CN1192787C - 治疗溃疡性结肠炎的中药制剂及其制备方法 - Google Patents
治疗溃疡性结肠炎的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗溃疡性结肠炎的中药制剂及其制备方法。本发明的中药制剂，它是由下述重量配比的原料制成：血竭1～10%、赤芍15～40%、青黛1～20%、赤石脂1～10%、儿茶15～40%、枯矾1～10%、白及5～30%、炉甘石1～10%。本发明的制备方法：赤芍、儿茶、枯矾采用水提；血竭、青黛混匀，加入聚乙二醇溶液；白及过筛与上述水提取液、血竭、青黛的聚乙二醇液混匀，再加入赤石脂、炉甘石共同研磨，加水，制成灌肠剂。本发明的灌肠剂具有良好的短、长期治疗溃疡性结肠炎的疗效。
Description
技术领域
本发明涉及一种治疗溃疡性结肠炎的中药制剂及其制备方法。
背景技术
溃疡性结肠炎或非特异性结肠炎(CUC)，是一种原因不明的慢性结肠炎。病变主要发生于结肠的粘膜，且以溃疡为主，可遍及整个结肠，急性期死亡率高，慢性期易引发癌变。临床主要症状为：腹泻、脓血便、腹痛和里急后重。病程迁延，常反复发作。近年来此病有增加的趋势。此病可见于任何年龄，男稍多于女。本病的病因尚未完全清楚，其发病可能与免疫、遗传、感染、精神紧张等因素有关。目前大多数学者倾向于认为：本病既有自身免疫机制的参与，也有遗传倾向。
传统医学认为本病属于“久泄”、“痢疾”、“肠风”和“脏毒”等范畴。病因多由于感受暑热寒湿，或内伤饮食生冷，脾胃内伤，运化失常，湿浊下注大肠，蕴结不解，引起胃肠腑气壅阻，气血凝滞或夹湿，或夹寒湿。
目前临床上治疗溃疡性结肠炎的方法很多，包括西医疗法、中医疗法和针灸疗法。
西医疗法：
西医疗法所使用的药物有氟派酸、柳氮磺胺嘧啶(SASP)、免疫抑制剂、皮质类固醇和灭滴灵等，由于溃疡性结肠炎病情的复杂性，治疗效果的缓慢性，因此长期大量使用西药非常容易产生严重的不良反应。
针灸疗法：
徐非等[特定穴位埋线治疗溃疡性结肠炎的临床观察[J]针灸临床杂志，1998，14(6)：41～42]采用特定埋线法，取大肠俞、天枢、足三里穴，用2～3号羊肠线埋入，1次/月，与西药对比取得了良好的疗效。刘立寿等[电针加气功治疗溃疡性结肠炎疗效分析[J]上海针灸杂志1998，17(2)：19～20]采用气功和针刺的方法治疗本病，针灸组有效率为57％，气功组有效率为57％。综合以上报道，尽管针灸等疗法取得了一些疗效，但尚存在以下问题：①缺乏严谨的科学设计；②针灸治疗对于本病远期疗效不是很满意。
中医疗法：
中医认为本病的病因主要与六淫邪袭，尤其是湿热之邪、饮食所伤、情志郁结及禀赋不足等有关。病机是本虚标实，虚实夹杂。中医采用辩证论治的方法，在治疗溃疡性结肠炎方面取得了一些进展，包括以下方面：
①中药内服法，邵术清等[锡散类内服治疗慢性结肠炎28例报告[J].江西中医药，2000，31(3)：61.1]采用锡类散加薏苡仁口服，以养胃健脾之法，治疗溃疡性结肠炎，取得了好的效果；田止学[温肾扶脾汤治疗脾肾阳虚性慢性结肠炎44例[J].河南中医药学刊，2000，15(2)：19～20]采用制附子、肉桂等治疗脾阳虚型结肠炎，总有效率达95.5％；周健华[益肠丸治疗慢性结肠炎50例[J]河南中医药学刊，2000，15(2)：20]采用黄连、补骨脂等内服治疗慢性结肠炎，总有效率达88％。
以上报道的内服治疗方法虽然取得了很好的疗效，但由于溃疡性结肠炎病变部位多在肠之远端，故若仅仅采用辩证论治内服治疗，恐药力难集中于病所，所以单纯采用内服治疗，不利于对病灶的直接治疗作用。
②中药灌肠治疗，仲过生[中药保留灌肠治疗慢性结肠炎278例疗效观察[J].江西中药，1996，27(4)：34]采用蒲公英、残蛾等灌肠治疗溃疡性结肠炎，疗效令人满意；王碧辉[溃结清治疗慢性非特异性结肠炎[J].中医杂志，1992，(3)：20]采用梅花点舍丹加其他中药灌肠治疗溃疡性结肠炎，取得了很好的效果。冷伟[辩证治疗溃疡性结肠炎[J].陕西中医，1996，17(1)：16]采用云南白药与锡类散保留灌肠治疗溃疡性结肠炎，总有效率达97％；申请号为97125835.X(治疗溃疡性结肠炎和直肠炎的散剂)的专利采用珍珠、黄连、血竭、大黄等原料，治疗此病，取得了一定的疗效。
