CN116059322A - 一种治疗和预防肿瘤的口服制剂及其制备方法 - Google Patents
一种治疗和预防肿瘤的口服制剂及其制备方法 Download PDFInfo
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Abstract
本发明实施例公开了一种治疗和预防肿瘤的口服制剂及其制备方法。本发明提供的口服制剂通过改善肿瘤体内微环境,改良生长肿瘤环境为生长正常组织细胞的环境,达到治疗癌症的目的,对人体正常细胞无杀灭作用,不会像放化疗药物对人体正常细胞和机能产生损伤,而且可配合放化疗药物同时服用。经过多年癌症晚期患者临床试验,大多患者服用一个月症状均有明显改善,且无不良反应报道。本发明口服制剂的原料均为符合国家食品标准的药食同源原料,常规服用不会有副作用,临床应用亦未见明显副作用。
Description
技术领域
本发明实施例涉及制剂制备技术领域,具体涉及一种治疗和预防肿瘤的口服制剂及其制备方法。
背景技术
据世界卫生组织(WHO)发布的《全球癌症报告2012》预测,全球癌症病例呈现迅猛增长态势,2012年,全球新增癌症病例达到1400多万例,并预计在未来20年将达到每年2200万的水平,同期癌症死亡人数也将从每年820万飙升至1300万。
多年来抗肿瘤药物虽然有不断的进展,但随着诸多靶向药物市场逐步成熟后,新药开发进入平台期。许多重磅药物随着专利到期等因素,业绩在逐步下滑。目前新药市场亟待机制新、低毒、广谱的重磅抗肿瘤新药。此外,肿瘤发生率急剧上升,抗肿瘤药物疗效极其有限,导致大部分中晚期肿瘤肆虐而医生束手无策。切实有效的抗肿瘤新药的问世是广大肿瘤患者梦寐以求的大事;如果自主创新的药物占领我国乃至世界市场,是肿瘤患者的福音。
发明内容
为此,本发明实施例提供一种治疗和预防肿瘤的口服制剂及其制备方法。
为了实现上述目的,本发明实施例提供如下技术方案:
根据本发明实施例的第一方面,提供一种治疗和预防肿瘤的口服制剂,其特征在于,包括如下重量份数的原料:大豆肽粉2-100份、骨胶原蛋白肽2-100份、鱼胶原蛋白肽2-100份、(6S)-5-甲基四氢叶酸,氨基葡萄糖盐1-5份、吡咯并喹啉醌二钠盐1-5份、小牛胸腺肽粉1-5份、雪莲培养物1-10份、鱼精水解蛋白粉1-10份、蛹虫草粉2-50份、芦笋粉2-60份、香菇粉2-60份、蒲公英粉2-60份、黄精粉2-50份、姜黄2-30份、5'-鸟苷酸二钠1-20份、红枣粉2-100份、菊粉1-100份、牛磺酸1-90份、水苏糖2-80份。
进一步地,所述治疗和预防肿瘤的口服制剂,包括如下重量份数的原料:包括如下重量份数的原料:大豆肽粉2-50份、骨胶原蛋白肽2-50份、鱼胶原蛋白肽2-50份、(6S)-5-甲基四氢叶酸,氨基葡萄糖盐1-2份、吡咯并喹啉醌二钠盐1-2份、小牛胸腺肽粉1-2份、雪莲培养物1-5份、鱼精水解蛋白粉1-5份、蛹虫草粉2-20份、芦笋粉2-30份、香菇粉2-30份、蒲公英粉2-30份、黄精粉2-20份、姜黄2-10份、5'-鸟苷酸二钠1-10份、红枣粉2-50份、菊粉1-50份、牛磺酸1-40份、水苏糖2-30份。
进一步地,所述治疗和预防肿瘤的口服制剂,包括如下重量份数的原料:大豆肽粉2份、骨胶原蛋白肽2份、鱼胶原蛋白肽2份、(6S)-5-甲基四氢叶酸,氨基葡萄糖盐1份、吡咯并喹啉醌二钠盐1份、小牛胸腺肽粉1份、雪莲培养物1份、鱼精水解蛋白粉1份、蛹虫草粉2份、芦笋粉2份、香菇粉2份、蒲公英粉2份、黄精粉2份、姜黄2份、5'-鸟苷酸二钠1份、红枣粉2份、菊粉1份、牛磺酸1份、水苏糖2份。
