CN105535711A - 一种治疗多囊卵巢综合征伴痤疮的药物组合物 - Google Patents
一种治疗多囊卵巢综合征伴痤疮的药物组合物 Download PDFInfo
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Abstract
本发明属于医药技术领域,具体涉及一种治疗多囊卵巢综合征伴痤疮的药物组合物。该药物组合物由玫瑰花、香附、当归藤、六月雪、女贞子、枸杞子、土茯苓、隔山消、千针万线草、野丁香根、白茅根、红母鸡草为原料药精心制成。诸药互相作用,具有疏肝解郁、化瘀散滞、清热养阴、泻火解毒、滋补肝肾、养血和血之功效,对多囊卵巢综合征伴痤疮,尤其是肝经郁火型多囊卵巢综合征伴痤疮有极强的针对性疗效。
Description
技术领域
本发明属于医药技术领域,具体涉及一种治疗多囊卵巢综合征伴痤疮的药物组合物。
背景技术
多囊卵巢综合征(polycysticovariansyndrome,PCOS)是一种发病多因性、临床表现呈多态性的内分泌综合征,以慢性无排卵、高雄激素血症和卵巢多囊性改变为临床主要特征,是妇产科临床上较为常见的内分泌紊乱性疾病,在中国乃至世界都是导致生育期妇女月经紊乱最常见的原因之一。临床表现多为月经失调、卵巢呈多囊性改变,LH/FSH比值升高,肥胖、痤疮、多毛等,多囊卵巢综合征患者多不易妊娠,如果妊娠,妊娠后常会发生早期流产、妊娠期糖尿病、妊娠期高血伍病、小样儿等多样化的综合征,提高了流产的危险。并且伴随年龄的增长会出现日益明显的胰岛素抵抗、高胰岛素血症、肥胖、高脂血症、糖尿病、高血压、冠心病等代谢性并发症。
多囊卵巢综合征的发病原因尚不明确,多数医家认为多囊卵巢综合征是在诸多因素作用下,产生了一系列复杂的生理病理改变,最终导致下丘脑-垂体-卵巢轴功能失调,西医认为其病因主要与内分泌系统、神经系统失调有关,还涉及遗传、环境、免疫、心理等多方面因素。中医古典医籍中无多囊卵巢综合征的相关记载,但根据其临床表现特点可归属于“月经后期”、“月经过少”、“闭经”、“不孕”、“癥瘤”等范畴。在临床实践中,据多囊卵巢综合征患者的主诉、病史及体征,认为其发生是外感邪气、内伤七情、饮食不节、痰湿、瘀血、劳伤气血、脏器不足共同作用的结果。
目前西医治疗多囊卵巢综合征主要是应用促排卵药、避孕药及激素类药物,虽能暂时取得一定疗效,但远期疗效较差,副作用较大,不能长期应用,且对于痤疮没有效果。而中医学的多系统协同调理,多靶点共同作用,其整体观念及辨证论治在治疗多囊卵巢综合征伴痤疮上有着独特的优势和潜力,未见明显的毒副作用,远期疗效较为满意。因此研制效果更为显著的治疗多囊卵巢综合征的中药制剂具有重大的意义。
发明内容
为了解决上述问题,本发明旨在提供一种治疗肝郁血热型多囊卵巢综合征的药物组合物及其制备方法。
本发明的一个目的是提供一种治疗多囊卵巢综合征伴痤疮的药物组合物。
本发明的另一个目的是提供一种治疗多囊卵巢综合征伴痤疮的药物组合物的制备方法。
发明人结合古今先贤的理论与自己的临床经验,把西医辨病、辨因的微观检测与中医宏观辨证施治相结合,提供的一种治疗多囊卵巢综合征伴痤疮的药物组合物,由玫瑰花、香附、当归藤、六月雪、女贞子、枸杞子、土茯苓、隔山消、千针万线草、野丁香根、白茅根、红母鸡草为原料药精心制成。
本发明优选技术方案是本发明所述的药物组合物由以下重量份的原料药制成:
玫瑰花15-30份、香附8-26份、当归藤10-25份、六月雪10-20份、女贞子10-30份、枸杞子15-35份、土茯苓25-50份、隔山消8-18份、千针万线草10-20份、野丁香根5-15份、白茅根8-26份、红母鸡草10-20份。
