CN105381070A - 犀角地黄药物组合物在制备预防及治疗表皮生长因子受体抑制剂所致相关皮疹药物中的用途 - Google Patents
犀角地黄药物组合物在制备预防及治疗表皮生长因子受体抑制剂所致相关皮疹药物中的用途 Download PDFInfo
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Abstract
本发明提供犀角地黄药物组合物在制备预防及治疗表皮生长因子受体抑制剂所致相关皮疹药物中的用途,所述犀角地黄药物组合物包括作为有效成分的犀角、赤芍、生地和牡丹皮。本发明将用于重症肝炎、肝昏迷、尿毒症、过敏性紫癜急性白血病、败血症等症的犀角地黄汤的药物组合物创造性用于预防及治疗表皮生长因子受体抑制剂所致皮疹,临床疗效较好,毒性低,可以长期服用。
Description
技术领域
本发明属于医药领域,涉及一种犀角地黄药物组合物的新用途,具体为犀角地黄药物组合物在制备预防及治疗表皮生长因子受体抑制剂所致相关皮疹药物中的用途。
背景技术
随着社会和科技的发展,癌症治疗观念由经验科学向循证医学、由细胞攻击模式向靶向性治疗模式转变。利用肿瘤特异的信号传导或特异代谢途径控制的“靶点治疗”是肿瘤研究的热点。
靶向药物是指针对已经明确的致癌驱动基因的抗肿瘤药物。其目的是使药物或其载体能瞄准特定的以驱动基因为靶点,使肿瘤细胞特异性地死亡,而不影响人体内的正常细胞。靶向制剂可以使药物在目标局部形成相对较高的浓度,从而在提高药效的同时抑制毒副作用,减少对正常组织、细胞的伤害。目前已有靶向药物的靶点有EGFR,HER2,EML4-ALK,KRAS。
但是目前抗肿瘤靶向药物也难免存在各种副作用,尤其是靶向药物所致的皮疹及黏膜炎等。这些皮损类副作用严重影响肿瘤患者的生活质量。而且发生Ⅲ,Ⅳ度毒性的患者占1/3,此类患者被迫减少靶向药物的药量甚至停药,影响治疗效果,导致肿瘤复发和转移。
目前临床常用治疗或缓解上述皮损的药物包括保湿剂,激素类外用药,和内服美满霉素,保湿剂和激素类外用药作用不明显,内服美满霉素毒性较大,尤其是药物性肝损。因此,对于靶向药物,特别是表皮生长因子抑制剂所致皮疹,临床上尚没有很好的治疗方法。
犀角地黄汤为中药方剂,属于清热剂,具有清热解毒,凉血散瘀之功效。主治热入血分证,热扰心神,身热谵语,舌绛起刺,脉细数;热伤血络,斑色紫黑、吐血、衄血、便血、尿血等,舌绛红,脉数;蓄血瘀热,喜忘如狂,漱水不欲咽,大便色黑易解等。目前此中药方剂仍为常规用途,临床应用于治疗重症肝炎、肝昏迷、弥漫性血管内凝血、尿毒症、过敏性紫癜、急性白血病等血分热盛者;治血证,大便黑,衂后脉微,发狂发黄当汗下,汗内有淤血。
发明内容
本发明为了解决上述问题,提供一种犀角地黄药物组合物的新用途,达到有效预防及治疗表皮生长因子受体抑制剂所致相关皮疹,疗效较好且毒性较低的目的。
为实现上述发明目的,本发明采用以下技术方案:
犀角地黄药物组合物在制备预防及治疗表皮生长因子受体抑制剂所致相关皮疹药物中的用途,所述犀角地黄药物组合物包括作为有效成分的犀角、赤芍、生地和牡丹皮。
进一步,所述犀角地黄药物组合物包括以下重量克数的有效成分:犀角20-40克,赤芍12-36克,生地6-18克,牡丹皮3-15克。
进一步,所述犀角地黄药物组合物包括以下重量克数的有效成分:犀角25-35克,赤芍18-30克,生地9-15克,牡丹皮6-12克。
进一步,所述犀角地黄药物组合物包括以下重量克数的有效成分:犀角30克,赤芍24克,生地12克,牡丹皮9克。
进一步,所述表皮生长因子受体抑制剂为吉非替尼、厄洛替尼、埃克替尼、阿法替尼、西妥昔单抗中的一种或多种。
进一步,所述犀角地黄药物组合物还包括大青叶、连翘、紫花地丁、蒲公英、黄连、炒麦芽、白术生中的一种或多种。
