CN104474468A - 一种治疗不孕不育的中药组合物及其制备方法 - Google Patents
一种治疗不孕不育的中药组合物及其制备方法 Download PDFInfo
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Abstract
一种治疗不孕不育的中药组合物及其制备方法，由党参、菟丝子、麸炒白术、茯苓、山药、槲寄生、郁金、续断、炒白芍、盐杜仲、甘草、熟地黄、淫羊藿、制地龙配伍组成，对女性患者胎漏、崩漏、带下、气虚血瘀、经络不利、气血双亏、输卵管不畅、经脉不调、闭经、痛经、白带异常、子宫内膜异位症、子宫发育不良、习惯性流产、妊娠漏血、胎动不安、胎漏、崩漏、月经不调、崩漏下血等症有切实疗效。
Description
技术领域
本发明涉及一种由中草药为原料药的中药组合物及其制备方法，具体的说是涉及一种治疗不孕不育的中药组合物及其制备方法。
背景技术
不孕不育是从古至今常见的妇科疾病，原因众多复杂，且现在受污染等多方面不利因素的影响，此病呈递增趋势，所以生产促孕的药品繁多，但其促孕功能单一，缺少标本兼治的功效，致使患者步入误区，直至身体不适、病情恶化、胎儿畸形、滑胎小产、终身不孕等。
发明内容
本发明针对上述不足，从临床医疗用药需求及中医组方辨证原则出发 提出一种主治多年不孕不育，调理内生殖环境、祛瘀疏通的配伍组合中药组合物及其制造方法。本发明所述的中药组合物是由下列重量份数配比的原料制备成的药剂：
党参12-18g、菟丝子9-15g、麸炒白术7-13g、茯苓9-15g、山药12-18g、槲寄生7-13g、郁金9-15g、续断12-18g、炒白芍9-15g、盐杜仲9-15g、甘草2-8g、熟地黄5-11g、淫羊藿7-13g、制地龙12-18g。优选配比为：党参15g、菟丝子12g、麸炒白术10g、茯苓12g、山药15g、槲寄生10g、郁金12g、续断15g、炒白芍12g、盐杜仲12g、甘草5g、熟地黄8g、淫羊藿10g、制地龙15g。所述药剂为胶囊剂、片剂或丸剂。
所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中党参、菟丝子、麸炒白术、茯苓、山药、槲寄生、郁金、续断、炒白芍、盐杜仲、甘草、熟地黄、淫羊藿、制地龙粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将步骤干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤（2）中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。
有益效果
多年的临床使用和试验，证实本发明所述的中药组合物有雌激素样活性，抑制子宫平滑肌收缩和镇痛，提高免役能力作用。
本发明药物各原料药药效如下：
党参：味甘，性平。[功能与主治]：补中益气、止渴、健脾益肺，养血生津。用于脾肺气虚，食少倦怠，咳嗽虚喘，气血不足，面色萎黄，心悸气短，津伤口渴，内热消渴。 懒言短气、四肢无力、食欲不佳、气虚、气津两虚、气血双亏以及血虚萎黄等症。
菟丝子：归经：气味辛，甘，平 无毒。[功能与主治]：补肾益精，养肝明目。适用于肝肾不足的腰膝筋骨酸痛，腿脚软弱无力、阳痿遗精、呓语、小便频数、尿有余沥、头晕眼花、视物不清、耳鸣耳聋以及妇女带下、习惯性流产等症。具有较好的壮阳作用：实验证明：菟丝子有提高果蝇性活力的作用，使其交配率明显增加，其作用强弱与给药浓度成正相关．对因氢化可的松所致的小鼠“阳虚”模型，用菟丝子后能使其阳虚症状有一定的恢复作用，但未能使动物恢复至正常对照组水平。实验表明：菟丝子水煎液给“阳虚”小鼠灌胃，可使其体重、肾重、胸腺重、白细胞数、红细胞数、血红蛋白以及超氧化物歧化酶的活力显著增加；给雄性小鼠灌胃，可显著延长小鼠的游泳时间和在缺氧条件下的存活时间，对小鼠的非特异性抵抗力亦有增强作用。
麸炒白术：先将锅用中火烧热，撒入麦麸。待冒烟时，投入白术片，不断翻炒，至白术呈焦黄色，逸出焦香气，取出，筛去麦麸，放凉。能缓和燥性，借麸入中，增强健脾、消肿作用。用于脾胃不和，运化失常，食少胀满倦怠乏力，表虚自汗。
