CN108578560B - 一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物及其制备方法 - Google Patents
一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物及其制备方法,该中药组合物包括以下重量计的原料药物:当归10‑16g、何首乌15‑20g、知母10‑12g、川楝子10‑16g、桑寄生5‑10g、女贞子15‑20g、远志5‑10g、夏枯草5‑10g、熟地黄10‑16g、补骨脂15‑18g、巴戟天12‑15g、露蜂房12‑15g、煅龙骨10‑12g、山茱萸4‑8g、甘草15‑20g。本发明在中医辨证与辨病论治理论指导下,按君臣佐使原则进行遣药组方,诸药合用,以养血柔肝,滋阴补肾,散结通络为主,兼具活血化瘀、清热解毒、祛风除湿之功效,主要针对肝肾阴虚型自身免疫性肝炎,对其它证型的自身免疫性肝炎也有一定的治疗效果。
Description
技术领域
本发明涉及一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物及其制备方法,属于中药技术领域。
背景技术
自身免疫性肝炎是由自身免疫反应介导的慢性进行性肝脏炎症性疾病,其临床特征为不同程度的血清转氨酶升高、高γ-球蛋白血症、自身抗体阳性,组织学特征为以淋巴细胞、浆细胞浸润为主的界面性肝炎,严重病例可快速进展为肝硬化和肝衰竭。该病在世界范围内均有发生,在欧美国家发病率相对较高,在我国其确切发病率和患病率尚不清楚,但国内文献报道的病例数呈明显上升趋势。现代医学治疗主要以糖皮质激素等免疫抑制剂为主,减轻肝脏的自身弥漫异性炎症反应,同时采用保肝、退黄、降酶等药物治疗,但其弊端却逐渐显现。中药治疗自身免疫性肝炎以其特色被现代医者所接纳和推广。中医药诊治肝病历史悠久,早在中国汉代的《黄帝内经》上便有“诸风掉眩,皆属于肝”的论述,在治疗上提出:“肝主春,足厥阴,少阳主治,其日甲乙;肝苦急,急食甘以缓之”、“急食辛以散之,用辛补之,酸泻之”。现代医者在此基础上多有发挥,不同的医生对自身免疫性肝炎证型有其自身的看法,基本的认知是将自身免疫性肝炎分为:肝郁脾虚型、湿热中阻型、瘀血阻络型和肝肾阴虚型。中医治疗主要采用辨证施治的手段治疗自身免疫性肝炎,本发明主要针对肝肾阴虚型自身免疫性肝炎的治疗。
发明内容
针对现有技术的不足,本发明的目的是提供一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物及其制备方法,能够有效治疗肝肾阴虚型自身免疫性肝炎。
为了实现上述目的,本发明的技术方案是:
一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物,包括以下重量计的原料药物:当归10-16g、何首乌15-20g、知母10-12g、川楝子10-16g、桑寄生5-10g、女贞子15-20g、远志5-10g、夏枯草5-10g、熟地黄10-16g、补骨脂15-18g、巴戟天12-15g、露蜂房12-15g、煅龙骨10-12g、山茱萸4-8g、甘草15-20g。
一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物的制备方法,包括以下步骤:
(1)按重量称取当归、何首乌、知母、川楝子、桑寄生、女贞子、远志、煅龙骨,混合,加入混合原料药物10-15倍重量的水煎煮2-3次,每次1-1.5h,过滤,合并滤液并浓缩成80℃下相对密度为1.20-1.30的浸膏A;
(2)按重量称取夏枯草、熟地黄、补骨脂、巴戟天、露蜂房、山茱萸、甘草,混合,加入混合原料药物10倍重量的石油醚,回流提取1-2h,脱脂,弃去石油醚提取液;药渣挥干石油醚,加入药渣5-15倍重量的体积浓度90%的乙醇,在70-80℃条件下回流提取2-3次,每次1-1.5h,过滤,合并滤液经减压回收乙醇至无醇味,并浓缩成60℃下相对密度为1.10-1.12的浸膏B;
