CN105920085B - 一种具有减毒功效的组合物及其制备方法和应用 - Google Patents
一种具有减毒功效的组合物及其制备方法和应用 Download PDFInfo
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- CN105920085B CN105920085B CN201610221425.4A CN201610221425A CN105920085B CN 105920085 B CN105920085 B CN 105920085B CN 201610221425 A CN201610221425 A CN 201610221425A CN 105920085 B CN105920085 B CN 105920085B
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Abstract
本发明涉及一种具有减毒功效的组合物，所述组合物的原料主要包括：黑豆：甘草为(1‑40)：1。本发明进一步公开一种具有减毒功效的组合物，所述组合物的原料组成为：黑豆10‑40重量份、糙米10‑60重量份、甘草1‑10重量份、黑木耳1‑10重量份、罗汉果0.1‑10重量份。研究表明，本发明组合物具减毒、排毒功效。对于化疗药物引起的毒副作用，如免疫功能下降、骨髓抑制、消化障碍、肝肾毒性、神经系统毒性、皮肤毒以及全身衰弱和疲劳等均具有明显缓解作用。
Description
技术领域
本发明涉及一种组合物及其制备方法和应用，具体涉及一种具有减毒功效的组合物及其制备方法和应用。
背景技术
黑豆为豆科植物大豆的干燥成熟种子，味甘性平，归脾、肾经，具有益精明目，养血祛风、利水、活血解毒的功效。《本草纲目》载“黑豆有补肾养血、解毒、活血化瘀、乌发明目、延年益寿功效。”现代研究亦指出，黑豆能乌发、补肾益脾、抗衰老、降胆固醇、改善心肌的营养血流、润泽肌肤、明目、养血、激发胰岛素分泌和药食中毒等。
糙米是稻谷脱去外保护皮层稻谷后的颖果，内保护皮层(果皮、种皮、珠心层)完好的稻米籽粒。与普通精致白米相比，糙米维他命、矿物质与膳食纤维的含量更丰富，被视为是一种绿色的健康食品。《本草纲目》记载，糙米具有“和五脏、好颜色”的妙用。中医认为糙米味甘、性温，健脾养胃、补中益气，调和五脏、镇静神经、促进消化吸收。
黑木耳是一种食用菌，营养成分丰富，据现代科学分析，每100克干品中含蛋白质10.6克，脂肪0.2克，碳水化合物65克，粗纤维7克，钙375毫克，磷201毫克，铁185毫克，此外还含有维生素B1 0.15毫克，维生素B2 0.55毫克，盐酸2.7毫克。我国医学历来认为黑木耳有滋润强壮，清肺益气，补血活血，镇静止痛等功效。是中医用来治疗腰腿疼痛，手足抽筋麻木，痔疮出血和产后虚弱等病症常用的配方药物。据国外报道，黑木耳能减低血液凝块，缓和冠状动脉粥样硬化，对预防和治疗冠心病有特殊的效益。
罗汉果味甘性凉，归肺、大肠经，有润肺止咳、生津止渴的功效，适用于肺热或肺燥咳嗽、百日咳及暑热伤津口渴等，此外还有润肠通便的功效。罗汉果是国家首批批准的药食两用材料之一。现代医学证明，罗汉果对支气管炎、 高血压等疾病有显着疗效，还能起到防治冠心病、血管硬化、肥胖症的作用。营养价值高，有清热解暑、化痰止咳、凉血舒骨、清肺润肠和生津止渴等功效；可治急慢性气管炎、咽喉炎、支气管哮喘、百日咳、胃热、便秘、急性扁桃体炎等症，糖尿病患者亦宜服用。
甘草，甘、平，入脾、胃、肺经。益气补中；缓急止痛；润肺止咳；解毒；调和诸药。主要用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，脘腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性、烈性。
发明内容
