CN105663752A - 一种维生素e软胶囊 - Google Patents
一种维生素e软胶囊 Download PDFInfo
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- CN105663752A CN105663752A CN201610170505.1A CN201610170505A CN105663752A CN 105663752 A CN105663752 A CN 105663752A CN 201610170505 A CN201610170505 A CN 201610170505A CN 105663752 A CN105663752 A CN 105663752A
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Abstract
本发明属于中药制剂领域，具体提供了一种维生素E软胶囊，它所含的活性成分由下列重量份原料药提取制备而成：维生素E2份、长青草20份、细叶马料梢25份、金刚散30份、竻苋菜28份、硬叶女娄菜20份、九子连环草20份、小槐花18份、甘草5份，再采用常规生产工艺，制成软胶囊，本发明促进排便。
Description
技术领域
本发明涉及保健品技术领域，具体涉及一种用于促进排便的维生素E软胶囊。
背景技术
便秘是临床常见的复杂症状，而不是一种疾病，主要是指排便次数减少、粪便量减少、粪便干结、排便费力等。上述症状同时存在2种以上时，可诊断为症状性便秘。通常以排便频率减少为主，一般每2～3天或更长时间排便一次(或每周<3次)即为便秘。对一组健康人调查结果表明，排便习惯多为每日1～2次或1～2日1次(60％)，粪便多为成型或软便；少数健康人的排便次数可达1日3次(30％)，或3天1次(10％)，粪便半成型或呈腊肠样硬便。因此必须结合粪便的性状、本人平时排便习惯和排便有无困难作出有无便秘的判断。如超过6个月即为慢性便秘。传统治疗便秘的方法，中医多采用“大承气汤”、大黄，番泻叶，硫酸镁等通泄大便，不日复发后仍干结；西医多采用“果导糖”通便，或用“开塞通”缓解，存在着治标不能治本，疗效不稳定，治愈率较低，一般为20％，易复发的缺陷。
发明内容
为了解决上述问题，本发明的目的在于提供一种维生素E软胶囊及其应用。
为了达到这个目的，采用如下技术方案：
技术方案：一种维生素E软胶囊，它所含的活性成分由下列重量份原料药提取制备而成：维生素E2份、长青草20份、细叶马料梢25份、金刚散30份、竻苋菜28份、硬叶女娄菜20份、九子连环草20份、小槐花18份、甘草5份。
所述维生素E软胶囊，制备步骤为：取维生素E以外药材合并，加水煎煮两次，合并煎液，浓缩至65℃时相对密度为1.10-1.20，加入乙醇，搅拌，使含醇量按体积百分比计算达65-85％，静置，过滤，滤液减压浓缩至65℃时相对密度为1.20-1.30并回收乙醇得浓缩液，将浓缩液喷雾干燥，加入维生素E，添加辅料制成软胶囊。
所述维生素E软胶囊，煎煮条件为：第一次加水量为药材重量的8-12倍量，煎煮1-2h，第二次加水量为药材重量的6-10倍量，煎煮1-2h。
所述维生素E软胶囊，所述喷雾干燥条件为：进风温度为90-110℃，出风温度为60-90℃，物料温度为60-90℃，雾化压力为0.2-0.5兆帕，喷雾速度为1-10ml/s。
所述维生素E软胶囊在制备促进排便保健品中的应用。
