CN114053211A - 一种膏药组合物及其制备方法和应用 - Google Patents
一种膏药组合物及其制备方法和应用 Download PDFInfo
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- CN114053211A CN114053211A CN202111303194.9A CN202111303194A CN114053211A CN 114053211 A CN114053211 A CN 114053211A CN 202111303194 A CN202111303194 A CN 202111303194A CN 114053211 A CN114053211 A CN 114053211A
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Abstract
本发明涉及医疗保健技术领域,公开了一种膏药组合物及其制备方法和应用,所述膏药组合物包括以下重量份的组分:发热活性材料10‑25份,中药组合物30‑50份,金纳米材料0.1‑0.5份,透皮吸收剂1‑5份;所述发热活性材料包括电气石、麦饭石、锗石;按重量比计,所述电气石:所述麦饭石:所述锗石为(4‑8):(1‑2):1。本发明的膏药组合物能有效治疗风湿骨病,缓解患者的疼痛,酸胀症状。
Description
技术领域
本发明属于医疗保健技术领域,具体涉及一种膏药组合物及其制备方法和应用。
背景技术
风湿骨病泛指由风湿、类风湿所引起的各骨关节以及周身某部位的疼痛,属中医学“骨痹”范畴。目前常规的解释是,风湿性疾病主要是由于风寒引起的血液循环不通畅,致使包括肌、韧带、滑囊、筋膜的营养供给不良导致的疾病。风湿骨病多见于退行性骨关节病,骨质增生,椎间盘膨出、突出,韧带钙化,颈肩腰腿痛,是临床常见病、多发病、对患者的生活质量及身心健康具有严重的负面影响。
针对风湿骨病,目前人们采用的治疗手段大都是采用膏药贴和发热贴。膏药贴为了增加舒筋活血通络、祛风散寒除湿的药效,以及产生灼热感,其成分中往往含有辣椒提取液、激素、劣质艾叶、化学混合剂等。辣椒提取液对皮下组织有一定的伤害;激素、劣质艾叶、化学混合剂等成分会使部分患者产生过敏反应,存在一定的安全隐患。发热贴是利用铁粉氧化产生热量,其中的发热组分包括铁粉、活性炭、无机盐、水等,长时间使用容易造成低温烫伤。虽然现在市面上也出现了一些针对疼痛部位或穴位进行热灸作用的原理制成的理疗贴,但是治疗效果不佳。
因此,提供一种能够有效治疗风湿骨病的方法,具有十分重要的意义。
发明内容
本发明旨在至少解决上述现有技术中存在的技术问题之一。为此,本发明提出一种膏药组合物及其制备方法和应用,该膏药组合物能有效治疗风湿骨病,缓解患者的疼痛症状。
本发明的第一方面,提供一种膏药组合物,包括以下重量份的组分:
发热活性材料10-25份;
中药组合物30-50份;
金纳米材料0.1-0.5份;
透皮吸收剂1-5份。
在本发明的一些实施方式中,所述发热活性材料包括电气石、麦饭石、锗石。
在本发明的一些实施方式中,按重量比计,所述电气石:所述麦饭石:所述锗石为(4-8):(1-2):1。
在本发明的一些实施方式中,所述电气石、所述麦饭石、所述锗石的粒径范围为0.1-10μm。
