CN106466316A - 治疗糖蛋白相关疾病的医药组合物 - Google Patents
治疗糖蛋白相关疾病的医药组合物 Download PDFInfo
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Abstract
本发明提供一种治疗糖蛋白相关疾病的医药组合物及方法，其中该医药组合物包括：一第一有效剂量的苯酚红；以及一第二有效剂量的有机砷化合物。
Description
技术领域
本发明提供一种治疗糖蛋白相关疾病的医药组合物及方法，尤指一种以苯酚红及有机砷化合物治疗糖蛋白相关疾病的医药组合物及方法。
背景技术
目前临床上对于病毒疾病的治疗，大多以支持疗法为主，亦即使用输液疗法、补充营养等恢复体力增强免疫力，同时投予广效抗生素预防续发性感染，而疾病是否能够痊愈则视自身的免疫力而定。
蛇毒的治疗必须区分出血性蛇毒或神经性蛇毒，施以抗蛇毒生物血清中和毒性，产生免疫力并搭配抗生素，伤口红肿治疗时间超过7日以上。
朊毒体毒蛋白感染，如牛海绵状脑病变、羊骚痒症、贾库氏症，是脑细胞的糖分子与蛋白质糖化作用造成细胞代谢异常，导致蛋白质变性成感染性蛋白，大量的糖蛋白、淀粉蛋白沉淀堆积引起的神经病变。目前无任何有效药物治疗与预防。
至于昆虫及爬虫类毒蛋白感染，则为被蚊、蜂、蝎、蜘蛛、蜈蚣、蚁、隐翅虫等叮螫皮肤后，将注入有毒蛋白质感染人类与动物，轻则造成皮肤红肿、过敏、骚痒、发炎，重则发烧，同时扮演病毒媒介、带原者，将隶属黄病毒科(Flaviviridae)、黄病毒属(Flavivirus)下登革热病毒、西尼罗河病毒(West Nile virus)、寨卡病毒(Zika virus)等传染人类与动物。
至于异常病变的细胞，包括眼球细胞病变、脑细胞病变、细胞新陈代谢病变。其中眼球细胞病变的白内障，是由于眼球水晶体细胞构造糖分子与蛋白质糖化作用，因中老年退化、异常代谢造成类纤维蛋白堆积沉淀产生白内障膜，造成视觉障碍模糊，目前治疗上采取手术摘取、激光，无法完全避免疼痛、失明风险及手术费用高。眼球细胞病变的视网膜病变，则是视网膜的纤维膜、脉络膜感光细胞糖分子与蛋白质糖化作用，导致退化引起视力减退，一般建议补充维他命A、叶黄素等保健措施，无积极治疗效果，令医界束手无策。
此外，脑细胞病变的阿兹海默症则是脑细胞糖分子与蛋白质糖化作用，导致细胞代谢异常病变，糖蛋白、淀粉蛋白，沉淀堆积引起的老人失智、失忆、退化等造成的痴呆症状，目前医学上无法有效预防及治疗。帕金森氏症则是脑神经细胞的糖分子与蛋白质糖化作用，导致代谢异常病变、神经退化，淀粉蛋白、纤维蛋白，沉淀堆积引起的帕金森氏症，造成慢性的神经症状，目前医学上无法预防及有效治疗。
再者，细胞新陈代谢病变之胰脏炎则为胰脏细胞的糖分子与蛋白质糖化作用，致细胞异常代谢、退化，糖蛋白、淀粉蛋白沉淀堆积，造成胰脏肿胀、急慢性炎症、胰脏纤维化，医学上常归类为不明原因，靠自体免疫力，无有效药物治疗。肾脏炎为肾细胞的糖分子与蛋白质糖化作用，致细胞异常代谢、退化，纤维蛋白沉淀堆积，造成肾脏肿胀、急慢性炎症、肾脏纤维化，医学上常归类为不明原因，无有效药物治疗。肝炎、胆管炎则为肝细胞的糖分子与蛋白质糖化作用，致细胞异常代谢、糖蛋白、淀粉蛋白沉淀堆积，造成肝脏、胆管肿大、肿胀发炎、肝脏纤维化，医学上常归类为猛爆型肝炎、急性肝炎、胆管炎或不明原因，无有效药物治疗。
有鉴于此，目前急需发展一种治疗前述疾病的有效药物。
发明内容
本发明提供一种治疗糖蛋白相关疾病的方法，其包括：提供一第一有效剂量的苯酚红及一第二有效剂量的有机砷化合物至一所需主体。
本发明更提供一种治疗一所需主体的糖蛋白相关疾病的医药组合物，包括：一第一有效剂量的苯酚红及一第二有效剂量的有机砷化合物。
再者，本发明亦提供一种医药组合物用于制备治疗糖蛋白相关疾病药物的用途，其中该医药组合物包括：一第一有效剂量的苯酚红及一第二有效剂量的有机砷化合物。
在本发明中，通过合并使用苯酚红及有机砷化合物，而可抑制病原体中糖分子与蛋白质的作用，并抑制蛋白质的糖化作用。
苯酚红目前已知用于酸碱指示剂、诊断用药；而砷化合物曾经用于治疗梅毒、补血剂、除草剂、杀虫剂。
当苯酚红(Phenol Red)与有机砷化合物(Organic Arsenic compound)合并使用时，可抑制、阻碍病原体(如蛇毒蛋白、朊毒体毒蛋白、昆虫毒蛋白、爬虫类毒蛋白、病毒、及异常病变的细胞)糖分子(如糖、淀粉、及纤维素)与蛋白质、核酸、酶合成代谢糖化作用的途径，进而抑制病原体所引起的疾病与病变。因此，苯酚红与有机砷化合物合并使用可用来治疗或预防脊椎动物及哺乳动物的病毒感染(包括具有不同结构、形态的DNA及RNA病毒)、蛇毒蛋白感染(包括出血性蛇毒、及神经性蛇毒)、朊毒体毒蛋白感染(包括牛海绵状脑病变、羊骚痒症、及贾库氏症)、昆虫毒蛋白感染(包括蚊、蜂、蝎、蜘蛛、蜈蚣、蚁、隐翅虫毒蛋白感染)、爬虫类毒蛋白感染、异常眼球细胞病变(包括白内障、及视网膜)、异常脑细胞病变(包括阿兹海默症、及帕金森氏症)、以及细胞新陈代谢病变(包括胰脏炎、肾脏炎、肝炎、及胆管炎)。
在本发明中，当使用苯酚红与有机砷化合物的医药组合物时，合并使用的治疗效果比使用单一有机砷化合物更有效，且用途更广。此外，在本发明中，实验结果更证实，本发明的医药组合物针对多种不同类型病原体所导致的不同疾病均能展现良好疗效。其原因在于，活性成分能与病原体的糖蛋白受体结合，进入病原体蛋白质体，并框住蛋白颗粒；进而改变蛋白颗粒生化性状，使其失去活性与作用力。因此，病原体在宿主细胞内合成代谢无法进行，无法聚合连接氨基酸合成蛋白质结构的化学作用，导致病原体无法进行糖化作用，于是结构改变、变性凋亡，阻断合成、复制、分化的化学机制。因此，当使用本发明的医药组合物时，能够抑制阻碍病原体的糖分子(糖、淀粉、纤维素)与蛋白质、核酸、酶合成代谢糖化作用的途径，进而抑制病原体所引起的疾病与病变。
