CN1259970C - 治疗外感风寒的药物及其制备方法 - Google Patents
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Abstract
本发明是一种治疗外感风寒的药物及其制备方法。它是由下述重量配比的原料制成的药剂：皱叶香薷100～150，厚朴100～150，陈皮98～140，苍术100～150，广藿香98～140，大枣40～80，砂仁20～60，吴茱萸40～80，丁香40～80，干姜20～60，白胡椒20～60。本发明的药物解表散寒，理气化湿，和胃止痛。经临床验证，对外感受风寒，内伤湿滞所致的头痛鼻塞，巅顶冷痛，恶心呕吐，食谷欲吐，胸痛满闷，胃脘胀痛疗效显著，临床治疗总有效率为95%。
Description
技术领域
本发明是一种治疗外感风寒的药物，具体地说是以中草药为原料制备的中成药，本发明还涉及该药物的制备方法。
背景技术
溃疡病在临床上多表现为虚寒症状，遇暖或热敷则舒，遇冷则重，大便溏薄等。一般归纳为胃肠型感冒、慢性胃炎、消化性溃疡等病症。在目前临床上多用生胃酮、痢特灵、生胃宁治疗。而它们在临床上的治愈率分别为61.29％、52.85％、65.7％，以此看来治愈率较低。并且此类药物有大量的不良反应，如恶心、呕吐、腹泻、头晕、药物热、皮疹、肛门瘙痒、哮喘、直立性低血压、低血糖、肺浸润，并偶有溶血性贫血、黄疸及多发性神经炎。此类药物还对有药物过敏者，新生儿、孕妇及哺乳期妇女须慎用。
发明内容
本发明的目的是提供一种治疗脾胃虚寒型的消化性溃疡、胃肠型感冒、神经性呕吐、头痛及美尼尔氏综合征的药物及其制备方法。
本发明人研究认为：1.虚寒证在溃疡病中一直占主导地位，近年来在纤维胃镜的开展下，对溃疡病的改变有了新的认识，所以应将局部辨证和整体辨证相结合起来，有可能有更全面的认识。在总体说来病机具有整体阳虚，局部热瘀的特点，在临床上看，寒热的侧重程度不同，活动期多以热瘀为主，表现为寒热夹杂证，而稳定期多为脾胃虚寒为主，但不论何种证型均有局部热瘀的病机，所以在温补之季应加入少量清解理气之剂。即然脾胃虚寒为消化性溃疡的重要病机，辛甘温热药的应用关系甚大，具临床上有虚寒和实寒的不同，就应有相应的辛甘散寒和助阳之法，脾胃虚寒应辛温散寒，但在具有寒瘀气滞时应加入行滞之品而不能过重，以免耗气伤阳；在脾胃阳虚时且勿加理气消胀之品，不能以胀治胀，愈疏则愈胀。
2.邪气相当于攻击因子，螺杆茵感染。正气相当于胃粘膜的防护作用，而本发明的药物配有健脾益气药，可以促进防护因子的增强。加强上皮细胞的再生，调节粘膜血循环等作用。进而溃疡病中脾气虚弱与粘膜功能的减弱有相似之处。本发明根据此理论，特配制出本发明的药物来治疗脾胃虚寒型的消化性溃肠，胃肠型感昌，神经性呕吐，头痛及美尼尔氏综合征。病人对药物顺应性好。
本发明的药物是由下述重量配比的原料制成的：
皱叶香薷100～150，厚朴100～150，陈皮98～140，苍术100～150，广藿香98～140，大枣40～80，砂仁20～60，吴茱萸40～80，丁香40～80，干姜20～60，白胡椒20～60。
将上述各组分制成本发明药物的制备方法是：
1)中药材的预处理：将中药材拣选、清洗、干燥、炮炙、粉碎、灭菌进中间库；
2)净药粉经称量配料、混合、过筛、分装、即得散剂。