本发明的第一个目的在于提供一种具有减毒功效的组合物。
本发明的第二个目的在于提供该组合物的制备方法。
本发明的第三个目的在于提供该组合物在制备具有减轻化疗药物毒副作用的药物或食品中的应用。
本发明的目的是通过如下技术方案实现的：
一种具有减毒功效的组合物，该组合物的原料主要包括：黑豆和甘草。
进一步，所述黑豆和甘草的配比为(1-40)：1；更进一步，所述黑豆和甘草的配比为(4-20)：1；更进一步，所述黑豆和甘草的配比为15：1。
在一些实施方案中，所述组合物的原料还可以包括各类食品，如谷类食品：大麦、小麦、荞麦、燕麦、玉米、大米、小米、黑米、糙米、糯米、薏米、紫米、高粱等；豆类食品：黄豆、赤小豆、绿豆、大豆、蚕豆、豌豆、鹰嘴豆等；乳制品：液体乳、乳粉等；食用菌：香菇、草菇、蘑菇、木耳、银耳、猴头、竹荪、灵芝、虫草、松露、百灵等；蜂产品：蜂蜜、蜂王浆、蜂花粉、蜂产品：蜂蜜、蜂王浆、蜂胶、蜂花粉等；坚果类食品：杏仁、腰果、榛子、核桃、松子、板栗、白果等；海产品：海带、紫菜等；以及水果蔬菜等。
在一些实施方案中，所述组合物的原料还可以包括各类常用中药，如：罗汉果、山药、甘草、白扁豆、白扁豆花、龙眼肉(桂圆)、芡实、枣(大枣、酸枣、黑枣)、莲子、蜂蜜、人参、人参叶、太子参、刺五加、黄芪、红景天、西洋参、沙苑子、党参、绞股蓝、黄芩、白藓皮、秦艽、防风；活血药：白芷、桃仁、三七、川牛膝、玫瑰花、川芎、丹参、银杏叶、当归、红花、蒲黄、茜草、白芍、赤芍、益母草；行气药：代代花、佛手、香橼、橘皮、桔红、青果、桔梗枳壳、枳实、青皮、厚朴、厚朴花、佩兰、香附、木香、泽兰；丁香、八角茴香、小茴香、肉豆蔻、肉桂、花椒、姜(生姜、干姜)、砂仁、高良姜、薤白、黑胡椒、藿香、香薷、益智仁、黄芥子、白豆蔻、荜茇、姜黄、吴茱萸；小蓟、马齿苋、决明子、鱼腥草、栀子、槐米、槐花、蒲公英、菊花、金银花、淡竹叶、荷叶、昆布、胖大海、土茯苓、大蓟、野菊花、木贼、牛蒡子、牛蒡根、地骨皮、竹茹、牡丹皮、芦荟、苦丁茶、熟大黄、生何首乌、制大黄、番泻叶、积雪草、金荞麦、槐实、蒺藜、侧柏叶、桑白皮、桑枝、浙贝母、湖北贝母；玉竹、百合、鲜白茅根、鲜芦根、阿胶、火麻仁、杏仁(甜、苦)、郁李仁、黑芝麻、黄精、桑椹、枸杞子、苦参、北沙参、平贝母、玄参、生地黄、川贝母、石斛、麦门冬、天门冬、龟甲、熟地黄、鳖甲、白及；山楂、鸡内金、麦芽、莱菔子、乌梅、木瓜、余甘子；葛根、淡豆豉、薄荷、紫苏、紫苏籽、桑叶、五加皮；怀牛膝、墨旱莲、补骨脂、女贞子、制何首乌、骨碎补、覆盆子、金樱子；马鹿胎、马鹿茸、马鹿骨、巴戟天、蛤蚧、杜仲、杜仲叶、淫羊藿、菟丝子、胡芦巴、韭菜子；酸枣仁、牡蛎、柏子仁、天麻、远志、首乌藤、罗布麻、知母、石决明、珍珠；薏苡仁、茯苓、赤小豆、车前子、车前草、泽泻、白术、苍术；山茱萸、诃子、五味子、玫瑰茄、酸角；刀豆、白果、菊苣、榧子、枳椇子、沙棘；人参果、刺玫果、越橘。这些原料的增加并不影响基本原料发挥减轻化疗药物毒副作用，这些原料可以发挥其通常药典上记载的作用。
在一些实施方案中，所述组合物的原料组成为：黑豆10-40重量份、糙米10-60重量份、甘草1-10重量份；进一步，所述组合物的原料组成为：黑豆15-38重量份、糙米15-50重量份、甘草2-8重量份；更进一步，所述组合物的原料组成为：黑豆20-35重量份、糙米20-45重量份、甘草2-5重量份；更进一步，所述组合物的原料组成为：黑豆25-32重量份、糙米25-40重量份、甘草2-4重量份；更进一步，所述组合物的原料组成为：黑豆30重量份、糙米30重量份、甘草2重量份，或，黑豆28重量份、糙米35重量份、甘草3重量份。