此外，本发明医药组合物中的苯酚红更可作为有机砷化合物(如甲砷酸钠)的安定剂。
在本发明中，苯酚红更可作为有机砷化合物可合并成单一制剂、或者分开成两个制剂使用。
在本发明中，有机砷化合物可选自由甲砷酸钠(monosodium methanearsonate)、甲基砷酸(methylarsonic acid)、二甲基砷酸钠(sodium dimethylarsonate)、甲基砷酸二钠(disodium methylarsonate)、二甲基砷酸(cacodylic acid)及甲基砷酸钙(calciumacid methanearsonate)所组成的群组。
在本发明中，苯酚红的分子量为354，而CAS No.为143-74-8。甲砷酸钠的分子量为162，而CAS No.为2163-80-6。
在本发明中，糖蛋白相关疾病可由各种病毒所造成。在此，将美国国家生物技术信息中心(National Center for Biotechnology Information)病毒分类列举如下：
科：Retroviridae(反转录病毒科)
亚科：Orthoretrovirinae(正反转录病毒亚科)
属：Alpharetrovirus(α反转录病毒属)
种：Avian leukosis virus(禽白血病病毒)
属：Betaretrovirus(β反转录病毒属)
种：Jaagsiekte sheep retrovirus(绵羊肺腺瘤反转录病毒)
属：Deltaretrovirus(δ反转录病毒属)
种：Bovine leukemia virus(牛白血病病毒)
种：Primate T-lymphotropic virus 1(灵长类T淋巴细胞病毒1)
种：Primate T-lymphotropic virus 2(灵长类T淋巴细胞病毒2)
种：Primate T-lymphotropic virus 3(灵长类T淋巴细胞病毒3)
属：Gammaretrovirus(γ反转录病毒属)
种：Feline leukemia virus(猫白血病病毒)
种：Gibbon ape leukemia virus(GALV)(长臂猿白血病病毒)
种：Porcine type-C oncovirus(猪C型肿瘤病毒)
属：Lentivirus(慢病毒属)
种：Bovine immunodeficiency virus(牛免疫缺陷病毒)
种：Equine infectious anemia virus(马传染性贫血病毒)
种：Feline immunodeficiency virus(猫免疫缺陷病毒)
种：Human immunodeficiency virus 1(人类免疫缺陷病毒1)
种：Human immunodeficiency virus 2(人类免疫缺陷病毒2)
种：Puma lentivirus(彪马慢病毒)
种：Simian immunodeficiency virus(猴免疫缺陷病毒)
种：Visna/maedi virus(维斯纳/梅迪病毒)
亚科：Spumaretrovirinae(泡沫反转录病毒亚科)
属：Spumavirus(泡沫反转录病毒属)
种：African green monkey simian foamy virus(非洲绿猴猿泡沫病毒)
种：Bovine foamy virus(牛泡沫病毒)
种：Equine foamy virus(马泡沫病毒)
种：Feline foamy virus(猫泡沫病毒)
种：Macaque simian foamy virus(猕猴泡沫病毒)
种：Simian foamy virus(猴泡沫病毒)
科：Parvoviridae(细小病毒科)
亚科：Parvovirinae(细小病毒亚科)
属：Aveparvovirus(AVE细小病毒属)
种：Chicken parvovirus(鸡细小病毒)
种：Chicken parvovirus ABU-P1(鸡细小病毒ABU-P1)
种：Gallus gallus enteric parvovirus(鸡内金肠道细小病毒)
种：Turkey parvovirus 260(火鸡细小病毒260)
属：Bocaparvovirus(博卡病毒属)
种：Pinniped bocaparvovirus 1(鳍足类动物博卡细小病毒1)
种：Pinniped bocaparvovirus 2(鳍足类动物博卡细小病毒2)
种：Primate bocaparvovirus 1(灵长类动物博卡细小病毒1)
种：Primate bocaparvovirus 2(灵长类动物博卡细小病毒2)
种：Ungulate bocaparvovirus 1(有蹄类动物博卡细小病毒1)
种：Ungulate bocaparvovirus 2(有蹄类动物博卡细小病毒2)
种：Ungulate bocaparvovirus 3(有蹄类动物博卡细小病毒3)
种：Ungulate bocaparvovirus 4(有蹄类动物博卡细小病毒4)
种：Ungulate bocaparvovirus 5(有蹄类动物博卡细小病毒5)
属：Copiparvovirus(复制细小病毒属)
种：Ungulate copiparvovirus 1(有蹄类动物细小病毒复制1)
种：Ungulate copiparvovirus 2(有蹄类动物细小病毒复制2)
