CN115006483A - 一种治疗复发性口腔溃疡的中药制剂及其制备方法和应用 - Google Patents
一种治疗复发性口腔溃疡的中药制剂及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种治疗复发性口腔溃疡的中药制剂及其制备方法和应用,本发明所述中药制剂包括以下制备原料:黄芪、党参、茯苓、白术、甘草、生地、熟地黄、赤芍、黄连、肉桂、丹参、当归、山药、升麻、炒鸡内金、千里光,本发明所述中药制剂在复发性口腔溃疡治疗方面效果显著,能缓解口腔溃疡带来的疼痛,加快口腔溃疡愈合,还可以增强人体免疫功能,延长口腔溃疡发作间歇期,直至不再复发。
Description
技术领域
本发明涉及中药组合物技术领域,具体涉及一种治疗复发性口腔溃疡的中药制剂及其制备方法和应用。
背景技术
复发性口腔溃疡专指一类具有周期性、复发性、自限性的孤立的圆形或椭圆形的溃疡,具有“黄、红、凹、痛”的临床特征,即溃疡表面覆盖黄色假膜,周围有红晕带,中央凹陷,疼痛明显。复发性口腔溃疡是口腔粘膜病中常见的溃疡性损害疾病,长期反复发作将直接影响患者整个机体的免疫功能,引起代谢混乱,严重影响患者生活、工作、甚至发生恶变。
根据流行病调查,在国内成年人当中有10%-25%的人曾患有该病,在特定人群中,该比例可以达到50%,女性患病率一般高于男性。医学界普遍认为,该病发生是多种因素综合作用的结果,有免疫因素、遗传因素、系统性疾病因素、感染因素、环境因素等。
目前国内外西医尚没有治疗复发性口腔溃疡的特效方法。对于此慢性疾病,中医调节脏腑,改善患者气血循环,扶正祛邪双管齐下,相较西医更有优势。
复发性口腔溃疡现有治疗方法分为外治与内服,外治药物包括:蜂胶贴剂、西瓜霜、冰硼散、0.1%-0.2%葡萄糖酸氯己定溶液、0.5%聚维酮碘溶液、0.1%依沙吖啶溶液等;内服药物包括复合维生素B2、维生素C、牛黄解毒片等。近年来随着临床研究愈加深入,市场上也出现了一些治疗口腔溃疡的药物,如西地碘片、醋酸地塞米松贴等新产品,这些药物有的治标不治本,有的疗效不确切而逐渐退出了市场。
发明内容
针对现有技术的不足,本发明的目的在于提供一种治疗复发性口腔溃疡的中药制剂及其制备方法和应用。
为了实现上述目的,本发明采取如下技术方案:
一种治疗复发性口腔溃疡的中药制剂,以重量份计,包括以下制备原料:黄芪10-30份、党参10-30份、茯苓10-15份、白术6-12份、甘草3-10份、生地10-15份、熟地黄10-15份、赤芍6-12份、黄连2-5份、肉桂0.5-1份、丹参10-15份、当归6-12份、山药15-30份、升麻3-10份、炒鸡内金3-10份、千里光15-30份。
优选的,以重量份计,包括以下制备原料:黄芪30份、党参20份、茯苓10份、白术10份、甘草10份、生地10份、熟地黄10份、赤芍10份、黄连4份、肉桂1份、丹参10份、当归10份、山药20份、升麻10份、炒鸡内金10份、千里光20份。
优选的,所述中药制剂的剂型为片剂、胶囊剂、口服液、口含剂、颗粒剂、丸剂、散剂、膏剂、混悬剂中的一种或多种。
本发明提供了上述中药制剂的制备方法,具体步骤如下:将制备原料加工制成药物活性成分,随后以药物活性成分为原料,根据需要加入或不加载体,制成中药制剂。
