CN116898939A - 一种治疗腹泻型肠易激综合征的药物组合及其制备方法和应用 - Google Patents
一种治疗腹泻型肠易激综合征的药物组合及其制备方法和应用 Download PDFInfo
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Abstract
本发明涉及一种治疗腹泻型肠易激综合征的中药组合物及其应用，所述中药组合物由以下质量份计的中药原料提取制备而成：党参6‑30份，仙鹤草6‑30份，炒白术5‑20份，葛根10‑30份，茯苓5‑30份，黄芩3‑15份，黄连2‑15份，炒白芍6‑20份，陈皮3‑20份，砂仁3‑15份，炙甘草2‑20份。临床试验表明，本发明的治疗腹泻型肠易激综合征中药组合物对脾虚湿热型IBS‑D治疗4周后的主要疗效指标明显缓解(AR)应答率可达80.7％，IBS‑SSS评分较治疗前显著降低，中医证候评分明显改善，对脾虚湿热型IBS‑D疗效确切。
Description
技术领域
本发明属于中药治疗腹泻型肠易激综合征的领域，尤其是使用特定的成分及配比制成的中药组合物来治疗脾虚湿热型腹泻型肠易激综合征。
背景技术
肠易激综合征(irritable bowel syndrome，IBS)是一种以腹痛或腹部不适伴有排便习惯和(或)粪便性状改变为主要表现的常见的功能性胃肠病，全球成人患病率在4.1％(罗马IV标准)和10.1％(罗马III标准)之间。虽然IBS不是一种危及生命的疾病，但其与严重的疾病负担有关，包括生活质量下降，心理合并症发病率升高以及高治疗经济成本。IBS伴腹泻(IBS-D)是IBS的主要排便习惯亚型之一，约占IBS的30-40％。IBS-D的发病机制目前认为与胃肠动力异常、内脏高敏感性、脑-肠轴互动异常、肠道感染与免疫异常、肠道菌群紊乱和代谢异常、精神因素等有关。目前现代医学以缓解症状、对症治疗为主，如止泻解痉、联用益生菌制剂、调节肠道动力、抗焦虑等。一方面，单药物治疗常常难以缓解患者的症状，另一方面，多种药物联用导致的安全性顾虑增加，同时经济成本也相应提高，另外，停药后，患者症状时有反复等情况，使目前IBS-D的治疗效果不尽如人意。寻找一种疗效更加确切、安全性更高的药物成了IBS-D治疗所追求的方向。
腹泻型肠易激综合征属于中医“泄泻”、“腹痛”的范畴；发病诱因多为先天禀赋不足和(或)后天失养，情志失调、饮食不节、感受外邪等；病位在肠，主要涉及肝、脾(胃)、肾等脏腑；其核心病机为脾虚肝郁，脾虚是基础，肝郁是诱因，临床上常将本病分为6个证型进行辨证施治：脾虚湿盛证、肝郁脾虚证、脾肾阳虚证、肝气郁滞证、寒热错杂证、湿热阻滞证，分别选用参苓白术散、痛泻要方、附子理中汤、逍遥散、乌梅丸、葛根芩连汤加减治疗，其中以脾虚湿热型腹泻型肠易激综合征最为常见。
发明内容
本发明的发明目的是提供一种治疗脾虚湿热型腹泻型肠易激综合征的中药组合物。
为了实现上述发明目的，本发明采用了以下技术方案：
治疗腹泻型肠易激综合征的中药组合物，所述中药组合物由以下质量份计的中药原料提取制备而成：党参6-30份，仙鹤草6-30份，炒白术5-20份，葛根10-30份，茯苓5-30份，黄芩3-15份，黄连2-15份，炒白芍6-20份，陈皮3-20份，砂仁3-15份，炙甘草2-20份。
本发明中药组合物的各原料的最佳重量份数配比是：党参12份，仙鹤草12份，炒白术12份，葛根15份，茯苓12份，黄芩10份，黄连5份，炒白芍15份，陈皮10份，砂仁6份，炙甘草5份。
