CN105412536A - 一种鼻炎灵丸及其制备方法 - Google Patents
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Abstract
本发明公开了一种鼻炎灵丸及其制备方法,其特征在于取蒺藜21g,香橼63g,地骨皮42g,苍耳子(微炒)210g,辛夷168g,黄芩42g,薄荷40g,川贝母42g,粉碎成粗粉,置循环超声提取器中,加入水,锗粉,吐温60,超声取提,射流喷雾干燥,制得纳米提取粉,炼蜜泛丸,制得鼻炎灵丸,用于治疗祛风清热,消肿通窍。用于鼻渊、鼻塞、鼻流浊涕等急、慢性鼻炎,疗效显著优于市售鼻炎灵丸,取得了良好效果。
Description
技术领域
本发明涉及中药领域,具体涉及一种鼻炎灵丸及其制备方法。
背景技术
鼻炎灵丸祛风清热,消肿通窍。用于鼻渊、鼻塞、鼻流浊涕等急、慢性鼻炎。市售鼻炎灵丸由于组方和工艺原因,疗效不甚理想,制剂采用传统工艺制备,存在疗效低的缺点。
发明内容
本发明为克服上述不足,提供一种疗效高的鼻炎灵丸及其制备方法。
发明实施方案如下:
取蒺藜21g,香橼63g,地骨皮42g,苍耳子(微炒)210g,辛夷168g,黄芩42g,薄荷40g,川贝母42g,粉碎成40目粗粉,置循环超声提取器中,加入6280g水,6~8g锗粉,6~8g吐温60,选择超声频率50~60KHz,压力0.4~0.6Mpa提取30分钟,用80目筛过滤,得提取液;取提取液置射流喷雾干燥机中,控制进风温度38~48℃,压力0.02~0.04Mpa,流速每秒400~600米,得纳米提取粉;每100g纳米提取粉用炼蜜20-30g加适量的水泛丸,干燥,制成水蜜丸,制得鼻炎灵丸。
上述实施方案所提到的原材料标准如下:
蒺藜:中国药典2005年版一部标准。本品为蒺藜科植物蒺藜TribulusterrestrisL.的干燥成熟果实。秋季果实成熟时采割植株,晒干,打下果实,除去杂质。
香橼:中国药典2005年版一部标准。本品为芸香科植物构橼CitrusmedicaL.或香圆CitruswilsoniiTanaka的干燥成熟果实。秋季果实成熟时采收,趁鲜切片,晒干或低温干燥。香圆亦可整个或对剖两半后,晒干或低温干燥。
地骨皮:中国药典2005年版一部标准。本品为茄科植物枸杞LyciumchinenseMill.或宁夏枸杞LyciumbarbarumL.的干燥根皮。春初或秋后采挖根部,洗净,剥取根皮,晒干。
苍耳子:中国药典2005年版一部标准。本品为菊科植物苍耳XanthiumsibiricumPatr.的干燥成熟带总苞的果实。秋季果实成熟时采收,干燥,除去梗、叶等杂质。
辛夷:中国药典2005年版一部标准。本品为木兰科植物望春花MagnoliabiondiiPamp.、玉兰MagnoliadenudataDesr.或武当玉兰MagnoliasprengeriPamp.的干燥花蕾。冬末春初花未开放时采收.除去枝梗,阴干。
黄芩:中国药典2005年版一部标准。本品为唇形科植物黄芩ScutellariabaicalensisGeorgi的干燥根。春、秋二季采挖,除去须根及泥沙,晒后撞去粗皮,晒干。
薄荷:中国药典2005年版一部标准。本品为唇形科植物薄荷MenthahaplocalyxBriq.的干燥地上部分。夏、秋二季茎叶茂盛或花开至三轮时,选晴天,分次来割,晒干或阴干。
川贝母:中国药典2005年版一部标准。本品为百合科植物川贝母FritillariacirrhosaD.Don。暗紫贝母FritillariaunibracteataHsiaoetK.C.Hsia、甘肃贝母FritillariaprzewalskiiMaxim.或梭砂贝母FritillariadelavayiFranch.的干燥鳞茎。前三者按性状不同分别习称“松贝”和“青贝”,后者习称“炉贝”。夏、秋二季或积雪融化时采挖,除去须根、粗皮及泥沙,晒干或低温干燥。
锗粉:二氧化锗:CAS号:1310-53-8:行业标准:百灵威科技有限公司;
吐温60:中国药典2010年版二部标准;
以上鼻炎灵丸所用到的原材料均可从医药公司购买得到,并不限于典型生产厂家,只要满足质量标准均可用来实施本发明方案。
上述发明实施方案所提到的关键设备如下:
循环超声机:超声频率20~100KHz,
(典型生产厂家:北京弘祥隆生物技术开发有限公司)
射流喷雾干燥机:进风温度范围30~70℃,射流速度范围每秒300~900米;
(典型生产厂家:北京奈诺生物科技有限公司)
以上鼻炎灵丸所用到的原材料均可从医药公司购买得到,只要满足国家标准均可用来实施本发明方案。
上述发明方案中所用术语为药学专用术语,如“减压”等皆遵从中国药典规定和相关药学规范。
本发明中的单位g也可以是其它重量份,不影响本发明方案的实施。
本发明方案中所述的设备市场均有销售,并不限于典型生产厂家,只要技术指标能够达到要求,均可用来实现本发明。
