CN108186899A - 一种***的中药组合物及其制备方法与应用 - Google Patents
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Abstract
本发明公开了一种***的中药组合物,包括斑蝥、干蛤蟆、蟾酥、蜈蚣、全蝎、蜂房、山茨菇、雄黄、细辛、轻粉、冰片、白降丹、干蟾皮、七叶一枝花、白芨、浙贝母、昆布、海藻、牡蛎、玄参、蒲公英、龟板、鳖甲、鱼腥草、牡丹皮、连翘、金银花、生地、赤芍、白菊花、半枝莲、半边莲、海蛤壳、海浮石、猫爪草、灵芝、了哥王、石上柏、八月扎、虎杖、地榆。本发明还公开了一种***的中药组合物的制备方法及应用。本中药组合物配比科学合理,各原料之间协同配合增强,具有很好的抗癌解毒、扶正祛邪、平衡阴阳、提高机体免疫力及抗病能力的功效,可以有效的治疗多种肿瘤,应用范围广泛,且安全性高、毒副作用低。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种***的中药组合物及其制备方法与应用。
背景技术
随着生活水平的提高、环境污染以及生活压力不断增大,肿瘤发病率越来越高。迄今,以手术、放疗、化疗和分子靶向治疗为主的综合治疗是肿瘤最主要的治疗手段,化疗仍为癌症治疗的基石。
化疗药物在杀死癌症细胞的同时对正常机体细胞也产生了极大的损伤,导致不良反应的发生,其中主要包括骨髓抑制、胃肠道反应、神经毒性,肝肾功能损害等,严重的会导致患者化疗疗程的延迟或中断,影响治疗效果和患者生活质量,甚至导致患者死亡。
中医学认为肿瘤的发生是外邪、七情、饮食不节、脏腑功能失调等多种病因综合作用的结果。临床表现:1)局部有形之结:肿块,或软、或硬、或坚硬如岩,留于体内,或附着体表,触之有形,推之不移等。2)全身失调与衰竭:病至中、晚期,机体功能低下或失调,肺虚则短气、咳嗽;脾虚则消瘦、体乏、纳少;肝虚则目涩、爪甲不荣、月事不调;心虚则心悸、怔忡;肾虚则水肿、小溲不利等。五脏之衰,终致大骨枯槁,大肉下陷,面色萎黄,发枯神惫之恶候。
基本病机包括以下过程:
1)癌毒滋生癌病的病理过程虽异常复杂,但总由癌毒的滋生与留着某处为先。而癌毒的产生与外邪侵袭、饮食不节、情志失调、脏腑亏虚、高年体衰等因素相关。多由正气亏耗,邪气深伏久滞,其致病之性愈甚,酿成癌毒所致。
2)搏结痰瘀癌毒一旦留结,阻碍经络气机运行,津液不能正常输布则留结为痰,血液不能正常运行则停留为瘀,癌毒与痰瘀搏结,形成肿块。
3)猖狂伤体瘤体形成,则狂夺精微以自养,致使瘤体迅狂胀大。机体因失养而迅速衰弱,脏腑功能因癌毒内扰而失调,诸证叠起。
4)步入损途癌毒伤人,病呈进行性发展,虽体质强健者,也难免病情恶化。癌毒伤正,正气亏虚,无力制约癌毒,则癌毒愈强,而癌毒愈强,又愈耗伤正气,如此反复,终陷毒猖正损,难以回复之恶境。
综上,由恶性肿瘤的主要临床表现与基本病机过程可见,其病机要素涉及正邪两方面。邪者,癌毒与痰瘀;正者,失调与虚损。初期以癌毒为先;继之癌毒搏结痰瘀,阻滞气机,导致脏腑功能失调;晚期耗伤气血津液,致使机体步入损途。因此,初期以癌毒为主;中期癌毒、痰瘀、失调并举;晚期则癌毒、痰瘀、失调与虚损并见。
中医药在***方面具有独特的优势,其从整体观念出发,实现辩证论治,标本兼治,能够较好地改善患者症状,弥补手术,放治,化疗的不足,减轻放化疗的毒副作用,对于减轻肿瘤患者的症状和痛苦,提高生存质量,延长寿命,降低肿瘤患者的死亡率,都有其重要意义。
发明内容
本发明的目的在于提供一种***的中药组合物及其制备方法与应用。本发明人在中医学理论的基础上结合多年临床经验,提供的组合物配比科学合理,各原料之间协同配合增强,可以有效的治疗多种肿瘤,应用范围广泛,且安全性高、毒副作用低。