所述的治疗腹泻型肠易激综合征的中药组合物，制备方法步骤如下：以上11味药，加水煎煮2次，第一次加12倍量水，浸泡1小时，煎煮1.5小时，第二次加10倍量水，煎煮1小时，合并提取液，减压浓缩至70℃相对密度为1.15-1.20的浸膏，加辅料制备成固体制剂或液体制剂。
所述的治疗腹泻型肠易激综合征的中药组合物，辅料为医学上可以接受的辅料。
所述的治疗腹泻型肠易激综合征的中药组合物，所述固体制剂或液体制剂为膏剂、汤剂、丸剂、颗粒剂、胶囊剂、片剂、口服液、注射剂或散剂中的一种。
所述的治疗腹泻型肠易激综合征的中药组合物在制备治疗肠易激综合征的药品中的应用。
所述肠易激综合征为脾虚湿热型腹泻型肠易激综合征。
腹泻型肠易激综合征临床常见类型，本发明人通过三十年中医临床实践，总结出脾虚湿热证型的相关诊治经验。《黄帝内经》认为风、寒、暑、湿皆可致泄泻，明代医家李中梓《医宗必读·泄泻》中：“脾土强者,自能胜湿,无湿则不泄。”脾虚是导致泄泻的关键。凡饮食不节，情志失和，思虑太过，禀赋素虚，过于劳倦，久病失养，皆可损伤脾气，使其运化水湿功能减退，难以运载机体水液的正常代谢，积聚成湿。现代社会发展使人民生活质量提升，饮食种类繁多，过量饮酒、贪食肥甘厚腻，则助生湿邪，发为泄泻。湿邪日久从阳化热，酿生湿热，故临床以脾虚湿热型泄泻多见。脾虚与湿热相互为患，既有虚证迁延难愈的特点，又有湿热证胶着难解的特点，使疾病反复发作，难以根治。脾虚湿热一证还会导致腹痛，一方面脾虚津液敷布不及导致“不荣则痛”，另一方面湿热蕴于肠腑、气机不畅、传导失司而致腹痛。本发明人认为脾虚湿热型腹泻型肠易激综合征以脾虚为本，湿热为标，临床治疗上，以健脾、清热、利湿为主要治法，兼以缓急止痛，达到标本兼治的疗效。本发明以甘温补益、苦寒燥湿、酸甘缓急的药物配伍达到治疗腹泻型肠易激综合征腹泻、腹痛及腹部不适症状的疗效。
本发明方中此方中以党参、仙鹤草为君药，党参健脾益气以扶正，仙鹤草功在健脾补虚止泻。以白术、茯苓、茯苓、葛根、黄芩、黄连为臣药。白术、茯苓健脾除湿，收敛止泻补虚，助君药以健脾益气；葛根发脾胃清阳，止泻升津；黄芩、黄连性味为苦寒药对，清热之中，燥湿力强，直清里热，具有厚肠止利的功效。以白芍、陈皮、砂仁为佐药，其中白芍缓急止痛，减轻腹部疼痛症状，兼敛脾阴，与参术合用可于土中泄木；陈皮理气燥湿、醒脾和胃，兼治湿滞脘痞、腹部不舒；砂仁化湿止泻，温中之性反佐黄芩、黄连使不致寒凉。以炙甘草为使药，健脾和胃，和中益气，调和诸药，与白芍同用缓解脘腹疼痛。诸药合用，共奏“健脾益气、清热化湿、缓急止痛”之功效。
本发明各原料的药理作用如下：
现代药理研究证实党参、白术能调理肠道功能及免疫功能，有较好的调整肠道菌群的作用；白术对离体家兔小肠的起抑制作用，该调节与植物神经有关，且白术亦能促进肠道菌群中的有益菌如双歧杆菌、乳杆菌的增值，起到改善肠道内菌群状况的功能；葛根可明显减少番泻叶引起的小鼠腹泻次数，具有较好的抑制肠蠕动的作用；黄芩具有较为广泛的抗菌谱活性，对包括金黄色葡萄球菌在内的多种细菌、真菌具有良好的抑制作用，其提取物还可显著降低脂多糖(LPS)诱导小鼠小角质细胞(BV2)细胞中toll样受体4(TLR4)蛋白的表达；黄连具有广谱的抗菌活性,对革兰氏阳性菌(如金黄色葡萄球菌、肺炎双球菌等)、革兰氏阴性菌(如大肠杆菌、伤寒杆菌等)和真菌均能起到明显的抑制作用,其主要成分小檗碱还可通过影响肠黏膜上皮细胞分泌细胞因子,参与肠固有层淋巴细胞应答并发挥免疫调节作用来减轻小鼠肠黏