CN104288740A - 复方消渴胃宁合剂 - Google Patents

复方消渴胃宁合剂 Download PDF

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CN104288740A
CN104288740A CN201410588264.3A CN201410588264A CN104288740A CN 104288740 A CN104288740 A CN 104288740A CN 201410588264 A CN201410588264 A CN 201410588264A CN 104288740 A CN104288740 A CN 104288740A
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radix
stomach
rhizoma
spleen
thirst
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刘爱玲
马玉凤
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Abstract

本发明涉及中药配方领域，具体地说是一种复方消渴胃宁合剂，其特征在于由如下重量百分比的原料药制成，黄芪6～9％，白术4～7％，黄芩6～9％，黄连4～7％，姜半夏6～9％，干姜3～5％，炒莱菔子10～13％，炒麦芽0.1～0.2％，枳壳10～13％，竹茹3～6％，木香3～5％，藿香2～5％，山药3～6％，鸡内金3～6％，丹参4～6％，沙参2～5％，石斛2～4％，甘草2～4％，将上述原料药用水浸泡，煎熬后去渣得滤液。本发明原料成本低，依从性好，无毒副作用，具有健脾益胃，清热燥湿，理气化痰，活血化积，温胃降逆，消痞散结，佐以益气血、调脾胃的治疗大法。

