CN101400255A - 用于治疗细菌、病毒、真菌疾病、炎症以及疼痛的组合物 - Google Patents
用于治疗细菌、病毒、真菌疾病、炎症以及疼痛的组合物 Download PDFInfo
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Abstract
本发明涉及治疗细菌、病毒、真菌疾病；炎症或炎症相关病症；疼痛；和皮肤疾病的组合物和方法。该组合物包含有机溶剂萃取物，通过以下方法制备，所述方法包括以下步骤：(a)混合甲硫氨酸和水，(b)将次氯酸盐水溶液加入到甲硫氨酸溶液中并混合，(c)将与水不混溶的有机溶剂加入到(b)中并混合，以及(d)分离有机溶剂相和水相，以得到有机溶剂萃取物。
Description
技术领域
本发明涉及用于治疗细菌、病毒、真菌疾病；炎症或炎症相关病症；疼痛；和皮肤疾病的组合物和方法。该组合物可通过用有机溶剂萃取甲硫氨酸和次氯酸盐的反应产物来制备。
发明背景
人体易受到各种来源的许多不同类型感染的影响。病毒感染通常是普通感冒的形式，实际上每年都在影响所有人。虽然与感冒相关的咳嗽和打喷嚏可能仅仅是烦人的，但其他普通病毒感染可导致更加严重的后果。例如，在美国流感仍然是住院和死亡的主要原因，每年平均有36,000例死亡和114,000例住院。
细菌感染同样危险。葡萄球菌家族细菌所引起的葡萄球菌感染可导致许多严重的术后并发症。葡萄球菌感染也是食物中毒的主要元凶，可能导致危及生命的疾病如中毒性休克综合征(TSS)、肺炎、骨感染(骨髓炎)、哺乳期妇女的乳腺炎、心内膜炎(心脏内部感染)和菌血症(血液感染)。健康人体通常不会因为葡萄球菌感染而患上严重疾病，但免疫系统薄弱的个体，包括老人、新生儿以及慢性疾病患者，如糖尿病、癌症、肺病、肾病或HIV/AIDS患者则处于巨大风险中。
免疫系统薄弱的个体易受真菌感染。真菌感染在数以百万的人体中导致窦感染、脚癣和酵母感染等形式的疾病。
通用术语“疼痛”在本文中代表所有类型的疼痛，例如损伤导致的创伤性疼痛、术后疼痛、炎性疼痛；与诸如癌症、AIDS、关节炎、泡疹、偏头痛等疾病有关的疼痛；与神经病如糖尿病性神经病、灼痛、臂丛撕脱伤、枕骨神经痛、纤维肌痛、痛风以及其他形式的神经痛、神经病性和特发性疼痛综合征有关的疼痛；各种严重程度的疼痛，即轻度、中度和重度疼痛；急性和慢性疼痛；以及特定器官的疼痛，如眼睛和角膜疼痛、骨痛、心脏疼痛、皮肤/烧伤疼痛、内脏(肾、胆囊等)、关节、牙齿和肌肉疼痛。
结缔组织受到应力和损伤的不断干扰。急性或慢性冲击以及各种变性疾病的自然进程都会导致关节区域的疼痛炎症，这些区域包括颈部、背部、臂部、髋部、踝和脚。这些痛苦是普遍的，并且常常导致虚弱。
现有的疼痛治疗包括使用阿片类麻醉镇痛药如吗啡和芬太尼，非甾体抗炎药(NSAIDS)如阿司匹林、布洛芬和环加氧酶抑制剂，或离子通道阻滞剂如利多卡因和诺伐卡因(novacaine)。这些疗法都存在限制因素，例如它们可导致耐药性、依赖性、便秘、呼吸抑制和镇静(阿片类)。NSAIDS存在胃肠道副作用，增加出血时间并且不能有效治疗严重疼痛。
炎症是损伤导致的活组织局部反应，可由各种内源性和外源性因素引起。外源性因素包括物理、化学和生物因素。内源性因素包括炎性介质、抗原和抗体。内源性因素常常在外源性损伤的影响下发生。炎症反应常常伴随着细胞膜结构和渗透性的改变。在组织和器官水平，炎症表现为疼痛、肿胀、发红、温度升高、以及在一些情况下丧失功能。
炎症受到各种外源性和内源性物质的影响。内源性因素，即介质、抗原和自身抗原限定炎症反应的性质和类型，尤其是在损伤区中的病程中。在组织损伤限于产生介质的情况下，则发生急性炎症。如果该过程中还涉及免疫反应，通过抗原、抗体和自身抗原的相互作用，发生长期炎症过程。各种外源性试剂如感染、损伤、辐射也可通过破坏细胞膜，启动生物化学反应，导致分子水平炎症过程的病程。
非甾体抗炎药(NSAIDS)如阿司匹林可阻断炎症过程的某些链接，但这些药物不能稳定受损的细胞膜，使得它们对炎症过程的影响有限且不充分。
需要用于治疗细菌、病毒、真菌疾病；炎症或炎症相关病症；疼痛；和皮肤疾病的组合物和方法。该组合物应经济且容易制备，该方法应有效且没有明显的副作用。
发明概述
本发明涉及通过甲硫氨酸水溶液与次氯酸盐水溶液相互作用制备的有机溶剂萃取物，以及用与水不混溶的有机溶剂如矿物油来萃取反应产物。室温下，反应产物在与水不混溶的有机溶剂中稳定至少几个月。
