛋氨酸碘络合物的主要元素含量(%)
表1
样品编号 | C | N | I |
02-0926 | 22.21 | 5.20 | 45.27 |
02-0928 | 22.13 | 5.11 | 45.19 |
02-0930 | 22.34 | 5.14 | 46.49 |
观察均值 | 22.23±0.10 | 5.15±0.05 | 45.65±0.73 |
理论值 | 21.75 | 5.07 | 45.96 |
相对误差 | +2.2 | +1.6 | -0.67 |
以氨基酸碘络合物为原料药加入载体和辅料可制成不同剂型的药物:氨基酸碘消毒剂、氨基酸碘口服液、氨基酸碘粉、氨基酸碘散、氨基酸碘颗粒、氨基酸碘胶囊、氨基酸碘丸剂、氨基酸碘片剂、氨基酸碘栓剂、氨基酸碘注射液、氨基酸碘气雾剂、氨基酸碘膏和氨基酸碘食品。
蛋氨酸是动物体的必需氨基酸,由它络合而成的蛋氨酸氨基羧基络合碘是制备上述氨基酸碘药剂的首选原料药,成为消毒、杀菌、抗感染性病害、碘营养补剂的新剂型。
蛋氨酸可以是左旋(L),或消旋(DL)氨基酸。
氨基酸碘,主要以蛋氨酸碘为活性物的组合物(剂型),由下列各类物质组成通用配方:(以下皆为重量百分比)
(1)氨基酸碘 0.1-40
(2)溶剂 1-80
(3)表面活性剂 0.0-40
(4)食品添加剂 0.0-30
(5)食品 0.0-50
(6)其它载体或辅料 0.0-25
氨基酸碘组合物的通用制备方法是,氨基酸碘溶于溶剂和/或助溶剂,再加入其它载体和/或辅料,经混制、精制、均质、造型,包装而成;制备温度20-110℃,制备压力1-10MPa。
上述的氨基酸碘组合物可以用于制备防治病害的药物,这些病害是艾滋病,SARS病,对虾白斑综合症,桃拉病毒病,草鱼出血病,口腔炎,咽炎,阴道炎,肿瘤,家禽的消化道病,滴虫病,球虫病,人类的消化道病患或碘缺乏症。
本发明与现有技术相比具有如下的优点:
1.由于氨基酸碘是由营养素组成,使它成为高度安全的药物,并使药物具有营养功能,又更有利于保护环境;
2.氨基酸碘组合物,提供了综合给药途径的药剂,外用、内服和注射剂,全方位防治病原体对人类健康的危害,因而提高了防治病患的有效性。
3.氨基酸碘是一种以碘分子为配位中心的氨羧络合物,具有良好的稳定性,是非离子型的物质,又通过组合物的稀释、均化,对病原体有高度的亲和性,因而成为能兼杀病毒、病菌和原虫的三高杀手。
4.氨基酸碘组合物消毒剂(有效碘5%),只需一滴,稀释200-1000倍,几乎能杀灭一切病毒、病菌和滴虫等原虫,无毒害、无刺激、无残留,因而成为全民健康的家庭护士,将提高全民的健康水平,及时消除可能的病患,显著降低用药费用,降低资源的消耗。
5.提升和扩大了碘的用途。在养殖业、种植业、医疗卫生、营养药物等方面都将广为应用。护卫人类的健康和绿色产业。
下面,通过典型的实施例,详细说明氨基酸碘组合物的配方及其制造方法。
具体实施方式实施例1氨基酸碘消毒剂配方及其制备方法。
AAI-1-01(样品编号,以下同)
蛋氨酸碘(含有效碘45%) 50g
甘油 25g
苯甲酸钠 3g
聚氧乙烯壬基酚醚(7E0) 150g
磷酸 30g
水 1000ml
其制法:取氨基酸碘与甘油混合均匀后加热,边加热边搅拌,至85℃时停止加热,加入蒸馏水400ml,依次加入苯甲酸钠、聚氧乙烯壬基酚醚(7EO)和600ml蒸馏水,充分搅拌均匀后,冷却即得。
AAI-1-02
蛋氨酸碘(含有效碘45%) 100g
乙醇 50g
聚氧乙烯月桂酸酯(9EO) 200g
盐酸 15g
斯盘60 25g
水 1000ml
