CN105726823A - 一种治疗过敏性鼻炎的中药制剂及其制备方法 - Google Patents
一种治疗过敏性鼻炎的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明提供一种治疗过敏性鼻炎的中药制剂,其有效成份为按重量比配制的:荆芥、防风、柴胡、泽泻、远志、甘遂、金樱子、山萸肉、徐长卿、石菖蒲、茜草、天花粉、藁本、细辛。本发明药物所选药材配伍相宜,符合中医药学和现代医药学理论,并具有清热解毒,利湿、泻火、清瘀、润肺,以宣肺通窍,达到祛热邪,通鼻窍之功效。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,对治疗过敏性鼻炎具有显著疗效,见效较快,治愈后不复发,安全无毒副作用,成本较低,能够达到标本兼治的目的,具有临床推广价值。
Description
技术领域
本发明涉及本发明属于医用药物领域,具体地说,涉及一种治疗过敏性鼻炎的中药制剂及其制备方法。
背景技术
过敏性鼻炎是一种由鼻腔黏膜和黏膜下组织炎症引起的疾病,患者受花粉、真菌、动物皮毛、食物、药物接触、气候变迁等过敏源刺激会引发。以鼻痒、喷嚏、鼻分泌亢进、鼻黏膜肿胀等为主要特点,该病发病率高、常反复、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,目前治疗过敏性鼻炎常见的药物通常为西药,如抗组胺药、鼻腔局部用糖皮质激素喷剂、减充血剂、抗白三烯药和酮类药等,这些药物通常只能缓解症状,并不能根治过敏性鼻炎,而且长期服用这类药物会对身体产生较大副作用,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是治疗过敏性鼻炎较好的方案。研发一种副作用较小、治愈率高、效果好的中成药,对治疗过敏性鼻炎来说,显得非常重要。
发明内容
本发明提出了一种治疗过敏性鼻炎的中药制剂,该药剂能有效的对过敏性鼻炎症状进行治疗,其具体的技术方案如下:
一种治疗过敏性鼻炎的中药制剂,它由以下重量份配比的中药原料制作而成:
荆芥:8~12份;防风:5~10份;柴胡:10~14份;泽泻:5~8份;
远志:7~12份;甘遂:11~14份;金樱子13~18份;山萸肉12~17份;
徐长卿:10~14份;;茜草:8~12份;石菖蒲:14~17份
天花粉:6~10份;藁本:16~21份;细辛:9~12份。
根据权利要求1所述的一种治疗过敏性鼻炎的中药制剂,其特征在于:它由以下重量份的中药原料制作而成:
荆芥:10份;防风:7份;柴胡:12份;泽泻:6份;
远志:9份;甘遂:12份;金樱子:16份;山萸肉:14份;
徐长卿:12份;石菖蒲:15份;茜草:10份;
天花粉:8份;藁本:18份;细辛:10份。
本发明的优选方案中,所述中药制剂是颗粒剂。
一种治疗过敏性鼻炎的药物的制备方法,包括以下工艺步骤:
(1)按配方比将荆芥、防风、柴胡、泽泻、远志、甘遂、金樱子、山萸肉、徐长卿、石菖蒲、茜草、天花粉、藁本、细辛洗净,放入容器内,第一次加入9~11倍量的蒸馏水,浸泡3~4.5小时后,武火煮沸1~1.5小时,小火煎煮3.5~4.5小时,提取汁液;第二次加入5~8倍量蒸馏水,煮沸0.5~小时,提取汁液;第三次加入3~4倍量蒸馏水,煮沸0.5小时,提取汁液;合并三次提取液,过滤,得滤液;
(2)向滤液中加90%(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、70℃条件下减压浓缩成至70℃时相对密度为1.1,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85℃,物料温度为80℃,雾化压力为0.18兆帕,喷雾速度为4.5ml/s。),粉碎过80目筛,得到清膏粉和糊清;
(3)按照清膏粉:糊精1:2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60%乙醇,至制成软材,用13目不锈钢筛制粒,80℃干燥2小时,取出,放凉即得所述的颗粒剂,按每袋15g包装。
本发明所用各药用原料的药理学研究现状如下:
荆芥:味辛;微苦;性微湿;归经归肺;肝经;功效祛风;解表;透疹;止血;功效分类解表药;祛风药;主治感冒发热;头痛;目痒;咳嗽;咽喉肿痛;《纲目》:散风热,清头目,利咽喉,消疮肿。治项强,目中黑花,及生疮;
防风:味辛;甘;性微温;归经归膀胱;肺;脾;肝经;功效祛风解表;胜湿止痛;解痉;止痒;功效分类解表药;祛风药;主治外感风寒;头痛身痛;风湿痹痛;骨节酸痛;腹痛泄泻;肠风下血;破伤风;风疹瘙痒;疮疡初起;《长沙药解》:行经络,逐湿淫,通关节,止疼痛,舒筋脉,伸急孪,活肢节,起瘫痪,敛自汗、盗汗,断漏下、崩中;
柴胡:味苦;辛;性微寒;归经归肝;胆经;功效解表退热;疏肝解郁,升举阳气;功效分类解表药;主治外感发热;寒热往来;疟疾;肝郁胁痛乳胀;头痛头眩;月经不调;气虚下陷之脱肛;子宫脱垂;胃下垂;《日华子本草》:补五劳七伤,除烦止惊,益气力,消痰止嗽,润心肺,添精补髓,天行温疾,热狂乏绝,胸胁气满,健忘;
泽泻:味甘;淡;性寒;归经归肾;膀胱经;功效利水渗湿;泄热通淋;功效分类利水药;渗湿利尿药;主治小便不利;热淋涩痛;水肿胀满;泄泻;痰饮眩晕;遗精;《纲目》:泽泻,气平,味甘而淡,淡能渗泄,气味俱薄,所以利水而泄下;
远志:辛;苦;性微温;归经心;肝;脾;肾经;功效宁心安神;祛痰开窍;解毒消肿;功效分类安神药;祛痰药;主治心神不安;惊悸失眠;健忘;惊痫;咳嗽痰多;痈疽发背;乳房肿痛;《神农本草经》:主咳逆伤中,补不足,除邪气,利九窍,益智慧,耳目聪明,不忘,强志倍力;
甘遂:味苦;性寒;有毒;归经脾;肺;肾;膀胱;大肠;小肠经;功效泻水逐饮;破积通便;功效分类泻下药;主治水肿;腹水;留饮结胸;癫痫;喘咳;大小便不通;《汤液本草》:甘遂可以通水,而其气直透达所结处;
金樱子:酸涩;平;无毒;归经肾;膀胱;大肠;脾;肺经;功效固精,缩尿,涩肠,止带;功效分类收涩药;主治滑精;滑精;遗尿;尿频;久泻;久痢;白浊;白带;崩漏;脱肛;子宫下垂;《本草正》:止吐血,衄血,生津液,收虚汗,敛虚火,益精髓,壮筋骨,补五藏,养血气,平咳嗽,定喘急,疗怔忡惊悸,止脾泄血痢及小水不禁;
山萸肉:味酸;性微温;归经归肝;肾经;功效补益肝肾;收敛固脱;功效分类收涩药;补肾药;主治腰头晕目眩;耳聋耳鸣;腰膝酸软;跹精滑精;小便频数;虚汗不止;妇女崩漏;《别录》:肠胃风邪,寒热疝瘕,头风,风气去来,鼻塞,目黄,耳聋,面疱,温中,下气,出汗,强阴,益精,安五脏,通九窍,止小便利,明目,强力;
徐长卿:味辛;性温;归经肝;胃经;功效祛风止痛;祛风止痒;活血解毒;去痛止痒;消肿;功效分类祛风药;活血药;主治胃病;牙痛;风湿痹痛;腰痛;脘腹疼痛;牙痛;听候扑任痛;小便水利;泄泻;痢疾;湿疹;荨麻疹;毒蛇咬伤;《常用中草药手册》:祛风止痛,解毒消肿,温经通络;
茜草:苦;寒归肝;心经;归经肝;心;肾;脾;胃;心包经;功效凉血止血;活血化瘀;功效分类凉血止血药;活血化瘀药;主治血热咯血;吐血;衄血;尿血;便血;崩漏;经闭;产后瘀阻腹痛;跌打损伤;风湿痹痛;黄疸;疮痈;痔肿;《纲目》:茜草,气温行滞,味酸入肝,而咸走血,专于行血活血;
石菖蒲:味辛;苦;性微温;归经心;肝;脾经;功效化痰开窍;化湿行气;祛风利痹;消肿止痛;功效分类开窍药;理气药;祛风药;主治热病神昏;痰厥;健忘;耳鸣;耳聋;脘腹胀痛;噤口痢;风湿痹痛;跌打损伤;痈疽疥癣;《本草汇言》:石菖蒲,利气通窍,如因痰火二邪为眚,致气不顺、窍不通者,服之宜然;
天花粉:药性味甘;微苦;性微寒;归经归肺;胃经;功效清热生津;润肺化痰;消肿排浓;主治热病口渴;消渴多饮;肺热燥咳;疮疡肿毒;《本草汇言》:天花粉,退五脏郁热,如心火盛而舌干口燥,肺火盛而咽肿喉痹,脾火盛而口舌齿肿,痰火盛而咳嗽不宁;
藁本:味辛;性湿;归经归膀胱经;功效祛风胜湿;散寒止痛;功效分类解表药;主治风寒头痛;巅顶疼痛;风湿痹痛;疥癣;寒湿泄泻;腹痛;疝瘕;《药性沦》:治恶风流入腰,痛冷,能化小便,通血,去头风痛;
细辛:药性辛;温;小毒;归经肺;肾;心;肝;胆;脾经;功效散寒祛风;止痛;温肺化饮;通窍;主治风寒表证;头痛,牙痛;风湿痹痛;痰饮咳喘;鼻塞;鼻渊;口疮;《本草正义》:细辛,芳香最烈,故善开结气,宣泄郁滞,而能上达巅顶,通利耳目,旁达百骸,无微不至,内之宣络脉而疏通百节,外之行孔窍而直透肌肤。
