CN107432472B - 一种治疗腹泻的组合物及其应用 - Google Patents
一种治疗腹泻的组合物及其应用 Download PDFInfo
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- CN107432472B CN107432472B CN201710743148.8A CN201710743148A CN107432472B CN 107432472 B CN107432472 B CN 107432472B CN 201710743148 A CN201710743148 A CN 201710743148A CN 107432472 B CN107432472 B CN 107432472B
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Abstract
本发明涉及功能食品或保健食品，具体公开了一种治疗腹泻的组合物及其应用。所述组合物包含以下重量份的组分：人参5‑20份，芡实5‑20份，茯苓5‑15份，山药20‑30份，白扁豆5‑10份，炒莲子5‑10份，薏苡仁10‑20份，砂仁5‑10份，桔梗5‑10份，甘草5‑10份。本发明将所述组分配合共用，通过调节胃肠功能、补脾养胃、除湿止泻达到治疗腹泻的作用，可适用于饮食不规律、快速进餐、以及外食不卫生造成的具有腹泻问题的人群。本发明提供的颗粒剂便于携带、服用快速、口感适中，并有特有的香气。本发明的组合物在应用于治疗腹泻疾病中相比于常规的治疗腹泻的药物具有服用周期短、治愈效果好、无副作用等特点。
Description
技术领域
本发明涉及功能食品或保健食品，具体地说，涉及一种治疗腹泻的组合物及其应用。
背景技术
腹泻俗称“拉肚子”，是指排便次数明显超过平日***衡，造成菌群紊乱，反而使腹泻迁延不愈，或继发二重感染。较西医而言，中草药治疗具有整体调节，辨证施治的优点，无毒副作用更加安全有效。
人参味甘、微苦，性温、平。归脾、肺经、心经。具有大补元气，复脉固脱，补脾益肺，生津，安神的功效。芡实甘、涩、平。归脾、肾经。具有益肾固精，补脾止泻，除湿止带的功效。茯苓甘、淡，平。归心、肺、脾、肾经。具有利水渗湿，健脾，宁心的功效。常用于水肿尿少，痰饮眩悸，脾虚食少，便溏泄泻，心神不安，惊悸失眠。山药甘，平。归脾、肺、肾经。具有补脾养胃，生津益肺，补肾涩精。用于脾虚食少，久泻不止，肺虚喘咳，肾虚遗精，带下，尿频，虚热消渴。白扁豆甘，微温。归脾、胃经。用于脾胃虚弱，食欲不振，大便溏泻，白带过多，暑湿吐泻，胸闷腹胀。炒白扁豆健脾化湿，常用于脾虚泄泻。炒莲子、薏苡仁、砂仁、桔梗以及甘草等中药配伍多具有调节胃肠功能、补脾养胃、除湿止泻的功效。
发明内容
为了解决现有技术中存在的问题，本发明的目的是提供一种治疗腹泻的组合物及其应用。
为了实现本发明目的，本发明的技术方案如下：
本发明首先提供一种治疗腹泻的组合物，包含以下重量份的组分：人参5-20份，芡实5-20份，茯苓5-15份，山药20-30份，白扁豆5-10份，炒莲子5-10份，薏苡仁10-20份，砂仁5-10份，桔梗5-10份，甘草5-10份。
优选地，所述组合物包含以下重量份的组分：人参5-15份，芡实5-15份，茯苓5-10份，山药20-25份，白扁豆5-8份，炒莲子5-9份，薏苡仁10-15份，砂仁5-7份，桔梗5-8份，甘草5-8份。
更为优选地，所述组合物包含以下重量份的组分：人参15份，芡实15份，茯苓12份，山药23份，白扁豆7份，炒莲子9份，薏苡仁15份，砂仁6份，桔梗7份，甘草6份。
上述组合物中：
所述重量份可以是μg、mg、g、kg等医药领域公知的重量单位，也可以是其倍数，如1/10、1/100、10倍、100倍等。
本发明还提供了前述组合物在制备治疗腹泻功能食品或保健食品中的应用。
所述功能食品或保健食品可为医药保健领域常规剂型，如颗粒剂、片剂、胶囊、膏滋、饮料等。
