CN109674918A - 一种复方中药祛痹搽剂及其制备方法 - Google Patents

一种复方中药祛痹搽剂及其制备方法 Download PDF

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CN109674918A
CN109674918A CN201910066296.XA CN201910066296A CN109674918A CN 109674918 A CN109674918 A CN 109674918A CN 201910066296 A CN201910066296 A CN 201910066296A CN 109674918 A CN109674918 A CN 109674918A
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rhizoma
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CN109674918B (zh
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彭忠禄
林民庭
刘科峰
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Xiangnan University
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Abstract

本发明属于含有传统中药材的未确定结构的药物制剂技术领域，公开了一种复方中药祛痹搽剂的成分及其制备方法；中药组合物及其组分为细辛1g、肉桂2g、元胡3g、藁本4g、鸡血藤10g、川芎4g、白芍6g、黄芪10g、木香2g、羌活7g、独活5g、防风3g、香附4g、灸甘草4g、钩藤5g、宽筋藤4g和制川乌1g，与药用辅料组成医学上可接受的各类搽剂。本发明的制备方法是将复方中药粉末加水及醋酸置于真空旋转蒸发仪中熬制煎液；所获煎液加入无水乙醇静置，过滤，恒温水浴回流浓缩，抽滤，挥干乙醇，得复方中药提取物；将提取物溶入含有松节油等精油的有机溶剂中配制成本搽剂。本发明用于各种风湿疼痛等病症，具有祛风除痹止痛的疗效，具有使用方便、无毒副作用等优点。

Description

一种复方中药祛痹搽剂及其制备方法
技术领域
本发明属于含有元胡、鸡血藤、黄芪、钩藤等传统中药材的未确定结构的药物制剂技术领域，尤其涉及一种复方中药祛痹搽剂的成分及其制备方法。
背景技术
风湿性疾病(Rheumatic diseases)泛指影响骨、关节及其周围软组织的一组疾病，其特征在于炎症影响身体的连接或支撑结构，如关节、肌腱、韧带、骨骼和肌肉，一些风湿性疾病甚至影响器官，导致身体部分功能丧失而致残，对人类健康危害性大。现已发现100多种不同的风湿性疾病，在中老年人中发病率高。中老年人常见的风湿性疾病包括风湿和类风湿关节炎、肩周炎、颈椎病、骨质增生等，其中疼痛病症患者居多。风湿骨痛的治疗方法有西药治疗、物理治疗、推拿针灸治疗、封闭疗法、手术治疗等，但是副作用大或治疗费用高，给患者带来痛苦的同时也给社会和家庭带来沉重的经济负担。
现有技术存在的问题：现有西药治疗风湿性疾病主要采用非甾类抗炎药。这类药物具有一定对症治疗作用，但不能治本且其副作用不容忽视，例如：水杨酸类制剂的长期服用易损伤胃粘膜、无痛性出血、肝肾功能损害等副作用；布洛芬等止痛药易损伤肝肾，特别是伴有肾脏疾病的患者，可引起水肿，多尿等肾功能受损的症状，导致肾小球滤过膜的重吸收率降低，排除增多，降低了药物的使用效率；双氯芬酸止痛剂易导致胃肠道的腹泻、恶心及腹痛等，患者依从性低；风湿镇痛膏药效渗透慢易致过敏等。此外风湿性疾病也可手术治疗，但风险高，费用高，后遗症较多等特点。中医药是中华民族的瑰宝，千百年来验证的诸多祛风湿药具有不同程度的镇痛、解热、消炎、抗过敏作用，对西医诊为风湿性类风湿性关节炎、肌肉风湿痛、坐骨神经痛、腰脊劳损等病症具有相应治疗作用。然而，很多中医药在治疗风湿疼痛疾病中，需要现用现配、使用不方便、药方随意性较大、药效不明显等缺点，不利于推广使用。