本发明中的电气石具有独特的压电效应和热电效应,可以发射波长为4-14μm的远红外,与人体远红外波长很相配,对加速血液循环,扩张毛细静脉,改善人体微循环有显著作用,有利于药物的吸收。另外,电气石还可释放被称为“空气维生素”的负离子,能够很好改善和平衡人体的酸碱度,活化细胞,提高自愈率,对缓解亚健康状态有很大的作用,并能抑制身体的氧化。负离子和远红外线直接作用于病灶处,平衡阴阳,温经通络,温阳散寒,并能促进血液循环、镇痛祛邪,产生热效应。麦饭石及锗石同样具有释放远红外线和负离子的功效,能够促进血管扩张,促使药物有效成分充分吸收,具有显著的中药磁疗效果。本发明选取电气石、麦饭石及锗石,三者搭配作为发热活性材料,并通过调整三者的比例,使中药组合物的有效成分得到充分吸收,并辅以磁疗技术,进一步提高了对风湿骨病的治疗效果。
在本发明的一些实施方式中,所述中药组合物包括以下重量份的组分:
荜茇15-20份、红花5-20份、川芎8-12份、秦艽10-20份、细辛5-10份、透骨草15-25份、伸筋草15-25份、艾草5-10份、苍术20-25份、防己5-10份、葛根5-10份、干姜10-15份。
在本发明的一些优选的实施方式中,所述中药组合物包括以下重量份的组分:
荜茇15-18份、红花12-15份、川芎10-12份、秦艽10-15份、细辛8-10份、透骨草18-20份、伸筋草15-20份、艾草5-8份、苍术20-22份、防己8-10份、葛根5-8份、干姜10-12份。
本发明配方中的荜茇:镇痛健胃;红花:活血通径、散瘀止痛;川芎:活血行气、祛风止痛;秦艽:祛风湿、清虚热、止痹痛,主要成分是秦艽碱甲,具有抗炎、镇痛、抗过敏、镇静、解热等作用;细辛:镇静、镇痛、抗炎,细辛挥发油具有表面麻醉以及浸润麻醉作用;透骨草:祛风除湿、舒筋活血、散瘀消肿、解毒止痛;伸筋草:祛风除湿、舒筋活络,用于关节酸痛、屈伸不利;艾草:温经、去湿、散寒、止血、消炎、平喘、止咳、抗过敏;苍术:燥湿健脾、祛风散寒、明目;防己:祛风止痛、利水消肿、除湿通络;葛根:解肌理肌肉之邪,开发腠理而出汗,多治项背僵痛,具有扩张血管、促进血液循环,良好的活血通脉作用;干姜:温中逐寒、回阳通脉、驱寒去湿。
本发明创造性地利用具有镇痛作用的荜茇、具有镇痛消炎作用的细辛与其余十味药材进行科学搭配,能够在实现祛风除湿的效果上,进一步缓解风湿关节疼痛症状以及炎症反应,从而增强中药组合物的治疗效果。
在本发明的一些实施方式中,所述中药组合物中,各组分的粒径范围为0.01-20μm。
在本发明的一些实施方式中,所述金纳米材料为金纳米团簇和/或金纳米颗粒。
在本发明的一些实施方式中,所述金纳米材料的粒径范围为0.1-20nm。
在本发明的一些实施方式中,所述金纳米材料为有机胺改性金纳米材料。
在本发明的一些优选的实施方式中,所述有机胺为谷胱甘肽和/或牛血清白蛋白。
在本发明的一些实施方式中,所述金纳米材料的制备步骤包括:将所述有机胺与氯金酸在水存在下反应,纯化,即得。
在本发明的一些实施方式中,所述有机胺与所述氯金酸的质量比为(1-15):1。
在本发明的一些实施方式中,所述有机胺与所述氯金酸的浓度比为:(2.5-15):1。
在本发明的一些实施方式中,所述纯化的方法为超滤离心法。
在本发明的一些实施方式中,所述超滤离心法的截留分子量为3-100kDa。
在本发明的一些实施方式中,所述金纳米材料的制备步骤还包括加入还原剂。
在本发明的一些优选的实施方式中,所述还原剂包括抗坏血酸、柠檬酸钠、硼氢化钠中的至少一种,优选抗坏血酸。
在本发明的一些优选的实施方式中,所述还原剂与所述氯金酸的质量比为1:10~10:1。
金纳米材料在大鼠类风湿性关节炎模型中具有显著的抗炎作用,并能够抑制炎性细胞因子的产生,逆转软骨或骨的破坏,从而发挥治疗风湿性关节炎的作用。
在本发明的一些实施方式中,所述透皮吸收剂包括薄荷油、樟脑、冬青油、丁香油、桉叶油、丙三醇中的至少一种。
本发明的第二方面,提供上述膏药组合物的制备方法,包括以下步骤:
将所述发热活性材料、所述中药组合物、所述金纳米材料与所述透皮吸收剂混合。
在本发明的一些实施方式中,所述中药组合物中各组分的粒径范围为0.01-20μm,通过超微粉碎技术粉碎得到。
在本发明的一些实施方式中,所述发热活性材料中的电气石、麦饭石、锗石的粒径范围为0.1-10μm,通过球磨法粉碎得到。
本发明的第三方面,提供一种膏药,其制备原料包括上述膏药组合物,以及辅料。
在本发明的一些实施方式中,所述辅料的占比为60-90%,优选60-80%,更优选70-80%。
在本发明的一些实施方式中,所述辅料包括水凝胶,凡士林、羊毛脂中的至少一种,优选水凝胶。
在本发明的一些优选的实施方式中,所述水凝胶由水凝胶树脂粉与甘油、95%乙醇、10%酒石酸水溶液、丙二醇中的至少一种混合制得。
在本发明的一些优选的实施方式中,所述水凝胶为HQ841和/或HQ800。
本发明的第四方面,提供上述膏药组合物或膏药在制备治疗风湿骨病药物中的应用。
在本发明的一些实施方式中,所述风湿骨病包括风湿、类风湿、风寒麻木、腰酸腿痛、颈椎病、腰椎间盘突出、骨质增生、肩周炎、跟骨刺、产后风湿、坐骨神经痛、痛风、膝关节增生、肿大、关节红肿、热痛中的至少一种。
所述治疗风湿骨病药物的制剂类型可以为水凝胶剂、软膏剂、橡皮膏剂或涂膜剂。
根据本发明实施方式的膏药组合物,至少具备如下有益效果:
(1)本发明基于经络学说、磁医学、远红外保健理论、中医温热灸原理得到。电气石、麦饭石、锗石等发热活性材料能够释放远红外、负离子,搭配透皮吸收剂能够促进本发明的中药组合物的吸收。另外,本发明创造性的加入了金纳米材料,金纳米材料本身具有治疗风湿骨病的作用,除此之外,其还具备特殊的物理化学性质,能与多种类型药物发生相互作用,从而负载药物便于被人体吸收。因此,金纳米材料能够与本发明的中药组合物发挥协同作用,显著改善患者的风湿骨病症状;
(2)本发明对风湿、类风湿、风寒麻木、腰酸腿痛、颈椎病、腰椎间盘突出、骨质增生、肩周炎、跟骨刺、产后风湿、坐骨神经痛、痛风、膝关节增生、肿大、关节红肿、热痛等能起到祛风散寒,活血通络,消肿止痛等作用,治愈率高;
(3)本发明为即热型显效产品,无需外部电、热源;利用人体自身能量连续不断稳定释放能量,使得温度恒定,安全可靠;
(4)本产品为草本配方,安全可靠,原材料来源广;不添加任何香精、色素和防腐剂,使用简便、功效卓越,属自然疗法,对人体无任何毒副作用。
具体实施方式
以下将结合实施例对本发明的构思及产生的技术效果进行清楚、完整地描述,以充分地理解本发明的目的、特征和效果。显然,所描述的实施例只是本发明的一部分实施例,而不是全部实施例,基于本发明的实施例,本领域的技术人员在不付出创造性劳动的前提下所获得的其他实施例,均属于本发明保护的范围。实施例或对比例或测试例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者,均为可以通过市售购买获得的常规产品。
实施例
实施例1
一种膏药组合物,包括以下重量份的组分:
电气石7份、麦饭石2份、锗石1份、中药组合物50份、牛血清白蛋白改性金纳米颗粒0.2份、薄荷油2份、冬青油1份。
中药组合物包括以下重量份的组分:
荜茇16份、红花12份、川芎10份、秦艽13份、细辛8份、透骨草20份、伸筋草17份、艾草8份、苍术20份、防己9份、葛根8份、干姜12份。
