TW201904594A - 治療惡性腫瘤的中藥組合物、製備方法及其製劑 - Google Patents
治療惡性腫瘤的中藥組合物、製備方法及其製劑Info
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Abstract
本發明揭露一種治療惡性腫瘤的中藥組合物、其製備方法及其製劑。所述中藥組合物的原料藥組成為:喜樹果、鴉膽子油、斑蝥(製)、狼毒(製)、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草、茶葉。該藥在用於治療惡性腫瘤疾病時,能有效的抑制癌細胞的生存,調節因惡性腫瘤引起體內的酸鹼失衡及氧化還原狀況失衡,維持體內環境的狀態穩定性,促進正常的細胞代謝,具有療效好,毒副作用小的優點。
Description
本發明關於一種中藥組合物,特別關於用於治療惡性腫瘤的藥物組合物,本發明還關於該中藥組合物的製備方法及其製劑。
惡性腫瘤現稱為癌症(cancer),和它相對的是良性腫瘤。癌症是由於機體細胞失去正常調控,過度增殖而引起的疾病,常表現為局部組織的細胞異常增生而形成的局部腫塊。過度增殖的細胞稱癌細胞,癌細胞常可侵犯周圍組織(浸潤,invasion),甚至可經體內循環系統及/或淋巴系統轉移到身體其他部位,即為癌症轉移。癌症有多類型,而病症的嚴重程度取決於癌細胞所在部位,惡性程度是否發生轉移。一旦確認,當今常以結合手術、化療和放療的方式進行治療。如果癌症未經治療,一般來講最終結果將導致死亡。
癌症是機體正常細胞在多原因、多階段與多次突變所引起的一大類疾病。通常來講癌症的病因包括:機體在環境污染、化學污染(化學毒素)、電離輻射、自由基毒素、微生物(細菌、真菌、病毒等)及其代謝毒素、遺傳特性、內分泌失衡、免疫 功能紊亂等等各種致癌物質,以及致癌因素的作用下導致身體正常細胞發生癌變的結果。具體而言,前述癌變的原因如下所記載。
遺傳因素:癌症雖然目前不是明確的遺傳性疾病,但是越來越多的證據表明,癌症確實有遺傳傾向,特別是肝部有關癌症遺傳的證據較多。研究表明,基因是影響癌症遺傳的物質基礎。正常人體內的基因中,有一類叫原癌基因,另一類叫抑癌基因。原癌基因也稱為癌基因,如果發生突變,可以導致遺傳失調,在內外因素的作用下,使正常細胞變成癌細胞;抑癌基因能抑制或拮抗癌基因的功能及作用,若抑癌基因直接發生突變,也可導致細胞生長失調而發生癌變。所以說,原癌基因和抑癌基因可以說是對立統一的基因,如果原癌基因或者抑癌基因兩者之一發生衝突,就有可能發生癌症,這也是導致癌症遺傳性的一個潛在因素。
化學因素:這是目前發現的導致惡性腫癌發生的主要原因。目前醫學界已經發現1000多種化學物質具有致癌作用,其中與人類惡性腫癌關係比較密切的有三十餘種,比如,3,4-苯并芘類多環芳香烴、芥子氣、聯苯胺、苯胺、偶氮化合物、亞硝胺化合物、鉻、鎳、鋅、鎘、砷、鉬、桿、棉、氯乙烯、苯等,均是常見的致癌物質。還有一些化學物質對人類有潛在的致癌作用,比如農藥、家庭用化學清潔劑、消毒劑等。另外,研究表明,某些醫用藥物,如免疫抑製劑、激素類藥物等亦有致癌活性。不同的化學物質會引發不同的惡性腫瘤,比如長期大劑量接觸鉻可引發肺癌,而鎳接觸則會引起肺癌和鼻咽癌,砷接觸則會引發皮膚癌和肝癌,鎘接觸可引發前列腺癌,3,4-苯并芘則主要食於煤煙灰和煤焦油中,易引發陰囊癌和皮膚癌。
物理因素:研究顯示,對人類和動物有致癌作用的主要有電離輻射、X線、微波、電磁波、放射性物質、熱輻射、日光、紫外線、機械性刺激、灼熱、創傷等。人類受電離輻射易患白血病、骨肉瘤、甲狀腺癌等症,較大劑量的X線接觸或受大劑量紫外線照射,可誘發皮膚鱗狀細胞癌,長期接觸放射性物質或長期生活在放射性物質污染區域,容易得肺癌和白血病,長期食用過熱,過硬食物易誘發食管癌。
生物因素:生物致癌因素可分為兩種,其一是病毒,其二是黴菌。有些病毒潛伏到人體後,在一定條件下,就會誘發惡性腫瘤。與病毒有關的惡性腫瘤主要有鼻咽癌、宮頸癌、白血病、肝癌等。我們日常生活中食用的穀物、堅果和蔬菜等易受曲毒素、鐮刀菌、交鏈孢菌和雜色曲黴菌等多種黴菌的污染,導致誘發肝癌和胃癌。
HPV人類乳頭瘤病毒因素:HPV人類乳頭瘤病毒一般都是良性的,一但引起病變,也會引起呼吸道乳頭狀瘤(respiratory papillomatosis)及各種其他癌症。
生活方式影響:研究表明,不良的生活方式對癌症病變確實有一定影響,例如吸煙、飲食、運動、酒精、曬太陽以及性病等。癌症的發生也和體內褪黑激素的量相關,當需要長時間待在明亮的環境下,褪黑激素表現量會偏低,而癌症的發病率則較高。
擴散影響:腫瘤在其生長過程中,雖然能夠暫時藉由搭建血管解決自身給養問題,但是快速的增長一樣會將之推向資源和空間匱乏的邊緣,這時腫瘤就會擴散,並且開始入侵周圍的正常組織(癌症浸潤),並且通過血管轉移到遠端(癌症轉移)。