本发明与现有技术相比,具有以下有益效果:
本发明药物所选药材配伍相宜,符合中医药学和现代医药学理论,并具有清热解毒,利湿、泻火、清瘀、润肺,以宣肺通窍,达到祛热邪,通鼻窍之功效。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,对治疗过敏性鼻炎具有显著疗效,见效较快,治愈后不复发,安全无毒副作用,成本较低,能够达到标本兼治的目的,具有临床推广价值。
本发明药物与西药联用而降低西药用药量来减少不良反应,达到标本兼治,其效果更好。
具体实施方式
下面结合实施例对本发明的一种治疗过敏性鼻炎的中药制剂及其制备方法作进一步详细的说明。
实施例1
生成处方:荆芥:8份;防风:5份;柴胡:10份;泽泻:5份;
远志:7份;甘遂:11份;金樱子:13份;山萸肉:12份;
徐长卿:10份;;茜草:8份;石菖蒲:14份;
天花粉:6份;藁本:16份;细辛:9份。
制备过程:按配方比将荆芥、防风、柴胡、泽泻、远志、甘遂、金樱子、山萸肉、徐长卿、石菖蒲、茜草、天花粉、藁本、细辛洗净,放入容器内,第一次加入9~11倍量的蒸馏水,浸泡3~4.5小时后,武火煮沸1~1.5小时,小火煎煮3.5~4.5小时,提取汁液;第二次加入5~8倍量蒸馏水,煮沸0.5~小时,提取汁液;第三次加入3~4倍量蒸馏水,煮沸0.5小时,提取汁液;合并三次提取液,过滤,得滤液;
向滤液中加90%(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、70℃条件下减压浓缩成至70℃时相对密度为1.1,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85℃,物料温度为80℃,雾化压力为0.18兆帕,喷雾速度为4.5ml/s。),粉碎过80目筛,得到清膏粉和糊清;
按照清膏粉:糊精1:2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60%乙醇,至制成软材,用13目不锈钢筛制粒,80℃干燥2小时,取出,放凉即得所述的颗粒剂,按每袋15g包装。
用法用量:每日2次,早晚各1次,每次2袋,饭后温开水送服;15天为1个疗程,2~3个疗程即可见到显著效果,病情严重者酌增用量。
实施例2
生成处方:
荆芥:12份;防风:10份;柴胡:14份;泽泻:8份;
远志:12份;甘遂:14份;金樱子18份;山萸肉17份;
徐长卿:14份;;茜草:8~12份;石菖蒲:17份;
天花粉:10份;藁本:21份;细辛:12份。
本实施例的药物制备方法工艺步骤及用法用量与实施例1相同。
实施例3
生成处方:
荆芥:10份;防风:7份;柴胡:12份;泽泻:6份;
远志:9份;甘遂:12份;金樱子:16份;山萸肉:14份;
徐长卿:12份;石菖蒲:15份;茜草:10份;
天花粉:8份;藁本:18份;细辛:10份。
本实施例的药物制备方法工艺步骤及用法用量与实施例1相同。
临床资料:
1、病例选择:
作为治疗过敏性鼻炎的药物,选择确诊的过敏性鼻炎患者190例临床观察,病人随机分成治疗组和对照组两组,治疗组85例,其中男性37例,女性48例,年龄38~71岁,平均年龄54.5岁,平均病程3.5年;对照组85例,其中男性38例,女性47例,年龄41~70岁,平均年龄53.5岁,平均病程3年。
诊断标准:
1)临床症状:喷嚏、清水样涕、鼻塞、鼻痒等症状出现2项以上,每天症状持续或累计在1小时以上。可伴有眼痒、结膜充血等眼部症状;
2)前鼻镜检查:敏感性鼻炎的诊断可见鼻粘膜苍白水肿,大量清水样分泌物,若因持久性水肿可发生鼻息肉或息肉样变性;
3)鼻腔分泌物涂片检查:在变态反应发作期间,鼻分泌物中可见嗜酸性白细胞增多,敏感性鼻炎的诊断也可查见较多嗜酸性白细胞或肥大细胞;
4)变应性激发试验:一般用皮肤试验(划痕、皮内及接触法等),原理是有多种假定的变应物质,使与机体接触后,视有无反应出现,可协助诊断。
治疗组和对照组两组病例的病程、症状轻重程度基本一致,无显著差异,具有可比性。
2、药物选择:
治疗组服用本发明药物,口服即可,每日2次,早晚各1次,每次2袋,每袋15g,饭后温开水送服;15天为1个疗程,连续服用2~3个疗程。
