CN115364185A - 一种通降胃气治疗胃胀的中药片剂 - Google Patents
一种通降胃气治疗胃胀的中药片剂 Download PDFInfo
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Abstract
本发明公开了一种通降胃气治疗胃胀的中药片剂，本发明制备本发明治疗胃胀中药片剂最佳重量份配比范围是：紫苏梗200～300g，醋香附210～230g，麸炒枳壳210～240g，陈皮260～280g，大腹皮250～280g，郁金200～250g，金不换50～60g，神曲260～280g，炒山楂260～280g，当归260～280g，丹参250～280g，三七30～45g，赤芍260～290g，白芍260～290g，甘草100～120g。本发明与现有技术相比的优点在于：该治疗胃胀的中药片剂采用十五味中草药制成，利用十五味原料药的综合协同作用治疗胃胀，对人体副作用小，无须患者煎煮。具有治疗方法简便，价格低廉，疗效显著的特点。此片剂药力平和、力缓而不伤正，以疏肝和胃、通降胃气、活血止痛达通降之目的。对治疗胃胀有很好的作用。
Description
技术领域
本发明涉及中草药制剂技术领域，具体是指一种通降胃气治疗胃胀的中药片剂。
背景技术
胃胀是胃部胀满不适。中医称“痞满”，指患者自觉胃脘部痞塞不通、胸膈满闷不舒。胃胀是消化系统常见病，随着人们生活饮食习惯改变、生活压力增加，此病患病率逐年增加，严重影响人们的健康、生活质量。临床中常见引起胃胀的疾病有功能性消化不良、慢性胃炎、胃下垂、慢性胆囊炎、便秘等。本病发病机制复杂，主要包括胃肠动力障碍，内脏高敏感及HP感染等，最新的研究发现本病亦与胃电节律、胃肠激素、特定基因型、炎性细胞及社会心理学有关。此病属慢性疾病，病程长且易反复，单纯依靠西医胃肠动力药、平滑肌松弛剂、抗抑郁药以及心理治疗等方式，往往治疗效果有限。现代人们对于运用中药治疗此病越来越关注，中医药通过辨病和辨证论治相结合，可以明显改善患者症状，中医药学已经认识到片剂不仅可以达到平稳持久疗效，逐渐释放药物，作用持久，适合久服，而且剂量精准，携带、服用、储存、运输方便，受到越来多患者的青睐。从中医学角度而言，此病属中医之“胃脘痛”、“胃痞”的范畴，病变在胃，涉及肝、脾两脏。情志失调、饮食不节导致脾胃气机失常,胃失和降是本病的主要中医病因病机。
从中医理论来讲，胃胀的产生主要是由于各种病因影响到胃腑，使胃气不能正常和降，气机停滞于胃脘而形成的。目前，西医治疗胃胀主要加强胃动力，但是长期服用会造成人体的依赖性，而且由于药物是化学合成，对人体存在着一定的副作用，有时会因为产生药物过敏反应，导致患者难以坚持服用。因此，使用中药成分的增强胃动力的药物是较好的选择，但是，由于目前无针对多种原因致胃胀的方便使用的药剂，难以达到良好的治疗效果。
发明内容
本发明要解决的技术问题是克服以上技术问题，提供一种由中草药配制而成的制剂，疏肝和胃、通降胃气、活血止痛，以达到治疗各种原因导致胃胀的中药片剂。
为了达到上述目的，本发明提供以下技术方案：一种通降胃气治疗胃胀的中药片剂，本发明制备本发明治疗胃胀中药片剂最佳重量份配比范围是：紫苏梗200～300g，醋香附 210～230g，麸炒枳壳210～240g，陈皮260～280g，大腹皮250～280g，郁金200～250g，金不换50～60g，神曲260～280g，炒山楂260～280g，当归260～280g，丹参250～280g，三七 30～45g，赤芍260～290g，白芍260～290g，甘草100～120g。
一种通降胃气治疗胃胀的中药片剂的制备方法，包括如下步骤：
(1)取白芍、三七干燥，粉碎成细粉；
(2)取紫苏梗、醋香附、麸炒枳壳、陈皮、大腹皮、郁金、金不换、神曲、炒山楂、当归、丹参、赤芍、甘草十三味加水煎煮三次，第一次沸后1.5小时，第二次和第三次沸后 1小时，合并煎液，进行滤过。
