CN117281880A - 一种治疗胃癌前病变的中药组合物及其制备方法和应用 - Google Patents
一种治疗胃癌前病变的中药组合物及其制备方法和应用 Download PDFInfo
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- CN117281880A CN117281880A CN202310450885.4A CN202310450885A CN117281880A CN 117281880 A CN117281880 A CN 117281880A CN 202310450885 A CN202310450885 A CN 202310450885A CN 117281880 A CN117281880 A CN 117281880A
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明属于中药技术领域,特别是涉及一种治疗胃癌前病变的中药组合物及其制备方法和应用。该中药组合物的原料包括清半夏、薏苡仁、干姜、黄芩、黄连、三七、刘寄奴、党参、大枣、山药、石楠叶、灵芝、枳实、炒鸡内金和甘草。该中药组合物能够在几个月内消除腺瘤性胃息肉,使肠上皮化生、异型增生转成正常,从而能够用于治疗包括腺瘤性胃息肉,使肠上皮化生、异型增生在内的胃癌前病变。
Description
技术领域
本发明属于中药技术领域,特别是涉及一种治疗胃癌前病变的中药组合物及其制备方法和应用。
背景技术
胃癌是消化道恶性肿瘤中间发病率最高的一种恶性肿瘤,也我国最常见的恶性肿瘤之一。胃部黏膜从发生病变直至转化为胃癌的过程为:慢性浅表性胃炎→慢性萎缩性胃炎→肠上皮化生→异型增生→胃癌。慢性萎缩性胃炎是胃癌的癌前疾病,但由于慢性萎缩性胃炎并不一定会发展为肠上皮化生,并且,慢性萎缩性胃炎虽可癌变,但癌变率很低(目前研究数据发现癌变率不超过3%),与肠上皮化生、异型增生的病例表现有很大区别,并且肠上皮化生、异型增生并不一定伴随慢性萎缩性胃炎,因此,临床上只把病例表现为伴肠上皮化生、异型增生的胃炎称为胃癌前病变,例如将伴肠上皮化生、异型增生的慢性萎缩性胃炎称之为慢性萎缩性胃炎癌前病变,而不会将慢性萎缩性胃炎直接视为胃癌前病变。由于慢性萎缩性胃炎或非慢性萎缩性胃炎与肠上皮化生、异型增生存在病例上的差异,所以在药物治疗中,治疗慢性萎缩性胃炎或非萎缩性胃炎的药物也往往并不一定适用于治疗胃癌前病变。
发明内容
针对以上技术问题,本发明提供一种治疗胃癌前病变的中药组合物及其制备方法和应用。该中药组合物能够治疗肠上皮化生、异型增生、胃息肉等胃癌前病变,且防止复发。
为达到上述发明目的,本发明实施例采用了如下的技术方案:
一方面,本发明实施例提供一种中药组合物,其原料按质量份数配比包括清半夏8~12份、薏苡仁24~36份、干姜5~7份、黄芩8~12份、黄连5~7份、三七2~4份、刘寄奴8~12份、党参或人参8~12份、大枣29~43份、山药24~36份、石楠叶8~12份、灵芝8~12份、枳实8~12份、炒鸡内金8~12份和甘草5~7份。
清半夏为半夏的炮制加工品,性温,味辛,归脾胃肺经;温化寒痰、燥湿化痰、降逆止呕、消痞散结、消肿止痛;
薏苡仁味甘、淡,性凉,归脾、胃、肺经;利水渗湿,健脾止泻,除痹,排脓,解毒散结;