茯苓：味甘、淡，性平。归心、肺、脾、肾经。[功能与主治]利水渗湿，健脾，宁心。用于水肿尿少，痰饮眩悸，脾虚食少，便溏泄泻，心神不安，惊悸失眠。
山药：甘、平、无毒。归脾、肺、肾经。[功能与主治]补脾养胃，生津益肺，补肾涩精。用于脾虚食少，久泻不止，肺虚喘咳，肾虚遗精，带下，尿频，虚热消渴，补脾健胃，脾虚食少，泄泻便溏，白带过多。
槲寄生：味苦，性平。归肝、肾经。[功能与主治]祛风湿，补肝肾，强筋骨，安胎元。用于风湿痹痛，腰膝酸软，筋骨无力，崩漏经多，妊娠漏血，胎动不安，头晕目眩。
郁金：味辛、苦，性寒。归肝、心、肺经，具有行气化瘀、清心解郁、利胆退黄、活血止痛、行气解郁、清心凉血之用。
续断：[功能主治]补肝肾，续筋骨，调血脉。治腰背酸痛，足膝无力，胎漏，崩漏，带下，遗精，跌打损伤，金疮，痔漏，痈疽疮肿。
炒白芍：白芍含有芍药甙、牡丹酚、芍药花甙，尚含苯甲酸、挥发油、脂肪油、树脂、鞣质、糖、淀粉、粘液质、蛋白质、β－谷甾醇和三萜类等。白芍性凉，味苦酸，微寒，具有补血养血、平抑肝阳、柔肝止痛、敛阴止汗等功效，适用于阴虚发热、月经不调、胸腹胁肋疼痛、四肢挛急，泻痢腹痛、自汗盗汗、崩漏、带下等症。芍药甙有抗菌、解热、抗炎、增加冠状动脉流量、改善心肌营养血流、扩张血管、对抗急性心肌缺血、抑制血小板聚集、镇静、镇痛、解痉、抗溃疡、调节血糖的作用。白芍煎剂能抑制痢疾杆菌、肺炎链球菌、大肠杆菌、伤寒杆菌、溶血性链球菌、绿脓杆菌等。白芍的四大医疗作用：1、对心血管系统的作用。扩张冠状动脉，降低血压（d-儿茶精和没食子酸乙酯 有抗血栓和抗血小板聚集作用）；2、护肝作用。对四氯化碳、黄曲霉毒素B1、D-半乳糖胺 所致肝损伤有明显保护作用；3、解痉作用。对肠管和在位胃运动有抑制作用，显著对抗催产素引起的子宫收缩；4、镇痛作用。能抑制小鼠扭体、嘶叫、热板反应，对吗啡抑制扭体反应有协同作用，并能对抗戊四唑所致惊厥。白芍别名：白芍、花子、金芍药、杭芍、大白芍、生白芍、炒白芍、炒杭芍、酒白芍、醋白芍、焦白芍、白芍炭等。炒白芍又称炙白芍。为白芍片用麸以文火炒至微黄，略带焦斑，筛去麦麸，晾凉入药者。
盐杜仲：盐杜仲为炒杜仲，用盐水炒断丝，若黑又称杜仲炭，以补肝肾，安胎止血见长。杜仲味甘，性温。有补益肝肾、强筋壮骨、调理冲任、固经安胎的功效。 可治疗肾阳虚引起的腰腿痛或酸软无力，肝气虚引起的胞胎不固，阴囊湿痒等症。在《神农本草经》中被列为上品。现代研究杜仲具有清除体内垃圾，加强人体细胞物质代谢，防止肌肉骨骼老化，平衡人体血压，分解体内胆固醇，降低体内脂肪，恢复血管弹性，利尿清热，广谱抗菌，兴奋中枢神经，提高白血球药理作用。
甘草：《神农本草经》：味甘平。主五脏六府寒热邪气，坚筋骨，长肌肉，倍力，金创，解毒。久服轻身延年。生川谷。《长沙要解》：味甘，气平，性缓。入足太阴脾、足阳明胃经。备冲和之正味,秉淳厚之良资，入金木两家之界，归水火二气之间，培植中州，养育四旁，交媾精神之妙药，调济气血之灵丹。西医药理发现，甘草剂有抗炎和抗变态反应的功能，因此在西医临床上主要作为缓和剂。缓解咳嗽，祛痰，治疗咽痛喉炎；甘草或甘草次酸有去氧皮质酮类作用，对慢性肾上腺皮质功能减退症有良好功效；甘草制剂能促进胃部粘液形成和分泌，延长上皮细胞寿命，有抗炎活性，常用于慢性溃疡和十二指肠溃疡的治疗；甘草的黄酮具有消炎、解痉和抗酸作用；甘草也是人丹的主要原料之一。甘草还具有解毒，调节机体免疫功能等功效。
熟地黄：味甘；性温。归肝；肾经。[功能与主治]补血滋润；益精填髓；用于血虚萎黄；眩晕心悸；月经不调；崩不止；肝肾阴亏；潮热盗汗；遗精阳痿；不育不孕；月经不调；崩漏下血；腰膝酸软；耳鸣耳聋；头目昏花；须发早白；消渴；便秘；肾虚喘促。
淫羊藿：味辛甘性温，归肝肾经。补肾壮阳，祛风除湿。治阳痿不举，偏风不遂，小便淋沥，筋骨挛急，咳嗽，病后青盲，虚火牙痛，半身不遂，腰膝无力，风湿痹痛，四肢不仁。
