CN109954038A - 一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片及其制备工艺 - Google Patents

一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片及其制备工艺 Download PDF

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CN109954038A
CN109954038A CN201910377744.8A CN201910377744A CN109954038A CN 109954038 A CN109954038 A CN 109954038A CN 201910377744 A CN201910377744 A CN 201910377744A CN 109954038 A CN109954038 A CN 109954038A
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radix
treating
treatment
chinese medicine
rheumatic ostealgia
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朴永南
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Liaoning Blue Dolphin Medical Technology Co Ltd
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Liaoning Blue Dolphin Medical Technology Co Ltd
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Abstract

本发明涉及治疗风湿骨痛的技术领域，特别是涉及一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片及其制备工艺，其临床应用效果好，成本低，制作方便，易于推广；包括以下原料：红花、三七、鹿茸、肉桂、小茴香、五味子、牛膝、当归、川芎、骨碎补、淫羊藿、蛇床子、续断、杜仲、附子、鸡血藤、甘草、白芷、补骨脂、肉苁蓉、忍冬藤、青风藤、独活、羌活、艾叶、黄芪和鹿血；其制备工艺，包括以下步骤：S1、回流提取有效成分；S2、煎煮提取有效成分；S3、减压浓缩处理；S4、鹿血处理；S5、混合处理；本发明配方独特，提取工艺科学合理，得到的铁片具有良好的透皮率，使得药物在病灶有一个高效的作用浓度，保证了更明显的临床效果。

