CN110585389A - 一种用于治疗慢性胃炎和胃溃疡的药物及其制备方法 - Google Patents
一种用于治疗慢性胃炎和胃溃疡的药物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于治疗慢性胃炎和胃溃疡的药物及其制备方法，本发明的药物由麸炒白术、陈皮、砂仁及鸡内金制成；本发明的药物具有健胃醒脾、理气降逆止痛的作用，能有效治疗慢性胃炎和胃溃疡，减轻了患者痛苦，提高患者的生活质量，且疗效显著，安全性高、经济实惠、服用方便。
Description
技术领域
本发明涉及一种用于治疗慢性胃炎和胃溃疡的药物及其制备方法，属于药品技术的领域。
背景技术
慢性胃炎是指不同病因引起的胃黏膜的慢性炎症或萎缩性病变，本病无典型及特异的临床症状，大多数患者表现为上腹部饱胀或疼痛、嗳气等，属中医“胃痛”、“痞满”、“嘈杂”等范畴。其发病率极高，在各种胃病中居于首位，约占接受胃镜检查患者的90%以上，对人类健康的影响较大。胃溃疡是指发生在胃角、胃窦、贲门和裂孔疝等部位的溃疡，是消化性溃疡的一种，临床表现以上腹部疼痛为主，也可出现在左上腹部或胸骨、剑突后。常呈隐痛、钝痛、胀痛、烧灼样痛。胃溃疡的疼痛多在餐后1小时内出现，经1～2小时后逐渐缓解，直至下餐进食后再复现上述节律。部分患者可无症状，或以出血、穿孔等并发症作为首发症状。
中医典籍中并无“慢性胃炎”、“胃溃疡”病名记载，临床均以上腹疼痛、嗳气等为主要症状，故将其归属为中医“胃痛”、“痞满”、“嘈杂”等范畴。古典医籍对“胃痛”的论述较多，自《黄帝内经》开始即有关于“厥心痛”的内容，《灵枢·厥病》曰：“厥心痛，痛如锥针刺其心，心痛甚者，脾心痛也。”又云：“厥心痛，腹胀胸满，心尤痛甚，胃心痛也。”至《金匮要略》，张仲景将胃脘部称为心下、心中，将胃病分为痞证、胀证、满证与痛证，对后世很有启发。如“心中痞，诸逆心悬痛，桂枝生姜枳实汤主之。”“按之心下满痛者，此为实也，当下之，宜大柴胡汤。”综上，古代文献中所述胃脘痛常以“心痛”代之，当与现世之“胃痛”、“心痛”区分开来。痞满作为一种自觉症状始见于《内经》，《内经》有“否”、“满”、“否满”、“痞塞”之称，并初步阐述了该病的病因病机，《素问·至真要大论》说“饮食不节，起居不时，阴受之。阴受之则入五脏，入五脏则真满痞塞。”将痞满作为独立病证论治者，首见于《伤寒论》，张仲景在伤寒论中明确提出痞证的症状表现概念：“但满而不痛者，此为痞”，“按之自濡，但气痞也”，以泻心汤治疗胃痞，开创了辛开苦降的治法先河，一直被后世医家所效法。明清时期医家对痞满的病因、病机及辩证论治进行深入探讨，张景岳首先将痞满辩虚实，《景岳全书·痞满》云：“痞满一证，大有疑辩，则在虚实二字，凡有邪有滞而痞者，实痞也；无邪无滞而痞者，虚痞也；有胀，有痛而满者，实满也；无胀无痛而满者，虚满也。实痞、实满者可消可散；虚痞、虚满者，非大加温补不可。”慢性胃炎、胃溃疡具有发病率较高、病情迁延等特点，历代医家研究甚多。
因此，发明一种疗效显著，具有健胃醒脾，理气降逆止痛功效的药物，对减轻患者痛苦，提高患者的生活质量有重要意义。
发明内容
本发明的目的在于，提供一种用于治疗慢性胃炎和胃溃疡的药物。本发明的药物具有健胃醒脾、理气降逆止痛的作用，能有效治疗慢性胃炎和胃溃疡，减轻了患者痛苦，提高患者的生活质量，且疗效显著，安全性高、经济实惠、服用方便。
