CN113384656A - 一种治疗皮下痛风石的中药外用化石乳膏及其制备方法 - Google Patents
一种治疗皮下痛风石的中药外用化石乳膏及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗皮下痛风石的中药外用化石乳膏,其特征在于,包括:皂角刺、山慈菇、生牡蛎、土茯苓、僵蚕、威灵仙、白芷、地龙、乳香、没药、石见穿、紫花地丁;本发明制研制的痛风化石膏作用温和,化石止痛效果显著,定期使用可以有效减小痛风石及软化新出现的痛风结节,可避免口服药物对消化系统的损伤和对肝肾功能的影响,使用方便,无刺激,药物直达病灶,局部吸收而发挥疗效;我们相信痛风化石膏的研制开发成功,将会产生较好的社会效益与经济效益。
Description
技术领域
本发明属于中药配方技术领域,具体涉及一种治疗皮下痛风石的中药外用化石乳膏及其制备方法。
背景技术
痛风是嘌呤代谢紊乱及/或尿酸排泄减少所引起的一种晶体性关节炎,临床表现为高尿酸血症和尿酸盐结晶沉积所致的特征性急性关节炎、痛风石形成、痛风石性慢性关节炎,并可发生尿酸盐肾病、尿酸性尿路结石等,严重者可出现关节致残、肾功能不全。近年来,随着人民生活水平的提高,饮食结构中高脂肪、高蛋白成分增加,痛风的患病率逐年增高,且发病年龄呈年轻化趋势。
若长期反复发病未得到控制,就易出现痛风石。痛风石的发生与病程的长短和血尿酸浓度的高低呈正相关性。一般在急性痛风性关节炎初次发作后10年出现痛风石,也有部分患者病程小于10年。初次发作若未治疗,痛风石5年患病率为30%,10年为50%,20年可达72%。痛风石是单钠尿酸盐结晶沉积引起周围组织反复发生的慢性类肉芽肿样反应,是慢性期痛风的特征性表现,也是一种继发的特征性损伤。痛风石生长在痛风患者的关节、肌腱、耳廓等部位,其发病率占痛风患者的20~30%,长期的高尿酸血症,血尿酸是以速溶性的尿酸盐形式存在,如果速溶性的尿酸盐增多,就会以慢溶性的尿酸盐形式沉积于各种组织中,形成痛风石。痛风石除常见于鹰嘴囊、跟腱、第一跖趾关节、耳廓和指腹等典型部位外,也可发生于少见部位,如脊柱旁可造成脊髓或神经根受压、支气管造成气道阻塞、心脏瓣膜、巩膜和乳房等。部分痛风石透过皮肤可看见白色结节,破溃后可向外分泌白色结晶物质。痛风石还可对关节周围组织包括骨、关节软骨和肌腱等造成严重损害,包括骨质侵蚀、骨赘、骨膜反应和软骨损害等,出现关节功能活动受限、强直、甚至导致关节功能残废。有些位于皮下组织的痛风石可以引起局部破溃、坏死,由于尿酸盐结晶的刺激以及不断从创面排出,使得创面愈合困难,形成慢性溃疡和难治性溃疡,严重影响患者的日常工作和生活。如何更好地治疗痛风性关节炎已成为当今医学研究的重要课题。
目前,痛风石的治疗除了长期口服药物降尿酸药,使血清尿酸水平达标,加速痛风石溶解,还有口服枸橼酸氢钾钠颗粒溶解尿酸结石,只有手术切除治疗。现依据丰富的文献资料与临床经验,发明痛风化石膏,服务于广大痛风患者。我们认为急性痛风性关节炎主要是由于先天不足,复加饮食不节、酗酒或进食肥甘厚味,以致损伤脾胃,失其运化,酿生水湿痰饮。水湿痰饮积聚不化,郁而化热,痰湿水饮得热煎灼则形成湿浊热邪相夹为患。湿浊挟热流注于下焦,脉络受阻,气血运行不畅,而成瘀邪。湿浊瘀热痹着肢节,则产生急性痛风性关节炎的红肿热痛。若反复发作,痰浊湿热之邪留滞筋骨、经络,致气血津液运行不畅,积聚于此出现痛风石。因此,痛风石形成的基本病机是痰浊热毒、气血淤滞。据此,以拔毒清浊、活血通络为法制定出痛风化石膏外治方;该药的发现将为有痛风石的患者提供一种新的安全有效、副作用小的中药外用化石膏剂。
发明内容
本发明研制了一种治疗皮下痛风石的中药外用化石乳膏,该化石乳膏具有安全有效、副作用小的特点;
