CN112076276B - 一种治疗过敏性鼻炎的药物组合物及其制备方法 - Google Patents
一种治疗过敏性鼻炎的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗过敏性鼻炎的药物组合物及其制备方法。该组合物由由藿香4‑6份、苍耳子4‑6份、川芎4‑6份、薄荷4‑6份、丹参5‑7份、香附5‑7份、菊花4‑6份、黄芩5‑7份、太子参4‑6份、苍术2‑4份、生甘草2‑4份组成,可以有效治疗过敏性鼻炎,且具有良好依从性。本发明还提供了该组合物的制备方法。
Description
技术领域
本发明涉及中药领域,更具体地,涉及一种治疗过敏性鼻炎的药物组合物。
背景技术
过敏性鼻炎(hypersensitive rhinitis),又称变应性鼻炎,是日常生活很常见的一类疾病,其发病率高、病程长且易反复发作。我国成年人中过敏性鼻炎的患病率接近20%,且呈逐年上升的趋势。严重的过敏性鼻炎会影响睡眠,进而影响日常生活和工作,对生活质量的影响超过了高血压、糖尿病等重大疾病。过敏性鼻炎患者还可能合并中耳炎、诱发哮喘,对健康造成更大危害。
目前,过敏性鼻炎的治疗主要以脱敏、激素以及免疫等方法进行,通常短期疗效显著,但停药后效果难以维持,且上述脱敏药物、激素药物不能长期使用,无法维持效果,还容易出现黏膜干燥、鼻出血、口感、头疼等副作用。
中医药治疗过敏性鼻炎已有很长历史。早在《内经》中就有关于鼻鼽的病名记载。唐代孙思邈从肺肾虚辨证论治本病,金元时期刘河间从火热论,明清医家又从肺脾气虚角度论治。现代中医也从各个角度出发对过敏性鼻炎的治疗提出了各种方案,有应用古方加减,有新拟方。冯荣昌应用玉屏风散治疗过敏性鼻炎疗效颇佳;邓少贤用黄芪桂枝五物汤加减治疗过敏性鼻炎第一疗程实现有效率100%;有将《济生方》卷五记载的主治鼻渊、鼻流浊涕不止的苍耳子散,由辛夷、苍耳子、白芷、川芎、薄荷、贝母、淡豆豉、菊花、甘草组成,用于治疗过敏性鼻炎也取得不错效果。李明采用随机对照研究方法提出由茜草、紫草、防风、蝉衣、地龙、徐长卿、乌梅等原料药制成的汤药治疗过敏性鼻炎,也得到较西药疗效显著的结论。
近年来,中医药治疗过敏性鼻炎由于其辨证论治、整体考量、应用面广等优势日益受到关注。目前临床各医家治疗本病多采用汤剂,使用上不方便,也不便于服用,且药物质量的不稳定往往会对疗效造成较大影响。中成药中鼻炎康添加有马来酸氯苯那敏,容易引起困倦、嗜睡、口渴等不良反应。通窍鼻炎片与防芷鼻炎片均为纯中药制剂,其能够长期服用,但服用量较大,每次均为5-7片,且通常一日三次。此外,还有玉屏风颗粒,从扶正益气角度出发,通过增强抵抗力治疗过敏性鼻炎,起效较慢。
本申请的发明人在长期实践中提出了一种有效治疗过敏性鼻炎的药方,经过制剂实验筛选,完成了鼻炎颗粒整个产品的方案,可以运用于工业化大生产。该产品配方简单、制作工艺简便、给药方便、毒副作用小,能很好地改善患者的鼻炎症状,且不易复发。据此提出本申请。
发明内容
本申请提供了一种治疗过敏性鼻炎的药物组合物及其制备方法。该组合物由藿香4-6份、苍耳子4-6份、川芎4-6份、薄荷4-6份、丹参5-7份、香附5-7份、菊花4-6份、黄芩5-7份、太子参4-6份、苍术2-4份、生甘草2-4份组成。优选地,该组合物由藿香5份、苍耳子5份、川芎5份、薄荷5份、丹参6份、香附6份、菊花5份、黄芩6份、太子参5份、苍术3份、生甘草3份组成。
