CN105396069A - 一种用于治疗慢性胃炎的中药的制备方法 - Google Patents
一种用于治疗慢性胃炎的中药的制备方法 Download PDFInfo
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Abstract
本发明提供了一种用于治疗慢性胃炎的中药组合物的制备方法,由黄连、半夏、黄芩、佩兰、砂仁、丹参等药味作为原料制成,具有清热化湿、温中和胃、理气止痛、活血化瘀等功效,对慢性胃炎有显著的治疗效果,而且在实际研究过程中,采用超临界萃取、超声提取和回流提取相结合的制备方法,全面提高了所述组合物中有效组分含量,进而提升最终制剂的疗效,具有疗效明确、质量可控等特点。
Description
技术领域
本发明涉及一种用于治疗慢性胃炎的中药的制备方法,属于医药制剂技术领域。
背景技术
慢性胃炎是临床常见病,且发病率较高。其临床特点是病程长、缠绵难愈,给病人的生活和工作带来了诸多不便,个别还可发展到胃癌前病变甚至胃癌,危及生命健康。临床常见患者有消化不良表现,如反酸、暖气、早饱、食欲减退、恶心等。慢性萎缩性胃炎可以出现明显厌食和体重减轻,并伴有贫血。慢性胃炎是指多种有害因素反复损伤,导致胃粘膜的慢性炎症疾病。
幽门螺杆菌(HP)感染为慢性胃炎主要病因,HP的持续存在,致使腺体破坏,导致萎缩性胃炎、化生、异型增生,最终导致胃癌,世界卫生组织已将HP确定为Ⅰ类致癌因子,多数研究提示,根除HP可以减少胃黏膜萎缩和肠化生的发生或发展,因而减少胃癌的发生。随着HP对多种抗生素耐药菌株的出现,中医药在清除幽门螺杆菌方面具有明显优势。
在中医理论中,慢性胃炎属于“胃脘病”、“胃痞”范畴。就病因而论,脾胃虚弱为其内在因素,饮食不节、情志所伤、劳逸过度、寒邪内侵为其诱发因素。饮食不节,积滞不化,郁遏气机;忧思恼怒,肝失疏泄,气滞胃脘;过度辛劳则耗伤气血,过度安逸则气机不舒;寒邪内侵,凝滞胃脘,脾胃素虚,加之以上诸因素致气机不畅,郁滞胃脘,升降失常是本病的基本病机。本病产生多因寒邪凝滞、肝郁气滞、湿热内盛、饮食失节所致。治疗本病张仲景“半夏泻心汤”中有辛开苦降、寒热并调、攻补兼施之法,为后世治疗胃病明确了遣方用药的思路。清代李中《证治汇补·痞满》中对“本病的治疗,初宜舒郁、化痰、降火,久宜固中气佐以他药;有痰治痰,有火清火、郁则兼化。”本发明采用特殊的制备方法获得了有效成分高的中药提取物,其在治疗脾胃虚弱、气滞血淤的慢性胃炎方面有确切的疗效。
发明内容
本发明提供一种用于治疗慢性胃炎的中药组合物的制备方法,并且采用超临界萃取、超声提取和回流提取相结合的制备方法,提高了所述中药组合物中有效成分的含量,由此制得的中药组合物具有疗效明确、质量可控等特点。
为实现上述目的,一方面,本发明提供了一种用于治疗慢性胃炎的中药组合物的制备方法,所述中药组合物由如下重量配比的药材制成:黄连10-20份,半夏10-20份,黄芩10-20份,佩兰10-20份,砂仁10-20份,丹参10-20份,吴茱萸10-20份,佛手10-20份,白芍10-20份,生地10-20份,青皮10-20份,郁金10-20份,白花蛇舌草10-20份,白蔻仁10-20份,竹茹10-20份,瓜蒌仁10-20份,白术10-20份,白芷10-20份,甘草10-20份;
制备方法包括以下步骤:
(1)将黄连、白术、白芷加入到CO2超临界萃取器中,乙醇作为夹带剂,萃取压力20-40MPa,温度30-55℃,CO2流量2-4m1/g生药·min,萃取时间1-3h,得超临界萃取物和药渣;
(2)取半夏、黄芩、砂仁、丹参、白蔻仁药材,加入蒸馏水超声提取,滤过,滤液中加入乙醇醇沉,离心,获得乙醇滤液和药渣;
(3)取佩兰、吴茱萸、佛手、白芍、生地、青皮、郁金、白花蛇舌草、竹茹、瓜蒌仁、甘草药材以及步骤(1)和(2)所得药渣,加入乙醇回流提取,滤过,获得乙醇滤液;
(4)将步骤(2)、(3)中的乙醇滤液合并,回收乙醇后,再加入步骤(1)所制得的超临界萃取物,干燥并粉碎,即得。
在本发明的一个优选的实施方案中,所述中药组合物由如下重量配比的药材制成:黄连20份,半夏20份,黄芩15份,佩兰10份,砂仁12份,丹参15份,吴茱萸10份,佛手20份,白芍20份,生地12份,青皮15份,郁金10份,白花蛇舌草20份,白蔻仁15份,竹茹10份,瓜蒌仁15份,白术12份,甘草20份。
在本发明的一个优选的实施方案中,所述组合物由以下步骤制备而成:
(1)将黄连、白术、白芷加入到CO2超临界萃取器中,乙醇作为夹带剂,夹带剂占总萃取溶剂的体积百分比为2-5%,萃取压力20-40MPa,温度30-55℃,CO2流量2-4m1/g生药·min,萃取时间1-3h,得超临界萃取物和药渣;
(2)取半夏、黄芩、砂仁、丹参、白蔻仁药材,加入与药材重量比为6-8倍量的蒸馏水超声提取2-3次,每次30-50分钟,温度为50-80℃,超声频率60-90KHz,滤过,滤液中加入乙醇使得含醇量达到70-85%,静置,离心分离,获得乙醇滤液和药渣;
(3)取佩兰、吴茱萸、佛手、白芍、生地、青皮、郁金、白花蛇舌草、竹茹、瓜蒌仁、甘草药材以及步骤(1)和(2)所得药渣,加入与上述药材和药渣总重量比为6-10倍、浓度为70%-90%的乙醇回流提取1-3次,每次2-4h,滤过,合并乙醇滤液;
(4)将步骤(2)、(3)中的乙醇滤液合并,回收乙醇后,再加入步骤(1)所制得的超临界萃取物,干燥并粉碎成粒径为200-400μm的粉末,即得。
在本发明的进一步优选的实施方案中,所述组合物由以下步骤制备而成:
(1)将黄连、白术、白芷加入到CO2超临界萃取器中,乙醇作为夹带剂,夹带剂占总萃取溶剂的体积百分比为4%,萃取压力35MPa,温度45℃,CO2流量3m1/g生药·min,萃取时间2h,得超临界萃取物和药渣;
(2)取半夏、黄芩、砂仁、丹参、白蔻仁药材,加入与药材重量比为8倍量的蒸馏水超声提取3次,第一次40分钟,第二、三次各为30分钟,温度为65℃,超声频率75KHz,滤过,滤液中加入乙醇使得含醇量达到80%,静置,离心分离,获得乙醇滤液和药渣;
(3)取佩兰、吴茱萸、佛手、白芍、生地、青皮、郁金、白花蛇舌草、竹茹、瓜蒌仁、甘草药材以及步骤(1)和(2)所得药渣,加入与上述药材和药渣总重量比为10倍、浓度为75%的乙醇回流提取3次,第一次3h,第二、三次各2h,滤过,合并乙醇滤液;
(4)将步骤(2)、(3)中的乙醇滤液合并,回收乙醇后,再加入步骤(1)所制得的超临界萃取物,干燥并粉碎成粒径为200-300μm的粉末,即得。
另一方面,本发明还提供由所述制备方法得到的中药提取物。