属：Erythroparvovirus(红细小病毒属)
种：Primate erythroparvovirus 1(灵长类动物赤细小病毒1)
种：Primate erythroparvovirus 2(灵长类动物赤细小病毒2)
种：Primate erythroparvovirus 3(灵长类动物赤细小病毒3)
种：Primate erythroparvovirus 4(灵长类动物赤细小病毒4)
种：Ungulate erythroparvovirus 1(有蹄类动物赤细小病毒1)
属：Protoparvovirus(原细小病毒属)
种：Canine parvovirus(犬细小病毒)
种：Feline panleukopenia virus(猫瘟病毒)(193株)
种：Porcine parvovirus(猪细小病毒)
属：Tetraparvovirus(四细小病毒属)
种：Primate tetraparvovirus 1(灵长类第四细小病毒1)
种：Ungulate tetraparvovirus 1(有蹄类四细小病毒1)
种：Ungulate tetraparvovirus 2(有蹄类四细小病毒2)
种：Ungulate tetraparvovirus 3(有蹄类四细小病毒3)
种：Ungulate tetraparvovirus 4(有蹄类四细小病毒4)
Family：Paramyxoviridae(副粘病毒科)
亚科：Paramyxovirinae(副粘病毒亚科)
属：Avulavirus(鸟类德国麻疹病毒属)
种：Avian paramyxovirus 2(禽副粘病毒2)
种：Avian paramyxovirus 3(禽副粘病毒3)
种：Avian paramyxovirus 4(禽副粘病毒4)
种：Avian paramyxovirus 5(禽副粘病毒5)
种：Avian paramyxovirus 6(禽副粘病毒6)
种：Avian paramyxovirus 7(禽副粘病毒7)
种：Avian paramyxovirus 8(禽副粘病毒8)
种：Avian paramyxovirus 9(禽副粘病毒9)
种：Avian paramyxovirus 10(禽副粘病毒10)
种：Avian paramyxovirus 11(禽副粘病毒11)
种：Avian paramyxovirus 12(禽副粘病毒12)
种：Newcastle disease virus(新城病毒)
属：Henipavirus(亨尼巴病毒属)
种：Hendra virus(亨尼巴病毒)
种：Nipah virus(尼帕病毒)
属：Morbillivirus(麻疹病毒属)
种：Canine distemper virus(犬瘟热病毒)
种：Measles virus(麻疹病毒)
种：Rinderpest virus(牛瘟病毒)
属：Respirovirus(呼吸道病毒属)
种：Bovine parainfluenza virus 3(牛副流感病毒3)
种：Human parainfluenza virus 1(人副流感病毒1)
种：Human parainfluenza virus 3(人副流感病毒3)
种：Porcine parainfluenza virus 1(猪副流感病毒1)
种：Sendai virus(仙台病毒)
属：Rubulavirus(德国麻疹病毒属)
种：Human parainfluenza virus 2(人副流感病毒2)
种：Human parainfluenza virus 4(人副流感病毒4)
种：Mapuera virus(马普埃拉病毒)
种：Mumps virus(腮腺炎病毒)
种：Parainfluenza virus 5(副流感病毒5)
种：Porcine rubulavirus(猪腮腺炎病毒)
种：Simian virus 41(猿猴病毒41)
亚科：Pneumovirinae(肺炎病毒亚科)
属：Metapneumovirus(间质肺炎病毒属)
种：Avian metapneumovirus(禽肺炎病毒)
种：Human metapneumovirus(人类偏肺炎病毒)
属:Orthopneumovirus(正肺炎病毒属)
种：Bovine respiratory syncytial virus(牛呼吸道融合病毒)
种：Human respiratory syncytial virus(人呼吸道融合病毒)
种：Murine pneumonia virus(小鼠肺炎病毒)
属：Pneumovirus(肺炎病毒属)
种：Canine pneumovirus(犬肺炎病毒)
种：Feline pneumovirus(猫肺炎病毒)
种：Human respiratory syncytial virus A(人呼吸道融合病毒A)
种：Human respiratory syncytial virus B(人呼吸道融合病毒B)
种：Human respiratory syncytial virus S2(人呼吸道融合病毒S2)
种：Human respiratory syncytial virus strain RSS-2(人呼吸道融合病毒RSS-2)
种：Human respiratory syncytial virus MinA(人呼吸道融合病毒MinA)
种：Human respiratory syncytial virus MinB(人呼吸道融合病毒MinB)
种：Human respiratory syncytial virus MinFLC(人呼吸道融合病毒MinFLC)