Description

复方消渴胃宁合剂
技术领域
本发明涉及一种中成药制剂，具体地说是一种复方消渴胃宁合剂。
背景技术
众所周知，糖尿病胃轻瘫是由于糖尿病导致自主神经损伤，引起了胃动力异常及胃排空延迟，是糖尿病在消化道的常见慢性并发症之一，临床上约50％-70％的糖尿病患者存在早期胃轻瘫，有明显症状占10％，有研究显示，60岁以上的老年糖尿病患者的患病率更高，达74.4％。糖尿病引起的胃轻瘫的发生机制尚不十分清楚，绝大多数学者认为与糖尿病患者的自主神经病变、高血糖、血清胃肠激素、微血管病变及代谢紊乱有关，高血糖诱发内脏植物神经功能紊乱，支配胃肠神经受累使胃张力减低，胃扩张及胃蠕动减弱而引起胃排空时间延迟。对患者的生活和健康带来了严重的危害。目前西医治疗上尚无特效方法，除了积极控制血糖外，消化道症状主要是对症处理，胃轻瘫多用胃动力药物，目前一般使用莫沙比利、多潘立酮等治疗，莫沙比利该药可引起Q-T间期延长和室性心律紊乱，一般不宜用于心脏病患者；同时能阻断多巴胺D2受体出现锥体外系症状或泌乳、哮喘等情况；多潘立酮心脏病患者(心律失常)，或低血钾以及接受化疗的肿瘤患者，有可能加重心律紊乱；可有药疹、哮喘、锥体外系、泌乳素增高、嗜睡、头晕等症状；并禁用嗜鉻细胞瘤、乳癌、机械性肠梗阻、胃肠出血等疾病。
发明内容
本发明目的就是为了克服上述现有的技术不足，提供一种复方消渴胃宁合剂，原料成本低，依从性好，无毒副作用，具有健脾益胃，清热燥湿，理气化痰，活血化积，温胃降逆，消痞散结，佐以益气血、调脾胃的治疗大法。
本发明解决上述技术问题采用的技术方案是：一种复方消渴胃宁合剂，其特征在于由如下重量百分比的原料药制成，黄芪6～9％，白术4～7％，黄芩6～9％，黄连4～7％，姜半夏6～9％，干姜3～5％，炒莱菔子10～13％，炒麦芽0.1～0.2％，枳壳10～13％，竹茹3～6％，木香3～5％，藿香2～5％，山药3～6％，鸡内金3～6％，丹参4～6％，沙参2～5％，石斛2～4％，甘草2～4％，将上述原料药用水浸泡，煎熬后去渣得滤液。
本发明的有益效果是，原料成本低，依从性好，无毒副作用，具有健脾益胃，清热燥湿，理气化痰，活血化积，温胃降逆，消痞散结，佐以益气血、调脾胃的治疗大法。
具体实施方式
下面结合实施例对本发明作进一步的描述：
实施例1：
采用黄芪、白术、黄芩、黄连、姜半夏、干姜、炒莱菔子、炒麦芽、枳壳、竹茹、木香、藿香、山药、鸡内金、丹参、沙参、石斛、甘草。其组分(重量％)每副为黄芪8.3、白术6.2、黄芩8.1、黄连6.1、姜半夏8.1、干姜4.6、炒莱菔子10.8、炒麦芽0.2、枳壳11.3、竹茹4.4、木香4.6、藿香3.9、山药4.4、鸡内金4.9、丹参4.3、沙参3.9、石斛3.1、甘草2.8。取上述18种中药原料总重量58千克，精选洗净后在温室条件下用20000ml水浸泡30分钟左右，然后煎熬60分钟，常规去渣过滤，高压、灭菌工艺后，所得滤液共9000ml，袋分装，密封，每袋150ml，每天早晚各服一袋。
本发明的治疗原则：糖尿病胃轻瘫属于中医“痞满”、“反胃”、“呕吐”、“痞胀”等范畴，其病机多以虚实夹杂、寒热交错多见，其基本病机为脾胃虚弱，寒热互结中阻，痞塞不通，上下不能交泰所致。笔者通过长期临床观察，糖尿病胃轻瘫患者大多形体肥胖，喜肥甘、醇酒、厚味、辛辣刺激食物，损伤脾胃，脾胃运化失司，饮食久积胃肠，酿成内热，容易出现湿热中阻证；病后心情郁闷忧伤或乱用养阴益气中药，更容易加重痰湿；另外消渴日久，阴损气耗，脾胃虚弱，运化无力，致气滞血行不畅，胃络瘀阻，脾胃升降失常。《脾胃论》日：“呕吐哕皆属脾胃虚弱，或寒热所侵，或饮食所伤，致气上逆而食不得下”。《临证指南医案》中云：“脾宜升则健，胃宜降则和”。《证治要决.消渴》日：“气极虚则无能为力矣，一僧传用黄芪饮”。故本病为虚实夹杂、寒热错杂之证，脾胃虚弱为本，寒热错杂、气滞血瘀为标。故拟定健脾益胃，清热燥湿，理气化痰，活血化积，温胃降逆，消痞散结，佐以益气血、调脾胃的治疗大法。本发明中黄芪归脾肺经，性味甘微温，能补脾肺之气，为补气之要药，且有升举阳气的作用，配伍白术能补气健脾，增强脾胃运化功能；白术归脾胃经，性味苦甘温，归脾胃经，白术既能补气健脾，又可燥湿利水，为治脾虚积滞、痰饮之良药。现代研究，黄芪多糖具有反向调节血糖作用，既可保护低血糖，又可对抗高血糖；白术有促进胃肠蠕动和降低血糖的作用，两者共为君药。黄芩、黄连性味苦寒，长于清胃肠湿热，苦泄而寒，以降胃气之热，《本草正义》谓“黄连大苦大寒，苦能燥湿，寒能胜热，能泻降一切有余之湿热”。姜半夏味辛苦，性温而燥为燥湿化痰、降逆止呕之要药，配伍干姜辛开而温，以散脾气之寒。炒莱菔子性味辛甘平，归脾胃经，功擅消食化积，能除胀行滞及降气化痰、消食除满；炒麦芽性味甘平，归脾胃经，具有消食和中之功，能助淀粉性食物的消化，尤适用于米面、薯芋等食物积滞不化者，在运用补气健脾药时，配伍麦芽，可使补而不滞，六者共为臣药。