在一些实施方案中，所述组合物的原料组成为：黑豆10-40重量份、糙米 10-60重量份、甘草1-10重量份、黑木耳1-10重量份、罗汉果0.1-10重量份；进一步，所述组合物的原料组成为：黑豆15-38重量份、糙米15-50重量份、甘草2-8重量份、黑木耳2-8重量份、罗汉果0.2-5重量份；更进一步，所述组合物的原料组成为：黑豆20-35重量份、糙米20-45重量份、甘草2-5重量份、黑木耳2-5重量份、罗汉果0.2-2重量份；更进一步，所述组合物的原料组成为：黑豆25-32重量份、糙米25-40重量份、甘草2-4重量份、黑木耳2-4重量份、罗汉果0.3-1.5重量份；更进一步，所述组合物的原料组成为：黑豆30重量份、糙米30重量份、甘草2重量份、黑木耳2重量份、罗汉果0.5重量份；或，黑豆28重量份、糙米35重量份、甘草3重量份、黑木耳4重量份、罗汉果1.5重量份。
在一些实施方案中，本发明所述组合物可以是上述原料药直接混合得到的组合物；该组合物可以经常规工艺制成食品，或者作为肿瘤患者的食品。
在一些实施方案中，也可以是各原料合并后按常规方法提取得到的提取物，或提取物进一步经过精制纯化工艺得到的有效部位；还可以是由各原料分别单独按常规方法提取得到的提取物或各提取物进一步经过精制纯化工艺得到的有效部位组合后形成的组合物。其中，所述常规提取方法包括浸渍提取、煎煮提取、回流提取、渗漉提取、超声提取等；提取溶剂包括水、20-95％乙醇溶液；所述精制纯化工艺包括醇沉、萃取、硅胶色谱柱分离、大孔树脂柱分离等。
在一些实施方案中，本发明组合物可按照常规制剂工艺制备成常规口服剂型；如汤剂、茶剂、丸剂(滴丸、蜜丸、水丸、糊丸、蜡丸、浓缩丸)、散剂、酒剂、糖浆剂、浸膏剂、露剂、糕剂、片剂、袋泡剂、口服液、颗粒剂、胶囊剂、缓释、纳米制剂等。
在一些实施方案中，需要加入制剂领域常规辅料，包括：填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括：淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等；崩解剂包括：淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等；润滑剂包括：硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等；助悬剂包括：聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等；粘合剂包括，淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等。
本发明还提供了所述组合物在制备具有减轻化疗药物毒副作用的药物或食品中的应用，所述化疗药物包括紫杉烷类、胸苷酸合成酶抑制剂、有机铂化合物、烷基化抗肿瘤剂、拓扑异构酶抑制剂等常规化疗药物。
进一步，所述化疗药包括下述一种或多种：卡巴他赛、多西他赛、拉罗他赛、奥他赛、紫杉醇、替司他赛、卡巴他赛、多西他赛、拉罗他赛、奥他赛、紫杉醇、替司他赛、卡铂、顺铂、奈达铂、奥沙利铂、四硝酸三铂、沙铂、环磷酰胺、苯丁酸氮芥、苯达莫司汀、乌拉莫司汀、雌莫司汀、卡莫司汀、洛莫司汀、福莫司汀、尼莫司汀、雷莫司汀、链脲佐菌素、白消安、喜树碱、拓扑替康、伊立替康、鲁比替康、贝洛替康、依托泊苷、替尼泊苷、阿柔比星、柔红霉素、阿霉素、表阿霉素、伊达比星、氨柔比星、吡柔比星、戊柔比星、佐柔比星、米托蒽醌、匹杉琼中。
进一步，所述组合物在制备具有减轻化疗药物产生的皮肤损害作用的药物或食品中的应用；所述皮肤损害包括皮肤干燥、瘙痒，皮肤色素沉着，皮肤溃疡，痤疮样皮疹等症状。
进一步，所述组合物在制备具有减轻化疗药物产生的脱发作用的药物或食品中的应用。
进一步，所述组合物在制备具有减轻化疗药物产生的手足综合症作用的药物或食品中的应用。
临床研究表明，本发明组合物对化疗药物引起的皮肤干燥、皮肤色素沉淀、手足综合症、脱发、指甲变色等症状具有明显缓解作用。
实验例1 临床效果研究
