CN116370548A - 一种具有改善***功效的中药组合物及其制备方法与应用 - Google Patents
一种具有改善***功效的中药组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明公开了一种治疗***的中药组合物及其制备方法与应用,属于医药技术领域。该中药组合物由枸杞叶5~15份,柴胡5~15份,黄连0.3~3份,生石膏5~20份,益母草5~20份,泽兰5~20份,桂枝1~10份,苍术5~15份,枳实5~15份,炙甘草3~10份的原料制成。本发明提供的中药组合物,具有改善***体重增加,糖脂代谢异常,***紊乱,降低睾酮与促卵泡生成素水平,减少卵巢囊性卵泡数目的作用,功效可靠,安全性好,可用于制备改善***的相关医药产品。
Description
技术领域
本发明属于医药技术领域,尤其涉及一种改善***的中药组合物及其制备方法与应用。
背景技术
多囊卵巢综合症(Polycystic Ovary Syndrome,PCOS)是临床导致***的最常见妇科疾病之一,世界范围内患病率为5-20%,中国患病率为5.6%,其主要临床表现为月经稀发或后期、高雄激素血症及胰岛素抵抗、卵巢多囊样改变。此外,PCOS还与更高的代谢疾病风险相关,包括胰岛素抵抗,糖耐量受损,2型糖尿病、血脂异常和心血管疾病。目前为止,PCOS的病因及发病机制依然存在诸多不确定性,已经发现其可能与遗传因素、神经内分泌、免疫及代谢功能障碍和生活方式等因素密切相关。近年来,随着学习及生活压力的升高、不健康的饮食作息等生活习惯、环境内分泌干扰等影响,PCOS发病率呈逐年增高的趋势,如何有效满足临床患者诉求,预防PCOS诱导的远期健康风险成为亟待解决的问题。
多囊卵巢是一种多因素异质性强的疾病,目前还没有被批准用于治疗PCOS的药物,因此,需要针对患者需求进行个性化的治疗。目前主要应用周期性孕激素疗法、短效口服避孕药以及雌孕激素序贯治疗以调整***,以上疗法可能会导致患者出现高血压、肥胖、凝血功能异常以及异常子宫出血。使用螺内酯以改善雄激素性脱发时在应用期间可能会出现低血压副反应,大剂量使用时需要定期检测血钾水平。PCOS患者在服用二甲双胍改善胰岛素抵抗时,可能会出现恶心、腹胀、腹痛、腹泻等消化道症状,且肝肾功能不全者禁忌。对于用生育需求的PCOS患者常采用促***药物如来曲唑、***等以达到妊娠的目的,其主要缺点是促***药物增加了多胎妊娠以及卵巢过度刺激综合征风险,此外还会患者还会出现血管舒缩性潮热,视觉模糊或持久性视觉延迟等不良反应。
因此,近年来许多国内外学者纷纷致力于寻找一种安全有效的替代方法,使治疗PCOS的副作用能够降到最低。在中医的整体观念和辨证论治指导下,通过调节脏腑功能,阻滞病理产物的出现与相互转换,使得机体功能恢复阴阳平衡,从而维持女性正常的生理功能。
发明内容
发明目的:本发明的目的在于提供一种疗效可靠,安全性好,具有很好的改善***的中药组合物。本发明的另一目的是提供上述组合物的制备方法和应用。
技术方案:为了实现以上目的,本发明采取的技术方案为:
一种改善***的中药组合物,包括下列重量份数的原料:枸杞叶5~15份,柴胡5~15份,黄连0.3~3份,生石膏5~20份,益母草5~20份,泽兰5~20份,桂枝1~10份,苍术5~15份,枳实5~15份,炙甘草3~10份。