本发明的技术方案：一种用于治疗慢性胃炎和胃溃疡的药物，药用有效成分照重量组份计算，由麸炒白术50-70份，陈皮10-30份，砂仁5-15份及鸡内金20-40份制成。
前述的用于治疗慢性胃炎和胃溃疡的药物中，所述药物药用有效成分照重量组份计算，由麸炒白术55-65份，陈皮15-25份，砂仁8-13份及鸡内金25-35份制成。
前述的用于治疗慢性胃炎和胃溃疡的药物中，所述药物药用有效成分照重量组份计算，由麸炒白术60份，陈皮20份，砂仁10份及鸡内金30份制成。
前述用于治疗慢性胃炎和胃溃疡的药物的制备方法，取麸炒白术、陈皮、砂仁和鸡内金，与药物中可接受的辅料进行组合，或不加辅料，按照常规方法进行加工，制成相应的制剂。
前述用于治疗慢性胃炎和胃溃疡的药物的制备方法中，所述制剂为口服制剂。
前述用于治疗慢性胃炎和胃溃疡的药物的制备方法中，所述口服制剂为散剂、胶囊剂或片剂。
前述用于治疗慢性胃炎和胃溃疡的药物的制备方法中，所述散剂这样制备：按比例称取上述药物，打为粉末，即得该散剂。
前述用于治疗慢性胃炎和胃溃疡的药物的制备方法中，所述散剂这样制备：按比例称取上述药物，煎煮3 次，第一次用8倍量的水煎煮30min，第二次用6倍量的水煎煮20min，第三次用4倍量的水煎煮10min，过滤，合并煎液，浓缩成80℃时相对密度为 1.10-1.15的浸膏，将浸膏干燥，粉碎成细粉，另取细粉质量10%-30%的沉降碳酸钙混合均匀，过100目筛，分装即得。
前述用于治疗慢性胃炎和胃溃疡的药物的制备方法中，所述胶囊剂这样制备：按比例称上述药物，煎煮3 次，第一次用8倍量的水煎煮30min，第二次用6倍量的水煎煮20min，第三次用4倍量的水煎煮10min，过滤，合并煎液，浓缩成80℃时相对密度为 1.10-1.15的浸膏，50℃常压干燥或减压干燥，粉碎，过60目以下筛，装入胶囊，即得。
前述用于治疗慢性胃炎和胃溃疡的药物的制备方法中，所述片剂这样制备：按比例称上述药物，煎煮2次，每次1h，两次分别加12倍水，煎煮完成后分别用八层纱布过滤，合并滤液，50℃将滤液浓缩至相对密度为1.13的浸膏，50℃常压干燥或减压干燥，粉碎，过60目以下筛，加入适量辅料淀粉混匀，整粒，压片，用果维膜包薄膜衣，即得。
本发明由麸炒白术、陈皮、砂仁及鸡内金制成，其中麸炒白术，为菊科植物白术Atractylodes macrocephala Koidz.的干燥根茎，与麦麸炒制的制品；用于脾胃不和，运化失常，食少胀满倦怠乏力，表虚自汗。陈皮，为芸香科植物橘Citrus reticulata Blanco 及其栽培变种的干燥成熟果皮；功能主治：理气健脾，燥湿化痰；用于胸脘胀满，食少吐泻，咳嗽痰多。砂仁，为姜科植物阳春砂Amomum villosum Lour. 、绿壳砂Amomum villosumLour. var. xanthioides T. L. Wu et Senjen 或海南砂Amomum longiligulare T. L.Wu 的干燥成熟果实；功能主治：化湿开胃，温脾止泻，理气安胎；用于湿浊中阻，脘痞不饥，脾胃虚寒，呕吐泄泻，妊娠恶阻，胎动不安。鸡内金，为雉科动物家鸡Gallus gallusdomesticus Brisson的干燥沙囊内壁；功能主治健胃消食，涩精止遗；用于食积不消，呕吐泻痢，小儿疳积，遗尿，遗精。
方解：方中重用麸炒白术为君，取其健脾和胃，培固脾土之功。陈皮为臣，辅君药白术健脾和胃之功，同时兼行气止痛，针对胃脘疼痛及腹部胀满等症。砂仁与鸡内金同为佐药，协助君、臣健运脾胃，同时消食化积，消痞除胀。全方用药精简，重点突出，疗效显著。
