CN111419992A - 一种延缓卵巢衰老的组合物及其制备方法和用途 - Google Patents
一种延缓卵巢衰老的组合物及其制备方法和用途 Download PDFInfo
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Abstract
本发明提供了一种延缓卵巢衰老的食品、保健品或药物组合物,它是含有下述重量配比的原料制备而成:人参1~5份、覆盆子5~15份、葛根5~20份、桃仁3~15份、菊花6~20份、芦根10~40份、银耳0.5~5份、枸杞15~40份、牡蛎20~50份、佛手5~20份、玫瑰花4~12份。
Description
技术领域
本发明涉及一种延缓卵巢衰老的组合物及其制备方法和用途。
背景技术
卵巢早衰(premature ovarian failure,POF)是指妇女在40岁前,由于卵巢功能降低甚至衰竭,出现促性腺激素增高而雌激素降低,临床表现为继发性闭经并常伴围绝经期症状。本病在一般人群中发病率为1%~3%,在原发性闭经患者中发病率为10%~20%,在继发性闭经患者中发病率达4%~18%,近年来发病率逐年增高且向低龄化发展,成为医学研究的难题之一。传统中医尚无“卵巢早衰”病名,古称“经闭”、“经水早断”、“月事不来”等。中医认为女子生长、发育及生殖与肾息息相关,因此POF的主要病机为肾虚,治疗原则是补肾,疗效较好且毒副反应小,具有独特的优势。
目前认为,POF可能由遗传因素、先天性酶缺陷、物理化学性损害、免疫性损害、促性腺激素分泌异常或作用障碍,以及特发性原因引起,导致卵巢内卵细胞数量减少,或卵泡闭锁加速,或卵泡功能被破坏、或无功能,引起下丘脑—垂体—卵巢轴(HPO)异常,卵巢分泌性激素功能衰减,促性腺激素增高而雌激素降低,临床表现为继发性闭经、并常伴有潮热等围绝经期症状。POF发病机制十分复杂,虽然研究很多,但至今仍然不清楚。西医治疗十分棘手,主要采取雌孕激素补充疗法,需长期用药,且停药后容易反复,同时激素治疗有许多禁忌症、慎用症、副作用,长期使用会增加乳腺癌、子宫内膜癌、静脉血栓等疾病的危险性,降低患者用药依从性。其它如促排卵治疗、使用免疫抑制剂、卵巢异体移植等不仅效果不明显,而且毒副反应也大,费用也高,使用受到很大限制。目前中医治疗POF虽然疗效较好,但因其对发病理论认识不足和临床采取简单的辨证分型,可能会影响疗效的进一步提高。
发明内容
发明人通过长期的研究认为,除肾虚外,肝郁血瘀也是POF之主要病机,其主要的依据是:①肝脏在月经周期、经期与经量的调节方面有其独特的重要性。女性生殖生理。肝藏血,主疏泄,具有储藏血液、和调节血量、疏泄气机的作用,喜条达而恶抑郁。脏腑所化生之血,除营养周身外,储藏于肝。肝藏血有余,则下注冲脉血海盈满;肝气条达,任脉通畅,司血海之定期蓄溢,肝通过冲、任、督与胞宫相通,而使胞宫行使其藏泻有序的功能。肾精生血,肝血养精,精血同源,相互化生,共同为月经提供物质基础,调节子宫,使藏泻有序,月事以时下。故有“女子以肝为先天”之说。②肝气郁结、瘀阻冲任是经水早断之主要病理基础。肝喜调达恶抑郁,肝脏的生理功能失调,则肝气失于疏泄而气机郁结,冲任气机不畅则瘀血阻滞冲任,导致月事不下;而气不行血则血行不畅,气滞血瘀则肾失气血濡养,血不养精,精微不生又导致肾精亏损,天癸不充而早衰,月经不至。③POF的很多主要临床表现与其肝郁血瘀的病机密切相关。如月经停闭不行、精神抑郁或烦躁易怒、胸胁乳房胀痛、失眠多梦、小腹或少腹疼痛、头痛,舌紫黯或有瘀点、瘀斑,脉沉弦或沉涩等,尤其是POF的主要症状—情志不畅,精神抑郁或烦躁易怒常常伴随POF的整个病程。④七情”(精神)因素是导致POF发病的重要原因。随着社会经济的发展,竞争激烈,女性生活及工作压力越来越大,“七情”(精神)致病因素对女性的影响和作用程度也大大超过古时,情志不畅最先伤肝,肝气不舒,气机郁滞,血行不畅,胞脉阻闭则经水早断。情绪波动是POF发生的独立危险因素,POF中肝郁血瘀的比例越来越高,其原因在于HPO轴的生理活动受到大脑皮层神经中枢的影响,由于长期不良的精神因素,导致中枢神经系统与HPO轴功能失调,FSH和(或)LH异常分泌,排卵功能障碍,而发生POF。