作为优选方案,以上具有改善***的中药组合物,它包括下列重量份数的原料:枸杞叶12份,柴胡6份,黄连3份,生石膏15份,益母草12份,泽兰9份,桂枝6份,苍术6份,枳实9份,炙甘草6份。
作为优选方案,以上具有改善***的中药组合物,它包括下列重量份数的原料:枸杞叶10份,柴胡9份,黄连2份,生石膏15份,益母草15份,泽兰10份,桂枝6份,苍术9份,枳实10份,炙甘草6份。
作为优选方案,以上具有改善***的中药组合物,它包括下列重量份数的原料:
枸杞叶6份,柴胡6份,黄连3份,生石膏15份,益母草10份,泽兰10份,桂枝6份,苍术10份,枳实10份,炙甘草6份。
本发明的创新之处:
本发明是在***缺乏有效安全药物的情况下。基于中医药理论与***的病理机制,获得的改善***的有效组合物。
***,祖国传统医学认为与肾、肝、脾三脏功能失调及痰湿、血瘀等因素密切相关。肾阴虚,天癸不足,阴虚及阳,气化不力,不能协助肝脾以司运化,易致痰湿壅阻。若恣食膏粱厚味,饮食失节,损伤脾胃,脾虚则痰湿易生,故见形体肥胖。肝肾同源,肾阴虚水不涵木,心肝气郁,血行不畅,气滞血瘀,痰瘀互阻,胶结成癥,瘀阻胞宫,以致月经量少,后期而至,甚至闭止。痰瘀互阻,气血不畅,气火俱旺,故可见面部痤疮、毛发易长、口渴、心烦易怒、大便干结。因此,***临床易呈现本虚标实的特征,以肝经湿阻瘀热为标,脾肾俱虚为本。法当疏肝健脾益肾,清热利湿祛瘀。
方以枸杞叶滋肾益精,清热利湿;柴胡条达肝郁,疏畅气血。两者相伍,攻补兼施,邪去而正不伤,共为君药。黄连善清中焦湿热郁结,生石膏泻火除烦,生津止渴兼有透达之性。两者相伍,直泻肝经实热,存阴保津,透达而不闭遏,湿热得消。泽兰疏肝脾祛瘀,利水消肿。益母草入肝行血,消瘀化水。两者合用,活血不峻猛,利水不伤阴。两组药对,一重清热生津,一重消癥生新,共为臣药组合。苍术健脾燥湿,脾运得健,生痰之源可竭;枳实破气消积,化痰除痞,癥瘕集聚得消,共为佐药。桂枝温阳化气,通阳化浊,可助柴胡疏畅气血、泽兰益母通经祛瘀;与苍术相伍,则燥湿温化并用,疏郁通阳并施,增燥湿疏郁运脾之功;其温煦之性又可杜黄连石膏寒凉冰伏伤中之患。炙甘草与桂枝相伍,辛甘温通,助阳化气,又可顾护脾胃,防石膏黄连碍胃之弊。柴胡本为肝经要药,又可引药入肝。三药共为使药。
本发明十药共用,补泻同施,清热泻火,消痰祛瘀,肝气疏泄条达有常,脾肾分清泌浊得复,胞宫痰湿瘀阻得消,月经可调,诸症得宁。
本发明所述的具有改善***功效的中药组合物的制备方法,包括以下步骤:
(1)按重量份数取枸杞叶、柴胡、黄连、生石膏、益母草、泽兰、桂枝、苍术、枳实、炙甘草,混合,加水回流提取,过滤,收集滤液。
(2)取步骤(1)中的药渣,以水回流提取,过滤,收集滤液。
(3)取步骤(2)中的药渣,以水回流提取,过滤,收集滤液。
(4)取步骤(1)所得滤液、步骤(2)所得滤液、步骤(3)所得滤液,合并减压浓缩得浸膏,低温减压制得提取物。
作为优选方案,步骤(1)所述的回流提取条件为:首先加入药材重量10倍体积量的水,160℃回流提取90min。步骤(2)和步骤(3)回流条件为:加入药材重量8倍体积量的水,160℃回流提取60min。
有益效果说明:本发明提供的中药组合物,通过中医临床经验筛选得到。在动物模型上可有效改善PCOS模型大鼠的动情周期,降低模型大鼠血清中睾酮含量和促***/促卵泡生成素的含量,改善其卵巢多囊样改变,恢复模型大鼠的正常***。此外该中药组方能够减轻模型组大鼠体重,改善大鼠糖耐量异常,降低模型大鼠血清中甘油三酯,总胆固醇,低密度脂蛋白含量。上述研究表明本发明提供的中药组合物对PCOS有显著的改善作用,可用于制备具有改善PCOS的医药产品。
