CN115607608B - 一种复方花椒软膏剂及其制备方法 - Google Patents
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Abstract
本发明公开了一种复方花椒软膏剂及其制备方法,本发明所述药物由由花椒、艾叶、蒲公英、紫花地丁、地肤子、蛇床子、白鲜皮、野菊花、皂刺、雄黄、黄柏、川楝子、苦参、硫磺、紫草、炉甘石制成。本发明具有清热燥湿、解毒杀虫之功效,用于皮肤疥鲜,湿疹、痈疮疔毒、皮肤瘙痒等证。本发明制备方法易于操作,各相相互融合,制得的膏体颜色均一,无明显颗粒,易于涂布,产品质量较好。
Description
发明领域
本发明涉及一种复方花椒软膏剂及其制备方法,属于药品技术的领域。
背景技术
寄生于人体的疥疮和癣病均是较常见的皮肤病。疥疮多以手指缝最多见,亦常见于肘窝、腋下、小腹、腹股沟、臀部和腿部等所,甚则遍及全身。呈现针头大小的丘疹和水疱,痒甚,故体表常见抓痕和结痂。抓后有滋水者,称为湿疮;无滋水者,称为干疥;因搔破皮肤而感染化脓者,称为“脓窝疥”。本病多因风湿热邪郁于皮肤,接触传染,疥虫潜隐皮肤所致。癣病中医也有诸多之分。根据病损的部位、好发季节、好发年龄、临床病损特点不同,有诸多不同的名称。如松皮癣(又名白疮、类似银屑病)、吹花癣(桃花癣,多发于春月)、圆癣(金钱癣、笔管癣)、蛇皮癣(鱼鳞癣)、牛皮癣、鹅掌风(掌心风、鹅爪疯)、奶癣、股癣等等。其特点均以皮疹白屑,浸润肥厚、局部瘙痒,甚则刮破皮出血等。其病因多因血虚风燥,营卫失调,外受风邪,肌肤失养所致。
软膏剂是指药物与适宜基质均匀混合制成的具有一定稠度的外用半固体制剂。软膏剂按照药物在基质中的分散状态不同,可分为溶液型和混悬型。药物溶解或共熔于基质或基质组分中制成的是溶液型,药物细粉均匀分散于基质中制成的则为混悬型。由上可知,软膏剂中的药物可以溶解于基质中,也可以分散于基质中。如果选择合适的基质,使药物溶解于基质中的其中一相,从而使药物以分子形式存在,当两相混合时,药物就均匀分布在基质中。这样不仅可以保证药物剂量和药效,而且还可以避免药物颗粒的存在使软膏药物浓度局部过高引起对皮肤的刺激性。
科技的变革给现代医药制剂的发展也带来了巨大的改变,现在的中药软膏剂大多数是以石蜡、羊毛脂或脂质类乳化剂为基质。其渗透性强,起效快且对环境不易造成污染,不需要火烤,使用起来也极为简便。在制剂的过程中适当加入促进剂,如冰片、当归挥发油、氮酮等能使软膏剂中的药物的穿透力增强。复方中药软膏剂以湿润柔软的状态较佳,明代的医学家吴谦在《医宗金》就提到:“膏药当以湿润柔软、借湿以开窍、干则药气不入反添拘急之苦”,只是当是还没有更为科学的理论来证明它的危害,也没有找到制作像当代软膏剂的底料即基质。与传统的黑药膏相比,现代的软膏剂在基质选择和制作工艺上有科学、高效、方便卫生等特点,在很大程度上推动了中医药走出国门,也推动了中药的发展。
本发明选用具有清热燥湿、解毒杀虫的功效的软膏剂,用于皮肤疥鲜,湿疹、痈疮疔毒、皮肤瘙痒等证。易于制备操作,各相相互融合,制得的膏体颜色均一,无明显颗粒,易于涂布,产品质量较好。
发明内容
本发明所要解决的技术问题在于提供一种复方花椒软膏剂及其制备方法。本发明具有清热燥湿、解毒杀虫之功效,用于皮肤疥鲜,湿疹、痈疮疔毒、皮肤瘙痒等证。本发明制备方法易于操作,各相相互融合,制得的膏体颜色均一,无明显颗粒,易于涂布,产品质量较好。
为解决以上技术问题,本发明采用以下技术方案实现:
一种复方花椒软膏剂,其药用有效成分按照重量组分计算:由花椒80-160份、艾叶60-140份、蒲公英40-120份、紫花地丁40-120份、地肤子60-140份、蛇床子60-140份、白鲜皮40-120份、野菊花40-120份、皂刺60-140份、雄黄110-190份、黄柏60-140份、川楝子60-140份、苦参60-140份、硫磺110-190份、紫草40-120份、炉甘石60-140份制成。
前述的复方花椒软膏剂,其药用有效成分按照重量组分计算:由花椒100-140份、艾叶80-120份、蒲公英60-100份、紫花地丁60-100份、地肤子80-120份、蛇床子80-120份、白鲜皮60-100份、野菊花60-100份、皂刺80-120份、雄黄130-170份、黄柏80-120份、川楝子80-120份、苦参80-120份、硫磺130-170份、紫草60-100份、炉甘石80-120份制成。
具体的说,前述的复方花椒软膏剂,其药用有效成分按照重量组分计算:由花椒120份、艾叶100份、蒲公英80份、紫花地丁80份、地肤子100份、蛇床子100份、白鲜皮80份、野菊花80份、皂刺100份、雄黄150份、黄柏100份、川楝子100份、苦参100份、硫磺150份、紫草80份、炉甘石100份制成。
