CN117137996A - 一种益气固摄中药组合物及其制备方法和应用 - Google Patents
一种益气固摄中药组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种益气固摄中药组合物及其制备方法和应用,该中药组合物包含下述重量配比的原料:鹿角霜2‑6份、锻龙骨3‑7份、海螵蛸2‑6份、太子参2‑6份、红苍术2‑6份、炒地榆2‑6份、炒蒲黄2‑6份、制山茱萸2‑6份、益母草2‑6份、茜草2‑6份、白及2‑6份、乌贼骨2‑6份、升麻2‑6份、炒白术2‑6份、炙黄芪4‑8份。该中药组合物具有益气敛阴,固冲摄血之功效,全方之旨性味从甘、从温、从涩组合,发挥其能补、能收敛之功,藉以调整气血的功能,能平肾气亏虚,冲任失固,主治月经量多,经行淋漓不尽者(气阴两虚证),用于血崩、子宫功能性出血的具有理想的治疗效果。
Description
技术领域
本发明属于中药技术领域,具体涉及一种益气固摄中药组合物及其制备方法,还涉及该中药组合物在用于治疗血崩、子宫功能性出血的中的应用。
背景技术
正常有排卵的妇女如果在卵巢周期的末期,所排出的卵子未受精,则黄体退化,血内雌、孕激素水平随之而下降,出现子宫出血,临床上表现为月经。月经有很强的周期性、自律性,其机制仍未完全阐明。正常月经出血的机制中雌孕激素水平降低卵子未受精,黄体退化雌孕激素水平的下降是重要启动因素。近年关于子宫出血的研究认为血E2和孕酮水平的下降只是最初激发的因素,它们主要通过子宫内膜局部旁分泌调节,宫内膜局部因子的改变而引起出血。
血崩、子宫功能性出血为妇科常见病,属于功能失调性子宫出血(简称功能性子宫出血或功血),它是由于调节生殖的神经内分泌机制失常引起的异常子宫出血,全身及内外生殖器官无器质性病变存在。经药理学研究排卵型出血的发病机制为以下几方面;内膜纤溶系统功能亢进子;子宫内膜不同PG之间比例失衡;卵泡期子宫内膜血流增加,子宫内膜ET释放减少,白细胞浸润增多。西医治疗为减少经量或控制异常出血,调整月经周期。药物治疗多以雌孕激素合并应用,由于使用雌孕激素时间长,头晕、恶心、呕吐等消化道反应重,故患者不易坚持按时服药,一旦停药易复发;手术疗法以刮宫、子宫切除术或子宫内膜部分或完全切除术等。手术对患者具有创伤性,患者不愿接受。
而中医学认为,此病的形成有多种原因,而非一脏一腑,常气血同病,多脏受累。其中主要为虚、热、瘀所致。虚主要为肾虚、脾虚。先天禀赋不足,天癸初至,充任未盛,不能正常调摄经期,制约经血;或因房劳伤肾,或因胞宫受损,或因年老肾衰,皆可导致肾气亏虚,冲任失固,经血失调;或忧思劳倦伤脾,脾虚统摄无权,冲任失固而致崩漏。热者主要为素体阳盛,或郁久化火,或嗜食辛辣,内生实热,或感受热邪,迫血妄行而成崩漏;或素体阴虚,或久病伤阴,阴虚生热,虚火扰动血海,经血失约。瘀者,可由情志所伤,气滞血瘀,或感受寒热之邪,寒凝血瘀,热灼血滞,瘀血阻滞冲任,经血失调。
中医药治疗,根据病缓急和出血新久之异,本着“急则治其标,缓则治其本”的原则,灵活掌握塞流、澄源、复旧三法。该法一直是中医治疗本病的大法,即先辨证止血治标,贯彻:“有形之血不能速生,无形之气所当急固,无形生有形”,再根据不同的病因病机调经治本,具有整体调节的特色,其疗效显著,副反应少,而且远期疗效亦较稳定,对改善妇女健康具有较大的治疗优势。基于此法,本发明提供了一种益气固摄中药组合物,经数十年临床验证,疗效显著,安全,无毒副作用。
发明内容
本发明提供的益气固摄中药组合物以黄芪、白术、太子参为君药,鹿角霜、制山茱萸、升麻为臣药,煅龙骨、海螵蛸、炒地榆、茜草、红苍术、炒蒲黄、益母草、白及、乌贼骨九味为佐药,各组分协同或共用,从而使得该中药组合物具有益气敛阴,固冲摄血之功效,从甘、从温、从涩组合,发挥其能补、能收敛之功,藉以调整气血的功能,能平肾气亏虚,冲任失固,经血失调,主治月经量多,经行淋漓不尽者(气阴两虚证),用于血崩、子宫功能性出血的具有理想的效果。
为了实现上述目的,本发明采用以下技术方案:
本发明首先提供一种益气固摄中药组合物,其包含下述重量配比的原料:炙黄芪4-8份、炒白术2-6份、太子参2-6份、制山茱萸2-6份、鹿角霜2-6份、锻龙骨3-7份、海螵蛸2-6份、炒地榆2-6份、茜草2-6份、红苍术2-6份、炒蒲黄2-6份、益母草2-6份、白及2-6份、乌贼骨2-6份、升麻2-6份;
进一步方案,其包含下述重量配比的原料:炙黄芪4-6份、炒白术2-4份、太子参2-4份、制山茱萸2-4份、鹿角霜2-4份、锻龙骨3-5份、海螵蛸2-4份、炒地榆2-4份、茜草2-4份、红苍术2-4份、炒蒲黄2-4份、益母草2-4份、白及2-4份、乌贼骨2-4份、升麻2-4份;