(3)将浸膏A、浸膏B混合均匀,浓缩,干燥成干浸膏,粉碎,即得。
一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物的制备方法,按重量称取各原料药物,混合,加入原料药物总重量5-10倍的水浸泡30min,并煎煮2-3次,每次1-1.5h,过滤,合并滤液。
中药组合物还可以制成片剂、胶囊、颗粒剂。
上述各原料药物的药理作用:
当归,味甘、辛,性温。归肝、心、脾经。补血,活血,调经止痛,润燥滑肠。主血虚诸证,月经不调,经闭,痛经,症瘕结聚,崩漏,虚寒腹痛,痿痹,肌肤麻木,肠燥便难,赤痢后重,痈疽疮疡,跌扑损伤。
何首乌,味苦、甘、涩,性微温。归肝、心、肾经。补益精血,截疟,解毒,润肠通便。用于头晕眼花,须发早白,久疟不止,痈疽瘰疬,肠燥便秘。
知母,味苦,性寒。归肺、胃、肾经。清热除烦,泻肺滋肾。用于温热病壮热烦渴,肺热咳嗽,阴虚干咳,骨蒸潮热,内热消渴。
川楝子,味苦,性寒。用小毒。归肝、胃、小肠、膀胱经。行气止痛,杀虫。用于胁肋疼痛,脘腹疼痛,疝气疼痛,虫积腹痛,头癣。
桑寄生,味苦、甘,性平。归肝,肾经。祛风湿,补肝肾,强筋骨,安胎。用于风湿痹痛,腰膝酸痛,胎漏下血,胎动不安。
女贞子,味甘、苦,性凉,归肝、肾经。补益肝肾,明目,清虚热。用于头晕目眩,须发早白,视物昏花,阴虚发热。
远志,味苦、辛,性微温。归心、肺、肾经。安神益智,祛痰开窍,消痈肿。用于惊悸失眠,多梦健忘,神昏癫痫,咳嗽痰多,痈疽肿毒。
夏枯草,味辛、苦,性寒。归肝、胆经。清肝火,散郁结,平肝阳。用于目赤肿痛,目珠夜痛,瘰疬瘿瘤,眩晕头痛。
熟地黄,味甘,性微温。归肝、肾经。养血滋阴,补精益髓。用于血虚萎黄,眩晕心悸,月经不调,潮热盗汗,消渴,腰酸耳鸣。
补骨脂,味苦、辛,性大温。归肾、脾经。补肾壮阳,固精缩尿,温脾止泻。用于肾虚阳萎,腰膝冷痛,肾虚遗精,尿频遗尿,五更泄泻。
巴戟天,味辛、甘,性微温。归肾经。补肾助阳,祛风除湿。用于阳萎尿频,宫冷不孕,风湿痹痛。
露蜂房,味微甘,性平;小毒。归肝、胃、肾经。祛风止痛,攻毒消肿,杀虫止痒。临床主风温痹痛,风虫牙痛,痈疽恶疮,瘰疬,喉舌肿痛,痔漏,风疹瘙痒,皮肤顽癣。
煅龙骨,味甘、涩,性平。归心、肝、肾经。镇静安神,平肝潜阳,收敛固涩。用于神志不安,心悸失眠,烦躁易怒,头晕目眩,虚汗,遗精,带下,崩漏。
山茱萸,味酸,性微温。归肝、肾经。补益肝肾,收敛固涩。用于头晕目眩,腰膝酸软,崩漏,带下,月经过多,遗精,遗尿,大汗不止,体虚欲脱。
甘草,味甘,性平。归心、脾、肺、胃经。补脾益气,润肺止咳,清热解毒,缓解止痛,缓和药性。
本发明配方中当归补血活血,何首乌补肝肾,益精血,熟地黄养血滋阴,女贞子补益肝肾,补骨脂补肾壮阳,五者共为君药;夏枯草清肝泻火,桑寄生补益肝肾,知母清热滋肾,远志祛痰消肿,山茱萸补益肝肾,五者共为臣药;川楝子行气止痛,露蜂房祛风止痛,煅龙骨平肝潜阳,巴戟天补肾助阳,四者共为佐药;甘草补脾益气,润肺止咳,清热解毒,缓解止痛,调和诸药,为使药。
本发明的有益效果:
本发明在中医辨证与辨病论治理论指导下,按君臣佐使原则进行遣药组方,诸药合用,以养血柔肝,滋阴补肾,散结通络为主,兼具活血化瘀、清热解毒、祛风除湿之功效,主要针对肝肾阴虚型自身免疫性肝炎,对其它证型的自身免疫性肝炎也有一定的治疗效果。
本发明为纯中药制剂,使用安全、方便,无毒副作用,不易产生耐药性,不污染环境,不引发药源性疾病,原料来源广泛,成本低廉,效果明显,能够有效治疗肝肾阴虚型自身免疫性肝炎。
具体实施方式
以下结合实施例对本发明的具体实施方式作进一步详细说明。
实施例1
