CN107913357B - 一种中药组合物在制备治疗精子活力低下的药物/保健品中的新用途 - Google Patents
一种中药组合物在制备治疗精子活力低下的药物/保健品中的新用途 Download PDFInfo
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Abstract
本发明公开了一种中药组合物在制备治疗精子活力低下的药物/保健品中的新用途,所述中药组合物是由下列重量配比的原料药制备而成:虫草头孢菌粉5~30份、香菇1~20份、灵芝1~20份、山茱萸1~20份、肉苁蓉5~30份、玉竹5~30份、麦冬1~20份。本发明还提供了所述中药组合物的制备方法。本发明中药组合物可以提高精子活力的各项指标,毒副作用小,制备工艺简单,使用方便,具有较好的临床应用前景。
Description
技术领域
本发明涉及药物、保健食品领域,具体涉及一种中药组合物在制备治疗精子活力低下的药物/保健品中的新用途。
背景技术
精子的运动功能或运动能力的强弱直接关系到人类的生殖,只有正常作前向运动的精子才能确保精子抵达输卵管壶腹部与卵子结合形成受精卵。精子活力低下又称弱精症,是指精液参数中前向运动的精子小于50%或a级运动的精子小于25%的病症(国际分级法中Ⅲ级精子少于25%),弱精子症是精子质量低下最主要的类型,常与其它的精液异常症同时出现,据国内文献报道,因精子活力低下而导致的男性不育约占30%。
中医认为,男性精子的生成、与有无精子活力的强弱,关键就在于肾阳,所以,肾阳不足,精冷无力、或是因肾阴亏损,而引起精子活力低下;或是素体气虚血弱、及湿热内蕴精室,都可能引起男性精子活力低下。
发明内容
本发明的目的在于提供一种中药组合物在制备治疗精子活力低下的药物/保健品中的新用途。
本发明的另一目的在于提供所述中药组合物的制备方法。
本发明提供了一种中药组合物在制备治疗精子活力低下药物/保健品中的应用,所述中药组合物是由下列重量配比的原料药制备而成:虫草头孢菌粉5~30份、香菇1~20份、灵芝1~20份、山茱萸1~20份、肉苁蓉5~30份、玉竹5~30份、麦冬1~20份。
优选地,所述中药组合物是由下列重量配比的原料药制备而成:虫草头孢菌粉15~30份、香菇5~10份、灵芝5~10份、山茱萸5~10份、肉苁蓉15~30份、玉竹15~30份、麦冬5~10份。
更优选地,所述中药组合物是由下列重量配比的原料药制备而成:虫草头孢菌粉15份、香菇5份、灵芝5份、山茱萸5份、肉苁蓉15份、玉竹15份、麦冬5份。
前述中药组合物是以虫草头孢菌粉、香菇、灵芝、山茱萸、肉苁蓉、玉竹、麦冬的原药材、水提物或者有机溶剂提取物为活性成分,加上药学/保健品上可接受的辅料制备而成制剂。
其中,所述制剂为口服制剂。
优选地,所述口服制剂为口服液、冲剂、丸剂、片剂、散剂、颗粒剂、丹剂或汤剂。
更优选地,所述口服制剂为口服液。
前述中药组合物的制备方法包括如下步骤:
a)称取各重量配比的原料药;
b)加水或有机溶剂提取后,加入药学/保健品上可接受的辅料制备而成。
一种用于治疗精子活力低下的中药组合物,它是由以下方法制备得到:
a)称取各重量配比的原料药;
b)加水或有机溶剂提取后,加入药学/保健品上可接受的辅料制备而成。
本发明中药组合物是由虫草头孢菌粉、香菇、灵芝、山茱萸、肉苁蓉、玉竹、麦冬七味药物组成。
本发明所述“虫草头孢菌粉”是从天然冬虫夏草新鲜标本中分离得到的虫草头孢新菌株,采用生物工程技术精制而成。通过现代测试手段分析证明:其成分与天然冬虫夏草基本一致,富含多种氨基酸和微量元素,其中虫草酸、虫草素、虫草多糖、氨基酸的含量远远高于天然冬虫夏草。
