CN116270834A - 一种用于治疗胃肠功能紊乱的中药复方制剂及其制备方法和应用 - Google Patents
一种用于治疗胃肠功能紊乱的中药复方制剂及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种用于治疗胃肠功能紊乱的中药复方制剂,由下列药材制成:厚朴、麸炒枳壳、丁香和小茴香。并公开了中药复方制剂的制备方法,以及应用。中药复方制剂可用于制备治疗患者胃肠功能紊乱,促进肠功能恢复的药物,同时可用制备治疗肝硬化并发症疾病的药物中。本发明主要是经中医外治法进行治疗,通过在穴位或皮肤局部用中药制剂外敷能够促进药物吸收,无肝肾损伤及毒副作用,具有使用方便、安全、有效的特点,在临床应用中接受度高。并且制备简单、应用方便、价格低廉,可应用于肝腹水、肝硬化患者及胃肠功能紊乱患者相关疾病治疗的优势,因此,具有良好的商业价值和前景。
Description
技术领域
本发明属于中药领域,特别涉及一种用于治疗胃肠功能紊乱,促进肠功能恢复的复方制剂及其制备方法与应用。
背景技术
胃肠功能紊乱是胃肠道功能异常的一种疾病症候群总称,是胃肠道蠕动和消化功能异常导致的一种临床症状,也是外科术后常见的并发症,术后24h发生率可高达10%~30%。很多患者在术后,会经历胃肠道功能的恢复过程,即发生广泛意义上的术后胃肠功能紊乱。术后胃肠功能紊乱通常由麻醉药物的使用、手术过程中的创伤性牵拉刺激、肠壁损伤、腹腔内粘连、手术前后禁食、术后镇痛、长期卧床等因素引起,其主要临床表现为腹胀、恶心、呕吐、腹泻及便秘等消化道症状,可造成患者术后生活质量降低、住院时间延长、经济负担增加、医疗资源浪费等,严重者还可导致肠梗阻、伤口愈合不良、营养障碍及多器官功能衰竭等并发症。因此,尽快恢复术后患者的胃肠功能,有利于病人进食、可减少补液,减少机体感染及血栓等风险,对于预防其并发症也具有重要意义。
目前,现代医学治疗术后胃肠功能紊乱多采用以下方式:鼓励患者早期下床活动、禁食、服用促胃肠动力药物、持续胃肠减压、营养支持、维持水电解质酸碱平衡等,但其临床治疗手段较为有限且疗效不佳。
近年来,中医特色疗法在改善腹部术后胃肠功能紊乱方面越来越受到临床关注。中医学认为,根据不同临床表现,术后胃肠功能紊乱可归属于中医学中“痞满”“呕吐”“腹胀”“腹痛”“肠痹”“肠结”“便秘”等范畴。中医学认为腹部手术患者多因金刃直接损伤胃肠,破气留瘀,使脏腑虚弱、气血亏虚,致脾气虚弱,推动气血无力。手术后多有瘀血、痰饮阻滞经络,致使全身气机升降失司。脾气虚则脾升不健,胃气虚则胃降不和,脾胃升降失司则脏腑运化失调叫故本病属虚实夹杂之证,以脏腑、气血亏虚为本,血瘀、气滞、痰饮为标,病位主要在脾、胃、大肠、小肠,同时又与心、肝、胆等脏腑密切相关。中医药可在术前、术后不同阶段进行干预,体现了“治未病”的思想,能够预防术后胃肠功能紊乱的发生,在一定程度上可降低腹部术后胃肠功能紊乱的发生率,也能够减轻术后胃肠功能紊乱的病情,提高其临床疗效。术后胃肠功能紊乱的临床症状多样,而中医药的治疗方式亦多种多样,中医根据其临床具体情况进行辨证论治,临床疗效显著。
