CN108815448A - 一种治疗慢性结肠炎的中药颗粒剂 - Google Patents
一种治疗慢性结肠炎的中药颗粒剂 Download PDFInfo
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- CN108815448A CN108815448A CN201810782877.9A CN201810782877A CN108815448A CN 108815448 A CN108815448 A CN 108815448A CN 201810782877 A CN201810782877 A CN 201810782877A CN 108815448 A CN108815448 A CN 108815448A
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Abstract
本发明涉及医药技术领域,具体是一种治疗慢性结肠炎的中药颗粒剂和应用。本发明经药效学实验表明,对于慢性溃疡性结肠炎动物模型具有显著的治疗效果;本发明在临床用于慢性结肠炎的治疗,疗效显著,且未见严重不良反应发生,安全可靠;本发明将为慢性结肠炎的中医药治疗提供一种新的有效药物,丰富中药制剂学的研究内容,并为中药医院制剂向新药转化提供方法借鉴。
Description
技术领域
本发明涉及医药技术领域,具体地说,是一种治疗慢性结肠炎的中药颗粒剂及其制备方法和应用。
背景技术
慢性结肠炎是一种常见的多发性的以结肠、乙状结肠和直肠为发病部位的肠道疾病,该病的主要症状为左下腹疼、腹泻、里急后重、时便下粘液、便秘或泄泻交替性发生、时好时坏。据统计,近10年我国慢性结肠炎的发病率较上世纪50年代增长了10倍,已成为临床常见病和多发病之一。目前,西医治疗慢性结肠炎只适合于短期用药;若长期给药,还会引起严重的胃肠道反应、骨髓造血功能抑制、过敏等多种不良反应。因此,从传统中医药中寻找和开发新型抗慢性结肠炎药物具有良好的发展潜力和重要的科学价值。慢性结肠炎根据其典型临床表现,临床治疗应以燥湿化浊以治标、健脾安中止泻以培本为主要治法。
发明内容
本发明的目的在于提供一种治疗慢性结肠炎的中药颗粒剂及其制备方法和应用。
本发明的一种治疗慢性结肠炎的中药颗粒剂,是治疗慢性结肠炎的特色制剂,由白术、党参、白豆蔻、黄连、防风、乌梅、赤石脂7味药组成。本方系根据慢性结肠炎“脾气虚弱,湿蕴化热,波血及肝”的中医核心病机,选择具有健脾益气、清热燥湿、泻肝制酸作用的白术为君药;方中党参功能补益脾肺,白豆蔻功能化湿行气,为治疗湿阻气滞,脾胃不和之要药,二者合用,益气健脾治其本,行气化湿治其标,助君药健脾利湿止泻,共为臣药。黄连清热燥湿、厚肠止利,防风祛风解表,胜湿止痛,乌梅涩肠止泻、主治久泻久痢,共为佐药;赤石脂引药入大肠,用为使药。诸药合用,共奏健脾益气,利湿清热,涩肠止泻之功。
对该方的现代研究证实:白术主要含有挥发油和多糖类成分,其中挥发油中的内酯类成分具有抗炎、调节免疫作用,并具有改善胃肠道功能和促进营养物质吸收的功效,尤以白术内酯Ⅰ作用显著。同时,白术能促进胃粘膜细胞的增殖,刺激胃蛋白酶的分泌,并对应激性溃疡有很强的预防效果。党参含多种糖类、酚类、甾醇、皂甙及微量生物碱等成分,具有增强免疫力、改善微循环、增强造血功能等作用。白豆蔻含有多种挥发油类成分,能促进胃液分泌,增强胃肠蠕动,制止肠内异常发酵,祛除胃肠积气,有良好的芳香健胃作用。黄连中的小檗碱等生物碱类成分具有抗菌、抗炎、抑制血小板聚集、降血糖和抗心律失常等广泛的药理活性。