CN102526670B - 一种用于治疗胆囊炎的中药组合物及其制备方法 - Google Patents
一种用于治疗胆囊炎的中药组合物及其制备方法 Download PDFInfo
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Abstract
一种用于治疗胆囊炎的中药组合物,由以下重量份配比的原料制备而成:柴胡9份、黄芩9份、香附9份、川芎6份、枳壳15份、白芍18份、半夏9份、陈皮12份、金银花18份、大黄6份、芒硝3份、木香9份、延胡素9份、车前子9份、甘草6份、生姜9份、大枣12份。制备方法为:称取原料药:柴胡、黄芩、香附、川芎、枳壳、白芍、半夏、延胡素、车前子、金银花、木香、大黄、芒硝、陈皮、甘草、生姜、大枣。本发明药物具有清热解毒、通里攻下、清肝胆、利湿热、活血化瘀、理气止痛、健脾化积、推积致新之功能,用于治疗各型胆囊炎。
Description
技术领域
本发明涉及中药制剂领域,具体说是一种用于治疗胆囊炎的中药组合物,本发明还包括该中药组合物的制备方法。
背景技术
胆囊炎是内科消化系疾病中最为常见的病症,也是外科常见的急腹症,发病率仅次于阑尾炎,且近年来有逐渐增高的趋势。临床特征为右上腹部阵发性绞痛,伴明显触痛和腹肌紧张,并向右肩背放散痛,起病时多数有发热畏寒或寒战,恶心呕吐。根据发病的急缓和临床的表现可分为急性和慢性两类,均属胆系感染范畴。西医治疗分保守治疗和手术治疗。保守治疗以卧床休息,加强营养静脉输液、消炎抗菌素的应用;手术治疗为切除胆囊。但据国内外文献统计胆囊炎手术疗法的死亡率仍达0.5-3%,黄疸病例死亡率为10-15%,老年病例死亡率高达13.5-16%,手术并发病约为15%。故手术疗法作为治疗胆囊炎的基本疗法是不能令人满意的。目前这种病的中医治疗方法,包括针灸和内服中药几种。针灸可减轻疼痛缓解症状,改善胆道功能。穴位选用阳陵泉、足三里、内关、期门、章门、胆俞、中脘等穴。耳针可刺交感、神门、肝俞等区。内服中药包括:龙胆泻肝汤、疏肝利胆汤、疏肝和胃汤、健脾行气汤、消炎利胆片、舒肝利胆膏、清胆行气汤、清热利湿汤、清胆泻火汤、柴胡汤、茵陈汤调五芩散、茵陈合承气汤、大陷胸汤等,这些药虽然有一定的疗效,但仍不能令人满意。
发明内容
本发明所要解决的技术问题是提供一种疗效更好的用于治疗胆囊炎的中药组合物,本发明还提供该中药组合物的制备方法。
本发明的技术问题采用下述技术方案解决:
一种用于治疗胆囊炎的中药组合物,由以下原材料及重量份配比制备而成:
柴胡9份、黄芩9份、香附9份、川芎6份、枳壳15份、白芍18份、半夏9份、陈皮12份、金银花18份、大黄6份、芒硝3份、木香9份、延胡素9份、车前子9份、甘草6份、生姜9份、大枣12份。
本发明中药组合物的制备方法如下:
将上述重量份的原料混合,加水煎两次,每次加水量没过药面,每次煎30分钟,之后合并两次煎液,过滤后得滤液,即为胆囊炎口服液。