常见的中医疗法包括中药口服、外部使用膏药、药物熏蒸、针灸疗法、推拿按摩等。口服给药是最常用的给药方式,但对于胃肠功能紊乱患者而言,本身就有腹胀、恶心、呕吐、腹泻及便秘等症状,中药口感也不佳,口服给药加重了肠胃负担,可能由于恶心呕吐等症状导致无法服用,患者接受度较差。而且胃肠吸收能力差也可能导致药效见效慢。中医外治法是中医独特的治疗方法,一般在穴位或皮肤局部用中药制剂外敷能促进药物吸收,无肝肾损伤及毒副作用,具有使用方便、安全、有效的特点,在临床应用中接受度高。单味或多味中药根据配伍制成粉包,直接敷贴于相应的部位,结合人体经络学说从整体观出发进行治疗,药物在穴位处发挥刺激起到疏通经络等作用,随后经皮肤吸收进入血液循环发挥药物的药理作用。沈志斌等人以吴茱萸、小茴香、葱白等研末外敷神阙,发现有效促进术后肠功能恢复,减少肠粘连发生,缩短患者住院时间的功效。焦文芹等以行气通便贴于术后6h贴敷于患者神阙穴或脐周,结果表明行气通便贴能促进肠蠕动功能的恢复,对患者的康复、减少术后腹胀的发生极为有益,操作简单,使用方便。在发明专利CN 101757291 A中,陈坚等人公布了以丁香、沉香、枳壳或枳实、檀香、大黄或黄连、厚朴或苍术、麝香、巴豆霜、大枣和当归十味药加工制成的中药组合物,用于治疗急性腹泻、肠易激综合症等疾病,对各种慢性胃肠疾病的症状具有明显的改善作用。但该处方疗效有待改进,而且需要十味原料药,成本较高。
CN 102178914 A公开了一种治疗肠胃病的中药组合物,主要由如下原料药制备而成:A)20-30重量份甘草;B)1-10重量份盐和干姜的混合物,且上述盐与干姜的重量比为3:1;C)60-70重量份混合药料,上述混合药料包括厚朴、公丁香、小茴香、云木香、佛手、谷牙、枳壳和大麦牙,且厚朴、公丁香、小茴香、云木香、佛手、谷牙、枳壳与大麦牙的重量之比为1:1:1:1:1:1:1:1。CN 102178914 A所报道的处方共包括11种成分,且通过口服给药。口服给药对于肠胃功能紊乱患者可能加重肠胃负担,接受度差。
发明内容
本发明的目的在于提供一种安全有效、配制简单、价格适度的能够改善患者胃肠功能紊乱、促进肠功能恢复的中药复方制剂。
本发明所述的一种用于治疗胃肠功能紊乱的中药复方制剂,由下列药材制成:厚朴、麸炒枳壳、丁香、小茴香。
进一步,所述的中药复方制剂优选由下列重量份的药材制成:厚朴2-10份,麸炒枳壳2-10份,丁香3-10份,小茴香15-30份。
所述的中药复方制剂更优选由下列重量份的药材制成:厚朴3-8份,麸炒枳壳3-10份,丁香2-5份,小茴香20-28份。
所述的中药复方制剂更优选由下列重量份的药材制成:厚朴3-5份,麸炒枳壳3-6份,丁香2-3份,小茴香23-25份。
更进一步,所述的中药复方制剂更优选由下列重量份的药材制成:厚朴50份,麸炒枳壳50份,丁香30份,小茴香250份。
在本申请中,所述的中药复方制剂可以为散剂、膏剂、凝胶剂或贴敷剂,优选为散剂或膏剂。
所述中药复方制剂的给药方式是将散剂、膏剂、凝胶剂或贴敷剂贴敷于脐部。
本发明所述中药复方制剂可按以下之一的方法制备得到:
(一)取厚朴、麸炒枳壳、丁香、小茴香,按比例混合后研磨成粉末,用布袋包裹密封后置于微波炉中加热2~4min(优选3min)后取出,温度控制在38~45℃,制成散剂。
制得的含有药物散剂的布袋可以敷于腹部并用腹带固定。
(二):取厚朴、麸炒枳壳、丁香、小茴香,按比例混合后研磨成粉末,加体积分数70%的乙醇,乙醇的质量是所有药物质量的20~25倍,加热回流提取3次,每次1小时,所得提取液合并,蒸发并回收乙醇,所得提取物与外用辅料制成膏剂、凝胶剂或贴敷剂。