优选的,所述方法步骤如下:称取黄芪、党参、茯苓、白术、甘草、生地、熟地黄、赤芍、黄连、肉桂、丹参、当归、山药、升麻、炒鸡内金、千里光,然后将上述药物研磨成细粉,倒入蜂蜜,搅拌均匀,得到药团;再将药团压成条状,搓成药丸,得到丸剂。
优选的,所述方法步骤如下:称取黄芪、党参、茯苓、白术、甘草、生地、熟地黄、赤芍、黄连、肉桂、丹参、当归、山药、升麻、炒鸡内金、千里光,将上述药材混合后加水煎制,得到提取液;过滤提取液,然后将滤液浓缩成浸膏;以所得浸膏为药物活性成分,加入载体,制成中药制剂。
优选的,所述载体为中药制剂总重量的0.1%-99.9%;所述载体为甘露醇、山梨醇、氨基酸、氯化纳、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、丙二醇、乙醇、吐温60-80、蜂蜡、羊毛脂、液体石蜡、十六醇、没食子酸酯类、琼脂、尿素、尿囊索、碳酸钙、蜂蜜、淀粉、碳酸氢钙、聚乙二醇、环糊精、盐酸小檗碱、硬脂酸镁中的一种或多种;
其中,每次煎制的用水量为药材总重量的3-8倍,煎制的次数为1-3次,每次煎制的时间为1-3h。
优选的,所述方法步骤如下:称取黄芪、党参、茯苓、白术、甘草、生地、熟地黄、赤芍、黄连、肉桂、丹参、当归、山药、升麻、炒鸡内金、千里光,将上述药材混合后加水煎制,得到提取液;过滤提取液,浓缩滤液,然后加入乙醇至乙醇浓度达到60-70%,静置后过滤,得到第二滤液;将第二滤液蒸馏至乙醇完全挥发,得到浸膏;以所得浸膏为药物活性成分,加入载体,制成中药制剂;
其中,每次煎制的用水量为药材总重量的3-8倍,煎制的次数为1-3次,每次煎制的时间为1-3h。
优选的,所述方法步骤如下:称取黄芪、党参、茯苓、白术、甘草、生地、熟地黄、赤芍、黄连、肉桂、丹参、当归、山药、升麻、炒鸡内金、千里光,将上述药材混合加乙醇溶液回流提取,得到提取液;过滤提取液,然后将滤液蒸馏至乙醇完全挥发,得到浸膏;以所得浸膏为药物活性成分,加入载体,制成中药制剂;
其中,所述乙醇溶液的浓度为90%-95%,每次提取所用乙醇溶液的质量为药材总重量的3-8倍,每次提取的时间为1-3h,提取的次数为1-3次。
本发明还提供上述中药制剂在制备治疗复发性口腔溃疡药物中的应用。
与现有技术相比,本发明具有如下有益效果:
本方药具体配伍如下,
君药:黄芪,味甘性温,有补气养阴、托毒排脓、敛疮生肌的作用,为治疗口疮要药。
臣药:党参,味甘性平,具有健脾益肺,养血生津的作用;白术,味苦性温,能健脾益气、燥湿利水;茯苓,味甘、淡,性平,能健脾、渗利湿浊,鸡内金,味甘性平,健胃消食,使党参、黄芪补而不滞;山药,味甘性平,补脾养胃,生津益肺;当归,味甘、辛,性温,可补血活血;熟地黄,味甘,性微温,补血滋阴,益精填髓,以上共为臣药。
佐药:生地、千里光、黄连、赤芍,丹参,有清泄明火的作用,加升麻祛风升阳,清热解毒。
使药:肉桂,补火助阳,引火归元,与甘草调药和中,同为使药。诸药合用,扶正祛邪,标本同治。