本发明进一步优选技术方案是本发明所述的药物组合物由以下重量份的原料药制成:玫瑰花18-24份、香附16-22份、当归藤14-18份、六月雪10-15份、女贞子20-26份、枸杞子25-32份、土茯苓35-40份、隔山消8-13份、千针万线草15-20份、野丁香根7-12份、白茅根13-18份、红母鸡草11-16份。
本发明进一步优选技术方案是本发明所述的药物组合物由以下重量份的原料药制成:玫瑰花20份、香附18份、当归藤15份、六月雪12份、女贞子20份、枸杞子30份、土茯苓35份、隔山消10份、千针万线草15份、野丁香根8份、白茅根15份、红母鸡草12份。
发明人认为:肝为血脏,内藏有形之阴血,与肾藏之精相互转化,对女性进入青春期天癸的成熟泌至有着间接物质支持。若肝气不能畅达而失于疏泄,肾藏精施泄不足,天癸表达受到抑制,阻碍冲任相资,氤氲期肾中阴阳难以转化,排卵受阻,精卵相隔而难成孕,因此肝失疏泄是PCOS排卵障碍的重要因素。若肝气郁结不能得到及时治疗,疏泄失职,肝郁化火则见面部痤疮、毛发浓密、皮肤粗糙;同时肝气郁结、肝经郁火灼伤肝阴,进而损伤肾阴;炼血成瘀,阻滞于胞脉,冲任失畅,均可致血海不能按时满溢,致闭经、月经量少、月经后期等,多见于青春期女性。方中玫瑰花甘、微苦,温,主利肺脾,益肝胆,能舒肝胆之郁气,健脾调中活血降火,兼能破血消症;香附归肝、脾、三焦经,香而能窜,辛能散,微苦能降,微甘能和,与玫瑰花配伍,能解散郁气,能降肝火,能消磨积块,为君药。
当归藤苦,涩,温,能补血活血,强壮腰膝;六月雪淡、微辛,性凉,善健脾利湿,舒肝活血;女贞子甘、苦,凉,能养阴益肾,补气舒肝;枸杞子甘,平,润而滋补,兼能退热,专于补肾、润肺、生津、益气,为肝肾真阴不足、劳乏内热补益之要药,四药配伍补血活血以养肝血而解肝之郁,同时皆有滋肾强壮之功效,调理冲任以调经,为臣药。
隔山消味甘;微苦;性微温;能滋阴养血,强筋骨,健脾胃,解毒;千针万线草甘;性平,健脾养血,补肝益肾,以助君臣药。野丁香根微苦,凉,活血调经;清热解毒;红母鸡草辛;平,祛瘀调经,解毒,二药活血祛瘀,调经,解毒。白茅根甘能补脾益血,寒能凉血除内热,土茯苓甘淡,平,能利湿去热,能入络,搜剔湿热之蕴毒,二药伍用能利湿去热,消疮而通闭,六药具为佐使药。
诸药互相作用,具有疏肝解郁、化瘀散滞、清热养阴、泻火解毒、滋补肝肾、养血和血之功效,多囊卵巢综合征伴痤疮,尤其是肝郁血热型多囊卵巢综合征伴痤疮有极强的针对性疗效。
进一步地,本发明所述的药物组合物中各原料药的功能及功能主治如下。
玫瑰花:【性味】甘、微苦,温。【归经】归肝、脾经。【功能主治】行气解郁,和血,止痛。用于肝胃气痛,食少呕恶,月经不调,跌扑伤痛。【功能主治】理气解郁,和血散瘀。治肝胃气痛,新久风痹,吐血咯血,月经不调,赤白带下,痢疾,乳痈,肿毒。
香附:【性味】辛、微苦、微甘,平。【归经】归肝、脾、三焦经。【功能主治】行气解郁,调经止痛。用于肝郁气滞,胸、胁、脘腹胀痛,消化不良,胸脘痞闷,寒疝腹痛,乳房胀痛,月经不调,经闭痛经。【用法用量】6~9g。《纲目》:“香附之气平而不寒,香而能窜,其味多辛能散,微苦能降,微甘能和。乃气病之总司,女科之主帅也。”
当归藤:【性味】苦;涩;性温。【归经】肝;肾经。【功能主治】补血;活血;强壮腰膝。主血虚诸证;月经不调;闭经;产后虚弱;腰腿酸痛;跌打骨折。【用法用量】内服:煎汤,15~30g。外用:适量,鲜品捣敷。
六月雪:【性味】味淡、微辛,性凉。【功能主治】健脾利湿,舒肝活血。用于小儿疳积,急慢性肝炎,经闭,白带,风湿腰痛。
女贞子:【性味】甘、苦,凉。【归经】归肝、肾经。【功能主治】滋补肝肾,明目乌发。用于眩晕耳鸣,腰膝酸软,须发早白,目暗不明。《本草再新》:“养阴益肾,补气舒肝。治腰腿疼,通经和血。”
枸杞子:【性味】甘,平。【归经】归肝、肾经。【功能主治】滋补肝肾,益精明目。用于虚劳精亏,腰膝酸痛,眩晕耳鸣,内热消渴,血虚萎黄,目昏不明。本草经疏》:“枸杞子,润而滋补,兼能退热,而专于补肾、润肺、生津、益气,为肝肾真阴不足、劳乏内热补益之要药。”
