CN114796384A - 一种复方中药的纳米级中药外用混悬凝胶剂及其制备方法 - Google Patents
一种复方中药的纳米级中药外用混悬凝胶剂及其制备方法 Download PDFInfo
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Abstract
本发明提供一种复方中药的纳米级中药外用混悬凝胶剂及其制备方法。该制备方法包括如下步骤:1)将复方中药去除杂质、清洗,然后采用二氧化碳超临界萃取,收集中药挥发油;2)将步骤1)二氧化碳超临界萃取剩余的复方中药残渣进行烘干;3)研磨粉碎:将步骤2)干燥后的复方中药残渣用行星式球磨机研磨至微粒小于100纳米,得到复方中药粉末;4)按质量百分比将卡波姆940、泊洛沙姆、卵磷脂、丙二醇、聚山梨酯80、尼泊金乙酯混合,加少量蒸馏水水胀润;然后加入复方中药粉末、中药挥发油;再加20%三乙醇胺调pH5.5‑6.5,最后加入蒸馏水定容;5)超声混合;6)高剪切机剪切均质;7)灌入瓶子密封成品包装。
Description
技术领域
本发明属于中药纳米级技术加工领域,涉及一种复方中药的纳米级中药外用混悬凝胶剂及其制备方法。
背景技术
经皮给药系统(Transdermal Drug Delivery Systems,简称TDDs)或称经皮治疗系统(Transdermal Therapeutic system简称TTS)是药物通过皮肤吸收的一种方法,药物经由皮肤吸收进入人体血液循环并达到有效血药浓度、实现疾病治疗或预防一种给药新途径。与其他常规的给药途径相比,经皮给药具有避免肝脏首关效应及胃肠灭活、减少血药浓度波动、降低毒副反应、给药方便、患者顺应性好等优点。
然而,受皮肤角质层屏障功能的影响,仅有少数药物适于经皮给药,多数药物经皮给药后,并不能透过皮肤达到有效治疗浓度。近年来,通过化学(前体药物)、物理(超声、电致孔、离子导入、微针等)及制剂(经皮吸收促进剂、脂质体、固体脂质纳米、纳米结构脂质载体、纳米乳、纳米混悬剂)等方法,促进经皮给药领域的深入研究。
纳米级中药主要运用纳米制造技术进行加工,是现代中药发展的重要方向之一。中药加工至纳米尺寸时,由于其量子尺寸等效应导致其物理、化学特征的改变,从而使中药呈现出新功能,如提高生物利用度,增强靶向性,降低毒副作用,呈现新的药效,扩宽原药的适应症,丰富中药的剂型选择,减少用药量,节省中药资源等。纳米级中药一般不是简单的将中药材料进行粉碎至纳米量级,而是针对组成的中药方剂的某味药的有效部位,甚至是其有效成分进行纳米技术加工处理。
但是,目前大部分都是中药原料进行纳米粉碎的,其剂型以纳米级中药内服剂与纳米级中药注射剂较为多见,而少见皮肤给药制剂。目前中药经皮给药制剂的研究主要集中于纳米技术对少数成分比较明确的单体有效成分进行纳米处理制成纳米剂型,或将中药原料直接粉碎成纳米级的产品,对于中药复方纳米制剂研究还是很少见到,其主要原因是中医中药真正起药理作用的有效成分和有效部位研究本身机理尚不清晰,特别是中药复方有效成分还是一个未知的“黑箱”,造成经皮给药制剂的复方纳米级中药的透皮疗效无法保证。
因此,制备疗效显著的经皮给药的复方纳米级中药制剂成为需要解决的问题。
发明内容
为了解决上述问题,本发明的目的提供一种复方中药的纳米级中药外用混悬凝胶剂的制备方法,该方法先萃取中药中含有油脂的部分作为植物精油,然后再添加到纳米级的中药当中制成混悬凝胶剂,保持原方复方的有效成分,即药物透过屏障达到药物的迅速作用,使药物有效成分发挥力强,副作用少,安全性能高。
为了实现上述目的,本发明提供一种复方中药的纳米级中药外用混悬凝胶剂的制备方法,包括如下步骤:
1)将复方中药去除杂质、清洗,然后采用二氧化碳超临界萃取,收集中药挥发油;
2)将步骤1)二氧化碳超临界萃取剩余的复方中药残渣进行烘干;
