CN110064048A - 一种防治口腔疾病的组合药物及其制备方法 - Google Patents
一种防治口腔疾病的组合药物及其制备方法 Download PDFInfo
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Abstract
本发明属医药领域，涉及一种防治口腔疾病的组合药物，其组分包括核糖体失活蛋白、多糖、微量物质、抗(抑)菌剂。本发明以核糖体失活蛋白为活性成分，辅以微量物质、抗(抑)菌剂，能清除病原微生物，促进口腔溃疡创面的修复和愈合，同时阻隔口腔病原微生物对溃疡创面的接触和感染，通过保护创面的作用，减少外界对口腔溃疡面的刺激，能有效治疗口腔溃疡，特别对由局部创伤、免疫功能、病原微生物等引发的复发性口腔溃疡效果更好，适用于修复口腔黏膜炎和口腔溃疡，预防咽喉癌和口腔癌等严重疾病发生，具有较好的依从性，且安全无毒，具有良好的临床应用前景。
Description
技术领域
本发明属医药领域，涉及一种药物组合物及其制备方法，具体是一种防治口腔疾病的组合药物及其制备方法。
背景技术
口腔溃疡俗称“口疮”，是一种常见的口腔黏膜溃疡性损伤疾病。口腔溃疡有自发性疼痛或因食物刺激而产生灼痛，给人们日常生活带来不适，严重影响生活质量。临床上表现为口腔黏膜溃疡类损伤的类型有多种，其中复发性口腔溃疡(Recurrent oral ulcer，ROU)人群患病率达20％，为常见口腔黏膜病，可并发咽炎和牙周炎，其中病毒性ROU还可引发老年性痴呆，严重者甚至可导致咽喉癌和口腔癌等严重疾病发生，严重影响了人们的身体健康。
口腔溃疡的病因很复杂，其中病原微生物与口腔溃疡关系密切，发生机制可能与病毒感染、病毒与细菌混合感染、免疫失调等有关，此外局部创伤、精神紧张、食物、药物、营养不良、激素水平改变及维生素或微量元素缺乏、***性疾病和遗传也可能是重要起因之一。目前在ROU的治疗中，尚未有根治的特效药物和方法，特别是病毒性ROU国际上至今未研制出安全有效的治疗药物和方法。临床治疗以加速局部溃疡创面愈合和缓解疼痛为主，治疗原则为对症治疗、增强体质，达到减少复发次数、减轻患者疼痛、缩短治疗时间的目的。目前治疗技术与药物有西医药治疗、中医药治疗、中西医结合治疗和物理治疗。治疗方法各有千秋，但都治标不治本。目前国外应用较多的免疫促进剂和激素类药物，虽然对一些ROU效果较好，但长期应用可产生某些严重不良副作用。因此，临床上急需开发一种安全有效的ROU治疗产品，从本质上根治ROU。
发明内容
本发明的目的是提供一种防治口腔疾病的组合药物及其制备方法，以核糖体失活蛋白为活性成分，能有效治疗口腔溃疡，特别对由局部创伤、免疫功能、病原微生物等引发的复发性口腔溃疡效果更好，具有较好的依从性，且安全无毒。
本发明所采用的技术方案：
一种防治口腔疾病的组合药物，包括以下重量百分比的组分：
核糖体失活蛋白 0.005～0.1％
多糖 20～88％
微量物质 0.001～10％
抗(抑)菌剂 0.01～1％。
进一步地，所述的核糖体失活蛋白包括但不局限于以下的一种或几种：商陆核糖体失活蛋白、商陆生物活性因子CSE、商陆生物活性因子AVF、蓖麻核糖体失活蛋白、南瓜核糖体失活蛋白、苦瓜核糖体失活蛋白、丝瓜核糖体失活蛋白、茶树核糖体失活蛋白、苦丁茶核糖体失活蛋白、天花粉核糖体失活蛋白、玉米核糖体失活蛋白、椰菜核糖体失活蛋白。
进一步地，所述的微量物质包括但不局限于以下的一种或几种：锌、铁、硒、钙、维生素C和维生素B。
进一步地，所述的防治口腔疾病的组合药物还包括药用辅料，用于赋形、充当载体、提高稳定性、增溶、助溶、缓控释等，优选药用辅料为基质、溶剂、吸收促进剂、抗氧化剂、表面活性剂、粘合剂、赋形剂、崩解剂、润滑剂、甜味剂、矫味剂中的一种或多种。
进一步地，所述的防治口腔疾病的组合药物加入药用辅料后制成膜剂、冻干粉剂、泡腾剂、散剂、片剂、凝胶、胶囊、涂抹剂、栓剂、膏剂、喷剂、滴丸剂、乳液、溶液或悬浮液剂，优选膜剂、凝胶剂和冻干粉剂。
