CN107510813A - 用于降低癌症治疗药物副作用的医药组合物、制备方法及其用途 - Google Patents
用于降低癌症治疗药物副作用的医药组合物、制备方法及其用途 Download PDFInfo
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Abstract
本发明提供一种用于降低癌症治疗药物副作用的医药组合物,包括菇类、根茎类、果实种子类、叶类、花类、藻类、能量配置液、盐类配置液、补助剂以及抗氧化剂。所述医药组合物具有保护肝脏、提升自体免疫力、减缓癌痛、保护器官免于癌症治疗药物所造成的副作用或提升该化学治疗癌症药物治疗癌症的功效。
Description
技术领域
本发明是关于一种癌症用药,特别是一种可合并化疗治疗癌症药物使用的癌症用药。
背景技术
化学治疗是癌症患者重要的一个治疗方法,其是透过给予患者抗癌药物,以杀死体内的癌细胞。相较于传统的手术治疗和放射线治疗,化学治疗的优点是达到全身性的治疗,因此为目前最主要的癌症治疗方式,亦是转移性癌症患者最重要的治疗方式。
目前市售的化学治疗药物,可分为化合药物和标靶药物。化合药物包括扑类恶注射剂(Bleomycin)、顺铂(Cisplatin)、5-氟尿嘧啶(Fluorouracil,5-FU)、灭杀除癌锭(Methotrexate)、紫杉醇(Taxol)等,其作用机制是攻击分裂快速的细胞,因此除癌细胞外,人体正常细胞包括白血球、红血球、血小板、头发毛囊细胞、胃肠道表皮细胞、生殖细胞等等皆成为化学治疗药物的作用对象,导致患者服用后常伴随着如恶心呕吐、出血、腹泻、白血球过低而导致容易感染、落发、口腔或食道黏膜破损发炎、生育功能降低等等的副作用。
标靶药物,包括癌思停(Bevacizumab)、爱瑞莎(Iressa)以及得舒缓(Erlotinib)等,其作用机制是针对癌细胞上特有的抗原、蛋白等进行标靶治疗,因此仅能针对原发部位的癌细胞给予治疗,对于转移性癌症患者并没有效果,此外,标靶药物亦会有皮肤红疹、手足疼痛、口腔炎、腹泻、肠胃不适、发烧、肌肉酸痛、血压升高、肝功能受损等副作用产生。
另外,有些化学治疗药物,如Fluorouracil(5-FU)、Taxol(紫杉醇),更会引起患者心律不整、肝肾功能下降、疼痛、器官肥大等等,因而严重影响癌症患者的生活质量。因此,目前仍需要一种可以降低化学治疗药物副作用并提升其治疗功效的药物,用于合并治疗癌症。
发明内容
有鉴于此,本发明提供一种可合并化学治疗药物使用,并可用于降低癌症治疗药物副作用的医药组合物,包括菇类、根茎类、果实种子类、叶类、花类、藻类、能量配置液、盐类配置液、补助剂以及抗氧化剂。
本发明之一实施例中,所述菇类是选自桑黄24-36克、灵芝16-24克、巴西蘑菇16-24克、牛樟芝4-6克、冬虫夏草4-6克中的一种或多种。
本发明之一实施例中,所述根茎类是选自黄精16-24克、黄芪8-12克、丹参8-12克、党参8-12克、白花蛇舌草12-18克、杜仲12-18克、白术8-12克、天花粉8-12克、刺五加8-12克、麦冬8-12克、红景天8-12克、去皮甘草2.4-3.6克中的一种或多种。
本发明之一实施例中,所述果实种子类是选自薏仁12-18克、女贞子8-12克、五味子8-12克、发芽米9.6-14.4克、莲子8-12克、黑芝麻8-12克、玉米须8-12克、罗汉果8-12克、红葡萄皮萃取粉1.6-2.4克中的一种或多种。
本发明之一实施例中,所述叶类是选自菠菜8-12克、发芽青花菜8-12克、木瓜叶8-12克、荷叶6.4-9.6克中的一种或多种。
本发明之一实施例中,所述花类是选自贡菊8-12克、黄菊8-12克、金银花8-12克、洋甘菊8-12克中的一种或多种。
