CN112007121B - 治疗绝经综合征的口服冲剂及其制备工艺 - Google Patents
治疗绝经综合征的口服冲剂及其制备工艺 Download PDFInfo
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Abstract
本发明公开了一种治疗绝经综合征的口服冲剂及其制备工艺,本发明的治疗绝经综合征的口服冲剂,主要由桃仁、酸枣仁、玫瑰花、黑芝麻、桑葚等十一味中药按照一定配比和生产工艺制备制成。其特点是全部采用药食同源原料制成,药性温和、疗效显著、毒副作用极低,适合作为预防性药物和营养型保健类药物长期服用。通过本发明的制备工艺生产的治疗绝经综合征的口服冲剂,口感好、质量稳定,非常适合患有绝经综合征的人群长期服用。
Description
技术领域
本发明涉及医药技术领域,具体涉及一种治疗绝经综合征的口服冲剂及其制备工艺。
背景技术
围绝经期综合征又称更年期综合征(MPS)或简称绝经综合征,指妇女绝经前后出现性激素波动或减少所致的一系列以自主神经系统功能紊乱为主,伴有神经心理症状的一组症候群。围绝经期综合征中最典型的症状是潮热、潮红。多发生于45~55岁,大多数妇女可出现轻重不等的症状,有人在绝经过渡期症状已开始出现,持续到绝经后2~3年,少数人可持续到绝经后5~10年症状才有所减轻或消失。人工绝经者往往在手术后2周即可出现围绝经期综合征,术后2个月达高峰,可持续2年之久。因此,围绝经期综合征是一种周期很长,女性都会经历的疾病。
由于性激素含量的减少导致的围绝经期综合征的表现有:植物神经功能紊乱、生殖系统萎缩等,还可能出现一系列生理和心理方面的变化,如焦虑、抑郁和睡眠障碍等。西医可采用激素替代疗法(HRT)来治疗女性围绝经期综合征,然而激素替代疗法(HRT)通常包括单用雌激素疗法和雌激素、孕激素联合疗法,虽然二者的疗效肯定,但是由于存在适应症和禁忌症,甚至有诱发子宫内膜癌与乳腺癌的潜在危险,有研究表明雌激素疗法不是治疗女性绝经轻中度抑郁的有效方法。
中医认为,女性围绝经期综合征多以肾阴虚立论,认为本病的主要发病机制有以下几种:第一,女性年届“七七四十九”,肾气渐衰,天癸枯竭,冲、任二脉虚衰,精血不足,结果导致阴阳失衡;第二,乙癸同源,肾精不足可引起肝失所养,疏泄失常,肝郁气滞;第三,肾阴亏损,阳不潜藏,脉失于濡养,脏腑气血不相协调,因此常常出现忧虑、闷闷不乐、欲哭寡言,记忆力减退,注意力不集中,夜间多梦,或者极易烦躁,或者易多疑多虑,甚至喜怒无常等症状。其中,多数中医认为“肝肾阴虚、肝郁气滞”是女性围绝经期综合征的主要致病机制。
专利号为ZL021097402的中国发明专利公开了一种治疗更年期综合症的药物,其由黄连、肉桂、益智仁、枸杞子、山茱萸、女贞子、菟丝子、生地黄、石菖蒲、远志、酸枣仁、陈皮、泽泻配比制成药剂,其虽然具备治疗更年期综合征的药效,然而其药剂含有很多非药食同源类的药物,使得该药方的药性猛烈,只适合发病的更年期综合征患者短时间服用,不适宜处于更年期的群体预防性的服用或者长期服用。然而由于围绝经期综合征周期长,病症容易反复,所以急需研制一种药性温和的药物,该药物应适宜处于围绝经期的人群长期服用以预防围绝经期综合征的产生,或者用于治疗以发病的围绝经期综合征患者。
发明内容
有鉴于此,本发明的目的之一是提供一种治疗绝经综合征的口服冲剂,其解决了现有药物药性猛烈,不适合长期服用,以及不能作为提前预防绝经综合征发病药物来服用的问题。
为了实现上述目的,本发明采用的技术方案是:
一种治疗绝经综合征的口服冲剂,由以下重量配比的原料制成:桃仁40-60份、酸枣仁30-50份、玫瑰花40-60份、黑芝麻40-60份、桑葚50-70份、益智仁40-60份、紫苏40-60份、桑叶40-60份、百合20-40份、人参提取物15-21份、鱼腥草30-40份。
进一步,由以下重量配比的原料制成:桃仁45-55份、酸枣仁35-45份、玫瑰花45-55份、黑芝麻45-55份、桑葚55-65份、益智仁45-55份、紫苏35-55份、桑叶45-55份、百合25-35份、人参提取物15-21份、鱼腥草35-37份。
桃仁、酸枣仁、玫瑰花、黑芝麻、桑葚、益智仁、紫苏、桑叶、百合、人参、鱼腥草皆为卫生部发布的药食同源原料,这其中原料分别具备以下功效:
桃仁的功效:桃仁性甘平、味苦,入肺、肝、大肠经;有破血行瘀,润燥滑肠的功效;治经闭、痛经、瘕瘕痞块,跌打损伤、肠燥便秘。桃仁在本方中主要解决绝经综合征中肝郁气滞、脏腑气血不相协调的问题。肝气疏通从而解决烦躁、忧虑等问题。
酸枣仁的功效:具有养心补肝,宁心安神,敛汗,生津之功效。对于虚烦不眠,惊悸多梦,体虚多汗等症状有显着疗效,因此酸枣仁的可以显著缓解绝经综合征中的忧虑抑郁,易激动,失眠,烦躁,注意力不集中,健忘等精神神经症状。
鱼腥草的功效:性寒味辛,具有清热解毒和利尿通淋等功效,可治疗治热淋、白浊、白带,治妇女外阴瘙痒,肛痈;鱼腥草是一种天然的抗生素,其对于多种微生物具有抑制作用,如溶血性链球菌、金黄色葡萄球菌、流感杆菌以及肺炎球菌等等。鱼腥草在本方中主要起到以下两种作用:作用1)用于完全解除桃仁的残余毒性,鲜桃仁中含有苦杏仁甙,是一种有毒物质。它被人吃入胃里后,自身苦杏仁酶和胃酸的作用下,会水解释放出一种更加剧毒的氢氰酸。氢氰酸进入人体后,能抑制人体内几十种酶的活性,阻止呼吸递送氧,使组织细胞窒息,从而使人严重缺氧而死亡。虽然本方中桃仁经过加工炮制,但是考虑到作为一种长期服用的中药,所以用鱼腥草作为佐药,来解除人体使用桃仁后的残留毒性。鱼腥草全草含月桂醛,甲基壬酮,蕺菜碱,叶含槲皮甙及钾盐,甲基壬酮可部分与氢氰酸反应从而解除氢氰酸毒性。作用2)绝经综合征的临床表现包括:月经紊乱,外阴及阴道萎缩,易发生老年性阴道炎、子宫及阴道脱垂、泌尿生殖系统的器质性病变等,鱼腥草的利尿消炎作用,可以对上述症状起到很好的治疗作用。
玫瑰花的功效:性温味甘,有理气解郁、和血调经等功效,临床上可以用于女性月经不调。玫瑰花的疏肝解郁功效,可以调理血气,帮助缓解绝经综合征时的烦躁不良情绪。然而玫瑰花还具有收敛特性,会减缓肠道蠕动,所以便秘人群要忌喝。桃仁具有治疗肠燥便秘的功效,本方中通过桃仁与玫瑰花的配伍,不但加强了本方疏肝解郁的功效,同时通过桃仁对玫瑰花副作用的克制,解决了因长期单独服用玫瑰花导致的便秘问题。
黑芝麻的功效:黑芝麻味甘,性平,有滋补肝肾,益血润肠,通便,通乳的功能。黑芝麻的补肝肾功能,解决了绝经综合征中肝肾阴虚、肝郁气滞的问题,黑芝麻可作为臣药与桃仁、酸枣仁配伍,从而加强方剂的疏通肝肾、补肝肾的功能。
桑葚的功效:桑葚入药,始载于唐朝的《唐本草》。中医认为,桑葚味甘性寒,人心肝、肾经,有滋阴补血作用,并能治阴虚津少、失眠等。现代医学临床证明:桑葚有很好的滋补心、肝、肾,及养血祛风的功效,对降脂和减轻神经衰弱、动脉硬化、性功能衰弱、耳聋眼花、须发早白、内热消渴、血虚便秘、风湿关节疼痛均有显著疗效。桑葚中微量元素钼的含量4.6μg/kg,为百果之首,人体各种组织都含钼,肝、肾中含量最高,而绝经综合征的主要症状为“肝肾阴虚、肝郁气滞”,所以桑葚可以显著补充肝、肾中的钼含量,使肝、肾中钼含量维持正常水平,从而解决“肝肾阴虚、肝郁气滞”的症状。
