CN114099585A - 一种治疗过敏性紫癜的中药组合物及其制备方法、应用 - Google Patents
一种治疗过敏性紫癜的中药组合物及其制备方法、应用 Download PDFInfo
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- CN114099585A CN114099585A CN202210027380.2A CN202210027380A CN114099585A CN 114099585 A CN114099585 A CN 114099585A CN 202210027380 A CN202210027380 A CN 202210027380A CN 114099585 A CN114099585 A CN 114099585A
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Abstract
本发明属于中药技术领域,具体公开一种治疗过敏性紫癜的中药组合物及其制备方法。该中药组合物按重量份数计由以下原料组成:水牛角15‑30份、生地黄15‑30份、赤芍6‑15份、牡丹皮6‑15份、紫草25‑35份、黄芩6‑12份、连翘10‑20份、乌梅6‑15份、生甘草3‑8份、雷公藤15‑25份、忍冬藤25‑35份、络石藤25‑35份。本发明提供的中药组合物对血热妄行证非肾炎型反复发作的过敏性紫癜具有较佳的疗效,且选用的原料来源于天然植物,制备过程中也未添加任何化学试剂,安全无毒副作用。
Description
技术领域
本发明属于中药技术领域,具体公开一种治疗过敏性紫癜的中药组合物及其制备方法、应用。
背景技术
过敏性紫癜是儿童常见的,以白细胞破碎性小血管炎为主要病理改变的全身综合征,临床可表现为反复皮肤紫癜伴腹痛、关节痛及肾脏损伤,其中皮疹反复是导致肾脏损伤的独立危险因素,部分迁延不愈者可能发生更严重的肾损害,甚至进展为终末期肾病,严重威胁患儿生命健康,因此需尽早干预治疗,减少疾病反复。
目前治疗方面,临床多以抗过敏、改善血管通透性以及对症治疗为主,但多为经验治疗,缺乏高级别循证医学证据支持,且部分西医方案虽有疗效,却有一定的副作用以及治疗费用较高的问题。因此,研究一种安全性高、疗效佳的治疗反复发作性过敏性紫癜的药物以尽早控制皮疹,减少肾脏损伤具有较大的意义。
发明内容
针对以上技术问题,本发明提供以下技术方案:
本发明提供一种治疗过敏性紫癜的中药组合物,其按重量份数计由以下原料组成:水牛角15-30份、生地黄15-30份、赤芍6-15份、牡丹皮6-15份、紫草25-35份、黄芩6-12份、连翘10-20份、乌梅6-15份、生甘草3-8份、雷公藤15-25份、忍冬藤25-35份、络石藤25-35份。
优选地,其按重量份数计由以下原料组成:水牛角15份、生地黄30份、赤芍10份、牡丹皮10份、紫草30份、黄芩6份、连翘15份、乌梅10份、生甘草6份、雷公藤20份、忍冬藤30份、络石藤30份。
本发明还提供一种治疗过敏性紫癜的中药组合物的制备方法,包括以下步骤:按重量份数称取各原料,混合,加水煎煮,所得煎煮液过滤,即得所述中药组合物。
优选地,所述加水煎煮是第一次加入相当于原料总量8-12倍量的水,煎煮1.5-2.0h,过滤,收集第一次滤液,所得滤渣继续加入相当于其总重量6-8倍量的水,煎煮1.0-1.5h,过滤,收集第二次滤液,合并第一次滤液及第二次滤液,即得所述煎煮液。
本发明提供的上述中药组合物能够用于制备治疗血热妄行证非肾炎型反复发作的过敏性紫癜的药物。
本发明还提供一种治疗过敏性紫癜的中药制剂,其包括上述任一项所述的中药组合物,以及药学上可接受的辅料或载体。