干姜味辛,性热,归脾、胃、肾、心、肺经;温中散寒,回阳通脉,温肺化饮;
黄芩味苦,性寒,归肺、胆、脾、大肠、小肠经;清热燥湿,泻火解毒,止血,安胎;
黄连味苦,性寒,归心、脾、胃、肝、胆、大肠经,清热燥湿,泻火解毒;
三七味甘、微苦,性温,归肝、胃经;散瘀止血,消肿定痛;
刘寄奴味苦,性温,归心、肝和脾经;活血通经,散瘀止痛,止血消肿,消食化积;
甘草味甘,性平,归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药;
党参味甘,性平,归脾、肺经;健脾益肺,养血生津;
人参味甘、微苦,性温,归脾、肺经;大补元气,复脉固脱,补脾益肺,生津,安神;
大枣味甘,性温、归脾、胃经;补中益气,养血安神,缓和药性;
炒鸡内金味酸,性温,归脾、胃、小肠、膀胱经;健胃消食,涩精止遗,通淋化石;
山药味甘,性平,归脾、肺、肾经;益气养阴,补脾肺肾,涩精止带;
灵芝味甘,性平,归心、脾、肝、肾经;补气安神、止咳平喘;
石楠叶味辛、苦,性平,归肝、肾经;祛风湿,止痒,强筋骨,益肝肾;
枳实味苦、辛,性寒,归于脾、胃、肝经;破气消积、止咳化痰、止泻通便。
在本发明提供的上述组合物中:清半夏散结消痞,降逆止呕,薏苡仁健脾渗湿,解毒散结,炒鸡内金味酸而性温,健补脾胃,善化瘀积,能消脾胃之积,为君药;干姜温中散邪,黄芩、黄连苦寒,泄热消痞,三七活血止血,刘寄奴活血,为臣药;党参(或人参)、大枣甘温益气,补脾气,山药健脾,石楠叶疏风止痛,灵芝益气安神,扶正固本,枳实理气除胀,为佐药;甘草调和诸药,为使药。
经临床观察,本发明提供的上述中药组合物能够在3~6个月内消除腺瘤性胃息肉,使肠上皮化生、异型增生转成正常,并且能够迅速消除胃癌前病变造成的嗳气、胃胀、胃痛、消化不良等症状。
并且,该中药组合物通过灌肠还能够治疗结肠息肉。
本方在临床使用中,每重量份取1g作为每剂用量,每日服用1剂,每剂分早晚两次或早中晚三次服用,1个月为一疗程,连用3-6个疗程。服药期间可每3个月复查一次胃镜。
优选地,所述中药组合物的原料按质量份数配比包括清半夏9~11份、薏苡仁27~33份、干姜5.5~6.5份、黄芩9~11份、黄连5.5~6.5份、三七2.5~3.5份、刘寄奴9~11份、党参或人参9~11份、大枣32~40份、山药27~33份、石楠叶9~11份、灵芝9~11份、枳实9~11份、炒鸡内金9~11份和甘草5.5~6.5份。
优选地,所述中药组合物的原料按质量份数配比包括清半夏10份、薏苡仁30份、干姜6份、黄芩10份、黄连6份、三七3份、刘寄奴10份、党参或人参10份、大枣36份、山药30份、石楠叶10份、灵芝10份、枳实10份、炒鸡内金10份和甘草6份。
第二方面,本发明实施例还提供了上述中药组合物的制备方法为:将除三七以外的其余各所述原料以水提取,将三七粉碎。使用时,用水提液冲服三七粉,也可将所得提取液浓缩、干燥,与三七粉共同服用。
上述中药组合物的制备方法还可以选择将除三七以外的其余各原料分别以水提取,将所得提取液浓缩、干燥,得到各原料的提取物,将所得各原料的提取物按生药的质量份数配比进行混合;将三七粉碎。使用时,将各原料的提取物与三七粉共同服用。
优选地,所述提取方法为煎煮提取,提取2~3次,每次提取时间可选25~35min,优选提取2次,每次30min。
第三方面,本发明实施例还提供了上述中药组合物或按上述制备方法制得的中药组合物在制备治疗腺瘤性胃息肉的药物中的应用。
