CN105434648A - 一种治疗急性乳腺炎的中药组合物及其制备方法 - Google Patents
一种治疗急性乳腺炎的中药组合物及其制备方法 Download PDFInfo
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- CN105434648A CN105434648A CN201610052010.9A CN201610052010A CN105434648A CN 105434648 A CN105434648 A CN 105434648A CN 201610052010 A CN201610052010 A CN 201610052010A CN 105434648 A CN105434648 A CN 105434648A
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了一种治疗急性乳腺炎的中药组合物,其包括:白茎鸦葱、草血竭、元胡、凹头苋、蛋不老、赤甲红、鸨油、腹水草、含羞草、旱金莲、黄芪,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急性乳腺炎方面具有疗效好、成本低、治愈率高、无不良反应等优点。本发明的中药组合物疏肝理气,清热解毒,祛瘀散结,消肿止痛,疗程短、不易复发,可大量运用于临床实践中。
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急性乳腺炎的中药组合物及其制备方法。
背景技术
急性乳腺炎是乳腺的急性化脓性感染,是乳腺管内和周围***炎症,多发生于产后哺乳期的妇女,尤其是初产妇更为多见。有文献报道急性乳腺炎初产妇患病占50%,初产妇与经产妇之比为2.4:1。哺乳期的任何时间均可发生,但以产后3~4周最为常见,故又称产褥期乳腺炎。
产褥期乳腺炎常发生于第一次分娩后,根据病变发展过程分以下两种类型:淤积性乳腺炎和化脓性乳腺炎。产褥期乳腺炎即急性乳腺炎时***的化脓性感染,几乎所有病人均为初产妇,发病多在产后3~4周,临床主要表现为***的红、肿、热、痛,局部肿块、脓肿形成,体温升高,白细胞计数增高。在脓肿形成前以抗感染促进乳汁排出为主,脓肿形成后以切开引流为主。预后较好。
因此,亟需提供一种疗效好、成本低、治愈率高、无不良反应等优点、疏肝理气、清热解毒、祛瘀散结、消肿止痛、疗程短、不易复发、可大量运用于临床实践中的治疗急性乳腺炎的中药组合物。
发明内容
为了解决上述问题,本发明提供一种疗效好、成本低、治愈率高、无不良反应等优点、疏肝理气、清热解毒、祛瘀散结、消肿止痛、疗程短、不易复发、可大量运用于临床实践中的治疗急性乳腺炎的中药组合物。
本发明采用的技术方案是:一种治疗急性乳腺炎的中药组合物,所述中药组合物的各组份为白茎鸦葱、草血竭、元胡、凹头苋、蛋不老、赤甲红、鸨油、腹水草、含羞草、旱金莲、黄芪。
优选的,各种组份的重量份数比为白茎鸦葱25-35份、草血竭15-25份、元胡15-25份、凹头苋10-20份、蛋不老10-20份、赤甲红5-15份、鸨油5-15份、腹水草5-15份、含羞草5-15份、旱金莲5-15份、黄芪5-15份。
更优选的,各种组份的重量份数比为白茎鸦葱30-35份、草血竭20-25份、元胡20-25份、凹头苋10-15份、蛋不老10-15份、赤甲红5-10份、鸨油5-10份、腹水草5-10份、含羞草5-10份、旱金莲5-10份、黄芪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,草血竭、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,将凹头苋、蛋不老、赤甲红、鸨油用醇浓度为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,草血竭、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,将凹头苋、蛋不老、赤甲红、鸨油用醇浓度为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。
白茎鸦葱,味甘、苦,性微凉,清热解毒,祛风除湿,平喘。用于感冒发热,哮喘,乳腺炎,疔疮,关节痛,带状疱疹。
草血竭,味苦、涩,性微温,活血散瘀,止痛,止血。用于慢性胃炎,胃、十二指肠溃疡,痢疾,肠炎,***,红崩,白带,跌打损伤;外用治创伤出血。
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”。
常春藤,味哭、辛,性温,祛风利湿,活血消肿。用于风湿关节痛,腰痛,跌打损伤,急性结膜炎,肾炎水肿,闭经;外用治痈疖肿毒,荨麻疹,湿疹。
赤甲红,破血,通乳,消食积。
大麦泡,味涩、性温,消食积,止泻痢,解毒,活血,调经,止血。主治食积饱胀,肚痛腹泻,红白痢疾,红崩带下。外用治跌打损伤,黄水疮。
蛋不老,味辛、性平,祛风去湿,活血调经,止痛。用于感冒,虚劳咳嗽,***结核,风湿性关节炎,坐骨神经痛,跌打损伤,***,白带。
