CN112843162B - 一种和胃降逆、清热除湿的中药组合物、制备方法及应用 - Google Patents
一种和胃降逆、清热除湿的中药组合物、制备方法及应用 Download PDFInfo
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Abstract
本发明涉及一种和胃降逆、清热除湿的中药组合物、制备方法及其应用，该中药组合物由如下重量份的原料药制成：白芍3‑15份、木瓜3‑15份、黄连1‑8份、姜半夏3‑15份、牡蛎3‑18份、枳壳(麸炒)3‑15份、蒲公英3‑15份、代赭石8‑25份、白术3‑18份；其可用于和胃降逆，清热除湿，具体为治疗胆汁反流性胃炎中的应用。
Description
技术领域
本发明属于医药领域，具体涉及一种和胃降逆、清热除湿的中药组合物、制备方法及其应用。
背景技术
胆汁反流性胃炎(BRG)是指由多种因素导致胆汁反流入胃，引发胃黏膜发生充血、水肿、糜烂等病变的化学炎症性疾病，又名为碱性反流性胃炎(ARG)，属于慢性胃炎的一种类型，发病率约占慢性胃炎的22.6％。BRG以上腹部疼痛、餐后上腹饱胀、上腹部灼热不适、反酸、嗳气、恶心、呕吐等为主要临床表现，可分为原发性胆汁反流性胃炎和继发性胆汁反流性胃炎。
中医认为胆汁反流性胃炎的主要病因多为饮食不节、情志失调、饮酒过度、脾胃虚弱及手术损伤脾胃。其病位在肝、胆、脾、胃，以脾胃为本，肝胆为标；其病机多为本虚标实、虚实夹杂。本虚为脾失健运，升降失常，标实为肝胃不和，胃气上逆，湿热内蕴，胃络痹阻。胆胃同为六腑，以通为用。胆附于肝，共存胆汁，胆源由肝之作气所化生，汇集于胆，泄于小肠，参与饮食物的消化。肝胆疏泄正常，则脾胃升降有度，胆汁排泄正常。若胃气失和，气机上逆，则胆液逆流，发为本病。
现代医学对于该病的治疗以对症治疗为主。针对出现的不同消化道症状，以促胃动力药、胃粘膜保护剂联合抑酸药等方法治疗。但是单纯西医治疗后复发率高，在临床具有病程长、易反复、疗效欠佳等特点。胆汁反流易造成胃粘膜的肠化生等难题，仍然是现代医学尚未突破的瓶颈。
胆汁反流性胃炎的现代中医治疗多从整体出发，重视气机升降，强调脏腑关系。采取扶土抑木之法，主以健脾和胃，辅以舒肝降胆，使逆乱之气机升降有序，清阳得升，浊阴得降，从而脏腑阴阳平和。
本发明所述中药组合物是根据上述中医理论，经过长期临床实践，反复研究，精心筛选提炼的经验组合处方，具有和胃降逆、清热除湿的功效，尤其是对胆汁反流性胃炎有较好疗效。
发明内容
针对目前临床用药的不足，本发明的第一目的是提供一种和胃降逆、清热除湿的中药组合物。具体由如下中药原料药制备而成：白芍、木瓜、黄连、姜半夏、牡蛎、枳壳、蒲公英、代赭石、白术。
优选的，本发明所述的和胃降逆、清热除湿的中药组合物，它是由如下重量份的原料制备而成：白芍3-15份、木瓜3-15份、黄连1-8份、姜半夏3-15份、牡蛎3-18份、枳壳3-15份、蒲公英3-15份、代赭石8-25份、白术3-18份；
更优选地，是由如下重量份的原料制备而成的：白芍4-8份、木瓜4-8份、黄连2-5份、姜半夏4-8份、牡蛎8-12份、枳壳4-8份、蒲公英4-8份、代赭石13-17份、白术8-12份；
最优选地，是由如下重量份的原料制备而成的：
白芍6份、木瓜6份、黄连3份、姜半夏6份、牡蛎10份、枳壳6份、蒲公英6份、代赭石15份、白术10份；
白芍4份、木瓜4份、黄连2份、姜半夏4份、牡蛎8份、枳壳4份、蒲公英4份、代赭石13份、白术8份；
白芍8份、木瓜8份、黄连5份、姜半夏8份、牡蛎12份、枳壳8份、蒲公英8份、代赭石17份、白术12份。
其中，所述枳壳为麸炒枳壳
以下是本发明中药组合物原料药的性味及功能：
白芍为毛茛科植物芍药Paeonia lactiflora Pall的干燥根。性味苦、酸，微寒。归肝、脾经。功能养血调经，敛阴止汗，柔肝止痛，平抑肝阳。用于血虚萎黄，月经不调，自汗，盗汗，胁痛，腹痛，四肢挛痛，头痛眩晕。
木瓜为蔷薇科植物贴梗海棠Chaenomeles speciosa(Sweet)Nakai的干燥近成熟果实。性味酸，温。归肝、脾经。功能舒筋活络，和胃化湿。用于湿痹拘挛，腰膝关节酸重疼痛,暑湿吐泻,转筋挛痛，脚气水肿。
