CN105709193A - 一种含有艾叶的治疗慢性肠炎的中药制剂及其制备方法 - Google Patents
一种含有艾叶的治疗慢性肠炎的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明属于中药领域,涉及一种含有艾叶的治疗慢性肠炎的中药制剂及其制备方法。该中药制剂由以下重量份数的原料制备而成:艾叶2127份、榕树叶1926份、倒根野苏1722份、五月茶1521份、枳壳1622份、芡实915份、枸杞子1318份、绞股蓝1216份、荠菜613份、肉豆蔻1016份、生姜915份和甘草513份。本发明中药制剂具有健脾养胃化湿,益气燥湿消食之功效,治疗慢性肠炎具有显著疗效。经临床实验,采用本发明中药制剂的患者治愈后经6个月观察期后无复发现象。本发明中药制剂疗效好,治愈率高,无毒副作用,临床应用价值高,可以作为治疗慢性肠炎的药物使用。
Description
技术领域
本发明属于中药领域,尤其涉及一种含有艾叶的治疗慢性肠炎的中药制剂及其制备方法。
背景技术
肠炎是细菌、病毒、真菌和寄生虫等引起的小肠炎和结肠炎。临床表现主要有腹痛、腹泻、稀水便或黏液脓血便。部分病人可有发热及里急后重感觉,故亦称感染性腹泻。肠炎按病程长短不同,分为急性和慢性两类。慢性肠炎病程一般在两个月以上,临床常见的有慢性细菌性痢疾、慢性阿米巴痢疾、血吸虫病、非特异性溃疡性结肠炎和限局性肠炎等。
现代医学认为,腹泻的发病基础是胃肠道的分泌、消化、吸收等功能紊乱、障碍,使分泌量增加,食物不能被完全分解,吸收量减少,肠蠕动加快,最终导致粪质稀薄和排便次数增多。肠黏膜病理改变为结肠黏膜充血、水肿、出血。目前西医治疗主要采用水杨酸盐类药物及糖皮质激素等对该病进行消炎、止血、止泻治疗,其中柳氮磺胺吡啶被认为是治疗溃疡性结肠炎的首选药,但单纯应用疗效不理想、易复发。
在中医学上,慢性肠炎是“泄泻”的一种,病变主要累及脾胃和大、小肠等,并同时与肝、肾相关。这是因为脾主运化,大肠主津,小肠主液,患者常常因脾虚湿盛,长期运化失职,阴阳失调所致。治疗时宜注重健脾益气和固本止泻,使得阳气得升,浊阴得降,则治愈。
中国专利申请201010278766.8公开了一种治疗慢性肠炎的中药,是由干姜10-15份,毛姜4-12份,黄芪20-40份,当归10-15份,赤石脂15-25份,白术15-25份按一定量制备而成,该发明中药用于治疗慢性肠炎,但是该中药药理、药效都不明确。
发明内容
本发明要解决的技术问题是提供一种治疗慢性肠炎的中药制剂及其制备方法,具体的,涉及一种含有艾叶的治疗慢性肠炎的中药制剂及其制备方法,本发明中药制剂具有健脾养胃化湿,益气燥湿消食之功效,治疗慢性肠炎具有显著疗效。本发明中药制剂疗效好,治愈率高,无毒副作用,临床应用价值高,可以作为治疗慢性肠炎的药物使用。此外,本发明还提供相应的制造工艺将该中药制剂在保证疗效的前提下制成方便易用的制剂。
本发明中药制剂由以下重量份数的原料制备而成:
艾叶21-27份、榕树叶19-26份、倒根野苏17-22份、五月茶15-21份、枳壳16-22份、芡实9-15份、枸杞子13-18份、绞股蓝12-16份、荠菜6-13份、肉豆蔻10-16份、生姜9-15份和甘草5-13份。
进一步地,所述中药制剂由以下重量份数的原料制备而成:
艾叶21份、榕树叶19份、倒根野苏17份、五月茶15份、枳壳16份、芡实9份、枸杞子13份、绞股蓝12份、荠菜6份、肉豆蔻10份、生姜9份和甘草5份。
进一步地,所述中药制剂由以下重量份数的原料制备而成:
艾叶27份、榕树叶26份、倒根野苏22份、五月茶21份、枳壳22份、芡实15份、枸杞子18份、绞股蓝16份、荠菜13份、肉豆蔻16份、生姜15份和甘草13份。
进一步地,所述中药制剂由以下重量份数的原料制备而成:
艾叶份24、榕树叶份22、倒根野苏19份、五月茶18份、枳壳18份、芡实12份、枸杞子15份、绞股蓝14份、荠菜11份、肉豆蔻13份、生姜12份和甘草9份。
进一步地,所述中药制剂为胶囊剂、片剂、散剂、口服液、颗粒剂或丸剂。