一般采用常规的方法,与常规的外用辅料制成膏剂、凝胶剂或贴敷剂。
进一步,所述膏剂一般按以下方法制得:将提取物干燥,粉碎成细粉,过100目筛,加入脂溶性软膏基质,加热至50~55℃混合均匀,搅拌至室温,制成膏剂。
所述脂溶性软膏基质一般包括凡士林、植物油、动物油、羊毛脂、蜂蜡、固体石蜡中的一种或多种。
所述脂溶性软膏基质的质量用量一般为所有药物质量的3~6倍。
所述凝胶剂一般按以下方法制得:
将提取物干燥,磨成细粉,加入卡波姆和水,搅拌均匀,加氢氧化钠调节pH值至7.0,制成凝胶剂。
所有药物的质量、卡波姆、水的质量比为1:0.05~0.1:0.6~1。
所述贴敷剂一般按以下方法制得:
将提取物中加入甘油、氢氧化铝、丙烯酸钠,混合均匀得到组分1;将酒石酸、丙烯酸聚合物,水混合,溶解,得到组分2;将组分2缓慢加入组合1中,搅拌均匀后涂布于基布上,与保护膜复合,分切制成敷贴剂。
所有药物的质量、甘油、氢氧化铝、丙烯酸钠的质量比为1:6~15:0.1~0.3:2~4。
所有药物的质量、酒石酸、丙烯酸聚合物、水的质量比为1:0.:05~0.1:1~2:2~4。
本发明还提供所述的中药复方制剂在制备治疗胃肠功能紊乱的药物中的应用。
所述的胃肠功能紊乱疾病包括功能性消化不良、功能性腹胀/膨胀、肠易激综合征、功能性腹泻、功能性便秘中的一种或多种。
所述的功能性消化不良表现为餐后饱胀感、早饱、上腹痛和上腹烧灼感。所述的肠易激综合征表现为腹部不适、腹痛可在排气或排便后缓解、便秘和腹泻交替。所述的功能性便秘表现为大便呈硬块状、干球状;排便次数减少和排便困难。
本发明还提供所述的中药复方制剂在制备治疗腹胀、腹痛、恶心、呕吐、消化不良或排便困难疾病的药物中的应用。
本发明还提供所述的中药复方制剂在制备治疗肝硬化并发症疾病的药物中的应用。
本发明还提供所述的中药复方制剂在制备治疗的药物中的应用。
本发明所述的中药复方制剂的配方遵循中医辨证论治的基本原则,选取原料组成和用量配比,各组分之间能相互协调、相互促进,起到协同增效的作用。
中医理论认为六腑以通为用,术后患者元气大伤,气血两亏而气滞血瘀,阻于脏腑经络之间,使胃肠气机不通,脏腑通则顺,不顺则气滞,气滞而满胀,使其血脉疲阻,腑气壅滞。气机运化失调,糟粕无法传化,停留大肠,导致腹胀、腹痛、纳差,甚至烦躁、失眠等。应以行气通腑为治。而发明具有活血化瘀、补气除湿、行气导滞、除满消胀的作用,可恢复肠功能,使胃气下行而行气通便、除满消胀。方中小茴香为君药,性温味辛,芳香走窜,加热后能透皮吸收,行气活血而温经通脉;以厚朴为臣药,燥湿消痰,下气除满;佐之以麸炒枳壳,入脾、胃经,行气宽中、消积止痛;再以丁香为使药,温胃健脾、驱虫抗菌,丁香酚有抗炎、抑病毒、镇痛作用。将上述诸药打粉加热外敷于下腹部与脐周,透皮吸收后,行气活血,使药物由表及里,刺激胃肠蠕动,起到了促进胃肠功能恢复,消除腹胀的作用,同时还有消炎、抗菌、止痛作用。
本发明的创新点在于:
一是制备简便,应用方便,贴敷于脐部,不影响病人正常活动。
二是采取了脐部贴敷的方式给药,保证了治疗的时效性,可以避免口服给药增加胃肠道负担的可能性。
三是贴敷给药可经皮吸收,经血脉经络输送至脏腑气血阴阳失调之处,发挥效用。
四是经皮给药,避免病人因不能接耐受中药味道出现拒绝配合治疗。
五是疗效显著,相比现有的治疗肠胃病的外用药剂处方(如CN101757291A),本发明复方制剂的临床效果评价明显优于现有处方。