益智仁的功效:又名益智子,有补肾防衰的作用,主治温脾止泻,摄唾涎,暖肾,固精缩尿。益智仁在本方中入肾经。
紫苏的功效:又称桂荏、白苏、赤苏等,具备降低血脂、预防心脑血管疾病、提高记忆力、抗氧化、抗抑郁等功效。
桑叶的功效:具有补肝、清肝明目、治疗头晕眼花、失眠、消除眼部疲劳等功效。桑叶在本方中主要起到补肝和治疗失眠的作用。另外,桑叶中含有槲皮素,槲皮素可以与铝离子形成络合物,抑制老年人对铝离子的吸收,从而避免绝经患者出现记忆力减退或老年痴呆的问题。
百合的功效:具有养阴润肺;清心安神的功效。治疗情志不遂所致的虚烦惊悸、失眠多梦、精神恍惚。百合具有明显的镇静作用,可以延长人的睡眠时间。
人参提取物的功效:人参提取物是从五加科植物人参的根、茎叶中提取精制而成,其富含十八种人参单体皂甙,易溶解于乙醇。主要适用于冠心病、心绞痛、心率过缓、过快、室性早博、血压失调、神经衰弱、绝经综合征、疲劳过度、病后、产后、术后身体虚弱等症状;久服可以延年益寿,并能增强体力,治疗癌症患者因放疗和化疗引起的免疫功能低下等症。
本发明的目的之二是提供一种治疗绝经综合征的口服冲剂的制备工艺,通过该制备工艺生产的治疗绝经综合征的口服冲剂毒副作用更低、质量更加稳定,使得口服冲剂可长期食用。
本发明治疗绝经综合征的口服冲剂的制备工艺,包括以下步骤:
S1)前处理A:取相应重量分数的桃仁、酸枣仁、玫瑰花、黑芝麻、桑葚、益智仁、紫苏、桑叶、百合、鱼腥草放置在物料缓冲间,然后开启紫外灯,照射30分钟以后方可将物料送至洁净车间;
S2)前处理B:
桃仁、酸枣仁脱毒:将桃仁、酸枣仁经沸水煮至外皮微皱,然后再捞出浸入冷水中,搓去种皮,捞出晒干,将晒干的桃仁、酸枣仁与益智仁、黑芝麻混合后共同放入炒锅中采用清炒法炒至略有焦香气,将上述物料取出后转至干燥室内60℃干燥4h,然后放凉;
桑葚处理:将桑葚用水清洗,再放入玉米淀粉,用凉水浸泡,几分钟后捞出洗净,然后将桑葚烘干,使桑葚的含水量低于10%;
取相应重量分数的玫瑰花、紫苏、桑叶、百合、鱼腥草置入干燥室内60℃干燥4h,然后放凉;
S3)粉碎:将经过前处理B处理过的桃仁、酸枣仁、益智仁、黑芝麻、桑葚、玫瑰花、紫苏、桑叶、百合、鱼腥草置于粉碎机内粉碎;
S4)过筛:步骤3中的粉碎颗粒进行过筛,粉碎的细度达到160-170微米,即全部能通过药典五号筛,并含能通过药典六号筛不少于95%,得药粉备用;
S5)制软材:取相应重量分数的人参提取物溶于70%的乙醇溶液中,将上述溶入人参提取物的乙醇溶液喷洒至步骤4中制备的药粉,药粉与乙醇溶液的重量比为1:0.6-0.9,并加以搅拌均匀,制成软材;
S6)制粒:将上述软材用机械挤压法通过药典一号筛,制得湿颗粒;
S7)干燥:将制得的湿颗粒放入烘箱内,46℃干燥5-6h;
S8)整粒:干颗粒过药典一号筛整粒,再过药典四号筛筛去细粉;
S9)分剂量、包装:将步骤8中获得的整粒使用固定分量包装机进行包装成袋。
进一步,步骤9中整粒包装成袋后每袋净含量不超过19g。
进一步,步骤5中药粉与乙醇溶液的重量比为1:0.8。
进一步,步骤2中所述益智仁在清炒之前还需做如下处理:将所述益智仁去壳后,用盐水拌匀,静置5-10分钟,沥去盐水,然后烘干。盐炙后可缓和辛燥之性,主入肾经,增强补肾缩尿涩精的作用。
本发明的有益效果:
1)本发明的治疗绝经综合征的口服冲剂,其全部采用药食同源的药物,不但使得治疗绝经综合征的效果显著,而且具备很高的营养价值。另外,本发明的口服冲剂药性温和,口感好,可以长期服用,或者作用预防性药物服用。
2)本发明的治疗绝经综合征的口服冲剂,其用鱼腥草作为佐药,来解除人体服用桃仁可能产生的毒性,从而使本发明的口服冲剂得以长期服用。