种：Human respiratory syncytial virus MinL(人呼吸道融合病毒MinL)
种：Ovine respiratory syncytial virus(牛呼吸道融合病毒)
种：Pneumovirus dog/Ane4/USA/2008(肺炎病毒狗/Ane4/USA/2008)
种：Pneumovirus dog/Brne17/USA/2008(肺炎病毒狗/Brne17/USA/2008)
种：Pneumovirus HFR-2013(肺炎病毒HFR-2013)
种：Respiratory syncytial virus type A(呼吸道融合病毒A型)
Family：Coronaviridae(冠状病毒科)
亚科：Coronavirinae(冠状病毒亚科)
属：Alphacoronavirus(α冠状病毒属)
种：Canine coronavirus(犬冠状病毒)
种：Feline coronavirus(猫冠状病毒)
种：Human coronavirus 229E(人类冠状病毒229E)
种：Human coronavirus NL63(人类冠状病毒NL63)
种：Porcine epidemic diarrhea virus(猪流行性腹泻病毒)
种：Transmissible gastroenteritis virus(猪传染性胃肠炎病毒)
属：Betacoronavirus(β冠状病毒属)
种：Bovine coronavirus(牛冠状病毒)
种：Canine respiratory coronavirus(犬呼吸道冠状)
种：Equine coronavirus(马冠状病毒)
种：Human coronavirus OC43(人类冠状病毒OC43)
种：Porcine hemagglutinating encephalomyelitis virus(猪凝血性脑脊髓炎病毒)
种：Human coronavirus HKU1(人类冠状病毒HKU1)
种：Human coronavirus type 5(人类冠状病毒5型)
种：Middle East respiratory syndrome coronavirus(中东呼吸道综合症)
种：Severe acute respiratory syndrome-related coronavirus(严重急性呼吸道症候群相关的冠状病毒)
属：Deltacoronavirus(δ冠状病毒属)
种：Porcine coronavirus HKU15(猪冠状病毒HKU15)
属：Gammacoronavirus(γ冠状病毒属)
种：Duck coronavirus(鸭冠状病毒)
种：European turkey coronavirus 080385d(欧洲火鸡冠状病毒080385d)
种：Goose coronavirus(鹅冠状病毒)
种：Infectious bronchitis virus(传染性支气管炎病毒)
种：Pheasant coronavirus(雉冠状病毒)
种：Pigeon coronavirus(鸽子冠状病毒)
种：Turkey coronavirus(火鸡冠状病毒)
亚科：Torovirinae(托罗病毒亚科)
属：Torovirus(托罗病毒属)
种：Bovine torovirus(牛曲状病毒)
种：Equine torovirus(马曲状病毒)
种：Human torovirus(人类曲状病毒)
种：Porcine torovirus(猪曲状病毒)
科：Herpesviridae(疱疹病毒科)
亚科：Alphaherpesvirinae(α疱疹病毒亚科)
属：Iltovirus(传染性喉气管炎病毒属)
种：Gallid herpesvirus 1(禽疱疹病毒1)
种：Psittacid herpesvirus 1(鹦鹉疱疹病毒1)
属：Mardivirus(马立克病毒属)
种：Anatid herpesvirus 1(鸭疱疹病毒1)
种：Columbid herpesvirus 1(鸽疱疹病毒1)
种：Gallid herpesvirus 2(禽疱疹病毒2)
种：Gallid herpesvirus 3(禽疱疹病毒3)
种：Meleagrid herpesvirus 1(Turkey herpesvirus)
(火鸡疱疹病毒1(火鸡疱疹病毒))
属：Simplexvirus(单纯疱疹病毒属)
种：Bovine herpesvirus 2(牛疱疹病毒2)
种：Human herpesvirus 1(Herpes simplex virus type 1)
(人类疱疹病毒1(单纯疱疹病毒1型))
种：Human herpesvirus 2(人类疱疹病毒2)
种：Macacine herpesvirus 1(monkey B virus)
(猴疱疹病毒1(猴B病毒))
属：Varicellovirus(水痘病毒属)
种：Bovine herpesvirus 1(牛疱疹病毒1)
种：Bovine herpesvirus 5(牛疱疹病毒5)
种：Canid herpesvirus 1(犬科动物疱疹病毒1)
种：Caprine herpesvirus 1(goat herpesvirus)
(山羊疱疹病毒1(山羊疱疹病毒))
种：Equid herpesvirus 1(Equine herpesvirus 1)
(马科动物疱疹病毒1(马疱疹病毒1))
种：Equid herpesvirus 3(马科动物疱疹病毒3)
种：Equid herpesvirus 4(Equine herpesvirus 4)