可选/优选地，所述剂型为颗粒剂，包含以下重量份的组分：人参5-20份，芡实5-20份，茯苓5-15份，山药20-30份，白扁豆5-10份，炒莲子5-10份，薏苡仁10-20份，砂仁5-10份，桔梗5-10份，甘草5-10份，益生元50-100份，粘结剂2％-10％(用量为其他组分总重量的2％-10％)。
优选地，所述颗粒剂包含以下重量份的组分：人参5-15份，芡实5-15份，茯苓5-10份，山药20-25份，白扁豆5-8份，炒莲子5-9份，薏苡仁10-15份，砂仁5-7份，桔梗5-8份，甘草5-8份，益生元50-80份，粘结剂2％-8％(用量为其他组分总重量的2％-8％)。
更为优选地，所述颗粒剂包含以下重量份的组分：人参15份，芡实15份，茯苓12份，山药23份，白扁豆7份，炒莲子9份，薏苡仁15份，砂仁6份，桔梗7份，甘草6份，益生元60份，粘结剂5％(用量为其他组分总重量的5％)。
其中，所述益生元为低聚异麦芽糖、低聚果糖或低聚木糖。在本发明的具体实施方式中，所述益生元为低聚异麦芽糖，购自天津益倍元天然产物技术有限公司，其低聚异麦芽糖含量为大于80％。
其中，所述粘结剂为80％(体积分数)的酒精。
本发明进一步提供所述颗粒剂的制备方法：
1)将低聚异麦芽糖过筛，选取60目筛下细粉，按照配比称取人参粉、芡实粉、茯苓粉、山药粉、白扁豆粉、炒莲子粉、薏苡仁粉、砂仁粉、桔梗粉、甘草粉、低聚异麦芽糖细粉，混合均匀；
2)将混合好的细粉加入80％的酒精为粘合剂，制成60目的颗粒，在温度为50℃的条件下进行干燥，干燥时间60分钟，分装，即得。
可选地，所述剂型可为颗粒剂。制备时，可选择使用所述组合物的提取物。本发明所述人参、芡实、茯苓、山药、白扁豆、炒莲子、薏苡仁、砂仁、桔梗和甘草，均可按现有技术常规方法制备提取物，也可市售购得提取物。
本发明涉及到的原料或试剂均为普通市售产品，涉及到的操作如无特殊说明均为本领域常规操作。
在符合本领域常识的基础上，上述各优选条件，可以相互组合，得到具体实施方式。
本发明的有益效果在于：
1、本发明以人参、芡实、茯苓、山药、白扁豆、炒莲子、薏苡仁、砂仁、桔梗、甘草为主要原料，使各种成分合理组方、配合共用，通过调节胃肠功能、补脾养胃、除湿止泻达到治疗腹泻的作用，可适用于饮食不规律、快速进餐、以及外食不卫生造成的具有腹泻问题的人群。
2、本发明提供的颗粒剂便于携带、服用快速、口感适中，并有特有的香气。
3、经过实验，发现服用本发明提供的组合物和颗粒剂的志愿者，腹泻情况得到明显改善。
本发明的组合物在应用于治疗腹泻疾病中相比于常规的治疗腹泻的药物具有服用周期短、治愈效果好、无副作用等特点。
具体实施方式
下面将结合实施例对本发明的优选实施方式进行详细说明。需要理解的是以下实施例的给出仅是为了起到说明的目的，并不是用于对本发明的范围进行限制。本领域的技术人员在不背离本发明的宗旨和精神的情况下，可以对本发明进行各种修改和替换。
下述实施例中所用的材料、试剂等，如无特殊说明，均可从商业途径得到。
颗粒剂制备过程中，如无特殊说明，所使用的手段均为本领域常规的技术手段。
所述人参为种植5年以下人参原粉，购自天津益倍元天然产物技术有限公司；
所述芡实提取物为10：1比例提取物，购自天津益倍元天然产物技术有限公司；
所述茯苓提取物中茯苓多糖含量为30-50％，三萜酸含量为0.5-2％，购自天津益倍元天然产物技术有限公司；
所述山药提取物中薯蓣皂素含量为5-20％，购自天津益倍元天然产物技术有限公司；
所述白扁豆提取物为10：1比例提取物，购自天津益倍元天然产物技术有限公司；
所述炒莲子提取物为10：1比例提取物，购自天津益倍元天然产物技术有限公司；
所述薏苡仁提取物为10：1比例提取物，购自天津益倍元天然产物技术有限公司；
所述砂仁提取物为10：1比例提取物，购自天津益倍元天然产物技术有限公司；
所述桔梗提取物为10：1比例提取物，购自天津益倍元天然产物技术有限公司；
所述甘草提取物中甘草酸含量为2-5％，黄酮含量为2-5％，购自天津益倍元天然产物技术有限公司；
所述低聚异麦芽糖含量为大于80％，购自天津益倍元天然产物技术有限公司。
实施例1