也可以将上述组方制成片剂或胶囊剂或其它剂型。
本发明的药物解表散寒，理气化湿，和胃止痛。经临床验证，对外感受风寒，内伤湿滞所致的头痛鼻塞，脘腹胀痛，恶心呕吐，食谷欲吐之胃肠型感冒，脾胃虚寒，厥阴头痛，神经性呕吐、头痛、消化性溃疡，美尼尔氏综合征都有显著的疗效，临床治疗总有效率为95％；
为表明本发明药物对外感风寒的治疗效果，用以下系统临床观察予以说明。
1.对象与方法
1.1病例选择：治疗组选择胃肠型感冒，慢性胃炎和消化性溃疡患者300例，其中男168例，女132例，年龄18-63岁，平均年龄37.6岁，其中胃肠型感冒123例，慢性胃炎108例，消化性溃疡69例。但在以下两种情况下不列入临床总结范畴。
(1)具有心脑血管疾病，精神病患者不符合临床用药者范畴。
(2)不按规定服用药者不列入临床实验范畴。
1.2诊断标准
(1)胃肠型感冒：起病急，呕吐，腹泻，可伴腹痛，发热，头痛，鼻塞，流清水样鼻涕等症状。粪便量多稀薄，可伴酸臭味或带有泡沫。一般全身症状轻，大便常规：稀、可有食物残渣、偶有少量粘液、余无异常。血、尿常规无异常。
(2)慢性胃炎：反复上腹部疼痛、闷胀、恶心、呕吐、脘腹胀满隐痛或作痛。食后或劳累后加重，食纳减少，四肢倦怠，面色苍白或形寒肢冷，进凉食或遇风寒加重，喜温按，大便清稀，舌淡苔薄白，脉细弱或沉缓。经X线钡餐检查或胃镜检查诊断为慢性胃炎。
(3)消化性溃疡：反复上腹部疼痛，反酸，胃脘冷痛，喜暖喜按，遇冷，饥饿加重得食痛减，纳差，冷吐清水，畏寒肢冷，四肢乏力，大便溏薄。经X线钡餐检查发现龛影或胃镜检查发现溃疡病兆。
1.3方法
(1)胃肠型感冒服用本发明的药物(散剂)，每次一袋(5g)，每日三次，连服三天。
(2)慢性胃炎服用本发明的药物(散剂)，每次一袋(5g)，每日三次，连服一个月。
(3)消化性溃疡服用本发明的药物(散剂)，每次一袋(5g)，每日三次，连服一个月。服药前查大便潜血试验、小便及血常规、心电图或纤维胃镜检查。
2.结果
2.1疗效判断：
(1)临床治愈：恶心，呕吐，形寒肢冷，喜温喜按，脘腹胀满，冷痛或作痛，四肢乏力，进凉食或遇风寒加重，得食痛减，大便溏薄等症状消失，胃镜复查显示胃粘膜无充血，水肿，溃疡完全消失，为红色疤痕期。
(2)显效：畏寒肢冷、四肢无力、喜温喜按，遇冷、大便溏薄等寒证消失，饮食、大便尚可，胃镜复查显示溃疡基本消失，粘膜集中，粘膜充血、水肿明显减轻。
(3)好转：食纳减少，四肢倦怠、形寒肢冷、惧寒畏风等症状消失，饮食、大便尚可，胃镜复查显示溃疡大小缩小50％以上，粘膜充血、水肿减轻。
(4)无效：以上症状无减轻，饮食差，胃镜复查显示溃疡无改变，粘膜充血、水肿无好转。
2.2治疗效果：见附表(1、2)
附表1本发明的药物300例疗效观察
| 例数 | 临床治愈 | 显效 | 好转 | 无效 | |
| 胃肠型感胃 | 123 | 63 | 54 | 6 | 0 |
| 慢性胃炎 | 108 | 21 | 36 | 45 | 6 |
| 消化性溃疡 | 69 | 9 | 27 | 24 | 9 |
| 合计 | 300 | 93 | 117 | 75 | 15 |
附表2霍香正气水100例疗效观察
| 例数 | 临床治愈 | 显效 | 好转 | 无效 | |
| 胃肠型感胃 | 41 | 21 | 18 | 2 | 0 |