溃疡性结肠炎，目前病因尚不清楚，中医药治疗本疾病也积累了一定的经验。上述报道的疗法虽然对本病的治疗有一定的疗效，但治法也只是以解毒生肌、活血化瘀为主，对湿热瘀结所引起的溃疡性结肠炎没有做到对症治疗，且尚缺乏对疾病的分期及对远期疗效和防止复发的追踪研究，没有统一的治疗方案，给进一步研究有效的方药带来困难。
发明内容
本发明的目的是克服现有技术中的不足，提供一种由8味中药组成，具有良好的短、长期疗效的治疗溃疡性结肠炎的中药制剂及其制备方法。本发明的中药制剂以清热活血、祛湿生肌为依据，以混悬剂的形式，采用保留灌肠的给药方法，使药物直达病灶，提高病变部位的药物浓度，保护肠道的溃疡面，改进局部血运，较快促进炎症吸收及溃疡愈合，达到表面解毒，祛湿生肌的效果，并通过被动扩散原理维持一定的血药浓度，起到清热解毒、活血化瘀的全身效应。
本发明的目的通过下述技术方案予以实现。
本发明治疗溃疡性结肠炎的中药制剂按重量百分比由下述组分构成：血竭1～10％、赤芍15～40％、青黛1～20％、赤石脂1～10％、儿茶15～40％、枯矾1～10％、白及5～30％、炉甘石1～10％。
所述各组分的含量较好为：血竭3～7％、赤芍25～35％、青黛5～15％、赤石脂1～5％、儿茶25～35％、枯矾1～5％、白及10～20％、炉甘石1～5％。
所述各组分的含量最好为：血竭5.1％、赤芍30％、青黛10％、赤石脂3％、儿茶30％、枯矾3％、白及15％、炉甘石3％。
本发明治疗溃疡性结肠炎中药制剂的制备方法采取如下步骤：
(1)按重量百分比，备好下述原料：血竭1～10％、赤芍15～40％、青黛1～20％、赤石脂1～10％、儿茶15～40％、枯矾1～10％、白及5～30％、炉甘石1～10％；(2)取赤芍、儿茶和枯矾三味药材，加水浸泡、提取2-4次，合并水提取液，滤过、冷藏、浓缩、备用；(3)取血竭、青黛，混匀，加入聚乙二醇溶液搅拌、备用；(4)取白及、山梨酸钾，研磨，加入上述水提取液、血竭和青黛的聚乙二醇溶液，加入赤石脂、炉甘石共同研磨混匀，加水调节，即得。
所述步骤(2)的加水浸泡时间为0.5-1小时；所述的加水量与生药量比为10～14∶1；所述的冷藏时间为44-52小时；所述的滤液浓缩采用浓缩至药液体积与药材重量比为1升∶0.30-0.36千克。所述的步骤(3)聚乙二醇溶液为溶入西黄耆胶的聚乙二醇400溶液。所述步骤(4)粉碎后的白及、山梨酸钾的粒径为150μm。
其中聚乙二醇为聚乙二醇400，分装为70～90ml/瓶。
本发明是利用现代特殊提取工艺和高科技的质量控制手段，提高有效成分的含量和质量控制标准，真正保证药物的安全性和有效性。本发明优选剂型为灌肠剂，由于溃疡性结肠炎病变部位位于结肠粘膜，采用灌肠剂可以直接作用于肠道粘膜，保留时间长，浓度高，有利于药物吸收和发挥治疗作用，特别是本发明选用的中药具有收敛生肌之效，甚为适合于本病的治疗，故经临床使用，收到了极好的效果。
本发明以应用部分外用药为特点，采用治疗“外疡”的有效药物治疗溃结，具有良好的祛腐生肌的作用。可谓“外疡内治”，遵循“中医外治之理即内治之理，外治之药即内治之药”的原则，本发明选用了外用药或外用效果较好的药物，如炉甘石、儿茶、血竭、青黛等。炉甘石具有解毒敛疮，收湿防腐，生肌之功。儿茶治泄痢不止，有收湿敛疮的功效。本发明采取外用灌肠给药，使药物直达病灶，保持高浓度，从而达到高效、速效理想的治疗效果。
下面通过对本发明中药制剂动物实验研究和毒理学研究的阐述，进一步说明本发明的有益效果。
本发明的中药制剂药效学研究：
①对乙酸所致大鼠急性溃疡性结肠炎模型(UC)的防治作用：
大鼠乙酸性UC模型与人类UC急性期表现相似，动物出现粘液便或血便结肠水肿、肠壁变薄、出血糜烂等，镜下可见大面积的粘膜坏死，大量中性粒细胞浸润肠壁各层。本发明的中药制剂在0.25-1g生药/kg剂量下连续应用10天，可明显减轻上述结肠病变，对结肠粘膜损伤具有很好的保护和修复作用。