白术，菊科植物白术的根茎，以浙江于潜产者最佳，故又称为“于术”。其性甘、苦、温，归脾、胃经。具有益气健脾，燥湿利水，止汗，安胎等功效。本品甘苦性温，主归脾胃经，以健脾燥湿为主要作用，被前人誉之为“脾脏补气健脾第一要药”。《本草通玄》云：“补脾胃之药，更无出其右者。土旺则能健运，故不能食者，食停滞者，有痞积者，皆用之也。土旺则能胜湿，故患痰饮者，肿满者，湿痹者，皆赖之也。土旺则清气善升，而精微上奉，浊气善除，而糟粕下输，故吐泻者，不可阙也。”历代医家认为，白术经过麸炒过程，缓和了燥性，减少了对肠胃的刺激，增强了健脾和胃的功效。现代药理学研究发现，麸炒过程使挥发油这种燥性成分减少，内酯增加进而产生减毒增效的作用。方中重用麸炒白术为君，取其健脾和胃，培固脾土之功。陈皮为芸香科植物橘及其栽培变种的干燥成熟果实。秋末冬初果实成熟时采收果实，晒干或低温干燥，以陈久者为佳，故称陈皮。其性辛，苦，温，归脾、肺经。具有理气健脾，燥湿化痰之功。本品辛行温通，有行气止痛、健脾和胃之功，善疏理气机、调畅中焦而使之升降有序。陈皮为臣，辅君药白术健脾和胃之功，同时兼行气止痛，针对胃脘疼痛及腹部胀满等症。砂仁，姜科植物阳春砂、绿壳砂或海南砂的干燥成熟果实。其性辛，温。归脾胃、肾、经。具有化湿行气，温中止呕，安胎等功效。本品辛散温通，气味芬芳，其化湿醒脾，行气温中之效均佳，古人谓其：“为醒脾调胃要药。”故凡湿阻或气滞所致之脘腹胀痛等脾胃不和诸证常用。《本草汇言》云：“砂仁，温中和气之药也。若上焦之气梗逆而不下，下焦之气抑遏而不上，中焦之气凝聚而不舒，用砂仁治之，奏效最捷。”鸡内金，为雉科动物家鸡的沙囊内壁，药性甘，平。归脾、胃、小肠、膀胱经。功效为消食健胃，涩精止遗。《滇南本草》云：“宽中健脾，消食磨胃。治小儿乳食结滞，肚大筋青，痞积疳积。”本品消食化积作用较强，同时可健运脾胃，米面薯芋乳肉等各种食积证均被广泛运用。砂仁与鸡内金同为佐药，协助君、臣健运脾胃，同时消食化积，消痞除胀。全方用药精简，重点突出，疗效显著。
西医药理研究显示白术对肠管活动有双向调节作用，当肠管兴奋时呈抑制作用，而肠管抑制时呈兴奋作用；有防治实验性胃溃疡的作用；白术挥发油有镇静作用。白术的甲醇提取物对小肠上皮细胞（IEC-6）增值无影响，但对 IEC-6 迁移及迁移过程中蛋白表达和PLC-γ1m RNA 表达有促进作用，说明白术甲醇提取物是通过促进多胺介导的IEC-6 迁移发挥对胃肠黏膜损伤的修复作用。动物实验发现白术可抑制脾虚小鼠胃排空、调节胃肠运动紊乱，提高脾虚小鼠血清中胃动素和胃泌素水平；也有研究表明白术可以调节小鼠肠道菌群中的乳杆菌和双歧杆菌，促进其增值，改善菌群的状况。陈皮煎剂对家兔及小白鼠离体肠管，麻醉兔、犬胃及肠运动均有直接抑制作用。砂仁煎剂可增强胃的功能，促进消化液的分泌，可增进肠道运动，排出消化管内的积气；另有实验证实砂仁具有抗炎、镇痛等药理作用，针对慢性胃炎的炎症状态及疼痛均能较好的缓解。鸡内金粉剂口服后，胃液分泌量、酸度和消化力均见提高，胃运动机能明显增强；体外实验能增强胃蛋白酶、胰脂肪酶活性。综合全方四味药物药理性质，兼具了促进胃肠粘膜修复、增强胃肠消化功能、抗炎、镇痛等药理作用，针对慢性胃炎疼痛及炎症状态均有良好治疗作用。
与现有技术相比，本发明的药物具有健胃醒脾、理气降逆止痛的作用，能有效治疗慢性胃炎和胃溃疡，减轻了患者痛苦，提高患者的生活质量，且疗效显著，安全性高、经济实惠、服用方便。