前述复方花椒软膏剂的制备方法,按照比例称取方中所有药材,并按照常规的制备方法进行加工,制成相应的药物制剂。
前述药物制剂包括软膏剂。
前述软膏剂的制备方法按照以下步骤进行:
(1)按照比例称取方中所有药材,粉碎后混合均匀,放入圆底烧瓶中再加入乙醇溶液浸泡,再放于加热套上加热回流,放冷得提取液,即得A品;
(2)将冷却后的A品用压力泵抽滤,滤去残渣得无残渣的提取液,即得B品;
(3)取B品放入旋转蒸发仪,分离B品中的乙醇和水,转入烘箱中烘干即得提取物D。
(4)将纯化水和甘油加入蒸发皿中,再加入三乙醇胺和硬脂酸钠,在加热套上加热融化,得水相;
(5)将液体石蜡、白凡士林和羊毛脂加入蒸发皿中,再加入单硬脂酸甘油酯,放于加热套上加热融化,得油相;
(6)取水相和油相,将提取物D与步骤(5)中的水相混合均匀后,再加入步骤(5)中的油相中,并沿同一方向不断搅拌直至冷凝,即得软膏剂。
具体的说,前述软膏剂的制备方法按照以下步骤进行:
(1)按照比例称取方中所有药材,粉碎过200-300目筛后混合均匀,放入圆底烧瓶中再加入70-90%乙醇溶液浸泡2-10小时,药材与70-90%乙醇的比例为1g:10-20ml,再放于加热套上加热回流1-3.5h,放冷得提取液,即得A品;
(2)将冷却后的A品用压力泵抽滤,滤去残渣得无残渣的提取液,即得B品;
(3)取B品放入旋转蒸发仪,分离B品中的乙醇和水后,转入烘箱中烘干即得提取物D。
(4)将8-12g纯化水和2-4g甘油加入蒸发皿中,再加入0.06-0.15g三乙醇胺和0.5-2g硬脂酸钠,在加热套上加热融化至温度为70-90℃,得水相;
(5)将1-3g液体石蜡、1-3g白凡士林和0.5-2g羊毛脂加入蒸发皿中,再加入0.5-2g单硬脂酸甘油酯,放于加热套上加热融化至70-90℃,得油相;
(6)取70-90℃状态下的水相和油相,保持水相温度高于油相温度2-3℃,将0.3-0.8g提取物D与步骤(4)中的水相混合均匀后,再加入步骤(5)中的油相中,并沿同一方向不断搅拌直至冷凝,即得软膏剂。
更具体的说,前述软膏剂的制备方法按照以下步骤进行:
(1)按照比例称取方中所有药材,粉碎过300目筛后混合均匀,放入圆底烧瓶中再加入70%乙醇溶液浸泡6小时,药材与70%乙醇的比例为1g:20ml,再放于加热套上加热回流2.5h,放冷得提取液,即得A品;
(2)将冷却后的A品用压力泵抽滤,滤去残渣得无残渣的提取液,即得B品;
(3)取B品放入旋转蒸发仪,分离B品中的乙醇和水后,转入烘箱中烘干即得提取物D。
(4)将10g纯化水和3g甘油加入蒸发皿中,再加入0.09g三乙醇胺和1g硬脂酸钠,在加热套上加热融化至温度为75-85℃,得水相;
(5)将2g液体石蜡、2g白凡士林和1g羊毛脂加入蒸发皿中,再加入1g单硬脂酸甘油酯,放于加热套上加热融化至75-80℃,得油相;
(6)取75-85℃状态下的水相和油相,保持水相温度高于油相温度2-3℃,将0.5g提取物D与步骤(4)中的水相混合均匀后,再加入步骤(5)中的油相中,并沿同一方向不断搅拌直至冷凝,即得软膏剂。
与现有技术相比,本发明具有以下有益效果:
本发明所述复方花椒软膏剂由花椒、艾叶、蒲公英、紫花地丁、地肤子、蛇床子、白鲜皮、野菊花、皂刺、雄黄、黄柏、川楝子、苦参、硫磺、紫草、炉甘石制成。花椒为芸香科植物青椒Zanthoxylum schinifolium Sieb.et Zucc.或花椒Zanthoxylum bungeanum Maxim.的干燥成熟果皮;味辛,性温;归脾、胃、肾经;具有抗菌、温中散寒、止痛、除湿、杀虫、解鱼腥毒的功效;可治疗积食停饮、心腹冷痛、呕吐、齿痛、蛔虫病、阴痒、疮疥、蛲虫病;外治湿疹,阴痒。艾叶为菊科植物艾Artemisia argyi LevL et Vant.的干燥叶;夏季花未开时采摘,除去杂质,晒干;味辛、苦,性温;有小毒;归肝、脾、肾经;具有温经止血,散寒止痛;外用祛湿止痒的功效;用于吐血,衄血,崩漏,月经过多,胎漏下血,少腹冷痛,经寒不调,宫冷不孕;外治皮肤瘙痒;醋艾炭温经止血,用于虚寒性出血。蒲公英为菊科植物蒲英Taraxacummongolicum Hand.-Mazz.喊地蒲公英Taraxacum borealisinense Kitam.或同属数种植物的干燥全草;春至秋季花初开时采挖,除去;杂质,洗净,晒苦;味甘,性寒;归肝、胃经;具有清热解毒,消肿散结,利尿通淋的作用;用于疔疮肿毒,乳痈,瘰疬,目赤,咽痛,肺痈,肠痈,湿热黄疸,热淋涩痛。