本申请还提供了一种治疗过敏性鼻炎的药物制剂的制备方法,将上述药物组合物通过常规制药方法制得汤剂、颗粒剂、胶囊剂、片剂、滴丸等常规剂型产品。
本申请还提供了一种治疗过敏性鼻炎的鼻炎颗粒及其制备方法。该产品可以由如下的制备方法制得,包括:取藿香4-6份、苍耳子4-6份、川芎4-6份、薄荷4-6份,水蒸气蒸馏法提取2-5小时,收集挥发油和滤液1,备用;药渣加5-10倍量水提取1-3小时,与滤液1合并,减压浓缩至相对密度为1.05-1.10的浸膏,醇沉滤过,得滤液2,滤液2减压回收乙醇并再次减压浓缩为浸膏1,滤过,得滤液3;取丹参5-7份、香附5-7份、菊花4-6份、黄芩5-7份、太子参4-6份、苍术2-4份、生甘草2-4份,水提后过滤,滤液4浓缩为浸膏2;取5-10倍挥发油量的β-环糊精,加水,用高速乳化均质机研磨使其均匀,加入挥发油及少量氯化钠,研磨0.3-1小时,静置12h,以滤纸抽滤,真空干燥,粉碎,得挥发油包合物。将挥发油包合物粉末、浸膏1和浸膏2、矫味剂混合,得混合粉,用85%乙醇制粒,用量为配方量的28%,14目筛制软材,55℃烘箱烘干,14目筛整粒,得颗粒,即得。
更具体地,本申请的鼻炎颗粒及其制备方法,包括如下步骤:
(1)取藿香5份、苍耳子5份、川芎5份、薄荷5份加10倍量水,水蒸气蒸馏法提取4小时,收集挥发油和滤液,备用;药渣加9倍量水提取1.5小时,滤过,与上述滤液合并,减压浓缩至相对密度为1.05~1.08(55℃)的浸膏,冷却至室温,加乙醇使含醇量达80%,静置24小时以上,取上清液滤过,滤液减压回收乙醇并浓缩至相对密度为1.05~1.08(55℃)冷却至室温后用200目筛网滤过,滤液备用。
(2)取丹参6份、香附6份、菊花5份、黄芩6份、太子参5份、苍术3份、生甘草3份加10倍量水,提取2次,每次2小时,滤过,减压浓缩至相对密度1.03~1.05(55℃)冷却至室温后用200目筛网滤过,滤液继续浓缩至相对密度为1.20~1.26(55℃)的浸膏,与上述浸膏合并,减压干燥(70℃,压力-0.06~-0.08Mpa),粉碎,备用。
(3)取8倍挥发油量的β-环糊精,加6倍量β-环糊精的水,采用高速乳化均质机研磨使其均匀,加入挥发油及挥发油重量0.5%的氯化钠,研磨30分钟,静置12h,以滤纸抽滤,置真空干燥箱40℃以下干燥,粉碎,得挥发油包合物。
(4)将挥发油包合物粉末、干膏粉、麦芽糊精和三氯蔗糖(均过80目筛)混合30min,得混合粉,用85%乙醇制粒,用量为配方量的28%,14目筛制软材,55℃烘箱烘干,14目筛整粒,得颗粒,即得。
本申请的药物组合物仅由11味药材组成,药味精简,疗效显著,起效快,无明显副作用,总有效率高达99.5%以上。且经制剂研究后,选择部分原料药材进行挥发油提取,其余部分水提,佐以适合的制剂工艺,顺利提出一种适合大生产的制备方法,经动物实验确认该方法制得产品优于其它方法产品的效果,且该方法所得颗粒产品顺利通过中试研究的生产和检验。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面将对本申请的技术方案作更进一步的详细说明。显然,本申请的保护范围不受具体实施例的任何限制,本领域普通技术人员在没有做出创造性劳动下所得到的所有其他实施例,都落入本申请的保护范围内。
1、关于产品中各原料药的提取方法研究
中药复方在临床中通常以汤剂给药的方式进行,临床医生开方,患者自行取药后回家煎煮,往往会由于各人的不同操作而影响药物的疗效。现代中药制剂技术的发展,使得将这些临床疗效已然明确的中药复方,通过现代制剂的研究,实现中药制剂向工程化、***化、自动化的方向前进;并且避免药材精提后出现较强副作用的情况。
