CN107343926B - 一种治疗复发性口腔溃疡的中药组合物 - Google Patents
一种治疗复发性口腔溃疡的中药组合物 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组合物，其特征在于：由下述组份中药原料按质量比与水配制而成，熟地140‑160，知母95‑110，黄柏90‑110，玄参85‑95，茯苓45‑55，五味子25‑35，巴戟天90‑110，白及55‑65，川牛膝45‑55。本发明标本兼治，既能治本，又能治标，既考虑了疾病的特点，又考虑了患者的体质特点。能在治疗的同时，改善患者体质，增强患者免疫，避免复发。本发明疗效确切，安全可靠，服用方便，价格低廉，利于患者接受，制剂工艺简单，利于生产。
Description
技术领域
本发明涉及一种治疗口腔疾病的药物组合物，特别是一种治疗复发性口腔溃疡的中药组合物。
背景技术
“复发性口腔溃疡”是指人类口腔黏膜、包括牙龈、舌体、唇内、软腭等部位反复发生脓性或非脓性疼痛性溃疡。溃疡发作的频率因人而异，常见的有年发多次，隔月或每月发作，严重者此起彼伏，无间断地发作，而且逐年加重，终年不愈，甚至终身相伴。该病一般不危及生命，但痛苦不堪，影响学习、工作和生活。西医认为该病是心理因素、精神因素以及其它因素等七大病因。但具体的发病机制仍不清楚，因而目前西医对该病无特效药。祖国医学认为该病发生原因有外因和内因，内因责之于素体集热或阴虚，外因责之感受外邪。发病多有风热乘脾、心脾积热、阴虚火旺上攻口腔所致。由于脾开窍于口、舌为心之苗、肾脉连于舌本、络咽喉、胃经络于齿龈，故本病病变部分在心、脾胃、肾，关键是火邪灼伤口腔所致，证属虚火上炎型。目前中医治疗该病主要有内服牛黄解毒丸中成药治疗复发性口疮，青茶散对复发性口疮的治疗有一定效果。但其存在治标不治本、治疗时间长和相当部分人群不适的问题。
发明内容
本发明的目的在于克服现有技术的不足，提供一种既能治本，又能治标的治疗复发性口腔溃疡的中药组合物。本发明的目的通过下述技术方案来解决；一种治疗复发性口腔溃疡的中药组合物，由下述组份中药原料按质量比与水配制而成：熟地140-160，知母95-110，黄柏90-110，玄参85-95，茯苓45-55，五味子25-35，巴戟天90-110，白及55-65，川牛膝45-55。
必要时可加入苯甲酸钠3质量份和羟苯乙酯0.3质量份。
一种治疗复发性口腔溃疡的中药组合物生产方法：将以上九味饮片，加8-10倍水浸泡30分钟，煎煮2次，每次2小时，合并煎液，滤过，滤液浓缩至原料药的重量，静置12小时，滤过，滤液加入苯甲酸钠3质量份和羟苯乙酯0.3质量份，搅拌使溶解，加纯化水至1.3±0.1倍，搅匀，分装，即得合剂。
当然，本发明也可按中药传统方法制成丸剂或片剂，其具体方法是在液体制剂工艺的浓缩液基础上，进一步浓缩成膏剂后加入糖粉或淀粉制成颗粒剂或片剂。
本发明以熟地黄为君药，熟地黄能大补肾水，肾为水火之宅，肾水充足则不生虚火。黄柏、知母、玄参为臣药，黄柏与知母相配清泻虚火利于肾阴的生成，玄参既能泻火解毒又能滋阴降火，能清因肾水不足的虚火上炎，又能滋补肾阴，增强熟地的滋补作用，肾阴不足，虚火上炎，口腔溃烂。五味子能滋补肺阴，收敛肺金，肾属水，肺属金，金生水，子病及母，当补其母，肺阴充足能有利于肾阴的生成；巴戟天性温而不燥，引火归元而不至于损伤肾阴；茯苓能利肾浊，去脾湿，浊阴不去则新阴不生，同时通过去脾湿，降低熟地黄的滋腻性；白及寒凉苦泄，能散血中壅滞，味涩质粘能够消肿生肌，促进溃疡的愈合。故五味子、巴戟天、茯苓、白及四味的协调作用有利于肾中水火安宁，水火济济，共为佐药。川牛膝能引药入肾经，又能引热下行，为使药。与现有技木相比，本发明有以下的优点：
1、本发明标本兼治，既能治本，又能治标，既考虑了疾病的特点，又考虑了患者的体质特点。能在治疗的同时，改善患者体质，增强患者免疫，避免复发。
2、本发明在滋阴的同时加入生肌的白及，能加快溃疡面的修复，利于疾病的快速康复。
3、本发明用巴戟天引火归元，具有引火归元不伤阴的特点，能增效降低副作用。