方中虫草头孢菌粉在治疗心血管疾病、呼吸系统疾病、性功能障碍、肾功能衰竭、肝脏疾病、肿瘤以及血液、内分泌系统疾病等均具有较好的疗效;香菇具有降血脂、增强免疫力的功效;灵芝具有降血脂、降血糖的作用;山茱萸及其活性成分在降血糖、抗休克、强心、调节免疫、抗炎等方面均有作用;肉苁蓉性温、味甘咸,为补肾壮阳、润肠通便之要药,有“沙漠人参”的美誉,具有补肾壮阳、润肠通便、抗疲劳、抗衰老、增强机体免疫力及增强记忆力等作用;玉竹主要有强心、降血压、降血糖、降血脂和增强免疫功能等功效;麦冬皂苷类化学成分的药理学作用显著,在延缓衰老、改善学习记忆障碍、抗心脑血管疾病、抗肿瘤、抗炎和免疫调节等多方面均能发挥活性作用。
本方紧扣病机,以温肾阳、益肾气为主;并依据肺肾相关、“金水相生”理论,辅以补益肺气之品;又遵“善补阳者必欲阴中求阳”之旨,佐以养阴之药;而脾为后天之本,气血生化之源,故又少加益气健脾之品为使。
从药物性能功效分析:方中以虫草头孢菌粉为君。从文献及临床和实验报道可知,虫草头孢菌粉与冬虫夏草有相似功效。现代中药学教材称冬虫夏草功效:“补肾阳,益肾精,补肺气。止血化痰,止咳平喘”《本草从新》:“保肺益肾,止血化痰,已劳嗽。”《药性考》:“秘精益气,专补命门。”《云南中草药》:“补肺,壮肾阳。治痰次喘咳。”可知其既补肾阳益精,又补肺气而化痰止咳,为阴阳双补之品而以补阳为主,已含“阴中求阳”之旨;
肉苁蓉、山茱萸助君药增强温补之效,且均是阴阳双补之品,共为臣药。《日华子本草》谓肉苁蓉:“治男绝阳不兴,女绝阴不产,润五脏,长肌肉,暖腰膝,男子泄精,尿血,遗沥,带下阴痛。”《本草汇言》:肉苁蓉,养命门,滋肾气,补精血之药也。男子丹元虚冷而阳道久沉,妇人冲任失调而阴气不治,此乃平补之剂,温而不热,补而不峻,暖而不燥,滑而不泄,故有从容之名。”山茱萸助虫草补肾助阳,并能固摄肾气。《雷公炮炙论》谓其:“壮元气,秘精。”《名医别录》:“强阴,益精,安五脏,通九窍,止小便利,明目,强力。”《药性论》:“治脑骨痛,止月水不定,补肾气,兴阳道,添精髓,疗耳鸣,除面上疮,主能发汗,止老人尿不节。”《医学衷中参西录》:“山茱萸,大能收敛元气,振作精神,固涩滑脱。亦是肾中阴阳精气兼补之药。”
麦冬、玉竹、蜂蜜润肺养阴,玉竹、灵芝、香菇、蜂蜜益脾肺之气,同为佐使之药。其中,玉竹:《本草纲目》:“性平,味甘,柔润可食。故朱肱《南阳活人书》治风温自汗身重,语言难出,用萎蕤汤以之为君药。……用代参、耆,不寒不燥,大有殊功。”《本草经疏》:“萎蕤(玉竹),……以一药而所主多途,为效良伙,非由滋益阴精,增长阳气,其能若是乎?”《四声本草》谓其“补中益气”。《滇南本草》称:“补气血,补中健脾”。麦冬:《神农本草经》列为上品,言其“久服轻身,不老不饥”。《本草分经》:“甘、微苦,微寒。润肺清心、泻热生津、化痰止呕、治嗽行水”。《医学衷中参西录》:“能入胃以养胃液,开胃进食,更能入脾以助脾散精于肺,定喘宁嗽。”香菇:《本草纲目》谓其“甘,平,无毒”,《日用本草》:“益气,不饥。”《本经逢原》:“大益胃气。”《现代实用中药》:“为补偿维生素D的要剂,预防佝偻病并治贫血。”灵芝:《神农本草经》列为上品,谓其可“益心气”、“安精魂”、“补肝益气”、“坚筋骨”。诸药合用,肺肾同补,阴阳并调,共奏补肾培元,滋阴润肺之功。适用于肺肾气虚型高脂血症、慢性支气管炎恢复期出现腰膝酸软、遗精尿频、神疲纳差、咳嗽短气等症的辅助治疗。且全方所选之药均为药食两用之品,在确保疗效的同时,又兼顾了用药的安全性。
本发明中药组合物可以提高精子活力的各项指标,毒副作用小,制备工艺简单,使用方便,具有较好的临床应用前景,可用于制备治疗精子活力低下的药物/保健品。
本发明的中药组合物还可用于补肾润肺,还是一种辅助治疗慢性支气管炎、中医辨证属于肺肾两虚的药物,还用于高脂血症、慢性肝炎及癌症的辅助治疗;且本发明的中药组合物副作用小,安全性高。