发明人认为肝郁血瘀兼肾虚内热是POF的主要病机,临床治疗应该疏肝活血、滋肾清热。发明人在长期临床实践的基础上,精选“药食同源”的中药材组方,采用现代制作工艺技术研制而成“卵复春”。
为了解决上述问题,本发明提供了一种延缓卵巢衰老的食品、保健品或药物组合物,它是含有下述重量配比的原料制备而成:
人参1~5份、覆盆子5~15份、葛根5~20份、桃仁3~15份、菊花6~20份、芦根10~40份、银耳0.5~5份、枸杞15~40份、牡蛎20~50份、佛手5~20份、玫瑰花4~12份。
进一步地,它是由下述重量配比的原料制备而成的制剂:
人参1~5份、覆盆子5~15份、葛根5~20份、桃仁3~15份、菊花6~20份、芦根10~40份、银耳0.5~5份、枸杞15~40份、牡蛎20~50份、佛手5~20份、玫瑰花4~12份。
进一步地,它是由下述重量配比的原料制备而成的制剂:
人参3份、覆盆子10份、葛根10份、桃仁10份、菊花10份、芦根20份、银耳1份、枸杞20份、牡蛎30份、佛手9份、玫瑰花6份。
进一步地,所述制剂为口服制剂;
进一步地,所述口服制剂为汤剂、散剂、胶囊剂、片剂、颗粒剂。
本发明还提供了一种制备上述的食品、保健品或药物组合物的方法,它包括如下步骤:
1)按重量配比称取各原料;
2)取原料药的药粉、水或有机溶剂提取物,加上药学中可接受的辅料或辅助性成分制备成制剂。
本发明还提供了上述食品、保健品或药物组合物在制备用于预防或治疗卵巢早衰的药物或保健品中的用途。
本发明还提供了上述食品、保健品或药物组合物在制备用于疏肝活血的药物或保健品中的用途。
本发明还提供了上述食品、保健品或药物组合物在制备用于滋阴清热的药物或保健品中的用途。
方中佛手、玫瑰花疏肝解郁理气;桃仁、葛根活血化瘀;枸杞补肝肾,益精血,为滋肾补精养血之要药;覆盆子补益肝肾,固精;人参大补元气,补益肺肾心脾诸脏之气,并能补血活血、生津、安神;银耳补肾强精、养阴清热;芦根、菊花清热;牡蛎平肝潜阳、敛阴止汗。诸药配伍体现了疏肝活血、滋肾清热的治法,切中了病机。
本发明药物组合物可以有效治疗卵巢早衰,服用携带方便、口感良好,提高了患者用药依从性,应用前景良好。
显然,根据本发明的上述内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式,对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
实施例1、本发明食品、保健品或药物组合物的制备
1)处方:人参3kg、覆盆子10kg、葛根10kg、桃仁10kg、菊花10kg、芦根20kg、银耳1kg、枸杞20kg、牡蛎30kg、佛手9kg、玫瑰花6kg。
2)制备方法:
①按量取菊花、玫瑰、佛手,以20倍水提取,80℃煎煮5min,过滤得滤液;
②按量取人参、覆盆子、葛根、桃仁,粉碎,以70%乙醇提取,第一次以10倍70%乙醇提取1h,第一次以8倍70%乙醇提取1h,过滤得滤液,减压去除乙醇,得加水的混悬液;
③取②70%乙醇提取后剩余的残渣,与其余药材(芦根、牡蛎、枸杞、银耳),以水提取,第一次以10倍水提取1h,第一次以8倍水提取1h,过滤得滤液;