一种治疗皮下痛风石的中药外用化石乳膏,其特征在于,包括:皂角刺、山慈菇、生牡蛎、土茯苓、僵蚕、威灵仙、白芷、地龙、乳香、没药、石见穿、紫花地丁;上述成分按照以下重量配比:皂角刺25-35g、山慈菇15-25g、生牡蛎25-35g、土茯苓25-35g、僵蚕20-30g、威灵仙45-55g、白芷25-35g、地龙10-20g、乳香5-15g、没药5-15g、石见穿5-15g、紫花地丁10-20g;
优选的,所述一种治疗皮下痛风石的中药外用化石乳膏,各中药原料的重量配比为:皂角刺30g、山慈菇20g、生牡蛎30g、土茯苓30g、僵蚕25g、威灵仙50g、白芷30g、地龙15g、乳香10g、没药10、石见穿10g、紫花地丁15g;
本发明的另一目的在于提供一种治疗皮下痛风石的中药外用化石乳膏的制备方法,其特征在于,包括以下步骤:
S1:称重:按照如下重量配比称取各中药原料:皂角刺30g、山慈菇20g、生牡蛎30g、土茯苓30g、僵蚕25g、威灵仙50g、白芷30g、地龙15g、乳香10g、没药10、石见穿10g、紫花地丁15g;
S2:挥发油提取:处方十二味,取白芷、乳香、没药三味,按照材料与水1:10的量加水浸泡1.5-2h;采用水蒸汽蒸馏法提取挥发油,提取时长4-5h,收取挥发油备用;
S3:浸膏提取:S2中提取收集完挥发油后,将药渣过滤,药液另存;过滤得到的药渣与余下九味药材加水煎煮三次;将三次煎煮所得药液通过减压浓缩后制得浸膏备用;
S4:A相提取:称取硬脂酸150g、液状石蜡100g、白凡士林100g,将上述材料通过水浴加热融化制得A相;
S5:B相提取:称取甘油100g、三乙醇胺50g、羟苯乙酯2g,混合蒸馏水后水浴加热至溶解,加入S3中提取的浸膏,搅拌均匀,水浴加热保温的B相;
S6:乳膏制备:将S5中提取的B相缓慢加入S4提取的A相中,边加边搅拌,直至均质乳化且温度低于60℃,加入S2中提取的挥发油,继续搅拌,使其均质乳化,直至冷凝后分装,即制得乳膏。
优选的,所述S3中三次煎煮的方法为:第一次加相当于药材10倍量的水熬煮60min,过滤药渣,药液另存;第二次加相当于药渣8倍量的水熬煮40min,过滤药渣,药液另存;第三次加相当于药渣6倍量的水熬煮30min,过滤药渣,药液另存;
优选的,所述S3中需减压浓缩至相对密度为1.15-1.20;
优选的,所述S4和S5中水浴温度为75-82℃。
本发明配方中所使用中药材的药理及药性为:
方中以皂角刺为君,具有托毒、去脓、杀虫之功,治疗疮疡肿块、瘰疬顽癣。为疡毒药中为第一要剂。《本草汇言》“凡痈疽未成者,能引之以消散,将破者,能引之以出头,已溃者能引之以行脓;
山慈菇清热解毒,消痈散结,用于痈肿疔毒,瘰疬痰核,蛇虫咬伤,瘕痞块。《滇南本草》“消阴分之痰,止咳嗽,治喉痹,止咽喉痛。治毒疮,攻痈疽,敷诸疮肿毒,有脓者溃,无脓者消。”现代药理提示山慈菇中所含秋水仙碱及其加入稀氨溶液后的合成物秋水仙碱,均有与长春碱相似的抗肿瘤作用。秋水仙碱还有止咳、平喘及止痛作用;
生牡蛎味咸,软坚散结,用治痰火郁结之痰核,瘰疬,瘿瘤等。《本草纲目》”化痰软坚,清热除湿……消疝瘕积块,瘿疾结核;
土茯苓解毒,除湿,利关节。主治梅毒,淋浊,筋骨挛痛,脚气,疗疔疮,痈肿,瘰疬,梅毒及汞中毒所致的肢体拘挛,筋骨疼痛;
僵蚕具有祛风解痉,化痰散结的功效,临床多用于治有形之包块,如结节,咽肿痛,瘰疬,风疮瘾疹等。皆取其通散之能。《本草纲目》“散风痰结核、瘰疬、头风、风虫齿痛,皮肤风疮,丹毒作痒,……一切金疮,疔肿风痔。”山慈菇、生牡蛎、土茯苓、僵蚕共为臣药,助皂角刺拔毒消块;
威灵仙能祛风湿、利尿、通经、镇痛,用于风湿痹痛,肢体麻木,筋脉拘挛,屈伸不利,骨哽咽喉;
白芷祛风湿,活血排脓,生肌止痛。《日华子本草》“治目赤胬肉,及补胎漏滑落,破宿血,补新血,乳痈、发背、瘰疬、肠风、痔瘘,排脓,疮痍、疥癣,止痛生肌,去面皯疵瘢。”现代药理白芷中的提取物总香豆素具有镇痛和解痉作用,作用机制可能是通过抑制环氧化酶-2来抑制前列腺素的生成起到外周神经镇痛作用。同时可改善人体微循环,促进皮肤新陈代谢,消除色素在组织中过度堆积,去除色斑瘢痕,治疗皮肤疱痍疥癣等;
