CN100336555C - 一种抗肿瘤的参丹胶囊及其制备工艺 - Google Patents
一种抗肿瘤的参丹胶囊及其制备工艺 Download PDFInfo
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Abstract
本发明涉及一种抗肿瘤的的创新中成药，特别是参丹胶囊处方、处方组成及制备工艺。其特征是以传统的中药材人参(生晒参)、黄芪(生)、白术(麸炒)、鸡内金(生)、栝蒌、半夏(清)、厚朴、枳壳(炒)、郁金、丹参、全蝎、蜈蚣为原料，采用先进技术工艺，分别提取有效成分而制成的携带、服用方便，疗效高的中药制剂。具有益气健脾、理气化痰、活血行瘀。用于治疗肺癌、胃肠癌、乳腺癌等，改善肿瘤(脾虚痰瘀证)患者胸痛、胸胁胀痛、面色晄白，纳谷少馨、少气懒言、气短等症状。合并化疗治疗能够明显提高化疗疗效，提高化疗患者的生活质量，提高NK细胞活性，对化疗中的白细胞降低有保护作用。
Description
本发明涉及一种抗肿瘤的中成药，特别是参丹胶囊及其制备工艺。其特征是以人参、黄芪、白术、鸡内金、栝蒌、半夏、厚朴、枳壳、郁金、丹参、全蝎、蜈蚣、为原料，经科学工艺提取有效成份而成的一种创新中药制剂。
肿瘤现已成为严重威胁人类生命健康且较广泛的疾病，全世界每年有新发恶性肿瘤900万人，而死于该病的达700万人。中国有12亿人口，每年大约有160万新发恶性肿瘤患者，每年大约有130万人死于癌症，因此癌症正超过心脑血管疾病而成为第一死亡原因。肿瘤的防治已成为世界范围内广泛重视的课题，世界各国每年投入了大量人力、物力进行研究，但迄今为止，对其病因、病理仍不十分清楚，治疗方法尚无重大突破，不少国家已注意到使用传统医学的方法进行防治，特别是对具有数千年历史的中医中药非常关注。中国医药学是一个伟大的宝库，它是我国人民长期与疾病作斗争的智慧结晶，应用于现代科学的方法挖掘和发展它，在治疗恶性肿瘤的领域中是一次前景广阔而艰巨的事业。
中医药***，在历代中医药理论中具有非常丰富的论述，方法多样，手段独特。既有按中医药理论体系规律的辨证施治治疗方法，又有人们在实践探索中所总结的偏方、单方、验方等独特方法。“参丹”胶囊的研制，既是按照中医药理论扶正祛邪治则，而又容验方的实践经验的结晶。该发明的目的既为运用中医药理论，结合临床用药的大量实践探索用于辅助治疗中晚期胃部肿瘤患者化疗后的各种症状，提高其生活质量，延缓生命。该制剂有效率高、无毒副反应，为辅助治疗中晚期胃部肿瘤患者又增加新的有效疗法，它为中医药辅助治疗胃部肿瘤又提供了新的例证
本发明的目的：在于采用了全新的处方及制剂工艺，选用人参大补元气，补脾益肺，生津止渴，安神益智。黄芪益气升阳，固表止汗，利水消肿，托毒生肌，二者共为君药。白术(麸炒)、鸡内金、栝蒌、半夏(清)共为臣药。方中白术甘苦而温，系健脾益气之要药，与君药人参、黄芪合用，加强两味益气健脾作用，以扶正培其本。鸡内金性味甘平，具有健脾消食，消症化石作用。栝蒌甘寒，为清热化痰、宽胸化结之品。半夏(清)辛散苦燥温通，功擅燥湿化痰，消痞散结。厚朴、枳壳、郁金、丹参共为佐药。厚朴苦辛温燥，功能行气消积，燥湿除满，对于食积气滞、湿阻胀满皆有良效。