④合并①、③的滤液与②的混悬液,减压浓缩,并于60℃烘干。将干燥物与辅料(安赛蜜,麦芽糊精)混匀后,分装为3000袋,每袋15g。
使用方法:一日三次,饭后温水冲服。
实施例2、本发明食品、保健品或药物组合物的制备
1)处方:人参1kg、覆盆子15kg、葛根5kg、桃仁15kg、菊花6kg、芦根25kg、银耳1kg、枸杞30kg、牡蛎20kg、佛手16kg、玫瑰花3kg。
2)制备方法:
①按量取菊花、玫瑰、佛手,以20倍水提取,80℃煎煮5min,过滤得滤液;
②按量取人参、覆盆子、葛根、桃仁,粉碎,以70%乙醇提取,第一次以10倍70%乙醇提取1h,第一次以8倍70%乙醇提取1h,过滤得滤液,减压去除乙醇,得加水的混悬液;
③取②70%乙醇提取后剩余的残渣,与其余药材(芦根、牡蛎、枸杞、银耳),以水提取,第一次以10倍水提取1h,第一次以8倍水提取1h,过滤得滤液;
④合并①、③的滤液与②的混悬液,减压浓缩,并于60℃烘干。将干燥物与辅料(麦芽糊精)混匀后,分装为36000粒胶囊,每粒胶囊内容物1g。
使用方法:一日三次,一次4粒胶囊,饭后温水送服。
实施例3、本发明食品、保健品或药物组合物的制备
1)处方:人参3kg、覆盆子5kg、葛根20kg、桃仁3kg、菊花20kg、芦根10kg、银耳3kg、枸杞10kg、牡蛎40kg、佛手5kg、玫瑰花9kg。
2)制备方法:
①按量取菊花、玫瑰、佛手,以20倍水提取,80℃煎煮5min,过滤得滤液;
②按量取人参、覆盆子、葛根、桃仁,粉碎,以70%乙醇提取,第一次以10倍70%乙醇提取1h,第一次以8倍70%乙醇提取1h,过滤得滤液,减压去除乙醇,得加水的混悬液;
③取②70%乙醇提取后剩余的残渣,与其余药材(芦根、牡蛎、枸杞、银耳),以水提取,第一次以10倍水提取1h,第一次以8倍水提取1h,过滤得滤液;
④合并①、③的滤液与②的混悬液,减压浓缩,并于60℃烘干。将干燥物与辅料(硬脂酸镁、麦芽糊精)混匀,压制成72000片,每片0.5g。
使用方法:一日三次,一次2片,饭后温水送服。
以下通过具体试验例证明本发明的有益效果。
试验例1本发明药物治疗卵巢早衰临床应用情况统计
1.临床资料
1.1一般资料
2017年―2018年门诊治疗POF30例,病程(停经时间)3―56月,平均8.27±12.47月;年龄17―42岁,平均32.17±6.87岁;治疗前中医证候积分22―41分,平均29.87±5.24分。治疗前改良Kupperman评分16―33分,平均24.07±4.86分;病情程度:轻度9例,中度21例,重度0例。
1.2卵巢早衰西医诊断标准
参照《中华妇产科学》、《妇产科学》制定:①年龄小于40岁的妇女,正常月经建立后月经停止6个月,或按自身原有月经周期计算停止3个周期以上者;伴或不伴有围绝经期症状;②血清促卵泡生成素(FSH)﹥40IU/L或促黄体生成素(LH)﹥40IU/L,或伴有雌二醇(E2)﹤70pg/ml。
1.3改良Kupperman病情程度评定
①症状评分=基本分×程度评分;②各症状评分之和为总分;③病情分度:轻度15―20分,中度21―35,重度>35分。
1.4中医诊断标准
参照《中医病证诊断疗效标准》等制定:①年龄不超过40岁的妇女,既往月经正常,现出现3个周期以上停闭经;②伴或不伴有绝经前后诸症。
1.5中医辨证标准
(1)肝郁血瘀证:
主症:①月经停闭不行;②精神抑郁或烦躁易怒。次症:①胸胁、乳房胀痛;②失眠多梦;③小腹或少腹疼痛;④头痛。舌脉:舌紫黯,或有瘀点、瘀斑;脉沉弦或沉涩。凡具备上述2项主症,2项或以上次症,结合舌脉即可辨为本证。