石见穿具有活血化瘀、清热利湿、散结消肿之功。主治风湿骨痛、瘰疬疮肿、带状疱疹、跌打伤肿。《纲目》“主骨痛,大风,痈肿。”《苏州本产药材》“治噎膈,痰饮气喘;
地龙活血通络止痛,现代研究表明地龙提取液在体外有很好的抗凝作用,能使血液的凝血时间,凝血酶时间、凝血酶原时间均显著延长,并呈明显量效关系;能降低血液黏度,抑制血栓形成.其抗凝机制是,其对凝血酶-纤维蛋白原反应有直接的抑制作用.地龙尚有促纤溶作用,能使已形成的血栓溶解;
乳香、没药活血止痛、解毒消痈;威灵仙、白芷、石见穿、地龙、乳香、没药共为佐,以助君臣消结生肌、活血通络。紫花地丁清热解毒、凉血消肿,通络止痛,为使药。全方合用,共奏拔毒清浊、活血通络之功。
本发明的有益效果是:
本发明制研制的痛风化石膏作用温和,化石止痛效果显著,定期使用可以有效减小痛风石及软化新出现的痛风结节,可避免口服药物对消化系统的损伤和对肝肾功能的影响,使用方便,无刺激,药物直达病灶,局部吸收而发挥疗效;我们相信痛风化石膏的研制开发成功,将会产生较好的社会效益与经济效益。
附图说明
图1是一种治疗皮下痛风石的中药外用化石乳膏的制备方法流程图;
图2是实施例2病例使用本发明配方制备乳膏病情变化情况图;
图3是实施例3病例使用本发明配方制备乳膏病情变化情况图;
图4是实施例4病例使用本发明配方制备乳膏病情变化情况图。
具体实施方式
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例,都属于本发明保护的范围。
实施例1
按照以下方法制备得到本发明的治疗皮下痛风石的中药外用化石乳膏:
S1:称重:按照如下重量配比称取各中药原料:皂角刺30g、山慈菇20g、生牡蛎30g、土茯苓30g、僵蚕25g、威灵仙50g、白芷30g、地龙15g、乳香10g、没药10、石见穿10g、紫花地丁15g;
S2:挥发油提取:处方十二味,取白芷、乳香、没药三味,按照材料与水1:10的量加水浸泡2h;采用水蒸汽蒸馏法提取挥发油,提取时长4.5h,收取挥发油备用;
S3:浸膏提取:S2中提取收集完挥发油后,将药渣过滤,药液另存;过滤得到的药渣与余下九味药材加水煎煮三次;第一次加相当于药材10倍量的水熬煮60min,过滤药渣,药液另存;第二次加相当于药渣8倍量的水熬煮40min,过滤药渣,药液另存;第三次加相当于药渣6倍量的水熬煮30min,过滤药渣,药液另存;将三次煎煮所得药液通过减压浓缩至相对密度1.15-1.20后制得浸膏备用;
S4:A相提取:称取硬脂酸150g、液状石蜡100g、白凡士林100g,将上述材料通过80℃水浴加热融化制得A相;
S5:B相提取:称取甘油100g、三乙醇胺50g、羟苯乙酯2g,混合蒸馏水后通过80℃水浴加热至溶解,加入S3中提取的浸膏,搅拌均匀,80℃水浴加热保温的B相;
S6:乳膏制备:将S5中提取的B相缓慢加入S4提取的A相中,边加边搅拌,直至均质乳化且温度低于60℃,加入S2中提取的挥发油,继续搅拌,使其均质乳化,直至冷凝后分装,即制得乳膏。
实施例2
1)病例对象:
张某某,中老年男性,2017年12月到我科门诊就诊,双耳、双手、双肘、双臀、双膝、双足多个散在痛风石,最大者如“鸡蛋”大小,足趾痛风石破溃,四肢多关节肿痛,活动困难;门诊化验后肌酐124umol,血尿酸508umol/l,CRP14.86mg/L、ESR56mm/h;
2)治疗方案:
每日在患处涂抹三次痛风化石乳膏,每次30g,同时配合给予竹叶石膏汤3剂,1周后四肢关节肿痛明显好转,右足趾破溃口逐渐愈合,调整方药予健脾渗湿方,继续外用痛风化石膏,半月后右足趾破溃口愈合,痛风石逐渐缩小;复查肌酐118umol、血尿酸415umol/l、CRP4.06mg/L、ESR29mm/h。
实施例3
病例对象:
段某某,女性,50岁,到我科门诊就诊时,右手小拇指尖出现“豌豆”大小痛风石;给予痛风化石乳膏涂抹半个月,同时配合给予竹叶石膏汤,半个月后,痛风石消失。
