CN110038111B - 一种用于治疗慢性萎缩性胃炎的中药膏方制剂及其制备方法 - Google Patents
一种用于治疗慢性萎缩性胃炎的中药膏方制剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种用于治疗慢性萎缩性胃炎的中药膏方制剂及其制备方法,属于治疗慢性萎缩性胃炎的中药制剂技术领域。本发明提供了一种用于治疗慢性萎缩性胃炎的中药膏方制剂,由以下原料药制成:制附子、干姜、鹿角片、山茱萸、熟地、黄精、女贞子、人参、黄芪、山药、炒白术、苍术、白豆蔻、枳壳、枳实、厚朴、代代花、三棱、莪术、皂角刺、鸡内金和鳖甲。本发明用于治疗慢性萎缩性胃炎的中药膏方制剂可有效逆转萎缩之胃黏膜,同时,解决慢性萎缩性胃炎所致的脾肾(胃)亏虚、久病气滞血瘀湿阻之病理状态,明显改善或消除慢性萎缩性胃炎所致的上腹部痞闷胀满,疼痛,纳差,嗳气,乏力等症状。
Description
技术领域
本发明涉及一种用于治疗慢性萎缩性胃炎的中药膏方制剂及其制备方法,属于治疗慢性萎缩性胃炎的中药制剂技术领域。
背景技术
慢性萎缩性胃炎(CAG)是以胃黏膜局部性或广泛性的固有腺体萎缩(数量减少,功能降低),甚至消失为特征的消化系统常见病、多发病、难治病之一,常伴有肠上皮化生,异型增生(上皮内瘤变)及炎症反应,由于本病发病率高,常病情缠绵,迁延难愈,1978年世界卫生组织将肠腺化生和胃黏膜异型增生的慢性萎缩性胃炎列入胃癌的癌前状态或癌前病变,因此,慢性萎缩性胃炎越来越受到国内外医学界的广泛重视,目前,深入研究、寻求治疗慢性萎缩性胃炎的理想方法,使其逆转萎缩,阻断癌变已成为消化领域的重要研究方向之一。
迄今为止,现代医学对慢性萎缩性胃炎多为对症治疗,且无理想的治疗方法,而中医大多采用个体化的汤剂整体辨证施用方药,但由于需要服药时间长(一般6-9个月),口感差,煎药费时费力,患者难以坚持,因而影响疗效的可持续性,而研制上市的中成药甚少,且疗效不甚理想,因此,在规范病例标准、疗程和疗效评定的前提下,寻求效果理想,口服及携带方便的药物与剂型已是目前亟待解决的问题。
发明内容
本发明的目的在于提供一种用于治疗慢性萎缩性胃炎的中药膏方制剂,该中药膏方制剂可有效逆转萎缩之胃黏膜及明显改善上腹部痞闷胀满等症状。
一种用于治疗慢性萎缩性胃炎的中药膏方制剂,由以下重量份数的原料药制成:
制附子99-101份、干姜99-101份、鹿角片79-81份、山茱萸119-121份、熟地149-151份、黄精119-121份、女贞子99-101份、人参119-121份、黄芪149-151份、炒山药199-201份、炒白术149-151份、苍术119-121份、白豆蔻98-102份、枳壳118-122份、枳实148-152份、厚朴118-122份、代代花98-102份、三棱118-122份、莪术148-152份、皂角刺98-102份、鸡内金118-122份和鳖甲59-61份。
本发明是用于治疗慢性萎缩性胃炎的中药膏方制剂,其易吸收,携带及服用方便,有利于患者坚持服用。
治疗慢性萎缩性胃炎着眼于先天的理论依据:近些年来,中医对慢性萎缩性胃炎从脾、胃、肝论治的颇多,然而,历代医家先贤对于脾胃病从肾论治早有论述并极为推崇,如唐·孙思邈认为“补脾不如补肾”;宋·许叔微认为:肾为一身之根蒂,所以他补脾胃“常须缓补肾气”;明·张景岳极力倡导补肾,认为“五脏之精气,非此不能滋;五脏之阳气,非此不能发”,这是因为中医脏腑辨证理论认为:肾为先天之本,脾之健运、化生精微须借助于肾阳之温煦,故有“脾阳根于肾,命火生脾土”之说;脾为后天之本,气血生化之源,肾中精气亦有赖于水谷精微之充养,才能不断充盛,因此,肾与脾是先后天的关系,在生理上相互资助,相互促进,在病理上相互影响,互为因果,如肾阳不足,不能温煦脾阳,则可见脘腹冷痛,下利清谷,五更泄泻等症;脾阳久虚,亦可累及肾阳,而成脾肾阳虚之候。
治疗慢性萎缩性胃炎着眼于先天的临床体会:肾之阴阳为一身阴阳之本;脾胃之纳化须赖肾阳之温煦、肾阴之润养。肾阳旺盛方可温煦脾阳,使脾脏发挥其运化、升清的作用;而肾阴充沛,亦可滋润胃阴,使胃行使其受纳、和降的功能。在病理上,若肾阳虚衰,火不暖土,可致脾胃阳气虚弱;若肾阴亏虚,胃失濡养,可致胃阴亏虚;反之,若脾胃阴阳不足,日久必损肾之阴阳,终致肾之阴阳两虚。
由于慢性萎缩性胃炎病程较长,缠绵难愈,久必及肾,故治后天不忘先天,从肾治疗该病,温补肾脾,补肾益精,辅以益气促运,理气活血,除湿散结等治法,达到先天温补后天,后天滋养先天,标本同治,相辅相成,是治疗本病的重要方法之一,本发明的用于治疗慢性萎缩性胃炎的中药膏方制剂将对本病的治疗开辟一条重要的新途径。
本发明的用于治疗慢性萎缩性胃炎的中药组合药物的22味原料药中单味药的功效、主治病症、医籍记载及药理作用如下:
1、附子:辛,热。回阳救逆,散寒止痛。主治:心腹冷痛,脾泄冷痢,风寒湿痹等一切沉寒痼冷之症。医籍记载:《医学启源》:“去脏腑沉寒,补助阳气不足,温热脾胃”。《本草正义》:“附子,为通行十二经之要药,凡三焦经络,诸脏诸腑,果有真寒,无不可治”。药理作用:扩张血管,增加血流,改善血液循环;抗寒冷,提高耐缺氧能力;抗炎,镇痛。
2、干姜:辛,热。温中逐寒,回阳通脉。主治:脾胃寒证,见脘腹冷痛,呕吐泄泻等症,凡脾胃寒证,无论是外寒内侵之实证,或阳气不足之虚证均宜。医籍记载:《药品化义》:“干姜,专散里寒”。《本草求真》:“凡因寒内入,而见脏腑痼蔽,关节不通,经络阻塞,冷痹寒痢,反胃隔绝者,无不借此以为拯救除寒”。药理作用:兴奋豚鼠离体肠管,干姜的醚提取物和水提取物均有明显的镇痛作用。
3、鹿角片:咸,温。补肾助阳,行血散瘀。主治:肾阳不足症,瘀血作痛,虚劳内伤。医籍记载:《纲目》:“益肾补虚,强精活血”。《本草经疏》:“咸能入血软坚,温能通行散邪,故主少腹血结痛”。药理作用:抗炎。
4、山茱萸:酸,微温。补益肝肾,涩精气,固虚脱。主治:肝肾亏虚之头晕,目眩,腰膝酸软,阳痿,遗精,小便不禁等症。医籍记载:《药性论》:“补肾气,兴阳道,添精髓,疗耳鸣”。《别录》:“强阴,益精,安五脏,明目,强力”。药理作用:抗炎,抗菌;增强肌体抗应激能力,提高小鼠耐缺氧、抗疲劳能力。
5、熟地:甘,微温。滋阴养血,补精益髓。主治:精血亏虚之头晕眼花,心悸失眠,须发早白及肾阴不足之潮热盗汗,遗精,消渴等症。医籍记载:《纲目》:“填精髓,长肌肉,生精血,补五脏内伤不足,通血脉”。《本草从新》:“补脾阴,止久泻,治一切肝肾阴亏,虚损百病,为壮水之主药”。药理作用:延缓小鼠衰老,对失血性小鼠有明显作用,实验表明熟地补血作用与造血干细胞促进血细胞的产生有关。
6、黄精:甘,平。补中益气,补脾气,益脾阴,滋阴润肺。主治:脾胃气虚及脾胃阴虚之倦怠乏力,食欲不振,饮食无味,口干食少等,以及病后肾虚精亏之腰膝筋骨酸软等症。医籍记载:《别录》:“补中益气,安五脏”。《本草便读》:“此药味甘如饴,性平质润,为补养脾阴之正品”。药理作用:抗缺氧,抗疲劳,抗衰老;增强免疫功能;抗菌;黄精多糖具有免疫激活作用。
7、女贞子:苦,甘,平。补益肝肾,强腰膝,清肝明目。主治:肝肾阴虚之头昏目眩,腰膝酸软,须发早白等。医籍记载:《本经》:“主补中,安五脏,养精神,除百病”。《本草经疏》:“入肾除热补精之要品,肾得补,则五脏自安精神自足,百病去而身肥健也”。药理作用:升高外周白细胞数,能明显提高T淋巴细胞功能,具有增强体液免疫功能的作用;抗炎,抗癌,抗突变。
8、人参:甘,微苦,温。大补元气,补脾益肺,固脱生津。主治:气虚欲脱症;脾气不足之倦怠乏力、食欲不振、上腹痞满等症及久虚不复,一切气血津液不足之症。医籍记载:《别录》:“疗脾胃中冷,心腹鼓痛,胸胁逆满,通血脉,破坚积”。《日华子本草》:“调中治气,消食开胃”。药理作用:增强机体对各种有害刺激的防御能力;显著增强人体免疫力,抗缺氧,抗应激,抗疲劳,抗衰老,抗菌,抗病毒。
9、黄芪:甘,微温。补中益气,固表止汗,利尿消肿。主治:脾肺气虚或中气下陷证,如食少便溏,气短乏力,久泻脱肛等,并用于一切气衰血虚之证。医籍记载:《药品化义》:“黄芪,用蜜炒又能温中,主健脾”。《本草正义》:“黄芪,补益中土,温养脾胃,凡中气不振,脾土虚弱,清气下陷者最宜”。药理作用:增强机体免疫功能,延缓细胞衰老进程,抗应激,有较广泛的抗菌作用。
10、山药:甘,平。补脾气,益脾阴,补肺,益精。主治:脾虚气弱之食少便溏、泄泻及肾虚之遗精、尿频等症。医籍记载:《本草正》:“山药,能健脾补虚,滋精固肾,治诸虚百损,疗五劳七伤”。《药品化义》:“因其味甘气香,用之助脾,治脾虚腹泻,怠惰嗜卧,四肢困倦”。药理:具有诱导产生干扰素,增强人体免疫功能的作用。
11、白术:苦甘,温。补脾益胃,燥湿和中。主治:脾虚失运之食少便溏,脘腹胀满,倦怠无力,痰饮水肿等症。医籍记载:《医学启源》:“除湿益燥,和中益气,温中,去脾胃中湿,除胃热,强脾胃,进饮食,和胃,生津液,主四肢困倦,目不欲开,怠惰嗜卧,不思饮食”。药理作用:强壮机体,提高免疫,抗氧化,抗菌,抗肿瘤。
12、苍术:辛苦,温。健脾,燥湿,解郁。主治:湿阻中焦,运化失司之脘腹胀满,食欲不振,恶心呕吐,倦怠乏力等症。医籍记载:《珍珠囊》:“能健胃安神,诸湿肿非此不能除”。《本草正义》:“脾家郁湿,或为嗔胀,或为肿满,苍术一味,最为必须之品”。药理作用:苍术醇有促进肠胃运动作用。
13、白豆蔻:辛,温。化湿,行气,暖胃,宽中。主治:湿阻中焦、脾胃气滞之脘腹胀满,嗳气反胃,不思饮食等症。医籍记载:《本草经疏》:“白豆蔻,暖能消物,故又主消谷;温能通行,故主下气”。《医林纂要》:“温脾胃,化食,去冷积”。药理作用:调节胃肠功能,促进胃液分泌,增强消化力,驱除胃胀积气。
14、枳壳:苦辛,凉。破气,消积,行痰。主治:胸膈痰滞,胁胀,食积,噫气,呕逆。医籍记载:《日华子本草》:“健脾开胃,调五脏,下气,止呕逆,消痰,治反胃,霍乱泻痢,消食”。《主治秘诀》:“破心下坚痞,利胸中气,化痰,消食”。