3)研磨粉碎:将步骤2)干燥后的复方中药残渣用行星式球磨机研磨至微粒小于100纳米,得到复方中药粉末;
4)按质量百分比将卡波姆940 0.5%-2%、泊洛沙姆0.1%-0.4%、大豆卵磷脂0-8%、丙二醇1%-6%、聚山梨酯80 0-0.8%、尼泊金乙酯0-0.01%混合,加少量蒸馏水水胀润;然后加入复方中药粉末0.3%-2.5%、中药挥发油0.3%-2.5%;再加20%三乙醇胺调pH5.5-6.5,最后加入蒸馏水定容至100%;
5)超声混合10-20分钟;
6)高剪切机剪切均质,剪切速率15000rpm,均质时间15min;
7)灌入瓶子密封成品包装。
如上所述,步骤1)所述二氧化碳超临界萃取的条件为:萃取温度30~70℃,压力14~42MPa,萃取时间1~5小时。
如上所述,步骤2)所述烘干条件为:40-80℃烘干1-2小时。
本发明还提供一种采用上述的制备方法制备的复方中药的纳米级中药外用混悬凝胶剂。
纳米中药是指运用纳米技术制造的粒径小于100nm的中药有效成分、有效部位。当物质的颗粒小到1~100nm时,由于其量子效应、物质的局域性、巨大的表面及界面效应,会使物质的很多性能发生质变,呈现出许多既不同于宏观物体,也不同于单个孤立原子的奇异现象。
本发明提供的纳米级中药外用混悬凝胶剂,将中药进行纳米级的粉碎,由于纳米级中药的微粒表面积变大,表面活性提高,使纳米级中药很容易悬聚在一起。纳米中药的外用制剂是将超粉碎纳米级中药导入纳米载体表面的一种渗透体内制剂,可增加药物达到人体组织和导入疾病的红外热图像的靶点、靶向,达到消除症状和有效的治疗。
本发明的有益效果在于:
本发明提供一种纳米级中药外用混悬凝胶剂的制备方法,该制备方法将中药或中药复方的药材超粉碎到纳米级粒径小于100纳米级提取,通过挥发油及中药混合粉末与凝胶基质的作用制成混悬凝胶剂。该混悬凝胶剂通过局部按摩,振荡皮肤给药而成,通过透过皮肤吸收发挥全身治疗的作用。与其他常规中药剂给药途径相比,经皮肤给药具有减少,促进肝脏排毒功能,减轻胃肠和肾脏负担,降低药物毒性反应、减少副作用等。皮肤渗透,给药方便,针对性强,可以达到内病外治的良好效果。在临床上对椎间盘、颈椎病、腰椎病、乳腺增生、宫寒、妇科疾病、高血脂、高血压、睡眠不佳和皮肤色素、湿疹、牛皮癣以及调节气血、养生保健等方面都有明显的效果。
附图说明
图1A为采用本发明提供的方法制备的混悬凝胶剂的给实施例1中患者治疗前的热成像结果图。
图1B为采用本发明提供的方法制备的混悬凝胶剂的给实施例1中患者治疗后的热成像结果图。
图2A为采用本发明提供的方法制备的混悬凝胶剂的给实施例2中患者治疗前的热成像结果图。
图2B为采用本发明提供的方法制备的混悬凝胶剂的给实施例2中患者治疗后的热成像结果图。
图3A为采用本发明提供的方法制备的混悬凝胶剂的给实施例3中患者治疗前的热成像结果图。
图3B为采用本发明提供的方法制备的混悬凝胶剂的给实施例3中患者治疗后的热成像结果图。
图4A为采用本发明提供的方法制备的混悬凝胶剂的给实施例4中患者治疗前的热成像结果图。
图4B为采用本发明提供的方法制备的混悬凝胶剂的给实施例4中患者治疗后的热成像结果图。
图5A为采用本发明提供的方法制备的混悬凝胶剂的给实施例5中患者治疗前的热成像结果图。
图5B为采用本发明提供的方法制备的混悬凝胶剂的给实施例5中患者治疗后的热成像结果图。
具体实施方式
下面将对本发明的实施例进行详细、完善的描述,以使本发明的优点和特征能更易于被本领域技术人员理解,从而对本发明的保护范围做出更为清楚明确的界定。
本发明提供的纳米级中药外用混悬凝胶剂指在中医药理论的指导下,采用适宜的方法和基质,将中药或中药复方的药材细粉或药材经过合理的提取、分离、纯化等工艺所得到的有效部位、有效成分或其提取物制成的通过皮肤表面给药,从而通过局部或透过皮肤、黏膜的吸收发挥全身治疗作用的一种给药方式。与其他常规的给药途径相比,经皮给药具有避免肝脏首关效应及胃肠灭活、减少血药浓度波动、降低毒副反应、给药方便、患者顺应性好等优点。
