CN103550274A - 一种口腔用药制剂 - Google Patents
一种口腔用药制剂 Download PDFInfo
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- CN103550274A CN103550274A CN201310522333.6A CN201310522333A CN103550274A CN 103550274 A CN103550274 A CN 103550274A CN 201310522333 A CN201310522333 A CN 201310522333A CN 103550274 A CN103550274 A CN 103550274A
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Abstract
本发明公开一种口腔用药制剂,属于医药技术领域,该药物制剂以黄腐酸、甜叶菊、氯化钠为主剂加上辅料,制备为***片、咀嚼片、黏附片、口腔膜剂中的一种,本发明采用口腔局部用药制剂,克服全身用药作用慢、副作用大的缺点,该药物制剂对治疗口腔常见疾病加速口腔溃疡的愈合,有效抵抗口腔常见致病菌造成的口臭,牙龈炎等口腔病症具有很好的疗效,作用快且无副作用,本发明在临床保健方面上具有较高的价值,同时也为临床类药提供了一种新的选择。
Description
技术领域
本发明涉及一种口腔用药制剂,属于医药技术领域。
背景技术
口腔疾病是人类最常见、最多发的疾病之一,治疗口腔疾病的药物有很多,西药中的阿司匹林、双氯芬酸钠等解热镇痛药多为有机弱酸,可以刺激口腔黏膜,同时也容易产生***反应,导致口腔黏膜损伤;用氨苄西林、头孢氨苄、甲硝唑及替硝唑等抗菌药物抗菌范围广,常缺乏针对性,易造成抗生素;滥用,导制体内菌群失调,利于真菌生长,产生耐药性,诱发口腔***反应而产生溃疡;用甲硝唑、四环素、螺旋霉素等口服治疗牙周炎,这种全身用药的缺点是药物到达病变局部的浓度较低,而不良反应却很常见;治疗口腔疾病的中药材多达上百种,如穿心莲、元胡、金银花、连翘、独活等,产品成分较复杂,不易质量控制,针对现有药物的不足之处,开发一种质量容量控制,作用快,效果好,副作用小的治疗口腔疾病的药物很有必要。
黄腐酸是腐植酸中分子量最小、溶解度最高、生物活性最强、吸收效果最佳的部分,故药用以黄腐酸及其盐类为主,现已证明黄腐酸及其盐类具有抗溃疡、消炎镇痛、止血、调节免疫、改善微循环、去风湿、抗菌、抗病毒等作用,早在几千年前,李时珍在《本草纲目》中已有腐植酸药用的记载,主要以治疗鼻子出血、妇女气血痛及诸疮毒、金疮出血等疾病,黄腐酸及其盐属于天然产物对人体无任何毒副作用,无耐药性。腐植酸、黄腐酸的专利甚多,98%的是在农业方面的运用,目前仅有几例在药物方面的运用,如CN02108604.4一种含共轭亚油酸锌盐和腐殖酸钠的药用软膏;CN94115491.9黄腐酸钠和小柴碱制成膜剂药物治疗妇科病;CN10218355.7具有降血糖作用的黄腐酸钠;CN10541649.6黄腐酸钠在制备治疗腹泻药物中的应用,但没有涉及治疗口腔疾病药物的,本发明专利首次以黄腐酸为主药制成口腔局部用药制剂用在治疗口腔疾病药物中,具有新颖性、创造性和实用性。
甜叶菊,性甘味凉,菊科多年生草本植物,是一种低热量、高甜度的天然甜味剂。易溶于水,也具耐热性,不会增加身体的热量及糖分的负担,经大量药理实验证明,甜菊糖无毒副作用,食用安全,具有清热解毒、调节血压、降低血脂血糖、尿糖、抑菌止血、镇痛、减肥养颜、养阴生津等功效,是一种可替代蔗糖非常理想的甜味剂,符合现代人追求无糖、无碳水化合物、无脂肪的健康方式。
