CN107149611B - 一种蒙药鼻炎喷雾剂及其制备方法 - Google Patents
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Abstract
本发明属于医药领域，具体涉及一种蒙药鼻炎喷雾剂及其制备方法,一种蒙药鼻炎喷雾剂，其原料包括阿给挥发油、聚维酮K30、吐温‑80、苯扎溴铵和薄荷脑；其制备方法，包括以下步骤：提取阿给挥发油备用；另取聚维酮K30加入水中，搅拌使其溶解，放置30 min；然后在搅拌条件下，溶液中依次加入吐温‑80、阿给挥发油、苯扎溴铵和薄荷脑，再加入水灭菌后得到蒙药鼻炎喷雾剂。有益效果：喷雾剂具有良好的流动性和适当的粘着性，容易附于鼻腔黏膜，显效快，药效长，无毒副作用。对于多种鼻炎、鼻窦炎均具有显著的疗效，另对鼻衄也具有良好的治疗作用。
Description
技术领域
本发明属于医药领域，具体涉及一种蒙药鼻炎喷雾剂及其制备方法。
背景技术
鼻炎是鼻黏膜或黏膜下组织因为病毒感染、病菌感染、刺激物刺激等，导致鼻黏膜或黏膜下组织受损，所引起的急性或慢性炎症。急性鼻炎由病毒感染引起，后期常合并细菌感染，有传染性。慢性鼻炎是因炎症持续数月或反复发作，迁延不愈，一般包括慢性单纯性鼻炎、慢性肥厚性鼻炎。其他常见的鼻炎有：过敏性鼻炎、干燥性鼻炎、萎缩性鼻炎、血管运动性鼻炎等。鼻腔是呼吸系统的第一个门户，承担着对空气的过滤、调温、消毒灭菌等重要任务，鼻腔炎症势必对其功能造成负面影响，如果不能及时治疗，会使炎症向鼻窦蔓延，进而影响全身的健康水平。
目前，治疗鼻炎的药物很多，其中，应用较多的是各种鼻炎喷雾剂。现有鼻炎喷雾剂主要有西药喷雾剂和中药喷雾剂，但其中的西药喷雾剂多含激素，副作用较大，不宜常用。其中的中药喷剂大都需要多种名贵药材配伍，原料稀少，成本较高。此外，为了提高喷剂的雾化效果，要求药液具有良好的流动性。而当药液扩散到患部以后，又希望药液具有较好的粘着性，可以较长时间的附着在患部。显然，这是两种相反的要求，现有喷雾剂多具有较好的流动性，而附着性能多不满意。由于鼻腔所处环境恶劣，冷热无常，污物较多，加之构造曲折，不易清理，药物难以深入滞留，因而现有药品的治愈率都很低，致使鼻炎成为发病率高、治愈率低、易复发绵延的常见病。
发明内容
本发明的目的是提供一种原料广泛，成本低廉，安全无毒，兼具良好的流动性和粘着性，好对鼻炎具有显著疗效的蒙药喷雾剂。
本发明的另一目的是提供上述蒙药喷雾剂制备方法。
本发明的目的是通过下述技术方案实现的：研制一种蒙药鼻炎喷雾剂，其原料包括阿给挥发油、聚维酮K30、吐温-80、苯扎溴铵和薄荷脑；各原料的重量份数是：阿给挥发油2～4份，聚维酮K30 1～2份，吐温-80 0.8～1.6份，苯扎溴铵0.002份和薄荷脑0.02份（误差小于5%）。
所述的苯扎溴铵是新洁尔灭。
上述的蒙药鼻炎喷雾剂的制备方法，包括以下步骤：提取阿给挥发油备用；另取聚维酮K30加入水中，搅拌使其溶解，放置30 min；然后在搅拌条件下，溶液中依次加入吐温-80、阿给挥发油、苯扎溴铵和薄荷脑，再加入水灭菌后得到蒙药鼻炎喷雾剂。
所述阿给挥发油的提取方法是：先把阿给加水在室温下浸泡2小时后，再加热提取5小时，得到挥发油。
所述阿给挥发油在4～10℃下冷藏。
本发明的有益效果：喷雾剂具有良好的流动性和适当的粘着性，容易附于鼻腔黏膜，显效快，药效长，无毒副作用。对于多种鼻炎、鼻窦炎均具有显著的疗效，另对鼻衄也具有良好的治疗作用。主要原料阿给为草原多年生多产植物，且遍布全国各地，原料广泛，加工方便，造价低廉，应用前景非常可观。