为实现上述目的,本发明的第一方面提供了一种***的中药组合物,所述中药组合物由以下重量份数的原料制成:斑蝥5~15份、干蛤蟆15~40份、蟾酥5~15份、蜈蚣10~30份、全蝎10~30份、蜂房10~30份、山茨菇15~40份、雄黄7~20份、细辛5~15份、轻粉2~8份、冰片8~20份、白降丹2~10份、干蟾皮7~20份、七叶一枝花25~60份、白芨10~30份、浙贝母15~40份、昆布15~45份、海藻10~30份、牡蛎15~35份、玄参15~40份、蒲公英20~50份、龟板30~60份、鳖甲30~60份、鱼腥草15~40份、牡丹皮10~30份、连翘10~35份、金银花10~30份、生地10~25份、赤芍15~45份、白菊花10~30份、半枝莲20~50份、半边莲20~55份、海蛤壳15~40份、海浮石15~45份、猫爪草10~25份、灵芝25~50份、了哥王15~30份、石上柏15~30份、八月扎10~25份、虎杖10~30份、地榆15~30份。
进一步地,所述中药组合物由以下重量份数的原料制成:斑蝥5~10份、干蛤蟆15~30份、蟾酥5~10份、蜈蚣10~20份、全蝎10~20份、蜂房10~20份、山茨菇15~30份、雄黄7~15份、细辛5~10份、轻粉2~5份、冰片8~15份、白降丹2~5份、干蟾皮7~15份、七叶一枝花25~50份、白芨10~20份、浙贝母15~30份、昆布15~30份、海藻10~20份、牡蛎15~30份、玄参15~30份、蒲公英20~40份、龟板30~60份、鳖甲30~60份、鱼腥草15~30份、牡丹皮10~20份、连翘10~20份、金银花10~20份、生地10~15份、赤芍15~30份、白菊花10~20份、半枝莲20~40份、半边莲20~40份、海蛤壳15~30份、海浮石15~30份、猫爪草10~18份、灵芝25~50份、了哥王15~30份、石上柏15~30份、八月扎10~20份、虎杖10~20份、地榆15~30份。
进一步地,所述中药组合物由以下重量份数的原料制成:斑蝥10份、干蛤蟆30份、蟾酥10份、蜈蚣20份、全蝎20份、蜂房20份、山茨菇30份、雄黄15份、细辛10份、轻粉5份、冰片15份、白降丹5份、干蟾皮15份、七叶一枝花50份、白芨20份、浙贝母30份、昆布30份、海藻20份、牡蛎30份、玄参30份、蒲公英40份、龟板60份、鳖甲60份、鱼腥草30份、牡丹皮20份、连翘20份、金银花20份、生地15份、赤芍30份、白菊花20份、半枝莲40份、半边莲40份、海蛤壳30份、海浮石30份、猫爪草18份、灵芝50份、了哥王30份、石上柏30份、八月扎20份、虎杖20份、地榆30份。
进一步地,所述中药组合物以原料的水提取物为活性成分,加上药学上可接受的载体制成的制剂。
进一步地,所述制剂为口服液、颗粒剂、胶囊剂或片剂。
本发明的第二方面提供了一种上述的***的中药组合物的制备方法,所述方法包括以下步骤,
1)按照组合物配比称取相应重量份数的各原料,混合均匀后粉碎成粗粉;
2)在上述粗粉中加入原料总重量8~10倍量的水,煎煮1.5~3h,滤过,在滤渣中加入原料总重量4~6倍量的水,煎煮0.5~1.5h,滤过,合并两次煎煮液,煎煮液浓缩至60℃时相对密度为1.15~1.20的清膏,即得所述中药组合物。
进一步地,步骤2)所得到的清膏中加入药学上可接受的载体制成制剂。
本发明的第三方面提供了一种上述的中药组合物在制备***的药物中的应用。
进一步地,所述肿瘤包括肝癌、肺癌、胃癌、食道癌、胰腺癌、直肠癌、结肠癌、膀胱癌、脑部胶质肿瘤、卵巢癌、乳腺癌、子***、成骨肉癌、纵膈肿瘤、鼻咽癌、咽喉癌、***癌、甲状腺癌、肾癌、鳞状细胞癌、贲门癌以及白血病中的任一种。
本发明所选用各味中药的功效如下:
斑蝥:为芫青科昆虫南方大斑蝥Mylabris phalerata Pallas或黄黑小斑蝥Mylabris cichorii Linnaeus的干燥体。味辛,性热。归肝、胃、肾经。具有破血逐瘀,散结消瘸,攻毒蚀疮的功效。现代研究表明斑蝥含有的斑蝥素(亦称芫青素)具有抗癌活性,斑蝥素对小鼠腹水型肝癌和网织细胞肉瘤ARS均有一定的抑制作用,并能引起肝癌细胞明显萎缩、退化、胞浆多空泡等形态学改变。
干蛤蟆,又名干蟾,是蟾蜍科动物中华大蟾蜍(Bufo bufo gargarizans Cantor)或黑眶蟾蜍(Bufo melanostictus Schneider)的干燥全体。多于夏、秋二季捕捉杀死。味辛、凉,有毒。归肝、脾、肺经。蟾酥含数十种生物成分,有解毒、消肿、止痛功效。现代医学发现它有其他药物不可替代的强心、利尿、抗癌、麻醉、抗辐射、增加白血球的作用。