入组26人(统计学资料见表1)，均诊断为癌症，且正在进行化疗。将26人随机分为实验组和对照组，实验组13人同时服用实施例1制备的汤剂，对照组13人不服用汤剂。连续观察3个月，结果见表2。
表1 人口统计学资料和癌症相关指标
| 实验组(n＝13) | 对照组(n＝13) | |
| 年龄 | 54.0 | 55.0 |
| 性别％(数量) | ||
| 男 | 23.1(3) | 30.8(4) |
| 女 | 76.9(10) | 69.2(9) |
| 教育程度％(数量) | ||
| 小学 | 7.7(1) | 15.3(2) |
| 中学 | 30.8(4) | 38.5(5) |
| 中学以上 | 61.5(8) | 46.1(6) |
| 婚姻状况％(数量) | ||
| 已婚 | 76.9(10) | 76.9(10) |
| 分居/离婚 | 0(0) | 7.7(1) |
| 单身 | 23.1(3) | 15.3(2) |
| 工作状况％(数量) | ||
| 不需要工作 | 69.2(9) | 61.5(8) |
| 需要工作 | 30.8(4) | 38.5(5) |
| 主要癌症类型％(数量) | ||
| 乳腺癌 | 76.9(10) | 69.2(9) |
| 肺癌 | 7.7(1) | 15.3(2) |
| 直肠癌 | 15.3(2) | 15.3(2) |
| 癌症分级％(数量) | ||
| 0-II | 76.9(10) | 69.2(9) |
| III | 15.3(2) | 30.8(4) |
| IV | 7.7(1) | 0(0) |
| 主要化疗药％(数量) | ||
| 紫杉烷类 | 53.8(7) | 61.5(8) |
| 蒽环类 | 38.5(5) | 30.8(4) |
| 其他类 | 7.7(1) | 7.7(1) |
表2实验组合对照组化疗毒性比较
注：1级轻度；无症状或轻度症状；仅临床或诊断发现；无需治疗；
2级 中度；最小的、局部的或非侵入性治疗指征；年龄相关工具性日常生活活动受限；
3级 重度或重要医学意义，但不会立即危及生命；住院治疗或延长住院时间指征；致残；自理性日常生活活动受限；
4级危及生命，需紧急治疗。
结果表明，实验组和对照组比较，实验组皮肤毒性等级≥2级的发生率为 6.7％，显着低于对照组的22.8％。实验组尤其对皮肤干燥、皮肤色素沉淀、手足综合症、脱发、指甲变色等症状相对于对照组具有明显缓解作用，见表3。
表3主要症状≥2级的发生率
| 症状 | 实验组 | 对照组 |
| 皮肤干燥 | 0％ | 30.8％ |
| 皮肤色素沉淀 | 7.7％ | 38.5％ |
| 手足综合症 | 7.7％ | 38.5％ |
| 脱发 | 15.3％ | 53.8％ |
| 指甲变色 | 7.7％ | 53.8％ |
实验例2 动物试验研究
1实验方法：
样品的制备：
样品1：黑豆70g，加10-8-8倍双蒸馏水回流提取三次，每次40分钟，稀释到所需浓度8mg/ml；
样品2：黑豆70g+甘草10g，加10-8-8倍双蒸馏水回流提取三次，每次40分钟，稀释到所需浓度8mg/ml；
样品3：黑豆70g，糙米70g，黑木耳10g，罗汉果50g，加10-8-8倍双蒸馏水回流提取三次，每次40分钟，稀释到所需浓度20mg/ml；
样品4：黑豆70g，糙米70g，甘草10g，黑木耳10g，罗汉果40g，加10-8-8倍双蒸馏水回流提取三次，每次40分钟，稀释到所需浓度20mg/ml。
动物试验：采用MMTV-PyMT小鼠，各组6只。
分组：
A组：空白对照
B组：阿霉素(12mg/kg)
C组：阿霉素(12mg/kg)+样品1(2mg/kg，按每天自由饮水5ml计，则为8mg/ml)
D组：阿霉素(12mg/kg)+样品2(2mg/kg，按每天自由饮水5ml计，则为8mg/ml)
E组：阿霉素(12mg/kg)+样品3(5mg/kg，按每天自由饮水5ml计，则为20mg/ml)