经临床给药反馈,本发明的组合物对于治疗过敏性鼻炎的效果显著,因此,发明人在此基础上对该组合物进行研究。本发明的组合物由11味中药材组成,其中藿香、苍耳子、川芎、丹参、香附、菊花、黄芩、薄荷、苍术均为包含挥发油成分的药材,且上述药材的挥发油通常被认为是其活性部位。通常而言,将组合物中各原料药的活性部位提取精制后重新进行组合得到成方制剂是现有中药制剂的常规方法,但本申请的药物组合物在临床使用中一直是以水煎煮给药方式给予,发明人希望能在这两种方案中找到合适的平衡,在利用现代制剂技术的同时提高药效,且保证优异的安全性和依从性。。
实验动物:昆明种小白鼠80只,体重20±2g,雌雄各半。
药品:供试品的制备方法:将提取挥发油的药材加10倍量水,水蒸气蒸馏法提取4小时,收集挥发油、滤液和药渣,备用;将其他药材与药渣加10倍量水,提取2次,每次2小时,滤过,减压浓缩至相对密度1.03~1.05(55℃)冷却至室温后用200目筛网滤过,加入提取挥发油后得到的滤液,继续浓缩至粘稠状,加入挥发油,混匀。
表1 供试品的原料表(⊙为提取挥发油组,○为直接水提组)
1.1急性毒性试验
试验方法:将每个供试品对10只小鼠按照14.68g生药/kg,每天给药8次,连续用药7天。肉眼观察两组动物全身的一般情况,如小鼠的行为、状态、体征、饮水量、摄食情况、体重状况。并经处死小鼠后观察鼻黏膜变化,包括色泽、充血、水肿等。
评判标准:出现摄食减少、精神不振、体重减轻、行走不便等表现视为出现中毒反应;死亡例单独计算。
表2 急毒实验结果
例数(例) | 中毒反应例数(例) | 死亡例数(例) | |
供试品1 | 10 | 5 | 1 |
供试品2 | 10 | 0 | 0 |
供试品3 | 10 | 1 | 0 |
供试品4 | 10 | 2 | 0 |
供试品5 | 10 | 0 | 0 |
供试品6 | 10 | 0 | 0 |
供试品7 | 10 | 2 | 1 |
供试品8 | 10 | 0 | 0 |
急性毒性试验结果显示,各供试品因挥发油物质种类和含量的不同对产品的毒性具有较大影响。目前尚不明确原因,或许部分挥发油性成分之间出现效果的叠加或影响,出现较大毒性。实验显示,对于中药组合物而言,并非将其所有原料药各自所谓的有效成分提取出组合使用,即能具有原组合物的药效和安全性,而需要在制剂工艺提出时对各原料药的提取工艺在组合物的情况下进行筛选,以对其毒性进行审慎评估。
1.2药效试验
实验动物:SD大鼠120只,SPF级,雄性,周龄:4-6周,体重:180g-220g。
试验方法:根据2,4-二硝基氯苯丙酮溶液滴鼻法进行过敏性鼻炎大鼠模型造模,模型大鼠出现鼻红、搔抓鼻周、频繁喷嚏、大量鼻涕等典型过敏性鼻炎的行为变化。将供试品2、5、6、8各对20只大鼠按照7.68g生药/kg,每天给药1次;20只大鼠给予生理盐水,作为空白组;20只大鼠按照10mg/kg给药氯雷他定,作为对照组,每天给药一次。给药3天后,处死,取鼻黏膜,10%甲醛容易中,固定24小时,切片方向为皮肤组织块纵切面,HE染色,随机选取5个高倍视野(10*40)计数过敏性鼻炎大鼠鼻黏膜中EOS数。另外,还进行甲苯胺蓝染色,用于MC的计数。结果见表3。
表3 过敏性鼻炎的药效试验结果
组别 | EOS(个) | MC(个) | 脱颗粒MC(个) |
