CN108938759A - 一种治疗手足综合征的药物或者日化用品组合物及其制备方法和用途 - Google Patents
一种治疗手足综合征的药物或者日化用品组合物及其制备方法和用途 Download PDFInfo
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Abstract
本发明公开了一种治疗手足综合征的药物或者日化用品组合物,它是由包括如下重量配比的原料药制备而成的制剂:藁本5~30份、淫羊藿5~30份、桂枝10~40份、川牛膝5~30份、鸡血藤5~30份、赤芍5~30份、三七5~30份、紫草5~30份。本发明药物或者日化用品组合物可有效治疗手足综合征,应用前景良好。
Description
技术领域
本发明涉及一种治疗手足综合征的药物或者日化用品组合物及其制备方法和用途。
背景技术
国家癌症中心2015年发布数据表明,我国每年新确诊恶性肿瘤患者大约有350万,年均发生率约为264.85/10万。化疗和靶向治疗是恶性肿瘤治疗的常用有效手段,但化疗药物或生物靶向药物常引起一类周围神经毒性反应,即手足综合征(hand-foot syndrome,HFS),又称为掌跖红斑综合征或布格道夫反应。据统计,化疗药物所致HFS发病率高达45%~68%,生物靶向药物所致HFS发病率为10%~62%,HFS患者人群巨大,可表现为手足部皮肤出现红斑、水肿、水疱、脓疱、色素沉着、皮肤皲裂等皮肤损害,严重者还可出现指(趾)甲脱落、局部溃烂等表现,并伴有疼痛、麻木感等自觉症状的一系列症状,患者可因剧烈疼痛而无法行走,严重者可丧失部分生活处理能力,不但影响患者的生存质量及继续治疗,导致化疗或靶向治疗不能如期、按量进行,严重者还被迫中止治疗。因此,积极防治手足综合症具有重要的意义。
目前市场上并无针对性防治手足综合征的药品、化妆品或食品等成熟产品。针对手足综合征的治疗,西医常通过大剂量服用维生素B6,以及冰敷或擦抹皮质类固醇、湿润剂如尿素霜等。但是研究表明,这几种防治方式并不能达到良好的防治效果,症状严重要时必须降低化疗、靶向药物的剂量或停药,来缓解HFS的症状。
发明内容
本发明旨在提供一种有效治疗手足综合征的中药泡洗处方及以其提取物为主要原料制备外用产品的制备方法,对奥沙利铂、卡培他滨、阿帕替尼、替吉奥、力朴素、奈达铂、紫杉醇、舒尼替尼、索拉非尼、艾坦等化疗或靶向治疗药物引起的手足综合征,具有良好的预防和治疗效果。
本发明处方具有温经散寒、通络止痛的功效,经临床十余年的使用表明,其对患者手足部皮肤出现的红斑、水肿、水疱、脓疱、色素沉着、皮肤皲裂等皮肤损害,以及指(趾)甲脱落、局部溃烂等表现和疼痛、麻木感具有较好的临床疗效和安全性。
本发明提供了一种治疗手足综合征的药物或者日化用品组合物,它是由包括如下重量配比的原料药制备而成的制剂:
藁本5~30份、淫羊藿5~30份、桂枝10~40份、川牛膝5~30份、鸡血藤5~30份、赤芍5~30份、三七5~30份、紫草5~30份。
优选地,它还包括如下重量配比的原料药:
徐长卿5~30份、益母草5~30份、当归5~30份、乳香5~30份、没药5~30份松节5~30份、牡丹皮5~30份、黄芪5~30份、刺五加5~30份、薄荷2~10份、艾叶0.5~3份、地肤子0.5~3份、地黄0.5~3份、防风0.5~3份、大枣0.5~3份、灵芝0.5~3份、乌梅0.5~3份、冰片0.5~3份、白豆蔻0.5~3份。
进一步优选地,它是由包括如下重量配比的原料药制备而成的制剂:
藁本10份、淫羊藿20份、桂枝15份、川牛膝10份、徐长卿10份、益母草10份、鸡血藤10份、当归10份、赤芍15份、乳香10份、没药10份、三七10份、紫草10份、松节10份、牡丹皮10份、黄芪10份、刺五加10份、薄荷6份、艾叶1份、地肤子1份、地黄1份、防风1份、大枣1份、灵芝1份、乌梅1份、冰片1份、白豆蔻1份。
其中,它是由原料药的药粉、原料药的水或有机溶剂提取物为活性成分,加上药学上或者日化用品上常用的辅料或辅助性成分制备而成的制剂。
