CN104524522B - 一种治疗冻疮的复方软膏 - Google Patents
一种治疗冻疮的复方软膏 Download PDFInfo
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Abstract
本发明涉及一种治疗冻疮的复方软膏，本复方软膏由西药、中药、载体复方组成，西药有效成分及其重量份数为：乳酸伊莎吖啶0.8～1.2份，地塞米松0.5～1份，维生素E15～20份；中药有效成分的原料药及其重量份数为：紫草11～20份，红花25～35份，当归10～20份，白芷30～40份，桂枝20～30份，生姜20～30份；载体的重量份数为100～120份。经备料、中药原料药有效成分的提取、西药有效成分的溶解、有效成分与载体的混合制备而成。该复方软膏有效成分协同作用效果明显，能够有效消肿、止疼、止痒，促进伤口快速愈合、消腐生肌、短时间内治愈冻疮，使患病部位较快的恢复至未患病前的状态。
Description
技术领域
本发明涉及一种复方软膏，具体说是一种治疗冻疮的复方软膏。
背景技术
冻疮是一种冬季较为常见的疾病，是由空气寒冷和湿度偏高的协同作用及曾有冻疮史所产生的，皮损好发于手指、手背、面部、耳郭、足趾、足缘、足跟等处，常两侧同时分布；常见损害症状为局部淤血性暗紫红色隆起的水肿性红斑，境界不清，边缘呈鲜红色，表面紧张有光泽，质柔软；重度的可出现水疱，破裂形成糜烂或溃疡；痒感明显，遇热后加剧，溃烂后疼痛；它给患者带来病痛和苦恼，影响美观。当前，治疗冻疮的药物有多种，但使用后都不能在短时间内消肿，而且没有显著的灭菌效果和作用，对于糜烂与顽固性的冻疮不成彻底根治，治愈率较低。因此市场上迫切需要一种治疗效果显著且具有杀抑菌功效的冻疮产品。
发明内容
本发明的目的是针对现有治疗冻疮缺乏有效药物的不足，提出一种西药加中药的复方软膏，该复方软膏结合西药治标中药治本的传统做法，标本兼治，能够有效消肿、止疼、止痒，促进伤口快速愈合，短时间内治愈冻疮；还具有消腐生肌的作用，使患病部位较快恢复至未患病前的状态。
本发明目的是由以下技术方案实现的：
一种治疗冻疮的复方软膏，本复方软膏由西药、中药、载体复方组成，西药有效成分及其重量份数为：乳酸伊莎吖啶0.8～1.2份，地塞米松0.5～1份，维生素E15～20份；中药有效成分的原料药及其重量份数为：紫草11～20份，红花25～35份，当归10～20份，白芷30～40份，桂枝20～30份，生姜20～30份；载体的重量份数为100～120份。
进一步的，所述的一种治疗冻疮的复方软膏，西药有效成分及其重量份数为：乳酸伊莎吖啶1.0～1.2份、地塞米松0.5～0.8份、维生素E16～18份，中药有效成分的原料药及其重量份数为：紫草15～20份、红花28～32份、当归15～18份、白芷33～36份、桂枝24～26份、生姜25～28份。
进一步的，所述的一种治疗冻疮的复方软膏，西药有效成分及其重量份数为：乳酸伊莎吖啶1.1份、地塞米松0.6份、维生素E18份，中药有效成分的原料药及其重量份数为：紫草18份、红花30份、当归16份、白芷35份、桂枝25份、生姜27份。
进一步的，所述的一种治疗冻疮的复方软膏，载体为油性基质，为甘油、蜂蜡、羊脂肪、凡士林中的至少一种，载体的重量份数为105～115份。
本发明还提供了一种治疗冻疮的复方软膏的制备方法：