对于对右旋葡聚糖硫酸诱导的小鼠溃疡性结肠炎具有显著的抑制作用,可以剂量依赖性的减轻小鼠结肠炎症状,阻遏结肠黏膜病理改变,降低结肠组织MDA含量,增加MPO活力及SOD活性,其疗效与柳氮磺胺吡啶相当。防风主要含有挥发油、色原酮类、香豆素类、多糖等成分,其提取物具有抗菌、抗炎、抗过敏、止血和免疫调节等作用,乌梅中的有机酸类成分具有明显的抗菌、抗过敏作用,这些组分对于慢性结肠炎引起的出血、腹痛、腹泻等症状均具有良好的抑制作用。该方组方全面,配伍合理,对于久治不愈、反复发作的慢性结肠炎患者具有显著的治疗效果。处方中各药物明确的现代药学研究结果为采用现代制剂工艺将该方制备成符合现代生活需要的新的中药复方制剂提供了坚实的试验依据。
针对本发明的治疗慢性结肠炎的中药颗粒剂服用量大(20g/次,每日3次)、含有大量糖分,不适合糖尿病等特殊人群需要、现有的质量标准粗糙,制剂稳定性差等缺点,采用现代制剂工艺,将其开发成服用携带方便、适用范围广、稳定性好等适应现代生活和社会发展需要的中药六类新药,将具有良好的社会效益与经济效益。
本发明的第一方面,提供一种治疗慢性结肠炎的中药颗粒剂,由以下重量份的原料药制成:白术150-200份,党参100-120份,白豆蔻90-120份,黄连75-100份,防风60-90份,乌梅75-100份,赤石脂200-240份。
进一步的,所述的治疗慢性结肠炎的中药颗粒剂的制备方法,包括以下步骤:
(A)原料提取物干浸膏粉碎至细粉,过100目筛,将乳糖和干浸膏粉放于流化床的流化室中,通过调节风量至物料沸腾;
(B)物料经过预热后方可启动喷雾,当物料的温度达到40℃后,开雾化器,选用浓度是5%的HPMC作粘合剂,雾化器压力调整至0.1MPa,然后向流化室内喷入粘合剂,进行制粒;
(C)调节风机的转速为1700rpm,进风的温度为65℃,蠕动泵进料的速度为4→6→8HZ;
(D)待颗粒成型后,需要继续用50℃的热风进行干燥,大概0.5小时后,取出颗粒进行称重,分别把颗粒过1号筛及5号筛,最后进行整理收集可以过1号筛但是不能过5号筛的颗粒,分装即得。
进一步的,步骤(A)所述的原料提取物干浸膏的制备方法,包括以下步骤:
a、按配比称取白术、党参、白豆蔻、黄连、防风、乌梅,赤石脂,加入药材重量10倍的蒸馏水煎煮,煎煮次数2次,煎煮时间为每次1h;
b、滤过煎煮液,滤液浓缩至90-95℃相对密度为1:1.08~1.10,待冷至室温,加入95%乙醇调节醇沉浓度至70%;
c、4℃静置24小时,滤过,滤液减压浓缩回收乙醇,浓缩成50-60℃相对密度为1:1.25-1.30的浸膏;
d、再在60℃,1Mpa下进行减压干燥,得到提取物干浸膏。
本发明的第二方面,提供一种如上所述的治疗慢性结肠炎的中药颗粒剂在制备预防或治疗慢性结肠炎药物或保健食品中的应用。
本发明优点在于:
1、本发明经药效学实验表明,对于慢性溃疡性结肠炎动物模型具有显著的治疗效果。经临床试验,治疗慢性溃疡性结肠炎的有效率为95%,治疗慢性非溃疡性结肠炎的有效率为90%,与对照组相比具有显著统计学差异;
2、本发明在临床用于慢性结肠炎的治疗,疗效显著,且未见严重不良反应发生,安全可靠;
3、本发明将为慢性结肠炎的中医药治疗提供一种新的有效药物,丰富中药制剂学的研究内容,并为中药医院制剂向新药转化提供方法借鉴。
具体实施方式
下面结合实施例对本发明提供的具体实施方式作详细说明。
实施例1:
一种治疗慢性结肠炎的中药颗粒剂,由以下重量份的原料药制成:白术150份,党参100份,白豆蔻90份,黄连75份,防风60份,乌梅75份,赤石脂200份。
