CN106237177A - 用于改善湿热蕴脾证腹泻的中药组合物和制备方法及其应用 - Google Patents
用于改善湿热蕴脾证腹泻的中药组合物和制备方法及其应用 Download PDFInfo
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Abstract
本发明公开了一种用于改善湿热蕴脾证腹泻的中药组合物及其制备方法和应用，所述中药组合物的有效成分由下述重量份的原料药制备而成：茯苓10‑15份、苍术3‑9份、厚朴3‑9份、白术6‑10份、党参10‑20份、陈皮3‑9份、葛根10‑15份、薏苡仁10‑20份、大枣6‑15份、莲子6‑15份、芡实9‑15份、乌梅6‑12份、广藿香3‑10份、黄连2‑5份、金银花6‑12份、栀子6‑10份、秦皮6‑12份、鸡内金3‑10份、玉竹6‑12份。本发明所述的中药组合物配伍合理，诸药合用，共奏改善湿热蕴脾证腹泻之效。
Description
技术领域
本发明涉及中药领域，特别是涉及一种用于改善湿热蕴脾证腹泻的中药组合物和制备方法及其应用。
背景技术
功能性腹泻是临床上常见的一种消化性疾病，以腹泻为主要临床表现，是一种不伴有腹痛或腹部不适，持续性或反复发作排松散便或水样便的功能性肠病，是下消化道最为主要的功能性胃肠病之一。主要表现为胃肠蠕动过快，小肠吸收功能下降。实验室检查及特殊检查皆无器质性病变，此种疾病的发生常与精神因素、温度、食物等相关。随着生活节奏的加快，精神压力的增高，生活习惯及饮食结构的改变，功能性腹泻的发生率达9.7％，其发病率还有逐年增长趋势。
功能性腹泻在中医属“泄泻”范畴。影响因素有外感六淫之邪、饮食所伤、情志失调、形体劳倦，涉及脏腑有脾胃、肝、肾及大、小肠，但关系最为密切为脾胃。该病多由脾虚湿生，脾胃运化功能失调，肠道分清泌浊、传导功能失司所致；脾主运化，喜燥恶湿，脾气亏虚，健运失司，湿从中生，困阻于脾，水谷不化，清浊不分，并走大肠，混杂而下，而成泄泻。久泻津液亏虚，阴虚生热，乃伤脾阴。
发明内容
基于此，本发明目的之一在于提供一种用于改善湿热蕴脾证腹泻的中药组合物。
解决上述技术问题的具体技术方案如下：
一种用于改善湿热蕴脾证腹泻的中药组合物，所述中药组合物的有效成分由下述重量份的原料药制备而成：茯苓10-15份、苍术3-9份、厚朴3-9份、白术6-10份、党参10-20份、陈皮3-9份、葛根10-15份、薏苡仁10-20份、大枣6-15份、莲子6-15份、芡实9-15份、乌梅6-12份、广藿香3-10份、黄连2-5份、金银花6-12份、栀子6-10份、秦皮6-12份、鸡内金3-10份、玉竹6-12份。
优选的，所述中药组合物的有效成分由下述重量份的原料药制备而成：茯苓11-14份、苍术4-7份、厚朴4-7份、白术7-9份、党参12-18份、陈皮4-7份、葛根11-14份、薏苡仁12-18份、大枣8-12份、莲子8-12份、芡实10-14份、乌梅7-10份、广藿香4-8份、黄连2-4份、金银花7-10份、栀子7-9份、秦皮7-10份、鸡内金4-8份、玉竹7-10份。
优选的，所述中药组合物的有效成分由下述重量份的原料药制备而成：茯苓12-13份、苍术5-6份、厚朴5-6份、白术8-9份、党参15-16份、陈皮5-6份、葛根12-13份、薏苡仁15-16份、大枣9-10份、莲子9-10份、芡实12-13份、乌梅8-9份、广藿香5-6份、黄连2-3份、金银花8-9份、栀子8-9份、秦皮8-9份、鸡内金5-6份、玉竹8-9份。
本发明的另一目的在于提供一种上述用于改善湿热蕴脾证腹泻的中药组合物的制备方法，包括如下步骤：
(1)取茯苓、苍术、厚朴、白术、党参、陈皮、葛根、薏苡仁、大枣、莲子、芡实、乌梅、广藿香、黄连、金银花、栀子、秦皮和玉竹煎煮，过滤，浓缩，得清膏；
(2)鸡内金粉碎，与步骤(1)所得的清膏，混匀。
优选的，步骤(1)所述煎煮的时间为10-20min。