膜炎症；仙鹤草提取物可通过多种信号通路调控炎症反应发展，抑制炎症因子和相关受体的表达，发挥抗炎作用；砂仁挥发油中主要成分乙酸龙脑酯有显著的抑制番泻叶所致小鼠腹泻、冰醋酸所致小鼠疼痛和离体家兔小肠平滑肌运动的作用；陈皮可抑制肠道肌肉收缩，减轻肠管蠕动；茯苓对腹泻大鼠的小肠推进具有抑制作用，粗提物能抑制家兔离体空肠和盲肠平滑肌收缩运动，减轻腹泻；白芍可调整肠道功能紊乱，并有抗菌、镇静、解痉、消炎作用，对中枢性疼痛、中枢及脊髓反射弧兴奋均有抑制作用；甘草有镇静和对神经末梢的抑制作用，有明显的解痉和抗炎、抗变态反应等免疫调节作用，二者合用，则对中枢性及末梢性的肌肉痉挛、疼痛均有治疗作用。
在这里需特殊说明的是，该发明中药组合中，君药之一仙鹤草，在全方中具有关键作用。仙鹤草为蔷薇科植物龙芽草Agrimonia pilosa Ledeb.的干燥地上部分，味苦、涩，性平，归心、肝经。仙鹤草也叫“泻痢草”，《滇南本草》载：“仙鹤草治赤白痢下。”以其收涩之性，可用于治疗久泻不止，以助肠吸收功能的恢复；该药又称“脱力草”，《现代实用中药》载民间用其治疗脱力劳伤、精力痿顿：以仙鹤草一两，红枣十个，水煎，一日数回分服。国医大师干祖望曾将仙鹤草、仙茅、仙灵脾三药称为“三仙汤”，认为其有“中药的激素”作用，用于各种非外邪导致的神疲乏力。用仙鹤草治疗腹泻型肠易激综合征，其涩中有补，止中寓通，亦有补虚强壮之功，对慢性泻利虚实夹杂者有标本同治之功。发明人临床实践发现，在应用本发明中药方剂缺乏仙鹤草的处方中，患者腹泻改善情况明显差于含有仙鹤草的处方，仙鹤草在本发明中的作用是得到临床实践验证的。
临床试验表明，本发明的治疗腹泻型肠易激综合征中药组合物对脾虚湿热型IBS-D治疗4周后的主要疗效指标明显缓解(AR)应答率可达80.7％，IBS-SSS评分较治疗前显著降低，中医证候评分明显改善，对脾虚湿热型IBS-D疗效确切。
具体实施方式
下面结合具体实施例对本发明作进一步详细的说明。
实施例1
称取党参120g，仙鹤草120g，炒白术120g，葛根150g，茯苓120g，黄芩100g，黄连50g，炒白芍150g，陈皮100g，砂仁60g，炙甘草50g，以上11味药，加水煎煮2次，第一次加12倍量水，浸泡1小时，煎煮1.5小时，第二次加10倍量水，煎煮1小时，合并提取液，减压浓缩至相对密度为1.15-1.20(70℃)，加淀粉，喷雾干燥，制备成颗粒剂。
实施例2
称取党参60g，仙鹤草60g，炒白术50g，葛根300g，茯苓300g，黄芩30g，黄连150g，炒白芍200g，陈皮200g，砂仁30g，炙甘草20g，以上11味药，加水煎煮2次，第一次加12倍量水，浸泡1小时，煎煮1.5小时，第二次加10倍量水，煎煮1小时，合并提取液，减压浓缩至相对密度为1.15-1.20(70℃)，加糊精，压片，制备成片剂。
实施例3
称取党参300g，仙鹤草300g，炒白术200g，葛根100g，茯苓50g，黄芩150g，黄连20g，炒白芍60g，陈皮30g，砂仁150g，炙甘草200g，以上11味药，加水煎煮2次，第一次加12倍量水，浸泡1小时，煎煮1.5小时，第二次加10倍量水，煎煮1小时，合并提取液，减压浓缩至相对密度为1.15-1.20(70℃)，加蔗糖，制备成口服液。
实施例4
称取党参12g，仙鹤草12g，炒白术12g，葛根15g，茯苓12g，黄芩10g，黄连5g，炒白芍15g，陈皮10g，砂仁6g，炙甘草5g，加水浸泡30分钟，原料药的总重量与水的重量之比为1:40，煮沸，保持沸腾40分钟，分离得药渣和药液；药渣重复上述煎煮，合并2次药液，浓缩，共计400ml，分为2份。