附图说明
图1供试液和对照液TLC图谱；
图2供试液的GC-MS图谱。
具体实施方式
下面结合实施例对本发明作进一步详细的描述，但本发明的实施方式不限于所例举的实施例。
实施例1：
按重量份取阿给1000 g，加水在室温下浸泡2 h，加热提取5 h，收集其挥发油约(20 g)，置于冰箱（4～10℃）中冷藏，备用；取聚维酮K30 (10 g) 加入水中，搅拌溶解，放置30 min；然后在搅拌条 件下，溶液中依次加入吐温-80 (8 g)、阿给挥发油 (20 g）、苯扎溴铵 (9.5-11.5 mg) 和薄荷脑 (1 g)；然后加入水至1 L，灭菌后得到蒙药鼻炎喷雾剂，实验过程中称为“阿给鼻炎喷雾剂”。
使用方法：患者平卧，喷入鼻腔，一次喷入量为（0.05—0.14 mL），一日3—5次，一周为一个疗程。
药性分析：
阿给，汉名小白蒿，别名冷蒿，系菊科蒿属植物冷蒿Artemisia frigida Willd.的地上部分。据《蒙药学》记载阿给7~8月初采收，晒干，可全草入药。性味辛、温。具有止血、消肿、治伏痈疽等功能。主治各种出血，关节肿胀，肾热，月经不调，疮痈。《蒙医药方汇编》中收载：小白蒿水煮液口服，对鼻衄、月经过多、刀伤引起的出血具有特效，其中的鼻衄即鼻出血。另据民间验方，蒙古族在治疗家畜去势或外伤伤口生蛆时，在伤口内放进小白蒿粉或用小白蒿水煮液清洗。
聚维酮全称聚乙烯吡咯烷酮(polyvinyl pyrrolidone)，简称PVP，是一种非离子型高分子化合物，是N-乙烯基酰胺类聚合物中典型的精细化学品。现已发展成为非离子、阳离子、阴离子3大类，工业级、医药级、食品级3种规格。相对分子质量从数千至一百万以上的均聚物、共聚物和交联聚合物系列产品得到广泛应用。PVP有优良的生理惰性，不参与人体新陈代谢，又具有优良的生物相容性，对皮肤、粘膜、眼等不形成任何刺激。医药级PVP为国际倡导的三大药用新辅料之一，可用做片剂、颗粒剂的粘结剂、注射剂的助溶剂、胶囊的助流剂，眼药的去毒剂、延效剂，润滑剂和包衣成膜剂，液体制剂的分散剂和酶及热敏药物的稳定剂，还可用做低温保存剂。用于隐形眼镜可增加其亲水性和润滑性。PVP K30已获得国家医药管理部门的批准正式上市。
吐温-80即聚氧乙烯脱水山梨醇单油酸酯，简称聚山梨酯-80。为非离子型表面活性剂，有异臭，温暖而微苦，系一系列聚氧乙烯去水山梨醇的部分脂肪酸酯，广泛用作乳化剂和油类物质的增溶剂。据WHO的评估，按总聚山梨酯计算，日摄入量可高到25mg/kg体重，通常被认为是无毒、无刺激性的材料。
苯扎溴铵化学名称为十二烷基二甲基苄基溴化铵，是一种表面活性剂，具有洁净、杀菌消毒和灭藻作用，广泛用于杀菌、消毒、防腐、乳化、去垢、增溶等方面，是迄今工业循环水处理常用的非氧化性杀菌灭藻剂、黏泥剥离剂和清洗剂之一.。医用苯扎溴铵主要用于手术前皮肤消毒，粘膜和伤口消毒，手术器械消毒。苯扎溴铵为阳离子表面活性剂类广谱杀菌剂，能改变细菌胞浆膜通透性，使菌体胞浆物质外渗，阻碍其代谢而起杀灭作用，对革兰阳性细菌作用较强，0.1%以下浓度皮肤无刺激性，安全性好。苯扎溴铵2.7-3.3%（w/v）含量的商品名称是新洁尔灭。
薄荷脑系由薄荷的叶和茎中所提取，白色晶体，分子式C10H20O，为薄荷和欧薄荷精油中的主要成分。薄荷脑和消旋薄荷脑均可用作牙膏、香水、饮料和糖果等的赋香剂。在医药上用作刺激药，作用于皮肤或粘膜，有清凉止痒作用，内服可作为驱风药，用于头痛及鼻、咽喉炎症等，其酯用于香料和药物。