15、枳实:苦,寒。破气,散痞,消积,泻痰。主治:胸腹胀满,痞痛,痰癖,食积,便秘等症。医籍记载:《别录》:“逐停水,破结实,消胀满,心下急痞痛,逆气,安胃气”。《本草再新》:“破气,消痰,消食宽肠”。药理作用:枳壳与枳实均对胃肠平滑肌呈现双重功能,既能兴奋胃肠,使蠕动增强,又能降低肠平滑肌张力和解痉功效,其水煎剂灌胃能兴奋胃平滑肌。
16、厚朴:苦辛,温。温中,下气,燥湿,消积。主治:湿阻、食积、气滞所致的脾胃不和,脘腹胀满,为消除胀满之要药。医籍记载:《药性论》:“主疗宿食不消,除痰饮,去结水,破宿血,消化水谷,大温胃气,呕吐酸水,主心腹满”。《日华子本草》:“健脾,主反胃”。药理作用:厚朴煎剂对多种球菌、杆菌有抑制作用,厚朴酚对实验性胃溃疡有防治作用。
17、代代花:甘、微苦,平。行气宽中,和胃止呕,消食化痰。主治:胸腹胀满疼痛,食积不化,不思饮食,恶心呕吐,痰饮。医籍记载:《饮片新参》:“理气宽胸,开胃止呕”。《浙江中药手册》:“调气疏肝,治胸膈及脘宇痞痛”。药理作用:煎剂对人型结核杆菌有抑制作用。
18、三棱:苦、辛,平。破血,行气,消积,止痛。主治:气滞血瘀所致之诸症及食积气滞,脘腹胀满。医籍记载:《医学启源》:“主心膈痛,饮食不消,破气”。《医学衷中参西录》:“其行气之力,又能治心腹疼痛,胁下胀疼,一切血凝气滞之症”。药理作用:可引起家兔离体小肠肠管收缩加强,抑制血小板聚集,延长凝血酶原时间,降低全血粘度。
19、莪术:辛、苦,温。破血祛瘀,行气止痛。主治:气滞血瘀之症瘕积聚、疼痛,饮食不节、脾运失常之积滞不化、脘腹胀满疼痛之证。医籍记载:《开宝本草》:“主心腹痛,食滞不消”。《日华子本草》:“治一切气,开胃消食,通月经,消瘀血”。药理作用:免疫激活,促进白细胞回升,抗癌,抗凝,抗血栓,抗炎;直接兴奋平滑肌,故可用于气胀性绞痛。
20、皂角刺:辛、温。有消肿、排脓、托毒等效能,主要适于痈疽疮毒。现代药理学实验表明,皂角刺所含乙醇提取物可以有效刺激转化肉仔鸡T细胞和B细胞,促进其活化,继而提高细胞及体液免疫的功能;皂角皂苷还能通过延长凝血酶时间、降低凝血酶原活动度和纤维蛋白原含量而发挥抗凝血、抗血栓形成及改善微循环的作用;另外本品还具有抑菌、抗病毒、抗肿瘤等多种作用,可见皂角刺对于慢性萎缩性胃炎的治疗大有裨益。
21、鸡内金:甘,平。消积滞,健脾胃。主治:消化不良之食积胀满,呕吐反胃,疳积,泻痢等症。医籍记载:《滇南本草》:“宽中健脾,消食磨胃”。《要药分剂》:“入肝而除肝热,入脾而消脾积”。药理作用:人口服鸡内金后胃液分泌量、酸度及消化力均见增高,胃运动机能明显增强,表现在胃运动期之延长及蠕动波之增强,由于胃运动增强,故胃排空率也大大加快。
22、鳖甲:咸,寒。滋阴潜阳,软坚散结。主治:热病伤阴,虚风内动之肌肉颤动,劳热骨蒸,肝脾肿大,胁肋疼痛,经闭等症。医籍记载:《本经》:“主心腹癥瘕坚积”。《药性论》:“主宿食,癥块”。《日华子本草》:“去血气,破癥结”。药理作用:增强免疫,提高耐疲劳、耐寒、耐缺氧能力。
本发明用于治疗慢性萎缩性胃炎的中药膏方制剂的22味原料药中对药的功效:
(1)附子、干姜:附子为通行十二经脉纯阳之品,温诸脏腑之痼冷,干姜暖脾胃而散寒,回阳通脉,二药伍用,温阳回阳之力倍增。
(2)人参、黄芪:人参大补元气,补脾健运,黄芪补气升阳,益气固表。人参偏于补中,黄芪偏于实表,二药相合,一里一表,相互为用,其功益彰,更增补气健脾之力。
(3)白术、苍术:白术补脾燥湿,益气生血,苍术苦温辛烈,燥湿力胜;白术健脾力强,补多于散,苍术平胃燥湿,散多于补,二药伍用,一补一散,一脾一胃,则中焦得健,脾胃纳化如常,水湿得以运化。
(4)枳实、白术:二药伍用,枳实辛散温通,破气消积,泻痰导滞,消痞止痛,以泻为主,白术甘缓补中,补脾燥湿,益气生血,和中消滞,以补为要,二药参合,一泻一补,一走一守,一急一缓,相互制约,相互为用,可达补而不滞,消不伤正,健脾强胃,消食化积,消痞除满之功。
(5)枳壳、枳实:枳壳性缓主上,理气消胀,开胸快膈,行气于胸,枳实性烈,破气消积,泻痰除痞,行气于腹,二药伍用,直通上下,胸腹并治,行气消胀,消积除满,气行则痞满自除,疼痛自止。
(6)三棱、莪术:二药伍用,三棱为血中气药,破血中之气,功专破血祛瘀,行气止痛,化积消块,适于血瘀而后气滞之症;莪术为气中血药,破气中之血,功专行气破血,散瘀通经,消积化食,适于气滞而后血瘀之症,两药配伍,破血行气,活血化瘀,行气止痛,化积消癥力彰。
本发明的用于治疗慢性萎缩性胃炎的中药膏方制剂的方义分析:附子、干姜、鹿角片温中助阳,温补命门,散寒止痛;山茱萸、熟地、黄精、女贞子补肾益精,滋阴养血;人参、黄芪、山药、白术、苍术大补元气,补脾益胃,燥湿宽中;以上三组药物为君,主以温补先天,健运后天。枳壳、枳实、厚朴和胃降气,畅利胃肠;三棱、莪术、皂角刺、鳖甲活血祛瘀,消积止痛,以上两组药物为臣,藉以行气消积。佐以鸡内金消食化滞,健运脾胃;白豆蔻、代代花化湿有助于健脾,故以之为使。