复发性口腔溃疡“黄、红、凹、痛”的临床特征指,表面覆盖黄色假膜,周围有红晕带,中央凹陷,疼痛明显。黄色假膜、红晕带是热证的表现,方中生地、千里光、黄连、赤芍、丹参、升麻有清热解毒、凉血消痈的作用,可治疗热证。中央凹陷是虚证的表现,方中党参、黄芪、山药可以补益脾肺,养血生津,当归、熟地黄有补血养血、益精填髓的作用。因不通则痛、不荣则痛,方中当归、赤芍、丹参可以活血补血,也可缓解疼痛。
口腔溃疡溃疡反复发作,往往脏腑功能失调为本,口腔溃疡为标。通常认为“久病入肾,久病伤脾”,本方中党参、茯苓、白术、甘草合为四君子汤,有补益脾肾之功效,黄芪、熟地黄、肉桂、当归、山药同样可以补益脾肾,旨在标本同治,使口腔溃疡不再复发。
现代药理研究表明,口腔溃疡与微血管痉挛、血流量减少有关,本发明所制备得到的中药制剂中,丹参、赤芍、当归,可以缓解微血管痉挛、增加血流量,加快口腔溃疡愈合。
中医认为“五积皆可生火”,五积指五脏的积病,脾的积病叫做痞气,食滞胃脘、日久化热、胃火上熏口腔也是导致口腔溃疡的重要原因。鸡内金可健胃消食,治痞气,所以可以治疗口腔溃疡。另外,《本草纲目》中亦提到鸡内金可以“治一切口疮、牙疳诸疮”。
具体实施方式
以下通过具体较佳实施例对本发明作进一步详细说明,但本发明并不仅限于以下的实施例。
需要说明的是,无特殊说明外,本发明中涉及到的化学试剂均通过商业渠道购买。
实施例1
一种治疗复发性口腔溃疡的中药口服液的制备方法,包括如下步骤:
称取黄芪300g、党参200g、茯苓100g、白术100g、甘草100g、生地100g、熟地黄100g、赤芍100g、黄连50g、肉桂10g、丹参100g、当归100g、山药100g、升麻100g、炒鸡内金100g、千里光150g,共1810g,按1:5的比例加入9050ml纯净水,浸泡75min,回流提取3次,每次1h,将3次药液合并,浓缩至相对密度为1.1(80℃)的清膏,加乙醇使药液中乙醇浓度达到70%进行醇沉,后取上清液加250g蔗糖后定容至200mL,灌装,每瓶10ml,共20瓶,湿热灭菌法灭菌,即得成品。
实施例2
一种治疗复发性口腔溃疡的中药口服液的制备方法,包括如下步骤:
称取黄芪30g、党参20g、茯苓10g、白术10g、甘草10g、生地10g、熟地黄10g、赤芍10g、黄连5g、肉桂1g、丹参10g、当归10g、山药10g、升麻10g、炒鸡内金10g、千里光15g(以上原料均需过120目筛后再称取所需量),共181g,冷风吹干,40℃以下干燥得到极细粉,备好蜂蜜,蜂蜜与药粉的比例为1:1.5,将蜂蜜倒入锅中,开武火熬炼,沸腾后改用文火,沸腾后,再熬制30分钟,待蜂蜜出现纤维丝状,关火,将蜂蜜与药粉搅拌均匀,得到药团;将药团先压成条状,然后搓成药丸,得到丸剂。
实施例3
一种治疗复发性口腔溃疡的中药丸剂,制备方法如下:
称取黄芪30g、党参20g、茯苓10g、白术10g、甘草10g、生地10g、熟地黄10g、赤芍10g、黄连5g、肉桂1g、丹参10g、当归10g、山药10g、升麻10g、炒鸡内金10g、千里光15g,共181g,将上述药材混合后,在80℃的温度下烘干20min,过100目筛制得混合药粉,将薄荷与水按照1:10的质量比混合后加热,煮沸10分钟后经过20目筛网过滤后制得混合液,将混合液冷却至40℃后,按照1:1.5的质量比加入混合药粉,搅拌至桨状混合物,将桨状混合物在80℃的温度下加热膏状混合物,将膏状混合物置于模具中压制成饼状后再搓至成直径为1.5㎝的丸状物,将丸状物在50℃的温度下干燥后制得丸剂。