①按照以上所述的西药有效成分、中药有效成分的原料药和载体的重量份数备料；
②中药原料药有效成分的提取：将紫草、红花、当归、白芷、桂枝、生姜加入恒温提取罐中，将紫草10倍重量的纯净水加入提取罐中，95～100℃恒温搅拌30min，冷却至室温，取上清液；再次向提取罐中加入紫草10倍重量的纯净水，95～100℃恒温搅拌30min，冷却至室温，取上清液；合并两次所得上清液，将上清液经16层纱布过滤，滤液在压力-0.06～-0.08Mpa、温度为45～50℃条件下浓缩至粘稠状，其相对密度为45℃时1.12-1.18，将该中药提取液冷却至室温备用；
③将乳酸伊莎吖啶、地塞米松用重量份数为5份的无菌水溶解；
④将载体加热至50～55℃，搅拌条件下依次加入中药提取液，乳酸伊莎吖啶、地塞米松无菌水溶液和维生素E，搅拌均匀冷却至室温，包装备用。
本发明的治疗冻疮的复方软膏的使用方法：将复方软膏涂搽于患处，每日2～3次。
各有效成分的功效为：
乳酸依沙吖啶：具有消腐生肌、杀菌、消毒的功效。
地塞米松：为糖皮质激素，具有抗炎、抗过敏作用。
维生素E：具有消除自由基，祛斑美白的功效。
紫草：具有凉血、活血、解毒透疹的功效。
红花：性温，味辛，主治活血通径、散瘀止痛。用于经闭、痛经、恶露不行、症瘕痞块、跌打损伤。
当归：性温，味甘辛。归心、肝、脾经。补血活血，调经止痛，润燥滑肠。治月经不调，经闭腹痛，症瘕结聚，崩漏；血虚头痛，眩晕，痿痹；肠燥便难，赤痢后重；痈疽疮窃，跌扑损伤。
白芷：祛风，燥湿，消肿，止痛。治头痛，眉棱骨痛，齿痛，鼻渊，寒湿腹痛，肠风痔漏，赤白带下，痈疽疮疡，皮肤燥痒，疥癣。
桂枝：散寒解表；温通经脉；通阳化气。主风寒表证；寒湿痹痛；四肢厥冷；经闭痛经；症瘕结块；胸痹；心悸；痰饮；小便不利。用于风寒感冒，脘腹冷痛，血寒经闭，关节痹痛，痰饮，水肿，心悸，奔豚。
生姜：发汗解表，温中止呕，温肺止咳，解鱼蟹毒，解药毒；为芳香性辛辣健胃药，有温暖、兴奋、发汗、止呕、解毒等作用，特别对于鱼蟹毒，半夏、天南星等药物中毒有解毒作用。适用于外感风寒、头痛、痰饮、咳嗽、胃寒呕吐；在遭受冰雪、水湿、寒冷侵袭后，急以姜汤饮之，可增进血行，驱散寒邪。
其中，紫草、红花、当归活血通络，软化肿决，白芷消肿止痛，桂枝、生姜温表散寒，促进血液循环，辅以乳酸依沙吖啶、地塞米松的消腐生肌、杀菌、消毒作用和维生素E消除自由基，祛斑美白的作用，可以在清热解毒、杀菌消炎的同时，起到护肤的作用，中西药成分协同作用，标本兼治，可以更好的疗效。
本发明的有益效果：
本发明的治疗冻疮的复方软膏，针对冻疮的致病机理，采用中西合剂的方法治疗冻疮，中西药协同作用，能在快速有效缓解冻疮不适症状的同时，从根源上治疗冻疮。冻疮是由空气寒冷和湿度偏高的协同作用与外表皮肤，致皮肤局部血循环不畅而积滞成疮，针对冻疮的成因，该软膏利用紫草、红花、当归活血通络，软化肿决；用白芷消肿止痛；用桂枝、生姜温表散寒，促进血液循环；辅以乳酸依沙吖啶、地塞米松消腐生肌、杀菌、消毒和维生素E消除自由基，祛斑美白。各有效成分协同作用，疗效快，治疗效果好，不但能够清热、解毒，还能杀菌、消炎，清除自由基，美白护肤。本复方软膏具有消肿、止疼、止痒、促进伤口快速愈合、消腐生肌、不留色素、不留疤痕的作用，能够短时间内治愈冻疮，使患病部位恢复至未患病前的状态，本复方软膏无毒副作用，用药安全，使用方便。
具体实施方式