制备方法与上同。实施例2 氨基酸碘酊剂配方及其制备方法。
AAI-1-03
蛋氨酸碘(含有效碘45%) 160g
咪唑啉 150g
冰片 3g
乙醇 550ml
蒸馏水 1000ml
其制法:取氨基酸碘与乙醇混合均匀后加热,边加热边搅拌,至85℃时停止加热,加入冰片,溶解后,放冷至室温后,加入乙醇和水,搅拌均匀即得。
实施例3 氨基酸碘含漱液处方及其制备方法
AAI-1-04
蛋氨酸碘(含有效碘45%) 0.8g
甘油 35g
吐温-80 0.1g
磷酸 1g
蒸馏水 1000ml
制法:将磷酸与吐温-80研磨混匀后,加入甘油、蛋氨酸碘搅拌均匀,最后加入蒸馏水稀释至全量,搅匀即得。实施例4 氨基酸碘口服液配方及其制备方法。
AAI-2-01
蛋氨酸碘(含有效碘45%) 100g
蔗糖 50g
枸橼酸 5g
苯甲酸钠 2g
尼泊金乙酯 0.5g
蒸馏水 1000ml
制法:将蔗糖与枸橼酸用300ml蒸馏水溶解后,加入蛋氨酸碘混合均匀,再依次加入苯甲酸钠、尼泊金乙酯,再加入700ml的蒸馏水,充分搅拌均匀后,静置2小时后过滤,分装,灭菌即得。
AAI-2-02配方
蛋氨酸碘(含有效碘45%) 20g
乙酸 10g
乙醇 50g
蒸馏水 1000ml
制法:常温常压下按顺序溶解,静置2小时后过滤,分装,灭菌即得。
AAI-2-03配方
蛋氨酸碘(含有效碘45%) 5g
甘氨酸碘 5g
乙酸 10g
乙醇 30g
蒸馏水 1000ml
制法:常温常压下按顺序溶解,静置2小时后过滤,分装,灭菌即得。实施例5 氨基酸碘粉配方及其制备方法。
AAI-3-01配方
蛋氨酸碘(含有效碘45%) 50g
蛋氨酸 70g
赖氨酸 60g
柠檬酸 40g
蛋白粉加至 780g制法:常温常压下按顺序混合,粉碎后过号筛,分装,灭菌即得。
AAI-3-02配方
蛋氨酸碘(含有效碘45%) 20g
甘氨酸铁 15g
蛋氨酸 35g
赖氨酸 15g
蛋白粉 915g制法:常温常压下按顺序混合,粉碎后过号筛,分装,灭菌即得。
AAI-3-03配方
蛋氨酸碘(含有效碘45%) 5g
精氨酸碘 20g
蛋氨酸 10g
赖氨酸 5g
阳离子蛋白肽(QHC) 3g
蛋白粉 957g制法:常温常压下按顺序混合,粉碎后过号筛,分装,灭菌即得。AAI-3-04配方
蛋氨酸碘(含有效碘45%) 12g
蛋氨酸氨基碘 10g
蛋氨酸 25g
蛋白粉 953g制法:常温常压下按顺序混合,粉碎后过号筛,分装,灭菌即得。
AAI-3-05配方
蛋氨酸碘(含有效碘45%) 8g
板蓝根、杏仁、百合提取液 20g
蛋氨酸 5g
赖氨酸 7g
甘氨酸 15g
骨胶 945g制法:常温常压下按顺序混合,粉碎后过号筛,分装,灭菌即得。
AAI-3-06配方
蛋氨酸碘(含有效碘45%) 20g
阿司匹林 8g
蛋氨酸 40g
赖氨酸 5g
蛋白粉 927g制法:常温常压下按顺序混合,粉碎后过号筛,分装,灭菌即得。实施例6蛋甘氨酸碘口服液配方及其制备方法
AAI-2-03
蛋氨酸碘(含有效碘45%) 12g
乙酸 8g
蒸馏水 1000ml实施例7氨基酸碘粉配方及其制备方法。
AAI-3-01
蛋氨酸碘(含有效碘45%) 10g
蛋氨酸 70g
赖氨酸 6g
AAI-3-02
蛋氨酸碘(含有效碘45%) 12g
蛋氨酸 80g
赖氨酸 8g
AAI-3-03
蛋氨酸碘(含有效碘45%) 14g
蛋氨酸 75g
赖氨酸 7g
AAI-3-04
蛋氨酸碘(含有效碘45%) 18g
蛋氨酸 100g
AAI-3-05
蛋氨酸碘(含有效碘45%) 20g
蛋氨酸 90g
赖氨酸 10g
AAI-3-06
