CN106166196A - 一种治疗慢性肠炎的中药组合物及其制备方法 - Google Patents
一种治疗慢性肠炎的中药组合物及其制备方法 Download PDFInfo
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- CN106166196A CN106166196A CN201610879374.4A CN201610879374A CN106166196A CN 106166196 A CN106166196 A CN 106166196A CN 201610879374 A CN201610879374 A CN 201610879374A CN 106166196 A CN106166196 A CN 106166196A
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Abstract
本发明公开了一种治疗慢性肠炎的中药组合物,其包括:朝天罐、定草根、元胡、马鞭草、莱菔缨、马齿苋、牛奶菜、山豆花、含羞草、素馨花、王瓜根,本发明还公开了上述中药组合物的制备方法。采用此种中药组合物在治疗慢性肠炎方面具有疗效好、成本低、治愈率高、无不良反应等优点。本发明的中药能够起到清热利湿、健脾和胃、温阳益气、清肠化湿的作用,且疗效确切,见效快、无毒副作用,经临床验证治愈率较高。
Description
技术领域
本发明涉及一种医用配制品,尤其涉及一种用于治疗慢性肠炎的中药组合物及其制备方法。
背景技术
慢性肠炎是肠炎中的一种,包括慢性溃疡性肠炎、克隆氏病等,世界各国都有,是一种常见病和多发病,其病因至今不明。虽有多种学说:如感染因素,精神因素,酶的因素,遗传因素,免疫因素,保护物质缺乏因素等学说,但目前的医学科学发展还没有做出肯定的结论。流行病学调查结果显示:发达国家的发病率远远高于发展中国家,城市发病率高于农村,发达地区的发病率高于相对落后的地区。随着社会的发展发病率有上升趋势,慢性肠炎起病大多缓慢,开始腹泻、腹痛,并逐渐加重,出现血便和脓血便,同时伴有发热、乏力、消瘦等,也有急性起病,严重者有高热、多汗、进行性消瘦,暴发者可直接威胁生命,病员有体重减轻、面色苍白,还可伴发肛周炎症或背椎炎等,纤维结肠检查可见粘膜充血,水肿,溃疡和假息肉形成。病员迁延不愈,病程长者可达数10年,另有3%左右发生癌变。目前,国内外治疗慢性肠炎的方法较多,如西药治疗法,常用药有土霉素、阿托品、黄连素、呋喃唑酮等;如中药治疗法,常用药有藿香正气水、葛根芩连汤等。但是,在治愈率、治疗手段、治疗费用等方面难以达到满意的效果。
因此,亟需提供一种清热利湿、健脾和胃、温阳益气、清肠化湿、疗效确切、见效快、无毒副作用的治疗慢性肠炎的中药组合物。
发明内容
为了解决上述问题,本发明提供一种清热利湿、健脾和胃、温阳益气、清肠化湿、疗效确切、见效快、无毒副作用的治疗慢性肠炎的中药组合物。
本发明采用的技术方案是:一种治疗慢性肠炎的中药组合物,所述中药组合物的各组份为朝天罐、定草根、元胡、马鞭草、莱菔缨、马齿苋、牛奶菜、山豆花、含羞草、素馨花、王瓜根。
优选的,各种组份的重量份数比为朝天罐25-35份、定草根15-25份、元胡15-25份、马鞭草10-20份、莱菔缨10-20份、马齿苋5-15份、牛奶菜5-15份、山豆花5-15份、含羞草5-15份、素馨花5-15份、王瓜根5-15份。
更优选的,各种组份的重量份数比为朝天罐30-35份、定草根20-25份、元胡20-25份、马鞭草10-15份、莱菔缨10-15份、马齿苋5-10份、牛奶菜5-10份、山豆花5-10份、含羞草5-10份、素馨花5-10份、王瓜根5-10份。
其中,所述中药组合物的剂型为:薄膜衣片剂、丹剂、硬膏剂、糖浆剂、口服液、***剂、颗粒剂、散剂、注射剂、糖衣片剂、胶囊剂。
本发明还提供了上述中药组合物的制备方法,当所述中药的剂型为胶囊剂时,包括:
第一步,定草根、元胡按比例混合,用相当于混合物质量2-3倍的醇浓度为70-80%的正丙醇回流提取2-4次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1-2次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将马鞭草、莱菔缨、马齿苋、牛奶菜用醇浓度为80-90%的正丙醇提取2-3次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2-4倍量的水溶解,静止1-3小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2-3小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2-4倍;
