CN113456822B - 一种抑菌和/或脱敏的口腔用糊剂 - Google Patents

一种抑菌和/或脱敏的口腔用糊剂 Download PDF

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CN113456822B
CN113456822B CN202110803893.3A CN202110803893A CN113456822B CN 113456822 B CN113456822 B CN 113456822B CN 202110803893 A CN202110803893 A CN 202110803893A CN 113456822 B CN113456822 B CN 113456822B
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张文娟
王东隶
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Abstract

本发明属于药物制剂技术领域，具体涉及一种抑菌和/或脱敏的口腔用糊剂。本发明公开的口腔用糊剂包括脱敏活性成分、抑菌活性成分、粘合剂、固体基质、抗氧剂、溶剂。通过优选脱敏活性成分的种类及比例、优化脱敏活性成分和抑菌活性成分的配比及其他辅料的种类和用量，共同提高本品的脱敏和抑菌效果，通过筛选抗氧剂的种类及用量，解决了活性成分易被氧化的问题，提高产品的稳定性。

Description

一种抑菌和/或脱敏的口腔用糊剂
技术领域
本发明属于药物制剂技术领域，具体涉及一种抑菌和/或脱敏的口腔用糊剂。
背景技术
牙本质过敏症被定义为由暴露的牙本质产生的短暂疼痛，通常是响应化学、温度、触觉或渗透刺激的疼痛，这不能通过任何其他牙齿缺陷或病理学来解释。牙齿的外表面(牙釉质)的腐蚀和/或牙龈萎缩通常导致牙本质小管暴露，从而产生口腔和牙髓中的神经纤维之间的通路。在活体内已经显示，整个牙本质存在压力梯度，这导致流体向外流动。这种流体流动响应触觉、温度(热或冷)以及渗透刺激(高浓度糖等)而被干扰或增加，这被认为可导致牙髓内神经纤维的机械性刺激受体响应(被检测为疼痛)。牙本质过敏症是外界刺激暴露的牙本质而引起的一种主观症状，有牙齿酸软疼痛的症状，严重影响患者进食和身心健康。在口腔科疾病中牙本质过敏症属于一种常见病，发病率高，临床上常采用激光脱敏治疗或使用氟化物、氯化锶、氟化氨银、碘化银等药物来治疗，但这些单一药物各有其优缺点，治疗效果均不太理想，治疗有效率低，维持有效时间短，复发率高。
中国专利CN106581078A公开了以钙粉、二氧化硅、羧甲基纤维素、氯化锶、硝酸钾、氟化物、凝胶、十二烷基硫酸钠、香精和/或蜂房萃取液为主辅料的一种口腔脱敏糊剂及其制备方，但其有效成分容易被氧化，不易储存，长期稳定性不高。
随着牙齿敏感症患者增加，迫切需要开发与现有的牙齿敏感症治疗剂相比具有更优异的效果的治疗剂，并且增加治疗剂的抑菌效果防止牙齿蛀蚀，减缓牙齿外表面牙釉质的腐蚀，降低牙齿敏感的程度。
发明内容
克服现有技术的不足，本发明通过优化筛选主辅料、对制剂的处方进行改进，解决了活性成分容易被氧化的问题，提供一种长期稳定性高、能够有效缓解牙齿敏感和/或口腔抑菌的口腔用糊剂。
为了实现上述目的，本申请采用如下技术方案：
本发明提供了一种口腔用糊剂，所述的口腔用糊剂包括脱敏活性成分、抑菌活性成分、粘合剂、固体基质、抗氧剂、溶剂。
进一步的，按重量份计算，所述的脱敏活性成分4-12份、抑菌活性成分0.5-3份、粘合剂10-25份、固体基质50-80份、抗氧剂0.5-3份、溶剂10-20份。
优选为，脱敏活性成分8份、抑菌活性成分2份、粘合剂15份、固体基质60份、抗氧剂1份、溶剂14份。
进一步的，所述的脱敏活性成分选自氟化钠、氟化铵、氧化银、氟化亚锡、硝酸银、硝酸钾中的一种或多种，优选为硝酸银和氟化亚锡。