黄连是毛茛科植物黄连Coptis chinensis Franch.、三角叶黄连Coptisdeltoidea C.Y.Cheng et Hsiao或云连Coptisteeta Wall.的干燥根茎。性味苦，寒。归心、脾、胃、肝、胆、大肠经。功能清热燥湿，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，心悸不宁，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。
半夏为天南星科植物半夏Pinellia ternata(Thunb.)Breit的干燥块茎。性味辛、温；有毒。归脾、胃、肺经。燥湿化痰，降逆止呕，消痞散结。用于湿痰寒痰，咳喘痰多，痰饮眩悸，风痰眩晕，痰厥头痛，呕吐反胃，胸脘痞闷，梅核气；外治痈肿痰核。
牡蛎为牡蛎科动物长牡蛎Ostrea gigas Thimberg、大连湾牡蛎Ostreatalienwhanensis Crosse或近江牡蛎Ostrearivularis Gould的贝壳。性味咸，微寒。归肝、胆、肾经。重镇安神，潜阳补阴，软坚散结。用于惊悸失眠，眩晕耳鸣，瘰疬痰核，癥瘕痞块。煅牡蛎收敛固涩，制酸止痛。用于自汗盗汗，遗精滑精，崩漏带下，胃痛吞酸。
枳壳为芸香科植物酸橙(Citrus aurantium L.)及其栽培变种的干燥未成熟果实。性味苦、辛、酸，微寒。归脾、胃经。理气宽中，行滞消胀。用于胸胁气滞，胀满疼痛，食积不化，痰饮内停，脏器下垂。
蒲公英为菊科植物蒲公英Taraxacum mongolicum Hand.-Mazz.、碱地蒲公英Taraxacum borealisinense Kitam.或同属数种植物的干燥全草。性味苦、甘，寒。归肝、胃经。功能清热解毒，消肿散结，利尿通淋。用于疔疮肿毒，乳痈，瘰疬，目赤，咽痛，肺痈，肠痈，湿热黄疸，热淋涩痛。
赭石为氧化物类矿物刚玉族赤铁矿，主含三氧化二铁(Fe203)。采挖后，除去杂石。平肝潜阳，重镇降逆，凉血止血。用于眩晕耳鸣，呕吐，噫气，呃逆，喘息，吐血，齟血，崩漏下血。
白术为菊科植物白术Atractylodes macrocephala Koidz.的干燥根茎。健脾益气，燥湿利水，止汗，安胎。用于脾虛食少，腹胀泄泻，痰饮眩悸，水肿，自汗，胎动不安。
方中黄连清热除湿为君药，姜半夏和胃降逆，白术健脾除湿，共为臣药，蒲公英助黄连清热解毒，枳壳理气止痛，白芍缓急止痛，木瓜和胃化湿，共为佐药，牡蛎、代赭石重镇降逆，使气机下行，为使药。全方共凑清热除湿，和胃降逆之功效。
本发明的另一目的是提供本发明中药组合物的制备方法，具体如下：
取全部药材，混合后加水提取2-3次，每次加水量相当于药材总重量的6-12倍，每次提取时间为1-3小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，即得。
本发明的又一目的在于提供本发明所述中药组合物的制剂，其可通过将上述有效组分和药物可接受的载体混合制备得到。
本发明的中药组合物，其药物制剂形式可以是任何可药用的剂型，这些剂型包括：片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、丸剂、散剂、膏剂、丹剂、混悬剂、粉剂、溶液剂、注射剂、栓剂、软膏剂、硬膏剂、霜剂、喷雾剂、滴剂、贴剂。本发明的制剂，优选的是口服剂型，如：胶囊剂、片剂、口服液、颗粒剂、丸剂、散剂、丹剂、膏剂等。
本发明的中药组合物，其口服给药的制剂可含有常用的赋形剂，诸如粘合剂、填充剂、稀释剂、压片剂、润滑剂、崩解剂、着色剂、调味剂和湿润剂，必要时可对片剂进行包衣。
本发明的中药组合物制成药学上可接受的制剂或者作为有效活性物质基础制备药物组合物。
本发明的中药组合物，是单位剂量的药物制剂形式，所述单位剂量形式是指制剂的单位，如片剂的每片，胶囊的每粒胶囊，口服液的每瓶，颗粒剂每袋等。
本发明的中药组合物中的有效组分，其在制剂中所占重量百分比可以是0.1-99.9％，其余为药物可接受的载体。
本发明的目的还在于提供所述中药组合物在和胃降逆，清热除湿的作用，具体为治疗胆汁反流性胃炎中的应用。
与现有技术相比，本发明技术方案具有如下有益效果：
1、本发明结合现代中药药理研究，以和胃降逆，清热除湿为主，用于胆汁反流性胃炎，标本兼治，内外通调。
2、本发明中药组合物在胆汁反流性胃炎的辨证论治、遣方用药、特色治疗方面具有独特优势，治疗效果甚好。
3、采用本发明的中药组合物，不仅疗效显著，而且使用便利，刺激性小，患者的顺应性好。