第四步,将上述粉末和淀粉混合,随后进行制粒处理并干燥,得到混合物颗粒,再向混合物颗粒中加入硬脂酸镁,所述硬脂酸镁和所述混合物颗粒质量之比为0.25-100:0.5-100,获得胶囊内容物,将所述的胶囊内容物装入胶囊壳体中即得胶囊剂。
本发明还提供了上述中药组合物的制备方法,当所述中药的剂型为注射剂时,包括:
第一步,定草根、元胡按比例混合,用相当于混合物质量2-3倍的醇浓度为70-80%的正丙醇回流提取2-4次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1-2次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将马鞭草、莱菔缨、马齿苋、牛奶菜用醇浓度为80-90%的正丙醇提取2-3次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2-4倍量的水溶解,静止1-3小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2-3小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2-4倍;
第四步,将上述粉末混合,随后将其溶于质量为混合物2-4倍的水,搅拌下加入相对于粉末质量5%-15%的氢氧化钠助溶,过滤,加浓度为1mol/L的盐酸调节pH值为5-6,过滤,沉淀备用,滤液通过聚酰胺柱,先用水洗去杂质,随后用醇浓度为80-90%的正丙醇洗脱,收集正丙醇洗脱液,沉淀用醇浓度为80-90%的正丙醇提取2次,过滤,滤液与上述洗脱液合并,回收正丙醇,减压浓缩至膏体并喷雾干燥成粉末,将获得的粉末加相对于其质量1-2倍的氯化钠及注射用水适量,溶解后再进一步加注射用水至需要的体积,过滤,灌封,灭菌,获得需要的注射液。
朝天罐,味酸涩、性微寒,无毒,清热利湿,止咳,调经。用于急性胃肠炎,细菌性痢疾,消化不良,慢性支气管炎,吐血,***,白带。
定草根,味辛、甘,性平,清热除湿,活血化瘀,止咳化痰,利尿通乳。用于风湿疼痛,肠炎,痢疾,***,咳嗽痰多,跌打损伤,吐血,崩漏,乳汁不通;外用治骨折,外伤出血。
元胡又名延胡索、玄胡,为罂粟科紫堇属多年生草本植物,与白术、芍药、贝母等并称“浙八味”,为大宗常用中药。元胡史载于《开宝本草》,性温,味辛苦,入心、脾、肝、肺,是活血化瘀、行气止痛之妙品,尤以止痛之功效而著称于世。李时珍在《本草纲目》中归纳元胡有“活血,理气,止痛,通小便”四大功效,并推崇元胡“能行血中气滞,气中血滞,故专治一身上下诸痛”。
马鞭草,味苦,性微寒,清热解毒,截疟杀虫,利尿消肿,通经散瘀。主治:疟疾,血吸虫病,丝虫病,感冒发烧,急性胃肠炎,细菌性痢疾,肝炎,肝硬化腹水,肾炎水肿,***,阴囊肿痛,***,血瘀经闭,牙周炎,白喉,咽喉肿痛;外用治跌打损伤,疔疮肿毒。
马齿苋,味酸,性寒,清热利湿,凉血解毒。用于细菌性痢疾,急性胃肠炎,急性阑尾炎,乳腺炎,痔疮出血,白带;外用治疔疮肿毒,湿疹、带状疱疹。
莱菔缨,消食止渴,祛热解毒。主治胸中满闷,两胁作胀,化积滞,解酒毒。
牛奶菜,壮筋骨、健胃利肠。
山豆花,味甘,性平,健脾补虚。
含羞草,味甘、涩,性凉,清热利尿,化痰止咳,安神止痛。用于感冒,小儿高热,急性结膜炎,支气管炎,胃炎,肠炎,泌尿系结石,疟疾,神经衰弱;外用治跌打肿痛,疮疡肿毒。
素馨花,味苦,性平,行气调经止痛,清热散结。用于胃痛,肝炎,***,痛经,带下,口腔炎,皮肤搔痒,***,乳腺炎,***结核。
王瓜根,味苦、性寒,清热解毒,利尿消肿,散瘀止痛。用于毒蛇咬伤,急性扁桃体炎,咽喉炎,痈疮肿毒,跌打损伤,小便不利,胃痛。
本发明的有益效果:
相对于现有技术中的具有治疗慢性肠炎效果的药物,采用此种中药组合物在治疗慢性肠炎方面具有疗效好、成本低、治愈率高、无不良反应等优点。本发明的中药能够起到清热利湿、健脾和胃、温阳益气、清肠化湿的作用,且疗效确切,见效快、无毒副作用,经临床验证治愈率较高。
具体实施方式
实施例1:
(一)一种治疗慢性肠炎的中药,由以下原料药按重量份配比而成:
朝天罐30份、定草根25份、元胡20份、马鞭草15份、莱菔缨15份、马齿苋10份、牛奶菜10份、山豆花10份、含羞草10份、素馨花5份、王瓜根5份。
(二)制备方法:
第一步,定草根、元胡按比例混合,用相当于混合物质量2倍的醇浓度为70%的正丙醇回流提取2次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1-2次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将马鞭草、莱菔缨、马齿苋、牛奶菜用醇浓度为80-90%的正丙醇提取2-3次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2倍量的水溶解,静止1小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2倍;
第四步,将上述粉末和淀粉混合,随后进行制粒处理并干燥,得到混合物颗粒,再向混合物颗粒中加入硬脂酸镁,所述硬脂酸镁和所述混合物颗粒质量之比为0.25:0.5,获得胶囊内容物,将所述的胶囊内容物装入胶囊壳体中即得胶囊剂。
实施例2:
(一)一种治疗慢性肠炎的中药,由以下原料药按重量份配比而成:同实施例1。
(二)制备方法:
第一步,定草根、元胡按比例混合,用相当于混合物质量2倍的醇浓度为70%的正丙醇回流提取2次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将马鞭草、莱菔缨、马齿苋、牛奶菜用醇浓度为80%的正丙醇提取2次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2倍量的水溶解,静止1小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2倍;
第四步,将上述粉末混合,随后将其溶于质量为混合物2倍的水,搅拌下加入相对于粉末质量5%的氢氧化钠助溶,过滤,加浓度为1mol/L的盐酸调节pH值为5-6,过滤,沉淀备用,滤液通过聚酰胺柱,先用水洗去杂质,随后用醇浓度为80的正丙醇洗脱,收集正丙醇洗脱液,沉淀用醇浓度为80的正丙醇提取2次,过滤,滤液与上述洗脱液合并,回收正丙醇,减压浓缩至膏体并喷雾干燥成粉末,将获得的粉末加相对于其质量2倍的氯化钠及注射用水适量,溶解后再进一步加注射用水至需要的体积,过滤,灌封,灭菌,获得需要的注射液。
实施例3:
1、长期毒性试验过程:
应用Wistar大鼠(北京维通利华实验动物技术有限公司提供)将实验药物设定为高、中、低三个剂量,分别为实施例1配方的胶囊剂8g/kg、4g/kg、2g/kg。按人用剂量0.1g/kg/天片计算,分别为人用有效剂量的80倍、40倍和20倍;另设一对照组,连续灌胃给药90天、180天和部分动物停药10天后,观察对大鼠各项生理、生化指标的影响。实验结果表明:用不同剂量给大鼠连续口服180天,对大鼠的进食量和体重增长均无影响。对肝肾功能均未发现明显毒性作用。对血常规、血生化、尿液生化及骨髓片等均未见明显影响,各组间与对照组比较无明显差异。
2、急性毒性试验过程:
应用ICR小鼠(北京维通利华实验动物技术有限公司提供)40只,体重在25-30克,进行急性毒性实验。小鼠随机分为两组,即对照组、给药组,实验前禁食12小时,然后给予如实施例1制备得到的本发明的中药胶囊剂混悬液(将胶囊剂溶解在水中获得混悬液)灌胃,对给药的半数致死量(LD50)进行了试验测定,但未测到LD50,因此进行了最大耐受量试验。结果:以最大浓度(60%),最大给药量(120ml/kg,一日内份四次给完)100g/kg灌胃,相当于生药量60g/kg,相当于成人临床拟日用剂量的300倍(按75kg),七日内小鼠无一死亡,处死小鼠解剖观察各脏器未发现毒性反应,给药组与对照组小鼠无任何差异。
实施例4:
本发明的临床治疗观察如下:
(一)患者240例,120例为女性,120例为男性。
(二)诊断标准:
诊断标准:参照《内科学》中的诊断依据进行临床诊断:
1)发作时,出现腹泻、腹痛等,病久则呈现慢性营养不良,体格检查可有腹部压痛;2)大便常规可见白细胞,红细胞和少量脓细胞,大便培养可找到致病菌;3)X线钡剂检查和结肠镜检查可排除其他特异性肠道炎症。
(三)治疗方法:1组:采用如实施例1制备方法制得的胶囊剂100g,分成10份,每天早晨空腹服用一份,30天为一个疗程,连续服用两个疗程;2组:采用如实施例2制备方法制得的注射剂100g,分成10份,每天早晨空腹注射一份,30天为一个疗程,连续注射两个疗程;另设一对照组。
(四)疗效评定标准:
疗效标准:
整体疗效评定参照《中药新药临床研究指导原则》相关标准:
治愈:临床症状体征消失,恢复正常;
有效:临床症状体征基本或大部分消失;
无效:临床症状体征无改善。