实施例2:
一种治疗慢性结肠炎的中药颗粒剂,由以下重量份的原料药制成:白术200份,党参120份,白豆蔻120份,黄连100份,防风90份,乌梅100份,赤石脂240份。
实施例3:
一种治疗慢性结肠炎的中药颗粒剂,由以下重量份的原料药制成:白术160份,党参105份,白豆蔻95份,黄连80份,防风65份,乌梅80份,赤石脂210份。
实施例4:
一种治疗慢性结肠炎的中药颗粒剂,由以下重量份的原料药制成:白术170份,党参110份,白豆蔻100份,黄连85份,防风70份,乌梅85份,赤石脂220份。
实施例5:
一种治疗慢性结肠炎的中药颗粒剂,由以下重量份的原料药制成:白术180份,党参115份,白豆蔻110份,黄连90份,防风75份,乌梅90份,赤石脂230份。
实施例6:
一种治疗慢性结肠炎的中药颗粒剂,由以下重量份的原料药制成:白术190份,党参118份,白豆蔻115份,黄连95份,防风80份,乌梅95份,赤石脂225份。
实施例7:本发明的中药复方提取物
称取白术300g,党参200g、白豆蔻180g、黄连150g,防风120g,乌梅150g,赤石脂400g加入10倍量的水煎煮2次,煎煮时间为每次1小时,合并煎煮液,滤过,滤液浓缩至相对密度为1∶1.08~1.10(90-95℃),待冷至室温,加入95%乙醇调节溶液醇浓度至70%,4℃静置24小时,滤过,滤液减压浓缩回收乙醇,浓缩成相对密度为1∶1.25-1.30(50-60℃)的浸膏,再在60℃,1Mpa下进行减压干燥,得到提取物干浸膏。
实施例8:本发明的颗粒剂的制备
将实施例7所得的提取物干浸膏提取物干浸膏粉碎至细粉,过100目筛,称取20g乳糖和200g干浸膏粉放于流化床的流化室中,通过调节风量至物料沸腾。物料预热后方可启动喷雾,即当物料的温度达到40℃后,开雾化器,选用质量浓度是5%的HPMC作粘合剂,雾化器压力调整至0.1MPa,向流化室喷入粘合剂制粒,进行制粒。把风机的转速频率通过调节直至1700rpm,进风的温度设定为65℃,蠕动泵的速度设为4→6→8Hz(每个速度保持10分钟调整到下一转速,到达最高转速后保持不变至制备完成)。待颗粒成型后,需要继续用50℃的热风进行干燥,大概0.5小时后,取出颗粒进行称重,分别把颗粒过1号筛及5号筛,最后进行整理收集可以过1号筛但是不能过5号筛的颗粒。分装即得。
实施例9:临床试验
采用实施例8制备的颗粒剂,治疗慢性结肠炎患者60例,观察其有效性和安全性。其中,男36例,女24例,随机分成3组,即慢性溃疡性结肠炎治疗组、慢性非溃疡性结肠炎治疗组和对照组,每组20人。两个治疗组患者均口服本发明实施例8中制备的中药复方提取物颗粒剂,对照组所用的颗粒制剂为空白颗粒制剂,即不含中药复方提取物成分,以同样比例的乳糖和糊精加入焦糖色食用着色剂将颗粒制成与实施例8制备的颗粒制剂相同外观和口感,口服给药,每日2次,每次6g,用药疗程8周。整体评价病人恢复情况,分为显效、好转、无效3个层次。结果见表1。
表1治疗8周总体疗效改善评价表
有效率:(显效例数+好转例数)/全部病例数×100%
经过8周的治疗,治疗慢性溃疡性结肠炎的有效率为95%,治疗慢性非溃疡性结肠炎的有效率为90%,对照组的有效率为25%,治疗组要明显优于对照组。
两个治疗组共发生3例轻度恶心、腹胀或不适,对照组未见不良反应发生,组间相比无统计学差异,表明本发明的颗粒剂的安全性良好。
实施例10组方配伍剂量研究实验
采用药效学研究方法筛选本发明组方的药物配伍剂量。