其中,金代名医张元素曰:“附子以白术为佐,乃除寒湿之圣药”;近代中医大家张锡纯说:“三棱、莪术与参、术、芪诸药并用,大能开胃进食,调血和血”,“鸡内金与白术并用,为消化瘀积之要药,更为健补脾胃之妙品,脾胃健壮,益能运化药力以消积也”;首届国医大师朱良春说:“黄芪与莪术同用,可奏益气化瘀之力,病变往往可消弥于无形”。
纵观全方,温补肾阳,滋补肾精,健脾益气,理气燥湿,活血止痛,消食化滞,以本为主,以标为辅,标本同治,补消兼施,温而不燥,补而不壅,攻而不峻,注重近期与远期治疗相结合,使先天温补后天,后天滋养先天,二者相辅相成,从而使阳生阴长,脾胃纳化复常,而顽疾得瘳。
本发明的用于治疗慢性萎缩性胃炎的中药膏方制剂具有温补脾肾,益精养胃,理气化湿,活血化瘀,消食软坚之功能,临床主要治疗慢性萎缩性胃炎常见的脾肾亏虚、气滞血瘀湿阻患者,临床观察该膏方近期疗效理想,逆转萎缩之胃黏膜及远期疗效巩固,是中成药治疗慢性萎缩性胃炎上之创新。
本发明的用于治疗慢性萎缩性胃炎的中药膏方制剂可有效逆转萎缩之胃黏膜,同时,解决慢性萎缩性胃炎引起的脾肾(胃)亏虚、久病气滞血瘀湿阻之病理状态,明显改善或消除慢性萎缩性胃炎引起的上腹部痞闷胀满,疼痛,纳差,嗳气,乏力等症状。
优选地,由以下重量份数的原料药制成:
制附子100份、干姜100份、鹿角片80份、山茱萸120份、熟地150份、黄精120份、女贞子100份、人参120份、黄芪150份、炒山药200份、炒白术150份、苍术120份、白豆蔻100份、枳壳120份、枳实150份、厚朴120份、代代花100份、三棱120份、莪术150份、皂角刺100份、鸡内金120份和鳖甲60份。通过合理调整和优化各原料及其用量,得到的用于治疗慢性萎缩性胃炎的中药膏方制剂疗效更优,服用方便,具有良好的温补脾肾,益精养胃,理气化湿,活血化瘀,消食软坚之功能,临床上能够有效治疗慢性萎缩性胃炎常见的脾肾亏虚、气滞血瘀湿阻患者,逆转萎缩之胃黏膜且远期疗效巩固。
优选地,所述黄芪为蜜炙黄芪。蜜炙黄芪是蜂蜜和干燥的黄芪一起入锅炒制以后得到的黄芪,蜜炙黄芪的药用功效比生黄芪更长于补气生血。
优选地,所述枳壳为麸炒枳壳。麸炒枳壳药性缓和,增强了理气健胃的功效。
优选地,所述三棱为醋三棱。三棱醋制可加强破血行气,消积止痛的作用。
优选地,所述鳖甲为醋鳖甲。鳖甲醋制可增强消积止痛,软坚散结的作用。
本发明的目的还在于提供一种用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法。
一种用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法,包括以下步骤:
(1)将制附子、干姜、鹿角片、山茱萸、熟地、黄精、女贞子、黄芪、炒山药、炒白术、苍术、白豆蔻、枳壳、枳实、厚朴、代代花、三棱、莪术、皂角刺、鸡内金和鳖甲与水混合,浸泡;
(2)将步骤(1)浸泡后的混合料煎煮0.8-1.2小时,分离得到药汁和药渣;对药渣进行第2次加水煎煮0.8-1.2小时,分离得到药汁和药渣;对药渣进行第3次加水煎煮25-35分钟,分离得到药汁和药渣,弃去药渣,合并三次药汁;
(3)将步骤(2)得到的药汁进行浓缩,得到清膏,在清膏中加入人参,文火熬炼,不断搅拌均匀,直至膏汁成浓稠状,得到中药膏剂。
制备膏剂时,浸泡可令原料药充分吸收膨胀,有利于后续煎煮时原料药中有效成分的提取。通过对原料药和药渣的三次煎煮,有利于将原料药中的有效成分得以充分提取,如果煎煮三次后药汁尚浓,可再煎煮一次,将得到的所有药汁合并,静置后分离得到药汁。该制备方法简单,易操作。
膏剂又称膏滋,是中药传统中汤、丸、散、膏、丹五大剂型之一,它是由中药汤剂(煎剂)浓缩演变发展而来,是经过对药材的浸泡、煎煮、浓缩等一系列严格工艺加工后,根据病情不同,掺入某些辅料而制成的一种稠厚状半流质或半固体的制剂,其药物浓度高,药性稳定,相比汤剂和丸、散、片等剂型更易吸收,其质粘稠,服用后可直接贴附于胃壁,在胃内作用于病变部位时间长,因而其疗效更为显著,再者因其口感好,携带及服用方便,便于长期坚持,且经济实用,故深受广大患者的欢迎与青睐。
可以理解的是,步骤(3)中,本领域技术人员在清膏中加入人参时,为了口感和药效,将加入人参粉。
优选地,步骤(3)中,所述清膏与药汁的体积比为1:2.5-3.5。
优选地,步骤(3)中,所述膏剂与清膏的体积比为1:1.8-2.2。
优选地,步骤(3)中,所述人参为经过粉碎后过100目筛得到的人参粉。
具体实施方式
下面结合具体实施方式对本发明作进一步说明。
本发明的用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法中,步骤(1)中,所述浸泡的时间为1-1.5小时。
