CN106860679A - 一种治疗肝炎的中药组合物、其颗粒剂及制备方法 - Google Patents
一种治疗肝炎的中药组合物、其颗粒剂及制备方法 Download PDFInfo
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Abstract
本发明一种治疗肝炎的中药组合物、其颗粒剂及制备方法,属于中医药技术领域。所述中药组合物由下列重量份的原料药组成:黄芪250份、茯苓100份、灵芝150份、枸杞子300份、丹参200份、丹皮250份、虎杖250份和甘草200份。所述中药颗粒剂包括由上述原料药制备所得的活性成分和药学上可接受的载体。本发明具有以下优点:具有益气健脾、凉血化淤和清热解毒的功效;适用于各型慢性肝炎,肝硬变属肝郁脾虚,气血不足,余邪未清证型者。
Description
技术领域
本发明属于中医药技术领域,具体涉及一种治疗肝炎的中药组合物、其颗粒剂及制备方法。
背景技术
我国是病毒性肝炎的高发区,平均年发病约140万人左右,居法定传染病第三位。各类型肝炎中,以乙型肝炎在我国最为常见,约1.2亿人携带乙型肝炎病毒,而20%的乙型肝炎及50~60%的急性丙型肝炎会发展为慢性肝炎,目前我国约有300万慢性肝炎病患者,继而发展为肝硬化、肝衰竭和肝癌,每年死于肝病的人数约有50万。目前全国大约有5000万人患有肝纤维化、早期肝硬化。
慢性肝炎的发生,常有肝郁体质或素体脾虚的潜在因素。湿热疫毒侵淫肝胆,由于脾虚而无气不足,肝而疏泄失常,不能鼓邪外出,以致湿热疫毒留滞体内。肝郁脾虚、肝血淤阻、甚则脾肾两虚而致本病反复发作,可致癥瘕、臌胀,甚至黄疸、出血神昏、躁狂、昏聩不语。
发明内容
为了解决上述问题,本发明根据传统中医药理论,本发明的目的在于公开了一种治疗肝炎的中药组合物。
本发明的第二个目的在于公开了一种治疗肝炎的中药颗粒剂。
本发明的第三个目的在于公开了中药颗粒剂的制备方法。
本发明的中药组合物、颗粒剂具有益气健脾,凉血化淤,清热解毒,适用于各型慢性肝炎。
本发明的目的是通过以下技术方案实现的:
一种治疗肝炎的中药组合物,其中,所述中药组合物由下列重量份的原料药组成:黄芪250份、茯苓100份、灵芝150份、枸杞子300份、丹参200份、丹皮250份、虎杖250份和甘草200份。
上述技术方案所述的治疗肝炎的中药组合物,其中,所述中药组合物由下列重量的原料药组成:黄芪250g、茯苓100g、灵芝150g、枸杞子300g、丹参200g、丹皮250g、虎杖250g和甘草200g。
一种治疗肝炎的中药颗粒剂,其中,所述中药颗粒剂包括活性成分和药学上可接受的载体;
所述活性成分由原料药黄芪250份、茯苓100份、灵芝150份、枸杞子300份、丹参200份、丹皮250份、虎杖250份和甘草200份通过下述方法制备所得:
(1)、称取上述重量份的原料药,加水煎煮二次,第一次加10倍量水,煎煮2h;第二次加6~8倍量水,煎煮1.5h;
(2)、合并二次煎液,静置,滤过,滤液浓缩至稠膏,加乙醇至70%含醇量,静置;取上清液,回收乙醇至无醇味,浓缩至60℃下相对密度为1.35~1.38的稠膏,即得活性成分。
上述技术方案所述的中药颗粒剂,其中:所述药学上可接受的载体为糊精和糖粉;所述活性成分与糊精、糖粉之间的重量比为1:1:3。
一种治疗肝炎的中药颗粒剂的制备方法,其中,所述中药颗粒剂由原料药黄芪250份、茯苓100份、灵芝150份、枸杞子300份、丹参200份、丹皮250份、虎杖250份和甘草200份通过下述方法制备所得:
(1)、称取上述重量份的原料药,加水煎煮二次,第一次加10倍量水,煎煮2h;第二次加6~8倍量水,煎煮1.5h;