本发明之一实施例中,所述藻类是选自海藻8-12克、昆布8-12克、海带8-12克中的一种或多种。
本发明之一实施例中,所述能量配置液包含氯化铁4.5-5.5毫克以及蒸馏水200毫升。
本发明之一实施例中,所述盐类配置液包含深海盐112.5-137.5克、氯化镁27-33克、盐卤18-22毫升、氯化钙0.99-1.21克以及氯化钾0.495-0.605克。
本发明之一实施例中,所述补助剂包含柠檬酸18-22克、硒酵母18-22克、辅酶10270-330毫克或维生素C 2.7-3.3克。
本发明之一实施例中,所述抗氧化剂包含几丁质聚寡糖9-11克、谷胱甘肽4.5-5.5克、松树皮0.9-1.1克或褐藻多糖0.9-1.1克中的一种或多种。
本发明之一实施例中,所述医药组合物的pH值介于1.2-2之间。较佳地,所述医药组合物的pH值为1.2-1.8。
本发明另提供一种降低癌症治疗药物副作用的医药组合物的制备方法,包括:将中医原料加入水中,并浓缩成原料溶液;加入含有氯化铁(FeCl3)的水;加入含有深海盐、氯化镁、盐卤、氯化钙以及氯化钾的盐类配制液;加入含有柠檬酸、硒酵母、辅酶10以及维生素C的补助剂;加入含有几丁质聚寡糖、谷胱甘肽、松树皮以及褐藻多糖的抗氧化剂;混合后,进行发酵反应;以及进行离心步骤,以得到医药组合物。
本发明之一实施例中,所述中医原料包括菇类、根茎类、果实种子类、叶类、花类、藻类中的一种或多种。
本发明之一实施例中,所述菇类是选自桑黄24-36克、灵芝16-24克、巴西蘑菇16-24克、牛樟芝4-6克、冬虫夏草4-6克中的一种或多种,所述根茎类是选自黄精16-24克、黄芪8-12克、丹参8-12克、党参8-12克、白花蛇舌草12-18克、杜仲12-18克、白术8-12克、天花粉8-12克、刺五加8-12克、麦冬8-12克、红景天8-12克、去皮甘草2.4-3.6克中的一种或多种,所述果实种子类是选自薏仁12-18克、女贞子8-12克、五味子8-12克、发芽米9.6-14.4克、莲子8-12克、黑芝麻8-12克、玉米须8-12克、罗汉果8-12克、红葡萄皮萃取粉1.6-2.4克中的一种或多种,所述该叶类是选自菠菜8-12克、发芽青花菜8-12克、木瓜叶8-12克、荷叶6.4-9.6克中的一种或多种,所述花类是选自贡菊8-12克、黄菊8-12克、金银花8-12克、洋甘菊8-12克中的一种或多种,所述藻类是选自海藻8-12克、昆布8-12克、海带8-12克中的一种或多种。
本发明之一实施例中,所述医药组合物的pH值介于1.2-2之间。较佳地,所述癌症用药的pH值为1.2-1.8。
本发明之一实施例中,所述发酵反应是于常温下进行3-5天的发酵。
本发明进一步提供一种制备用于降低癌症治疗药物副作用的医药组合物的方法,所述医药组合物包含菇类、根茎类、果实种子类、叶类、花类、藻类、能量配置液、盐类配置液、补助剂以及抗氧化剂。
本发明之一实施例中,所述医药组合物具有保护肝脏、提升自体免疫力、减缓癌痛、保护器官免于癌症治疗药物所造成的副作用或提升所述癌症治疗药物治疗癌症的功效。
本发明之一实施例中,所述医药组合物的浓度为25μl/kg/day-84μl/kg/day。
本发明之一实施例中,所述医药组合物的使用方法为一日内分为3-10次使用,且每次使用时需将所述医药组合物稀释1/1000-3/1000倍后再使用。
本发明之一实施例中,所述癌症治疗药物包括化合药物或标靶药物。所述化合物包括5-氟尿嘧啶(5-FU)、紫杉醇(Taxol)、顺铂(cisplatin)、小红莓类(anthracycline)、环磷酰胺(cyclophosphamide)中的一种或多种。