本发明所述中药组合物在改善PCOS中的应用,将此中药组合物和药学上可接受的载体制成片剂、丸剂、散剂、汤剂、颗粒剂、煎膏剂或浸膏剂剂型的产品,临床服用方便,并且本发明提供的中药组合物,实验过程中未发现明显毒副作用,安全性好。
附图说明
图1为中药组合物对来曲唑诱导PCOS大鼠卵巢组织HE染色的结果图(标尺=200μm)。
图2为中药组合物对来曲唑诱导PCOS大鼠动情周期影响的结果图。A为各组代表性动情周期循环;B为不同组别动情周期各阶段占总动情周期的百分比。
图3为中药组合物对来曲唑诱导PCOS大鼠性激素影响的结果图。A为睾酮(T)水平;B为促***与***比值LH/FSH;C为***(FSH)水平;D为***(E2)水平。
图4为中药组合物对来曲唑诱导PCOS大鼠体重及口服葡萄糖耐量影响的结果图。A为体重;B为口服葡萄糖耐量曲线;C为葡萄糖耐量曲线下面积。
图5为中药组合物对来曲唑诱导PCOS大鼠脂代谢影响的结果图。A为肝脏油红O染色(标尺=100μm);B为总胆固醇;C为低密度脂蛋白胆固醇;D为总甘油三酯。
图6为中药组合物对脱氢表雄酮诱导PCOS大鼠卵巢组织HE染色的结果图(标尺=200μm)。
图7为中药组合物对脱氢表雄酮诱导PCOS大鼠动情周期影响的结果图。A为各组代表性动情周期循环;B为不同组别动情周期各阶段占总动情周期的百分比。
图8为中药组合物对来曲唑诱导PCOS大鼠性激素影响的结果图。A为睾酮T水平;B为促***LH水平;C为促***与***比值LH/FSH。
图9为中药组合物对来曲唑诱导PCOS大鼠脂代谢影响的结果图。A为肝脏油红O染色(标尺=100μm);B为总胆固醇;C为低密度脂蛋白胆固醇;D为总甘油三酯。
具体实施方式
下面结合具体实施例进一步阐明本发明,应理解这些实施例仅用于说明本发明而不用于限制本发明的范围,在阅读了本发明之后,本领域技术人员对本发明的各种等价形式的修改均落于本申请所附权利要求所限定的范围。
实施例1一种具有改善***功效的中药组合物的制备方法,包括如下步骤:
(1)准确称取枸杞叶12份,柴胡6份,黄连3份,生石膏15份,益母草12份,泽兰9份,桂枝6份,苍术6份,枳实9份,炙甘草6份。加入药材重量10倍量的水回流提取90min,过滤,收集滤液和滤渣。
(2)取步骤(1)中的药渣,加入药材重量8倍体积量的水回流提取60min,过滤,收集滤液。
(3)取步骤(2)中的药渣,加入药材重量8倍体积量的水回流提取60min,过滤,收集滤液。
(4)合并步骤(1)、步骤(2)与步骤(3)中所得滤液,减压浓缩得浸膏,低温减压制得中药组合物的提取物。
实施例2一种具有改善***功效的中药组合物的制备方法,包括如下步骤:
(1)准确称取枸杞叶10份,柴胡9份,黄连2份,生石膏15份,益母草15份,泽兰10份,桂枝6份,苍术9份,枳实10份,炙甘草6份。加入药材重量10倍量的水回流提取120min,过滤,收集滤液和滤渣。
(2)取步骤(1)中的药渣,加入药材重量10倍体积量的水回流提取120min,过滤,收集滤液。
(3)合并步骤(1)与步骤(2)中所得滤液,减压浓缩得浸膏,低温减压制得中药组合物的提取物。
实施例3一种具有改善***功效的中药组合物的制备方法,包括如下步骤:
(1)准确称取枸杞叶6份,柴胡6份,黄连3份,生石膏15份,益母草10份,泽兰10份,桂枝6份,苍术10份,枳实10份,炙甘草6份。加入药材重量10倍量的水回流提取120min,过滤,收集滤液和滤渣。
