CN104398913A - 一种治疗痛经的药物及其制备方法 - Google Patents

一种治疗痛经的药物及其制备方法 Download PDF

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CN104398913A
CN104398913A CN201410703954.9A CN201410703954A CN104398913A CN 104398913 A CN104398913 A CN 104398913A CN 201410703954 A CN201410703954 A CN 201410703954A CN 104398913 A CN104398913 A CN 104398913A
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顾蔷怡
高春娟
冷盛君
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顾蔷怡
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Abstract

一种治疗痛经的药物及其制备方法,它是由当归、赤白芍、川断、黄柏、薏苡仁、泽兰、泽泻、牛膝、玄胡素、乌药、桂皮、益母草、党参、陈皮、黄芪按照一定比例配伍而成。本发明中药组合物能够通经脉,活血祛瘀,调经消水,补中益气,健脾益肺,养血生津,活血通经,润燥滑肠,除血痹,破坚积,益气止痛,增强机体免疫力,加速血循环,升高血压及发汗,扩张血管,血循环加速,缓和肌肉痉挛性疼痛,降低子宫内膜前列腺素含量成效显著,对治疗和缓解经期疼痛具有较好的疗效,且无毒副作用。

Description

一种治疗痛经的药物及其制备方法
技术领域
[0001] 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 一种治疗痛经的药物及其制备方法。
背景技术
[0002] 痛经为最常见的妇科症状之一,指行经前后或月经期出现下腹部疼痛、坠胀,伴有 腰酸、腰痛或其他不适,症状严重影响生活质量者。痛经分为原发性痛经和继发性两类, 原发性痛经指生殖器官无器质性病变的痛经,占痛经90%以上;继发性痛经指由盆腔器质 性疾病引起的痛经。原发性痛经的发生主要与月经时子宫内膜前列腺素含量增高有关。 PGF2ci含量升高时造成痛经的主要原因。PGF2ci含量高可引起子宫平滑肌过强收缩,血管 痉挛,造成子宫缺血、乏氧状态而出现痛经。西医治疗痛经,主要是让女性患者服用前列腺 素合成酶抑制剂如布洛芬、酮洛芬、甲氯芬那酸、双氯芬酸,或者避孕药等,这些药物虽然对 缓解痛经具有一定疗效,但只能短暂缓解痛经,但不能治本。毒副作用很大。
发明内容
[0003] 本发明从临床医疗用药需求及中医组方辩证原则出发,提出一种主治原发性痛经 的药物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂:当归6_14g、赤 白巧6_14g、川断6_14g、黄柏6_14g、薏该仁10_20g、泽兰6_14g、泽泻6_14g、牛膝6_14g、玄 胡素6-14g、乌药3-10g、桂皮3-9g、益母草10-20g、党参10-20g、陈皮3-10g、黄芪15-25g。 优选配比为:当归l〇g、赤白巧l〇g、川断l〇g、黄柏l〇g、薏该仁15g、泽兰10g、泽泻10g、牛 膝l〇g、玄胡素l〇g、乌药6g、桂皮5g、益母草15g、党参15g、陈皮6g、黄苗20g。所述药剂为 汤剂、胶囊剂、片剂或丸剂。
[0004] 所述胶囊剂、片剂、丸剂的制备方法步骤如下: (1) 取方中当归、赤白芍、川断、黄柏、薏苡仁、泽兰、泽泻、牛膝、玄胡素、乌药、桂皮、益 母草、党参、陈皮、黄芪粉碎筛析; (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。
[0005] 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。
[0006] 本发明药物原料药的药理如下: 当归:具有补血,活血,调经止痛,润燥滑肠功效。主血虚诸证,月经不调,经闭,痛经,症 瘕结聚,崩漏,虚寒腹痛,痿痹,肌肤麻木,肠燥便难,赤痢后重,痈疽疮疡,跌扑损伤; 赤白芍:主治邪气腹痛,除血痹,破坚积,寒热,病疲,止痛,利小便,益气; 川断:补肝,强筋骨,定经络,止经中(筋骨)酸痛,安胎,适合用于治妇人白带,生新血, 破瘀血,落死胎,止咳嗽咳血,治赤白便浊。