其中,所述制剂是外用制剂。其中,所述制剂为洗剂、搽剂、膏剂、贴剂、巴布剂、精华液、霜剂、贴膜剂。
本发明还提供了前述组合物的制备方法,其特征在于:
(1)按照前述配比称取原料药;
(2)制备原料药的药粉、原料药的水或有机溶剂提取物,加入药学上或者日化用品上常用的辅料或辅助性成分,即得。
本发明还提供了前述组合物在制备治疗手足综合征的药品日化用品中的用途。
其中,所述手足综合征是奥沙利铂、卡培他滨、阿帕替尼、替吉奥、力朴素、奈达铂、紫杉醇、舒尼替尼、索拉非尼、艾坦等化疗或靶向治疗药物引起的手足综合征。
其中,所述药物是治疗手足部的皮肤红斑、水肿、水疱、脓疱、色素沉着、皮肤皲裂、指甲脱落、溃烂疼痛、麻木的药物。
本发明药物组合物中,其中,藁本、淫羊藿、桂枝、川牛膝诸药合用可达到温经通络止痛的作用,为本方的君药。三七、鸡血藤、当归、乳香、没药、牡丹皮、赤芍、艾叶诸药合用达到活血通络止痛,加强君药的通络止痛之力,为本方的臣药。刺五加、松节、徐长卿、益母草、防风五药合用能达祛风除湿止痛的效果能再次增强君臣之药的止痛效果,为本方的佐药。紫草具有凉血、活血、清热、解毒作用,则防止上述诸药过燥同时又有活血之功在本方中起到反佐的作用,亦为佐药。地肤子、地黄清热利湿凉血,白豆蔻理气宽中燥寒湿,大枣、灵芝滋阴补阳、补血补气达扶正之功,诸药共为佐药。黄芪具有益气,托脓外达促进疮疡愈合的功效;乌梅收涩促进创面愈合,冰片、薄荷辛凉具有挥发性外用时能促进皮肤对上述诸药的吸收,诸药共为本方的使药。
本发药物组合物具有温经散寒、通络止痛的功效,经临床十余年的使用表明,其对患者手足部皮肤出现的红斑、水肿、水疱、脓疱、色素沉着、皮肤皲裂等皮肤损害,以及指(趾)甲脱落、局部溃烂等表现和疼痛、麻木感具有较好的临床疗效和安全性,为临床治疗手足综合征提供一种的选择,应用前景良好。
下面通过具体实施方式对本发明做进一步详细说明,但是并不是对本发明的限制,根据本发明的上述内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
附图说明
图1本发明药物治疗前后对比图
图2本发明药物治疗前后对比图
具体实施方式
实施例1 本发明组合物的制备
处方:藁本10g、淫羊藿20g、桂枝15g、川牛膝10g、徐长卿10g、益母草10g、鸡血藤10g、当归10g、赤芍15g、乳香10g、没药10g、三七10g、紫草10g、松节10g、牡丹皮10g、黄芪10g、刺五加10g、薄荷6g、艾叶1g、地肤子1g、地黄1g、防风1g、大枣1g、灵芝1g、乌梅1g、冰片1g、白豆蔻1g。
煎煮后泡洗:按配比称取诸药,加入30倍水,浸泡20min后加热煎煮,煮沸25min后过滤得煎煮液,共煎煮2次,混合过滤液,直接使用。
实施例2 本发明组合物的制备
处方:藁本5g,淫羊藿30g,桂枝10g,川牛膝30g,徐长卿5g,益母草30g,鸡血藤5g,当归30g,赤芍5g,乳香30g,没药5g,三七30g,紫草5g,松节30g,牡丹皮5g,黄芪30g,刺五加5g,薄荷10,艾叶0.5g,地肤子3g,地黄0.5g,防风3g,大枣0.5g,灵芝3g,乌梅0.5g,冰片3g,白豆蔻0.5g。
按配比称取诸药,加入30倍水,浸泡20min后加热煎煮提取,提取温度为100℃,提取时间为25min,共提取3次。经十层纱布、滤纸(孔径80-120um)分别过滤完成除杂,再以加热蒸发、精制的方式进行滤液浓缩至10倍,即获得该处方的活性成分。加入化妆品上可接受的辅料,配方中提取液至少占比80%,制成精华液、膏霜类、贴膜类护肤品。
实施例3 本发明组合物的制备
处方:藁本30g,淫羊藿5g,桂枝40g,川牛膝5g,徐长卿30g,益母草5g,鸡血藤30g,当归5g,赤芍30g,乳香5g,没药30g,三七5g,紫草30g,松节5g,牡丹皮30g,黄芪5g,刺五加30g,薄荷2,艾叶03g,地肤子0.5g,地黄3g,防风0.5g,大枣3g,灵芝0.5g,乌梅3g,冰片0.5g,白豆蔻3g。