(五)治疗结果见表1:
表1治疗结果
组别 | 痊愈 | 有效 | 无效 |
对照组 | 0 | 5 | 75 |
1组 | 77 | 2 | 1 |
2组 | 79 | 1 | 0 |
上述实施例只是为了说明本发明的技术构思及特点,其目的是在于让本领域内的普通技术人员能够了解本发明的内容并据以实施,并不能以此限制本发明的保护范围。凡是根据本发明内容的实质所作出的等效的变化或修饰,都应涵盖在本发明的保护范围。
Claims (6)
1.一种治疗慢性肠炎的中药组合物,其特征在于:所述中药组合物的各组份为朝天罐、定草根、元胡、马鞭草、莱菔缨、马齿苋、牛奶菜、山豆花、含羞草、素馨花、王瓜根。。
2.如权利要求1所述的中药组合物,其特征在于:各种组份的重量份数比为朝天罐25-35份、定草根15-25份、元胡15-25份、马鞭草10-20份、莱菔缨10-20份、马齿苋5-15份、牛奶菜5-15份、山豆花5-15份、含羞草5-15份、素馨花5-15份、王瓜根5-15份。
3.如权利要求1所述的中药组合物,其特征在于:各种组份的重量份数比为朝天罐30-35份、定草根20-25份、元胡20-25份、马鞭草10-15份、莱菔缨10-15份、马齿苋5-10份、牛奶菜5-10份、山豆花5-10份、含羞草5-10份、素馨花5-10份、王瓜根5-10份。
4.如权利要求1-3中任一项所述治疗慢性肠炎的中药组合物,其特征在于,所述中药组合物的剂型为:薄膜衣片剂、丹剂、硬膏剂、糖浆剂、口服液、***剂、颗粒剂、散剂、注射剂、糖衣片剂、胶囊剂。
5.一种如权利要求1-3中任一项所述治疗慢性肠炎的中药组合物的制备方法,其特征在于:当所述中药的剂型为胶囊剂时,包括:
第一步,定草根、元胡按比例混合,用相当于混合物质量2-3倍的醇浓度为70-80%的正丙醇回流提取2-4次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1-2次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将马鞭草、莱菔缨、马齿苋、牛奶菜用醇浓度为80-90%的正丙醇提取2-3次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2-4倍量的水溶解,静止1-3小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2-3小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2-4倍;
第四步,将上述粉末和淀粉混合,随后进行制粒处理并干燥,得到混合物颗粒,再向混合物颗粒中加入硬脂酸镁,所述硬脂酸镁和所述混合物颗粒质量之比为0.25-100:0.5-100,获得胶囊内容物,将所述的胶囊内容物装入胶囊壳体中即得胶囊剂。
6.一种如权利要求1-3中任一项所述治疗慢性肠炎的中药组合物的制备方法,其特征在于:当所述中药的剂型为注射剂时,包括:
第一步,定草根、元胡按比例混合,用相当于混合物质量2-3倍的醇浓度为70-80%的正丙醇回流提取2-4次,合并滤液,减压浓缩、干燥并粉碎成粉末,随后用乙醇提纯1-2次,合并提取液,减压回收乙醇并浓缩至60℃下相对密度为1.21-1.24的膏体,干燥并粉碎成粉末;
第二步,将马鞭草、莱菔缨、马齿苋、牛奶菜用醇浓度为80-90%的正丙醇提取2-3次,合并提取液,减压浓缩并进行干燥、粉碎成粉末,将粉碎后的粉末加入相对于其质量为2-4倍量的水溶解,静止1-3小时,过滤,滤液减压浓缩为60℃下相对密度为1.21-1.24的膏体并干燥,粉碎成粉末;
第三步,将余下组份研成粉末按比例混合,加水煎煮2次,每次2-3小时,分别过滤,合并滤液,滤液浓缩成膏体并干燥,粉碎成粉末,所加入的水的质量为第三步的混合物质量的2-4倍;
第四步,将上述粉末混合,随后将其溶于质量为混合物2-4倍的水,搅拌下加入相对于粉末质量5%-15%的氢氧化钠助溶,过滤,加浓度为1mol/L的盐酸调节pH值为5-6,过滤,沉淀备用,滤液通过聚酰胺柱,先用水洗去杂质,随后用醇浓度为80-90%的正丙醇洗脱,收集正丙醇洗脱液,沉淀用醇浓度为80-90%的正丙醇提取2次,过滤,滤液与上述洗脱液合并,回收正丙醇,减压浓缩至膏体并喷雾干燥成粉末,将获得的粉末加相对于其质量1-2倍的氯化钠及注射用水适量,溶解后再进一步加注射用水至需要的体积,过滤,灌封,灭菌,获得需要的注射液。
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