CN104547531A - 一种外敷治疗月经不调的中药制剂及其制备方法 - Google Patents
一种外敷治疗月经不调的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开一种外敷治疗月经不调的中药制剂,属于中药领域。其由如下原料制得:益母草、党参、当归、川芎、白芍、熟地、牡丹皮、麦冬、地骨皮、柴胡、红花、牛膝、茯神、杜仲、沉香、葛根、鸡血藤、泽兰、茴香、人参、鹿茸、麻油、甘草。发明中药制剂外敷治疗月经不调,效果显著。与现有技术相比,发明中药制剂采用外敷的方法具有见效快、治疗效果好、标兼治、兼顾调理、减轻患者服药痛苦等技术优势,并且其生产工艺简便易行、设备简单、药效稳定、易于推广应用等技术优势。
Description
技术领域
本发明公开一种外敷治疗月经不调的中药制剂及其制备方法,属于中药领域。
技术背景
月经失调也称月经不调,是妇科常见疾病,表现为月经周期或出血量的异常,可伴月经前、经期时的腹痛及全身症状。病因可能是器质性病变或是功能失常。
中医对月经不调的辨证分型主要有以下几种:
1、脾肾气虚型
主证:月经周期紊乱,或先期而至,或后期未来,或先后无定,经期延长,经量多,经色淡,质稀薄,面色白,神疲乏力,气短懒言,头晕耳鸣,小腹冷坠,纳呆便溏,夜尿多。舌质淡胖有齿印,脉细无力,尺脉弱。治法:健脾补肾,益气调经。
2、肝肾阴虚型。
主证:月经周期多提前,或先后无定,经期延长,经色鲜红,量或多或少,两颧潮红,手足心热,咽于口燥,失眠多梦,小便黄少,大便于结。舌质红,苔少,脉细数。治法:滋养肝肾,清热调经。
3、气血虚弱型
主证:月经周期多延后,经量少,色淡,质稀,头晕眼花,心悸怔忡,面色萎黄,小腹空坠,舌质淡,苔薄白,脉细。治法:益气养血调经。
4、肝郁气滞型
主证:月经周期紊乱,或先期而至,或后期未来,或先后无定,经量或多或少,经行不畅,经色紫红,夹血块,胸胁、乳房、少腹胀痛,脘闷不舒,时叹息,暖气食少,舌质淡红,苔薄白,脉弦。治法:疏肝理气调经。
5、血寒型
主证:月经周期延后,量少,色黯,夹血块,小腹冷痛,得热痛减,畏寒肢冷。舌质淡黯,苔白,脉沉迟。治法:温经散寒调经。
本发明中药制剂在研制之初就兼顾各种分型,使本发明中药制剂的适用范围更广。
发明内容
本发明要解决的技术问题是开发一种对月经不调具有较好治疗效果的中药制剂,并且该中药制剂要克服传统中药个体差异大、服用不方便的缺点。
为解决上述技术问题,发明人从祖传中医理论知识和自身多年的中医临床实践出发,结合现代人患病特点和现代制剂技术的工艺要求,重新配伍药材,开发出一个全新的中药组方,并研制出将其做成现代临床需求的成品制剂的制备工艺,该中药制剂通过外敷肚脐周围或者下腹部可以达到最好的治疗作用,该中药制剂的优异的治疗效果已经得到临床实践的印证。该中药制剂的中药组方为(以重量份计):
益母草18-32份、党参12-24份、当归9-21份、川芎8-18份、白芍11-25份、熟地10-21份、牡丹皮8-20份、麦冬8-18份、地骨皮11-23份、柴胡8-18份、红花9-21份、牛膝9-19份、茯神8-18份、杜仲7-15份、沉香5-9份、葛根7-17份、鸡血藤9-21份、泽兰9-19份、茴香7-13份、人参4-7份、鹿茸4-7份、麻油10-20份、甘草8-14份。
在实践中优选出来的两个具有最佳治疗效果的组方配比为(以重量份计):
1、益母草25份、党参18份、当归15份、川芎13份、白芍18份、熟地16份、牡丹皮14份、麦冬13份、地骨皮17份、柴胡13份、红花15份、牛膝14份、茯神13份、杜仲11份、沉香7份、葛根12份、鸡血藤15份、泽兰14份、茴香10份、人参5份、鹿茸6份、麻油15份、甘草11份。