F组：阿霉素(12mg/kg)+样品4(5mg/kg，按每天自由饮水5ml计，则为20mg/ml)
A组进行腹腔注射0.2ml双蒸馏水一次，BCDEF组腹腔注射0.2ml阿霉素(12mg/kg)一次。AB组每天自由饮双蒸馏水0.2ml，CDEF组分别每天自由饮用相应的药物0.2ml，连续一周。每3天称一次体重。一周后，麻醉，心脏取血，处死。用细胞计数板计算血液中白细胞数(WBC)，和红细胞数(RBC)，用试剂盒测定丙氨酸氨基转移酶(ALT)，天门冬氨酸氨基转移酶(AST)，血尿素氮(BUN)和肌氨酸酐(Creatinine)。
2实验结果：结果见表4-5。
表4各样品对外周血中WBC和RBC的影响
| 组别 | 样品 | WBC(109/L) | RBC(10<sup>12</sup>/L) |
| A | 空白对照组 | 5.06±0.07 | 10.08±0.14 |
| B | 阿霉素组 | 1.11±0.10# | 5.75±0.25# |
| C | 阿霉素+样品1 | 1.13±0.16 | 5.81±0.25 |
| D | 阿霉素+样品2 | 1.59±0.43*<sup>@</sup> | 7.17±0.18* |
| E | 阿霉素+样品3 | 1.32±0.35* | 7.00±0.02* |
| F | 阿霉素+样品4 | 1.69±0.30*<sup>@</sup> | 7.43±0.24* |
注：和空白对照组比较，#p<0.05；和阿霉素组比较，*p<0.05
结果表明，和空白组比较，阿霉素组显著降低了WBC和RBC(p<0.05)；和阿霉素组比较，阿霉素+样品2组，阿霉素+样品3组，阿霉素+样品4组显著增加了WBC和RBC(p<0.05)。另外，样品4，样品2与样品3比较，也显著增加了WBC(p<0.05)。此外，由表4结果可以看出，黑豆与甘草配伍其效果明显优于单独使用黑豆。
表5各样本及组合物对外周血中AST,ALT,BUN和Creatinine的影响
注：和空白对照组比较，#p<0.05；和阿霉素组比较，*p<0.05
结果表明，和空白组比较，阿霉素组显著增加了ALT，AST和Creatinine的水平(p<0.05)；和阿霉素组比较，阿霉素+样品2组，阿霉素+样品3组，阿霉素+样品4组显著下调了ALT和Creatinine的水平(p<0.05)；阿霉素+样品2组和阿霉素+样品4组显著下调了AST的水平(p<0.05)。此外，由表5结果可以看出，黑豆与甘草配伍其效果明显优于单独使用黑豆。
具体实施方式
实施例1 汤剂
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g。
制法：按比例称取各原料，加水1200-1800ml，煎1小时液，即得，可第2次煎煮。
用法用量：每日饮用总量1000ml(相当于64.5g的原料)，每日4次(代茶饮用)。
实施例2 颗粒剂
组方：黑豆28g，糙米35g，甘草3g，黑木耳4g，罗汉果1.5g。
制法：按比例称取各原料，用10-8倍量95％乙醇水溶液回流提取2次，每次1小时，合并提取液，减压浓缩获得干膏，加适合的常规辅料(赋形剂、矫味剂等)，制成颗粒，按照服用量分装即得颗粒剂。
实施例3 胶囊剂
组方：黑豆20g，糙米45g，甘草2g，黑木耳5g和罗汉果0.3g。
制法：按比例称取各原料，用10-8倍量水煎煮2次，每次1小时，合并水煎液，减压浓缩获得干膏，加适合的常规辅料(赋形剂、矫味剂等)，制成颗粒，按照服用量分装于胶囊中，即得胶囊剂。
实施例4 口服液
组方：黑豆40g，糙米15g，甘草8g，黑木耳3g和罗汉果4g。
制法：按比例称取各原料，用10-8-8倍量水煎煮提取3次，每次1小时，合并三次提取液，减压浓缩获得相应浓度的浓缩液，加适合的常规辅料(矫味剂，抑菌剂等)，按照服用量分装于一定规格的容器中，即得合剂(口服液)或酊剂。
