CN108273002A - 一种治疗骨关节炎的透皮软膏 - Google Patents
一种治疗骨关节炎的透皮软膏 Download PDFInfo
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Abstract
本发明公开了一种治疗骨关节炎的透皮软膏,包括中草药提取干膏、樟脑、冰片、桉叶油、液体石蜡、甘油、氮酮和凡士林;所述中草药提取干膏包括以下重量份数的各中草药:炙甘草20份、全当归20份、制附子30份、炒白芍20份、白术30份、姜黄10份、桂枝40份。本发明的治疗骨关节炎的透皮软膏可长时间紧贴粘附和铺展于皮肤表面,透过表皮到达表皮下组织起局部的治疗作用,提高患者的用药依用性,治愈率高。
Description
技术领域
本发明涉及中草药技术领域,尤其是一种治疗骨关节炎的透皮软膏。
背景技术
骨关节炎是临床上一种常见的慢性骨关节退行性疾病,其中发生于膝关节的骨关节炎因严重疼痛和功能障碍而备受关注。临床流行病学研究提示,在超过55岁的人群中,膝关节在放射学上有骨关节改变者约有68%。随着我国社会老龄化的加剧,这一发病率可能会进一步升高。患有这种疾病需长时间用药,而且大多数患者都难以根治。
目前药物治疗骨关节炎的方法主要有口服药物和外用传统膏药、贴膏剂及凝胶剂。长期口服药物不但对胃黏膜有一定的刺激,还会引起肠道菌群失调,使免疫功能降低,而出现胃黏膜炎症、肠道功能紊乱、药物吸收不全、影响药物的疗效,或容易引起肠胃不适的状况,降低患者的依从性。外用传统膏药、贴膏剂和凝胶剂长时间的覆盖在皮肤的表面,不但影响皮肤的呼吸,还会出现接触性皮炎,患者的依从性低。
发明内容
本发明的目的在于提供一种治疗骨关节炎的透皮软膏。
为实现上述目的,本发明采用以下内容:
一种治疗骨关节炎的透皮软膏,包括中草药提取干膏、樟脑、冰片、桉叶油、液体石蜡、甘油、氮酮和凡士林;所述中草药提取干膏包括以下重量份数的各中草药:炙甘草20份、全当归20份、制附子30份、炒白芍20份、白术30份、姜黄10份、桂枝40份。
进一步地,所述透皮软膏,每500克中,包括中草药提取干膏、樟脑10克、冰片10克、桉叶油5mL、液体石蜡20克、甘油100克、氮酮10mL和其余量为凡士林;所述中草药提取干膏包括各中草药:炙甘草20克、全当归20克、制附子30克、炒白芍20克、白术30克、姜黄10克、桂枝40克。
进一步地,所述透皮软膏是将中草药提取干膏溶解在甘油中,之后与樟脑、冰片、桉叶油、液体石蜡、氮酮、凡士林在60℃混合得到。
进一步地,所述中草药提取干膏的制备,包括将浸泡后的制附子煎煮一段时间;向其中加入浸泡后的炙甘草、白术、全当归、炒白芍,煎煮一段时间;向其中加入浸泡后的桂枝、姜黄,煎煮一段时间,倒出一次煎取液;再加水煎煮一段时间,倒出二次煎取液;合并一次煎取液和二次煎取液,用乙醇醇沉,取上清液,浓缩,烘干,制成中草药提取干膏。
进一步地,所述中草药提取干膏的制备,包括以下步骤:
1)在容器中加入800mL水,浸泡制附子20分钟,煎煮1小时;
2)把浸泡20分钟后的炙甘草、白术、全当归、炒白芍放进容器内,煎煮30分钟;
3)把浸泡20分钟的桂枝、姜黄放进锅,再一起煎煮10分钟,倒出一次煎取液;
4)向容器中加600mL水,煎煮30分钟,倒出二次煎取液;
5)合并一次煎取液和二次煎取液,用50%乙醇醇沉24小时;
6)取上清液,浓缩为稠膏,烘干,制成干膏,用空气能粉碎机粉碎后备用。
本发明具有以下优点:
本发明的治疗骨关节炎的透皮软膏可长时间紧贴粘附和铺展于皮肤表面,透过表皮到达表皮下组织起局部的治疗作用,提高患者的用药依用性,治愈率高。
具体实施方式
为了更清楚地说明本发明,下面结合优选实施例对本发明做进一步的说明。本领域技术人员应当理解,下面所具体描述的内容是说明性的而非限制性的,不应以此限制本发明的保护范围。