②对2，4-二硝基氯苯诱导的溃疡性结肠炎模型(UC)的防治作用：
2，4-DNCB攻击后结肠粘膜出现以溃疡为主的炎症反应。该模型所造成的结肠损伤涉及范围小，但程度严重，便于受试药物的疗效评价。本发明的中药制剂0.5-2g生药/kg剂量下，无论是防治给药还是治疗给药均能使结肠粘膜大面积溃疡的发生率降低，粘膜受损多为浅表或局部，表现出了较好抗溃疡作用。说明该药对过敏炎症造成的结肠溃疡有确实疗效。
③对大肠杆菌复制的大鼠溃疡性结肠炎模型(UC)的防治作用：
大肠杆菌复制的UC模型在症状、病程及组织学改变都与人UC病变相似，其抗原为肠道正常菌丛之一，更接近于自然情况。在模型鼠上我们看到了循环免疫复合物增加，它的出现和存在是溃疡性结肠炎出现和维持的病理基础。经本发明的中药制剂0.5-2g生药/kg剂量治疗能使模型鼠的上述血清检测指标的异常发生相反的变化，相应的结肠组织学病变也得到明显的改善，粘膜损伤得以修复。
④抗炎作用：
本发明的中药制剂对急性炎症水肿和慢性增殖性炎症均有很好的抗炎作用，这对治疗UC病变的肠道炎症是不可缺少的。
⑤镇痛作用及解痉作用：
在小鼠醋酸扭体和水浴甩尾反应实验，表明本发明的中药制剂具有明显的镇痛作用，且药效维持时间长。另外，该药对豚鼠回肠有明显的解痉作用。
⑥抑菌和杀菌作用：
本发明的中药制剂对五种常见的肠道细菌具有较好的抑菌和杀菌作用。
本发明的中药制剂毒理学研究：
①急性毒性试验：
小鼠一日内结肠给予受试药，本发明的中药制剂灌肠剂0.66ml/10g(分两次)，其剂量为18.6g生药/kg，药后连续观察7天，未出现任何毒性反应，20只小鼠全部存活，生长良好，该药结肠给药对小鼠的最大耐受量为18.6g生药/kg。
②对大鼠肠道粘膜的刺激试验：
大鼠结肠给予本发明的中药制剂灌肠剂3.8g生药/kg，经24小时、48小时和7天观察大鼠肠道粘膜的反应，结果表明该药无明显的粘膜刺激作用，临床使用比较安全。
③长期毒性试验：
本发明的中药制剂灌肠剂，大鼠结肠给药2.2g生药/kg和1.1g生药/kg，每天一次，连续给药3个月，观察一般药物反应，检测血液学，血液生化和病理组织学指标等，结果未见明显的与药物有关的毒性反应，各项指标与对照组基本一致，表明该药结肠给药的毒性较小，临床应用安全性较高。
具体实施方式
下面列举实施例，进一步描述本发明。各实施例仅用于说明本发明，并不限制本发明。
实施例1
(1)配方用量：血竭14g、赤芍84g、赤石脂8.4g、儿茶84g、白及42g、炉甘石8.4g、青黛28g、枯矾8.4g；(2)赤勺、儿茶、枯矾的提取：赤勺、儿茶、枯矾，加水浸泡0.5小时，煎煮两次，每次1小时，合并煎液，滤过，滤液冷藏48小时后，再次滤过，滤液浓缩至600-1000ml；(3)血竭、青黛聚乙二醇液的制备：取血竭、青黛、西黄耆胶1.5g，加入聚乙二醇-400 28ml中，充分搅拌均匀，加入上述浓缩液中，备用；(4)白及的研磨加入：取粉碎成细粉(粒径为150μm)的白及、山梨酸钾2g一起研磨混匀后，加入上述备用液中；(5)赤石脂、炉甘石的加入：再加入赤石脂、炉甘石共同研磨，混匀，并用水调节到1000ml，充分研磨后，分装，灭菌，即得。
本品为棕色较粘稠的混悬液体，久置可见沉淀，振摇即分散均匀。
实施例2
(1)配方用量：血竭22.1g、赤芍69g、赤石脂25g、儿茶69g、白及28g、炉甘石22.1g、青黛25g、枯矾17g；(2)～(5)步骤同实施例1。
实施例3
(1)配方用量：血竭19g、赤芍67g、赤石脂19g、儿茶67g、白及47g、炉甘石17g、青黛27.1g、枯矾14.1g；(2)～(5)步骤同实施例1。
实施例4
(1)配方用量：血竭11g、赤芍91g、赤石脂14g、儿茶91g、白及28g、炉甘石11g、青黛19g、枯矾12.2g；(2)～(5)步骤同实施例1。
实施例5