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喷),每天早晚各1次,每次每鼻孔1喷,连用1个月为1个疗程。喷鼻后适当用淡盐水清洗鼻腔。
3、疗效判定:
(1)治愈:临床症状全部消失,前鼻镜检查和鼻腔分泌物涂片检查均正常。
(2)显效:临床症状明显改善,前鼻镜检查和鼻腔分泌物涂片检查症状有所改善。
(3)有效:临床症状有所改善,体征有所减轻,偶有复发。
(4)无效:通过治疗后临床症状无减轻或加重。
4、结果:
例数 | 治愈 | 显效 | 有效 | 无效 | 治愈率 | 总有效率 | |
治疗组 | 85 | 29 | 40 | 12 | 4 | 34.1% | 95.3% |
对照组 | 85 | 15 | 35 | 17 | 18 | 17.6% | 78.8% |
以上结果显示,治疗组的治愈率和总有效率明显高于对照组。
典型病例举例:
1、李某,男,49岁,四川宜宾人。患者患过敏性鼻炎五年余,鼻塞鼻痒,打喷嚏,流眼泪,流鼻涕,头晕头胀,常在春季发病,服用多种药物效果不佳,服用本发明药物2个疗程后,上述症状明显改善,服药4个疗程后,症状基本消失,半年后随访,病情无复发。
2、唐某,女,58岁,新疆石河子人。患者2年前出现过敏性鼻炎,服本药前仍是鼻涕如清水,严重鼻塞,伴有头痛,常处于感冒状态。服用本发明药物治疗,服用2个疗程后,症状有所好转,服用3个疗程后,症状全部消失,前鼻镜检查和鼻腔分泌物涂片检查均正常,1年后随访无复发。
3、方某,男,35岁,河北唐山人。患者因长期不注重感冒治疗,导致过敏性鼻炎,长期鼻塞严重,鼻腔受轻微刺激即发生流眼泪,流鼻涕现象,且头晕不断,影响正常工作。服用本发明药物治疗,服用1个疗程后,患者感觉鼻腔舒畅,鼻塞减轻。继续服用2个疗程后,,鼻塞、头痛等症状消失,1年后随访未复发。
Claims (4)
1.一种治疗过敏性鼻炎的中药制剂,其特征在于:它由以下重量份配比的中药原料制作而成:
荆芥:8~12份;防风:5~10份;柴胡:10~14份;泽泻:5~8份;
远志:7~12份;甘遂:11~14份;金樱子13~18份;山萸肉12~17份;
徐长卿:10~14份;;茜草:8~12份;石菖蒲:14~17份
天花粉:6~10份;藁本:16~21份;细辛:9~12份。
2.根据权利要求1所述的一种治疗过敏性鼻炎的中药制剂,其特征在于:它由以下重量份的中药原料制作而成:
荆芥:10份;防风:7份;柴胡:12份;泽泻:6份;
远志:9份;甘遂:12份;金樱子:16份;山萸肉:14份;
徐长卿:12份;石菖蒲:15份;茜草:10份;
天花粉:8份;藁本:18份;细辛:10份。
3.根据权利要求1所述的一种治疗过敏性鼻炎的中药制剂,其特征在于:所述中药制剂是颗粒剂。
4.一种如权利要求1或2或3所述治疗过敏性鼻炎的药物的制备方法,其特征在于:包括以下工艺步骤:
按配方比将荆芥、防风、柴胡、泽泻、远志、甘遂、金樱子、山萸肉、徐长卿、石菖蒲、茜草、天花粉、藁本、细辛洗净,放入容器内,第一次加入9~11倍量的蒸馏水,浸泡3~4.5小时后,武火煮沸1~1.5小时,小火煎煮3.5~4.5小时,提取汁液;第二次加入5~8倍量蒸馏水,煮沸0.5~小时,提取汁液;第三次加入3~4倍量蒸馏水,煮沸0.5小时,提取汁液;合并三次提取液,过滤,得滤液;
向滤液中加90%(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、70℃条件下减压浓缩成至70℃时相对密度为1.1,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85℃,物料温度为80℃,雾化压力为0.18兆帕,喷雾速度为4.5ml/s,粉碎过80目筛,得到清膏粉和糊清;
按照清膏粉:糊精1:2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60%乙醇,至制成软材,用13目不锈钢筛制粒,80℃干燥2小时,取出,放凉即得所述的颗粒剂,按每袋15g包装。
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