六是本发明专利处方仅有四味药材,成本低,易得,利于推广。
综上所述,该中药复方制剂有较好的治疗患者胃肠功能紊乱,促进肠功能恢复的应用前景,同时可用治疗肝硬化并发症疾病的药物中,与现存的西药药物相比,本发明主要是经中医外治法进行治疗,通过在穴位或皮肤局部用中药制剂外敷能够促进药物吸收,无肝肾损伤及毒副作用,具有使用方便、安全、有效的特点,在临床应用中接受度高。并且制备简单、应用方便、价格低廉,可同时应用于肝腹水、肝硬化患者及胃肠功能紊乱患者相关疾病治疗的优势,因此,具有良好的商业价值和前景。
具体实施方式
为使本申请的目的、技术方案和优点更加清楚明白,下文中将结合实施例对本申请的技术方案进行详细说明,本发明的保护范围不限于此。
实施例1
取下列配比原料药:厚朴50克,麸炒枳壳50克,丁香30克,小茴香250克,混合后研磨成粉末,用规格为20cm×20cm的布袋,包裹密封后置于微波炉中,600瓦加热3min后取出,轻轻抖动,温度控制在40℃左右,制成散剂,即得。
实施例2
取下列配比原料药:厚朴25克,麸炒枳壳25克,丁香30克,小茴香160克,混合后研磨成粉末,加体积分数70%乙醇20倍量,加热回流提取3次,每次1小时,提取液合并,回收乙醇,干燥,粉碎成细粉,过100目筛,加入脂溶性软膏基质凡士林1000克,加热至55℃混合均匀,搅拌至室温,制成膏剂,即得。
实施例3
取下列配比原料药:厚朴30克,麸炒枳壳25克,丁香50克,小茴香280克,混合后研磨成粉末,加体积分数70%乙醇20倍量,加热回流提取3次,每次1小时,提取液合并,回收乙醇,干燥,磨成细粉,加入卡波姆30克,水300克,搅拌均匀,氢氧化钠调节PH至7.0,制成凝胶剂,即得。
实施例4
取下列配比原料药:厚朴80克,麸炒枳壳90克,丁香90克,小茴香250克,混合后研磨成粉末,加70%乙醇20倍量,加热回流提取3次,每次1小时,提取液合并,回收乙醇,加入甘油4000克,氢氧化铝65克,丙烯酸钠1200克,混合均匀为组分1;取酒石酸32克,加入纯化水1200克,丙烯酸聚合物640克,溶解,为组分2;组分2缓缓加入组分1中,充分搅拌均匀,涂布,与保护膜复合,分切制成敷贴剂,即得。
实施例5
取下列配比原料药:厚朴90克,麸炒枳壳90克,丁香80克,小茴香290克,混合后研磨成粉末,加70%乙醇22倍量,加热回流提取3次,每次1小时,提取液合并,回收乙醇,加入甘油8000克,氢氧化铝95克,丙烯酸钠2000克,混合均匀为组分1;取酒石酸52克,加入纯化水1900克,丙烯酸聚合物1040克,溶解,为组分2;组分2缓缓加入组分1中,充分搅拌均匀,涂布,与保护膜复合,分切制成敷贴剂,即得。
实施例6
取下列配比原料药:厚朴60克,麸炒枳壳50克,丁香35克,小茴香150克,混合后研磨成粉末,加70%乙醇20倍量,加热回流提取3次,每次1小时,提取液合并,回收乙醇,干燥,粉碎成细粉,加入脂溶性软膏基质羊毛脂1500克,加热至55℃混合均匀,搅拌至室温,制成膏剂,即得。
实施例7
取下列配比原料药:厚朴90克,麸炒枳壳40克,丁香40克,小茴香270克,混合后研磨成粉末,用规格为30cm×25cm的布袋,包裹密封后置于微波炉中加热4min后取出,轻轻抖动,温度控制在40℃左右,制成散剂,即得。
实施例8临床用药实验方案
1、一般资料
