CN106265678B - 一种用于治疗面瘫的膏药及其制备方法 - Google Patents
一种用于治疗面瘫的膏药及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种能有效治疗面瘫的膏药及其制备方法，本发明膏药由以下组分组成，十六醇、单硬脂酸甘油酯、十八烷酸、甲基硅油、液体石蜡、丙三醇、对羟基苯甲酸乙基己基酯、吐温80、加兰他敏注射液、月桂氮卓酮组成，制备成药膏后，涂于面部，经过按摩充分与经穴及面部局部神经肌肉接头部位接触吸收，可达到相互作用，相得益彰的目的，从而发挥扶正与祛邪两大优势，具有疗效好、治愈率高、使用安全、无毒副作用的特点。
Description
技术领域
本发明涉及医药技术领域，更具体地说，涉及一种用于治疗面瘫的膏药及其制备方法。
背景技术
目前，国内外针对面瘫的治疗手段，临床上多采用西药、中成药、中药熏蒸、穴位贴敷、穴位注射、针灸、电针、红外线等手段进行治疗的。实践证明：中药熏蒸、穴位注射、针灸、电针、红外线虽然有一定的疗效，但使用繁琐，每天还要留有充足的时间、配备一定的器具、要有一定的环境才能进行治疗，且疗程长，一般患者不易坚持足疗程；西药品种繁多，毒副作用较大，尤其对肠胃反应剧烈；中成药是通过益气活血、化瘀通络的药理作用而改善症状的；传统面瘫按摩膏贴治疗面瘫已有数十年历史，确实有一定的疗效，但存在疗效不稳定、含铅量大、毒性大、副作用多、易过敏、易污染衣服、局部不易清洗干净等诸多不足。
发明内容
本发明的目的在于克服现有技术中存在的缺陷，提供一种能有效治疗面瘫的膏药及其制备方法，本发明膏药经过按摩充分与经穴及面部局部神经肌肉接头部位接触吸收，可达到相互作用，相得益彰的目的，从而发挥扶正与祛邪两大优势，具有疗效好、治愈率高、使用安全、无毒副作用的特点。是一种治疗面瘫简便、无痛、易操作的方式。
本发明公开了一种用于治疗面瘫的膏药，具体由以下组分组成：十六醇60-70g、单硬脂酸甘油酯50-60g、十八烷酸9-11g、甲基硅油10-30g、液体石蜡120-140mL、丙三醇120-140mL、对羟基苯甲酸乙基己基酯2-3g、吐温8012-14mL、加兰他敏注射液20-30mL、月桂氮卓酮20-30mL，余量用水补足。经过将上述药物进行上述组合，使得各组分功效产生协同作用，具有健脾益气，活血通络功效，从而达到消除无菌性炎症、增强肌肉力量的效果。
更进一步地，一种用于治疗面瘫的膏药，由以下组分组成：十六醇65g、单硬脂酸甘油酯55g、十八烷酸10g、甲基硅油20g、液体石蜡130mL、丙三醇130mL、对羟基苯甲酸乙基己基酯2.5g、吐温8013mL、加兰他敏注射液27.5mL、月桂氮卓酮27.5mL，余量用水补足。
更进一步地，所用月桂氮卓酮为0.5-3％月桂氮卓酮，月桂氮卓酮具有极强的透皮作用，其作用大大超过常用的有毒性的二甲基亚砜，1％的月桂氮卓酮的透皮增强作用比50％的二甲基亚砜的作用大13倍。
更进一步地，月桂氮卓酮为3％月桂氮卓酮。
一种用于治疗面瘫的膏药的制备方法，具体包括以下步骤：
(1)将十六醇、单硬脂酸甘油酯、十八烷酸、甲基硅油、液体石蜡、对羟基苯甲酸乙基己基酯和吐温80加热恒温70-80℃溶解，搅拌均匀，作为油相；