隔山消:【性味】味甘;微苦;性微温;【归经】脾;胃;肾经。【功能主治】补肝肾;强筋骨;健脾胃;解毒。主肝肾两虚;头昏眼花;失眠健忘;须发早白;阳痿;遗精;腰膝酸攀登;脾虚不运;脘腹胀满;仞欲不振;泄泻;产后乳少;鱼口疮毒。【用法用量】内服:煎汤,9-15g外用:鲜品适量,捣敷。《陕西中草药》:滋阴养血,健脾顺气,镇静止痛,催乳。治胃痛腹胀,虚劳,肾虚腰痛,阳萎,小儿痞块,白带,乳汁不足。
千针万线草:【性味】甘;性平。【归经】肝;脾;肾经。【功能主治】健脾养血;补肝益肾;消肿。主贫血;精神短少;头晕心慌;耳鸣眼花;潮热;遗精;月经不调;带下;骨折;乳腺炎。【用法用量】内服:煎汤,15-30g;或炖肉服。外用:适量,鲜品捣敷。
野丁香根:【性味】涩;微苦;凉。【归经】肝;肾经。【功能主治】活血调经;清热解毒。主月经不调;痛经;风湿关节疼痛;偏头痛;尿路感染;毒蛇咬伤;跌打损伤;外伤感染。【用法用量】内服:煎汤,15-30g。外用:适量,捣敷。
红母鸡草:【性味】甘辛;平。【归经】肝经。【功能主治】祛瘀调经,解毒,止痛。主跌打损伤,子宫脱垂,脱肛,闭经,牛皮癣,牙痛,头痛。【用法用量】内服:煎汤,9-15g。外用:适量,捣敷;或制成膏剂涂搽。
白茅根:【性味】甘,寒。【归经】归肺、胃、膀胱经。【功能主治】凉血止血,清热利尿。用于血热吐血,衄血,尿血,热病烦渴,黄疸,水肿,热淋涩痛;急性肾炎水肿。《本草求原》:白茅根,和上下之阳,清脾胃伏热,生肺津以凉血,为热血妄行上下诸失血之要药。
土茯苓:【性味】甘淡;平。【归经】肝;胃;脾经。【功能主治】清热除湿;泄浊解毒;通利关节。主梅毒;淋浊;泄泻;筋骨挛痛;脚气;痈肿;疮癣;瘰疬;瘿瘤及汞中毒。【用法用量】内服:煎汤,10-60g。外用:适量,研末调敷。《本草正义》:土茯苓,利湿去热,能入络,搜剔湿热之蕴毒。为治疗痤疮要药。
为了更好地表达本发明的药物组合物,本发明的药物组合物可由玫瑰花、香附、当归藤、六月雪、女贞子、枸杞子、土茯苓、隔山消、千针万线草、野丁香根、白茅根、红母鸡草或其水或其有机溶剂提取物为活性成分,加入药学上可接受的辅料或辅助性成分制备成药学上常用的剂型。
所述的药学上可接受的载体或辅助性成分,如淀粉、糖粉、糊精、微晶纤维、可压性淀粉、微粉硅胶、果糖、羧甲基淀粉钠、羧甲基纤维素钠、羟丙基甲基纤维素、植物油、卵磷脂、聚乙二醇、丙二醇、尼泊金乙酯、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁、聚乙烯吡咯烷酮、甘油、土温80、琼脂、碳酸钙、碳酸氢钙,等等。
其中,所述的药剂是口服剂型,比如:片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、颗粒剂、蜜丸剂、散剂、丹剂、溶液剂等。
优选地,上述所述的药物组合物优选制成片剂、胶囊剂或颗粒剂,最优选为胶囊剂。
本发明还提供了该药物组合物的制备方法,它包括如下步骤:将所述玫瑰花、香附、当归藤、六月雪、女贞子、枸杞子、土茯苓、隔山消、千针万线草、野丁香根、白茅根、红母鸡草按处方比例混合,加入相对于混合物质量4~10倍的水,煎煮2~3小时,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的水,煎煮1~2小时,过滤获得第二提取液;将第一提取液和第二提取液合并,加乙醇使含醇量为30%v/v,静置24小时后,得到上清液,再经截流分子量为7500-9000的超滤柱超滤,超滤液减浓缩至相对密度1.05-1.10(60℃测得),在进风温度140~150℃,出风温度75~80℃条件下进行喷雾干燥,得到药物活性成分;该成分单独或与药物可接受的载体混合,依照制剂学常规技术制成。