胃息肉从病例上分为增生性息肉和腺瘤性息肉,前者并非真正的肿瘤,癌变率一般不超过2%,而后者的癌变率可达30%以上,瘤体直径大于2cm、绒毛状腺瘤、异型增生III度者癌变率更高,目前最常用的方法是手术切除,然而手术切除后仍有可能复发。本发明提供的组合物能够有效去除腺瘤性胃息肉,并防止复发,大大降低复发率,改善患者生存状态。
优选地,上述药物为口服制剂。
第四方面,本发明实施例还提供了上述中药组合物或按上述制备方法制得的中药组合物在制备治疗肠上皮化生的药物中的应用。
优选地,上述药物为口服制剂。
第五方面,本发明实施例还提供了上述中药组合物或按上述制备方法制得的中药组合物在制备治疗异型增生的药物中的应用。
优选地,上述药物为口服制剂。
第六方面,本发明实施例还提供了上述中药组合物或按上述制备方法制得的中药组合物在制备治疗结肠息肉的药物中的应用。
优选地,该药物为灌肠制剂。
该中药组合物通过灌肠能够治疗结肠息肉,可制成治疗结肠息肉的灌肠药物。
附图说明
图1为本发明实施例12中案例1在服药前的胃镜检查图;
图2为本发明实施例12中案例1在服药前的病例检查图;
图3为本发明实施例12中案例1在服药后的胃镜检查图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合具体实施例,对本发明进行进一步举例说明。应当理解,此处所描述的具体实施例仅用以解释本发明,并不用于限定本发明。
以下实施例中所使用的清半夏、薏苡仁、干姜、黄芩、黄连、三七、刘寄奴、党参、人参、大枣、山药、灵芝、炒鸡内金、甘草和枳实均符合《中国药典》(2020年版)一部正文各药材项下的有关规定。石楠叶符合卫生部药品标准中药材第一册(1992年版)石楠叶项下的有关规定。
以下实施例中所采用的原料、试剂等,如无特殊说明,均从商业途径获得。
实施例1
本发明实施例提供了一种中药组合物,每剂的原料为:清半夏10g、薏苡仁30g、干姜6g、黄芩10g、黄连6g、三七3g、刘寄奴10g、党参10g、大枣36g、山药30g、石楠叶10g、灵芝10g、枳实10g、炒鸡内金10g和甘草6g。
制备方法为:将三七粉碎,得三七粉;取其余中药的饮片,加水至没过药材,加热至沸腾后保持微沸25min,过滤后,向药渣中加水至没过药渣,加热至沸腾后保持微沸25min,过滤,合并滤液,得水煎液。
使用时以水煎液冲服三七粉。
实施例2
本发明实施例提供了一种中药组合物,每剂的原料为:清半夏9g、薏苡仁33g、干姜5.5g、黄芩9g、黄连5.5g、三七2.5g、刘寄奴11g、党参9g、大枣40g、山药27g、石楠叶9g、灵芝9g、枳实9g、炒鸡内金9g和甘草5.5g。
制备方法为:将三七粉碎,得三七粉;取其余中药的饮片,加水至没过药材,加热至沸腾后保持微沸30min,过滤后,向药渣中加水至没过药渣,加热至沸腾后保持微沸25min,过滤,合并滤液,得水煎液。
使用时以水煎液冲服三七粉。
实施例3
本发明实施例提供了一种中药组合物,每剂的原料为:清半夏11g、薏苡仁27g、干姜6.5g、黄芩11g、黄连6.5g、三七3.5g、刘寄奴9g、党参11g、大枣32g、山药33g、石楠叶11g、灵芝11g、枳实11g、炒鸡内金11g和甘草6.5g。