(2)水加热恒温70-80℃，作为水相；
(3)将加兰他敏注射液加入水相，搅拌均匀；将月桂氮卓酮加入油相，搅拌均匀；
(4)将油相加入水相，3000-4000r/min搅拌，控制温度在70-80℃，待油相全部加入后，加入丙三醇，持续搅拌直至乳化，冷却分装。
更进一步地，一种用于治疗面瘫的膏药的制备方法，具体包括以下步骤：
(1)将十六醇、单硬脂酸甘油酯、十八烷酸、甲基硅油、液体石蜡、对羟基苯甲酸乙基己基酯和吐温80加热恒温75℃溶解，搅拌均匀，作为油相；
(2)水加热恒温75℃，作为水相；
(3)将加兰他敏注射液加入水相，搅拌均匀；将月桂氮卓酮加入油相，搅拌均匀；
(4)将油相加入水相，3500r/min搅拌，控制温度在75℃，待油相全部加入后，加入丙三醇，持续搅拌直至乳化，冷却分装。
更进一步地，加兰他敏注射液加入水相为缓慢加入，边加边搅拌。
更进一步地，月桂氮卓酮加入油相为缓慢加入，边加边搅拌。
更进一步地，月桂氮卓酮为3％月桂氮卓酮。
更进一步地，本发明膏药的使用方法是涂于面部，进行面部按摩，2-3次/日。
本发明产生的有益效果：
1.组方合理，使用安全，载药量大、高效、无毒副作用；
2.不刺激皮肤、不过敏、不沾染衣物，已清除；
3.原料均为常用药，价格合理，且制备方法简单，成本低廉；
4.可明显兴奋肌肉，提高面神经各节段肌肉的兴奋，在面瘫常规治疗上显著提高临床疗效；
5.治疗范围广，各型、各时期的面瘫患者均可使用。
具体实施方式
以下通过实施例来对本发明所述一种治疗面瘫的膏药做进一步的阐述：
实施例1
一种用于治疗面瘫的膏药，具体由以下组分组成：十六醇600-700g、单硬脂酸甘油酯500-600g、十八烷酸90-110g、甲基硅油100-300g、液体石蜡1200-1400mL、丙三醇1200-1400mL、对羟基苯甲酸乙基己基酯20-30g、吐温80120-140mL、加兰他敏注射液200-300mL、月桂氮卓酮200-300mL，余量用水补足。
制备方法具体包括以下步骤：
(1)将十六醇、单硬脂酸甘油酯、十八烷酸、甲基硅油、液体石蜡、对羟基苯甲酸乙基己基酯和吐温80加热恒温70-80℃溶解，磁力搅拌均匀，作为油相；
(2)水加热恒温70-80℃，作为水相；
(3)将加兰他敏注射液逐步加入水相，边加边搅拌均匀；将月桂氮卓酮逐步加入油相，边加边搅拌均匀；
(4)将油相加入水相，3000-4000r/min搅拌，控制温度在70-80℃，待加入全部油相后，加入丙三醇，持续搅拌直至乳化，冷却分装。
使用方法：先将患处清洗干净，进行面部按摩，2-3次/日。
实施例2
一种用于治疗面瘫的膏药，具体由以下组分组成：十六醇600g、单硬脂酸甘油酯500g、十八烷酸90g、甲基硅油100g、液体石蜡1200mL、丙三醇1200mL、对羟基苯甲酸乙基己基酯20g、吐温80120mL、加兰他敏注射液200mL、月桂氮卓酮200mL，余量用水补足。
制备方法具体包括以下步骤：
(1)将十六醇、单硬脂酸甘油酯、十八烷酸、甲基硅油、液体石蜡、对羟基苯甲酸乙基己基酯和吐温80加热恒温70℃溶解，磁力搅拌均匀，作为油相；
(2)水加热恒温70℃，作为水相；
(3)将加兰他敏注射液逐步加入水相，边加边搅拌均匀；将0.5％月桂氮卓酮逐步加入油相，边加边搅拌均匀；