紫花地丁本品为堇菜科植物紫花地丁Viola yedoensis Makino的干燥全草;味苦、辛,性寒;归心、肝经;具有清热解毒,凉血消肿的功效;用于疔疮肿毒,痈疽发背,丹毒,毒蛇咬伤。地肤子本品为藜科植物地肤Kochia scoparia(L.)Schrad.的干燥成熟果实;味辛、苦,性寒;归肾、膀胱经;具有清热利湿,祛风止痒的功效;用于小便涩痛,阴痒带下,风疹,湿疹,皮肤瘙痒。蛇床子本品为伞形科植物蛇床Cnidium monnieri(L.)Cuss.的干燥成熟果实;味辛、苦,性温;有小毒。归肾经;具有燥湿祛风,杀虫止痒,温肾壮阳的功效;用于阴痒带下,湿疹瘙痒,湿痹腰痛,肾虚阳痿,宫冷不孕。白鲜皮为芸香科植物白鲜Dictamnus dasycarpus Turcz.的干燥根皮;味苦,性寒;归脾、胃、膀胱经;具有清热燥湿,祛风解毒的功效;用于湿热疮毒,黄水淋漓,湿疹,风疹,疥癣疮癞,风湿热痹,黄疸尿赤。野菊花为菊科植物野菊Chrysanthemum indicum L.的干燥头状花序;味苦、辛,性微寒;归肝、心经;具有清热解毒,泻火平肝的功效;用于疔疮痈肿,目赤肿痛,头痛眩晕。皂刺为豆科植物皂荚Gleditsia sinensis Lam.的干燥棘刺;味辛,性温;归肝、胃经;具有消肿托毒,排脓,杀虫的功效;用于痈疽初起或脓成不溃;外治疥癣麻风。雄黄为硫化物类矿物雄黄族雄黄,主含二硫化二砷(AS2S2);味辛,性温;有毒;归肝、大肠经;具有解毒杀虫,燥湿祛痰,截疟的功效;用于痈肿疔疮,蛇虫咬伤,虫积腹痛,惊痫,疟疾。黄柏为芸香科植物黄皮树Phellodendron chinense Schneid.的干燥树皮;味苦,性寒;归肾、膀胱经;具有清热燥湿,泻火除蒸,解毒疗疮的功效;用于湿热泻痢,黄疸尿赤,带下阴痒,热淋涩痛,脚气痿躄,骨蒸劳热,盗汗,遗精,疮疡肿毒,湿疹湿疮。盐黄柏滋阴降火。用于阴虚火旺,盗汗骨蒸。川楝子为楝科植物川楝Melia toosendan Sieb.et Zucc.的干燥成熟果实;味苦,性寒;有小毒;归肝、小肠、膀胱经;具有疏肝泄热,行气止痛,杀虫的功效;用于肝郁化火,胸胁、脘腹胀痛,疝气疼痛,虫积腹痛。苦参为豆科植物苦参Sophora flavescens Ait.的干燥根;味苦,性寒;归心、肝、胃、大肠、膀胱经;具有清热燥湿,杀虫,利尿的功效;用于热痢,便血,黄疸尿闭,赤白带下,阴肿阴痒,湿疹,湿疮,皮肤瘙痒,疥癣麻风;外治滴虫性阴道炎。硫磺别名硫,是一种非金属单质,化学式为S,为淡黄色脆性结晶或粉末,有特殊臭味,不溶于水,微溶于乙醇、乙醚,易溶于二硫化碳;味酸、性温、有毒,归肾和大肠经;功效是外用能杀虫止痒;可用于疥癣、湿疹、皮肤瘙痒。紫草为紫草科植物新疆紫草Arnebia euchroma(Royle)Johnst.或内蒙紫草Arnebia guttata Bunge的干燥根;味甘、咸,性寒;归心、肝经;具有清热凉血,活血解毒,透疹消斑的功效;用于血热毒盛,斑疹紫黑,麻疹不透,疮疡,湿疹,水火烫伤。炉甘石为碳酸盐类矿物方解石族菱锌矿,主含碳酸锌(ZnCO3);味甘,性平;归肝、脾经;具有解毒明目退翳,收湿止痒敛疮的功效;用于目赤肿痛,睑弦赤烂,翳膜遮睛,胬肉攀睛,溃疡不敛,脓水淋漓,湿疮瘙痒。
方解:方中花椒杀虫燥湿止痒为君药,艾叶、雄黄、硫磺等助君药杀虫止痒,且解毒疗疮,共为臣药;蒲公英、紫花地丁、野菊花等清热解毒,黄柏、白鲜皮、苦参、川楝子、地肤子等解毒祛湿,皂刺消肿杀虫;于清热解毒之中,伍以散结消肿之品,炉甘石解毒敛疮,收湿止痒,紫草凉血解毒,共为佐药以助君药燥湿止痒,并佐制君臣药温热之性;诸药合用,共奏清热燥湿、解毒杀虫之功,用于皮肤疥鲜,湿疹、痈疮疔毒、皮肤瘙痒等证。
本发明制备成软膏剂的有益效果:
1、本发明提出的复方花椒软膏剂中,三乙醇胺、单硬脂酸甘油酯、硬脂酸钠、羊毛脂、液体石蜡、白凡士林的质量是最为合适的复方花椒软膏剂基质处方配比,使膏体外观形状好,平整细腻,易于涂布,便于生产。即该处方工艺稳定,质量可控,合理可行。
2、以提取物质量为指标,对乙醇浓度、料液比、浸泡时间以及回流时间在单因素考察的基础上设计正交实验,确定了该软膏剂中药的最佳提取工艺:⑴称取复方中的中药各3g,将这些中药全部放入圆底烧瓶中再加入70%乙醇溶液,料液比为1:20,浸泡6小时,放于加热套上加热回流2.5小时,放冷得提取液;⑵将冷却后的提取液用压力泵抽滤得无残渣的提取液;⑶用旋转蒸发仪将无残渣提取液中的乙醇和水旋出来,旋至只剩极少量溶剂后,将其转入烘箱中烘干即得提取物。
3、本发明优选配方制备的软膏剂基质均匀,主药的活性成分能够充分的分散于基质中,无油水分离现象,具有良好的黏着性,质地柔软细腻,易于涂抹并展开。
