CN117064983A - 一种基于竹叶黄酮治疗鼻炎的药物制备方法 - Google Patents
一种基于竹叶黄酮治疗鼻炎的药物制备方法 Download PDFInfo
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Abstract
本发明公开了一种基于竹叶黄酮治疗鼻炎的药物制备方法,克服了现行治疗鼻炎反复发作的缺陷及不良反应,其药物组份为竹叶黄酮和辛夷挥发油。本发明简化中药药物组分利用竹叶黄酮和辛夷的组合发挥协同增效作用,增强其抗炎和抗过敏作用,从而更好地治疗缓解鼻炎症状。此外,配伍使用减少竹叶黄酮和辛夷挥发油的副作用,提高药物的安全性和耐受性。本发明产品制备方法简单,制得的产品性能优异,有效药物成分深入病灶部位,起效快,使炎症得到迅速排除,疗效好,治愈率高,显效率达75.0%以上,治愈率67.0%以上。
Description
技术领域
本发明涉及中药制剂技术领域,具体涉及一种基于竹叶黄酮治疗鼻炎的药物制备方法。
背景技术
鼻炎即鼻腔炎性疾病,包括过敏性鼻炎、慢性鼻炎、慢性鼻窦炎等,是由病毒、细菌、变应原、各种理化因子以及某些全身性疾病引起的鼻腔黏膜的炎症。鼻炎症状有很多种,依据鼻炎的种类不同,鼻炎症状也有所不同,典型的症状表现为鼻塞、流鼻血、鼻内发痒、畏寒、发热、食欲不振、头痛、头昏等症状。我国是鼻咽癌高发国之一,全世界80%的鼻咽癌发生在我国,其中有90%是由于鼻炎久治不愈造成病情恶化所致。
西医认为,鼻炎是由于发热感冒病毒性感染引起的,临床上西医的治疗效果不尽人意,治疗上常采用抗生素杀菌消炎、手术、激光等治疗方案,虽能见效快,但痛苦大、易复发、且医疗费用高。中医认为,鼻炎的外在病因主要是寒邪、火热之邪等作用引起,其中主要以寒邪为主,寒邪造成患者窍络不通,出现淤血,同时寒气上升造成肺气、肺寒。因此治疗鼻炎首先应清肺益脾,利用中医药治疗鼻炎可达到疗效可靠,毒副作用小,具有广阔的前景。
竹叶黄酮是一种以天然竹叶为主要原料制成的天然黄酮类化合物,有效成分主要是黄酮糖苷和香豆素类内酯,主要稳定成分为竹叶碳苷黄酮,包括荭草苷、异荭草苷、牡荆苷和异牡荆苷四类。竹叶黄酮性能稳定,不易降解,能直接深入到病变的位置,达到治疗的效果,具有抗过敏、抗炎、抗菌、抗病毒、保护心血管等多种生理活性。竹叶黄酮在多功能食品添加剂、医药中间体、功能性食品及化妆品等多个领域市场前景广阔。
辛夷挥发油作为中药辛夷发挥药用价值的主要活性部位,辛夷挥发油从辛夷花蕾或辛夷花苞中提取而得的药效最佳,其化学成分丰富,药理作用广泛,但辛夷挥发油在临床中的实际应用却很少。近年来,芳香疗法在治疗焦虑、抑郁、痴呆等中枢神经系统疾病方面具有显著效果,中药挥发油经鼻腔给药沿嗅神经入脑、发挥中枢治疗作用的研究已成为热点。辛夷挥发油在鼻腔给药上表现出良好的治疗作用,且脂溶性强,易于透过血脑屏障,不仅可自身入脑发挥药用价值,还可作为其他药物的载体,促进药效物质的吸收。
本发明所要解决的技术问题在于,寻求一种配方简单、制作工艺简便,疗效好、见效快、无毒副作用且给药方便,药剂易于制造,成本低廉的新药是本领域技术人员亟需解决的问题。
发明内容