本发明的用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法中,步骤(1)中,所述浸泡的加水量为:每1kg的原料加水5L。实际操作时,可加水至高出药面9-12cm。优选为加水至高出药面10cm。
本发明的用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法中,步骤(3)中,所述清膏与药汁的体积比为1:3。
本发明的用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法中,步骤(3)中,所述膏剂与清膏的体积比为1:2。
本发明的用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法中,步骤(3)中,所述浓缩为大火煎煮至药汁稠厚时,改用小火浓缩,得到清膏。所述清膏的状态是将清膏滴在纸上不散开。
用于治疗慢性萎缩性胃炎的中药膏方制剂的实施例1
本实施例的用于治疗慢性萎缩性胃炎的中药膏方制剂,由以下重量的原料药制成:
制附子100g、干姜100g、鹿角片80g、山茱萸120g、熟地150g、黄精120g、女贞子100g、人参粉120g、蜜炙黄芪150g、炒山药200g、炒白术150g、苍术120g、白豆蔻100g、麸炒枳壳120g、枳实150g、厚朴120g、代代花100g、醋三棱120g、莪术150g、皂角刺100g、鸡内金120g和醋鳖甲60g。
用于治疗慢性萎缩性胃炎的中药膏方制剂的实施例2
本实施例的用于治疗慢性萎缩性胃炎的中药膏方制剂,由以下重量的原料药制成:
制附子99g、干姜101g、鹿角片79g、山茱萸121g、熟地149g、黄精119g、女贞子101g、人参粉121g、黄芪151g、炒山药199g、炒白术149g、苍术119g、白豆蔻102g、枳壳122g、枳实152g、厚朴118g、代代花102g、醋三棱118g、莪术152g、皂角刺98g、鸡内金118g和醋鳖甲59g。
用于治疗慢性萎缩性胃炎的中药膏方制剂的实施例3
本实施例的用于治疗慢性萎缩性胃炎的中药膏方制剂,由以下重量的原料药制成:
制附子101g、干姜99g、鹿角片81g、山茱萸119g、熟地151g、黄精121g、女贞子99g、人参粉119g、蜜炙黄芪149g、山药201g、炒白术151g、苍术121g、白豆蔻98g、麸炒枳壳118g、枳实148g、厚朴122g、代代花98g、三棱122g、莪术148g、皂角刺102g、鸡内金122g和鳖甲61g。
用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法的实施例1
本实施例的用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法,按照用于治疗慢性萎缩性胃炎的中药膏方制剂的实施例1称取各原料药,包括以下步骤:
(1)浸泡
将配齐的药料检查无误后,将人参粉单独置放,然后将制附子、干姜、鹿角片、山茱萸、熟地、黄精、女贞子、黄芪、山药、炒白术、苍术、白豆蔻、枳壳、枳实、厚朴、代代花、三棱、莪术、皂角刺、鸡内金、鳖甲一并放入洁净的不锈钢锅内,加适量的水浸润药料,令其充分吸收膨胀,稍后再加水以高出药面10厘米左右,浸泡1.2小时。
(2)煎煮
把浸泡后的原料药上火煎煮。先用大火煮沸,再用小火煮1小时左右,此时药汁渐浓,即可用纱布过滤出头煎药汁,再加清水浸润药渣后即可上火煎煮,煎法同前,煮沸1小时过滤取汁,此为二煎,再加清水煮沸半小时,此为三煎,滤净药汁后即将药渣倒弃。将前三煎所得药汁合并,静置后再沉淀过滤,得到药汁。
(3)浓缩
将步骤(2)得到的过滤净的药汁倒入锅中,进行浓缩,可以先用大火煎熬,加速水分蒸发,并随时撇去浮沫,让药汁慢慢变成稠厚,待为原料药的2倍质量时,再改用小火进一步浓缩,此时应不断搅拌,因为药汁转稠时容易结底焦化,在搅拌到药汁滴在纸上不散开为度,此时关火,即为经过浓缩而成的清膏。
(4)收膏
把人参粉倒入步骤(3)得到的清膏中,在小火上慢慢熬炼,不断搅拌均匀,用膏板挑起锅内的浓缩膏呈水平面5—10秒钟(室温不低于5℃),再将膏板呈90度直角,膏呈薄片状流下,即可关火得到膏剂。
(5)存放
待步骤(4)收膏完成后得到的膏剂冷却后,装入清洁干净的瓷质容器内,先不加盖,用干净纱布遮盖容器口,放置一夜,待完全冷却后,再加盖,放入阴凉处或冰箱冷藏。
用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法的实施例2-3