根据本发明的上述内容,按照本发明相关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本发明中药组合物口服液的制备
1.原料:如表1所示。
2.制备方法:
(1)按表1和表2中的重量配比称取原料药;
(2)原料药加水煎煮或有机溶剂提取,提取液浓缩,再加入药学/保健食品上可接受的辅料或辅助性成分制备成口服液。
表1实施例1的处方
处方 | 用量1 | 用量2 | 用量3 |
虫草头孢菌粉 | 150g | 200g | 300g |
香菇 | 50g | 75g | 100g |
灵芝 | 50g | 75g | 100g |
山茱萸 | 50g | 75g | 100g |
肉苁蓉 | 150g | 200g | 300g |
玉竹 | 150g | 200g | 300g |
麦冬 | 50g | 75g | 100g |
实施例2本发明中药组合物口服液的制备1.原料:如表2所示。
2.制备方法:同实施例1。
表2实施例2的处方
处方 | 用量1 | 用量2 | 用量3 |
虫草头孢菌粉 | 100g | 200g | 300g |
香菇 | 50g | 75g | 100g |
灵芝 | 50g | 75g | 100g |
山茱萸 | 50g | 75g | 100g |
肉苁蓉 | 100g | 100g | 100g |
玉竹 | 150g | 200g | 300g |
麦冬 | 50g | 75g | 100g |
实施例3本发明中药组合物口服液的制备1.原料:如表3所示。
2.制备方法:同实施例1。
表3实施例3的处方
处方 | 用量1 | 用量2 | 用量3 |
虫草头孢菌粉 | 300g | 300g | 300g |
香菇 | 50g | 75g | 100g |
灵芝 | 50g | 75g | 100g |
山茱萸 | 50g | 75g | 100g |
肉苁蓉 | 300g | 300g | 300g |
玉竹 | 150g | 200g | 300g |
麦冬 | 50g | 75g | 100g |
实施例4~6本发明中药组合物口服液的制备
1.原料:如表4所示。
2.制备方法:同实施例1。
表4实施例4~6的处方
处方 | 实施例4 | 实施例5 | 实施例6 |
虫草头孢菌粉 | 50g | 300g | 150g |
香菇 | 100g | 50g | 10g |
灵芝 | 10g | 200g | 50g |
山茱萸 | 100g | 50g | 10g |
肉苁蓉 | 50g | 300g | 100g |
玉竹 | 150g | 100g | 50g |
麦冬 | 10g | 200g | 50g |
以下通过具体临床试验证明本发明的有益效果。
实验例所用原料、试剂及仪器
(1)实验原料
本发明制剂不同剂量组:取实施例1制备的中药组合物口服液三种处方制成的制剂。
阴性对照组:超纯水。
阳性对照组:肉苁蓉、虫草头孢菌粉分别制备成1.00g/ml的制剂。
(2)实验动物
由北京维通利华试验动物技术有限公司提供,动物质量合格证号:小鼠11400700155415,金黄地鼠11400700160468。
小鼠:CD-1(ICR),SPF级,雄性,60只,开始使用时为24-32g,34-40日龄。
地鼠:金黄地鼠,SPF级,雌性80只,使用时为8周龄。
(3)实验试剂
实验试剂如表5所示。
表5实验试剂
试剂名称 | 生产厂家 | 批号 |
注射用血促性素 | 宁波第二激素厂 | 160310 |
注射用绒促性素 | 宁波第二激素厂 | 160222 |
