CN117018152A - 一种中药组合物在制备治疗或预防***性红斑狼疮药物中的应用 - Google Patents
一种中药组合物在制备治疗或预防***性红斑狼疮药物中的应用 Download PDFInfo
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- CN117018152A CN117018152A CN202311022006.4A CN202311022006A CN117018152A CN 117018152 A CN117018152 A CN 117018152A CN 202311022006 A CN202311022006 A CN 202311022006A CN 117018152 A CN117018152 A CN 117018152A
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- lupus erythematosus
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Abstract
本申请提出一种中药组合物在制备治疗或预防***性红斑狼疮药物中的应用,该中药组合物包括:厚朴1~100份、焦槟榔1~100份、煨草果1~100份、麻黄1~100份、苦杏仁1~100份、羌活1~100份、生姜1~100份、广藿香1~100份、佩兰1~100份、苍术1~100份、茯苓1~160份、白术1~120份、石膏1~100份、焦山楂1~100份、焦六神曲1~100份、焦麦芽1~100份、地龙1~100份、徐长卿1~100份、绵马贯众1~100份、葶苈子1~100份。该中药组合物能降低小鼠尿蛋白含量和抗ds‑DNA、ANA水平,减轻小鼠肾脏受累程度,对降植烷诱导的***性红斑狼疮小鼠有明显的保护作用。
Description
技术领域
本申请属于中药技术领域,具体涉及中药组合物在制备治疗或预防***性红斑狼疮的药物中的应用。
背景技术
***性红斑狼疮(Systemic lupus erythematosus,SLE)是一种累及多***多脏器的自身免疫性疾病,临床表现复杂多样,病因至今未明,大量研究显示遗传、病毒感染、内分泌失调、免疫异常和一些环境因素与本病的发病有关。本病发病年龄大多为20~40岁,多见于青壮年育龄女性,临床症状较为复杂,病情进展迅速且不易根治,可累及多个脏器***,严重影响患者生命健康和生存质量。目前治疗SLE的主流药物为糖皮质激素、免疫抑制剂类药物,但长期使用激素和免疫抑制剂不可避免的会带来一些严重毒副作用,例如高血脂、高血压、消化道溃疡、动脉粥样硬化性、骨质疏松、股骨头坏死、肝功能损害、骨髓抑制及继发感染等,对患者治疗安全性带来较大隐患。传统医学文献中并无***性红斑狼疮病名,但其临床表现在文献中有类似描述,如“日晒疮”、“蝴蝶丹”、“阴阳毒”等,内因为先天禀赋不足,外因为起居不慎,日光暴晒感受邪毒,七情内伤,劳欲过度等,致脏腑气血阴阳失调,毒热和淤血内生而发病。因此,中医认为其基本病机是先天不足,有以肾阴虚亏为本或后天失养,导致湿热和瘀毒产生,瘀和毒热是***性红斑狼疮的主要病机。
中医在治疗***性红斑狼疮中具有很强的抗炎和消炎作用,并能减少免疫抑制剂的副作用,减少感染肿瘤的发病,中医还有抵抗激素副作用的功能。另外,中医传统医疗保健对***性红斑狼疮的治疗也有很大的帮助。因此,中医药在缓解患者临床症状、减少西药毒副作用及用量、提高患者生存质量等方面,具有较明显的特色和优势,获得较好的疗效。针对开发一种治疗***性红斑狼疮的中药组合物具有显著的社会效益。
发明内容
中医治疗***性红斑狼疮是恢复机体的内在平衡状态或与外界环境的平衡状态以整体观念为指导而进行的辨证论治,以人为本,个体化针对性强,无任何副作用。另外,中药治病讲究辨证论治,针对每一个病人、不同的病情来用药因人施治,使用的药材都是纯天然草药和矿物、卫生环保、毒副作用少,而且质量稳定,价格也比较低。