氯化钠就是食盐,是人体不可缺少的成分,很早以前,就用来漱口,洁牙,具有消毒、抗炎等作用,无任何副作用,黄腐酸和氯化钠的抗菌消炎作用是肯定的,药效实验和临床证明,两种按合适的比例混合应用在治疗口腔疾病中有一定协同作用。
本发明采用口腔局部用药制剂,对于口腔疾病患者来说,局部用药能最快的减轻口腔疾病所带来的痛苦,***片是使药物缓慢溶解于口腔内,产生持久局部作用的片剂,咀嚼片是口腔中咀嚼或使片剂融化后吞服,在咀嚼过程中,药物在口腔内停留发挥作用,生物黏附片是可应用于口腔的特定区段,通过该处上皮细胞黏膜输送药物,膜剂是局部给药最理想的剂型,贴于口腔内的溃疡部位,提高患处的药物浓度,加快溃疡面的愈合,口腔用药制剂的专利有CN101028516A,采用环丙沙星,乙酰螺旋霉素,甲硝唑等西药的治疗作用,有一定副作用;查阅相关文献,至今未见以黄腐酸、甜叶菊、氯化钠三种为药剂,治疗口腔疾病的报道。
发明内容
本发明的目的是提供一种口腔用药制剂,该制剂以黄腐酸、甜叶菊、氯化钠为主药,加上辅料,按照常规的制备工艺制备为***片、咀嚼片、黏附片和膜剂。
本发明所述口腔用药制剂由以下原料按重量百分比制得,黄腐酸10~20%、甜叶菊5~10%、氯化钠3~6%,余量为辅料,各组分含量之和为100%,所述的制剂为***片、咀嚼片、黏附片、膜剂中的一种;
当本发明所述口腔用药制剂中的辅料及其重量百分比为:填充剂30~50%、粘合剂15~25%、润滑剂10~15%,矫味剂2~4%辅料的时候,所述口腔用药制剂为***片、咀嚼片、黏附片中的一种,所有辅料质量百分比均以原料的总质量为基准,所有原料的质量百分比之和为100%;
所述的填充剂指淀粉、可压性淀粉、糊精、甘露醇中的一种或者几种按任意比例混合后得到的混合物;
所述的粘合剂指乙醇、羧甲基纤维素钠、羟丙基甲基纤维素、PVP-K30、卡波姆、微晶纤维素、β-环糊精中的一种或几种按任意比例混合后得到的混合物;
所述的润滑剂指硬脂酸镁、磷酸氢钙、聚乙二醇、微粉硅胶中的一种或几种按任意比例混合后得到的混合物;
所述的矫味剂指薄荷油、薄荷醇、山梨醇中的一种。
当本发明所述口腔用药制剂中的辅料及其重量百分比为:成膜材料30~50%、矫味剂5~10%、增塑剂5~15%、填充剂5~10%、脱膜剂2~8%的时候,所述口腔用药制剂为口腔膜剂,所有辅料的质量百分比均以原料的质量总和为基准;
所述的成膜材料为***胶、琼脂、聚乙烯醇、乙烯-醋酸乙烯共聚物、羟丙基纤维素、羧甲基纤维素等中的一种或几种按任意比例混合后得到的混合物;
所述的矫味剂为薄荷油、甘露醇、香兰素、甜橙香料中的一种或几种按任意比例混合后得到的混合物;
所述的增塑剂为聚乙二醇、山梨醇中的一种;
所述的填充剂为淀粉、糊精、甘露醇、磷酸钙、聚维酮中的一种;
所述的脱膜剂为甘油、淀粉、聚山梨脂-80中的一种。
本发明所述黄腐酸为药用级黄腐酸或者参照专利申请200810233669.X“褐煤氧化降解生产腐植酸及其盐的方法”中方法制得的黄腐酸(用无污染的过氧化氢作为氧化剂,并经过纯化,制得黄腐酸),市购的精制黄腐酸经重金属检测不超标后,也可以使用。
本发明的有益效果:
(1)本发明所述口腔用药制剂,制备简单,使用方便,便于贮存,携带,剂型丰富,满足不同需要,适合大规模生产;
(2)本发明所述口腔用药制剂中的甜叶菊既作为药剂,又作为甜味剂,省去了常规配方中使用蔗糖、葡萄糖、乳糖作为填充剂,可降低口腔有害细菌增殖,减少龋齿发生,是糖尿病患者的理想选择;
(3)本发明所述口腔用药制剂,用天然产物黄腐酸、甜叶菊、氯化钠三种为药剂,对人体无任何毒副作用,质量容易控制;
(4)本发明克服使用西药副作用大的缺点,治疗效果好,作用快,使用安全,无副作用;