本方专为血热妄行证非肾型反复发作性过敏性紫癜而设。方中以苦咸性寒之水牛角为君药,直入血分,清心肝而解热毒,且寒而不凉遏;生地味甘性寒,善于清解营血分之热而有凉血止血之功,既可助水牛角清热凉血,又能滋阴生津以复已失之阴血;牡丹皮苦寒入血分,善于清解营血分实热,具有凉血而不留瘀,活血而不动血的特点,可收化斑之效,赤芍味苦微寒,清热解毒,凉血散瘀,于热盛出血者尤宜,紫草咸寒入肝经血分,既能凉血活血,又善解毒透疹,与生地、丹皮、赤芍共为臣药,如此君臣相合,凉血与活血散瘀并用,以凉血解毒为重,使热清血宁而无耗血动血之虑,凉血止血又无冰伏留瘀之弊,用药甚合血热妄行之病机。黄芩、忍冬藤、络石藤、连翘、乌梅、雷公藤为佐药,黄芩苦寒,能清热泻火,凉血止血,“六气皆从火化”,且小儿素体热盛,邪气蕴结日久易化毒化火动血,正所谓“无毒不生斑”,可见热毒雍盛,蕴结不去,灼伤脉络亦是病机关键,故治疗上当解热毒,散郁结,而黄芩泻火解毒之力较强,与君臣之药相合可增强解毒凉血之效;忍冬藤性寒味甘,清热解毒之力较弱而清热疏风作用突出;连翘性味苦寒,外可疏散风热,内可清热解毒,两药相配可轻清透邪,使初入营血分之热有外透之机,以求“透热转气”;乌梅性酸、涩,功擅收敛可防血“溢”,水牛角清热凉血以治“瘀”,乌梅又可助水牛角清营凉血之力,二者相得益彰;且乌梅与生地、紫草相配,酸甘化阴,养血生血;络石藤、忍冬藤俱为藤蔓之属,缠绕蔓延,犹如网络,纵横交错无所不至,功擅入经络搜邪,既可祛除深伏络脉之邪气,又可引药入经,达到通经活络之功;雷公藤性寒味苦辛,功擅祛风除湿,活血通络,解毒消肿,乃为反复发作性过敏性紫癜专设,与络石藤、忍冬藤相伍控制皮疹疗效显著;生甘草解毒和中,调和诸药,以为使药。诸药相合,共奏清热凉血解毒、活血通络化斑之功,使血热得除,血分安宁,紫癜自消。
对比现有技术,本发明的有益效果为:
本发明提供的中药组合物对血热妄行证非肾炎型反复发作的过敏性紫癜具有较佳的疗效,且本发明选用的原料来源于天然植物,制备过程中也未添加任何化学试剂,安全无毒副作用。
具体实施方式
下面结合具体实施方式进行详细描述,但应当理解本发明的保护范围并不受具体实施方式的限制。
实施例1
一种治疗过敏性紫癜的中药组合物,其由以下原料组成:水牛角15g、生地黄15g、赤芍6g、牡丹皮6g、紫草25g、黄芩6g、连翘10g、乌梅6g、生甘草3g、雷公藤15g、忍冬藤25g、络石藤25g。
实施例2
一种治疗过敏性紫癜的中药组合物,其由以下原料组成:水牛角18g、生地黄20g、赤芍15g、牡丹皮8g、紫草35g、黄芩12g、连翘18g、乌梅8g、生甘草8g、雷公藤15g、忍冬藤28g、络石藤28g。
实施例3
一种治疗过敏性紫癜的中药组合物,其由以下原料组成:水牛角15g、生地黄30g、赤芍10g、牡丹皮10g、紫草30g、黄芩6g、连翘15g、乌梅10g、生甘草6g、雷公藤20g、忍冬藤30g、络石藤30g。。
实施例4
一种治疗过敏性紫癜的中药组合物,其由以下原料组成:水牛角15g、生地黄18g、赤芍12g、牡丹皮12g、紫草35g、黄芩12g、连翘13g、乌梅13g、生甘草3g、雷公藤20g、忍冬藤35g、络石藤35g。
实施例5
一种治疗过敏性紫癜的中药组合物,其由以下原料组成:水牛角30g、生地黄30g、赤芍8g、牡丹皮15g、紫草32g、黄芩10g、连翘20g、乌梅20g、生甘草5g、雷公藤25g、忍冬藤35g、络石藤35g。
上述实施例提供的中药组合物的制备方法为:称取各原料,混合,第一次加入相当于原料总量8倍量的水,煎煮1.5h,过滤,收集第一次滤液,所得滤渣继续加入相当于其总重量6倍量的水,煎煮1.0h,过滤,收集第二次滤液,合并第一次滤液及第二次滤液,过滤,即得。
实施例6
一种治疗过敏性紫癜的中药组合物,与实施例1的不同在于制备方法不同,具体为:称取各原料,混合,第一次加入相当于原料总量12倍量的水,煎煮2.0h,过滤,收集第一次滤液,所得滤渣继续加入相当于其总重量8倍量的水,煎煮1.5h,过滤,收集第二次滤液,合并第一次滤液及第二次滤液,过滤,即得。
由于实施例1-5制备得到的中药组合物的效果基本相同,故以下仅以实施例3为例进行效果说明。
1、资料
筛选河南中医药大学儿科肾脏病区2~18岁辨证为血热妄行证非肾炎型反复发作的HSP(过敏性紫癜,Henoch-Schonlein purpura)的门诊及住院患儿为研究对象,随机分为中医组及西医组,中医组采用本发明实施例3提供的中药组合物治疗,西医组予氯雷他定+维生素C片+泼尼松片治疗,2组患儿共治疗4周,随访8周,每周评价患儿的皮疹疗效及全身症状缓解情况,观察不良反应,统计肾损发生率,并检测0~4周患儿的血尿常规、24小时尿蛋白、肝肾功及0周、4周免疫六项指标水平,进行统计分析。