2、益母草27份、党参17份、当归17份、川芎14份、白芍19份、熟地17份、牡丹皮15份、麦冬12份、地骨皮16份、柴胡12份、红花14份、牛膝13份、茯神12份、杜仲12份、沉香6份、葛根13份、鸡血藤16份、泽兰13份、茴香11份、人参4份、鹿茸5份、麻油16份、甘草12份。
将上述中药组方做成成品制剂的制备工艺为以下步骤:
(1)按中药组方分别称取各味原料药材,备用;
(2)将益母草、党参、当归、川芎、白芍、熟地、牡丹皮、麦冬、地骨皮、柴胡、红花、牛膝、茯神、杜仲、葛根、鸡血藤、泽兰、茴香、甘草分别粉碎,加入5-10倍重量的纯化水,浸泡12-24小时,回流煎煮2次,每次2-5小时,过滤,保留滤渣,合并滤液,浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(3)将步骤(2)的滤渣加5-8倍重量的浓度65-80%的乙醇,回流提取2次,每次2-6小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(4)将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.30-1.35的中药浸膏,继续减压干燥,得干浸膏,粉碎磨细,过120目筛,得细粉a,备用;
(5)将沉香、人参、鹿茸分别干燥,研磨,过120目筛,得细粉b,备用;
(6)将细粉a和细粉b混合均匀,加入熟化的麻油,混匀得中药原料稠膏;
(7)将中药原料稠膏添加辅料,利用现代通用的中药制剂技术制成临床需要的成品剂型,如膏药、贴膏剂、软膏剂、涂膜剂、搽剂等剂型。
本发明所用中药原料的性质特点及功效来源:
益母草:本品为唇形科植物益母草的新鲜或干燥地上部分。味苦、辛,性微寒;归肝、心包经;活血调经,利尿消肿。
党参:本品为桔梗科植物党参、素花党参(西党参)或川党参的干燥根。味甘,性平;归脾、肺经;补中益气,健脾益肺。
当归:本品为伞形科植物当归的干燥根。味甘、辛,性温;归肝、心、脾经;补血活血,调经止痛,润肠通便。
川芎:本品为伞形科植物川芎的干燥根茎。味辛,性温;归肝、胆、心包经;活血行气,祛风止痛。
白芍:本品为毛茛科植物芍药的干燥根。味苦、酸,性微寒;归肝、脾经;平肝止痛,养血调经,敛阴止汗。
熟地:本品为生地黄的炮制加工品。味甘,性微温;归肝、肾经;滋阴补血,益精填髓。
牡丹皮:本品为毛茛科植物牡丹的干燥根皮。味苦、辛,性微寒;归心、肝、肾经;清热凉血,活血化瘀。
麦冬:本品为百合科植物麦冬(沿阶草)的干燥块根。味甘,微苦,性微寒;归心、肺、胃经;养阴生津,润肺清心。
地骨皮:本品为茄科植物枸杞或宁夏枸杞的干燥根皮。味甘,性寒;归肺、肝、肾经;凉血除蒸,清肺降火。
柴胡:本品为伞形科植物柴胡或狭叶柴胡的干燥根。味苦,性微寒;归肝、胆经;和解表里,疏肝,升阳。
红花:别名红蓝花 、刺红花,菊科、红花属植物。味辛,性温;入心、肝经;活血通经,去瘀止痛。
牛膝:本品为苋科植物牛膝的干燥根。味苦、酸,性平;归肝、肾经;补肝肾,强筋骨,逐瘀通经,引血下行。
茯神:茯苓菌核中间(白茯苓)抱有松根或细松木心者的部份。味甘、性平;宁心安神。
杜仲:本品为杜仲科植物杜仲的干燥树皮。味甘,性温;归肝、肾经;补肝肾,强筋骨,安胎。
沉香:本品为瑞香科植物白木香含有树脂的木材。味辛、苦,性微温;归脾、胃、肾经;行气止痛,温中止呕,纳气平喘。
葛根:本品为豆科植物野葛或甘葛藤的干燥根。味甘、辛,性凉;归脾、胃经;解肌退热,生津,透疹,升阳止泻。
鸡血藤:本品为豆科植物密花豆(大血藤、血风藤、三叶鸡血藤、九层风)的干燥藤茎。味苦、甘,性温;归肝、肾经;补血,活血,通络。
