CN107929698A - 一种治疗不孕不育的外敷药贴组合物 - Google Patents
一种治疗不孕不育的外敷药贴组合物 Download PDFInfo
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Abstract
本发明属于中药技术领域,涉及一种以中草药为原料的治疗不孕不育的外敷药贴;其原料包括茯苓,炒杭芍,丹皮,全当归,广橘红,炒杏仁,法半夏,炒杜仲,泽兰,牡蛎粉,炒干姜,石楠叶,炒女贞子,石菖蒲,补骨脂,草寇仁,芡实,棕炭,茜草根,桃仁,丹参;将选用的各味中药加工后磨制成20~30目的药粉后与发热体混合制成外敷药贴,其中发热体包含氯化铁、铁粉和盐酸;外敷贴使用时,外敷贴中的组合物遇空气自行发热,所含挥发性成份不断从药贴中透出,在主穴及配穴中形成具有45~60℃温湿度的“药雾”,在热力的作用下,直达穴位,迅速渗入经络,促进药物吸收;其能够调整体质平衡,产生固肾安胎、调肝健脾、促进怀孕之效,应用环境友好。
Description
技术领域:
本发明属于中药技术领域,涉及一种以中草药为原料的治疗不孕不育的外敷药贴,特别是一种以中草药为原料的治疗不孕不育的外敷药贴组合物及其制备工艺和使用方法。
背景技术:
目前,不孕不育症已经成为世界上继肿瘤和心脑血管病后的第三大疾病。据国家权威部门的相关统计,不孕不育发生率是15~20%,中国目前约有近4千万不孕不育症患者,而且每年以数十万的速度递增,其中,女方占最主要原因,中医药在治疗不孕不育方面有良好的前景和独特的效果,中医认为:肾为先天之本,肾主封藏,为藏精之脏,主生殖,人的禀赋高低、健康状况都是由肾决定的;脾为后天之本,精血生化之源,脾虚则生化无源而致不孕,女子以肝为先天之本,肝主藏血,主疏泄,肝郁气滞亦是引起女子不孕症的常见病机,论治则当安五脏、通气血,调经种子为主;中医辩证机理:平人水土温暖,肝木温升,生意畅遂,阴阳交媾,一承雨露,便能受孕;脾肾虚寒,命门火衰,胞宫寒冷,生意全无,则不孕育;肾寒则脾湿,脾湿则肝木郁陷,胆火上逆;脾湿肾寒,肝木郁陷,下焦寒凝,胞宫虚冷,故症见腰膝酸困无力,小腹冷痛,不易怀子,或不能怀子;胆火上逆,故症见夜热毛蒸,心烦易怒,头昏失眠,口苦咽干;肝郁气滞,疏泄不遂,故月经失调,或前错后错,或行经腹痛,或量多紫黑成块,或色淡量少,或艰涩不利,或带下清稀;上有虚热,中下湿寒,故脉现细濡,关寸大,舌苔白腻。因此,寻求一种治疗不孕不育的外敷药贴组合物,针对肝脾肾的调理以及人体不同体质与病因病机,选取针对性敷贴贴于经络穴位,调整体质平衡,使人体脏腑、气血与阴阳平和,产生固肾安胎、调肝健脾、促进怀孕之效。
发明内容:
本发明的目的在于克服现有技术存在的缺点,寻求设计提供一种固肾安胎、调肝健脾、促进怀孕的中药外敷贴组合物,调节不孕不育体质以期使其达到平和质,从而促进生育。
为了实现上述目的,本发明所述外敷药贴组合物中各原料按重量组分为:茯苓9g,炒杭芍9g,丹皮9g,全当归9g,广橘红9g,炒杏仁9g,法半夏9g,炒杜仲12g,泽兰15g,牡蛎粉30g,炒干姜9g,石楠叶60g,炒女贞子15g,石菖蒲9g,补骨脂15g,草寇仁6g,芡实12g,棕炭12g,茜草根9g,桃仁9g,丹参15g。
