CN109394942A - 一种治疗不孕症的中药制剂及其制备方法 - Google Patents
一种治疗不孕症的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明提出了一种治疗不孕症的中药制剂及其制备方法。中药制剂是由下列重量份的原料药制成：当归1～3份、川芎1～4份、路路通1～3份、白芍1～3份、皂角刺1～3份、香附1～3份、党参1～3份、生白术1～3份、黄芪1～4份、木香0.5～2份、熟地黄1～3份、桑寄生1～4份、吴茱萸0.5～2份、肉桂0.5～2份。采用如下步骤：将中药制剂的原料药洗净去杂，晾干，粉碎成颗粒，加水浸泡1小时，加水煎煮两次，取两次煎液，滤过，热风封闭带中，高温灭菌，包装即可。具有安全、无毒副作用的优点，而且应用后效果明显，治愈率高，而且原料药材价格相对比较便宜，价格低廉。
Description
技术领域
本发明涉及一种治疗不孕症的中药制剂及其制备方法。
背景技术
不孕症是指男女同居2年以上，双方生殖功能正常，未避孕而未受孕者；或曾经怀孕又2年以上未再受孕者，称为“不孕症”。前者称为“原发性不孕症”，后者称为“继发性不孕症”。古称前者为“全不产”，后者为“断绪”。据世界卫生组织统计，不育夫妇占已婚育龄夫妇的7%～15%。中医临床上对不孕病的辨证治疗取得很好的效果，现有技术的中药制剂配方很多，但是各有各的优缺点，兼具疗效确切、安全无毒副作用且价格低廉的配方确很少见，因此发明一种既安全，又有效的中药制剂，具有重大意义。
发明内容
本发明是在传统中医辨证治疗的基础上结合现代最新科研成果研制而成，提出一种疗效确切、安全无毒副作用的治疗不孕症的中药制剂；本发明的目的还在于提供一种上述中药制剂的制备方法。
本发明的治疗不孕症的中药制剂的技术方案是这样实现的：一种治疗不孕症的中药制剂是由下列重量份的原料药制成：当归1～3份、川芎1～4份、路路通1～3份、白芍1～3份、皂角刺1～3份、香附1～3份、党参1～3份、生白术1～3份、黄芪1～4份、木香0.5～2份、熟地黄1～3份、桑寄生1～4份、吴茱萸0.5～2份、肉桂0.5～2份。
在上述方案的基础上，更优选的重量配比为：当归1.5～2.5份、川芎1.5～2.5份、路路通1.5～2.5份、白芍1.5～2.5份、皂角刺1.5～2.5份、香附1.5～2.5份、党参1.5～2.5份、生白术1.5～2.5份、黄芪1.5～3.5份、木香1.0～1.5份、熟地黄1.5～2.5份、桑寄生1.5～3份、吴茱萸1～1.5份、肉桂1～1.5份。
在上述方案的基础上，最佳的重量配比为：当归2份、川芎3份、路路通2份、白芍2份、皂角刺2份、香附2份、党参3份、生白术2份、黄芪3份、木香1份、熟地黄2份、桑寄生3份、吴茱萸1份、肉桂0.5份。
采用了上述技术方案，本发明治疗不孕症的中药制剂的有益效果为：服用该制剂以后没有任何不良反应，三大常规化验及肝肾功能检测未发现异常，具有安全、无毒副作用的优点，而且应用后效果明显，治愈率高，而且原料药材价格相对比较便宜，价格低廉。
本发明中药制剂的制备方法的技术方案是这样实现的：中药制剂的制备方法，顺序采用如下步骤：将中药制剂的原料药洗净去杂，晾干，粉碎成颗粒，加水浸泡1小时，加水煎煮两次，取两次煎液，滤过，热风封闭带中，高温灭菌，包装即可。
在上述方案的基础上，进一步优化得到以下方案，两次煎煮的第一次加总药材10倍量的水，煎煮1.5～2小时，取煎液，滤过；第二次加总药材7倍量的水，煎煮1～1.2小时，取煎液，滤过。
在上述方案的基础上，进一步优化得到以下方案，灭菌过程在105℃条件下进行。
在上述方案的基础上，进一步优化得到以下方案，煎煮时放入多功能提取罐中进行。
采用了上述技术方案，本发明中药制剂的制备方法的有益效果为：采用该方法对中药制剂的原料药材进行加工，制备而成的汤药疗效好、治愈率高、无毒副作用，且该制备方法操作简单方便，可操作性强。