浙江大学医学院附属杭州西溪医院住院部符合标准的80例外科阑尾炎手术术后且出现胃肠功能紊乱的患者,按照随机数字表法,分为四组,对照组共三组,每组20例,试验组一组,共20例。四组年龄、性别、病程等具有可比性。
2、纳入标准
符合西医诊断标准及中医诊断者;头脑意识清晰,能够清楚的表达个人意见;年龄在18岁以上65岁以下者;试验前2周内未接受同类药物及方法治疗者;对本研究相关事项知情同意者;能够服从医生的治疗安排,能够配合医生的治疗和随访。
3、干预措施
1)试验组:在本申请中,随机选取给予本发明中药复方制剂的患者20例作为试验组(配比按照实施例1中的方法制备:厚朴50克,麸炒枳壳50克,丁香30克,小茴香250克),于术后第三天,开始给予实施例1的散剂,敷于腹部并用腹带固定,以免其滑落,一天一次,每次2小时(相当于厚朴50克,麸炒枳壳50克,丁香30克,小茴香250克),外敷7天一个疗程,且在治疗期间患者均停用其他改善患者胃肠功能紊乱,促进肠功能恢复的药物(其他诸如每日服用治疗高血压等疾病的药物患者不停用)。记录患者肠鸣音时间,排气时间、排便时间及时长、并分别于给药前、给药后2天和7天采集血液指标等。
2)对照组1:随机选取20例,给予发明专利CN 101757291 A中的中药复方制剂的患者作为对照组(配比按照发明专利CN 101757291 A中实施例29的方法制备:丁香150g、沉香150g、枳壳150g、檀香90g、黄连200g、苍术150g、麝香4.5g、巴豆霜60g、大枣500g和当归90g)。具体给药方法是:给予发明专利CN 101757291 A中实施例29中贴剂,用法用量外敷7天一个疗程,一天一次,每次2小时,其余处理方法同试验组。
3)对照组2:随机选取20例,给予以下配方:按照本专利中实施例1中的方法制备散剂(仅除去厚朴这味药材):麸炒枳壳50克,丁香30克,小茴香250克,具体给药方法是:给予散剂,敷于腹部并用腹带固定,以免其滑落,一天一次,每次2小时,外敷7天一个疗程,其余处理方法同试验组。
4)对照组3:随机选取20例,给予以下配方:按照实施例1中的方法制备散剂(仅除去小茴香这味药材):厚朴50克,麸炒枳壳50克,丁香30克,具体给药方法是:给予散剂,敷于腹部并用腹带固定,以免其滑落,一天一次,每次2小时,外敷7天一个疗程,其余处理方法同试验组。
4、疗效指标
表1中药复方制剂的临床效果评价结果
基线/疗效指标 | 试验组(n=20) | 对照组1(n=20) | 对照组2(n=20) | 对照组3(n=20) |
年龄/岁 | 41±10 | 39±8 | 38±6 | 40±5 |
性别(男) | 12(60%) | 13(65%) | 9(45%) | 11(55%) |
身高体重指数(BMI/Kg.m-2) | 23.66±4.10 | 24.76±3.45 | 25.10±3.99 | 24.17±4.38 |
肠鸣音恢复时间(h) | 7.02±0.32▲ | 10.15±0.41 | 11.13±0.65 | 14.75±0.78▲▲ |
首次肛门排气时间(h) | 10.23±0.35▲ | 13.76±0.65 | 16.48±0.92▲ | 20.37±1.08 |
首次排便时间(h) | 15.54±0.73▲▲ | 21.26±1.15 | 25.44±2.09 | 27.42±2.87▲ |
腹胀完全缓解时间(h) | 18.97±1.56▲ | 25.84±2.11 | 29.11±2.97▲ | 32.48±3.65 |
