CN100486597C - 一种治疗鼻塞、头痛的中药组合物及其制备方法 - Google Patents
一种治疗鼻塞、头痛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鼻塞、头痛的中药组合物，该组合物是由白芷和川芎制成。本发明治疗确切、无副作用、服用方便。
Description
发明领域
本发明涉及一种中药组合物，特别是一种治疗鼻塞、头痛的中药组合物及其制备方法。
背景技术
风寒所致的鼻塞不通、偏正头痛是冬春季节发病率较高的内科疾病。其病机是风邪挟寒上犯头部，清阳之气受阻，气血凝滞，阻遏络道而发头痛；若风寒之邪犯肺，则肺失宣肃，气机不利而生鼻窒。白芷性味辛温，归胃、大肠、肺经。辛能散能行，白芷辛温走窜，善入头部祛风散寒，川芎性味辛温，归肝、胆、心包经，具活血行气，止痛之功。现代药学研究证明：白芷含欧前胡素，异欧前胡素、白芷素、白芷醚等成分，是白芷镇痛、镇静、抗菌抗炎等主要有效成分。川芎含川芎嗪、生物碱及阿魏酸等酚性物质，是川芎活血止痛的主要有效成分。
技术内容
本发明的目的在于提供一种具有治疗鼻塞、头痛作用、吸收快、疗效好、无副作用、服用方便的中药组合物及其制备方法；本发明另一目的在于提供上述组合物的新的制药用途。
本发明的目的是通过如下技术方案实现的：
白芷 400-2000重量份 川芎 100-500重量份
取白芷、川芎粉碎成块状，药材粉碎度为药材直径为0.3-1cm，加水4-8倍，提取挥发油，水提液浓缩至60℃下稠膏相对密度不低于1.30，用10-16倍量的乙醇回流提取1小时，过滤，得滤液。提油后的药渣加10-15倍的乙醇加热回流提取1-2次，滤过，得滤液。合并滤液和减压浓缩至60℃下相对密度不低于1.30的稠膏，70℃下真空干燥，粉碎成粉末，加入挥发油，备用。将上述提取的混合物结合常规辅料制成任何临床上可接受的药剂，使每0.54g药剂含相当1.41g生药。
本发明制成的胶囊口服量为1次3粒，每日3次。本发明胶囊服用后崩解时间为4-6分钟，成品中欧前胡素含量为0.517-0.569％。与现有技术相比，本发明胶囊起效快、疗效好、口服量小、服用方便。
经实验研究本发明药物具有确切的疗效，而且本发明药物的制备方法也使得药剂所含生药量为最优化，本发明药物提取液含生药量可达每毫升17g。本发明药物经国家医药管理局天津药物研究所研究表明具有抑菌、抗炎、镇痛和改善微循环和降低血液粘度的作用。
实验例1
受试药物：
本发明提取物为棕黄色液体，含量8g/毫升(相当含生药量，下同)。批号930821，由连云港康缘制药有限责任公司提供，冰箱内保存，试验前用蒸馏水稀释成所需浓度，供动物试验。
试验动物：
昆明种小鼠：体重18～22g，140只，雌雄兼用。
大耳白家兔：体重2.2～3.2kg，42只，雌雄兼用
由天津药物研究院动物室提供，动物饲养在26土2℃中央调控的观察室内，动物合格证书“津发001号”
试验菌株：
金黄色葡萄球菌(6538)，乙型溶血性链球菌(32210)，绿脓杆菌(27853)均由天津市防病中心提供。
试验方法的选择和试验结果
(一)、祛邪作用—体外抑菌试验
采用平皿二倍稀释法，按微生物试验常规操作，分别将金黄色葡萄球菌、乙型溶血性链球菌和绿脓杆菌菌株用相应的培养液增菌后进行活菌计数，并稀释成cfu/ml浓度的菌液备用。精确吸取都梁提取物加入50℃左右的营养琼脂内立即混匀，制成不同浓度药液的营养平皿，然后吸取待检菌液0.1ml，均匀涂布于平皿表面，置37℃暖箱中培养48小时，观察结果。以无菌生长平皿所含供试药物最低浓度为最小抑菌浓度。同时设不含供试药的平皿作为阴性对照。结果可见，该药对金黄色葡萄球菌、乙型溶血性链球菌和绿脓杆菌均有抑菌作用(见表1)。最小抑菌浓度分别为0.29/ml，0.04g/ml及0.5g/ml。
表1 本发明提取物抑菌试验结果
(二)、抗炎作用——对小鼠巴豆油耳廓肿胀的影响