本发明的中药组合物具有清热化湿、温中和胃、理气止痛、活血化瘀等功效,对慢性胃炎有显著的治疗效果,而且在实际研究过程中,对所述组合物的制备方法进行了创新性的研究,确定了黄连、白术、白芷进行超临界萃取,半夏、黄芩、砂仁、丹参、白蔻仁进行超声提取,以及其它药味连同上述药渣进行醇提取的技术方案,并进一步优化操作参数,全面提高了所述组合物中有效组分含量,进而提升最终制剂的疗效,而且,该制备方法具有易于操作、疗效明确之特点,其所带来的有益效果和非显而易见性之特点,对于本领域的技术人员来说,通过现有技术的教导并运用常规的实验手段是不能够得出的。
具体实施方式
通过以下实施方式进一步详细说明本发明的技术方案。需要指出的是,以下说明仅仅是对本发明要求保护的技术方案的举例说明,并非对这些技术方案的任何限制。本发明的保护范围以所附权利要求书记载的内容为准。
实施例1:
取黄连20份,半夏20份,黄芩15份,佩兰10份,砂仁12份,丹参15份,吴茱萸10份,佛手20份,白芍20份,生地12份,青皮15份,郁金10份,白花蛇舌草20份,白蔻仁15份,竹茹10份,瓜蒌仁15份,白术12份,甘草20份,按以下步骤进行制备:
(1)将黄连、白术、白芷加入到CO2超临界萃取器中,乙醇作为夹带剂,夹带剂占总萃取溶剂的体积百分比为4%,萃取压力35MPa,温度45℃,CO2流量3m1/g生药·min,萃取时间2h,得超临界萃取物和药渣;
(2)取半夏、黄芩、砂仁、丹参、白蔻仁药材,加入与药材重量比为8倍量的蒸馏水超声提取3次,第一次40分钟,第二、三次各为30分钟,温度为65℃,超声频率75KHz,滤过,滤液中加入乙醇使得含醇量达到80%,静置,离心分离,获得乙醇滤液和药渣;
(3)取佩兰、吴茱萸、佛手、白芍、生地、青皮、郁金、白花蛇舌草、竹茹、瓜蒌仁、甘草药材以及步骤(1)和(2)所得药渣,加入与上述药材和药渣总重量比为10倍、浓度为75%的乙醇回流提取3次,第一次3h,第二、三次各2h,滤过,合并乙醇滤液;
(4)将步骤(2)、(3)中的乙醇滤液合并,回收乙醇后,再加入步骤(1)所制得的超临界萃取物,干燥并粉碎成粒径为200-300μm的粉末,即得。
实施例2:
取黄连15份,半夏20份,黄芩10份,佩兰15份,砂仁20份,丹参10份,吴茱萸20份,佛手10份,白芍10份,生地15份,青皮20份,郁金15份,白花蛇舌草10份,白蔻仁10份,竹茹20份,瓜蒌仁10份,白术10份,甘草15份,按以下步骤进行制备:
(1)将黄连、白术、白芷加入到CO2超临界萃取器中,乙醇作为夹带剂,夹带剂占总萃取溶剂的体积百分比为3%,萃取压力30MPa,温度40℃,CO2流量2.5m1/g生药·min,萃取时间2.5h,得超临界萃取物和药渣;
(2)取半夏、黄芩、砂仁、丹参、白蔻仁药材,加入与药材重量比为8倍量的蒸馏水超声提取2次,第一次50分钟,第二次为40分钟,温度为55℃,超声频率80KHz,滤过,滤液中加入乙醇使得含醇量达到70%,静置,离心分离,获得乙醇滤液和药渣;
(3)取佩兰、吴茱萸、佛手、白芍、生地、青皮、郁金、白花蛇舌草、竹茹、瓜蒌仁、甘草药材以及步骤(1)和(2)所得药渣,加入与上述药材和药渣总重量比为8倍、浓度为80%的乙醇回流提取3次,第一次2.5h,第二、三次各1.5h,滤过,合并乙醇滤液;
(4)将步骤(2)、(3)中的乙醇滤液合并,回收乙醇后,再加入步骤(1)所制得的超临界萃取物,干燥并粉碎成粒径为200-300μm的粉末,即得。