(4)将油相加入水相，3000r/min搅拌，控制温度在70℃，待加入全部油相后，加入丙三醇，持续搅拌直至乳化，冷却分装。
使用方法：先将患处清洗干净，进行面部按摩，2-3次/日。
实施例3
一种用于治疗面瘫的膏药，具体由以下组分组成：十六醇650g、单硬脂酸甘油酯550g、十八烷酸100g、甲基硅油200g、液体石蜡1300mL、丙三醇1300mL、对羟基苯甲酸乙基己基酯25g、吐温80130mL、加兰他敏注射液275mL、3％月桂氮卓酮275mL，余量用水补足。制备方法具体包括以下步骤：
(1)将十六醇、单硬脂酸甘油酯、十八烷酸、甲基硅油、液体石蜡、对羟基苯甲酸乙基己基酯和吐温80加热恒温75℃溶解，磁力搅拌均匀，作为油相；
(2)水加热恒温75℃，作为水相；
(3)将加兰他敏注射液逐步加入水相，边加边搅拌均匀；将月桂氮卓酮逐步加入油相，边加边搅拌均匀；
(4)将油相加入水相，3500r/min搅拌，控制温度在75℃，待加入全部油相后，加入丙三醇，持续搅拌直至乳化，冷却分装。
使用方法：先将患处清洗干净，进行面部按摩，2-3次/日。
实施例4
一种用于治疗面瘫的膏药，具体由以下组分组成：十六醇700g、单硬脂酸甘油酯600g、十八烷酸110g、甲基硅油300g、液体石蜡1400mL、丙三醇1400mL、对羟基苯甲酸乙基己基酯30g、吐温80140mL、加兰他敏注射液300mL、3％月桂氮卓酮300mL，余量用水补足。
制备方法具体包括以下步骤：
(1)将十六醇、单硬脂酸甘油酯、十八烷酸、甲基硅油、液体石蜡、对羟基苯甲酸乙基己基酯和吐温80加热恒温80℃溶解，磁力搅拌均匀，作为油相；
(2)水加热恒温80℃，作为水相；
(3)将加兰他敏注射液逐步加入水相，边加边搅拌均匀；将3％月桂氮卓酮逐步加入油相，边加边搅拌均匀；
(4)将油相加入水相，4000r/min搅拌，控制温度在80℃，待加入全部油相后，加入丙三醇，持续搅拌直至乳化，冷却分装。
使用方法：先将患处清洗干净，进行面部按摩，2-3次/日。
使用本发明实施例2-4治疗面瘫的临床研究资料
一、一般资料
本发明面瘫膏药用于临床治疗1501例病人，其中，男684例，女817例；年龄18-75岁，病程1天-3年。随机分成4组，分别是实施2-4组和对照组。其中实施例2组370例；实施例3组384例；实施例4组372例；对照组375例。
上述患者符合下述面瘫诊疗标准；
1.中医诊断标准：参照普通高等教育“十五”国家级规划教材《针灸学》(石学敏主编，中国中医药出版社，2007年)。
(1)起病突然，春秋多发，常有受寒史或一侧面颊、耳内、耳前、耳后完骨处的疼痛或发热，部分患者初起可表现为一侧牙疼、一侧面部疼痛或者一侧头部疼痛。
(2)一侧面部板滞，麻木，流泪，额纹消失，鼻唇沟变浅，眼不能闭合，口角向健侧牵拉。
(3)一侧不能作闭眼，鼓腮，露齿等动作。
(4)肌电图可表现为异常。
2.西医诊断要点：参照普通高等教育“十五”国家级规划教材《神经内科学》第五版(王维治主编，人民卫生出版社，2004年)
(1)病史：起病急，常有受凉吹风史，或有炎症、病毒感染史。
(2)表现：一侧面部表情肌突然瘫痪、病侧额纹消失，眼裂不能闭合，鼻唇沟变浅，口角下垂，鼓腮、吹口哨时漏气，食物易滞留于病侧齿颊间，可伴有病侧舌前2/3味觉丧失，听觉过敏，多泪等。
