CN106138803A - 一种治疗老年肠燥病的药物组合物及其制备方法 - Google Patents
一种治疗老年肠燥病的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗老年肠燥病的药物组合物及其制备方法,本发明药物组合物是以水八角莲、冰草根、斑蝥、蝼蛄、L‑脯氨酸、N‑脒基酪胺为原料药,配比而成,可按常规制剂工艺制成各种剂型,治疗老年肠燥病疗效显著。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种治疗老年肠燥病的药物组合物及其制备方法。
背景技术
肠燥症又称结肠痉挛,是最常见的消化系统失调,至少百分之10-15%的成人发生,约90%的病例与心理压力有关。主要症状为腹痛,肠胃不适,便秘,或下痢。近12个月内,连续或间歇性,有以上症状达12周以上。老年人的发病率更高,应当引起社会的关注,目前治疗老年肠燥病的药物主要有麻仁润肠丸、痔根断等。这些药物虽有一定疗效,但效果还是不令人十分满意。
水八角莲:为小檗科植物水八角莲的全草。拉丁植物动物矿物名:Dysosmadifformis(Hemsl.et Wils.)T.H.Wang[Podophyllum difformis Hemsl.et Wils.]春、夏季采收,洗净,晒干。【原形态】水八角莲,多年一草本。戏直立,细弱,无毛,基部有黄棕色薄纸质的鳞叶包被。根茎横走,细小,节间有近圆形的碗状小凹,生多数侧根,表面黄棕色,被白色或淡黄色毛。叶互生,薄纸质;叶柄着生于叶片的中部,长5-10cm;叶片通常2,稀3,叶不等大,表状多种,常呈偏心形,长5-11cm,宽8-18cm,先端为宽楔形,基部多为圆形,上面有时带紫红色,下面绿色或杰绿色,边缘不裂或有时具不明显的4-8浅裂,有稀疏的腺状锯齿。伞形花序有花2-5朵,生于离叶不远的叶柄近顶处,花梗长不及2cm,下弯,有长柔毛;萼片早落;花瓣6,深红色,浅状长圆形;雄蕊6,长约7mm,内弯,药隔先端延长成细尖。子房上位,一室。浆果小,球形。种子多数。花期4-6月,果期6-9月。【生境分部】生态环境:生于生海拔800-1800m的山坡林下。资源分布:分布于湖北、湖南、广西、四川、贵州、云南等地。【功能主治】清热解毒。主角膜炎;咽喉炎;鼻炎等。【摘录】《中华本草》。
冰草根:为禾本科植物赖草的根。秋季采挖,洗净晒干。【原形态】赖草,又名:厚穗碱草、厚穗冰草、滨草、老披碱。【生境分部】生于润湿肥沃沙地、渠边、田埂、丘间低地。分布东北、河北、甘肃、宁夏、青海、新疆、陕西、山西、内蒙古等地。【性味】甘,寒。【功能主治】清热,止血,利尿。治感冒,鼻出血,哮喘。【摘录】《中药大辞典》。
斑蝥:本品为芫菁科昆虫南方大斑蝥Mylabris phalerata Pallas 或黄黑小斑蝥Mylabris cichorii Linnaeus 的干燥体。夏、秋二季捕捉,闷死或烫死,晒干。【性状】南方大斑蝥:呈长圆形,长1.5~2.5cm,宽0.5~1cm。头及口器向下垂,有较大的复眼及触角各1对,触角多己脱落。背部具革质鞘翅1对,黑色,有3条黄色或棕黄色的横纹;鞘翅下面有棕褐色薄膜状透明的内翅2片。胸腹部乌黑色,胸部有足3对。有特殊的臭气。【性味】辛,热;有大毒。【归经】归肝、胃、肾经。【功能主治】破血消癓,功毒蚀疮,引赤发泡。用于癓瘕肿块,积年顽癣,瘰疬,赘疣,痈疽不溃,恶疮死肌。【摘录】《中国药典》。
蝼蛄:蝼蛄科昆虫蝼蛄Gryllotalpa africana Palisot et Beaurois或大蝼蛄G.unispina Saussure的成虫全体。夏秋捕捉,开水烫死,晒干。【性味】咸,寒。有小毒。【归经】归膀胱、大肠、小肠经。【功能主治】利水消肿。用于水肿、腹水、小便不利等症。【摘录】《全国中草药汇编》。
L-脯氨酸(L-Proline):分子式:C5H9NO2,分子量:115.13,CAS 登录号:147-85-3,密度:1.35,熔点:228-233 ºC,比旋光度:-85.5 º (c=4, H2O),水溶性:可溶。
N-脒基酪胺(N-Guanyltyramine):分子式:C9H13N3O,分子量:179.22,CAS 登录号:60-20-8,密度:1.241g/cm3沸点:399.064°C at 760 mmHg ,闪点:195.147°C。
发明内容
本发明的目的是克服背景技术的不足,提供一种有效治疗老年肠燥病的药物组合物及其制备方法。
本发明是采用如下技术方案实现的:
制成该治疗老年肠燥病的药物组合物的原料药的组成和重量份为:
水八角莲4150—4250g、冰草根2250—2350g、斑蝥2850—2950g、蝼蛄1050—1150g、L-脯氨酸57—67g、N-脒基酪胺69—79g。
优选的用于治疗老年肠燥病的药物组合物,是由如下重量份的原料药组成:
水八角莲4200g、冰草根2300g、斑蝥2900g、蝼蛄1100g、L-脯氨酸60g、N-脒基酪胺70g。
一种治疗老年肠燥病的药物组合物,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