泽兰:本品为唇形科植物毛叶地瓜儿苗的干燥地上部分。味苦、辛,性微温;归肝、脾经;活血化瘀,行水消肿。
茴香:为伞形科植物茴香的果实。味辛,性温;入肾、膀胱、胃经;温肾散寒,和胃理气。
人参:本品为五加科植物人参的干燥根。味甘、微苦,性平;归脾、肺、心经;大补元气,复脉固脱,补脾益肺,生津,安神。
鹿茸:本品为鹿科动物梅花鹿或马鹿的雄鹿未骨化密生茸毛的幼角。味甘、咸,性温;归肾、肝经;壮肾阳,益精血,强筋骨,调冲任,托疮毒。
麻油:本品为脂麻科植物脂麻的成熟种子用压榨法得到的脂肪油。味甘,性凉;入手阳明经;润燥通便,解毒,生肌。
甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
本发明中药组方的组方分析:
该组方是以益母草、党参、白芍、地骨皮、鸡血藤、当归、熟地为君药,活血补血、补中益气、清肺降火、调经止痛、活血化瘀;以红花、牡丹皮、牛膝、茯神、川芎、泽兰为臣药,去瘀止痛、逐瘀通经、安神行气、行水消肿;以麦冬、柴胡、人参、鹿茸、麻油为佐药,养阴生津、疏肝升阳、补脾益肺、益精强骨、润燥通便;以杜仲、沉香、葛根、茴香为使药,行气止痛、生津透疹、温肾散寒、补肾强骨;以甘草调和诸药性,使诸药协同作用,互为阴阳,从而具有补血益气、调经止痛、活血化瘀、逐瘀通经、养阴生津、温肾散寒等功效,外敷治疗月经不调具有十分显著的效果。
与现有技术相比,本发明中药制剂采用外敷的方法具有见效快、治疗效果好、标本兼治、兼顾调理、减轻患者服药痛苦等技术优势,并且其生产工艺简便易行、设备简单、药效稳定、易于推广应用等技术优势。
本发明中药制剂的动物动性试验
1、基本资料
试验药品:按本发明中药组方和生产工艺生产的中药原料稠膏,加纯化水调制成稀糊。
试验所用动物:普通级NIH小鼠,体重21g±4g,雌雄各半,雌性小鼠均无孕;SD大鼠,初始体重219±12g,雌雄各半,雌性大鼠均无孕。
2、急性毒性试验
应用小鼠进行急性毒性实验表明:小鼠灌胃本发明的中药稀糊,在771.3g生药/kg剂量下,给药后小鼠出现轻微活动减少,2小时左右恢复正常,给药后连续观察7天,无一小鼠死亡,且全身状况、饮食、摄水、小便和体重增长均正常。实验结果表明:小鼠灌胃本发明的中药胶囊剂的最大给药量为771.3g生药/kg/d(LD50>771.3g生药/kg)。本发明的中药制剂每日临床用药总量为0.25g生药/kg/d;按体重计,小鼠灌胃本发明中药制剂的耐受量为临床病人的3085.2倍,且本发明中药制剂为外敷使用药品,因此,提示该药急性毒性极低,临床用药安全。
3、长期毒性试验
选用SD大鼠,给予三种剂量的本发明中药胶囊剂:45.0g生药/kg、15.0g生药/kg、5.0g生药/kg(单位体重给药量按临床用药量的20倍计算,临床用药量依据《中华人民共和国药典》2010 年版一部)。每天灌胃一次,连续90天,末次给药后24小时各组活杀1/2动物(雌雄各半),其余1/2动物继续观察2周后活杀。试验期间观察动物的外观、一般行为、摄食量、体重变化;给药后90天和停药2周进行血液学(RBC、HB、网织红细胞、PLT、CT、WBC及分类)和血液生化(AST、ALT、ALP、Glu、BUN、Crea、TP、T.BIL、ALB、CHOL)、尿液生化、脏器系数、病理组织学等指标检查。
试验结果表明:本发明的中药制剂在高、中、低剂量组动物一般状态良好,外观体征、行为活动、进食量和体重增长均无异常变化;三个剂量组及对照组血液学检查、血液生化学、尿液生化检查均在正常范围,组间无显著差异;各组主要脏器组织病理学检查未见明显异常。上述指标停药2周后也未见改变。本试验用药剂量分别为临床用药剂量的180、60、20倍,根据试验结果:本发明中药制剂在高、中、低三个剂量(45.0g生药/kg、15.0g生药/kg、5.0g生药/kg)连续90天给药对大鼠无明显影响,无明确的毒性靶器官和敏感指标,恢复期观察也未见延迟性毒性反应,且本发明中药制剂为外敷使用药品,提示本发明的中药制剂临床应用的剂量安全性很高。