枳壳苦酸微寒，具有理气宽胸，行气消积之功，为治气滞胸闷要药。枳、朴二药合用，行气消积效佳。郁金、丹参皆为寒性活血祛瘀止痛药物，为治疗瘕结块常用之品，其中郁金又能行气疏肝解郁，气行则血行，以加强活血之力。丹参活血祛瘀，善治癥瘕积聚。以上四药合用共奏消食化痰、行气活血之功，针对痰结、湿聚、气滞、血瘀等病理产物，促其消散化解，重在祛邪。全蝎、蜈蚣蠕动之物，性善走窜，入络剔毒，能引诸药直达病所，具有引经作用，故而为方中使药。参丹”胶囊由十二味中药组成，根据制定质量标准的原则，设计了定性定量分析方法。
鉴别项：(1)由于蜈蚣和全蝎的药材原粉入药，所以制定两者的显微鉴别方法。
(2)以人参皂苷Rg1，Re，Rb1和黄芪甲苷为对照品制定了人参和黄芪的鉴别方法。
(3)以丹参酮IIA为对照品制定了丹参的鉴别方法。
(4)以橙皮苷为对照品制定了枳壳的鉴别方法。
含量测定项：由于人参为君药又属贵重药材，因此，采用HPLC法制定了人参中人参皂苷Re、Rgl的含量测定方法。并规定每粒含人参皂苷不得少于0.08mg。
本发明是这样实现的：选用人参(生晒参)100g、丹参75g加80％乙醇加热提取三次，每次一小时，滤过，药渣备用，合并滤液，回收乙醇浓缩至相对密度1.18～1.20(50℃)。取白术(麸炒)60g、厚朴60g、郁金100g、枳壳(炒)60g，加水适量，提取挥发油，药渣与黄芪(生)150g、栝蒌90g、半夏(清)60g及人参(生晒参)、丹参药渣合并，加水煎煮三次，每次一小时，滤过，合并滤液，浓缩至相对密度为1.18～1.20(50℃)。与上述乙醇提取浓缩液合并，继续浓缩至相对密度为1.30～1.35(50℃)。加入鸡内金(生)100g全蝎30g蜈蚣45g细粉混匀，80℃以下干燥，粉碎，备用。挥发油与β-环糊精按1∶10比例包结，冷藏，过滤，40℃以下干燥，粉碎过筛，与上述干膏粉混合加适量淀粉混匀，装1000粒胶囊，即得。
4.本发明的优点：由于本发明的剂型为胶囊剂，携带、服用方便，开水冲服，1口服，每日3次，每次6粒，用药42天为一疗程。由于加入鸡内金(生)100g全蝎30g蜈蚣45g细粉，减少了辅料使用量；人参(生晒参)、丹参加80％乙醇加热提取三次，每次一小时，滤过，药渣备用，合并滤液，回收乙醇至相对密度1.18～1.20(50℃)。取白术(麸炒)、厚朴、郁金、枳壳(炒)，加水适量，提取挥发油，药渣与黄芪(生)、栝蒌、半夏(清)g及人参(生晒参)、丹参药渣合并，加水煎煮三次，每次一小时，能够充分提取利用其有效成分，通过药效学实验，结果表明：当用与4～16g/kg剂量灌胃时，对S180小鼠肉瘤的抑瘤率为37.79～50.57％；对EAC小鼠腹水癌的抑瘤率32.91～49.28％.；对HepA肝癌的抑瘤率为21.71～43.43％；本品对三种瘤谱各剂量组动物体重无明显降低作用；“参丹”胶囊大剂量组能明显增强荷瘤小鼠脾淋巴细胞转化功能和提高荷瘤小鼠对碳粒的廓清速率；具有提高荷瘤小鼠脾NK细胞活性、促进NK细胞体外杀伤K562细胞活性的作用；对环磷酰胺致小鼠外周血白细胞降低有一定保护作用；该药还具有促进荷瘤小鼠T淋巴细胞免疫及提高单核细胞吞噬功能的作用。长毒性实验以相当与临床人用量(0.16g/kg)的62.5，31.3倍及空白对照组。每日灌胃二次，连续给药90天，结果表明，大鼠进食，活动，皮毛良好，各组动物体重与给药前相比均有增加，血液学检测、血液生化学检测等各项指标及脏器系数与对照组比较均无明显差异(P＞0.05)。病理学检查各组动物心、肝、脾、肺、肾、脑、胃、小肠、子宫、睾丸等脏器与对照组比较均未见明显病理形态学改变。