目前,治療癌症的主要手段依靠西醫,常以結合手術、化 療及/或放療的方式進行治療。但上述治療方式在殺除癌症細胞的同時,也會損傷健康細胞,患者還需經受手術、化療、放療帶來的痛苦及不良副作用,所以西醫治療普遍存在著治癒率較低、以及易復發的問題,另外也存在著醫療費用較高的問題。幾年來,以中醫療法治療惡性腫瘤逐漸引起醫學重視,中醫療法因其副作用小且治療費用較低的優勢,正在臨床上日益應用,並取得較好的療效。
本發明所要解決的技術問題在於提供一種治療惡性腫瘤的中藥組合物,並進一步揭露其製備方法。
為了解決上述技術問題,本發明提供了一種治療惡性腫瘤的中藥組合物,所述中藥組合物的原料藥組成為:1-30重量份的喜樹果;1-30重量份的鴉膽子油;0.1-0.9重量份的斑蝥;1-30重量份的狼毒;1-30重量份的土貝母;1-30重量份的腫節風;1-30重量份的夏枯草;1-20重量份的莪術;1-15重量份的黃芪;1-15重量份的丹參;1-15重量份的茯苓;1-15重量份的三七;1-15重量份的桑黃;1-30重量份的蒲公英;1-30重量份的絞股藍;1-15重量份的甘草;1-20重量份的茶葉。
較佳的,所述中藥組合物的原料藥組成為:4-18重量份的喜樹果;4-15重量份的鴉膽子油;0.2-0.7重量份的斑蝥;4-15重量份的狼毒;4-20重量份的土貝母;4-18重量份的腫節風;5-20重量份的夏枯草;4-15重量份的莪術;4-15重量份的黃芪;4-8重量份的丹參;5-12重量份的茯苓;4-11重量份的三七;4-9重量份的桑黃;5-20重量份的蒲公英;5-20重量份的絞股藍;4-10重量份的甘草;4-15重量份的茶葉。
更佳的,所述中藥組合物的原料藥組成為:5-12重量份的喜樹果;5-12重量份的鴉膽子油;0.3-0.8重量份的斑蝥;5-12重量份的狼毒;6-18重量份的土貝母;6-15重量份的腫節風;6-15重量份的夏枯草;6-12重量份的莪術;6-12重量份的黃芪;5-8重量份的丹參;6-9重量份的茯苓;6-10重量份的三七;6-8重量份的桑黃;6-15重量份的蒲公英;8-15重量份的絞股藍;6-9重量份的甘草;6-12重量份的茶葉。
本發明還揭露一種由所述的治療惡性腫瘤的中藥組合物,添加常規輔料,按照常規製程製備成的臨床可接受的製劑。
更佳的,所述製劑包括膠囊劑、顆粒劑、貼劑、針劑、合劑或丸劑。
所述輔料包括醫用澱粉、乳糖、β環糊精、硬脂酸鎂、山茶油、水楊酸、白凡士林、冰醋酸、固體石蠟、蜂蜜、生石灰、蒸餾水中的至少一種。
本發明還揭露一種製備所述製劑的方法,包括取選定量的喜樹果、鴉膽子油、斑蝥、狼毒、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草和茶葉混勻的步驟,並添加常規輔料,按照常規製程製成臨床可接受的製劑。
更佳的,所述製備所述製劑的方法,包括如下步驟:S1:取選定量的斑蝥與糯米置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足,備用;S2:取選定量的狼毒片,加米醋拌勻,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉,備用;S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、鴉 膽子油、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草和茶葉混勻,添加常規輔料,按照常規製程製成臨床可接受的製劑。
所述步驟S1中,加入的斑蝥與糯米的質量比為1:2;所述步驟S2中,加入的狼毒片與米醋的質量比為10:3。
最佳的,所述製備方法,包括如下步驟:S1:取選定量的斑蝥與糯米置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足,備用;S2:取選定量的狼毒片,加米醋拌勻,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉,備用;S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草和茶葉混勻,加水浸泡後,加熱至沸騰並煎煮,取煎煮液加入選定量的鴉膽子油混勻,固液分離後,收集濾液文火濃縮至比重為1.30-1.35的濃縮液,烘乾並加入常規輔料,製得臨床可接受的膠囊劑;或者S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草和茶葉混勻,粉碎成粗顆粒狀,加水浸泡後,加熱煎煮並收集煎煮液,隨後加入選定量的鴉膽子油,文火蒸發至比重為0.9-1.1的蒸發液,冷卻後加入60wt%的乙醇充分混勻沉降,取上清液並減壓回收乙醇,濃縮至比重為1.2-1.5的濃縮液,隨後文火蒸發至稠膏狀,烘乾並加入常規輔料,製得臨床可接受的顆粒劑;或者S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、土 貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草和茶葉,粉碎並過200目篩;取蜂蜜置於瓷鍋中熬製,並加入選定量的鴉膽子油拌勻,加入上述原料粉末混勻,冷卻後製得臨床可接受的丸劑;或者S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草、茶葉混勻,加水浸泡後,加熱煎煮並收集煎煮液,隨後加入選定量的鴉膽子油混勻,固液分離並收集濾液文火濃縮至比重為1.30-1.35的濃縮液,然後加入濃度為0.9%的氯化鈉溶液,製得臨床可接受的中藥針劑。
所述加入的蜂蜜與中藥原料藥總和的質量配比為(3-6):100。
本發明還揭露一種治療惡性腫瘤的貼劑,所述貼劑的原料藥組成為:1-30重量份的喜樹果;1-30重量份的鴉膽子油;0.1-0.9重量份的斑蝥;1-30重量份的狼毒;1-30重量份的土貝母;1-30重量份的腫節風。
本發明還揭露一種製備所述治療惡性腫瘤的貼劑的方法,包括以下步驟:S1:取選定量的斑蝥與糯米置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足,備用;S2:取選定量的狼毒片,加米醋拌勻,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉,備用;S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、土貝母、腫節風,置粉碎機粉碎過200目細篩,備用;S4:取生石灰投入到裝有清水的容器中,反應後得石灰水, 待石灰水澄清十五天之後,取出澄清石灰水,裝於容器待用,取選定量的鴉膽子油及生山茶油,加入至裝有石灰水容器裡,攪拌成糊狀,最後加入步驟S3製備的細粉,製得臨床可接受的貼劑。
所述步驟S4中加入的生石灰與清水的質量配比為1:5,取出的澄清石灰水與所述山茶油的質量配比為1:1。
本發明所述中藥組合物,是在傳統中醫藥理論指導下,並結合現代醫學的研究成果,在大量前期試驗研究的基礎上,精選十七味中藥原料重新組方。本發明所述中藥組合物,以喜樹果、鴉膽子、斑蝥、狼毒為君藥,主攻惡毒;以土貝母、腫節風、夏枯草、莪術、黃芪、丹三、茯苓、三七、桑黃、蒲公英,此十味藥為臣藥,達到清熱解毒逐積,活血化瘀之效;以絞股藍、甘草、茶葉為佐使藥,共奏解毒攻毒、扶正驅邪的功效。本發明所述中藥組合物的個別組分描述如下。
喜樹果:味苦、辛、性寒,有抗癌散結、清熱解毒、活血消腫的功效,並有抗腫瘤的作用,喜樹鹼能使癌細胞發生變性、壞死、核固縮、濃染、染色質凝聚,胞漿多空泡等形態學改變,還能使癌細胞和宿主肝細胞超微結構發生變化,最終導致癌細胞溶解破壞而促進細胞死亡。
鴉膽子:味苦、性寒,有清熱止痢、解毒殺蟲的功效,有抗腫瘤作用,鴉膽子含有大量脂肪酸,特別是不飽和脂肪酸,故有效明顯的抗癌作用,鴉膽子苦素、鴉膽子苦烯、鴉膽子苦醇、鴉膽子苷、鴉膽子油等多種不同成分,均有不同程度的抗腫瘤作用,以鴉膽子油作用最為明顯,鴉膽子醇、鴉膽子苦醇和鴉膽子苷A、D、E對P388淋巴細胞、白血病DNA聚合酶、RNA聚合酶、胸苷酸合成酶(thymidylate synthetase)、雙氫葉 酸還原酶、磷酸核糖焦磷酸氨轉移酶(phosphoribosyl pyrophosphate aminotransferase)和組織蛋白酶的活性有邊緣抑制作用,抑制RNA和蛋白質合成。以鴉膽子苦醇作用最強,並能抑制P388細胞增殖及細胞內已糖激酶,磷酸果糖激酶和琥珀酸脫氫酶的活性。鴨膽子含的黃花菜木脂素A,鴉膽子苦素D、E,鴉膽子苦苷A,鴉膽子苷A、H、F、I、J、L、P,鴉膽子苦醇及去氫鴉膽子醇均顯示有抗P388淋巴性白血病活性。鴉膽子苷AB對W256、ECA艾氏腹水癌也有抑制作用。
斑蝥:味辛、性溫,有大毒,有攻毒蝕瘡,破血散結的功效,有抗腫瘤作用,斑蝥素是斑蝥的活性成份,對肝臟和癌細胞有較強的親和性、斑蝥素,首先能抑制癌細胞蛋白質合成,繼而影響RNA和DNA合成,最終抑制癌細胞的生長和分裂。
狼毒:味苦、辛、性平,有逐水祛痰,破積殺蟲的功效,狼毒中的格尼迪木任對多種腫瘤有較強的抑制作用。
土貝母:味苦、性涼,歸肺、胃經,有抗癌作用,土貝母糖苷I對多種移植性腫瘤有抑制作用,有清熱化痰、散結拔毒的功效。