本发明中药制剂的皮肤刺激性试验:
1、试验药物:按本发明中药组方和制备工艺生产的软膏剂,规格为折合1.5g生药/g软膏。
2、实验方法:
取健康豚鼠20只,随机分成两组,每组10只,将豚鼠背部脊柱两侧将脱毛剂均匀涂上,使去毛范围约20平方厘米。洗净脱毛剂归笼观察24小时,一组豚鼠分别涂本发明中药软膏2g、4g和6g,分别含生药3g、6g 和9g,另一组涂溶媒0.8ml每日二次,连续一周,实验结束后,将豚鼠处死,心、肝、肾及脱毛皮肤做病理检验。
3、结果:
上述三组用药豚鼠躯干脱毛区,未见局部皮肤有水肿、充血、红斑、出血点及溃疡。用药组豚鼠毛发色泽、摄食、四肢活动等对照组无明显差异,病理组织学检查,给药组心、肝、肾及脱毛皮与对照字比较也无明显差异。结果提示,本发明中药制剂无局部刺激作用,也未见全身毒性表现。表明本发明中药外用制剂使用安全。
具体实施方式
实施例1
按本发明中药组方优选配比1的比例生产贴膏剂:
(1)按中药组方分别称取益母草2500g、党参1800g、当归1500g、川芎1300g、白芍1800g、熟地1600g、牡丹皮1400g、麦冬1300g、地骨皮1700g、柴胡1300g、红花1500g、牛膝1400g、茯神1300g、杜仲1100g、沉香700g、葛根1200g、鸡血藤1500g、泽兰1400g、茴香1000g、人参500g、鹿茸600g、麻油1500g、甘草1100g,备用;
(2)将益母草、党参、当归、川芎、白芍、熟地、牡丹皮、麦冬、地骨皮、柴胡、红花、牛膝、茯神、杜仲、葛根、鸡血藤、泽兰、茴香、甘草分别粉碎,加入7倍重量的纯化水,浸泡18小时,回流煎煮2次,每次3小时,过滤,保留滤渣,合并滤液,浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(3)将步骤(2)的滤渣加7倍重量的浓度75%的乙醇,回流提取2次,每次3小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(4)将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.30-1.35的中药浸膏,继续减压干燥,得干浸膏,粉碎磨细,过120目筛,得细粉a,备用;
(5)将沉香、人参、鹿茸分别干燥,研磨,过120目筛,得细粉b,备用;
(6)将细粉a和细粉b混合均匀,加入熟化的麻油,混匀得中药原料稠膏;
(7)将中药原料稠膏添加辅料,利用现代通用的中药制剂技术制成贴膏剂,折合生药7.5g/贴。
实施例2
按本发明中药组方优选配比1的比例生产贴膏剂:
(1)按中药组方分别称取益母草2700g、党参1700g、当归1700g、川芎1400g、白芍1900g、熟地1700g、牡丹皮1500g、麦冬1200g、地骨皮1600g、柴胡1200g、红花1400g、牛膝1300g、茯神1200g、杜仲1200g、沉香600g、葛根1300g、鸡血藤1600g、泽兰1300g、茴香1100g、人参400g、鹿茸500g、麻油1600g、甘草1200g,备用;
