CN107126509A - 一种抗癌药物组合物及其用途 - Google Patents
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Abstract
本发明属于医药技术领域，具体涉及一种抗癌药物组合物及其用途，该组合物是一种广谱抗癌剂，对多种癌症均具有治疗或辅助治疗的作用。
Description
技术领域
本发明属于医药技术领域，具体涉及一种抗癌药物组合物及其用途，该组合物是一种广谱抗癌剂，对多种癌症均具有治疗或辅助治疗的作用。
背景技术
癌症是一大类恶性肿瘤的统称，是严重威胁人类健康和生命的主要疾病之一。癌症的主要特点是癌细胞无休止地增生和迁移，不断消耗患者体内大量的营养物质，同时释放多种毒素，导致人体消瘦、无力、贫血、食欲不振、发热以及严重的脏器功能受损等。目前恶性肿瘤的治疗主要有西医和中医两种治疗方法，西医治疗目前主要是手术治疗、放疗、化疗及尚未成熟的靶向给药和细胞疗法等，其主要以治标为主，往往在去除或杀死癌细胞的同时，对人的机体正常组织产生很大的损伤或不可逆转的损害，对患者造成较大的痛苦，如头晕、呕吐、掉发、器官衰竭、免疫力降低等，而且费用较高，一般家庭难以承受。
中医认为，癌症的产生和发展是各种极为复杂的内外因素综合作用，导致正气虚弱和癌毒产生的结果。正气虚弱是癌症的病理基础，癌毒是癌症的致病要因，故中医认为扶助正气是癌症治疗的根本，解除癌毒是癌症治疗的关键。近年来，利用中医药治疗肿瘤的研究和报道较多，中医药作为癌症的治疗手段已受到越来越多的人关注，但真正采用提高人体免疫力，延缓细胞老化，调节内循环，排出体内毒素的方式治疗癌症并取得显著疗效的抗癌中药组合物较少。
因此，为减轻癌症患者的痛苦，克服采用传统的放、化疗治疗癌症所带来的一系列问题，本发明人基于中医药对慢性炎症、囊肿和癌症发病机理的认识和分析，创新治疗路径，通过提高人体免疫力，调节内循环，延缓细胞老化，排出体内毒素和滞溜水分，起到消除体内炎症，恢复机体正常免疫功能，进而使人体恢复正常的生理状态，达到治疗癌症的目的。发明人通过十余年的临床实践探索，反复优化和调整配方，最终获得本发明的药物组合物，并取得了意想不到的抗癌效果。
发明内容
本发明所要解决的技术问题是提供一种具有防治癌症作用的组合物，该组合物是一种广谱抗癌剂。
本发明所要解决的另一技术问题是提出该组合物在防治癌症疾病等相关领域的应用。
本发明具体的技术方案如下：
本发明提供一种组合物，其特征在于，按重量份数计算，其成分由以下物质组成：刺梨果叶0.5-30份，余甘子果叶0.5-30份，石榴皮籽0.5-30份，蜂蜜 0.5-30份，山竹果肉皮0.5-30份，椰子0.5-30份，柠檬肉皮0.5-30份，生核桃 0.5-30份，天麻0.1-5份，灵芝0.1-5份，辣木籽叶0.1-5份，猫爪草0.01-2份，重楼0.01-2份。
优选的，所述的组合物，其特征在于，按重量份数计算，其成分由以下物质组成：刺梨果叶1-20份，余甘子果叶1-20份，石榴皮籽1-20份，蜂蜜1-20 份，山竹果肉皮1-20份，椰子1-20份，柠檬肉皮1-20份，生核桃1-20份，天麻0.2-2份，灵芝0.2-2份，辣木籽叶0.2-2份，猫爪草0.02-1份重楼0.01-1份。
本发明提供了上述的组合物中各物质的使用部位和处理方法，其特征在于，所述刺梨果叶由新鲜或干燥后的刺梨果和/或刺梨叶组成；所述余甘子果叶由新鲜或干燥后的余甘子果和/或余甘子叶组成；所述石榴皮籽由新鲜或干燥后的石榴皮和/或石榴子组成；所述山竹果肉皮由新鲜或干燥后的山竹果肉和/或山竹果皮组成；所述柠檬肉皮由新鲜或干燥后的柠檬肉和/或柠檬皮组成；所述辣木籽叶由新鲜或干燥后的辣木籽和/或辣木叶组成。
本发明提供了所述的组合物的制备方法和剂型，其特征在于，所述组合物的制备方法为取所述物质经粉碎、煎煮、醇提、浸泡、渗漉、发酵中的一种或多种方法制备得粉末、溶液或清膏后，采用常规制剂手段制备成口服制剂。
优选的，本发明所述的组合物的剂型为片剂、颗粒剂、胶囊剂、口服液、糖浆、丸剂、膏剂、茶剂等。
本发明提供了所述的组合物的用途，即：在制备治疗癌症的药物或辅助治疗癌症的药物、保健食品及食品中的应用。