Description

一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片及其制 备工艺
技术领域
本发明涉及治疗风湿骨痛的技术领域，特别是涉及一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片及其制备工艺。
背景技术
风湿骨痛病是风寒湿邪侵入人体所致，风寒湿邪侵入人体后，导致筋脉阻塞不通，“不通则痛”，由此常引起人体关节、骨膜、肌肉等部位红肿疼痛，风湿骨痛是骨科疼痛范围疾病的统称，以骨质病理性增生变形、炎症或关节磨损导致局部关节、肌肉、韧带活动障碍，伴发疼痛为主要症状的疾病。可发生在颈椎、腰椎、关节及跟骨等处，包括关节炎、滑膜炎、腱鞘炎，颈椎病，腰椎病等。本病好发于40岁以上的中老年及从事承重、久站、久坐，以及在潮湿寒冷地方工作及睡眠的工作人员。以活动范围较大的关节、脊椎的病变多见。风湿骨痛的病因迄今未明，多归属风寒湿邪范畴，关于其病因说法很多，如机械说、机能说、血管障碍、新陈代谢障碍、内分泌障碍等。基本认识是在内因基础上，由外因的诱发而导致发病。目前西医采用非激素类消炎止痛药物、理疗及手术治疗，对缓解症状有一定效果，但迄今尚无特别有效的治疗方法。
风湿骨痛从其病理而论可归属于中医“骨痹”范畴。在《黄帝内经》中已有“骨痹”的病名，指出其临床以“骨重不可举，骨髓酸痛”为主症，病机则有“肾不生则髓不能满”及“寒气至”的内因及诱因，嗣后在《中藏经》、《景岳全书》、《医碥》中都有相关的病因病机论述。
近代中医学认为肾虚是本病内在病机，肝肾亏虚，气滞血瘀，外因则主要为风寒湿邪之侵淫，及外伤劳损。肝主筋，肾主骨，骨之强壮，筋之轻灵，均有赖肝血肾精的濡润，故肝肾充盈，则筋骨强劲，关节滑利，运动灵活。待步入中年之后，肝血肾精渐亏，致使筋骨失养，外邪诱因乘虚而入，致使酿疾。诚如《中藏经》曰：“骨痹者，精气日衰，邪气妄入。”气滞血瘀却是其内蕴之实质病理，其临床症状的引发，多因骨关节病变引起周围软组织炎症、肿胀、纤维化或疤痕化，并有局部肌肉痉挛，致使该处血运障碍，瘀血阻络，出现明显的疼痛症状。而某些由于闪扭外伤为诱因者，更是局部气滞血瘀，经络损伤，血行不畅之因素所导致。寒湿痹阻、风寒湿邪之入侵，常是诱发本病的外在因素，这是在肾虚的基础上，邪气乘虚而人。本病多见于劳伤或久站、久坐者，皆由于久站伤肉、久坐伤骨、久劳伤肾之故，外邪侵淫而致伤骨。
超声透皮靶向给药技术最早在美国广泛临床应用，2008年进入中国，由于能实现局部靶向给药，在减少用药量的同时，使得药物在病灶部位浓度集中，明显的提高了临床治疗效果；并且由于用药量减少，而且药物直接作用于病灶，不经过全身循环，避免了药物对胃肠道，血管、肝肾的伤害，从而大大降低了药物的不良反应。超声透皮给药，操作简单，无创面无痛苦，安全有效，开启了临床治疗的绿色新通道，在医院很快给医生患者认可。2009年正式列为国家医保收费；现也有采用超声透皮靶向给药的方式治疗患者的风湿骨痛，但是其治疗效果较差，并且成本较高，制作步骤繁琐，不利于有效推广。
发明内容
为解决上述技术问题，本发明提供一种临床应用效果好，成本低，制作方便，易于推广的用于治疗风湿骨痛的中药超声靶向给药耦合贴片及其制备工艺。
本发明的一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片，包括以下原料：红花、三七、鹿茸、肉桂、小茴香、五味子、牛膝、当归、川芎、骨碎补、淫羊藿、蛇床子、续断、杜仲、附子、鸡血藤、甘草、白芷、补骨脂、肉苁蓉、忍冬藤、青风藤、独活、羌活、艾叶、黄芪和鹿血。
具体的，所述一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片，包括以下重量的原料：红花30～100g；三七30～90g；鹿茸4～17g；肉桂7～54g；小茴香25～80g；五味子20～85g；牛膝45～130g；当归70～185g；川芎15～90g；骨碎补60～140g；淫羊藿30～95g；蛇床子55～160g；续断70～140g；杜仲25～95g；附子80～170g；鸡血藤85～170g；甘草40～105g；白芷60～130g；补骨脂55～130g；肉苁蓉30～100g；忍冬藤120～210g；青风藤50～130g；独活40～100g；羌活30～100g；艾叶20～90g；黄芪115～190g；鹿血8～36g。
进一步的，所述一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片，还包括促渗剂，所述促渗剂为丙二醇、氮酮和薄荷油的组合物。
进一步的，所述促渗剂中各组分的重量比为：3％～8％的丙二醇、2％～7％的氮酮和0.2％～1.0％的薄荷油。
本发明的一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片的制备工艺，包括以下步骤：
S1、回流提取有效成分：将三七、鹿茸和肉桂打成粗粉，与红花、小茴香和五味子混合均匀，并向其中加入总重量6～12倍量的回流提取液，浸泡50min～2.5h，在50℃～100℃下回流提取40min～2.5h，过滤；再向过滤出的滤渣中加入6～12倍量的回流提取液，继续回流提取30min～2h，合并滤液后称重备用，滤渣分离备用；
S2、煎煮提取有效成分：将当归、川芎、骨碎补、淫羊藿、蛇床子、续断、杜仲、附子、鸡血藤、甘草、白芷、补骨脂、牛膝、肉苁蓉、忍冬藤、青风藤、独活、羌活、艾叶和黄芪混合，并向其中加入总重量7～15倍的水，浸泡50min～3h，并加入S1中剩余的滤渣，加热至沸腾，持续30min～3h，过滤，再向滤渣中加入总重量6～15倍的水，加热至沸腾，持续30min～2.5h，过滤，将两次过滤得到的滤液合并；
S3、减压浓缩处理：将S2中得到的合并滤液在60℃～90℃下进行减压浓缩，浓缩至原体积的1/7～1/4，得到浓缩液；