(3)脑CT、MRI检查正常。
二、疾病分级评分
1.急性期：发病15天以内。
2.恢复期：发病15天至6个月(发病半月—面肌连带运动出现)。
3.后遗症期(联动期和痉挛期)：发病6个月以上(面肌连带运动出现以后)
病例被纳入后，本发明面瘫药膏在使用时不分期，不分型。住院患者均予以常规治疗，包括：针灸、中药熏蒸等。
三、治疗方法
实施例2-4组，患者每日使用相应实施例制成的面瘫药膏，涂于面部按摩，使充分吸收，2-3次/日。
对照组采用常规治疗。
1.疗效评定标准：
表1 House—Brackmann面神经功能评价分级量表
表2症状体征量化表
面部残疾指数(FDI)调查问卷
四、试验结果
| 组别 | 治愈 | 好转 | 无效 | 治愈率％ | 好转率％ | 无效率％ |
| 实施例2组 | 352 | 15 | 3 | 95.14 | 4.05 | 0.80 |
| 实施例3组 | 373 | 10 | 1 | 97.13 | 2.60 | 0.26 |
| 实施例4组 | 357 | 13 | 2 | 95.97 | 3.49 | 0.54 |
| 对照组 | 330 | 25 | 20 | 88.00 | 6.67 | 5.33 |
试验结果证实，本发明实施例2-4能有效治疗面瘫，且明显优于常规治疗组。
本发明药膏所使用的典型案例有：
病例一：患者白某，男，29岁。以"左侧面部活动不灵7天"为主诉，门诊以"面神经麻痹"之诊断收住入院。既往体质一般，入院症见：左侧面部活动不灵，左侧抬眉、耸鼻不能，左眼闭合不全，漏睛2mm，用力时可完全闭合，自觉左眼干涩、流泪，示齿口角向右歪斜，左侧口角夹食漏水，鼓腮漏气，纳可，夜休可，二便基本正常。查体：生命体征正常，一般情况可，心肺腹查体未见明显异常。神经系统检查：左侧额纹、鼻唇沟消失，左眼闭合不全，露睛2mm，贝尔氏征(+)，示齿口角向右侧歪斜，鼓腮左侧口角漏气。舌前2/3味觉无减退。颜面部触觉、痛觉、温觉对称存在；四肢肌力及肌张力正常，生理反射存在，病理反射未引出，脑膜刺激征阴性。House-Brackmann面神经功能评价分级量表：Ⅲ级；症状体征量化表评分：19分；面部残疾指数调查问卷：35分。中医诊断：面瘫病(风寒阻络),西医诊断：面神经麻痹.治疗上中医治疗以祛风散寒，活血通络为法，予针灸，配合穴位贴敷、中药熏蒸、红外线等治疗；静滴刺五加、葛根素葡萄糖，西医以缓解神经根水肿、营养神经等对症治疗为原则，口服醋酸泼尼松片、维生素B1片、B6片、甲钴胺胶囊、地巴唑、胞磷胆碱钠片，肌注鼠神经生长因子治疗；外用面瘫摩膏。经治疗患者诉左侧面部不灵较前好转，左侧额纹加深，抬眉及耸鼻力量较前好转，左眼可闭合，口角歪斜不明显，左侧鼓腮稍漏气，稍有少量的夹食漏水。出院House-Brackmann面神经功能评价分级量表：Ⅰ级；症状体征量化表评分：3分；面部残疾指数调查问卷：39分。