实施例4
一种治疗复发性口腔溃疡的中药片剂,制备方法如下:
称取黄芪30g、党参20g、茯苓10g、白术10g、甘草10g、生地10g、熟地黄10g、赤芍10g、黄连5g、肉桂1g、丹参10g、当归10g、山药10g、升麻10g、炒鸡内金10g、千里光15g,共181g;
S1:将部分药材投入到提取罐中,连续进行两次煎煮,过滤,得到滤液;第一次煎煮时加入的水的质量为物料质量的10倍,煎煮时间为2小时,第二次煎煮时加入的水的质量为物料质量的8倍,煎煮时间为2小时,将另外一部分药材粉碎后投入到渗漉罐中,密封,放置渗漉至溶液无色,煎煮用的药材与渗漉用的药材的质量比为6:1,用于渗漉的药材粉碎成60目;
S2:将步骤S1中煎煮后得到的滤液与渗漉后得到的渗漉液分别浓缩后进行混合得到清膏,所得清膏在常温时的相对密度为1.40;
S3:将步骤S2中的清膏与淀粉按照1.2:1的质量比例进行混合制得湿颗粒,将湿颗粒进行干燥至水分2.0%;
S4:将步骤S3中干燥后的湿颗粒进行粉碎并过筛;
S5:将步骤S4中得到的粉末与盐酸小檗碱、淀粉、糊精先干混之后再用85%乙醇溶液湿混,然后进行制粒;粉末与盐酸小檗碱、淀粉、糊精的质量比为1:1:3:1,85%乙醇溶液的添加量为物料总质量的23%;
S6:将步骤S5中得到的颗粒经过干燥和整理后与硬脂酸镁进行混合,硬脂酸镁的质量为干颗粒质量的3‰;
S7:压片、包糖衣、打光、晾片。铝塑包装、外包装。
实施例5
一种治疗复发性口腔溃疡的中药胶囊剂的制备方法,包括如下步骤:
称取黄芪30g、党参20g、茯苓10g、白术10g、甘草10g、生地10g、熟地黄10g、赤芍10g、黄连5g、肉桂1g、丹参10g、当归10g、山药10g、升麻10g、炒鸡内金10g、千里光15g,共181g,按1:5的比例加入905ml纯净水,浸泡75min,回流提取3次,每次1h,将3次药液合并,浓缩至相对密度为1.1(80℃)的清膏,加乙醇使药液中乙醇浓度达到70%进行醇沉,然后将滤液蒸馏至乙醇完全挥发,浓缩成浸膏,以该浸膏为活性成分,加入将稠膏、淀粉、糊精按10:3:1混匀,并加入环糊精包合物,制备软材,采用挤出制粒法制备颗粒,将制得的湿颗粒置于60℃烘箱内干燥2h,整粒,装胶囊,即得中药胶囊剂。
为了探究本发明所述中药制剂的有益效果,本发明作了如下测试:
选择2015年1月至2021年12月于温州老年病医院、张和堂国医馆、南浦卫生院就诊的复发性口腔溃疡患者128例,采用随机数字表法将这些患者随机分为对照组和治疗组,两组患者的基本情况、年龄、病程等方面无显著性差异,具有可比性,这128例患者的平均年龄为42.15岁,平均病程为两年四个月。
其中,治疗组患者每日午饭后半小时、晚饭后半小时服用实施例1所制得的中药口服剂,共2次,一共治疗7天。
对照组患者每日午饭后半小时、晚饭后半小时使用牛黄解毒片治疗,每次3片,每日两次,一共治疗7天。
统计方法采用SPSS18.0统计软件进行统计分析,技术资料采用T检验,其中P<0.05,具有统计学意义。
组别 | 例数 | 痊愈 | 好转 | 无效 | 总有效率(%) |