本发明还涉及治疗细菌、病毒、真菌疾病；炎症或炎症相关病症；疼痛；或皮肤疾病的方法。该方法包括给予需要治疗的对象包含根据本发明制备的有机溶剂萃取物的组合物的步骤。该组合物可通过已接受的任何全身给药方式应用，包括外用、口服和胃肠外(例如静脉内、肌内、皮下或直肠给药)。优选外用给药和口服给药。
发明详述
本发明描述了适用于治疗各种疾病或病症的有机溶剂萃取物。通过以下方法制备有机溶剂萃取物，该方法包括以下步骤：(a)将甲硫氨酸与水混合，(b)将次氯酸盐水溶液加入到甲硫氨酸溶液中，在0℃到环境温度的温度范围内进行混合，(c)将与水不混溶的有机溶剂加入(b)中并混合，和(d)分离有机溶剂相与水相，得到有机溶剂萃取物。
有机溶剂萃取物的制备过程包括先制备反应产物，然后萃取到与水不混溶的有机溶剂中以稳定该反应产物。
反应产物的制备包括先将甲硫氨酸与水混合直到形成悬浮液。甲硫氨酸可以是L-甲硫氨酸、D-甲硫氨酸或其混合物。混合优选在惰性气体如氩气下进行。混合时间通常是几秒到几分钟。混合可通过任何混合方式进行，例如通过掺混仪。
将次氯酸盐如次氯酸钠的水溶液加入到甲硫氨酸溶液中并且充分混合。然后静置反应混合物直到混合物澄清，过多的甲硫氨酸在顶部形成泡沫。可任选地去除泡沫。反应在0℃到环境温度的温度范围内进行，优选低温如0-5℃。反应优选在惰性气体如氩气下进行。
反应产物在水中不稳定，因而用与水不混溶的有机溶剂萃取。适用于本发明的与水不混溶的有机溶剂优选是极性约为0.1-7.5的半极性或非极性溶剂，如矿物油、己烷、庚烷、二氯甲烷、植物油或乙酸乙酯。更优选非极性溶剂。甲硫氨酸/次氯酸盐反应后立即进行萃取，优选5分钟内，优选2分钟内，更优选1分钟内进行萃取。
让水-有机溶剂混合物沉降。通过任何技术人员已知的方法如倾倒或吸液从水相分离有机相，得到有机溶剂萃取物。任选地通过过滤、倾析、离心或技术人员已知的任何方式去除有机溶剂萃取物中的任何不溶性残留物。室温下(22-28℃)该反应产物在有机溶剂中稳定至少一个月，优选3个月，更优选6个月或一年。
在一典型的反应中，采用700-800毫升蒸馏水、20-100克甲硫氨酸和300-500毫升3-12％的次氯酸盐。在一典型的萃取过程中，使用约200-300毫升或更多与水不混溶的有机溶剂。上述反应试剂的量可按比例上调或下调。
本发明有机溶剂萃取物适用于治疗许多疾病或病症。有机溶剂萃取物可直接使用，或者可以药物组合物的形式给予，该组合物还包含药学上可接受的载体。在一个实施方式中，有机溶剂萃取物可掺入在任何可接受的载体中，包括能够稳定活性成分并且可通过外用应用而将活性成分递送至患病区域的乳膏、凝胶、洗剂或其他类型的悬浮液。在另一实施方式中，药物组合物可以是以下剂型，如片剂、胶囊、颗粒剂、细颗粒剂、粉末剂、糖浆剂、栓剂、注射剂等。上述药物组合物可通过常规方法制备。
在一个实施方式中，本发明提供了治疗细菌性疾病如葡萄球菌感染的方法。
在另一实施方式中，本发明提供了治疗病毒性疾病如流感感染的方法。
在另一实施方式中，本发明提供了治疗真菌性疾病如脚癣、酵母感染以及真菌感染引起的窦感染的方法。
在另一实施方式中，本发明提供了治疗皮肤疾病如烧伤或晒伤导致的皮肤损伤、皮肤色斑或疣突的方法。
在另一实施方式中，本发明提供了治疗炎症或炎症相关病症的方法。本发明缓解与炎症或炎症相关病症有关的症状，如疼痛、肿胀、发红、温度升高、或在一些情况下丧失功能。
在又一实施方式中，本发明提供了缓解疼痛症状而不论疼痛原因如何的方法。可用本发明方法治疗的一般术语“疼痛”包括创伤性疼痛、神经性疼痛、器官疼痛和与疾病相关的疼痛。创伤性疼痛包括损伤引起的疼痛、术后疼痛和炎性痛。神经性疼痛包括神经病性和特发性疼痛综合征、以及与神经病有关的疼痛如糖尿病性神经病、灼痛、臂丛撕脱伤、枕骨神经痛、纤维肌痛、痛风以及其他形式的神经痛。器官疼痛包括眼睛、角膜、骨、心脏、皮肤/烧伤、内脏(肾、胆囊等)、关节、牙齿和肌肉的疼痛。疾病相关疼痛包括与癌症、AIDS、关节炎、疱疹和偏头痛有关的疼痛。本发明能够缓解各种严重程度的疼痛，即轻度、中度和重度疼痛；急性和慢性疼痛。例如，本发明能有效治疗炎性关节炎或变性关节炎导致的疼痛、关节痛、肌肉疼痛、肌腱疼痛和烧伤疼痛。