剂型选择：目前，喷剂主要有喷雾剂(Spray)、气雾剂(Aerosol)和粉雾剂(Drypowder inhaler)三种剂型。气雾剂是借助抛射剂的压力将内容物呈雾状物喷出；粉雾剂依赖人呼吸作动力，以吸入为主；喷雾剂则不含抛射剂，借助手动泵的压力将内容物以雾状形态喷出，既安全又可靠，特别适于舌下、鼻腔黏膜等部位给药，故选择了喷雾剂。
药效学研究。
1、体外抗菌试验：实验选用3种菌种，分别为肺炎链球菌、溶血性链球菌和葡萄球菌。每菌种取无菌小试管9支，管内加入液体培养基 (肺炎球菌用血肉汤，余用普通肉膏汤 )0.5 mL，取鼻炎喷雾剂药液0.5mL置第1管混匀后取出 0.5 mL至第 2管 ,混匀后再取出0.5 mL至第3管 ,依次递增稀释至第8管。这样，药物稀释度依次为 1∶2、1∶4、1∶8、1∶16、1∶32、1∶64、1∶128、1∶256。第9管不加药物作阴性对照。每管内加入上述稀释菌液0. 05 mL，摇匀，置37℃培养24 h。 凡抑制试验菌生长的药物最高稀释倍数管即为最低抑菌浓度(MIC)。MIC结果为肺炎链球菌1∶64、溶血性链球菌1∶32和葡萄球菌1∶64。以上结果显示，阿给鼻炎喷雾剂对肺炎链球菌、溶血性链球菌和葡萄球菌有明显的抑制作用。
2、抗炎试验：
将小白鼠按体重随机分为生理盐水、阿给鼻炎喷雾剂组 (实例1-4)及林可霉素( 60万 u /kg) 6组，每组 10只，分别腹腔注射上述药物，0. 5 mL /只，每天1次，连续3次，末次给药后30 min，于小白鼠右耳两侧涂0. 1 mL致炎物质 ( 2%巴豆油、 5%蒸馏水、 20%无水乙醇、73%乙醚 )，左耳不涂以作对照。 4 h后将小白鼠断颈处死，沿耳廓基线剪下双耳，用打孔器 (直径9 mm)分别在同一部位取下圆耳片，用扭力天平称重，以左右两侧耳重之差为肿胀度。实验结果见表1。
表 1阿给鼻炎喷雾剂对巴豆油致小白鼠耳廓肿胀的影响 (x±s)
注: 与生理盐水组比，** P < 0. 01。
从表1可知，阿给鼻炎喷雾剂对巴豆油所致小白鼠耳廓肿胀度明显减轻。说明该药具有对抗巴豆油所致炎症反应的作用。
3、体内抑菌试验：将小白鼠按体重随机分为6组，每组10只，每组分别腹腔注射生理盐水、阿给鼻炎喷雾剂组(实例1-4)及林可霉素 ( 60万 u /kg) 6组0. 5mL，每天1次，连续4次。首次给药后 18 h，将乙型链球菌和绿脓杆菌培养24 h的肉膏汤培养基按1 mL/只腹腔注射进行攻击，然后观察并记录小白鼠在攻击96 h后的死亡情况。实验结果表明在攻击96 h后，生理盐水组小白鼠全部死亡，阿给鼻炎喷雾剂组(实例1-4)和林可霉素组无死亡。与生理盐水组均有非常显著性差异 ( P < 0. 01)。说明鼻炎喷雾剂对腹腔注射链球菌和绿脓杆菌小白鼠所致的全身性感染有明显治疗作用。
4、另据多例临床观察，本品粘性适中，流动性良好。能够形成细小颗粒，在粘膜表面展开均匀，并且迅速成膜，不易流失，对多种鼻炎效果良好。特别是对于鼻衄即鼻出血具有良好的治疗效果，分析原因，应是药品通过浸润和杀菌作用，使鼻内血管得到软化和修复。与内服阿给治疗鼻衄的经验相比，外用喷雾剂治疗鼻衄简便易行，更为可取，收到了意想不到的效果。
阿给鼻炎喷雾剂的薄层鉴别：