进一步地，所述的防治口腔疾病的组合药物制成膜剂，其制备方法如下：
将海藻酸钠溶解于纯化水中，加入核糖体失活蛋白、微量物质、多糖和抗(抑)菌剂，混合均匀；倒入模具中，低温冷冻真空干燥成膜。
进一步地，所述的防治口腔疾病的组合药物制成凝胶剂，其制备方法包括以下步骤：
(1)将核糖体失活蛋白、微量物质、多糖和抗(抑)菌剂溶解于纯化水中，混合均匀；
(2)将凝胶基质加入适量纯化水，充分溶胀；
(3)将步骤(1)制得的溶液，加入步骤(2)制得的凝胶液中，均匀搅拌后，按规格分装。
进一步地，所述的防治口腔疾病的组合药物制成复合剂型，包括冻干粉和溶解液，其中冻干粉包括核糖体失活蛋白、微量物质和多糖；溶解液包括水和抗(抑)菌剂。使用时先用溶解液清洗口腔，再喷撒冻干粉，其制备方法包括以下步骤：
(1)将核糖体失活蛋白、微量物质、多糖和辅料，混合均匀，制成冻干粉，按规格分装；
(2)将抗(抑)菌剂溶解于纯化水中，混合均匀，制成溶解液，按规格分装。
本发明以核糖体失活蛋白为活性成分，辅以微量物质、抗(抑)菌剂，能清除病原微生物，促进口腔溃疡创面的修复和愈合，同时阻隔口腔病原微生物对溃疡创面的接触和感染，通过保护创面的作用，减少外界对口腔溃疡面的刺激，能有效治疗口腔溃疡，特别对由局部创伤、免疫功能、病原微生物等引发的复发性口腔溃疡效果更好，适用于修复口腔黏膜炎和口腔溃疡，预防咽喉癌和口腔癌等严重疾病发生，具有较好的依从性，且安全无毒，具有良好的临床应用前景。
具体实施方式
下面结合实施例，对本发明的具体实施方式作进一步详细描述。以下实施例用于说明本发明，但不用来限制本发明的范围。下列实施例中未注明具体条件的实验方法，通常按照常规条件，或按照制造厂商所建议的条件。
一、防治口腔疾病的药物剂型制备
实施例1、口腔膜剂的制备
1)将3g海藻酸钠溶于适量纯化水中，加入6mg商陆核糖体失活蛋白、80mg锌、300mg维生素C、15g多糖和0.05g葡萄糖酸氯己定，混合均匀；
2)倒入模具中，低温冷冻真空干燥成膜。
实施例2、口腔凝胶剂的制备
1)将20g多糖、20mg苦瓜核糖体失活蛋白、150mg铁、15mg维生素B、0.2g葡萄糖酸氯己定溶解于纯化水中，混合均匀；
2)将1g卡波姆加入适量纯化水，充分溶胀后，调PH值为7；
3)将步骤(1)加入步骤(2)制得的凝胶液中，均匀搅拌后，按规格分装。
实施例3、口腔复合剂制备
1)将10mg茶核糖体失活蛋白、5mg硒、10mg维生素B2、和10g多糖溶解于纯化水中，混合均匀，低温冷冻真空干燥；
2)将步骤(1)加入辅料卡拉胶，混合均匀
3)将步骤(2)加入步骤(1)制得的溶液中，混合均匀制成冻干粉。
4)醋酸氯已定0.15份、水99.85份，混合均匀制成溶解液。
二、安全性评价
对本发明制备的口腔制剂做了药理学研究。结果表明，本发明制备的口腔制剂是安全的。
1)小鼠经口急性毒理试验：本发明制备的口腔制剂小鼠经口急性毒理试验，未出现异常反应，安全。
2)大鼠长期毒性试验：本发明制备的口腔制剂连续使用30天未出现异常反应，安全。
3)仓鼠口腔黏膜刺激试验：本发明制备的口腔制剂对口腔黏膜无刺激，安全。
三、试用效果
对本发明制备的口腔制剂做了初步试用观察。结果表明，本发明制备的口腔制剂对口腔溃疡具有显著的疗效。
随机挑选口腔溃疡患者60例，平均分成三组，每组20例，分别使用实施例1、实施例2、实施例3所制得的药物治疗。治疗方式：患处给药，每日4次(每日3餐后及临睡前)，给药7天后复诊，结果见表1。疗效评价如下：
痊愈：给药7天溃疡愈合，疼痛消失。
有效：给药7天溃疡面缩小，疼痛减轻。
无效：给药7天溃疡面无明显改变或疼痛无明显减轻甚至加重。
总有效率＝(痊愈数+有效数)/总例数×100％。
表1
| 组别 | 总例数 | 痊愈 | 有效 | 无效 | 痊愈率 | 总有效率 |
| 实施例1 | 20 | 16 | 2 | 2 | 80 | 90 |
| 实施例2 | 20 | 18 | 1 | 1 | 90 | 95 |