附图说明
图1:线性关系标准曲线图;
图2:样品色谱图;
图3:样品加标品色谱图。
具体实施方式
下面结合实施例对本发明作进一步的说明,但并不作为对本发明限制的依据。
实施例1。
处方:花椒12g,艾叶10g、蒲公英8g、紫花地丁8g、地肤子10g、蛇床子10g、白鲜皮8g、野菊花8g、皂刺10g、雄黄15g、黄柏10g、川楝子10g、苦参10g、硫磺15g、紫草8g、炉甘石10g制成。
工艺:
(1)按照比例称取方中所有药材,粉碎过300目筛后混合均匀,放入圆底烧瓶中再加入70%乙醇溶液浸泡6小时,药材与70%乙醇的比例为1g:20ml,再放于加热套上加热回流2.5h,放冷后用压力泵抽滤,滤去残渣得无残渣的提取液,取无残渣的提取液放入旋转蒸发仪,分离乙醇和水后,转入烘箱中烘干即得提取物。
(2)将10g纯化水和3g甘油加入蒸发皿中,再加入0.09g三乙醇胺和1g硬脂酸钠,在加热套上加热融化至温度为75℃,得水相;
(3)将2g液体石蜡、2g白凡士林和1g羊毛脂加入蒸发皿中,再加入1g单硬脂酸甘油酯,放于加热套上加热融化至77℃,得油相;
(4)取0.5g提取物与水相混合均匀后,再加入油相中,并沿同一方向不断搅拌直至冷凝,即得软膏剂。
用法用量:每天早晚一次,涂于患处。
实施例2。
处方:花椒8g、艾叶6g、蒲公英4g、紫花地丁4g、地肤子6g、蛇床子6g、白鲜皮4g、野菊花4g、皂刺6g、雄黄11g、黄柏6g、川楝子6g、苦参6g、硫磺11g、紫草4g、炉甘石6g制成。
工艺:
(1)按照比例称取方中所有药材,粉碎过200目筛后混合均匀,放入圆底烧瓶中再加入70%乙醇溶液浸泡2小时,药材与70%乙醇的比例为1g:10ml,再放于加热套上加热回流1h,放冷后的A品用压力泵抽滤,滤去残渣得无残渣的提取液,取无残渣的提取液放入旋转蒸发仪,分离乙醇和水后,转入烘箱中烘干即得提取物。
(2)将8g纯化水和2g甘油加入蒸发皿中,再加入0.06g三乙醇胺和0.5g硬脂酸钠,在加热套上加热融化至温度为70℃,得水相;
(3)将1g液体石蜡、1g白凡士林和0.5g羊毛脂加入蒸发皿中,再加入0.5g单硬脂酸甘油酯,放于加热套上加热融化至73℃,得油相;
(4)取0.3g提取物与水相混合均匀后,再加入油相中,并沿同一方向不断搅拌直至冷凝,即得软膏剂。
用法用量:每天早晚一次,涂于患处。
实施例3。
处方:花椒16g、艾叶14g、蒲公英12g、紫花地丁12g、地肤子14g、蛇床子14g、白鲜皮12g、野菊花12g、皂刺14g、雄黄19g、黄柏14g、川楝子14g、苦参14g、硫磺19g、紫草12g、炉甘石14g制成。
工艺:(1)按照比例称取方中所有药材,粉碎过300目筛后混合均匀,放入圆底烧瓶中再加入90%乙醇溶液浸泡10小时,药材与90%乙醇的比例为1g:20ml,再放于加热套上加热回流3.5h,放冷后的A品用压力泵抽滤,滤去残渣得无残渣的提取液,取无残渣的提取液放入旋转蒸发仪,分离乙醇和水后,转入烘箱中烘干即得提取物。
(2)将12g纯化水和4g甘油加入蒸发皿中,再加入0.15g三乙醇胺和0.5-2g硬脂酸钠,在加热套上加热融化至温度为85℃,得水相;
(3)将3g液体石蜡、3g白凡士林和2g羊毛脂加入蒸发皿中,再加入2g单硬脂酸甘油酯,放于加热套上加热融化至88℃,得油相;
(4)取0.8g提取物与水相混合均匀后,再加入油相中,并沿同一方向不断搅拌直至冷凝,即得软膏剂。
用法用量:每天早晚一次,涂于患处。
实施例4。
处方:花椒10g、艾叶12g、蒲公英4g、紫花地丁12g、地肤子10g、蛇床子12g、白鲜皮6g、野菊花12g、皂刺9g、雄黄15g、黄柏10g、川楝子14g、苦参6g、硫磺19g、紫草8g、炉甘石11g制成。
工艺:(1)按照比例称取方中所有药材,粉碎过250目筛后混合均匀,放入圆底烧瓶中再加入80%乙醇溶液浸泡6小时,药材与80%乙醇的比例为1g:15ml,再放于加热套上加热回流3h,放冷后的A品用压力泵抽滤,滤去残渣得无残渣的提取液,取无残渣的提取液放入旋转蒸发仪,分离乙醇和水后,转入烘箱中烘干即得提取物。
(2)将10g纯化水和3.5g甘油加入蒸发皿中,再加0.1g三乙醇胺和2g硬脂酸钠,在加热套上加热融化至温度为80℃,得水相;
(3)将3g液体石蜡、1.5g白凡士林和0.5g羊毛脂加入蒸发皿中,再加入1g单硬脂酸甘油酯,放于加热套上加热融化至83℃,得油相;
(4)取0.6g提取物与水相混合均匀后,再加入油相中,并沿同一方向不断搅拌直至冷凝,即得软膏剂。
用法用量:每天早晚一次,涂于患处。
实施例5。