制备方法为:将50mL浓度为50mg/mL的牛血清白蛋白溶液与50mL浓度为10mmol/L的氯金酸溶液混合,室温下搅拌30min,然后加入1g抗坏血酸继续搅拌2h,之后通过超滤管(截留分子量为3-100kDa)在6000-8000r/min的离心机中超滤3-5min,如此超滤3-4次后制得粒径范围为0.1-20nm的牛血清白蛋白改性金纳米颗粒。通过超微粉碎法将上述中药组合物各成分粉碎为粒径大小为0.01-20μm的粉末,得中药组合物粉末。按照配比将电气石、麦饭石、锗石球磨至粒径范围为0.1-10μm后,与牛血清白蛋白改性金纳米颗粒、薄荷油、冬青油和中药组合物混合,搅拌均匀,得到混合料。将HQ841水凝胶树脂粉与适量甘油、95%乙醇混合均匀得水凝胶,再将制得的混合料与水凝胶以2:8的比例混合制膏。
实施例2
一种膏药组合物,包括以下重量份的组分:
电气石10份、麦饭石3份、锗石2份、中药组合物40份、牛血清白蛋白改性金纳米团簇0.4份、丁香油1份、桉叶油2份、丙三醇2份。
中药组合物包括以下重量份的组分:
荜茇15份、红花13份、川芎12份、秦艽10份、细辛10份、透骨草18份、伸筋草15份、艾草6份、苍术20份、防己10份、葛根5份、干姜10份。
制备方法为:取50mL浓度为50mg/mL的牛血清白蛋白溶液与50mL浓度为10mmol/L的氯金酸溶液混合,调节pH值,室温下搅拌1h,之后通过超滤管(截留分子量为3-100kDa)在6000-8000r/min的离心机中超滤3-5min,如此超滤3-4次后制得粒径范围为0.1-20nm的牛血清白蛋白改性金纳米团簇。通过超微粉碎法将上述中药组合物中各成分粉碎为粒径大小为0.01-20μm的粉末,得中药组合物粉末。按照配比将电气石、麦饭石、锗石球磨至粒径范围为0.1-10μm后,与牛血清白蛋白改性金纳米团簇、丁香油、桉叶油、丙三醇和中药组合物混合,搅拌均匀,得到混合料。将HQ841水凝胶树脂粉与适量甘油、丙二醇混合均匀得水凝胶,再将制得的混合料与水凝胶以3:7的比例混合制膏。
实施例3
一种膏药组合物,包括以下重量份的组分:
电气石15份、麦饭石4份、锗石2份、中药组合物35份、谷胱甘肽改性金纳米团簇0.1份、丁香油4份。
中药组合物包括以下重量份的组分:
荜茇16份、红花12份、川芎12份、秦艽15份、细辛9份、透骨草18份、伸筋草16份、艾草8份、苍术20份、防己9份、葛根5份、干姜10份。
制备方法为:取50mL浓度为30mmol/L的谷胱甘肽溶液与100mL浓度为10mmol/L的氯金酸溶液混合,室温下搅拌20min,静置2min,在温和搅拌下将混合液加热到60-80℃,加热3-4h,然后通过超滤管(截留分子量为3-100kDa)在6000-8000r/min的离心机中超滤3-5min,如此超滤3-4次后制得粒径范围为0.1-20nm的谷胱甘肽改性金纳米团簇。通过超微粉碎法将上述中药成分粉碎为粒径大小为0.01-20μm的粉末,得中药组合物粉末。按照配比将电气石、麦饭石、锗石球磨至粒径范围为0.1-10μm后,与谷胱甘肽改性金纳米团簇、丁香油和中药组合物混合,搅拌均匀,得到混合料。将HQ800水凝胶树脂粉与适量甘油、95%乙醇混合均匀得水凝胶,再将制得的混合料与水凝胶以3:7的比例混合制膏。
对比例1
与实施例2的配方相同,区别在于电气石、麦饭石与锗石的重量比为2:1:1。
对比例2
与实施例2的配方相同,区别在于电气石、麦饭石与锗石的重量比为6:3:1。
对比例3
与实施例2的配方相同,区别在于不加金纳米材料。
对比例4
对比例4为市售麝香壮骨膏。
测试例
选择以软组织疼痛为主诉的患者140例,其中男74例,女66例,年龄19-70岁,平均年龄为(46.2±5.4)岁。患者的症状主要包括风湿、类风湿、腰酸腿痛、颈椎病、肩周炎等,将140位患者随机分为7个组,每组各20人。