2、临床诊断标准
西医诊断标准:
过敏性紫癜诊断标准参照“江载芳,申昆玲等主编的诸福棠《实用儿科学》第8版”:
①发病前1-3周有上呼吸道感染史或服用某些食物、药物等病史。
②发病较急,以皮肤紫癜为主要临床表现,多见于双下肢伸侧及臀部,对称分布,分批出现,形态不一,高出皮面,压之不退色,可融合成片形成瘀斑,可伴有荨麻疹、血管神经水肿、关节疼痛、腹痛等。
③血小板计数正常或升高,出血、凝血时间、血块收缩时间均正常。
④排除其他疾病引起的血管炎及紫癜。
中医辨证分型标准:
参照过敏性紫癜中医诊疗指南及“十三·五”国家级规划教材《中医儿科学》:
血热妄行证
血热主症:皮肤骤见青紫或鲜紫色瘀点瘀斑,此起彼伏;
血热次症:身热烦渴、面红目赤,可伴有齿衄、鼻衄,甚或便血、尿血,舌质红绛,苔黄燥,脉数有力。
中医症状量化评分标准:参考《中药新药临床研究指导原则》第一版,具体见表1及表2。
表1皮疹(主症)评分标准
表2次症量化评分标准
3、纳入排除标准
(1)纳入病例标准
①符合西医诊断标准;
②3岁≤年龄≤16岁;
③符合辨证分型血热妄行证;
④法定监护人及受试者定期坚持门诊治疗及随访;
⑤患儿及患儿家属同意并签署知情同意书。
(2)排除标准
①不符合中西医诊断标准者;
②符合中西医诊断标准,但伴有严重消化道症状或肾脏损伤表现者;
③合并其他脏器损害;
④伴有原发性心血管、肝、肾及造血系统和精神、神经系统疾病;
⑤同时患有其它急慢性疾病者(如免疫缺陷病等)。
(3)脱落标准
筛选合格进入临床研究的受试者,无论任何原因退出,只要未完成研究方案的治疗周期,均为脱落病例;未满疗程,但临床症状自愈者不作为脱落病例。
(4)剔除标准
病例纳入后,发现不符合纳入标准者;患者依从性差,未按规定用药,自行加用或改用其它药物,无法评价疗效者。
4、疗效评定标准
(1)皮疹(主症)疗效判定参照《中药新药临床研究指导原则》[8]。
①临床控制:皮疹全部消退持续无新出;
②显效:皮疹消退≥70%或皮疹全部消退,但治疗期间紫癜少量新出1~2次;
③有效:70%>皮疹消退≥30%;或皮疹全部消退,但治疗期间紫癜少量新出3~5次;
④无效:皮疹消退不足30%;或皮疹全部消退,但反复新出>5次。
(2)临床疗效评价综合中医量化总积分以及尿常规检查,参考《中药新药临床研究指导原则》试行版,分为临床控制、显效、好转、无效。
①临床控制:症状、体征消失或基本消失,疗效指数≥95%,尿常规无异常;
②显效:症状、体征显著改善,疗效指数≥70%,尿常规无异常;
③有效:症状、体征均有减轻,疗效指数≥30%,尿常规无显著异常;
④无效:症状、体征均无改善或加重,疗效指数<30%,尿常规示血尿或蛋白尿者。
计算公式(尼莫地平法)为:
疗效指数(n)=[治疗前积分-治疗后积分/治疗前积分疗效指数]×100%
5、实验方法和步骤
5.1、受试者招募和分组
采用门诊和住院病历筛选方法,招募符合纳入标准的辨证属于血热妄行证的HSP患儿90例,采用随机的方法,随机分为实施例3组45例、西医组45例,并登记受试者信息,签署知情同意书后进入临床研究。
5.2、受试者临床治疗
1)中医组治疗方案:予实施例3提供的中药组合物,总疗程共4周。
2)西医组治疗方案:氯雷他定+维生素C片+醋酸泼尼松片,疗程共4周。
①氯雷他定片(开瑞坦,规格:10mg/片×6片,拜耳医药上海股份有限公司,国药准字H10970410)。用法用量:12岁以上的儿童,每次10mg,日1次;2~12岁儿童,体重>30kg,每次10mg,日1次;体重≤30kg,每次5mg,日1次。
②维生素C片(规格:100mg/片×100片,华南药业有限公司,国药准字H44020774)。用法用量:100mg~300mg/kg·d。
③醋酸泼尼松片:浙江仙琚制药有限公司,每片5mg,符合GMP标准,国药准字号H33021207。予泼尼松片1mg/kg/d进行口服,分3次,3天后改为晨起顿服,2天减5mg,直至减停,最大量不超过80mg。
6、统计分析
