CN108926672B - 一种治疗系统性红斑狼疮的中药组合物 - Google Patents
一种治疗系统性红斑狼疮的中药组合物 Download PDFInfo
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Abstract
本发明涉及用于治疗系统性红斑狼疮的中药组合物,可有效解决系统性红斑狼疮的无毒副作用治疗的用药问题,其解决的技术方案是,以下重量份数计的原料药物:生石膏10‑60份、生地10‑25份、玄参6‑18份、玉竹3‑15份、僵蚕5‑10份、蝉蜕3‑9份、青蒿5‑20份、旱莲草3‑18份、槐花5‑12份、生藕节6‑30份和鬼箭羽3‑12份制作,将上述原料药物混合在一起,加水浸没,浸泡30‑60分钟,武火煎沸,在文火煮30分钟,过滤得第一次滤液,药渣加水侵泡,武火煎沸,文火煎30分钟,过滤,经第二次滤液,合并两次滤液,混匀,即得。本发明中药汤剂具有清热养阴,透邪解毒,凉血化瘀之功效,成本低、没有明显毒副作用、治疗有效率较高,经济和社会效益显著。
Description
技术领域
本发明涉及医药,特别是一种用于治疗系统性红斑狼疮的中药组合物。
背景技术
系统性红斑狼疮(SLE)是一种病因未明的免疫复合物介导的血管炎,是累及多系统、多器官的具有多种自身抗体的弥漫性结缔组织病。其病因目前认为是在遗传素质的基础上,由于环境因素(如紫外线、病毒、药物、化学品)及神经内分泌等的作用而引发本病。在治疗方面糖皮质激素、免疫抑制剂仍是迄今治疗SLE的主要方案,但长期服用激素及免疫抑制剂可产生明显的毒副作用。因此,治疗系统性红斑狼疮药物上的改进和创新是目前亟需解决的问题。
发明内容
针对上述情况,为克服现有技术之缺陷,本发明之目的就是提供一种用于治疗系统性红斑狼疮的中药组合物,可有效解决系统性红斑狼疮的无毒副作用治疗的用药问题。
本发明解决的技术方案是,一种用于治疗系统性红斑狼疮的中药组合物,由以下重量份数计的原料药物:生石膏10-60份、生地10-25份、玄参6-18份、玉竹3-15份、僵蚕5-10份、蝉蜕3-9份、青蒿5-20份、旱莲草3-18份、槐花5-12份、生藕节6-30份和鬼箭羽3-12份制作,将上述原料药物混合在一起,加水浸没,浸泡30-60分钟,武火煎沸,在文火煮30分钟,过滤得第一次滤液,药渣加水侵泡,武火煎沸,文火煎30分钟,过滤,经第二次滤液,合并两次滤液,混匀,即得。
本发明中药汤剂具有清热养阴,透邪解毒,凉血化瘀之功效,成本低、没有明显毒副作用、治疗有效率较高,是治疗系统性红斑狼疮药物上的创新,经济和社会效益显著。
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详细说明。
本发明在具体实施中,可由以下实施例实现。
实施例1
本发明在具体实施中,可由以下重量计的原料药物:生石膏20-50份、生地15-20份、玄参10-14份、玉竹6-12份、僵蚕6-8份、蝉蜕5-7份、青蒿8-16份、旱莲草8-14份、槐花7-10份、生藕节10-20份、鬼箭羽6-10份,将上述原料药物混合在一起,加水浸没,浸泡30-60分钟,武火煎沸,在文火煮30分钟,过滤得第一次滤液,药渣加水侵泡,武火煎沸,文火煎30分钟,过滤,经第二次滤液,合并两次滤液,混匀,即得。
实施例2