实施例4
病例对象:
余某某,女性,手部关节有多处痛风结石形成,且透过皮肤可见白色结节;给予痛风化石乳膏涂抹半个月,同时配合给予竹叶石膏汤,一个月后,食指第三关节处痛风石消失,第一关节处痛风石明显变小。
在本说明书的描述中,参考术语“一个实施例”、“示例”、“具体示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中,对上述术语的示意性表述不一定指的是相同的实施例或示例。而且,描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
以上公开的本发明优选实施例只是用于帮助阐述本发明。优选实施例并没有详尽叙述所有的细节,也不限制该发明仅为所述的具体实施方式。显然,根据本说明书的内容,可作很多的修改和变化。本说明书选取并具体描述这些实施例,是为了更好地解释本发明的原理和实际应用,从而使所属技术领域技术人员能很好地理解和利用本发明。本发明仅受权利要求书及其全部范围和等效物的限制。
Claims (6)
1.一种治疗皮下痛风石的中药外用化石乳膏,其特征在于,包括:皂角刺、山慈菇、生牡蛎、土茯苓、僵蚕、威灵仙、白芷、地龙、乳香、没药、石见穿、紫花地丁;上述成分按照以下重量配比:皂角刺25-35g、山慈菇15-25g、生牡蛎25-35g、土茯苓25-35g、僵蚕20-30g、威灵仙45-55g、白芷25-35g、地龙10-20g、乳香5-15g、没药5-15g、石见穿5-15g、紫花地丁10-20g。
2.根据权利要求1所述一种治疗皮下痛风石的中药外用化石乳膏,其特征在于,各中药原料的重量配比为:皂角刺30g、山慈菇20g、生牡蛎30g、土茯苓30g、僵蚕25g、威灵仙50g、白芷30g、地龙15g、乳香10g、没药10、石见穿10g、紫花地丁15g。
3.一种治疗皮下痛风石的中药外用化石乳膏的制备方法,其特征在于,包括以下步骤:
S1:称重:按照如下重量配比称取各中药原料:皂角刺30g、山慈菇20g、生牡蛎30g、土茯苓30g、僵蚕25g、威灵仙50g、白芷30g、地龙15g、乳香10g、没药10、石见穿10g、紫花地丁15g;
S2:挥发油提取:处方十二味,取白芷、乳香、没药三味,按照材料与水1:10的量加水浸泡1.5-2h;采用水蒸汽蒸馏法提取挥发油,提取时长4-5h,收取挥发油备用;
S3:浸膏提取:S2中提取收集完挥发油后,将药渣过滤,药液另存;过滤得到的药渣与余下九味药材加水煎煮三次;将三次煎煮所得药液通过减压浓缩后制得浸膏备用;
S4:A相提取:称取硬脂酸150g、液状石蜡100g、白凡士林100g,将上述材料通过水浴加热融化制得A相;
S5:B相提取:称取甘油100g、三乙醇胺50g、羟苯乙酯2g,混合蒸馏水后水浴加热至溶解,加入S3中提取的浸膏,搅拌均匀,水浴加热保温的B相;
S6:乳膏制备:将S5中提取的B相缓慢加入S4提取的A相中,边加边搅拌,直至均质乳化且温度低于60℃,加入S2中提取的挥发油,继续搅拌,使其均质乳化,直至冷凝后分装,即制得乳膏。
4.根据权利要求3所述一种治疗皮下痛风石的中药外用化石乳膏的制备方法,其特征在于,所述S3中三次煎煮的方法为:第一次加相当于药材10倍量的水熬煮60min,过滤药渣,药液另存;第二次加相当于药渣8倍量的水熬煮40min,过滤药渣,药液另存;第三次加相当于药渣6倍量的水熬煮30min,过滤药渣,药液另存。
5.根据权利要求3所述一种治疗皮下痛风石的中药外用化石乳膏的制备方法,其特征在于,所述S3中需减压浓缩至相对密度为1.15-1.20。
6.根据权利要求3所述一种治疗皮下痛风石的中药外用化石乳膏的制备方法,其特征在于,所述S4和S5中水浴温度为75-82℃。
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