进一步方案,其包含下述重量配比的原料:炙黄芪4份、炒白术2份、太子参2份、制山茱萸2份、鹿角霜2份、锻龙骨3份、海螵蛸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、乌贼骨2份、升麻2份;
或者炙黄芪6份、炒白术4份、太子参4份、制山茱萸4份、鹿角霜4份、锻龙骨5份、海螵蛸4份、炒地榆4份、茜草4份、红苍术4份、炒蒲黄4份、益母草4份、白及4份、乌贼骨4份、升麻4份;
或者炙黄芪8份、炒白术6份、太子参6份、制山茱萸6份、鹿角霜6份、锻龙骨7份、海螵蛸6份、炒地榆6份、茜草6份、红苍术6份、炒蒲黄6份、益母草6份、白及6份、乌贼骨6份、升麻6份;
进一步方案,所述的中药组合物是任何一种药学上可接受的剂型。
进一步方案,所述的药学上可接受的剂型为颗粒剂、口服溶液剂、片剂、汤剂或丸剂。
进一步方案,所述中药组合物用于治疗血崩、子宫功能性出血,对经行淋漓不尽者(气阴两虚证)具有理想的治疗效果。
本发明进一步提供了一种如前述任一项所述的益气固摄中药组合物的制备方法,包括下列步骤:
A)按配比称取鹿角霜、煅龙骨、海螵蛸、乌贼骨四味药,加6倍量水煎煮四次,每次3小时,合并煎液,滤过,滤液静置,取上清液,备用;
B)按配比称取炙黄芪、白术、太子参、制山茱、萸升麻、炒地榆、茜草、红苍术、炒蒲黄、益母草、白及、升麻十二味药,加8倍量水煎煮二次,每次2小时,合并煎液,滤过,滤液静置;
C)取步骤B)上清液浓缩至相对密度为1.13~1.20(75~80℃)的清膏(75~80℃),放冷,加乙醇使含醇量达到65%,静置24小时,取上清液,备用;
D)取步骤C)上清液,减压回收乙醇后,加入步骤A)中的上清液,减压浓缩至相对密度为1.25~1.30(75~80℃)的稠膏;
E)将上述步骤D)得到的稠膏,80℃以下减压干燥,粉碎成细粉,过80目筛,取干膏粉,备用;
F)将上述步骤E)得到的干膏粉加辅料混匀,制粒,60~70℃干燥,即得所述中药组合物。
与现有技术相比,本发明具有以下有益效果:
本发明提供的益气固摄中药组合物中,主药炙黄芪、炒白术、太子参甘补大补脾元真气,取有形之气当须急固之意,辅以鹿角霜、制山茱萸、升麻养血摄血、升举阳气、滋肾固冲养血滋肾之功益,配煅龙骨、海螵蛸、乌贼骨、炒地榆、茜草、红苍术、炒蒲黄、益母草、白及塞流固摄、收敛止血。其中海螵蛸配红苍术是治疗“功血”效果显著的药对;方中三味骨甲类药物:煅龙骨、海螵蛸、乌贼骨联合运用,可谓气力精全、性味雄健,固涩力宏的方组。全方同奏固冲塞流、益气培元、标本同治之功。主治血崩、子宫功能性出血。
本发明所选取的原料药之间符合“君臣佐使”配伍原则,方中以黄芪、白术、太子参为君药,具有大补脾元真气的功效;黄芪味甘,性温,具有益气补中之功效,主治脾胃气虚,中气下陷,自汗盗汗,气虚水肿,气虚乏力,食少便塘等症。白术,味苦、甘,性温;具有健脾益气,燥湿利水,止汗,安胎功效,主治脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。太子参味甘、微苦,性平,具有益气健脾,生津润肺之效。用于脾虚体倦,食欲不振,病后虚弱,气阴不足,自汗口渴,肺燥干咳等病症。
以鹿角霜、制山茱萸、升麻为臣药,鹿角霜味咸、涩,性温。具有温肾助阳,收敛止血功效。主治脾肾阳虚,白带过多,遗尿尿频,崩漏下血,疮疡不敛等症状。山茱萸味酸、涩,性微温。具有补益肝肾,收涩固脱功效。用于眩晕耳鸣,腰膝酸痛,阳痪遗精,遗尿尿频,崩涌带下,大汗虚脱,内热消渴等病症。二者协同作用,以养血摄血、滋肾固冲。升麻辛甘微寒,具有升举阳气之功,主治气虚下陷,脏器脱垂,崩漏下血,入脾胃经,善引脾胃清阳之气上升。
煅龙骨、海螵蛸、炒地榆、茜草、红苍术、炒蒲黄、益母草、白及、乌贼骨等九味药塞流固摄、收敛止血是为佐使药。海螵蛸苦辛消化、制酸敛疡为佐药,能够养中兼清,补中有行,可强胃健脾,温血解毒,促进强健脾胃、养血解毒,共奏健脾和胃,理气止痛、温中散寒,疏肝解郁。其中龙骨配乌贼骨联合应用,可谓气力精全,性味雄健,固涩力宏。海螵蛸配红苍术是治疗“功血”效果显著的药对,红苍术为蓼科拳参,功能凉血入肝经血分,常用于治疗血热妄行所致崩漏,配伍海螵蛸相得益彰。;益母草、茜草、炒地榆、炒蒲黄、白及均为凉血止血良药,方中益母草辛散苦泄,主入血分,功善活血调经,为妇科经产病的要药。白及味涩质黏,为收敛止血要药,可用治体内外诸出血证。
本发明提供的益气固摄中药组合物具有调整气血的功能,能平肾气亏虚,冲任失固。实际应用中,根据患者的临床症状予以药材的加减,灵活调整药材剂量,能够更有效地控制疾病进展。由此,改善患者的月经周期失去正常规律,经量过多,经期延长,甚至不规则阴道流血等症状,对血崩、子宫功能性出血的具有明显疗效。