蛋氨酸碘(含有效碘45%) 20g
蛋氨酸 70g
赖氨酸 5g实施例8 氨基酸碘散配方及其制备方法。
AAI-4-01
蛋氨酸碘(含有效碘45%) 12g
赖氨酸 70g
卵磷脂 15g
骨粉 903g
AAI-4-02
氨基酸碘(含有效碘45%) 20g
冰片 2.5g
薄荷脑 2.5g
蛋白粉 975g
制法 取20g氨基酸碘与975g蛋白粉混合均匀后,以等量递增研配法加入冰片、薄荷脑,共研磨混匀后,过筛,分装即得。
AAI-4-03
蛋氨酸碘(含有效碘45%) 20g
蛋氨酸 100g
卵磷脂 8g
阿司匹林 6g
甲消唑 5g
蛋白粉 861g
制法:常温常压下按顺序混合,粉碎后过号筛,分装,灭菌即得。
AAI-4-04
蛋氨酸碘(含有效碘45%) 15g
赖氨酸 50g
卵磷脂 4g
烷基酰胺丙基甜菜碱 3g
蛋白粉 928g
制法:常温常压下按顺序混合,粉碎后过号筛,分装,灭菌即得。实施例9 氨基酸碘颗粒配方及其制备方法。
AAI-5-01
蛋氨酸碘(含有效碘45%) 16g
乙醇 10g
甲基纤维素 1g
糖粉 75g制法 取蛋氨酸碘与适量乙醇混匀至糊状,再加入到甲基纤维素、糖粉组分之中,充分搅拌均匀后,用1号筛制粒。60℃干燥,整粒,分装成每包10g即得。
AAI-5-02
蛋氨酸碘(含有效碘45%) 19g
赖氨酸 70g
卵磷脂 6g
乙醇 15g
甲基纤维素 9g
糖粉 60g
制法:取蛋氨酸碘与乙醇混匀至糊状,再加入到甲基纤维素、糖粉组分之中,充分搅拌均匀后,用1号筛制粒。60℃干燥,整粒,分装成每包10g即得。实施例10 氨基酸碘胶囊配方及其制备方法。
AAI-6-01处方
蛋氨酸碘(含有效碘45%) 18g
赖氨酸 80g
甲基纤维素 1g
硬脂酸镁 1g
制法:取蛋氨酸碘与赖氨酸混合均匀后,再混合甲基纤维素与硬脂酸镁,干燥,粉碎,过筛,装胶囊即得。
AAI-6-02
蛋氨酸碘(含有效碘45%) 4g
赖氨酸 70g
卵磷脂 7g
甘油 15g
硬脂酸镁 10g
蛋白粉 200g
制法:取蛋氨酸碘与赖氨酸混合均匀后,再混合甲基纤维素与硬脂酸镁,干燥,粉碎,过筛,装胶囊即得。
AAI-6-03
蛋氨酸碘(含有效碘45%) 19g
赖氨酸 70g
卵磷脂 9g
甘油 3g
天门冬氨酸锌 10g
甘氨酸铁 8g
骨粉 100g
制法 取蛋氨酸碘与赖氨酸混合均匀后,再混合其它各组分,干燥,粉碎,过筛,装胶囊即得。实施例10 氨基酸碘丸配方及其制备方法。
AAI-7-01
蛋氨酸碘(含有效碘45%) 15g
赖氨酸 80g
蜂蜜 10g
薄荷油 2g
制法:取蛋氨酸碘与赖氨酸混合均匀,低温干燥后粉碎成细粉,过筛,混匀。最后加入蜂蜜与薄荷油成丸,包装即得。
实施例11 氨基酸碘片剂配方及其制备方法。
AAI-8-01
蛋氨酸碘(含有效碘45%) 15g
赖氨酸 80g
酒石酸 2g
十二烷基硫酸钠 1g
羧甲基纤维素 1g
硬脂酸镁 1g
蛋白粉 30
制法:取蛋氨酸碘与赖氨酸混合均匀。将羧甲基纤维素加水适量,待其自然溶胀后搅拌均匀;取除硬脂酸镁以外的原、辅料,加入上述溶液制得软材,过16目筛制粒,烘干,过筛,整粒,最后加入硬脂酸镁混合,压片即得。实施例十二 氨基酸碘栓剂的处方及其制法。
AAI-9-01 处方
蛋氨酸碘(含有效碘45%) 100g
甘油 150g
聚乙二醇400 80g
聚乙二醇4000 80g
制法 按处方称取各药,热熔法制备栓剂500枚。实施例12 氨基酸碘注射液配方及其制备方法。
AAI-10-01 处方
蛋氨酸碘(含有效碘45%) 5g
氯化钠 9g
无水乙醇 5g