具体实施方式
下面对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
本发明的治疗不孕症的中药制剂的具体实施例：按下述重量称取原料药：当归2份、川芎3份、路路通2份、白芍2份、皂角刺2份、香附2份、党参3份、生白术2份、黄芪3份、木香1份、熟地黄2份、桑寄生3份、吴茱萸1份、肉桂0.5份。
其他实施例中：上述原料药的重量配比可按照下面所述范围调整：当归1～3份、川芎1～4份、路路通1～3份、白芍1～3份、皂角刺1～3份、香附1～3份、党参1～3份、生白术1～3份、黄芪1～4份、木香0.5～2份、熟地黄1～3份、桑寄生1～4份、吴茱萸0.5～2份、肉桂0.5～2份。例如：当归2份、川芎2份、路路通2份、白芍2份、皂角刺1.5份、香附1.5份、党参2份、生白术2份、黄芪2.5份、木香1.5份、熟地黄2份、桑寄生3份、吴茱萸1.5份、肉桂1份。
采用以上原料药材，其药物机理如下：
当归：药性温，味甘、辛。归肝经、心经、脾经。甘温补润，辛能行散，主入肝、心，兼入脾经。善补血活血、调经止痛、润肠通便，并能散寒，凡血虚血瘀有寒之证均宜，兼肠燥便秘者尤佳，既为妇科调经之要药，又为内科补血之佳品。
川芎：药性辛，温。入肝、胆经。行气开郁，祛除风燥湿，活血止痛。治风冷头痛旋晕，胁痛腹疼，寒痹筋挛，经闭，难产，产后瘀阻块痛，痈疽疮疡。用于月经不调，经闭痛经，瘕腹痛，胸胁刺痛，跌扑肿痛，头痛，风湿痹痛。
路路通：药味苦，性平。肝、肾经。有祛风活络，利水，通经的作用。可用于关节痹痛，麻木痉挛，水肿胀满，乳少，经闭。
白芍：药味苦、酸，性微寒。归肝、脾经。养血调经，敛阴止汗，柔肝止痛，平抑肝阳。用于血虚萎黄，月经不调，自汗，盗汗，胁痛，腹痛，四肢挛痛，头痛眩晕。
皂角刺：药味辛，性温。归肝、胃经。消肿托毒，排脓，杀虫。用于痈疽初起或脓成不溃；外治疥癣麻风。
香附：药性平，味辛、微苦、微甘。归肝、脾、三焦经。疏肝解郁，理气宽中，调经止痛。用于肝郁气滞，胸胁胀痛，疝气疼痛，乳房胀痛，脾胃气滞，脘腹痞闷，胀满疼痛，月经不调，经闭痛经。
党参：药味甘，性平。归脾、肺经。补中，益气，生津。治脾胃虚弱，气血两亏，体倦无力，食少，口渴，久泻，脱肛。
生白术：药味苦，甘，性温。归脾、胃经。健脾益气，燥湿利水，止汗，安胎。用于脾虚食少，腹胀泄泻，痰饮眩悸，水肿，自汗，胎动不安。土白术健脾，和胃，安胎。用于脾虚食少，泄泻便溏，胎动不安。
黄芪：药性温，味甘。补气固表，托毒排脓，利尿，生肌。用于气虚乏力、久泻脱肛、自汗、水肿、子官脱垂、慢性肾炎蛋白尿、糖尿病、疮口久不愈合。
木香：药味辛、苦；性温。归脾；大肠、三焦经。行气，止痛，健脾，消食。主治：行气止痛；调中导滞。主胞胁胀满足；脘腹胀痛；嗳吐泄泻；痢疾后重。用于胸脘胀痛、泻痢后重、食积不消、不思饮食，中气不省；突发耳聋；蛇虫咬伤；牙痛。
熟地黄：药味甘，性微温。入肝、肾经。滋阴，补血。治阴虚血少，腰膝痿弱，劳嗽骨蒸，遗精，崩漏，月经不调，消渴，溲数，耳聋，目昏。
桑寄生：药味苦甘，性平。入肝、肾经。补肝肾，强筋骨，除风湿，通经络，益血，安胎。治腰膝酸痛，筋骨痿弱，偏枯，脚气，风寒湿痹，胎漏血崩，产后乳汁不下。治久咳，舌纵、眩晕。
吴茱萸：药味辛、苦，性热。归肝、脾、胃、肾经。有散寒止痛，降逆止呕，助阳止泻的功效。用于厥阴头痛，寒疝腹痛，寒湿脚气，经行腹痛，脘腹胀痛，呕吐吞酸，五更泄泻。
肉桂：药味辛、甘，性大热。归肾、脾、心、肝经。有补火助阳，引火归元，散寒止痛，温通经脉的功效。用于阳痿宫冷，腰膝冷痛，肾虚作喘，虚阳上浮，眩晕目赤，心腹冷痛，虚寒吐泻，寒疝腹痛，痛经经闭。
