CN107661465A - 一种治疗肺结核的中药组合物及其制备方法 - Google Patents
一种治疗肺结核的中药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肺结核的中药组合物,其包括:白绿叶、炮仗花叶、北沙参、管仲、金合欢、百里香、百部、抱树莲、蕙兰、石油菜、竹叶参,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肺结核方面具有疗效好、成本低、治愈率高、无不良反应等优点。本发明的中药具有清热降火,滋阴润肺,止咳平喘,补益脾、肺、肾,疗效确切,副作用小的优点。
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肺结核的中药组合物及其制备方法。
背景技术
结核病是由结核分枝杆菌引起的慢性传染病,可侵及许多脏器,以肺部结核感染最为常见。排菌者为其重要的传染源。人体感染结核菌后不一定发病,当抵抗力降低或细胞介导的变态反应增高时,才可能引起临床发病。若能及时诊断,并予合理治疗,大多可获临床痊愈。结核菌属于放线菌目,分枝杆菌科的分枝杆菌属,为有致病力的耐酸菌。主要分为人、牛、鸟、鼠等型。对人有致病性者主要是人型菌,牛型菌少有感染。结核菌对药物的耐药性,可由菌群中先天耐药菌发展而形成,也可由于在人体中单独使用一种抗结核药而较快产生对该药的耐药性,即获得耐药菌。耐药菌可造成治疗上的困难,影响疗效。
目前,用于治疗肺结核的药物较多,虽然能起到一定的作用,但其存在治愈率低、治疗时间长、副作用大、费用较高等不足。
发明内容
为了解决上述问题,本发明提供一种具有清热降火、滋阴润肺、止咳平喘、补益脾、肺、肾、疗效确切、副作用小的治疗肺结核的中药组合物。
本发明采用的技术方案是:一种治疗肺结核的中药组合物,所述中药组合物的各组份为白绿叶、炮仗花叶、北沙参、管仲、金合欢、百里香、百部、抱树莲、蕙兰、石油菜、竹叶参。
优选的,各种组份的重量份数比为白绿叶25-35份、炮仗花叶15-25份、北沙参15-25份、管仲10-20份、金合欢10-20份、百里香5-15份、百部5-15份、抱树莲5-15份、蕙兰5-15份、石油菜5-15份、竹叶参5-15份。
更优选的,各种组份的重量份数比为白绿叶30-35份、炮仗花叶20-25份、北沙参20-25份、管仲10-15份、金合欢10-15份、百里香5-10份、百部5-10份、抱树莲5-10份、蕙兰5-10份、石油菜5-10份、竹叶参5-10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、口含剂、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,炮仗花叶、北沙参按比例混合,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,将管仲、金合欢、百里香、百部用醇浓度为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,炮仗花叶、北沙参按比例混合,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,将管仲、金合欢、百里香、百部用醇浓度为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。
白绿叶,味酸、性平,利尿排石,止咳定喘,行气止痛。主治慢性肾炎,胃痛,慢性支气管炎,支气管肺结核。
炮仗花叶,味苦、微涩,性平,清热、利咽喉,用于肺结核、咳嗽、咽喉肿痛、肝炎、支气管炎。
北沙参,味甘、微苦,性微寒,归肺、胃经,养阴清肺,益胃生津。用于肺热燥咳,劳嗽痰血,热病津伤口渴。
管仲,味苦涩、性寒,归脾、大肠经,清热解毒,涩肠止泻,凉血止血。主赤白下痢;肠炎腹泻;肠风下血;肺痨咯血;吐血;崩漏带下;外伤出血;疔疮;烫烧伤。
百里香,味辛,性微温,祛风解表,行气止痛,止咳,降压。用于感冒,咳嗽,头痛,牙痛,消化不良,急性胃肠炎,高血压病。
金合欢,味微酸、涩,性平,消痈排脓,收敛止血。主治肺结核,冷性脓肿,风湿性关节炎。
百部,味甘、苦,性微温,归肺经,润肺下气止咳,杀虫。用于新久咳嗽,肺痨咳嗽,百日咳;外用于头虱,体虱,蛲虫病,阴痒。蜜百部润肺止咳。用于阴虚劳嗽。
抱树莲,味甘、淡,性微凉,清热解毒,止血消肿。用于黄疸,淋巴结结核,腮腺炎,肺结核咯血,血崩,乳腺癌,跌打损伤。
蕙兰,味苦、甘,性温,润肺止咳。
石油菜,味甘、淡,性凉,清热解毒,润肺止咳,消肿止痛。用于肺热咳嗽,肺结核病,肾炎水肿;外用治跌打损伤,烧烫伤,疮疖肿毒。
竹叶参,味甘、微苦,性平,补肺肾,镇咳,健胃止血。主治气虚头晕,耳鸣虚咳,病后食欲不振,吐血。
本发明的有益效果:
相对于现有技术中的具有治疗肺结核效果的药物,采用此种中药组合物在治疗肺结核方面具有疗效好、成本低、治愈率高、无不良反应等优点。本发明的中药具有清热降火,滋阴润肺,止咳平喘,补益脾、肺、肾,疗效确切,副作用小的优点。
具体实施方式
实施例1:
(一)一种治疗肺结核的中药,由以下原料药按重量份配比而成:
白绿叶30份、炮仗花叶25份、北沙参20份、管仲15份、金合欢15份、百里香10份、百部10份、抱树莲10份、蕙兰10份、石油菜5份、竹叶参5份。
(二)制备方法:
第一步,炮仗花叶、北沙参按比例混合,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,将管仲、金合欢、百里香、百部用醇浓度为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)一种治疗肺结核的中药,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,炮仗花叶、北沙参按比例混合,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,将管仲、金合欢、百里香、百部用醇浓度为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180例,100例为男性,80例为女性。
(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.初期仅感疲劳乏力,干咳,食欲不振,形体逐渐消瘦,病重者可出现咳(咯)血,潮热,颧红,盗汗,形体明显消瘦等症。2.常有与肺结核患者密切接触史。3.病灶部位呼吸音减弱,或闻及支气管呼吸音及湿罗音。4.痰液涂片、浓缩或培养,结核菌多呈阳性。5.血沉增快。6.结核菌素皮试呈强阳性。7.X线摄片示肺部可见结核病灶。必要时可作X线断层摄片。
(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:症状消失,肺部病灶吸收钙化,痰菌检查转阴;
有效:症状改善,肺部病灶部分吸收;
无效:症状及病灶无变化。
(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 | 0 | 60 |
1组 | 57 | 2 | 1 |
2组 | 59 | 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)
1.一种治疗肺结核的中药组合物,其特征在于:所述中药组合物的各组份为白绿叶、炮仗花叶、北沙参、管仲、金合欢、百里香、百部、抱树莲、蕙兰、石油菜、竹叶参。
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白绿叶25-35份、炮仗花叶15-25份、北沙参15-25份、管仲10-20份、金合欢10-20份、百里香5-15份、百部5-15份、抱树莲5-15份、蕙兰5-15份、石油菜5-15份、竹叶参5-15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白绿叶30-35份、炮仗花叶20-25份、北沙参20-25份、管仲10-15份、金合欢10-15份、百里香5-10份、百部5-10份、抱树莲5-10份、蕙兰5-10份、石油菜5-10份、竹叶参5-10份。
4.如权利要求1-3中任一项所述治疗肺结核的中药组合物,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、口含剂、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中任一项所述治疗肺结核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,炮仗花叶、北沙参按比例混合,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,将管仲、金合欢、百里香、百部用醇浓度为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中任一项所述治疗肺结核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,炮仗花叶、北沙参按比例混合,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,将管仲、金合欢、百里香、百部用醇浓度为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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