作为本发明的一种实施方式,所述犀角地黄药物组合物包括犀角20-40克,赤芍12-36克,生地6-18克,牡丹皮3-15克,大青叶20-30g,连翘15-25g,紫花地丁15-25g,蒲公英18-22g,黄连6-9g,炒麦芽16-24g,白术生12-17g。
进一步,所述犀角地黄药物组合物还包括大青叶、金银花、连翘、紫花地丁、蒲公英、黄芩、炒麦芽、白术生、丹参、紫草、赤小豆、桑白皮、白鲜皮中的一种或多种。
作为本发明的另一种实施方式,所述犀角地黄药物组合物包括犀角20-40克,赤芍12-36克,生地6-18克,牡丹皮3-15克,大青叶20-30g,金银花15-27g,连翘15-25g,紫花地丁15-25g,蒲公英18-22g,黄芩10-15g,炒麦芽16-24g,白术生12-17g,丹参10-15g,紫草18-22g,赤小豆9-15g,桑白皮8-12g,白鲜皮6-10g。
进一步,所述药物组合物制成适用于口服给药、皮肤给药、静脉注射给药、舌下给药的药物剂型中的一种。
与现有技术相比,本技术方案具有以下优点:
本发明的犀角地黄药物组合物将用于重症肝炎、肝昏迷、尿毒症、过敏性紫癜急性白血病、败血症等症的犀角地黄汤的药物组合物创造性用于预防及治疗表皮生长因子受体抑制剂所致皮疹,本发明的药物组合物可以使得皮肤在对于表皮生长因子受体(EGFR)通路抑制的同时,上调了旁通路或通过自分泌原理再次激活皮肤EGFR通路,从而改善了皮肤及粘膜的再生能力,实现改善肿瘤患者由于靶向药物导致的皮损,特别是皮疹和粘膜炎。临床实践中证明,本发明的药物组合物在预防和治疗表皮生长因子受体抑制剂所致皮疹和粘膜炎方面,疗效较好,毒性低,可以长期服用。
具体实施方式
肿瘤晚期患者在采用靶向药物治疗时,需要长期服用表皮因子受体抑制剂,直至产生耐药性,而此过程中产生的皮损,特别是皮疹和粘膜炎等长期困扰患者,影响患者的生活质量,严重者甚至导致停药。发明人是在临床实践中,创造性的发现了犀角地黄药物组合物的新用途,将常用于重症肝炎、肝昏迷、尿毒症、过敏性紫癜急性白血病、败血症等症的犀角地黄药物组合物,用于治疗上述皮疹和粘膜炎,取得了良好疗效。
本发明中以传统的犀角地黄汤的主药作为有效成分,包括犀角,生地,赤芍和牡丹皮。其中犀角多采用水牛角来替代。
进一步的,我们在此传统配方基础上,根据中药君臣佐使理论,结合清营汤,黄连翘赤小豆汤,特制犀角地黄药物组合物预防及治疗表皮生长因子受体抑制剂所致相关皮疹,在临床上取得较好疗效。此处犀角地黄药物组合物除了上述四种主要有效成分,还可以根据患者的实际情况或者肿瘤的治疗进程和反应,添加大青叶、金银花、连翘、紫花地丁、蒲公英、黄连、黄芩、炒麦芽、白术生、丹参、紫草、赤小豆、桑白皮、白鲜皮中的一种或多种。
本发明的犀角地黄药物组合物可制成适用于口服给药、皮肤给药、静脉注射给药、舌下给药等各种药物剂型。
传统的如煎汤,或制丸,即可实现口服给药。也可以将药物组合物按照现代药剂学的制药技术进一步进行精细加工,添加适量赋形剂实现以固体、溶液、乳化液、分散体、胶束、脂质体等形式使用,具体使用形式包括片剂、颗粒剂、丸剂、胶囊剂、含片、水悬剂或油悬剂、酊剂、可分散粉剂、溶液剂、乳剂、悬浮剂及其他适宜形式。可用的载体包括乳糖、葡萄糖、蔗糖、蜂蜜、糊精、微晶纤维素、阿拉伯胶、明胶、甘露糖醇、淀粉糊、硬脂酸镁、滑石、硅胶、以及其他适用于以固体、半固体或液体形式生产制备的载体。另外可以使用辅助试剂、稳定剂、增稠剂,还可以选用一种或多种调味剂、着色剂、保鲜剂等来提供适口性好的药物制品。优选的,选择微晶纤维素、糊精、乳糖、硬脂酸镁等作为药物辅料。
下面结合具体实施例对本发明做进一步说明。
实施例1:
按以下重量称取原料:水牛角20g,赤芍12g,生地6g,牡丹皮3g。作汤剂,用水煎服,水牛角镑片先煎,余药后下。以水九升,煮取三升,分三服。
实施例2
按以下重量称取原料:水牛角25g,赤芍18g,生地9g,牡丹皮6g。作汤剂,用水煎服,水牛角镑片先煎,余药后下。以水九升,煮取三升,分三服。