申请人为验证本发明的效果进行了大量的实验研究，以下为本发明实验研究的结果：
实验例，临床研究：
患者秦某，女，42岁。2017年09月20日初诊。1周前患者因进食辛辣后出现胃脘部疼痛，伴食欲不振，腹部胀满不适等，无恶心呕吐，无呕血、便血及黑便，精神稍差，小便正常，大便不成形。体格检查：心率：73次/分，血压：137/69mmHg，发育正常，营养中等，神志清楚，痛苦面容，心肺听诊无特殊，腹软，上腹部压痛，无反跳痛及肌紧张，肝、脾触诊无异常，墨菲氏征阴性。脊柱四肢无异常。神经***查体无异常。舌淡，苔薄白，边有齿痕，脉沉细无力。辅助检查：胃镜检查结果：慢性非萎缩性胃炎伴轻度糜烂。中医诊断：胃痛-脾胃虚弱证。治则：健脾和胃，理气降逆止痛。服用本发明实施例1的药物：餐前温水送服，20g/次，3次/日。并嘱避免进食辛辣冰冷等刺激性食物。2017年10月26日复诊，患者诉已无胃痛症状，饮食较前明显改善，无腹胀症状。
患者孔某，男，57岁，2018年2月18日初诊。患者主诉：反复胃脘部隐痛7+年。7+年前患者因大量饮酒后感胃脘部疼痛，饮食差，时有黑便，就诊于就近诊所，予“泮托拉唑肠溶胶囊、铝碳酸镁片、健胃消食片”等药物治疗后症状好转，之后不规律服用上述药物至今（仅疼痛时服用），2+年前曾行胃镜检查，结果提示慢性非萎缩性胃炎，伴糜烂，胃窦多发溃疡。目前症见：胃脘部疼痛，伴腹胀，肢软乏力，食欲不振，无恶心呕吐，无腹泻、黑便、呕血、便血等症，精神稍差，睡眠尚可，小便正常，大便时干时稀。舌淡暗，苔白腻，脉细滑。体格检查：血压151/79mmHg，精神欠佳，神志清楚，心肺听诊无异常；上腹部压痛明显，无反跳痛及肌紧张，墨菲氏征阴性，肝、脾触诊无异常。脊柱四肢无异常。神经***查体无异常。辅助检查：2+年前胃镜检查结果：慢性非萎缩性胃炎，伴糜烂。中医诊断：胃痛-脾胃失和。治则：健脾和胃，理气降逆止痛。长期服用本发明实施例1的药物，餐前温水送服，20g/次，3次/日。嘱忌酒。2018年08月11日复诊。患者自服药至今，胃脘部疼痛症状未再发作，饮食可，大小便调畅。
综上所述，本发明的药物具有健胃醒脾、理气降逆止痛的作用，能有效治疗慢性胃炎和胃溃疡，减轻了患者痛苦，提高患者的生活质量，且疗效显著，安全性高、经济实惠、服用方便。
具体实施方式
下面结合实施例对本发明作进一步的说明，但并不作为对本发明限制的依据。
实施例1.用于治疗慢性胃炎和胃溃疡的散剂及其制备方法
配方：麸炒白术60g，陈皮20g，砂仁10g，鸡内金30g。
制备方法：按比例称取上述药物，打为粉末，即得该散剂。
用法用量：口服，餐前温水送服，一日三次，每次20g。
实施例2.用于治疗慢性胃炎和胃溃疡的散剂及其制备方法
配方：麸炒白术70g，陈皮30g，砂仁15g，鸡内金40g。
制备方法：按比例称取上述药物，煎煮3次，第一次用8倍量的水煎煮30min，第二次用6倍量的水煎煮20min，第三次用4倍量的水煎煮10min，过滤，合并煎液，浓缩成80℃时相对密度为 1.13的浸膏，将浸膏干燥，粉碎成细粉，另取细粉质量20%的沉降碳酸钙混合均匀，过100目筛，分装即得。
用法用量：口服，餐前温水送服，一日三次，每次15-20g。
实施例3.用于治疗慢性胃炎和胃溃疡的胶囊剂及其制备方法
配方：麸炒白术500g，陈皮100g，砂仁50g及鸡内金200g。