(2)将益母草、党参、当归、川芎、白芍、熟地、牡丹皮、麦冬、地骨皮、柴胡、红花、牛膝、茯神、杜仲、葛根、鸡血藤、泽兰、茴香、甘草分别粉碎,加入7倍重量的纯化水,浸泡18小时,回流煎煮2次,每次3小时,过滤,保留滤渣,合并滤液,浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(3)将步骤(2)的滤渣加7倍重量的浓度75%的乙醇,回流提取2次,每次3小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(4)将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.30-1.35的中药浸膏,继续减压干燥,得干浸膏,粉碎磨细,过120目筛,得细粉a,备用;
(5)将沉香、人参、鹿茸分别干燥,研磨,过120目筛,得细粉b,备用;
(6)将细粉a和细粉b混合均匀,加入熟化的麻油,混匀得中药原料稠膏;
(7)将中药原料稠膏添加辅料,利用现代通用的中药制剂技术制成贴膏剂,折合生药7.5g/贴。
实施例3
按本发明中药组方最大范围的比例生产贴膏剂:
(1)按中药组方分别称取益母草3200g、党参2400g、当归2100g、川芎1800g、白芍2500g、熟地2100g、牡丹皮2000g、麦冬1800g、地骨皮2300g、柴胡1800g、红花2100g、牛膝1900g、茯神1800g、杜仲1500g、沉香900g、葛根1700g、鸡血藤2100g、泽兰1900g、茴香1300g、人参700g、鹿茸700g、麻油2000g、甘草1400g,备用;
(2)将益母草、党参、当归、川芎、白芍、熟地、牡丹皮、麦冬、地骨皮、柴胡、红花、牛膝、茯神、杜仲、葛根、鸡血藤、泽兰、茴香、甘草分别粉碎,加入7倍重量的纯化水,浸泡18小时,回流煎煮2次,每次3小时,过滤,保留滤渣,合并滤液,浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(3)将步骤(2)的滤渣加7倍重量的浓度75%的乙醇,回流提取2次,每次3小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(4)将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.30-1.35的中药浸膏,继续减压干燥,得干浸膏,粉碎磨细,过120目筛,得细粉a,备用;
(5)将沉香、人参、鹿茸分别干燥,研磨,过120目筛,得细粉b,备用;
(6)将细粉a和细粉b混合均匀,加入熟化的麻油,混匀得中药原料稠膏;
(7)将中药原料稠膏添加辅料,利用现代通用的中药制剂技术制成贴膏剂,折合生药7.5g/贴。
实施例4
按本发明中药组方最小范围的比例生产贴膏剂:
(1)按中药组方分别称取益母草1800g、党参1200g、当归900g、川芎800g、白芍1100g、熟地1000g、牡丹皮800g、麦冬800g、地骨皮1100g、柴胡800g、红花900g、牛膝900g、茯神800g、杜仲700g、沉香500g、葛根700g、鸡血藤900g、泽兰900g、茴香700g、人参400g、鹿茸400g、麻油1000g、甘草800g,备用;
(2)将益母草、党参、当归、川芎、白芍、熟地、牡丹皮、麦冬、地骨皮、柴胡、红花、牛膝、茯神、杜仲、葛根、鸡血藤、泽兰、茴香、甘草分别粉碎,加入7倍重量的纯化水,浸泡18小时,回流煎煮2次,每次3小时,过滤,保留滤渣,合并滤液,浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(3)将步骤(2)的滤渣加7倍重量的浓度75%的乙醇,回流提取2次,每次3小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(4)将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.30-1.35的中药浸膏,继续减压干燥,得干浸膏,粉碎磨细,过120目筛,得细粉a,备用;