蟾酥:是蟾蜍耳后腺及表皮腺体的分泌物,白色乳状液体或浅黄色浆液。味甘、辛,性温。归心经。具有解毒,止痛,开窍醒神之功效。现代药理学表明蟾酥含有的蟾毒内酯类物质对小鼠肉瘤180、兔BP瘤、子***14、腹水型肝癌等均有抑制作用;蟾酥有止痛、提高免疫、抗炎等多种功效。
蜈蚣:本品为蜈蚣科动物少棘巨蜈蚣Scolopendra subspinipes mutilansL.Koch的干燥体。味辛,性温。归肝、脾、肺经。具有败毒抗癌、息风解痉、退炎治疮的功效。现代药理学研究表明,蜈蚣对移植性小鼠肉瘤、艾氏腹水癌、白血病、肝癌瘤体等的癌细胞均有抑制作用。
全蝎:为钳蝎科动物东亚钳蝎Buthus martensii Karsch的干燥体,味辛,辛平。归肝经。具有息风镇痉,攻毒散结,通络止痛的功效。全蝎对带瘤小鼠的肿瘤生长有明显抑制作用。
蜂房:为胡蜂科昆虫果马蜂、日本长脚胡蜂或异腹胡蜂的巢。味甘,性平。归胃经。具有攻毒杀虫,祛风止痛之功效。体外实验露蜂房能抑制人肝癌细胞。
山茨菇:本品为兰科植物杜鹃兰、独蒜兰或云南独蒜兰的干燥假鳞茎,味甘,微辛;性寒。归肝、胃、肺经。具有消肿,散结,化痰,解毒的功效。研究表明山茨菇多糖对H22肝癌小鼠具有一定的肿瘤抑制作用。
雄黄:是硫化物类矿物雄黄矿石。主要成分是二硫化二砷。有解毒杀虫、燥湿祛痰,截疟,定惊的功效。雄黄对实验动物及体外实验有抗菌、抗血吸虫、抑制疟原虫及抑瘤作用。
细辛:马兜铃科植物北细辛、汉城细辛或华细辛的干燥根和根茎。味辛,性温。归心、肺、肾经。具有解表散寒,祛风止痛,通窍,温肺化饮的功效。此外,细辛还具有抗炎免疫、局部麻醉、提高新陈代谢、抗菌作用,亦可用于肿瘤患者化疗和放疗所致的白细胞减少。
轻粉:别称汞粉、峭粉、银粉等,为粗制氯化亚汞结晶。味辛,性寒。归大肠、小肠经。具有杀虫、攻毒、敛疮、祛痰消积、逐水通便的功效。轻粉用于治疗多种肿瘤,食道癌和乳腺癌及恶性淋巴瘤。
冰片:是龙脑香科植物龙脑香的树脂和挥发油加工品提取获得的结晶,是近乎于纯粹的右旋龙脑。味辛、苦,性微寒。有开窍醒神、清热消肿、止痛的功能。冰片具有抑菌、抗炎的作用;对局部感觉神经有轻微的刺激作用,止痛及温和的防腐作用,可用于神经痛。
白降丹:主要含氯化汞及氯化亚汞。具有拔毒消肿,去腐杀虫的功效。主治痈疽发背,一切疗毒,无名肿毒,以及赘瘤、息肉、瘘管、恶疮、皮肤肿瘤等。
干蟾皮:是蟾蜍科动物中华大蟾蜍或黑眶蟾蜍等的皮。味苦,性凉。入心,肺,脾,大肠经。消肿解毒,止痛利尿。研究表明干蟾皮适用于多种肿瘤,如肝癌、肺癌、胃癌、恶性淋巴瘤、肠癌、食管癌、白血病等;外治皮肤癌、***、乳腺癌等。
七叶一枝花:性微寒,味苦,归肝。具有清热解毒,消肿止痛,凉肝定惊的功效。研究表明七叶一枝花的乙醇提取物可抑制HeLa瘤株、L929瘤株生长;甲醇提取物和水提物均对艾氏腹水瘤EAC有效;总皂苷亦可抑制H22实体瘤的生长。
白芨:味苦、甘涩、性微寒。入肝、胃、肺经。具有收敛止血,消肿生肌的功效。研究表明白芨对结核杆菌,肿瘤细胞等有明显抑制作用。
浙贝母:为百合科多年生草本植物浙贝母的干燥鳞茎,归肺、心经,具有清热化痰止咳,解毒散结消肿的功效。
昆布:味咸,性寒,入肝、胃、肾经。具有软坚散结、消痰,利水的功效。
海藻:苦咸,性寒。归肺、脾、肾、肝、胃经。具有软坚、消痰、利水、退肿的功效。研究表明海藻含有的褐藻胶具有抗肿瘤作用,海藻中富含的硒也有阻断癌细胞代谢、抑制癌细胞***和生长的作用。
牡蛎:又名牡蛤,味咸,微寒。归肝、肾经。具有平肝潜阳,软坚散结,收敛固涩的作用。现代药理研究表明,牡蛎具有细胞毒作用、诱导癌细胞凋亡、调节人体免疫功能、抗肿瘤血管生成等抗癌理作用。
玄参:为玄参科植物玄参及北玄参的根,性微寒,味甘、苦、咸。归肺经、胃经、肾经。具有凉血滋阴、泻火解毒的功效。研究表明玄参所含有的玄参多糖对食管癌Eca-109肿瘤、肉瘤S180肿瘤表现出一定的抑制作用。