基于中医的以上种种优点,为解决上述***性红斑狼疮治疗的技术问题,本申请提供了一种中药组合物在制备治疗或预防***性红斑狼疮药物中的应用,该中药组合物包括:厚朴1~100份、焦槟榔1~100份、煨草果1~100份、麻黄1~100份、苦杏仁1~100份、羌活1~100份、生姜1~100份、广藿香1~100份、佩兰1~100份、苍术1~100份、茯苓1~160份、白术1~120份、石膏1~100份、焦山楂1~100份、焦六神曲1~100份、焦麦芽1~100份、地龙1~100份、徐长卿1~100份、绵马贯众1~100份、葶苈子1~100份。所述应用,可以是包括治疗或预防在内的一切有益于改善患者相应症状的方式。
进一步地,该中药组合物包括:厚朴10~80份、焦槟榔10~80份、煨草果10~80份、麻黄10~60份、苦杏仁10~60份、羌活10~80份、生姜10~60份、广藿香10~80份、佩兰10~60份、苍术10~80份、茯苓10~160份、白术10~120份、石膏10~80份、焦山楂10~50份、焦六神曲10~80份、焦麦芽10~60份、地龙10~80份、徐长卿10~80份、绵马贯众10~60份、葶苈子10~80份。
可选地,该中药组合物包括:厚朴30~50份、焦槟榔20~30份、煨草果30~50份、麻黄20~30份、苦杏仁20~30份、羌活30~50份、生姜30~50份、广藿香30~50份、佩兰20~30份、苍术30~50份、茯苓120~150份、白术80~100份、石膏30~50份、焦山楂20~30份、焦六神曲30~50份、焦麦芽20~30份、地龙30~50份、徐长卿30~50份、绵马贯众20~30份、葶苈子30~50份。
具体地,中药组合物还可以是:厚朴50份、焦槟榔30份、煨草果30份、麻黄20份、苦杏仁30份、羌活50份、生姜50份、广藿香50份、佩兰30份、苍术50份、茯苓150份、白术100份、石膏50份、焦山楂30份、焦六神曲30份、焦麦芽30份、地龙50份、徐长卿50份、绵马贯众30份、葶苈子50份。
上述的组合物可以由原料直接研磨成粉,也可以是经过任何常规手段制得的提取物或其它形态等。
具体地,前述治疗***性红斑狼疮的药物包括口服给药剂型、注射给药剂型或外用给药剂型。
根据药物的剂型按比例称取原料药后,在制备中加入药学可接受的辅料,如填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等,按照药学领域的常规生产方法制备,制成药剂学可接受的常规剂型,包括但不限于汤剂、颗粒剂、胶囊剂、片剂、口服液、丸剂、酊剂、糖浆剂、栓剂、凝胶剂、喷雾剂、注射剂。
本申请还提供了前述任一项中药组合物的制备方法,该制备方法包括:按照组方分别称取厚朴、焦槟榔、煨草果、麻黄、苦杏仁、羌活、生姜、广藿香、佩兰、苍术、茯苓、白术、石膏、焦山楂、焦六神曲、焦麦芽、地龙、徐长卿、绵马贯众、葶苈子,分别加水提取两次,第一次加6倍量水,提取1.5小时,第二次加4倍量水,提取1.0小时,合并提取液,过滤,滤液浓缩至相对密度1.10~1.15,离心滤过,滤液真空干燥,喷雾干燥粉碎,即得。
进一步地,上述中药组合物颗粒的制备方法步骤如下:
按照组方分别取厚朴50份、焦槟榔30份、煨草果30份、麻黄20份、苦杏仁30份、羌活50份、生姜50份、广藿香50份、佩兰30份、苍术50份、茯苓150份、白术100份、石膏50份、焦山楂30份、焦六神曲30份、焦麦芽30份、地龙50份、徐长卿50份、绵马贯众30份、葶苈子50份,加入水回流提取2次,第一次加入6倍水,提取1.5小时,第二次加入4倍水,提取1.0小时,合并提取液,过滤,滤液浓缩至相对密度1.10~1.15,离心滤过,滤液真空干燥,喷雾干燥,得中间体组合物,加入三氯蔗糖和糊精,混匀,得颗粒剂。
发明的有益效果
本申请提供的中药组合物能显著降低降植烷诱导的***性红斑狼疮小鼠模型尿蛋白含量,减轻小鼠肾脏受累程度;显著降低抗ds-DNA(抗双链DNA抗体)和ANA(抗核抗体)水平,对降植烷诱导的***性红斑狼疮小鼠模型有明显的保护作用,提示中药组合物对***性红斑狼疮具有一定的治疗作用。
具体实施方式
本申请旨在提供一种中药组合物在制备治疗或预防***性红斑狼疮的药物中的应用。为了使得本领域技术人员能够更加清楚地了解本申请的技术方案,以下将结合具体的实施例详细说明本申请的技术方案。以下实验如未注明具体条件者,均按照常规条件或制造商建议的条件进行,所用原料药或辅料,以及所用试剂或仪器未注明生产厂商者,均为可以通过市购获得的常规产品。未注明详细条件的实验方法是按照常规试验方法或按照供应商所建议的操作说明书进行的。