体重19—22g雄性小鼠，随机分组，每组10只，设模型对照组，供试药本发明提取物8g/kg、4g/kg和2g/kg三个剂量组，分别每日灌胃给药1次，连续3天。空白对照组灌胃等体积的蒸馏水。于末次给药后30分钟各只小鼠左耳壳涂3％巴豆油0.02ml致炎，2小时后将小鼠处死，剪下两耳，冲下0.7cm园耳片，精确称重，以左、右耳片重量差敝为肿胀度，比较给药组与对照组肿胀度的差异，经t检验测定结果表明高、中二个剂量的供试药对小鼠耳廓肿胀均有明显的抑制作用，8g/kg剂量组与对照组比较，差异非常显著(P<0.001)，2g/kg剂景组无明显差异，结果可见8g/kg和4g/kg的本发明药物提取物能明显抑制巴豆油性小鼠耳廓肿胀，表明该药具有一定的抗炎作用(见表2)。
表2 本发明提取物对小鼠耳肿胀的影响(X土sD)
与对照组比较*P<0.05**P<0.05**P<0.01***P<0.001(下同)
(三)、镇痛作用—对小鼠温热致痛甩尾时间的影响
取19—22g小鼠40只，随机分组，每组10只，雌雄各半，设空白对照组、供试药本发明提取物8g/kg，4g/kg和2g/kg三个剂量组。各组小鼠灌胃给予相应药液1次，空白对照组给予等体积的蒸馏水。各组小鼠皆在给药前及给药后30分钟、60分钟及120分钟分别测定小鼠甩尾时间(即自尾下端1/3浸入55℃土0.5℃恒温水浴中起至鼠尾勾起甩动止)，用给药后小鼠甩尾时间减去给药前甩尾时向为延长小鼠甩尾时向，与空白对照组进行比较，进行T检验。结果可见该药灌胃给药1次，三个剂量都能明显延长小鼠温热致痛甩尾时间，与空白对照组相比，差异非常显著(P<0.01，P<0.001)本
试验结果表明8g/kg、4g/kg和2g/kg本发明提取物具有明显的镇痛作用(见表3)。
表3 本发明提取物对小鼠甩尾时间的影响(X土SD)
(四)、对家兔外周微循环障碍和血液粘度的影响
健康家兔，雌雄兼用，随机分为模型组、及供试药本发明提取物(4g/kg和2g/kg)两个剂量组，每组8—10只，灌胃给药、每日1次，连续3日，于末次给药40分钟后，戊巴比妥钠麻醉，用立体解剖显微镜80倍观察兔球结膜微循环情况，观察记录毛细血管交点数、血液的流速(快速“0”、中速“1”、慢速“2”、停止“3”)、血液的流态(直线状“0”、虚线状“1”、粒絮状“2”、淤滞状“3”)。然后兔耳静脉注射10％高分子右旋糖酐6ml/kg，造成家兔微循环障碍、高粘滞血症的病理模型。造型后20分钟，观察记录球结膜毛细管网交点数，血液流速及流态的变化。造型30分钟后，心脏取血、肝素抗凝，用BME-1型血液粘度计(上海)测定全血和血浆粘度。
结果表明，本发明提取物4g/kg和2g/kg两个剂量口服给药均有明显改善高分子右旋糖酐对家兔所致微循环障碍，对血液流速、血液流态及毛细血管网交点数都有非常显著性差异(P<0.01)，结果见表4、表5。
表4 本发明提取物对实验性家兔球结膜微循的影响(X土SD)
与模型对照组比较*p<0.05**p<0.01***p<0.01下同
表5 本发明提取物对实验性家兔血粘度的影响(X土SD)
结论
本研究结果表明：本发明提取物对金色葡萄球菌，乙型溶血性链球菌和绿脓杆菌均有明显的抑菌作用，其最小仰菌浓度分别为0.2g/ml、0.04g/ml和0.58/ml。灌胃给药2g/kg、4g/kg和8g/kg剂量能明显抑制小鼠耳廓肿胀和延长温热致痛小鼠甩尾时间，本发明药物具有一定的抗炎和镇痛作用。4g/kg和2g/kg剂量灌胃给药可显著抑制和改善高分子右旋糖酐所致家兔的微循环障碍，降低血液粘度、促进血液循环。
综上所述药效学试验证明，本发明提取物具有抑菌、抗炎、镇痛利改善微循环、降低血液粘度的药理作用，本研究为该药的临床应用提供了科学依据。本发明药物经临床研究表明对治疗鼻塞、头痛有确切的疗效。
实验例二：
本发明制成的软胶囊经江苏省中医院、南京市中医院及苏北人民医院对100例风寒头痛的临床验证表明其治愈率为77％，总有效率为96％。
(一)、中医诊断标准：头痛呈发作性，多发在额颞，后脑部位，鼻塞不通，恶风恶寒；发病较急，病发前可有受凉、疲劳等诱因。
(二)、观察方法与内容：包括疗效性观察：主要观察头痛、鼻塞流涕、恶风恶寒，口不渴，舌苔、脉象等变化，安全性观察：为一般体检项目，血、尿、大便常规、心电图、肝肾功能检查等。
(三)、治疗方法：治疗组口服本发明胶囊每次3粒，每日3次。3天为一疗程，观察一个疗程，观察期间禁服其它类似药品。
(四)、疗效标准
1、症状评分标准：
偏正头痛：
重度痛不能参加活动 6分
中度痛但不停止活动 4分