优选的，所述煎煮的时间为10-15min。
本发明的另一目的在于提供一种上述中药组合物在制备用于改善湿热蕴脾证腹泻的药品或保健品中的应用。
本发明所述的一种用于改善湿热蕴脾证腹泻的中药组合物及其准备方法和应用具有以下优点和有益效果：
1)本发明所述的中药组合物配伍合理，诸药合用，共奏用于改善湿热蕴脾证腹泻之效，该中药组合物以运脾为主，清湿热为辅，补阴加之，相互协同，显著改善湿热蕴脾所致功能性腹泻，尤其是可显著改善由脾气虚湿热引发的腹泻。
2)本发明所述制备方法，简单、方便。
具体实施方式
以下将结合具体实施例对本发明做进一步说明，以便本领域技术人员更清楚的了解本发明，但并不因此限制本发明。
实施例1
本实施例涉及一种用于改善湿热蕴脾证腹泻的中药组合物，其有效成分由下述重量的原料药制备而成：茯苓12g、苍术6g、厚朴6g、白术9g、党参15-16g、陈皮6g、葛根12g、薏苡仁16g、大枣9g、莲子9g、芡实12g、乌梅9g、广藿香6g、黄连3g、金银花9g、栀子9g、秦皮9g、鸡内金6g、玉竹9g。
上述用于改善湿热蕴脾证腹泻的中药组合物的制备方法，步骤如下：
取茯苓、苍术、厚朴、白术、党参、陈皮、葛根、薏苡仁、大枣、莲子、芡实、乌梅、广藿香、黄连、金银花、栀子、秦皮和玉竹煎煮10-15min，过滤，滤渣继续煎煮10min，过滤，合并两次滤液，浓缩至清膏，加入鸡内金混匀，即可。
实施例2
本实施例涉及一种用于改善湿热蕴脾证腹泻的中药组合物，其有效成分由下述重量的原料药制备而成：茯苓10g、苍术3g、厚朴3g、白术6g、党参10g、陈皮3g、葛根10g、薏苡仁10g、大枣6g、莲子6g、芡实9g、乌梅6g、广藿香3g、黄连2g、金银花6g、栀子6g、秦皮6g、鸡内金3g、玉竹6g。
上述用于改善湿热蕴脾证腹泻的中药组合物的制备方法参照实施例1。
实施例3
本实施例涉及一种用于改善湿热蕴脾证腹泻的中药组合物，其有效成分由下述重量的原料药制备而成：茯苓14g、苍术7g、厚朴7g、白术9g、党参18g、陈皮7g、葛根14g、薏苡仁18g、大枣12g、莲子12g、芡实14g、乌梅10g、广藿香8g、黄连4g、金银花10g、栀子9g、秦皮10g、鸡内金8g、玉竹10g。
上述用于改善湿热蕴脾证腹泻的中药组合物的制备方法参照实施例1。
以下结合实践中典型病例对本发明的有益效果做进一步说明。
1、病人概况：选择220例，均符合《肠易激综合征中西医结合诊疗方案》中诊断标准。中医诊断为脾气虚湿热证，具体如下：
脾气虚弱证：主症：①腹泻、便溏，有黏液或少量脓血。②纳差食少。③肢体倦怠。④舌质淡胖或齿痕，苔薄白。次症：①腹胀肠鸣。②腹部隐痛喜按。③面色萎黄。④脉细弱或濡缓。证型确定：具备主症2项加次症2项，或主症第1项加次症3项。
大肠湿热证：主症：①腹泻黏液脓血便。②腹痛或里急后重。③肛门灼痛。④舌苔黄厚或腻。次症：①身热。②口干口苦。③小便短赤。④脉滑数或濡数。证型确定：具备主症2项加次症2项，或主症第1项加次症3项。
随机将病人平均分为治疗组1(55例，男性24例，女性31例，年龄43-55岁，病程1～2年)、治疗组2(55例，男性27例，女性28例，年龄40-58岁，病程1～3年)、治疗组3(55例，男性21例，女性34例，年龄51-58岁，病程1～2年)和对照组(55例，男性18例，女性37例，年龄49-60岁，病程1～3年)。四组性别、年龄、病程等比较无显著性差异(P>0.05)，具有可比性。
2、治疗方法
治疗组1-3分别服用实施例1-3所制得的中药组合物，2次/日。对照组服用：茯苓12g、苍术6g、厚朴6g、白术9g、党参15-16g、陈皮6g、葛根12g、薏苡仁16g、大枣9g、莲子9g、芡实12g、乌梅9g、广藿香6g、黄连3g、金银花9g、栀子9g、秦皮9g，制备方法参照实施例1，2次/日。四组疗程为4周，治疗期间停用其他药物，避免辛辣寒凉食物。
3、观测内容