(2)肾虚内热证:
主症:①月经停闭不行;②潮热汗出。次症:①头晕耳鸣;②腰膝酸软或酸痛;③阴部干涩;④五心烦热;⑤心悸怔忡。舌脉:舌红少苔,脉细数。
凡具备上述2项主症,3项或以上次症,结合舌脉即可辨为本证。
POF肝郁血瘀兼肾虚内热证中医辨证标准:凡同时具备肝郁血瘀证和肾虚内热证辨证标准者,即可辨证为POF肝郁血瘀兼肾虚内热证。
1.6中医症状分级评分标准
主症:月经停闭不行3个周期、3~6个周期、大于6个周期,潮热汗出3次</天、3~9次/天≥10/天均分别记3、6、9分;精神抑郁、烦躁易怒,按轻中重分别记3、6、9分;次症:按轻中重分别记1、2、3分;舌脉不记分。
1.7纳入标准
①符合POF西医、中医诊断标准,及其POF肝郁血瘀兼肾虚内热证中医辨证标准;②年龄16岁至40岁的妇女;③改良Kupperman评分≥15分。
1.8排除标准
①年龄<16岁或>40岁的妇女;②近3个月未使用其他药物或药食同源的配方、食品、保健品治疗或调理本病者;③先天性生殖器发育异常,后天器质性疾病而导致的原发或继发性停闭经者;④生理性闭经或怀疑由其他原因引起的停闭经患者;⑤合并心、脑血管、肝、肾、内分泌和造血系统等严重原发性疾病、慢性消耗性疾病、感染性疾病及精神病患者;⑥对本配方组成有过敏史者。
2.方法
2.1药品:本发明实施例1获得的药物。
2.2服用方法及疗程每次服用药品1袋(15g),溶入150ml开水后冲服,1日3次,疗程60天。
2.3疗效判定标准
①疾病疗效评定标准:参照《中医病证诊断疗效标准》执行。治愈:月经来潮,连续3次以上正常行经;好转:月经恢复来潮,但月经周期未正常;未愈:月经仍未来潮。②中医证候疗效标准:参照《中药新药临床研究指导原则》,证候积分下降率=(治疗前积分-治疗后积分)/治疗前积分×100%。痊愈:中医证候积分下降率≥95%;有效:各症状有所改善,中医证候积分下降率30%~95%;无效:各症状未见改善,甚至加重,中医证候积分下降率<30%。③改良Kupperman评分疗效标准:痊愈:Kupperman评分积分下降率≥95%;有效:各症状有所改善,Kupperman评分积分下降率30%~95%;无效:各症状未见改善,Kupperman评分积分下降率<30%。
2.4数据处理
计量资料以均数±标准差(x±s)表示,并行t检验,应用SPSS11.9统计软件做统计分析。
3.治疗结果
经治疗60天后,效果满意,无副作用发生。
3.1治疗后疗效结果治疗后疗效结果见表1。
表1治疗后疗效结果
3.2治疗前后患者积分变化
治疗后中医证候积分、Kupperman评分低于治疗前,经t检验,P均<0.001,有非常显著性差异,见表2。
表2治疗前后积分(分)比较
采用本发明的药物组方,治疗卵巢早衰(POF)不仅取得了满意效果,并且十分安全无副作用、服用携带方便、口感良好,提高了患者用药依从性,同时对研究和治疗卵巢早衰(POF)提出了新的思路。
试验例2本发明药物组合物治疗自身免疫性卵巢早衰小鼠的作用
1.试验材料
1.1试剂:超敏雌二醇方面试剂盒,卵泡刺激素方面试剂盒,促黄体生产激素方面试剂盒(北京北方生物技术研究所);弗氏完全佐剂(CFA),弗氏不完全佐剂(IFA),sigma公司,戊酸雌二醇。
1.2实验动物:BLAL/C小鼠,18-22g,由成都达硕实验动物有限公司(SPF级,合格证号:SCXK(川)2015-030)。
1.3SPF级实验动物环境:室温:18~22℃,相对湿度:40~70%。医学实验动物环境设施合格证书:SCXK(川)2015-100号。
1.4受试样品:本发明实施例1获得的药物。
2.试验方法