本发明的目的在于提供一种基于竹叶黄酮治疗鼻炎的药物制备方法,以解决上述背景技术中提出的问题。为实现上述目的,本发明提供如下技术方案:
一种基于竹叶黄酮治疗鼻炎的药物制备方法,所述药物由下列重量份组成的活性原料药制成:竹叶黄酮8-55份、辛夷挥发油(从辛夷花蕾或花苞提取而得)15-45份;
进一步的,所述的药物由以下重量份组成的活性原料药制成:竹叶黄酮10-53份、辛夷挥发油(从辛夷花蕾或花苞提取而得)18-42份。
进一步的,所述的一种基于竹叶黄酮治疗鼻炎的药物制备方法,其特征在于将活性药粉加入常规辅料,按照常规工艺,制成乳剂。
本发明提供了一种基于竹叶黄酮治疗鼻炎的药物制备方法,制成乳剂包括如下步骤:
a、按所需量称取竹叶黄酮,加入纯化水,再加入丝氨酸,置于恒温环境中搅拌使竹叶黄酮溶解,得竹叶黄酮溶液备用;
b、按所需量称取辛夷挥发油,加入步骤a中竹叶黄酮溶液,再加入司盘-80乳化剂,用力沿一个方向研磨至成乳剂备用;
c、步骤b制得乳剂,倒入干净的容器中,密封保存,储存至干燥环境,避免直接暴露在阳光或强光,温度控制2-8℃内制成乳剂。
进一步的,所述步骤a中纯化水加入量为竹叶黄酮重量的5-15倍,优选8-12倍;丝氨酸加入量为竹叶黄酮重量的0.03-0.12倍,优选0.05-0.10倍;环境温度为50-65℃,优选55-60℃。
进一步的,所述的步骤b中司盘80加入量为竹叶黄酮、纯化水和辛夷挥发油三者总重量的1.8%-3.5%,优选2.2%-3.1%。
进一步的,一种基于竹叶黄酮治疗鼻炎的乳剂的使用方法如下:使用前应先将鼻腔清洗干净,然后取适量乳剂涂抹于鼻翼外部或鼻孔周围皮肤;每日使用2~3次,每次使用适量,使用七日为一个疗程。
本发明药物组合物的药理功效:
竹叶黄酮为竹叶提取物,其味甘苦、性寒;功效:抗菌,抗病毒,抗心肌缺血,降血脂,抗氧化,防治肝损伤,保护胃黏膜,抗疲劳,除臭增香。
辛夷挥发油由辛夷花蕾或辛夷花苞提取制得,其味辛、性温;功效:具有发散风寒、通鼻窍的功效,临床上用于治疗风寒头痛鼻塞、治疗热性或寒性鼻渊导致的头痛、鼻疮等疾病。
本发明简化中药药物组分利用竹叶黄酮和辛夷挥发油组合发挥协同增效作用,增强其抗炎和抗过敏作用,从而更好地治疗缓解鼻炎症状;此外,配伍使用减少竹叶黄酮和辛夷挥发油的副作用,提高它们的安全性和耐受性。取得的有益效果为:(1)本发明取材草本植物,药源丰富,无毒副作用,无药物依赖性,药效干扰少的优势。药物配方科学合理,药物协同增效,直达病灶所在,药到病除且全部为外用药物,效果好,无复发;(2)可以直接作用于鼻腔内,通过皮肤迅速吸收,消炎杀菌效果好,通气快、用药少、药效长、且携带方便,使用方便,适于临床推广使用;(3)本发明产品可制备多种剂型且制备方法简单,制得的产品性能优异,产品对各类鼻炎具有极佳的治疗效果,显效率达75.0%以上,治愈率67.0%以上。
具体实施方式
下面结合具体实施例,对本发明作进一步的解释说明。应当理解,这些实施例是本发明优选出的实施方案,仅用于具体说明。根据以上论述和这些实施例,本领域技术人员可确定本发明的必要特征,在不偏离于本发明的宗旨和技术范围内,可对本发明进行各种变化和修改,以适应各种用途和条件。实施例未注明具体条件者,按照常规条件或制造商建议的条件进行。