本发明还请求保护上述药物组合物在制备治疗多囊卵巢综合征伴痤疮的药物中的用途。在临床观察过程中,152例患者均完成临床观察,无脱落退出病例。经过本发明药物治疗三个疗程的PCOS伴痤疮患者,参照《中药新药临床研究指导原则》判定标准PCOS疗效,治疗病例76例,显效45例,有效29例,无效2例,显效率59.2%,总有效率97.4%,观察组与对照组显效率、总有效率比较,差异有统计学意义(P<0.05),说明观察组较对照组可以明显的提高多囊卵巢综合征患者的临床治愈率及显效率;参照《寻常座疮严重程度分级和疗效判定标准》痤疮的疗效,痊愈12例,显效22例,好转33例,无效9例,显效率42.6%,总有效率88.2%,观察组显效率、总有效率明显高于对照组,且差异具有统计学意义(P<0.01),说明观察组较对照组可以明显的提高多囊卵巢综合征患者痤疮的临床治愈率及显效率。
本发明相对与现有技术,有如下明显优势:首先,本发明药物组合物组方主要是依据多囊卵巢综合征伴痤疮特别是肝郁血热型多囊卵巢综合征伴痤疮的病机特点研制而成,对肝郁血热型多囊卵巢综合征伴痤疮有极强的针对性疗效。
本发明组方精简,配伍合理,成本低廉,经临床应用验证,其疗效确切,药性平和,未出现毒副作用及明显不良反应,安全系数高。
本发明中药制剂采用先进提取设备和工艺,充分提取有效成分,可制成方便口服或携带的中药制剂,如片剂、胶囊剂或颗粒剂。
具体实施方式
以下通过具体实施例进一步描述本发明,本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内,对本发明进行的变更、组合或替换,对于本领域的技术人员来说是显而易见的,且包含在本发明的范围之内。
实施例1胶囊剂
处方:玫瑰花20份、香附18份、当归藤15份、六月雪12份、女贞子20份、枸杞子30份、土茯苓35份、隔山消10份、千针万线草15份、野丁香根8份、白茅根15份、红母鸡草12份。
制备方法:
将所述玫瑰花、香附、当归藤、六月雪、女贞子、枸杞子、土茯苓、隔山消、千针万线草、野丁香根、白茅根、红母鸡草按处方比例混合,加入相对于混合物质量4~10倍的水,煎煮2~3小时,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的水,煎煮1~2小时,过滤获得第二提取液;将第一提取液和第二提取液合并,加乙醇使含醇量为30%v/v,静置24小时后,得到上清液,再经截流分子量为7500-9000的超滤柱超滤,超滤液减浓缩至相对密度1.05-1.10(60℃测得),在进风温度140~150℃,出风温度75~80℃条件下进行喷雾干燥,得到药物活性成分,依照制剂学常规技术制成。
本实施例胶囊剂,每粒含有生药1.1g。
实施例2片剂
处方:玫瑰花18份、香附15份、当归藤12份、六月雪10份、女贞子25份、枸杞子25份、土茯苓30份、隔山消8份、千针万线草18份、野丁香根10份、白茅根10份、红母鸡草15份。
制备方法:将所述玫瑰花、香附、当归藤、六月雪、女贞子、枸杞子、土茯苓、隔山消、千针万线草、野丁香根、白茅根、红母鸡草按处方比例混合,加入相对于混合物质量4~10倍的水,煎煮2~3小时,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的水,煎煮1~2小时,过滤获得第二提取液;将第一提取液和第二提取液合并,加乙醇使含醇量为30%v/v,静置24小时后,得到上清液,再经截流分子量为7500-9000的超滤柱超滤,超滤液减浓缩至相对密度1.05-1.10(60℃测得),在进风温度140~150℃,出风温度75~80℃条件下进行喷雾干燥,得到药物活性成分,依照制剂学常规技术制成。
本实施例片剂,每片含有生药1.0g。
实施例3颗粒剂
