CN113230199A - 一种外用中药制剂配方 - Google Patents
一种外用中药制剂配方 Download PDFInfo
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Abstract
本发明涉及中药复方配伍方剂的技术领域,特别是涉及一种外用中药制剂配方,其本次研究通过临床观察可以提供有效的组方,实现科研成果的高效转化和市场推广,推动中医药科技成果的转化,带动中医药皮肤健康产业的持续发展,形成良好的经济效益和社会效益;针对红斑类皮肤问题的中药复方配伍方剂,有以下质量百分配比的原料组成:黄柏10‑20、黄连5‑10、黄芩5‑10、马齿苋10‑30、鱼腥草10‑30、野菊花10‑30、寒水石10‑30、石膏10‑30、白芨10‑30、地骨皮10‑20、地榆10‑30、槐花10‑30、赤芍10‑30、甘草10‑30。
Description
技术领域
本发明涉及中药复方配伍方剂的技术领域,特别是涉及一种外用中药制剂配方。
背景技术
外用中药制剂配方是一种红斑类皮肤问题的中药复方,玫瑰痤疮等红斑类的皮肤问题虽然是临床常见问题,单纯的应用西医治疗虽然有一定疗效,但大剂量、长时期的服用抗生素,运用光电疗法等容易导致机体产生耐药,皮肤屏障功能受损,而且有复发率较高,不良反应较大,治疗效果无法达到预期要求,外用药物还易引发局部刺激、皮肤干燥以及过敏等不良反应,并且目前市场上关于临床组方的有效的化妆品相对较少,大多数都是基于单味中药或单味植物药组合而成,缺乏必要的中医基础理论和组方研究。
发明内容
为解决上述技术问题,本发明提供一种研究通过临床观察可以提供有效的组方,实现科研成果的高效转化和市场推广,推动中医药科技成果的转化,带动中医药皮肤健康产业的持续发展,形成良好的经济效益和社会效益的一种外用中药制剂配方。
本发明的一种外用中药制剂配方,针对红斑类皮肤问题的中药复方配伍方剂,有以下质量百分配比的原料组成:
黄柏10-20、黄连5-10、黄芩5-10、马齿苋10-30、鱼腥草10-30、野菊花10-30、寒水石10-30、石膏10-30、白芨10-30、地骨皮10-20、地榆10-30、槐花10-30、赤芍10-30、甘草10-30。
本发明的一种外用中药制剂配方,针对红斑类皮肤问题的中药复方配伍方剂,功效为:
(1)黄连、黄柏、黄芩、寒水石、石膏为大寒之品,有清热泻火之功,配合具有清热凉血之功的槐花、地堬,针对红斑。
(2)马齿苋、野菊花、鱼腥草清热解毒,配合具有清热燥湿之功的黄柏、黄连,针对脓疱。
(3)地骨皮、麦冬滋阴凉血,针对红斑类皮肤及用药后可能出现的脱屑等现象。
(4)白芨消肿生肌,起到促进皮肤再生的作用。
本发明的一种外用中药制剂配方,本次研究通过临床观察可以提供有效的组方,组方包括以下步骤:
1、资料与方法。
2、结果。
3、讨论。
本发明的一种外用中药制剂配方,在选方用药上也选用了化妆品目录的药物;通过在选方用药上选用了化妆品目录的药物,方便进行成果转化,实现科研成果的高效转化和市场推广,推动中医药科技成果的转化,带动中医药皮肤健康产业的持续发展,形成良好的经济效益和社会效益。
与现有技术相比本发明的有益效果为:黄连、黄柏、黄芩、寒水石、石膏为大寒之品,有清热泻火之功,配合具有清热凉血之功的槐花、地堬,针对红斑;马齿苋、野菊花、鱼腥草清热解毒,配合具有清热燥湿之功的黄柏、黄连,针对脓疱;地骨皮、麦冬滋阴凉血,针对红斑类皮肤及用药后可能出现的脱屑等现象;白芨消肿生肌,起到促进皮肤再生的作用,诸药合用,既可清透肌肤郁热,又可凉血生肌、润泽肌肤,从而达到治疗修复的效果。
具体实施方式
下面对本发明的具体实施方式作进一步详细描述。以下实施例用于说明本发明,但不用来限制本发明的范围。
本发明的一种外用中药制剂配方,针对红斑类皮肤问题的中药复方配伍方剂,有以下质量百分配比的原料组成:
黄柏10-20、黄连5-10、黄芩5-10、马齿苋10-30、鱼腥草10-30、野菊花10-30、寒水石10-30、石膏10-30、白芨10-30、地骨皮10-20、地榆10-30、槐花10-30、赤芍10-30、甘草10-30。