表1具体实施例的活性原料药配比
编号 | 竹叶黄酮:辛夷挥发油(重量比) |
实施例1 | 1:3 |
实施例2 | 1.5:2.5 |
实施例3 | 2:2 |
实施例4 | 2.5:1.5 |
实施例5 | 3:1 |
对比例1 | 4:0 |
对比例2 | 0:4 |
实施例1
一种基于竹叶黄酮治疗鼻炎的药物制备方法,由以下重量组成的活性原料药制成:竹叶黄酮(竹叶提取物,购于扶风斯诺特生物科技有限公司,纯度40%)10g、辛夷挥发油(从辛夷花蕾或花苞提取而得)30g。
其制成乳剂包括如下步骤:
a、称取竹叶黄酮10g,加入100g纯化水,再加入0.8g丝氨酸,置于60℃环境中恒温搅拌使竹叶黄酮溶解,得竹叶黄酮溶液备用;
b、称取辛夷挥发油30g,加入到步骤a中竹叶黄酮溶液,加入3.5g司盘80乳化剂,用力沿一个方向研磨至成乳剂备用;
c、步骤b制得乳剂,倒入干净的容器中,密封保存,储存至干燥环境,避免直接暴露在阳光或强光,温度控制4℃制成乳剂。
实施例2
一种基于竹叶黄酮治疗鼻炎的药物制备方法,称取竹叶黄酮15g、辛夷挥发油25g、150g纯化水、1.2g丝氨酸和4.8g司盘80,其余制备方法均按照实施例1制备,得到乳剂。
实施例3
一种基于竹叶黄酮治疗鼻炎的药物制备方法,称取竹叶黄酮20g和辛夷挥发油20g、200g纯化水、1.6g丝氨酸和6.0g司盘80,其余制备方法均按照实施例1制备,得到乳剂。
实施例4
一种基于竹叶黄酮治疗鼻炎的药物制备方法,称取竹叶黄酮25g和辛夷挥发油15g、250g纯化水、2.0g丝氨酸和7.3g司盘80,其余制备方法均按照实施例1制备,得到乳剂。
实施例5
一种基于竹叶黄酮治疗鼻炎的药物制备方法,称取竹叶黄酮30g和辛夷挥发油10g、300g纯化水、2.4g丝氨酸和8.5g司盘80,其余制备方法均按照实施例1制备,得到乳剂。
对比例1
一种基于竹叶黄酮治疗鼻炎的药物制备方法,称取竹叶黄酮40g、400g纯化水、1.2g丝氨酸和11.0g司盘80,其余制备方法均按照实施例1制备,得到乳剂。
对比例2
一种基于竹叶黄酮治疗鼻炎的药物制备方法,称取辛夷挥发油40g和1.0g司盘80,其余制备方法均按照实施例1制备,得到乳剂。
临床实验
(1)患者:共420例患者,临床症状为鼻塞、鼻痒、流鼻涕、喷嚏、头昏、头痛等症状出现2项以上(含2项),每天症状持续或累计在0.5小时以上。可伴有眼痒、结膜充血等眼部症状。体征常见鼻黏膜苍白、水肿,总鼻道及鼻底可见清涕或黏涕。可并发荨麻疹,哮喘等症,常因接触花粉、烟雾、粉尘、化学气味而发病或因环境变化亦会诱发。
其中,感染性鼻炎122例、药物性鼻炎92例、急性鼻炎60例、萎缩性鼻炎84例、职业性鼻炎62例;男性213例,女性207例;年龄最大者68岁,最小者13岁;病程最长者23年,最短者1年。
按照实施例1-5和对比例1-2配比制得的中药制剂,使用前应先将鼻腔清洗干净,然后取适量乳剂涂抹于鼻翼外部或鼻孔周围皮肤。每日使用2~3次,每次使用适量,使用七日为一个疗程,各应用于上述60个病例观察,试用取得较为理想的治疗效果。
(2)主要观察:
分别观察用药后第一天、第二天、第三天、第五天、第七天的鼻腔变化情况,观察鼻塞、鼻痒、流鼻涕、水肿、眼部等变化情况。
(3)疗效标准:
治愈:病症完全消失,一个月内无复发;
显效:鼻塞、流涕症状明显减轻,嗅觉逐渐显好转;
好转:喷嚏、鼻塞、流涕症状有所好转,嗅觉减退有所好转;
无效:通过治疗症状无减轻或加重。
(4)实验结果见表2。
表2临床实验结果
由表1结果可知实施例1-5与对比例1-2治愈率比较,本发明制备的中药制剂治愈率更高,疗效更好。本发明提供的鼻炎药物组合物对于鼻炎具有很好地治疗效果,大部分鼻炎患者能够基本痊愈,实施例显效率达75.0%以上,治愈率67.0%以上。而在实际病例实验中,若基本痊愈则停止用药,仍有不适症状则继续服药至1个月。在用药过程中,达到症状减轻所需的用药次数约为6-8次,见效较快;达到基本症状消失的程度约为20-25次,治愈率较高。综合本发明说明书中提及的诸多优点,本发明的鼻炎药物组合物是极具应用价值的鼻炎药物。
以上内容是结合具体的优选实施方式对本发明所做出的进一步详细说明,不能认定本发明的具体实施仅限于这些说明。对于本发明所属领域的普通技术人员来说,在不脱离本发明的技术方案及其发明构思加以等同替换或改变,都应涵盖在本发明的保护范围之内。
Claims (7)
1.一种基于竹叶黄酮治疗鼻炎的药物制备方法,其特征在于是由下列重量份组成的活性原料药制成:竹叶黄酮8-55份、辛夷挥发油(从辛夷花蕾或花苞提取而得)15-45份。
2.一种基于竹叶黄酮治疗鼻炎的药物制备方法,其特征在于是由下列重量份组成的活性原料药制成:竹叶黄酮10-53份、辛夷挥发油(从辛夷花蕾或花苞提取而得)18-42份。
3.根据权利要求1或2所述的一种基于竹叶黄酮治疗鼻炎的药物制备方法,其特征在于将活性药粉加入常规辅料,按照常规工艺,制成乳剂。
4.根据权利要求3所述的一种基于竹叶黄酮治疗鼻炎的药物制备方法,其特征在于制成乳剂的步骤如下:
a、按所需量称取竹叶黄酮,加入纯化水,再加入丝氨酸,置于恒温环境中搅拌使竹叶黄酮溶解,得竹叶黄酮溶液备用;
b、按所需量称取辛夷挥发油,加入步骤a中竹叶黄酮溶液,再加入司盘80乳化剂,用力沿一个方向研磨至成乳剂备用;
c、步骤b制得乳剂,倒入干净的容器中,密封保存,储存至干燥环境,避免直接暴露在阳光或强光,温度控制2-8℃内制成乳剂。
5.根据权利要求4所述的一种基于竹叶黄酮治疗鼻炎的药物制备方法,其特征在于步骤a中纯化水加入量为竹叶黄酮重量的5-15倍,优选8-12倍;丝氨酸加入量为竹叶黄酮重量的0.03-0.12倍,优选0.05-0.10倍;环境温度为50-65℃,优选55-60℃。
6.根据权利要求5所述的一种基于竹叶黄酮治疗鼻炎的药物制备方法,其特征在于步骤b中司盘80加入量为竹叶黄酮、纯化水和辛夷挥发油三者总重量的1.8%-3.5%,优选2.2%-3.1%。
7.根据权利要求5所述的一种基于竹叶黄酮治疗鼻炎的药物制备方法,其特征在于使用前应先将鼻腔清洗干净,然后取适量乳剂涂抹于鼻翼外部或鼻孔周围皮肤;每日使用2~3次,每次使用适量,使用七日为一个疗程。
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