枳壳苦泄辛散，行气消积，以通痞塞之功，枳壳能兴奋胃肠平滑肌，增强胃肠蠕动；竹茹善清胃热，止呕吐，《本经逢原》：“竹茹清胃府之热，为虚烦、烦渴、胃虚呕逆之要药”。木香辛开苦降，芳香性燥，可升可降，通行胃肠，为行气止痛之要药，擅长于调中宣滞，行气止痛，适宜于脘腹气滞胀痛之证，木香配伍在补益药中起到补而不滞作用；藿香芳香行散，既能化湿浊，又能和中止呕，为治湿阻呕吐之要药，木香、藿香合用能祛痰湿陈腐之气。鸡内金性味甘平，具有运脾消食之功，本品消食力量较强，有化坚消石，且有健运脾胃之功，特别适用于脾胃虚弱、食积不化之证。山药性味甘平，性质平和，为平补脾胃之良药，既能补脾气，又益脾阴，因补气养阴而止渴，为治疗糖尿病之要药。丹参性味苦微寒，能通行血脉，功善于活血化瘀，以活血凉血见长，对血热瘀滞较为适宜，丹参有改善微循环，抑制凝血，促进纤溶，降低血液粘稠度、降糖作用。沙参、石斛两者善养胃阴，生津液为滋养胃阴之要药，共为佐药。甘草性味甘平，既能缓和药物烈性调和诸药的作用，又可调和脾胃，健脾益气，以固后天之本，为使药。诸药合用，本发明的组方，研究证实，健脾、补阴、理气类中药对胃肠道运动有调整作用，可促进消化液分泌，增强消化功能，使胃肠蠕动加快，胃肠吸收改善，食欲增加；健脾药有促进胃肠内容物排空的作用；补阴药能促进胃液分泌而帮助消化，使肠蠕动加快而通便，理气药对胃肠有温和的刺激作用，能健胃驱除消化道积气。故本方具有健脾益胃，清热燥湿，理气化痰，活血化积，温胃降逆，消痞散结，佐以益气血、调脾胃之功，总之，本方寒热并用，苦辛相投，攻补同施，具有和阴阳，顺升降，调虚实之功，为和解治痞之良方，能有效治疗糖尿病性胃轻瘫。
本发明各原料还可按下表所列比例(重量百分比)混合的实施例来实现，其煎熬程序、口服方法与实施例1相同，其含量如下表所示。
下面结合我院进行的临床试验对本发明作进一步详细地描述：
1、病例选择：临床随机选择56例患者，男27例，女29例，年龄40-74岁，平均56.2±5.8岁，病程6年-20年，平均11.7±3.8年；所有患者均给予基础治疗，包括糖尿病教育、饮食管理、运动治疗、控制血糖、血压。所有患者给予口服降糖药物或胰岛素治疗，使空腹血糖、餐后2小时血糖、糖化血红蛋白达标(空腹血糖＜7.8mmol/L，餐后2小时血糖＜11.1mmol/L，糖化血红蛋白＜7.0％，)。
2、诊断标准：所有病例均参照WHO(1999年)糖尿病诊断和分类委员会提出糖尿病诊断标准。具体诊断标准：①有糖尿病症状(典型症状包括多饮、多尿和不明原因的体质量下降)加随机血糖(指不考虑上次用餐时间，1天中任意时段的血糖)≥11.1mmol/L或空腹血糖(空腹状态指至少8小时没有进食热量)≥7.0mmol/L或糖尿病负荷后2小时血糖≥11.1mmol/L；②无糖尿病症状者，需另日重测血糖以明确诊断。糖尿病胃轻瘫诊断标准参照《实用临床胃肠病学》，具体病例选择标准：①有糖尿病病史，病程＞5年以上；②临床表现：食欲不振，早饱，餐后饱胀，恶心，打嗝，呕吐，便秘，上腹部不适；③体征：部分病例胃部饱满，震水音阳性；④X线钡餐检查胃扩张，蠕动减弱或消失，排空延缓，胃内容物滞留增多，排除其他原因引起的胃部疾病者⑤无溃疡及幽门梗阻⑥临床上已纠正糖尿病酮症酸中毒、心力衰竭、高血压、感染、水电解质酸碱平衡等并发症，血糖、血压控制稳定。排除病例①合并严重的心脑血管病者，②严重肝肾功能不全者，③妊娠或哺乳期妇女者，④对本药过敏者，⑤正在服用胃动力药或抑制胃肠运动的药物患者，⑥未按规定用药或资料不全等影响疗效或安全性判断者。
3、疗效标准：包括临床治愈、显效、有效、无效，治疗结束评价总疗效。疗效标准参照《中药新药临床研究指导原则》中有关疗效标准拟定。临床治愈：临床症状、体征完全消失，X线钡餐透视检查胃蠕动及胃排空正常；显效：临床症状、体征基本消失或主要症状、体征消失，X线钡餐透视检查胃蠕动及胃排空基本正常或明显好转；有效：临床症状、体征明显减轻，X线钡餐透视检查胃蠕动及胃排空时间明显缩短；无效：临床症状、体征无明显改善，X线钡餐透视检查胃蠕动及胃排空时间无明显改善。
4、治疗方法：每次服用复方消渴胃宁合剂150ml，每日早、晚两次空腹服用，10天为1疗程，连续服用本发明治疗二至三个疗程。
5、治疗结果：本发明治疗56例，治愈7例(12.50％)，显效20例(35.7％)，有效25例(44.7％)，无效4例(7.1％)，总有效率92.9％。

Claims (1)

1.一种复方消渴胃宁合剂，其特征在于：由如下重量百分比的原料药制成，黄芪6～9％，白术4～7％，黄芩6～9％，黄连4～7％，姜半夏6～9％，干姜3～5％，炒莱菔子10～13％，炒麦芽0.1～0.2％，枳壳10～13％，竹茹3～6％，木香3～5％，藿香2～5％，山药3～6％，鸡内金3～6％，丹参4～6％，沙参2～5％，石斛2～4％，甘草2～4％，将上述原料药用水浸泡，煎熬后去渣得滤液。
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