(2)、合并二次煎液,静置,滤过,滤液浓缩至稠膏,加乙醇至70%含醇量,静置;取上清液,回收乙醇至无醇味,浓缩至60℃下相对密度为1.35~1.38的稠膏;
(3)、取步骤(2)所得稠膏,按照稠膏:糊精:糖粉为1:1:3的重量比称取糊精和糖粉,混匀,制粒过14目筛,80~90℃下干燥,整粒,即得中药颗粒剂。
本发明所述中药颗粒剂为12g/袋;开水冲服,一次12—24g,一日2次。
本发明中药组合物中的原料药为:
黄芪:本品为豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao或膜荚黄芪Astragalus membranaceus(Fisch.)Bge.的干燥根。本品应符合中国药典2010年版一部第283页黄芪项下之有关规定。
茯苓:本品为多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的干燥菌核。本品应符合中国药典2010年版一部第224页茯苓项下之有关规定。
灵芝:本品为多孔菌科真菌赤芝Ganoderma lucidum(Leyss.ex Fr.)Karst或紫芝Ganoderma sinense Zhao,Xu et Zhang的干燥子实体。本品应符合中国药典2010年版一部第174页灵芝项下之有关规定。
枸杞子:本品为茄科植物宁夏枸杞Lycium barbarum L.的干燥成熟果实。本品应符合中国药典2010年版一部第232页枸杞子项下之有关规定。
丹参:本品为唇形科植物丹参Salvia miltiorrhiza Bge.的干燥根及根茎。本品应符合中国药典2010年版一部第70页丹参项下之有关规定。
丹皮:本品为毛茛科植物牡丹Paeonia suffruticosa Andr.的干燥根皮。本品应符合中国药典2010年版一部第160页牡丹皮项下之有关规定。
虎杖:本品为蓼科植物虎杖Polygonum cuspidatum Sieb.et Zucc.的干燥根茎和根。本品应符合中国药典2010年版一部第194页虎仗项下之有关规定。
甘草:本品为豆科植物甘草Glycyrrhiza uralensis Fisch.、胀果甘草Glycyrrhiza inflata Bat.或光果甘草Glycyrrhiza glabra L.的干燥根及根茎。本品应符合中国药典2010年版一部第80页甘草项下之有关规定。
本发明具有以下有益效果:
本发明的中药组合物、其颗粒剂具有益气健脾、凉血化淤和清热解毒的功效。适用于各型慢性肝炎,肝硬变属肝郁脾虚,气血不足,余邪未清证型者。
附图说明:
1、图1为各组大鼠病理表现。
具体实施方式:
为使本发明的技术方案便于理解,以下结合具体实施例对本发明中药组合物、其颗粒剂及制备方法作进一步的说明。
实施例1:一种治疗肝炎的中药组合物:
称取原料药黄芪250g、茯苓100g、灵芝150g、枸杞子300g、丹参200g、丹皮250g、虎杖250g和甘草200g,即得中药组合物。
实施例2:一种治疗肝炎的中药颗粒剂:
(1)、称取原料药黄芪250g、茯苓100g、灵芝150g、枸杞子300g、丹参200g、丹皮250g、虎杖250g和甘草200g;加水煎煮二次,第一次加10倍量水,加热煎煮2h;第二次加6~8倍量水,加热煎煮1.5h;
(2)、合并二次煎液,静置,滤过,滤液浓缩至稠膏,加乙醇至70%含醇量(即稠膏和乙醇混合物中含醇量为70%),静置;取上清液,回收乙醇至无醇味,浓缩至60℃下相对密度为1.35~1.38的稠膏;
(3)、取步骤(2)所得稠膏,按照稠膏:糊精:糖粉为1:1:3的重量比称取糊精和糖粉,混匀,制粒过14目筛,80~90℃下干燥,整粒,即得中药颗粒剂。