附图：是根据本发明提出的工艺流程。
实施例：选用人参(生晒参)100g、丹参75g加80％乙醇加热提取三次，每次一小时，滤过，药渣备用，合并滤液，回收乙醇浓缩至相对密度1.18～1.20(50℃)。取白术(麸炒)60g、厚朴60g、郁金100g、枳壳(炒)60g，加水适量，提取挥发油，药渣与黄芪(生)150g、栝蒌90g、半夏(清)60g及人参(生晒参)、丹参药渣合并，加水煎煮三次，每次一小时，滤过，合并滤液，浓缩至相对密度为1.18～1.20(50℃)。与上述乙醇提取浓缩液合并，继续浓缩至相对密度为1.30～1.35(50℃)。加入鸡内金(生)100g全蝎30g蜈蚣45g细粉混匀，80℃以下干燥，粉碎，备用。挥发油与β-环糊精按1∶10比例包结，冷藏，过滤，40℃以下干燥，粉碎过筛，与上述干膏粉混合加适量淀粉混匀，装1000粒胶囊，即得参丹胶囊。
Claims (3)
1.一种抗肿瘤的药物，该药物为胶囊制剂，其特征在于：每粒胶囊中含有至少0.08毫克的人参皂苷Re和Rg1，以及每1000粒胶囊采用的原料药配方为：生晒人参100克、生黄芪150克、麸炒白术60克、生鸡内金100克、栝蒌90克、清半夏60克、厚朴60克、炒枳壳60克、郁金100克、丹参75克、全蝎30克、蜈蚣45克。
2.一种抗肿瘤药物的制备方法，其特征在于包括如下步骤：
(1)按照如下配方称取原料药：生晒人参10重量份、生黄芪15重量份、麸炒白术6重量份、生鸡内金10重量份、栝蒌9重量份、清半夏6重量份、厚朴6重量份、炒枳壳6重量份、郁金10重量份、丹参7.5重量份、全蝎3重量份、蜈蚣4.5重量份；
(2)取生晒人参、丹参加入80％的乙醇提取3次，每次1小时，过滤收集滤液，在50摄氏度回收乙醇而将滤液浓缩至相对密度为1.18-1.20，药渣备用；
(3)取麸炒白术、厚朴、郁金、炒枳壳，加水适量，提取挥发油，药渣备用；
(4)将生黄芪、栝蒌、清半夏与步骤(2)所得药渣和步骤(3)所得药渣合并，加水煎煮3次，每次1小时，过滤收集滤液并浓缩至相对密度为1.18-1.20；
(5)将步骤(2)获得的浓缩滤液与步骤(4)获得的浓缩滤液合并，于50摄氏度继续浓缩至相对密度为1.30-1.35；
(6)将生鸡内金、全蝎、蜈蚣粉碎成的细粉与步骤(5)获得的浓缩液混合，80摄氏度以下干燥，粉碎后备用；
(7)将步骤(3)制得的挥发油与β-环状糊精按照1∶10的比例包结，过滤后，在40摄氏度以下干燥，粉碎后过筛；
(8)将步骤(7)得到的粉末与步骤(6)获得的干粉混合。
3.根据权利要求2所述的方法，其中还包括将步骤(8)所得的混合物制备成胶囊的步骤，其中所述的胶囊每粒含有至少0.08毫克的人参皂苷Re和Rg1。
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