(5)本发明所得产品咸甜适中,清凉爽口,即能治病,又能满足消费者口味的需求。
具体实施方式
下面结合实施例对本发明作进一步详细说明,但本发明保护范围不局限于所述内容。
实施例1
本实施例以黄腐酸、甜叶菊、氯化钠为主药,加上辅料,按照常规的制备工艺制备***片,各原料的量如表1所示:
表1. 制备***片的原料
本实施例所述***片按常规的方法制备得到,具体步骤如下:
(1)将药剂和辅料分别粉碎,过100目备用;
(2)称取50g甜叶菊加250ml沸水保温回流40min,过滤,滤渣再加100ml沸水保温回流20min,过滤,合并两次滤液备用;
(3)用滤液溶解黄腐酸制成低粘性的溶液,再按配比加入氯化钠、糊精、甘露醇食用乙醇、羧甲基纤维素钠、微晶纤维素和80g去离子水不断搅拌,制成软硬适中的软材,过20目筛,制粒;
(4)在60℃下真空干燥该混合物,将该混合物与硬脂酸镁、微粉硅胶、磷酸氢钙、薄荷油充分混合10min,压片,每片重量0.5g,即得***片。
实施例2
本实施例以黄腐酸、甜叶菊、氯化钠为主药,加上辅料,按照常规的制备工艺制备咀嚼片,各原料的量如表2所示:
表2. 制备咀嚼片的原料
本实施例所述咀嚼片按常规的方法制备得到,具体步骤如下:
(1)将药剂和辅料分别粉碎,过100目备用;
(2)称取100g甜叶菊加250ml沸水保温回流40min,过滤,滤渣再加100ml沸水保温回流20min,过滤,合并两次滤液备用;
(3)用滤液溶解黄腐酸制成低粘性的溶液,加淀粉混匀制成软材;
(4)再加入β-环糊精、淀粉、聚乙二醇、山梨醇充分混合,置密闭的桶中放置4h,压片,每片重量0.5g,即得咀嚼片。
实施例3
本实施例以黄腐酸、甜叶菊、氯化钠为主药,加上辅料,按照常规的制备工艺制备黏附片,各原料的量如表3所示:
表3. 制备黏附片的原料
本实施例所述黏附片按常规的方法制备得到,具体步骤如下:
(1)将药剂和辅料分别粉碎,过100目备用;
(2)称取60g甜叶菊加250ml沸水保温回流40min,过滤,滤渣再加100ml沸水保温回流20min,过滤,合并两次滤液备用;
(3)按量把氯化钠、羟丙基甲基纤维素、卡波姆初步混合,然后加入甜叶菊滤液充分混合60min;
(4)取出混合物料烘干至水分3%,加入磷酸氢钙、硬脂酸镁、微粉硅胶、薄荷醇混合均匀后,压片,每片重量0.5g,即得黏附片。
实施例4
本实施例以黄腐酸、甜叶菊、氯化钠为主药,加上辅料,按照常规的制备工艺制备膜剂,各原料的量如表4所示:
表4.制备膜剂
本实施例所述口腔膜剂按常规的方法制备得到,具体步骤如下:
(1)将药剂和辅料分别粉碎,过100目备用;
(2)称取50g甜叶菊加250ml沸水保温回流40min,过滤,滤渣再加100ml沸水保温回流20min,过滤,合并两次滤液备用;
(3)取聚乙烯醇加300ml水浸泡溶胀,然后用水浴加热80℃溶解,过滤,备用;
(4)取药用黄腐酸钠、氯化钠、羧甲基纤维素、琼脂、甘露醇、山梨醇、聚维酮、甘油溶于400ml水中,加入甜叶菊滤液和聚乙烯醇胶浆,混合,搅拌均匀;
(5)将混合液除气泡,涂抹于洁净的玻璃板上,制膜,于35℃烘箱中干燥24h,起膜即可,将膜裁成每张1.5×2.0cm,每张重0.25g。
实施例5
本实施例以黄腐酸、甜叶菊、氯化钠为主药,加上辅料,按照常规的制备工艺制备膜剂,各原料的量如表5所示:
表5. 制备膜剂
本实施例所述口腔膜剂按常规的方法制备得到,具体步骤如下:
(1)将药剂和辅料分别粉碎,过100目备用;
(2)称取100g甜叶菊加250ml沸水保温回流40min,过滤,滤渣再加100ml沸水保温回流20min,过滤,合并两次滤液备用;