一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物,包括以下重量计的原料药物(一剂):当归14g、何首乌18g、知母10g、川楝子10g、桑寄生5g、女贞子18g、远志8g、夏枯草8g、熟地黄14g、补骨脂15g、巴戟天12g、露蜂房15g、煅龙骨11g、山茱萸4g、甘草15g。
其制备方法,包括以下步骤:
(1)按重量称取当归、何首乌、知母、川楝子、桑寄生、女贞子、远志、煅龙骨,混合,加入混合原料药物10倍重量的水煎煮3次,每次1h,过滤,合并滤液并浓缩成80℃下相对密度为1.20-1.30的浸膏A;
(2)按重量称取夏枯草、熟地黄、补骨脂、巴戟天、露蜂房、山茱萸、甘草,混合,加入混合原料药物10倍重量的石油醚,回流提取1h,脱脂,弃去石油醚提取液;药渣挥干石油醚,加入药渣10倍重量的体积浓度90%的乙醇,在80℃条件下回流提取2次,每次1h,过滤,合并滤液经减压回收乙醇至无醇味,并浓缩成60℃下相对密度为1.10-1.12的浸膏B;
(3)将浸膏A、浸膏B混合均匀,浓缩,干燥成干浸膏,粉碎,即得。
实施例2
一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物,包括以下重量计的原料药物(一剂):当归10g、何首乌15g、知母11g、川楝子16g、桑寄生10g、女贞子15g、远志6g、夏枯草5g、熟地黄16g、补骨脂16g、巴戟天15g、露蜂房12g、煅龙骨10g、山茱萸5g、甘草20g。
其制备方法:按重量称取各原料药物,混合,加入原料药物总重量5倍的水浸泡30min,并煎煮2次,每次1h,过滤,合并滤:。
实施例3
一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物,包括以下重量计的原料药物(一剂):当归16g、何首乌20g、知母12g、川楝子14g、桑寄生8g、女贞子20g、远志10g、夏枯草10g、熟地黄10g、补骨脂18g、巴戟天14g、露蜂房12g、煅龙骨12g、山茱萸8g、甘草16g。
其制备方法同实施例1。
对照例
作为对照例的中药组合物,包括以下重量计的原料药物(一剂):丹参12g、茜草10g、丹皮15g、夏枯草10g、虎杖10g、茯苓12g、大青叶8g、厚朴8g、白术12g、当归15g、红花14g、元胡6g、川芎10g、柴胡13g、肉桂7g、黄芪9g、香附13g。
其制备方法参照实施例2。
有关实验资料如下:
1、纳入标准和排除标准
纳入标准:
(1)符合自身免疫性肝炎诊断标准的患者,参照2010年美国肝病学会自身免疫性肝炎诊治指南;
(2)年龄18-65岁;
(3)未用药,或服用药物但停药2周后;
(4)获得知情同意书。
排除标准:
(1)排除合并有严重肾、脑、心内科疾病者;
(2)年龄18岁以下或65岁以上;
(3)妊娠、哺乳期妇女;
(4)因病毒性、药物性、酒精性及其他性原因导致的肝损害患者。
1.2中医辨证标准:
肝肾阴虚型:劳累尤甚,或有灼热感,头晕耳鸣,两目干涩,口燥咽干,失眠多梦,潮热或五心烦热,腰膝酸软,鼻齿衄,女子经少经闭。舌体瘦质红少津,或有裂纹,苔少,脉细数无力。
1.3治疗方案:
于2016年4月-2017年12月,符合纳入标准的肝肾阴虚型自身免疫性肝炎患者78例,男49例,女29例,随机分为试验组和对照组,每组39例。试验组分别服用实施例1的中药组合物,每日一剂,分两次服用;对照组服用对照例的中药组合物,每日一剂,分两次服用。10天为一疗程,观察服用7个疗程的情况。
1.4观察指标:
分别对患者治疗前后症状总积分、TBiL(总胆红素)、ALT(谷丙转氨酶)、ALP(碱性磷酸酶)、AST(谷草转氨酶升高)、γ-GT(γ-谷氨酰转肽酶)进行观察。
症状积分的计算方法:患者治疗前后症状积分变化,临床主要症状包括乏力、纳差、腹胀、尿黄:无症状为0分,轻度为2分,中度为4分,重度为6分。
1.5疗效评价:
痊愈:临床症状消失,肝功能恢复正常;
有效:临床症状好转,症状积分减少50%以上,肝功能指标好转,下降50%以上者;
无效:未达到以上标准视为无效。
总有效率=(痊愈例+有效例)/病例数×100%
1.6统计学方法:
应用spss软件统计分析,计量资料采用t检验,P<0.05为差异有显著性。
2、结果
2.1症状积分及肝功能:
治疗后试验组和对照组症状积分及肝功能均较治疗前改善,本发明的中药组合物在改善症状积分及肝功能上优于对照组,差异有统计学意义(P<0.05),见表1。
表1治疗前后症状积分及肝功能比较
2.2总有效率:
结果表明,本发明中药组合物的效果明显优于对照组的中药组合物,其中,本发明中药组合物试验组痊愈21例,有效16例,无效2例,总有效率94.9%,对照组痊愈14例,有效17例,无效8例,总有效率79.5%,两者比较有统计学意义(P<0.05)。
以上所述仅为本发明最佳的实施例,对于本领域的技术人员来说,本发明可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (7)
1.一种治疗肝肾阴虚型自身免疫性肝炎的中药组合物,其特征在于,由以下重量计的原料药物组成:当归10-16g、何首乌15-20g、知母10-12g、川楝子10-16g、桑寄生5-10g、女贞子15-20g、远志5-10g、夏枯草5-10g、熟地黄10-16g、补骨脂15-18g、巴戟天12-15g、露蜂房12-15g、煅龙骨10-12g、山茱萸4-8g、甘草15-20g。
2.根据权利要求1所述的中药组合物,其特征在于,由以下重量计的原料药物组成:当归14g、何首乌18g、知母10g、川楝子10g、桑寄生5g、女贞子18g、远志8g、夏枯草8g、熟地黄14g、补骨脂15g、巴戟天12g、露蜂房15g、煅龙骨11g、山茱萸4g、甘草15g。
3.根据权利要求1所述的中药组合物,其特征在于,由以下重量计的原料药物组成:当归10g、何首乌15g、知母11g、川楝子16g、桑寄生10g、女贞子15g、远志6g、夏枯草5g、熟地黄16g、补骨脂16g、巴戟天15g、露蜂房12g、煅龙骨10g、山茱萸5g、甘草20g。
4.根据权利要求1所述的中药组合物,其特征在于,由以下重量计的原料药物组成:当归16g、何首乌20g、知母12g、川楝子14g、桑寄生8g、女贞子20g、远志10g、夏枯草10g、熟地黄10g、补骨脂18g、巴戟天14g、露蜂房12g、煅龙骨12g、山茱萸8g、甘草16g。
5.一种如权利要求1-4任一项所述的中药组合物的制备方法,其特征在于,包括以下步骤:
(1)按重量称取当归、何首乌、知母、川楝子、桑寄生、女贞子、远志、煅龙骨,混合,加入混合原料药物10-15倍重量的水煎煮2-3次,每次1-1.5h,过滤,合并滤液并浓缩成80℃下相对密度为1.20-1.30的浸膏A;
(2)按重量称取夏枯草、熟地黄、补骨脂、巴戟天、露蜂房、山茱萸、甘草,混合,加入混合原料药物10倍重量的石油醚,回流提取1-2h,脱脂,弃去石油醚提取液;药渣挥干石油醚,加入药渣5-15倍重量的体积浓度90%的乙醇,在70-80℃条件下回流提取2-3次,每次1-1.5h,过滤,合并滤液经减压回收乙醇至无醇味,并浓缩成60℃下相对密度为1.10-1.12的浸膏B;
(3)将浸膏A、浸膏B混合均匀,浓缩,干燥成干浸膏,粉碎,即得。
6.一种如权利要求1-4任一项所述的中药组合物的制备方法,其特征在于,按重量称取各原料药物,混合,加入原料药物总重量5-10倍的水浸泡30min,并煎煮2-3次,每次1-1.5h,过滤,合并滤液。
7.一种如权利要求1-4任一项所述的中药组合物的制备方法,其特征在于,所述 中药组合物制成片剂、胶囊、颗粒剂。
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