本发明的一种外用中药制剂配方,针对红斑类皮肤问题的中药复方配伍方剂,功效为:
(1)黄连、黄柏、黄芩、寒水石、石膏为大寒之品,有清热泻火之功,配合具有清热凉血之功的槐花、地堬,针对红斑。
(2)马齿苋、野菊花、鱼腥草清热解毒,配合具有清热燥湿之功的黄柏、黄连,针对脓疱。
(3)地骨皮、麦冬滋阴凉血,针对红斑类皮肤及用药后可能出现的脱屑等现象。
(4)白芨消肿生肌,起到促进皮肤再生的作用。
本次研究通过临床观察提供有效的组方如下:
1、资料与方法
1.1一般资料:共招募60例符合受试标准的玫瑰痤疮患者,受试者均来自于2020年7月-2020年9月就诊于四川省德阳市中西医结合医院皮肤科门诊的玫瑰痤疮患者。
1.2观察方法与治疗方案
1.21观察方法:以随机数字表法将60例患者随机分为3组,分别对应治疗组、对照一组、对照二组,三组所有患者均为女性。治疗过程中,有9例患者,由于不良反应或依从性不好,中途出组,其余51例患者的基本情况为:治疗组的平均年龄为(29.50±9.36)岁,对照一组的平均年龄为(29.59±10.96)岁,对照二组的平均年龄为(26.88±8.83)岁。
受试者按照就诊的先后顺序确立编号(即第n个受试者对应n号),然后根据每个编号对应的组别给予相应的治疗方案,所有受试者均在签订知情同意书之后开始治疗,观察时间为6周,观察医生分别在治疗开始前、治疗第3周、第6周进行病情记录,具体病情主要是玫瑰痤疮相关的10项临床症状和体征,包括:灼热、干燥、脱屑、丘疹、脓疱、红斑、潮红肿胀、刺痛、毛细血管扩张、瘙痒;以及不良反应情况。
1.2.2治疗方案:3组的治疗方案分别为:治疗组:外用中药制剂1天2次,每次加水煎至3%的浓度,湿敷30分钟,中药配方颗粒1袋,1天3次口服,米诺环素50mg,1日2次口服;对照一组:中药配方颗粒1袋,1天3次口服,米诺环素50mg,1日2次口服,生理盐水湿敷;对照二组:米诺环素50mg,1日2次口服、生理盐水湿敷。
外用中药制剂配方的组成为:
1.3诊断标准
根据《中国玫瑰痤疮诊疗专家共识(2016)》有关“玫瑰痤疮”的诊断确立。
1.4纳入标准
所有受试者的年龄为18-60岁,同意接受相应的治疗方案并签订知情同意书。
1.5排除标准
①3期鼻赘期的玫瑰痤疮患者;②过敏体质者或对研究药物过敏者;③患有脂溢性皮炎、激素依赖性皮炎等慢性非特性皮肤疾病者;④合并严重心脑血管、肝、肾及造血系统等疾病者;⑤精神疾病患者;⑥妊娠及哺乳期妇女;⑦正在接受其他可能影响试验药物疗效的治疗。
1.6统计学方法
2、结果
2.1组间评分及有效率比较
2.1.1治疗前评分比较
三组受试者,治疗前的10项玫瑰痤疮临床表现积分和总积分,组间对比均具有可比性(P>0.05)。(见表1)
2.1.2治疗第3周评分及有效率比较
2.1.2.1治疗第3周评分比较
治疗第3周,三组患者10项玫瑰痤疮临床表现积分和总积分,组间对比均无统计学意义(P>0.05),且每组的所有积分均呈递减,表明三个组的方案均有效果,组间疗效在治疗第3周时相当。
2.1.2.2治疗第3周有效率比较
三组的有效率,在治疗第3周、第6周分别如下:
2.1.3治疗第6周评分及有效率比较
2.1.3.1治疗第6周评分比较
治疗第6周,三组患者10项玫瑰痤疮临床表现积分和总积分,组间对比均无统计学意义(P>0.05),且每组的所有积分均呈递减,表明三个组的方案均有效果,组间疗效在治疗第6周时也相当。
2.1.3.2治疗第6周有效率比较
2.2组内前后评分比较
2.2.1治疗组组内治疗前后各项评分比较
与治疗前相比,治疗第3周,灼热、干燥、脱屑、丘疹、红斑、潮红肿胀、刺痛、瘙痒这些皮损的变化有统计学意义(P<0.05);治疗第6周,所有皮损的变化均有统计学意义(P<0.05),治疗第6周与第3周相比,灼热、干燥、脱屑、丘疹、脓疱、红斑、刺痛、瘙痒的变化有统计学意义(P<0.05),表明这些临床表现在整个治疗过程中持续缓解。
表4治疗组组内治疗前后各项评分比较