[0007] 黄柏:具有清热,燥湿,泻火,解毒功效,治热痢,泄泻,消渴,黄疸,痿甓,梦遗,淋 浊,痔疮,便血,赤白带下,骨蒸劳热,目赤肿痛,口舌生疮,疮疡肿毒; 薏苡仁:有健脾渗湿,除痹止泻功效,用于水肿、脚气、小便不利、湿痹拘挛、脾虚泄泻; 泽兰:[性味、归经]辛,微温,入肝、膀胱经,具有活血祛瘀,利尿退肿功效,用于血滞 经闭、症癜、产后瘀痛,水肿,跌打损伤 泽泻:性味:甘,寒;归经:入肾、膀胱经;功效:具有利水,渗湿,泄热功效,治小便不 利,水肿胀满,呕吐,泻痢,痰饮,脚气,淋病,尿血; 牛膝:归经:入肝、肾经;具有活血通经功效,治产后腹痛,月经不调; 玄胡素:主治:尿血、皮下气痛或气块痛,久患心痛,身热足寒,腰体痛,偏、正头风,咳 嗽; 乌药:现代医学证实,具有挥发油的兴奋作用:能兴奋大脑皮质,促进呼吸,兴奋心肌, 加速血循环,升高血压及发汗,扩张血管,血循环加速,缓和肌肉痉挛性疼痛;具有抑菌作 用:对金黄色葡萄球菌,甲型溶血性链球菌,伤寒杆菌,变形杆菌,绿脓杆菌,大肠杆菌均有 抑制作用;对消化道的影响:对胃肠平滑肌有双重作用,能增加消化液的分泌;止血作用: 能明显缩短血浆再钙化时间,促进血凝及良好的止血作用; 桂皮:益肝肾,通经脉,散风寒,除湿痹,暖腰膝,止呕吐。治筋骨疼痛,寒泄腹痛,霍乱呕 吐,噎膈胸满,膀胱寒疝,腰膝现冷,风湿痹痛及跌损瘀滞等症; 益母草:主治活血,祛瘀,调经,消水。治月经不调,胎漏难产,胞衣不下,产后血晕,瘀血 腹痛,崩中漏下,尿血,泻血,痈肿疮疡。[6]祛瘀生新,又可用于跌打损伤,对女性湿热盆腔 炎症有一定疗效; 党参:党参味甘,性平。有补中益气、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; 陈皮:主治理气健脾,燥湿化痰,用于胸脘胀满,食少吐泻,咳嗽痰多; 黄芪:性味:甘,微温。归经:归肺、脾、肝、肾经。有增强机体免疫功能、保肝、利尿、抗衰 老、抗应激、降压和较广泛的抗菌作用;功能主治:用于表虚自汗、急慢性肾炎水肿、阳气虚 弱、疮瘍溃破、肺气虚证、气虚衰弱;肺气虚证:咳喘日久,气短神疲,痰雍于肺无力咯出。温 肺定喘,健肺气之品。脾生痰,肺储痰,所以健太阴以祛痰,黄芪补气所以尤善治气虚。气虚 衰弱:倦怠乏力,或中气下陷、脱肛、子宫脱垂。表虚自汗:多用于体虚表弱所致的自汗。
[0008] 中医学认为痛经多有情志所伤、起居不慎或六淫为害等不同病因,并与素体及经 期、经期前后特殊的生理环境有关。其病机主要是在此期间受到致病因素的影响,导致冲任 瘀阻或寒凝经脉,使气血运行不畅,胞宫经血流通受碍,以致"不通则痛":或冲任、胞宫失于 濡养,不荣而痛.其病位在冲任、胞宫,变化在气血,表现为痛怔。其所以随月经周期发作, 是与经期冲任气血变化有关。
[0009] 因此,本发明以黄芪为君药,增强机体免疫力,保肝,利尿,抗菌,治阳气虚弱、肺气 虚证。以益母草、党参、薏苡仁为臣药,活血祛瘀,调经消水,补中益气,止渴,健脾益肺,养血 生津,健脾渗湿,除痹止泻。以当归、赤白芍、川断、黄柏、泽兰、泽泻、牛膝、玄胡素为佐药,补 血活血,调经止痛,润燥滑肠,除血痹,破坚积,益气止痛,利小便,治白带、赤白便浊,生新 血,破瘀血,清热解毒,燥湿泻火,消渴,治赤白带下、便血,利尿退肿,渗湿泄热,活血通经, 治腹痛,月经不调,身热足寒,腰体痛。使以乌药、陈皮、桂皮,抑菌止血,加速血循环,升高血 压及发汗,扩张血管,血循环加速,缓和肌肉痉挛性疼痛,理气健脾,燥湿化痰,通经脉,散风 寒,除湿痹,暖腰膝。本发明所述的药物承中医之精髓、严谨组方,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。
[0010] 有益效果 本发明中药组合物能够通经脉,活血祛瘀,调经消水,补中益气,健脾益肺,养血生津, 活血通经,润燥滑肠,除血痹,破坚积,益气止痛,增强机体免疫力,加速血循环,升高血压及 发汗,扩张血管,血循环加速,缓和肌肉痉挛性疼痛,降低子宫内膜前列腺素含量成效显著, 对治疗和缓解经期疼痛具有较好的疗效,且无毒副作用。 临床试验: 1、病例选择: 女性痛经固定周期在5天以上患者58例。