本发明方法包括给予需要治疗的对象包含根据本发明制备的有机溶剂萃取物的组合物的步骤。本发明组合物可通过任何已接受的全身给药方式应用，包括外用、口服、胃肠外(例如静脉内、肌内、皮下或直肠)以及其他全身给药途径。组合物剂量可根据损伤程度及各个患者的个体响应而变化。优选外用给药和口服给药。
外用时，优选将该组合物应用于患病区域并摩擦渗透。该组合物可每天应用1-5次，优选每天1-3次，优选每天3次。活性化合物透过皮肤并被递送至不适部位。本领域技术人员将理解，除外用之外的许多递送机制如可摄入片剂、可摄入液体、吸入剂和气雾剂也可合适的。
下面的实施例进一步阐述本发明。这些实施例仅仅是为了阐述本发明而不应解释为限制性的。
实施例
实施例1.产物的制备
在掺混仪中合并720-750ml0-4℃的蒸馏水和20g DL甲硫氨酸细粉(新泽西州瑞奇费尔得帕克的德固赛公司(Degussa Corp.，Richfield Park，NJ)并在氩气下混合几秒钟。甲硫氨酸固体均匀悬浮在蒸馏水中之后，加入370-400ml0-4℃的次氯酸钠漂白剂(Clorox bleach)(6％次氯酸钠)并在氩气下以一定掺混速率混合30秒。将反应物静置30秒-1分钟，直到溶液澄清并在顶部形成泡沫。泡沫是过多的甲硫氨酸，任选地可去除。
立即(<2分钟)将溶液倾倒到萃取掺混仪中，室温下加入240ml矿物油(得克萨斯州圣麦克的STO油品公司(STO Oil Corp.，San Marcos，TX))，然后在氩气下以低速掺混20秒。
让水-油混合物沉降3-4小时，然后取出油相，通过20微米滤纸过滤。滤液储存在开口容器中3天以使氩气散逸，油滤液即可用作产物。
实施例2.肝毒性试验
在大鼠中进行实施例1产物的肝毒性体内评价。
对照组10只大鼠未进行处理，用于基线血清酶和组织学的对照分析。
第二组10只大鼠用标准盐水溶液每天强饲2次，以测定重复操作和强饲对肝的影响。
第三组25只大鼠单用矿物油每天强饲2次。
第四组25只大鼠用实施例1的产物每天强饲2次。
28天之后，麻醉这些大鼠并根据标准方法检测它们的肝。结果是，摄取实施例1的产物不会引起任何肝毒性征兆。
实施例3.感染的治疗
使用实施例1的产物治疗发生各种感染的对象。结果总结在表1中。
表1
| 对象 | 病症 | 应用方法 | 应用 | 结果 |
| 对象1 | 腿部葡萄球菌感染 | 外用 | 3个月 | 症状缓解 |
| 对象2 | 窦病症 | 外用 | 1周 | 症状缓解 |
实施例4.关节和肌肉疼痛的治疗
用实施例1的产物来治疗患关节痛、虫咬疼痛或烧伤疼痛的对象。结果总结在表2中。
表2
| 对象 | 病症 | 应用方法 | 缓解时间 |
| 对象1 | 髋关节疼痛 | 外用 | 立即 |
| 对象3 | 关节炎疼痛 | 外用 | 立即 |
| 对象4 | 背部/膝盖疼痛 | 外用 | 立即 |
| 对象5 | 膝盖疼痛 | 外用 | 立即 |
| 对象6 | 背部/膝盖疼痛 | 外用 | 立即 |
| 对象7 | 髋部疼痛 | 外用 | 立即 |
| 对象8 | 关节炎手 | 外用 | 立即 |
| 对象2 | 手部烧伤疼痛 | 外用 | 立即 |
| 对象1 | 虫咬疼痛 | 外用 | 立即 |
表2表明，在患有各种疼痛的对象中外用所述产物能立即缓解疼痛。
实施例5 伤口或损伤的治疗
将实施例1的产物每天3次外用于患烧伤或皮肤疾病的个体，如表3所示。应用该产物后，对象的症状得到缓解。
表3
| 对象 | 病症 | 应用方法 | 应用时间 |
| 对象1 | 烧伤 | 外用 | 3天 |
| 对象9 | 面部晒斑 | 外用 | 3个月 |
| 对象10 | 紫外线晒伤 | 外用 | 3天 |
| 对象11 | 皮肤晒伤 | 外用 | 2个月 |
| 对象12 | 皮肤晒伤 | 外用 | 2个月 |
| 对象13 | 面部皮肤出血 | 外用 | 2周 |
| 对象2 | 疣 | 外用 | 3周 |
| 对象14 | 腿部和脚步的糖尿病疮 | 外用 | 1周 |
现在以全面、清楚、简明且准确的方式描述了本发明及其制备和使用的方式和方法，使得本发明所属领域的任何技术人员能够制备和使用本发明。应理解，上文仅描述了本发明的优选实施方式，可进行改进而不会背离权利要求书所限定的本发明的范围。为具体指明和清楚要求本发明的主题，所附的权利要求书概括了说明书。
Claims (12)
1.一种通过包括以下步骤的方法制备的有机溶剂萃取物：
(a)混合甲硫氨酸和水，