根据本发明实施例的第二方面,提供如上任一项所述的治疗和预防肿瘤的口服制剂的制备方法,包括:
将各原料分别进行研磨处理,得各原料细料;
将各原料细料按重量份数进行备料,然后混合均匀即可。
进一步地,所述各原料细料的粒径为50-100目。
本发明中的主要原料功效:
大豆肽粉:指大豆蛋白质经大豆蛋白酶解制得的肽。以3~6个氨基酸组成的寡肽为主,能快速补充人体氮源,恢复体力,解除疲劳。大豆肽具有低抗原性、抑制胆固醇、促进脂质代谢及发酵等功能,还能快速补充蛋白质源,消除疲劳以及作为双歧杆菌增殖因子。
骨胶原蛋白肽:作为一种小分子肽,分子量更低,具有更好的消化吸收性,可直接被肠道吸收,进入血液,达到皮肤、肝脏、肾脏等身体各个部位。研究表明,骨胶原蛋白肽还具有低致敏性、抗氧化、抗疲劳、增强免疫力、促进矿物质吸收、延缓皮肤衰老、促进骨骼形成等方面的作用。
鱼胶原蛋白肽:可有效防止骨质疏松,对维持骨结构的完整性及骨生物力学特性非常重要;促进代谢和提高免疫力的作用。
(6S)-5-甲基四氢叶酸,氨基葡萄糖盐:是叶酸的一种化合物来源,也是叶酸的活性形式。
吡咯并喹啉醌二钠盐:被称为第十四种维生素,具有多种生物功能,不仅是生物条件性营养素和氧化还原调节剂,还是一种新辅基,可以促进酶的生长,在酶反应中担负着传递功能,能刺激微生物生长,因此常用作促生长因子。还具有治疗心脏病,神经性疾病,保护肝脏的作用,以及抗氧化的作用。
小牛胸腺肽粉:具有免疫调节的作用,可以增强人体抗辐射的能力,以及增强人体细胞免疫功能的作用。
雪莲培养物:主要药理作用镇痛、抗炎、抗风湿;抑制血小板聚集、降血脂、改善血液循环;对免疫系统具有调节作用;同时还有抗氧化、抗辐射、和抗疲劳等多方面的药效学作用。
鱼精水解蛋白粉:具有很高的营养性和功能性,能降血压、助呼吸、促消化、抑肿瘤、抗血栓、强化肝功能、抑制血液凝固等。在医学领域里,鱼精蛋白也得到了广泛应用,它可延迟或阻止胰岛素释放,或作为肝素解毒剂等。
蛹虫草粉:补肺阴、补肾阳,蛹虫草的作用是治肾虚,阳萎遗精,腰膝酸痛,病后虚弱,中医认为其起扶正固本作用,对老年性慢性支气管炎、肺原性心脏病有显著疗效,能提高肝脏解毒能力,起护肝作用,提高身体抗病毒和抗辐射能力。
芦笋粉、香菇粉、蒲公英粉、黄精粉、姜黄为扶正填充剂。
5'-鸟苷酸二钠、红枣粉、菊粉为口味调和剂。
牛磺酸、水苏糖为代谢调节剂。
本发明实施例具有如下优点:
1、本发明提供的口服制剂通过改善肿瘤体内微环境,改良生长肿瘤环境为生长正常组织细胞的环境,达到治疗癌症的目的,对人体正常细胞无杀灭作用,不会像放化疗药物对人体正常细胞和机能产生损伤,而且可配合放化疗药物同时服用。经过多年癌症晚期患者临床试验,大多患者服用一个月症状均有明显改善,且无不良反应报道。
2、本发明提供的口服制剂与传统肿瘤治疗方案有明显的互补性,两者有机结合,将大大提高患者生存质量,延长患者生存周期,并有望治愈中晚期肿瘤患者。
3、本发明口服制剂的原料均为符合国家食品标准的药食同源原料,常规服用不会有副作用,临床应用亦未见明显副作用。但对蛋白质、氨基酸过敏的超敏体质患者,不建议服用。
具体实施方式
以下由特定的具体实施例说明本发明的实施方式,熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
本实施例提供一种治疗和预防肿瘤的口服制剂,其原料为:大豆肽粉2份、骨胶原蛋白肽2份、鱼胶原蛋白肽2份、(6S)-5-甲基四氢叶酸,氨基葡萄糖盐1份、吡咯并喹啉醌二钠盐1份、小牛胸腺肽粉1份、雪莲培养物1份、鱼精水解蛋白粉1份、蛹虫草粉2份、芦笋粉2份、香菇粉2份、蒲公英粉2份、黄精粉2份、姜黄2份、5'-鸟苷酸二钠1份、红枣粉2份、菊粉1份、牛磺酸1份、水苏糖2份。
