CN105596571A - 一种制备治疗过敏性鼻炎的中药组合物颗粒剂的方法 - Google Patents
一种制备治疗过敏性鼻炎的中药组合物颗粒剂的方法 Download PDFInfo
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Abstract
本发明公开了一种制备治疗过敏性鼻炎的中药组合物颗粒剂的方法，涉及中药技术领域。本发明以如下原料制得中药组合物：槐花、露蜂房、藿香、蒺藜、黄柏、大蓟、白芷、蒲公英、紫花地丁、夏枯草。本发明制得的中药组合物在治疗过敏性鼻炎的临床疗效显著，疗效稳定而持久。
Description
本申请是申请人杨献美、张霞提出的发明专利申请（发明名称为：一种治疗过敏性鼻炎的中药组合物，申请号为：2013107416136，申请日为：2013年12月30日）的分案申请。
技术领域
本发明属于中医药技术领域，涉及一种制备治疗过敏性鼻炎的中药组合物的方法。
背景技术
过敏性鼻炎属鼻腔黏膜和黏膜下组织的炎症，诱发于花粉、真菌、动物皮毛、食物、药物接触、气候变迁等过敏或非特异性刺激。该病具有发作反复和频繁的特点，发病率高、难以根治。很多患者因为嗅觉或睡眠不良导致食欲减退，对工作和生活都会造成极大的影响，如果长期迁延不治，病情就会不断发展，或诱发鼻窦炎、鼻息肉、过敏性哮喘、睡眠呼吸暂停综合征、冠心病、心肌梗死、高血压、脑血管意外等疾病。由于过敏性鼻炎的发病机理还没有完全搞清楚．彻底根治尚难以做到，临床以药物治疗为主，包括口服抗组胺药和鼻腔局部用糖皮质激素喷剂。但是传统抗组胺类治疗药物和有些激素类药存在副作用大、不良反应多的缺点，服药后可能出现便秘、口干、鼻黏膜干燥、痰液变浓等症状，并产生困乏和疲倦，对肝、肾也有损害，严重者还将导致肥胖、感染、色素沉着等病症。所以选择无副作用的中药和不良反应少而疗效好的糖皮质激素类药物联合用药是治疗过敏性鼻炎较好的方案。
丙酸倍氯米松鼻喷雾剂是一种强效局部用糖皮质激素，其药效机制是通过鼻腔内用药，来增强内皮细胞、平滑肌细胞和溶酶体膜的稳定性，抑制免疫反应和降低抗体合成，使组织胺等过敏活性介质的释放减少和活性降低，并降低抗原—抗体结合时激发的酶促过程，抑制支气管收缩物质的合成和释放，降低平滑肌的收缩反应，从而达到治疗过敏性鼻炎的效果，用药后有较好的抗炎作用。相关研究资料显示，该药经鼻腔喷入，每次每鼻孔2揿，每日2次，每揿50μg，其临床有效率达75％以上，但药物不良反应发生率为12％。
如果开发一种副作用较小的中成药，从而协同丙酸倍氯米松在不降低效疗的情况下减小副作用的发生率，这显得非常重要。
发明内容
鉴于糖皮质激素等西药存在较大的副作用，本发明的目的在于提供一种治疗过敏性鼻炎的中药组合物，从而配合低剂量西药用药，不仅降低了不良反应发生率，而且提高了疾病治疗效果。
本发明的目的是这样实现的：
一种治疗过敏性鼻炎的中药组合物，由如下重量份的中药材原料制备而成：槐花20-30份、露蜂房30-42份、藿香15-22份、蒺藜15-22份、黄柏20-30份、大蓟6-12份、白芷6-12份、蒲公英20-30份、紫花地丁20-30份、夏枯草15-22份。
优选地，如上所述治疗过敏性鼻炎的中药组合物，它由如下重量份的中药材原料制备而成：槐花23-27份、露蜂房34-38份、藿香17-20份、蒺藜17-20份、黄柏23-27份、大蓟8-10份、白芷8-10份、蒲公英23-27份、紫花地丁23-27份、夏枯草17-20份。
在本发明的一个最优选的实施例中，如上所述的中药组合物由如下重量份的中药材原料制备而成：槐花25份、露蜂房36份、藿香18份、蒺藜18份、黄柏25份、大蓟8份、白芷8份、蒲公英25份、紫花地丁25份、夏枯草18份。
优选地，上述的治疗过敏性鼻炎的中药组合物是口服制剂。
再进一步优选地，上述的治疗过敏性鼻炎的中药组合物是颗粒剂。