本发明之一实施例中,所述器官为心脏、肝脏、肾脏或脾脏。
附图说明
图1A为各组公鼠于第14天时的肿瘤体积。
图1B为各组公鼠于第14天时抑制肿瘤体积的倍数变化图。
图2A为接肿大肠癌细胞后,各组公鼠血清中丙氨酸转氨酶(Alanine aminotransferase)的表达量。
图2B为接肿肺腺癌细胞后,各组公鼠血清中丙氨酸转氨酶(Alanine aminotransferase)的表达量。
图3为接肿大肠癌细胞后,各组公鼠血液中免疫细胞的数量,其中:
图3A为白血球的数量;图3B为淋巴细胞的数量;图3C为单核球的数量;图3D为颗粒性球的数量;图3E为血小板的数量。
图4为接肿肺腺癌细胞后,各组公鼠血液中免疫细胞的数量,其中:
图4A为白血球的数量;图4B为红血球的数量;图4C为单核球的数量;图4D为颗粒性球的数量;图4E为血小板的数量。
图5为接肿大肠癌细胞后,各组公鼠血液中细胞激素的表达量,其中:
图5A为人类细胞激素IL-8的表达量;图5B为人类细胞激素IL-6的表达量;图5C为人类细胞激素IL-1RA的表达量;图5D为人类细胞激素TNF-α的表达量;图5E为老鼠细胞激素G-CSF的表达量;图5F为老鼠细胞激素IL-12的表达量;图5G为人类细胞激素IL-12的表达量。
图6为接肿肺腺癌细胞后,各组公鼠血液中细胞激素的表达量,其中:
图6A为人类细胞激素IL-6的表达量;图6B为人类细胞激素TNF-α的表达量;图6C为老鼠细胞激素G-CSF的表达量;图6D为人类细胞激素IL-12的表达量。
7图为各组公鼠于不同天数引发疼痛的比较图。
图8为各组公鼠器官重量,其中:图8A为公鼠心脏重量;图8B为公鼠肝脏重量;图8C为公鼠脾脏重量;图8D为公鼠肾脏重量。
具体实施方式
实施例一、本发明医药组合物的制备
首先,将表1所述的一种或多种中医原料制备成浓缩液,该浓缩液的制备流程为:(1)取360克中医原料,并加入6倍的水,制成约2160毫升的溶液;(2)于高温(约70℃)环境下,将该溶液以减压方式浓缩成1200毫升;(3)将浓缩后的溶液冷藏静置,并于两天后去除5%沉淀物,已取得浓缩液。
表1、本发明医药组合物的原料
接着,取上述浓缩液200毫升(内含60克的固体量),依序加入能量配置液、盐类配置液、补助剂及抗氧化剂,混合搅拌后于常温(25℃)下进行发酵,发酵时间约3-7天,较佳为3天。其中,该能量配置液为含5毫克氯化铁(FeCl3)的蒸馏水200毫升,该盐类配制液包含125克深海盐、30克氯化镁、20毫升盐卤、1.1克氯化钙(CaCl2)以及0.55克氯化钾(KCL),该补助剂包含20克柠檬酸、20克硒酵母、300毫克(浓度10%)辅酶10(Q10)以及3克维生素C,该抗氧化剂包含10克(浓度70%)几丁质聚寡糖、5克(浓度98%)谷胱甘肽、1克(浓度80%)松树皮以及1克(浓度80%)褐藻多糖。
将上述发酵后的液体,加入蒸馏水使其总体积为500毫升,搅拌静置一天后,以1500rpm离心15分钟用以分离沉淀物,该上清液即为本发明的医药组合物,内含25%深海盐、6%氯化镁,且该医药组合物的pH值为1.5±0.3,以保持产品的安定。
实施例二、本发明医药组合物对肿瘤生长的影响
将7周龄大且体重20-24克的公鼠(CB17/Icr-Prkdcscid/IcrIcoCrlBltw),以皮下接种方式给予3×106HT-2大肠癌细胞(100μL PBS含50%基质胶(matrigel))或1×107A549肺腺癌细胞(100μL PBS含50%基质胶(matrigel)),使其诱发大肠癌或肺腺癌。待肿瘤体积生长到200mm3时,将公鼠分为以下三组:(一)控制组,于第0-14天皆不给予任何药物;(二)对照组,于第0、7天给予化疗药物5-FU(100mg/kg)或cisplatin(4mg/kg);以及(三)实验组,在给予5-FU或cisplatin之前7天就开始给予本发明医药组合物,并连续给予21天,每天给予2次,每次剂量为0.5-1.67μL/只(公鼠),其中在第0、7天给予化疗药物5-FU(100mg/kg)或cisplatin(4mg/kg)时不给予本发明医药组合物。于第14天给药后,取出肿瘤块测量其重量。