1.实验动物
健康雄性SD大鼠,清洁级,体重在180g~200g,购于第二军医大学实验动物中心(动物合格证号:SCXK2017-0003),自由饮水和进食。
2.试药
分别取本发明实施例1、实施例2、实施例3配伍剂量的中药原料药,按实施例7-8的药材提取工艺、颗粒剂制备工艺制备出处方编号为1-3的供试样品1、样品2、样品3,进行药效学研究。
3.动物分组及慢性溃疡性结肠炎大鼠模型的建立
取雄性SD大鼠60只,随机分成6组,即正常对照组,模型组,阳性对照药柳氮磺胺砒啶组,样品1、样品2、样品3组,每组10只。禁食不禁水24h后,除正常对照组外,其余各组大鼠造模,腹腔注射2%的戊巴比妥纳,使大鼠轻微麻醉后,将直径2mm的乳胶管经***轻轻***大鼠体内大约8cm处,将造模剂TNBS溶于50%乙醇水溶液,将TNBS溶液用注射器一次性注入到大鼠的肠腔内,TNBS剂量为按体重100mg/kg,将大鼠的尾部提起,倒置30秒,防止造模剂渗漏,使造模剂充分渗透入大鼠的肠腔。
4.给药方法及评价指标
造模后6h开始给药,每日一次,连续给药10d。给药组分别每日灌胃给药2ml;正常对照组及模型组大鼠每日灌胃同体积的生理盐水。分别观察不同样品组对慢性溃疡性结肠炎模型大鼠体重变化、腹泻、便血的影响。
各组大鼠给药10d后,注射过量戊巴比妥钠致死,剖开大鼠腹部,观察肠道大体改变。将距***10cm长的末段结肠取出,沿肠系膜纵行切开,用冰生理盐水冲洗,用滤纸吸干水分后称质量。将黏膜面向上展开,观察黏膜损伤并按照Wallace和Keenan1990年的评分标准进行评分:0分,无炎症和溃疡;1分,局部充血但无溃疡;2分,溃疡但无充血;3分,一处溃疡及炎症;4分,两处或两处以上溃疡及炎症;5分,溃疡延伸超过2cm。
5.实验结果
5.1不同配比样品颗粒对慢性溃疡性结肠炎模型大鼠体重变化的影响
正常对照组大鼠由于禁食1d,体重在略微减轻后逐渐恢复到最初体重,并逐渐增加至原体重的115%。TNBS模型组大鼠的体重在造模后迅速下降,在第2d降到原始体重的86%,在1~7d内体重显著低于正常组大鼠体重(P<0.05),3组样品中,样品1、样品3和阳性对照组大鼠体重恢复较快,5~6d逐渐恢复到最初体重,且1~7d内大鼠的体重显著高于模型大鼠(P<0.05)。
5.2不同配比样品颗粒对慢性溃疡性结肠炎模型大鼠腹泻及便血的影响
各组大鼠在1、3、5、7d内发生腹泻与便血的大鼠个数见表2。正常对照组大鼠没有发生腹泻和便血,TNBS造模后的大鼠表现为毛色杂乱无光泽,神情倦怠萎靡,在第1d均出现了不同程度的腹泻与便血。但是模型组大鼠在7d内发生腹泻与便血的个数显著多于样品组和阳性对照组。说明3组样品和阳性对照药对模型大鼠的腹泻与便血具有抑制作用,其中样品1组效果和阳性对照药相当。
表2样品颗粒对慢性溃疡性结肠炎模型大鼠腹泻及便血的影响(n=10)
5.3样品颗粒对慢性溃疡性结肠炎模型大鼠结肠损伤评分的影响
将大鼠解剖后观察结肠外观及黏膜表面发现,模型组大鼠的结肠多数与相邻脏器有轻度粘连,结肠充血水肿,在肛口向上8cm处有较大的溃疡性病灶,病灶处结肠壁增厚,肠黏膜表面发生溃疡糜烂坏死,与正常组大鼠相比,结肠明显变短。3组样品及阳性对照组均可以改善结肠充血水肿等炎性症状,减少溃疡面积,减轻结肠重量,降低模型大鼠结肠损伤评分(P<0.05),结果见表3。
表3样品颗粒对慢性溃疡性结肠炎模型大鼠结肠损伤评分的影响
*P<0.05vs TNBS模型组;**P<0.01vs TNBS模型组
研究结果表明,样品1(实施例1)具有最优的药效作用,与阳性对照药相当。