4、本发明的中药组合物配方科学严谨，制备方法简单，制备成本低，具有很大的临床应用价值。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述，但本领域技术人员将会理解，下列实施例仅用于说明本发明，而不应视为限定本发明的范围。实施例中的实验方法，如无特殊说明，均为常规方法；所用的药材原料、试剂材料等，如无特殊说明，均为市售购买产品。
实施例1
取白芍6克、木瓜6克、黄连3克、姜半夏6克、牡蛎10克、枳壳(麸炒)6克、蒲公英6克、代赭石15克、白术10克，混合后加水提取3次，每次加水量相当于药材总重量的8倍，每次提取时间为2小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，即得。
实施例2
取白芍4克、木瓜4克、黄连2克、姜半夏4克、牡蛎8克、枳壳(麸炒)4克、蒲公英4克、代赭石13克、白术8克，混合后加水提取3次，每次加水量相当于药材总重量的8倍，每次提取时间为2小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，即得。
实施例3
取白芍8克、木瓜8克、黄连5克、姜半夏8克、牡蛎12克、枳壳(麸炒)8克、蒲公英8克、代赭石17克、白术12克，混合后加水提取2次，每次加水量相当于药材总重量的6倍，每次提取时间为3小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，即得。
实施例4
取白芍6克、木瓜3克、黄连3克、姜半夏3克、牡蛎6克、枳壳(麸炒)6克、蒲公英6克、代赭石10克、白术6克，混合后加水提取2次，每次加水量相当于药材总重量的6倍，每次提取时间为3小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，即得。
实施例5
取白芍10克、木瓜10克、黄连5克、姜半夏8克、牡蛎10克、枳壳(麸炒)10克、蒲公英10克、代赭石20克、白术8克，混合后加水提取2次，每次加水量相当于药材总重量的10倍，每次提取时间为1小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，即得。
实施例6
取白芍12克、木瓜10克、黄连6克、姜半夏8克、牡蛎10克、枳壳(麸炒)12克、蒲公英10克、代赭石10克、白术12克，混合后加水提取3次，每次加水量相当于药材总重量的8倍，每次提取时间为2小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，即得。
实施例7
取白芍15克、木瓜5克、黄连5克、姜半夏10克、牡蛎18克、枳壳(麸炒)15克、蒲公英10克、代赭石15克、白术10克，混合后加水提取2次，每次加水量相当于药材总重量的6倍，每次提取时间为3小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，粉碎成细粉，即得。
实施例8
取白芍8克、木瓜8克、黄连4克、姜半夏8克、牡蛎15克、枳壳(麸炒)8克、蒲公英8克、代赭石15克、白术8克，混合后加水提取1次，每次加水量相当于药材总重量的12倍，每次提取时间为3小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，即得。
实施例9
取白芍5克、木瓜2克、黄连2克、姜半夏5克、牡蛎5克、枳壳(麸炒)5克、蒲公英5克、代赭石5克、白术5克，混合后加水提取3次，每次加水量相当于药材总重量的10倍，每次提取时间为1小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，即得。
实施例10
取白芍3克、木瓜3克、黄连1克、姜半夏3克、牡蛎3克、枳壳(麸炒)3克、蒲公英3克、代赭石8克、白术3克，混合后加水提取3次，每次加水量相当于药材总重量的8倍，每次提取时间为2小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，即得。
实施例11：
将实施例1-10任一所得细粉，加入适量淀粉及溶剂，制成颗粒，干燥，整粒，即得。
实施例12：
将实施例1-10任一所得细粉，加入适量淀粉及溶剂，制成颗粒，干燥，整粒，于颗粒中加入适量微粉硅胶，混匀后，装入胶囊，制成胶囊剂。
实施例13：