结果显示,如图1A、1B,与控制组相比,给予化疗药物5-FU的公鼠(即对照组),平均能减少6.3%的肿瘤体积,其抑制效果为控制组的1倍,然而,合并给予化疗药物5-FU及本发明医药组合物的公鼠(即实验组),能有效减少34.1%的肿瘤体积,其抑制效果为控制组的5.4倍,有此可知,本发明医药组合物具有促进化疗药物5-FU抑制肿瘤的效果。
实施例三、本发明医药组合物对肝脏功能的影响
许多研究已证实,癌细胞会经血流进入肝脏,进而影响肝功能。因此,将上述实施例二的各组公鼠,于第14天给药后,采集各组公鼠的血清,用以分析其肝指数丙氨酸转氨酶(Alanine amino transferase,ALT)的表达量。
参考图2A,图中正常鼠为没有接踵大肠癌细胞,亦不给予任何药物。结果显示,与正常鼠相比,控制组中公鼠血清的ALT浓度增加,表示大肠癌细胞确实造成公鼠肝脏受损。而与控制组相比,对照组的ALT浓度增加,而实验组的ALT浓度降低至与正常鼠的ALT相近。
如图2B,图中正常鼠为没有接踵肺腺癌细胞,亦不给予任何药物。结果显示,与正常鼠、控制组相比,对照组的ALT浓度增加,而实验组的ALT浓度降低至与正常鼠的ALT相近。由以上结果可知,化疗药物5-FU及Cisplatin不具有保护肝脏免于癌细胞破坏的功效,反而是增加肝脏负担,并加速肝脏受损,然而本发明医药组合物具有保护肝脏作用,并使其维持正常的肝功能状态,以增加对抗癌细胞的功效。
实施例四、本发明医药组合物对免疫系统的影响
已知免疫细胞、细胞激素在抑制恶性肿瘤的生长上扮演着一个重要的角色,为了了解本发明医药组合物对于免疫细胞的影响,将上述实施例二的各组公鼠,于第14天给药后,采集各组公鼠的血液,用以分析免疫细胞、细胞激素的表达量。
如图3A-3E所示,图中正常鼠为没有接踵大肠癌细胞,亦不给予任何药物。结果显示,与控制组、对照组相比,本发明医药组合物能有效提升血液中白血球(white bloodcell)(图3A)、淋巴细胞(lymphocytes)(图3B)、单核球(monocytes)(图3C)、颗粒性球(granulocytes)(图3D)以及血小板(platelet)(图3E)的数量。
如图4A-4E所示,图中正常鼠为没有接踵肺线癌细胞,亦不给予任何药物。结果显示,与控制组、对照组相比,本发明医药组合物能有效提升血液中白血球(white bloodcell)(图4A)、红血球(Red blood cell)(图4B)、单核球(monocytes)(图4C)、颗粒性球(granulocytes)(图4D)以及血小板(platelet)(图4E)的数量。
如图5A-5G所示,图中正常鼠为没有接踵大肠癌细胞,亦不给予任何药物。结果显示,与控制组、对照组相比,本发明医药组合物能减少人类细胞激素IL-8(图5A)、IL-6(图5B)、IL-1RA(图5C)、TNF-α(图5D)的表现,并增加老鼠细胞激素G-CSF(血球生长激素)(图5E)、IL-12(p70)(图5F)的表达以及增加人类IL-12(p70)(图5G)的表达。
如图6A-6D所示,图中正常鼠为没有接踵肺腺癌细胞,亦不给予任何药物。结果显示,与控制组、对照组相比,本发明医药组合物能减少人类细胞激素IL-6(图6A)、TNF-α(图6B)的表达,并增加老鼠细胞激素G-CSF(血球生长激素)(图6C)以及增加人类IL-12(p70)(图6D)的表达。综合以上结果可知,本发明医药组合物有助于癌症患者提升自体免疫力。