实施例5：为了证明本发明的临床疗效，下面利用实施例4制得的中药汤剂对脾虚湿热型腹泻型肠易激综合征患者进行临床试验。
一、临床资料
1、诊断标准：
西医诊断标准：参照罗马Ⅳ诊断标准中腹泻型肠易激综合征的诊断依据，反复发作的腹痛，近3个月内平均发作至少每周1日，伴有以下2项或2项以上：①与排便相关；②伴有排便频率的改变；③伴有粪便性状(外观)改变。诊断前症状出现至少6个月，近3个月符合以上诊断标准。经相关检查排除器质性疾病。
中医诊断标准：中医泄泻的诊断标准参考《中药新药临床研究指导原则》。中医证候的诊断标准参考2017年由中华中医药学会脾胃病分会拟定的《肠易激综合征中医诊疗共识意见》制定脾虚湿热证诊断标准，主症：①泻下急迫或不爽；②大便色黄臭秽；③腹痛隐隐；④舌红胖大，边有齿痕，苔黄腻；⑤脉滑数。次症：①肛口灼热；②食后腹胀，食欲不振；③神疲纳呆，四肢倦怠；④口干口苦；符合主证2项及以上，次证2项及以上即可诊断。
2、纳入标准
①符合腹泻型肠易激综合征西医诊断标准及中医诊断标准；②患者年龄在18-65岁之间，性别不限；③签署知情同意。
3、排除标准
①伴发严重疾病，甚至生命体征不稳定者；②妊娠或哺乳期妇女。
4、研究对象
选取2019年1月至2022年12月期间于江苏省第二中医院脾胃病科门诊及住院患者符合纳入标准的83例患者作为研究对象，男性44例，女性39例。
二、治疗方法
给予患者服用实施例4制得的中药汤剂，每日1剂，每剂400mL，早晚饭后半小时温服，每次服用200mL。疗程为4周。
三、观察指标
1、一般资料，包括年龄、身高、体重等。
2、疗效指标
主要疗效指标：①明显缓解(AR)应答率评价：每周对患者询问：“在过去的1周内，您的IBS症状有明显减轻吗？”患者回答“是”或“否”。每1周观察统计一次,共4次。4周中至少有2周对AR的回答为“是”，记为“应答”，其他情况则为“无应答”。以应答的人数进行评定。②IBS症状严重程度量表(IBS-SSS)治疗前后积分变化。IBS症状严重程度量表包括腹痛程度、腹痛频率、腹胀程度、排便满意度及对生活的影响5个方面进行评分，每项满分均为100分，总分500分。评定标准：1)正常：≤75分；2)轻度：76～175分；3)中度：176～300分；4)重度：＞300分。在治疗前后各观察一次，共2次。
次要疗效指标：中医脾虚湿热证候疗效：中医脾虚湿热证候积分评估方法：根据临床主、次要症状进行评分，泻下急迫或不爽、大便色黄臭秽、腹痛隐隐为主症，将症状按无、轻、中、重分别记0、2、4、6分；以肛口灼热、食后腹胀+食欲不振、神疲纳呆+四肢倦怠、口干口苦为次症，按无、轻、中、重分别记0、1、2、3分。评定方法：采用尼莫地平法计算症状疗效。疗效指数＝[(治疗前积分－治疗后积分)÷治疗前积分]×100％。其中痊愈、显效、有效、无效分别是指：痊愈：脾虚湿热证的主次要症状消失或基本消失，疗效指数≥90％；显效：脾虚湿热证的主次要症状明显改善，疗效指数≥70％且＜90％；有效：脾虚湿热证的主次要症状有好转，30％≤疗效指数＜70％；无效：脾虚湿热证的主次要症状均无明显改善，甚或加重，疗效指数＜30％。
四、统计方法
1、统计描述
对于计量资料，正态分布资料用表示，非正态分布资料用M(P25，P75)表示；对于计数资料，用频数表示。
2、统计分析