(1)配方用量：血竭8g、赤芍97g、赤石脂6g、儿茶97g、白及47g、炉甘石6g、青黛14g、枯矾2.2g；(2)～(5)步骤同实施例1。
Claims (10)
1.一种治疗溃疡性结肠炎的中药制剂，其特征在于，它按重量百分比由下述组分制成，血竭1～10％、赤芍15～40％、青黛1～20％、赤石脂1～10％、儿茶15～40％、枯矾1～10％、白及5～30％、炉甘石1～10％。
2.根据权利要求1所述的治疗溃疡性结肠炎的中药制剂，其特征在于，它按重量百分比由下述组分制成：血竭3～7％、赤芍25～35％、青黛5～15％、赤石脂1～5％、儿茶25～35％、枯矾1～5％、白及10～20％、炉甘石1～5％。
3.根据权利要求1所述的治疗溃疡性结肠炎的中药制剂，其特征在于，它按重量百分比由下述组分制成：血竭5.1％、赤芍30％、青黛10％、赤石脂3％、儿茶30％、枯矾3％、白及15％、炉甘石3％。
4.一种治疗溃疡性结肠炎中药制剂的制备方法，其特征在于，它采取如下步骤：
(1)按重量百分比备好下述原料：血竭1～10％、赤芍15～40％、青黛1～20％、赤石脂1～10％、儿茶15～40％、枯矾1～10％、白及5～30％、炉甘石1～10％；
(2)取赤芍、儿茶和枯矾三味原料，加水浸泡、提取2-4次，合并水提取液，滤过、冷藏、浓缩、备用；
(3)取血竭、青黛混匀，加入聚乙二醇溶液搅拌备用；
(4)取自及、山梨酸钾研磨，加入上述水提取液、血竭和青黛的聚乙二醇溶液，加入赤石脂、炉甘石共同研磨混匀，加水调节，即得。
5.根据权利要求4所述治疗溃疡性结肠炎中药制剂的制备方法，其特征在于，所述步骤(2)的加水浸泡时间为0.5-1小时。
6.根据权利要求4所述治疗溃疡性结肠炎中药制剂的制备方法，其特征在于，所述步骤(2)的加水量与生药量比为10～14∶1。
7.根据权利要求4所述治疗溃疡性结肠炎中药制剂的制备方法，其特征在于，所述步骤(2)的冷藏时间为44-52小时。
8.根据权利要求4所述治疗溃疡性结肠炎中药制剂的制备方法，其特征在于，所述步骤(2)的滤液浓缩采用浓缩至药液体积与药材重量比为1升：0.30-0.36千克。
9.根据权利要求4所述治疗溃疡性结肠炎中药制剂的制备方法，其特征在于，所述步骤(3)的聚乙二醇溶液为溶入西黄耆胶的聚乙二醇400溶液；
10.根据权利要求4所述治疗溃疡性结肠炎中药制剂的制备方法，其特征在于，所述步骤(4)的白及、山梨酸钾的颗粒度为150微米。
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| CN101961374B (zh) * | 2010-09-27 | 2012-02-01 | 康锦星 | 一种治疗胃溃疡和胃糜烂的药物 |
| CN102614379A (zh) * | 2012-03-30 | 2012-08-01 | 赵风旗 | 一种治疗溃疡的中药组合物及其制备和应用 |
| CN102805856B (zh) * | 2012-08-27 | 2013-10-02 | 李怀章 | 一种治疗慢性溃疡性结肠炎的中药冲剂 |
| CN103656018A (zh) * | 2012-09-19 | 2014-03-26 | 孙久印 | 治疗口腔溃疡的外用中药粉剂配方 |
| CN104225260B (zh) * | 2014-10-14 | 2017-06-16 | 杨华岳 | 一种治疗溃疡性结肠炎的灌肠中药粉 |
| CN104474352A (zh) * | 2014-12-22 | 2015-04-01 | 济南伟传信息技术有限公司 | 治疗急性肠炎的茶 |
| CN110267672A (zh) * | 2016-12-20 | 2019-09-20 | 首尔大学医院 | 用于预防或治疗炎性肠病的包含青黛提取物或其级分作为有效成分的药物组合物 |
| US20180288724A1 (en) * | 2017-03-30 | 2018-10-04 | Htc Corporation | Device and Method of Handling Radio Access Technology Capabilities |