实施例五、本发明医药组合物对癌痛的影响
癌痛为癌症引起的疼痛,是癌症患者最常见的症状之一,也是癌症患者最畏惧的症状之一,若没有适当的控制疼痛,往往严重影响癌症患者的生活质量。因此,为了解本发明医药组合物对癌痛的影响,将6-7龄大且体重20-24克的雌鼠(ICR)分为控制组、对照组及实验组这三组,其中控制组为没有给予任何药物,对照组与实验组皆为第0-5天连续给予癌痛指标药物紫杉醇(20mg/kg),藉此诱发雌鼠产生疼痛作用,而实验组在给予紫杉醇(Taxol)之前7天就开始给予本发明医药组合物,并连续给予21天,每天给予2次,每次剂量为0.5-1.67uL/只(雌鼠)。接着,于给药期间第3、7、14天,分别进行闪尾痛觉测试(Tail-Flick Unit 37360),该测试是以红外线热源对雌鼠尾部加热,用以分析闪尾延迟秒数(tail flick latency/sec),藉此评估痛觉阈值改变的程度。
如图7所示,图中对照组的闪尾秒数较少,表示紫杉醇(Taxol)确实会导致老鼠的疼痛敏感度增加,然而与对照组相比,不论是第3、7及14天,实验组皆有延长闪尾秒数,表示本发明医药组合物具有减缓癌痛的功效。
实施例六、本发明医药组合物对各器官的影响
化疗药物常见的副作用是造成器官肥大,因此为了解本发明医药组合物对于各器官的影响,本试验将上述实施例五的雌鼠,于第15天后牺牲,分别取心脏、肝脏、脾脏及肾脏并秤重。
如他8A-8D所示,与控制组相比,给予紫杉醇(Taxol)的雌鼠(即对照组),其心脏(图8A)、肝脏(图8B)、脾脏(图8C)及肾脏(图8D)都明显较重。然而在实验组的雌鼠,其心脏(图8A)、肝脏(图8B)、脾脏(图8C)及肾脏(图8D)的重量皆明显降低,甚至比控制组低。由此可知,本发明医药组合物具有保护器官免于化疗药物造成的副作用。
Claims (23)
1.一种用于降低癌症治疗药物副作用的医药组合物,包括菇类、根茎类、果实种子类、叶类、花类、藻类、能量配置液、盐类配置液、补助剂以及抗氧化剂。
2.如权利要求1所述医药组合物,其特征是,所述菇类是选自桑黄24-36克、灵芝16-24克、巴西蘑菇16-24克、牛樟芝4-6克、冬虫夏草4-6克中的一种或多种。
3.如权利要求1所述医药组合物,其特征是,所述根茎类是选自由黄精16-24克、黄芪8-12克、丹参8-12克、党参8-12克、白花蛇舌草12-18克、杜仲12-18克、白术8-12克、天花粉8-12克、刺五加8-12克、麦冬8-12克、红景天8-12克、去皮甘草2.4-3.6克中的一种或多种。
4.如权利要求1所述医药组合物,其特征是,所述果实种子类是选自薏仁12-18克、女贞子8-12克、五味子8-12克、发芽米9.6-14.4克、莲子8-12克、黑芝麻8-12克、玉米须8-12克、罗汉果8-12克、红葡萄皮萃取粉1.6-2.4克中的一种或多种。
5.如权利要求1所述医药组合物,其特征是,所述叶类是选自菠菜8-12克、发芽青花菜8-12克、木瓜叶8-12克和荷叶6.4-9.6克。
6.如权利要求1所述医药组合物,其特征是,所述花类是选自贡菊8-12克、黄菊8-12克、金银花8-12克或洋甘菊8-12克中的一种或多种。
7.如权利要求1所述医药组合物,其特征是,所述藻类是选自海藻8-12克、昆布8-12克或海带8-12克中的一种或多种。
8.如权利要求1所述医药组合物,其特征是,所述能量配置液包含氯化铁4.5-5.5毫克以及蒸馏水200毫升。