BWW精子培养液 | PanEra | 20160601 |
透明质酸酶 | BIOSHARP | SLBL1922V |
矿物油 | SIGMA‐ALDRICH | SLBG5292V |
胰酶 | 杭州科易生物技术有限公司 | 2016012403 |
(4)实验仪器
实验仪器信息如表6所示。
表6实验仪器信息
仪器名称 | 型号 | 生产厂家 | 仪器编号 |
电子天平 | PB1501‐L | METTLERTOLEDO | E089904 |
电子分析天平 | AL104 | METTLERTOLEDO | E083702 |
解剖显微镜 | S8AP0 | Leica | E133701 |
试验例1本发明中药组合物的异种穿卵实验
1、实验方法
阴性对照组(超纯水,20ml/kg)、本发明实施例1中药组合物口服液处方用量1(20ml/kg)、用量2(20ml/kg)、用量3(20ml/kg)各组动物灌胃给予相应剂量药物,给药28天。
雌性金黄地鼠腹腔注射40IU/只的注射用血促性素,52-56小时后腹腔注射40IU/只的注射用绒促性素。18-22小时后颈椎脱臼处死动物,即刻剖开腹部剪取输卵管放入37℃预热的矿物油中。在体视显微镜下,撕开输卵管壶腹部挤压出卵丘复合物并引入含有0.1%透明质酸酶的BWW精子培养液中消化,以去除颗粒细胞。将卵用BWW培养液清洗后用含0.1%胰蛋白酶的BWW培养液去除透明带。将得到的卵子用BWW培养液清洗后保存备用。
取精子悬液稀释至(1~2)×106/ml,取稀释液1ml置于1.5ml离心管中密封培养(37℃,3h)使精子获能。取精子悬液200μl加入至含有20~30个卵的BWW液滴中,充分混合后进行孵育(37℃,3h)使其受精。体视显微镜下观察异种穿卵结果,以卵内有膨大精子头为受精标准,计算受精率。指标检查结果经计算机SPSS软件包统计处理,以Mean±SD表示。报告中列出各剂量组各项统计分析指标与溶剂对照组比较后在0.05,0.01和0.001显著水平的结果。
2、实验结果
表7不同配比实施例1口服液对小鼠精子异种穿卵结果的影响(Mean±SD,n=12)
组别 | 药物 | 剂量 | 受精率% |
阴性对照组 | 超纯水 | 20ml/kg | 0.33±0.11 |
实施例1 | 用量1口服液 | 20ml/kg | 0.40±0.16* |
实施例1 | 用量2口服液 | 20ml/kg | 0.36±0.14 |
实施例1 | 用量3口服液 | 20ml/kg | 0.36±0.13 |
注:与阴性对照组相比,P<0.05;
本发明实施例1口服液不同处方的异种穿卵实验结果表明,补肾润肺口服液处方用量1优于其它配比。
实施例2本发明中药组合物与单位药的药效对比实验
1、实验方法
睾丸重量:动物末次给药后1小时,颈椎脱臼处死。即刻取出两侧睾丸称重。
精子活力:动物处死后,迅速取出两侧的附睾尾分别放入37℃预热过的加有0.2ml的BWW精子培养液的离心管内,剪碎附睾尾37℃孵育5分钟使精子游出后进行精子检测。
异种穿卵:取精子悬液稀释至(1~2)×106/ml,取稀释液1ml置于1.5ml离心管中密封培养(37℃,3h)使精子获能。取精子悬液200μl加入至含有20~30个卵的BWW液滴中,充分混合后进行孵育(37℃,3h)使其受精。体视显微镜下观察异种穿卵结果,以卵内有膨大精子头为受精标准,计算受精率。
2、统计方法
指标检查结果经计算机SPSS软件包统计处理,以Mean±SD表示。报告中列出各剂量组各项统计分析指标与溶剂对照组比较后在0.05,0.01和0.001显著水平的结果。
3、实验结果
表8实施例1中用量1口服液对小鼠睾丸重量的影响(Mean±SD,n=12)