| 实施例3 | 20 | 17 | 1 | 2 | 85 | 90 |
结果表明本发明制备的口腔制剂对口腔溃疡具有显著的疗效。其中实施例2的效果最好，痊愈率为90％，总有效率为95％。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明技术原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (9)
1.一种防治口腔疾病的组合药物，其特征在于，包括以下重量百分比的组分：
核糖体失活蛋白 0.005～0.1％
多糖 20～88％
微量物质 0.001～10％
抗(抑)菌剂 0.01～1％。
2.根据权利要求1所述的组合药物，其特征在于：所述的核糖体失活蛋白包括但不局限于以下的一种或几种：商陆核糖体失活蛋白、商陆生物活性因子CSE、商陆生物活性因子AVF、蓖麻核糖体失活蛋白、南瓜核糖体失活蛋白、苦瓜核糖体失活蛋白、丝瓜核糖体失活蛋白、茶树核糖体失活蛋白、苦丁茶核糖体失活蛋白、天花粉核糖体失活蛋白、玉米核糖体失活蛋白、椰菜核糖体失活蛋白。
3.根据权利要求1所述的组合药物，其特征在于：所述的微量物质包括但不局限于以下的一种或几种：锌、铁、硒、钙、维生素C和维生素B。
4.根据权利要求1所述的组合药物，其特征在于：所述的防治口腔疾病的组合药物还包括药用辅料，所述药用辅料为基质、溶剂、吸收促进剂、抗氧化剂、表面活性剂、粘合剂、赋形剂、崩解剂、润滑剂、甜味剂、矫味剂中的一种或多种。
5.根据权利要求1所述的组合药物，其特征在于：所述的防治口腔疾病的组合药物加入药用辅料后制成膜剂、冻干粉剂、泡腾剂、散剂、片剂、凝胶、胶囊、涂抹剂、栓剂、膏剂、喷剂、滴丸剂、乳液、溶液或悬浮液剂，优选膜剂、凝胶剂和冻干粉剂。
6.根据权利要求1所述的组合药物，其特征在于：所述的防治口腔疾病的组合药物制成膜剂，其制备方法如下：
将海藻酸钠溶解于纯化水中，加入核糖体失活蛋白、微量物质、多糖和抗(抑)菌剂，混合均匀；倒入模具中，低温冷冻真空干燥成膜。
7.根据权利要求1所述的组合药物，其特征在于：所述的防治口腔疾病的组合药物制成凝胶剂，其制备方法包括以下步骤：
(1)将核糖体失活蛋白、微量物质、多糖和抗(抑)菌剂溶解于纯化水中，混合均匀；
(2)将凝胶基质加入适量纯化水，充分溶胀；
(3)将步骤(1)制得的溶液，加入步骤(2)制得的凝胶液中，均匀搅拌后，按规格分装。
8.根据权利要求1所述的组合药物，其特征在于：所述的防治口腔疾病的组合药物制成复合剂型，包括冻干粉和溶解液，其中冻干粉包括核糖体失活蛋白、微量物质和多糖；溶解液包括水和抗(抑)菌剂。
9.一种权利要求8所述的组合药物制成复合剂型的制备方法，其特征在于，包括以下步骤：
(1)将核糖体失活蛋白、微量物质、多糖和辅料，混合均匀，制成冻干粉，按规格分装；
(2)将抗(抑)菌剂溶解于纯化水中，混合均匀，制成溶解液，按规格分装。
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Address after: No. 5 Yaogu 1st Road, National High tech Industrial Park, Haikou City, Hainan Province, 570311 Applicant after: Senruipu Life Science Pharmaceutical (Hainan) Group Co.,Ltd. Address before: 570000 No.5, Yaogu 1st Road, national high tech Industrial Park, Haikou City, Hainan Province Applicant before: HAINAN SR-BIOPHARMA CO.,LTD. |
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