本发明选用柴胡是因为苦干无毒、微寒,为少阳经表药,主心腹肠胃中结气,饮食积聚寒热邪气,推陈出新,除心下之烦热。胆为清净之府,无出无入,不可汗不可吐,其经在半表半里,故法从和解,柴胡性升而散、属阳,故能达表散邪也,邪结则心下烦热,邪散则烦热自解,阳气下陷则为饮食聚气,阳气上升则清气上行。脾胃之气阳道,则饮食之气自消散。柴胡性清以疏肝胆之气治两肋刺痛。选用黄芩是因为苦平无毒,泄实火,清湿热、气平禀天秋凉之金气,入手太阴肺经,其味无毒得南方之火味,入手少阴心经。气味俱降阴也。心者火脏也,十二官之君,诸热之主也。苦平清心,故主诸热,黄疸者湿热乘脾之症也,脾为太阴湿土,土湿热则本色现而发黄疸。黄芩苦平清肺,肺亦太阴,太阴湿热退而脾疸亦平也。肺与大肠相表里,黄芩清肺,肺清则通调水道,而湿热下逐,肠道复其燥金之性。则泄痢愈也。黄芩清肺则气化。下及膀胱,而水下逐矣。仲景用黄芩有三耦,气分热结者与柴胡相耦。选用白芍是因为苦平无毒、泻肝敛阴气,和脾止痛泻及镇痛。气薄味厚,升而微降,阳中阴。又可升可降,阴也降也。为手足太阴引经药,入肝经血分,和血脉,收阴气,敛逆气,理中气,治脾虚中满,心下痞,胁下痛。专入脾经血分,能泻肝家火邪,故其所收而补,制肝补脾,徒健脾经,脾主中焦,以其正补脾经,故能缓中土。脾虚则水泛滥,脾实则水气自去故去水气。土坚则水清,故利膀胱大小肠。中焦不治则恶气乘虚而入为腹疼痛,补脾则中自和而邪不能留,腹痛自止矣。又白芍得春气为盛而百花之殿,能收拾肝气,使归根反本,不至于有馀肆暴犯肺伤脾,乃养肝之圣药。选用木香是因为辛温无毒,为三焦气分散药,能散滞气,调诸气,泄肺气。治九种心痛,积年冷气。味辛而苦,下气宽中,然三焦则以中焦为要,故凡脾胃虚寒凝滞而见吐泻停食,肝虚寒入,而见气郁气逆,木香辛香苦味,则能下气而宽中,中气则上下皆通,达到通则不痛之效。选用枳壳是因为苦寒无毒,能破气消积痞,化痰利胸膈,逐停水破结石,安胃气,消胀满,治心下急痞痛逆风胁风痛。选用半夏是因为辛平能燥湿化痰,降逆止吐,主治痰饮呕吐,旁治心痛逆满。然其辛温体滑性燥,能走能散能燥能润,和胃健脾、补肝润肾。半夏味辛,辛则液化而利便,故能燥能润也。脾苦湿必得味辛气温以为之燥,半夏辛温能於脾中涤痰除垢,痰去而健脾。故能健脾也。既能温脾以降痰又合生姜暖胃以除呕,和柴胡治少阳寒热往来,则胃更见和谐,他迂气逆能下,迂郁结能开。选用延胡素是因为辛温无毒,有利于止痛,活血散瘀之功能。入足厥阴肝经,亦入手少阴心经,温则能和畅,和畅则气行,辛则能润而走散,走散血活,血活气行,故主破血诸症能行血中气滞,气中血滞。选用大黄是因为苦寒无毒,禀天寒之水气,入手太阳寒水小肠径,味苦无毒得地南方之火味,入手少阴心经,手少阳相火三焦经气味俱降,阴也。浊阴归六腑味厚则泄,兼入足阳明胃经,为荡涤之品也,味厚为阴,则入阴风,血者阴也,心主者也,血凝则瘀,大黄入心,味苦下泄,则闭者通,阴和于阳,而寒热止矣病瘕积聚皆有形之实邪,大黄所至荡平,故能破之,小肠为受盛之官无物不受,传化失职,则饮留食积矣,大黄入小肠而下泄,所以下留饮宿食也,味厚则泻,浊阴归六腑,大黄味厚为阴,故入胃与大肠,而有荡涤之功也。消积下血,则陈者去而新者进,所以又有推陈致新之功焉。其推陈致新者,以胃润而能通利水谷,不使阻凝肠胃中也。肠胃无碍,则阳明胃与太阴脾,调和而食消化矣。大黄能兼行火实得火能生土之机括,何者,大黄色黄气香,故为脾药,然黄中通理,狀如绵文食色深紫,非火之贯於土耶,火气必得土气之通,而后能舒,土气必得火气贯入,而后能行。选用车前子,是因为甘寒无毒,有利水清热之功效。行走水道,其主气癃,止痛通肾气。小便利则湿去,湿去则庳除,伤中者必起烦热,甘寒而润下,润下则烦热除,故主伤中。为肝肾膀胱三经之要药。能强阴益精,明目疗赤痛,轻身而耐老。选用金银花是因为甘寒无毒,主治寒热风肿,久服轻身,长年益寿。主胀满下痢,消痛散毒,补虚疗风。