处方:花椒10g、艾叶14g、蒲公英9g、紫花地丁12g、地肤子7g、蛇床子11g、白鲜皮12g、野菊花5g、皂刺8g、雄黄12g、黄柏13g、川楝子12g、苦参9g、硫磺18g、紫草12g、炉甘石8g制成。
工艺:(1)按照比例称取方中所有药材,粉碎过300目筛后混合均匀,放入圆底烧瓶中再加入75%乙醇溶液浸泡4小时,药材与75%乙醇的比例为1g:10ml,再放于加热套上加热回流1.5h,放冷后的A品用压力泵抽滤,滤去残渣得无残渣的提取液,取无残渣的提取液放入旋转蒸发仪,分离乙醇和水后,转入烘箱中烘干即得提取物。
(2)将11g纯化水和2.5g甘油加入蒸发皿中,再加入0.9g三乙醇胺和1.5g硬脂酸钠,在加热套上加热融化至温度为80℃,得水相;
(3)将1g液体石蜡、3g白凡士林和0.5g羊毛脂加入蒸发皿中,再加入2g单硬脂酸甘油酯,放于加热套上加热融化至82℃,得油相;
(4)取0.3g提取物与水相混合均匀后,再加入油相中,并沿同一方向不断搅拌直至冷凝,即得软膏剂。
用法用量:每天早晚一次,涂于患处。
实施例6。
处方:花椒16g、艾叶14g、蒲公英4g、紫花地丁4g、地肤子10g、蛇床子12g、白鲜皮8g、野菊花9g、皂刺12g、雄黄17g、黄柏11g、川楝子11g、苦参9g、硫磺11g、紫草5g、炉甘石13g制成。
工艺:(1)按照比例称取方中所有药材,粉碎过200目筛后混合均匀,放入圆底烧瓶中再加入85%乙醇溶液浸泡8小时,药材与85%乙醇的比例为1g:20ml,再放于加热套上加热回流2h,放冷后的A品用压力泵抽滤,滤去残渣得无残渣的提取液,取无残渣的提取液放入旋转蒸发仪,分离乙醇和水后,转入烘箱中烘干即得提取物。
(2)将9g纯化水和3.5g甘油加入蒸发皿中,再加入0.12g三乙醇胺和2g硬脂酸钠,在加热套上加热融化至温度为77℃,得水相;
(3)将1g液体石蜡、1.5g白凡士林和2g羊毛脂加入蒸发皿中,再加入1g单硬脂酸甘油酯,放于加热套上加热融化至80℃,得油相;
(4)取0.6g提取物与水相混合均匀后,再加入油相中,并沿同一方向不断搅拌直至冷凝,即得软膏剂。
用法用量:每天早晚一次,涂于患处。
本发明进行了大量的实验研究,以下为本发明实验研究的结果:
1.提取与制备工艺优化
1.1提取工艺的优化
1.1.1提取率的确定
由于用到的中药种类较多,计算单一成分不太准确,提取率采用称量蒸发后得到的浸膏的质量与所用的中药总质量之比来计算,即
提取率=(浸膏质量÷中药总质量)×100%#(1)
1.1.2实验方法与内容
处方:花椒12g,艾叶10g、蒲公英8g、紫花地丁8g、地肤子10g、蛇床子10g、白鲜皮8g、野菊花8g、皂刺10g、雄黄15g、黄柏10g、川楝子10g、苦参10g、硫磺15g、紫草8g、炉甘石10g制成。
实验方法:按照处方量称取药材,依照正交实验的九组数据条件,以第一组为例,将无水乙醇与纯水混合按条件配成70%的乙醇,将复方中药与配成的70%乙醇以1:10的比例混合,即在圆底烧瓶中加入48g中药和480ml的70%乙醇,浸泡2小时后,安装回流提取装置,让浸泡后的药物在加热套上加热回流1小时,回流结束后冷却至室温,用真空泵抽滤药液,抽滤后取滤液用旋转蒸发仪将液体挥发至接近浸膏的状态,再将浸膏装入烧杯中放入烘箱烘干后称重即得中药总提取物的质量。
正交实验设计:以乙醇浓度(A)、乙醇与药物比例(B)、浸泡时间(C)以及回流时间(D)为主要因素,以四因素三水平进行排列设计正交实验,按照实验方法进行九组正交实验,计算每组实验的提取率,考察指标:提取率。
表1.1四因素三水平
1.1.3实验结果
表1.2正交实验组合与结果
表1.3方差分析结果
方差来源 | 离差平方和 | 自由度 | 均方 | F |
A | 9.8901 | 2 | 4.9451 | 2.3944 |
B | 9.8502 | 2 | 4.9251 | 2.3846 |
C | 4.423 | 2 | 2.2112 | 1.0706 |
D | 2.3188 | 2 | 1.1594 | 0.5614 |
由表1.2、表1.3可知,各因素对十六味中药的提取率的影响顺序依次为A>B>C>D,其中A与B的离差平方和值较大且两者差值不大,因此A和B对提取率影响较大且影响强度差别不大,C和D较A、B值小,对提取率的影响弱于A和B,经分析A选择水平1、B选择水平3、C选择水平2、D选择水平3,组合为A1B3C2D3,即乙醇浓度为70%、中药与乙醇比例为1:20、浸泡时间为6小时、回流时间为150分钟。
1.1.4讨论