应该指出,以下详细说明都是例示性的,旨在对本申请提供进一步的说明。除非另有指明,本文使用的所有技术和科学术语具有与本申请所属技术领域的普通技术人员通常理解的相同含义。以下实施例仅是为了进一步阐明本申请的技术方案,而不是用来限制本申请的保护范围。
实施例1组合物颗粒剂的制备
按照组方分别称取以下原料药:厚朴50份、焦槟榔30份、煨草果30份、麻黄20份、苦杏仁30份、羌活50份、生姜50份、广藿香50份、佩兰30份、苍术50份、茯苓150份、白术100份、石膏50份、焦山楂30份、焦六神曲30份、焦麦芽30份、地龙50份、徐长卿50份、绵马贯众30份、葶苈子50份。将上述称取的药材,加入水回流提取2次,第一次加入6倍水,提取1.5小时,第二次加入4倍水,提取1.0小时,合并提取液,过滤,滤液浓缩至相对密度1.10~1.15,离心滤过,滤液真空干燥,喷雾干燥粉碎,得中间体,加入三氯蔗糖和糊精,混匀,得颗粒剂。
实验例1对***性红斑狼疮小鼠模型尿蛋白的影响
建立动物模型:将36只6~8周龄,体重为18~22g的SPF级BALB/c雌性小鼠在SPF环境下适应性饲养7天后,采用随机数字表法,随机抽取6只作为对照组,正常饲料喂养饮水。其余30只进行造模,给予一次性腹腔注射0.5mL降植烷(上海源叶生物科技有限公司,100mL,货号S44062)进行造模,对照组一次性腹腔注射0.5mL生理盐水。
在造模24小时后,开始分别给药,将小鼠随机分为模型组、组合物高、中、低剂量组(组合物为实施例1制备)、醋酸***组(浙江仙琚制药股份有限公司,规格:5mg*100片/盒,产品批号:LA22243),每组各6只。根据***片成人临床用法用量:口服一次5-10mg(1-2片),一日10-60mg(2-12片)。成人体重以60kg计算,则成人日用量为60mg/60kg=1mg/kg。小鼠用量的等效量为1mg/kg×9.1=9.1mg/kg。按照计算剂量各给药组小鼠灌胃给药,每天1次,每周5次,整体试验周期为6个月,小鼠喂药剂量为按动物体重每次灌胃0.1mL/10g。对照组、模型组均每日灌相同体积的蒸馏水,每天1次,每周5次,整体试验周期为6个月。
在小鼠注射降植烷或生理盐水后,每月采用尿蛋白试纸(桂林优利特医疗电子有限公司,批号20152400047)测定1次小鼠尿蛋白,根据试纸反应区显色程度与试纸标准色版进行比对,判断尿蛋白含量范围(g/L):(-):0;(±):0.15~0.30;(+):0.30~1.00;(++):1.00~3.00;(+++):3.00~5.00;(++++):≥5.00。
实验结果显示:对照组的尿蛋白量≤±,不随时间改变而增加,模型组注射降植烷后1个月开始出现蛋白尿,多为++或+++,表明造模成功。而组合物中、高剂量组相较模型组均有明显改善,多为±或+,见表1。
表1小鼠尿蛋白跟踪监测数据
注:出现率是指根据试纸反应区显色程度判断尿蛋白含量后,结果分别判定为(-)、(±)、(+)、(++)、(+++)、(++++)的小鼠个数与该组小鼠总个数的比值。
实验例2对***性红斑狼疮小鼠模型血清中抗ds-DNA、ANA的影响
小鼠模型建立和给药方式与实施例1相同,小鼠腹腔注射降植烷或生理盐水后的1、2、3、4、5、6个月,于眼眶静脉丛采取小鼠外周血,4℃静置2小时后离心(3500r/min)12min(冷冻离心机,eppendorf,5804R),分别取血清移入EP管中,采用小鼠抗双链DNA抗体(ds-DNA)ELISA试剂盒(上海研谨生物科技有限公司,货号:F02112)和小鼠抗核抗体(ANA)ELISA检测试剂盒(上海酶联生物科技,货号:ml002245)按照各试剂盒说明书,每月测定1次抗ds-DNA和ANA浓度,用酶标仪(Molecular Devices公司)读取数值,共测定6次。采用GraphPadprism 7统计软件进行数据处理,所有数据以均数±标准差来表示。选择单因素方差分析(One-way ANOVA)检验联合Dunnett的多重比较测试方法进行数据统计分析,P<0.05代表数据具有统计意义。
实验结果显示:与正常对照组相比,模型组小鼠抗ds-DNA浓度显著高于对照组(P<0.001)。与模型组比较,组合物中、高剂量组可显著降低小鼠抗ds-DNA浓度(P<0.05、P<0.01、P<0.001)。对于ANA,与正常对照组相比,模型组小鼠ANA浓度显著高于对照组(P<0.001)。与模型组比较,中药组合物中、高剂量组可显著降低小鼠ANA浓度(P<0.05、P<0.001)。结果见表2和表3。