9.如权利要求1所述医药组合物,其特征是,所述盐类配置液包含深海盐112.5-137.5克、氯化镁27-33克、盐卤18-22毫升、氯化钙0.99-1.21克以及氯化钾0.495-0.605克。
10.如权利要求1所述医药组合物,其特征是,所述补助剂包含柠檬酸18-22克、硒酵母18-22克、辅酶10 270-330毫克以及维生素C2.7-3.3克。
11.如权利要求1所述医药组合物,其特征是,所述抗氧化剂包含几丁质聚寡糖9-11克、谷胱甘肽4.5-5.5克、松树皮0.9-1.1克以及褐藻多糖0.9-1.1克。
12.如权利要求1所述医药组合物,其特征是,所述医药组合物的pH值介于1.2-2之间。
13.一种降低癌症治疗药物副作用的医药组合物的制备方法,包括:
将中医原料加入水中,并浓缩成原料溶液;
加入含有氯化铁(FeCl3)的水;
加入含有深海盐、氯化镁、盐卤、氯化钙以及氯化钾的盐类配制液;
加入含有柠檬酸、硒酵母、辅酶10以及维生素C的补助剂;
加入含有几丁质聚寡糖、谷胱甘肽、松树皮以及褐藻多糖的抗氧化剂;
混合后,进行发酵反应;以及
进行离心步骤,以得到医药组合物,
其中所述医药组合物的pH值介于1.2-2之间。
14.如权利要求13所述方法,其特征是,所述中医原料包括菇类、根茎类、果实种子类、叶类、花类、藻类中的一种或多种。
15.如权利要求14所述方法,其特征是,所述菇类是选自桑黄24-36克、灵芝16-24克、巴西蘑菇16-24克、牛樟芝4-6克、冬虫夏草4-6克中的一种或多种,所述根茎类是选自黄精16-24克、黄芪8-12克、丹参8-12克、党参8-12克、白花蛇舌草12-18克、杜仲12-18克、白术8-12克、天花粉8-12克、刺五加8-12克、麦冬8-12克、红景天8-12克、去皮甘草2.4-3.6克中的一种或多种,所述果实种子类是选自薏仁12-18克、女贞子8-12克、五味子8-12克、发芽米9.6-14.4克、莲子8-12克、黑芝麻8-12克、玉米须8-12克、罗汉果8-12克、红葡萄皮萃取粉1.6-2.4克中的一种或多种,所述叶类是选自菠菜8-12克、发芽青花菜8-12克、木瓜叶8-12克、荷叶6.4-9.6克中的一种或多种,所述花类是选自贡菊8-12克、黄菊8-12克、金银花8-12克、洋甘菊8-12克中的一种或多种,所述藻类是选自海藻8-12克、昆布8-12克、海带8-12克中的一种或多种。
16.如权利要求13所述方法,其特征是,所述发酵反应是在常温下进行3-5天的发酵。
17.一种制备用于降低癌症治疗药物副作用的医药组合物的方法,其特征是,所述医药组合物如权利要求1所述,所述医药组合物具有保护器官免于癌症治疗药物所造成的副作用的功效。
18.如权利要求17所述方法,其特征是,所述医药组合物的浓度为25μl/kg/day-84μl/kg/day。
19.如权利要求17所述方法,其特征是,所述医药组合物的使用方法为一日内分为3-10次使用,且每次使用时须将所述医药组合物稀释1/1000-3/1000倍后再使用。
20.如权利要求17所述方法,其特征是,所述癌症治疗药物为化合药物或标靶药物。
21.如权利要求17所述方法,其特征是,所述化合药物包括5-氟尿嘧啶(5-FU)、紫杉醇(Taxol)、顺铂(cisplatin)、小红莓类(anthracycline)、环磷酰胺(cyclophosphamide)中的一种或多种。
22.如权利要求17所述方法,其特征是,所述医药组合物具有保护肝脏、提升自体免疫力、减缓癌痛、或提升该癌症治疗药物治疗癌症的功效。
23.如权利要求17所述方法,其特征是,所述器官为心脏、肝脏、肾脏或脾脏。
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