病例二：患者李某，女，70岁。以"左侧面部活动不灵1天"为主诉，门诊以"1、面神经麻痹；2、高血压病3级；3、脑梗死"之诊断收住入院。入院症见：左侧面部活动力量差，左侧抬眉力差，左眼用力时可闭合，偶自觉左眼皮跳动，左眼流泪不适，左侧耸鼻力差，示齿口角向右歪斜，左侧鼓腮漏气、喝水漏水、吃饭夹食，左耳伴有疼痛，纳可，眠可，二便基本正常。查体：生命体征正常，一般情况可，心肺腹查体未见明显异常。神经系统检查：双眼睑无下垂，双眼球各方向运动自如，左侧额纹、鼻唇沟变浅，左眼可闭合，贝尔氏征(-)，示齿口角向右侧歪斜，鼓腮左侧口角漏气。舌前2/3味觉减退。颜面部触觉、痛觉、温觉对称存在；四肢肌力及肌张力正常，生理反射存在，病理反射未引出，脑膜刺激征阴性。中医诊断：面瘫病(热毒入络证)，西医诊断：1、面神经麻痹；2、高血压病3级；3、脑梗死；4、冠心病；5、糖尿病；6、浅表性胃炎；7、风湿性关节；8、乙型肝炎；9、脂肪肝；10、脑萎缩；11、左眼白内障，中医治疗以祛风清热、活血健脾益气，祛瘀通络为法，予以针灸治疗为主，配合穴位贴敷、中药熏蒸等治疗，口服脑心通胶囊；静滴苦碟子注射液。西医治疗方案：西医以营养神经、降压、降糖、抑制胃酸等对症治疗为原则，口服维生素B1片、B6片、甲钴胺胶囊、苯磺酸左旋氨氯地平片、富马酸比索洛尔、阿卡波糖片、辛伐他汀片、奥美拉唑肠溶片、地巴唑片、醋酸泼尼松片,静滴注射用硫辛酸。外用面瘫摩膏。经治疗患者左侧面部活动力增强，左侧抬眉力可，左眼可闭合，尚偶自觉左眼皮跳动，左眼无流泪，左侧耸鼻力可，示齿口角无歪斜，无夹食漏水，耳后无疼痛。出院House-Brackmann面神经功能评价分级量表：Ⅱ级；症状体征量化表评分：5分；面部残疾指数调查问卷：41分。
病例三：患者曹某，男，67岁，以"左侧面部活动不灵2月余"为主诉，门诊以"面神经麻痹"收住入院。入院症见：左侧抬眉、耸鼻力弱，左上眼睑略下垂，左眼闭合力弱，无漏睛，偶流泪，口角向右歪斜，示齿口角向右歪斜，左侧口角鼓腮轻度漏气、夹饭、漏水，纳可，眠可，二便调。查体：生命体征基本正常，心肺腹(-)。神经系统检查：神清语利，左侧额纹、鼻唇沟较右侧浅，口角右偏，示齿口角向右歪斜，双侧触觉、痛觉、温觉对称存在。双侧眼裂不等大，左侧眼裂较右侧略大，眼睑闭合完全，贝尔氏征(-)。四肢肌力5级，肌张力正常。生理反射存在，病理反射未引出，脑膜刺激征阴性。中医诊断：面瘫病(气虚痰瘀内阻证)，西医诊断：1、面神经麻痹；2、高血压病2级；3、颈动脉粥样硬化斑块形成；4、多发腔梗；5、脑萎缩，中医治疗方案：中医治疗以益气化痰、活血通络为法，以针灸治疗为主，配合穴位贴敷、隔姜灸、低频脉冲电治疗；静滴参芪扶正注射液、大株红景天注射液。西医治疗方案：西医治以营养神经、降压、抗血小板聚集等对症支持处理为主，口服酒石酸美托洛尔片、拜阿司匹林肠溶片。外用面瘫摩膏。经治疗患者左侧抬眉、耸鼻力可，左侧眼睑无下垂，左眼闭合可，无漏睛、流泪，口角无歪斜、鼓腮无漏气、无夹饭漏水。出院House-Brackmann面神经功能评价分级量表：Ⅰ级；症状体征量化表评分：1分；面部残疾指数调查问卷：43分。