结果采用SPSS23.0软件进行统计分析。计数资料以频数、百分比表示;计量资料选用均数±标准差表示;计数资料用χ2检验和Fisher确切概率法统计;计量资料符合正态分布及方差齐性时,两组间选用两独立样本t检验,计量资料不符合正态分布及方差齐性时,两组间选用Mann-Whitney U秩和检验。
7、测定指标
1)疗效指标:①主要疗效指标:皮疹疗效(包括皮疹消退时间、皮疹消退数量、皮疹复发次数);②次要疗效指标:全身症状缓解情况(中医症状量化积分),治疗0~4周各记录一次。
2)检查指标:0~4周检测血常规、尿常规、24小时检四项、肝肾功;治疗0周、4周免疫六项水平。
3)安全指标:每周观察患儿的白细胞、肝酶、消化道症状(腹痛、恶心、呕吐、腹泻等)、生殖系统症状(女性患儿月经情况)。
8、结果
对最终纳入的84例(治疗组43例、对照组41例)反复发作性过敏性紫癜患儿进行观察,发现消癜通络方能显著促进皮疹消退、改善中医症状积分,其皮疹疗效(93.02%vs73.17%)、临床疗效(95.35%vs75.61%)显著优于对照组常规方案(P<0.05),且两者安全性无统计学差异。具体如下:
8.1、皮疹(主症)疗效比较
治疗4周后,治疗组有效者40例,占93.02%,无效者3例,占6.98%;对照组有效者30例,占73.17%,无效者11例,占26.83%,两组患儿皮疹疗效比较具有统计学差异(P<0.05),见表3。
表3两组患儿皮疹疗效比较
8.2、临床疗效比较
治疗4周后,治疗组有效者41例,占95.35%,无效者2例,占4.65%;对照组有效者31例,占75.61%,无效者10例,占24.39%,两组患儿临床疗效比较具有统计学差异(P<0.05),见表4。
表4两组患儿临床疗效比较
8.3、治疗前后皮疹(主症)积分、总积分的比较
治疗4周,两组皮疹(主症)积分、中医症状量化总积分较治疗前均显著下降,具有统计学差异(P<0.05);治疗组与对照组治疗后皮疹(主症)积分、总积分间均有统计学差异(P<0.05),见表5。
表5两组患儿治疗前后皮疹(主症)积分、总积分比较
注:与治疗前相比,aP<0.05
8.4、安全性比较
两组患儿治疗期间不良反应发生率如表6所示。
治疗组白细胞下降1例,谷草转氨酶升高1例,恶心者1例。对照组谷草转氨酶升高3例,腹痛者1例,经对症治疗后缓解,不影响治疗。两组不良事件反应发生率分别为6.98%、9.76%,差异无统计学差异(P>0.05)。
表6两组患儿治疗期间不良反应发生率
以上公开的仅为本发明的几个具体实施例,但是,本发明实施例并非局限于此,任何本领域的技术人员能思之的变化都应落入本发明的保护范围。
Claims (6)
1.一种治疗过敏性紫癜的中药组合物,其特征在于,其按重量份数计由以下原料组成:水牛角15-30份、生地黄15-30份、赤芍6-15份、牡丹皮6-15份、紫草25-35份、黄芩6-12份、连翘10-20份、乌梅6-15份、生甘草3-8份、雷公藤15-25份、忍冬藤25-35份、络石藤25-35份。
2.根据权利要求2所述的治疗过敏性紫癜的中药组合物,其特征在于,其按重量份数计由以下原料组成:水牛角15份、生地黄30份、赤芍10份、牡丹皮10份、紫草30份、黄芩6份、连翘15份、乌梅10份、生甘草6份、雷公藤20份、忍冬藤30份、络石藤30份。
3.根据权利要求1或2所述的治疗过敏性紫癜的中药组合物的制备方法,其特征在于,包括以下步骤:按重量份数称取各原料,混合,加水煎煮,所得煎煮液过滤,浓缩,即得所述中药组合物。
4.根据权利要求3所述的治疗过敏性紫癜的中药组合物的制备方法,其特征在于,所述加水煎煮是第一次加入相当于原料总量8-12倍量的水,煎煮1.5-2.0h,过滤,收集第一次滤液,所得滤渣继续加入相当于其总重量6-8倍量的水,煎煮1.0-1.5h,过滤,收集第二次滤液,合并第一次滤液及第二次滤液,即得所述煎煮液。
5.一种权利要求1或2所述的中药组合物在制备治疗血热妄行证非肾炎型反复发作的过敏性紫癜的药物中的应用。
6.一种治疗过敏性紫癜的中药制剂,其特征在于,其包括权利要求1或2所述的中药组合物,以及药学上可接受的辅料或载体。
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