通过考察乙醇浓度、中药与乙醇的比例、浸泡时间以及回流时间四个因素,可以发现乙醇浓度在70%的时候提取率是最高的,当乙醇的浓度大于70%时,提取率降低,主要原因可能是十六种中药中的某些化合物在乙醇浓度增大时出现溶解度减小的情况。乙醇为半极性溶剂,溶解性能介于极性与非极性溶剂中间。它不仅可以溶解一些水溶性成分,如生物碱及其盐类、糖、苷类以及苦味质等;还能溶解一些非极性物质,如树脂、内酯、挥发油、芳烃类化合物等,较少量的脂肪也可以被乙醇溶解。乙醇能与水任意比例混合,许多提取实验中经常使用不同浓度的乙醇有选择性的浸提中药材的有效成分。通常乙醇含量在90%以上时适用于浸提挥发油、树脂、有机酸、叶绿素等成分;乙醇含量在50%-70%时,适用于浸提生物碱、苷类等成分;乙醇含量在50%以下时,适用于浸提苦味质、蒽醌类等化合物;而乙醇含量大于40%时,能够起到延缓多种物质,如酯类、苷类等成分的水解和增加制剂稳定性的作用,乙醇含量在20%以上时还能起到防腐的作用。在料液比为1:20、浸泡时间为6小时、回流时间为150分钟时提取率最大,比较合理的解释是:十六种中药中的某些成分与水和乙醇存在一定的溶解比,随着乙醇量、浸泡时间以及回流时间的增加,溶剂中能够溶解较多的中药成分,达到一定值时,浸泡时间的增加不再使中药中成分浓度增加,浸泡时间过长不仅耗时,有可能还会使药效降低。但是,由于中药与乙醇的比例和回流时间这两个因素没有进行更大值的实验,可能还存在增加这两个因素的值时提取率下降的情况。此外需要指出的是,在提取工艺优化的相关研究中,以中药材的浸膏提取率作为标准评价工艺的好坏时会存在些许问题,如油状物浸膏存在影响称量、浸膏的干燥程度不同等现象,可能会对最后的提取工艺条件的确定造成干扰,因此这些都是还需要考虑并把控的因素。
除了以上四点试验的因素对提取率有影响外,还可以通过以下方法来提高中药的提取率。
可以将用到的中药材进行超微粉处理,中药材经过超微粉处理后细胞壁破碎率高达95%,不仅能破坏细胞之间的细胞层,还能将细胞打碎,粉碎后得到的中药材微粉可以全通过300目筛(孔内径为47um)。细胞经破壁处理后,细胞中的活性成分充分暴露,使提取溶剂能与活性成分直接接触,可以缩短提取时间,提高了中药材体外溶出度,特别是对大分子成分提取率的提高更为明显。在进行每组实验时,每次称取的中药材都只提取一次就丢弃了,事实上丢弃的中药中还残留着些许中药成分,将回流过一次的中药加入溶剂后进行二次回流提取也是一种提高提取率的方法。
1.2软膏剂制备工艺优化
1.2.1实验方法与内容
制备方法:确定水的用量为10g、甘油用量为3g,依照正交实验的九组条件,以第一组为例,准备两个洁净且干燥的蒸发皿,称取水10g、甘油3g、三乙醇胺0.09g、硬脂酸钠0.5g为水相全部加在一个蒸发皿中,再称取液体石蜡1g、白凡士林1g、羊毛脂1g为油相加在另一个蒸发皿中,将两个蒸发皿分别放在两个加热套上加热,用温度计控制两相温度都在75-80℃且水相温度高于油相温度2-3℃,蒸发皿中的物质加热融化且温度达到要求后,将水相缓慢加入油相中,按同一方向搅拌均匀,再一直搅拌直至冷凝。
正交实验设计:固定水的用量为10g、甘油的用量为3g,以三乙醇胺、单硬脂酸甘油酯、硬脂酸钠以及油相(液体石蜡、白凡士林、羊毛脂)的比例为主要因素在三个水平下设计正交实验,将设计的九次实验做出的软膏从外观、是否流动、涂布性、有无颗粒四个方面进行简单的打分,总分为10分。
表1.4四因素三水平
1.2.2实验结果
九组软膏描述如下:
①:颜色为棕绿色,质地较稀,不易流动,易涂布于手背上,涂在手背上较光滑无明显颗粒感;
②:颜色较1号浅,质地较1号细腻,易涂布于手背上,涂在手背上无明显颗粒感;
③:颜色较2号深,质地较稀,极缓慢流动,易涂布于手背上且涂上较光滑,无明显颗粒感;
④:颜色为棕绿色,质地稀,极缓慢流动,易涂布与手背上,涂于手背出现辅料颗粒;
⑤:颜色较4号浅,质地光滑,不易流动,易涂布与手背上且光滑,无明显颗粒感;
⑥:颜色浅棕色,质地较稀,缓慢流动,易涂布于手背上且光滑,无明显颗粒感;
⑦:颜色与6号无差异,不易流动,质地较光滑,易涂布于手背上且无明显颗粒感;
⑧:颜色与7号无差异,易流动,质地稀,易涂布于手背上较光滑且无明显颗粒感;
⑨:颜色棕色,质地稀,缓慢流动,涂布于手背上不易展开,无明显颗粒感。
表1.5正交实验组合与结果
表1.6方差分析结果
方差来源 | 离差平方和 | 自由度 | 均方 | F |
A | 0.2 | 2 | 0.1 | 1.25 |
B | 2.7 | 2 | 1.35 | 16.875 |
C | 3.46 | 2 | 1.7 | 21.25 |
D | 4.5 | 2 | 2.2 | 27.5 |
