CN106344846A - 一种缓解肿瘤放化疗所致的胃肠道副反应的中药制剂 - Google Patents
一种缓解肿瘤放化疗所致的胃肠道副反应的中药制剂 Download PDFInfo
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Abstract
本发明涉及中药，具体涉及一种缓解肿瘤放化疗所致的胃肠道副反应的中药制剂。其特征在于，所采用的原料药的重量份配比为：胆南星2～4份、姜竹茹4～6份、佛手柑4～6份、炒枳实5～7份、半夏曲5～7份、焦谷5～7份、麦芽5～7份、代代花1～3份。所述中药制剂能够明显改善放化疗所致的胃肠道反应，缓解恶心呕吐、头昏和不思饮食等症状，提高患者的生存质量。
Description
技术领域
本发明涉及中药，具体涉及一种缓解肿瘤放化疗所致的胃肠道副反应的中药制剂。
背景技术
肿瘤放化疗发展速度快，已成为癌症治疗中的最重要手段之一，几乎可用于所有的癌症治疗，但会给患者带来许多副作用。肿瘤化疗药物对胃肠道的损伤反应，最主要的表现是引起恶心、呕吐。临床多采取对症处理，即应用药物抑制呕吐。根据化疗药物致吐作用强弱，分为高度、中度、低度、微小四类。目前常用的止吐药有以下几种：
1、5-羟色胺受体激动剂枢丹(ondansetron)，控制急性胃肠道反应方面最为有效。常见副作用是头痛和便秘，一般较轻微。
2、甾体类激素：机制尚不清，但被认为是有效和安全的止吐药。当与其他类型止吐药合用，呕吐域值可明显升高。化疗引起中度致吐时，可用地塞米松8mg；高度致吐时，可增加剂量至20mg。副作用常见为失眠和血糖升高，与应用地塞米松剂量和治疗间隔时间有关。
3、神经激肽-1-受体激动剂：aprepitant代表该类新型止吐药，是一种选择性的、中枢神经系统通过性的、口服非肽类的神经激肽-1-受体激动剂。副作用主要是与其他药物相互作用。
4、多巴胺受体激动剂：为酚噻嗪类；丁酰苯类；苯甲酰胺类。Metoclopramide应用最多，在轻-中度致吐药物时给予保守剂量即可发挥止吐作用。副作用，尤其是在大剂量应用时，主要为锥体外系症状、镇静作用和直立位的低血压。
上述药物本身带有副作用，加剧了化疗患者的身体代谢负担，或者会减弱化疗药物的药效。而传统中药擅于从提高免疫力，促进机体正常机能恢复的角度发挥治疗作用，而且对机体生理功能无明显损伤。因此，有必要研发出有效缓解癌症患者化疗引起的胃肠道不适的中药制剂。
发明内容
为了减轻肿瘤患者放化疗后的胃肠道反应，避免现有止吐药物的副作用，本发明提供一种治疗肿瘤放化疗后胃肠道反应的中药制剂。所述中药制剂能够明显改善放化疗所致的胃肠道反应，缓解恶心呕吐、头昏和不思饮食等症状，提高患者的生存质量。
本发明请求保护的技术方案如下：
一种缓解肿瘤放化疗所致的胃肠道副反应的中药制剂，其特征在于，所采用的原料药的重量份配比为：
胆南星2～4份、姜竹茹4～6份、佛手柑4～6份、炒枳实5～7份、半夏曲5～7份、焦谷5～7份、麦芽5～7份、代代花1～3份。
优选地，所述原料药的重量份配比为：
胆南星2.5～3.5份、姜竹茹4.5～5.5份、佛手柑4.5～5.5份、炒枳实5.5～6.5份、半夏曲5.5～6.5份、焦谷5.5～6.5份、麦芽5.5～6.5份、代代花1.5～2.5份。
优选地，所述原料药的重量份配比为：
胆南星3份、姜竹茹5份、佛手柑5份、炒枳实6份、半夏曲6份、焦谷6份、麦芽6份、代代花2份。
优选地，所述中药制剂的剂型为颗粒剂、片剂、胶囊剂、丸剂或汤剂。
优选地，任一上述中药制剂，还包括药学上可接受的辅料。
优选地，所述辅料指药物赋形剂或药物矫味剂。