| 慢性胃炎 | 36 | 7 | 4 | 15 | 10 |
| 消化性溃疡 | 23 | 3 | 6 | 5 | 9 |
| 合计 | 100 | 31 | 28 | 22 | 19 |
藿香正气水对照组注意事项较多，不便于携带，病人顺应性差、口感较差，小儿不宜服用，而本发明的药物充分弥补了它的不足，并且疗效显著。万应散治疗胃肠型感冒，慢性胃炎和消化性溃疡临床治愈93例，显效117例，好转75例，无效15例，总有效285例，占95％。
典型病例
陈×，男，29岁，干部。因畏寒、发热伴呕吐、腹泻一天就诊。患者一天前因“受凉”后，自觉全身不适，畏寒、腹部闷胀，不思饮食。呕吐两次，均为胃内容物，腹泻四次，大便量多、清稀、有泡沫、无粘液脓血便、无里急后重，腹痛不明显。查：一般体温38.5℃，咽红、腹软、无明显压痛、肠鸣音活跃。余(一)。大便常规：稀、黄有食物残渣。中医脉案：腹痛、肠鸣音活跃。余(一)。大便常规：稀、黄有食物残渣，余(一)。血常规无异常。诊断：胃肠型感冒。中医脉案：腹痛、肠鸣、泄泻、大便为感受寒湿之证。给服本发明的药物(散剂)，每次一袋(5g)，每日三次，连服三天，患者服用一天后自觉症状明显减轻、无呕吐、腹泻两次、可少许进食、三天后症状消失，饮食可、大便成形。
附图说明
图1是本发明的中药材预处理工艺流程图。
图2是本发明的散剂生产工艺流程图。
具体实施方式
实施例1：
按下述配比称取原料(千克)：
皱叶香薷100，厚朴100，陈皮98，苍术100，广藿香98，大枣40，砂仁20，吴茱萸40，丁香40，干姜20，白胡椒20。
用上述原料按以下步骤制备：
1)中药材的预处理：将中药材拣选、清洗、干燥、炮炙、粉碎、灭菌进中间库；
2)净药粉经称量配料、混合、过筛、分装、即得散剂(每袋5克)。
实施例2：
按下述配比称取原料(千克)：
皱叶香薷136，厚朴136，陈皮134，苍术136，广藿香134，大枣68，砂仁40，吴茱萸68，丁香68，干姜40，白胡椒40。
用上述原料按实施例1的方法制备；或按现有技术的方法制成片剂。
实施例3：
按下述配比称取原料(千克)：
皱叶香薷150，厚朴150，陈皮140，苍术150，广藿香140，大枣80，砂仁60，吴茱萸80，丁香80，干姜60，白胡椒60。
用上述原料按实施例1的方法制备；或按现有技术的方法制成胶囊剂。
Claims (3)
1、一种治疗外感风寒的药物，其特征在于它是由下述重量配比的原料制成的药剂：
皱叶香薷100～150，厚朴100～150，陈皮98～140，苍术100～150，广藿香98～140，大枣40～80，砂仁20～60，吴茱萸40～80，丁香40～80，干姜20～60，白胡椒20～60。
2、权利要求1所述的治疗外感风寒的药物的制备方法，其特征在于按以下步骤制备：
1)中药材的预处理：将中药材皱叶香薷、厚朴、陈皮、苍术、广藿香、大枣、砂仁、吴茱萸、丁香、干姜、白胡椒拣选，清洗，干燥，炮炙，粉碎，灭菌进中间库；
2)净药粉经称量配料、混合、过筛、分装、即得散剂。
3、根据权利要求1所述的治疗外感风寒的药物，其特征在于该药物是片剂或胶囊剂或丸剂或颗粒剂。
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