根据下述实施例，可以更好地理解本发明。然而，本领域的技术人员容易理解，实施例所描述的具体的物料配比、工艺条件及其结果仅用于说明本发明而不应当也不会限制权利要求书中所详细描述的本发明。
实施例1
一种治疗冻疮的复方软膏，以重量份计，有效成分的含量为：乳酸伊莎吖啶1.1g、地塞米松0.6g、维生素E18g、紫草18g、红花30g、当归16g、白芷35g、桂枝25g、生姜27g；载体为：甘油40g、蜂蜡80g。
一种治疗冻疮的复方软膏制备方法：
①按照以上所述的西药有效成分、中药有效成分的原料药和载体的重量备料；
②中药原料药有效成分的提取：将紫草、红花、当归、白芷、桂枝、生姜加入恒温提取罐中，将紫草10倍重量的纯净水加入提取罐中，95～100℃恒温搅拌30min，冷却至室温，取上清液；再次向提取罐中加入紫草10倍重量的纯净水，95～100℃恒温搅拌30min，冷却至室温，取上清液；合并两次所得上清液，将上清液经16层纱布过滤，滤液在压力-0.06～-0.08Mpa、温度为45～50℃条件下浓缩至粘稠状，其相对密度为45℃时1.12～1.18，将该中药提取液冷却至室温备用；
③将乳酸伊莎吖啶、地塞米松用5ml无菌水溶解；
④将载体加热至50～55℃，搅拌条件下依次加入中药提取液，乳酸伊莎吖啶、地塞米松无菌水溶液和维生素E，搅拌均匀冷却至室温，包装备用。
使用方法：
将复方软膏涂搽于患处，每日2～3次。
实施例2
一种治疗冻疮的复方软膏，以重量份计，有效成分的含量为：乳酸伊莎吖啶1.0g、地塞米松0.5g、维生素E16g、紫草15g、红花28g、当归15g、白芷33g、桂枝24g、生姜25g；载体为：甘油40g、羊脂肪60g。
一种治疗冻疮的复方软膏制备方法：
①按照以上所述的西药有效成分、中药有效成分的原料药和载体的重量备料；
②中药原料药有效成分的提取：将紫草、红花、当归、白芷、桂枝、生姜加入恒温提取罐中，将紫草10倍重量的纯净水加入提取罐中，95～100℃恒温搅拌30min，冷却至室温，取上清液；再次向提取罐中加入紫草10倍重量的纯净水，95～100℃恒温搅拌30min，冷却至室温，取上清液；合并两次所得上清液，将上清液经16层纱布过滤，滤液在压力-0.06～-0.08Mpa、温度为45～50℃条件下浓缩至粘稠状，其相对密度为45℃时1.12～1.18，将该中药提取液冷却至室温备用；
③将乳酸伊莎吖啶、地塞米松用5ml无菌水溶解；
④将载体加热至50～55℃，搅拌条件下依次加入中药提取液，乳酸伊莎吖啶、地塞米松无菌水溶液和维生素E，搅拌均匀冷却至室温，包装备用。
使用方法：
将复方软膏涂搽于患处，每日2～3次。
实施例3
一种治疗冻疮的复方软膏，以重量份计，有效成分的含量为：乳酸伊莎吖啶1.2g、地塞米松0.8g、维生素E18g、紫草20g、红花32g、当归18g、白芷36g、桂枝26g、生姜28g；载体为：甘油45g、凡士林60g。
一种治疗冻疮的复方软膏制备方法：
①按照以上所述的西药有效成分、中药有效成分的原料药和载体的重量备料；
②中药原料药有效成分的提取：将紫草、红花、当归、白芷、桂枝、生姜加入恒温提取罐中，将紫草10倍重量的纯净水加入提取罐中，95～100℃恒温搅拌30min，冷却至室温，取上清液；再次向提取罐中加入紫草10倍重量的纯净水，95～100℃恒温搅拌30min，冷却至室温，取上清液；合并两次所得上清液，将上清液经16层纱布过滤，滤液在压力-0.06～-0.08Mpa、温度为45～50℃条件下浓缩至粘稠状，其相对密度为45℃时1.12～1.18，将该中药提取液冷却至室温备用；