然而,受皮肤角质层屏障功能的影响,仅有少数药物适于经皮给药,多数药物经皮给药后,并不能透过皮肤达到有效治疗浓度。近年来,通过化学(前体药物)、物理(超声、电致孔、离子导入、微针等)及制剂(经皮吸收促进剂、脂质体、固体脂质纳米、纳米结构脂质载体、纳米乳、纳米混悬剂)等方法,促进皮肤外部给药领域的深入研究,同时,扩大了中医中药内病外治的应用范围。
复方中药实施方案
仙方活命饮加减:白芷6g;防风6g;当归6g;赤芍药6g;乳香6g;没药6g;皂角刺6g;三七6g;红花6g;浙贝6g;花粉6g;金银花9g;陈皮9g;甘草6g;血竭6g;川芎6g;丹参20g;桃仁10g;白芥子6g;麻黄6g;知母9g;肉桂6g;檀香6g。
仙方活命饮出处《校注妇人良方》,具有清热解毒,消肿溃坚,活血止痛的功效。
仙方活命饮加减混悬凝胶剂的制备方法包括如下步骤:
1.按照上述比例配制复方中药,除杂质、清洗,然后采用二氧化碳超临界萃取,收集中药挥发油;
二氧化碳超临界萃取的条件为:萃取温度60℃,压力30MPa,萃取时间3小时;
2.将二氧化碳超临界萃取剩余的复方中药残渣进行烘干;烘干条件为:40-80℃烘干1-2小时;
3.研磨粉碎:将干燥后的复方中药残渣用行星式球磨机研磨至微粒小于100纳米,得到复方中药粉末;
4.按质量百分比将卡波姆940 2%、泊洛沙姆0.3%、卵磷脂4%、丙二醇4%、聚山梨酯80 0.4%、尼泊金乙酯0.01%混合,加少量蒸馏水水胀润;然后加入复方中药粉末2%、中药挥发油1.5%;再加20%三乙醇胺调pH5.5-6.5,最后加入蒸馏水定容;
5)超声混合15分钟;
6)高剪切机剪切均质,剪切速率15000rpm,均质时间15min;
7)灌入瓶子密封成复方仙方活命饮加减混悬凝胶剂。
首先采用医用红外热像诊疗仪观测患者的人体代谢热,了解患者的人体代谢热所表达的健康状况和疾病信息,通过图像化数据化表达确定人体十二经脉和各个部位的证向、靶向、靶点,然后给予外部皮肤给药,通过观察临床上红外热成像图的色差改变,来判断药物对患者病情的改善效果。
实施例1
患者季某某,男,年龄:46,首次诊疗时间:2022.3.4,中医辨证诊断:肾阴阳两虚兼肝阳上亢,西医诊断:高血压(150/92mmHg)、血肌酐升高(160μmol/L),病人主诉:头晕、腰疼。
热成像参数:红外温宽:9.6,舱内温度:26℃
诊疗过程:患者于2022年3月4日来诊,自述头晕腰痛,用红外热像仪(舱体式)靶向定位发现患者背侧有两块芭蕉叶状蓝色肾冷区,如图1A所示,其中,图1A中a为患者正面,b和c分别为患者两侧面,d为患者背面。从图1A可以看出,患者为肾阳不足,相火不归藏。
选用复方仙方活命饮加减混悬凝胶剂,取穴涂抹混悬凝胶剂,并使用砭石温灸仪加热振荡摩擦,手法缓慢,轻柔,直至皮肤出现小红点,通过皮肤给药促进吸收以达到内病外治效果。
取穴膀胱经:心俞穴、督俞穴、膈俞穴、肝俞穴、胆俞穴、脾俞穴、胃俞穴、三焦俞穴、肾俞穴。
隔天一次,10天一个疗程,连续治疗一个疗程后患者前来复诊自述头晕症状大为减轻,腰痛症状消失,血肌酐(105μmol/L)指标恢复正常。现场测量高血压恢复正常指标(130/85mmHg),再次用红外热像仪(舱体式)靶向定位,如图1B所示,其中中a为患者正面,b和c分别为患者两侧面,d为患者背面。
从图1B可以看出,患者背侧肾冷区已经缩小,由原来大面积的深蓝色转为小面积浅蓝色与黄色,已经接近正常体温,肾冷区温度升高提示肾阳虚得到改善。
实施例2
患者郑某某,女,年龄:47,诊疗时间:2022.3.4,中医辨证诊断:肾气不足兼肝阳上亢,西医诊断:高血压(140/90mmHg),病人主诉:头晕、潮热。
热成像参数:红外温宽:9.6,舱内温度:26℃