(马科动物疱疹病毒4(马疱疹病毒4))
种：Equid herpesvirus 8(马科动物疱疹病毒8)
种：Equid herpesvirus 9(马科动物疱疹病毒9)
种：Felid herpesvirus 1(猫科动物疱疹病毒1)
种：Human herpesvirus 3(Varicella-zoster virus)
(人疱疹病毒3(水痘-带状疱疹病毒))
种：Suid herpesvirus 1(Pseudorabies virus)
(猪疱疹病毒1(假性狂犬病毒))
亚科：Betaherpesvirinae(β疱疹病毒亚科)
属：Cytomegalovirus(巨细胞病毒属)
种：Aotine herpesvirus 1(夜猴疱疹病毒1)
种：Cebine herpesvirus 1(犬疱疹病毒1)
种：Human herpesvirus 5(Human cytomegalovirus)
(人类疱疹病毒5(人巨细胞病毒))
种：Macacine herpesvirus 3(Rhesus cytomegalovirus)
(猴疱疹病毒3(恒河猴巨细胞病毒))
种：Panine herpesvirus 2(Chimpanzee cytomegalovirus)
(黑猩猩疱疹病毒2(黑猩猩巨细胞病毒))
属：Proboscivirus(长鼻动物病毒属)
种：Elephantid herpesvirus 1(大象疱疹病毒1)
属：Roseolovirus(玫瑰疹病毒属)
种：Human herpesvirus 6A(人类疱疹病毒6A)
种：Human herpesvirus 6B(人类疱疹病毒6B)
种：Human herpesvirus 7(人类疱疹病毒7)
亚科：Gammaherpesvirinae(γ疱疹病毒亚科)
属：Lymphocryptovirus(淋巴潜伏病毒属)
种：Human herpesvirus 4(Epstein-Barr virus)
(人类疱疹病毒4(Epstein-Barr病毒))
属：Macavirus(马卡病毒属)
种：Bovine herpesvirus 6(牛疱疹病毒6)
种：Caprine herpesvirus 2(山羊疱疹病毒2)
种：Ovine herpesvirus 2(羊疱疹病毒2)
属：Percavirus(马疱疹病毒属)
种：Equid herpesvirus 2(Equine herpesvirus 2)
(马科动物疱疹病毒2(马疱疹病毒2))
种：Equid herpesvirus 5(马科动物疱疹病毒5)
属：Rhadinovirus(猴病毒属)
种：Bovine herpesvirus 4(牛疱疹病毒4)
种：Human herpesvirus 8(人类疱疹病毒8)
在本发明中，可更对该所需主体使用一医药上可接受的载体。因此，本发明的一药物组合物更可包括一医药上可接受的载体。其中，该医药上可接受的载体可选自由溶剂、缓冲液(如，磷酸盐缓冲生理盐水(phosphate buffered saline,PBS)、林格氏液(Ringer’ssolution)以及汉克氏溶液(Hank’s solution))、悬浮剂、分解剂、崩解剂、分散剂、黏结剂、安定剂、螯合剂、稀释剂、胶凝剂、防腐剂、润滑剂、吸收延迟剂以及脂质体所组成的群组。
在本发明中，医药组合物可利用熟习此技艺者所详知的技术而被制造成医疗药品，这包括但不限于：注射品(例如，无菌的水性溶液或分散液)、无菌的粉末、锭剂、片剂、贴剂、口含锭、胶囊、分散性粉末或细颗粒、溶液、悬浮液、乳剂、糖浆、酏剂、浓浆以及类似之物。
在本发明中，“治疗”一词意指对一具有前述疾病、此疾病症状或患病倾向的患者施用苯酚红及有机砷化合物，以赋予治疗效果的目的，如治愈、缓解、改变、影响、改善或预防上述疾病、其症状或患病倾向。
在本发明中，“第一或第二有效剂量”一词意指赋予被治疗的患者治疗效果所需的苯酚红或有机砷化合物的含量。视治疗的疾病类型、给药的路径、赋形剂的使用及其他共同使用的试剂的可能性，所属技术领域具有通常知识者可确认并变化有效剂量。
在本发明中，苯酚红及有机砷化合物可以通过本技术领域已知的方法投药，例如：非经肠道途径来投药、腹膜内注射、皮下注射、肌肉内注射以及静脉内注射。较佳为，苯酚红及有机砷化合物系通过静脉内或肌肉内注射方式投药。
在本发明中，苯酚红及有机砷化合物的投药剂量与投药次数会视下列因素而变化：要被治疗的疾病的严重性，投药途径，以及要被治疗的主体之年龄、身体状况与反应。一般而言，依据本发明的医药品的每日投药剂量通常是依照主体体重，且可以单一剂量或是分成数个剂量的形式投药，只要苯酚红及有机砷化合物是同时投药或在几分钟内投药即可。
在本发明中，苯酚红的第一有效剂量并无特殊限制，可根据疾病的严重程度作调整。较佳地，第一有效剂量为每公斤的该所需主体提供0.1mg至5.0mg。更佳地，第一有效剂量为每公斤的该所需主体提供0.5mg至1.5mg。
在本发明中，有机砷化合物的第二有效剂量也无特殊限制，可根据疾病的严重程度作调整。较佳地，第二有效剂量为每公斤的该所需主体提供0.1mg至10.0mg。更佳地，第二有效剂量为每公斤的该所需主体提供0.8mg至2.0mg。
在本发明中，当苯酚红配制成溶液形式时，第一有效剂量可为0.1mg/cc至5.0mg/cc，且较佳为0.8mg/cc至3.0mg/cc。当有机砷化合物配制成溶液形式时，第二有效剂量为0.1mg/cc至10.0mg/cc，且较佳为2.0mg/cc至6.0mg/cc。
附图说明