相应地,所述中药制剂的制备方法包含下述步骤:
S1、将艾叶、榕树叶、倒根野苏、五月茶、枳壳、芡实、枸杞子、绞股蓝、荠菜、肉豆蔻、生姜和甘草分别去杂质,洗净,烘干,粉碎成粗粉;加入上述粗粉8-11倍纯化水,煎煮2-3次,每次1-3小时,过滤,合并滤液,减压干燥,将滤液浓缩成55-65℃时相对密度为1.15-1.20的水提浓缩液;
S2、将S1得到的水提浓缩液浓缩至60-70℃环境下相对密度为1.25-1.36,即为中药浸膏;
S3、将步骤S2得到的中药浸膏添加辅料制成成品中药制剂。
本发明所用组分的来源、性味、归经及功效:
艾叶:为菊科植物艾的干燥叶;味辛、苦,性温,归肝、脾、肾经;温经止血,散寒止痛,调经安胎,除湿止痒,通经活络。
榕树叶:为桑科植物榕树的叶片;味淡,性凉;活血散瘀,解热理湿。
倒根野苏:为唇形科植物蓝萼香茶散的全草或叶;味苦,性凉;健胃消食,清热解毒。
五月茶:为大戟科五月茶,以根、叶入药;味酸,性温;归肺、肾经;健脾,生津,活血,解毒。
枳壳:为芸香科植物酸橙及其栽培变种的干燥未成熟果实;味苦、辛、酸,性温;归脾、胃经;理气宽中,行滞消胀。
芡实:为睡莲科植物芡的干燥成熟种仁;味甘、涩,性平;归脾、肾经;益肾固精,补脾止泻,祛湿止带。
枸杞子:为茄科植物宁夏枸杞的干燥成熟果实;其味甘,性平;归肝、肾经;滋肾,润肺,补肝,明目。
绞股蓝:葫芦科绞股蓝属植物绞股蓝,以根状茎入药;味苦,性寒;归肺、脾、肾经;清热,补虚,解毒。
荠菜:十字花科,荠属植物荠的通称,味甘,性平,凉,入肝、肺、脾经;具有和脾,清热,利水,消肿,平肝,止血,明目的功效。
肉豆蔻:为肉豆蔻科肉豆蔻属植物肉豆蔻的干燥种仁;味辛,性温;归脾、胃、大肠经;温中行气,涩肠止泻。
生姜:为姜科植物姜的新鲜根茎;味辛,性微温;归肺、脾、胃经;解表散寒,温中止呕,化痰止咳。
甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
本发明中药的组方分析:
依据中医对具有消炎止痛功效的辨证和中药材的配伍理论,结合现代人的身体素质和现代制药技术的特点,合理科学的搭配各味药材,形成本发明中药组方。本发明组方是以艾叶为君药,散寒止痛,通经活络;以榕树叶、倒根野苏和五月茶为臣药,健胃健脾,清热解毒,消食生津;以枳壳、芡实、枸杞子、绞股蓝和荠菜为佐药,理气宽中,益肾固精,补脾止泻,行滞消胀;以肉豆蔻、生姜和甘草为使药,温中行气,调和诸药;君臣佐使诸药配合,协同促进,相辅相成,最终达到健脾养胃化湿,益气燥湿消食的功效,适用慢性肠炎的患者。
与现有技术相比,本发明具有如下技术优势:
1、本发明中药制剂能够显著降低慢性肠炎小鼠结肠匀浆中炎症介质IL-6、IL-13的浓度。
2、与当前治疗慢性肠炎的化学治疗药物相比,本发明中药制剂为天然纯中药制剂,不良反应和副作用显著降低,且本发明中药制剂作用全面,药物治疗效果更佳,有效地解决了慢性肠炎的发病根源,并提高了患者的生活质量。
3、本发明中药制剂还具有配伍科学、治愈率高、不易复发等优点。
具体实施方式
本领域技术人员应理解,以下实施例中所公开的技术代表本发明人发现的在本发明的实践中发挥良好作用的技术。然而,在所公开的具体实施方案中可以做出许多改变,并仍然获得相同或相似的结果,而不脱离本发明的精神和范围。
实施例1:
本发明实施例1中药制剂由以下重量份数的原料制备而成:艾叶21份、榕树叶19份、倒根野苏17份、五月茶15份、枳壳16份、芡实9份、枸杞子13份、绞股蓝12份、荠菜6份、肉豆蔻10份、生姜9份和甘草5份。
制备方法如下:
S1、将艾叶、榕树叶、倒根野苏、五月茶、枳壳、芡实、枸杞子、绞股蓝、荠菜、肉豆蔻、生姜和甘草分别去杂质,洗净,烘干,粉碎成粗粉;加入上述粗粉9倍的纯化水,煎煮2次,每次2小时,过滤,合并滤液,减压干燥,将滤液浓缩成60℃时相对密度为1.15的水提浓缩液;
S2、将S1得到的水提浓缩液浓缩至65℃环境下相对密度为1.30,即为中药浸膏;
S3、将中药浸膏添加辅料,以现代中药制剂常规工艺制成胶囊。
实施例2:
本发明实施例2中药制剂由以下重量份数的原料制备而成:艾叶27份、榕树叶26份、倒根野苏22份、五月茶21份、枳壳22份、芡实15份、枸杞子18份、绞股蓝16份、荠菜13份、肉豆蔻16份、生姜15份和甘草13份。
制备方法同实施例1。
实施例3:
本发明实施例3中药制剂由以下重量份数的原料制备而成:艾叶份22、榕树叶份20、倒根野苏18份、五月茶16份、枳壳17份、芡实10份、枸杞子14份、绞股蓝13份、荠菜8份、肉豆蔻11份、生姜10份和甘草7份。
制备方法同实施例1。
实施例4:
本发明实施例4中药制剂由以下重量份数的原料制备而成:艾叶份26、榕树叶份24、倒根野苏21份、五月茶20份、枳壳20份、芡实14份、枸杞子17份、绞股蓝15份、荠菜12份、肉豆蔻15份、生姜14份和甘草11份。
制备方法同实施例1。
实施例5:
本发明实施例5中药制剂由以下重量份数的原料制备而成:艾叶份24、榕树叶份22、倒根野苏19份、五月茶18份、枳壳18份、芡实12份、枸杞子15份、绞股蓝14份、荠菜11份、肉豆蔻13份、生姜12份和甘草9份。
制备方法同实施例1。
本发明中药制剂对慢性肠炎模型动物炎症介质的影响
一、实验动物:SPF级雄性BALB/c小鼠50只,8周龄,体重22±2g,由中国医学科学院实验动物中心提供。
二、实验药物:本发明实施例1和实施例5制备得到的胶囊剂加入3倍质量的水溶解;阳性对照药为肠炎宁片,做同样处理(江西天施康弋阳制药有限公司,国药准字150826Z30)。
三、模型制造:给予小鼠饮用含有7%葡聚糖硫酸钠(dextransulfatesodium,DSS)的饮用水维持10天。
四、实验方法:
1、随机挑选50只小鼠分为10组,正常对照组、模型组、阳性对照组、实验1组、实验2组。实验1、2组分别给与实验例1和5制得的药物,正常对照组给予正常饮水。其余7组进行造模处理。造模成功后开始给药。
五、实验结果
表1造模小鼠神结肠匀浆的炎症介质IL-6、IL-13的变化
组别 | 数量 | 计量g/kg | IL-6(ng/L) | IL-13(ng/L) |
正常对照组 | 10 | 10.32±5.18 | 7.62±4.32 | |
模型组 | 10 | - | 38.12±5.14△△ | 19.42±6.98△△ |
阳性对照组 | 10 | 0.75 | 13.54±5.21** | 10.74±6.02* |
实验1组 | 10 | 0.8 | 14.14±3.13** | 11.84±6.54* |
实验2组 | 10 | 0.8 | 12.54±3.84** | 9.84±4.36* |
与正常对照组比较ΔΔP<0.05;与模型组比较*P<0.05,**P<0.01;
从实验结果可以看出,与正常对照组相比模型组小鼠体内炎症介质IL-6、IL-13浓度显著增高,说明造模成功;本发明中药制剂各实施例组均能显著降低造模小鼠体内炎症介质IL-6、IL-13浓度,说明本发明中药制剂能够显著抑制慢性肠炎小鼠的炎症反应,实验例5制得的中药制剂效果最为显著,并且优于阳性对照组。综上所述,本发明中药制剂可以显著降低慢性肠炎小鼠体内炎症介质IL-6、IL-13,对慢性肠炎小鼠的炎症反应抑制作用显著。
本发明中药制剂对慢性肠炎临床志愿者患者的疗效观察
一、诊断标准
参照第四届全国慢性非感染性肠道病学术研讨会制定的《慢性结肠炎的诊断及疗效标准》中有关慢性结肠炎的相关内容确定:
1、持续或反复发作的腹泻、腹痛半年以上;;
2、大便常规及培养排除慢性菌痢、慢性阿米巴痢、肠结核、结肠癌等;
3、结肠镜检查可见黏膜细颗粒状弥漫性充血、水肿、糜烂或溃疡。
二、疗效标准
参照1992全国慢性非感染肠道病学术研讨会制定的慢性肠炎治疗疗效判定标准而定:
治愈:临床症状完全消失,采用纤维肠镜检查发现肠黏膜恢复正常,停药后6个月内没有复发;
有效:临床症状基本消失,采用纤维肠镜检查发现肠黏膜呈轻度炎性反应,并可看见少量假息肉;
无效:在治疗疗程满后,临床症状和纤维肠镜检查肠黏膜均没有明显改善。
三、临床试验
1、一般资料