空白组 | 9.23±1.52 | 21.92±3.57 | 14.22±5.71 |
对照组 | 3.13±1.33 | 8.35±3.47 | 4.73±1.54 |
供试品2 | 3.11±1.29 | 8.03±3.92 | 4.25±1.69 |
供试品5 | 3.97±1.87 | 8.97±3.56 | 5.47±1.56 |
供试品6 | 5.12±1.63 | 11.78±3.86 | 7.07±1.72 |
供试品8 | 4.26±1.67 | 10.59±3.54 | 7.82±1.95 |
药效试验结果显示,与空白组相比,对照组和各供试品组鼻黏膜组织中EMS、MC、脱颗粒MC值降低明显,疗效显著。在3天的给药疗程中,供试品2组的效果与对照组相当,略优于对照组;供试品8组为常规水提组,疗效介于供试品2/5组与供试品6组之间,进一步确认不同的提取方式对组合物的疗效具有较大影响。上述药效试验显示,本发明的产品能很好地治疗过敏性鼻炎。
2、临床试验效果
病例情况:选取75例过敏性鼻炎患者,所有患者均确诊为过敏性鼻炎并符合相当诊断。将其按照自主意愿选择氯雷他定片作为对照组,以及选择本申请实施例1制得的中药颗粒作为观察组。观察组共38例,男21例、女17例,年龄15-60岁,病程2个月-5年,平均2.5±1.3年。对照组37例,男23例,女14例,年龄19-55岁,病程8个月-6年,平均2.6±1.2年。两组患者差异无统计意义,具有可比性。
治疗方案:观察组服用本申请实施例1制得的中药颗粒剂产品,一次一袋,一天2次,饭后一小时服用;对照组采用氯雷他定片治疗。以1个月为1个疗程,患者治疗期间要密切观察不良反应情况,一旦出现则及时停止给药。
疗效判定标准:依据《关于变应性鼻炎的诊治原则和推荐方案》中的标准对患者症状进行打分,分值为0-3分,分值越高说明症状越严重。采用显效、有效及无效3个标准对患者临床效果进行判定;显效为患者黏膜色泽恢复正常,下鼻甲无肿胀、症状评分下降超过50%;有效为患者黏膜色泽基本恢复正常、下鼻甲无肿胀或轻微肿胀,症状评分下降20-49%;无效:患者病情与症状无明显变化,甚至加重;总有效率=(显效例数+有效例数)/总例数*100%。
结果见下表4。
表4 临床试验结果
*:P<0.05
两组患者临床治疗效果比较,观察组患者临床有效率为97.37%,对照组因7例患者用药3天后有严重不良反应放弃治疗,临床有效率为75.68%,如果排除掉7例未完成治疗的患者后,对照组的临床有效率为93.33%,但该组中还有8例患者出现胃肠道不适和皮疹的不良反应。本次研究结果显示,本申请的产品在患者依从性上明显优于氯雷他定,且在此基础上获得了明显优于氯雷他定片的临床治疗效果。
具体实施方式
实施例1
取藿香1250g、苍耳子1250g、川芎1250g、薄荷1250g加10倍量水,水蒸气蒸馏法提取4小时,收集挥发油和滤液,备用;药渣加9倍量水提取1.5小时,滤过,与上述滤液合并,减压浓缩至相对密度为1.05~1.08(55℃)的浸膏,冷却至室温,加乙醇使含醇量达80%,静置24小时以上,取上清液滤过,滤液减压回收乙醇并浓缩至相对密度为1.05~1.08(55℃)冷却至室温后用200目筛网滤过,滤液备用。取丹参1500g、香附1500g、菊花1250g、黄芩1500g、太子参1250g、苍术750g、生甘草750g加10倍量水,提取2次,每次2小时,滤过,减压浓缩至相对密度1.03~1.05(55℃)冷却至室温后用200目筛网滤过,滤液继续浓缩至相对密度为1.20~1.26(55℃)的浸膏,与上述浸膏合并,减压干燥(70℃,压力-0.06~-0.08Mpa),粉碎,备用。