③将乳酸伊莎吖啶、地塞米松用5ml无菌水溶解；
④将载体加热至50～55℃，搅拌条件下依次加入中药提取液，乳酸伊莎吖啶、地塞米松无菌水溶液和维生素E，搅拌均匀冷却至室温，包装备用。
使用方法：
将复方软膏涂搽于患处，每日2～3次。
实施例4
一种治疗冻疮的复方软膏，以重量份计，有效成分的含量为：乳酸伊莎吖啶0.8g、地塞米松0.5g、维生素E15g、紫草11g、红花25g、当归10g、白芷30g、桂枝20g、生姜20g；载体为：甘油45g、羊脂肪65g。
一种治疗冻疮的复方软膏制备方法：
①按照以上所述的西药有效成分、中药有效成分的原料药和载体的重量备料；
②中药原料药有效成分的提取：将紫草、红花、当归、白芷、桂枝、生姜加入恒温提取罐中，将紫草10倍重量的纯净水加入提取罐中，95～100℃恒温搅拌30min，冷却至室温，取上清液；再次向提取罐中加入紫草10倍重量的纯净水，95～100℃恒温搅拌30min，冷却至室温，取上清液；合并两次所得上清液，将上清液经16层纱布过滤，滤液在压力-0.06～-0.08Mpa、温度为45～50℃条件下浓缩至粘稠状，其相对密度为45℃时1.12～1.18，将该中药提取液冷却至室温备用；
③将乳酸伊莎吖啶、地塞米松用5ml无菌水溶解；
④将载体加热至50～55℃，搅拌条件下依次加入中药提取液，乳酸伊莎吖啶、地塞米松无菌水溶液和维生素E，搅拌均匀冷却至室温，包装备用。
使用方法：
将复方软膏涂搽于患处，每日2～3次。
实施例5
一种治疗冻疮的复方软膏，以重量份计，有效成分的含量为：乳酸伊莎吖啶1.2g、地塞米松1g、维生素E20g、紫草20g、红花35g、当归20g、白芷40g、桂枝30g、生姜30g；载体为：甘油50g、羊脂肪63g。
一种治疗冻疮的复方软膏制备方法：
①按照以上所述的西药有效成分、中药有效成分的原料药和载体的重量备料；
②中药原料药有效成分的提取：将紫草、红花、当归、白芷、桂枝、生姜加入恒温提取罐中，将紫草10倍重量的纯净水加入提取罐中，95～100℃恒温搅拌30min，冷却至室温，取上清液；再次向提取罐中加入紫草10倍重量的纯净水，95～100℃恒温搅拌30min，冷却至室温，取上清液；合并两次所得上清液，将上清液经16层纱布过滤，滤液在压力-0.06～-0.08Mpa、温度为45～50℃条件下浓缩至粘稠状，其相对密度为45℃时1.12～1.18，将该中药提取液冷却至室温备用；
③将乳酸伊莎吖啶、地塞米松用5ml无菌水溶解；
④将载体加热至50～55℃，搅拌条件下依次加入中药提取液，乳酸伊莎吖啶、地塞米松无菌水溶液和维生素E，搅拌均匀冷却至室温，包装备用。
使用方法：
将复方软膏涂搽于患处，每日2～3次。
本发明的药效分析：
治愈：损害症状为局部淤血性暗紫红色隆起的水肿性红斑，境界不清，边缘呈鲜红色，表面紧张有光泽，质柔软；重度的可出现水疱，破裂形成糜烂或溃疡；痒感明显，遇热后加剧，溃烂后疼痛等全部消失。
好转：自觉症候如局部淤血性暗紫红色隆起的水肿性红斑，境界不清，边缘呈鲜红色，表面紧张有光泽，质柔软；重度的可出现水疱，破裂形成糜烂或溃疡；痒感明显，遇热后加剧，溃烂后疼痛；等部分消失。
无效：症状无明显改善。