具体实施方式
为了便于理解本发明,下面将结合具体的实施例对本发明进行更全面的描述。但是,本发明可以以许多不同的形式来实现,并不限于本文所描述的实施方式。相反地,提供这些实施方式的目的是使对本发明的公开内容理解的更加透彻全面。
除非另有定义,本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的,不是旨在于限制本发明。
本发明第一方面公开了一种益气固摄中药组合物,其包含下述重量配比的原料:炙黄芪4-8份、炒白术2-6份、太子参2-6份、制山茱萸2-6份、鹿角霜2-6份、锻龙骨3-7份、海螵蛸2-6份、炒地榆2-6份、茜草2-6份、红苍术2-6份、炒蒲黄2-6份、益母草2-6份、白及2-6份、乌贼骨2-6份、升麻2-6份。
进一步方案,该中药组合物包含下述重量配比的原料:炙黄芪4-6份、炒白术2-4份、太子参2-4份、制山茱萸2-4份、鹿角霜2-4份、锻龙骨3-5份、海螵蛸2-4份、炒地榆2-4份、茜草2-4份、红苍术2-4份、炒蒲黄2-4份、益母草2-4份、白及2-4份、乌贼骨2-6份、升麻2-6份。
优选的,在本发明的一个或多个实施例中,该中药组合物包含下述重量配比的原料:炙黄芪4份、炒白术2份、太子参2份、制山茱萸2份、鹿角霜2份、锻龙骨3份、海螵蛸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、乌贼骨2份、升麻2份。
或者炙黄芪6份、炒白术4份、太子参4份、制山茱萸4份、鹿角霜4份、锻龙骨5份、海螵蛸4份、炒地榆4份、茜草4份、红苍术4份、炒蒲黄4份、益母草4份、白及4份、乌贼骨4份、升麻4份;
或者炙黄芪8份、炒白术6份、太子参6份、制山茱萸6份、鹿角霜6份、锻龙骨7份、海螵蛸6份、炒地榆6份、茜草6份、红苍术6份、炒蒲黄6份、益母草6份、白及6份、乌贼骨6份、升麻6份;
进一步方案,所述的中药组合物还包括药学上可接受的辅料,从而使得该中药组合物可以是任何一种药学上可接受的剂型,如颗粒剂、口服溶液剂、片剂、汤剂、胶囊剂或丸剂。
进一步方案,本发明中所述中药组合物用于治疗血崩、子宫功能性出血的。
本发明第二方面提供了一种本发明第一方面中任一项所述的中药组合物的制备方法,对原料依次进行水提、醇沉、减压干燥、一步制粒,从而最大限度地从药物组合物中提取出有效组分使得药用物质基础未发生明显改变,制成颗粒剂、口服溶液剂、片剂、汤剂或丸剂后仍具有相同的效果。具体的该中药组合物的制备,包括下列步骤:
A)鹿角霜、煅龙骨、海螵蛸、乌贼骨四味药,加6倍量水煎煮四次,每次3小时,合并煎液,滤过,滤液静置,取上清液,备用;
B)炙黄芪等剩余十一味药,加8倍量水煎煮二次,每次2小时,合并煎液,滤过,滤液静置;
C)取步骤B)上清液浓缩至相对密度为1.15的清膏(75~80℃),放冷,加乙醇使含醇量达到65%,静置24小时;优选的,浓缩温度为70-80℃;
D)取步骤C)上清液,减压回收乙醇后,加入步骤A)所得鹿角霜等提取液,减压浓缩至相对密度为1.25~1.30(75~80℃)的稠膏;
E)将上述步骤D)得到的稠膏,80℃以下减压干燥,粉碎成细粉末,过80目筛,
F)将上述步骤E)得到的干膏粉加辅料混匀,制粒,60~70℃干燥,即得所述中药组合物。
干燥、粉碎后,可以按照本领域技术人员常规的工艺手段将所述中药组合物制成相应的剂型,具体如下:
当所述中药组合物为颗粒剂时,干燥后的固体物粉碎、过筛,再与辅料混匀,以水为粘合剂,用流化床一步制粒,干燥,整粒,包装,即得;所述步骤的流化床一步制粒参数为风机频率20-40Hz、进风量80-150m3/h、进风温度85℃、物料温度75-85℃、出风温度55-65℃、供液泵转速30r/min。
当所述中药组合物为片剂时,干燥后的固体物粉碎、过筛,再与辅料混匀制粒压片即得;所述步骤的制粒为流化床制粒,压片参数为压力范围15~30KN。
当所述中药组合物为胶囊剂时,干燥后的固体物粉碎、过筛,再与辅料混匀制粒灌胶囊即可。
当所述中药组合物为汤剂时,中药原料经水提,滤过制成汤剂即得。
当所述中药组合物为口服溶液剂时,中药原料经水提、醇沉、滤过、浓缩、稀配、冷藏等工艺制成口服液即得;所述步骤的稀配为浓缩液加纯化水稀释,3-10℃冷藏48小时。
下面结合具体的实施例对本发明的技术方案进行更加完整的说明。
实施例1中药组合物的制备
该中药组合物包含以下原料:炙黄芪4份、炒白术2份、太子参2份、制山茱萸2份、鹿角霜2份、锻龙骨3份、海螵蛸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、乌贼骨2份、升麻2份。