3)本发明的治疗绝经综合征的口服冲剂,通过桃仁与玫瑰花的配伍,不但加强了本方疏肝解郁的功效,同时通过桃仁对玫瑰花副作用的克制,解决了因长期单独服用玫瑰花导致的便秘问题。
4)本发明的治疗绝经综合征的口服冲剂,由于其中黑芝麻具备益血润肠,通便的功效,所以黑芝麻既可作为臣药与桃仁、酸枣仁配伍,从而加强方剂的疏通肝肾、补肝肾的功能,又可以作为佐药与玫瑰花配伍,缓解因长期服用玫瑰花导致的便秘问题,使得本方剂可以长期服用无副作用。
5)通过本发明的制备工艺生产的治疗绝经综合征的口服冲剂,其毒副作用极低、质量更加稳定,非常适合处于绝经的人群长期服用。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚,下面将结合具体实施例对本发明作进一步地详细描述。
实施例1治疗绝经综合征的口服冲剂
本实施例中的口服冲剂,由以下原料制成:桃仁40g、酸枣仁30g、玫瑰花40g、黑芝麻40g、桑葚50g、益智仁40g、紫苏40g、桑叶40g、百合20g、人参提取物15g、鱼腥草30g。
实施例2治疗绝经综合征的口服冲剂
本实施例中的口服冲剂,由以下原料制成:桃仁60g、酸枣仁50g、玫瑰花60g、黑芝麻60g、桑葚70g、益智仁50g、紫苏50g、桑叶40g、百合20g、人参提取物15g、鱼腥草30g。
实施例3治疗绝经综合征的口服冲剂
本实施例中的口服冲剂,由以下原料制成:桃仁45g、酸枣仁35g、玫瑰花45g、黑芝麻45g、桑葚55g、益智仁55g、紫苏55g、桑叶55g、百合35g、人参提取物21g、鱼腥草37g。
实施例4治疗绝经综合征的口服冲剂
本实施例中的口服冲剂,由以下原料制成:桃仁55g、酸枣仁45g、玫瑰花55g、黑芝麻55g、桑葚65g、益智仁45g、紫苏35g、桑叶45g、百合25g、人参提取物15g、鱼腥草35g。
实施例5治疗绝经综合征的口服冲剂的制备工艺
本实施例中的制备工艺,包括以下步骤:
S1)前处理A:取相应重量分数的桃仁、酸枣仁、玫瑰花、黑芝麻、桑葚、益智仁、紫苏、桑叶、百合、鱼腥草放置在物料缓冲间,然后开启紫外灯,照射30分钟以后方可将物料送至洁净车间;
S2)前处理B:
桃仁、酸枣仁脱毒:将桃仁、酸枣仁经沸水煮至外皮微皱,然后再捞出浸入冷水中,搓去种皮,捞出晒干,将晒干的桃仁、酸枣仁与益智仁、黑芝麻混合后共同放入炒锅中采用清炒法炒至略有焦香气,将上述物料取出后转至干燥室内60℃干燥4h,然后放凉;所述益智仁在清炒之前还需做如下处理:将所述益智仁去壳后,用盐水拌匀,静置8分钟,沥去盐水,然后烘干。盐炙后可缓和益智仁辛燥之性,主入肾经,增强补肾缩尿涩精的作用。
桑葚处理:将桑葚用水清洗,再放入玉米淀粉,用凉水浸泡,几分钟后捞出洗净,然后将桑葚烘干,使桑葚的含水量低于10%;桑葚用淀粉浸泡可以脱毒去污。
取相应重量分数的玫瑰花、紫苏、桑叶、百合、鱼腥草置入干燥室内60℃干燥4h,然后放凉;本方中玫瑰花、紫苏、桑叶、百合、鱼腥草皆不经清炒法处理,因此,可以极大地保留药材中的挥发性成分,不但保持了药效,而且保留了药材自身的香味成分,使得制成的口服冲剂更加清香,口感更好。
S3)粉碎:将经过前处理B处理过的桃仁、酸枣仁、益智仁、黑芝麻、桑葚、玫瑰花、紫苏、桑叶、百合、鱼腥草置于粉碎机内粉碎;
S4)过筛:步骤3中的粉碎颗粒进行过筛,粉碎的细度达到160-170微米,即全部能通过药典五号筛,并含能通过药典六号筛不少于95%,得药粉备用;
S5)制软材:取相应重量分数的人参提取物溶于70%的乙醇溶液中,将上述溶入人参提取物的乙醇溶液喷洒至步骤4中制备的药粉,药粉与乙醇溶液的重量比为1:0.8,并加以搅拌均匀,制成软材;以上述方式向药材中添加提交人参提取物,可以最大限度地保持人参提取物的药效。