解决上述技术问题的难度和意义：
1、风湿性疾病病因复杂、机制不清，目前通过西医西药彻底治愈的可能性很小。中医药是中华民族的瑰宝，民间流传下来的祛风湿药及新中药处方对风湿性疾病都具有一定疗效，所以积极开发和挖掘中医药治疗风湿性疾病具有现实意义。
2、很多中药的使用具有很多不足，而开发外用搽剂可避免诸多缺点。外用搽剂可长期保存、使用方便、价格实惠，避免内脏损伤及诸多不良反应，患者依从性高，易于被接受和推广。
发明内容
针对现有技术存在的问题，本发明提供了一种复方中药祛痹搽剂的成分及其制备方法。
本发明实现了一种复方中药祛痹搽剂，所述复方中药祛痹搽剂中的复方中药组合物由细辛1g、肉桂2g、元胡3g、藁本4g、鸡血藤10g、川芎4g、白芍6g、黄芪10g、木香2g、羌活7g、独活5g、防风3g、香附4g、灸甘草4g、钩藤5g、宽筋藤4g和制川乌1g组成。
本发明的另一目的在于提供一种所述复方中药祛痹搽剂的制备方法，所述复方中药祛痹搽剂的制备方法包括：
步骤一，复方中药组合物60℃烘焙干燥后，称取细辛1g、肉桂2g、元胡3g、藁本4g、鸡血藤10g、川芎4g、白芍6g、黄芪10g、木香2g、羌活7g、独活5g、防风3g、香附4g、灸甘草4g、钩藤5g、宽筋藤4g和制川乌1g，粉碎后搅拌均匀过80目筛备用；
步骤二，将复方中药组合物粉末置于真空旋转蒸发仪，加水500mL及醋酸10mL大火煮沸后，文火熬制至300mL，冷却后加入2倍体积无水乙醇静置2～4小时，过滤，得药液I和药渣Ⅰ；药渣Ⅰ重复上述步骤二，得药液II；
步骤三，合并药液Ⅰ和药液II，恒温80℃水浴回流浓缩，再2500目抽滤，50～60℃挥干，粉碎，过200目，得复方提取物；
步骤四，将复方提取物50g，添加樟脑2g、冰片1g，溶入含有肉桂油20mL、茶子油10mL，柠檬醛1mL、松节油450mL的有机溶剂中，制成本搽剂。
本发明的另一目的在于提供一种所述中药组合物制备的复方中药祛痹搽剂的使用方法，所述的中药搽剂的使用方法为：在皮肤完好情况下用手外搽至发热，1～10mL/次，3～4次/天。
本发明的另一目的在于提供一种所述中药组合物制备的复方中药祛痹搽剂的治疗和/或预防风湿疼痛等病症的药物。
本发明的复方中药祛痹搽剂对风湿疼痛(颈椎病、腰椎病、关节炎等所致疼痛)等病症的治疗作用进行了药效学试验，试验结果显示，本发明的制剂具有药物局部渗透力强、活血化瘀祛风除痹止痛的疗效，特别对风湿疼痛症状临床治疗效果好，不良反应少，安全系数高，治疗费用低，患者依从性高，无其西药治疗及手术治疗的不良反应。
附图说明
图1是本发明实施例提供的复方中药祛痹搽剂的制备方法流程图。
具体实施方式
本发明此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
本发明旨在解决现有非甾类抗炎药治疗各种风湿疼痛等病症疗效及不良反应等问题，包括但不限于非甾类抗炎药治疗的疗效以及对机体的不良反应等。本发明以治疗各种风湿疼痛(颈椎病、腰椎病、关节炎等所致疼痛)等病症达到祛风除痹止痛的疗效，临床应用效果好，能降低口服止痛药的不良反应。
本发明的应用原理如下描述：
本发明实施例提供的复方中药祛痹搽剂中的复方中药组合物由细辛1g、肉桂2g、元胡3g、藁本4g、鸡血藤10g、川芎4g、白芍6g、黄芪10g、木香2g、羌活7g、独活5g、防风3g、香附4g、灸甘草4g、钩藤5g、宽筋藤4g和制川乌1g组成。
如图1所示，本发明实施例提供的复方中药祛痹搽剂的制备方法包括以下步骤：
S101：复方中药组合物烘焙干燥、粉碎过筛备用；
S102：复方中药粉末置于真空旋转蒸发仪，加水及醋酸大火煮沸后，文火熬制至一定体积，冷却后加无水乙醇，静置，过滤，得药液；
