CN104127531B - 一种治疗肠胃炎的中药组合物及其制备方法 - Google Patents
一种治疗肠胃炎的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于中药领域，涉及一种治疗肠胃炎的中药组合物及其制备方法。本发明的提供一种治疗或预防肠胃炎的中药组合物，其包括如下组分：黄芩6-13份，大黄2-12份，山楂1-15份，木香10-15份，珍珠伞10-15份，鸡内金5-15份，黄连2-10份，甘草10-15份。本发明药物组合物尤其在治疗急性肠胃炎时，显示出显著的抗炎活性，且存在明显的量效关系。
Description
技术领域
本发明属于中药技术领域，具体涉及一种治疗肠胃炎的中药组合物及其制备方法。
背景技术
胃炎是任何病因引起的胃黏膜炎症，常伴有上皮损伤和细胞再生。当胃黏膜炎症缺如或很轻时，此种胃黏膜病变宜称为胃病。胃炎是最常见的消化***疾病之一。肠炎是细菌、病毒、真菌和寄生虫等引起的小肠炎和结肠炎。临床表现主要有腹痛、腹泻、稀水便或黏液脓血便。部分病人可有发热及里急后重感觉，故亦称感染性腹泻。肠炎按病程长短不同，分为急性和慢性两类。慢性肠炎病程一般在两个月以上，临床常见的有慢性细菌性痢疾、慢性阿米巴痢疾、血吸虫病、非特异性溃疡性结肠炎和限局性肠炎等。
中医认为，本病多因外受湿热、疫毒之气，内伤饮食生冷，损伤脾胃及脏腑而成，属于“肠辟、肠胃炎”范畴。《素问·太阴阳明论》云:“饮食不节，起居不时……下为飨泄，久为肠辟。”，《证治汇补》指出:“肠辟者，谓湿热积于肠中.即今肠胃炎也，故曰无疾不成泻，泻乃湿、热、食积三者”。在治疗上应采取辨证论治的方法，《景岳全书》云:“凡治肠胃炎，最当察虚实，辨寒热，此泻泻最大关系，若四者不明，则杀人甚易也。”，故本病辨证首辨寒、热、虚、实，临证当据腹痛、里急后重、泻色，并参合舌脉而辨。湿热型以腹痛、泻下赤白脓血、苔黄腻、脉滑数为辨证要点。病机为湿热之邪侵入肠胃，气血阻滞，不通则痛，故腹痛，里急后重；湿热郁滞于大肠，经络受损，故下泻赤白脓血；苔黄腻、脉滑数为湿热之象。治则宜清热化湿，调气行血。
发明内容
现有技术中化学药物治标不治本，且容易损伤胃肠道粘膜，药物毒副作用大，本发明公开了一种治疗急性肠胃炎的中药组合物，该中药组合物疗效好，副作用小，它由以下重量份的原料制得：黄芩6-13份，大黄2-12份，山楂1-15份，木香10-15份，珍珠伞10-15份，鸡内金5-15份，黄连2-10份，甘草10-15份。
本发明所述中药组合物中，所述的黄芩别名山茶根、土金茶根。为唇形科植物黄芩(Scutellaria baicalensis Georgi)，以根入药。有清热燥湿，凉血安胎，解毒功效。主治温热病、上呼吸道感染、肺热咳嗽、湿热黄胆、肺炎、痢疾、咳血、目赤、胎动不安、高血压、痈肿疖疮等症。黄芩的临床应用抗菌比川芎还好，而且不产生抗药性。
大黄，性味苦，寒；归经入胃、大肠、肝经。功能主治：泻热毒，破积滞，行瘀血。治实热便秘，谵语发托，食积痞满，痢疾初起，里急后重，瘀停经闭，癥瘕积聚，时行热疫，暴眼赤痛，吐血，衄血，阳黄，水肿，淋浊，溲亦，痈疡肿毒，疔疮，汤火伤。泻热通肠，凉血解毒，逐瘀通经。用于实热便秘、积滞腹痛、泻痢不爽、湿热黄疸。
山楂，性味归经酸，甘，微温。归脾、胃、肝经。功效：消食健胃，行气散瘀。用于肉食积滞，胃脘胀满，泻痢腹痛，瘀血经闭，产后瘀阻，心腹刺痛，疝气疼痛；高脂血症。焦山楂消食导滞作用增强。用于肉食积滞，泻痢不爽。