取实施例1-4的蒙药阿给鼻炎喷雾剂1.0 mL，加环己烷5 mL萃取，萃取液作为供试液。以桉油精对照品环己烷溶液（1 mg/mL）为对照液。分别取供试液（10 µL）和对照液（5 µL），点于同一硅胶G板上，以环己烷-乙酸乙酯（10:1）为展开剂，展开，取出晾干，喷10%硫酸乙醇溶液，加热显色，结果见图1。供试液薄层色谱图中，在与对照品相应位置上显相同颜色的斑点。供试液和对照液TLC图谱见图1，其中，1-4为实施例1-的供试液；5为对照液。
阿给鼻炎喷雾剂的含量测定：
采用GC-MS法测定蒙药阿给鼻炎喷雾剂中按油精和樟脑的含量。色谱条件：色谱柱为TR-5MS (30 m × 0.25 mm I.D. × 0.25 µm film)；载气为氦气；柱温为程序升温（初始温度40℃，以5℃/min速率至100℃；再以2℃/min速率至120℃；然后以10℃/min速率至220℃）；气化室温度为250℃。在上述色谱条件下，按油精和樟脑达到基线分离 (R>1.5)，理论塔板数均不低于20000，分离色谱图见图2。
阿给鼻炎喷雾剂的pH检查：取蒙药阿给鼻炎喷雾剂4瓶，测定其pH值为6.5。
阿给鼻炎喷雾剂的稳定性研究。
（1）、蒙药阿给鼻炎喷雾剂强光照射影响稳定性试验：实施例1-4的蒙药阿给鼻炎喷雾剂（含包装）在2800LX光照1、3、5、10天，分别进行薄层色谱检测及含量指标检测。实验结果表明被检测成分斑点与对照品一致，含量未发生明显变化。
（2）、蒙药阿给鼻炎喷雾剂（含包装）高温恒温的稳定性试验：实施例1-4的蒙药阿给鼻炎喷雾剂在40℃恒温保持1、5、15、30天，分别进行薄层色谱检测及含量指标检测。实验结果表明被检测成分斑点与对照品一致，含量未发生明显变化。
实施例2：一种蒙药阿给鼻炎喷雾剂，有以下方法制备得到：取阿给1000 g，加水在室温下浸泡2 h，加热提取5 h，收集其挥发油，置于冰箱（4～10℃）中冷藏，备用。取聚维酮K30 (5 g) 加入水中，搅拌使其溶解，放置30 min；然后在搅拌条件下，溶液中依次加入吐温-80 (8 g)、阿给挥发油 (20 mL)、苯扎溴铵 (9.5-11.5 mg)和香精(1 g)；然后加入水至1 L，灭菌后得到蒙药阿给鼻炎喷雾剂。
药效学研究、薄层鉴别、含量测定、pH检查及稳定性研究：照实例1描述的方法进行研究，实验结果见表2。
表2 阿给鼻炎喷雾剂对巴豆油致小白鼠耳廓肿胀的影响 (x±s)
注: 与生理盐水组比，** P < 0. 01
实施例3：一种蒙药“阿给”鼻炎喷雾剂，有以下方法制备得到：取阿给1000 g，加水在室温下浸泡2 h，加热提取5 h，收集其挥发油，置于冰箱（4～10℃）中冷藏，备用。取聚维酮K30 (10 g) 加入水中，搅拌使其溶解，放置30 min；然后在搅拌条件下，溶液中依次加入吐温-80 (4 g)、阿给挥发油 (10 mL)、苯扎溴铵(9.5-11.5 mg)和香精(1 g)；然后加入水至1 L，灭菌后得到蒙药阿给鼻炎喷雾剂。
药效学研究、薄层鉴别、含量测定、pH检查及稳定性研究：照实例1描述的方法进行研究，实验结果见表3。
表3 阿给鼻炎喷雾剂对巴豆油致小白鼠耳廓肿胀的影响 (x±s)
注: 与生理盐水组比，** P < 0. 01。
实施例4：一种蒙药阿给鼻炎喷雾剂，有以下方法制备得到：取阿给1000 g，加水在室温下浸泡2 h，加热提取5 h，收集其挥发油，置于冰箱（4～10℃）中冷藏，备用。取聚维酮K30 (5 g) 加入水中，搅拌使其溶解，放置30 min；然后在搅拌条件下，溶液中依次加入吐温-80 (4 g)、阿给挥发油 (5 mL)、苯扎溴铵 (9.5-11.5 mg)和香精(1 g)；然后加入水至1L，灭菌后得到蒙药“阿给”鼻炎喷雾剂。