4、本发明寒热并用，补泻兼施，性味平和，可长时间服用。
5、本发明疗效确切，安全可靠，服用方便，价格低廉，利于患者接受，制剂工艺简单，利于生产。
使用方法：合剂每日三次，每次30-40ml，丸剂和片剂也为每日三次，每次为原药的22-26克左右。
本发明经多种试验，对治疗复发性口腔溃疡有确切的疗效，毒性小，具体实验及结果如下：
1、知黄溃疡合剂对角叉菜胶致小鼠足肿胀的影响
取体重为18～22g的雄性小鼠52只，随机分为5组。分别为模型组、醋酸泼尼松组10mg/kg、知黄溃疡合剂5 g原生药/kg、10g原生药/kg、20g原生药/kg。模型组给予等体积0.5%CMC-Na溶液，其余各组分别灌胃相应药物，每天2次，连续3天，末次给药后30min，各小鼠左后足皮下注射1%角叉菜胶0.05ml， 4h后脱臼处死小鼠，从踝关节处对称剪下鼠足，称重，以左、右足重量差作为肿胀度，结果进行统计学分析。结果见表1。
与模型组比较：** P<0.01，下同。
由表1可知，知黄溃疡合剂10g原生药/kg对角叉菜胶致小鼠足肿胀有显著的抑制作用。
2、知黄溃疡合剂对大鼠口腔溃疡的影响
按照参考文献并结合本实验室前期建立的方法制备大鼠口腔溃疡模型。具体操作步骤：将大鼠用水合氯醛（350mg/kg）腹腔注射麻醉，于大鼠口腔右侧颊部黏膜下注射20%醋酸0.05ml/只，正常对照组则注射等量生理盐水，大鼠在24h后即可形成口腔溃疡。造模第二天（24h后）除正常对照组外，将造模成功的60只大鼠随机分为5组，分别为模型对照组、阳性对照组（桂林西瓜霜200mg/kg）、知黄溃疡合剂高中低剂量组（16、8、4g原生药/kg）。知黄溃疡合剂灌胃给药（留约0.5ml药液缓慢注入大鼠口腔，使药液与溃疡面充分接触）；桂林西瓜霜直接取药粉，给药时将药粉（大鼠剂量的 1/4）均匀涂于溃疡面上，剩余药粉（大鼠剂量的3/4）以0.5% CMC-Na溶液制备成混悬液后灌胃大鼠。模型对照组和正常对照组分别灌胃等量0.5% CMC-Na溶液，每天2次，连续5天，末次给药后1h处死动物，肉眼观察溃疡表面愈合情况并分级；取溃疡处口腔黏膜用甲醛固定，做HE染色观察。
肉眼观察评级指标：溃疡表面愈合情况分级:0 级，肉眼观察溃疡恢复至正常状态;Ⅰ级，表面无明显假膜;Ⅱ级，溃疡表面有薄层黄白色假膜，周围无水肿; Ⅲ级，溃疡表面假膜较厚，且周围伴有炎性水肿。结果见表2。
**与模型组比较：P<0.01
经肉眼评价各组动物溃疡愈合级数，阳性组西瓜霜与知黄溃疡合剂8g原生药/kg能显著提高溃疡愈合程度，与模型组比较有显著性差异（P<0.01）。知黄溃疡合剂16g原生药/kg口腔黏膜溃疡恢复情况较模型组有一定改善，但差异无统计学意义。
组织病理学评分：口腔溃疡组织学分级标准，参考相关文献，结合本实验实际情况，拟定诊断标准如表3所示。各组大鼠口腔黏膜溃疡部位组织学分级结果见表4。
与模型组比较：*P<0.05。
3、毒性试验
预试验结果显示小鼠灌胃知黄溃疡合剂无法测定的其半数致死量（LD50）。故进行知黄溃疡合剂最大耐受量测定：将体重为小鼠18g－22g 的小鼠40只，雌雄各半，随机均分为对照组、知黄溃疡合剂组。动物在禁食不禁水16 h后，分别灌胃最大体积（0.4ml/10g）、最大浓度（1.5g/kg）的知黄溃疡合剂或等体积蒸馏水。24h内共给药2次，每隔6h给药一次，观察并记录给药后14天内小鼠的反应情况，实验结束时处死动物，取心、肝、脾、肺、肾称湿重，计算脏器指数，结果见表5、表6、表7。
表5可见，经口给予知黄溃疡合剂部分小鼠有拉稀便症状，约5h后恢复，但动物无死亡。
与对照组比较 ** P<0.01，下同。
由表6可见，知黄溃疡合剂给药一周后雌性小鼠体重增长与对照组比较显著减慢（P<0.01），有统计学差异；给药两周后恢复正常，对照组比较无统计学差异。
由表7可见，知黄溃疡合剂小鼠各脏器指数与对照组比较无统计学差异。表明，小鼠经口给予知黄溃疡合剂无明显急性毒性作用，测得小鼠口服知黄溃疡合剂的最大耐受量为120g原生药/kg，相当于临床人拟用剂量的109.1倍。
具体实施方式