制备方法为:将三七粉碎,得三七粉;取其余中药的饮片,加水至没过药材,加热至沸腾后保持微沸30min,过滤后,向药渣中加水至没过药渣,加热至沸腾后保持微沸20min,过滤,合并滤液,得水煎液。
使用时以水煎液冲服三七粉。
实施例4
本发明实施例提供了一种中药组合物,每剂的原料为:清半夏8g、薏苡仁36g、干姜5g、黄芩8g、黄连5g、三七2g、刘寄奴12g、党参8g、大枣43g、山药24g、石楠叶8g、灵芝8g、枳实8g、炒鸡内金8g和甘草5g。
制备方法为:将三七粉碎,得三七粉;将其余中药的饮片分别加水至没过药材,加热至沸腾后保持微沸25min,过滤后,向药渣中加水至没过药渣,加热至沸腾后保持微沸20min,过滤,合并滤液,干燥,即得各中药提取物。
使用时将各中药提取物以温开水分散开,冲服三七粉。
实施例5
本发明实施例提供了一种中药组合物,每剂的原料为:清半夏12g、薏苡仁24g、干姜7g、黄芩12g、黄连7g、三七4g、刘寄奴8g、党参12g、大枣29g、山药36g、石楠叶12g、灵芝12g、枳实12g、炒鸡内金12g和甘草7g。
制备方法为:将三七粉碎,得三七粉;将其余中药的饮片分别加水至没过药材,加热至沸腾后保持微沸30min,过滤后,向药渣中加水至没过药渣,加热至沸腾后保持微沸30min,过滤,合并滤液,干燥,即得各中药提取物。
使用时将各中药提取物以温开水分散开,冲服三七粉。
实施例6
本发明实施例提供了一种中药组合物,每剂的原料为:清半夏10g、薏苡仁30g、干姜6g、黄芩10g、黄连6g、三七3g、刘寄奴10g、人参10g、大枣36g、山药30g、石楠叶10g、灵芝10g、枳实10g、炒鸡内金10g和甘草6g。
制备方法为:将三七粉碎,得三七粉;取其余中药的饮片,加水至没过药材,加热至沸腾后保持微沸25min,过滤后,向药渣中加水至没过药渣,加热至沸腾后保持微沸25min,过滤,合并滤液,得水煎液。
使用时以水煎液冲服三七粉。
实施例7
本发明实施例提供了一种中药组合物,每剂的原料为:清半夏9g、薏苡仁33g、干姜5.5g、黄芩9g、黄连5.5g、三七2.5g、刘寄奴11g、人参9g、大枣40g、山药27g、石楠叶9g、灵芝9g、枳实9g、炒鸡内金9g和甘草5.5g。
制备方法为:将三七粉碎,得三七粉;取其余中药的饮片,加水至没过药材,加热至沸腾后保持微沸30min,过滤后,向药渣中加水至没过药渣,加热至沸腾后保持微沸25min,过滤,合并滤液,得水煎液。
使用时以水煎液冲服三七粉。
实施例8
本发明实施例提供了一种中药组合物,每剂的原料为:清半夏11g、薏苡仁27g、干姜6.5g、黄芩11g、黄连6.5g、三七3.5g、刘寄奴9g、人参11g、大枣32g、山药33g、石楠叶11g、灵芝11g、枳实11g、炒鸡内金11g和甘草6.5g。
制备方法为:将三七粉碎,得三七粉;取其余中药的饮片,加水至没过药材,加热至沸腾后保持微沸30min,过滤后,向药渣中加水至没过药渣,加热至沸腾后保持微沸20min,过滤,合并滤液,得水煎液。
使用时以水煎液冲服三七粉。
实施例9
本发明实施例提供了一种中药组合物,每剂的原料为:清半夏8g、薏苡仁36g、干姜5g、黄芩8g、黄连5g、三七2g、刘寄奴12g、人参8g、大枣43g、山药24g、石楠叶8g、灵芝8g、枳实8g、炒鸡内金8g和甘草5g。