(1)一般资料：对计量资料先进行正态性检验，符合正态分布且方差齐性时，采用两独立样本均数的t检验，方差不齐或不符合正态分布时，采用两独立样本的秩和检验；对计数资料，采用四格表资料的卡方检验。
(2)疗效评价：组内比较(如治疗组治疗前后症状积分比较)，采用配对样本t检验。
(3)统计结果以P＜0.05为差异有统计学意义，P＞0.05为差异无统计学意义。
(4)统计使用SPSS20.0软件进行统计分析。
五、试验结果
1、一般情况：所有患者的年龄、身高、体重等一般资料均无统计学差异，具有可比性。
2、IBS主要疗效指标：明显缓解(AR)应答率
治疗4周后，所有患者的IBS主要疗效指标明显缓解应答统计结果，如表1所示：
表1患者治疗4周后IBS主要效应指标AR应答统计结果
从表1可以看出，使用本发明的组合物治疗4周后，患者IBS主要疗效指标明显缓解(AR)应答率可达80.7％。
3、IBS主要疗效指标：IBS症状严重程度(IBS-SSS)评分
治疗4周前后，所有患者的IBS-SSS评分统计结果，如表2所示：
表2患者治疗4周前后IBS-SSS评分统计结果
从表2可以看出，使用本发明的组合物治疗4周后，患者IBS-SSS评分明显下降，差异有统计学意义(P＜0.05)
4、IBS次要疗效指标：中医脾虚湿热证候疗效，结果如表3所示：
表3中医脾虚湿热证候疗效
从表3可以看出，使用本发明的组合物治疗4周后，患者中医脾虚湿热证后疗效显著，总有效率达78.3％。
六、结论
本发明的治疗腹泻型肠易激综合征中药组合物对脾虚湿热型IBS-D治疗4周后的主要疗效指标明显缓解(AR)应答率可达80.7％，IBS-SSS评分较治疗前显著降低，中医证候评分明显改善，IBS次要疗效指标总有效率78.3％，由此表明，本发明治疗腹泻型肠易激综合征的中药组合物对脾虚湿热型IBS-D疗效确切。
Claims (7)
1.一种治疗腹泻型肠易激综合征的中药组合物，其特征在于，所述中药组合物由以下质量份计的中药原料提取制备而成：党参6-30份，仙鹤草6-30份，炒白术5-20份，葛根10-30份，茯苓5-30份，黄芩3-15份，黄连2-15份，炒白芍6-20份，陈皮3-20份，砂仁3-15份，炙甘草2-20份。
2.根据权利要求1所述的治疗腹泻型肠易激综合征的中药组合物，其特征在于，所述中药组合物由以下质量份计的中药原料提取制备而成：党参12份，仙鹤草12份，炒白术12份，葛根15份，茯苓12份，黄芩10份，黄连5份，炒白芍15份，陈皮10份，砂仁6份，炙甘草5份。
3.根据权利要求1所述的治疗腹泻型肠易激综合征的中药组合物，其特征在于，制备方法步骤如下：以上11味药，加水煎煮2次，第一次加12倍量水，浸泡1小时，煎煮1.5小时，第二次加10倍量水，煎煮1小时，合并提取液，减压浓缩至70℃相对密度为1.15-1.20的浸膏，加辅料制备成固体制剂或液体制剂。
4.根据权利要求3所述的治疗腹泻型肠易激综合征的中药组合物，其特征在于，辅料为医学上可以接受的辅料。
5.根据权利要求3所述的治疗腹泻型肠易激综合征的中药组合物，其特征在于，所述固体制剂或液体制剂为膏剂、汤剂、丸剂、颗粒剂、胶囊剂、片剂、口服液、注射剂或散剂中的一种。
6.权利要求1所述的治疗腹泻型肠易激综合征的中药组合物在制备治疗肠易激综合征的药品中的应用。
7.根据权利要求6所述的应用，其特征在于，所述肠易激综合征为脾虚湿热型腹泻型肠易激综合征。
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