将200名入选的慢性肠炎临床志愿者患者随机均分成2组,每组100人,分别为治疗组和对照组,各组年龄、症状等影响因素,经统计学处理,无显著性差异,符合分组条件。
2、治疗方法
治疗组:服用实施例5制备得到的胶囊,每日3次,每次2.5g,连服一个月;
对照组:服用肠炎宁片(江西天施康弋阳制药有限公司,国药准字150826Z30,0.42g*12片*4板/盒),一次4片,一日3次,连服一个月。
3、治疗结果,如表2所示。
表2治疗效果
组别 | 例数 | 治愈 | 有效 | 无效 | 总有效率 |
治疗组 | 100 | 88 | 8 | 4 | 96% |
对照组 | 100 | 59 | 20 | 12 | 88% |
本试验采用肠炎宁片作为对照组,肠炎宁片由地锦草、金毛耳草、樟树根、香薰和枫香树叶等中药精心提炼而成,具有清热利湿,行气的功效,临床上可用于治疗慢性肠炎。从治愈率和总有效率上可看出,本发明中药制剂的的治愈率明显高于对照组,总有效率大于90%,也远高于对照组的总有效率。采用本发明中药制剂的患者治愈后经6个月观察期后,并无复发。此外,所有受试者经体格检查,血、尿常规、心电图、肝肾功能等安全性检查,进一步证实本发明中药制剂在不良反应、治病兼调理两个方面有显著的治疗优势,具有推广应用的价值。
由于已经通过以上较佳实施例描述了本发明,在本发明的精神和/或范围内,任何针对本发明的替换/或组合来实施本发明,对于本领域的技术人员来说都是显而易见的,且包含在本发明之中。
Claims (6)
1.一种含有艾叶的治疗慢性肠炎的中药制剂,其特征在于,所述中药制剂由以下重量份数的原料制备而成:
艾叶21-27份、榕树叶19-26份、倒根野苏17-22份、五月茶15-21份、枳壳16-22份、芡实9-15份、枸杞子13-18份、绞股蓝12-16份、荠菜6-13份、肉豆蔻10-16份、生姜9-15份和甘草5-13份。
2.如权利要求1所述的含有艾叶的治疗慢性肠炎的中药制剂,其特征在于,所述中药制剂由以下重量份数的原料制备而成:
艾叶21份、榕树叶19份、倒根野苏17份、五月茶15份、枳壳16份、芡实9份、枸杞子13份、绞股蓝12份、荠菜6份、肉豆蔻10份、生姜9份和甘草5份。
3.如权利要求1所述的含有艾叶的治疗慢性肠炎的中药制剂,其特征在于,所述中药制剂由以下重量份数的原料制备而成:
艾叶27份、榕树叶26份、倒根野苏22份、五月茶21份、枳壳22份、芡实15份、枸杞子18份、绞股蓝16份、荠菜13份、肉豆蔻16份、生姜15份和甘草13份。
4.如权利要求1所述的含有艾叶的治疗慢性肠炎的中药制剂,其特征在于,所述中药制剂由以下重量份数的原料制备而成:
艾叶份24、榕树叶份22、倒根野苏19份、五月茶18份、枳壳18份、芡实12份、枸杞子15份、绞股蓝14份、荠菜11份、肉豆蔻13份、生姜12份和甘草9份。
5.如权利要求1-4任一所述的含有艾叶的治疗慢性肠炎的中药制剂,其特征在于,所述中药制剂为胶囊剂、片剂、散剂、口服液、颗粒剂或丸剂。
6.如权利要求1-4任一所述的含有艾叶的治疗慢性肠炎的中药制剂的制备方法,其特征在于,所述中药制剂的制备方法包含下述步骤:
S1、将艾叶、榕树叶、倒根野苏、五月茶、枳壳、芡实、枸杞子、绞股蓝、荠菜、肉豆蔻、生姜和甘草分别去杂质,洗净,烘干,粉碎成粗粉;加入上述粗粉8-11倍纯化水,煎煮2-3次,每次1-3小时,过滤,合并滤液,减压干燥,将滤液浓缩成55-65℃时相对密度为1.15-1.20的水提浓缩液;
S2、将S1得到的水提浓缩液浓缩至60-70℃环境下相对密度为1.25-1.36,即为中药浸膏;
S3、将步骤S2得到的中药浸膏添加辅料制成成品中药制剂。
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CN102973916A (zh) * | 2012-11-20 | 2013-03-20 | 青岛大学医学院附属医院 | 一种治疗慢性肠炎的中药方剂及其制造方法 |
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