(3)浓缩至1000-1500ml，加2倍量乙醇，静置24小时以上，取上清液，回收乙醇，浓缩至稠膏状。
(4)与以上细粉混匀，干燥，粉碎，制粒，干燥，压制成1000片，添加交联聚维酮 XL-10和硬脂酸镁，包薄膜衣，即得治疗胃胀的中药片剂。
优选的，所述步骤(1)白芍和三七在80摄氏度进行干燥粉碎为细粉。
优选的，所述步骤(4)制粒之后进行干燥的温度为80摄氏度。
本发明上述中药原料组份中，每组份原料药的药性特点及功效如下：
方中君药：紫苏梗、枳壳；
紫苏梗：性味辛、甘，微温。归肺、脾、胃经。临床常用来治疗中焦气滞诸证，适用于胸腹气滞、痞闷作胀及胎动不安、胸胁胀痛等。研究发现，芳香类中药多含挥发油，具有增强胃肠运动的作用，紫苏梗所含挥发油主要成分为紫苏醛、十六烷酸和紫苏醇，研究示紫苏梗水提液对肢体缺血再灌注大鼠离体单个结肠平滑肌细胞有明显的收缩作用，其作用主要通过胞外Ca2+内流介导，可促进消化液分泌，增进胃肠蠕动。
枳壳：性味苦、辛、酸，温。归脾、胃、大肠经。为芸香科植物酸橙及其栽培变种的接近成熟的果实(去瓤)，生用或麸炒用。长于行气开胸，宽胸除胀，广泛用于食积停滞、胸脘胀痛等证。主要含黄酮类化合物，挥发油和少量的生物碱等成分。100％的枳壳水煎液能增强绵羊小肠的位相收缩，加强小肠的排空作用。枳壳水煎液的各种浓度(25％、50％、 75％、100％)对离体兔肠均有抑制效应，并呈现量效关系。枳壳水煎剂对正常的小鼠胃排空功能无明显影响，但能加强正常小鼠的小肠推进关系。Aline de MoraesPultrinit等研究结果表明，枳壳还具有抗焦虑的作用。
臣药：陈皮、香附。
陈皮：味甘苦温,理气醒脾消滞。为芸香科植物橘及其栽培变种干燥成熟久置的外果皮。国内外研究人员在橘皮中发现了一些特有的黄酮成分，这些物质具有防治心血管疾病、镇静消炎、抗菌杀虫等作用。研究表明陈皮有促进胃肠动力及促进小肠推进作用，可调节胃肠动力。
香附：性味辛、微苦、微甘，平。归肝、脾、三焦经。具有疏肝解郁，调经解郁，理气调中之效。为莎草科植物的干燥根茎。研究发现香附挥发油能明显协同戊巴比妥钠对小鼠的镇静作用，对由物理化学刺激引起的疼痛有较强的镇痛作用，可抑制离体家兔肠管的收缩，并且具有抗炎抗菌作用。研究表明其可调节肠道平滑肌。
佐药：大腹皮、郁金、金不换、神曲、炒山楂、当归、丹参、三七、赤芍、白芍。
大腹皮：味苦、辛，性微温，归脾、胃、大肠、小肠经。辛能行散，行气宽中之捷药。现代药理研究，大腹皮有兴奋胃肠平滑肌，促进胃动力的作用，能通过迷走神经介导和肠神经系统的胆碱能神经途径介导。
郁金：味辛苦，性温，归肝心肺胆。是姜科植物郁金的干燥块根，具有行气化痰、清心解郁、利胆退黄的功效。郁金具有调节免疫功能，抑制中枢神经，改善血液流变性，抗自由基损伤等作用。研究表明郁金二酮能明显延长家猫的各期睡眠，说明郁金二酮具有明显的中枢神经抑制效应。且研究示其可抑制胃酸对胃黏膜的刺激，减少胃黏膜氧化损伤进而抑制胃炎的发展。《本草经疏》中言：“郁金，本入血分治气药。此药能降气......”。郁金味辛能散能行，既入气分以行气解郁止痛，又达血分以活血化瘀。
金不换：又名土大黄，味苦性寒，为蓼科植物(红丝酸模)。据《本草纲目拾遗》记载“金不换具有清热解毒，破瘀生新，消肿痛，止血等功效。”金不换具有理气活血、破瘀生新、消肿生肌、清热解毒,兼有较强的抑制HP作用之效。可保护胃黏膜、抗炎、镇痛，可以减轻胃黏膜病理性损害。荆州道地药材，可以治疗HP相关的胃炎，可保护胃黏膜、抗炎、镇痛，可以减轻胃黏膜病理性损害。现代药理研究其具有促进血液凝固,降低血管脆性,加强毛细血管收缩性作用，其含止血有效成分磷酸铵镁,根中所含酸模素具有强力抗菌作用。
神曲：甘、辛，温。归脾、胃经。消食导滞。功效应用：消食和胃。主治饮食积滞，脘腹胀满，食少纳呆。神曲因含有多量酵母菌和复合维生素B，故有增进食欲，维持正常消化机能等作用。