(2)取步骤(1)中的药渣,加入药材重量6倍体积量的水回流提取120min,过滤,收集滤液。
(3)合并步骤(1)与步骤(2)中所得滤液,减压浓缩得浸膏,低温减压制得中药组合物的提取物。
实施例4本发明中药组合物改善来曲唑诱导大鼠PCOS的实验研究
一、实验材料与药物
1.药物与试剂
来曲唑购自上海麦克林生物有限公司,羧甲基纤维素钠购自上海源叶生物科技有限公司,二甲双胍购自上海源叶生物科技有限公司,大鼠睾酮(T)酶联免疫分析(ELISA)试剂盒,大鼠促卵泡生成素(FSH)酶联免疫分析(ELISA)试剂盒,大鼠促***(LH)酶联免疫分析(ELISA)试剂盒,大鼠***(E2)酶联免疫分析(ELISA)试剂盒,大鼠胰岛素(INS)酶联免疫分析(ELISA)试剂盒购自南京建成生物工程有限公司,血糖仪及血糖试纸购自罗氏公司。
受试药物:本发明实施例1制备得到的中药组合物的提取物。
2.实验仪器
酶标仪(美国Perkin-Elmer公司);BT125型电子天平(赛多利斯科学仪器有限公司);KQ-250E型超声波清洗器(昆山禾创超声仪器有限公司);Anke GL-16GII型离心机(上海安亭科学仪器厂)。
3.实验动物
SPF级21日龄SD雌性大鼠,购自南京中医药大学实验动物中心,合格证号SCXK(沪)2022-0004。
二、实验方法
1.PCOS大鼠模型的建立与中药组合物给药
来曲唑1mg/kg/d联合高脂喂养21日龄雌性SD大鼠28天,构建PCOS模型。镜下观察PCOS模型大鼠卵巢中囊性卵泡明显增多,几乎看不见卵泡和黄体,也未见***,表明建模成功。
将实施例2中药组合物提取物加生理盐水配置成浓度为1g/ml的药液,储存在4℃下待用。中药组根据实验动物等效计量的研究方法,按“人与动物体表面积折算的等效剂量比值表”,由人换算成大鼠的剂量为低剂量为4.67g/kg/d,中剂量即9.35g/kg/d,高剂量为18.71g/kg/d。将造模成功的SD大鼠平均分成五组,每组8只,其中模型组灌胃给予来曲唑1mg/kg/d,给药组在模型的基础上,低剂量组按4.67g/kg/d灌胃给予本发明中药组合物提取物,中剂量组按9.35g/kg/d灌胃给予本发明中药组合物提取物,高剂量组按18.71g/kg/d灌胃给予本发明中药组合物提取物,阳性对照组在模型的基础上给予二甲双胍200mg/kg/d灌胃,选取未进行造模处理的雌性SD大鼠8只,作为空白对照组,1mL/100g/d生理盐水灌胃,给药28天后,处死大鼠,取血清进行性激素测定,取卵巢组织,进行HE染色,取肝脏进行油红O染色。
2.药效评价方法
每日09:00各组大鼠通过棉签蘸取生理盐水取***涂片,显微镜下观察细胞涂片监测大鼠的动情周期是否规律。给药28天后,动物禁食不禁水14h后,检测大鼠的空腹血糖,空腹胰岛素,以及口服葡萄糖耐量。各组大鼠末次给药结束后腹主动脉取血,室温静置2h后于低温超速离心机进行离心(4℃,3000rpm/min,15min),分离得到的血清,采用ELISA试剂盒检测各组大鼠血清中T、E2、FSH水平;取肝脏行油红O染色,观察药物对肝脏脂质积累的干预作用,另取卵巢组织行HE染色,观察药物对PCOS大鼠卵巢组织形态的干预作用。
3.数据处理
所有实验数据均采用SPSS18.0统计处理软件进行统计学处理,结果以平均值加减方差表示,组间差异采用t检验,P<0.05为差异有统计学意义。
三、实验结果