治疗效果：本发明的一种治疗湿疹的复方酊剂经过100例湿疹患者进行治疗，92例痊愈，8例好转，总有效率达到100％。
典型病例：
病例1：患者王某，男，38岁，患者患冻疮3年，患病皮肤出现水疱，破裂形成糜烂，痒感明显，使用本发明的一种治疗冻疮的复方软膏2周后症状明显减轻，继续使用4周后，症状完全消失，随访1年未复发。
病例2：患者杨某，女，45岁。患者患冻疮5年，患病皮肤出现溃烂，使用本发明的一种治疗冻疮的复方软膏4周后症状明显减轻，继续使用3周后，症状完全消失，随访3年未复发。
病例3：患者程某，女，50岁。患者患冻疮3年，患病皮肤有淤血性暗紫红色隆起的水肿性红斑，境界不清，边缘呈鲜红色，表面紧张有光泽，质柔软；使用本发明的一种治疗冻疮的复方软膏2周后症状明显减轻，继续使用1周后，症状完全消失，随访2年未复发。
以上实施方式只为说明本发明的技术构思及特点，其目的在于让熟悉此项技术的人了解本发明内容并加以实施，并不能以此限制本发明的保护范围，凡根据本发明精神实质所做的等效变化或修饰，都应涵盖在本发明的保护范围内。
Claims (5)
1.一种治疗冻疮的复方软膏，其特征在于，本复方软膏由西药、中药、载体复方组成，西药有效成分及其重量份数为：乳酸伊莎吖啶0.8～1.2份，地塞米松0.5～1份，维生素E15～20份；中药有效成分的原料药及其重量份数为：紫草11～20份，红花25～35份，当归10～20份，白芷30～40份，桂枝20～30份，生姜20～30份；载体的重量份数为100～120份。
2.根据权利要求1所述的一种治疗冻疮的复方软膏，其特征在于，西药有效成分及其重量份数为：乳酸伊莎吖啶1.0～1.2份、地塞米松0.5～0.8份、维生素E16～18份，中药有效成分的原料药及其重量份数为：紫草15～20份、红花28～32份、当归15～18份、白芷33～36份、桂枝24～26份、生姜25～28份。
3.根据权利要求1所述的一种治疗冻疮的复方软膏，其特征在于，西药有效成分及其重量份数为：乳酸伊莎吖啶1.1份、地塞米松0.6份、维生素E18份，中药有效成分的原料药及其重量份数为：紫草18份、红花30份、当归16份、白芷35份、桂枝25份、生姜27份。
4.根据权利要求1所述的一种治疗冻疮的复方软膏，其特征在于，载体为油性基质，为甘油、蜂蜡、羊脂肪、凡士林中的至少一种，载体的重量份数为105～115份。
5.一种治疗冻疮的复方软膏的制备方法：
①按照权利要求1～4任一项所述的西药有效成分、中药有效成分的原料药和载体的重量份数备料；
②中药原料药有效成分的提取：将紫草、红花、当归、白芷、桂枝、生姜加入恒温提取罐中，将紫草10倍重量的纯净水加入提取罐中，95～100℃恒温搅拌30min，冷却至室温，取上清液；再次向提取罐中加入紫草10倍重量的纯净水，95～100℃恒温搅拌30min，冷却至室温，取上清液；合并两次所得上清液，将上
清液经16层纱布过滤，滤液在压力-0.06～-0.08Mpa、温度为45～50℃条件下浓缩至粘稠状，其相对密度为45℃时1.12～1.18，将该中药提取液冷却至室温备用；
③将乳酸伊莎吖啶、地塞米松用重量份数为5份的无菌水溶解；
④将载体加热至50～55℃，搅拌条件下依次加入中药提取液，乳酸伊莎吖啶、地塞米松无菌水溶液和维生素E，搅拌均匀冷却至室温，包装备用。
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