一种治疗老年肠燥病的药物组合物,其特征在于药物组合物与化学药或中药组成的治疗老年肠燥药物。
一种治疗老年肠燥病的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:水八角莲4150—4250g、冰草根2250—2350g、斑蝥2850—2950g、蝼蛄1050—1150g、L-脯氨酸57—67g、N-脒基酪胺69—79g;
制备方法:
(1)按原料药配比取水八角莲、冰草根、斑蝥、蝼蛄、L-脯氨酸、N-脒基酪胺,混匀,用重量百分比浓度15%乙醇作为溶剂,在49.5℃温浸提取,提取次数为5次,每次提取时间为34小时,每次溶剂用量为原料药总重量的49.5倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.13,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度54%乙醇作为溶剂,加热回流提取8次,每次提取时间为1.2小时,每次溶剂用量为药渣A重量的11倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.13,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度61%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度61%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
优选的一种治疗老年肠燥病的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:水八角莲4200g、冰草根2300g、斑蝥2900g、蝼蛄1100g、L-脯氨酸60g、N-脒基酪胺70g;
制备方法:
(1)按原料药配比取水八角莲、冰草根、斑蝥、蝼蛄、L-脯氨酸、N-脒基酪胺,混匀,用重量百分比浓度15%乙醇作为溶剂,在49.5℃温浸提取,提取次数为5次,每次提取时间为34小时,每次溶剂用量为原料药总重量的49.5倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.13,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度54%乙醇作为溶剂,加热回流提取8次,每次提取时间为1.2小时,每次溶剂用量为药渣A重量的11倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.13,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度61%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度61%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
一种治疗老年肠燥的药物组合物的制备方法,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
一种治疗老年肠燥病的药物组合物的制备方法,其特征在于药物组合物与化学药或中药组成治疗老年肠燥病药物。
具体实施方式
实施例1:治疗老年肠燥病的药物组合物及其制备方法
治疗老年肠燥病的药物组合物的原料药的组成和重量份为:水八角莲4200g、冰草根2300g、斑蝥2900g、蝼蛄1100g、L-脯氨酸60g、N-脒基酪胺70g;
制备方法:
(1)按原料药配比取水八角莲、冰草根、斑蝥、蝼蛄、L-脯氨酸、N-脒基酪胺,混匀,用重量百分比浓度15%乙醇作为溶剂,在49.5℃温浸提取,提取次数为5次,每次提取时间为34小时,每次溶剂用量为原料药总重量的49.5倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.13,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度54%乙醇作为溶剂,加热回流提取8次,每次提取时间为1.2小时,每次溶剂用量为药渣A重量的11倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.13,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度61%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度61%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例2:治疗老年肠燥病的药物组合物及其制备方法
治疗老年肠燥病的药物组合物的原料药的组成和重量份为:水八角莲4150g、冰草根2350g、斑蝥2850g、蝼蛄1150g、L-脯氨酸57g、N-脒基酪胺79g;
制备方法:
(1)按原料药配比取水八角莲、冰草根、斑蝥、蝼蛄、L-脯氨酸、N-脒基酪胺,混匀,用重量百分比浓度15%乙醇作为溶剂,在49.5℃温浸提取,提取次数为5次,每次提取时间为34小时,每次溶剂用量为原料药总重量的49.5倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.13,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度54%乙醇作为溶剂,加热回流提取8次,每次提取时间为1.2小时,每次溶剂用量为药渣A重量的11倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.13,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度61%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度61%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例3:治疗老年肠燥病的药物组合物及其制备方法
治疗老年肠燥病的药物组合物的原料药的组成和重量份为:水八角莲4150g、冰草根2250g、斑蝥2950g、蝼蛄1050g、L-脯氨酸67g、N-脒基酪胺69g;
制备方法:
(1)按原料药配比取水八角莲、冰草根、斑蝥、蝼蛄、L-脯氨酸、N-脒基酪胺,混匀,用重量百分比浓度15%乙醇作为溶剂,在49.5℃温浸提取,提取次数为5次,每次提取时间为34小时,每次溶剂用量为原料药总重量的49.5倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.13,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度54%乙醇作为溶剂,加热回流提取8次,每次提取时间为1.2小时,每次溶剂用量为药渣A重量的11倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.13,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度61%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度61%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例4:片剂的制备
取实施例1药物组合物309g,加入淀粉101g,混匀,制粒,干燥,加微晶纤维素35g,硬脂酸镁3g,混匀,压制成1000片, 即得药物组合物片剂。
实施例5:胶囊的制备
取实施例2药物组合物308g,加入淀粉84g,混匀,制粒,干燥,整粒,加入适量硬脂酸镁,混匀,装胶囊1000粒,即得药物组合物胶囊。
实施例6:滴丸的制备
称取聚乙二醇 6000 193g水浴(80℃)加热煮熔,加入实施例3药物组合物14g,充分搅拌均匀,以液体石蜡为冷却剂,置玻璃管(4*80cm)中,冷却温度为5℃,滴口内外径为7.0/2.0(mm/mm),滴口距液面为2.5cm,滴速以每分60滴为最佳条件,用棉布吸干滴丸表面的冷凝剂,即得药物组合物滴丸。
实施例7:治疗老年肠燥病的药物组合物
治疗老年肠燥病的药物组合物的原料药的组成和重量份为:
水八角莲4150g、蝼蛄2150g、L-脯氨酸45g、N-脒基酪胺50g。
实施例8:治疗老年肠燥病的药物组合物
治疗老年肠燥病的药物组合物的原料药的组成和重量份为:
水八角莲4100g、蝼蛄2200g、L-脯氨酸40g、N-脒基酪胺55g。
实施例9:治疗老年肠燥病的药物组合物
治疗老年肠燥病的药物组合物的原料药的组成和重量份为:
水八角莲4200g、蝼蛄2100g、L-脯氨酸50g、N-脒基酪胺45g。
实验例1:治疗老年肠燥病的试验研究
1、临床资料
选择济南市中心医院2013年8月—2014年8月收治的老年肠燥病100例患者,男52例,女48例;年龄67~84岁,病程4~21年。 所有病例,均为极度虚弱之体,中医辨证为肠燥、津枯,因粪块致不完全性肠梗 阻。临床表现:腹胀,腹痛数日不排便,不排气。口干唇燥,舌红少津,苔黄燥, 脉细涩或弦细。检查:中下腹部压痛,无反跳痛,肌紧张,全腹未扪及包块,肠鸣音活跃。腹部X 线透视示:中腹部多有大量积气及液平面。
2、治疗方法
口服该药物组合物(实施例1药物组合物批号20130226)治疗,每日3次,每次1.5g,连用3周后进行疗效判定。
3、疗效标准
本组病例疗效评定标准依据卫生部制定的《中药新药临床研究指导原则》(1993年)。临床痊愈:大便正常,或恢复至病前水平,其它症状完全消失。显效:便秘明显改善,间隔时间及便质接近正常,或大便稍干而排便间隔时间在72h以内,其它症状大部分消失。有效:排便间隔时间缩短至1d,或便质干结改善,其它症状均有好转。无效:便秘及其它症状均无改善。
4、治疗结果