本发明涉及的中药材具有如下来源：槐花选用豆科植物槐（SophorajaponicaL.）的干燥花朵；露蜂房选用胡蜂科昆虫黄星长脚黄蜂或多种近缘昆虫的巢；藿香选用唇形科植物藿香的干燥茎叶蒺藜选用蒺藜科植物蒺藜TribulusterrestrisL.的干燥成熟果实；黄柏选自芸香科植物黄皮树或黄檗的干燥树皮；白芷选用伞形科植物川白芷的根；大蓟选自菊科植物蓟CirsiumjaponicumDC.的干燥地上部分；蒲公英选自干燥蒲公英的全草；紫花地丁选用紫花地丁的干燥全草；夏枯草选用唇形科植物夏枯草PrunellavulgarisL.的干燥果穗。
将上述各中药材制备成本发明的复方颗粒剂的制备方法，包括如下步骤：按处方量称取清洗干净的槐花、露蜂房、藿香、蒺藜、黄柏、大蓟、白芷、蒲公英、紫花地丁和夏枯草，合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮1.5h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15的浸膏，加95%(v/v)乙醇使含醇量达75%(v/v)，搅拌，静置24小时，过滤，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥（条件为进风温度为100℃，出风温度为80℃，物料温度为80℃，雾化压力为0.2兆帕，喷雾速度为5ml/s。），粉碎过80目筛，得到清膏粉；按照清膏粉：糊精1：1-3的重量比称取清膏粉、糊精，将清膏粉与糊精投入槽型混合机中，搅拌20分钟，边搅拌边缓缓加入适量乙醇溶液，至制成软材，用12目不锈钢筛制粒，65-75℃干燥2小时，取出，放凉即得所述的颗粒剂。
本发明的中药组合物治疗过敏性鼻炎的临床疗效显著，相对于西药作用快却在药物疗效过后症状多复发的特点，本发明的中药方剂具有治疗作用慢但疗效稳定而持久的优点，可与西药联用而降低西药用药量来减少不良反应发生率。
具体实施方式
以下是本发明的具体实施例，对本发明的技术方案做进一步作描述，但是本发明的保护范围并不限于这些实施例。凡是不背离本发明构思的改变或等同替代均包括在本发明的保护范围之内。
实施例1
生药处方：槐花25份、露蜂房36份、藿香18份、蒺藜18份、黄柏25份、大蓟8份、白芷8份、蒲公英25份、紫花地丁25份、夏枯草18份。
制备工艺：按处方量称取清洗干净的上述中药材，合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮1.5h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15的浸膏，加95%(v/v)乙醇使含醇量达75%(v/v)，搅拌，静置24小时，过滤，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥（条件为进风温度为100℃，出风温度为80℃，物料温度为80℃，雾化压力为0.2兆帕，喷雾速度为5ml/s。），粉碎过80目筛，得到清膏粉；按照清膏粉：糊精1：2.5的重量比称取清膏粉、糊精，将清膏粉与糊精投入槽型混合机中，搅拌20分钟，边搅拌边缓缓加入55%乙醇，至制成软材，用12目不锈钢筛制粒，65-75℃干燥2小时，取出，放凉即得所述的颗粒剂，按每袋15g包装。
实施例2
生药处方：槐花22份、露蜂房42份、藿香20份、蒺藜20份、黄柏30份、大蓟10份、白芷10份、蒲公英23份、紫花地丁27份、夏枯草22份。
制备工艺：按处方量称取清洗干净的上述中药材，合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮1.5h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15的浸膏，加95%(v/v)乙醇使含醇量达75%(v/v)，搅拌，静置24小时，过滤，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥（条件为进风温度为100℃，出风温度为80℃，物料温度为80℃，雾化压力为0.2兆帕，喷雾速度为5ml/s。），粉碎过80目筛，得到清膏粉；按照清膏粉：糊精1：3的重量比称取清膏粉、糊精，将清膏粉与糊精投入槽型混合机中，搅拌20分钟，边搅拌边缓缓加入55%乙醇，至制成软材，用12目不锈钢筛制粒，65-75℃干燥2小时，取出，放凉即得所述的颗粒剂，按每袋15g包装。