以下通过具体试验例来说明本发明中药颗粒剂(以下称:新肝灵颗粒)所具有的有益效果。
试验例1:
一、材料:
SD大鼠;阳性药水飞蓟素;试验药新肝灵颗粒(由实施例2制备所得);血清纤维化指标放射免疫分析试剂盒。
二、方法:
1、动物分组:SD大鼠60只。体质量为180-200g。随机分6组,每组10只:A组(对照组)、B组(空白模型组)、C1组(新肝灵颗粒小剂量组)、C2组(新肝灵颗粒中剂量组)、C3组(新肝灵颗粒高剂量组)、D组(水飞蓟素对照组)。
2、造模及给药方法:除正常对照组(A组)sc花生油溶液外(2次/周,每次3mL/kg体质量);其余5组同期造模,在无菌条件下sc CCl4花生油溶液(CCl4浓度为400ml/L),2次/周,每次3ml/kg体质量,持续8周。
8周后A、B组大鼠仅给予正常饮食;其余各组在正常饮食同时,C1、C2、C3组每日给予新肝灵颗粒,三组所用药含生药量分别为1.2g/kg体质量、2.5g/kg体质量、5.0g/kg体质量,稀释成不同浓度溶液5mL后ig,1次/天;D组给予水飞蓟素生理盐水5mL ig,1次/天,剂量为50m/kg体质量.连续给药8周后完成.
3、标本检测:采用化学发光法按照试剂盒说明检测肝纤维化指标,包括血清透明质酸酶(HA)、血清Ⅳ型胶原(ⅣC)、血清Ⅲ型前胶原口(ⅢP);取大鼠肝脏作常规HE染色及Masson染色并进行图像分析,观察肝组织纤维化程度及胶原纤维百分比。
统计学处理数据用mean±SD表示,所有数据采用SPSS12.0软件进行分析,不同治疗组与模型组之间比较,定性资料采用χ2检验,定量资料采用,检验进行统计分析,P<0.05为显著性差异。P<0.01为极显著差异。
三、结果:
1、各组大鼠肝脏病理表现如图1所示:
A组肝细胞整齐排列,脂质空泡未见形成,未见汇管区炎症,可见肝小叶结构清晰,肝纤维化及假小叶未见形成;
B组大量脂质空泡可见形成,汇管区可见大量炎性细胞浸润,成纤维细胞大量增生,肝细胞广泛变性呈片状坏死.汇管区可见大量假小叶形成,肝小叶间隔明显增宽和大量胶原纤维沉积;
C1、C2、C3、D组:C1组同B组相比,未见明显差异,大量脂质空泡形成,汇管区可见大量炎性细胞浸润、成纤维细胞增生,肝细胞广泛变性及点状、片状坏死及较多假小叶形成。C2组同模型组相比,脂质空泡有所减少,肝细胞坏死程度有所减轻,假小叶形成较少,仍明显可见、较多胶原纤维沉积。C3、D组同B组相比,脂质空泡明显减少,肝细胞坏死程度明显减轻,假小叶形成、胶原纤维沉积明显减少。
2、各组大鼠肝纤维化病变半定量结果:半定量判断标准见如表1所示。A组大鼠纤维化程度为0,C1、C2、C3和D组大鼠纤维化程度与B组比较,有差异(11.8±4.7,11.1±4.1,6.5±3.2,6.3±2.9vs15.9±5.3.均P<0.05)。以上数据为半定量计数结果,计算公式:L+P+2×(N×W)
表1纤维化半定量计分系统
计分:L+P+2×(N×W):标本内仅—细纤维隔,W计分0.5:间隔宽居二者之间者,计分取平均值。
3、各组大鼠肝纤维化指标定量检测结果:
检测结果如表2所示,C3、D组大鼠血清透明质酸酶(HA)、血清Ⅳ型胶原(IVC)及血清III型前胶原(PIIIP)水平较B组降低(159.67±41.03,179.87±10.03vs289.94±73.03;17.97±1.96,18.02±2.36vs35.03±5.93;20.03±2.96,26.03±4.87vs35.96±7.97;P<0.001或0.05,表2)。
表2各组大鼠肝纤维化结果(mean±SD,μg/L)
aP<0.05,bP<0.001VS B组.