图1为实施例1的感染猫免疫缺陷病毒治疗期间白血球数量变化图。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚明白，以下结合具体实施例，并参照附图，对本发明作进一步的详细说明。
在往后的实施例中，将使用包含苯酚红(2mg/cc)及甲砷酸钠(4mg/cc)的溶液；而后称之为“LuMC5”。此外，并使用仅包含甲砷酸钠(4mg/cc)的溶液；而后称之为“MASA”。必须注意的是，在下述实施例中，仅提供本发明的其中一种医药组合物配方。本技术领域者均了解，活性成分的浓度及医药组合物中的各成分，可在不偏离本发明申请专利范围下进行调整。
实施例1
在此，选用与HIV同科(反转录病毒科(Retroviridae))同属(慢病毒属(Lentivirus))的猫免疫缺陷病毒(feline immunodeficiency virus(FIV))来进行临床实验。LuMC5是通过静脉或肌肉内注射投药至被感染的猫，每公斤注射0.4cc，每日1至2次。结果如下表1及图1所示。
表1.感染猫免疫缺陷病毒治疗期间血液细胞检验数据(检测公司为LEZENReference Lab)
NEU：嗜中性粒细胞(Neutrophils)/LYM：淋巴细胞(Lymphocytes)/MONO：单核细胞(Monocytes)/EOSI：噬酸性粒细胞(Eosinophils)/BASO：嗜碱性粒细胞(Basophils)/Hg：红血球(Hemoglobin)/HCT：血容积比(Hematocrit)/
如表1及图1结果所示，FIV感染的猫在第3天时免疫细胞快速回升，不会发展出后天免疫缺陷症所造成的艾滋病症出现，如弓浆虫症、真菌性肺囊炎、肿瘤等发生。经治疗后，FIV感染的猫成为一个健康的带原者。
此外，治疗FIV感染的猫投药期4-14天即可，4-14天即侦测不到病毒。因此，可等待高病毒量时阶段性投药控制即可，不用长期投药，而破坏自体免疫系统。
因此，以LuMC5组合物治疗FIV感染主体，不会发展出后天免疫缺陷症的艾滋病出现，同时可抑制弓浆虫、真菌性肺囊炎等并发症发生，达到治疗及预防的双重效果。
实施例2
在本实施例中，使用MSMA及LuMC5二种药物治疗感染病毒的脊椎动物及哺乳动物。在此，选用5个病毒科别下的7种病毒来进行临床活体实验；其中，病毒分类依据美国国家生物技术信息中心为依据。
实验对象：台湾惠明兽医院就诊的猫狗
临床实验的7种病毒：
科：Retroviridae(反转录病毒科)
属：Gammaretrovirus(γ反转录病毒属)
种：Feline leukemia virus(猫白血病病毒)
属:Lentivirus(慢病毒属)
种：Feline immunodeficiency virus(猫免疫缺陷病毒)
科：Parvoviridae(细小病毒科)
种：Canine parvovirus(犬细小病毒)
种：Feline panleukopenia virus(猫瘟病毒)
科：Paramyxoviridae(副粘病毒科)
属：Morbillivirus(麻疹病毒属)
种：Canine distemper virus(犬瘟热病毒)
科：Coronaviridae(冠状病毒科)
属：Alphacoronavirus(α冠状病毒科)
种：Feline coronavirus(猫冠状病毒)
科：Herpesviridae(疱疹病毒科)
属：Varicellovirus(水痘病毒属)
种：Felid herpesvirus 1(猫科动物疱疹病毒1)
治疗方式：静脉或肌肉注射每公斤0.4cc每日1-2次
检测公司：Genomics BioSci&TechCo.,Ltd.(简称G公司)
MountainVet Biotech Co.,Ltd.(简称M公司)
VETE Co.,Ltd.(简称V公司)
LEZEN Reference Lab(简称L公司)
检测规格：G&M公司是使用实时定量PCR检测系统(real-time quantitative PCRdetecting system)(灵敏度(sensitivity)>99％)，V公司是使用PCR或RT-PCR方式。
检测方法：检测目标基因为猫免疫不全病毒的长链末端重复(LTR)基因(longterminal repeat(LTR)gene)、犬细小病毒的病毒蛋白2(VP2)基因(virus protein 2(VP2)gene)、犬瘟热病毒的核鞘蛋白基因(nucleocapsid gene,N gene)等。病毒的含量是利用将所得到的PCR产物的循环阈值(cycle threshold(Ct)value)根据预先已具有不同已知浓度的标准品相对于它们的循环阈值所作出的一标准曲线而被计算出。
7种病毒临床实验成果如下表2-1至2-7所示。
表2-1.猫白血病病毒(Feline leukemia virus)临床实验成果：
表2-2.猫免疫缺陷病毒(feline immunodeficiency virus)临床实验成果：
表2-3.犬细小病毒(canine parvovirus)临床实验成果：
表2-4.猫瘟病毒(feline panleukopenia virus)临床实验成果：
表2-5.犬瘟热病毒(canine distemper virus)临床实验成果：
表2-6.猫冠状病毒(feline coronavirus)临床实验成果：
表2-7.猫科动物疱疹病毒1(felid herpesvirus 1)临床实验成果：
*a：“+”意指有检测到病毒。
*b：“-”意指没有检测到病毒。
*c：受试动物未定量侦测。
●：表示并未受病原感染或病原极其微量。