治疗方法:实验组受试者分别于疼痛病灶处薄抹一层本发明的膏药组合物,每次12h,每日涂抹1次,15天为一疗程;对照组受试者分别于疼痛病灶处外贴市售麝香壮骨膏,每次贴12h,每日更换1次,15天为一疗程;每日检查患者病灶处疼痛情况;听取患者病情反馈,并做好记录。
评价方法:以病灶或其辐射区域的疼痛、寒凉、酸胀、活动受限等症状的减轻或消失作为治疗效果的评判标准。(1)无效:症状没有明显变化;有效:疼痛、寒凉、酸胀等症状减轻,功能活动有所改善;显效:疼痛、寒凉、酸胀等症状显著改善,功能活动基本恢复正常;另外,(2)采用疼痛视觉模拟(VAS)评分评价疼痛程度,VAS评分依等级从0-10分,0分代表无疼痛,10分代表疼痛剧烈。
疗效评价结果见表1。
表1实施例1-3和对比例1-4的膏药对患者的治疗效果
VAS评分结果见表2。
表2患者治疗前后的VAS值
项目 | 患者数 | 治疗前 | 治疗后 |
实施例1 | 20 | 5.11±0.64 | 3.20±0.41<sup>*</sup> |
实施例2 | 20 | 5.54±0.28 | 2.76±0.14<sup>**</sup> |
实施例3 | 20 | 5.27±0.16 | 3.06±0.62<sup>**</sup> |
对比例1 | 20 | 5.72±0.39 | 4.57±0.22<sup>*</sup> |
对比例2 | 20 | 5.44±0.21 | 4.08±0.46<sup>*</sup> |
对比例3 | 20 | 5.24±0.66 | 4.48±0.36 |
对比例4 | 20 | 5.40±0.36 | 3.12±0.28<sup>**</sup> |
注:与治疗前比较*P<0.05,**P<0.01。
另外,本发明还通过动物实验验证了制备的膏药对于关节炎大鼠的抗炎作用。
选取24只SPF级别的雄性SD大鼠,体重200±20g,随机分为8组,即6个实验组,一个阳性对照组,一个模型对照组。各组大鼠右后足跖皮下注射0.1mL的Freund’s佐剂诱导雄性SD大鼠的佐剂性关节炎。注射佐剂后第8天开始用药:实验组大鼠分别薄涂一层本发明制备的膏药(约2g),模型对照组外涂等量的空白辅料(约2g),阳性对照组大鼠外涂20mg/kg/d的氢化可的松。每日涂药1次,连续给药30天。末次涂药后1h,大鼠腹主动脉取血,采集血清,依照试剂盒的操作步骤测定各组大鼠血清中IL-1β、TNF-α的含量。IL-1β、TNF-α的含量测定结果见表3。
表3关节炎大鼠血清中IL-1β、TNF-α的含量
项目 | IL-1β(ng/L) | TNF-α(ng/L) |
实施例1 | 0.359±0.016<sup>**</sup> | 0.875±0.452<sup>*</sup> |
实施例2 | 0.311±0.032<sup>**</sup> | 0.851±0.462<sup>*</sup> |
实施例3 | 0.322±0.051<sup>*</sup> | 0.901±0.314 |
对比例1 | 0.384±0.063 | 1.152±0.356 |
对比例2 | 0.341±0.024<sup>**</sup> | 1.144±0.330 |
对比例3 | 0.407±0.078 | 1.313±0.218 |
氢化可的松 | 0.308±0.044<sup>**</sup> | 0.914±0.196<sup>*</sup> |
模型对照组 | 0.501±0.046 | 1.618±0.348 |
注:与模型组比较*P<0.05,**P<0.01;实施例组1-3与阳性对照组的IL-1β、TNF-α含量均无显著性差异。