按配比称取诸药,加入30倍水,浸泡20min后加热煎煮提取,提取温度为100℃,提取时间为25min,共提取3次。经十层纱布、滤纸(孔径80-120um)分别过滤完成除杂,再以加热蒸发、精制的方式进行滤液浓缩至10倍,即获得该处方的活性成分。加入化妆品上可接受的辅料,配方中提取液至少占比80%,制成精华液、膏霜类、贴膜类护肤品。
以下通过试验例具体说明本发明的有益效果。
试验例1 本发明组合物治疗手足综合征的研究
1、实验方法
①临床资料:选取2012年7月-2016年3月住院恶性肿瘤患者88例,均经病理确诊,其中接受化疗的病例52例,接受靶向治疗的病例36例,总共有男性39例,女性49例,其中结直肠癌31例,乳腺癌27例,胃癌21例,宫颈癌7例,输卵管癌2例。
②分组与给药方法:分用药组和对照组,用药组使用发明实施例1制备的药物泡洗手足,每日一剂,分2次使用,每次30分钟,直到治疗结束。对照组使用湿润烫伤膏。
④观察指标:采用美国国立癌症研究所(NCI)手足综合征的分级标准评级,对患者用药前后的评级进行评价。
⑤疗效评定标准:
有效性评定指标:显效:治疗后,症状消失或改善明显,降低2级;有效:治疗后症状改善,降至下1级;治疗后无改善,症状升级。
⑥数据统计:采用卡方检验,以P<0.05为有统计学意义。
2、实验结果
入组88例,可评价患者87例,不可评价1例。统计结果见表1-2。
表1用药组与对照组手足综合征的分级比较(用药前)
注:Δ表示与对照组比较P<0.05
表2用药组与对照组手足综合征的分级比较(治疗结束时)
注:Δ表示与对照组比较P<0.05
实验结果说明,本发明组合物对化疗或靶向药物引起的红斑、水肿、水疱、脓疱、皮肤皲裂、疼痛、溃烂等手足综合征症状具有明显的治疗作用,并能预防手足综合征的发生。48例用药组显效32例,有效9例,总有效率达85.4%,未见明显副反应。
试验例2 本发明组合物治疗手足综合征的研究
1、实验方法
①临床资料:选取2016年4月至2017年4月住院恶性肿瘤患者36例,均经病理确诊为接受化疗或靶向治疗的患者,用药包括奥沙利铂、卡培他滨、阿帕替尼、替吉奥、力朴素、奈达铂、紫杉醇、舒尼替尼、索拉非尼、艾坦等,共有36例,其中结直肠癌12例,乳腺癌8例,胃癌7例,宫颈癌7例,输卵管癌1例,甲状腺癌1例。
②分组与给药方法:分用药组和对照组,用药组使用本发明实施例2制备的精华液泡洗手足,早晚各一次;使用霜涂抹患处,每次适量外擦手足部,1日4次,早晚可在精华液泡洗后涂抹。对照组使用湿润烫伤膏。
④观察指标:采用美国国立癌症研究所(NCI)手足综合征的分级标准评级,对患者用药前后的评级进行评价。
⑤疗效评定标准:
有效性评定指标:显效:治疗后,症状消失或改善明显,降低2级;有效:治疗后症状改善,降至下1级;治疗后无改善,症状升级。
⑥数据统计:采用卡方检验,以P<0.05为有统计学意义。
2、实验结果
入组36例,可评价患者36例。统计结果见表3-4。
表3用药组与对照组手足综合征的分级比较(用药前)
注:Δ表示与对照组比较P<0.05
表4用药组与对照组手足综合征的分级比较(治疗结束时)
实验结果说明,本发明组合物对化疗或靶向药物(奥沙利铂、卡培他滨、阿帕替尼、替吉奥、力朴素、奈达铂、紫杉醇、舒尼替尼、索拉非尼、艾坦)引起的红斑、水肿、水疱、脓疱、皮肤皲裂、疼痛、溃烂等手足综合征症状具有明显的治疗作用。22例用药组显效15例,有效5例,总有效率达90.9%,未见明显副反应。
典型案例1
患者欧阳某某,男,66岁,甲状腺癌,口服阿帕替尼,出现足部脱屑,溃瘍,裂口,色素沉着,伴有剧烈的疼痛,严重影响日常生活。手足综合征分级属3级。用药(使用发明实施例3制备的药物泡洗手足,每日一剂,分2次使用,每次30分钟,直到治疗结束)7天后患者手足综合征的症状明显改善,尤其是溃瘍与裂口,几近痊愈,稍有红斑与皮肤较微瘦痒,无疼痛(如图1所示)。
典型案例2
患者巫某某,女,50岁,卵巢癌,口服奥沙利铂+卡培他滨,出现手部色素沉着、干枯,感觉麻木、迟钝,影响日常生活。用药(使用发明实施例1制备的药物泡洗手足,每日一剂,分2次使用,每次30分钟,直到治疗结束)14天后患者手足综合征痊愈,手部皮肤无色素沉着,皮肤恢复红润有弹性,不再感觉麻木(如图2所示)。