腹水草,味苦、辛,性凉,利尿消肿,散瘀解毒。用于腹水,水肿,小便不利,***,闭经,跌打损伤;外用治腮腺炎,疔疮,烧烫伤,毒蛇咬伤。
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。
旱金莲,味辛、性凉,清热解毒。用于眼结膜炎,痈疖肿毒。
黄芪,味甘、性温,归肺、脾经,补气固表,利尿托毒,排脓,敛疮生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,痈疽难溃,久溃不敛,血虚痿黄,内热消渴;慢性肾炎蛋白尿,糖尿病。
本发明的有益效果:
相对于现有技术中的具有治疗急性乳腺炎效果的药物,采用此种中药组合物在治疗急性乳腺炎方面具有疗效好、成本低、治愈率高、无不良反应等优点。本发明的中药组合物疏肝理气,清热解毒,祛瘀散结,消肿止痛,疗程短、不易复发,可大量运用于临床实践中。
具体实施方式
实施例1:
(一)一种治疗急性乳腺炎的中药,由以下原料药按重量份配比而成:
白茎鸦葱30份、草血竭25份、元胡20份、凹头苋15份、蛋不老15份、赤甲红10份、鸨油10份、腹水草10份、含羞草10份、旱金莲5份、黄芪5份。
(二)制备方法:
第一步,草血竭、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,将凹头苋、蛋不老、赤甲红、鸨油用醇浓度为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)一种治疗急性乳腺炎的中药,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,草血竭、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,将凹头苋、蛋不老、赤甲红、鸨油用醇浓度为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,均为女性。
(二)诊断标准:
诊断标准:参照《实用妇产科学》中急性乳腺炎的诊断标准:(1)患者均为哺乳期妇女,尤以未满月的初产妇为多;(2)初起***内有疼痛性肿块,伴排乳不畅,脓肿形成时***肿痛加重,肿块***,有波动感;(3)患者腋下常有***肿大伴疼痛;(4)全身多有恶寒,发热,头痛,周身不适,白细胞计数增加。
(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,肿块消散,排乳正常通畅,血液化验白细胞正常。
有效:症状消失,肿块缩小,排乳部分通畅,血液化验白细胞正常。
无效:症状无改变或加重。
(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 | 12 | 48 |
1组 | 58 | 1 | 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)
1.一种治疗急性乳腺炎的中药组合物,其特征在于:所述中药组合物的各组份为白茎鸦葱、草血竭、元胡、凹头苋、蛋不老、赤甲红、鸨油、腹水草、含羞草、旱金莲、黄芪。
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茎鸦葱25-35份、草血竭15-25份、元胡15-25份、凹头苋10-20份、蛋不老10-20份、赤甲红5-15份、鸨油5-15份、腹水草5-15份、含羞草5-15份、旱金莲5-15份、黄芪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茎鸦葱30-35份、草血竭20-25份、元胡20-25份、凹头苋10-15份、蛋不老10-15份、赤甲红5-10份、鸨油5-10份、腹水草5-10份、含羞草5-10份、旱金莲5-10份、黄芪5-10份。
4.如权利要求1-3中任一项所述治疗急性乳腺炎的中药组合物,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中任一项所述治疗急性乳腺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,草血竭、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,将凹头苋、蛋不老、赤甲红、鸨油用醇浓度为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中任一项所述治疗急性乳腺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,草血竭、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,将凹头苋、蛋不老、赤甲红、鸨油用醇浓度为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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