本发明的有益效果为：
1)本发明组合物用于癌症治疗时，疗效显著；用于癌症化疗时的辅助治疗时，可大大减轻患者的痛苦，提高其生活质量。
2)本发明提供的组合物能提高免疫力，帮助改善内循环，排出体内癌毒，其基于中医药基础理论的指导，对多种癌症均具有显著疗效，具有广泛的临床用途。
3)本发明提供的组合物所用材料全部为纯天然中草药或食品，具有使用安全，无毒副作用等特点；该组合物所用材料来源广泛，价格低廉，可大大减轻患者服用时的经济负担。
4)本发明组合物制备工艺简单，使用方便。
附图说明
图1结直肠癌HCT-116肿瘤体积随时间变化情况图(n＝5)。
图2乳腺癌MDA-MB-231肿瘤体积随时间变化情况图(n＝5)。
图3肺癌H1975肿瘤体积随时间变化情况图(n＝5)。
具体实施方式
下面结合实施例，更具体地说明本发明的内容。应当理解，本发明的实施并不局限于下面的实施例，对本发明所做的任何形式上的变通和/或改变都将落入本发明保护范围。
在本发明中，若非特指，所有的份、百分比均为重量单位。下述实施例中的方法，如无特别说明，均为本领域的常规方法。
实施例1：取刺梨果叶30g、余甘子果叶30g、石榴皮籽30g、山竹果肉皮 18g、椰子18g、柠檬肉皮18g、生核桃18g、天麻5g、灵芝5g、辣木籽叶3g、猫爪草2g、重楼2g，加入处方总重量6倍的水，浸泡半小时，煎煮2次，每次 2小时，过滤，合并药液，加入蜂蜜30g，混匀，即得。
实施例2：取刺梨果0.5g、余甘子叶0.5g、石榴皮0.5g、山竹果肉1.5g、椰子1.5g、柠檬肉1.5g、生核桃1g、天麻0.5g、灵芝0.5g、辣木籽0.1g、猫爪草 0.01g、重楼0.01g，粉碎成细粉，服用时，与蜂蜜3g一起，用水冲服。
实施例3：取刺梨叶2g、余甘子果2g、石榴籽1g、山竹果皮0.5g、椰子0.5g、柠檬肉皮0.5g、生核桃0.5g、天麻0.1g、灵芝0.1g、辣木叶0.5g、猫爪草0.5g、重楼0.05g，粉碎成粗粉，加入蜂蜜3g，用开水冲泡成茶，即得。
实施例4：取刺梨果叶27g、余甘子果叶27g、石榴皮籽27g、蜂蜜27g、山竹果肉皮15g、椰子15g、柠檬肉皮15g、生核桃15g、天麻3g、灵芝3g、辣木籽叶3g、猫爪草2g、重楼1g，加入药材总重量3倍的水，密封，置阴凉处发酵 3个月，过滤，即得。
实施例5：取刺梨果叶10g、余甘子果叶10g、石榴皮籽10g、山竹果肉皮 30g、椰子30g、柠檬肉皮30g、生核桃30g、天麻1g、灵芝1g、辣木籽叶5g、猫爪草0.5g、重楼0.3g，粉碎成粗粉，以50％的乙醇浸润，并以2ml/min的流速进行渗漉提取，收集3倍处方重量的提取液，加入蜂蜜10g，混匀，即得。
实施例6：取刺梨果叶9g、余甘子果叶9g、石榴皮籽9g、山竹果肉皮6g、椰子6g、柠檬肉皮6g、生核桃6g、天麻1.5g、灵芝1.5g、辣木籽叶1.5g、猫爪草0.6g、重楼0.3g，加入药材总重量6倍的水，浸泡半小时，提取2次，每次2 小时，过滤，合并药液，浓缩至相对密度为1.1～1.2g/ml(60℃)，得浸膏，向浸膏中加入蜂蜜9g及适量辅料制粒、干燥后，分装成颗粒剂或压成片剂或充填成胶囊剂，即得。
实施例7：取刺梨果叶25kg、余甘子果叶30kg、石榴皮籽20kg、山竹果肉皮18kg、椰子10kg、柠檬肉皮10kg、生核桃18kg、天麻5kg、灵芝3kg、辣木籽叶3kg、猫爪草2kg、重楼1kg，加入处方总重量6倍的水，浸泡半小时，煎煮2次，每次2小时，过滤，合并药液，加入蜂蜜30kg，混匀，分装成100ml/ 瓶，即得。
实施例8：取刺梨果叶30kg、余甘子果叶27kg、石榴皮籽27kg、蜂蜜20kg、山竹果肉皮25kg、椰子15kg、柠檬肉皮10kg、生核桃15kg、天麻6kg、灵芝3kg、辣木籽叶5kg、猫爪草2kg、重楼2kg，加入药材总重量3倍的水，密封，置阴凉处发酵3个月，过滤，分装成100ml/瓶，即得。