S4、鹿血处理：采集配方量的新鲜鹿血，并向其中加入抗凝剂，在2000～5000r/min的转速下离心处理10～40min，取上清液，冷冻备用；
S5、混合处理：将S1得到的合并滤液和S3得到的浓缩液按照1：1的比例混合均匀，再加入S4中得到的上清液，最后加入3％～8％的丙二醇、2％～7％的氮酮和0.2％～1.0％的薄荷油，搅拌均匀即可，得到最终药液。
进一步的，所述S1中的回流提取液为70％的乙醇溶液。
进一步的，所述S3中的减压浓缩条件为：真空度为-0.09Mpa～-0.06Mpa。
进一步的，将贴片浸入到S5中得到的最终药液中，浸透后捞起，使用离心机进行离心处理10～100s，转速为100～500r/min，使得每个贴片上的载药量为2.5g±0.2g。
与现有技术相比本发明的用于治疗风湿骨痛的中药超声靶向给药耦合贴片具有以下有益效果：
第一、本发明的用于治疗风湿骨痛的中药超声靶向给药耦合贴片配方独特：方中采用红花、三七、当归、川芎、黄芪、鸡血藤补肝益气、活血止痛，通经活络；鹿茸、淫羊藿、杜仲、肉桂、附子、五味子、肉苁蓉、骨碎补、补骨脂、续断、牛膝、鹿血温补肾阳，强筋健骨；独活、羌活、白芷、小茴香、忍冬藤、蛇床子、艾叶、青风藤祛风散寒，行气燥湿；甘草调和诸药；
第二、本发明的用于治疗风湿骨痛的中药超声靶向给药耦合贴片提取工艺科学合理，针对各味药的功效成分，进行分别提取，三七、鹿茸、肉桂、红花、小茴香、五味子采用乙醇回流提取；回流提取剩余的药渣和当归、川芎、骨碎补、淫羊藿、蛇床子、续断、杜仲、附子、鸡血藤、甘草、白芷、补骨脂、牛膝、肉苁蓉、忍冬藤、青风藤、独活、羌活、艾叶、黄芪一起进行煎煮提取；将鹿血抗凝处理之后，离心提取，以保证血液中的酶、激素、氨基酸等微量元素不受破坏，完全保留在上清液中，并除去血红蛋白血小板等不适合透皮吸收的大分子，即参考了传统中医的熬制原则，又采用了现在医药技术提取纯化，以保证药物的充分利用，减少杂质的干扰；
第三、本发明的用于治疗风湿骨痛的中药超声靶向给药耦合贴片中加入了由丙二醇、氮酮和薄荷油组成的促渗剂，由于促渗剂的组合利用，让药物透皮率增加数倍至数百倍，使得药物在病灶有一个高效的作用浓度，保证了更明显的临床效果。
具体实施方式
下面结合实施例，对本发明的具体实施方式作进一步详细描述。以下实施例用于说明本发明，但不用来限制本发明的范围。
实施例
回流提取有效成分：将30～90g三七、4～17g鹿茸和7～54g肉桂打成粗粉，与30～100g红花、25～80g小茴香和20～85g五味子混合均匀，并向其中加入总重量6～12倍量的70％的乙醇溶液，浸泡50min～2.5h，在50℃～100℃下回流提取40min～2.5h，过滤；再向过滤出的滤渣中加入6～12倍量的70％的乙醇溶液，继续回流提取30min～2h，合并滤液后称重备用，滤渣分离备用；
煎煮提取有效成分：将70～185g当归、15～90g川芎、60～140g骨碎补、30～95g淫羊藿、55～160g蛇床子、70～140g续断、25～95g杜仲、80～170g附子、85～170g鸡血藤、40～105g甘草、60～130g白芷、55～130g补骨脂、45～130g牛膝、30～100g肉苁蓉、120～210g忍冬藤、50～130g青风藤、40～100g独活、30～100g羌活、20～90g艾叶和115～190g黄芪混合，并向其中加入总重量7～15倍的水，浸泡50min～3h，并加入S1中剩余的滤渣，加热至沸腾，持续30min～3h，过滤，再向滤渣中加入总重量6～15倍的水，加热至沸腾，持续30min～2.5h，过滤，将两次过滤得到的滤液合并；
减压浓缩处理：将S2中得到的合并滤液在60℃～90℃下进行减压浓缩，真空度为-0.09Mpa～-0.06Mpa，浓缩至原体积的1/7～1/4，得到浓缩液；
鹿血处理：采集8～36g的新鲜鹿血，并向其中加入抗凝剂，在2000～5000r/min的转速下离心处理10～40min，取上清液，冷冻备用；
混合处理：将S1得到的合并滤液和S3得到的浓缩液按照1：1的比例混合均匀，再加入S4中得到的上清液，最后加入3％～8％的丙二醇、2％～7％的氮酮和0.2％～1.0％的薄荷油进行促渗，搅拌均匀即可，得到最终药液。
将贴片浸入到S5中得到的最终药液中，浸透后捞起，使用离心机进行离心处理10～100s，转速为100～500r/min，使得每个贴片上的载药量为2.5g±0.2g。
使用本发明的用于治疗风湿骨痛的中药超声靶向给药耦合贴片对各类风湿骨病患者进行治疗效果研究：
将2018年2月至2018年8月之间的87例风湿骨痛病人进行超声药物靶向治疗。87例病人中，男39例，女48例，年龄27岁～64岁，平均47岁。其中滑膜炎28例(包括胳膊、腿关节滑膜炎)，肩周炎12例，颈椎病25例，腰疼病19例，其他3例(网球肘1例、运动拉伤2例)。所有病人均每天超声靶向药物治疗2次，每次30min，两次治疗间隔时间不少于8h。部分患者效果良好，五天停止治疗，所有患者治疗十天后全部停止。治疗情况统计如下表：
综合上述数据，可以得到以下结论，采用本发明的用于治疗风湿骨痛的中药超声靶向给药耦合贴片对患者进行中药超声靶向渗透治疗，使药物直达病所，简单易行，效果明显，同时减少了药物对人体内的毒副作用，做到了中医中药“避其短而扬其长”的用药宗旨。
所以，治疗风湿骨痛，以补肾为基础，从根本上去除风湿骨痛的病因。本发明的用于治疗风湿骨痛的中药超声靶向给药耦合贴片本着培元固本、扶正祛邪、以通为用的原则，方中诸药补益肝阴、温补脾肾，养血行气、祛风散寒、除湿蠲痹、活血止痛、舒经活络，对风湿骨痛可标本兼治。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明技术原理的前提下，还可以做出若干改进和变型，这些改进和变型也应视为本发明的保护范围。