用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法的实施例2-3的制备方法同用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法的实施例1,用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法的实施例2-3中各原料药的用量与用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法的实施例1不同。用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法的实施例2-3中所用的各原料药与用于治疗慢性萎缩性胃炎的中药膏方制剂的实施例2-3中的各原料药的用量一一对应。
试验例1
(一)、诊断标准
1、西医诊断标准:参照2012年中华医学会消化病学分会制定的《中国慢性胃炎共识意见》和2002年国家药品监督管理局制定的《中药新药治疗慢性萎缩性胃炎的临床研究指导原则》。
(1)临床症状和体征
CAG临床主要表现为上腹部不适、饱胀、疼痛等,可伴有食欲不振、嘈杂反酸、嗳气、恶心、口苦等症状。查体多无明显体征,有时可有上腹轻压痛。
(2)胃镜诊断标准
①CAG可见正常橘红色黏膜消失,病变黏膜色泽以白为主,有时可见大片苍白区。
②黏膜皱襞深度变浅甚至消失,胃镜下可见细小血管(初期可透见小血管,后期可见树枝状大血管)。
③黏膜腺体萎缩,黏膜变薄,部分可见黏膜不平,颗粒状改变,即所谓“过形成”状态。
(3)病理诊断标准
病理活检为诊断CAG的金标准,病理示胃黏膜固有腺体萎缩或肠化,即可诊断为CAG。
(4)病变程度分度标准
①胃镜下黏膜病变分度标准
轻度:胃镜下可见病变黏膜色泽整体以白为主,透见细小血管,红白相间,局限分布。
中度:镜下见病变区呈弥漫分布,黏膜色泽灰白、苍白,可见大片血管网。
重度:除上述表现外,可见胃黏膜呈颗粒状凹凸不平。
②黏膜慢性炎症分度标准
轻度:炎性细胞仅出现在黏膜浅层(不超过1/3黏膜层),数量少。
中度:炎性细胞侵及固有层,分布较密集,不超过黏膜层的2/3。
重度:炎性细胞侵及黏膜全层(深达黏膜肌层),数量多。
③腺体萎缩病理学分度标准
轻度:固有腺体数目减少不超过1/3。
中度:固有腺体数目减少介于1/3~2/3之间。
重度:剩余固有腺体数目不超过1/3,仅有少数残存腺体或完全消失。
④腺体肠化病理学分度标准
轻度:肠化部分不超过腺体和表面上皮总面积的1/3。
中度:肠化部分在腺体和表面上皮总面积的1/3~2/3之间。
重度:肠化部分超出腺体和表面上皮总面积的2/3。
2、中医诊断标准:参照《中药新药治疗慢性萎缩性胃炎的临床研究指导原则》及七版中医内科学教材拟定。
主症:(1)胃脘部胀满,或胀痛,或隐痛,或刺痛,或灼痛;(2)食欲减退或食后饱胀。
次证:(1)腹部胀满;(2)呃逆嗳气;(3)神疲懒言;(4)腰膝酸软;(5)肢体倦怠;(6)畏寒肢冷;(7)大便溏泻;(8)面色萎黄。
舌象:舌质红或淡红,或暗红;苔薄白或稍腻。
脉象:细弱、或虚弱。
注:按上述症状、胃镜、病理的轻重分为轻、中、重三级并积分。
3、试验病例标准:
(1)纳入病例标准:
符合西医诊断标准和中医诊断标准(主证必备,次症两项或两项以上及舌、脉象具备),即可纳入试验病例。
(2)排除病例标准(包括不适应症或剔除标准)
①年龄在18岁以下或65岁以上,妊娠或哺乳期妇女,过敏体质及对本药过敏者。
②有胃、十二指肠溃疡,胃粘膜有重度异型增生或病理诊断疑有恶变者。
③合併有心血管、脑血管、肝、肾及造血系统等严重原发性疾病,精神病患者。
④不符合纳入标准,未按规定用药,无法判断疗效,或资料不全等影响或安全性判断者。
(二)、临床资料
治疗组30例患者中,男性12例,女性18例,年龄最大者64岁,最小者28岁,病程最长者72月,最短者12月。
对照组30例患者中,男性14例,女性16例,年龄最大者62岁,最小者29岁,病程最长者48月,最短者1月。
治疗组和对照组患者性别、年龄、病程相比较差异无显著性(P>0.05),具有可比性。
(三)、治疗方案
治疗组:用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法的实施例1得到的膏方制剂,每次空腹口服5g,每日2次。
对照组:胃复春片,每次空腹口服4粒,每日3次。
疗程:三个月为一疗程,共观察两个疗程。
(四)、观察项目与方法
1、症状观察
制定统一表格,对胃脘部胀满,胀痛,隐痛,刺痛,或灼痛,食欲减退,食后饱胀,神疲懒言,肢体倦怠等临床症状进行观察,每月记录一次症状变化(患者若有不适或与本病有关的特殊情况,可随时就诊并做记录),认真书写病例。
2、胃镜和病理观察
均由经验丰富的内镜和病理医师专人负责,所有病例在治疗前后胃镜检查,分别在窦部小弯或大弯2点、或胃角部小弯1点可能存在的病灶取活检组织,标本要足够大,达到黏膜肌层。不同部位的标本必须分瓶装,并向病理科提供取材部位、内镜所见和简要病史,病理检查应报告每一块活检标本的组织学变化。
(五)、疗效评定标准