实施例1：一种治疗复发性口腔溃疡的中药组合物，由下述组份中药原料按质量比与水配制而成：熟地150g，知母100g，黄柏110g，玄参90g，茯苓50g，五味子35g，巴戟天100g，白及 60g， 川牛膝 50g，苯甲酸钠3g，羟苯乙酯0.3g。
一种治疗复发性口腔溃疡的中药组合物生产方法：将以上九味饮片投料，加8-10倍水浸泡30分钟，煎煮2次，每次2小时，合并煎液，滤过，滤液浓缩至原料药的重量，静置12小时，滤过，滤液加入苯甲酸钠3质量份和羟苯乙酯0.3质量份，搅拌使溶解，加纯化水至1.3士0.1倍，搅匀，分装，即得合剂。
实施例2：一种治疗复发性口腔溃疡病的中药组合物，由下述组份中药原料按质量比与水配制而成：熟地140g，知母95g，黄柏90g，玄参95g，茯苓45g，五味子 25g，巴戟天110g，白及65g，川牛膝45g。生产方法：将以上九味饮片投料，加8-10倍水浸泡30分钟，煎煮2次，每次2小时，合并煎液，滤过，滤液浓缩至原料药的质量，静置12小时，滤过，滤液浓缩至稠膏状、加入赋形剂糖粉或淀粉，拌匀制成丸剂，分装。
实施例3：一种治疗复发性口腔溃疡病的中药组合物，由下述组份中药原料按质量比与水配制而成：熟地160g，知母110g，黄柏105g，玄参 85g，茯苓 55g，五味子30g，巴戟天90g，白及55g，川牛膝55g 。生产方法：将以上九味饮片投料，加8-10倍水浸泡30分钟，煎煮2次，每次2小时，合并煎液，滤过，滤液浓缩至原料药的质量，静置12小时，滤过，滤液浓缩至稠膏状、加入赋形剂糖粉或淀粉，拌匀压制成片剂，分装。
实施例4：一种治疗复发性口腔溃疡病的中药组合物，由下述组份中药原料按质量比与水配制而成：熟地140g，知母110g， 黄柏105g，玄参 95g， 茯苓 55g，五味子 25g，巴戟天105g，白及55g，川牛膝45g 。生产方法：将以上九味饮片投料，加8-10倍水浸泡30分钟，煎煮2次，每次2小时，合并煎液，滤过，滤液浓缩至原料药的质量，静置12小时，滤过，滤液加入苯甲酸钠3质量份和羟苯乙酯0.3质量份，搅拌使溶解，加纯化水至1.3士0.1倍，搅匀，分装，即得合剂。
实施例5：一种治疗复发性口腔溃疡病的中药组合物，由下述组份中药原料按质量比与水配制而成：熟地150g，知母100g，黄柏100g，玄参 90g，茯苓 50g，五味子30g，巴戟天100g，白及60g，川牛膝50g 。生产方法：将以上九味饮片投料，加8-10倍水浸泡30分钟，煎煮2次，每次2小时，合并煎液，滤过，滤液浓缩至原料药的质量，静置12小时，滤过，滤液加入苯甲酸钠3质量份和羟苯乙酯0.3质量份，搅拌使溶解，加纯化水至1.3士0.1倍，搅匀，分装，即得合剂。
Claims (4)
1.一种治疗复发性口腔溃疡的中药组合物，其特征在于：由下述组份中药原料按质量比与水配制而成，熟地140-160，知母95-110，黄柏90-110，玄参85-95，茯苓45-55，五味子25-35，巴戟天90-110，白及55-65，川牛膝45-55。
2.根据权利要求1所述的一种治疗复发性口腔溃疡的中药组合物，其特征在于：由下述组份中药原料按质量比与水配制而成，熟地150，知母100，黄柏100，玄参90，茯苓50，五味子30，巴戟天100，白及60，川牛膝50。
3.一种治疗复发性口腔溃疡的中药组合物，其特征在于：由下述组份中药原料按质量比与苯甲酸钠3质量份、羟苯乙酯0.3质量份、水配制而成，熟地140-160，知母95-110，黄柏90-110，玄参85-95，茯苓45-55，五味子25-35，巴戟天90-110，白及55-65，川牛膝45-55。
4.一种权利要求3所述的治疗复发性口腔溃疡的中药组合物生产方法：其特征在于：按下列步骤进行，将九味饮片，加8-10倍水浸泡30分钟，煎煮2次，每次2小时，合并煎液，滤过，滤液浓缩至原料药的重量，静置12小时，滤过，滤液加入苯甲酸钠3质量份和羟苯乙酯0.3质量份，搅拌使溶解，加纯化水至1.3±0.1倍，搅匀，分装，即得合剂。
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