上述治疗和预防肿瘤的口服制剂的制备方法为:将各原料分别进行研磨处理,得粒径为50-100目的各原料细料;将各原料细料按重量份数进行备料,然后混合均匀即可。
实施例2
本实施例提供一种治疗和预防肿瘤的口服制剂,其原料为:大豆肽粉25份、骨胶原蛋白肽10份、鱼胶原蛋白肽20份、(6S)-5-甲基四氢叶酸,氨基葡萄糖盐1份、吡咯并喹啉醌二钠盐2份、小牛胸腺肽粉2份、雪莲培养物2份、鱼精水解蛋白粉5份、蛹虫草粉10份、芦笋粉5份、香菇粉10份、蒲公英粉10份、黄精粉5份、姜黄2份、5'-鸟苷酸二钠1份、红枣粉10份、菊粉5份、牛磺酸10份、水苏糖5份。上述口服制剂的制备方法同实施例1。
实施例3
本实施例提供一种治疗和预防肿瘤的口服制剂,其原料为:大豆肽粉10份、骨胶原蛋白肽20份、鱼胶原蛋白肽10份、(6S)-5-甲基四氢叶酸,氨基葡萄糖盐2份、吡咯并喹啉醌二钠盐2份、小牛胸腺肽粉1份、雪莲培养物5份、鱼精水解蛋白粉2份、蛹虫草粉15份、芦笋粉10份、香菇粉20份、蒲公英粉5份、黄精粉10份、姜黄5份、5'-鸟苷酸二钠5份、红枣粉20份、菊粉20份、牛磺酸15份、水苏糖10份。上述口服制剂的制备方法同实施例1。
测试例1体外细胞抑瘤实验研究
肿瘤细胞选择:Hela、Bel-7402两个细胞株。试验方法:MTT法体外抑瘤实验。将实施例1的口服制剂配制成不同浓度,细胞分组及抑制结果见表1。
表1
体外细胞实验证明:实施例1的口服制剂抑制肿瘤效果显著,抑制率达到81%。
测试例2动物体内抑瘤实验研究
实验动物选取:选取BALB/c小鼠48只,SPF级,均购自山大实验动物中心。雌雄各半,鼠龄5周,体重22.5±2.5g。
荷瘤小鼠模型建立:将生长状态良好的CT26细胞悬液1000rpm离心5min,去掉上清液,然后加入培养液,调整细胞浓度为5×106个/ml,用注射器植入小鼠右侧腋部皮下组织内,每只0.2ml。接种后每日观察小鼠精神、饮食、饮水、活动及大小便等一般生存状态,接种后定时观察成瘤情况。
荷瘤小鼠移植瘤模型分组实验:将荷瘤成功后的48只BALB/c小鼠随机分为三组,分别为对照组、低剂量组、高剂量组,每天早晚各给药一次;对照组饲喂生理盐水,每天早晚各一次。连续用药12天,用药期内注意观察小鼠的生存状态(精神、饮食、饮水、活动及大小便等一般生存状态),定时观察肿瘤生长情况。连续给药7d,停药次日处死动物,剥离皮下瘤块,称瘤重,比较各组瘤块生长情况,按抑瘤率(%)=(对照组瘤重-实验组瘤重)/对照组瘤重×100%计算抑瘤率。实施例1的口服制剂对荷瘤小鼠的抑瘤效果见表2。
表2
组别 | 给药剂量 | 抑瘤率/% |
对照组 | 0.9%生理盐水1ml | --- |
低剂量组 | 1ml(0.69mg/ml) | 56.7% |
高剂量组 | 1ml(1.95mg/ml) | 74.5% |
动物实验证明:实施例1的口服制剂的抑制肿瘤效果显著,高剂量组抑瘤率达74.5%,用药期间小鼠体重没有降低,无明显副作用。
测试例3临床试验
1、临床资料
选择晚期恶性肿瘤患者214例作为研究对象,其中,肺癌42例、肝癌30例、胃癌63例、乳腺癌55例、肾癌19例,其他5例,使用实施例1的口服制剂进行治疗。服用方法:取口服制剂3g加温开水100ml,冲调均匀后饮用;每日1-2袋,每次1袋。
2、疗效判定标准