本实验A组大鼠肝组织结构正常,肝细胞未见变性、坏死及脂肪变性,病理切片肝纤维化半定量计分为0;B组大鼠肝组织结构被严重破坏,肝实质少量的纤维组织增生,汇管区炎性细胞浸润,肝细胞发生明显的脂肪变性,周边区可见多量的坏死细胞,肝静脉明显淤血,证实炎症表现及早期肝纤维化形成,病理切片肝纤维化半定量计分为16.1±5.5。按照中华肝脏病学会肝纤维化学组制定的诊断标准,两组肝组织活检肝纤维化半定量计分系统评分相差≥2分为有效,证实造模是成功的。
本实验中,C1、C2、C3组大鼠新肝灵颗粒干预后大鼠的肝纤维化指标、病理检查结果与B组大鼠对应指标比较,均具有显著性差异,证实了新肝灵颗粒具有能够改善肝脏纤维化的作用。新肝灵颗粒干预的三组大鼠的肝纤维化指标与水飞蓟素阳性对照组比较,无统计学差异,提示新肝灵颗粒对CCl4,引起的肝纤维化的治疗作用与公认有效的水飞蓟素的治疗作用相当。
以上所述,仅为本发明的较佳实施例,并非对本发明作任何形式上和实质上的限制,凡熟悉本专业的技术人员,在不脱离本发明技术方案范围内,当可利用以上所揭示的技术内容,而作出的些许更动、修饰与演变的等同变化,均为本发明的等效实施例;同时,凡依据本发明的实质技术对以上实施例所作的任何等同变化的更动、修饰与演变,均仍属于本发明的技术方案的范围内。
Claims (5)
1.一种治疗肝炎的中药组合物,其特征在于,所述中药组合物由下列重量份的原料药组成:黄芪250份、茯苓100份、灵芝150份、枸杞子300份、丹参200份、丹皮250份、虎杖250份和甘草200份。
2.根据权利要求1所述的治疗肝炎的中药组合物,其特征在于,所述中药组合物由下列重量的原料药组成:黄芪250g、茯苓100g、灵芝150g、枸杞子300g、丹参200g、丹皮250g、虎杖250g和甘草200g。
3.一种治疗肝炎的中药颗粒剂,其特征在于,所述中药颗粒剂包括活性成分和药学上可接受的载体;
所述活性成分由原料药黄芪250份、茯苓100份、灵芝150份、枸杞子300份、丹参200份、丹皮250份、虎杖250份和甘草200份通过下述方法制备所得:
(1)、称取上述重量份的原料药,加水煎煮二次,第一次加10倍量水,煎煮2h;第二次加6~8倍量水,煎煮1.5h;
(2)、合并二次煎液,静置,滤过,滤液浓缩至稠膏,加乙醇至70%含醇量,静置;取上清液,回收乙醇至无醇味,浓缩至60℃下相对密度为1.35~1.38的稠膏,即得活性成分。
4.根据权利要求3所述的中药颗粒剂,其特征在于:所述药学上可接受的载体为糊精和糖粉;所述活性成分与糊精、糖粉之间的重量比为1:1:3。
5.一种治疗肝炎的中药颗粒剂的制备方法,其特征在于,所述中药颗粒剂由原料药黄芪250份、茯苓100份、灵芝150份、枸杞子300份、丹参200份、丹皮250份、虎杖250份和甘草200份通过下述方法制备所得:
(1)、称取上述重量份的原料药,加水煎煮二次,第一次加10倍量水,煎煮2h;第二次加6~8倍量水,煎煮1.5h;
(2)、合并二次煎液,静置,滤过,滤液浓缩至稠膏,加乙醇至70%含醇量,静置;取上清液,回收乙醇至无醇味,浓缩至60℃下相对密度为1.35~1.38的稠膏;
(3)、取步骤(2)所得稠膏,按照稠膏:糊精:糖粉为1:1:3的重量比称取糊精和糖粉,混匀,制粒过14目筛,80~90℃下干燥,整粒,即得中药颗粒剂。
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