实验结束后,迅速摘取卵巢组织使用多聚甲醛固定,进行HE染色。正常对照组大鼠的卵巢在HE染色下可见多个不同发育阶段的卵泡及黄体,颗粒细胞形态完整且排列整齐。模型组PCOS大鼠卵巢中囊性卵泡增多、无黄体形成,表明大鼠未发生***,部分卵泡严重闭锁,颗粒细胞层稀疏排列,甚至消失。图1结果表明,给予中药组合物提取物后大鼠闭锁卵泡的数量显著减少,次级卵泡的数量增加,卵巢内黄体丰富和有多个不同发育阶段的卵泡,颗粒细胞层增厚并紧密聚集,形态接近正常对照组及阳性对照组,尤其是低剂量组,效果明显。
动情周期监测结果显示,空白对照组大鼠动情周期规则,呈现出规律的动情前期、动情期、动情后期、动情间期。模型组PCOS大鼠失去正常动情周期,***涂片呈现持续性动情间期。由图2可以看出,二甲双胍组、中药组合物提取物中剂量组和高剂量组大鼠由持续的动情间期,逐渐出现动情期、动情后期,间期的循环变化,且随着治疗越来越有规律。由此可见,中药组合物提取物中剂量组对PCOS大鼠的发情周期具有调节作用。表明本发明中药组合物可以调节PCOS大鼠动情周期紊乱。
根据试剂盒说明书测定大鼠血清中T、E2、LH、FSH含量。由图3结果可知,与正常组大鼠相比,模型组PCOS大鼠血清中雄激素T水平明显增高,LH/FSH含量升高,E2含量降低,FSH含量下降,亦进一步证实本发明造模方法造模成功。中药组合物及二甲双胍治疗后T和LH/FSH水平显著下降,E2和FSH水平显著升高。结果显示采用本发明中药组合物治疗后,各激素水平显著恢复稳态,证实本发明中药组合物可以改善PCOS激素紊乱。
由图4可以看出,与正常组相比,PCOS模型组体重明显增高,口服糖耐量试验(OGTT)明显受损,二甲双胍组及中药组合物提取物的低剂量、中剂量组对口服葡萄糖耐量异常有明显改善作用,而且其对应的曲线下面积AUC减小。结果表明本发明中药组合物可以调节PCOS大鼠的体重及糖耐量异常,从而改善PCOS。
由图5可以看出,与正常组相比,PCOS模型组肝脏脂肪变性严重,血清中总胆固醇、甘油三酯和低密度脂蛋白含量升高。二甲双胍组及中药组合物提取物低剂量、中、高剂量组能够明显改善肝脏脂肪积累情况。此外,中药组合物提取物能够显著降低PCOS大鼠血清中总胆固醇、甘油三酯和低密度脂蛋白含量,结果表明本发明中药组合物可以调节PCOS大鼠的肝脏及血清脂质代谢,从而改善PCOS。
实施例5本发明中药组合物改善脱氢表雄酮诱导大鼠PCOS的实验研究
一、实验材料与药物
1.药物与试剂
脱氢表雄酮购自上海麦克林生物有限公司,羧甲基纤维素钠购自上海源叶生物科技有限公司,二甲双胍购自上海源叶生物科技有限公司,大鼠睾酮(T)酶联免疫分析(ELISA)试剂盒,大鼠促卵泡生成素(FSH)酶联免疫分析(ELISA)试剂盒,大鼠促***(LH)酶联免疫分析(ELISA)试剂盒,大鼠胰岛素(INS)酶联免疫分析(ELISA)试剂盒购自南京建成生物工程有限公司,血糖仪及血糖试纸购自罗氏公司。
受试药物:本发明实施例1制备得到的中药组合物的提取物。
2.实验仪器
酶标仪(美国Perkin-Elmer公司);BT125型电子天平(赛多利斯科学仪器有限公司);KQ-250E型超声波清洗器(昆山禾创超声仪器有限公司);Anke GL-16GII型离心机(上海安亭科学仪器厂)。
3.实验动物
SPF级21日龄SD雌性大鼠,购自南京中医药大学实验动物中心,合格证号SCXK(沪)2022-0004。
二、实验方法
1.PCOS大鼠模型的建立与中药组合物给药