取8倍量β-环糊精,加6倍量水,采用高速乳化均质机研磨使其均匀,加入挥发油,研磨30分钟,静置12h,以滤纸抽滤,置真空干燥箱40℃以下干燥,粉碎,得挥发油包合物245g。将挥发油包合物粉末、干膏粉、麦芽糊精1533g和三氯蔗糖5g(均过80目筛)混合30min,得混合粉,用85%乙醇制粒,用量为配方量的28%,14目筛制软材,55℃烘箱烘干,14目筛整粒,得颗粒,即得鼻炎颗粒。
实施例2
取藿香1250g、苍耳子1250g、川芎1250g、薄荷1250g加10倍量水,水蒸气蒸馏法提取4小时,收集挥发油和滤液,备用;药渣加9倍量水提取1.5小时,滤过,与上述滤液合并,减压浓缩至相对密度为1.05~1.08(55℃)的浸膏,冷却至室温,加乙醇使含醇量达80%,静置24小时以上,取上清液滤过,滤液减压回收乙醇并浓缩至相对密度为1.05~1.08(55℃)冷却至室温后用200目筛网滤过,滤液备用。取丹参1250g、香附1250g、菊花1250g、黄芩1250g、太子参1250g、苍术1000g、生甘草1000g加10倍量水,提取2次,每次2小时,滤过,减压浓缩至相对密度1.03~1.05(55℃)冷却至室温后用200目筛网滤过,滤液继续浓缩至相对密度为1.20~1.26(55℃)的浸膏,与上述浸膏合并,减压干燥(70℃,压力-0.06~-0.08Mpa),粉碎,备用。取8倍量β-环糊精,加6倍量水,采用高速乳化均质机研磨使其均匀,加入挥发油,研磨30分钟,静置12h,以滤纸抽滤,置真空干燥箱40℃以下干燥,粉碎,得挥发油包合物245g。将挥发油包合物粉末、干膏粉、麦芽糊精1533g和三氯蔗糖5g(均过80目筛)混合30min,得混合粉,用85%乙醇制粒,用量为配方量的28%,14目筛制软材,55℃烘箱烘干,14目筛整粒,得颗粒,即得鼻炎颗粒。
Claims (7)
1.一种治疗过敏性鼻炎的药物制剂,其特征在于以藿香4-6份、苍耳子4-6份、川芎4-6份、薄荷4-6份、丹参5-7份、香附5-7份、菊花4-6份、黄芩5-7份、太子参4-6份、苍术2-4份、生甘草2-4份为原料药,通过如下方法具体包括:取藿香4-6份、苍耳子4-6份、川芎4-6份、薄荷4-6份,水蒸气蒸馏法提取2-5小时,收集挥发油和滤液1,备用;药渣加5-10倍量水提取1-3小时,与滤液1合并,减压浓缩至相对密度为1.05-1.10的浸膏,醇沉滤过,得滤液2,滤液2减压回收乙醇并再次减压浓缩为浸膏1,滤过,得滤液3;取丹参5-7份、香附5-7份、菊花4-6份、黄芩5-7份、太子参4-6份、苍术2-4份、生甘草2-4份,水提后过滤,滤液4浓缩为浸膏2;取5-10倍挥发油量的β-环糊精,加水,用高速乳化均质机研磨使其均匀,加入挥发油及少量氯化钠,研磨0.3-1小时,静置12h,以滤纸抽滤,真空干燥,粉碎,得挥发油包合物;将挥发油包合物粉末、浸膏1和浸膏2、矫味剂混合,得混合粉后根据常规制药方法制得汤剂、颗粒剂、胶囊剂、片剂、滴丸产品。
2.如权利要求1所述的制剂,原料药为藿香5份、苍耳子5份、川芎5份、薄荷5份、丹参6份、香附6份、菊花5份、黄芩6份、太子参5份、苍术3份、生甘草3份。