处方:玫瑰花22份、香附18份、当归藤18份、六月雪15份、女贞子20份、枸杞子35份、土茯苓35份、隔山消12份、千针万线草10份、野丁香根12份、白茅根15份、红母鸡草12份。
制备方法:
将所述玫瑰花、香附、当归藤、六月雪、女贞子、枸杞子、土茯苓、隔山消、千针万线草、野丁香根、白茅根、红母鸡草按处方比例混合,加入相对于混合物质量4~10倍的水,煎煮2~3小时,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的水,煎煮1~2小时,过滤获得第二提取液;将第一提取液和第二提取液合并,加乙醇使含醇量为30%v/v,静置24小时后,得到上清液,再经截流分子量为7500-9000的超滤柱超滤,超滤液减浓缩至相对密度1.05-1.10(60℃测得),在进风温度140~150℃,出风温度75~80℃条件下进行喷雾干燥,得到药物活性成分,依照制剂学常规技术制成。
本实施例颗粒剂,每袋含有生药3.0g。
实施例4胶囊剂
处方:玫瑰花24份、香附16份、当归藤20份、六月雪15份、女贞子25份、枸杞子20份、土茯苓40份、隔山消15份、千针万线草20份、野丁香根10份、白茅根20份、红母鸡草15份。
制备方法:参照实施例1。
实施例5胶囊剂
处方:玫瑰花20份、香附10份、当归藤12份、六月雪10份、女贞子30份、枸杞子15份、土茯苓50份、隔山消15份、千针万线草10份、野丁香根15份、白茅根25份、红母鸡草15份。
制备方法:参照实施例1。
实施例6胶囊剂
处方:玫瑰花25份、香附15份、当归藤20份、六月雪20份、女贞子10份、枸杞子20份、土茯苓35份、隔山消15份、千针万线草10份、野丁香根5份、白茅根25份、红母鸡草10份。
制备方法:参照实施例1。
实施例7胶囊剂
处方:玫瑰花21份、香附20份、当归藤15份、六月雪15份、女贞子25份、枸杞子25份、土茯苓40份、隔山消12份、千针万线草15份、野丁香根7份、白茅根17份、红母鸡草11份。
制备方法:参照实施例1。
实施例8临床观察试验
1资料与方法
1.1一般资料:观察2014年1月至2014年12月就诊于我院妇科门诊确诊为多囊卵巢综合征伴痤疮的患者152例,随机分为观察组与对照组进行观察,每组76例。观察组年龄18-27岁,平均年龄21.3±2.7岁,病程最长3.5年,最短6个月,平均1.55±0.78年;月经稀发28例,合并多毛18例。对照组年龄18-26岁,平均20.9±2.5岁;病程最长3.5年,最短5个月,平均1.46±0.71年;月经稀发29例,合并多毛19例。两组一般资料比较无统计学差异(P>0.05),具有可比性。
1.2诊断标准:
1.2.1多囊卵巢综合征诊断标注:参照2003年鹿特丹PCOS会议修订的标准:(1)月经稀发或闭经;(2)临床和(或)生化指标提示存在高雄激素血症(高雄激素血症的临床表现包括痤疮、多毛);(3)超声提示多囊卵巢:一侧或双侧卵巢有≥12个直径在2-9mm的小卵泡,和(或)卵巢体积增大>10mL。以上(1)-(3)具备任意2个或3个者可诊断多囊卵巢综合征。
1.2.2面部痤疮的诊断标准:参照国家中医药管理局1994年发布的《中医临床病证诊断疗效标准》中医粉刺的诊断标准拟定:
在毛囊口,呈现小米粒大小红色丘疹,继而形成脓、硬结样白色粉刺或黑头粉刺、甚至可形成硬结性囊肿;青春期男女的面部,常伴有皮脂溢出;女性患者多伴有月经不调。
痤疮病情分级与评分标准:参照1997年10月中华医学美容分会皮肤美容学组制定的《寻常座疮严重程度分级和疗效判定标准》,将寻常性座疮分为3度九级,拟定评分如下:
轻度:1级:少于25个,1分;2级26-50个,2分;3级51-75个,3分
中度:1级:76-100个,4分;2级多于100个,5分;3级伴有l-2个结节或囊肿,6分