具体制备步骤如下:
1)鹿角霜、煅龙骨、海螵蛸、乌贼骨四味药,加6倍量水煎煮四次,每次3小时,合并煎液,滤过,滤液静置,取上清液,备用;
2)炙黄芪等剩余十一味药,加8倍量水煎煮二次,每次2小时,合并煎液,滤过,滤液静置;
3)取步骤2)上清液浓缩至相对密度为1.15的清膏(75℃),放冷,加乙醇使含醇量达到65%,静置24小时;
4)取步骤3)上清液,减压回收乙醇后,加入步骤1)所得的上清液,减压浓缩至相对密度为1.25的稠膏;
5)将上述稠膏,80℃以下减压干燥,粉碎成细粉,过80目筛,加糊精2份,混匀,用70%乙醇制粒,60℃干燥,得所述中药组合物。
实施例2中药组合物的制备
炙黄芪6份、炒白术4份、太子参4份、制山茱萸4份、鹿角霜4份、锻龙骨5份、海螵蛸4份、炒地榆4份、茜草4份、红苍术4份、炒蒲黄4份、益母草4份、白及4份、乌贼骨4份、升麻4份;
制备方法同实施例1。
实施例3中药组合物的制备
炙黄芪8份、炒白术6份、太子参6份、制山茱萸6份、鹿角霜6份、锻龙骨7份、海螵蛸6份、炒地榆6份、茜草6份、红苍术6份、炒蒲黄6份、益母草6份、白及6份、乌贼骨6份、升麻6份;
制备方法同实施例1。
相关拆方中药组合物的制备
对比例1缺益母草、白及药物组方
取炙黄芪4份、炒白术2份、太子参2份、制山茱萸2份、鹿角霜2份、锻龙骨3份、海螵蛸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、乌贼骨2份、升麻2份;
制备方法同实施例1。
对比例2缺红苍术、海螵蛸药物组方
取炙黄芪4份、炒白术2份、太子参2份、制山茱萸2份、鹿角霜2份、锻龙骨3份、炒蒲黄2份、炒地榆2份、茜草2份、益母草2份、白及2份、乌贼骨2份、升麻2份;
制备方法同实施例1。
对比例3缺炒地榆、茜草药物组方
取炙黄芪4份、炒白术2份、太子参2份、制山茱萸2份、鹿角霜2份、锻龙骨3份、海螵蛸2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、乌贼骨2份、升麻2份;
制备方法同实施例1。
对比例4缺龙骨、乌贼骨药物组方
取炙黄芪4份、炒白术2份、太子参2份、制山茱萸2份、鹿角霜2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、海螵蛸2份、升麻2份;
制备方法同实施例1。
对比例5缺升麻和黄芪药物组方
炒白术2份、太子参2份、制山茱萸2份、鹿角霜2份、锻龙骨3份、海螵蛸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、海螵蛸2份。
制备方法同实施例1。
对比例6缺山茱萸、鹿角霜药物组方
炙黄芪4份、炒白术2份、太子参2份、锻龙骨3份、海螵蛸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份;
对比例7缺白术、太子参药物组方
炙黄芪4份、制山茱萸2份、鹿角霜2份、锻龙骨3份、海螵蛸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份;
制备方法同实施例1。
对比例8缺黄芪、白术药物组方
太子参2份、制山茱萸2份、鹿角霜2份、锻龙骨3份、海螵蛸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、乌贼骨2份、升麻2份。
对比例9缺黄芪、山茱萸药物组方
太子参2份、炒白术2份、鹿角霜2份、锻龙骨3份、海螵蛸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、乌贼骨2份、升麻2份。
对比例10缺黄芪、白术、升麻药物组方
太子参2份、制山茱萸2份、鹿角霜2份、锻龙骨3份、海螵蛸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、乌贼骨2份。
对比例11缺龙骨、乌贼骨、鹿角霜药物组方
取炙黄芪4份、炒白术2份、太子参2份、制山茱萸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、海螵蛸2份、升麻2份;
对比例12缺黄芪、太子参物组方
取炒白术2份、制山茱萸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、海螵蛸2份、升麻2份、乌贼骨2份、鹿角霜2份、锻龙骨2份。
测试例
试验例1:考察本发明组合物对小鼠凝血时间和出血时间的影响
该试验例的目的是研究本发明组合物对小鼠凝血时间和出血时间的影响。