注射用水 1000ml
制法:取300ml注射用水,加入氯化钠搅拌均匀后,缓缓加入溶于无水乙醇的氨基酸碘,随加随搅拌,最后加入注射用水至全量,过滤,检测PH值及含量合格后灌封,100℃灭菌30min即得。
AAI-10-02
蛋氨酸碘(含有效碘45%) 16g
精氨酸碘 5g
卵磷脂 5g
赖氨酸 10g
卵磷脂 5g
乙二醇 10g
注射用水 1000ml
制法:取适量注射用水,依序加入各组分搅拌均匀后,随加随搅拌,最后加入注射用水至全量,过滤,检测PH值及含量合格后灌封,100℃灭菌30min即得。实施例13 氨基酸碘气雾剂配方及其制备方法。
AAI-11-01
氨基酸碘(含有效碘45%) 75g
甘油 50g
F12/F11 70g
丙二醇 5ml
蒸馏水 1000毫升
制法 取氨基酸碘与甘油混合均匀后加入其它溶剂,最后搅拌均匀即得。
AAI-11-02
蛋氨酸碘(含有效碘45%) 20g
赖氨酸 70g
十八烷基胺醋酸盐 8g
吐温80 10g
二氯甲烷 35ml
蒸馏水 1000ml
制法:取氨基酸碘溶于少量水,再混合其它溶剂,最后搅拌均匀即得。
AAI-11-03
蛋氨酸碘(含有效碘45%) 15g
赖氨酸 80g
薄荷油 10g
吐温80 8g
二氯甲烷 35ml
二甲基亚砜 10ml
水 1000ml
制法:取氨基酸碘溶于水,再混合其它溶剂,最后搅拌均匀即得。
AAI-11-04
蛋氨酸碘(含有效碘45%) 18g
赖氨酸 85g
磺基琥珀酸酯4910 7g
丁酸 8g
吐温80 10g
二氯甲烷 35g
蒸馏水 1000ml
制法:取氨基酸碘溶于水,再混合其它溶剂,最后搅拌均匀即得。实施例14 氨基酸碘膏的配方及其制备方法。
AAI-12-01软膏剂
蛋氨酸碘(含有效碘45%) 18g
白凡士林 140g
硬脂酸 150g
吐温-80 30g
甘油 75g
单硬脂酸甘油酯 60g
尼泊金乙酯 1g
蒸馏水 1000ml
制法:取白凡士林、硬脂酸、单硬脂酸甘油酯置水浴加热熔融至80℃,为油相;另取吐温-80、甘油、尼泊金乙酯溶于蒸馏水并加热至70℃,为水相。两相同温度时将油相缓缓加入到水相中,搅拌至60℃得基质备用。取氨基酸碘与10g甘油混匀成糊状,分次加入上述配好的乳剂基质中,边加边搅拌,至冷凝即得。实施例15 氨基酸碘食品的配方及其制备方法。
AAI-14-01
蛋氨酸碘(含有效碘45%) 10g
麦胚粉 880g
海藻粉 100g
乙醇 30ml
AA-14-02配方
蛋氨酸碘(含有效碘45%) 20g
麦胚粉 990g
海藻粉 100g
乙醇 30ml
制法:将氨基酸碘溶于食用乙醇,加热至45℃,待溶解后加入海藻粉,60℃驱除溶剂,然后与麦胚粉均匀混合,分装灭菌即得。
AAI-14-03
蛋氨酸碘(含有效碘45%) 10g
麦胚粉 900g
海藻粉 150g
乙醇 20ml
制备方法同上。
AAI-14-04
蛋氨酸碘(含有效碘45%) 20g
麦胚粉 950g
海藻粉 50g
乙醇 10ml
制备方法同上。实施例16 氨基酸碘搽剂的处方及其制备方法。
AAI-13-01配方
蛋氨酸碘(含有效碘45%) 20g
斯盘80 10g
丙酸 8g
二甲基砜 15ml
苯甲醇 5ml
乙醇 50ml
蒸馏水 1000ml
制法:取氨基酸碘溶于水,再混合其它溶剂,最后搅拌均匀即得。
AAI-13-02 配方
蛋氨酸碘(含有效碘45%) 10g
油酸三异丙醇胺酯 4g
氯化羟基磷酸酯十二叔胺酯铵 5g
乙醇 10ml
冰片 35ml
蒸馏水 1000ml
制法:取氨基酸碘溶于水,再混合其它溶剂,最后搅拌均匀即得。