上述中药制剂的制备方法，包括如下步骤：
(1)按所述种类和重量配比取所述原料药，将胆南星、姜竹茹、佛手柑、炒枳实、半夏曲、焦谷、麦芽放入煎煮容器中，加入6～10倍重量的水，先煎煮1.5-3小时后，再加入代代花，继续煮1-1.5小时，倒出煎液，备用；
(2)向药渣中加入5-7倍重量的水，煎煮0.5-1.5小时，倒出煎液，备用；
(3)合并步骤(1)和(2)所得煎液，过滤并浓缩滤液。
优选地，
步骤(1)中，加入8倍重量的水，先煎煮1.5小时后，再加入代代花，继续煮1小时；
步骤(2)中，加入6倍重量的水，煎煮1小时。
优选地，步骤(3)中，过滤并浓缩滤液至三分之一体积，冷却，加入沉降剂，搅拌，冷藏过夜，过滤弃去沉淀物，将药液继续浓缩成稠膏，在90℃以下干燥，粉碎，制粒，装入胶囊，即得。
本发明提供一种治疗肿瘤放化疗后胃肠道反应的中药制剂，原料药包括胆南星、姜竹茹、佛手柑、炒枳实、半夏曲、焦谷、麦芽、代代花。所述原料药的药理药效如下：
胆南星：本品为制天南星的细粉与牛、羊或猪胆汁经加工而成，或为生天南星细粉与牛、羊或猪胆汁经发酵加工而成，可在中药房购买到；性凉，味辛、苦；归肝、脾、肺经；具有清热化痰，息风定惊之功效；用于痰热咳嗽、咯痰黄稠、中风痰迷、癫狂惊痈。
姜竹茹：为禾本科植物淡竹、青竿竹、大头典竹等的茎秆去外皮刮出的中间层，可在中药房购买到；性微寒，味甘；归脾、胃、胆经；具有清热化痰，凉血，除烦止呕之功效；用于烦热呕吐、呃逆、痰热咳喘、吐血、衄血，崩漏，恶阻，眙动，惊痫。
佛手柑：芸香科植物佛手的果实，可在中药房购买到；性温，味辛、酸、苦；归肝、胃经；具有疏肝理气，和胃止痛，燥湿化痰之功效；用于胁痛胸闷，脘腹胀满，咳嗽痰多。
炒枳实：性微寒，味苦、辛；归脾、胃、大肠经；具有破气消积，化痰除痞的功效；用于食积停滞，腹痛便秘，泻痢后重，痰阻胸痞，胸痹结胸，子宫脱垂，胃下垂、脱肛。可在中药房购买到。
半夏曲：为半夏加面粉、姜汁等制成的曲剂，可在中药房购买到。性温，味辛，甘；具有止咳化痰，平喘降逆，和胃止呕，消痞散结之功效；主治风寒咳嗽，喘息气急，湿疾冷饮，胸院满闷，久咳不愈，顽疾不化。
焦谷：消食和中,健脾开胃，用于食积不消，腹胀口臭，脾胃虚弱，不饥食少。可在中药房购买到。
麦芽：性平，味甘；归脾、胃、肝经；具有消食健胃，回乳消胀之功效；用于食积不消，脘腹胀闷，乳汁郁积，乳房肿痛。可在中药房购买到。
代代花：拉丁文名：Citrus aurantium L.属芸香科、柑橘属植物，别名，酸橙、回青橙、玳玳；可在中药房购买到。性平，味甘、微苦；具有理气宽胸，开胃止呕之功效；用于胸闷不舒、不思饮食、呕恶等症。
本发明的中药药剂，采用主要作用于脾胃经，大都性平或微温的食药同源材料佛手柑、炒枳实、焦谷、麦芽达到疏肝理气，和胃止痛、消食健胃开胃的目的，使化疗患者的肠胃功能逐渐恢复强健正常；辅以微辛的半夏曲、胆南星、代代花，起到止咳化痰、平喘降逆、理气宽胸，开胃止呕的作用，降低各种肠胃不适。
具体实施方式
下面通过具体实施例对本发明进行详细说明，需要理解的是，以下实施例仅作为对本发明的解释和说明，不以任何方式限制本发明的保护范围。
如无特殊说明，以下实施例中的原料药均为重量份。原料药：胆南星、姜竹茹、佛手柑、炒枳实、半夏曲、焦谷、麦芽和代代花，在一般中药房可购买到。
实施例1－7.本发明中药制剂的制备
表1.实施例1－7中药制剂的配方
按表1称取原料药，将胆南星、姜竹茹、佛手柑、炒枳实、半夏曲、焦谷、麦芽放入煎煮容器中，加入8倍重量的水，先煎煮1.5小时，再加入代代花，继续煮1小时，倒出煎液；然后向药渣中再加入6倍重量的水煎煮1小时，倒出煎液；合并煎液，过滤，滤液浓缩至三分之一体积，冷却至室温，加入沉降剂，搅拌，冷藏过夜，过滤去除沉淀物，将药液继续浓缩至挂旗成稠膏时，装入搪瓷盘中，在90℃以下烤干，粉碎，制粒，装入1号胶囊，分装瓶中即可。