由表1,2可知,用实施例1-3制备得到的膏药对患者进行涂抹治疗后,受试患者的软组织疼痛以及酸胀的症状得到显著改善,四个疗程后,患者的显效率达到70-85%;另外,大部分患者在三个疗程结束后,软组织疼痛,酸胀的情况就显著减少。与实施例2相比,对比例1降低了电气石的用量,结果四个疗程后,患者的显效率下降,仅为50%。同样的,与实施例2相比,对比例2增加了麦饭石的用量,第四个疗程后,显效患者的数量无明显增加,膏药的发热效果以及磁疗效果下降,导致促进药物吸收的作用减弱。与实施例2相比,对比例3不添加金纳米材料,患者的显效率不佳,仅为45%。对比例1-3中患者的疼痛感降低,但降低程度均不及实施例1-3。对比例4为市售麝香壮骨膏,由表中数据可知,患者贴敷麝香壮骨膏60天后,显效率达到65%,但是显效时间较实施例1-3慢,大部分患者在四个疗程之后软组织疼痛,酸胀的情况才显著减少。
由表3可以看出,与模型对照组相比,阳性对照组血清中IL-1β、TNF-α的含量均显著下降,提示关节炎大鼠造模成功。与模型对照组相比,实施例1-3与对比例1-3制得的膏药均能降低大鼠血清中IL-1β、TNF-α的含量,但实施例1-3的作用较对比例1-3更加显著,与阳性对照药氢化可的松的抗炎作用近乎相当,表明实施例1-3制备的膏药能够显著的抑制IL-1β、TNF-α炎症因子的分泌,具有显著的抗炎作用。
上面对本发明实施例作了详细说明,但是本发明不限于上述实施例,在所属技术领域普通技术人员所具备的知识范围内,还可以在不脱离本发明宗旨的前提下作出各种变化。此外,在不冲突的情况下,本发明的实施例及实施例中的特征可以相互组合。
Claims (10)
1.一种膏药组合物,其特征在于,包括以下重量份的组分:
发热活性材料10-25份;
中药组合物30-50份;
金纳米材料0.1-0.5份;
透皮吸收剂1-5份;
所述发热活性材料包括电气石、麦饭石、锗石;
按重量比计,所述电气石:所述麦饭石:所述锗石为(4-8):(1-2):1。
2.根据权利要求1所述的膏药组合物,其特征在于,所述中药组合物包括以下重量份的组分:
荜茇15-20份、红花5-20份、川芎8-12份、秦艽10-20份、细辛5-10份、透骨草15-25份、伸筋草15-25份、艾草5-10份、苍术20-25份、防己5-10份、葛根5-10份、干姜10-15份。
3.根据权利要求2所述的膏药组合物,其特征在于,所述中药组合物包括以下重量份的组分:
荜茇15-18份、红花12-15份、川芎10-12份、秦艽10-15份、细辛8-10份、透骨草18-20份、伸筋草15-20份、艾草5-8份、苍术20-22份、防己8-10份、葛根5-8份、干姜10-12份。
4.根据权利要求1-3任一项所述的膏药组合物,其特征在于,所述中药组合物中,各组分的粒径范围为0.01-20μm。
5.根据权利要求1所述的膏药组合物,其特征在于,所述金纳米材料为金纳米团簇和/或金纳米颗粒;进一步地,所述金纳米材料的粒径范围为0.1-20nm。
6.根据权利要求1所述的膏药组合物,其特征在于,所述金纳米材料为有机胺改性金纳米材料。
7.根据权利要求1所述的膏药组合物,其特征在于,所述透皮吸收剂包括薄荷油、樟脑、冬青油、丁香油、桉叶油、丙三醇中的至少一种。
8.一种如权利要求1-7任一项所述的膏药组合物的制备方法,其特征在于,包括以下步骤:
将所述发热活性材料、所述中药组合物、所述金纳米材料与所述透皮吸收剂混合。
9.一种膏药,其特征在于,所述膏药的制备原料包括权利要求1-7任一项所述的膏药组合物,以及辅料。
10.一种如权利要求1-7任一项所述的膏药组合物或权利要求9所述的膏药在制备治疗风湿骨病药物中的应用。
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