按重量分别称取干燥的人参粉15份，芡实粉15份，茯苓粉12份，山药粉23份，白扁豆粉7份，炒莲子粉9份，薏苡仁粉15份，砂仁粉6份，桔梗粉7份，甘草粉6份，低聚异麦芽糖粉60份，三氯蔗糖0.2％，混合均匀，喷洒粘结剂5％。制成60目的颗粒，在温度为50℃的条件下进行干燥，干燥时间60分钟，分装。
实施例2
按重量分别称取干燥的人参粉10份，芡实10份，茯苓10份，山药30份，白扁豆5份，炒莲子7份，麸炒薏苡仁13份，砂仁8份，桔梗7份，甘草10份，低聚异麦芽糖粉60份，混合均匀，喷洒粘结剂5％。三氯蔗糖0.2％，制成60目的颗粒，在温度为50℃的条件下进行干燥，干燥时间60分钟，分装。
实施例3
按重量分别称取干燥的人参粉5份，芡实5份，茯苓5份，山药20份，白扁豆5份，炒莲子10份，麸炒薏苡仁20份，砂仁10份，桔梗15份，甘草10份，低聚异麦芽糖粉60份，三氯蔗糖0.2％，混合均匀，喷洒粘结剂5％。制成60目的颗粒，在温度为50℃的条件下进行干燥，干燥时间60分钟，分装。
实施例4
按重量分别称取干燥的人参粉7份，芡实7份，茯苓13份，山药25份，白扁豆5份，炒莲子9份，麸炒薏苡仁10份，砂仁9份，桔梗14份，甘草8份，低聚异麦芽糖粉60份，三氯蔗糖0.2％，混合均匀，喷洒粘结剂5％。制成60目的颗粒，在温度为50℃的条件下进行干燥，干燥时间60分钟，分装。
实施例5
按重量分别称取干燥的人参粉15份，芡实提取物15份，茯苓提取物12份，山药提取物23份，白扁豆提取物7份，炒莲子提取物9份，薏苡仁提取物15份，砂仁提取物6份，桔梗提取物7份，甘草提取物6份，低聚异麦芽糖粉60份，微晶纤维素20份，羧甲基淀粉5份，硬脂酸镁1％，混合均匀，直接粉末压片。
实验例1
证明本组合物具有治疗腹泻的实验
1、人群选择：选取25～45岁腹泻患者，男女各60人。
2、实验分组：120名志愿者平均分成6组，这6组志愿者分别服用实施例1-4中的组合物和对比例1、2中的药物。对比例1按使用说明书服用苯已哌啶(治疗急、慢性功能性腹泻)，一次1片，一日3次。对比例2按使用说明书服用诺氟沙星(治疗细菌感染引起的腹泻)，一次4粒，一日2次。
3、实验方法：服用实施例1-4的志愿者按照剂量服用，每日3餐饭后服用一次，每次5g温水送服，连续服用7天。服用对比例1、2的志愿者按照说明书服用，连续服用7天。
4、实验结果见下表：
| 完全治愈例 | 显著治愈例 | 基本无效例 | |
| 实施例1 | 16 | 2 | 2 |
| 实施例2 | 14 | 3 | 3 |
| 实施例3 | 11 | 6 | 3 |
| 实施例4 | 13 | 3 | 4 |
| 对比例1 | 9 | 6 | 5 |
| 对比例2 | 7 | 7 | 6 |
从表中的治愈结果可以得出，本发明的实施例1-4治疗腹泻的疗效显著的优于对比例1和对比例2。说明本发明的组合物具有治疗腹泻的作用，并且对于急、慢性功能性腹泻和细菌感染引起的腹泻均有明显效果。同时服用实施例1-4的患者没有出现对比例1、2中患者出现的腹部不适、恶心呕吐、头晕嗜睡等副作用。说明本发明的组合物安全有效、无副作用。
虽然，上文中已经用一般性说明及具体实施方案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 (2)
1.一种治疗腹泻的药物制剂，其特征在于，所述制剂为颗粒剂，所述颗粒剂的原料包含治疗腹泻的组合物，所述组合物由以下重量份的组分组成：人参15份，芡实15份，茯苓12份，山药23份，白扁豆7份，炒莲子9份，薏苡仁15份，砂仁6份，桔梗7份，甘草6份；
所述颗粒剂的原料还包括益生元60份和重量为前述组分总重量5%的粘结剂。
2.根据权利要求1所述的制剂，其特征在于，其制备方法包括如下步骤：
1）将益生元过筛，选取60目筛下细粉，所述益生元为低聚异麦芽糖，按照配比称取人参粉、芡实粉、茯苓粉、山药粉、白扁豆粉、炒莲子粉、薏苡仁粉、砂仁粉、桔梗粉、甘草粉、低聚异麦芽糖细粉，混合均匀；
2）将混合好的细粉加入粘结剂，制成60目的颗粒，在温度为50℃的条件下进行干燥，干燥时间60分钟，分装，即得。
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