AAI-12-03配方
蛋氨酸碘(含有效碘45%) 15g
水 80g
乙醇 10g
多元醇磷酸酯(PAPE) 8g
尼泊金乙酯 35g
制法:取氨基酸碘溶于水,再混合其它溶剂,最后搅拌均匀即得。
氨基酸碘食品的制备方法。
氨基酸碘的共同特性,是通过缓慢释放出碘分子,卤化病原体的蛋白质,达到杀灭病毒、病菌和滴虫。根据稳定性试验,40℃,1atm,开口条件下,氨基酸碘时均挥发量(μg/g.h)为:6.70,碘酊为436.5。氨基酸碘的稳定性为碘酊的65倍,有利于活性碘分子与病原体的密切接触,而更有效的杀灭病原体。通常,病毒或细菌的致病数量约在万个~百万个/ml之间。在上述条件下,氨基酸碘释放碘分子的数目为3.8万亿个/g,或38亿个/mg。因此氨基酸碘对病原体保有绝对优势的兵力。
氨基酸碘进行了广泛的病原体杀灭试验,包括病毒、细菌和滴虫。试验一:草鱼出血病毒杀灭试验
草鱼出血病毒强毒株稀释后与氨基酸碘稀释液等量混合,置4℃冰箱作用4h,而后人工感染健康草鱼:
氨基酸碘剂量(有效碘,μg/ml) 死亡率(%)
0 83.3
0.025 80
0.05 40
0.1 0
0.2 0
结果说明,氨基酸碘在有效碘≥0.1μg/ml,可杀灭草鱼出血病毒,使之失活。
试验二 口蹄疫病毒杀灭试验
口蹄疫病毒0.5ml 10000L D50剂量与氨基酸碘稀释液4.5ml混合5min,取其中1ml与中和剂9ml作用10min,皮下接种昆明小鼠,室温观察两周,小鼠死亡率:
氨基酸碘剂量(有效碘,μg/ml) 死亡率(%)
0 100
25 25
50 0
100 0
结果说明,氨基酸碘在有效碘≥50μg/ml,可杀灭口蹄疫病毒,使之失活。试验三 HIV病毒体外杀灭试验
方法:氨基酸碘液用无菌去离子水稀释成不同浓度的稀释液,0.5ml与0.5mlHIV-1悬液(105TCID50)分别作用1min,5min,10min,吸取0.2ml,加中和剂(1%硫代硫酸钠)0.1ml,室温下作用2min,加细胞培养液1ml,在96孔细胞培养板中测定病毒滴度。37℃(5%CO2)培养7天,逐日观察结果,以细胞病变作为病毒存在指标。
结果:不同浓度的氨基酸碘液对HIV的灭活效果
作用不同时间的平均感染滴度(TCID50)
试验分组
1min 5min 10min
氨基酸碘组
(有效碘,μg/ml)
50 <1.00 <1.00 <1.00
25 2.33 <1.00 <1.00
10 5.00 4.77 4.00
中和剂组 - - 6.50
中和产物组 - - 6.33
消毒剂组 - - <1.00
病毒对照 - - 6.77
说明:<1.00为未见细胞病变。
结果说明,氨基酸碘在有效碘≥25μg/ml,作用5min,可杀灭HIV病毒,使之失活。试验四:金黄葡萄球菌杀灭试验
方法:氨基酸碘用无菌蒸馏水稀释成不同浓度的稀释液;制作载样(菌)片,含菌量106CFU/片;中和剂为0.03mol PBS液,其中含0.1%卵磷脂,0.55吐温80,0.5%硫代硫酸钠。不同浓度的氨基酸碘液与菌片作用一定时间后,中和之,然后在35℃培养48h,作活菌菌落计数。
表2:不同浓度的氨基酸碘液对金黄葡萄球菌的杀灭率(%),对照:1.22·106cfu/片
试验说明,氨基酸碘有效碘100μg/ml,5min,金黄葡萄球菌99%以上将被杀灭;300μg/ml,1min,金黄葡萄球菌100%将被杀灭。试验五 大肠杆菌杀灭试验
作用时间(min) | 1 | 3 | 5 | 7 | |
有效碘量(μg/ml) | 300 | 100 | 100 | 100 | 100 |