实施例
一种治疗骨关节炎的透皮软膏,共500克,先提取中草药提取干膏,包括以下步骤:
1)在容器中加入800mL水,浸泡30克制附子20分钟,煎煮1小时;
2)把浸泡20分钟后的20克炙甘草、30克白术、20克全当归、20克炒白芍放进容器内,煎煮30分钟;
3)把浸泡20分钟的40克桂枝、10克姜黄放进锅,再一起煎煮10分钟,倒出一次煎取液;
4)向容器中加600mL水,煎煮30分钟,倒出二次煎取液;
5)合并一次煎取液和二次煎取液,用50%乙醇醇沉24小时;
6)取上清液,浓缩为稠膏,烘干,制成干膏,用空气能粉碎机粉碎后备用。
之后,将中草药提取干膏溶解在100克甘油中,之后与10克樟脑、10克冰片、5mL桉叶油、20克液体石蜡、10mL氮酮、其余量的凡士林在60℃混合得到透皮软膏。
本申请的透皮软膏的各组分是通过一系列筛选实验来确定的。筛选透皮制剂中的组分举例:
透皮制剂基质中的凡士林、液体石蜡与羊毛脂的使用比例是影响患者使用时的舒适度的重要因素,通过单因素考查,优选出安全经济的使用比例。透皮制剂的透皮性是药物起效的关键所在,故透皮渗透剂的种类选择是影响制剂疗效的关键问题,通过单因素考查,筛选出安全经济的透皮渗透剂,再用询问总结法进行考查,根据透皮与多种肤质接触的感知确定合适的透皮渗透剂用量。
选择50名志愿者,尝试在皮肤表面涂膏,记录各自感受。
表1一次筛选实验
方案 | 感受汇总(人数) |
方案1a:液体石蜡2%,羊毛脂0,氮酮1% | 舒服(48),清爽(46),清凉感稍弱(44) |
方案1b:液体石蜡2%,羊毛脂0,氮酮2% | 舒眼(45),清爽(47),清凉感强(44) |
方案1c:液体石蜡2%,羊毛脂0,氮酮3% | 舒服(44),清爽(38),清凉感强(45) |
方案1d:液体石蜡2%,羊毛脂5%,氮酮1% | 舒服(37),有点油(27),清凉感稍弱(47) |
方案1e:液体石蜡2%,羊毛脂5%,氮酮2% | 舒服(34),有点油(29),清凉感强(42) |
方案1f:液体石蜡2%,羊毛脂5%,氮酮3% | 舒眼(39),有点油(28),清凉感强(44) |
方案1g:液体石蜡2%,羊毛脂10%,氮酮1% | 舒服(31),油腻(34),清凉感稍弱(49) |
方案1h:液体石蜡2%,羊毛脂10%,氮酮2% | 舒服(28),油腻(37),清凉感强(25) |
方案1i:液体石蜡2%,羊毛脂10%,氮酮3% | 舒服(24),油腻(38),清凉感强(30) |
方案1j:液体石蜡2%,羊毛脂15%,氮酮1% | 舒服(19),很油腻(50),清凉感稍弱(50) |
方案1k:液体石蜡2%,羊毛脂15%,氮酮2% | 舒服(17),很油腻(50),清凉感强(6) |
方案1l:液体石蜡2%,羊毛脂15%,氮酮3% | 舒服(14),很油腻(50),清凉感强(10) |
在表1完成后,重新选择50名志愿者,尝试在皮肤表面涂膏,记录各自感受,结果如下表2中所示。
表2二次筛选实验
方案 | 感受汇总(人数) |
方案2a:液体石蜡3%,羊毛脂0,氮酮2% | 舒服(47),清爽(48),清凉感强(46) |
方案2b:液体石蜡3%,羊毛脂0,氮酮3% | 舒服(45),有点滑(48),清凉感强(48) |
方案2c:液体石蜡3%,羊毛脂5%,氮酮2% | 舒服(38),有点滑(32),有点油(40),清凉感强(42) |
方案2d:液体石蜡3%,羊毛脂5%,氮酮3% | 舒服(45),有点滑(40),有点油(37),清凉感强(44) |
方案3a:液体石蜡4%,羊毛脂0,氮酮2% | 舒服(38),有点滑(43),清凉感强(40) |
方案3b:浓体石蜡4%,羊毛脂0,氮酮3% | 舒服(40),有点滑(46),清凉感强(42) |
方案3c:液体石蜡4%,羊毛脂5%,氮酮2% | 舒服(34),有点滑(47),有点油(48),清凉感强(30) |
