CN106668092A - 治疗牙周炎的药物组合物及其制备方法 - Google Patents
治疗牙周炎的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗牙周炎的药物组合物及其制备方法,本发明药物组合物是以蝈蝈、千日红、远志酸、镰叶瘤足蕨、白桦脂酸为原料药,配比而成,可按常规制剂工艺制成各种剂型,治疗牙周炎疗效显著。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种治疗牙周炎的药物组合物及其制备方法。
背景技术
牙周炎是侵犯牙龈和牙周支持组织的慢性破坏性疾病,其主要特征为牙周袋形成和袋壁的炎症。 牙槽骨吸收和牙齿松动, 同时伴见牙龈红肿出血等症状。 它是导致成年人牙齿丧失的主要原因。 由于牙周炎是口腔中最常见的疾病,成年人中患病率高达 90%, 病程长, 治愈率低, 给患者造成极大的痛苦, 损害健康, 影响生命质量。牙周炎属中医“牙宣”、 “齿衄”、 “齿牙动摇”、 “风疳”、 “食床” 等范畴。 中医认为, 牙龈发炎、 出血、红肿、 疼痛及口臭, 大多由胃火上蒸、 肾阴不足、 火热邪毒外侵所致。 治以先养阴清热,攻毒败毒, 止痛消肿为主,中医认为 “齿为骨之余, 肾主骨, 故与肾关系密切, 肾阴亏虚, 火热毒邪循经上犯所致, 故后期应以滋补肾阴, 以清虚热”。 现代医学常以局部治疗为主, 制定周密而长期的治疗计划, 往往因病人难以坚持良好的自我菌斑控制而导致疾病的再度发生, 费时费事而收效甚微。
白细胞介素8(IL-8)是近十年来发现的一种新的细胞趋化因子,在白细胞介素1(IL-1)、肿瘤坏死因子-A(tumor necrosis factor-A,TNF-A)、脂多糖等刺激下单核细胞、巨噬细胞、牙龈成纤维细胞等都能产生IL-8。IL-8主要通过影响中性粒细胞的功能在炎症过程中造成组织病理损害。目前已在多种疾病中检测出高水平IL-8,有学者认为IL-8可能是造成组织损害的重要因子之一,抑制IL-8的产生可减轻组织病损程度。牙周炎时龈沟液和龈组织中均含有较高水平IL-8。
镰叶瘤足蕨:为瘤足蕨科瘤足蕨属植物镰叶瘤足蕨Plagiogyria rankanensisHayata[P.distinctissima Ching;P.adnata Bedd.]的全草或根茎。夏、秋季采收,洗净,晒干。【性味】辛;凉。【归经】入膀胱、肺、肝三经。【功能主治】发表清热;祛风止痒;透疹。主流行性感冒;麻疹;皮肤瘙痒;血崩;扭伤。【原植物形态】 植株高30-45cm。具直立或斜升的根茎。叶簇生,二型;营养叶柄长14-18cm,基部三棱形,有1-2对气囊体,向上略呈三棱形或半圆形;叶片狭长三角形或卵状披针形,长17-25cm,基部宽8-11cm,一回羽状分裂;羽片纸质,15-20对,互生,长4-6cm,宽8-13mm,上下面均为绿色,渐尖头,向上微弯呈镰状披针形,基部不对称,上侧沿叶轴上延,下侧圆形,边缘近全缘或有齿;叶脉羽状,侧脉单一或二叉状。孢子叶叶柄长30-40cm;叶片一回羽状,长14-22cm,宽4-6cm;羽片15-25对,极度收缩呈线形,长5-7cm,宽2-3mm;侧脉通常二叉,伸至叶边1/2处。孢子囊生于小脉顶部,成熟时布满羽片下面。收载于中药大辞典。
蝈蝈:本品为螽斯科螽斯属动物螽斯Gampsaocleis gratiosa BrunnerWattenwyl.的全体。夏、秋季捕捉,捕后沸水烫死,晒干或烘干。【性味】味辛;微甘;性平。【功能主治】利水消肿;通络止痛。主水肿尿少;腰膝肿痛;湿脚气。【性状】本品全体呈长圆形,灰绿色或黄褐色。头略呈圆形,复眼1对,卵圆形,触角1对,长鞭状,多脱落;前胸背板略呈细长圆柱形,中后胸被翅;胸足3对,多脱落,后足较大。气腥。收载于中药大辞典。
千日红:本品为芡科植物千日红Gomphrena globosa L.的干燥头状花序。秋季花盛开时采收,晒干。【性味】甘,平。【功能与主治】祛痰,平喘。用于慢性支气管炎,喘息性支气管炎。【性状】本品呈球形或矩圆形,直径1.5~2cm,玫瑰红色、粉红色或白色。总苞片2,绿色,心形或卵形,两面具毛,以下表面为密。花覆瓦状排列,每花具1卵形干膜质状苞片;小苞片2,三角状披针形,玫瑰红色或白色,膜质,具光泽;花被5,线状披针形,色浅,密被白色长柔毛;雄蕊5,花丝连合,花药微伸出;雌蕊1。胞果类球形,内有棕色种子1。体轻。气微,味淡。收载于上海市中药材标准1994(上海市卫生局)。
远志酸(Polygalacic acid):CAS号22338-71-2,分子式C30H48O6,分子量504.70。【成分来源】桔梗 Platycodon grandiflorum。
白桦脂酸(Betulinic acid):CAS号472-15-1,分子式C30H48O3,分子量456.71。【生物活性】抗肿瘤(W256)。【成分来源】 大枣Ziziphus jujuba,树形杜鹃Rhododendronarboreum,喜树Camptotheca acuminata。
2个原料药的结构:
白桦脂酸(Betulinic acid) 远志酸(Polygalacic acid)。
发明内容
本发明的目的是克服背景技术的不足,提供一种有效治疗牙周炎的药物组合物及其制备方法。
本发明是采用如下技术方案实现的:
制成该治疗牙周炎的药物组合物的原料药的组成和重量份为:
蝈蝈124-128重量份 千日红120-122重量份 远志酸12-16重量份 镰叶瘤足蕨110-118重量份 白桦脂酸6-8重量份。
优选的用于治疗牙周炎的药物组合物,是由如下重量份的原料药组成:
蝈蝈126重量份 千日红121重量份 远志酸14重量份 镰叶瘤足蕨114重量份 白桦脂酸7重量份。
一种治疗牙周炎的药物组合物,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
一种治疗牙周炎的药物组合物,其特征在于药物组合物与化学药或中药组成的治疗牙周炎药物。
一种治疗牙周炎的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:蝈蝈124-128重量份 千日红120-122重量份 远志酸12-16重量份 镰叶瘤足蕨110-118重量份 白桦脂酸6-8重量份;