在100例患者中,痊愈50例(50.0%),显效37例(37.0 %),有效9例(9.0 %) , 无效4例(4.0%), 总有效率96.0% 。
实验例2:典型病例
周XX,男,75岁,患了肠燥便秘,便意少,便次也少;排便艰难、费力;排便不畅;大便干结、还伴有失眠、烦躁、焦虑等精神心理障碍。2014年12月开始口服该药物组合物(实施例1药物组合物批号20130226)治疗,每日3次,每次1.5g,连用3周诸状消失,后继续服用2月彻底治愈。
齐XX,女,74岁,肠燥病患者,主要症状:便次也少,排便艰难,费力,大便干结,还伴有烦躁、焦虑等。2015年1月开始口服该药物组合物(实施例1药物组合物批号20130226)治疗,每日3次,每次1.5g,连用4周诸状消失,后继续服用2月彻底治愈。
Claims (8)
1.一种治疗老年肠燥病的药物组合物,其特征在于制成该药物组合物的原料药的组成和重量份为:
水八角莲4150—4250g、冰草根2250—2350g、斑蝥2850—2950g、蝼蛄1050—1150g、L-脯氨酸57—67g、N-脒基酪胺69—79g。
2.根据权利要求1所述一种治疗老年肠燥病的药物组合物,其特征在于制成该药物组合物的原料药的组成和重量份为:
水八角莲4200g、冰草根2300g、斑蝥2900g、蝼蛄1100g、L-脯氨酸60g、N-脒基酪胺70g。
3.根据权利要求1所述一种治疗老年肠燥病的药物组合物,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
4.根据权利要求1所述一种治疗老年肠燥病的药物组合物,其特征在于药物组合物与化学药或中药组成的治疗老年肠燥病药物。
5.一种治疗老年肠燥病的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:水八角莲4150—4250g、冰草根2250—2350g、斑蝥2850—2950g、蝼蛄1050—1150g、L-脯氨酸57—67g、N-脒基酪胺69—79g;
制备方法:
(1)按原料药配比取水八角莲、冰草根、斑蝥、蝼蛄、L-脯氨酸、N-脒基酪胺,混匀,用重量百分比浓度15%乙醇作为溶剂,在49.5℃温浸提取,提取次数为5次,每次提取时间为34小时,每次溶剂用量为原料药总重量的49.5倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.13,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度54%乙醇作为溶剂,加热回流提取8次,每次提取时间为1.2小时,每次溶剂用量为药渣A重量的11倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.13,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度61%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度61%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
6.根据权利要求5所述一种治疗老年肠燥病的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:水八角莲4200g、冰草根2300g、斑蝥2900g、蝼蛄1100g、L-脯氨酸60g、N-脒基酪胺70g;
制备方法:
(1)按原料药配比取水八角莲、冰草根、斑蝥、蝼蛄、L-脯氨酸、N-脒基酪胺,混匀,用重量百分比浓度15%乙醇作为溶剂,在49.5℃温浸提取,提取次数为5次,每次提取时间为34小时,每次溶剂用量为原料药总重量的49.5倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.13,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度54%乙醇作为溶剂,加热回流提取8次,每次提取时间为1.2小时,每次溶剂用量为药渣A重量的11倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.13,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度61%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度61%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
7.根据权利要求5所述一种治疗老年肠燥病的药物组合物的制备方法,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
8.根据权利要求5所述一种治疗老年肠燥病的药物组合物的制备方法,其特征在于药物组合物与化学药或中药组成治疗老年肠燥病药物。
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