本发明所述石楠叶采用以下过程加工:选用鲜品石楠叶用水洗净,去除杂质后用重量百分比为3~5%的小苏打水溶液按1:5~8的重量比浸泡6小时,控水后阴干;然后再用脱脂牛奶按1:3~5的重量比浸泡3~5小时,晾干后切丝,文火慢炒,边炒边喷洒蜂蜜,按照5斤石楠叶、1斤蜂蜜的比例的方式进行炮制,蜜炙时间为1小时;所述的杭白芍用即墨老酒按5:1的重量比炒制而成,控温120~150度慢炒过程中加入即墨老酒;使用同样方法炒干姜、炒杜仲;广橘红、炒杏仁、法夏清理肺气降逆效果好,生牡蛎、泽兰具有化瘀散结、活血调经的功效。
本发明选用各味中药磨制成20~30目的药粉后与发热体制成外敷药贴,贴敷经络穴位;所述发热体包括氯化铁、铁粉和盐酸,外敷药贴的具体制备过程为:将铁粉用20~30目的网筛过筛,除去大于20~30目的部分,将20~30目以下的铁粉和药粉按比例混合,搅拌均匀后加入重量百分比50~60%的氯化铁水溶液继续搅拌,搅拌均匀后放置冷却得组合物分装到包装袋备用;其中铁粉:氯化铁:药粉的重量比为30:9:10,所采用的发热体温度能持续6~8h;使用时将外敷药贴贴于三阴交穴或关元穴,并根据不同体质类型,贴敷于相应配穴。
本发明所述包装袋分内、外两层,其中内袋直接用于包装药粉与发热体制成的外敷药贴组合物,内袋的表面开有一定大小和数量的小孔,用于控制空气进入的速度从而实现控制发热温度和恒温时间的目的,小孔的大小和数量根据所需发热温度和恒温时间确定;外袋采用密封性好的塑料袋隔绝空气。
本发明所述外敷药贴组合物使用时,外敷药贴遇空气自行发热,所含挥发性成份不断从药贴中透出,在主穴及配穴中形成具有45~60℃温湿度的“药雾”,在热力的作用下,直达穴位,迅速渗入经络,促进药物吸收;外敷药贴使用时的平均温度在53℃,具有与人体辐射吸收相应波长的远红外辐射率,与人体接触后,辐射出远红外线作用于人体,产生共振吸收及穿透皮层组织,起到改善人体微循环等作用,有助于生物酶的生长,加强人体组织的再生功能,促进新陈代谢,增强免疫功能,促进血液循环,同时使血管扩张、加快血流,改善人体血液循环、促进药物透皮吸收。
本发明与现有技术相比,其药物配伍科学合理,杜绝临床中常见失误,一是一见患者上身热,即诊断为阴虚,继而采取寒凉滋腻之药物,进一步攻伐患者相当虚弱的肾阳;二是一见患者下身寒,即诊断为宫寒,一味强调温补肾阳,导致患者上身之热更盛,进一步耗阴,不仅不能治愈患者还能进一步引起其他不适问题,或者引发新的病症;而且所采用的外敷药贴制备方法简单,制成的外敷药贴贴敷没有副作用,疗效高,价格低,具有补肾填精,活血养血的作用和功效,适应于闭经、功血、肾虚兼气血不足之男女不育症。
具体实施方式:
下面通过实施例对本发明作进一步的详述。
实施例1:
本实施例所述外敷药贴组合物中各原料按重量组分为:茯苓9g,炒杭芍9g,丹皮9g,全当归9g,广橘红9g,炒杏仁9g,法半夏9g,炒杜仲12g,泽兰15g,牡蛎粉30g,炒干姜9g,石楠叶60g,炒女贞子15g,石菖蒲9g,补骨脂15g,草寇仁6g,芡实12g,棕炭12g,茜草根9g,桃仁9g,丹参15克;其中,所述石楠叶起润肾补肝、壮命门火、温肾兴阳、提高子宫性兴奋程度的作用,治疗性机能减退,幼稚子宫,石楠叶略有小毒,为降低药物副作用,石楠叶采用以下过程加工:选用上等鲜品石楠叶,先用自来水洗净,去除杂质后用重量百分比为3~5%的小苏打水溶液按1:5~8的重量比浸泡六小时,控水后阴干;然后再用脱脂牛奶按1:3~5的重量比浸泡3~5小时,晾干后切丝,文火慢炒,边炒边喷洒蜂蜜,按照5斤石楠叶、1斤蜂蜜的比例的方式进行炮制,蜜炙时间为1小时,采取蜜炙炮制方式制备的石楠叶效果更佳,能更好的发挥药效;所述的杭白芍用即墨老酒按5:1的重量比炒制而成,增强行气解郁、疏肝之功效;使用同样方法炒干姜、炒杜仲增强温暖中下焦功效;广橘红、炒杏仁、法夏清理肺气降逆效果好,生牡蛎、泽兰具有化瘀散结、活血调经的功效。