实施例5 片剂
组方：黑豆10g，糙米50g，甘草2g，黑木耳10g和罗汉果10g。
制法：按比例称取各原料，用10-8倍量70％乙醇水溶液超声提取2次，每次40分钟，合并提取液，减压浓缩获得相应浓度的浓缩液，加适合的常规辅料，制成软材，压片分装即得片剂。
实施例6 汤剂
组方：黑豆30g，甘草2g。
制法：同实施例1制备成汤剂。
实施例7 颗粒剂
组方：黑豆40g，甘草1g。
制法：同实施例2制备成颗粒剂。
实施例8 胶囊剂
组方：黑豆40g，甘草40g。
制法：同实施例3制备成胶囊剂。
实施例9
组方：黑豆30g，甘草2g，山药15g，大枣6g。
实施例10
组方：黑豆30g，甘草3g，山药20g，人参3g，三七3g。
实施例11
组方：黑豆30g，甘草5g，黄芪10g，当归6g，人参5g。
实施例12
组方：黑豆30g，甘草10g，苦参5g，黄芩5g，马齿苋9g。
实施例13
组方：黑豆30g，甘草2g，当归10g，熟地黄10g，黄芩5g，防风5g。
实施例14
组方：黑豆30g，甘草3g，黄芩5g，马齿苋10g，苦参6g，蒲公英10g。
实施例15
组方：黑豆30g，甘草5g，山药15g，大枣5g，桂圆5g，莲子6g，
实施例16
组方：黑豆30g，甘草6g，黄芩5g，白芍10g，蒲公英10g，薄荷5g。
实施例17
组方：黑豆30g，甘草1.5g，当归8g，秦艽5g，防风5g。
实施例18
组方：黑豆30g，甘草10g，熟地黄10g，白芍10，山药15g。
实施例19
组方：黑豆30g，甘草2g，黄芩3g，党参10g，白术6g
实施例20
组方：黑豆30g，甘草2g，制何首乌6g，防风5g，党参10g，枸杞6g。
实施例21
组方：黑豆30g，甘草2g，糙米30g，燕麦15g。
实施例22
组方：黑豆30g，甘草5g，木耳10g，银耳10g。
实施例23
组方：黑豆30g，甘草5g，罗汉果4g，蜂蜜2g。
实施例24
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，山药15g，大枣6g。
实施例25
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，山药20g，人参3g，三七3g。
实施例26
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，黄芪10g，当归6g，人参5g。
实施例27
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，苦参5g，黄芩5g，马齿苋9g。
实施例28
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，当归10g，熟地黄10g，黄芩5g，防风5g。
实施例29
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，黄芩5g，马齿苋10g，苦参6g，蒲公英10g。
实施例30
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，山药15g，大枣5g，桂圆5g，莲子6g，
实施例31
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，黄芩5g，白芍10g，蒲公英10g，薄荷5g。
实施例32
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，当归8g，秦艽5g，防风5g。
实施例33
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，熟地黄10g，白芍10，山药15g。
实施例34