能补虚者因其芳香味甘,能养血者因其毒结血凝,服此毒气顿解,而血自尔克养之谓也。能除热解毒,能和营卫,能疗风养血,能除痢宽肠。选用香附,是因为味辛微寒,性平无毒,有理气开郁之功效,与木香、枳壳、白芍、川芎配伍治疗肝郁气滞,胸肋胀痛。选用川芎是因为味辛性温无毒,辛能行散,温能通活,故有活血行气止痛的作用。与柴胡、白芍、枳壳、陈皮配伍治疗肝郁气滞之胁痛。选用芒硝是因为味辛咸苦大寒无毒,泻热通便,润燥软坚,与大黄配伍荡涤邪热。选用甘草是因为甘平无毒,安魂定魄清热和药补虚,补五劳七伤,一切虚损,主五脏六腑邪热寒气,通九窍利百脉、益精养气、通行十二经脉,解百药之毒,可浮可沉,可升可降,可内可外,可上可下,有和有缓有补有泻,居中之道尽矣。选用生姜是因为味辛性微温,发表散寒温中止呕,消炎行水、解毒、回阳救逆。选用大枣是因为味甘性温、补脾益气、养心安神、调和诸药。这样就共同达到清热解毒通里攻下,清肝胆,利湿热,活血化瘀,理气止痛,健脾化积,推陈致新之目的。
本发明中所属的柴胡属伞形科柴胡Bupleurum falcatum L(拉丁)之干根。
本发明中所属的白芍属毛茛科植物白芍Paeonia Albiflora(拉丁)之干根。
本发明中所属的黄芩属玄参科植物黄芩Scutellaria baicalensis ,Georgi之干根。
本发明中所属的木香属菊科植物木香Saussurea lappa clarke之干根。
本发明中所属的枳壳属芸香科植物枳壳Nelumbium Speciosum之青果。
本发明中所属的半夏属天南星科植物半夏Pinellia Tuberifera(拉丁)之干燥球状块茎。
本发明中所属的延胡素属罂粟科延胡素Corydalis ternafe Nakai之干燥块茎。
本发明中所属的川芎属伞形科藁本属植物川芎Ligusticum wallchii Franch之根茎。
本发明中所属的车前子属车前草科植物车前Planfaqoasiafica L之干籽。
本发明中所属的香附属莎草科莎草属植物香附Crperus rotundus L之根茎。
本发明中所属的金银花属忍冬科植物忍冬Lonicerajaponia干燥之花。
本发明中所属的芒硝Mirabilitum dcpuratum 系由盐碱地产的硫酸钠精制而成。
本发明中所属的大黄属大黄属蓼科植物大黄Rhubazb之地干茎。
本发明中所属的陈皮属芸香科、柑属多种植物Cortexaurantii(拉丁)之果皮。
本发明中所属的生姜属姜科植物姜Zingiher officinale Rosc的根茎。
本发明中所属的甘草属山草类豆科属的甘草Liquorice kppt 之干燥根。
本发明中所属的枣为鼠李科植物枣Zizyphus juiuba Mill的干燥成熟果实。
本发明药物的活性组份,可以加入制不同剂型时所需的各种常规辅料,如崩解剂、润滑剂、粘合剂等常规的中药制剂方法,制备成任何一种常用口服剂型,如丸剂、散剂、片剂、胶囊剂、口服液等。
本发明药物具有清热解毒、通里攻下、清肝胆、利湿热、活血化瘀、理气止痛、健脾化积、推积致新之功能,用于治疗各型胆囊炎。
具体实施方式
以下通过实验例来进一步阐述本发明药物的有益效果,这些试验例包括本发明药物(以下称为胆囊炎口服液)的药效学试验和临床疗效观察试验。
本发明药物对家兔白细胞的影响
实验材料:
本发明药物胆囊炎口服液,消炎利胆片,由广东汕头制药厂生产,致菌液自备。
试验方法:
取禁食12小时的家兔30只,雌雄不拘,体重在1.5-2.5kg之间,用2%戊巴比妥钠腹腔麻醉(40mg/kg),上腹部剪毛,消毒后沿腹正中线切开皮腹约6-l2cm,沿腹白线切开腹壁,暴露肝脏,用组织钳钳夹胆囊底部,向胆囊内注入致菌液lml,结扎针眼,关闭腹腔,伤口严格消毒,放入消毒后干燥的免笼内饲养。将家兔随机分成空白组、对照组、试验组各组处理如下:空白组服5ml/kg量蒸馏水。对照组消炎利胆片溶液按1.5ml/kg(消炎利胆片每片重1克,去糖衣后研成粉末,再用蒸馏水配成0.3克/ml的溶液)。灌胃一日二次。试验组用胆囊炎口服液5ml/kg灌胃一日一次。并于造模前及造模后1天、3天、10天采血计数白细胞。数据X±S表示,见表1。
表1:胆囊炎口服液对家兔外周血白细胞数的影响(X±S)。
如表所示:造模前各组白细胞数基本相似,造模后1天、3天、10天空白组白细胞数明显升高;而对照组、用药组造模后1天升高,3天后白细胞数明显降低,用药组白细胞数下降尤为明显。重复测量的方差分析结果表明,不同时间各组的白细胞数间差异有统计学意义。F=270.23,P<0.0001;各处理组间比较,F=219.55,P<0.0001差异有统计学意义。进一步作各处理组问的两两比较,F=219.55,P<0.0001,差异有统计学意义。进一步作和处理组间的两两比较。结果表明,各组间差异均有统计学意义。P<0.001。不同时间任意两组间比较,差异均有统计学意义。P<0.0001.
[试验例2]本发明药物治疗各型胆囊炎临床观察:
1、临床资料:
收治患者1020例,均经B超检查,部分经彩超检查作为诊断依据,其中男405例,女615例,年龄20-30岁68例;30-40岁302例;40-50岁482例;50-70岁168例。急性单纯性胆囊炎237例,急性化脓性胆囊炎22例,急性化脓性胆管炎合并休克10例,急性胆囊炎合并结石43例,慢性胆囊炎453例,慢性胆囊炎合并结石203例,慢性胆囊炎急性发作52例。
2、诊断标准:
(1)中医诊断标准:
传统医学虽无胆囊炎的病名,但对其病的症候和诊断早有认识和记载,本病的临床特点是右上腹及胁肋痛或上腹部心窝处痛,发热或寒热往来或伴有黄疸常有胃脘胀闷、恶心、嗳气、腹胀满等症状。因此传统医学的胁痛、胃病、肝气痛、肝胃不和、肝脾不和、黄疸、结胸少阳病、胆胀、肝胀等病症中包含了急慢性胆囊炎、胆管炎。传统医学认为本病是由内伤七情、肝气郁结、肝失疏泄、胆失通降、胆汁郁积郁久化热,或因饮食不节,脾胃受损,运化失司,湿热内生,湿热交蒸蕴结不散则发病,其辨证分型可分为三型。
气滞型:主要证见右胁酸痛或窜痛,不发烧,舌质淡红或微红脉弦细或弦紧。
湿热型:主要证见右胁持续性胀痛多发冷发烧,或身黄、日黄、尿黄浊或赤浊、便结、舌质红、舌苔黄腻或厚、脉弦滑或洪数。
脓毒型:主要证见为右胁持续性灼痛、口干渴、高烧寒战、腹胀而满、尿短赤、大便燥结、舌红或绛、苔黄燥或有芒刺,脉弦滑数或细数。
(2)西医诊断标准
<1>病史:急性胆道感染除首发病例外,多有反复发作的病史,有的既往有胆道蛔虫或黄疸病史。
<2>典型症状:有腹痛、恶心、呕吐、发烧。腹痛早期多为右上腹部阵发性痛,随着炎症的发展,腹痛转为持续性,伴有阵发性加重。部分病人腹痛向右肩背放散、恶心、呕吐多在腹痛发作不久出现,呕吐物为胃内容物,吐后腹痛不能缓解,少数病人可吐蛔虫、发热、发病初期可无发热或有低热,感染严重者可有高热寒战。