150 | 96.0 | 99.5 | 100 | 100 | |
100 | 77.5 | 98.2 | 99.6 | 100 |
方法:类似试验四,大肠杆菌代替金黄葡萄球菌。
表3:不同浓度的氨基酸碘液对大肠杆菌的杀灭率(%),对照:9.98·105cfu/片
试验说明,氨基酸碘有效碘150μg/ml,5min,大肠杆菌99%以上将被杀灭;300μg/ml,5min,大肠杆菌100%将被杀灭试验六 氨基酸碘对淋球菌杀灭试验
作用时间(min) | 1 | 3 | 5 | 7 | |
有效碘量(μg/ml) | 300 | 99.8 | 99.9 | 100 | 100 |
150 | 81.0 | 94.0 | 99.9 | 99.9 | |
100 | 34.9 | 57.9 | 84.0 | 98.6 |
方法:氨基酸碘(有效碘5%)用无菌蒸馏水稀释成不同浓度的稀释液,稀释倍数分别为250;500;1000;1500;2000;5000;10000;每管0.9ml备用。
制备淋球菌盐水液。含菌106CFU/ml。分别取0.1ml菌液与上0.9m氨基酸碘液混合均匀后计时,作用时间(min)分别为:1;2;5;10;20。然后挑取一接种环该液接种到GC培养基上,置于含5%CO2的35℃培养箱孵育24-48h,观察结果。无菌水代替消毒液作对照。
表4:不同浓度的氨基酸碘液对淋球菌的灭活效果
氨基酸碘液浓度(稀释倍数) | 250 | 500 | 1000 | 1500 | 2000 | 5000 | 10000 | 对照 | |
作用时 | 1 | - | - | - | - | - | + | + | + |
2 | - | - | - | - | - | - | + | + | |
5 | - | - | - | - | - | - | + | + |
间(min) | 10 | - | - | - | - | - | - | + | + |
20 | - | - | - | - | - | - | + | + |
结果显示,淋球菌与5000倍氨基酸碘液(有效碘10μg/ml)作用2min即被杀灭。试验七 氨基酸碘杀灭支原体试验
方法、操作步骤和条件类似如试验六,用支原体代替淋球菌,接种到支原体培养基。
表5:不同浓度的氨基酸碘液对支原体的灭活效果
结果显示,淋球菌与2500倍氨基酸碘液(有效碘20μg/ml)作用2min即被杀灭。试验八 氨基酸碘杀灭化脓性链球菌试验
氨基酸碘液浓度(稀释倍数) | 250 | 500 | 1000 | 1500 | 2000 | 2500 | 对照 | |
作用时间(min) | 1 | - | - | - | + | + | + | + |
2 | - | - | - | - | - | - | + | |
5 | - | - | - | - | - | - | + | |
10 | - | - | - | - | - | - | + | |
20 | - | - | - | - | - | - | + |
方法、操作步骤和条件类似如试验六,用链球菌代替淋球菌,接种到血平板培养基。
表6:不同浓度的氨基酸碘液对化脓性链球菌的灭活效果
氨基酸碘液浓度(稀释倍数) | 250 | 500 | 1000 | 1500 | 2000 | 2500 | 对照 | |
作用时 | 1 | - | - | - | + | + | + | + |
2 | - | - | - | + | + | + | + | |
5 | - | - | - | + | + | + | + |