蒲公英:味甘,微苦,性寒。归肝、胃经。有利尿、缓泻、退黄疸、利胆等功效。研究表明蒲公英含蒲公英甾醇、胆碱、菊糖、果胶等化学成分,具有抗菌、通乳、抗肿瘤、利胆等作用。
龟板:性微寒,味微咸、气微腥。含胶质、钙盐、脂肪和角蛋白等。具有滋阴降火,补心肾,潜阻退虚热等功效。研究表明龟板能提高机体抗肿瘤的免疫能力,其提取物对肉瘤S180、艾氏腹水瘤和腹水型肝癌有抑制作用。
鳖甲:鳖科动物鳖的背甲。味咸,微寒,归肝经、肾经。具有养阴清热,平肝熄风,软坚散结的功效。鳖甲具有抑制***增生,提高血浆蛋白,散结消肿的功效,可提高抗肿瘤的免疫能力。
鱼腥草:味辛、性微寒,归肺经。具有清热解毒、利水消肿、利尿通淋的功效。现代药理实验表明,鱼腥草具有抗菌、抗病毒、提高机体免疫力、利尿等作用。鱼腥草黄酮提取物对肿瘤细胞具有抑制作用。
牡丹皮:又名丹皮,为芍药科植物牡丹的干燥根皮。味辛、苦,性凉。具有清热凉血,活血化瘀的功效。近代药理研究表明,丹皮有抗凝血、降压、抗炎、抑制中枢神经***等功能。丹皮所含有的丹皮酚对肝癌、结肠癌、胃癌等多种肿瘤细胞具有抑制作用。
连翘:为木犀科植物连翘的干燥果实。味苦,性微寒。归肺、心、小肠经。具有清热解毒,消肿散结的功效。现代药理学研究表明,连翘具有抗炎、抗菌、抗病毒、解热、镇痛、强心、利尿、抑制磷酸二酯酶、降血压、抑制弹性蛋白酶活力、抗内毒素等作用。
金银花:性寒,味甘,归肺、胃经。具有清热解毒、凉血化淤、消炎退肿之功效。现代药理学研究表明,金银花具有抗病原、抗毒、抗炎、促进炎性细胞吞噬、降血、对肉瘤S180和艾式腹水癌有明显的细胞毒作用。
生地:也叫生地黄,来源于玄参科多年生草本植物地黄的新鲜或干燥的块根。味甘、苦,性寒。归心、肝、肾经。具有凉血清热、滋阴补肾、生津止渴的功效。现代药理研究表明,生地黄具有抗辐射、保肝、降低血,糖、强心、止血、利尿、抗真菌等作用,可应用于多种病症。
赤芍:为毛茛科植物芍药或川赤芍的干燥根。性味苦,微寒。归肝经。具有清热凉血、散瘀止痛、敛阴止汗的功效。现代药理学研究表明,赤芍具有保肝、抗血栓形成、抗血小板聚集、降血糖、抗动脉粥样硬化及抗肿瘤等多种药理作用。
白菊花:性辛、甘、苦,微寒。归肺、肝经。功效疏散风热,平肝明目,清热解毒。可用治疔疮肿毒。
半枝莲:为唇形科植物半枝莲的全草及根。又名狭叶韩信草、并头草。性凉,味微苦。功能为清热解毒、活血化瘀、利水消肿。主治毒蛇咬伤、疔疮疖肿、肝炎、肿瘤等病证。动物实验证实,半枝莲对肉瘤180、艾氏腹水癌、脑瘤22等均有一定抑制作用。
半边莲:为桔梗科植物半边莲的干燥全草。味辛,性平,归心、小肠、肺经。具有清热解毒、利尿消肿之效。现代药理研究表明半边莲具有细胞毒作用、诱导癌细胞凋亡、影响癌基因表达、抗肿瘤血管生成等抗癌药理作用。
海蛤壳:为帘蛤科动物文蛤或青蛤的贝壳。具有活血散寒、缓解痛经,强身健体、健脾补气、补肾壮阳、暖和身体的功效。
海浮石:为火成岩类岩石浮石的块状物或胞孔科动物脊突苔虫、瘤苔虫等的骨胳。味咸,性寒。归肺、肾经。清肺化痰,软坚散结。用于肺热咳嗽,痰稠色黄,咯血,支气管炎,***结核。
猫爪草:为毛莨科植物小毛莨的块根。味甘辛,性平,归肝,肺经。具有解毒,化痰散结的功效。科学表明猫爪草提取物猫爪草皂苷及多糖在治疗颈***结核,抗癌应用方面(包括甲状腺肿瘤,淋巴肉瘤,慢性粒细胞性白血病,肺癌等)有很大的临床疗效。
灵芝:多孔蓖科真菌灵芝的子实体。味甘,性平。归心、肺、肝、肾经。滋补强壮。用于健脑、消炎、利尿、益肾。灵芝所含的最有效成分之一灵芝多糖具有抗肿瘤及免疫调节作用。
了哥王:瑞香科植物南岭荛花的干燥根或根皮。味苦,性寒。归肺、胃经。具有清热解毒,散结逐水的功效。现代药理学研究表明了哥王具有抗肿瘤、利尿、抑菌等作用。
石上柏:味甘,性平。清热解毒,抗癌,止血。研究表明石上柏所含的生物硷对小鼠肉瘤有较好的抑制作用。
八月扎:为木通科植物,木通、三叶木通、白木通的果实,味苦,性寒;归肝、脾经。具有舒肝理气,活血止痛,除烦利尿的功效。研究表明八月扎含有的豆甾醇、皂甙及多糖等对肝癌、胃癌等消化***肿瘤,以及肺癌、乳腺癌有一点的治疗效果。