腫節風:味辛苦、性平,有祛風除濕、活血散瘀、清熱解毒的功效,腫節風揮發油、浸育對自血病615細胞、TM755、肺腺病615、白髮乳腺癌615、自發腹水型AL771、艾氏腹水癌、肉瘤180、肉瘤37、瓦克癌256均有一定的抑制作用。
夏枯草:味苦、辛、性寒,有清肝瀉火,解鬱散結,消腫解毒的功效,夏枯草所含的熊果酸對細胞P388、L1210和人體腫瘤細胞A-549具有顯著細胞毒性,對艾氏腹水瘤及肉瘤S180均有抑制作用。
莪術:味辛、苦、性溫,有破血行氣,消積止痛的功效, 有抗腫瘤的作用,對體外培養的肝癌細胞有較強的殺傷作用,能明顯抑制RNA聚合酶活性,使DNA吸收光譜移位及螢光強度增加。
黃芪:味甘、性微溫,有補氣升陽、固表止汗、行水消腫、托毒生肌的功效,有抗腫瘤的作用,黃芪多糖對癌性腹水淋巴細胞啟動有增效作用,服用者癌性腹水中CTL細胞易被IL-2啟動,啟動時間縮短、擴增倍數大。此外,還對正常人及腫瘤患者外周血單個核細胞在體外分泌TNF具有明顯地促進作用,對TNF-α和TNF-β均有增強作用,黃芪能顯著增強肺癌浸潤淋巴細胞(TIL)的體外殺傷活性,與人參皂苷合用對TIL細胞具有協同正向調節作用。
丹參:味苦、微辛、性微寒,有涼血消腫、活血祛瘀、養血安神的功效,有促進組織修復和再生的作用,丹參酮ⅡA可通過影響癌基因表達及DNA多聚酶活性,抑制HL-60細胞合成,從而抑制細胞增殖,誘導細胞分化。
茯苓:味甘、淡、性平,有利水滲濕、健脾補中、寧心安神的功效,茯苓多糖對生長遲緩型的移植腫癌具有顯著抑制作用,茯苓多糖體的抗腫瘤作用機制主要是增強了機體的免疫功能,啟動了免疫監視系統,提高機體對癌細胞特異性抗原的免疫能力,發揮機體的抗癌能力,使被啟動的補體通過影響Mφ、淋巴細胞及體液因子等,協同殺傷腫瘤細胞。
三七:味甘、微苦、性溫,有止血散瘀、消腫定痛的功效,有抗腫瘤作用,三七中的人參苷Rb1、Rd、Rh1、Rh2均能使培養的腫瘤細胞受到抑制,Rh1直接作用於細胞膜,Rh2能使癌細胞再分化誘導逆轉成非癌細胞。
桑黃:味微苦、性寒,有抗癌作用,強化免疫力,誘導癌 細胞自行死亡,能抑制癌細胞的增殖及轉移。
蒲公英:味苦、甘、性寒,有清熱解毒,散結消腫,除濕利尿的功效。
絞股藍:味甘、性溫,有補虛潤燥、祛風活血、消腫解毒的功效,有抗腫瘤作用,絞股藍能防止正常細胞癌化,並促使細胞發揮自我治癒能力,引導癌化細胞恢復正常。絞股藍對人胃腺癌(SGC-7901)細胞Co照射效應有明顯的影響,顯示細胞存活比率提高,S期細胞明顯增加,G1期、G2期細胞比例減少。絞股藍中,絞股藍皂苷XX可直接殺滅S180內瘤細胞。絞股藍皂苷XX1在體外顯著抑制肝癌細胞生長。絞股藍皂苷對體外培養的肺癌、子宮癌、黑色素腫瘤細胞有抑制作用。絞股藍中的人參二醇和原人參二醇有一定抗腫瘤活性,絞股藍多糖對腫瘤細胞有較強的抑制殺滅作用。絞股藍抑制腫瘤細胞,增殖和增強免疫功能的作用,主要表現在對腫癌細胞有絲分裂的阻斷,干擾DNA合成過程及提高其突變能力。GPS可使環磷醯胺所致的姐妹染色體互換頻率增高顯著下降。絞股藍能使直腸腺癌細胞的DNA合成降低,核分裂數減少,細胞變性壞死。
甘草:味甘、性平,有益氣補中、緩急止痛、潤肺止咳、瀉火解毒、調和藥性的功效。
茶葉:味苦、甘、性涼,有消利頭目,除煩止渴消食化痰、利尿解毒的功效,有抗腫瘤、抗誘變作用,綠茶多酚(GTP)能抑制黃麴黴素B(AFB)和苯丙芘BP等,調節免疫作用,綠茶可改善環磷醯胺所損害的骨髓造血功能,使其白細胞和紅細胞數上升,有基因調節的作用。
本發明所述中藥組合物,對56例均患有晚期原發性肝癌的確診患者進行臨床實驗,治療效果中症狀完全緩解12例、部分 緩解20例、穩定22例,總有效率高達為96.4%,表明本發明藥物可有效控制腫瘤的生長,抑制癌細胞擴散,同時可改善患者肝區疼痛、身體乏力、食欲不振等症狀,從而提高患者生存品質,延長患者生存期。除此之外,本發明藥物對肺癌、淋巴癌、胃癌、食道癌、膀胱癌、卵巢癌、前列腺癌、胰腺癌等其它腫瘤病和對已做過手術、放療、化療的腫瘤患者的康復治療同樣有理想的治療效果。
為了使本發明的目的、技術方案和優點更加清楚,下面將對本發明的實施方式作進一步地詳細描述。本發明可以以許多不同的形式實施,而不應該被理解為限於在此闡述的實施例。相反,提供這些實施例,使得本發明將是徹底和完整的,並且將把本發明的構思充分傳達給本領域技術人員,本發明將僅由權利要求來限定。
實施例1:本發明的治療惡性腫瘤的中藥組合物(膠襄劑)
本實施例所述治療惡性腫瘤的膠囊劑的中藥組合物組成:
本實施例所述治療惡性腫瘤的膠囊劑的製備方法,包括如 下步驟:S1:按質量比1:2取斑蝥與糯米,置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足備用;S2:取狼毒片,加入0.3倍狼毒片重量的米醋拌勻,悶潤至透,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉備用;S3:取經步驟S1、S2處理後的斑蝥0.8g、狼毒片10g,以及喜樹果12g、土貝母6g、腫節風6g、夏枯草12g、莪述9g、黃芪9g、丹參8g、茯苓9g、三七10g、桑黃6g、蒲公英12g、絞股藍15g、甘草6g、茶葉6g,加入500ml水浸泡30分鐘後,加熱至沸、煎煮90分鐘,過濾出煎出液,藥渣按上述方法煎出2次,收集各煎出液,加入鴉膽子油12g,攪拌均勻,離心分離後,將分離液文火濃縮至比重為1.30的濃縮液,烘乾,按質量比為1:1加β環糊精,製得治療惡性腫瘤膠囊劑。
實施例2:本發明的治療惡性腫瘤的中藥組合物(顆粒沖劑)
本實施例所述治療惡性腫瘤的顆粒劑的中藥組合物組成:
本實施例所述治療惡性腫瘤的顆粒劑的製備方法,包括如下步驟: S1:按質量比1:2取斑蝥與糯米,置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足備用;S2:取狼毒片,加入0.3倍狼毒片重量的米醋拌勻,悶潤至透,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉備用;S3:取經步驟S1、S2處理後的斑蝥0.5g、狼毒片9g,以及喜樹果12g、土貝母12g、腫節風15g、夏枯草9g、莪術9g、黃芪9g、丹參5g、茯苓6g、三七6g、桑黃6g、蒲公英6g、絞股藍8g、甘草9g、茶葉12g,粉碎成粗顆粒狀,置於容器中,加入500ml的水浸泡30分鐘後,加熱至沸,煎煮90分鐘,過濾出煎出液,藥渣按上述方法煎出3次,收集各煎出液,加入鴉膽子油12g,文火蒸發至比重為1.0的蒸發液,冷卻後加入1.5倍量的60%乙醇充分混勻,放置過夜,次日取上清液(必要時過濾),沉澱物用2倍量的60%乙醇洗滌得洗液,合併洗液和上清液,減壓回收乙醇,濃縮至比重為1.2的濃縮液,靜置36小時,過濾,文火蒸發至稠膏狀,烘乾,按質量比為1:1加入醫用澱粉,製得治療惡性腫瘤中藥顆粒沖劑。
實施例3:本發明的治療惡性腫瘤的中藥組合物(貼劑)
本實施例的治療惡性腫瘤貼劑的中藥組合物組成:
本實施例的治療惡性腫瘤貼劑的製備方法,包括如下步驟:S1:按質量比1:2取斑蝥與糯米,置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、 去翅、去足備用;S2:取狼毒片,加入0.3倍狼毒片重量的米醋拌勻,悶潤至透,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉備用;S3:取經步驟S1、S2處理後的斑蝥0.8g、狼毒片12g,以及喜樹果12g、土貝母18g、腫節風15g,置粉碎機粉碎過200目細篩,篩成細粉待用;S4:取生石灰投入到裝有清水的容器中,所述生石灰與清水的質量比為1:5,反應後得石灰水,待石灰水澄清十五天之後,取出澄清石灰水12g,裝於容器待用,取生山茶油12g、鴉膽子油12g加入置裝有石灰水容器裡,攪拌成糊狀,最後加入步驟S3製備的細粉,製得治療惡性腫瘤貼劑。
實施例4:本發明的治療惡性腫瘤的中藥組合物(大蜜丸)
本實施例所述治療惡性腫瘤的大蜜丸中藥組合物組成:
本實施例所述治療惡性腫瘤的大蜜丸的製備方法,包括如下步驟:S1:按質量比1:2取斑蝥與糯米,置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足備用; S2:取狼毒片,加入0.3倍狼毒片重量的米醋拌勻,悶潤至透,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉備用;S3:取經步驟S1、S2處理後的斑蝥0.6g、狼毒片6g,以及喜樹果9g、土貝母9g、腫節風9g、夏枯草12g、莪術6g、黃芪12g、丹參6g、茯苓6g、三七10g、桑黃8g、蒲公英6g、絞股藍9g、甘草9g、茶葉9g,放於粉碎機粉碎,過200目細篩,篩成粉末備用;S4:取生蜂蜜6g置於瓷鍋中熬至用手黏上能抽2-3公分的絲為止,加入鴉膽子油9g,拌勻,加入步驟S3製備的粉末,混勻放涼,製得治療惡性腫瘤口服大蜜丸。
實施例5:本發明的治療惡性腫瘤的中藥組合物(小蜜丸)
本實施例所述治療惡性腫瘤的小蜜丸的中藥組合物組成:
本實施例所述治療惡性腫瘤的小蜜丸的製備方法,包括如下步驟:S1:按質量比1:2取斑蝥與糯米,置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足備用;S2:取狼毒片,加入0.3倍狼毒片重量的米醋拌勻,悶潤 至透,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉備用;S3:取經步驟S1、S2處理後的斑蝥0.8g、狼毒片6g,以及喜樹果10g、土貝母15g、腫節風15g、夏枯草15g、莪術7g、黃芪7g、丹參7g、茯苓7g、三七7g、桑黃7g、蒲公英15g、絞股藍15g、甘草7g、茶葉7g,放於粉碎機粉碎,過200目細篩,篩成粉末備用;S4:取生蜂蜜7g置於瓷鍋中熬至用手黏上能抽2-3公分的絲為止,加入鴉膽子油10g,拌勻,加入步驟S3製備的粉末,混勻放涼,製得治療惡性腫瘤口服小蜜丸。
實施例6:本發明的治療惡性腫瘤的中藥組合物(水蜜丸)
本實施例所述治療惡性腫瘤的水蜜丸的中藥組合物組成:
本實施例所述治療惡性腫瘤的水蜜丸的製備方法:S1:按質量比1:2取斑蝥與糯米,置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足備用;S2:取狼毒片,加入0.3倍狼毒片重量的米醋拌勻,悶潤至透,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉備用; S3:取經步驟S1、S2處理後的斑蝥0.2g、狼毒片4g,以及喜樹果4g、土貝母4g、腫節風4g、夏枯草5g、莪術4g、黃芪6g、丹參8g、茯苓12g、三七11g、桑黃4g、蒲公英5g、絞股藍5g、甘草9g、茶葉9g,放於粉碎機粉碎,過200目細篩,篩成粉末備用;S4:取生蜂蜜5g置於瓷鍋中熬至用手黏上能抽2-3公分的絲為止,加入鴉膽子油4g,拌勻,加入步驟S3製備的粉末,混勻放涼,製得治療惡性腫瘤口服水蜜丸。
實施例7:本發明的治療惡性腫瘤的中藥組合物(針劑)
本實施例所述治療惡性腫瘤的針劑的中藥組合物組成:
本實施例所述治療惡性腫瘤的針劑的製備方法:S1:按質量比1:2取斑蝥與糯米,置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足備用;S2:取狼毒片,加入0.3倍狼毒片重量的米醋拌勻,悶潤至透,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉備用;S3:取經步驟S1、S2處理後的斑蝥0.5g、狼毒片6g,以及喜樹果9g、土貝母9g、腫節風9g、夏枯草9g、莪術12g、黃 芪6g、丹參8g、茯苓6g、三七10g、桑黃8g、蒲公英12g、絞股藍8g、甘草7g、茶葉7g,加入500ml水浸泡30分鐘後,加熱至沸、煎煮90分鐘,過濾出煎出液,藥渣按上述方法煎出2次,收集各煎出液,加入鴉膽子油9g,攪拌均勻,離心分離後,將分離液文火濃縮至比重為1.35的濃縮液,然後按照1:1的比例加入濃度為0.9%的氯化鈉溶液,攪拌均勻,製得治療惡性腫瘤中藥針劑。
實驗例
實驗例1對肝癌的治療效果
一、對肝癌腫瘤細胞株的抑制實驗
1、材料
1.1藥物:稱取喜樹果12g、斑蝥(製)0.8g、狼毒片(製)10g、土貝母6g、腫節風6g、夏枯草12g、莪術9g、黃芪9g、丹參8g、茯苓9g、三七10g、桑黃6g、蒲公英12g、絞股藍15g、甘草6g、茶葉6g,加入500ml水浸泡30分鐘後,加熱至沸、煎煮90分鐘,過濾出煎出液,藥渣按上述方法煎出2次,收集各煎出液,加入鴉膽子油12g,攪拌均勻,離心分離後,將分離液文火濃縮至比重為1.30的濃縮液。
1.2動物:KM小鼠,體重20±3g。
1.3瘤株:肝癌HepS22。
2、實驗方法
取荷瘤傳代鼠脫頸椎處死,切開皮膚,選擇腫瘤生長良好、無壞死或液化的癌組織,按1:3加入無菌生理鹽水,用組織勻漿器製成癌細胞懸液,在實驗小鼠腋窩皮下接種0.2ml。接種後次日隨機分組,每組12隻。
實驗設高、中、低劑量給藥三個實驗組、模型組和對照組。
其中高劑量實驗組給藥量為1g/kg體重,中劑量實驗組給藥量為0.5g/kg體重,低劑量實驗組給藥量為0.1g/kg體重。
對照組給環磷醯胺20mg/kg體重。
模型組給無菌生理鹽水1g/kg體重。
灌胃給藥,每天一次,給藥10天後處死。
稱體重,摘瘤,稱重,計算抑瘤率,計算公式如下:抑瘤率(100%)=(1-給藥組平均瘤重/模型組平均瘤重)×100%。
3、統計學方法
資料採用SPSS17.0軟體進行統計分析,計量資料以X±S表示,治療前後指標比較採用t檢驗;計數資料採用X2檢驗。P<0.05表示差異具有統計學意義。
4、實驗結果
與模型組比較:P<0.05;與對照組比較:P<0.05
實驗結果表明:本發明中藥組合物對小鼠實驗性肝腫瘤有明顯的抑制作用。本發明中藥組合物高劑量組的抑瘤率明顯高於西藥環磷醯胺對照組,且具有顯著性差異。
二、中藥組合物臨床實驗: 在2014年1月至2016年12月期間對87例原發性肝癌患者治療的臨床實驗報告如下:
1、一般資料
本次研究選取的56例患者均為晚期原發性肝癌的確診患者,全部符合《臨床診療指南》中與原發性肝癌的相關的診斷標準。56例患者中男33例,女23例,平均年齡44歲。
臨床分期:Ⅱ期35例,Ⅲ期21例。
2、治療方法
患者服用本發明實施例1製得的膠囊劑,每次2粒,每日3次,1個月為一療程,連續服用3個療程。
3、療效判斷標準:完全緩解:腫瘤組織完全消失,血清甲胎蛋白恢復至正常範圍;部分緩解:腫瘤組織縮小50%以上,血清甲胎蛋白恢復至正常範圍;穩定:腫瘤組織縮小或增大均不足25%;惡化:腫瘤組織增大大於20%。
4、實驗結果:臨床症狀改善:肝區疼痛改善率為82.5%,疲乏無力改善率為76.9%,食欲不振改善率為83.2%。
治療效果:完全緩解12例,占總病例數的21.4%;部分緩解20例,占總病例數的35.7%;穩定22例,占總病例數的39.3%;惡化2例,占總病例數的3.6%。總有效率為96.4%。
實驗結果表明:本發明中藥組合物可有效控制腫瘤的生長,抑制癌細胞擴散,同時可改善患者肝區疼痛、身體乏力、食欲不振等症狀,從而提高患者生存品質,延長患者生存期。
除肝癌外,本發明藥物對肺癌、淋巴癌、胃癌、食道癌、膀胱癌、卵巢癌、前列腺癌、胰腺癌等其它腫瘤病和對已做過手術、放療、化療的腫瘤患者的康復治療同樣有理想的治療效果。
其它腫瘤臨床治療效果統一評價標準:臨床治癒:原有症狀消失;顯效:原有症狀比分消失;好轉:原有病情有所減輕;無效:症狀體征無變化。
實驗例2
使用本發明實施例1製備的膠囊劑治療32例患有胃癌的病患3-6個療程後,觀察所述32例患有胃癌的患者的治療效果,其中治癒18例,顯效8例,好轉5例,無效1例,總有效率為96.9%。
實驗例3
使用本發明實施例2製備的顆粒沖劑治療29例患有肺癌的病患3-5個療程後,觀察所述29例患有肺癌的患者的治療效果,其中治癒22例,顯效5例,好轉1例,無效1例,總有效率為95.5%。
實驗例4
使用本發明實施例2製備的顆粒沖劑治療25例患有膀胱癌的病患3-5個療程後,觀察所述25例患有膀胱癌的患者的治療效果,其中治癒14例,顯效6例,好轉3例,無效2例,總有效率為92.0%。
實驗例5
使用本發明實施例2製備的顆粒沖劑治療18例患有卵巢癌 的病患3-5個療程後,觀察所述18例患有卵巢癌的患者的治療效果,其中治癒11例,顯效3例,好轉3例,無效1例,總有效率為94.4%。
實驗例6
使用本發明實施例3製備的貼劑治療16例患有前列腺癌的病患3-5個療程後,觀察所述16例患有前列腺癌的患者的治療效果,其中治癒10例,顯效2例,好轉4例,無效0例,總有效率為100%。
實驗例7
使用本發明實施例4製備的口服大蜜丸治療30例患有食道癌的病患3-6個療程後,觀察所述30例患有食道癌的患者的治療效果,其中治癒8例,顯效7例,好轉3例,無效2例,總有效率為93.3%。
實驗例8
使用本發明實施例7製備的中藥複方針劑治療23例患有淋巴癌的病患3-6個療程後,觀察所述23例患有淋巴癌的患者的治療效果,其中治癒14例,顯效4例,好轉3例,無效2例,總有效率為91.1%。
顯然,上述實施例僅僅是為清楚地說明所作的舉例,而並非對實施方式的限定。對於所屬領域的普通技術人員來說,在上述說明的基礎上還可以做出其它不同形式的變化或變動。這裡無需也無法對所有的實施方式予以窮舉。而由此所引伸出的顯而易見的變化或變動仍處於本發明的保護範圍之中。
Claims (10)
- 一種治療惡性腫瘤的中藥組合物,前述中藥組合物的原料藥組成為:1-30重量份的喜樹果;1-30重量份的鴉膽子油;0.1-0.9重量份的斑蝥;1-30重量份的狼毒;1-30重量份的土貝母;1-30重量份的腫節風;1-30重量份的夏枯草;1-20重量份的莪術;1-15重量份的黃芪;1-15重量份的丹參;1-15重量份的茯苓;1-15重量份的三七;1-15重量份的桑黃;1-30重量份的蒲公英;1-30重量份的絞股藍;1-15重量份的甘草;以及1-20重量份的茶葉。
- 如請求項1所記載之治療惡性腫瘤的中藥組合物,其中前述中藥組合物的原料藥組成為:4-18重量份的喜樹果;4-15重量份的鴉膽子油;0.2-0.7重量份的斑蝥;4-15重量份的狼毒; 4-20重量份的土貝母;4-18重量份的腫節風;5-20重量份的夏枯草;4-15重量份的莪術;4-15重量份的黃芪;4-8重量份的丹參;5-12重量份的茯苓;4-11重量份的三七;4-9重量份的桑黃;5-20重量份的蒲公英;5-20重量份的絞股藍;4-10重量份的甘草;以及4-15重量份的茶葉。