(1)动物造模
实验室自制小鼠卵透明带制剂(ZP),每只小鼠按0.1ml免疫试剂(ZP+CFA)注射双后脚脚掌,每次免疫间隔2周,并以ZP与IFA等量混合液加强免疫2次,正常对照组注射等量生理盐水。
(2)剂量分组及受试样品给予时间
实验设三个剂量组、一个西药阳性组、一个模型对照组组、一个正常对照组。试验药物按人临床剂量的20×,40×和60×口服灌胃给药,分别为15g/kg,30g/kg,45g/kg,戊酸雌二醇剂量0.18mg/kg,正常对照组、模型对照组口服灌胃等量蒸馏水。共给药30天。
(2)实验步骤
实验结束后,小鼠摘除眼球采血,离心,取血清。按试剂盒说明书操作要求,采用放免法测定FSH、LH、E2的含量。
各组实验数据以均数±标准差表示,进行单因素方差分析,P<0.05为差异有统计学意义。
3.试验结果
模型对照组与正常对照组比较,FSH、LH均明显升高、E2下降显著,说明自身免疫性卵巢早衰小鼠模型成立。各给药组灌胃30d后,药物中、高剂量组能明显降低FSH、LH的含量(P<0.01,P<0.05),升高E2的浓度(P<0.05),说明受试药物对卵巢早衰小鼠具有一定的治疗作用。实验结果见表1。
表1受试样品对自身免疫性卵巢早衰致小鼠的作用
注:与正常对照组比较,**表示P<0.01;与模型对照组比较,#表示P<0.05,##表示P<0.01.
实验结果说明,本发明药物可以治疗卵巢早衰。
总之,为确保POF患者用药安全,发明人选择上述“药食同源”的中药材采用现代制作工艺技术研制而成“卵复春”,治疗POF不仅取得了满意效果,并且十分安全无副作用、服用携带方便、口感良好,提高了患者用药依从性,同时对研究和治疗POF提出了新的思路。
Claims (9)
1.一种延缓卵巢衰老的食品、保健品或药物组合物,其特征在于:它是含有下述重量配比的原料制备而成:
人参1~5份、覆盆子5~15份、葛根5~20份、桃仁3~15份、菊花6~20份、芦根10~40份、银耳0.5~5份、枸杞15~40份、牡蛎20~50份、佛手5~20份、玫瑰花4~12份。
2.根据权利要求1所述的食品、保健品或药物组合物,其特征在于:它是由下述重量配比的原料制备而成的制剂:
人参1~5份、覆盆子5~15份、葛根5~20份、桃仁3~15份、菊花6~20份、芦根10~40份、银耳0.5~5份、枸杞15~40份、牡蛎20~50份、佛手5~20份、玫瑰花4~12份。
3.根据权利要求1所述的食品、保健品或药物组合物,其特征在于:它是由下述重量配比的原料制备而成的制剂:
人参3份、覆盆子10份、葛根10份、桃仁10份、菊花10份、芦根20份、银耳1份、枸杞20份、牡蛎30份、佛手9份、玫瑰花6份。
4.根据权利要求1~3任一项所述的食品、保健品或药物组合物,其特征在于:所述制剂为口服制剂。
5.根据权利要求4所述的食品、保健品或药物组合物,其特征在于:所述口服制剂为汤剂、散剂、胶囊剂、片剂、颗粒剂。
6.一种制备权利要求1~5任一项所述的食品、保健品或药物组合物的方法,其特征在于:它包括如下步骤:
1)按重量配比称取各原料;
2)取原料药的药粉、水或有机溶剂提取物,加上药学中可接受的辅料或辅助性成分制备成制剂。
7.权利要求1~5任一项所述的食品、保健品或药物组合物在制备用于预防或治疗卵巢早衰的药物或保健品中的用途。
8.权利1~5任一项所述的食品、保健品或药物组合物在制备用于疏肝活血的药物或保健品中的用途。
9.权利1~5任一项所述的食品、保健品或药物组合物在制备用于滋阴清热的药物或保健品中的用途。
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