对照组 | 64 | 12 | 31 | 21 | 67.19 |
治疗组 | 64 | 52 | 9 | 3 | 95.31 |
判定标准 | 症状 |
痊愈 | 口腔溃疡完全愈合 |
好转 | 口腔溃疡“黄、红、凹、痛”症状改善 |
无效 | 临床症状改善不明显 |
治疗结果如上表所示,对照组痊愈12人,好转31人,无效21人,总有效率67.19%;治疗组痊愈52人,好转9人,无效3人,总有效率95.31%,治疗组总有效率显著高于对照组,说明本发明制成的中药口服剂治疗口腔溃疡具有显著优势。
下面选取8名患者案例,进一步说明本发明治疗复发性口腔溃疡的优势。
病例1:陈某,女,41岁。
主诉:口腔溃疡反复发作3年,近两周加重。
病史:患口腔溃疡,疼痛,影响进食,可见舌根外侧溃疡疮面2-3mm,溃疡周围水肿,疮面下陷,伴倦怠懒言,面色淡白,四肢不温,便溏,舌质淡,苔白,脉沉。
初诊日期:2015年5月10日。
中医诊断:口疮;西医诊断:复发性口腔溃疡;辨证分型:脾肾阳虚。
治疗方法:实施例1制得的中药口服液,每日中饭、晚饭后半小时服用一瓶。治疗7日。
二诊日期:2015年5月17日。
二诊结果:初次治疗后疼痛消失,疮面改善;口服液再服7日。
三诊日期:2015年5月24日,疮面愈合。
病例2:吴某,女,40岁.
主诉:口腔溃疡反复发作9年,加重8天。
病史:可见口腔下唇及舌尖米点大溃疡,疮面淡红,表面多覆盖黄白色分泌物,进食灼热、刺痛;思虑、劳累后溃疡加重,伴乏力少气、懒言、心悸、纳呆、大便干结,口唇干燥,舌质淡,边有齿痕,苔净,脉沉细。
初诊日期:2015年7月7日。
中医诊断:口疮;西医诊断:复发性口腔溃疡;辨证分型:心脾亏虚,阴火上乘
治疗方法:实施例1制得的中药口服液,每日中饭、晚饭后半小时服用一瓶。治疗7日。
复诊结果:初次治疗后疼痛消失,疮面改善;口服液再服3日,巩固治疗。
病例3:蔡某,女,46岁。
主诉:口腔溃疡反复发作5年,加重14天。
病史:神疲乏力、胃纳不香;时常头晕,劳累加重。口腔右颊部,溃疡面3-4mm左右,周围暗红肿胖,斑纹暗灰色,舌质偏红,有紫斑,苔薄,脉细涩。
初诊日期:2016年4月5日。
中医诊断:口疮;西医诊断:复发性口腔溃疡;辨证分型:正气虚衰,瘀阻脉络。
治疗方法:实施例1制得的中药口服液,每日中饭、晚饭后半小时服用一瓶,治疗7日。
复诊结果:初次治疗后疼痛减轻,疮面减小;口服液再服5日,巩固治疗。
病例4:黄某,男,39岁。
主诉:患复发性口腔溃疡8年,加重10天。
病史:口腔左颊部溃疡大小3mm左右,基底浅,呈灰黄色,边缘红晕不显,头晕心悸、气短乏力、胃纳不香、动则加剧,面白少华,疼痛影响进食,舌质淡,苔薄白,脉细弱。
初诊日期:2016年4月5日。
中医诊断:口疮;西医诊断:复发性口腔溃疡;辨证分型:脾肾气虚。
治疗方法:实施例1制得的中药口服液,每日中饭、晚饭后半小时服用一瓶,治疗7日。
二诊日期:2016年4月12日。
二诊结果:初次治疗后疼痛减轻,疮面改善;再治疗7日。
三诊日期:2016年4月19日。
三诊结果:疮面治愈,疼痛消失。
病例5:徐某,男,32岁。
主诉:口腔溃疡反复发作三月。