质量标准：应符合《中华人民共和国药典》90年版一部胶囊剂项下有关各项规定。检查项目：①水分：硬胶囊剂的内容物水分含量不得过9.0％；②装量差异：内容物重0.33±0.03g。
功能主治：肿瘤放化疗后胃肠反应，恶心呕吐，头昏，不思饮食。
用法用量：口服，一日三次，一次四粒。
贮藏：密封。
实验例8.本发明中药制剂对恶心呕吐的治疗效果
1.病例资料
化疗后引发恶心呕吐的癌症患者84例，男47例，女37例；年龄34～72岁，病程5个月～2年半；肺癌33例，胃癌25例，乳腺癌14例，头颈癌7例，其它恶性肿瘤5例；化疗后均表现出胃肠道反应，临床症状为恶心、呕吐、不思饮食；所有患者无其它身体疾病，已排除其它可能引起恶心呕吐的原因，并且化疗前24小时内没有出现恶心呕吐的症状。
2.治疗方法
将患者随机分为实验组(42例)和对照组(42例)，两组患者的基本资料无显著性差异，具有可比性。所有患者接受一个周期(5天)含顺铂的化疗。
对照组：不服用任何缓解或治疗恶心呕吐的药物。
实验组：口服本发明实施例1制备的胶囊，一日三次，一次四粒，连续服用5天。
3.疗效评价标准
按照WHO抗癌药急性及亚急性毒性分级标准，将恶心呕吐分为四个等级：0级：无恶心呕吐；Ⅰ级：轻微恶心，无呕吐；Ⅱ级：每日呕吐1～2次；Ⅲ级：每日呕吐3～5次；Ⅳ级：难以控制的呕吐，每日超过5次。
根据以上标准，0级和Ⅰ级为显效，Ⅱ级为有效，Ⅲ、Ⅳ级为无效，显效病例数和有效病例数的总和除以总病例数为有效率。
4.临床治疗结果
所有患者按时完成了化疗，从化疗第一天开始观察并记录患者的恶心呕吐症状以及其它生理反应。如表2所示，与对照组相比，本发明中药制剂能够有效缓解化疗引起的恶心呕吐，并且实验组患者在治疗过程中生命体征平稳，血常规等检查结果与对照组患者相比无明显变化。
表2.本发明中药制剂止吐效果
实施例9.本发明中药制剂与格拉司琼联合给药的治疗效果
病例资料及疗效评价标准同实施例8。
1.治疗方法
将患者随机分为实验组(42例)和对照组(42例)，两组患者的基本资料无显著性差异，具有可比性。所有患者接受一个周期(5天)含顺铂的化疗。
对照组：在化疗前20分钟以及化疗后4小时分别对患者给予3mg/次的格拉司琼，持续给药5天。
实验组：在对照组的基础上口服本发明实施例1制备的胶囊，一日三次，一次四粒，连续服用5天。
2.临床治疗结果
(1)止吐效果
所有患者按时完成了化疗和相应的呕吐治疗，从化疗第一天开始观察并记录患者的恶心呕吐症状以及其它生理反应。结果表明，本发明中药制剂与格拉司琼联合给药能够有效控制化疗引起的恶心呕吐，与对照组相比差异显著(表3)。并且实验组患者在治疗过程中生命体征平稳，血常规等检查结果与对照组患者相比无明显变化。
表3.本发明中药制剂与格拉司琼联合给药的止吐效果
(2)副反应
对照组患者：头晕1例，腹胀5例，便秘14例；治疗组患者：头晕0例，腹胀2例，便秘8例。由此可见，服用本发明的中药制剂不仅没有副作用，还能有效降低西药引起的副反应，对肿瘤患者化疗后产生的头晕、恶心呕吐等症状具有显著疗效。
Claims (9)
1.一种缓解肿瘤放化疗所致的胃肠道副反应的中药制剂，其特征在于，所采用的原料药的重量份配比为：
胆南星2～4份、姜竹茹4～6份、佛手柑4～6份、炒枳实5～7份、半夏曲5～7份、焦谷5～7份、麦芽5～7份、代代花1～3份。
2.根据权利要求1所述的中药制剂，其特征在于，所述原料药的重量份配比为：