表2抗ds-DNA浓度(n=6)
注:与空白对照组相比,###P<0.001;与模型组相比,**P<0.01,***P<0.001。
表3ANA浓度(n=6)
注:与空白对照组相比,###P<0.001;与模型组相比,*P<0.05,**P<0.01,***P<0.001。
本申请所提出的中药组合物能显著降低模型动物的尿蛋白含量和降低抗ds-DNA和ANA水平。
本申请的上述实施例仅是为了能够清楚地说明本申请所作的举例,而并非是对本申请的实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。凡在本申请的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本申请权利要求的保护范围之内。
Claims (8)
1.一种中药组合物在制备治疗或预防***性红斑狼疮的药物中的应用,其特征在于,所述中药组合物包括:厚朴1~100份、焦槟榔1~100份、煨草果1~100份、麻黄1~100份、苦杏仁1~100份、羌活1~100份、生姜1~100份、广藿香1~100份、佩兰1~100份、苍术1~100份、茯苓1~160份、白术1~120份、石膏1~100份、焦山楂1~100份、焦六神曲1~100份、焦麦芽1~100份、地龙1~100份、徐长卿1~100份、绵马贯众1~100份、葶苈子1~100份。
2.根据权利要求1所述的应用,其特征在于,所述中药组合物包括:厚朴10~80份、焦槟榔10~80份、煨草果10~80份、麻黄10~60份、苦杏仁10~60份、羌活10~80份、生姜10~60份、广藿香10~80份、佩兰10~60份、苍术10~80份、茯苓10~160份、白术10~120份、石膏10~80份、焦山楂10~50份、焦六神曲10~80份、焦麦芽10~60份、地龙10~80份、徐长卿10~80份、绵马贯众10~60份、葶苈子10~80份。
3.根据权利要求2所述的应用,其特征在于,所述中药组合物包括:厚朴30~50份、焦槟榔20~30份、煨草果30~50份、麻黄20~30份、苦杏仁20~30份、羌活30~50份、生姜30~50份、广藿香30~50份、佩兰20~30份、苍术30~50份、茯苓120~150份、白术80~100份、石膏30~50份、焦山楂20~30份、焦六神曲30~50份、焦麦芽20~30份、地龙30~50份、徐长卿30~50份、绵马贯众20~30份、葶苈子30~50份。
4.根据权利要求1~3任一所述的应用,其特征在于,所述***性红斑狼疮药物的剂型包含口服给药剂型、注射给药剂型或外用给药制剂。
5.根据权利要求4所述的应用,其特征在于,所述***性红斑狼疮药物的剂型包括汤剂、颗粒剂、胶囊剂、片剂、口服液、丸剂、酊剂、糖浆剂、凝胶剂、喷雾剂、注射液。
6.根据权利要求1~3任一所述的应用,其特征在于,所述中药组合物制备方法包括:按照组方分别称取厚朴、焦槟榔、煨草果、麻黄、苦杏仁、羌活、生姜、广藿香、佩兰、苍术、茯苓、白术、石膏、焦山楂、焦六神曲、焦麦芽、地龙、徐长卿、绵马贯众、葶苈子,加入水回流提取2次,合并提取液,过滤,将滤液浓缩滤过后干燥粉碎,即得。
7.根据权利要求6所述的应用,其特征在于,所述中药组合物的制备方法包括:第一次回流提取加入6倍水,提取1.5小时,第二次回流提取加入4倍水,提取1.0小时;将两次的提取液合并过滤后,浓缩至相对密度1.10~1.15,离心滤过,滤液真空干燥,喷雾干燥粉碎,即得。
8.根据权利要求1~3任一所述的应用,其特征在于,所述中药组合物颗粒的制备方法包括:按照组方分别称取厚朴、焦槟榔、煨草果、麻黄、苦杏仁、羌活、生姜、广藿香、佩兰、苍术、茯苓、白术、石膏、焦山楂、焦六神曲、焦麦芽、地龙、徐长卿、绵马贯众、葶苈子,加入水回流提取2次,第一次加入6倍水,提取1.5小时,第二次加入4倍水,提取1.0小时,合并提取液,过滤,滤液浓缩至相对密度1.10~1.15,离心滤过,滤液真空干燥,喷雾干燥粉碎,得中间体组合物,加入三氯蔗糖和糊精,混匀,得颗粒剂。
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