Claims (8)

1.一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片，其特征在于，包括以下原料：
红花、三七、鹿茸、肉桂、小茴香、五味子、牛膝、当归、川芎、骨碎补、淫羊藿、蛇床子、续断、杜仲、附子、鸡血藤、甘草、白芷、补骨脂、肉苁蓉、忍冬藤、青风藤、独活、羌活、艾叶、黄芪和鹿血。
2.如权利要求1所述的一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片，其特征在于，包括以下重量的原料：
红花30～100g；三七30～90g；鹿茸4～17g；肉桂7～54g；小茴香25～80g；五味子20～85g；牛膝45～130g；当归70～185g；川芎15～90g；骨碎补60～140g；淫羊藿30～95g；蛇床子55～160g；续断70～140g；杜仲25～95g；附子80～170g；鸡血藤85～170g；甘草40～105g；白芷60～130g；补骨脂55～130g；肉苁蓉30～100g；忍冬藤120～210g；青风藤50～130g；独活40～100g；羌活30～100g；艾叶20～90g；黄芪115～190g；鹿血8～36g。
3.如权利要求1所述的一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片，其特征在于，还包括促渗剂，所述促渗剂为丙二醇、氮酮和薄荷油的组合物。
4.如权利要求3所述的一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片，其特征在于，所述促渗剂中各组分的重量比为：3％～8％的丙二醇、2％～7％的氮酮和0.2％～1.0％的薄荷油。
5.一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片的制备工艺，其特征在于，包括以下步骤：
S1、回流提取有效成分：将三七、鹿茸和肉桂打成粗粉，与红花、小茴香和五味子混合均匀，并向其中加入总重量6～12倍量的回流提取液，浸泡50min～2.5h，在50℃～100℃下回流提取40min～2.5h，过滤；再向过滤出的滤渣中加入6～12倍量的回流提取液，继续回流提取30min～2h，合并滤液后称重备用，滤渣分离备用；
S2、煎煮提取有效成分：将当归、川芎、骨碎补、淫羊藿、蛇床子、续断、杜仲、附子、鸡血藤、甘草、白芷、补骨脂、牛膝、肉苁蓉、忍冬藤、青风藤、独活、羌活、艾叶和黄芪混合，并向其中加入总重量7～15倍的水，浸泡50min～3h，并加入S1中剩余的滤渣，加热至沸腾，持续30min～3h，过滤，再向滤渣中加入总重量6～15倍的水，加热至沸腾，持续30min～2.5h，过滤，将两次过滤得到的滤液合并；
S3、减压浓缩处理：将S2中得到的合并滤液在60℃～90℃下进行减压浓缩，浓缩至原体积的1/7～1/4，得到浓缩液；
S4、鹿血处理：采集配方量的新鲜鹿血，并向其中加入抗凝剂，在2000～5000r/min的转速下离心处理10～40min，取上清液，冷冻备用；
S5、混合处理：将S1得到的合并滤液和S3得到的浓缩液按照1：1的比例混合均匀，再加入S4中得到的上清液，最后加入3％～8％的丙二醇、2％～7％的氮酮和0.2％～1.0％的薄荷油，搅拌均匀即可，得到最终药液。
6.如权利要求5所述的一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片的制备工艺，其特征在于，所述S1中的回流提取液为70％的乙醇溶液。
7.如权利要求5所述的一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片的制备工艺，其特征在于，所述S3中的减压浓缩条件为：真空度为-0.09Mpa～-0.06Mpa。
8.如权利要求5所述的一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片的制备工艺，其特征在于，还包括以下步骤：
将贴片浸入到S5中得到的最终药液中，浸透后捞起，使用离心机进行离心处理10～100s，转速为100～500r/min，使得每个贴片上的载药量为2.5g±0.2g。
CN201910377744.8A 2019-04-30 2019-04-30 一种用于治疗风湿骨痛的中药超声靶向给药耦合贴片及其制备工艺 Pending CN109954038A (zh)

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