2.2.2对照一组组组内治疗前后各项评分比较
与治疗前相比,治疗第3周、第6周,灼热、干燥、丘疹、脓疱、红斑、潮红肿胀、刺痛、毛细血管扩张、瘙痒这些临床表现的变化有统计学意义(P<0.05);治疗第6周与第3周相比,灼热、干燥、脱屑、丘疹、红斑、潮红肿胀、瘙痒的变化有统计学意义(P<0.05),表明这些临床表现在整个治疗过程中持续缓解。
2.2.3对照二组组内治疗前后各项评分比较
与治疗前相比,治疗第3周、第6周,灼热、干燥、脱屑、丘疹、脓疱、潮红肿胀、毛细血管扩张、瘙痒这些临床表现的变化有统计学意义(P<0.05),其中治疗第6周比治疗前的红斑变化也有统计学意义(P=0.028);治疗第6周与第3周相比,灼热、丘疹、红斑、毛细血管扩张的变化有统计学意义(P<0.05),表明这些临床表现在整个治疗过程中持续缓解。
3.讨论
从统计结果看,治疗组与两个对照组之间的疗效,在治疗第3周、第6周两个时间点的对比均没有统计学差异,表明不同治疗的疗效相当。不过从组内对比分析,每个组的治疗在不同时间段对玫瑰痤疮临床表现种类的影响有区别,这表明不同的治疗方案的疗效随时间推移的变化趋势并非完全一致,总结如下:
治疗组:第3周,有8种临床表现较治疗前有显著差异;第6周,所有10种临床表现均较治疗前有显著差异。
对照一组:第3周,有9种临床表现较治疗前有显著差异;第6周,有9种临床表现较治疗前有显著差异。
对照二组:第3周,有8种临床表现较治疗前有显著差异;第6周,有9种临床表现较治疗前有显著差异。
由此可知:治疗组的方案,随时间推移,在第3周时虽然没有对照一组的方案改善临床表现的种类多,但在治疗第6周时对临床表现的改善最完全;对照一组在第3周时改善临床表现的种类最多,但最终没有像治疗组那样改善了所有的临床表现。
综合治疗时间与疗效,可以得出:中药联合米诺环素口服配合生理盐水湿敷治疗玫瑰痤疮的方案,在阶段性的疗效可能优于中药联合米诺环素配合外用中药制剂湿敷、单用米诺环素配合生理盐水湿敷这两个方案;但在疗程结束时,中药联合米诺环素配合外用中药制剂湿敷的效果要优于这两种药物口服配合生理盐水的方案以及单用米诺环素配合生理盐水湿敷的方案,表明在足疗程治疗的情况下,中药联合米诺环素配合外用中药制剂湿敷的治疗方案是最优选择;与单用米诺环素配合生理盐水湿敷相比,中西药联合口服、外用中药替代生理盐水湿敷,确实能达到更显著的疗效。
本发明的一种外用中药制剂配方,在选方用药上也选用了化妆品目录的药物;通过在选方用药上选用了化妆品目录的药物,方便进行成果转化,实现科研成果的高效转化和市场推广,推动中医药科技成果的转化,带动中医药皮肤健康产业的持续发展,形成良好的经济效益和社会效益。
本发明所实现的主要功能为:本次研究通过临床观察可以提供有效的组方,而且在选方用药上也选用了化妆品目录的药物,方便进行成果转化,实现科研成果的高效转化和市场推广,推动中医药科技成果的转化,带动中医药皮肤健康产业的持续发展,形成良好的经济效益和社会效益。
本发明的一种外用中药制剂配方,只要能够达成其有益效果的均可进行实施。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明技术原理的前提下,还可以做出若干改进和变型,这些改进和变型也应视为本发明的保护范围。
Claims (3)
1.一种外用中药制剂配方,其特征在于,针对红斑类皮肤问题的中药复方配伍方剂,有以下质量百分配比的原料组成:
黄柏10-20、黄连5-10、黄芩5-10、马齿苋10-30、鱼腥草10-30、野菊花10-30、寒水石10-30、石膏10-30、白芨10-30、地骨皮10-20、地榆10-30、槐花10-30、赤芍10-30、甘草10-30。
2.如权利要求1所述的一种外用中药制剂配方,其特征在于,本次研究通过临床观察可以提供有效的组方。
3.如权利要求1所述的一种外用中药制剂配方,其特征在于,在选方用药上也选用了化妆品目录的药物。
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