注:与对照组1比较,▲P<0.05,▲▲P<0.01
表2中药复方制剂的术后血液及炎症指标评价结果
基线/疗效指标 | 试验组(n=20) | 对照组1(n=20) | 对照组2(n=20) | 对照组3(n=20) |
血清白介素6(给药前)(pg/ml) | 26.72±3.10 | 25.29±2.56 | 24.16±2.33 | 27.08±3.02 |
血清白介素6(2d) | 14.97±1.43 | 18.54±1.98 | 21.08±1.49 | 23.76±2.12▲ |
血清白介素6(7d) | 6.18±0.95▲ | 8.33±0.85 | 11.09±0.79▲ | 14.16±1.24 |
快速C反应蛋白(CRP)(给药前)(mg/L) | <0.50 | <0.50 | <0.50 | <0.50 |
快速C反应蛋白(CRP)(2d) | 8.11±0.88▲ | 12.23±0.97 | 12.78±1.54 | 13.61±1.38▲ |
快速C反应蛋白(CRP)(7d) | <0.50 | 2.18±0.16 | 3.22±0.27▲▲ | 3.43±0.19 |
白细胞计数(给药前)(×109/L) | 12.45±2.96 | 13.73±3.13 | 13.14±2.54 | 14.09±2.28 |
白细胞计数(2d) | 9.46±2.47▲▲ | 11.65±3.56 | 12.09±2.65 | 12.93±2.87 |
白细胞计数(7d) | 3.22±0.83▲ | 6.35±1.54 | 10.05±1.87▲ | 9.36±1.23 |
中性粒细胞比率(给药前)(%) | 75.9±8.44 | 78.5±7.98 | 74.46±6.41 | 76.38±6.39 |
中性粒细胞比率(2d) | 60.82±6.63▲ | 72.5±6.15 | 70.51±5.81 | 71.92±6.29▲ |
中性粒细胞比率(7d) | 43.3±4.61 | 53.4±3.77 | 62.22±4.01 | 60.86±3.98 |
注:与对照组1比较,▲P<0.05,▲▲P<0.01
表3中药组方的胃肠功能指标评价结果
基线/疗效指标 | 试验组(n=20) | 对照组1(n=20) | 对照组2(n=20) | 对照组3(n=20) |
血清MTL(给药前)(ng/L) | 230.72±18.24 | 246.34±16.67 | 250.12±15.75 | 239.86±17.20 |
血清MTL(2d) | 277.86±19.33▲ | 261.11±20.40 | 263.36±18.52▲ | 251.19±21.29 |
血清MTL(7d) | 340.67±22.17 | 297.57±17.85 | 289.14±15.99▲ | 281.08±19.37 |
血清GAS(给药前)(ng/L) | 75.78±12.15 | 85.54±10.56 | 79.36±11.53 | 82.61±12.49▲ |
血清GAS(2d) | 89.56±15.63 | 97.46±17.38 | 84.15±13.52 | 88.48±14.72▲ |