<3>典型体征:全身体征一般多为急性症状,严重时可出现不同程度的脱水或酸中毒,甚至血压下降 (所谓“胆道休克”)体温升高,严重时可达39℃以上。腹部体征,除了发生胆汁性腹膜炎外,腹式呼吸多无影响。胆囊极度胀大时,右上腹常可见到突出于腹壁的肿物。一般在右上腹有不同程度的压痛,严重时可有反跳痛和腹肌紧张。如果病变局限在胆囊时,压痛、反跳痛和腹肌紧张局限于右上腹部,如果病变主要是在胆总管时,则压痛以剑突下偏右侧为主。右上腹部胆囊区次之。莫非(Murpby)氏征阳性。
<4>化验检查:常规化验可见白细胞计数和中性细胞计数增高,严重病二氧化碳结合力下降,非蛋白氮可能增高。
<5>超声检查:B超检查是诊断胆囊炎不可缺少的手段,并多无困难。急性炎症时可见到肿大炎变、胆囊切面声像图,可见胆囊壁增厚 (正常小于3mm),不光滑亦不规则,腔内可见炎性光点或胆汁沉积现象。
<6>X线检查:处于急性发作时的胆囊胆道感染;只能进行腹部平片的X线检查,可能发现增大的胆囊阴影、阳性结石、肠管扩张与积气。急性炎症消退后可行内窥镜逆行胆胰造影。
3、治疗方法:
口服本发明药物每次 l50ml,一日三次。
4、疗效标准:
显效:临床症状和体征消失,化验血象正常,B超炎变消失。
有效:临床症状和体征减轻,化验血象下降,B超炎变减轻。
无效:临床症状和体征无变化,化验血象及B超检查炎变无变化。
恶化:症状和体征加重或增多,化验血象升高,B超炎变加重。
5、疗效结果 (见表)
总之,采用胆囊炎口服液治疗各型胆囊炎1020例,结果显效928例,其中,急性单纯性胆囊炎237例,急性化脓性胆囊炎20例,急性化脓性胆管炎合并休克4例,急性胆囊炎合并结石40例,慢性胆囊炎433例,慢性胆囊炎合并结石181例,慢性胆囊炎急性发作13例,显效率91%。有效:88例,其中,急性化脓胆囊炎2例,急性化脓性胆管炎合并休克2例,急性胆囊炎合并结石3例,慢性胆囊炎20例,慢性胆囊炎合并结石22例,慢性胆囊炎急性发作39例,有效率8.6%。无效:4例(均属化脓性胆管炎,4例中2例中转手术),无效率0.4%。
经治疗后疗效观察
下面结合实施例对本发明做进一步详细的说明:
实施例1
1、称取柴胡9g、黄芩9g、香附9g、川芎6g、枳壳15g、白芍18g、半夏9g、陈皮12g、金银花18g、大黄6g、芒硝3g、木香9g、延胡素9g、车前子9g、甘草6g、生姜9g、大枣12g。
2、将各种原料药混和,加水煎两次,每次煎30分钟,合并两次煎液过滤后所得滤液,即成本发明药物胆囊炎口服液,装瓶高压消毒后备用。
Claims (2)
1.一种用于治疗胆囊炎的中药组合物,其特征在于由以下重量份的原料制成:
柴胡9份、黄芩9份、香附9份、川芎6份、枳壳15份、白芍18份、半夏9份、陈皮12份、金银花18份、大黄6份、芒硝3份、木香9份、延胡素9份、车前子9份、甘草6份、生姜9份、大枣12份;
按下述方法制备:
将上述重量份的原料混合,加水煎两次,每次加水量没过药面,每次煎30分钟,之后合并两次煎液,过滤后得滤液,即为胆囊炎口服液。
2.根据权利要求1所述的一种用于治疗胆囊炎的中药组合物,其特征在于所述制备方法中加入制不同剂型时所需的各种常规辅料崩解剂、润滑剂、粘合剂,按照常规的中药制剂制备方法,制备成任何一种常用口服剂型,包括:丸剂、散剂、片剂及胶囊。
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