炒山楂：性温,味甘、酸、涩,归脾、胃、肝经,具有消食健胃、行气散瘀、化浊降脂的功效。山楂所含脂肪酸能促进脂肪消化，并增加胃消化酶的分泌而促进消化，对胃肠道功能有一定调整作用。欧贤红等研究发现广山楂水提物通过增加胃液的分泌量、总酸度和总酸排出量,以及增加胃蛋白酶的活性和胃蛋白酶排出量；增加正常小鼠小肠的张力、频率、活力,使肠管兴奋,从而达到助消化的作用。
当归：性温，味甘、辛。有补血活血、调经止痛、润肠通便之效。为伞形科植物当归的干燥根，研究表明，当归具有抗血栓及改善血液流变学的作用并能改善外周及脑的血液循环，当归中性油对实验性心肌缺血有明显的保护作用。
丹参：味苦，微寒，归心、心包、肝经，具有活血化瘀、凉血消痈，养血安神之效。现代药理研究证实丹参具有改善微循环，抗血小板凝聚，抑制炎症反应等功效。丹参可增加胃黏膜血流量，促进胃黏膜恢复，起到消炎生肌的作用。
三七：甘、微苦，温，归肝、胃经，功效：散瘀止血，消肿定痛。主治：用于咯血，吐血，衄血，便血，崩漏，外伤出血，胸腹刺痛，跌扑肿痛。窦薇等建立溃疡性结肠炎模型，从小鼠的体质量、血便发生率和结肠组织病理程度考察，实验结果表明，提示三七素能明显改善溃疡性结肠炎小鼠的体重减轻症状和血便率，并且对结肠黏膜损伤具有修复作用。三七可通过促进前列腺素E2的分泌，进而抑制胃酸的分泌，舒张胃黏膜血管，改善胃黏膜血供，促进黏液的生成，加固胃黏膜物理屏障。
白芍：性味苦酸、微寒，归肝、脾经。为毛茛科植物芍药的干燥根，有益血敛阴、柔肝止痛、平抑肝阳的功效。现代药理研究表明，白芍有抗炎、护肝及镇痛的作用，动物实验研究发现白芍总苷对小鼠免疫功能增高或降低呈反向调节作用。芍药中的主要成分芍药苷具有较好的抗炎、解痉作用。白芍与甘草合用有协同镇痛及对胃黏膜有修复作用。
赤芍：苦，微寒。归肝经。有清热凉血，活血祛瘀的功效。赤芍总苷为赤芍的总提取物,主要为单萜苷类化合物，研究表明其具有抗凝血、改善微循环、清除氧自由基等作用。研究发现赤芍总苷可促进胃肠平滑肌运动，故赤芍可改善胃黏膜的缺血状态，增强胃部微循环。
使药：甘草。
甘草：为豆科植物甘草属胀果甘草或光果甘草的干燥根及根茎，本品药性平和通行十二经脉，健脾益气、缓急止痛，调和药性。除具有镇痛、镇咳、抗炎、抗溃疡、抗变态反应等作用外，还能增强机体免疫功能，防治病毒性肝炎、抗癌。甘草含甘草泛酸，有保护胃黏膜的屏障作用。
本发明与现有技术相比的优点在于：片剂作用持久，适合久服，而且剂量精准，携带、服用、储存、运输方便。该治疗胃胀的中药片剂采用十五味中草药制成，利用十五味原料药的综合协同作用治疗胃胀，对人体副作用小，无须患者煎煮。具有治疗方法简便，价格低廉，疗效显著的特点。此片剂药力平和、力缓而不伤正，以疏肝和胃、通降胃气、活血止痛达通降之目的。对治疗胃胀有很好的作用。
具体实施方式
所举实施例是为了更好地对本发明的内容进行说明，但并不是本发明的内容仅限于所举实施例。所以熟悉本领域的技术人员根据上述发明内容对实施方案进行非本质的改进和调整，还包括各具体实施方式间的任意组合，仍属于本发明的保护范围。
实施例1：紫苏梗278g，醋香附222g，麸炒枳壳222g，陈皮278g，大腹皮278g，郁金222g，金不换56g，神曲278g，炒山楂278g，当归278g，丹参278g，三七39g，赤芍 278g，白芍278g，甘草111g。
(1)取白芍、三七干燥，白芍和三七在80摄氏度进行干燥粉碎为细粉；
(2)取紫苏梗、醋香附、麸炒枳壳、陈皮、大腹皮、郁金、金不换、神曲、炒山楂、当归、丹参、赤芍、甘草十三味加水煎煮三次，第一次沸后1.5小时，第二次和第三次沸后 1小时，合并煎液，进行滤过。
(3)浓缩至1000-1500ml，加2倍量乙醇，静置24小时以上，取上清液，回收乙醇，浓缩至稠膏状。
(4)与以上细粉混匀，干燥，粉碎，制粒，干燥，压制成1000片，制粒之后进行干燥的温度为80摄氏度，添加交联聚维酮XL-10和硬脂酸镁，包薄膜衣，即得治疗胃胀的中药片剂。