虎杖:蓼科植物虎杖的干燥根茎和根,味微苦,性微寒。归肝、胆、肺经。具有利湿退黄、清热解毒、散瘀止痛、化痰止咳的功效。现代研究:降压,减慢心率,加强心肌收缩力,保护心脏、降血脂;抑制血小板聚集,抗休克,改善微循环;抗菌、抗病毒、抗癌抗氧化;平喘,镇咳、镇静、镇痛,止血、抗炎。
地榆:蔷薇科地榆属多年生草本植物,纺锤形粗壮跟,短柄小叶,***花瓣,果实包藏萼筒内。性寒,味苦酸,无毒;归肝、肺、肾和大肠经。有凉血止血,清热解毒,培清养阴,消肿敛疮等功效。
本发明具有如下优点:
1、本发明根据肿瘤发生的中医学理论,从众多原药材中进行筛选与复配,经多年临床实践治疗验证,所得到的组合物配比科学合理,各原料之间协同配合增强,具有很好的抗癌解毒、扶正祛邪、平衡阴阳、提高机体免疫力及抗病能力的功效。并且对多种恶性肿瘤细胞均具有强的杀灭作用,应用范围广泛,能很好地改善临床症状,减少肿瘤患者痛苦,延长生存期,提高患者生存质量的作用,且经长期实验研究表明,本发明提供的中药组合物安全性高,毒副作用低。
2、本发明提供的制备方法简便易行、可操作性强,制剂药效稳定、易于推广应用。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。
实施例1
本实施例的***的中药组合物由以下重量份数的原料制成:斑蝥10份、干蛤蟆30份、蟾酥10份、蜈蚣20份、全蝎20份、蜂房20份、山茨菇30份、雄黄15份、细辛10份、轻粉5份、冰片15份、白降丹5份、干蟾皮15份、七叶一枝花50份、白芨20份、浙贝母30份、昆布30份、海藻20份、牡蛎30份、玄参30份、蒲公英40份、龟板60份、鳖甲60份、鱼腥草30份、牡丹皮20份、连翘20份、金银花20份、生地15份、赤芍30份、白菊花20份、半枝莲40份、半边莲40份、海蛤壳30份、海浮石30份、猫爪草18份、灵芝50份、了哥王30份、石上柏30份、八月扎20份、虎杖20份、地榆30份。
制备方法包括以下步骤:
1)按照上述组合物配比称取相应重量份数的原料,混合均匀后粉碎成粗粉;
2)在上述粗粉中加入原料总重量8倍量的水,煎煮1.5h,滤过,在滤渣中加入原料总重量4倍量的水,煎煮0.5h,滤过,合并两次煎煮液,煎煮液浓缩至60℃时相对密度为1.15的清膏,即得所述中药组合物,添加适当的辅料,以现代中药制剂常规工艺制成口服液。
实施例2
本实施例的***的中药组合物由以下重量份数的原料制成:斑蝥5份、干蛤蟆20份、蟾酥8份、蜈蚣10份、全蝎10份、蜂房20份、山茨菇20份、雄黄10份、细辛5份、轻粉6份、冰片10份、白降丹8份、干蟾皮10份、七叶一枝花40份、白芨10份、浙贝母20份、昆布15份、海藻10份、牡蛎20份、玄参20份、蒲公英20份、龟板30份、鳖甲45份、鱼腥草15份、牡丹皮25份、连翘10份、金银花10份、生地20份、赤芍20份、白菊花10份、半枝莲30份、半边莲20份、海蛤壳20份、海浮石15份、猫爪草10份、灵芝30份、了哥王20份、石上柏15份、八月扎20份、虎杖10份、地榆25份。
制备方法包括以下步骤:
1)按照上述组合物配比称取相应重量份数的原料,混合均匀后粉碎成粗粉;
2)在上述粗粉中加入原料总重量10倍量的水,煎煮3h,滤过,在滤渣中加入原料总重量6倍量的水,煎煮1.5h,滤过,合并两次煎煮液,煎煮液浓缩至60℃时相对密度为1.20的清膏,即得所述中药组合物,添加适当的辅料,以现代中药制剂常规工艺制成颗粒剂。
实施例3
本实施例的***的中药组合物由以下重量份数的原料制成:斑蝥15份、干蛤蟆40份、蟾酥5份、蜈蚣25份、全蝎30份、蜂房10份、山茨菇40份、雄黄20份、细辛8份、轻粉8份、冰片20份、白降丹10份、干蟾皮8份、七叶一枝花60份、白芨25份、浙贝母40份、昆布20份、海藻25份、牡蛎15份、玄参15份、蒲公英30份、龟板50份、鳖甲55份、鱼腥草20份、牡丹皮30份、连翘30份、金银花25份、生地25份、赤芍45份、白菊花30份、半枝莲50份、半边莲55份、海蛤壳40份、海浮石40份、猫爪草20份、灵芝25份、了哥王30份、石上柏25份、八月扎25份、虎杖30份、地榆15份。