1.1实验动物
昆明种小鼠、SD大鼠,由安徽省实验动物中心提供,SCXK(皖)2011-002。动物具体情况见以下各实验所述。
1.2方法与结果
取体重为18-22g的昆明种雌性小鼠,随机分为20组:对照组,宫血停颗粒(9g/kg)组,塞流止崩汤(10.6g/kg)组,实施例1(5.3、10.6、21.2g/kg)组,实施例2(10.6g/kg)组,实施例3(10.6g/kg)组,对比例1-12(10.6g/kg)组,每组12只。各组每天灌胃给药(ig),用药组每天给相应药物,对照组每天给予等体积蒸馏水。第5天给药后40min后用内径为1mm的毛细玻璃管插入小鼠眼内毗至球后静脉丛取血,取血5cm以上。每隔15s折断毛细玻璃管一小段,检查有无血凝丝,从采血到出现血凝丝的时间即为凝血时间。
各组小鼠第7天给药40min后将其装入小鼠固定器内固定,露出鼠尾,用利剪于小鼠尾尖3mm处横断,待血液自行溢出开始计时,每隔15s用滤纸吸去血滴一次,直至血液自然停止(滤纸吸时无血)为止,此即为出血时间。
结果如表1所示,与对照组比较,宫血停颗粒、塞流止崩汤、实施例1(10.6、21.2g/kg)和对比例1-12对小鼠凝血时间和出血时间都有一定的缩短作用。表明本发明组合物能够促进小鼠的凝血功能,缩短小鼠出血时间,对比例1-12中拆方后各组方对以上两个方面都有改善作用,但无统计学差异,说明拆方组效果明显不如全方组。
表1实施例1对小鼠凝血时间和出血时间的影响(n=12)
与对照组比较:*P<0.05
该研究结果可知,小鼠凝血时间和出血时间测定结果显示,实施例1-3和对比例1-12对小鼠凝血时间和出血时间都有一定的缩短作用。
试验例2:本发明组合物对未成年大鼠性腺发育和PT、APTT的影响
该试验例的目的是研究本发明组合物对未成年大鼠性腺发育和PT、APTT的影响。
2.1实验动物
昆明种小鼠、SD大鼠,由安徽省实验动物中心提供,SCXK(皖)2011-002。动物具体情况见以下各实验所述。
2.2方法与结果
取SD雌性未成年大鼠,体重为40-60g,鼠龄6-7周,随机分为18组:对照组,宫血停颗粒(7g/kg)组,塞流止崩汤(8g/kg)组,实施例1(4、8、16g/kg)组,对比例1-12(8g/kg)组,每组8只。用药组每天灌胃给相应药物14天,对照组每天给予同体积蒸馏水每日灌服。实验前,给药7天,14天称体重。
第14天给药后lh,用10%水合氯醛溶液腹腔注射麻醉大鼠(0.35ml/100g体重),腹主动脉取血4ml,其中取1.8ml装于预先备好的装有0.2ml 3.8%枸橼酸钠抗凝的试管中,3000r/min离心15min,取上清-20℃冻存,用来测其凝血酶原和部分凝血活酶时间。将剩余血液装于未加抗凝的试管中,静置20分钟后,以3000转/分离心15min,取血清,-20℃保存备用,用放免法测量血清激素雌二醇和孕酮。
腹主动脉取血处死大鼠后立即于相同部位专人取子宫、卵巢,并剥离附着于子宫壁上的结缔组织和脂肪组织,精密称重,计算脏器指数。
大鼠体重测量结果显示(表2),各组大鼠的体重在给药7d和14d均出现明显增长,但与对照组比较,宫血停颗粒、塞流止崩汤、实施例1三个剂量和对比例1-12组对未成年大鼠的体重未见明显影响。对比例1-12中拆方后各组方对未成年大鼠的体重未见明显影响,但无统计学差异,说明拆方组效果明显不如全方组。
表2实施例1对未成年大鼠体重的影响(n=8)
与对照组比较:*P>0.05
子宫和卵巢测定结果显示(表3),与对照组比较,宫血停颗粒、塞流止崩汤、实施例1(8、16g/kg)和对比例1-12组给药14d均能够增加未成年大鼠的子宫的重量和子宫指数,实施例1(16g/kg)给药14d能够明显增加未成年大鼠的卵巢的重量,而对卵巢指数没有明显的影响,表明本发明组合物能够促进未成年大鼠子宫和卵巢的生长和发育。对比例1-12中拆方后各组方对未成年大鼠的子宫的重量和子宫指数都有增加作用,但无统计学差异,说明拆方组效果明显不如全方组。
表3实施例1对未成年大鼠子宫和卵巢的影响(n=8)
与对照组比较:*P<0.05
血清雌激素(雌二醇、E2)和孕激素(P)检测结果显示(表4),与对照组比较,宫血停颗粒、塞流止崩汤和实施例1(8、16 g/kg)给药14d能够明显增加未成年大鼠血清雌二醇和孕激素的含量。表明本发明组合物可能具有促进性腺轴发育的作用。对比例1-12中拆方后各组方对未成年大鼠的子宫的重量和子宫指数都有增加作用,但无统计学差异,说明拆方组效果明显不如全方组。
表4实施例1对未成年大鼠雌二醇和孕激素的影响(n=8)/>
与对照组比较:*P<0.05