本发明维生素E(VitaminE)是一种脂溶性维生素，其水解产物为生育酚，是最主要的抗氧化剂之一。溶于脂肪和乙醇等有机溶剂中，不溶于水，对热、酸稳定，对碱不稳定，对氧敏感，对热不敏感，但油炸时维生素E活性明显降低。生育酚能促进性激素分泌，使男子精子活力和数量增加；使女子雌性激素浓度增高，提高生育能力，预防流产，还可用于防治男性不育症、烧伤、冻伤、毛细血管出血、更年期综合症、美容等方面。近来还发现维生素E可抑制眼睛晶状体内的过氧化脂反应，使末梢血管扩张，改善血液循环，预防近视眼发生和发展。维生素E苯环上的酚羟基被乙酰化，酯水解为酚羟基后为生育酚。人们常误认为维生素E就是生育酚。郑州鸿祥化工有限公司生产。
长青草为黄杨科粉蕊黄杨属植物顶蕊三角咪PachysandraterminalisSieb.etZucc.，以全草入药。全年可采，洗净切段，晒干。祛风止咳，舒筋活络，调经止带。用于慢性气管炎，风湿性关节炎，小腿转筋，白带，闭经，精神病烦燥不安。
细叶马料梢为豆科植物中华胡枝子的根或全草，作药用。拉丁学名LespedezachinensisG.Don，清热止痢，祛风，截疟。治急性细菌性痢疾，关节痛，疟疾。本发明以全草入药。
金刚散为葡萄科植物三裂叶蛇葡萄的根或根皮。祛风活络，消肿解毒，止血生肌。治风湿痹痛，跌打损伤，骨折，痈肿疔疮。本发明以根入药。
竻苋菜为苋科植物刺苋的根或全草。清热，利湿，解毒，消肿。治痢疾，便血，浮肿，白带，胆结石，瘰疬，痔疮，疔疮，喉痛，蛇咬伤。
硬叶女娄菜为石竹科植物粗壮女娄菜的全草。拉丁名：SilenefirmaSieb.EtZucc.，8～9月种子成熟时采收，晒干。清热解毒；利尿；调经。主治咽喉肿痛；(耳亭)耳出脓；小便不利。
九子连环草为兰科植物虾脊兰全草或根茎。拉丁名：CalanthediscolorLindl.，春、夏季花后采收，洗净，鲜用或晒干。清热解毒；活血止痛。主瘰疡；痈肿；咽喉肿痛；痔疮；风湿痹痛；跌打损伤。本发明以全草入药。
小槐花为豆科山蚂蝗属植物小槐花Desmodiumcaudatum(Thunb.)DC.，以根或全株入药。夏、秋采集，洗净晒干，鲜用四季可采。清热解毒，祛风利湿。用于感冒发烧，肠胃炎，痢疾，小儿疳积，风湿关节痛；外用治毒蛇咬伤，痈疖疔疮，乳腺炎。本发明以根入药。其余中药为药典品种。
有益效果：本发明长青草、细叶马料梢、金刚散、竻苋菜清热，利湿，解毒，消肿为君药，硬叶女娄菜、九子连环草、小槐花葵清热解毒；活血止痛为臣药，维生素E、甘草为佐使药，全方相互配伍，清热解毒，促进排便效果明显。
具体实施方式
以下通过实施例形式，对本发明的上述内容再作进一步的详细说明，但不应将此理解为本发明上述主题的范围仅限于以下的实例，凡基于本发明上述内容所实现的技术均属于本发明的范围。
实施例1：取维生素E2份、长青草20份、细叶马料梢25份、金刚散30份、竻苋菜28份、硬叶女娄菜20份、九子连环草20份、小槐花18份、甘草5份备用，取维生素E外药材合并，加水煎煮两次，第一次加水量为药材重量的8倍量，煎煮2h，第二次加水量为药材重量的6倍量，煎煮2h，合并煎液，浓缩至65℃时相对密度为1.10，加入乙醇，搅拌，使含醇量按体积百分比计算达85％，静置，过滤，滤液减压浓缩至65℃时相对密度为1.20并回收乙醇得浓缩液，将浓缩液喷雾干燥，加入维生素E，添加辅料制成软胶囊剂。所述喷雾干燥条件为：进风温度为90℃，出风温度为90℃，物料温度为60℃，雾化压力为0.5兆帕，喷雾速度为1ml/s。