实施例3
按以下重量称取原料:水牛角30g,赤芍24g,生地12g,牡丹皮9g。作汤剂,用水煎服,水牛角镑片先煎,余药后下。以水九升,煮取三升,分三服。
实施例4
按以下重量称取原料:水牛角35g,赤芍30g,生地15g,牡丹皮12g。作汤剂,用水煎服,水牛角镑片先煎,余药后下。以水九升,煮取三升,分三服。
实施例5
按以下重量称取原料:水牛角40g,赤芍36g,生地18g,牡丹皮15g。作丸剂,将上述原料磨成细粉,混合均匀,炼蜜为丸,蜡皮封固。
实施例6
按以下重量称取原料:水牛角30g,赤芍24g,生地12g,牡丹皮9g,大青叶20g,连翘20g,紫花地丁20g,蒲公英20g,黄连8g,炒麦芽20g,白术生15g。作汤剂,用水煎服,水牛角镑片先煎,余药后下。以水九升,煮取三升,分三服。
实施例7
按以下重量称取原料:水牛角30g,赤芍24g,生地12g,牡丹皮9g,大青叶20g,金银花20g,连翘20g,紫花地丁20g,蒲公英20g,黄芩15g,炒麦芽20g,白术生15g,丹参10g,紫草20g,赤小豆10g,桑白皮10g,白鲜皮8g。作汤剂,用水煎服,水牛角镑片先煎,余药后下。以水九升,煮取三升,分三服。
临床治疗实例:
患者徐XX,男性,39岁。2012年6月份因发热、咳嗽、胸闷气急起病,诊断为:右肺腺癌伴广泛转移,cT1aN3M1b(纵隔、胸膜、心包、骨转移),IV期。于2012-06-19日起予以特罗凯1#qd靶向治疗至今,最佳疗效:PR。服药2周后出现Ⅲ至IV度皮疹,具体症状为:颜面部、前胸及后背密集分布针尖至粟粒大小毛囊炎样丘疹,部分融合,有瘙痒)。
发明人针对患者的实际情况,给予犀角地黄药物组合物,具体的,本实施例中犀角地黄药物组合物汤剂配方为:
水牛角30g,赤芍20g,生地20g,牡丹皮9g,大青叶20g,连翘20g,紫花地丁20g,蒲公英20g,黄连8g,炒麦芽20g,白术生15g,紫草15g。作汤剂,用水煎服,水牛角镑片先煎,余药后下。以水九升,煮取三升,分三服。
服用半个月后,针对患者的实际情况,将上述汤剂改为第二剂汤药水牛角30g,赤芍20g,生地20g,牡丹皮9g,大青叶30g,连翘20g,紫花地丁20g,蒲公英20g,黄连8g,炒麦芽20g,白术生15g。作汤剂,用水煎服,水牛角镑片先煎,余药后下。以水九升,煮取三升,分三服。
服用第二剂汤药一个月后,针对患者的实际情况,将上述汤剂改为第三剂汤药:水牛角30g,赤芍20g,生地15g,牡丹皮9g,大青叶30g,连翘20g,紫花地丁20g,蒲公英20g,黄连8g,炒麦芽20g,白术生15g。作汤剂,用水煎服,水牛角镑片先煎,余药后下。以水九升,煮取三升,分三服。
给予第三剂犀角地黄药物组合物汤剂服用2月后,皮疹明显消退。目前患者仍继续服用第三剂汤剂,颜面部已无明显皮疹。
本发明虽然已以较佳实施例公开如上,但其并不是用来限定本发明,任何本领域技术人员在不脱离本发明的精神和范围内,都可以利用上述揭示的方法和技术内容对本发明技术方案做出可能的变动和修改,因此,凡是未脱离本发明技术方案的内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化及修饰,均属于本发明技术方案的保护范围。
Claims (10)
1.犀角地黄药物组合物在制备预防及治疗表皮生长因子受体抑制剂所致相关皮疹药物中的用途,所述犀角地黄药物组合物包括作为有效成分的犀角、赤芍、生地和牡丹皮。
2.根据权利要求1所述的用途,其特征在于,所述犀角地黄药物组合物包括以下重量克数的有效成分:犀角20-40克,赤芍12-36克,生地6-18克,牡丹皮3-15克。
3.根据权利要求2所述的用途,其特征在于,所述犀角地黄药物组合物包括以下重量克数的有效成分:犀角25-35克,赤芍18-30克,生地9-15克,牡丹皮6-12克。