血浆PT和APTT检测结果显示(表5),与对照组比较,宫血停颗粒、塞流止崩汤和实施例1(4、8、16g/kg)给药14d能够明显缩短未成年大鼠血浆PT和APTT时间,表明本发明组合物可能具有促进凝血功能和止血的作用。对比例1-12中拆方后各组方对未成年大鼠血浆PT和APTT时间都有缩短作用,但无统计学差异,说明拆方组效果明显不如全方组。
表5本发明血浆PT和APTT的影响(n=8)
组别 | 剂量(g/kg) | PT(s) | APTT(s) |
对照组 | - | 21.39±5.12 | 28.51±4.61 |
宫血停 | 7 | 15.22±3.10* | 22.24±5.42* |
塞流止崩汤 | 8 | 15.33±3.51* | 21.85±4.74* |
实施例1低剂量 | 4 | 16.60±3.87 | 23.37±5.16 |
实施例1中剂量 | 8 | 15.54±3.07* | 22.13±4.10* |
实施例1高剂量 | 16 | 15.05±2.50* | 21.05±3.98** |
对比例1 | 8 | 13.03±2.32 | 22.73±5.10 |
对比例2 | 8 | 16.12±3.21 | 22.85±4.90 |
对比例3 | 8 | 15.95±2.56 | 22.35±3.65 |
对比例4 | 8 | 14.23±2.96 | 22.42±3.54 |
对比例5 | 8 | 13.99±3.17 | 22.31±2.98 |
对比例6 | 8 | 15.88±3.95 | 22.55±4.31 |
对比例7 | 8 | 16.14±3.32 | 22.93±3.36 |
对比例8 | 8 | 16.84±3.05 | 23.13±2.34 |
对比例9 | 8 | 14.99±3.17 | 21.31±2.98 |
对比例10 | 8 | 13.88±3.43 | 20.55±4.38 |
对比例11 | 8 | 12.14±3.32 | 20.93±3.37 |
对比例12 | 8 | 15.84±3.38 | 21.13±2.38 |
与对照组比较:*P<0.05;**P<0.01
试验例3:本发明组合物对大鼠在体子宫收缩性的影响
该试验例的目的是研究本发明组合物对大鼠在体子宫收缩性的影响。
3.1实验动物
昆明种小鼠、SD大鼠,由安徽省实验动物中心提供,SCXK(皖)2011-002。动物具体情况见以下各实验所述。
3.2方法与结果
取SD雌性大鼠,体重为200-240g,随机分为18组:对照组,宫血停颗粒(7g/kg)组,塞流止崩汤(8g/kg)组,实施例1(4、8、16g/kg)组,对比例1-12(8g/kg)组,每组8只。各组大鼠给药5天,于实验前48h灌胃给戊酸雌二醇(0.35mg/kg),给药2次,人工促使动物处于动情期,以提高子宫平滑肌收缩性。实验时给大鼠腹腔注射25%乌拉坦0.5ml/100g进行麻醉,麻醉后将其仰位固定于手术台上,剪去下腹部毛。在下腹部作4cm长的切口,打开腹腔,找出一侧子宫角,轻轻剥离周围组织并用温乐氏液冲洗干净,在其中点用一手术线悬吊与张力换能器相连,将近阴道端和近卵巢端缝合在特制浴管的两端,将切口处的腹壁围绕特制浴管用线做荷包缝合以固定,并用手术灯照射保温。在特制浴管中加入温乐氏液5ml,打开BL-420E生物机能实验系统软件,调零,定标,在“输入信号”下选择“通道”的“张力”。在大鼠上腹部作一长约3cm切口,找到十二指肠,待大鼠子宫收缩稳定后描记10min,然后用注射器向十二指肠内注入相应药物,记录给药后30,60,90,120min子宫平滑肌收缩幅度、频率、平均张力。
实验结果显示,与对照组比较,宫血停颗粒、塞流止崩汤实施例1(4、8、16g/kg)组和对比例1-12(8g/kg)组在给药后90和120min能明显增加大鼠子宫收缩频率;塞流止崩汤能增加给药后90min大鼠子宫收缩的平均张力,能增加给药后120min大鼠子宫收缩的最大张力和平均张力。实施例1(8g/kg)能够增加给药后90和120min大鼠子宫收缩的最大张力和平均张力。实施例1(16g/kg)能增加给药后90min大鼠子宫收缩的平均张力和120min最大张力。对比例1-12中拆方后各组方大鼠能增加给药后90和120min大鼠子宫收缩的最大张力和平均张力。但无统计学差异,说明拆方组效果明显不如全方组。实验结果表明,本发明组合物具有促进子宫收缩的作用。见表6。
表6本发明对大鼠在体子宫收缩性的影响(n=8)
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与对照组比较:*P<0.05,**P<0.01