间(min) | 10 | - | - | - | - | + | + | + |
20 | - | - | - | - | - | + | + |
结果显示,化脓性链球菌与1000倍氨基酸碘液(有效碘50μg/ml)作用1min即被杀灭。
试验九 氨基酸碘杀灭须癣毛癣菌试验
方法、操作步骤和条件类似如试验六,用须癣毛癣菌代替淋球菌,接种到沙堡弱培养基上,25℃培养箱孵育4天。
表7:不同浓度的氨基酸碘液对须癣毛癣菌的灭活效果
氨基酸碘液浓度(稀释倍数) | 250 | 500 | 1000 | 1500 | 2000 | 2500 | 对照 | |
作用时间(min) | 1 | - | + | + | + | + | + | + |
2 | - | - | + | + | + | + | + | |
5 | - | - | + | + | + | + | + | |
10 | - | - | + | + | + | + | + | |
20 | - | - | + | + | + | + | + |
结果显示,须癣毛癣菌与500倍氨基酸碘液(有效碘100μg/ml)作用2min即被杀灭。试验十氨基酸碘杀灭阴道毛滴虫试验
方法、操作步骤和条件类似如试验六,用阴道毛滴虫代替淋球菌,接种到滴虫培养基上,34℃培养箱孵育4天。
表8:不同浓度的氨基酸碘液对阴道毛滴虫的灭活效果
氨基酸碘液浓度(稀释倍数) | 250 | 500 | 1000 | 1500 | 2000 | 对照 | |
作 | 1 | + | + | + | + | + | + |
用时间(min) | 2 | - | + | + | + | + | + |
5 | - | - | + | + | + | + | |
10 | - | - | + | + | + | + | |
20 | - | - | + | + | + | + |
结果显示,阴道毛滴虫与250倍氨基酸碘液(有效碘200μg/ml)作用2min即被杀灭。
此外,氨基酸碘对一些水体致病菌有很低的抑制浓度。如对柱状屈挠杆菌M165,MIC,抑制浓度为0.0125ppm;对弧菌E311和嗜水气单胞菌SX7,MIC抑制浓度为0.025ppm。
因此氨基酸碘是一把三刃剑:它是病毒、病菌和原虫的三高杀手。可以制成各种抗感染药品,抗病毒药,抗菌药,抗原虫药和抗肿瘤药物。
首先,可以制成抗病毒药品。一些重大的疑难病毒性病患,如艾滋病,必需采取三管齐下的方法,外用(涂抹、冲洗、漱口)、内服(口服液、散剂、胶囊,清理消化道,进入血液、体液)和静脉注射(杀灭血液中,体液中的病毒),最为有效。氨基酸碘制剂将提供安全、有效、全面的药物。
口腔炎、咽炎是一种高发病,主要是由细菌引起,试验已证明,氨基酸碘有明显的效果。氨基酸碘可以制成防治口腔炎、咽炎的药品。
阴道炎是妇科最常见的疾患。也是由细菌引起。用氨基酸碘制成的药品,冲洗剂、软膏、栓剂均有良效。
氨基酸碘的粉剂用于制作防治家禽的消化道病患、球虫病的药品。
氨基酸碘口服液、氨基酸碘胶囊用于制作防治人类的消化道病患的药品。
氨基酸碘口服液、氨基酸碘胶囊、氨基酸碘散用于制作防治人类的消化道病患的药品。
中国是实施全民加碘盐的国家,全世界大部分人都缺碘,氨基酸碘食品提供了补充碘的新途径。
Claims (11)
1、一种氨基酸碘组合物,其特征在于:该组合物由作为活性成分的氨基酸碘、载体及辅料组成,其重量百分比组成如下:氨基酸碘0.1-90%,载体和辅料为余量。
2、根据权利要求1所述的氨基酸碘组合物,其特征在于:氨基酸碘是氨基酸的氨基羧基络合碘,络合剂是简单氨基酸和/或多肽。