制备方法：按比例称上述药物，煎煮3 次，第一次用8倍量的水煎煮30min，第二次用6倍量的水煎煮20min，第三次用4倍量的水煎煮10min，过滤，合并煎液，浓缩成80℃时相对密度为 1.10-1.15的浸膏，50℃常压干燥或减压干燥，粉碎，过60目以下筛，装入胶囊，即得。
用法用量：温水送服，每次1-2粒，一天三次。
实施例4.用于治疗慢性胃炎和胃溃疡的片剂及其制备方法
配方：麸炒白术55g，陈皮15g，砂仁8g及鸡内金25g。
制备方法：按比例称上述药物，煎煮2次，每次1h，两次分别加12倍水，煎煮完成后分别用八层纱布过滤，合并滤液，50℃将滤液浓缩至相对密度为1.13的浸膏，50℃常压干燥或减压干燥，粉碎，过60目以下筛，加入适量辅料淀粉混匀，整粒，压片，用果维膜包薄膜衣，即得。
用法用量：温水送服，每次1-2片，一天三次。
Claims (10)
1.一种用于治疗慢性胃炎和胃溃疡的药物，其特征在于：药用有效成分照重量组份计算，由麸炒白术50-70份，陈皮10-30份，砂仁5-15份及鸡内金20-40份制成。
2.根据权利要求1所述的用于治疗慢性胃炎和胃溃疡的药物，其特征在于：所述药物药用有效成分照重量组份计算，由麸炒白术55-65份，陈皮15-25份，砂仁8-13份及鸡内金25-35份制成。
3.根据权利要求2所述的用于治疗慢性胃炎和胃溃疡的药物，其特征在于：所述药物药用有效成分照重量组份计算，由麸炒白术60份，陈皮20份，砂仁10份及鸡内金30份制成。
4.一种如权利要求1-3中任一项所述用于治疗慢性胃炎和胃溃疡的药物的制备方法，其特征在于：取麸炒白术、陈皮、砂仁和鸡内金，与药物中可接受的辅料进行组合，或不加辅料，按照常规方法进行加工，制成相应的制剂。
5.根据权利要求4所述用于治疗慢性胃炎和胃溃疡的药物的制备方法，其特征在于：所述制剂为口服制剂。
6.根据权利要求5所述用于治疗慢性胃炎和胃溃疡的药物的制备方法，其特征在于：所述口服制剂为散剂、胶囊剂或片剂。
7.根据权利要求6所述用于治疗慢性胃炎和胃溃疡的药物的制备方法，其特征在于：所述散剂这样制备：按比例称取上述药物，打为粉末，即得该散剂。
8.根据权利要求6所述用于治疗慢性胃炎和胃溃疡的药物的制备方法，其特征在于：所述散剂这样制备：按比例称取上述药物，煎煮3 次，第一次用8倍量的水煎煮30min，第二次用6倍量的水煎煮20min，第三次用4倍量的水煎煮10min，过滤，合并煎液，浓缩成80℃时相对密度为 1.10-1.15的浸膏，将浸膏干燥，粉碎成细粉，另取细粉质量10%-30%的沉降碳酸钙混合均匀，过100目筛，分装即得。
9.根据权利要求6所述用于治疗慢性胃炎和胃溃疡的药物的制备方法，其特征在于：所述胶囊剂这样制备：按比例称上述药物，煎煮3 次，第一次用8倍量的水煎煮30min，第二次用6倍量的水煎煮20min，第三次用4倍量的水煎煮10min，过滤，合并煎液，浓缩成80℃时相对密度为 1.10-1.15的浸膏，50℃常压干燥或减压干燥，粉碎，过60目以下筛，装入胶囊，即得。
10.根据权利要求6所述用于治疗慢性胃炎和胃溃疡的药物的制备方法，其特征在于：所述片剂这样制备：按比例称上述药物，煎煮2次，每次1h，两次分别加12倍水，煎煮完成后分别用八层纱布过滤，合并滤液，50℃将滤液浓缩至相对密度为1.13的浸膏，50℃常压干燥或减压干燥，粉碎，过60目以下筛，加入适量辅料淀粉混匀，整粒，压片，用果维膜包薄膜衣，即得。
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