木香是菊科植物云木香和川木香的通称。别名：蜜香、青木香、五香、五木香、南木香、广木香、云木香。有行气止痛；调中导滞；健脾消滞的功效，但阴虚津液不足者慎服。行气滞宜生用，止泻痢宜煨用。芳香不宜久煎。用于脾胃气滞所致的脘腹胀痛、食少呕吐，常配砂仁、陈皮同用。用于肝胆气滞引起的胁痛，可配川楝、枳壳同用。用于健脾消滞，可调胃肠滞气。治疗腹痛、腹泻、里急后重，可配人参、白术、砂仁、半夏、附子、赤茯芩等同用。木香辛温香散，能升能降，通理三焦之气，尤其善行胃肠之气而止痛，兼有健脾消食之功，凡脾胃大肠气滞所致诸证均为常用之品。
珍珠伞，性味辛，苦，性微温；归经肝，肾，肺经；功能主治活血止痛，清利咽喉。主跌打损伤，骨折，风湿痹痛，白喉，咽喉肿痛，胃溃疡。
鸡内金，性味与归经：味甘，平。归脾、胃、小肠、膀胱经。功能与主治：消食积，止遗尿，化结石。用于水肿腹胀，泻痢，食积，反胃吐酸，小儿疳疾，泌尿系结石，遗尿。
黄连，性味与归经：苦，寒。归心、脾、胃、肝、胆、大肠经。功能与主治：清热燥湿，泻火解毒。用于湿热痞满，呕吐吞酸，泻痢，黄疸，高热神昏，心火亢盛，心烦不寐，血热吐衄，目赤，牙痛，消渴，痈肿疔疮；外治湿疹，湿疮，耳道流脓。酒黄连善清上焦火热。用于目赤，口疮。姜黄连清胃和胃止呕。用于寒热互结，湿热中阻，痞满呕吐。萸黄连舒肝和胃止呕。用于肝胃不和，呕吐吞酸。
甘草，性味甘，平。归经入脾、胃、肺经。功能主治：和中缓急，润肺，解毒，调和诸药。炙用，治脾胃虚弱，食少，腹痛便溏，劳倦发热，肺痿咳嗽，心悸，惊痫；生用，治咽喉肿痛，消化性溃疡，痈疽疮疡，解药毒及食物中毒。
中医学认为，肠胃炎多因饮食不节、情志所伤、劳倦而发病，并根据病因及症状的不同，分为寒湿、暑湿、虚寒、食滞四种类型，患者应根据，临床表现，合理地选择食物，辩证施治。本发明中药组合物在中药组分选择上充分考虑散寒、祛湿，同时本发明中药组合物具有显著的抗炎效果。本发明对上述诸味中药的重量份数进行了优选，优选的条件是中西药配伍使用后药物对急性肠胃炎治疗效果的增强。作为本发明的一个最优选实施例，本发明中药组合物主要由以下重量份的原料制得：黄芩10份，大黄8份，山楂8份，木香12份，珍珠伞12份，鸡内金9份，黄连6份，甘草12份。
为了更好地表达本发明的中药组合物，本发明的中药组合物可以制备成临床上常用的剂型。比如，粉状制剂、散剂、丸剂、丹剂、膏剂、颗粒剂、片剂、胶囊剂等。优选地，本发明中药组合物按照常规制备工艺制备成片剂、胶囊剂、颗粒剂。
本发明还提供了一种上述所述中药组合物的制备方法，其主要包含下述步骤：黄芩、大黄、山楂、黄连、甘草用乙醇回流提取；木香加4-9倍量水，浸泡0.5-3小时，蒸馏提取2-5小时，收集挥发油，加适量β-环糊精制成包合物，蒸馏后的药渣与残留液另器存放；珍珠伞、鸡内金与木香提取挥发油后药渣、残留液和黄芩等回流后药渣合并，加水4-12倍水煎煮1-3次，每次0.5-3小时，合并煎煮液，加乙醇至浓度为40-80％，放置12-48小时，过滤，醇沉液与回流液合并，减压回收乙醇，浓缩至浸膏，浸膏干燥成细粉，加入挥发油包合物，再加适量辅料混匀，用常规制剂方法制成临床所能接受的各种剂型。如片剂、胶囊剂、颗粒剂等。
本发明还请求保护上述中药组合物在制备治疗急性肠胃炎药物中的用途。本发明药物组合物在治疗急性肠胃炎时，显示出显著的抗炎活性。本发明药效实施例8显示，与模型组比较，本发明中药组合物低中高三个剂量组均可显著抑制二甲苯引起的耳廓肿胀的致炎作用(P＜0.01，P＜0.05)，表明本发明中药组合物具有显著抑制二甲苯诱导的小鼠耳肿胀的作用，且其对耳肿胀的降低效果存在显著的量效关系。同样实验条件下，阳性对照药肠胃炎宁胶囊组也显著降低耳肿胀值(P＜0.01)。
本发明是发明人经过反复研究，逐步改进，最后成功的一种疗效较好的治疗急性肠胃炎的药物，为表明本发明药物对急性肠胃炎的治疗效果，本发明对211例服用本药物的肠胃炎患者进行了临床观察，取得了较好的疗效，在211例患者中，用药4天后，治愈177例，治愈率占83.88％，好转33例，显效率占15.64％，总有效率99.53％，无效1例，无效率占0.47％。