血清GAS(7d) | 137.05±20.66▲▲ | 115.39±20.65 | 103.31±19.05▲▲ | 108.58±18.82 |
注:与对照组比较,▲P<0.05,▲▲P<0.01
5、结果分析
从表1~表3中数据可以看出本发明中的中药复方制剂对术后胃肠功能的恢复有良好的效果,这也验证了该配方中各位药材所对应的中医理论。在表1中,患者肠鸣音时间、排气时间、排便时间及时长等的恢复明显早于给予发明专利CN101757291A中的中药复方制剂的患者。在表2和表3中,对术后血液及炎症指标的评价、胃肠功能指标的评价也都优于给予发明专利CN101757291A中的中药复方制剂的患者。且试验组敷贴后未发现任何不良反应及并发症,方法简便,疗效确定,具有一定的应用前景和价值。
而对照组2、3分别是单独去除厚朴、小茴香药材的处方,表1~3数据表明,缺少一味药材会导致药效显著降低,如肠鸣音恢复时间、首次肛门排气时间、首次排便时间都都明显增长,炎症指标的评价、胃肠功能指标的评价也较差。可见本发明处方中的四味药缺一不可,不可精简,协同作用达到最佳的药效。
实施例9临床用药实验方案
1、一般资料
浙江大学医学院附属杭州西溪医院门诊及住院部符合标准的150例患者,未经治疗或治疗不愈者,包括胃肠功能紊乱(30例)、功能性便秘(30例)、功能性腹泻(30例)、功能性腹胀/膨胀(30例)及肠易激综合征(30例)均为观察对象。按照随机数字表法,共分为六组,六组年龄、性别、病程等具有可比性。
2、诊断标准
采用2016罗马Ⅳ标准,所选病例均符合胃肠功能紊乱、功能性便秘、功能性腹泻、功能性腹胀/膨胀及肠易激综合征。所有病例均经胃、结肠内或X线钡剂造影检查,排除胃、十二指肠,结肠器质性病变。
3、纳入标准
符合西医诊断标准及中医诊断者;头脑意识清晰,能够清楚的表达个人意见;年龄在18岁以上65岁以下者;试验前2周内未接受同类药物及方法治疗者;对本研究相关事项知情同意者;能够服从医生的治疗安排,能够配合医生的治疗和随访。
4、剔除标准
1)有器质性消化系统疾病者,如息肉,肿瘤等。
2)有肾,内分泌,免疫系统及血液系统严重原发病者:糖尿病、尿毒症等。
3)孕妇及哺乳期妇女。
4)不符合诊断标准的。
5、干预措施
在本申请中,给予本发明中药复方制剂的患者共180例(配比按照实施例1中的方法制备:厚朴50克,麸炒枳壳50克,丁香30克,小茴香250克),给予实施例1的散剂,敷于腹部并用腹带固定,以免其滑落,一天一次,每次2小时(相当于厚朴50克,麸炒枳壳50克,丁香30克,小茴香250克),外敷7天一个疗程,且在治疗期间患者均停用其他改善患者胃肠功能紊乱,促进肠功能恢复的药物(其他诸如每日服用治疗高血压等疾病的药物患者不停用)。记录患者治疗前后症状和体征的变化,每日大便次数、量、形状等。
6、症状程度评定标准
参照《中药新药临床指导药原则》:根据症状的轻、中、重度分别记1、2、3分。
1)症状统计法
无症状(-):记0分;轻度(+):偶尔出现记1分;中度(++):经常出现记2分;重度(+++):持续存在记3分。
2)排泄
A无症状及成型软便(-):每日1-2次记0分;
B轻度(+):症状较轻,不影响生活及工作,大便每日2-3次,糊状便或粘液便,记1分;
C中度(++):症状稍重,影响工作及生活,但尚能忍受,大便蛋花样或粘液状,,每日4-5次,记2分;
D重度(+++):症状严重,严重影响生活或工作,难以忍受,大便稀水样,每日超过6次,记3分。