组别 | 药物 | 剂量 | 睾丸重量/g |
阴性对照组 | 超纯水 | 20ml/kg | 0.22±0.02 |
阳性对照组<sup>a</sup> | 肉苁蓉 | 20ml/kg | 0.22±0.02 |
阳性对照组<sup>a</sup> | 虫草头孢菌粉 | 20ml/kg | 0.23±0.03 |
实验组<sup>a</sup> | 用量1口服液 | 10ml/kg | 0.26±0.03<sup>**##</sup> |
注:a,为临床等效剂量;与正常对照组相比,**,P<0.01;与阳性对照组相比,##,P<0.01。
本发明中药组合物口服液组的临床等效剂量的睾丸重量较阴性对照对照组和肉苁蓉、虫草头孢菌粉组显著升高(P<0.01),表明本发明中药组合物口服液临床等效剂量可提高小鼠睾丸重量。
表9实施例1中用量1口服液对小鼠附睾尾精子的影响(Mean±SD)
注:a,为临床等效剂量;与正常对照组相比,*,P<0.05;与阳性对照组相比,P>0.05。
表10实施例1中用量1口服液对小鼠附睾尾精子的影响(Mean±SD)
注:a,为临床等效剂量;与正常对照组相比,*,P<0.05;与阳性对照组相比,P>0.05。
反应精子活动力的主要指标中,肉苁蓉、头孢菌粉、本发明中药组合物口服液组动物附睾尾精子的平均路径速度(VAP,μm/s)、直线运动速度(VSL,μm/s)、曲线运动速度(VCL,μm/s)、精子头侧摆幅度(ALH,μm/s)、前向性(STR,%)和直线性(LIN,%)等绝对数值均高于阴性对照组,其中肉苁蓉组、头孢菌粉组补肾润肺口服液组的VCL显著升高(P<0.05)。
该结果表明肉苁蓉、头孢菌粉和本发明中药组合物口服液对小鼠附睾尾精子的活力有一定促进作用。本发明中药组合物口服液组的VAP、VSL、VCL、STR、LIN与肉苁蓉、头孢菌粉临床最大等效剂量组相比虽未见统计学差异,但绝对数值均有所升高。
综上可知,本发明中药组合物口服液对小鼠睾丸重量和精子活力有一定的提高作用。
综上所述,本发明中药组合物口服液可显著提高精子活力,疗效显著,制备工艺简单,使用方便,具有较好的临床应用前景,可用于制备治疗精子活力低下的药物/保健品。
Claims (7)
1.一种中药组合物在制备提高精子活力的药物/保健品中的应用,其特征在于:所述中药组合物是由下列重量配比的原料药制备而成:虫草头孢菌粉15份、香菇5份、灵芝5份、山茱萸5份、肉苁蓉15份、玉竹15份、麦冬5份。
2.根据权利要求1所述应用,其特征在于:所述中药组合物是以虫草头孢菌粉、香菇、灵芝、山茱萸、肉苁蓉、玉竹、麦冬的原药材、水提物或者有机溶剂提取物为活性成分,加上药学/保健品上可接受的辅料制备而成制剂。
3.根据权利要求2所述应用,其特征在于:所述制剂为口服制剂。
4.根据权利要求3所述应用,其特征在于:所述口服制剂为口服液、冲剂、丸剂、片剂、散剂、颗粒剂、丹剂或汤剂。
5.根据权利要求4所述应用,其特征在于:所述口服制剂为口服液。
6.根据权利要求1所述应用,其特征在于:所述中药组合物的制备方法包括如下步骤:
a)称取各重量配比的原料药;
b)加水或有机溶剂提取后,加入药学/保健品上可接受的辅料制备而成。
7.一种用于治疗精子活力低下的中药组合物,其特征在于:所述中药组合物是由下列重量配比的原料药制备而成:虫草头孢菌粉15份、香菇5份、灵芝5份、山茱萸5份、肉苁蓉15份、玉竹15份、麦冬5份;它是由以下方法制备得到:
a)称取各重量配比的原料药;
b)加水或有机溶剂提取后,加入药学/保健品上可接受的辅料制备而成。
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