病史:舌尖溃疡大小2-3mm左右,呈灰黄色,边缘红晕明显,口干、咽干、心烦、失眠多梦、大便干结,疼痛影响进食,舌红少津,脉细数。
初诊日期:2016年6月7日。
中医诊断:口疮;西医诊断:复发性口腔溃疡;辨证分型:心火亢盛
治疗方法:实施例1制得的中药口服液,每日中饭、晚饭后半小时服用一瓶,治疗7日。
二诊日期:2016年4月12日。
二诊结果:初次治疗后疼痛减轻,疮面改善;再治疗7日。
三诊日期:2016年4月19日。
三诊结果:疮面治愈,疼痛消失。
病例6:杨某,男,40岁。
主诉:口腔溃疡反复发作两月,近一周疼痛明显。
病史:舌面中间溃疡大小2-3mm左右,基底深凹,呈灰黄色,边缘有红晕带,饥不欲食、神疲乏力、面白少华,舌红无苔,脉细弱。
初诊日期:2016年8月10日。
中医诊断:口疮;西医诊断:复发性口腔溃疡;辨证分型:胃阴亏虚,虚火上乘
治疗方法:实施例1制得的中药口服液,每日中饭、晚饭后半小时服用一瓶。治疗7日。
二诊日期:2016年8月17日。
二诊结果:初次治疗后疼痛减轻,红晕带近乎消失,疮面改善;再治疗7日。
三诊日期:2016年8月24日。
三诊结果:疮面治愈,疼痛消失。
病例7:李某,女,67岁。
主诉:口腔溃疡反复发作十余年。
病史:舌面根部溃疡大小2-3mm左右,基底凹陷,呈灰黄色,边缘有红晕带,神疲乏力、食少纳呆、大便溏薄、失眠多梦、健忘、腰膝酸软、面色萎黄,舌质淡红,苔薄白,脉细弱。
初诊日期:2017年7月10日。
中医诊断:口疮;西医诊断:复发性口腔溃疡;辨证分型:脾肾两虚
治疗方法:实施例1制得的中药口服液,每日中饭、晚饭后半小时服用一瓶,治疗7日。
二诊日期:2017年月17日。
二诊结果:疮面治愈,疼痛消失。
病例8:吕某,女,67岁。
主诉:口腔溃疡反复发作三年。
病史:口腔左侧面颊部溃疡大小3-4mm左右,基底凹陷,呈暗红色,周围红晕带不明显,胃隐隐作痛、脘痞不舒、神疲乏力、食少纳呆、面色暗黄,舌红无苔,脉沉细。
初诊日期:2018年4月4日。
中医诊断:口疮;西医诊断:复发性口腔溃疡;辨证分型:脾气亏虚
治疗方法:实施例1制得的中药口服液,每日中饭、晚饭后半小时服用一瓶,治疗7日。
二诊日期:2018年4月11日。
二诊结果:疮面治愈,疼痛消失。
由上述测试数据可以看出,本发明所述中药制剂在治疗复发性口腔溃疡方面有着突出的效果,不仅能够缓解口腔溃疡带来的疼痛,使溃疡快速愈合,还能改善患者因疼痛而引起的负面情绪,使患者的生活质量显著提高。
最后需要说明的是:以上实施例不以任何形式限制本发明。对本领域技术人员来说,在本发明基础上,可以对其作一些修改和改进。因此,凡在不偏离本发明精神的基础上所做的任何修改或改进,均属于本发明要求保护的范围之内。
Claims (10)
1.一种治疗复发性口腔溃疡的中药制剂,其特征在于,以重量份计,包括以下制备原料:黄芪10-30份、党参10-30份、茯苓10-15份、白术6-12份、甘草3-10份、生地10-15份、熟地黄10-15份、赤芍6-12份、黄连2-5份、肉桂0.5-1份、丹参10-15份、当归6-12份、山药15-30份、升麻3-10份、炒鸡内金3-10份、千里光15-30份。