制备方法:
(1)按原料药配比取蝈蝈、千日红、远志酸、镰叶瘤足蕨、白桦脂酸,混匀,用重量百分比浓度37%乙醇作为溶剂,在30℃温浸提取,提取次数为14次,每次提取时间15小时,每次溶剂用量为原料药总重量的19倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.05,滤过,药液通过D900大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度46%乙醇溶液洗脱D900大孔吸附树脂柱,收集重量百分比浓度46%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度64%乙醇作为溶剂,加热回流提取7次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的30倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过S-8大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度43%乙醇溶液洗脱S-8大孔吸附树脂柱,收集重量百分比浓度43%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
优选的一种治疗牙周炎的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:蝈蝈126重量份 千日红121重量份 远志酸14重量份 镰叶瘤足蕨114重量份 白桦脂酸7重量份;
制备方法:
(1)按原料药配比取蝈蝈、千日红、远志酸、镰叶瘤足蕨、白桦脂酸,混匀,用重量百分比浓度37%乙醇作为溶剂,在30℃温浸提取,提取次数为14次,每次提取时间15小时,每次溶剂用量为原料药总重量的19倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.05,滤过,药液通过D900大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度46%乙醇溶液洗脱D900大孔吸附树脂柱,收集重量百分比浓度46%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度64%乙醇作为溶剂,加热回流提取7次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的30倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过S-8大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度43%乙醇溶液洗脱S-8大孔吸附树脂柱,收集重量百分比浓度43%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
一种治疗牙周炎的药物组合物的制备方法,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
一种治疗牙周炎的药物组合物的制备方法,其特征在于药物组合物与化学药或中药组成治疗牙周炎药物。
药物组合物治疗牙周炎疗效显著。
具体实施方式
实施例1:治疗牙周炎的药物组合物及其制备方法
治疗牙周炎的药物组合物的原料药的组成和重量份为:蝈蝈126g 千日红121g 远志酸14g 镰叶瘤足蕨114g 白桦脂酸7g;
制备方法:
(1)按原料药配比取蝈蝈、千日红、远志酸、镰叶瘤足蕨、白桦脂酸,混匀,用重量百分比浓度37%乙醇作为溶剂,在30℃温浸提取,提取次数为14次,每次提取时间15小时,每次溶剂用量为原料药总重量的19倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.05,滤过,药液通过D900大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度46%乙醇溶液洗脱D900大孔吸附树脂柱,收集重量百分比浓度46%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度64%乙醇作为溶剂,加热回流提取7次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的30倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过S-8大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度43%乙醇溶液洗脱S-8大孔吸附树脂柱,收集重量百分比浓度43%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例2:治疗牙周炎的药物组合物及其制备方法
治疗牙周炎的药物组合物的原料药的组成和重量份为:蝈蝈124g 千日红122g 远志酸12g 镰叶瘤足蕨118g 白桦脂酸6g;
制备方法:
(1)按原料药配比取蝈蝈、千日红、远志酸、镰叶瘤足蕨、白桦脂酸,混匀,用重量百分比浓度37%乙醇作为溶剂,在30℃温浸提取,提取次数为14次,每次提取时间15小时,每次溶剂用量为原料药总重量的19倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.05,滤过,药液通过D900大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度46%乙醇溶液洗脱D900大孔吸附树脂柱,收集重量百分比浓度46%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度64%乙醇作为溶剂,加热回流提取7次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的30倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过S-8大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度43%乙醇溶液洗脱S-8大孔吸附树脂柱,收集重量百分比浓度43%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例3:治疗牙周炎的药物组合物及其制备方法