实施例9：取刺梨果10kg、余甘子叶8kg、石榴皮10kg、山竹果肉15kg、椰子20kg、柠檬肉皮20kg、生核桃10kg、天麻1kg、灵芝1kg、辣木籽5kg、猫爪草0.5kg、重楼0.6kg，粉碎成粗粉，以50％的乙醇浸润，并以30ml/min的流速进行渗漉提取，收集3倍处方重量的提取液，加入蜂蜜15kg，混匀，分装成 100ml/瓶，即得。
实施例10：取刺梨果叶9kg、余甘子果叶12kg、石榴籽6kg、山竹果肉皮 9kg、椰子6kg、柠檬皮15kg、生核桃6kg、天麻1kg、灵芝1.5kg、辣木叶1.5kg、猫爪草1kg、重楼0.6kg，加入药材总重量6倍的水，浸泡半小时，提取2次，每次2小时，过滤，合并药液，浓缩至相对密度为1.1～1.2g/ml(60℃)，得浸膏，向浸膏中加入蜂蜜12kg及适量辅料制粒、干燥后，分装成颗粒剂或压成片剂或充填成胶囊剂，即得。
实施例11本发明组合物体外抗癌活性研究结果
为评价本发明组合物的体外抗癌活性，发明人采用MTT法，考察了本发明组合物对20种肿瘤细胞株的生长抑制活性，包括肺癌、结直肠癌、乳腺癌、食管癌、白血病、肝癌、前列腺癌、宫颈癌、胃癌和骨肉瘤。结果如表1所示。
表1体外抗肿瘤活性(n＝3)
| 肿瘤细胞 | 达到IC50时的稀释浓度 | 肿瘤细胞 | 达到IC50时的稀释浓度 |
| A549 | (0.55±0.07)％ | MCF7 | (1.15±0.35)％ |
| H1299 | (0.48±0.26)％ | MDA-MB-453 | (1.59±0.33)％ |
| H1975 | (1.61±0.33)％ | MDA-MB-231 | (2.21±0.16)％ |
| HCT-116 | (1.26±0.10)％ | ECA-109 | (9.28±1.73)％ |
| HT-29 | (6.27±1.25)％ | KYSE-150 | (2.08±0.57)％ |
| SW620 | (2.65±1.30)％ | BGC-823 | (6.98±2.50)％ |
| K562 | (0.58±0.19)％ | HepG2 | (3.12±0.64)％ |
| MV4-11 | (1.21±0.16)％ | BELE-7404 | (3.95±1.49)％ |
| PC3 | (1.22±0.33)％ | Hela | (1.7±0.29)％ |
| DU145 | (0.85±0.21)％ | 143B | (2.54±0.15)％ |
根据表1可知，本发明组合物对所选的20个肿瘤细胞株都具有良好的生长抑制活性，表明该药具有广谱的抗癌活性。
实施例12本发明组合物体内抗癌活性研究
为评价本发明组合物在体内抗癌效果，发明人研究了本发明的组合物对结直肠癌细胞HCT-116，乳腺癌MDA-MB-231和非小细胞肺癌H1975三种裸鼠皮下瘤的生长抑制作用，结果显示：本发明组合物对三种皮下瘤均具有显著的体内抑制效果，对结直肠癌HCT-116、乳腺癌MDA-MB-231和肺癌H-1975的抑瘤率分别为71.1％、66.5％、60.9％，详见说明书附图1、附图2和附图3。
实施例13本发明组合物的临床应用效果
本发明的组合物已临床应用十余年，经数百例患者临床验证，该组合物能显著提高免疫力，帮助改善内循环，排出体内癌毒，对多种癌症均具有良好的治疗效果，具有广泛的临床用途。该组合用于癌症化疗时的辅助治疗时，可大大减轻患者的痛苦，提高其生活质量。以下为该组合物临床应用的部分典型病例：
1.曾某某，女，45岁。病人右乳房出现32.5*16.4mm大小肿块，乳房刺痛。服用本组合物100天后，进行CT扫描，于局部未见明显异常密度影。
2.许某某，男18岁，学生。病人枯瘦如柴，面色苍白，下肢不遂，医院检查确定为高级别血管瘤(病灶肿块位于右大腿处，体积为51.8*13.0mm)，医院认为化疗只有20％把握并建议截肢。服用本组合物三个疗程(注：每个疗程21 天，每天服用三次)后，肿块缩小为16.0*7.2mm，转为良性囊肿；继续服用本组合物一个疗程后，肿块消失，并基本恢复正常的生理机能。
3.彭某某，男，60岁。病人前列腺癌向肺部转移，经化疗两疗程后，全身无力，头发脱落，多发小淋巴结，引起器官功能性衰竭，无法继续化疗，医院建议回家休养两个月(实际为建议放弃治疗)。服用本组合物两个疗程后，病人已能正常活动，生活自理。经医院检查，前列腺大小形态正常，双肺透亮度增加，未见明显结节；继续服用两个疗程后，身体基本恢复正常。