2.根据权利要求1所述的中药制剂,其特征在于,以重量份计,包括以下制备原料:黄芪30份、党参20份、茯苓10份、白术10份、甘草10份、生地10份、熟地黄10份、赤芍10份、黄连4份、肉桂1份、丹参10份、当归10份、山药20份、升麻10份、炒鸡内金10份、千里光20份。
3.根据权利要求1或2所述的中药制剂,其特征在于,所述中药制剂的剂型为片剂、胶囊剂、口服液、口含剂、颗粒剂、丸剂、散剂、膏剂、混悬剂中的一种或多种。
4.一种如权利要求1或2所述中药制剂的制备方法,其特征在于,具体步骤如下:将制备原料加工制成药物活性成分,随后以药物活性成分为原料,根据需要加入或不加载体,制成中药制剂。
5.根据权利要求4所述的制备方法,其特征在于,所述方法步骤如下:称取黄芪、党参、茯苓、白术、甘草、生地、熟地黄、赤芍、黄连、肉桂、丹参、当归、山药、升麻、炒鸡内金、千里光,然后将上述药物研磨成细粉,倒入蜂蜜,搅拌均匀,得到药团;再将药团压成条状,搓成药丸,得到丸剂。
6.根据权利要求4所述的制备方法,其特征在于,所述方法步骤如下:称取黄芪、党参、茯苓、白术、甘草、生地、熟地黄、赤芍、黄连、肉桂、丹参、当归、山药、升麻、炒鸡内金、千里光,将上述药材混合后加水煎制,得到提取液;过滤提取液,然后将滤液浓缩成浸膏;以所得浸膏为药物活性成分,加入载体,制成中药制剂。
7.根据权利要求4或6所述的制备方法,其特征在于,所述载体为中药制剂总重量的0.1%-99.9%;所述载体为甘露醇、山梨醇、氨基酸、氯化纳、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、丙二醇、乙醇、吐温60-80、蜂蜡、羊毛脂、液体石蜡、十六醇、没食子酸酯类、琼脂、尿素、尿囊索、碳酸钙、蜂蜜、淀粉、碳酸氢钙、聚乙二醇、环糊精、盐酸小檗碱、硬脂酸镁中的一种或多种;
其中,每次煎制的用水量为药材总重量的3-8倍,煎制的次数为1-3次,每次煎制的时间为1-3h。
8.根据权利要求4所述的制备方法,其特征在于,所述方法步骤如下:称取黄芪、党参、茯苓、白术、甘草、生地、熟地黄、赤芍、黄连、肉桂、丹参、当归、山药、升麻、炒鸡内金、千里光,将上述药材混合后加水煎制,得到提取液;过滤提取液,浓缩滤液,然后加入乙醇至乙醇浓度达到60-70%,静置后过滤,得到第二滤液;将第二滤液蒸馏至乙醇完全挥发,得到浸膏;以所得浸膏为药物活性成分,加入载体,制成中药制剂;
其中,每次煎制的用水量为药材总重量的3-8倍,煎制的次数为1-3次,每次煎制的时间为1-3h。
9.根据权利要求4所述的制备方法,其特征在于,所述方法步骤如下:称取黄芪、党参、茯苓、白术、甘草、生地、熟地黄、赤芍、黄连、肉桂、丹参、当归、山药、升麻、炒鸡内金、千里光,将上述药材混合加乙醇溶液回流提取,得到提取液;过滤提取液,然后将滤液蒸馏至乙醇完全挥发,得到浸膏;以所得浸膏为药物活性成分,加入载体,制成中药制剂;
其中,所述乙醇溶液的浓度为90%-95%,每次提取所用乙醇溶液的质量为药材总重量的3-8倍,每次提取的时间为1-3h,提取的次数为1-3次。
10.一种如权利要求1-3任一项所述中药制剂在制备治疗复发性口腔溃疡药物中的应用。
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