制备方法为:将三七粉碎,得三七粉;将其余中药的饮片分别加水至没过药材,加热至沸腾后保持微沸25min,过滤后,向药渣中加水至没过药渣,加热至沸腾后保持微沸20min,过滤,合并滤液,干燥,即得各中药提取物。
使用时将各中药提取物以温开水分散开,冲服三七粉。
实施例10
本发明实施例提供了一种中药组合物,每剂的原料为:清半夏12g、薏苡仁24g、干姜7g、黄芩12g、黄连7g、三七4g、刘寄奴8g、人参12g、大枣29g、山药36g、石楠叶12g、灵芝12g、枳实12g、炒鸡内金12g和甘草7g。
制备方法为:将三七粉碎,得三七粉;将其余中药的饮片分别加水至没过药材,加热至沸腾后保持微沸30min,过滤后,向药渣中加水至没过药渣,加热至沸腾后保持微沸30min,过滤,合并滤液,干燥,即得各中药提取物。
使用时将各中药提取物以温开水分散开,冲服三七粉。
实施例11
本发明实施例提供了实施例1的中药组合物的临床应用数据统计。
统计对象:2018~2022年就诊于河北省人民医院中医科门诊的胃癌前病变患者共计108例,其中萎缩性胃炎伴轻度、中度、重度肠上皮化生分别8、6、3例,非萎缩性胃炎伴轻度、中度、重度肠上皮化生分别12、22、6例,萎缩性胃炎伴轻度、中度、重度腺瘤性胃息肉分别6、5、2例,非萎缩性胃炎伴轻度、中度、重度腺瘤性胃息肉分别15、20、3例。
以上例病例均自就诊日起服用本发明实施例1提供的中药组合物,每天服用1剂,分早晚两次服用。其中各症状的疗程均为3个月。经治疗后,治愈(肠上皮化生消失,腺瘤性胃息肉消除)率为98%(治愈106例),有效(肠上皮化生减轻,腺瘤性胃息肉缩小)率为2%(2人有效)。随访2年(2021年3月前治愈的患者,共计82人)后,99%的已康复患者(共81人)无复发,症状减轻的患者中,所有患者未显示出原症状加重。
实施例12
本发明实施例提供了实施例1的中药组合物的临床应用具体案例:
案例1:周某,女,55岁,2021年10月就诊时主诉上腹不适(胃胀,嗳气,胃痛)3个月。曾于2021年8月经检查胃镜(如图1所示):食管粘膜光滑,血管网清晰;贲门齿线下缘小弯侧粘膜充血,NBI观察呈茶色改变;胃腔空虚,胃体粘膜规整,蠕动好,胃角弧形,粘膜光滑柔软,胃窦粘膜红白相间;幽门圆形;十二指肠球降部未见异常。检查诊断为慢性非萎缩性胃炎,病理诊断(如图2所示)为粘膜慢性炎症伴中度肠上皮化生。经服用本发明实施例1的组合物1个月(每日一剂)后,胃胀、嗳气、胃痛症状消除,继续服用2个月(每日一剂)后,临床检查(如图3所示)显示:食管粘膜光滑,血管网清晰,齿状线清晰;贲门开闭好;胃腔空虚,胃体粘膜规整,蠕动好,胃角弧形,粘膜光滑柔软,胃窦粘膜红白相间,以红为主;幽门圆形;十二指肠球降部未见异常。检查诊断为慢性非萎缩性胃炎。
案例2:王某某,女,41岁,2022年4月份就诊时主诉胃脘胀满不适、嗳气、胃痛3个月,曾于2022年2月7日在当地医院查胃镜提示:食道下段粘膜可见一条纵行充血带,长度约0.3cm,齿线清,胃底粘膜未见异常,胃体前壁可见两个0.3*0.3cm,0.4*0.4cm山田I型息肉,表面粘膜光滑,胃角光滑呈拱形,胃窦粘膜红白相间,以红为主,斑片状充血;幽门圆形,开闭良。十二指肠球部正常,球后及降段未见明显异常。提示:反流性食管炎(LA-A),胃多发息肉,慢性非萎缩性胃炎。经服用本发明实施例1的组合物1个月(每日一剂)后,胃胀、嗳气、胃痛症状消除,继续服用2个月(每日一剂)后,临床检查显示:食道下段粘膜散在纵行充血水肿,齿状线清晰;贲门开闭好;胃底粘膜未见异常,胃体粘膜散在片状糜烂,胃角光滑呈拱形,胃窦粘膜红白相间,以红为主,充血水肿明显,散在片状糜烂及陈旧出血点。幽门科技爱你,圆形,开闭良。十二指肠球部正常,球后及降段未见明显异常。诊断:反流性食管炎,慢性非萎缩性胃炎。