(b)将次氯酸盐水溶液加入到(a)中并在0℃到环境温度的温度范围内混合，
(c)将与水不混溶的有机溶剂加入到(b)中并混合，以及
(d)分离有机溶剂相。
2.如权利要求1所述的有机溶剂萃取物，其特征在于，所述与水不混溶的有机溶剂是己烷、庚烷、二氯甲烷、矿物油、植物油或乙酸乙酯。
3.如权利要求2所述的有机溶剂萃取物，其特征在于，所述与水不混溶的有机溶剂是矿物油或己烷。
4.如权利要求1所述的有机溶剂萃取物，其特征在于，所述步骤(a)和(b)在惰性气体下进行。
5.如权利要求1所述的有机溶剂萃取物，其特征在于，所述甲硫氨酸是D-甲硫氨酸、L-甲硫氨酸或其混合物。
6.一种治疗对象细菌感染的方法，所述方法包括给予患有细菌感染的对象包含如权利要求1所述的有机溶剂萃取物的组合物的步骤。
7.一种治疗对象病毒感染的方法，所述方法包括给予患有病毒感染的对象包含如权利要求1所述的有机溶剂萃取物的组合物的步骤。
8.一种治疗对象真菌感染的方法，所述方法包括给予患有真菌感染的对象包含如权利要求1所述的有机溶剂萃取物的组合物的步骤。
9.一种治疗对象疼痛的方法，所述方法包括给予患有疼痛的对象包含如权利要求1所述的有机溶剂萃取物的组合物的步骤。
10.如权利要求9所述的方法，其特征在于，所述疼痛是关节痛、肌肉痛或烧伤疼痛。
11.一种治疗对象皮肤疾病的方法，所述方法包括将包含如权利要求1所述的有机溶剂萃取物的组合物外用于对象患病皮肤区域的步骤。
12.一种治疗对象炎症或炎症相关疾病的方法，所述方法包括给予患有炎症或炎症相关疾病的对象包含如权利要求1所述的有机溶剂萃取物的组合物的步骤。
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| BR (1) | BRPI0621416A2 (zh) |
| CA (1) | CA2645881A1 (zh) |
| DE (1) | DE602006018367D1 (zh) |
| MX (1) | MX2008011934A (zh) |
| WO (1) | WO2007108807A1 (zh) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109453194A (zh) * | 2018-11-21 | 2019-03-12 | 四川水喜宝科技发展有限公司 | 一种物理灭菌活化养目的中药组合物及组合套装 |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| JP5587969B2 (ja) * | 2009-03-18 | 2014-09-10 | オラテック インダストリーズ リミティド ライアビリティ カンパニー | 炎症及び疼痛の処置用の化合物 |
| EP2651407B1 (en) | 2010-12-15 | 2016-12-21 | Olatec Industries LLC | 3-methanesulfonylpropionitrile for treating inflammation and pain |
| AU2013271836B2 (en) * | 2012-06-05 | 2018-03-01 | Olatec Therapeutics Llc | Method for treating skin inflammatory diseases |
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| GB2106389B (en) * | 1981-07-16 | 1985-07-17 | Nat Res Dev | The inhibition of growth in fungi |
| US5053429A (en) * | 1988-04-08 | 1991-10-01 | The Lithox Corporation, Inc. | Treating inflammatory pain with methionine |
| US5084482A (en) * | 1990-04-10 | 1992-01-28 | The Lithox Corporation | Methods for inhibiting inflammatory ischemic, thrombotic and cholesterolemic disease response with methionine compounds |