(3)取聚乙烯醇加300ml水浸泡溶胀,然后用水浴加热80℃溶解,过滤,备用
(4)取药用黄腐酸钠、氯化钠、乙烯-醋酸乙烯共聚、羟丙基纤维素、薄荷油、山梨醇、磷酸钙、聚山梨脂溶于400ml水中,加入甜叶菊滤液混合,搅拌均匀;
(5)将混合液除气泡,涂抹于洁净的玻璃板上,制膜,于35℃烘箱中干燥24h,起膜即可,将膜裁成每张1.5×2.0cm,每张重0.25g。
实施例6
本实施例以黄腐酸、甜叶菊、氯化钠为主药,加上辅料,按照常规的制备工艺制备膜剂,各原料的量如表6所示:
表6. 制备膜剂
本实施例所述口腔膜剂按常规的方法制备得到,具体步骤如下:
(1)将药剂和辅料分别粉碎,过100目备用;
(2)称取80g甜叶菊加250ml沸水保温回流40min,过滤,滤渣再加100ml沸水保温回流20min,过滤,合并两次滤液备用;
(3)取聚乙烯醇加300ml水浸泡溶胀,然后用水浴加热80℃溶解,过滤,备用;
(4)取药用黄腐酸钠、氯化钠、***胶、香兰素、甜橙香料、聚乙二醇、糊精、
淀粉溶于400ml水中,加入甜叶菊滤液和聚乙烯醇胶浆,混合,搅拌均匀;
(5)将混合液除气泡,涂抹于洁净的玻璃板上,制膜,于35℃烘箱中干燥24h,起膜即可,将膜裁成每张1.5×2.0cm,每张重0.25g。
药效实验:
本发明所述的口腔用药制剂的药效实验
(1)体外的抗菌活性实验:采用中华人民共和国卫生行业标准WS/T248-2005:厌氧菌的抗微生物药敏感试验方法—琼脂稀释法,对6种口腔常见的致病菌进行体外的抗菌活性实验,根据MIC值测定结果可以比较几种抗菌药物的效果,实验方法如下:
① 抗菌药物贮存液制备:配制质量百分比浓度为1%黄腐酸溶液,质量百分比浓度为1%氯化钠溶液,质量百分比浓度为1%甜叶菊提取溶液(用无菌去离子水配制);
② 药物实验液配制:取配置好的药物贮存液,用无菌BHI肉汤培养基对倍稀释,配制成对倍递减的实验溶液:溶液浓度分别为400、200、100、50、25 mg/ml,置5℃保存;
③ 含药琼脂平皿的配制:选用BHI琼脂作为实验琼脂培养基,取药物实验液与温度为45-55 ℃的BHI营养琼脂混合并立即倾注于无菌平皿中,待冷却后备用,含药琼脂平皿的药物质量浓度分别为:80、40、20、10、5、2.5mg/ml ;
④ 实验菌株准备:选用口腔临床常见的口腔致病优势菌作为本实验的实验菌株,细菌名称如下: 菌株1为白色念珠菌,菌株2为金黄色葡萄球菌,菌株3为产黑色素类杆菌,菌株4为牙龈卟啉单胞菌;菌株5为化脓性球菌,菌株6为大肠肝菌;
⑤ 实验菌液的准备:校正菌液浓度为105CFU/ml,在每个BHI琼脂表面接种实验菌株2μl,置于厌氧培养箱中培养48h,取48h纯培养物接种BHI肉汤并放置厌氧培养箱内培养48h;
⑥MIC值测定:釆用厌氧菌的抗微生物药敏感试验方法—琼脂稀释法,测定A黄腐酸、B甜叶菊、C氯化钠、D黄腐酸+甜叶菊(1∶1)、E黄腐酸+氯化钠(1∶1)、F黄腐酸+甜叶菊+氯化钠混合物(1∶1∶1)、G去离子水(对照试验),七种药物对6株口腔临床常见优势菌的最小抑菌浓度(MIC)。
六种实验药物对6株口腔临床常见优势菌的MIC值结果见表7。
表7.六种实验药物水溶液对口腔主要致病菌的MIC值(mg/ml)
实验结果显示:这三种药物对6株口腔临床常见优势菌有明显的抑制作用,但存在差异,其中黄腐酸抑菌作用最佳,甜叶菊、氯化钠区别不大、三种药物相互混合后有协同作用,其中黄腐酸与氯化钠的协同作用效果最明显,黄腐酸与甜叶菊的协同作用不太明显,但综合考虑,兼顾无糖需要,三种溶液混合是最理想的选择。
(2)口腔用药制剂的菌斑指数实验