将实施例1-10任一所得细粉，加入适当溶剂及辅料，如淀粉、糊精，干燥，粉碎，过100筛，可按常规工艺制备成散剂。
药效实验：对胆汁反流性胃炎大鼠的治疗作用
实验目的：建立胆汁反流性胃炎大鼠模型，考察不同实施例药物的治疗效果。
实验材料：
SD大鼠/SPF级，雌雄各半，6-8周，180-220g，购于斯贝福(北京)生物技术有限公司；
实验方法：
胆汁反流性胃炎是一种特殊且常见的胃炎，是由胆汁和十二指肠其他内容物通过幽门逆流至胃后引起的炎症性病变。目前西医对胆汁反流性胃炎的主要治疗包括手术和采用胃动力药物、胆盐类药物、抑制胃酸药物等。但手术成功率低，复发率高，而西药疗效不一，且长期使用毒副作用较多，复发率也较高，反而加重患者痛苦。中医将胆汁反流性胃炎归属于“胃脘痛”、“吐酸”、“嘈杂”等病证，并取得了确切的疗效。本研究旨在探讨中药反流清合剂对胆汁反流性胃炎大鼠的治疗作用。
将大鼠分别按数字随机表法分为9组：空白对照组、模型对照组、阳性对照组、实施例1、2、3、5、6、8。除正常对照组大鼠外，其余各组大鼠采用每100mL含有牛磺胆酸钠3.0g、胰酶2.0g、卵磷脂0.3g的灌流液灌胃复制模型，灌胃给药体积为15mL·kg-1，每天1次，连续35d，正常对照组给予等容量的蒸馏水。各给药组在开始复制模型的第2～5周连续给药，每天于复制模型结束6h后灌胃给药，每天1次。
最后1次灌胃给药后禁食(不禁水)24h，眼眶取血，3000rpm，离心10min，取血清和血浆，－20℃保存，按照Elisa试剂盒方法测定血清胃泌素(GAS)含量和血浆胃动素(MTL)含量。处死动物，以冰生理盐水冲洗胃内容物，胃窦组织用载玻片刮取胃黏膜，称质量后，用冷生理盐水制备10％的匀浆，按照试剂盒说明书操作，Elisa测定胃黏膜中瘦素(LEP)、前列腺素(PG)E2的含量。实验结果如表1所示：
表1实验结果
与空白对照组相比：■P≤0.05，■■P≤0.01；与模型对照组相比：▲P≤0.05，▲▲P≤0.01
由结果可知，与空白对照组相比，模型对照组LEP和(PG)E2均降低，具有极显著差异，与模型对照组相比，阳性对照组和实施例1、2、3、5、6、8均能够升高LEP和(PG)E2，具有统计学意义的差异，其中实施例1-3效果较为优异。
Claims (11)
1.一种和胃降逆、清热除湿的中药组合物，其特征在于，由如下中药原料药制备而成：白芍3-15份、木瓜3-15份、黄连1-8份、姜半夏3-15份、牡蛎3-18份、枳壳3-15份、蒲公英3-15份、代赭石8-25份、白术3-18份。
2.根据权利要求1所述的中药组合物，其特征在于，由如下重量份的原料药制备而成：白芍4-8份、木瓜4-8份、黄连2-5份、姜半夏4-8份、牡蛎8-12份、枳壳4-8份、蒲公英4-8份、代赭石13-17份、白术8-12份。
3.根据权利要求1或2所述的中药组合物，其特征在于，由如下重量份的原料药制备而成：白芍6份、木瓜6份、黄连3份、姜半夏6份、牡蛎10份、枳壳6份、蒲公英6份、代赭石15份、白术10份。
4.根据权利要求1或2所述的中药组合物，其特征在于，由如下重量份的原料药制备而成： 白芍4份、木瓜4份、黄连2份、姜半夏4份、牡蛎8份、枳壳4份、蒲公英4份、代赭石13份、白术8份。
5.根据权利要求1或2所述的中药组合物，其特征在于，由如下重量份的原料药制备而成： 白芍8份、木瓜8份、黄连5份、姜半夏8份、牡蛎12份、枳壳8份、蒲公英8份、代赭石17份、白术12份。
6.根据权利要求1-5任一所述中药组合物，其特征在于，所述枳壳为麸炒枳壳。
7.根据权利要求1-5任一所述中药组合物的制备方法，具体如下：
取全部药材，混合后加水提取2-3次，每次加水量相当于药材总重量的6-12倍，每次提取时间为1-3小时，合并提取液，滤过，滤液浓缩至60-70℃时相对密度为1.20-1.30的清膏，干燥，粉碎成细粉，即得。
8.根据权利要求1-5任一所述中药组合物的制剂，其特征在于，由有效量的中药组合物及药学可接受的载体混合制备得到。
9.根据权利要求8所述的制剂，其特征在于，所述制剂为胶囊剂、片剂、口服液、颗粒剂、丸剂、散剂、丹剂、膏剂。
10.根据权利要求1-5任一所述中药组合物在制备和胃降逆、清热除湿的药物中的应用。
11.根据权利要求10所述应用，其特征在于，所述和胃降逆、清热除湿的药物是指治疗胆汁反流性胃炎的药物。
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