制备方法包括以下步骤:
1)按照上述组合物配比称取相应重量份数的原料,混合均匀后粉碎成粗粉;
2)在上述粗粉中加入原料总重量9倍量的水,煎煮2h,滤过,在滤渣中加入原料总重量5倍量的水,煎煮1h,滤过,合并两次煎煮液,煎煮液浓缩至60℃时相对密度为1.18的清膏,即得所述中药组合物,添加适当的辅料,以现代中药制剂常规工艺制成胶囊剂。
实施例4
本实施例的***的中药组合物由以下重量份数的原料制成:斑蝥12份、干蛤蟆15份、蟾酥15份、蜈蚣30份、全蝎15份、蜂房30份、山茨菇15份、雄黄8份、细辛15份、轻粉4份、冰片15份、白降丹5份、干蟾皮20份、七叶一枝花30份、白芨30份、浙贝母15份、昆布15份、海藻30份、牡蛎15份、玄参40份、蒲公英50份、龟板40份、鳖甲30份、鱼腥草40份、牡丹皮10份、连翘35份、金银花30份、生地10份、赤芍15份、白菊花25份、半枝莲20份、半边莲50份、海蛤壳15份、海浮石45份、猫爪草25份、灵芝50份、了哥王15份、石上柏30份、八月扎10份、虎杖20份、地榆30份。
制备方法包括以下步骤:
1)按照上述组合物配比称取相应重量份数的原料,混合均匀后粉碎成粗粉;
2)在上述粗粉中加入原料总重量8倍量的水,煎煮2.5h,滤过,在滤渣中加入原料总重量4倍量的水,煎煮1.5h,滤过,合并两次煎煮液,煎煮液浓缩至60℃时相对密度为1.20的清膏,即得所述中药组合物,添加适当的辅料,以现代中药制剂常规工艺制成片剂。
试验例
一、为了表明本发明中药组合物的***的效果,本发明进行了下列疗效试验。
1、患者资料
选择近30年来我门诊就诊的肿瘤患者,共622例,其中男性383例,女性239例,年龄为5~80岁,肝癌62例、肺癌58例、胃癌40例、食道癌25例、胰腺癌15例、直肠癌37例、结肠癌28例、膀胱癌48例、脑部胶质肿瘤12例、卵巢癌30例、乳腺癌55例、子***22例、成骨肉癌18例、纵膈肿瘤11例、鼻咽癌37例、咽喉癌47例、***癌9例、甲状腺癌16例、肾癌7例、鳞状细胞癌9例、贲门癌20例、白血病16例。将上述患者随机分为试验组和对照组,两组分别311人,两组患者在性别、年龄、肿瘤类别等方面比较,差异无统计学意义(P>0.05),具有可比性。
2、疗效评定标准
治愈:患者经过治疗后,肿瘤瘤体缩小10%以上,临床症状全部消失,连续观察半年至一年无复发者;
显效:患者经过治疗后,肿瘤瘤体缩小1~10%,临床症状明显消失;
无效:患者经过治疗后,临床症状未见改善或者加重。
3、治疗方法
试验组:服用本发明实施例1制得的口服液,相当于原药材量130克,每天早、晚饭后各服用一次。
对照组:采用化疗及放疗治疗。
15天为1个疗程,6个疗程后复查。
4、治疗结果
经过6个疗程的治疗,试验组和对照组的疗效结果见表1。
表1
组别 | 治愈/人 | 显效/人 | 无效/人 | 总有效率 |
试验组 | 157 | 128 | 26 | 91.6% |
对照组 | 68 | 135 | 108 | 65.3% |
本发明临床实验证明,本发明提供的中药组合物对各类肿瘤的总有效率为91.6%,长期服用可抑制和预防细胞病变,增强人体免疫功能,且无毒副作用。
二、典型案例
1、张某,男,67岁,在当地医院检查,诊断为直肠癌,服用本发明实施例2制备的颗粒剂,每日两次,每次30克,症状见好,坚持用药2年,症状消失,全身情况好转,且能参加一些体力劳动。
2、刘某,58岁,患有肺癌,在医院剖胸,见病灶巨大,侵及左上纵膈及心包未能切除,连续服用本发明实施例3制备的胶囊剂一个月,每天2次,每次20克,休息10天后继续服用,经治疗5个月,肺部病灶稳定,继续服药,二个月后复检,胸片所见病灶渐见缩小,用药2年后,临床症状基本消失。
3、刘某,男,41岁。肝区疼痛,腹大如鼓,食欲不佳,在广州某医院检查后诊断为肝癌,服用本发明实施例1制备的口服液,每天2次,每次200毫升,6个月后病情明显好转,继续服药,1年后症状及体征消失,已追访五年仍健在。