诊疗过程:患者于2022年3月4日来诊,自述头晕伴有夜间潮热,现场测量血压140/90mmHg(属于高血压),用红外热成像靶向定位,发现患者背侧有两处明显肾冷区,如图2A所示,其中,图2A中a为患者正面,b为患者侧面,c和d为患者背面。从图2A可以看出,患者为肾阳虚,心肾不交。
选用复方仙方活命饮纳米混悬凝胶剂,取穴涂抹混悬凝胶剂,并使用砭石温灸仪加热振荡摩擦,手法缓慢,轻柔,直至皮肤出现小红点,通过皮肤给药促进吸收以达到内病外治效果。
取穴膀胱经:肝俞穴、胆俞穴、脾俞穴、胃俞穴、三焦俞穴、肾俞穴、盲门穴、志室穴。
隔天一次,10天一个疗程,连续治疗一个疗程后患者前来复诊,病人自述头晕症状消失,夜间潮热的症状得到很大的缓解,现场测量血压(130/80mmHg)为正常指标。再次用红外热像仪(舱体式)靶向定位,如图2B所示,其中,图2B中a为患者正面,b为患者侧面,c和d为患者背面。从图2B可以看出,患者背侧肾冷区已经明显缩小,肾冷区颜色由蓝黑色转为黄绿色且趋于均匀,已经接近正常体温,提示提示肾阳虚,心肾不交均有改善。
实施例3
患者冯某某,女,年龄:54,诊疗时间:2021.12.29,中医辨证诊断:心肾不交,西医诊断:高血压(140/95mmHg)、动脉硬化,病人主诉:头晕、失眠。
热成像参数:红外温宽:9.6,舱内温度:26℃
诊疗过程:患者于2021年12月29日来诊自述头晕失眠多年,现场测量血压(140/95mmHg)属于高血压,用红外热成像靶向定位,如图3A所示,其中,图3A中a为患者正面,b和c分别为患者两侧面,d为患者背面。从图3A可以看出,患者背侧有两处明显蓝黑色肾冷区,四肢厥冷,提示肾阳衰微。
选用复方仙方活命饮纳米混悬凝胶剂,取穴涂抹混悬凝胶剂,并使用砭石温灸仪加热振荡摩擦,手法缓慢,轻柔,直至皮肤出现小红点,通过皮肤给药促进吸收以达到内病外治效果。
取穴膀胱经:胃俞穴、三焦俞穴、肾俞穴、气海俞穴、大肠俞穴、魂门穴;督脉:灵台穴-命门穴。
隔天一次,10天一个疗程,连续治疗一个疗程后患者前来复诊,病人自述头晕症状消失,失眠得到了很好的改善。现场测量血压(130/85mmHg),再次用红外热像仪(舱体式)靶向定位,如图3B所示,其中,图3B中a为患者正面,b和c分别为患者两侧面,d为患者背面。从图3B可以看出,患者背部与四肢温度升高,背侧肾冷区明显缩小,肾冷区颜色由蓝黑色转为黄绿色且部分出现红色,已经非常接近正常体温,提示肾阳衰微有明显改善。
实施例4
患者陈某某,男,年龄:47,诊疗时间:2022.2.2,中医辨证诊断:肝肾阴虚、肝阳上亢,西医诊断:高血糖(空腹8.7mmol/L)、高尿酸(血尿酸562umol/L),病人主诉:足痛,下肢无力。
热成像参数:红外温宽:9.6,舱内温度:26℃
诊疗过程:患者于2022年2月2日来诊自述足痛,下肢无力,医院检查提示高血糖高尿酸。用红外热成像靶向定位,如图4A所示,其中,图4A中a为患者正面,b和c分别为患者两侧面,d为患者背面。从图4A可以看出,患者背侧有明显蓝黑色的一大一小两处肾冷区且左侧尤甚,提示肝肾阴虚、肝阳上亢。
选用复方仙方活命饮纳米混悬凝胶剂,取穴涂抹混悬凝胶剂,并使用砭石温灸仪加热振荡摩擦,手法缓慢,轻柔,直至皮肤出现小红点,通过皮肤给药促进吸收以达到内病外治效果。
取穴膀胱经:膈俞穴、肝俞穴、胆俞穴、胃俞穴、三焦俞穴、肾俞穴、气海俞穴、膏肓穴、神堂穴、盲门穴、志室穴。督脉:灵台穴-命门穴。
隔天一次,10天一个疗程,连续治疗三个疗程后患者前来复诊,病人自述足痛症状消失,下肢无力的症状有所缓解。高血糖得到控制(空腹6.2mmol/L),高尿酸(血尿酸380umol/L),再次用红外热像仪(舱体式)靶向定位,如图4B所示,其中,图4B中a为患者正面,b和c分别为患者两侧面,d为患者背面。从图4B可以看出,患者背侧肾冷区已经缩小且左右肾区温度趋于平衡,颜色由蓝黑色转为黄绿色兼有小部分蓝色,已经接近正常体温,提示肝肾阴虚、肝阳上亢均有改善。