S103：药液恒温水浴回流浓缩，过目抽滤，挥干，粉碎，得复方提取物；
S104：复方提取物及辅药等溶入松节油等有机溶剂中配制成本搽剂。
在本发明的优选实施例中，本发明的中药材包括细辛、肉桂、元胡、藁本、鸡血藤、川芎、白芍、黄芪、木香、羌活、独活、防风、香附、灸甘草、钩藤、宽筋藤、制川乌。
在本发明的优选实施例中，本发明中添加醋酸，按配制比例添加。
在本发明的优选实施例中，本发明中添加无水乙醇，按配制比例添加。
在本发明的优选实施例中，本发明中添加樟脑、冰片辅药，按配制比例添加。
在本发明的优选实施例中，本发明中添加肉桂油、茶子油，柠檬醛，按配制比例添加。
在本发明的优选实施例中，本发明中使用挥发性有机溶剂松节油，按配制比例添加。。
本发明提供的复方中药祛痹搽剂各组分的药理作用有：细辛：性温，解表散寒，祛风止痛；用于风湿痹痛，风寒感冒。肉桂：性热，补元阳，温脾胃，除和冷，通血脉；用于腰膝冷痛，闭经。元胡：性温，活血止痛，除痹镇痛；用于气滞血瘀，胸肋、脘腹疼痛，跌仆胀痛。藁本：性温，祛风散寒，除湿止痛；用于风寒表症，风湿痹痛。鸡血藤：性温，补血行血，通经活络；用于麻木瘫痪，风湿痹痛，血虚萎黄。川芎：性温，活血行气，祛风止痛，行气开郁；用于气血瘀滞(胸肋痛)，风湿痹痛。白芍：性微寒，羊血柔肝，缓冲止痛；用于胸腹肋疼痛，肝区疼痛者。黄芪：性温，表虚自汗，阴虚盗汗；用于气虚乏力。木香：性温，行气，止痛，健脾消食；用于胸脘胀痛，行气止痛。羌活：性温，散表寒，祛风湿，利关节；用于肩背酸痛，风湿痹痛。独活：性温，祛风除湿，痛痹止痛；用于风寒湿痹，腰膝疼痛。防风：性温，祛风解表，胜湿止痛；用于四肢麻痹，关节疼痛，风湿痹痛。香附：性平，行气解郁，调经止痛；用于肝郁气滞，胸肋胀痛。灸甘草：性温，益气滋阴，通阳复脉；用于脾胃虚弱，倦怠乏力。钩藤：性凉，清热平肝，熄风止痉；用于肝火上逆头痛目赤，肝阳上亢头晕目眩。宽筋藤：性凉，舒筋活络，祛风止痛；用于风湿痹痛，坐骨神经痛，腰肌劳损，跌打损伤。制川乌：性热，祛风除湿，温经止痛；用于风寒湿痹，关节冷痛，寒疝作痛及麻醉止痛。
本发明提供的复方中药祛痹搽剂各组分的药理作用主要有：解表散寒，除痹止痛，舒筋活络通血气。
本发明涉及的复方中药祛痹搽剂是选用民间的祛风湿药物精制而成，外用以治疗各种风湿疼痛(颈椎病、腰椎病、关节炎等所致疼痛)等病症，临床应用效果好，同时避免了诸多现有用药的不良反应，是祛风除痹止痛的良药。不良反应：局部具有轻微刺激。
下面结合具体实施例对本发明的应用原理作进一步的描述。
比较例1
1一般资料
本发明经过100例膝关节炎患者进行系统的临床研究。本组病例均来源于医院肾内科(风湿免疫科)，所有患者均以疼痛为主要临床症状，且主要运用阿司匹林等非甾类抗炎药缓解病情。
患者膝关节炎分级量化为I～IV级。诊断标准：根据膝关节骨性关节炎的临床表现及影像学X线片和相关检验资料分五期。
I期 早期膝关节爬山或较大的活动后症状加重，日常活动量大后可有轻微胀痛，X线片往往未见明显异常改变。
II期 早中期膝关节反复肿胀疼痛，屈曲下蹲功能受限，上下楼梯时加重。握膝伸屈检查，可打及细微磨砂感，X线片可见，膝内外侧关节间隙略微改变或无异常。
III期 中期膝关节活动度仍可正常，早晨起床时或久坐后站起行走困难，胀痛明显，握膝伸屈检查，打及磨砂感明显。关节反复肿胀，X线片可见内外侧关节间隙不等高，关节缘唇状增生。
IV期 中晚期膝关节长期肿胀，伸曲活动明显受限下蹲后需手撑地或扶物方可站起，X线片可见内外侧关节间隙明显不等高、关节边缘骨赘形成、软骨下骨硬化。
V期 晚期常见下肢肌肉萎缩，更显膝关节肿胀，僵硬，伸曲功能丧失，部分人膝外翻或内翻。X线片一侧或内外侧关节间隙近消失，关节边缘大量骨赘形成，部分病例可见膝后、骸上囊部散在的、不规则的赘生物高密度影，靠近关节部分骨质硬化、囊变，部分人可同时伴有股骨骸、胫骨平台下骨质疏松存在。
2方法