本发明在具体实施中,可由以下重量计的原料药物:生石膏35份、生地16份、玄参12份、玉竹9份、僵蚕7份、蝉蜕13份、青蒿12份、旱莲草11份、槐花9份、生藕节15份、鬼箭羽8份,将上述原料药物混合在一起,加水浸没,浸泡30-60分钟,武火煎沸,在文火煮30分钟,过滤得第一次滤液,药渣加水侵泡,武火煎沸,文火煎30分钟,过滤,经第二次滤液,合并两次滤液,混匀,即得。
实施例3
本发明在具体实施中,一种用于治疗系统性红斑狼疮的中药组合物,制成:生石膏30g、生地15g、玄参14g、玉竹10g、僵蚕8g、蝉蜕12g、青蒿11g、旱莲草10g、槐花8g、生藕节14g和鬼箭羽8g,将上述原料药物混合在一起,加水浸没,浸泡30-60分钟,武火煎沸,在文火煮30分钟,过滤得第一次滤液,药渣加水侵泡,武火煎沸,文火煎30分钟,过滤,经第二次滤液,合并两次滤液,混匀,即得。
实施例4
本发明在具体实施中,一种用于治疗系统性红斑狼疮的中药组合物,可由以下重量计的原料药物制成:生石膏50g、生地12g、玄参16g、玉竹8g、僵蚕9g、蝉蜕5g、青蒿18g、旱莲草7g、槐花10g、生藕节12g、鬼箭羽10g,将上述原料药物混合在一起,加水浸没,浸泡30-60分钟,武火煎沸,在文火煮30分钟,过滤得第一次滤液,药渣加水侵泡,武火煎沸,文火煎30分钟,过滤,经第二次滤液,合并两次滤液,混匀,即得。
实施例5
本发明在具体实施中,一种用于治疗系统性红斑狼疮的中药组合物,可由以下重量计的原料药物制成:生石膏15g、生地22g、玄参8g、玉竹13g、僵蚕6g、蝉蜕8g、青蒿8g、旱莲草16g、槐花7g、生藕节27g、鬼箭羽6g,将上述原料药物混合在一起,加水浸没,浸泡30-60分钟,武火煎沸,在文火煮30分钟,过滤得第一次滤液,药渣加水侵泡,武火煎沸,文火煎30分钟,过滤,经第二次滤液,合并两次滤液,混匀,即得。
上述中药组合物可根据服用的实际需要,按常规方法制成散剂、丸剂、片剂、胶囊、汤剂、口服液或任一种所需用的制剂,本申请请求保护的核心与关键是中药组合物的配伍,不在于剂型,凡是采用本中药组合物制成的任何剂型,均属于本发明请求保护的范围。
在上述药物中:
生石膏:性味甘、辛,大寒。归经归肺、胃经。功能主治清热泻火,除烦止渴。用于外感热病,高热烦渴,肺热喘咳,胃火亢盛,头痛,牙痛。
生地黄:甘,寒。归经归心、肝、肾经。功能主治鲜地黄:清热生津,凉血,止血。用于热病舌绛烦渴,阴虚内热,骨蒸劳热,内热消渴,吐血,衄血,发斑发疹。
玄参:性味甘、苦、咸,微寒。归经归肺、胃、肾经。功能主治凉血滋阴,泻火解毒。用于热病伤阴,舌绛烦渴,温毒发斑,津伤便秘,骨蒸劳嗽,目赤,咽痛,瘰疠,白喉,痈肿疮毒。
玉竹:性味甘,微寒。归经归肺、胃经。功能主治养阴润燥,生津止渴。用于肺胃阴伤,燥热咳嗽,咽干口渴,内热消渴。
僵蚕:性味咸、辛,平。归经归肝、肺、胃经。功能主治祛风定惊,化痰散结。用于惊风抽搐,咽喉肿痛,皮肤瘙痒,颌下淋巴结炎,面神经麻痹。
蝉蜕:性味甘,寒。归经归肺、肝经。功能主治散风除热,利咽,透疹,退翳,解痉。用于风热感冒,咽痛,音哑,麻疹不透,风疹瘙痒,目赤翳障,惊风抽搐,破伤风。
青蒿:性味苦、辛,寒。归经归肝、胆经。功能主治清热解暑,除蒸,截疟。用于暑邪发热,阴虚发热,夜热早凉,骨蒸劳热,疟疾寒热,湿热黄疸。
旱莲草性味甘、酸,寒。归经归肾、肝经。功能主治滋补肝肾,凉血止血。用于牙齿松动,须发早白,眩晕耳鸣,腰膝酸软,阴虚血热、吐血、衄血、尿血,血痢,崩漏下血,外伤出血。