具体实施方式
本发明的具体实施例1
取蒺藜21g,香橼63g,地骨皮42g,苍耳子(微炒)210g,辛夷168g,黄芩42g,薄荷40g,川贝母42g,粉碎成40目粗粉,置循环超声提取器中,加入6280g水,6g锗粉,6g吐温60,选择超声频率50KHz,压力0.4Mpa提取30分钟,用80目筛过滤,得提取液;取提取液置射流喷雾干燥机中,控制进风温度38℃,压力0.02Mpa,流速每秒400米,得纳米提取粉;每100g纳米提取粉用炼蜜20g加适量的水泛丸,干燥,制成水蜜丸,制得鼻炎灵丸。
本发明的具体实施例2
取蒺藜21g,香橼63g,地骨皮42g,苍耳子(微炒)210g,辛夷168g,黄芩42g,薄荷40g,川贝母42g,粉碎成40目粗粉,置循环超声提取器中,加入6280g水,8g锗粉,8g吐温60,选择超声频率60KHz,压力0.6Mpa提取30分钟,用80目筛过滤,得提取液;取提取液置射流喷雾干燥机中,控制进风温度48℃,压力0.04Mpa,流速每秒600米,得纳米提取粉;每100g纳米提取粉用炼蜜30g加适量的水泛丸,干燥,制成水蜜丸,制得鼻炎灵丸。
本发明的具体实施例3
取蒺藜21g,香橼63g,地骨皮42g,苍耳子(微炒)210g,辛夷168g,黄芩42g,薄荷40g,川贝母42g,粉碎成40目粗粉,置循环超声提取器中,加入6280g水,7g锗粉,7g吐温60,选择超声频率55KHz,压力0.5Mpa提取30分钟,用80目筛过滤,得提取液;取提取液置射流喷雾干燥机中,控制进风温度43℃,压力0.03Mpa,流速每秒500米,得纳米提取粉;每100g纳米提取粉用炼蜜25g加适量的水泛丸,干燥,制成水蜜丸,制得鼻炎灵丸。
以上实施例说明,采用本发明实施方案的极端条件和优化条件均能制成鼻炎灵丸。下面以实施例3制得的鼻炎灵丸考察本发明的实际效果:
(一)实施例3鼻炎灵丸与市售鼻炎灵丸治疗鼻渊、鼻塞、鼻流浊涕等急、慢性鼻炎临床疗效观察
1病例情况
统计门诊和住院病例,共观察鼻渊、鼻塞、鼻流浊涕等急、慢性鼻炎病例102例,平均年龄42岁。将患者分为两组,试验组服用实施例3鼻炎灵丸,对照组服用传统鼻炎灵丸。
2疗效评定标准
依据中药新药临床研究指导原则中医证候疗效判定标准:
治愈:中医临床症状、体征消失或基本消失,证候积分减少≥95%。
显效:中医临床症状、体征明显改善,证候积分减少≥70%。
有效:中医临床症状、体征均有好转,证候积分减少≥30%。
无效:中医临床症状、体征均均无明显改善或者加重,证候积分减少<30%。
计算公式:[(治疗前积分-治疗后积分)÷治疗前积分]×100%。
3临床观察结果
表1实施例3鼻炎灵丸和市售鼻炎灵丸临床疗效对比
上述临床疗效观察结果表明,本发明制备的鼻炎灵丸在治疗鼻渊、鼻塞、鼻流浊涕等急、慢性鼻炎时,疗效显著高于市售鼻炎灵丸,p<0.05。
Claims (3)
1.一种治疗鼻渊、鼻塞、鼻流浊涕等急、慢性鼻炎的中药,其特征是取蒺藜21g,香橼63g,地骨皮42g,苍耳子(微炒)210g,辛夷168g,黄芩42g,薄荷40g,川贝母42g,粉碎成40目粗粉,置循环超声提取器中,加入6280g水,6~8g锗粉,6~8g吐温60,选择超声频率50~60KHz,压力0.4~0.6Mpa提取30分钟,用80目筛过滤,得提取液;取提取液置射流喷雾干燥机中,控制进风温度38~48℃,压力0.02~0.04Mpa,流速每秒400~600米,得纳米提取粉;每100g纳米提取粉用炼蜜20-30g加适量的水泛丸,干燥,制成水蜜丸,制得鼻炎灵丸。
2.根据权利要求1所述中药的制备方法,其特征是取蒺藜21g,香橼63g,地骨皮42g,苍耳子(微炒)210g,辛夷168g,黄芩42g,薄荷40g,川贝母42g,粉碎成40目粗粉,置循环超声提取器中,加入6280g水,6~8g锗粉,6~8g吐温60,选择超声频率50~60KHz,压力0.4~0.6Mpa提取30分钟,用80目筛过滤,得提取液;取提取液置射流喷雾干燥机中,控制进风温度38~48℃,压力0.02~0.04Mpa,流速每秒400~600米,得纳米提取粉;每100g纳米提取粉用炼蜜20-30g加适量的水泛丸,干燥,制成水蜜丸,制得鼻炎灵丸。
3.根据权利要求1所述中药的制备方法,其特征是取蒺藜21g,香橼63g,地骨皮42g,苍耳子(微炒)210g,辛夷168g,黄芩42g,薄荷40g,川贝母42g,粉碎成40目粗粉,置循环超声提取器中,加入6280g水,7g锗粉,7g吐温60,选择超声频率55KHz,压力0.5Mpa提取30分钟,用80目筛过滤,得提取液;取提取液置射流喷雾干燥机中,控制进风温度43℃,压力0.03Mpa,流速每秒500米,得纳米提取粉;每100g纳米提取粉用炼蜜25g加适量的水泛丸,干燥,制成水蜜丸,制得鼻炎灵丸。
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