轻度痛不影响活动 2分
无头痛 0分
2、疗效标准：
根据各项指标评分标准，先计算出各项指标治疗前的积分值，然后算出治疗后与治疗前积分数比值，以此比值判定疗效。
1)临床痊愈 分数比值在0至0.2之间者
2)显效 分数比值在0.2至0.5之间者
3)有效 分数比值在0，6至0，8之间者
4)无效 分数比值在0，8以上者
(五)、结果：150例风寒头痛的临床验证表明其治愈率为77％，总有效率为96％。(见表6)
表6 100例临床观察
实施例1
取白芷1130克、川芎282克；取白芷、川芎粉碎成块状，药材粉碎度为药材直径为0.5-1cm，加水6倍，提取挥发油，水提液浓缩至稠膏相对密度不低于1.30(60℃)，用14倍量的乙醇回流提取1小时，过滤，得滤液；提油后的药渣加14倍的乙醇加热回流提取2次，滤过，得滤液；合并滤液和减压浓缩至相对密度不低于1.30(60℃)的稠膏，真空干燥(70℃以下)，粉碎成粉末，加入挥发油，与适量植物油于胶体磨磨研混匀，压入软胶囊壳中即得；使每粒内容物重0.54g，相当1.41g生药。
实施例2
取白芷1500克、川芎375克；取白芷、川芎粉碎成块状，药材粉碎度为药材直径为0.3cm，加水8倍，提取挥发油，水提液浓缩至稠膏相对密度不低于1.342(60℃)，用16倍量的乙醇回流提取1小时，过滤，得滤液；提油后的药渣加14倍的乙醇加热回流提取2次，滤过，得滤液；合并滤液和减压浓缩至相对密度不低于1.30(60℃)的稠膏，真空干燥(70℃以下)，粉碎成粉末，加入挥发油，与适量植物油于胶体磨磨研混匀，压入软胶囊壳中即得；使每粒内容物重0.54g，相当1.41g生药。
Claims (2)
1、一种中药组合物在制备改善微循环障碍中升高毛细血管网交点数药物中的应用，所述组合物是由下列重量份的原料药制成的：白芷1500重量份、川芎375重量份。
2、一种中药组合物在制备降低血液粘度药物中的应用，所述组合物是由下列重量份的原料药制成的：白芷1500重量份、川芎375重量份。
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| PCT/CN2001/001590 WO2003045406A1 (fr) | 2001-11-29 | 2001-11-29 | Formulation de pharmacopee chinoise contre les maux d'estomac, les douleurs intercostales, les maux de tete et les regles douloureuses |
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| CN102824458A (zh) * | 2012-07-28 | 2012-12-19 | 陈双玲 | 一种气虚血瘀型痛经用中药 |
| CN102895333A (zh) * | 2012-10-30 | 2013-01-30 | 冯悦 | 一种治疗软组织损伤的中药制剂 |
| CN104225282A (zh) * | 2014-10-09 | 2014-12-24 | 张秀峰 | 一种用于治疗产后头痛的中药 |
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Non-Patent Citations (4)
| Title |
|---|
| 川芎白芷药对（都梁丸）的药理作用研究. 徐军等.中药药理与临床，第8卷第3期. 1992 |
| 川芎白芷药对(都梁丸)的药理作用研究. 徐军等.中药药理与临床，第8卷第3期. 1992 * |
| 都梁滴丸. 中药质量标准WS-002-(Z-002)-2000. 2000 |
| 都梁滴丸. 中药质量标准WS-002-(Z-002)-2000. 2000 * |
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| WO2003045406A1 (fr) | 2003-06-05 |
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