本实施例选用具有温补肾气、滋补肝肾、健脾培本、止血安胎的20味中药,精制成20~80目的药粉后与发热体制成外敷药贴,贴敷经络穴位,发挥固肾健脾、调肝行气、安胎止呕之功;所述发热体包括氯化铁、铁粉和盐酸,外敷药贴的具体制备过程为:将铁粉用20~30目的网筛过筛,除去大于20目的部分,将20~30目以下的铁粉和药粉按比例混合,搅拌均匀后加入重量百分比50~60%的氯化铁水溶液继续搅拌,搅拌均匀后放置冷却得组合物分装到包装袋备用;其中铁粉:氯化铁:药粉的重量比为30:9:10,所采用的发热体温度能持续6~8h;使用时将外敷药贴贴于三阴交穴或关元穴,并根据不同体质类型,贴敷于相应配穴。
本实施例所述包装袋分内、外两层,其中内袋直接用于包装药粉与发热体制成的外敷药贴组合物,内袋的表面开有一定大小和数量的小孔,用于控制空气进入的速度从而实现控制发热温度和恒温时间的目的,小孔的大小和数量根据所需发热温度和恒温时间确定;外袋采用密封性好的塑料袋隔绝空气。
本实施例所述外敷药贴组合物根据坎离砂原理,通过热传导给药,具有远红外理疗、热疗、药疗三重功效;使用时,外敷药贴遇空气自行发热,所含挥发性成份不断从药贴中透出,在主穴及配穴中形成具有45~60℃温湿度的“药雾”,在热力的作用下,直达穴位,迅速渗入经络,促进药物吸收;外敷药贴使用时的平均温度在53℃,具有与人体辐射吸收相应波长的远红外辐射率,与人体接触后,辐射出远红外线作用于人体,产生共振吸收及穿透皮层组织,起到改善人体微循环等作用,有助于生物酶的生长,加强人体组织的再生功能,促进新陈代谢,增强免疫功能,促进血液循环,同时使血管扩张、加快血流,改善人体血液循环、促进药物透皮吸收。
实施例2:
本实施例使用实施例1制备的组合,在某中西医结合中心的不孕不育患者观察发现,绝大多数的不孕患者,上身热下身寒者多,但其实上身热多系虚热,为其标,不是阴虚内热;下身寒系命门火衰,为其本,治疗不孕症的过程当中采取“清上温下”治疗原则,通过所述外敷药贴组合物,融补于调之中,月经调畅,胞宫温暖,即可正常怀孕;本实施例采用所述外敷药贴,每三天治疗一次,以7次为一疗程,一疗程后重新评价体质,疗效判定标准:
(1)痊愈:顺利妊娠,症状消失;或体质评估转化分<30分,且平和质转化分≥80分;
(2)显效:顺利妊娠,体质评估:30分≤转化分<40分,60分≤平和质转化分<80分;或虽未妊娠,但症状消失,体质评估转化分<30分,平和质转化分≥80分;
(3)有效:症状好转或消失,体质评估:30分≤转化分<40分,平和质转化分≥60分或体质评估转化分<30分,平和质转化分≥60分;
(4)无效:未能成功妊娠,偏颇体质症状仍存在,症状仍存在或体质评估评分>40分。
本实施例共进行体质评估患者810人次,其中评估出来只有一种体质占73.4%,两种体质占21.5%,三种体质及以上占5.1%,具体情况如表1:
表1:体质量表评估统计结果
通过进行体质评估并运用贴敷进行效果观察,并对治疗组及对照组进行统计分析结果如表2:
表2:治疗组与对照组好转率统计表
备注:“好转”包括痊愈、显效、有效;对照组:运用贴敷,P<0.01