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，黄芩3g，党参10g，白术6g
实施例35
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，制何首乌6g，防风5g，党参10g，枸杞6g。
实施例36
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，燕麦15g。
实施例37
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，银耳10g。
实施例38
组方：黑豆30g，糙米30g，甘草2g，黑木耳2g，罗汉果0.5g，蜂蜜2g。
实施例39
将实施例9-39按如下方法制备各实验样品：按比例称取各原料，加水1200-1800ml，煎1小时液。
同实验例1的临床观察方法，选择癌症为肺癌，化疗药为紫杉烷类，每日饮用总量1000ml(相当于64.5g的原料)，每日4次。观察在化疗药使用中服用实施例9-39对减轻皮肤损害的效果：
主要症状≥2级的发生率区间
| 症状 | 实验组 |
| 皮肤干燥 | 0--5％ |
| 皮肤色素沉淀 | 7--10％ |
| 手足综合症 | 7--10％ |
| 脱发 | 14--18％ |
| 指甲变色 | 7--14％ |
以上各实施例组方及其制成的剂型均可实现本发明目的，对化疗药物产生的皮肤损害，如皮肤干燥、瘙痒，皮肤色素沉着，皮肤溃疡，痤疮样皮疹以及脱发、手/足综合征均有显著的缓解作用。
Claims (7)
1.一种具有减毒功效的组合物，其特征在于，所述组合物的原料组成为：黑豆10-50重量份、糙米10-60重量份、甘草1-10重量份、黑木耳1-10重量份、罗汉果0.1-10重量份。
2.如权利要求1所述的组合物，其特征在于，所述组合物的原料组成为：黑豆15-45重量份、糙米15-50重量份、甘草2-8重量份、黑木耳2-8重量份、罗汉果0.2-5重量份；
或，黑豆20-40重量份、糙米20-45重量份、甘草2-5重量份、黑木耳2-5重量份、罗汉果0.2-2重量份；
或，黑豆25-35重量份、糙米25-40重量份、甘草2-4重量份、黑木耳2-4重量份、罗汉果0.3-1.5重量份。
3.如权利要求1所述的组合物，其特征在于，所述组合物的原料组成为：黑豆30重量份、糙米30重量份、甘草2重量份、黑木耳2重量份、罗汉果0.5重量份；
或，黑豆28重量份、糙米35重量份、甘草3重量份、黑木耳4重量份、罗汉果1.5重量份。
4.如权利要求1-3任一项所述的组合物，其特征在于，所述组合物按照常规制剂工艺制备成常规口服剂型，包括汤剂、茶剂、丸剂、散剂、酒剂、糖浆剂、浸膏剂、露剂、片剂、冲剂、袋泡剂、口服液、颗粒剂、胶囊剂、缓释剂、纳米剂。
5.如权利要求1-3任一项所述的组合物在制备具有减轻化疗药物毒副作用的药物中的应用，其特征在于，所述化疗药物选自紫杉烷类、胸苷酸合成酶抑制剂、有机铂化合物、烷基化抗肿瘤剂、拓扑异构酶抑制剂中的任意一种或多种。
6.如权利要求5所述的应用，其特征在于，所述化疗药物选自卡巴他赛、多西他赛、拉罗他赛、奥他赛、紫杉醇、替司他赛、卡铂、顺铂、奈达铂、奥沙利铂、四硝酸三铂、沙铂、环磷酰胺、苯丁酸氮芥、苯达莫司汀、乌拉莫司汀、雌莫司汀、卡莫司汀、洛莫司汀、福莫司汀、尼莫司汀、雷莫司汀、链脲佐菌素、白消安、喜树碱、拓扑替康、伊立替康、鲁比替康、贝洛替康、依托泊苷、替尼泊苷、阿柔比星、柔红霉素、阿霉素、表阿霉素、伊达比星、氨柔比星、吡柔比星、戊柔比星、佐柔比星、米托蒽醌和匹杉琼中的任意一种或多种。
7.如权利要求5所述的应用，其特征在于，所述化疗药物毒副作用为皮肤损害、脱发或手足综合症。
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