在本实施例中，MSMA投药期4～14日(平均9天)，而LuMC5投药期3～9日(平均5.7天)。当以静脉、肌肉、皮下点滴注射MSMA或LuMC5，3-5小时退烧、精神状态转好，检体的病毒量2～5日内大幅度下滑至微量，5～8日由微量至侦测不到病毒。感染症状迅速改善。
实施例3
在本实施例中，使用LuMC5治疗感染出血性蛇毒蛋白与神经性蛇毒蛋白的哺乳动物。
实验对象：台湾惠明兽医院就诊的猫狗
治疗方式：静脉或肌肉注射每公斤0.4cc每日1-2次
本实施例之临床实验成果如下表3-1至3-3所示。
表3-1.感染龟壳花蛇毒(出血性蛇毒)临床实验成果：
表3-2.感染赤尾青竹丝蛇毒(出血性蛇毒)临床实验成果：
表3-3.感染眼镜蛇蛇毒(神经性蛇毒)临床实验成果：
由本实施例的结果可知，当以静脉、肌肉、皮下点滴注射LuMC5治疗被感染主体时，10分钟内解除流鼻血及浓稠口水，30分钟内解除精神抑郁，50分解除血尿，1-36小时内陆续解除肿胀并恢复健康。因此，使用本发明的LuMC5可完美控制病情。相较于注射生物血清制剂中和毒素，其需7-14天产生抗体细胞吞噬毒蛋白颗粒而7天以后才消肿，本发明的LuMC5可在短时间内舒缓症状而能产生优异的治疗效果。
实施例4
在本实施例中，使用LuMC5治疗哺乳动物被蚊、蜂、蝎、蜘蛛、蜈蚣、蚁、隐翅虫叮咬。
实验对象：台湾惠明兽医院就诊的被蜂叮咬的狗，体重：27Kg
治疗方式：静脉或肌肉注射，每公斤0.4cc每日2次
治疗结果如下表4-1所示。
表4-1
治疗结果显示，治疗后精神好转、食欲恢复，尾巴摇摆活动力正常。
实验对象：被蚊子叮咬的人类，体重：79Kg
治疗方式：以LuMC5涂抹皮肤叮咬处，1日1-2次
治疗结果系如下表4-2所示。
表4-2
由本实施例的结果显示，LuMC5可有效解除蚊虫毒蛋白引起皮肤搔痒肿胀。如果被病媒蚊叮上，立刻涂上LuMC5滴剂，将抑制病毒蛋白糖化作用。此外，对于严重蛋白质过敏、造成发烧及倦怠可以注射LuMC5解除不适应症；对于疫区病毒带原蚊叮咬皮肤，立即涂上药膏或滴剂于患部消肿。因此，本发明的LuMC5可有效预防及减轻登革热病毒、西尼罗河病毒(West Nile virus)、寨卡病毒(Zika virus)等传染人类与动物。
实施例5
在本实施例中，使用LuMC5治疗哺乳动物眼球细胞病变引起的白内障、视网膜病变。
实验对象：台湾惠明兽医院就诊的猫狗
治疗方式：含有1-2mg/cc的苯酚红及3-4mg/cc的甲砷酸钠眼药水，每日2-3次，每次1滴
结果如下表5-1及表5-2所示。
表5-1.博美犬白内障临床治疗成果：
表5-2.黄金猎犬白内障临床治疗成果：
实施例6
在本实施例中，使用LuMC5治疗哺乳动物细胞新陈代谢病变(包括胰脏炎、肾脏炎、肝炎、胆管炎)。
实验对象：台湾惠明兽医院就诊的猫狗
治疗方式：静脉或肌肉注射，每公斤 0.4cc每日1次
检测公司：LEZEN Reference Lab(简称L公司)
结果如下表6-1至6-4所示。
表6-1
表6-2.狗(编号160714)于治疗期间血液检验数据
表6-3
表6-2.狗(编号160805)于治疗期间血液检验数据
由前述实施例5及6结果所示，当治疗眼球细胞病变(如白内障、视网膜)时，只需用LuMC5制成的眼药水定时定量点眼使用即可。当治疗脑细胞病变(如阿兹海默症、帕金森氏症)，只需用LuMC5制成外用贴剂或药膏于定点定时定量使用，可经由颈动脉皮肤血管吸收进入脑部达到预防病发、病变之效果。当治疗细胞新陈代谢病变(如胰脏炎、肾脏炎、肝炎、胆管炎)时，可以静脉、肌肉、皮下点滴连续5-7日注射LuMC5，即有效解除肿胀发炎。
实施例7
当治疗PRION毒蛋白感染(如牛海绵状脑病变、羊骚痒症、人类贾库氏症)时，可以LuMC5制成外用贴剂或药膏于定点定时定量使用，可经由颈动脉皮肤血管吸收进入脑部达到预防病发的效果。
以上所述的具体实施例，对本发明的目的、技术方案和有益效果进行了进一步详细说明，应理解的是，以上所述仅为本发明的具体实施例而已，并不用于限制本发明，凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (20)
1.一种治疗一所需主体的糖蛋白相关疾病的医药组合物，包括：
一第一有效剂量的苯酚红；以及
一第二有效剂量的有机砷化合物。
2.根据权利要求1所述的医药组合物，其中该有机砷化合物选自由甲砷酸钠、甲基砷酸、二甲基砷酸钠、甲基砷酸二钠、二甲基砷酸和甲基砷酸钙所组成的群组。
3.根据权利要求1所述的医药组合物，其中该所需主体为脊椎动物。
4.根据权利要求3所述的医药组合物，其中该所需主体为哺乳动物。
5.根据权利要求1所述的医药组合物，其中该糖蛋白相关疾病为病毒感染、蛇毒蛋白感染、朊毒体感染、昆虫毒蛋白感染、爬虫类毒蛋白感染或异常病变的细胞。
6.根据权利要求5所述的医药组合物，其中该糖蛋白相关疾病为病毒感染、出血性蛇毒蛋白感染、神经性蛇毒蛋白感染、牛海绵状脑病变、羊骚痒症、贾库氏症、蚊毒蛋白感染、蜂毒蛋白感染、蝎毒蛋白感染、蜘蛛毒蛋白感染、蜈蚣毒蛋白感染、蚁毒蛋白感染、隐翅虫毒蛋白感染、白内障、视网膜、阿兹海默症、帕金森氏症、胰脏炎、肾脏炎、肝炎或胆管炎。
7.根据权利要求1所述的医药组合物，其中该糖蛋白相关疾病由反转录病毒科、细小病毒科、副粘病毒科、冠状病毒科或疱疹病毒科的病毒所造成。
8.根据权利要求7所述的医药组合物，其中该糖蛋白相关疾病是由正反转录病毒亚科、泡沫反转录病毒亚科、细小病毒亚科、副粘病毒亚科、肺炎病毒亚科、冠状病毒亚科、托罗病毒亚科、α疱疹病毒亚科、β疱疹病毒亚科、或γ疱疹病毒亚科的病毒所造成。