实施例2：取维生素E2份、长青草20份、细叶马料梢25份、金刚散30份、竻苋菜28份、硬叶女娄菜20份、九子连环草20份、小槐花18份、甘草5份备用，取维生素E外药材合并，加水煎煮两次，第一次加水量为药材重量的12倍量，煎煮1h，第二次加水量为药材重量的10倍量，煎煮1h。合并煎液，浓缩至65℃时相对密度为1.20，加入乙醇，搅拌，使含醇量按体积百分比计算达65％，静置，过滤，滤液减压浓缩至65℃时相对密度为1.30并回收乙醇得浓缩液，将浓缩液喷雾干燥，加入维生素E，添加辅料制成软胶囊剂，所述喷雾干燥条件为：进风温度为110℃，出风温度为60℃，物料温度为90℃，雾化压力为0.2兆帕，喷雾速度为10ml/s。
实施例3.本发明对便秘小鼠小肠推进运动的影响
动物：健康ICR小鼠，雌雄各半，重18-22g，由南京医科大学动物中心提供，生产许可证号SCXK(苏)2002-0031。
药物与试剂：按上述实施例1制备本发明软胶囊剂，口服给药，给药量5g生药/kg为低剂量，10g生药/kg为中剂量，给药量20g生药/kg为高剂量。酚酞片(果导糖片)，山东省莒南制药厂，规格：100mg*100片/盒，批号20100106，人日用量0.8g/天，相当于每只小鼠用量为0.8gx0.0026＝0.002g，以公斤计算，给药量为0.1g/kg，以3倍量为给药剂量，即阳性组给予酚酞片0.3g/kg。其余试剂均为国产分析纯。复方地芬诺酯片，武进制药厂，20140324。
试验过程：取ICR小鼠60只，以复方地芬诺酯片50m/kg灌胃造模，连续10天，期间正常饮食，形成便秘模型，随机分组，每组约10只，雌雄各半，分为正常组，模型组、阳性药组，本发明颗粒剂高、中、低三个剂量组，给药同上，连续给药14d，实验前禁食不禁水12h，末次给药后2h，分别用体积分数为5％的炭末阿拉伯胶混悬液lml/g灌服，20min后处死各组小鼠，剖腹测量每只鼠小肠炭末移动距离及小肠总长度，换算成炭末移动距离占小肠总长度的百分率，t检验判断组间差异，结果见表1。
表1本发明颗粒剂对便秘小鼠小肠推进运动的影响(n＝10)
与模型组比较，**P<0.01*P<0.05，与阳性药组比较，##P<0.01#P<0.05
结果：本发明药物组与模型组比较，有明显促进便秘小鼠小肠推进运动，促进小鼠胃肠运动，具有显著性差异，与阳性药比较，本发明药物高中剂量组在促进便秘小鼠小肠推进运动方面具有显著性差异，效果好于阳性药。
Claims (5)
1.一种维生素E软胶囊，其特征在于，它所含的活性成分由下列重量份原料药提取制备而成：维生素E2份、长青草20份、细叶马料梢25份、金刚散30份、竻苋菜28份、硬叶女娄菜20份、九子连环草20份、小槐花18份、甘草5份。
2.如权利要求1所述维生素E软胶囊，其特征在于制备步骤为：取维生素E以外药材合并，加水煎煮两次，合并煎液，浓缩至65℃时相对密度为1.10-1.20，加入乙醇，搅拌，使含醇量按体积百分比计算达65-85％，静置，过滤，滤液减压浓缩至65℃时相对密度为1.20-1.30并回收乙醇得浓缩液，将浓缩液喷雾干燥，加入维生素E，添加辅料制成软胶囊。
3.如权利要求2所述维生素E软胶囊，其特征在于，煎煮条件为：第一次加水量为药材重量的8-12倍量，煎煮1-2h，第二次加水量为药材重量的6-10倍量，煎煮1-2h。
4.如权利要求2所述维生素E软胶囊，其特征在于，所述喷雾干燥条件为：进风温度为90-110℃，出风温度为60-90℃，物料温度为60-90℃，雾化压力为0.2-0.5兆帕，喷雾速度为1-10ml/s。
5.根据权利要求1所述维生素E软胶囊在促进排便保健品中的应用。
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