- 如請求項1所記載之治療惡性腫瘤的中藥組合物,其中前述中藥組合物的原料藥組成為:5-12重量份的喜樹果;5-12重量份的鴉膽子油;0.3-0.8重量份的斑蝥;5-12重量份的狼毒;6-18重量份的土貝母;6-15重量份的腫節風;6-15重量份的夏枯草;6-12重量份的莪術;6-12重量份的黃芪;5-8重量份的丹參;6-9重量份的茯苓; 6-10重量份的三七;6-8重量份的桑黃;6-15重量份的蒲公英;8-15重量份的絞股藍;6-9重量份的甘草;以及6-12重量份的茶葉。
- 一種製劑,其係由請求項1至3中任一項所記載之治療惡性腫瘤的中藥組合物,添加常規輔料,按照常規製程製備成的臨床可接受的製劑。
- 如請求項4所記載之製劑,其中前述製劑包括膠囊劑、顆粒劑、貼劑、針劑、合劑或丸劑。
- 一種製備請求項4或5所記載之製劑的方法,包括取選定量的喜樹果、鴉膽子油、斑蝥、狼毒、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草和茶葉混勻的步驟;以及添加常規輔料,按照常規製程製成臨床可接受的製劑的步驟。
- 如請求項6所記載之方法,其中前述方法包括以下步驟:S1:取選定量的斑蝥與糯米置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足,備用;S2:取選定量的狼毒片,加米醋拌勻,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉,備用;S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、鴉膽子油、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草和茶葉混勻,添加常規輔料,按照常規製程製成臨床可接受的製劑。
- 如請求項6所記載之方法,其中前述方法包括以下步驟:S1:取選定量的斑蝥與糯米置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足,備用;S2:取選定量的狼毒片,加米醋拌勻,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉,備用;S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草和茶葉混勻,加水浸泡後,加熱至沸騰並煎煮,取煎煮液加入選定量的鴉膽子油混勻,固液分離後,收集濾液文火濃縮至比重為1.30-1.35的濃縮液,烘乾並加入常規輔料,製得臨床可接受的膠囊劑;或者S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草和茶葉混勻,粉碎成粗顆粒狀,加水浸泡後,加熱煎煮並收集煎煮液,隨後加入選定量的鴉膽子油,文火蒸發至比重為0.9-1.1的蒸發液,冷卻後加入60wt%的乙醇充分混勻沉降,取上清液並減壓回收乙醇,濃縮至比重為1.2-1.5的濃縮液,隨後文火蒸發至稠膏狀,烘乾並加入常規輔料,製得臨床可接受的顆粒劑;或者S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草和茶葉,粉碎並過200目篩;取蜂蜜置於瓷鍋中熬製,並加入選定量的鴉膽子油拌勻,加入上述原料粉末混勻,冷卻後製得臨床可接受的丸劑;或者 S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、土貝母、腫節風、夏枯草、莪術、黃芪、丹參、茯苓、三七、桑黃、蒲公英、絞股藍、甘草、茶葉混勻,加水浸泡後,加熱煎煮並收集煎煮液,隨後加入選定量的鴉膽子油混勻,固液分離並收集濾液文火濃縮至比重為1.30-1.35的濃縮液,然後加入濃度為0.9%的氯化鈉溶液,製得臨床可接受的中藥針劑。
- 一種治療惡性腫瘤的貼劑,前述貼劑的原料藥組成為:1-30重量份的喜樹果;1-30重量份的鴉膽子油;0.1-0.9重量份的斑蝥;1-30重量份的狼毒;1-30重量份的土貝母;以及1-30重量份的腫節風。
- 一種製備請求項9所記載之治療惡性腫瘤的貼劑的方法,包括係下步驟:S1:取選定量的斑蝥與糯米置熱鍋內,用文火加熱,拌炒至糯米呈黃棕色,取出,除去糯米、放涼,將斑蝥去頭、去翅、去足,備用;S2:取選定量的狼毒片,加米醋拌勻,置鍋內,用文火炒乾,取出放涼,貯存於乾燥容器內密閉,備用;S3:取處理後的斑蝥、狼毒片,以及選定量的喜樹果、土貝母、腫節風,置粉碎機粉碎過200目細篩,備用;S4:取生石灰投入到裝有清水的容器中,反應後得石灰水,待石灰水澄清十五天之後,取出澄清石灰水,裝於容器待用,取選定量的鴉膽子油及生山茶油,加入至裝有石灰 水容器裡,攪拌成糊狀,最後加入步驟S3製備的細粉,製得臨床可接受的貼劑。
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