4、何某,男,54岁,左下肢运动失灵四个月,头痛一个月,病情逐日加重,伴呕吐,眼花及听力减退,眼底有明显***水肿。左顶部颅板变薄。左侧肢体瘫痪(肌力减弱),脑血管造影显示右顶部似有肿瘤。临床诊断为右顶区占位性病变(脑肿瘤),入院后用镇静镇痛药物,依旧不能治疗头痛。后用本发明实施例2制备的颗粒剂,每天2次,每次20克,治疗10天后头痛基本消失,用药2年视为好转。可以看到墙上宣传画字迹,继续用药一个半月后,眼底***水肿消失,瘫痪肢体恢复功能,继续服用6个月肿瘤全消失了。
5、赵某,女,35岁,大病困难,便细如挤出牙膏,在某医院直肠镜和肛诊检查发现离***6厘米的直肠处有高低不平新生物,突出肠内,呈环状狭窄,肠管仅约为0.4厘米,接触出血,经活检证实为恶性肿瘤。服用本发明实施例4制备的片剂,每天3次,每次15克,治疗2个月,肿块溃烂,大便转向正常。出院后继续服用2年,情况良好,追访七年,病人仍健在。
6、彭某,男,63岁,工人,患者不适已半年余,主要表现为胸闷胁痛,腹胀暖气,纳食后即感冒且胃部不适,口燥便干,心悸头眩。检查结果显示,形体消瘦,体重51公斤,左上腹能触及肿块,质地软硬,左锁骨上触及***,红血球330万/mm3,血红蛋白8克%,大便潜血,血况28mm/小时,胃液检查无游离酸,X线钡餐检查,胃小弯部充盈缺损,直径为2cm,边缘不齐,粘膜皱壁粗乱,胃壁强直,蠕动波不能通过。诊断为胃癌。服用本发明实施例1制备的口服液,每天2次,每次200毫升,15天后,病情减轻,饮食增加,心悸头眩消失,面急转红润,大便已畅,精神爽快,继续服用半年,体重已增至68公斤,且已上班工作,检测腹部肿块已消失。红血球已增至450万/mm3,血沉降至18mm/小时,胃液游离酸为19单位,大便潜血(±),钡餐检查病变不明显,嘱其注意饮食起居,适当服药,随时复查,又追访2年,病人仍健在。
7、梁某,男,56岁,食管上段癌。吞食障碍已一年余,近3个月仅能进流食,舌根部有艺刺10多个,艺抽水长2-3毫米,服用本发明实施例3制备的胶囊剂,每天2次,每次15克,每次用药后半小时,腹内作响,有发热,食管觉疼,闭目躺卧半小时,反应消失,用药8次后开始腹泻,一昼夜泻下12次,泻物极臭,泻后觉轻快,色根部艺刺消失,用药5天后能进食豆腐,大米饭,半个月后能吃包子、馒头、窝窝头,日进主食7-8两,用药10个月时,食管造影显示病变好转,服药13个月后,其后拍片检查已不见病灶,追访7年,仍健在。
8、刘某,女,46岁,开始感觉少腹下附,疼痛,憋胀,有里急后重感,经某肿瘤医院检查诊断为***3期茶花型。见患者面色黛黑,形空荡荡枯瘦,精神疲惫,懒音无力,食欲不振,***无分泌物,时感疼痛下坠,服用本发明实施例4制备的片剂,每天2次,每次10克,10天后,疼痛、下坠感已减。继续服药1个月后,***有少量出血,前后服药3个月,诸症消失,后追访10年,患者健在。
9、邓某,女,33岁,患者发明左侧***有一鸡蛋大肿物,在北京某医院作病理检查,报告为“乳腺腺癌”,后行根治术,并作45天治疗,4个月后右侧***又出现核桃大肿物,双侧腋下,颈部也有大小不等的硬性肿物,因此又前去北京求治,诊断为癌肿广泛转移,无法医疗,转回原址,后服用本发明实施例2制备的颗粒剂,每天2次,每次25克,30天后,各处肿物开始变小,精神渐好,服药至180天,体重增加40余斤,精神佳,经复查,未见异常,后每半年去某肿瘤医院复查一次,均未发现异常,追访近7年,患者仍健在。
10、于某,女,45岁,患者发现颈部有指头肿块,不痛不痒,并不介意,以后逐渐长大,后发明肿块已如鸭蛋大小,经医院确诊为甲状腺腺瘤,服用本发明实施例3制备的胶囊剂,每天2次,每次25克,30天后,再经医院检查,肿块已消,随访一切均好,现正常参加各种劳动。
11、陈某,女,21岁,头顶长一豆大肿物,半年后长成栗子大小,曾在某医院切开引流,出血约200毫升。此后肿物迅速长大,呈菜花状,病理切片检查诊断为血管血瘤。其后服本发明实施例4制备的片剂,每天2次,每次10克,一个月后肿瘤明显缩小,两个月后肿瘤脱落。
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 (9)