胆南星2.5～3.5份、姜竹茹4.5～5.5份、佛手柑4.5～5.5份、炒枳实5.5～6.5份、半夏曲5.5～6.5份、焦谷5.5～6.5份、麦芽5.5～6.5份、代代花1.5～2.5份。
3.根据权利要求1所述的中药制剂，其特征在于，所述原料药的重量份配比为：
胆南星3份、姜竹茹5份、佛手柑5份、炒枳实6份、半夏曲6份、焦谷6份、麦芽6份、代代花2份。
4.根据权利要求1～3任一所述的中药制剂，其特征在于，所述中药制剂的剂型为颗粒剂、片剂、胶囊剂、丸剂或汤剂。
5.根据权利要求1～3任一所述的中药制剂，其特征在于，还包括药学上可接受的辅料。
6.根据权利要求5所述的中药制剂，其特征在于，所述辅料指药物赋形剂或药物矫味剂。
7.权利要求1～3任一所述的中药制剂的制备方法，其特征在于，包括如下步骤：
(1)按所述种类和重量配比取所述原料药，将胆南星、姜竹茹、佛手柑、炒枳实、半夏曲、焦谷、麦芽放入煎煮容器中，加入6～10倍重量的水，先煎煮1.5-3小时后，再加入代代花，继续煮1-1.5小时，倒出煎液，备用；
(2)向药渣中加入5-7倍重量的水，煎煮0.5-1.5小时，倒出煎液，备用；
(3)合并步骤(1)和(2)所得煎液，过滤并浓缩滤液。
8.根据权利要求7所述的制备方法，其特征在于，
步骤(1)中，加入8倍重量的水，先煎煮1.5小时后，再加入代代花，继续煮1小时；
步骤(2)中，加入6倍重量的水，煎煮1小时。
9.根据权利要求7或8所述的制备方法，其特征在于，步骤(3)中，过滤并浓缩滤液至三分之一体积，冷却，加入沉降剂，搅拌，冷藏过夜，过滤弃去沉淀物，将药液继续浓缩成稠膏，在90℃以下干燥，粉碎，制粒，装入胶囊，即得。
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101480485A (zh) * | 2008-01-09 | 2009-07-15 | 熊烈 | 一种用半夏等中草药研制的抗恶心呕吐药 |
| CN104784584A (zh) * | 2015-04-27 | 2015-07-22 | 刘晓红 | 抑制放疗胃肠道反应的药膳及制备方法 |
| CN104906539A (zh) * | 2015-06-09 | 2015-09-16 | 山东省医学科学院附属医院 | 一种防治化疗引起的延迟性恶心呕吐的中药组合物及其应用 |
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2016
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101480485A (zh) * | 2008-01-09 | 2009-07-15 | 熊烈 | 一种用半夏等中草药研制的抗恶心呕吐药 |
| CN104784584A (zh) * | 2015-04-27 | 2015-07-22 | 刘晓红 | 抑制放疗胃肠道反应的药膳及制备方法 |
| CN104906539A (zh) * | 2015-06-09 | 2015-09-16 | 山东省医学科学院附属医院 | 一种防治化疗引起的延迟性恶心呕吐的中药组合物及其应用 |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110478466A (zh) * | 2019-07-31 | 2019-11-22 | 四川大学华西医院 | 一种改善肿瘤放化疗患者胃肠功能的药物组合物及其制备方法和用途 |
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