9.根据权利要求8所述的医药组合物，其中该糖蛋白相关疾病是由α反转录病毒属、β反转录病毒属、δ反转录病毒属、γ反转录病毒属、慢病毒属、泡沫反转录病毒属、AVE细小病毒属、博卡病毒属、复制细小病毒属、红细小病毒属、原细小病毒属、四细小病毒属、鸟类德国麻疹病毒属、亨尼巴病毒属、麻疹病毒属、呼吸道病毒属、德国麻疹病毒属、间质肺炎病毒属、正肺炎病毒属、肺炎病毒属、α冠状病毒属、β冠状病毒属、δ冠状病毒属、γ冠状病毒属、托罗病毒属、传染性喉气管炎病毒属、马立克病毒属、单纯疱疹病毒属、水痘病毒属、巨细胞病毒属、长鼻动物病毒属、玫瑰疹病毒属、淋巴潜伏病毒属、马卡病毒属、马疱疹病毒属或猴病毒属的病毒所造成。
10.根据权利要求9所述的医药组合物，其中该糖蛋白相关疾病是由禽白血病病毒、绵羊肺腺瘤反转录病毒、牛白血病病毒、灵长类T淋巴细胞病毒1、灵长类T淋巴细胞病毒2、灵长类T淋巴细胞病毒3、猫白血病病毒、长臂猿白血病病毒、猪C型肿瘤病毒、牛免疫缺陷病毒、马传染性贫血病毒、猫免疫缺陷病毒、人类免疫缺陷病毒1、人类免疫缺陷病毒2、彪马慢病毒、猴免疫缺陷病毒、维斯纳/梅迪病毒、非洲绿猴猿泡沫病毒、牛泡沫病毒、马泡沫病毒、猫泡沫病毒、猕猴泡沫病毒、猴泡沫病毒、鸡细小病毒、鸡细小病毒ABU-P1、鸡内金肠道细小病毒、火鸡细小病毒260、鳍足类动物博卡细小病毒1、鳍足类动物博卡细小病毒2、灵长类动物博卡细小病毒1、灵长类动物博卡细小病毒2、有蹄类动物博卡细小病毒1、有蹄类动物博卡细小病毒2、有蹄类动物博卡细小病毒3、有蹄类动物博卡细小病毒4、有蹄类动物博卡细小病毒5、有蹄类动物细小病毒复制1、有蹄类动物细小病毒复制2、灵长类动物赤细小病毒1、灵长类动物赤细小病毒2、灵长类动物赤细小病毒3、灵长类动物赤细小病毒4、有蹄类动物赤细小病毒1、犬细小病毒、猫瘟病毒、猪细小病毒、灵长类第四细小病毒1、有蹄类四细小病毒1、有蹄类四细小病毒2、有蹄类四细小病毒3、有蹄类四细小病毒4、禽副粘病毒2、禽副粘病毒3、禽副粘病毒4、禽副粘病毒5、禽副粘病毒6、禽副粘病毒7、禽副粘病毒8、禽副粘病毒9、禽副粘病毒10、禽副粘病毒11、禽副粘病毒12、新城病毒、亨尼巴病毒、尼帕病毒、犬瘟热病毒、麻疹病毒、牛瘟病毒、牛副流感病毒3、人副流感病毒1、人副流感病毒3、猪副流感病毒1、仙台病毒、人副流感病毒2、人副流感病毒4、马普埃拉病毒、腮腺炎病毒、副流感病毒5、猪腮腺炎病毒、猿猴病毒41、禽肺炎病毒、人类偏肺炎病毒、牛呼吸道融合病毒、人呼吸道融合病毒、小鼠肺炎病毒、犬肺炎病毒、猫肺炎病毒、人呼吸道融合病毒A、人呼吸道融合病毒B、人呼吸道融合病毒S2、人呼吸道融合病毒RSS-2、人呼吸道融合病毒MinA、人呼吸道融合病毒MinB、人呼吸道融合病毒MinFLC、人呼吸道融合病毒MinL、牛呼吸道融合病毒、肺炎病毒狗/Ane4/USA/2008、肺炎病毒狗/Brne17/USA/2008、肺炎病毒HFR-2013、呼吸道融合病毒A型、犬冠状病毒、猫冠状病毒、人类冠状病毒229E、人类冠状病毒NL63、猪流行性腹泻病毒、猪传染性胃肠炎病毒、牛冠状病毒、犬呼吸道冠状、马冠状病毒、人类冠状病毒OC43、猪凝血性脑脊髓炎病毒、人类冠状病毒HKU1、人类冠状病毒5型、中东呼吸道综合症、严重急性呼吸道症候群相关的冠状病毒、猪冠状病毒HKU15、鸭冠状病毒、欧洲火鸡冠状病毒080385d、鹅冠状病毒、传染性支气管炎病毒、雉冠状病毒、鸽子冠状病毒、火鸡冠状病毒、牛曲状病毒、马曲状病毒、人类曲状病毒、猪曲状病毒、禽疱疹病毒1、鹦鹉疱疹病毒1、鸭疱疹病毒1、鸽疱疹病毒1、禽疱疹病毒2、禽疱疹病毒3、火鸡疱疹病毒、牛疱疹病毒2、人类疱疹病毒1、人类疱疹病毒2、猴疱疹病毒1、牛疱疹病毒1、牛疱疹病毒5、犬科动物疱疹病毒1、山羊疱疹病毒1、马科动物疱疹病毒1、马科动物疱疹病毒3、马科动物疱疹病毒4、马科动物疱疹病毒8、马科动物疱疹病毒9、猫科动物疱疹病毒1、人疱疹病毒3、猪疱疹病毒1、夜猴疱疹病毒1、犬疱疹病毒1、人类疱疹病毒5、猴疱疹病毒3、黑猩猩疱疹病毒2、大象疱疹病毒1、人类疱疹病毒6A、人类疱疹病毒6B、人类疱疹病毒7、人类疱疹病毒4、牛疱疹病毒6、山羊疱疹病毒2、羊疱疹病毒2、马科动物疱疹病毒2、马科动物疱疹病毒5、牛疱疹病毒4或人类疱疹病毒8的病毒所造成。
11.根据权利要求1所述的医药组合物，更包括一医药上可接受的载体。
12.根据权利要求11所述的医药组合物，其中该医药上可接受的载体选自由溶剂、缓冲液、悬浮剂、分解剂、崩解剂、分散剂、黏结剂、安定剂、螯合剂、稀释剂、胶凝剂、防腐剂、润滑剂、吸收延迟剂以及脂质体所组成的群组。
13.根据权利要求1所述的医药组合物，其中该第一有效剂量为每公斤的该所需主体提供0.1mg至5.0mg。
14.根据权利要求13所述的医药组合物，其中该第一有效剂量为每公斤的该所需主体提供0.5mg至1.5mg。
15.根据权利要求1所述的医药组合物，其中该第一有效剂量为0.1mg/cc至5.0mg/cc。
16.根据权利要求15所述的医药组合物，其中该第一有效剂量为0.8mg/cc至3.0mg/cc。
17.根据权利要求1所述的医药组合物，其中该第二有效剂量为每公斤的该所需主体提供0.1mg至10.0mg。
18.根据权利要求17所述的医药组合物，其中该第二有效剂量为每公斤的该所需主体提供0.8mg至2.0mg。
19.根据权利要求1所述的医药组合物，其中该第二有效剂量为0.1mg/cc至10.0mg/cc。
20.根据权利要求19所述的医药组合物，其中该第二有效剂量为2mg/cc至6mg/cc。
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