实施例2：紫苏梗265g，醋香附212g，麸炒枳壳212g，陈皮265g，大腹皮265g，郁金212g，金不换56g，神曲265g，炒山楂265g，当归265g，丹参265g，三七35g，赤芍 265g，白芍265g，甘草102g。
(1)取白芍、三七干燥，白芍和三七在80摄氏度进行干燥粉碎为细粉；
(2)取紫苏梗、醋香附、麸炒枳壳、陈皮、大腹皮、郁金、金不换、神曲、炒山楂、当归、丹参、赤芍、甘草十三味加水煎煮三次，第一次沸后1.5小时，第二次和第三次沸后 1小时，合并煎液，进行滤过。
(3)浓缩至1000-1500ml，加2倍量乙醇，静置24小时以上，取上清液，回收乙醇，浓缩至稠膏状。
(4)与以上细粉混匀，干燥，粉碎，制粒，干燥，压制成1000片，制粒之后进行干燥的温度为80摄氏度，添加交联聚维酮XL-10和硬脂酸镁，包薄膜衣，即得治疗胃胀的中药片剂。
实施例3：紫苏梗286g，醋香附225g，麸炒枳壳236g，陈皮286g，大腹皮286g，郁金212g，金不换58g，神曲286g，炒山楂286g，当归286g，丹参286g，三七43g，赤芍 286g，白芍286g，甘草119g。
(1)取白芍、三七干燥，白芍和三七在80摄氏度进行干燥粉碎为细粉；
(2)取紫苏梗、醋香附、麸炒枳壳、陈皮、大腹皮、郁金、金不换、神曲、炒山楂、当归、丹参、赤芍、甘草十三味加水煎煮三次，第一次沸后1.5小时，第二次和第三次沸后1小时，合并煎液，进行滤过。
(3)浓缩至1000-1500ml，加2倍量乙醇，静置24小时以上，取上清液，回收乙醇，浓缩至稠膏状。
(4)与以上细粉混匀，干燥，粉碎，制粒，干燥，压制成1000片，制粒之后进行干燥的温度为80摄氏度，添加交联聚维酮XL-10和硬脂酸镁，包薄膜衣，即得治疗胃胀的中药片剂：行气通降片。
为了说明本发明对胃病的疗效，对以下二种疾病进行对比试验：
1.行气通降片治疗功能性消化不良肝胃不和证的临床观察试验；
2.行气通降片治疗HP相关性胃炎肝胃不和证的临床观察试验；
对比试验1。
1、行气通降片治疗功能性消化不良肝胃不和证的临床观察试验。
1.1、治疗方法。
将符合西医功能性消化不良诊断标准和肝胃不和证中医辩证标准的60例患者首先按性别、年龄、病程分层，然后各层病例再用随机数字表法分为两组。
1.11、试验组30例，对照组30例。试验组：服用行气通降片，一次4片，一日3次，餐前半小时口服；
1.12、对照组服用莫沙比利片，每次5mg，一日3次，餐前半小时口服。
两组均以4周为一疗程。
1.2评估指标。
1.21、观察记录两组患者在治疗前后的临床症状，并采用健康状况调查问卷(SF-36量表)、Hamilton焦虑他评量表(HAMA)及Hamilton抑郁他评量表(HAMD)对患者用药前后生活质量及焦虑抑郁状态进行评分和分析。两组总有效率进行统计学比较，差异具有显著性 (P<0.05)。
1.22、症状积分前后差值比较：两组患者在神疲乏力、胃纳减少、胃脘隐痛、食后腹胀便溏、恶心呕吐、烦躁失眠、口干苦或咽部梗阻感等八个症状方面的比较(P>0.05)，差异无统计学意义；在嗳气反酸及胁痛两个方面的比较(P<0.05)，差异有统计学意义。
1.23、在SF-36量表的评分比较中，试验组在精神健康方面的改善优于对照组。两组患者在VT、SF、RE、MH四个维度比较(P<0.05)，差异具有统计学意义。
1.24、试验组患者焦虑、抑郁症状的改善优于对照组。两组患者HAMA、HAMD量表评分，经卡方检验(P<0.05)，差异具有统计学意义。
1.3、结果。
试验组好转9例、显效12例、临床治愈6例，有效率为90％；对照组好转15例、显效 8例、临床治愈2例，有效率为83.3％。两组总有效率进行统计学比较，差异具有显著性 (P<0.05)，试验组及对照组在治疗功能性消化不良方面均有效，且试验组效果优于对照组。试验组除了能有效改善患者的临床症状之外对患者生活质量及焦虑抑郁状态亦能有效改善，且具有治疗简单、方便、安全、有效、毒副作用少等优点，值得临床推广。