1.一种***的中药组合物,其特征在于,所述中药组合物由以下重量份数的原料制成:斑蝥5~15份、干蛤蟆15~40份、蟾酥5~15份、蜈蚣10~30份、全蝎10~30份、蜂房10~30份、山茨菇15~40份、雄黄7~20份、细辛5~15份、轻粉2~8份、冰片8~20份、白降丹2~10份、干蟾皮7~20份、七叶一枝花25~60份、白芨10~30份、浙贝母15~40份、昆布15~45份、海藻10~30份、牡蛎15~35份、玄参15~40份、蒲公英20~50份、龟板30~60份、鳖甲30~60份、鱼腥草15~40份、牡丹皮10~30份、连翘10~35份、金银花10~30份、生地10~25份、赤芍15~45份、白菊花10~30份、半枝莲20~50份、半边莲20~55份、海蛤壳15~40份、海浮石15~45份、猫爪草10~25份、灵芝25~50份、了哥王15~30份、石上柏15~30份、八月扎10~25份、虎杖10~30份、地榆15~30份。
2.根据权利要求1所述的***的中药组合物,其特征在于,所述中药组合物由以下重量份数的原料制成:斑蝥5~10份、干蛤蟆15~30份、蟾酥5~10份、蜈蚣10~20份、全蝎10~20份、蜂房10~20份、山茨菇15~30份、雄黄7~15份、细辛5~10份、轻粉2~5份、冰片8~15份、白降丹2~5份、干蟾皮7~15份、七叶一枝花25~50份、白芨10~20份、浙贝母15~30份、昆布15~30份、海藻10~20份、牡蛎15~30份、玄参15~30份、蒲公英20~40份、龟板30~60份、鳖甲30~60份、鱼腥草15~30份、牡丹皮10~20份、连翘10~20份、金银花10~20份、生地10~15份、赤芍15~30份、白菊花10~20份、半枝莲20~40份、半边莲20~40份、海蛤壳15~30份、海浮石15~30份、猫爪草10~18份、灵芝25~50份、了哥王15~30份、石上柏15~30份、八月扎10~20份、虎杖10~20份、地榆15~30份。
3.根据权利要求1所述的***的中药组合物,其特征在于,所述中药组合物由以下重量份数的原料制成:斑蝥10份、干蛤蟆30份、蟾酥10份、蜈蚣20份、全蝎20份、蜂房20份、山茨菇30份、雄黄15份、细辛10份、轻粉5份、冰片15份、白降丹5份、干蟾皮15份、七叶一枝花50份、白芨20份、浙贝母30份、昆布30份、海藻20份、牡蛎30份、玄参30份、蒲公英40份、龟板60份、鳖甲60份、鱼腥草30份、牡丹皮20份、连翘20份、金银花20份、生地15份、赤芍30份、白菊花20份、半枝莲40份、半边莲40份、海蛤壳30份、海浮石30份、猫爪草18份、灵芝50份、了哥王30份、石上柏30份、八月扎20份、虎杖20份、地榆30份。
4.根据权利要求1~3中任一项权利要求所述的***的中药组合物,其特征在于,所述中药组合物以原料的水提取物为活性成分,加上药学上可接受的载体制成的制剂。
5.根据权利要求4所述的***的中药组合物,其特征在于,所述制剂为口服液、颗粒剂、胶囊剂或片剂。
6.一种权利要求1所述的***的中药组合物的制备方法,其特征在于,所述方法包括以下步骤,
1)按照组合物配比称取相应重量份数的各原料,混合均匀后粉碎成粗粉;
2)在上述粗粉中加入原料总重量8~10倍量的水,煎煮1.5~3h,滤过,在滤渣中加入原料总重量4~6倍量的水,煎煮0.5~1.5h,滤过,合并两次煎煮液,煎煮液浓缩至60℃时相对密度为1.15~1.20的清膏,即得所述中药组合物。
7.根据权利要求6所述的***的中药组合物的制备方法,其特征在于,步骤2)所得到的清膏中加入药学上可接受的载体制成制剂。
8.权利要求1所述的中药组合物在制备***的药物中的应用。
9.根据权利要求8所述的应用,其特征在于,所述肿瘤包括肝癌、肺癌、胃癌、食道癌、胰腺癌、直肠癌、结肠癌、膀胱癌、脑部胶质肿瘤、卵巢癌、乳腺癌、子***、成骨肉癌、纵膈肿瘤、鼻咽癌、咽喉癌、***癌、甲状腺癌、肾癌、鳞状细胞癌、贲门癌以及白血病中的任一种。
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