①受试对象:受试者来自玉溪腐植酸有限公司,共50人,年龄20到50岁,患有口腔溃疡,牙周炎,牙龈出血,口气中至少一种,菌斑指数PLI≥1.5,龈炎指数GI≥1.0;
②试验方法:把50人平均分成5组,组1(1%黄腐酸液组),组2(1%甜叶菊液组),组3(1%氯化钠组),组4(前三种以体积比1∶1∶1的混合溶液),组5(去离子水对照组),每天用餐后漱口,六周后测定PLI值;
③PLI测定:牙菌斑指数(PLI)按照显示剂检查法测定;
④功效判定标准及效果:
表8.受试者在六周后在相同时间测定PLI的平均变化值及效果
实验结论:在本实验中,随着治疗进行,六周后PLI值明显下降,实验组数据均低于对照组,采用SPSS 10.0 软件进行统计学分析(p<0.05),菌斑指数差别有显著统计学意义,结果显示:组1(1%黄腐酸液组)效果明显,组4(体积比1∶1∶1的混合溶液)效果最好,表明黄腐酸口腔制剂中主要成分是黄腐酸活性成分,能促进微循环,对牙龈炎起到一定的作用,添加适宜的药物后,能达到更好的效果,可以作为一种理想的牙龈炎、口腔溃疡,牙周炎,牙龈出血等口腔疾病的治疗药物。
(3)口腔用药制剂的临床实验:
①受试对象:受试者来自玉溪腐植酸有限公司,共80人,男43人,女37人,年龄最大70岁,年龄最小18岁,受试者都具有轻重不一的一种或者几种口腔疾病;
②治疗方法:片剂每天三次,每次一片,膜剂每天三次,每次二张,每一剂型20人,疗程3-15天,以口气、牙龈肿痛缓解、口腔溃疡面缩小或愈合,止血、止痛、且发病次数减少为有效依据,无上述改善为无效;
③治疗效果:
表9.黄腐酸口腔用药制剂治疗效果
实验结果:口腔用药制剂能加速口腔溃疡的愈合,有效抵抗口腔常见致病菌造成的口臭,牙龈炎等口腔病症具有疗效好,作用快,且有效率≥90%,是值得推广的一种新型口腔药物。
Claims (3)
1.一种口腔用药制剂,其特征在于:口腔用药制剂由以下原料按重量百分比制得,黄腐酸10~20%、甜叶菊5~10%、氯化钠3~6%,余量为辅料,各组分含量之和为100%,所述口腔用药制剂为***片、咀嚼片、黏附片、膜剂中的一种。
2.根据权利要求1所述的口腔用药制剂,其特征在于:当口腔用药制剂中的辅料及其重量百分比为:填充剂30~50%、粘合剂15~25%、润滑剂10~15%,矫味剂2~4%辅料的时候,所述口腔用药制剂为***片、咀嚼片、黏附片中的一种,所有辅料质量百分比均以原料的总质量为基准;
所述的填充剂为淀粉、可压性淀粉、糊精、甘露醇中的一种或者几种按任意比例混合后得到的混合物;
所述的粘合剂为乙醇、羧甲基纤维素钠、羟丙基纤维素、PVP-K30、卡波姆、微晶纤维素、β-环糊精中的一种或几种按任意比例混合后得到的混合物;
所述的润滑剂为硬脂酸镁、磷酸氢钙、聚乙二醇、微粉硅胶中的一种或几种按任意比例混合后得到的混合物;
所述的矫味剂为薄荷油、薄荷醇、山梨醇中的一种。
3.根据权利要求1所述的口腔用药制剂,其特征在于:当辅料及其重量百分比为:成膜材料30~50%、矫味剂5~10%、增塑剂5~15%、填充剂5~10%、脱膜剂2~8%的时候,所述口腔用药制剂为口腔膜剂,所有辅料的质量百分比均以原料的质量总和为基准;
所述的成膜材料为***胶、琼脂、聚乙烯醇、乙烯-醋酸乙烯共聚物、羟丙基纤维素、羧甲基纤维素等中的一种或几种按任意比例混合后得到的混合物;
所述的矫味剂为薄荷油、甘露醇、香兰素、甜橙香料中的一种或几种按任意比例混合后得到的混合物;
所述的增塑剂为聚乙二醇、山梨醇中的一种;
所述的填充剂为淀粉、糊精、甘露醇、磷酸钙、聚维酮中的一种;
所述的脱膜剂为甘油、硬脂酸、聚山梨脂-80中的一种。
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