[0011] 2、诊断标准 疼痛呈痉挛性,位于下腹部耻骨上,可放射至腰骶部和大腿内侧,伴有恶心、呕吐、腹 泻、头晕、乏力等症状,严重时面色发白、出冷汗,妇科检查无其它异常发现。
[0012] 3、治疗方案 实施例2所制胶囊,早中晚饭后半小时各一次,每次4粒,每粒0. 3g,2天为一个疗程,2 个疗程后观察统计。
[0013] 4、疗效评价标准 显效:痛经周期缩短,且疼痛感减缓或消失; 有效:疼痛感减缓或消失,痛经周期无明显变化; 无效:痛经周期、疼痛感无明显变化; 总有效率=显效率+有效率。
[0014] 5、数据统计 6、结论
Figure CN104398913AD00051
根据诊断标准和疗效评价标准,按照治疗方案治疗58例痛经固定周期在5天以上的女 性患者,痛经周期明显缩短,且疼痛感减缓或消失的显效病例53例,显效率达到91. 38% ;有 效5例,总有效率达到100%。
[0015] 药效学试验: 本发明药物治疗缩宫素所致雌性大鼠痛经模拟试验:选择雌性大鼠30只,分为对照 组、治疗组各15只,对照组和治疗组均注射己烯雌酚,每日1次,连续5天。治疗组注射己烯 雌酚后的第二天灌胃本发明药物,每天一次,连续4天,记录两组雌性大鼠扭体的次数。发 现治疗组雌性大鼠的扭体次数明显少于对照组,且扭体周期明显短于对照组。
[0016] 子宫内膜前列腺素含量检测:第3天开始,用大鼠前列腺素F2a(PGF2CI)ELISA 检测试剂盒检查对照组合治疗组,利用双抗体夹心法,检测血浆中对应PGF2α标本的平均 含量,治疗组PGF2CI平均含量明显低于对照组。本发明药物对能够有效降低子宫内膜前列 腺素含量(PGF2α指标含量),加强在体大鼠子宫平滑肌的抑制,明显减弱子宫收缩,降低疼 痛,缩短周期。
[0017] 急毒性试验:较大剂量和较长疗程服用对大鼠的生长无显著毒性,对大鼠的脑、 心、肝、肾等切片形态学检查未见明显毒性损伤改变,试验显示,本药物毒性甚小。
具体实施方式
[0018] 实施例1 : 一种治疗痛经的药物及其制备方法。它是由以下重量份数配比的原料 药制备而成的药剂:当归6-14g、赤白巧6-14g、川断6-14g、黄柏6-14g、薏该仁10-20g、泽 兰6-14g、泽泻6-14g、牛膝6-14g、玄胡素6-14g、乌药3-10g、桂皮3-9g、益母草10-20g、党 参10-20g、陈皮3-10g、黄芪15-25g。所述药剂为胶囊剂、片剂或丸剂。
[0019] 按照下述重量份数配比称取原料药: 当归6-14g、赤白芍6-14g、川断6-14g、黄柏6-14g、薏苡仁10-20g、泽兰6-14g、泽泻 6-14g、牛膝6-14g、玄胡素6-14g、乌药3-10g、桂皮3-9g、益母草10-20g、党参10-20g、陈皮 3_10g、黄苗 15_25g。
[0020] 所述胶囊剂、片剂、丸剂的制备方法步骤如下: (1) 取方中当归、赤白芍、川断、黄柏、薏苡仁、泽兰、泽泻、牛膝、玄胡素、乌药、桂皮、益 母草、党参、陈皮、黄芪粉碎筛析; (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。
[0021] 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。
[0022] 实施例2 :-种治疗痛经的药物及其制备方法。它是由以下重量份数配比的原料 药制备而成的药剂:当归l〇g、赤白巧l〇g、川断l〇g、黄柏l〇g、薏该仁15g、泽兰10g、泽泻 l〇g、牛膝l〇g、玄胡素l〇g、乌药6g、桂皮5g、益母草15g、党参15g、陈皮6g、黄苗20g。所述 药剂为胶囊剂、片剂或丸剂。
[0023] 按照下述重量份数配比称取原料药: 当归10g、赤白巧10g、川断10g、黄柏10g、薏该仁15g、泽兰10g、泽泻10g、牛膝10g、玄 胡素l〇g、乌药6g、桂皮5g、益母草15g、党参15g、陈皮6g、黄苗20g。
[0024] 所述胶囊剂、片剂、丸剂的制备方法步骤如下: (1)取方中当归、赤白芍、川断、黄柏、薏苡仁、泽兰、泽泻、牛膝、玄胡素、乌药、桂皮、益 母草、党参、陈皮、黄芪粉碎筛析; (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。
[0025] 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。
[0026] 实施例3 :本发明药物还可以为汤剂、口服液、颗粒剂等。