具体实施方式
以下通过具体实施例进一步描述本发明，本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内，对本发明进行的变更、组合或替换，对于本领域的技术人员来说是显而易见的，且包含在本发明的范围之内。
实施例1
处方：黄芩10份，大黄8份，山楂8份，木香12份，珍珠伞12份，鸡内金9份，黄连6份，甘草12份；
制备方法：黄芩、大黄、山楂、黄连、甘草用乙醇回流提取；木香加6倍量水，浸泡2小时，蒸馏提取3.5小时，收集挥发油，加适量β-环糊精制成包合物，蒸馏后的药渣与残留液另器存放；珍珠伞、鸡内金与木香提取挥发油后药渣、残留液和黄芩等回流后药渣合并，加水8倍水煎煮2次，每次2小时，合并煎煮液，加乙醇至浓度为75％，放置24小时，过滤，醇沉液与回流液合并，减压回收乙醇，浓缩至浸膏，浸膏干燥成细粉，加入挥发油包合物，再加适量辅料混匀，用常规制剂方法制成片剂。
实施例2
处方：黄芩10份，大黄8份，山楂8份，木香12份，珍珠伞12份，鸡内金9份，黄连6份，甘草12份；
制备方法：黄芩、大黄、山楂、黄连、甘草用乙醇回流提取；木香加6倍量水，浸泡2小时，蒸馏提取3.5小时，收集挥发油，加适量β-环糊精制成包合物，蒸馏后的药渣与残留液另器存放；珍珠伞、鸡内金与木香提取挥发油后药渣、残留液和黄芩等回流后药渣合并，加水8倍水煎煮2次，每次2小时，合并煎煮液，加乙醇至浓度为75％，放置24小时，过滤，醇沉液与回流液合并，减压回收乙醇，浓缩至浸膏，浸膏干燥成细粉，加入挥发油包合物，再加适量辅料混匀，用常规制剂方法制成胶囊剂。
实施例3
处方：黄芩6份，大黄2份，山楂1份，木香10份，珍珠伞10份，鸡内金5份，黄连2份，甘草10份；
制备方法：黄芩、大黄、山楂、黄连、甘草用乙醇回流提取；木香加9倍量水，浸泡1小时，蒸馏提取2小时，收集挥发油，加适量β-环糊精制成包合物，蒸馏后的药渣与残留液另器存放；珍珠伞、鸡内金与木香提取挥发油后药渣、残留液和黄芩等回流后药渣合并，加水12倍水煎煮1次，每次0.5小时，合并煎煮液，加乙醇至浓度为40％，放置48小时，过滤，醇沉液与回流液合并，减压回收乙醇，浓缩至浸膏，浸膏干燥成细粉，加入挥发油包合物，再加适量辅料混匀，用常规制剂方法制成片剂。
实施例4
处方：黄芩13份，大黄12份，山楂15份，木香15份，珍珠伞15份，鸡内金15份，黄连10份，甘草15份；
制备方法：黄芩、大黄、山楂、黄连、甘草用乙醇回流提取；木香加4倍量水，浸泡3小时，蒸馏提取5小时，收集挥发油，加适量β-环糊精制成包合物，蒸馏后的药渣与残留液另器存放；珍珠伞、鸡内金与木香提取挥发油后药渣、残留液和黄芩等回流后药渣合并，加水4倍水煎煮3次，每次3小时，合并煎煮液，加乙醇至浓度为80％，放置12小时，过滤，醇沉液与回流液合并，减压回收乙醇，浓缩至浸膏，浸膏干燥成细粉，加入挥发油包合物，再加适量辅料混匀，用常规制剂方法制成片剂。
实施例5
处方：黄芩6份，大黄12份，山楂1份，木香15份，珍珠伞10份，鸡内金15份，黄连2份，甘草15份；
制备方法：黄芩、大黄、山楂、黄连、甘草用乙醇回流提取；木香加9倍量水，浸泡0.5小时，蒸馏提取2小时，收集挥发油，加适量β-环糊精制成包合物，蒸馏后的药渣与残留液另器存放；珍珠伞、鸡内金与木香提取挥发油后药渣、残留液和黄芩等回流后药渣合并，加水4倍水煎煮1次，每次3小时，合并煎煮液，加乙醇至浓度为60％，放置24小时，过滤，醇沉液与回流液合并，减压回收乙醇，浓缩至浸膏，浸膏干燥成细粉，加入挥发油包合物，再加适量辅料混匀，用常规制剂方法制成片剂。
实施例6
处方：黄芩13份，大黄2份，山楂15份，木香10份，珍珠伞15份，鸡内金5份，黄连10份，甘草10份；