实施例5
患者陈某某,男,年龄:47,诊疗时间:2022.1.28,中医辨证诊断:肾阴阳两虚兼阳明腑实,西医诊断:甘油三酯(3.51mmol/L)、高尿酸(600umol/L)、前列腺增生,病人主诉:头晕、便秘。
热成像参数:红外温宽:9.6,舱内温度:26℃
诊疗过程:患者于2022年1月28日来诊,自述头晕,长年便秘,医院检查提示高血脂高尿酸异常,甘油三酯(3.51mmol/L)、高尿酸(600umol/L)、前列腺增生,用红外热成像靶向定位,如图5A所示,其中,图5A中a为患者正面,b和c分别为患者两侧面,d为患者背面。从图5A可以看出,患者背侧有两处明显蓝黑色的芭蕉叶状肾冷区,提示肾气虚。
选用复方仙方活命饮纳米混悬凝胶剂,取穴涂抹混悬凝胶剂,并使用砭石温灸仪加热振荡摩擦,手法缓慢,轻柔,直至皮肤出现小红点,通过皮肤给药促进吸收以达到内病外治效果。
取穴膀胱经:膈俞穴、肝俞穴、胆俞穴、胃俞穴、三焦俞穴、肾俞穴、膈关穴、魂门穴、阳纲穴、意舍穴、胃仓穴、盲门穴、志室穴;督脉:命门穴。
隔天一次,10天一个疗程,连续治疗三个疗程后,患者前来复诊,自诉头晕症状消失,甘油三酯症状恢复正常值(1.67mmol/L)、高尿酸(391umol/L)、前列腺增生得到有效缓解,无尿频尿急症状。再次用红外热像仪(舱体式)靶向定位,如图5B所示,其中,图5B中a为患者正面,b和c分别为患者两侧面,d为患者背面。从图5B可以看出,患者背侧芭蕉叶状肾冷区明显缩小,颜色由蓝黑色转为黄绿色兼有小部分淡蓝色,已经基本达到正常体温,提示提示肾阳虚改善。
从上述实施例可以看出,本发明提供的中药纳米级混悬凝胶剂,通过振荡刮痧方式进行皮肤给药,结合红外热成像图谱的热量分布和色差定位给药位置,内病外治和皮肤给药,它具有促进肝脏排毒功能,减轻胃肠和肾脏负担,降低药物毒性反应、减少副作用等。根据红外热成像图谱,辨别出人体十二经脉、脏腑、阴阳、虚实、表里关系,并作出证向、靶向、靶点、靶穴的诊断,通过皮肤给药从而达到内病外治的有效措施。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对本发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (4)
1.一种复方中药的纳米级中药外用混悬凝胶剂的制备方法,其特征在于,包括如下步骤:
1)将复方中药去除杂质、清洗,然后采用二氧化碳超临界萃取,收集中药挥发油;
2)将步骤1)二氧化碳超临界萃取剩余的复方中药残渣进行烘干;
3)研磨粉碎:将步骤2)干燥后的复方中药残渣用行星式球磨机研磨至微粒小于100纳米,得到复方中药粉末;
4)按质量百分比将卡波姆940 0.5%-2%、泊洛沙姆0.1%-0.4%、大豆卵磷脂0-8%、丙二醇1%-6%、聚山梨酯80 0-0.8%、尼泊金乙酯0-0.01%混合,加少量蒸馏水水胀润;然后加入复方中药粉末0.3%-2.5%、中药挥发油0.3%-2.5%;再加20%三乙醇胺调pH5.5-6.5,最后加入蒸馏水定容至100%;
5)超声混合10-20分钟;
6)高剪切机剪切均质,剪切速率15000rpm,均质时间15min;
7)灌入瓶子密封成品包装。
2.如权利要求1所述的复方中药的纳米级中药外用混悬凝胶剂的制备方法,其特征在于,步骤1)所述二氧化碳超临界萃取的条件为:萃取温度30~70℃,压力14~42MPa,萃取时间1~5小时。
3.如权利要求1所述的复方中药的纳米级中药外用混悬凝胶剂的制备方法,其特征在于,步骤2)所述烘干条件为:40-80℃烘干1-2小时。
4.一种如权利要求1-3任一项所述的制备方法制备的复方中药的纳米级中药外用混悬凝胶剂。
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