| WO2022080523A1 (ko) * | 2020-10-14 | 2022-04-21 | 엠테라파마 주식회사 | 청대, 닥나무, 및 가래나무의 복합 생약 추출물을 포함하는 염증성 장질환의 예방 또는 치료용 조성물 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4017615A (en) * | 1970-10-29 | 1977-04-12 | Syntex Corporation | Propylene carbonate ointment vehicle |
| ES2093032T3 (es) * | 1989-10-19 | 1996-12-16 | Shiseido Co Ltd | Material compuesto de polimero hidrofilo y mineral de silicato y su uso. |
| CN1051236C (zh) * | 1994-06-06 | 2000-04-12 | 郭文峰 | 止血散 |
| US5800817A (en) * | 1996-03-11 | 1998-09-01 | Verge; Andre J. | Plant extracts and therapy for insulin deficiencies |
| CN1202361A (zh) * | 1997-06-18 | 1998-12-23 | 中国医科大学附属第一医院 | 治疗炎性肠病的中药青黛散 |
| CN1057697C (zh) * | 1997-12-25 | 2000-10-25 | 刘旭山 | 治疗溃疡性结肠炎和直肠炎的散剂及其制备方法 |
| CA2410893A1 (en) * | 2000-06-01 | 2001-12-06 | Theralife, Inc. | Compositions for enhancing therapeutic effects containing herbals and/or nutritional supplements and/or minerals and/or vitamins |
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- 2003-03-05 AU AU2003221285A patent/AU2003221285A1/en not_active Abandoned
- 2003-03-05 EP EP03709574A patent/EP1484065A1/en not_active Withdrawn
- 2003-03-05 US US10/507,149 patent/US7354570B2/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014206310A1 (zh) | 2013-06-26 | 2014-12-31 | 天士力制药集团股份有限公司 | 一种中药制剂在制备预防和/或治疗克罗恩病的药物中的用途 |
Also Published As
| Publication number | Publication date |
|---|---|
| US7354570B2 (en) | 2008-04-08 |
| WO2003075937A1 (fr) | 2003-09-18 |
| EP1484065A1 (en) | 2004-12-08 |
| CN1376489A (zh) | 2002-10-30 |
| US20060003026A1 (en) | 2006-01-05 |
| AU2003221285A1 (en) | 2003-09-22 |
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