试验例4:本发明组合物对流产药物致早孕大鼠子宫出血量的影响
该试验例的目的是研究本发明组合物对流产药物致早孕大鼠子宫出血量的影响。
4.1实验动物
昆明种小鼠、SD大鼠,由安徽省实验动物中心提供,SCXK(皖)2011-002。动物具体情况见以下各实验所述。
4.2方法与结果
将雌雄SD大鼠按1:1比例合笼,次日晨检查有无阴道栓,以发现有阴道栓为妊娠第l天。将妊娠大鼠随机分为19组:正常对照组,模型组(米非司酮+米索前列醇),宫血停颗粒(7g/kg)组,塞流止崩汤(8g/kg)组,实施例1(4、8、16g/kg)组,对比例1-12(8g/kg)组,每组8只。于妊娠第8天除正常组外分别灌胃米非司酮8.3mg/kg(8:00)和米索前列醇100ug/kg(18:00),同时于阴道内放人棉球(棉球重80mg),次日8:00和18:00将棉球取出,放入塑料袋中密闭冷藏保存,同时置换新棉球于阴道内,收集1周内(第8~14天)各组大鼠阴道出血的棉球,放入塑料袋中密闭冷藏保存,观察阴道出血情况。其他药物从妊娠第8天连续ig给药至妊娠第14天,将收集的每鼠阴道棉球进行出血量测定。
第14天给药后lh,用10%水合氯醛溶液腹腔注射麻醉大鼠(0.35ml/100g体重),腹主动脉取血1.8ml装于预先备好的装有0.2ml 3.8%枸橼酸钠抗凝的试管中,3000r/min离心15min,取上清-20℃冻存,用来测其凝血酶原和部分凝血活酶时间。
出血量测定方法:
(1)大鼠尾静脉血红蛋白吸管采血0.02mL,加入50g/L NaOH溶液4mL中混匀待用。
(2)将收集的每鼠每天子宫出血棉球分别置于烧杯内,根据出血量的情况加适量NaOH溶液浸泡挤压搓洗棉球血渍,浸洗后的溶液倒入另一烧杯内保存。再加适量NaOH溶液浸泡棉球,挤压搓洗血渍,倒入保存容器。根据棉球血渍洗脱情况,决定是否再浸洗1-2次。
(3)将先后所有浸提液混匀,记录所用NaOH溶液总量,取5mL浸提液3000转离心5min,分别取:1)已离心的浸提液4mL;2)大鼠尾静脉血50g/L NaOH溶液4mL;3)以50g/LNaOH为空白对照,在546nm波长记录吸光度(A)值。
(4)子宫出血量计算公式:子宫出血量(mL)=尾静脉血量(0.02mL)×子宫内棉球浸提液A值×V2/(尾静脉血A值×V1)。其中V1=稀释尾静脉血所用50g/L NaOH溶液量(4mL),V2=浸提子宫血所用50g/L NaOH溶液量(mL)。
实验结果显示,与对照组比较,流产药物可致模型组早孕大鼠子宫出血量明显增加;与模型组比较,宫血停、塞流止崩汤,实施例1(4、8、16g/kg)组和对比例1-12组,均可明显减少流产药物致早孕大鼠子宫出血量。表明本发明组合物对子宫出血有一定的抑制作用。对比例1-12中拆方后各组方早孕大鼠组合物对子宫出血有一定的抑制作用。但无统计学差异,说明拆方组效果明显不如全方组。实验结果表明,本发明组合物具有对子宫出血的抑制作用。见表7。
表7实施例1对流产药物致早孕大鼠子宫出血量的影响(n=8)
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与对照组比较:**P<0.01;与模型组比较:△P<0.05
表8结果显示,与对照组比较,模型组大鼠PT,APTT明显延长;与模型组比较,宫血停、塞流止崩汤和实施例1(4、8、16g/kg)组可明显缩短流产药物致早孕子宫出血大鼠血浆PT、APTT,表明本发明组合物对流产药物致早孕子宫出血大鼠凝血功能具有一定的促进作用。拆方各组方对以上两个方面都有改善作用,但无统计学差异,说明拆方组效果明显不如全方组。
表8实施例1血浆PT和APTT的影响(n=8)
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与对照组比较:*P<0.05;与模型组比较:△P<0.05,△△P<0.01
结论
以上实验主要观察了本发明组合物对出凝血时间、子宫和卵巢发育、子宫收缩功能、对大鼠不完全流产子宫出血的影响。下面从以下几个方面对实验结果进行讨论分析。
(1)本发明组合物的止血作用
小鼠凝血时间和出血时间测定结果显示,本发明组合物对小鼠凝血时间和出血时间都有一定的缩短作用。本发明组合物对未成年大鼠实验结果显示,本发明给药14d能够明显缩短未成年大鼠血浆PT和APTT时间。本发明组合物对流产药物致早孕大鼠子宫出血实验结果显示,本发明组合物可明显减少流产药物致早孕大鼠子宫出血量。本发明组合物可明显缩短流产药物致早孕子宫出血大鼠血浆PT、APTT。实验结果显示本发明组合物具有一定的止血作用,提示可能对月经过多具有治疗作用。
(2)本发明组合物对激素水平的调节作用