药效学研究、薄层鉴别、含量测定、pH检查及稳定性研究：照实例1描述的方法进行研究，实验结果见表4。
表4 阿给鼻炎喷雾剂对巴豆油致小白鼠耳廓肿胀的影响 (x±s)
注: 与生理盐水组比，** P < 0. 01。
Claims (9)
1.一种蒙药鼻炎喷雾剂，其特征在于：其原料为以下重量份数的成分：阿给挥发油2～4份，聚维酮K30 1～2份，吐温-80 0.8～1.6，苯扎溴铵0.002份和香精0.02份。
2.根据权利要求1所述的蒙药鼻炎喷雾剂，其特征在于：所述蒙药鼻炎喷雾剂的制备方法为以下步骤：提取阿给挥发油备用；另取聚维酮K30加入水中，搅拌使其溶解，放置30min；然后在搅拌条件下依次加入吐温-80、阿给挥发油、苯扎溴铵和薄荷脑，再加入水灭菌后得到蒙药鼻炎喷雾剂。
3.根据权利要求2所述的蒙药鼻炎喷雾剂，其特征在于：所述阿给挥发油的提取方式是：先把阿给加水在室温下浸泡2小时后，再加热提取5小时，得到挥发油。
4.根据权利要求3所述的蒙药鼻炎喷雾剂，其特征在于：所述阿给挥发油在4～10℃下冷藏。
5.一种蒙药鼻炎喷雾剂，其特征在于：所述蒙药鼻炎喷雾剂的制备方法为以下步骤：按重量份取阿给1000 g，加水在室温下浸泡2 h，加热提取5 h，收集其挥发油20 g，置于冰箱4～10℃中冷藏，备用；取聚维酮K30 10 g加入水中，搅拌溶解，放置30 min；然后在搅拌条件下，溶液中依次加入吐温-80 8 g、阿给挥发油 20 g、苯扎溴铵 9.5-11.5 mg和薄荷脑 1g；然后加入水至1 L，灭菌后得到蒙药鼻炎喷雾剂。
6.根据权利要求1或5所述的蒙药鼻炎喷雾剂，其特征在于：所述蒙药鼻炎喷雾剂的薄层鉴别方法是：取蒙药鼻炎喷雾剂1.0 mL，加环己烷5 mL萃取，萃取液作为供试液；以桉油精对照品环己烷溶液1 mg/mL为对照液；分别取供试液10 µL和对照液5 µL，点于同一硅胶G板上，以环己烷-乙酸乙酯10:1为展开剂，展开，取出晾干，喷10%硫酸乙醇溶液，加热显色，供试液薄层色谱图中，在与对照品相应位置上显相同颜色的斑点。
7.根据权利要求1或5所述的蒙药鼻炎喷雾剂，其特征在于：所述蒙药鼻炎喷雾剂的含量测定方法是：采用GC-MS法测定蒙药鼻炎喷雾剂中桉油精和樟脑的含量；色谱条件：色谱柱为TR-5MS ，30 m × 0.25 mm I.D. × 0.25 µm film；载气为氦气；柱温为程序升温，初始温度40℃，以5℃/min速率至100℃；再以2℃/min速率至120℃；然后以10℃/min速率至220℃；气化室温度为250℃；在上述色谱条件下，桉油精和樟脑达到基线分离，R>1.5，理论塔板数均不低于20000。
8.根据权利要求1或5所述的蒙药鼻炎喷雾剂，其特征在于：所述蒙药鼻炎喷雾剂的pH值为6.5。
9.根据权利要求1或5所述的蒙药鼻炎喷雾剂，其特征在于：所述蒙药鼻炎喷雾剂的稳定性试验方法是：
（1）强光照射试验：包装的蒙药鼻炎喷雾剂在2800LX光照1、3、5、10天，分别进行薄层色谱检测及含量指标检测，被检测成分斑点与对照品一致，含量未发生明显变化；
（2）高温试验：包装后的蒙药鼻炎喷雾剂在40℃恒温保持1、5、15、30天，分别进行薄层色谱检测及含量指标检测，被检测成分斑点与对照品一致，含量未发生明显变化。
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