脱氢表雄酮60mg/kg/d皮下注射联合高脂饲养21日龄雌性SD大鼠28天以构建PCOS模型。镜下观察PCOS模型大鼠卵巢中囊性卵泡明显增多,动情周期紊乱表明建模成功。
将实施例2中中药组合物提取物加生理盐水配置成浓度为1g/ml的药液,储存在4℃下待用。中药组根据实验动物等效计量的研究方法,按“人与动物体表面积折算的等效剂量比值表”,由人换算成大鼠的剂量为低剂量为4.67g/kg/d,中剂量即9.35g/kg/d,高剂量为18.71g/kg/d。将SD模型大鼠平均分成五组,每组8只,其中模型组皮下注射脱氢表雄酮60mg/kg/d,给药组在模型的基础上,低剂量组按4.67g/kg/d灌胃给予本发明中药组合物的提取物,中剂量组按9.35g/kg/d灌胃给予本发明中药组合物的提取物,高剂量组按18.71g/kg/d灌胃给予本发明中药组合物的提取物,阳性对照组在模型的基础上给予二甲双胍200mg/kg/d灌胃,选取未进行建模处理的雌性SD大鼠8只,作为空白对照组(正常组),生理盐水灌胃1mL/100g/d,给药28天后,处死大鼠,取血清进行性激素测定,取卵巢组织,进行HE染色。
2.药效评价方法
每日09:00对各组大鼠通过棉签蘸取生理盐水取***涂片,检测大鼠的动情周期是否规律。各组大鼠末次给药结束后腹主动脉取血,室温静置2h后于低温超速离心机进行离心(4℃,3000rpm/min,15min),分离得到的血清,根据相关试剂盒操作说明,采用ELISA试剂盒检测各组大鼠血清T、E2、FSH水平;取肝脏行油红O染色,观察药物对肝脏脂质积累的干预作用,另取卵巢组织行HE染色,观察药物对PCOS大鼠卵巢组织形态的干预作用。
3.数据处理
所有实验数据均采用SPSS18.0统计处理软件进行统计学处理,结果以平均值加减方差表示,组间差异采用t检验,P<0.05为差异有统计学意义。
三、实验结果
实验结束后,迅速摘取卵巢组织使用多聚甲醛固定,进行HE染色。正常对照组大鼠的卵巢在HE染色下可见多个不同发育阶段的卵泡及黄体,颗粒细胞形态完整且排列整齐。模型组PCOS大鼠卵巢中囊性卵泡增多,部分卵泡严重闭锁,颗粒细胞稀疏排列,甚至消失。图6结果表明,给予中药组合物提取物后大鼠闭锁卵泡的数量显著减少,次级卵泡的数量增加,卵巢内黄体丰富和多个不同发育阶段的卵泡,颗粒细胞层增厚并紧密聚集,形态接近正常对照组及阳性对照组,尤其是高剂量组效果明显。
动情周期监测结果显示,空白对照组大鼠动情周期规则,呈现出规律的动情前期、动情期、动情后期、动情间期。模型组PCOS大鼠失去正常动情周期,***涂片呈现持续性动情间期。由图7可以看出,二甲双胍组、中药组合物提取物的中剂量组和高剂量组大鼠由持续的动情间期,逐渐出现动情期、动情后期,间期的循环变化,且随着治疗越来越有规律。由此可见,中药组合物提取物的中剂量组对PCOS大鼠的发情周期具有调节作用。表明本发明中药组合物可以调节PCOS大鼠动情周期紊乱。
根据试剂盒说明书测定大鼠血清中T、E2、LH、FSH含量。由图8结果可知,与正常组大鼠相比,模型组PCOS大鼠血清中雄激素T水平明显增高,LH/FSH含量升高,亦进一步证实本发明造模方法造模成功。中药组合物治疗后T和LH/FSH水平显著下降。结果显示采用本发明中药组合物治疗后,各激素水平显著恢复稳态,证实本发明中药组合物可以改善PCOS激素紊乱。