实施例1对未成年大鼠实验结果显示,实施例1(8、16g/kg)给药14d能够明显增加未成年大鼠的子宫的重量和子宫指数,实施例1(16g/kg)给药14d能够明显增加未成年大鼠的卵巢的重量而对卵巢指数没有明显的影响。血清雌激素和孕激素检测结果显示,实施例1(8、16g/kg)给药14d能够明显增加未成年大鼠血清雌二醇和孕激素的含量。激素水平失调是月经过多的重要原因之一,本发明组合物通过增加大鼠血清雌二醇和孕激素的水平,促进子宫发育,这些作用有利于月经过多的治疗。
(3)本发明组合物增强子宫收缩作用
在体子宫收缩实验结果显示,实施例1(4、8、16g/kg)组在给药后90和120min能明显增加大鼠子宫收缩频率;实施例1(8g/kg)能够增加给药后90和120min大鼠子宫收缩的最大张力和平均张力。实施例1(16g/kg)能增加给药后90min大鼠子宫收缩的平均张力和120min最大张力。提示本发明组合物能够增强子宫的收缩频率和收缩力,有助于月经过多的治疗。
(4)与塞流止崩汤和阳性对照药的比较
从实验结果看,本发明组合物中剂量在止血、调节激素水平、增强子宫收缩等方面,与塞流止崩汤和阳性药比较,其作用相当,没有差异。
实验结果表明,本发明组合物具有一定的止血、抗炎、促进子宫发育和性腺成熟,增加子宫收缩频率和张力,促进凝血、减少流产药物致子宫出血等作用,对月经过多具有一定的治疗作用,临床应用较安全有效。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (8)
1.一种益气固摄中药组合物,其特征在于,其包含下述重量配比的原料:炙黄芪4-8份、鹿角霜2-6份、锻龙骨3-7份、海螵蛸2-6份、太子参2-6份、红苍术2-6份、炒地榆2-6份、炒蒲黄2-6份、制山茱萸2-6份、益母草2-6份、茜草2-6份、白及2-6份、乌贼骨2-6份、升麻2-6份、炒白术2-6份。
2.如权利要求1所述的益气固摄中药组合物,其特征在于,其包含下述重量配比的原料:炙黄芪4-6份、炒白术2-4份、太子参2-4份、制山茱萸2-4份、鹿角霜2-4份、锻龙骨3-5份、海螵蛸2-4份、炒地榆2-4份、茜草2-4份、红苍术2-4份、炒蒲黄2-4份、益母草2-4份、白及2-4份、乌贼骨2-4份、升麻2-4份。
3.如权利要求1所述的益气固摄中药组合物,其特征在于,其包含下述重量配比的原料:炙黄芪4份、炒白术2份、太子参2份、制山茱萸2份、鹿角霜2份、锻龙骨3份、海螵蛸2份、炒地榆2份、茜草2份、红苍术2份、炒蒲黄2份、益母草2份、白及2份、乌贼骨2份、升麻2份;
或者炙黄芪6份、炒白术4份、太子参4份、制山茱萸4份、鹿角霜4份、锻龙骨5份、海螵蛸4份、炒地榆4份、茜草4份、红苍术4份、炒蒲黄4份、益母草4份、白及4份、乌贼骨4份、升麻4份;
或者炙黄芪8份、炒白术6份、太子参6份、制山茱萸6份、鹿角霜6份、锻龙骨7份、海螵蛸6份、炒地榆6份、茜草6份、红苍术6份、炒蒲黄6份、益母草6份、白及6份、乌贼骨6份、升麻6份。
4.如权利要求1-3任一项所述的益气固摄中药组合物,其特征在于,所述的中药组合物是任何一种药学上可接受的剂型。
5.如权利要求4所述的益气固摄中药组合物,其特征在于,所述的药学上可接受的剂型为颗粒剂、片剂、口服液、汤剂、胶囊剂或丸剂。
6.如权利要求1-3任一项所述的益气固摄中药组合物用于治疗血崩、子宫功能性出血。
7.一种权利要求1-3中任一项所述的益气固摄中药组合物的制备方法,其特征在于,包括下列步骤:
A)按配比称取鹿角霜、煅龙骨、海螵蛸、乌贼骨四味药,加4~8倍量水煎煮四次,每次1~3小时,合并煎液,滤过,滤液静置,取上清液,备用;
B)按配比称取炙黄芪、炒白术、太子参、制山茱萸、炒地榆、茜草、红苍术、炒蒲黄、益母草、白及、升麻十一味药,加4~6倍量水煎煮二次,每次1~3小时,合并煎液,滤过,滤液静置;
C)取步骤B)上清液在70~80℃温度中进行浓缩,浓缩至相对密度为1.13~1.20的清膏,放冷,加乙醇使含醇量达到65%,搅匀,静置24小时,取上清液,备用;
D)取步骤C)中的上清液,减压回收乙醇后,加入步骤A)中的上清液,在75~80℃减压浓缩至相对密度为1.25~1.30的稠膏,备用;
E)对上述步骤D)得到的稠膏置于80℃以下减压干燥,粉碎、筛选,得到干膏粉备用;
F)将上述步骤E)得到的干膏粉加辅料混匀,经过制粒、干燥后,即得所述中药组合物。
8.如权利要求7所述的制备方法,其特征在于,所述步骤F)的,所述干燥的温度为60-70℃。
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