实施例3
取黄连10份,半夏10份,黄芩15份,佩兰20份,砂仁10份,丹参20份,吴茱萸15份,佛手10份,白芍20份,生地20份,青皮10份,郁金20份,白花蛇舌草15份,白蔻仁20份,竹茹10份,瓜蒌仁15份,白术20份,甘草10份,按以下步骤进行制备:
(1)将黄连、白术、白芷加入到CO2超临界萃取器中,乙醇作为夹带剂,夹带剂占总萃取溶剂的体积百分比为5%,萃取压力40MPa,温度50℃,CO2流量3m1/g生药·min,萃取时间3h,得超临界萃取物和药渣;
(2)取半夏、黄芩、砂仁、丹参、白蔻仁药材,加入与药材重量比为7倍量的蒸馏水超声提取3次,第一次30分钟,第二、三次为40分钟,温度为60℃,超声频率70KHz,滤过,滤液中加入乙醇使得含醇量达到80%,静置,离心分离,获得乙醇滤液和药渣;
(3)取佩兰、吴茱萸、佛手、白芍、生地、青皮、郁金、白花蛇舌草、竹茹、瓜蒌仁、甘草药材以及步骤(1)和(2)所得药渣,加入与上述药材和药渣总重量比为9倍、浓度为85%的乙醇回流提取2次,第一次4h,第二次3h,滤过,合并乙醇滤液;
(4)将步骤(2)、(3)中的乙醇滤液合并,回收乙醇后,再加入步骤(1)所制得的超临界萃取物,干燥并粉碎成粒径为200-300μm的粉末,即得。
为了进一步验证本发明中药组合物的疗效,将上述具体实施例1-3中制备的成品进行了相应的临床试验,现将结果报告如下。
临床观察及疗效
1.一般资料:
收集受试病例80例,作为研究对象,其中男性45例,女性35例;年龄为20~63岁,平均年龄(40.31±1.26)岁;病程6个月~3年;随机分为4组,其中实施例1组20例、实施例2组20例、实施例3组20例,对照组(胃脘舒颗粒药物组)20例,所有患者按照年龄、性别、病程、临床症状等,各组在一般资料方面均无显著性差异,具有可比性。
诊断标准:参照《中医症诊疗标准及与方剂选用》及《常见疾病诊断依据与疗效判断诊断》:胃镜检查发现胃黏膜充血水肿、溃疡面及出血点、糜烂点。胃黏膜及胃液尿素酶快速诊断试纸法测试幽门螺旋杆菌(HP)为阳性。具有胃脘部胀痛、灼热感、反复吐酸、打嗝等上消化道症状等,满足上述条件,即可确诊为慢性胃炎确诊。
2.治疗方法
治疗组口服本发明实施例1组、2组、3组药物,每次服用2个剂量单位,每日3次;对照组口服胃脘舒颗粒,每日2次,每次1袋,均以4周为一个疗程,连续服用4个疗程。治疗期间,均配合一定的饮食、心理和作息习惯等调理。
3.疗效评价
显效:治疗后,幽门螺杆菌检查阴性,临床症状和体征恢复正常,纤维胃镜检查胃粘膜病灶消失。有效:治疗后,幽门螺杆菌检查阴性,临床症状和体征有不同程度改善,纤维胃镜检查胃粘膜病灶有不同程度好转。无效:治疗后,幽门螺杆菌检查阳性,临床症状、体征和胃粘膜病灶无变化或加重。
3.1试验结果
经过4个疗程的药物治疗后,其大多数慢性胃炎患者,出现的反酸、嗳气、食欲减退、恶心、腹部胀痛、打嗝等症状都有明显的改善,且幽门螺杆菌检查为阴性,胃粘膜病灶有不同程度好转。本发明实施例1组、2组、3组总有效率分别为90%、85%、80%,其中,本发明实施例1组的疗效最佳,而对照组胃脘舒颗粒药物组的有效率仅为75.0%,结果表明,本发明技术方案制备的中药制剂在治疗胃炎疾病方面的临床疗效显著,并优于胃脘舒颗粒药物组,并且在治疗过程中,未发现各实施例组药物的不良反应。