病例四：患者李某，女，70岁。以"左侧面部活动不灵近1月"为主诉，门诊以"面神经麻痹"之诊断收住入院。入院症见：左侧面部活动力量较差，左侧抬眉力差，抬眉时可见数道较浅额纹，用力时左眼可闭合，左眼偶有流泪，左侧耸鼻力差，示齿时口角向右侧歪斜，左侧口角吃饭无夹食、喝水无漏水、鼓腮无漏气，左耳后疼痛，自觉左侧眼睑及口唇周围跳动，食纳可，夜休可，二便调。查体：生命体征正常，心肺腹查体未见明显异常。神经系统检查：双眼睑无下垂，双眼球各方向运动自如，左侧额纹、鼻唇沟变浅，左眼可闭合，贝尔氏征(-)，示齿口角向右侧歪斜，鼓腮左侧口角无漏气。舌前2/3味觉减退。颜面部触觉、痛觉、温觉对称存在；四肢肌力及肌张力正常，生理反射存在，病理反射未引出，脑膜刺激征阴性。中医诊断：面瘫病(气虚血瘀证)。西医诊断：1、面神经麻痹；2、高血压病3级；3、脑梗死；4、冠心病；5、糖尿病；6、浅表性胃炎；7、风湿性关节炎；8、乙型肝炎；9、脂肪肝；10、脑萎缩；11、左眼白内障；12、肝囊肿，中医治疗方案：中医治疗以益气活血、化瘀通络为法，予针灸、穴位贴敷、中药熏洗蒸、中频脉冲、低频脉冲治疗，口服脑心通胶囊、四磨汤口服液；西医治疗方案：西医以营养神经、降压、降糖、抑制胃酸等对症治疗为原则，口服维生素B1片、B6片、甲钴胺胶囊、苯磺酸左旋氨氯地平片、富马酸比索洛尔、阿卡波糖片、辛伐他汀片、奥美拉唑肠溶片、地巴唑片,静滴杏芎氯化钠注射液，肌注鼠神经生长因子。外用面瘫摩膏，经治疗患者左侧面部活动力量可，左侧抬眉力可，左眼可闭合，无流泪，耸鼻力可，示齿口角无歪斜，左耳无疼痛，偶有左侧眼睑及口唇周围跳动。出院House-Brackmann面神经功能评价分级量表：Ⅰ级；症状体征量化表评分：3分；面部残疾指数调查问卷：40分。
Claims (5)
1.一种用于治疗面瘫的膏药的制备方法，其特征在于：包括以下步骤：由以下组分组成：十六醇65g、单硬脂酸甘油酯55g、十八烷酸10g、甲基硅油20g、液体石蜡130mL、丙三醇130mL、对羟基苯甲酸乙基己基酯2.5g、吐温80 13mL、加兰他敏注射液27.5mL、月桂氮卓酮27.5mL，余量用水补足；所述月桂氮卓酮为0.5-3％月桂氮卓酮；
(1)将十六醇、单硬脂酸甘油酯、十八烷酸、甲基硅油、液体石蜡、对羟基苯甲酸乙基己基酯和吐温80加热恒温70-80℃溶解，搅拌均匀，作为油相；
(2)水加热恒温70-80℃，作为水相；
(3)将加兰他敏注射液加入水相，搅拌均匀；将月桂氮卓酮加入油相，搅拌均匀；
(4)将油相加入水相，3000-4000r/min搅拌，控制温度在70-80℃，待油相全部加入后，加入丙三醇，持续搅拌直至乳化，冷却分装。
2.根据权利要求1所述一种用于治疗面瘫的膏药的制备方法，其特征在于：包括以下步骤：
(1)将十六醇、单硬脂酸甘油酯、十八烷酸、甲基硅油、液体石蜡、对羟基苯甲酸乙基己基酯和吐温80加热恒温75℃溶解，搅拌均匀，作为油相；
(2)水加热恒温75℃，作为水相；
(3)将加兰他敏注射液加入水相，搅拌均匀；将月桂氮卓酮加入油相，搅拌均匀；
(4)将油相加入水相，3500r/min搅拌，控制温度在75℃，待油相全部加入后，加入丙三醇，持续搅拌直至乳化，冷却分装。
3.根据权利要求2所述一种用于治疗面瘫的膏药的制备方法，其特征在于：加兰他敏注射液加入水相为缓慢加入，边加边搅拌。
4.根据权利要求2所述一种用于治疗面瘫的膏药的制备方法，其特征在于：月桂氮卓酮加入油相为缓慢加入，边加边搅拌。
5.根据权利要求2所述一种用于治疗面瘫的膏药的制备方法，其特征在于：所述月桂氮卓酮为3％月桂氮卓酮。
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