实施例3
生药处方：槐花30份、露蜂房30份、藿香22份、蒺藜15份、黄柏23份、大蓟6份、白芷8份、蒲公英28份、紫花地丁30份、夏枯草17份。
制备工艺：按处方量称取清洗干净的上述中药材，合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮1.5h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15的浸膏，加95%(v/v)乙醇使含醇量达75%(v/v)，搅拌，静置24小时，过滤，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥（条件为进风温度为100℃，出风温度为80℃，物料温度为80℃，雾化压力为0.2兆帕，喷雾速度为5ml/s。），粉碎过80目筛，得到清膏粉；按照清膏粉：糊精1：3的重量比称取清膏粉、糊精，将清膏粉与糊精投入槽型混合机中，搅拌20分钟，边搅拌边缓缓加入55%乙醇，至制成软材，用12目不锈钢筛制粒，65-75℃干燥2小时，取出，放凉即得所述的颗粒剂，按每袋15g包装。
实施例4中药颗粒剂对过敏性鼻炎患者的疗效研究
63例确诊的过敏性鼻炎患者，男35例，女28例，年龄16～63岁，平均37.1±8.6岁，病程半年至12年。所有患者均连续3个月以上有鼻塞、鼻痒、流清水样鼻涕、打喷嚏等症状，鼻腔检查可见黏膜苍白水肿或鼻甲充血肿胀，变应原皮肤点刺试验呈阳性，特异性IgE抗体检测呈阳性。将患者随机分为两组，其中试验组32例，对照组31例，两组患者的性别、年龄、病程等基本资料比较，无显著行差异，具有可比性。
对照组患者单纯使用丙酸倍氯米松鼻喷雾剂(葛兰素史克生产，商品名：伯克纳，规格50μg*200揿)，每天早晚各1次，每次每鼻孔1揿，连用1个月为1个疗程。喷鼻后适当用淡盐水清洗鼻腔。试验组在使用丙酸倍氯米松鼻喷雾剂药物的基础上，冲服中药颗粒剂（按照本发明实施例1的处方和工艺制备而成）2袋/d，早晚各一袋，连续用药1个月。治疗期间不使用其他治疗方法，戒烟限酒，少吃辛辣油腻食物。治疗结束后，按如下标准统计疗效：
显效：临床症状及体征基本消失，半年以上无复发；
有效：临床症状基本消失．体征明显减轻，偶有复发；
无效：临床症状体征与治疗前相比无明显改变或加重。
治疗结束后，随访6-9个月并统计各组疗效，具体试验结果参见表1。
表1两组疗效情况比较
Claims (1)
1.一种制备治疗过敏性鼻炎的中药组合物颗粒剂的方法，其特征在于包括如下工艺步骤：
（1）称取清洗干净的如下重量份的原料：槐花25份、露蜂房36份、藿香18份、蒺藜18份、黄柏25份、大蓟8份、白芷8份、蒲公英25份、紫花地丁25份、夏枯草18份；
（2）将以上原料合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮1.5h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15的浸膏，加95%v/v乙醇使含醇量达75%v/v，搅拌，静置24小时，过滤，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥条件为进风温度为100℃，出风温度为80℃，物料温度为80℃，雾化压力为0.2兆帕，喷雾速度为5ml/s；粉碎过80目筛，得到清膏粉；按照清膏粉：糊精1：1-3的重量比称取清膏粉、糊精，将清膏粉与糊精投入槽型混合机中，搅拌20分钟，边搅拌边缓缓加入适量乙醇溶液，至制成软材，用12目不锈钢筛制粒，65-75℃干燥2小时，取出，放凉即得所述的颗粒剂。
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