3)疾病的程度判定标准
A轻度:主要症状积分小于或等于总积分的30%;
B中度:主要症状积分大于或等于总积分的30%,且小于70%;
C重度:主要症状积分大于或等于总积分的70%。
7、疗效判定标准及统计方法
1)治愈:主要症状消失,大便形成,每日1-2次,疗效指数为100%;
2)显效:主要临床症状基本消失,大便次数2-3次每日,疗效指数大于或等于75%,小于100%;
3)有效:主要临床症状好转,大便形成及次数均有好转,疗效指数大于或等于30%,小于75%;
4)无效:主要临床症状没有改变,疗效指数小于30%;
疗效指数=(治疗前主要症状总分值-治疗后主要症状总分值)/治疗前主要症状总分值×100%。
8、疗效结果
表4各种临床治疗前后疗效评价结果
9、结果分析
从表4数据可以看出,本发明中药复方制剂对包括胃肠功能紊乱、功能性便秘、功能性腹泻、功能性腹胀/膨胀及肠易激综合征等各种慢性胃肠疾病都具有较好的治疗效果。临床结果也表明,本发明中药复方制剂治疗慢性胃肠疾病的各病种效果统计学无显著性差异,能够明显缓解临床症状。对单病种主要症状的改善效果明显,总有效率均可达到90%以上。且在用药期间未发现明显副作用,有较好的应用前景,值得进一步的开发。
Claims (10)
1.一种用于治疗胃肠功能紊乱的中药复方制剂,其特征在于所述中药复方制剂由下列药材制成:厚朴、麸炒枳壳、丁香和小茴香。
2.如权利要求1所述的中药复方制剂,其特征在于所述的中药复方制剂由下列重量份的药材制成:厚朴2-10份,麸炒枳壳2-10份,丁香3-10份,小茴香15-30份。
3.如权利要求1所述的中药复方制剂,其特征在于所述的中药复方制剂由下列重量份的药材制成:厚朴3-8份,麸炒枳壳3-10份,丁香2-5份,小茴香20-28份。
4.如权利要求1所述的中药复方制剂,其特征在于所述的中药复方制剂由下列重量份的药材制成:厚朴3-5份,麸炒枳壳3-6份,丁香2-3份,小茴香23-25份。
5.如权利要求1所述的中药复方制剂,其特征在于中药复方制剂由下列重量份的药材制成:厚朴50份,麸炒枳壳50份,丁香30份,小茴香250份。
6.如权利要求1~5之一所述的中药复方制剂,其特征在于所述的中药复方制剂为散剂、膏剂、凝胶剂或贴敷剂。
7.如权利要求6所述的中药复方制剂,其特征在于所述的中药复方制剂按以下方法之一制备得到:
(一)取厚朴、麸炒枳壳、丁香、小茴香,按比例混合后研磨成粉末,用布袋包裹密封后置于微波炉中加热2~4min后取出,温度控制在38~45℃,制成散剂;
(二):取厚朴、麸炒枳壳、丁香、小茴香,按比例混合后研磨成粉末,加体积分数70%的乙醇,乙醇的质量是所有药物质量的20~25倍,加热回流提取3次,每次1小时,所得提取液合并,蒸发并回收乙醇,所得提取物与外用辅料制成膏剂、凝胶剂或贴敷剂。
8.如权利要求1~5之一所述的中药复方制剂在制备治疗胃肠功能紊乱的药物中的应用。
9.如权利要求1~5之一所述的中药复方制剂在制备治疗腹胀、腹痛、恶心、呕吐、消化不良或排便困难疾病的药物中的应用。
10.如权利要求1~5之一所述的中药复方制剂在制备治疗肝硬化并发症疾病的药物中的应用。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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