槐花、性味苦,微寒。归经归肝、大肠经。功能主治凉血止血,清肝泻火。用于便血,痔血,血痢,崩漏,吐血,衄血,肝热目赤,头痛眩晕。
生藕节、性味甘、涩,平。归经归肝、肺、胃经。功能主治止血,消瘀。用于吐血,咯血,尿血,崩漏。
鬼箭羽、性味苦;辛;寒。归经肝经。功能主治破血通经;解毒消肿;杀虫。主症瘕结块;心腹疼痛;闭经;痛经;崩中漏下;产后瘀滞腹痛;恶露不下;疝气;历节痹痛;疮肿;跌打伤痛;虫积腹痛;烫火伤;毒蛇咬伤。
本发明中药汤剂具有起效快,疗效稳定,患者依从性好,具有清热养阴,透邪解毒,凉血化瘀之功效,有效改善系统性红斑狼疮发生及进展等优点,并经临床试验取得了满意的效果,有关试验资料如下:
1病例选择
系统性红斑狼疮(SLE)是一种多发于青年女性的累及多脏器的自身免疫性炎症性结缔组织病,早期、轻型和不典型的病例日渐增多。有些重症患者(除患者有弥漫性增生性肾小球肾炎者外),有时亦可自行缓解。有些患者呈“一过性”发作,经过数月的短暂病程后疾病可完全消失。
1.1临床随机选择66名患者。按就诊顺序随机分为治疗组和对照组各33例。治疗组33例:男性3例,女性30例;平均年龄(36.1±10.42)岁;平均病程(25.4±6.93)月。对照组33例:男性2例,女性31例;平均年龄(37.5±7.62)岁;平均病程(24.7±5.47)月。2组一般资料比较无显著性差异(P>0.05),具有可比性。所有患者均符合1997年美国风湿病学会修订的诊断标准,并符合《中药新药临床研究指导原则》中系统性红斑疮的中医辨证标准。
2治疗方案
对照组:给予醋酸泼尼松片0.2~1mg/(kg·d),口服;硫酸羟基氯喹片每次0.1g,每日2次,口服。治疗组:中西医结合治疗,西药用法、用量同前,中药给予本发明中药汤剂150ml,2次/日。
两组均治疗3个月。
3疗效评定:
3.1激素日用量,统计两组患者治疗前后使用糖皮质激素的日平均用量,统一计算为醋酸泼尼松片的用量。
3.2 SLE-DAI评分治疗前后参照临床SLE-DAI积分表[郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002]评价两组患者的SLE-DAI。
3.3疗效标准参照《中药新药临床研究指导原则》[郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002]。
治愈:治疗后主症消失,主要化验指标恢复正常。
显效:治疗后主症好转,主要化验指标趋于正常。
有效:治疗后主症有所改善,主要化验指标数值有所下降。
无效:未达到有效标准,甚至有加重之趋势。
5.1临床疗效
治疗组治愈率为15.2%、显效率为51.5%、有效率为30.3%,无效率为3%,总有效率97%,临床治愈及无效率、总有效率与对照组比较,具有显著性差异。见表1。
表1两组治疗后临床疗效比较n(%)
组别(n) | 治愈 | 显效 | 有效 | 无效 | 总有效率 |
对照组(33) | 3(9) | 14(42.4) | 10(30.3) | 6(18.2) | 27(81.8) |
治疗组(33) | 5(15.2)* | 17(51.5) | 10(30.3) | 1(3)* | 32(96.9)* |
*与对照组比较,P<0.05
5.2 SLEDAI评分
对照组治疗后与本组治疗前比较,SLE-DAI评分降低,有显著统计学意义。治疗组疗后与本组治疗前比较,SLE-DAI评分降低,有显著统计学意义。治疗组治疗后与对照组治疗后比较,SLE-DAI评分降低,有显著统计学意义。具体见表2。