将症状大便泄泻、腹胀、肠鸣、食欲不振、倦怠乏力、小便短赤，根据《中药新药治疗泄泻临床研究指导原则》症状分级量化表，症状程度分为轻度、中度、重度3级，分别积分为1、2、3分。疗程结束后复查血常规、尿常规和生化指标。
采用spss进行数据分析，采用x±s表示，治疗前后采用配对样本t检验，各组间比较采用两组独立样本t检验，计数资料采用X2检验。
4、疗效标准
根据《中药新药治疗泄泻临床研究指导原则》证候疗效判定标准，疗效指数＝[(治疗前症状积分-治疗后症状积分)/治疗前症状积分]×100％。
痊愈：≥95％；显效：70％≤疗效指数＜95％；有效：30％≤疗效指数＜70％；无效：疗效指数＜30％。
5、治疗结果
四组疗效比较结果见表1。从表1可以看出，总有效率治疗组1>治疗组3>治疗组2>对照组。说明实施例所制得的中药组合物可显著改善因脾气虚湿热所导致的腹泻。四组治疗前后未见明显不良反应，血、尿常规及生化指标未见异常变化。
表1
| 组别 | 例 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
| 对照组 | 55 | 21 | 13 | 14 | 7 | 87.3％ |
| 治疗组1 | 55 | 31 | 18 | 4 | 2 | 96.4％ |
| 治疗组2 | 55 | 26 | 15 | 9 | 5 | 90.9％ |
| 治疗组3 | 55 | 28 | 16 | 7 | 4 | 92.7％ |
Claims (7)
1.一种用于改善湿热蕴脾证腹泻的中药组合物，其特征在于，所述中药组合物的有效成分由下述重量份的原料药制备而成：茯苓10-15份、苍术3-9份、厚朴3-9份、白术6-10份、党参10-20份、陈皮3-9份、葛根10-15份、薏苡仁10-20份、大枣6-15份、莲子6-15份、芡实9-15份、乌梅6-12份、广藿香3-10份、黄连2-5份、金银花6-12份、栀子6-10份、秦皮6-12份、鸡内金3-10份、玉竹6-12份。
2.根据权利要求1所述的用于改善湿热蕴脾证腹泻的中药组合物，其特征在于，所述中药组合物的有效成分由下述重量份的原料药制备而成：茯苓11-14份、苍术4-7份、厚朴4-7份、白术7-9份、党参12-18份、陈皮4-7份、葛根11-14份、薏苡仁12-18份、大枣8-12份、莲子8-12份、芡实10-14份、乌梅7-10份、广藿香4-8份、黄连2-4份、金银花7-10份、栀子7-9份、秦皮7-10份、鸡内金4-8份、玉竹7-10份。
3.根据权利要求2所述的用于改善湿热蕴脾证腹泻的中药组合物，其特征在于，所述中药组合物的有效成分由下述重量份的原料药制备而成：茯苓12-13份、苍术5-6份、厚朴5-6份、白术8-9份、党参15-16份、陈皮5-6份、葛根12-13份、薏苡仁15-16份、大枣9-10份、莲子9-10份、芡实12-13份、乌梅8-9份、广藿香5-6份、黄连2-3份、金银花8-9份、栀子8-9份、秦皮8-9份、鸡内金5-6份、玉竹8-9份。
4.一种如上述权利要求1-3任一项所述的用于改善湿热蕴脾证腹泻的中药组合物的制备方法，其特征在于，包括如下步骤：
(1)取茯苓、苍术、厚朴、白术、党参、陈皮、葛根、薏苡仁、大枣、莲子、芡实、乌梅、广藿香、黄连、金银花、栀子、秦皮和玉竹煎煮，过滤，浓缩，得清膏；
(2)鸡内金粉碎，与步骤(1)所得的清膏，混匀。
5.根据权利要求4所述的用于改善湿热蕴脾证腹泻的中药组合物的制备方法，其特征在于，步骤(1)所述煎煮的时间为10-20min。
6.根据权利要求5所述的用于改善湿热蕴脾证腹泻的中药组合物的制备方法，其特征在于，所述煎煮的时间为10-15min。
7.如权利要求1-3任一项所述的用于改善湿热蕴脾证腹泻的中药组合物在制备用于改善湿热蕴脾证腹泻的药品或保健品中的应用。
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