随机选择50例患者，停用原治疗药物七日后给予本实验药物治疗。对照组50例使用口服阿司匹林(3-5g/d)。试验组采用本发明复方中药祛痹搽剂外搽治疗，2次/d。疗程为4周，1个疗程结束后，休息2～3d进行下一疗程，连用3个疗程。
3结果
两组患者的性别、年龄、病程、临床症状等比较，差异无统计学意义(P>0.05)。对照组中，阿司匹林可较好缓解患者的临床症状(疼痛)，但恶心、呕吐、上腹部不适或疼痛，过敏反应、胃黏膜损伤、肝损害、肾损害、神经精神等不良反应多。复方中药祛痹搽剂对患者的临床症状(疼痛)有很大缓解，减轻了患者的痛苦，不良反应少。
比较例2
药效实例，蔡某，65岁，膝关节反复疼痛10余年，每逢雨季关节疼痛症状明显，诊断为膝关节炎。用复方中药祛搽剂后疼痛逐渐消失，3个月无复发，无任何不良反应，显示了本复方中药祛痹搽剂对于膝关节炎具有很好临床疗效。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (10)

1.一种复方中药祛痹搽剂，其特征在于，所述复方中药祛痹搽剂中的中药组合物由细辛1g、肉桂2g、元胡3g、藁本4g、鸡血藤10g、川芎4g、白芍6g、黄芪10g、木香2g、羌活7g、独活5g、防风3g、香附4g、灸甘草4g、钩藤5g、宽筋藤4g和制川乌1g组成。
2.如权利要求1所述的中药祛痹搽剂，其特征在于，所述中药组合物由细辛1g、肉桂2g、元胡3g、藁本4g、鸡血藤10g、川芎4g、白芍6g、黄芪10g、木香2g、羌活7g、独活5g、防风3g、香附4g、灸甘草4g、钩藤5g、宽筋藤4g和制川乌1g组成。
3.根据权利要求1所述的复方中药祛痹搽剂，其特征在于，所述中药复方制剂还包括药学上可接受的辅料；优选地所述辅料为制剂上常用的药用辅料；优选地为肉桂油、茶子油，柠檬醛、樟脑、冰片、松节油。
4.一种如权利要求1所述复方中药祛痹搽剂的制备方法，其特征在于，所述复方中药祛痹搽剂的制备方法包括以下步骤：
步骤一，复方中药组合物60℃烘焙干燥后，称取细辛1g、肉桂2g、元胡3g、藁本4g、鸡血藤10g、川芎4g、白芍6g、黄芪10g、木香2g、羌活7g、独活5g、防风3g、香附4g、灸甘草4g、钩藤5g、宽筋藤4g和制川乌1g，粉碎后搅拌均匀过80目筛备用；
步骤二，将复方中药组合物粉末置于真空旋转蒸发仪，加水500mL及醋酸10mL大火煮沸后，文火熬制至300mL，冷却后加入2倍体积无水乙醇静置2～4小时，过滤，得药液I和药渣Ⅰ；药渣Ⅰ重复上述步骤二，得药液II；
步骤三，合并药液Ⅰ和药液II，恒温80℃水浴回流浓缩，再2500目抽滤，50～60℃挥干，粉碎，过200目，得复方提取物；
步骤四，将复方提取物50g，添加樟脑2g、冰片1g，溶入含有肉桂油20mL、茶子油10mL，柠檬醛1mL、松节油450mL的有机溶剂中，制成本搽剂。
5.如权利要求4所述的复方中药祛痹搽剂的制备方法，其特征在于，所述步骤二，添加500mL水及10mL醋酸，大火煮沸后文火熬制，煎剂加入2倍体积无水乙醇静置，过滤。
6.如权利要求4所述的复方中药祛痹搽剂的制备方法，其特征在于，所述步骤三，药液恒温80℃水浴回流浓缩，再2500目抽滤，50～60℃挥干，得复方提取物。
7.如权利要求4所述的复方中药祛痹搽剂的制备方法，其特征在于，所述步骤四，将复方提取物50g，添加樟脑2g、冰片1g，溶入含有肉桂油20mL、茶子油10mL，柠檬醛1mL、松节油450mL的有机溶剂中。
8.如权利要求4所述的复方中药祛痹搽剂的制备方法，其特征在于，所述制剂是指由中药材提取物加入适宜的辅料采用常规制剂技术制成的中药搽剂。
9.如权利要求4所述的复方中药祛痹搽剂的使用方法，其特征在于，所述的中药搽剂的使用方法为：皮肤完好情况下用手外搽至发热，1～10mL/次，3～4次/天。
10.权利要求1-3所述的中药复方制剂，权利要求4-7所述的中药复方制剂的制备方法在制备用于治疗和预防风湿疼痛等病症的药物中的应用。
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