重度:1级伴有3-5结节或囊肿,7分;2级,伴有6个以下结节或囊肿,8分;3级,伴有结节、囊肿及肥厚性瘫痕或窦道,9分。
注:皮损计数部位选右或左侧面部,以中心线划界,包括半侧额部、颧部、颊部、领部、领部总和计算。治疗后,若全部消失则为0分。若治疗后仍为原级,但有所减轻,则可计算小分,每好转10%可减去0.1分。非活动性病变(包括色素沉着、坑点状瘫痕)不作评分指数。
1.2.3中医辨证标准参:考参考中华人民共和国卫生部制定《中华人民共和国国家标准·中医临床诊疗术语症候部分》、《中药新药治疗月经不调的临床研究指导原则》以及普通高等教育中医药规划教材《中医妇科学》第七版教材,结合实际拟定证候诊断标准,如下:肝郁血热型:主证:月经先后不定或周期紊乱,经量少或闭经,经色紫黯;次证:经夹血块或痛经,经前乳房胀痛,情志不畅,心烦易怒,口苦咽干;舌脉:舌红,边有瘀点,苔薄黄,脉弦数。具各主证之一项,次证两项或以上,加舌脉方可诊断。
1.3排除标准:辨证不符合肝郁血热证者;合并可引起高雄激素血症的其他疾病,如先天性肾上腺皮质增生、库欣综合征和肿瘤者;合并高泌乳素血症、糖尿病、甲状腺功能异常等内分泌疾病者;近3个月曾接受性激素或影响脂类代谢的药物治疗者;对本研究药物过敏者;不能配合治疗及观察者。
1.4治疗方法:
观察组:口服本发明实施例1制备的胶囊,每日2次,每次2-4粒,饭后半小时服用。一个月经周期为一疗程,逢经期停用,共治疗3个疗程。
对照组:于自然月经或撤退性出血第5天开始口服达英-35(每片含醋酸环丙孕酮2mg和炔雌醇35μg),每日1片,连服21天),停药后待撤退性出血第5天起重复服用,共3个疗程。
两组患者在治疗期间均不服用其他药物,耐心向患者解释病情,消除患者心理顾虑,嘱患者精神乐观,劳逸适度,忌食生冷及辛辣。
1.5观察指标:
1.5.1观察治疗前、治疗3个周期后患者的月经改善情况(主要询问患者月经来潮时间,月经量、色、质情况)和排卵情况(自测基础体温),以及B超测量子宫、卵巢各径线大小,排卵时子宫内膜厚度;
1.5.2记录用药前后每次月经前期面部座疮的情况;
1.5.3检测肝功能水平,以观察两组的毒副反应情况。
1.6疗效标准:
1.6.1多囊卵巢综合征疗效标准:参照《中药新药临床研究指导原则》标准拟订。显效:月经周期恢复正常,停药后月经规则连续>3个周期,临床症状明显减轻,基础体温双相,生理激素水平基本正常,B超提示卵巢恢复正常大小;有效:月经周期基本恢复正常,停药后3个周期病情偶有复发,临床症状有所减轻,生理激素水平趋于正常,B超提示卵巢较治疗前有所缩小;无效:月经紊乱,甚或仍然闭经,临床症状及生理激素水平无明显改善,B超检查无明显改善。总有效率=(显效例数+有效例数)/总例数×100%。
1.6.2痤疮疗效判定标准:根据积分法判定,疗效指数:(疗前积分-疗后积分)/疗前积分×100%。痊愈:皮损疗效指数>95%,自觉症状消失;显效:60%<皮损疗效指数<95%,自觉症状明显改善;有效:20%<皮损疗效指数<60%,自觉症状有所改善;无效:皮损疗效指数<20%,或反见增多,自觉症状无改善。总有效率=(痊愈例数+显效例数+有效例数)/总例数×100%。
1.7统计学方法:采用SPSS15.0统计软件进行计算。各数值以表示,计量资料采用t检验,计数资料采用χ2检验,以P<0.05为差异有统计学意义。
2结果
临床观察过程中无退出、无脱落病例,全部完成临床观察。
2.1两组患者多囊卵巢综合征疗效比较:观察组显效45例,有效29例,无效2例,显效率59.2%,总有效率97.4%;对照组显效22例,有效38例,无效16例,显效率28.9%,总有效率78.9%,观察组与对照组显效率、总有效率比较,差异有统计学意义(P<0.05),说明观察组较对照组可以明显的提高多囊卵巢综合征患者的临床治愈率及显效率。见表1。