其中治疗组中痊愈280例,显效124例,有效87例,好转率81.8%,对比结果提示,运用贴敷结合辨证施治,与单纯运用辨证论治相比,具有统计学意义(P<0.01);从上述临床治疗结果可看出,本实施例所述外敷药贴单独使用有较好效果,也可与其他中药配合使用,无副作用,操作简易,患者容易接受,具体临床病例介绍如下:
病例1:梁某,女,28岁,不孕,症状为面色微黄,面有瘀斑,脉沉细,舌质淡红,苔白薄,齿痕明显,瘀点浮现;倦怠乏力,上身热,夜间尤甚,小腹凉,脐下三指周围明显,脐周有跳动感觉;每月例假延后3~5天,经前腹痛,腰下坠、腰酸困,行经小腹冷痛、例假艰涩,色黑、硬块;胸胀、刺痛感明显;大便粘腻,小便清长;纳可,眠差多梦;平素烦躁易怒,
辩证:脾湿肾寒肝郁胃逆
治则:健脾温肾疏肝降胃
采用本实施例外敷贴治疗前进行体质评估:平和质61.5分,气虚质23.4分,阳虚质15.7分,阴虚质8.6分,痰湿质52分,湿热质43.9分,血瘀质27.8分,气郁质54.6分,特禀质0分;评为痰湿质、湿热质、气郁质;予行贴敷疗法,三天一次,七次为一疗程;两疗程后患者重新进行体质评估,结果为:平和质81.5分,气虚质16.2分,阳虚质12.7分,阴虚质8.3分,痰湿质21.6分,湿热质23.4分,血瘀质6.6分,气郁质22分,特禀质0分;就诊后两月确诊妊娠,并顺利诞下健康男婴。
病例2:黄某,女,34岁,不孕,症状:面色恍白、乏力、倦怠,脉细、弦数、尺稍浮、关寸大,舌胖、淡红、苔白、腻、齿痕、瘀点明显,舌下淤血,患者先后四次自然流产,眠差、时常失眠,纳呆,便溏、粘腻,上身烦热多汗,下身凉、小腹冷痛、腰凉,手心灼热;每月例假提前5天,色黑、量少,持续7天月经结束;
辩证:脾湿肾寒肺敛不及肝木疏泄过旺
治则:健脾温肾疏肝敛肺补气养血
采用本实施例外敷贴治疗前进行体质评估:平和质67.5分,气虚质24.4分,阳虚质137分,阴虚质7.9分,痰湿质53分,湿热质43.9分,血瘀质25.8分,气郁质53.6分,特禀质0分,评为痰湿质、气郁质;予行贴敷疗法,三天一次,七次为一疗程。两疗程后患者重新进行体质评估,结果为:平和质83.5分,气虚质13.2分,阳虚质12.7分,阴虚质5.6分,痰湿质23.6分,湿热质24.4分,血瘀质7.8分,气郁质20.5分,特禀质0分,就诊后三个月确诊妊娠,并诞下健康龙凤胎。
本实施例进行体质评估时采用体质评估表,体质评估表根据“中医体质量表——中医体质分类与评定表”制定;体质判定标准为:回答《中医体质分类与判定表》中的全部问题,每一问题按5级评分,计算原始分及转化分,依标准判定体质类型,其中原始分=各个条目的分值相加;转化分数=[(原始分~条目数)/(条目数×4)]×100,平和质为正常体质,气虚质、阳虚质、阴虚质、痰湿质、湿热质、瘀血质、气郁质、特禀质8种体质为偏颇体质,平和质与偏颇体质判定标准表见表3:
表3:平和质与偏颇体质判定标准表
本实施例中九种体质的穴位选配“九种体质”,依据《中医体质分类与判定》标准,该标准是我国第一部指导和规范中医体质研究及应用的文件,旨在为体质辨识及与中医体质相关疾病的防治、养生保健、健康管理提供依据,使体质分类科学化、规范化,本实施例将所述外敷药贴贴于人体的主穴,即三阴交穴和关元穴,另外,根据人体不同的体质,同时贴于不同的配穴,具体如下:
主穴是三阴交穴及关元穴,三阴交属足太阴脾经,是足太阴脾经、足少阴肾经、足厥阴肝经交会穴,位于足内踝尖上3寸,胫骨内侧缘后方,三阴交具有调节妇科内分泌的作用;因为此穴为足太阴脾经、足少阴肾经、足厥阴肝经交会之处,所以应用广泛,既可健脾益血,也可调肝补肾;关元穴属于任脉,任主胞胎,能调节月经,促进女子生殖功能,维持妊娠,主治一切与生殖系统相关疾病,关元穴位于下腹部,前正中线,脐下3寸;具有温肾益精,回阳补气,调理冲任,除寒通络的作用,关元穴有强壮作用,为保健要穴,关为门户,元为元气,意在守住元气的关口,故关元也称“丹田”,同时也是血液灌注的地方,血液聚在关元穴,使之转化成肾精,而则肾精是强壮身体、延长寿命之本;《黄帝内经》称肾为“作强之官,伎巧出焉”,惟肾为能作强,而男女构精,人物化生,伎巧从是而出;故肾气充盛则精力充沛,生殖机能正常,胎孕得以化生。
Claims (3)
1.一种治疗不孕不育的外敷药贴组合物,其特征在于各原料按重量组分为:茯苓9g,炒杭芍9g,丹皮9g,全当归9g,广橘红9g,炒杏仁9g,法半夏9g,炒杜仲12g,泽兰15g,牡蛎粉30g,炒干姜9g,石楠叶60g,炒女贞子15g,石菖蒲9g,补骨脂15g,草寇仁6g,芡实12g,棕炭12g,茜草根9g,桃仁9g,丹参15g;所述石楠叶采用以下过程加工:选用鲜品石楠叶用水洗净,去除杂质后用重量百分比为3~5%的小苏打水溶液按1:5~8的重量比浸泡6小时,控水后阴干;然后再用脱脂牛奶按1:3~5的重量比浸泡3~5小时,晾干后切丝,文火慢炒,边炒边喷洒蜂蜜,按照5斤石楠叶、1斤蜂蜜的比例的方式进行炮制,蜜炙时间为1小时;所述的杭白芍用即墨老酒按5:1的重量比炒制而成,控温120~150度慢炒过程中加入即墨老酒;使用同样方法炒干姜、炒杜仲;广橘红、炒杏仁、法夏清理肺气降逆效果好,生牡蛎、泽兰具有化瘀散结、活血调经的功效,并与其他成份协同增效。
2.根据权利要求1所述的治疗不孕不育的外敷药贴组合物,其特征在于将选用的各味中药磨制成20~30目的药粉后与发热体制成外敷药贴,贴敷经络穴位;所述发热体包括氯化铁、铁粉和盐酸,外敷药贴的具体制备过程为:将铁粉用20~30目的网筛过筛,除去大于20~30目的部分,将20~30目以下的铁粉和药粉按比例混合,搅拌均匀后加入重量百分比50~60%的氯化铁水溶液继续搅拌,搅拌均匀后放置冷却得组合物分装到包装袋备用;其中铁粉:氯化铁:药粉的重量比为30:9:10,所采用的发热体温度能持续6~8h;使用时将外敷药贴贴于三阴交穴或关元穴,并根据不同体质类型,贴敷于相应配穴。
3.根据权利要求2所述的治疗不孕不育的外敷药贴组合物,其特征在于所述包装袋分内、外两层,其中内袋直接用于包装药粉与发热体制成的外敷药贴组合物,内袋的表面开有一定大小和数量的小孔,用于控制空气进入的速度从而实现控制发热温度和恒温时间的目的,小孔的大小和数量根据所需发热温度和恒温时间确定;外袋采用密封性好的塑料袋隔绝空气;本发明所述外敷药贴组合物使用时,外敷药贴遇空气自行发热,所含挥发性成份不断从药贴中透出,在主穴及配穴中形成具有45~60℃温湿度的“药雾”,在热力的作用下,直达穴位,迅速渗入经络,促进药物吸收;外敷药贴使用时的平均温度在53℃,具有与人体辐射吸收相应波长的远红外辐射率,与人体接触后,辐射出远红外线作用于人体,产生共振吸收及穿透皮层组织,起到改善人体微循环等作用,有助于生物酶的生长,加强人体组织的再生功能,促进新陈代谢,增强免疫功能,促进血液循环,同时使血管扩张、加快血流,改善人体血液循环、促进药物透皮吸收。
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