参照国家药品监督管理局2002年制定的《中药新药临床研究指导原则》(包括:中医证候疗效评定标准、胃镜疗效评定标准、病理疗效评定标准)。
1、中医证候疗效评定标准
证候疗效指数=(治疗前症状积分-治疗后症状积分)/治疗前症状积分×100%。
根据积分情况进行疗效对比分析。
①临床痊愈
治疗前症状、体征消失或者基本消失,疗效指数≥90%。
②显效
治疗前症状、体征明显改善,疗效指数≥70%,疗效指数<90%。
③有效
治疗前症状、体征均有好转,疗效指数≥30%,疗效指数<70%。
④无效
治疗前症状、体征均无明显改善,甚或加重,疗效指数<30%。
2、胃镜及病理疗效评定标准
①临床痊愈
胃镜复查胃黏膜慢性炎症明显好转,病理组织学检查证实腺体萎缩、肠上皮化生恢复正常或消失。
②显效
胃镜复查胃黏膜慢性炎症好转,病理组织学检查证实腺体萎缩、肠上皮化生恢复正常或减轻两个级度。
③好转
胃镜复查胃黏膜病变范围缩小1/2以上,病理组织学检查证实慢性炎症减轻一个级度以上,腺体萎缩、肠上皮化生减轻。
④无效
胃镜检查胃黏膜相无明显好转或加重,病理组织学检查证实腺体萎缩、肠上皮化生无改善,甚至加重。
(六)、统计学处理
数据分析采用SAS 9.1统计分析软件进行,两组组间疗效分析采用Wilcoxon秩和检验。
(七)、结果
1、两组病例中医证候疗效分析
治疗组和对照组的中医证候疗效见表1。
表1治疗组和对照组的中医证候疗效
组别 | 例数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率% |
治疗组 | 30 | 18 | 6 | 3 | 3 | 90.0** |
对照组 | 30 | 10 | 5 | 5 | 10 | 66.7 |
与对照组比较:*P<0.05,**P<0.01,下同。
如表1所示,治疗组30例,总有效率为90.0%;对照组30例,总有效率为66.7%。两组病例中医证候疗效比较经两样本秩和检验,具有显著差异性(P<0.01),说明治疗组在中医证候疗效方面优于对照组。
2、两组病例胃镜疗效比较
治疗组和对照组的胃镜疗效见表2。
表2治疗组和对照组的胃镜疗效
组别 | 例数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率% |
治疗组 | 30 | 19 | 5 | 4 | 2 | 93.3** |
对照组 | 30 | 9 | 5 | 5 | 11 | 63.3 |
治疗组30例患者中,总有效率达93.3%;对照组30例患者中,总有效率为63.3%,两组胃镜疗效经两样本秩和检验,P<0.01,具有显著性差异,说明治疗组的胃镜疗效优于对照组。
3、两组病例萎缩疗效比较
治疗组和对照组的萎缩疗效见表3。
表3治疗组和对照组的萎缩疗效
组别 | 例数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率% |
治疗组 | 30 | 17 | 3 | 2 | 8 | 73.3* |
对照组 | 30 | 7 | 3 | 4 | 16 | 46.7 |
治疗组30例患者中,总有效率达73.3%;对照组30例患者中,总有效率为46.7%,两组患者胃粘膜萎缩改善情况经两样本秩和检验,P<0.05,具有显著性差异,说明治疗组肠上皮化生改善情况明显优于对照组。
4、两组病例肠上皮化生疗效比较
治疗组和对照组的肠上皮化生疗效见表4。
表4治疗组和对照组的肠上皮化生疗效
组别 | 肠化例数数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率% |
治疗组 | 17 | 9 | 5 | 1 | 2 | 88.0* |
对照组 | 16 | 5 | 2 | 1 | 8 | 50.0 |
治疗组30例患者中,总有效率达88.0%;对照组30例患者中,总有效率为50.0%,两组患者肠上皮化生改善情况经两样本秩和检验,P<0.05,具有显著性差异,说明治疗组肠上皮化生改善情况明显优于对照组。
5、毒副作用
治疗组和对照组病例治疗前后均未出现明显的不良反应及明显毒副作用。
试验例2典型病例
典型病例1:张某某,男,51岁。2017年11月12日初诊。
自述6年前因工作繁忙,生活及饮食无规律,渐感胃脘部胀满、隐痛,食欲下降,自购胃必治、健胃消食片、吗丁啉等药间断服用近3个月,2011年9月经当地市级医院行胃镜检查,提示慢性浅表性胃炎,口服奥美拉唑肠溶胶囊及中药50余剂,症状消失停药。2013年夏季,因饮服冰镇啤酒,突感胃脘疼痛,痞闷胀满,食欲不振,大便溏泄而入院,经静脉点滴,中药汤剂,西药治疗,症状基本消失而出院,平时间断口服奥美拉唑肠溶片、莫沙必利片、木香顺气丸等,症状时轻时重。2017年6月17日经河南中医药大学第一附属医院行电子胃镜检查,提示慢性萎缩性胃炎(++)伴肠上皮化生(+),经服中药汤剂及西药效果不佳。现在症:胃脘痞满、隐痛,饭后尤甚,食欲不佳,饮食量少,进食温热食品自感较舒适,大便溏薄,日两次,腰膝酸软,时有眩晕耳鸣,气短乏力,舌质淡,苔白润,脉沉细。给予用于治疗慢性萎缩性胃炎的中药膏剂的制备方法的实施例1得到的膏剂,每次5g,每日两次,饭后两小时冲服。20天后复诊,自述便溏消失,食欲增加,其余诸症均轻。继服至2018年7月,自感症状完全消失,饮食正常,经河南中医药大学第一附属医院电子胃镜复查,提示慢性浅表性胃炎,病理提示:(胃窦)粘膜慢性炎。患者自虑复发,要求继续服药,嘱每日一次冲服,连服3个月。