有效:食欲恢复、体力恢复、疼痛感减轻、CT显示瘤体缩小、肿瘤指标恢复正常等内外指标表现。
显效:生存状态明显好转、CT显示肿瘤缩小、肿瘤指标恢复正常。
无效:未见明显变化。
3、结果
通过214例晚期恶性肿瘤患者临床服用证明,有效69例,显效102例,无效43例。临床总有效率80%,显效率48%,无效率20%。且临床证实无副作用,对肿瘤高危人群的预防也有很好的效果。
典型案例
例一:赵XX,男,58岁,肺癌晚期,单用实施例1的口服制剂进行治疗,连用三个月后,肺癌病变缩小,中央癌变组织出现凋亡,目前病情稳定。
例二:刘XX,女,65岁,2020年中分化腺癌-晚期,培美曲松+顺铂治疗4个疗程,出现颅内转移;改用实施例1的口服制剂治疗三个月,颅内转移几近消失,病情稳定。一年后复查见肺内病灶稳定,脑内病灶消失,直至目前患者健康存活。
例三:王X,女,46岁,乳腺癌晚期并肝转移。服用实施例1的口服制剂三个月后,肿瘤标志物恢复到正常值,CT检查多出肿瘤瘤体缩小,患者已能正常生活。
例四:李XX,女,41岁,体检检测肿瘤标志物-糖类抗原72-4数值为44.20,严重超过限值6.9,属癌症高危人群。患者服用实施例1的口服制剂半个月,肿瘤标志物-糖类抗原72-4数值下降为21.70,下降过半,胃蛋白酶原恢复正常。
虽然,上文中已经用一般性说明及具体实施例对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (5)
1.一种治疗和预防肿瘤的口服制剂,其特征在于,包括如下重量份数的原料:大豆肽粉2-100份、骨胶原蛋白肽2-100份、鱼胶原蛋白肽2-100份、(6S)-5-甲基四氢叶酸,氨基葡萄糖盐1-5份、吡咯并喹啉醌二钠盐1-5份、小牛胸腺肽粉1-5份、雪莲培养物1-10份、鱼精水解蛋白粉1-10份、蛹虫草粉2-50份、芦笋粉2-60份、香菇粉2-60份、蒲公英粉2-60份、黄精粉2-50份、姜黄2-30份、5'-鸟苷酸二钠1-20份、红枣粉2-100份、菊粉1-100份、牛磺酸1-90份、水苏糖2-80份。
2.根据权利要求1所述的治疗和预防肿瘤的口服制剂,其特征在于,包括如下重量份数的原料:大豆肽粉2-50份、骨胶原蛋白肽2-50份、鱼胶原蛋白肽2-50份、(6S)-5-甲基四氢叶酸,氨基葡萄糖盐1-2份、吡咯并喹啉醌二钠盐1-2份、小牛胸腺肽粉1-2份、雪莲培养物1-5份、鱼精水解蛋白粉1-5份、蛹虫草粉2-20份、芦笋粉2-30份、香菇粉2-30份、蒲公英粉2-30份、黄精粉2-20份、姜黄2-10份、5'-鸟苷酸二钠1-10份、红枣粉2-50份、菊粉1-50份、牛磺酸1-40份、水苏糖2-30份。
3.根据权利要求1所述的治疗和预防肿瘤的口服制剂,其特征在于,包括如下重量份数的原料:大豆肽粉2份、骨胶原蛋白肽2份、鱼胶原蛋白肽2份、(6S)-5-甲基四氢叶酸,氨基葡萄糖盐1份、吡咯并喹啉醌二钠盐1份、小牛胸腺肽粉1份、雪莲培养物1份、鱼精水解蛋白粉1份、蛹虫草粉2份、芦笋粉2份、香菇粉2份、蒲公英粉2份、黄精粉2份、姜黄2份、5'-鸟苷酸二钠1份、红枣粉2份、菊粉1份、牛磺酸1份、水苏糖2份。
4.权利要求1-3任一项所述的治疗和预防肿瘤的口服制剂的制备方法,其特征在于,包括:
将各原料分别进行研磨处理,得各原料细料;
将各原料细料按重量份数进行备料,然后混合均匀即可。
5.根据权利要求4所述的治疗和预防肿瘤的口服制剂的制备方法,其特征在于,所述各原料细料的粒径为50-100目。
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