由图9可以看出,与正常组相比,PCOS模型组肝脏脂肪变性严重,血清中总胆固醇、甘油三酯和低密度脂蛋白含量升高。二甲双胍组及中药组合物低剂量、中、高剂量组能够明显改善肝脏脂肪积累情况。此外,中药组合物能够显著降低PCOS大鼠血清中总胆固醇、甘油三酯和低密度脂蛋白含量,结果表明本发明中药组合物可以调节PCOS大鼠的肝脏及血清脂质代谢,从而改善PCOS。
以上基于来曲唑联合高脂以及脱氢表雄酮联合高脂诱导的两种PCOS大鼠模型的研究结果表明,中药组合物可有效改善两种PCOS大鼠模型的动情周期,降低PCOS动物血清中睾酮含量和促***/促卵泡生成素的含量,改善其卵巢多囊样改变,恢复模型动物的正常***。此外该中药组合物能够减轻PCOS动物的体重,改善动物糖耐量异常,降低PCOS动物血清中甘油三酯,总胆固醇,低密度脂蛋白含量,改善肝脏脂质积累。上述研究表明本发明提供的中药组合物对PCOS患者,***紊乱,肥胖,糖脂代谢异常有显著的改善作用,可用于制备具有改善PCOS的药品或保健品,适合PCOS患者。
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,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (8)
1.一种具有改善***功效的中药组合物,其特征在于,它包括下列重量份数的原料:枸杞叶5~15份,柴胡5~15份,黄连0.3~3份,生石膏5~20份,益母草5~20份,泽兰5~20份,桂枝1~10份,苍术5~15份,枳实5~15份,炙甘草3~10份。
2.根据权利要求1所述的具有改善***功效的中药组合物,其特征在于,它包括下列重量份数的原料:枸杞叶12份,柴胡6份,黄连3份,生石膏15份,益母草12份,泽兰9份,桂枝6份,苍术6份,枳实9份,炙甘草6份。
3.根据权利要求1所述的具有改善***功效的中药组合物,其特征在于,它包括下列重量份数的原料:枸杞叶10份,柴胡9份,黄连2份,生石膏15份,益母草15份,泽兰10份,桂枝6份,苍术9份,枳实10份,炙甘草6份。
4.根据权利要求1所述的具有改善***功效的中药组合物,其特征在于,它包括下列重量份数的原料:枸杞叶6份,柴胡6份,黄连3份,生石膏15份,益母草10份,泽兰10份,桂枝6份,苍术10份,枳实10份,炙甘草6份。
5.权利要求1~5任一项所述的具有改善***功效的中药组合物的制备方法,其特征在于,它包括以下步骤:
(1)按重量份数取枸杞叶、柴胡、黄连、生石膏、益母草、泽兰、桂枝、苍术、枳实、炙甘草,混合,加水回流提取,过滤,收集滤液;
(2)取步骤(1)中的药渣,以水回流提取,过滤,收集滤液;
(3)取步骤(2)中的药渣,以水回流提取,过滤,收集滤液;
(4)取步骤(1)所得滤液、步骤(2)所得滤液、步骤(3)所得滤液,合并减压浓缩得提取物。
6.根据权利要求5所述的具有改善***功效的中药组合物的制备方法,其特征在于,步骤(1)所述的回流提取条件为:首先加入药材重量10~15倍体积量的水,160℃回流提取90~120min;步骤(2)和步骤(3)回流条件为:加入药材重量6~10倍体积量的水,160℃回流提取60~120min。
7.权利要求1~5任一项所述的中药组合物在制备改善***的医药产品中的应用。
8.根据权利要求7所述的应用,其特征在于,将中药组合物的提取物和药学上可接受的载体制成片剂、丸剂、散剂、汤剂、颗粒剂、煎膏剂或浸膏剂剂型的药物。
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