治疗牙周炎的药物组合物的原料药的组成和重量份为:蝈蝈128g 千日红120g 远志酸16g 镰叶瘤足蕨110g 白桦脂酸8g;
制备方法:
(1)按原料药配比取蝈蝈、千日红、远志酸、镰叶瘤足蕨、白桦脂酸,混匀,用重量百分比浓度37%乙醇作为溶剂,在30℃温浸提取,提取次数为14次,每次提取时间15小时,每次溶剂用量为原料药总重量的19倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.05,滤过,药液通过D900大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度46%乙醇溶液洗脱D900大孔吸附树脂柱,收集重量百分比浓度46%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度64%乙醇作为溶剂,加热回流提取7次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的30倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过S-8大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度43%乙醇溶液洗脱S-8大孔吸附树脂柱,收集重量百分比浓度43%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例4:片剂的制备
取实施例1药物组合物100g,加入淀粉230g,混匀,制粒,干燥,加微晶纤维素130g,硬脂酸镁10g,混匀,压制成1100片, 即得药物组合物片剂。
实施例5:胶囊的制备
取实施例2药物组合物110g,加入淀粉340g,混匀,制粒,干燥,整粒,加入适量硬脂酸镁,混匀,装胶囊1500粒,即得药物组合物胶囊。
实施例6:滴丸的制备
称取聚乙二醇 6000 120g水浴(80℃)加热煮熔,加入实施例3药物组合物10g,充分搅拌均匀,以液体石蜡为冷却剂,置玻璃管(4*80cm)中,冷却温度为2℃,滴口内外径为7.0/2.0(mm/mm),滴口距液面为2.3cm,滴速以每分62滴为最佳条件,用棉布吸干滴丸表面的冷凝剂,即得药物组合物滴丸。
实验例1:治疗牙周炎的试验研究
一.材料与方法
1.来源
选择成人牙周炎患者20例,男8例,女12例。每例口中选患牙1个。记录牙龈指数(ging-ival index,GI) 0-3;牙周袋深度(pocket depth,PD)3-7 mm,每个患牙牙周袋最深处≥6mm;附着水平(attachment level,AL)3-8 mm。受试者无明显全身疾患,3个月内未用过抗菌药、止痛药和免疫抑制剂。
2.龈沟液采集、定量
将患者随机分为两组,每组10人,龈上洁治后用无菌干棉条擦干牙面,隔湿。将已制备好的2mm×20mm的Whatman I号滤纸条分别插入患牙的近中、远中、颊及舌侧牙周袋内,2分钟后取出。测量滤纸浸润面积的长和宽,用浸润面积换算龈沟液量。测量后将滤纸条的浸润部分剪入含300μl生理盐水的冻存管中,每管收集1个患牙的4条滤纸,收集的样本立即保存于-70℃冰箱内待测。患者龈上洁治后,一组服用药物组合物(实施例1药物组合物),另一组不服用任何药物。所有患者1周后均作龈下洁治术(在无麻醉情况下,去除龈下牙石和袋壁上的部分肉芽)。1个月后复诊,用同样方法采集龈沟液。
3.GCF中IL-8检测
用IL-8 ELISA试剂盒(第四军医大学免疫学教研室提供)对样本中IL-8进行检测。上述样本常温下解冻,各取100μl加入已包被好IL-8抗体的96孔板中,并用生理盐水设空白对照。根据ELISA间接夹心法进行检测,反应中止后,用酶联免疫检测仪在波长为410 nm处测定OD值,用标准品绘制标准曲线,并根据该曲线换算样本中IL-8浓度。
二.结果
1.治疗前后患牙各项临床指标比较:患牙经治疗1个月后,两组患牙牙龈指数值均较治疗前显著下降(P<0.05),但两组间无显著差别;服药组治疗后龈沟液量较治疗前显著下降(P<0.05),而对照组治疗前后龈沟液量无显著改变,治疗后两组间龈沟液量的差异有显著性(P<005);其余各项临床指标均无显著变化。
2.治疗前后龈沟液中IL-8的变化
1个月后,服用固齿膏组龈沟液中IL-8水平显著降低(P<0.01);对照组龈沟液中IL-8水平无明显改变(P>0.05);治疗后龈沟液中IL-8水平显著低于对照组(P<0.01),见表1。
表1 治疗前后龈沟液中IL-8水平(mg/L, x±s)
组别 | 例数 | 治疗前 | 治疗后 |
服药组 | 10 | 0.705±0.465 | 0.383±0.312** |
对照组 | 10 | 0.736±0.637 | 0.823±0.527 |
注:与对照组比较, **P<0.01。
Claims (8)
1.一种治疗牙周炎的药物组合物,其特征在于制成该药物组合物的原料药的组成和重量份为:
蝈蝈124-128重量份 千日红120-122重量份 远志酸12-16重量份 镰叶瘤足蕨110-118重量份 白桦脂酸6-8重量份。
2.根据权利要求1所述一种治疗牙周炎的药物组合物,其特征在于制成该药物组合物的原料药的组成和重量份为:
蝈蝈126重量份 千日红121重量份 远志酸14重量份 镰叶瘤足蕨114重量份 白桦脂酸7重量份。
3.根据权利要求1所述一种治疗牙周炎的药物组合物,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
4.根据权利要求1所述一种治疗牙周炎的药物组合物,其特征在于药物组合物与化学药或中药组成的治疗牙周炎药物。
5.一种治疗牙周炎的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:蝈蝈124-128重量份 千日红120-122重量份 远志酸12-16重量份 镰叶瘤足蕨110-118重量份 白桦脂酸6-8重量份;