《药性赋》载：淫羊藿疗风寒之痹，且补阴虚而助阳。现代医学证实，淫羊藿主要含黄酮类化合物、木脂素、生物碱、挥发油等． 淫羊藿等植物中含有蜡醇（Ceryl alcohol）、卅一烷（Hentriacontane）、植物甾醇（Phytosterol）、棕榈酸（Palmitic acid）、硬脂酸（Stearic acid）、油酸（Oleic acid）、亚油酸（Linoleic acid）、亚麻酸（Linolenic acid）、银杏醇（Bilobanol）、木兰碱（Magnoflorin）、葡萄糖（Glucose）、果糖（Fructose）、维生素E 等。淫羊藿的叶和茎中含淫羊藿甙（Icariin）、淫羊藿次甙（Icariside）、去氧甲基淫羊藿甙（des- O-Methylicariin）、β-去水淫羊藿素（β-anhy -Droicaritin）、淫羊藿糖甙（Epimedoside）A、B、C、D、E。此外， 箭叶淫羊藿尚含异槲皮素（Iso- quercetin）、淫羊藿-3-O-α-鼠李糖甙（Icaritin- -3-O-α-rhamnoside）、金丝桃甙（Hyperin）；箭叶淫羊藿甙（Sagittatoside）A、B、C；箭叶淫羊藿素（Sagittatin）A、B 等．
制地龙：热病惊狂、小儿惊风、咳喘、头痛目赤、咽喉肿痛、小便不通、风湿关节疼痛，半身不遂等症。外用涂丹毒、漆疮等症。1.清热息风：主治壮热惊痫，动风抽搐。2.清肺定喘:可治肺热痰咳气喘，对肺热型支气管哮喘疗效较好。3.利尿通淋：适用于湿热下注，热淋涩痛。4.通行经络:可用治热痹节肿赤痛；适当配伍也可治寒痹；配伍益气行血药常用于气虚血瘀，经络不利，偏瘫失语者。对平滑肌的作用：从广地龙提取出的淡黄色结晶，能使已孕和未孕大鼠或豚鼠离体子宫紧张度明显升高，浓度增加可使之呈痉挛收缩状态；静注1mg/kg，可使家兔在位子宫紧张度升高，静注 3～6mg/kg或灌服 10～20mgl/kg，可使慢性子宫瘘管家兔子宫收缩明显增强。此外，该结晶0.5～ 1mg/kg静注，对家兔在位肠管亦有明显兴奋作用，对大鼠后肢血管灌流亦表现明显兴奋，但对在体豚鼠支气管作用较弱。
本发明所述的中药组合物是民间秘方与现代相结合；是传统汤药改变而成的新一代制品，具有补中益气、养血生津、补肝肾、调血脉、升高子宫紧张度、滋阴、促孕益母等疗效。经临床观察显示本发明所述的中药组合物对妇女的胎漏、崩漏、带下、气虚血瘀、经络不利、气血双亏、输卵管不畅、经脉不调、闭经、痛经、白带异常、子宫内膜异位症、子宫发育不良、习惯性流产、妊娠漏血、胎动不安、胎漏、崩漏、月经不调、崩漏下血等症有切实疗效。
本发明所述的中药组合物通过临床证明：在针对妇科病、促孕方面，本发明所述的中药组合物对治疗不育不孕症总有效率达百分之九十五，且本发明的加工方法简单，流程少，降低了其成本，本发明所述的中药组合物承中医之精髓、严谨组方：补血强筋、润肠通便、养容颜、促孕益母；破血行气、消积止痛、祛瘕痞、安胎定神；活血调经、祛瘀止痛、顺理气、生克相济；诸药君臣佐使合用，补破结合、相得益彰，符合中医用药规律和辨证施治的原则。
药效学试验结果表明：本发明对气血双亏引起的身体虚弱、腿软腰软有补益作用、且能补血、调经止痛、散瘀疏通、促孕益母。
雌激素样作用：幼年大鼠灌喂本发明所述的中药组合物，可使子宫内膜增加，镜下观察可见子宫内膜增厚，细胞呈双层均匀排列，腺胞较多、体积较大，并呈腺体分泌状态，卵泡也逐步发育、直至成熟；大鼠饮用本发明所述的中药组合物，可维持和延长黄体激素细胞的正常功能；
抑制子宫平滑肌收缩：本发明所述的中药组合物可抑制垂体后叶素对离体子宫的收缩作用；
镇痉作用：本发明所述的中药组合物可减少腹腔注射醋酸所致小鼠产扭体反应的次数；
增强免疫能力：灌喂本发明所述的中药组合物，能提高正常小鼠对血中碳粒的清除速度和抗体形成细胞的量，促进Ｂ细胞受抗原刺激后的分裂增殖，增加幼鼠胸腺指数，增强小鼠腹腔巨噬细胞吞噬鸡红细胞的能力；
急毒性试验：本发明所述的中药组合物促进造血作用，对急性失血模型小鼠灌胃本发明所述的中药组合物，能促进红细胞和血红蛋白的恢复，提高血红蛋白的含量，缩短小鼠出血时间和血浆复钙时间，延长小鼠常压而缺氧死亡和负重游泳时间，毒理试验研究结果显示，其急毒性甚小，较大剂量和较长疗程服用对大鼠的生长、造血功能无显著毒性，对大鼠的脑、心、肝、肺、肾等切片形态学检查未见明显毒性损伤改变，证明其安全性。
具体实施方式
实施例1：一种治疗不孕不育的中药组合物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂：党参12-18g、菟丝子9-15g、麸炒白术7-13g、茯苓9-15g、山药12-18g、槲寄生7-13g、郁金9-15g、续断12-18g、炒白芍9-15g、盐杜仲9-15g、甘草2-8g、熟地黄5-11g、淫羊藿7-13g、制地龙12-18g。所述药剂为胶囊剂、片剂或丸剂。