案例3:周某某,女,55岁,2021年8月21日就诊时主诉胃胀、嗳气、胃痛3个月,查胃镜提示:贲门炎,慢性非萎缩性胃炎,病理(贲门)诊断为慢性炎症伴中毒肠上皮化生。年末症状:胃胀,嗳气,舌红,苔黄,脉滑。2021年10月8日起,服用本发明实施例5的组合物,水煎服,日一剂分二次,早晚饭后半小时后服。经服药1个月(每日一剂)后,胃胀、嗳气、胃痛症状消除,继续服药2个月(每日一剂),2022年1月18日复查胃镜,提示为慢性非萎缩性胃炎。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换或改进等,均应包含在本发明的保护范围之内。
Claims (9)
1.一种中药组合物,其特征在于,所述中药组合物的原料按质量份数配比包括清半夏8~12份、薏苡仁24~36份、干姜5~7份、黄芩8~12份、黄连5~7份、三七2~4份、刘寄奴8~12份、党参或人参8~12份、大枣29~43份、山药24~36份、石楠叶8~12份、灵芝8~12份、枳实8~12份、炒鸡内金8~12份和甘草5~7份。
2.根据权利要求1所述的中药组合物,其特征在于,所述中药组合物的原料按质量份数配比包括清半夏9~11份、薏苡仁27~33份、干姜5.5~6.5份、黄芩9~11份、黄连5.5~6.5份、三七2.5~3.5份、刘寄奴9~11份、党参或人参9~11份、大枣32~40份、山药27~33份、石楠叶9~11份、灵芝9~11份、枳实9~11份、炒鸡内金9~11份和甘草5.5~6.5份。
3.根据权利要求2所述的中药组合物,其特征在于,所述中药组合物的原料按质量份数配比包括清半夏10份、薏苡仁30份、干姜6份、黄芩10份、黄连6份、三七3份、刘寄奴10份、党参或人参10份、大枣36份、山药30份、石楠叶10份、灵芝10份、枳实10份、炒鸡内金10份和甘草6份。
4.权利要求1~3任一项所述的中药组合物的制备方法,其特征在于,将除三七以外的其余各原料以水提取,将三七粉碎;或
将除三七以外的其余各原料分别以水提取,将所得提取液浓缩、干燥,得到各原料的提取物,将所得各原料的提取物按生药的质量份数配比进行混合;将三七粉碎。
5.根据权利要求4所述的制备方法,其特征在于,所述提取方法为煎煮提取,提取2~3次,每次提取时间为25~35min。
6.权利要求1~3任一项所述中药组合物或按权利要求4或5所述制备方法制得的中药组合物在制备治疗腺瘤性胃息肉的药物中的应用。
7.权利要求1~3任一项所述中药组合物或按权利要求4或5所述制备方法制得的中药组合物在制备治疗肠上皮化生的药物中的应用。
8.权利要求1~3任一项所述中药组合物或按权利要求4或5所述制备方法制得的中药组合物在制备治疗异型增生的药物中的应用。
9.权利要求1~3任一项所述中药组合物或按权利要求4或5所述制备方法制得的中药组合物在制备治疗结肠息肉的药物中的应用。
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