实施例11临床观察
为了进一步考察本发明组方配伍的临床应用效果,我们将本发明药物组方与文献报道组方进行临床效果对比观察。
1、方法
试验组药物组成:白术30g,党参20g、白豆蔻18g、黄连15g,防风12g,乌梅15g,赤石脂40g;
对照组药物组成:白术30g,黄连15g,防风12g,乌梅15g。
两组处方均按常规方法水煎煮,口服给药。
选取慢性结肠炎患者60例,其中男性32例,女性28例,随机分为两组,分别为试验组和对照组。两组患者分别口服试验组药物和对照组药物水煎液,每日早晚各一次,连续服用一周后,停用一天。用药8周后考察两组药物的临床效果和不良反应发生率。
2、结果
两组药物均对慢性结肠炎患者具有良好的治疗效果,试验组的有效率为93.4%,对照组的有效率为86.6%。试验组有1例病人出现轻度腹胀现象;对照组有2例病人出现恶心、2例病人出现腹泻症状。试验组不良反应发生率(3.33%)低于对照组(13.3%)。
表4治疗8周总体疗效改善评价表
有效率=(显效例数+好转例数)/全部病例数×100%。
以上已对本发明创造的较佳实施例进行了具体说明,但本发明创造并不限于所述实施例,熟悉本领域的技术人员在不违背本发明创造精神的前提下还可做出种种的等同的变型或替换,这些等同的变型或替换均包含在本申请权利要求所限定的范围内。
Claims (5)
1.一种治疗慢性结肠炎的中药颗粒剂,其特征在于,由以下重量份的原料药制成:白术150-200份,党参100-120份,白豆蔻90-120份,黄连75-100份,防风60-90份,乌梅75-100份,赤石脂200-240份。
2.根据权利要求1所述的治疗慢性结肠炎的中药颗粒剂,其特征在于,由以下重量份的原料药制成:白术150份,党参100份,白豆蔻90份,黄连75份,防风60份,乌梅75份,赤石脂200份。
3.根据权利要求1所述的治疗慢性结肠炎的中药颗粒剂,其特征在于,所述的颗粒剂的制备方法包括以下步骤:
(A)原料提取物干浸膏粉碎至细粉,过100目筛,将乳糖和干浸膏粉放于流化床的流化室中,通过调节风量至物料沸腾;
(B)物料经过预热后方可启动喷雾,当物料的温度达到40℃后,开雾化器,选用浓度是5%的HPMC作粘合剂,雾化器压力调整至0.1MPa,然后向流化室内喷入粘合剂,进行制粒;
(C)调节风机的转速为1700rpm,进风的温度为65℃,蠕动泵进料的速度为4→6→8HZ;
(D)待颗粒成型后,需要继续用50℃的热风进行干燥,大概0.5小时后,取出颗粒进行称重,分别把颗粒过1号筛及5号筛,最后进行整理收集可以过1号筛但是不能过5号筛的颗粒,分装即得。
4.根据权利要求3所述的治疗慢性结肠炎的中药颗粒剂,其特征在于,步骤A所述的原料提取物干浸膏的制备方法,包括以下步骤:
a、按配比称取白术、党参、白豆蔻、黄连、防风、乌梅,赤石脂,加入药材重量10倍的蒸馏水煎煮,煎煮次数2次,煎煮时间为每次1h;
b、滤过煎煮液,滤液浓缩至90-95℃相对密度为1:1.08~1.10,待冷至室温,加入95%乙醇调节醇沉浓度至70%;
c、4℃静置24小时,滤过,滤液减压浓缩回收乙醇,浓缩成50-60℃相对密度为1:1.25-1.30的浸膏;
d、再在60℃,1Mpa下进行减压干燥,得到提取物干浸膏。
5.一种如权利要求1-4任一所述的治疗慢性结肠炎的中药颗粒剂在制备预防或治疗慢性结肠炎药物或保健食品中的应用。
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