(5)将沉香、人参、鹿茸分别干燥,研磨,过120目筛,得细粉b,备用;
(6)将细粉a和细粉b混合均匀,加入熟化的麻油,混匀得中药原料稠膏;
(7)将中药原料稠膏添加辅料,利用现代通用的中药制剂技术制成贴膏剂,折合生药7.5g/贴。
实施例5
按本发明中药组方范围内的任意比例生产贴膏剂:
(1)按中药组方分别称取益母草1800g、党参2400g、当归900g、川芎1800g、白芍1100g、熟地2100g、牡丹皮800g、麦冬1800g、地骨皮1100g、柴胡1800g、红花900g、牛膝1900g、茯神800g、杜仲1500g、沉香500g、葛根1700g、鸡血藤900g、泽兰1900g、茴香700g、人参700g、鹿茸400g、麻油2000g、甘草800g,备用;
(2)将益母草、党参、当归、川芎、白芍、熟地、牡丹皮、麦冬、地骨皮、柴胡、红花、牛膝、茯神、杜仲、葛根、鸡血藤、泽兰、茴香、甘草分别粉碎,加入7倍重量的纯化水,浸泡18小时,回流煎煮2次,每次3小时,过滤,保留滤渣,合并滤液,浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(3)将步骤(2)的滤渣加7倍重量的浓度75%的乙醇,回流提取2次,每次3小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(4)将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.30-1.35的中药浸膏,继续减压干燥,得干浸膏,粉碎磨细,过120目筛,得细粉a,备用;
(5)将沉香、人参、鹿茸分别干燥,研磨,过120目筛,得细粉b,备用;
(6)将细粉a和细粉b混合均匀,加入熟化的麻油,混匀得中药原料稠膏;
(7)将中药原料稠膏添加辅料,利用现代通用的中药制剂技术制成贴膏剂,折合生药7.5g/贴。
实施例6
本发明中药贴剂的临床试验
1、一般资料
本次临床试验的受试者均由某市妇幼保健院妇科提供,共计210例,年龄18-39岁,平均年龄28.3岁,均已被医院确诊患有月经不调症,表现为月经先后无定期、经期延长、月经过多、月经过少、经血浓稠或稀薄等。将受试者按年龄、病情等平均分成3个组,使各组之间具备统计学意义上的可比性,每组70例,分别为:对照组,试验1组,试验2组。
2、试验药品
对照药:同仁乌鸡白凤丸,规格:每100粒重12g,国药准字Z11020026,北京同仁堂股份有限公司同仁堂制药厂。
试验药:本发明实施例1、实施例2所生产的中药贴剂,规格:折合生药7.5g/贴。
3、试验方法
对照组口服同仁乌鸡白凤丸,每次1丸,每日2次;试验1组、试验2组分别使用实施例1、实施例2生产的贴剂,每次1贴,每日2次,贴于肚脐处;一个月为一个疗程,所有受试者均连续治疗3个疗程,痊愈者可随时中止给药,对治愈者在停止治疗6个月后,进行跟踪回访,记录复发病例。治疗期间,所有患者均停止服用其他药品和营养保健品。
4、评判标准
治愈:月经恢复规律,28-32 天为一周期,经量正常,经期适中,一般为3-7 天;
有效:月经先后无定期、经期延长、月经过多、月经过少、经血浓稠或稀薄等月经不调相关症状好转或有所改善;
无效:患者原有月经不调症状没有任何改善,甚至更加严重;
复发:治愈的患者在停止给药6个月内重新出现原有症状。
5、试验结果
所有试验病例全部完成后,将试验数据统计分析如表1所示:
表1 试验数据统计分析表
组别 | 例数 | 治愈(率) | 有效 | 无效 | 总有效率 | 复发(率) |
对照组 | 70 | 21(30.0%) | 31 | 18 | 74.3% | 6(28.6%) |