由表1.5、表1.6可知,以上四因素对软膏剂的制备的影响程度为D>C>B>A,其中因素A三乙醇胺用量的离差平方和为0.2接近于0,对软膏成品的影响较小,而另外三个因素对软膏成品均匀一定的影响。经分析A可选择水平1或水平3,从用量上考虑则选择水平1,B选择水平2,C选择水平3,D选择水平2,组合为A1B2C3D2,即三乙醇胺用量为0.09g、单硬脂酸甘油酯用量为1.0g、硬脂酸钠用量为1g,液体石蜡、白凡士林、羊毛脂比例为2:2:1。
1.2.3讨论
本实验以外观性状、是否流动、涂布性以及有无颗粒等作为考察指标,对软膏工艺的辅料用量进行筛选得到了复方花椒软膏剂的最佳制备工艺条件,配方为三乙醇胺0.09g、单硬脂酸甘油酯1g、硬脂酸钠1g、油相比例(液体石蜡:白凡士林、羊毛脂)2:2:1。在最初的正交实验方案中,硬脂酸钠的三个水平为6g、7g、8g,但在加入6g硬脂酸钠制备软膏时,冷却后的成品不是软膏状的半固体物质,而是像蜡状的固体物质,重复两次后结果还是相同,在将硬脂酸钠用量减少到0.5g时,冷却后的成品成软膏状,因此将硬脂酸钠的水平改为0.5g、0.75g、1g。当硬脂酸钠越多时,膏体涂布性和延展性变差、稠度过大,稳定性下降。软膏中的硬脂酸钠通常是乳化油状物,将随着水分的蒸发,产生硬脂酸钠薄膜,对皮肤起到保护效果,但如果含量过高会使软膏变硬而成蜡状固体,润滑作用减小。
四个因素中,三乙醇胺用量对软膏制备影响最小,几乎无明显影响,可能由于三个水平的跨度较小以及总的用量较小使得表现出对软膏制备无明显影响。以上A1B2C3D2能制得最佳软膏剂的原因可能是,每个基质间或许存在着一定的联系,基质间存在着相互影响作用,单硬脂酸甘油酯具有乳化作用,其他因素固定时其用量的增加可以增强乳化能力,但到一定值时由于乳化能力的增强使得不易成形为软膏;而油相比例的增大或许影响了硬脂酸钠的作用,忽略其他因素影响,可将第3组与第7组比较,当油相比例由2:2:1变为3:3:1时,软膏由不易流动变为极缓慢流动,可能是因为油相增多,对比起来使得硬脂酸钠的乳化能力减小。
2.复方软膏剂质量控制标准初步研究
2.1软膏剂的最终评分标准
在对软膏剂进行评分时主要从以下四个方面进行评分:
1.外观:即从软膏剂的颜色评价,因为中药提取物的颜色较黑,所以加入提取物后的软膏颜色较浅的评分较高;
2.流动性:质地柔软但不易流动的软膏评分较高;
3.涂布性:将软膏涂于手背上,易于涂抹并展开的软膏评分较高;
4.有无颗粒:将软膏涂于手背上,质感细腻光滑无颗粒感的软膏评分较高。
2.2蒙花苷含量测定
2.2.1仪器与试药仪器:高效液相色谱仪(安捷伦)、电子天平(AL104)、移液枪、超声仪、试药:甲醇(分析纯)、复方花椒软膏剂成品、蒙花苷标准品(生物公司购买)、超纯水、流动相甲醇为色谱纯
2.2.2方法与结果
(1)色谱条件
色谱柱:Agilent C18(4.6*250mm,5um);柱温:30℃;流速:1.0ml/min;流动相:甲醇-水(57:43);检测波长:326nm;进样量:20ul。
(2)供试品溶液的配制
取5g复方花椒软膏剂成品(该成品按照实施例1制备)加入烧杯中,量取25ml甲醇加入软膏中,称定质量,密封后放入超声仪器中超声30分钟,超声完毕后补足损失的甲醇再将混合物进行过滤,取续滤液保存即得供试品溶液。
(3)标准品溶液的配制
精密称定5mg的蒙花苷标准品,置于10ml的容量瓶中,加入甲醇定容至刻度,摇匀,备用。
(4)线性关系考察
用移液枪精密量取0.1ml、0.5ml、1ml、2ml、3ml的蒙花苷标准品溶液于10ml容量瓶中,加入甲醇定容至刻度,摇匀,配制成浓度分别为5、25、50、100、150ug/ml的溶液。分别取上述溶液各20ul进样,在上述色谱条件下进行分析。以标准品溶液浓度(ug/ml)为横坐标,峰面积为纵坐标,绘制标准曲线并进行回归计算。结果表明,蒙花苷在5~150ug/ml内呈良好的线性关系,回归方程为Y=17.42958X-14.20966,r=0.99933(n=5)。标准曲线见图1。
(5)样品测定结果
取配制好的样品溶液按(4)项下的方法操作,在上述色谱条件下进样分析,样品色谱图见图2。
经计算机拟合出的标准曲线及预期RT=6.460min,分析出保留时间为6.635min的峰为蒙花苷,其峰面积为82.05261,代入(4)项下得到的回归方程计算得样品浓度为5.52293ug/ml,经计算制成的复方花椒软膏剂的浓度为27.6147ug/g。采用高效液相色谱法测定软膏中蒙花苷的含量,结果显示出峰时间以及峰形均较好,且蒙花苷能与其他物质较好分离,含量测定准确,该方法适用于软膏中蒙花苷的含量测定。
2.3讨论
根据以上四点评分标准筛选出的软膏具有颜色较浅、不易流动有良好的附着性、易于涂抹、质感光滑细腻无颗粒等特点。
表2.1样品主要峰信息