按照下述重量份数配比称取原料药：
党参12-18g、菟丝子9-15g、麸炒白术7-13g、茯苓9-15g、山药12-18g、槲寄生7-13g、郁金9-15g、续断12-18g、炒白芍9-15g、盐杜仲9-15g、甘草2-8g、熟地黄5-11g、淫羊藿7-13g、制地龙12-18g。
所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中党参、菟丝子、麸炒白术、茯苓、山药、槲寄生、郁金、续断、炒白芍、盐杜仲、甘草、熟地黄、淫羊藿、制地龙粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将步骤干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤（2）中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。
实施例2：一种治疗不孕不育的中药组合物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂：党参15g、菟丝子12g、麸炒白术10g、茯苓12g、山药15g、槲寄生10g、郁金12g、续断15g、炒白芍12g、盐杜仲12g、甘草5g、熟地黄8g、淫羊藿10g、制地龙15g。所述药剂为胶囊剂、片剂或丸剂。
按照下述重量份数配比称取原料药：
党参15g、菟丝子12g、麸炒白术10g、茯苓12g、山药15g、槲寄生10g、郁金12g、续断15g、炒白芍12g、盐杜仲12g、甘草5g、熟地黄8g、淫羊藿10g、制地龙15g。
所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中党参、菟丝子、麸炒白术、茯苓、山药、槲寄生、郁金、续断、炒白芍、盐杜仲、甘草、熟地黄、淫羊藿、制地龙粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将步骤干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤（2）中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。
Claims (5)
1.一种治疗不孕不育的中药组合物，其特征在于它是由以下重量份数配比的原料药制备而成的药剂：党参12-18g、菟丝子9-15g、麸炒白术7-13g、茯苓9-15g、山药12-18g、槲寄生7-13g、郁金9-15g、续断12-18g、炒白芍9-15g、盐杜仲9-15g、甘草2-8g、熟地黄5-11g、淫羊藿7-13g、制地龙12-18g。
2.根据权利要求1所述的治疗不孕不育的中药组合物，其特征在于它是由以下重量份数配比的原料药制备而成的药剂：党参15g、菟丝子12g、麸炒白术10g、茯苓12g、山药15g、槲寄生10g、郁金12g、续断15g、炒白芍12g、盐杜仲12g、甘草5g、熟地黄8g、淫羊藿10g、制地龙15g。
3.根据权利要求1或2所述的治疗不孕不育的中药组合物，其特征在于：所述药剂为胶囊剂、片剂或丸剂。
4.根据权利要求3所述的治疗不孕不育的中药组合物，其特征在于：所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中党参、菟丝子、麸炒白术、茯苓、山药、槲寄生、郁金、续断、炒白芍、盐杜仲、甘草、熟地黄、淫羊藿、制地龙粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将步骤干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
5.根据权利要求4所述的治疗不孕不育的中药组合物的制备方法，其特征在于步骤（2）中所述的混合物，加水煎煮的次数为2次，第一次为60-80分钟，第二次为40-60分钟。
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