组别 | 例数 | 治疗前 | 治疗后 |
对照组 | 33 | 10.38±2.81 | 5.63±2.19b |
治疗组 | 33 | 10.15±3.05 | 3.78±1.53bc |
与治疗前比较,a、P<0.05,b、P<0.01;与对照组同期比较c、P<0.05
5.3糖皮质激素每日用量
治疗组治疗后与治疗前比较,激素用量显著下降(P<0.01),治疗组治疗后与对照组治疗后比较,激素用量明显降低(P<0.05)。见表3。
组别 | 治疗前 | 疗后3个月 |
对照组 | 29.57±3.75 | 25.64±8.57 |
治疗组 | 28.29±5.36 | 18.36±6.24bc |
与治疗前比较,a、P<0.05,b、P<0.01;与对照组同期比较c、P<0.05
6.结论
综上,本发明中药组合物具有清热养阴,透邪解毒,凉血化瘀之功效,可有效改善系统性红斑狼疮病人临床症状,改善SLE-DAI评分。提高治疗系统性红斑狼疮的临床疗效,有效率达到97%,降低临床激素用量,无毒副作用,是中药上的创新,具有良好的治疗系统性红斑狼疮的效果,有巨大的临床意义。
Claims (4)
1.一种用于治疗系统性红斑狼疮的中药组合物,其特征在于,由以下重量份数计的原料药物:生石膏10-60份、生地10-25份、玄参6-18份、玉竹3-15份、僵蚕5-10份、蝉蜕3-9份、青蒿5-20份、旱莲草3-18份、槐花5-12份、生藕节6-30份和鬼箭羽3-12份制成,将上述原料药物混合在一起,加水浸没,浸泡30-60分钟,武火煎沸,在文火煮30分钟,过滤得第一次滤液,药渣加水浸泡,武火煎沸,文火煎30分钟,过滤,得第二次滤液,合并两次滤液,混匀,即得。
2.根据权利要求1所述的用于治疗系统性红斑狼疮的中药组合物,其特征在于,由以下重量计的原料药物:生石膏20-50份、生地15-20份、玄参10-14份、玉竹6-12份、僵蚕6-8份、蝉蜕5-7份、青蒿8-16份、旱莲草8-14份、槐花7-10份、生藕节10-20份和鬼箭羽6-10份制成,将上述原料药物混合在一起,加水浸没,浸泡30-60分钟,武火煎沸,在文火煮30分钟,过滤得第一次滤液,药渣加水浸泡,武火煎沸,文火煎30分钟,过滤,得第二次滤液,合并两次滤液,混匀,即得。
3.根据权利要求1所述的用于治疗系统性红斑狼疮的中药组合物,其特征在于,由以下重量计的原料药物:生石膏50g、生地12g、玄参16g、玉竹8g、僵蚕9g、蝉蜕5g、青蒿18g、旱莲草7g、槐花10g、生藕节12g和鬼箭羽10g制成,将上述原料药物混合在一起,加水浸没,浸泡30-60分钟,武火煎沸,在文火煮30分钟,过滤得第一次滤液,药渣加水浸泡,武火煎沸,文火煎30分钟,过滤,得第二次滤液,合并两次滤液,混匀,即得。
4.根据权利要求1所述的用于治疗系统性红斑狼疮的中药组合物,其特征在于,由以下重量计的原料药物:生石膏15g、生地22g、玄参8g、玉竹13g、僵蚕6g、蝉蜕8g、青蒿8g、旱莲草16g、槐花7g、生藕节27g和鬼箭羽6g制成,将上述原料药物混合在一起,加水浸没,浸泡30-60分钟,武火煎沸,在文火煮30分钟,过滤得第一次滤液,药渣加水浸泡,武火煎沸,文火煎30分钟,过滤,得第二次滤液,合并两次滤液,混匀,即得。
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