典型病例2:刘某某,男,55岁。2018年1月3日初诊。
患者因饮食不节,加之劳累致上腹部胀满疼痛已近3年,先后服用中药汤剂、香砂养胃丸、三九胃泰冲剂、温胃舒冲剂、奥美拉唑肠溶胶囊等药物,症状基本消失,但常因饮食失宜或劳累而诱发。2017年9月2日在当地市级医院行胃镜检查,提示慢性萎缩性胃炎,病理提示(胃窦)慢性萎缩性胃炎(+),局灶腺体肠上皮化生(+)。现症见胃脘胀痛,进食后尤甚,纳差,嗳气,大便不成形,每日一次,腰酸微痛,轻度失眠,多梦,耳鸣,周身乏力,自感畏寒。给予用于治疗慢性萎缩性胃炎的中药膏剂的制备方法的实施例1得到的膏剂,每次5g,每日两次,饭后两小时冲服。2月1日患者复诊,自感胃脘胀痛减轻,食欲较前增加,大便基本成形,腰痛、乏力、畏寒等症亦有不同程度的改善,继服至6月中旬,自觉症状完全消失,身感有力,经河南中医药大学第一附属医院电子胃镜检查,提示贲门炎、慢性浅表性胃炎,病理提示:(胃窦)慢性浅表性炎,遂停药观察。
Claims (10)
1.一种用于治疗慢性萎缩性胃炎的中药膏方制剂,其特征在于,由以下重量份数的原料药制成:
制附子99-101份、干姜99-101份、鹿角片79-81份、山茱萸119-121份、熟地149-151份、黄精119-121份、女贞子99-101份、人参119-121份、黄芪149-151份、炒山药199-201份、炒白术149-151份、苍术119-121份、白豆蔻98-102份、枳壳118-122份、枳实148-152份、厚朴118-122份、代代花98-102份、三棱118-122份、莪术148-152份、皂角刺98-102份、鸡内金118-122份和鳖甲59-61份。
2.根据权利要求1所述的用于治疗慢性萎缩性胃炎的中药膏方制剂,其特征在于,由以下重量份数的原料药制成:
制附子100份、干姜100份、鹿角片80份、山茱萸120份、熟地150份、黄精120份、女贞子100份、人参120份、黄芪150份、炒山药200份、炒白术150份、苍术120份、白豆蔻100份、枳壳120份、枳实150份、厚朴120份、代代花100份、三棱120份、莪术150份、皂角刺100份、鸡内金120份和鳖甲60份。
3.根据权利要求1或2所述的用于治疗慢性萎缩性胃炎的中药膏方制剂,其特征在于,所述黄芪为蜜炙黄芪。
4.根据权利要求1或2所述的用于治疗慢性萎缩性胃炎的中药膏方制剂,其特征在于,所述枳壳为麸炒枳壳。
5.根据权利要求1或2所述的用于治疗慢性萎缩性胃炎的中药膏方制剂,其特征在于,所述三棱为醋三棱。
6.根据权利要求1或2所述的用于治疗慢性萎缩性胃炎的中药膏方制剂,其特征在于,所述鳖甲为醋鳖甲。
7.一种如权利要求1所述的用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法,其特征在于,包括以下步骤:
(1)将制附子、干姜、鹿角片、山茱萸、熟地、黄精、女贞子、黄芪、炒山药、炒白术、苍术、白豆蔻、枳壳、枳实、厚朴、代代花、三棱、莪术、皂角刺、鸡内金和鳖甲与水混合,浸泡;
(2)将步骤(1)浸泡后的混合料煎煮0.8-1.2小时,分离得到药汁和药渣;对药渣进行第2次加水煎煮0.8-1.2小时,分离得到药汁和药渣;对药渣进行第3次加水煎煮25-35分钟,分离得到药汁和药渣,弃去药渣,合并三次药汁;
(3)将步骤(2)得到的药汁进行浓缩,得到清膏,在清膏中加入人参,文火熬炼,不断搅拌均匀,直至膏汁成浓稠状,得到中药膏剂。
8.根据权利要求7所述的用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法,其特征在于,步骤(3)中,所述清膏与药汁的体积比为1:2.5-3.5。
9.根据权利要求7所述的用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法,其特征在于,步骤(3)中,所述膏剂与清膏的体积比为1:1.8-2.2。
10.根据权利要求7所述的用于治疗慢性萎缩性胃炎的中药膏方制剂的制备方法,其特征在于,步骤(3)中,所述人参为经过粉碎后过100目筛得到的人参粉。
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