对比试验2。
2、行气通降片治疗HP相关性胃炎肝胃不和证的临床观察试验。
2.1治疗方法。
将符合西医HP相关性胃炎诊断标准和中医肝胃不和证诊断标准的60例患者按doll’s 临床病例随机表法分为两组。
2.11、对照组(西医组)和试验组(中西结合组)。对照组：奥美拉唑肠溶片20mg，Bid；克拉霉素分散片0.5g，Bid；阿莫西林胶囊1.0g，Bid。
2.22、试验组：在西药的基础上加行气通降片，2.0g，Tid；两组均治疗10天。
2.2、评估指标。
2.21、观察两组前后中医症状及PRO量表积分变化和HP的根除情况。
2.22、中医各症状积分前后比较：两组在4个主要症状积分比较，差异有统计学意义 (P<0.05)。
2.23、在PRO量表的评分比较中，两组在反流、消化不良、排便、心理4个维度比较，差异具有统计学意义(P<0.05)。
2.3、结果。
2.31、试验组临床症状有效率为90％；HP根除率为90％，对照组临床症状有效率为70％，HP根除率为66.67％，两组比较，差异具有统计学意义(P<0.05)。
2.32、中医各症状积分前后比较：两组在4个主要症状积分比较，差异有统计学意义 (P<0.05)。
2.33、在PRO量表的评分比较中，两组在反流、消化不良、排便、心理4个维度比较，差异具有统计学意义(P<0.05)。
2.34、两组在改善HP相关性胃炎患者临床症状及根除HP方面均有效，但试验组明显优于对照组。
2.35、试验组对患者报告临床结局(PRO)量表中的反流、消化不良、排便、心理4个维度方面有有效改善，明显优于对照组。
2.36、行气通降片联合标准三联法治疗HP相关性胃炎具有治疗安全、简单、方便、有效、毒副作用少，不良反应轻，易于让患者接受等优点，值得临床推广。
以上对本发明及其实施方式进行了描述，这种描述没有限制性，本发明所示的也只是本发明新型的实施方式之一，实际的结构并不局限于此。总而言之如果本领域的普通技术人员受其启示，在不脱离本发明新型创造宗旨的情况下，不经创造性的设计出与该技术方案相似的结构方式及实施例，均应属于本发明的保护范围。
Claims (4)
1.一种通降胃气治疗胃胀的中药片剂，本发明制备本发明治疗胃胀中药片剂最佳重量份配比范围是：紫苏梗200～300g，醋香附210～230g，麸炒枳壳210～240g，陈皮260～280g，大腹皮250～280g，郁金200～250g，金不换50～60g，神曲260～280g，炒山楂260～280g，当归260～280g，丹参250～280g，三七30～45g，赤芍260～290g，白芍260～290g，甘草100～120g。
2.根据权利要求1所述的一种通降胃气治疗胃胀的中药片剂的制备方法，其特征在于：
(1)取白芍、三七干燥，粉碎成细粉；
(2)取紫苏梗、醋香附、麸炒枳壳、陈皮、大腹皮、郁金、金不换、神曲、炒山楂、当归、丹参、赤芍、甘草十三味加水煎煮三次，第一次沸后1.5小时，第二次和第三次沸后1小时，合并煎液，进行滤过。
(3)浓缩至1000-1500ml，加2倍量乙醇，静置24小时以上，取上清液，回收乙醇，浓缩至稠膏状。
(4)与以上细粉混匀，干燥，粉碎，制粒，干燥，压制成1000片，添加交联聚维酮XL-10和硬脂酸镁，包薄膜衣，即得治疗胃胀的中药片剂。
3.根据权利要求2所述的一种通降胃气治疗胃胀的中药片剂，其特征在于：所述步骤(1)白芍和三七在80摄氏度进行干燥粉碎为细粉。
4.根据权利要求2所述的一种通降胃气治疗胃胀的中药片剂，其特征在于：所述步骤(4)制粒之后进行干燥的温度为80摄氏度。
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