综上,本发药物组合物具有温经散寒、通络止痛的功效,经临床十余年的使用表明,其对患者手足部皮肤出现的红斑、水肿、水疱、脓疱、色素沉着、皮肤皲裂等皮肤损害,以及指(趾)甲脱落、局部溃烂等表现和疼痛、麻木感具有较好的临床疗效和安全性,为临床治疗手足综合征提供一种的选择,应用前景良好。
Claims (10)
1.一种治疗手足综合征的药物或者日化用品组合物,其特征在于:它是由包括如下重量配比的原料药制备而成的制剂:
藁本5~30份、淫羊藿5~30份、桂枝10~40份、川牛膝5~30份、鸡血藤5~30份、赤芍5~30份、三七5~30份、紫草5~30份。
2.根据权利要求1所述的组合物,其特征在于:它还包括如下重量配比的原料药:
徐长卿5~30份、益母草5~30份、当归5~30份、乳香5~30份、没药5~30份、松节5~30份、牡丹皮5~30份、黄芪5~30份、刺五加5~30份、薄荷2~10份、艾叶0.5~3份、地肤子0.5~3份、地黄0.5~3份、防风0.5~3份、大枣0.5~3份、灵芝0.5~3份、乌梅0.5~3份、冰片0.5~3份、白豆蔻0.5~3份。
3.根据权利要求2所述的组合物,其特征在于:它是由包括如下重量配比的原料药制备而成的制剂:
藁本10份、淫羊藿20份、桂枝15份、川牛膝10份、徐长卿10份、益母草10份、鸡血藤10份、当归10份、赤芍15份、乳香10份、没药10份、三七10份、紫草10份、松节10份、牡丹皮10份、黄芪10份、刺五加10份、薄荷6份、艾叶1份、地肤子1份、地黄1份、防风1份、大枣1份、灵芝1份、乌梅1份、冰片1份、白豆蔻1份。
4.根据权利要求1~3任意一项所述的组合物,其特征在于:它是由原料药的药粉、原料药的水或有机溶剂提取物为活性成分,加上药学上或者日化用品上常用的辅料或辅助性成分制备而成的制剂。
5.根据权利要求1~3任意一项所述的组合物,其特征在于:所述制剂是外用制剂。
6.根据权利要求5所述的组合物,其特征在于:所述制剂为洗剂、搽剂、膏剂、贴剂、巴布剂、精华液、霜剂、贴膜剂。
7.权利要求1~6任意一项所述组合物的制备方法,其特征在于:
(1)按照权利要求1~3任意一项所述配比称取原料药;
(2)制备原料药的药粉、原料药的水或有机溶剂提取物,加入药学上或者日化用品上常用的辅料或辅助性成分,即得。
8.权利要求1~6任意一项所述的组合物在制备治疗手足综合征的药品或者日化用品中的用途。
9.根据权利要求8所述的用途,其特征在于:所述手足综合征是奥沙利铂、卡培他滨、阿帕替尼、替吉奥、力朴素、奈达铂、紫杉醇、舒尼替尼、索拉非尼、艾坦等化疗或靶向治疗药物引起的手足综合征。
10.根据权利要求9所述的用途,其特征在于:所述药物是治疗手足部的皮肤红斑、水肿、水疱、脓疱、色素沉着、皮肤皲裂、指甲脱落、溃烂疼痛、麻木的药物。
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CN113144034A (zh) * | 2021-05-11 | 2021-07-23 | 张彩云 | 一种具有防治手足综合征作用的中药组合物及其制备方法 |
CN115337341A (zh) * | 2021-05-12 | 2022-11-15 | 江苏省中医院 | 一种用于抗手足综合征的中药组合物及制备方法与应用 |
CN115414590A (zh) * | 2022-07-24 | 2022-12-02 | 慈溪市人民医院医疗健康集团(慈溪市人民医院) | 一种化疗手足综合症的治疗配方及专用的治疗手套 |
CN115414590B (zh) * | 2022-07-24 | 2023-12-22 | 慈溪市人民医院医疗健康集团(慈溪市人民医院) | 一种化疗手足综合症的治疗配方及专用的治疗手套 |
CN116115657A (zh) * | 2023-03-10 | 2023-05-16 | 中国科学院基础医学与肿瘤研究所(筹) | 一种细梗香草或其提取物作为药物的用途 |
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