制备方法:
(1)按原料药配比取蝈蝈、千日红、远志酸、镰叶瘤足蕨、白桦脂酸,混匀,用重量百分比浓度37%乙醇作为溶剂,在30℃温浸提取,提取次数为14次,每次提取时间15小时,每次溶剂用量为原料药总重量的19倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.05,滤过,药液通过D900大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度46%乙醇溶液洗脱D900大孔吸附树脂柱,收集重量百分比浓度46%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度64%乙醇作为溶剂,加热回流提取7次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的30倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过S-8大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度43%乙醇溶液洗脱S-8大孔吸附树脂柱,收集重量百分比浓度43%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
6.根据权利要求5所述一种治疗牙周炎的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:蝈蝈126重量份 千日红121重量份 远志酸14重量份 镰叶瘤足蕨114重量份 白桦脂酸7重量份;
制备方法:
(1)按原料药配比取蝈蝈、千日红、远志酸、镰叶瘤足蕨、白桦脂酸,混匀,用重量百分比浓度37%乙醇作为溶剂,在30℃温浸提取,提取次数为14次,每次提取时间15小时,每次溶剂用量为原料药总重量的19倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.05,滤过,药液通过D900大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度46%乙醇溶液洗脱D900大孔吸附树脂柱,收集重量百分比浓度46%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度64%乙醇作为溶剂,加热回流提取7次,每次提取时间为0.7小时,每次溶剂用量为药渣A重量的30倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过S-8大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度43%乙醇溶液洗脱S-8大孔吸附树脂柱,收集重量百分比浓度43%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
7.根据权利要求5所述一种治疗牙周炎的药物组合物的制备方法,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
8.根据权利要求5所述一种治疗牙周炎的药物组合物的制备方法,其特征在于药物组合物与化学药或中药组成治疗牙周炎药物。
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WO2021103263A1 (zh) * | 2019-11-29 | 2021-06-03 | 广东博溪生物科技有限公司 | 脂多糖在建立人牙龈成纤维细胞应激衰老模型中的应用 |
RU2751809C1 (ru) * | 2020-12-18 | 2021-07-19 | Федеральное государственное автономное образовательное учреждение высшего образования "Северо-Восточный федеральный университет имени М.К.Аммосова" | Способ лечения пародонтита |
RU2751810C1 (ru) * | 2020-12-18 | 2021-07-19 | Федеральное государственное автономное образовательное учреждение высшего образования "Северо-Восточный федеральный университет имени М.К.Аммосова" | Способ лечения хронического пародонтита |
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WO2021103263A1 (zh) * | 2019-11-29 | 2021-06-03 | 广东博溪生物科技有限公司 | 脂多糖在建立人牙龈成纤维细胞应激衰老模型中的应用 |
RU2751809C1 (ru) * | 2020-12-18 | 2021-07-19 | Федеральное государственное автономное образовательное учреждение высшего образования "Северо-Восточный федеральный университет имени М.К.Аммосова" | Способ лечения пародонтита |
RU2751810C1 (ru) * | 2020-12-18 | 2021-07-19 | Федеральное государственное автономное образовательное учреждение высшего образования "Северо-Восточный федеральный университет имени М.К.Аммосова" | Способ лечения хронического пародонтита |
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