4.根据权利要求3所述的用途,其特征在于,所述犀角地黄药物组合物包括以下重量克数的有效成分:犀角30克,赤芍24克,生地12克,牡丹皮9克。
5.根据权利要求1所述的用途,其特征在于,所述表皮生长因子受体抑制剂为吉非替尼、厄洛替尼、埃克替尼、阿法替尼、西妥昔单抗中的一种或多种。
6.根据权利要求1所述的用途,其特征在于,所述犀角地黄药物组合物还包括大青叶、连翘、紫花地丁、蒲公英、黄连、炒麦芽、白术生中的一种或多种。
7.根据权利要求6所述的用途,其特征在于,所述犀角地黄药物组合物包括犀角20-40克,赤芍12-36克,生地6-18克,牡丹皮3-15克,大青叶20-30g,连翘15-25g,紫花地丁15-25g,蒲公英18-22g,黄连6-9g,炒麦芽16-24g,白术生12-17g。
8.根据权利要求1所述的用途,其特征在于,所述犀角地黄药物组合物还包括大青叶、金银花、连翘、紫花地丁、蒲公英、黄芩、炒麦芽、白术生、丹参、紫草、赤小豆、桑白皮、白鲜皮中的一种或多种。
9.根据权利要求8所述的用途,其特征在于,所述犀角地黄药物组合物包括犀角20-40克,赤芍12-36克,生地6-18克,牡丹皮3-15克,大青叶20-30g,金银花15-27g,连翘15-25g,紫花地丁15-25g,蒲公英18-22g,黄芩10-15g,炒麦芽16-24g,白术生12-17g,丹参10-15g,紫草18-22g,赤小豆9-15g,桑白皮8-12g,白鲜皮6-10g。
10.根据权利要求1所述的用途,其特征在于,所述药物组合物制成适用于口服给药、皮肤给药、静脉注射给药、舌下给药的药物剂型中的一种。
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CN110179885A (zh) * | 2019-04-03 | 2019-08-30 | 赵琼 | 犀角地黄药物组合物在制备预防及治疗表皮生长因子受体抑制剂所致相关皮疹药物中的用途 |
US10583111B2 (en) | 2017-12-13 | 2020-03-10 | Onquality Pharmaceuticals China Ltd. | Method for preventing or treating diseases associated with the inhibition of EGFR |
US10987336B2 (en) | 2018-04-16 | 2021-04-27 | Onquality Pharmaceuticals China Ltd. | Method of preventing or treating side effect of tumor therapy |
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US10583111B2 (en) | 2017-12-13 | 2020-03-10 | Onquality Pharmaceuticals China Ltd. | Method for preventing or treating diseases associated with the inhibition of EGFR |
US10987336B2 (en) | 2018-04-16 | 2021-04-27 | Onquality Pharmaceuticals China Ltd. | Method of preventing or treating side effect of tumor therapy |
CN110179885A (zh) * | 2019-04-03 | 2019-08-30 | 赵琼 | 犀角地黄药物组合物在制备预防及治疗表皮生长因子受体抑制剂所致相关皮疹药物中的用途 |
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