4.代某某，男，52岁。病人CT结果为：1).S8、S5/6占位，倾向恶性占位。 2).肝硬化，脾增大，出现大量腹水。3).双下肺炎性病灶并双侧腹腔积液。4). 双侧腹侧壁软组织肿胀。病人胸部以下可见完全水肿，且无法进食和排泄，卧床不能动，注射利尿针后一天排尿量仅350ml。服用本组合物三天后，排尿量达到 3000ml，大小便正常，开始消肿；服用约两个疗程后，全身肿胀消除，能够自主行走；继续服用三个疗程后，基本痊愈。
5.徐某某，女，39岁。病人进行阴道超声检查，子宫大小为72*64*74mm，前位增大，宫肌回声不均匀，子宫肌层可见多个大小不等回声光团，最大位于后壁，大小约为37*34mm，内回声不均匀，医生诊断为多发性子宫肌瘤。经服用本组合物100天后，通过超声检查可见子宫包膜基本光滑完整，实质回声均匀，宫颈可探及数个无回声暗区，较大的约为4*3mm。
Claims (6)
1.一种抗癌药物组合物，其特征在于，按重量份数计算，其由以下物质组成：刺梨果叶0.5-30份，余甘子果叶0.5-30份，石榴皮籽0.5-30份，蜂蜜0.5-30份，山竹果肉皮0.5-30份，椰子0.5-30份，柠檬肉皮0.5-30份，生核桃0.5-30份，天麻0.1-5份，灵芝0.1-5份，辣木籽叶0.1-5份，猫爪草0.01-2份，重楼0.01-2份。
2.根据权利要求1所述的组合物，其特征在于，按重量份数计算，其由以下物质组成：刺梨果叶1-20份，余甘子果叶1-20份，石榴皮籽1-20份，蜂蜜1-20份，山竹果肉皮1-20份，椰子1-20份，柠檬肉皮1-20份，生核桃1-20份，天麻0.2-2份，灵芝0.2-2份，辣木籽叶0.2-2份，猫爪草0.02-1份重楼0.01-1份。
3.根据权利要求1-2所述的组合物，其特征在于，所述刺梨果叶由新鲜或干燥后的刺梨果和/或刺梨叶组成；所述余甘子果叶由新鲜或干燥后的余甘子果和/或余甘子叶组成；所述石榴皮籽由新鲜或干燥后的石榴皮和/或石榴子组成；所述山竹果肉皮由新鲜或干燥后的山竹果肉和/或山竹果皮组成；所述柠檬肉皮由新鲜或干燥后的柠檬肉和/或柠檬皮组成；所述辣木籽叶由新鲜或干燥后的辣木籽和/或辣木叶组成。
4.根据权利要求1-3所述的中药组合物，其特征在于，所述中药组合物的制备方法为取所述物质经粉碎、煎煮、醇提、浸泡、渗漉、发酵中的一种或多种方法制备得粉末、溶液或清膏后，采用常规制剂手段制备成口服制剂。
5.根据权利要求4所述的中药组合物，其特征在于，所述的口服制剂为片剂、颗粒剂、胶囊剂、口服液、糖浆、丸剂、膏剂、茶剂等。
6.根据权利要求1-5所述的中药组合物，在制备治疗癌症或辅助治疗癌症的药物、保健食品及食品中的应用。
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2018171672A1 (zh) * | 2017-03-24 | 2018-09-27 | 贵州省金黔果生物科技有限责任公司 | 一种抗癌药物组合物及其用途 |
| US10953062B2 (en) | 2017-03-24 | 2021-03-23 | Guizhou Jin Qian Fruit Biotechnology Co., Ltd. | Anticancer pharmaceutical composition and application thereof |
Also Published As
| Publication number | Publication date |
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| US10953062B2 (en) | 2021-03-23 |
| WO2018171672A1 (zh) | 2018-09-27 |
| US20200030401A1 (en) | 2020-01-30 |
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