试验 1 组 | 70 | 41(58.6%) | 23 | 6 | 91.4% | 1(2.4%) |
试验 2 组 | 70 | 44(62.9%) | 22 | 4 | 94.3% | 2(4.5%) |
6、结论
与对照组相比,两个实验组的治愈率均显著高于对照组,总有效率也均显著高于对照组,而复发率远远低于对照组,因此,本发明中药制剂与现有技术相比具有十分显著的技术优势,取得了意想不到的技术成果。
Claims (6)
1.一种外敷治疗月经不调的中药制剂,其特征在于由如下重量份的原料制成:益母草18-32份,党参12-24份,当归9-21份,川芎8-18份,白芍11-25份,熟地10-21份,牡丹皮8-20份,麦冬8-18份,地骨皮11-23份,柴胡8-18份,红花9-21份,牛膝9-19份,茯神8-18份,杜仲7-15份,沉香5-9份,葛根7-17份,鸡血藤9-21份,泽兰9-19份,茴香7-13份,人参4-7份,鹿茸4-7份,麻油10-20份,甘草8-14份。
2.如权利要求1所述的外敷治疗月经不调的中药制剂,其特征在于由如下重量份的原料制成:益母草25份,党参18份,当归15份,川芎13份,白芍18份,熟地16份,牡丹皮14份,麦冬13份,地骨皮17份,柴胡13份,红花15份,牛膝14份,茯神13份,杜仲11份,沉香7份,葛根12份,鸡血藤15份,泽兰14份,茴香10份,人参5份,鹿茸6份,麻油15份,甘草11份。
3.如权利要求1所述的外敷治疗月经不调的中药制剂,其特征在于由如下重量份的原料制成:益母草27份,党参17份,当归17份,川芎14份,白芍19份,熟地17份,牡丹皮15份,麦冬12份,地骨皮16份,柴胡12份,红花14份,牛膝13份,茯神12份,杜仲12份,沉香6份,葛根13份,鸡血藤16份,泽兰13份,茴香11份,人参4份,鹿茸5份,麻油16份,甘草12份。
4.一种制备如权利要求1-3任一所述外敷治疗月经不调的中药制剂的方法,其特征在于包括以下工艺步骤:
(1)按中药组方分别称取各味原料药材,备用;
(2)将益母草、党参、当归、川芎、白芍、熟地、牡丹皮、麦冬、地骨皮、柴胡、红花、牛膝、茯神、杜仲、葛根、鸡血藤、泽兰、茴香、甘草分别粉碎,加入5-10倍重量的纯化水,浸泡12-24小时,回流煎煮2次,每次2-5小时,过滤,保留滤渣,合并滤液,浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(3)将步骤(2)的滤渣加5-8倍重量的浓度65-80%的乙醇,回流提取2次,每次2-6小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至55℃相对密度为1.20-1.25的浓缩液备用;
(4)将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.30-1.35的中药浸膏,继续减压干燥,得干浸膏,粉碎磨细,过120目筛,得细粉a,备用;
(5)将沉香、人参、鹿茸分别干燥,研磨,过120目筛,得细粉b,备用;
(6)将细粉a和细粉b混合均匀,加入熟化的麻油,混匀得中药原料稠膏;
(7)将中药原料稠膏添加辅料,利用现代通用的中药制剂技术制成临床需要的成品剂型。
5.如权利要求1-3任一所述的外敷治疗月经不调的中药制剂,其特征在于:所述中药制剂为膏药、贴膏剂、软膏剂、涂膜剂和搽剂。
6.如权利要求1-3任一所述的外敷治疗月经不调的中药制剂,其特征在于:所述中药制剂的临床用药部位为肚脐周围和下腹部。
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