方案3d:浓体石蜡4%,羊毛脂5%,氮酮3% | 舒服(30),有点滑(49),有点油(50),清凉感强(33) |
方案4a:液体石蜡5%,羊毛脂0,氮酮2% | 舒服(45),有点滑(49),清凉感强(44) |
方案4b:液体石蜡5%,羊毛脂0,氮酮3% | 舒服(23),有点滑(50)清凉感强(46) |
方案4c:液体石蜡5%,羊毛脂5%,氟酮2% | 舒服(20),有点滑(50),有点油(50),清凉感强(15) |
方案4d:液体石蜡5%,羊毛脂5%,氮酮3% | 舒服(18),有点滑(50),有点油(50),清凉感强(18) |
从上表可看出,氮酮1%时渗透不足,2%和3%没有很大差别,从经济效益出发,选择2%;液体石蜡2%和3%没有很大差别,从经济效益出发,选择2%;不使用羊毛脂时效果更好。
应用实例
附子为君药,虽然经过炮制毒性大减,但是口服给药还是有一定的危险性。本申请的透皮软膏作为外用制剂,降低了口服药物中毒的危险,又可以直接作用于疾病部位,透过表皮到达表皮下组织起到治疗作用,从而提高患者的用药依从性;使用方便,可以随时随地的涂抹,根据患者的病情增减涂抹的次数和药量。应用结果见表3中。
表3使用本申请的透皮软膏的治愈情况
从上表可知,本申请的透皮软膏用于腰膝痹痛、痛风等等中的治疗效果都良好。
显然,本发明的上述实施例仅仅是为清楚地说明本发明所作的举例,而并非是对本发明的实施方式的限定,对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动,这里无法对所有的实施方式予以穷举,凡是属于本发明的技术方案所引伸出的显而易见的变化或变动仍处于本发明的保护范围之列。
Claims (5)
1.一种治疗骨关节炎的透皮软膏,其特征在于,包括中草药提取干膏、樟脑、冰片、桉叶油、液体石蜡、甘油、氮酮和凡士林;所述中草药提取干膏包括以下重量份数的各中草药:炙甘草20份、全当归20份、制附子30份、炒白芍20份、白术30份、姜黄10份、桂枝40份。
2.根据权利要求1所述的一种治疗骨关节炎的透皮软膏,其特征在于,所述透皮软膏,每500克中,包括中草药提取干膏、樟脑10克、冰片10克、桉叶油5mL、液体石蜡20克、甘油100克、氮酮10mL和其余量为凡士林;所述中草药提取干膏包括各中草药:炙甘草20克、全当归20克、制附子30克、炒白芍20克、白术30克、姜黄10克、桂枝40克。
3.根据权利要求1或2所述的一种治疗骨关节炎的透皮软膏,其特征在于,所述透皮软膏是将中草药提取干膏溶解在甘油中,之后与樟脑、冰片、桉叶油、液体石蜡、氮酮、凡士林在60℃混合得到。
4.根据权利要求1所述的一种治疗骨关节炎的透皮软膏,其特征在于,所述中草药提取干膏的制备,包括将浸泡后的制附子煎煮一段时间;向其中加入浸泡后的炙甘草、白术、全当归、炒白芍,煎煮一段时间;向其中加入浸泡后的桂枝、姜黄,煎煮一段时间,倒出一次煎取液;再加水煎煮一段时间,倒出二次煎取液;合并一次煎取液和二次煎取液,用乙醇醇沉,取上清液,浓缩,烘干,制成中草药提取干膏。
5.根据权利要求4所述的一种治疗骨关节炎的透皮软膏,其特征在于,所述中草药提取干膏的制备,包括以下步骤:
1)在容器中加入800mL水,浸泡制附子20分钟,煎煮1小时;
2)把浸泡20分钟后的炙甘草、白术、全当归、炒白芍放进容器内,煎煮30分钟;
3)把浸泡20分钟的桂枝、姜黄放进锅,再一起煎煮10分钟,倒出一次煎取液;
4)向容器中加600mL水,煎煮30分钟,倒出二次煎取液;
5)合并一次煎取液和二次煎取液,用50%乙醇醇沉24小时;
6)取上清液,浓缩为稠膏,烘干,制成干膏,用空气能粉碎机粉碎后备用。
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