制备方法：黄芩、大黄、山楂、黄连、甘草用乙醇回流提取；木香加6倍量水，浸泡0.5小时，蒸馏提取5小时，收集挥发油，加适量β-环糊精制成包合物，蒸馏后的药渣与残留液另器存放；珍珠伞、鸡内金与木香提取挥发油后药渣、残留液和黄芩等回流后药渣合并，加水6倍水煎煮2次，每次2小时，合并煎煮液，加乙醇至浓度为75％，放置24小时，过滤，醇沉液与回流液合并，减压回收乙醇，浓缩至浸膏，浸膏干燥成细粉，加入挥发油包合物，再加适量辅料混匀，用常规制剂方法制成片剂。
实施例7
处方：黄芩10份，大黄8份，山楂8份，木香12份，珍珠伞12份，鸡内金9份，黄连6份，甘草12份；
制备方法：黄芩、大黄、山楂、黄连、甘草用乙醇回流提取；木香加6倍量水，浸泡2小时，蒸馏提取3.5小时，收集挥发油，加适量β-环糊精制成包合物，蒸馏后的药渣与残留液另器存放；珍珠伞、鸡内金与木香提取挥发油后药渣、残留液和黄芩等回流后药渣合并，加水8倍水煎煮2次，每次2小时，合并煎煮液，加乙醇至浓度为75％，放置24小时，过滤，醇沉液与回流液合并，减压回收乙醇，浓缩至浸膏，浸膏干燥成细粉，加入挥发油包合物，再加适量辅料混匀，用常规制剂方法制成颗粒剂。
实施例8 本发明中药组合物对二甲苯致小鼠耳肿胀的影响
取昆明种小鼠50只，20±2g，♀♂各半，分5组，10只/组，即模型组、肠胃炎宁胶囊组(山东仙河药业有限公司)、本发明中药组合物(按实施例2所述中药组合物处方和制备工艺制得)低剂量组、中剂量组和高剂量组。每只ig给药1次/d；给药4d，末次药后60min，小鼠左耳均匀涂抹二甲苯0.1mL/只致肿，2h后剪下双耳，用9mm打孔器在左右耳廓相同部位打孔，两侧耳片分别称重，以肿胀率作为肿胀程度指标，按公式计算，比较药物组与对照组间的差异，结果见表1。
表1.本发明中药组合物对二甲苯致小鼠耳肿胀的影响
注：与模型组组比较，*p<0.05，**p<0.01。
结果显示，与模型组比较，本发明中药组合物低中高三个剂量组均可显著抑制二甲苯引起的耳廓肿胀的致炎作用(P＜0.01，P＜0.05)，表明本发明中药组合物具有显著抑制二甲苯诱导的小鼠耳肿胀的作用，且其对耳肿胀的降低效果存在显著的量效关系。同样实验条件下，阳性对照药肠胃炎宁胶囊组也显著降低耳肿胀值(P＜0.01)。
Claims (6)
1.一种治疗肠胃炎的中药组合物，其特征在于它由以下重量份的原料制得：黄芩6-13份，大黄2-12份，山楂1-15份，木香10-15份，珍珠伞10-15份，鸡内金5-15份，黄连2-10份，甘草10-15份。
2.如权利要求1所述的中药组合物，其特征在于它由以下重量份的原料制得：黄芩10份，大黄8份，山楂8份，木香12份，珍珠伞12份，鸡内金9份，黄连6份，甘草12份。
3.一种制备如权利要求1或2所述的中药组合物的方法，其特征在于，包括以下步骤：黄芩、大黄、山楂、黄连、甘草用乙醇回流提取；木香加4-9倍量水，浸泡0.5-3小时，蒸馏提取2-5小时，收集挥发油，加适量β-环糊精制成包合物，蒸馏后的药渣与残留液另器存放；珍珠伞、鸡内金与木香提取挥发油后药渣、残留液和黄芩等回流后药渣合并，加水4-12倍水煎煮1-3次，每次0.5-3小时，合并煎煮液，加乙醇至浓度为40-80％，放置12-48小时，过滤，醇沉液与回流液合并，减压回收乙醇，浓缩至浸膏，浸膏干燥成细粉，加入挥发油包合物，再加适量辅料混匀，用常规制剂方法制成临床所能接受的各种剂型。
4.如权利要求3所述的方法，其特征在于，所述剂型是散剂、丸剂、丹剂、膏剂、颗粒剂、片剂、胶囊剂。
5.如权利要求4所述的方法，其特征在于，所述剂型是片剂、胶囊剂、颗粒剂。
6.如权利要求1或2所述的中药组合物在制备治疗急性肠胃炎药物中用途。
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