峰 | 保留时间(min) | 峰面积 |
1 | 4.63 | 29.99573 |
2 | 5.566 | 90.91225 |
3 | 6.635 | 82.05261 |
4 | 7.443 | 253.69637 |
5 | 8.576 | 48.34578 |
6 | 9.536 | 76.3876 |
在色谱分析时,计算机拟合点为6.460min,但样品中没有保留时间为6.460峰,而是在6.635min时有一个吸收峰,初步推测这个峰为蒙花苷,但不能做出肯定的判断,采用在样品中加入标准品的方法来检测是否为蒙花苷,若为同一物质样品峰与标准品峰会发生重合且峰面积叠加,若不是同一物质则情况相反,色谱图见图3。
表2.2样品加标品主要峰信息
峰 | 保留时间(min) | 峰面积 |
1 | 4.685 | 13.37004 |
2 | 5.654 | 35.24804 |
3 | 6.531 | 608.91046 |
4 | 7.571 | 211.37828 |
5 | 8.732 | 55.29461 |
6 | 9.677 | 53.93759 |
从图2、3以及表2.1、2.2结合来看,由于样品与样品加标品不是同一天跑样,因此会有差异,但样品加标品中未出现新的峰,可以看出样品中保留时间为6.635min的物质与样品加标品中保留时间为6.531min的物质为同一物质,峰面积由82.05261增大为608.91046,峰面积出现叠加情况,可以判断样品中保留时间为6.635的物质即为蒙花苷。出现以上现象可能是因为样品的基体效应,由于所用到的中药种类多达16种,除蒙花苷外,其中还存在着许多未知物质的影响,这些物质及其含量都会影响蒙花苷的出峰时间即保留时间。
但本实验对软膏的评价仅对其表面外观性状等进行评价,以及对野菊花中的蒙花苷这一成分进行了含量测定。除此之外,在条件允许的情况下,还可进行更深层次的质量研究。
人体的组织液PH值在7.0-7.4之间,软膏剂用于皮肤表面,因此制得的软膏在测量PH时应控制在这个范围。将制得的软膏涂于玻片上置于显微镜下观察粒度。还应检测软膏的稳定性。将软膏进行离心处理后观察有无破乳以及色泽、均匀度改变等现象;将离心处理的乳膏置于-20℃冰箱24h,观察有无分层破乳、以及色泽、均匀度改变等现象;将离心处理的软膏置于50℃恒温箱24h,观察有无分层破乳、霉败以及色泽、均匀度改变等现象;还可将软膏置于恒定温度及相对湿度的培养箱中,连续放置3个月,观察其稳定性。可采用薄层色谱分析法对复方软膏剂中的成分如苦参碱进行定性分析,检测其中是否含有苦参碱这一成分。
Claims (2)
1.一种复方花椒软膏剂,其特征在于:其药用有效成分按照重量组分计算:由花椒100-140份、艾叶80-120份、蒲公英60-100份、紫花地丁60-100份、地肤子80-120份、蛇床子80-120份、白鲜皮60-100份、野菊花60-100份、皂刺80-120份、雄黄130-170份、黄柏80-120份、川楝子80-120份、苦参80-120份、硫磺130-170份、紫草60-100份、炉甘石80-120份制成;
所述复方花椒软膏剂的制备方法按照以下步骤进行:
(1)按照比例称取方中所有药材,粉碎过300目筛后混合均匀,放入圆底烧瓶中再加入70%乙醇溶液浸泡6小时,药材与70%乙醇的比例为1g :20ml,再放于加热套上加热回流2.5h,放冷得提取液,即得A品;
(2)将冷却后的A品用压力泵抽滤,滤去残渣得无残渣的提取液,即得B品;
(3)取B品放入旋转蒸发仪,分离B品中的乙醇和水后,转入烘箱中烘干即得提取物D;
(4)将10g纯化水和3g甘油加入蒸发皿中,再加入0.09g三乙醇胺和1g硬脂酸钠,在加热套上加热融化至温度为75-85℃,得水相;
(5)将2g液体石蜡、2g白凡士林和1g羊毛脂加入蒸发皿中,再加入1g单硬脂酸甘油酯,放于加热套上加热融化至75-80℃,得油相;
(6)取75-80℃状态下的水相和油相,且保持水相温度高于油相温度2-3℃,将0.5g提取物D与步骤(4)中的水相混合均匀后,再加入步骤(5)中的油相中,并沿同一方向不断搅拌直至冷凝,即得软膏剂。
2.如权利要求1所述的复方花椒软膏剂,其特征在于:其药用有效成分按照重量组分计算:由花椒120份、艾叶100份、蒲公英80份、紫花地丁80份、地肤子100份、蛇床子100份、白鲜皮80份、野菊花80份、皂刺100份、雄黄150份、黄柏100份、川楝子100份、苦参100份、硫磺150份、紫草80份、炉甘石100份制成。
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