本发明中药制剂的制备方法的具体实施例：取上述原料药洗净去杂，晾干，粉碎成颗粒，加水浸泡1小时，置多功能提取罐中加水煎煮二次，第一次加总药材10倍量的水，煎煮1.5～2小时，取煎液，滤过。第二次加总药材7倍量的水，煎煮1～1.2小时，取两次煎液，滤过，热封闭袋中，105℃高温灭菌，包装即得。本发明制成的治疗不孕症的汤剂为塑料封装袋，每袋280ml。口服，一次一袋，每日2～3次，一个月为一个疗程。
在其他实施例中：煎煮所用的器皿可替换为现有技术中常用的煎煮容器；灭菌过程的温度可适当提高。
实验验证：
按下述重量称取原料药：当归2份、川芎3份、路路通2份、白芍2份、皂角刺2份、香附2份、党参3份、生白术2份、黄芪3份、木香1份、熟地黄2份、桑寄生3份、吴茱萸1份、肉桂0.5份。
按下述方法制备汤剂：取上述原料药洗净去杂，晾干，粉碎成颗粒，加水浸泡1小时，置多功能提取罐中加水煎煮二次，第一次加总药材10倍量的水，煎煮1.5～2小时，取煎液，滤过。第二次加总药材7倍量的水，煎煮1～1.2小时，取两次煎液，滤过，热封闭袋中，105℃高温灭菌，包装即得。本发明制成的治疗不孕症的汤剂为塑料封装袋，每袋280ml。口服，一次一袋，每日2～3次，一个月为一个疗程。
临床实验验证周期：2年
临床验证疗效结果如下：依照本发明药物加减，治疗不孕症患者83例。服用试例汤剂，每次1袋，一日2～3次，饭前半小时服用，一个月为一个疗程，连续服用三个疗程观察疗效，治愈55例，占66.26%，好转24例，占28.91%，未愈4例占4.81%，总有效率达95.18%。经三个疗程治疗后，病人无任何不良反应，三大常规化验及肝肾功能检测未发现异常。
疗效评价
治愈：2年内受孕者。
好转：虽未受孕,但与本病有关的症状、体征及实验室检查有改善。
未愈：症状、体征及实验室检查均无改善。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (7)
1.一种治疗不孕症的中药制剂，其特征在于，中药制剂是由下列重量份的原料药制成：当归1～3份、川芎1～4份、路路通1～3份、白芍1～3份、皂角刺1～3份、香附1～3份、党参1～3份、生白术1～3份、黄芪1～4份、木香0.5～2份、熟地黄1～3份、桑寄生1～4份、吴茱萸0.5～2份、肉桂0.5～2份。
2.根据权利要求1所述的治疗不孕症的中药制剂，其特征在于，中药制剂是由下列重量份的原料药制成：当归1.5～2.5份、川芎1.5～2.5份、路路通1.5～2.5份、白芍1.5～2.5份、皂角刺1.5～2.5份、香附1.5～2.5份、党参1.5～2.5份、生白术1.5～2.5份、黄芪1.5～3.5份、木香1.0～1.5份、熟地黄1.5～2.5份、桑寄生1.5～3份、吴茱萸1～1.5份、肉桂1～1.5份。
3.根据权利要求2所述的治疗不孕症的中药制剂，其特征在于，中药制剂是由下列重量份的原料药制成：当归2份、川芎3份、路路通2份、白芍2份、皂角刺2份、香附2份、党参3份、生白术2份、黄芪3份、木香1份、熟地黄2份、桑寄生3份、吴茱萸1份、肉桂0.5份。
4.一种如权利要求1所述的治疗不孕症的中药制剂的制备方法，其特征在于，顺序采用如下步骤：将中药制剂的原料药洗净去杂，晾干，粉碎成颗粒，加水浸泡1小时，加水煎煮两次，取两次煎液，滤过，热风封闭带中，高温灭菌，包装即可。
5.根据权利要求4所述的中药制剂的制备方法，其特征在于，两次煎煮的第一次加总药材10倍量的水，煎煮1.5～2小时，取煎液，滤过；第二次加总药材7倍量的水，煎煮1～1.2小时，取煎液，滤过。
6.根据权利要求4或5所述的中药制剂的制备方法，其特征在于，灭菌过程在105℃条件下进行。
7.根据权利要求4或5所述的中药制剂的制备方法，其特征在于，煎煮时放入多功能提取罐中进行。
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