| AU2003295579A1 (en) * | 2002-11-15 | 2004-06-15 | Regents Of The University Of California | Anti-microbial agents derived from methionine sulfoximine analogues |
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2006
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- 2006-03-20 DE DE602006018367T patent/DE602006018367D1/de active Active
- 2006-03-20 CN CN2006800539294A patent/CN101400255B/zh not_active Expired - Fee Related
- 2006-03-20 MX MX2008011934A patent/MX2008011934A/es not_active Application Discontinuation
- 2006-03-20 AU AU2006340367A patent/AU2006340367B2/en not_active Ceased
- 2006-03-20 JP JP2009501394A patent/JP5086331B2/ja not_active Expired - Fee Related
- 2006-03-20 CA CA002645881A patent/CA2645881A1/en not_active Abandoned
- 2006-03-20 AT AT06739456T patent/ATE488137T1/de not_active IP Right Cessation
- 2006-03-20 WO PCT/US2006/010665 patent/WO2007108807A1/en active Application Filing
- 2006-03-20 BR BRPI0621416-9A patent/BRPI0621416A2/pt not_active Application Discontinuation
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109453194A (zh) * | 2018-11-21 | 2019-03-12 | 四川水喜宝科技发展有限公司 | 一种物理灭菌活化养目的中药组合物及组合套装 |
Also Published As
| Publication number | Publication date |
|---|---|
| JP5086331B2 (ja) | 2012-11-28 |
| DE602006018367D1 (de) | 2010-12-30 |
| EP1996014B1 (en) | 2010-11-17 |
| ATE488137T1 (de) | 2010-12-15 |
| EP1996014A4 (en) | 2009-11-11 |
| MX2008011934A (es) | 2008-11-27 |
| AU2006340367B2 (en) | 2012-12-20 |
| CN101400255B (zh) | 2012-07-04 |
| WO2007108807A1 (en) | 2007-09-27 |
| AU2006340367A1 (en) | 2007-09-27 |
| BRPI0621416A2 (pt) | 2011-12-06 |
| JP2009534305A (ja) | 2009-09-24 |
| CA2645881A1 (en) | 2007-09-27 |
| EP1996014A1 (en) | 2008-12-03 |
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