3、根据权利要求1所述的氨基酸碘组合物,其特征在于:氨基酸碘是氨基酸的非离子态的氨基络合碘,络合剂是简单氨基酸和/或多肽。
4、根据权利要求1或2或3所述的氨基酸碘组合物,其特征在于:载体和辅料是无机溶剂和/或有机溶剂,无机溶剂是水、盐酸、硫酸、磷酸其中一种或一种以上的混合物;有机溶剂是乙醇、乙二醇、丙三醇、乙酸、丙酸、丁酸、乳酸、二甲基亚砜、二甲基砜、苯甲醇其中一种或一种以上的混合物。
5、根据权利要求1或2或3所述的氨基酸碘组合物,其特征在于:载体和辅料是阳离子表面活性剂、阴离子表面活性剂、两性离子表面活性剂或非离子表面活性剂;阳离子表面活性剂是烯酰胺乙基型烯基咪唑啉季铵化物、阳离子蛋白肽、十八烷基胺醋酸盐或油酸三异丙醇胺酯;阴离子表面活性剂是烷基酚聚氧乙烯醚磷酸酯、磺基琥珀酸酯4910或多元醇磷酸酯;两性离子表面活性剂是烷基酰胺丙基甜菜碱、氨基酸类咪唑啉表面剂或氯化羟基磷酸酯十二叔胺酯铵;非离子表面活性剂是AEO-8、聚氧乙烯壬基酚醚、聚氧乙烯月桂酸酯、斯盘60、斯盘80、吐温60、或吐温80。
6、根据权利要求1或2或3所述的氨基酸碘组合物,其特征在于:载体和辅料是包括营养素类、无机盐、螯合盐、脂类、调味剂类、增香剂类、乳化增稠剂类、被膜剂类其中一种或一种以上的食品添加剂,营养素类是蛋氨酸、赖氨酸、精氨酸或甘氨酸;维生素类是维生素B1、维生素B2或肌醇;无机盐、螯合盐类是葡糖酸锌,葡糖酸亚铁,葡糖酸钙,氨基酸锌,氨基酸铜,氨基酸锰,氨基酸亚铁或氨基酸硒;脂类是油脂、大豆磷脂、卵磷脂、神经节苷脂或胆酸羊毛脂;分散剂是聚乙二醇;调味剂类是核糖核苷酸钙或甘草甜素;增香剂类是肉桂油、柠檬油、苯甲醇、尼泊金乙酯、苯氧乙醇、冰片或薄荷油;乳化增稠剂类是羟丙基纤维素、海藻酸、甲壳质、酪蛋白或明胶;被膜剂是蜂蜡、聚乙烯醇或石蜡油。
7、根据权利要求1或2或3所述的氨基酸碘组合物,其特征在于:载体和辅料还包括食品和/或合成药物,食品是蜂蜜、白糖、红塘、蛋黄粉、蛋白粉、鱼精粉、海藻粉或海带粉;解热镇痛药是阿司匹林、萘普生或芬布芬;抗虫药是青蒿素或甲消唑;抗真菌药是酮康唑或咪康唑;抗过敏药类是氢化可的松、去氢可的松、苯海拉明或扑尔敏。
8、根据权利要求2或3所述的氨基酸碘组合物,其特征在于:组成氨基酸碘组合物的络合剂为简单氨基酸和/或多肽,简单氨基酸是丙氨酸、精氨酸、天冬酰胺、天冬氨酸、胱氨酸、谷氨酰胺、谷氨酸、甘氨酸、组氨酸、异亮氨酸、亮氨酸、赖氨酸、甲硫氨酸、苯丙氨酸、脯氨酸、丝氨酸、苏氨酸、色氨酸、酪氨酸、或缬氨酸;多肽是由不同氨基酸残基组成的,所含氨基酸是脯氨酸、甘氨酸、天冬氨酸、精氨酸、赖氨酸、蛋氨酸、酪氨酸、谷酰氨酸、胱氨酸或组氨酸;多肽是甘精促皮质肽,丝赖促皮质肽,胸腺肽或HR多肽。
9、根据权利要求8所述的氨基酸碘组合物,其特征在于:所述的络合剂蛋氨酸和碘络合而成的氨基羧基络合碘,具有如下化学结构:
10、权利要求1~9中任意一项所述的氨基酸碘组合物的制备方法,其特征在于包括:氨基酸碘溶于溶剂和/或助溶剂,再加入其它载体和/或辅料,经混制、精制、均质、造型,包装而成;制备温度20-110℃,制备压力1-10MPa。
11、权利要求1~9中任意一项所述的氨基酸碘组合物在制备防治病害的药物中的应用,这些病害是艾滋病,SARS病,对虾白斑综合症,桃拉病毒病,草鱼出血病,口腔炎,咽炎,阴道炎,肿瘤,家禽的消化道病,滴虫病,球虫病,人类的消化道病患或碘缺乏症。
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