Claims (5)

1. 一种治疗痛经的药物,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:当归6-14g、赤白芍6-14g、川断6-14g、黄柏6-14g、薏苡仁10-20g、泽兰6-14g、泽泻 6-14g、牛膝6-14g、玄胡素6-14g、乌药3-10g、桂皮3-9g、益母草10-20g、党参10-20g、陈皮 3_10g、黄苗 15_25g。
2. 根据权利要求1所述的治疗痛经的药物,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:当归l〇g、赤白巧l〇g、川断l〇g、黄柏l〇g、薏该仁15g、泽兰10g、泽泻 l〇g、牛膝l〇g、玄胡素l〇g、乌药6g、桂皮5g、益母草15g、党参15g、陈皮6g、黄苗20g。
3. 根据权利要求1或2所述的治疗痛经的药物,其特征在于:所述药剂为汤剂、胶囊 齐U、片剂或丸剂。
4. 根据权利要求3所述的治疗痛经的药物,其特征在于:所述胶囊剂、片剂、丸剂的制 备方法步骤如下: (1) 取方中当归、赤白芍、川断、黄柏、薏苡仁、泽兰、泽泻、牛膝、玄胡素、乌药、桂皮、益 母草、党参、陈皮、黄芪粉碎筛析; (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所述的治疗痛经的药物的制备方法,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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