结果表明,本发明的中药组合物具有制备工艺科学合理、疗效可控等优点,其高效、精简的药材提取工艺,有力地保证了本发明中药组合物在治疗慢性胃炎方面的显著效果。
以上所述仅为本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原料的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (7)
1.一种用于治疗慢性胃炎的中药组合物的制备方法,其特征在于,所述中药组合物由如下重量配比的药材制成:黄连10-20份,半夏10-20份,黄芩10-20份,佩兰10-20份,砂仁10-20份,丹参10-20份,吴茱萸10-20份,佛手10-20份,白芍10-20份,生地10-20份,青皮10-20份,郁金10-20份,白花蛇舌草10-20份,白蔻仁10-20份,竹茹10-20份,瓜蒌仁10-20份,白术10-20份,白芷10-20份,甘草10-20份;
所述制备方法包括以下步骤:
(1)将黄连、白术、白芷加入到CO2超临界萃取器中,乙醇作为夹带剂,萃取压力20-40MPa,温度30-55℃,CO2流量2-4m1/g生药·min,萃取时间1-3h,得超临界萃取物和药渣;
(2)取半夏、黄芩、砂仁、丹参、白蔻仁药材,加入蒸馏水超声提取,滤过,滤液中加入乙醇醇沉,离心,获得乙醇滤液和药渣;
(3)取佩兰、吴茱萸、佛手、白芍、生地、青皮、郁金、白花蛇舌草、竹茹、瓜蒌仁、甘草药材以及步骤(1)和(2)所得药渣,加入乙醇回流提取,滤过,获得乙醇滤液;
(4)将步骤(2)、(3)中的乙醇滤液合并,回收乙醇后,再加入步骤(1)所制得的超临界萃取物,干燥并粉碎,即得。
2.根据权利要求1所述的制备方法,其特征在于,所述中药组合物由如下重量配比的药材制成:黄连20份,半夏20份,黄芩15份,佩兰10份,砂仁12份,丹参15份,吴茱萸10份,佛手20份,白芍20份,生地12份,青皮15份,郁金10份,白花蛇舌草20份,白蔻仁15份,竹茹10份,瓜蒌仁15份,白术12份,甘草20份。
3.根据权利要求1所述的制备方法,其特征在于,所述制备方法包括以下步骤:
(1)将黄连、白术、白芷加入到CO2超临界萃取器中,乙醇作为夹带剂,夹带剂占总萃取溶剂的体积百分比为2-5%,萃取压力20-40MPa,温度30-55℃,CO2流量2-4m1/g生药·min,萃取时间1-3h,得超临界萃取物和药渣;
(2)取半夏、黄芩、砂仁、丹参、白蔻仁药材,加入与药材重量比为6-8倍量的蒸馏水超声提取2-3次,每次30-50分钟,温度为50-80℃,超声频率60-90KHz,滤过,滤液中加入乙醇使得含醇量达到70-85%,静置,离心分离,获得乙醇滤液和药渣;
(3)取佩兰、吴茱萸、佛手、白芍、生地、青皮、郁金、白花蛇舌草、竹茹、瓜蒌仁、甘草药材以及步骤(1)和(2)所得药渣,加入与上述药材和药渣总重量比为6-10倍、浓度为70%-90%的乙醇回流提取1-3次,每次2-4h,滤过,合并乙醇滤液;
(4)将步骤(2)、(3)中的乙醇滤液合并,回收乙醇后,再加入步骤(1)所制得的超临界萃取物,干燥并粉碎成粒径为200-400μm的粉末,即得。
4.根据权利要求1所述的制备方法,其特征在于,所述制备方法包括以下步骤:
(1)将黄连、白术、白芷加入到CO2超临界萃取器中,乙醇作为夹带剂,夹带剂占总萃取溶剂的体积百分比为4%,萃取压力35MPa,温度45℃,CO2流量3m1/g生药·min,萃取时间2h,得超临界萃取物和药渣;
(2)取半夏、黄芩、砂仁、丹参、白蔻仁药材,加入与药材重量比为8倍量的蒸馏水超声提取3次,第一次40分钟,第二、三次各为30分钟,温度为65℃,超声频率75KHz,滤过,滤液中加入乙醇使得含醇量达到80%,静置,离心分离,获得乙醇滤液和药渣;
(3)取佩兰、吴茱萸、佛手、白芍、生地、青皮、郁金、白花蛇舌草、竹茹、瓜蒌仁、甘草药材以及步骤(1)和(2)所得药渣,加入与上述药材和药渣总重量比为10倍、浓度为75%的乙醇回流提取3次,第一次3h,第二、三次各2h,滤过,合并乙醇滤液;
(4)将步骤(2)、(3)中的乙醇滤液合并,回收乙醇后,再加入步骤(1)所制得的超临界萃取物,干燥并粉碎成粒径为200-300μm的粉末,即得。
5.根据权利要求1所述的制备方法,其特征在于,所述制备方法包括以下步骤:
(1)将黄连、白术、白芷加入到CO2超临界萃取器中,乙醇作为夹带剂,夹带剂占总萃取溶剂的体积百分比为3%,萃取压力30MPa,温度40℃,CO2流量2.5m1/g生药·min,萃取时间2.5h,得超临界萃取物和药渣;
(2)取半夏、黄芩、砂仁、丹参、白蔻仁药材,加入与药材重量比为8倍量的蒸馏水超声提取2次,第一次50分钟,第二次为40分钟,温度为55℃,超声频率80KHz,滤过,滤液中加入乙醇使得含醇量达到70%,静置,离心分离,获得乙醇滤液和药渣;
(3)取佩兰、吴茱萸、佛手、白芍、生地、青皮、郁金、白花蛇舌草、竹茹、瓜蒌仁、甘草药材以及步骤(1)和(2)所得药渣,加入与上述药材和药渣总重量比为8倍、浓度为80%的乙醇回流提取3次,第一次2.5h,第二、三次各1.5h,滤过,合并乙醇滤液;
(4)将步骤(2)、(3)中的乙醇滤液合并,回收乙醇后,再加入步骤(1)所制得的超临界萃取物,干燥并粉碎成粒径为200-300μm的粉末,即得。
6.根据权利要求1所述的制备方法,其特征在于,所述制备方法包括以下步骤:
(1)将黄连、白术、白芷加入到CO2超临界萃取器中,乙醇作为夹带剂,夹带剂占总萃取溶剂的体积百分比为5%,萃取压力40MPa,温度50℃,CO2流量3m1/g生药·min,萃取时间3h,得超临界萃取物和药渣;
(2)取半夏、黄芩、砂仁、丹参、白蔻仁药材,加入与药材重量比为7倍量的蒸馏水超声提取3次,第一次30分钟,第二、三次为40分钟,温度为60℃,超声频率70KHz,滤过,滤液中加入乙醇使得含醇量达到80%,静置,离心分离,获得乙醇滤液和药渣;
(3)取佩兰、吴茱萸、佛手、白芍、生地、青皮、郁金、白花蛇舌草、竹茹、瓜蒌仁、甘草药材以及步骤(1)和(2)所得药渣,加入与上述药材和药渣总重量比为9倍、浓度为85%的乙醇回流提取2次,第一次4h,第二次3h,滤过,合并乙醇滤液;
(4)将步骤(2)、(3)中的乙醇滤液合并,回收乙醇后,再加入步骤(1)所制得的超临界萃取物,干燥并粉碎成粒径为200-300μm的粉末,即得。
7.根据权利要求1-6中任一项所述的制备方法制得的中药提取物。
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