表1两组患者疗效比较(n%,例)
注:与对照组比较,*P<0.05。
2.2两组患者治疗前后座疮疗效比较:观察组痊愈12例,显效22例,好转33例,无效9例,显效率42.6%,总有效率88.2%;对照组痊愈0例,显效6例,好转14例,无效56例,显效率7.9%,总有效率26.3%,观察组显效率、总有效率明显高于对照组,且差异具有统计学意义(P<0.01),说明观察组较对照组可以明显的提高多囊卵巢综合征患者痤疮的临床治愈率及显效率。具体结果见表2。
表2两组患者治疗前后座疮疗效比较,例
注:与对照组比较,*P<0.01。
2.3安全性观察两组患者治疗前后肝功能、肾功能检查均无异常。观察组服药期间无明显不适,对照组19例出现药物不良反应,如突破性出血、体重轻度增加、乳胀、头晕,未经特殊处理,症状逐渐消失。
故相比于西药常规疗法,本发明药物应用于多囊卵巢综合征伴痤疮患者的临床疗效更佳,疗效值得肯定,在临床治疗中应加以推广应用。
Claims (10)
1.一种治疗多囊卵巢综合征伴痤疮的药物组合物,其特征在于由玫瑰花、香附、当归藤、六月雪、女贞子、枸杞子、土茯苓、隔山消、千针万线草、野丁香根、白茅根、红母鸡草为原料药制成。
2.如权利要求1所述的药物组合物,其特征在于由以下重量份的原料药制成:玫瑰花15-30份、香附8-26份、当归藤10-25份、六月雪10-20份、女贞子10-30份、枸杞子15-35份、土茯苓25-50份、隔山消8-18份、千针万线草10-20份、野丁香根5-15份、白茅根8-26份、红母鸡草10-20份。
3.如权利要求2所述的药物组合物,其特征在于由以下重量份的原料药制成:玫瑰花18-24份、香附16-22份、当归藤14-18份、六月雪10-15份、女贞子20-26份、枸杞子25-32份、土茯苓35-40份、隔山消8-13份、千针万线草15-20份、野丁香根7-12份、白茅根13-18份、红母鸡草11-16份。
4.如权利要求3所述的药物组合物,其特征在于由以下重量份的原料药制成:玫瑰花20份、香附18份、当归藤15份、六月雪12份、女贞子20份、枸杞子30份、土茯苓35份、隔山消10份、千针万线草15份、野丁香根8份、白茅根15份、红母鸡草12份。
5.如权利要求1-4任一所述的药物组合物,其特征在于所述药物组合物制成为口服剂型。
6.如权利要求5所述的药物组合物,其特征在于所述口服剂型优选为片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、颗粒剂、蜜丸剂、散剂、丹剂、溶液剂等。
7.如权利要求6所述的药物组合物,其特征在于所述口服剂型优选为片剂、胶囊剂或颗粒剂。
8.如权利要求7所述的药物组合物,其特征在于所述口服剂型最优选为胶囊剂。
9.如权利要求1-4任一所述的药物组合物,其特征在于制备方法包括如下步骤:将所述玫瑰花、香附、当归藤、六月雪、女贞子、枸杞子、土茯苓、隔山消、千针万线草、野丁香根、白茅根、红母鸡草按处方比例混合,加入相对于混合物质量4~10倍的水,煎煮2~3小时,过滤获得第一提取液;过滤获得的药渣再加入相对于所述药渣质量2~4倍的水,煎煮1~2小时,过滤获得第二提取液;将第一提取液和第二提取液合并,加乙醇使含醇量为30%v/v,静置24小时后,得到上清液,再经截流分子量为7500-9000的超滤柱超滤,超滤液减浓缩至相对密度1.05-1.10(60℃测得),在进风温度140~150℃,出风温度75~80℃条件下进行喷雾干燥,得到药物活性成分;该成分单独或与药物可接受的载体混合,依照制剂学常规技术制成。
10.如权利要求1-4任一所述的药物组合物在制备治疗多囊卵巢综合征伴痤疮的药物中的用途。
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