3.如权利要求1所述的药物制剂的制备方法,其特征在于以藿香4-6份、苍耳子4-6份、川芎4-6份、薄荷4-6份、丹参5-7份、香附5-7份、菊花4-6份、黄芩5-7份、太子参4-6份、苍术2-4份、生甘草2-4份为原料药,方法具体包括:取藿香4-6份、苍耳子4-6份、川芎4-6份、薄荷4-6份,水蒸气蒸馏法提取2-5小时,收集挥发油和滤液1,备用;药渣加5-10倍量水提取1-3小时,与滤液1合并,减压浓缩至相对密度为1.05-1.10的浸膏,醇沉滤过,得滤液2,滤液2减压回收乙醇并再次减压浓缩为浸膏1,滤过,得滤液3;取丹参5-7份、香附5-7份、菊花4-6份、黄芩5-7份、太子参4-6份、苍术2-4份、生甘草2-4份,水提后过滤,滤液4浓缩为浸膏2;取5-10倍挥发油量的β-环糊精,加水,用高速乳化均质机研磨使其均匀,加入挥发油及少量氯化钠,研磨0.3-1小时,静置12h,以滤纸抽滤,真空干燥,粉碎,得挥发油包合物;将挥发油包合物粉末、浸膏1和浸膏2、矫味剂混合,得混合粉后根据常规制药方法制得汤剂、颗粒剂、胶囊剂、片剂、滴丸产品。
4.一种治疗过敏性鼻炎的鼻炎颗粒的制备方法,其特征在于:取藿香4-6份、苍耳子4-6份、川芎4-6份、薄荷4-6份,水蒸气蒸馏法提取2-5小时,收集挥发油和滤液1,备用;药渣加5-10倍量水提取1-3小时,与滤液1合并,减压浓缩至相对密度为1.05-1.10的浸膏,醇沉滤过,得滤液2,滤液2减压回收乙醇并再次减压浓缩为浸膏1,滤过,得滤液3;取丹参5-7份、香附5-7份、菊花4-6份、黄芩5-7份、太子参4-6份、苍术2-4份、生甘草2-4份,水提后过滤,滤液4浓缩为浸膏2;取5-10倍挥发油量的β-环糊精,加水,用高速乳化均质机研磨使其均匀,加入挥发油及少量氯化钠,研磨0.3-1小时,静置12h,以滤纸抽滤,真空干燥,粉碎,得挥发油包合物,将挥发油包合物粉末、浸膏1和浸膏2、矫味剂混合,得混合粉,用85%乙醇制粒,用量为配方量的28%,14目筛制软材,55℃烘箱烘干,14目筛整粒,得颗粒,即得。
5.一种治疗过敏性鼻炎的鼻炎颗粒的制备方法,其特征在于:(1)取藿香5份、苍耳子5份、川芎5份、薄荷5份加10倍量水,水蒸气蒸馏法提取4小时,收集挥发油和滤液,备用;药渣加9倍量水提取1.5小时,滤过,与上述滤液合并,减压浓缩至55℃下相对密度为1.05~1.08的浸膏,冷却至室温,加乙醇使含醇量达80%,静置24小时以上,取上清液滤过,滤液减压回收乙醇并浓缩至55℃下相对密度为1.05~1.08,冷却至室温后用200目筛网滤过,滤液备用;
(2)取丹参6份、香附6份、菊花5份、黄芩6份、太子参5份、苍术3份、生甘草3份加10倍量水,提取2次,每次2小时,滤过,减压浓缩至55℃相对密度1.03~1.05,冷却至室温后用200目筛网滤过,滤液继续浓缩至55℃下相对密度为1.20~1.26的浸膏,与上述浸膏合并,在70℃,压力-0.06~-0.08Mpa减压干燥,粉碎,备用;
(3)取8倍挥发油量的β-环糊精,加6倍量水,采用高速乳化均质机研磨使其均匀,加入挥发油及挥发油重量0.5%的氯化钠,研磨30分钟,静置12h,以滤纸抽滤,置真空干燥箱40℃以下干燥,粉碎,得挥发油包合物;
(4)将挥发油包合物粉末、干膏粉、麦芽糊精和三氯蔗糖均过80目筛混合30min,得混合粉,用85%乙醇制粒,用量为配方量的28%,14目筛制软材,55℃烘箱烘干,14目筛整粒,得颗粒,即得。
6.如权利要求3或4所述方法制得的鼻炎颗粒。
7.权利要求1或2所述的产品在制备治疗过敏性鼻炎的药物中的应用。
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