S6)制粒:将上述软材用机械挤压法通过药典一号筛,制得湿颗粒;
S7)干燥:将制得的湿颗粒放入烘箱内,46℃干燥5-6h;
S8)整粒:干颗粒过药典一号筛整粒,再过药典四号筛筛去细粉;
S9)分剂量、包装:将步骤8中获得的整粒使用固定分量包装机进行包装成袋,每袋净含量不超过19g。
上述说明是针对本发明较佳可行实施例的详细说明,实施例并非用以限定本发明的专利申请范围,凡本发明所提示的技术精神下所完成的同等变化或修饰变更,均应属于本发明所涵盖专利范围。
Claims (6)
1.一种治疗绝经综合征的口服冲剂,其特征在于,由以下重量配比的原料制成:桃仁40-60份、酸枣仁30-50份、玫瑰花40-60份、黑芝麻40-60份、桑葚50-70份、益智仁40-60份、紫苏40-60份、桑叶40-60份、百合20-40份、人参提取物15-21份、鱼腥草30-40份。
2.根据权利要求1所述的一种治疗绝经综合征的口服冲剂,其特征在于,由以下重量配比的原料制成:桃仁45-55份、酸枣仁35-45份、玫瑰花45-55份、黑芝麻45-55份、桑葚55-65份、益智仁45-55份、紫苏35-55份、桑叶45-55份、百合25-35份、人参提取物15-21份、鱼腥草35-37份。
3.一种如权利要求1或2中所述的治疗绝经综合征的口服冲剂的制备工艺,其特征在于,包括以下步骤:
S1)前处理A:取相应重量分数的桃仁、酸枣仁、玫瑰花、黑芝麻、桑葚、益智仁、紫苏、桑叶、百合、鱼腥草放置在物料缓冲间,然后开启紫外灯,照射30分钟以后方可将物料送至洁净车间;
S2)前处理B:
桃仁、酸枣仁脱毒:将桃仁、酸枣仁经沸水煮至外皮微皱,然后再捞出浸入冷水中,搓去种皮,捞出晒干,将晒干的桃仁、酸枣仁与益智仁、黑芝麻混合后共同放入炒锅中采用清炒法炒至略有焦香气,将上述物料取出后转至干燥室内60℃干燥4h,然后放凉;
桑葚处理:将桑葚用水清洗,再放入玉米淀粉,用凉水浸泡,几分钟后捞出洗净,然后将桑葚烘干,使桑葚的含水量低于10%;
取相应重量分数的玫瑰花、紫苏、桑叶、百合、鱼腥草置入干燥室内60℃干燥4h,然后放凉;
S3)粉碎:将经过前处理B处理过的桃仁、酸枣仁、益智仁、黑芝麻、桑葚、玫瑰花、紫苏、桑叶、百合、鱼腥草置于粉碎机内粉碎;
S4)过筛:S3) 中的粉碎颗粒进行过筛,粉碎的细度达到160-170微米,即全部能通过药典五号筛,并含能通过药典六号筛不少于95%,得药粉备用;
S5)制软材:取相应重量分数的人参提取物溶于70%的乙醇溶液中,将上述溶入人参提取物的乙醇溶液喷洒至S4) 中制备的药粉,药粉与乙醇溶液的重量比为1:0.6-0.9,并加以搅拌均匀,制成软材;
S6)制粒:将上述软材用机械挤压法通过药典一号筛,制得湿颗粒;
S7)干燥:将制得的湿颗粒放入烘箱内,46℃干燥5-6h;
S8)整粒:干颗粒过药典一号筛整粒,再过药典四号筛筛去细粉;
S9)分剂量、包装:将S8) 中获得的整粒使用固定分量包装机进行包装成袋。
4.根据权利要求3所述的制备工艺,其特征在于,S9) 中整粒包装成袋后每袋净含量不超过19g。
5.根据权利要求4所述的制备工艺,其特征在于,S5) 中药粉与乙醇溶液的重量比为1:0.8。
6.根据权利要求5所述的制备工艺,其特征在于,S2) 中所述益智仁在清炒之前还需做如下处理:将所述益智仁去壳后,用盐水拌匀,静置5-10分钟,沥去盐水,然后烘干。
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