具体的，所述的硝酸银和氟化亚锡的重量份比为1:1-4，优选为1:3。
进一步的，所述的抑菌活性成分选自氯已定、碳酸氢铵、戊二醛中的一种或多种，优选为氯已定。
具体的，所述的脱敏活性成分和菌成分的重量比为1:0.1-0.3，优选为1:0.25。
进一步的，所述的固体基质选自白陶土、滑石粉、碳酸钙、碳酸镁中的一种或多种，优选为白陶土；所述的粘合剂选自西黄蓍胶、卡波姆、环糊精、海藻酸钠中的一种或多种，优选为西黄蓍胶；所述的溶剂选自甲基丙烯酸羟乙酯溶液或/和正磷酸溶液，优选为质量分数为5％的甲基丙烯酸羟乙酯溶液；所述的抗氧剂选自丁基羟基苗香醚、二丁基羟基甲苯、没食子儿茶素没食子酸酯、叔丁基对苯二酚中的一种或多种，优选为没食子儿茶素没食子酸酯。
本发明的第二个目的在于提供所述的口腔用糊剂在缓解牙齿敏感和/或抑制口腔细菌的应用。
与现有的技术相比，本发明的有益效果在于：
(1)优选脱敏活性成分的种类及比例，提高本品的脱敏效果；
(2)优化脱敏活性成分和抑菌活性成分的比例及其他辅料的种类和用量，共同提高本品的脱敏、抑菌效果及各项物理性能；
(3)通过筛选抗氧剂的种类，解决了活性成分易被氧化的问题，提高稳定性。
具体实施方式
为了使本发明的目的、技术方案更加清楚明白，以下结合实施例，对本发明做进一步的说明，但是本发明的保护范围并不限于这些实施例，实施例仅用于解释本发明。本领域技术人员应该理解的是，凡是不背离本发明构思的改变或等同替代均包括在本发明的保护范围之内。下面结合实施例对本发明进一步描述，但本发明并不为实施例所限制。
实施例1：
Figure BDA0003165579220000031
制备方法：
将上述原辅料混合，搅拌混匀，即得。
实施例2：
Figure BDA0003165579220000032
制备方法：同实施例1。
实施例3：
Figure BDA0003165579220000033
制备方法：同实施例1。对比实施例1：
Figure BDA0003165579220000041
制备方法：同实施例1。对比实施例2：
Figure BDA0003165579220000042
制备方法：同实施例1。对比实施例3：
Figure BDA0003165579220000043
制备方法：同实施例1。对比实施例4：
Figure BDA0003165579220000044
Figure BDA0003165579220000051
制备方法：同实施例1。
验证实施例
一、稳定性检测
分别检测本发明实施例1-3、对比实施例1-4制备的口腔用糊剂在常温下保存6个月、在42℃烘箱75％湿度中保存6个月后的产品性状、霉变情况以及硬化情况。
表1各实施例产品性状、霉变情况以及硬化情况
Figure BDA0003165579220000052
本发明保护方案所制备的口腔用糊剂的稳定性及长期稳定性优异，均未发现变硬情况、霉变情况等，而对比实施例的糊剂稳定性不及本发明，尤其是对比实施例3在42℃6个月后出现沉淀、颜色发黄、发生霉变、产生异味、变硬等情况，不易储存。
二、杀菌性能检验
本产品对大肠杆菌、金黄色葡萄球菌、白色念珠菌的杀菌性能进行实验，结果见下表所示，表中试验数据为三次结果平均值，
Figure BDA0003165579220000061
为平均杀菌率(％)。需要说明的是，在此只列举了作用5分钟时的杀菌效果，如后续需要10、15、30分钟的杀菌实验数据，亦可提供。
表2各实施例杀菌性能情况
Figure BDA0003165579220000062
本发明保护方案所制备的口腔用糊剂对金黄色葡萄球菌、大肠杆菌、白色念珠菌作用5分钟，杀菌率≥99.6％，具有显著的杀菌作用。对比实施例方案所制备的糊剂杀菌效果明显不及本发明实施例。
三、临床病例总结
1.临床统计病例
1.1病例选择
门诊病例45例，均为牙齿过敏病例。
1.2治疗方法
将患牙严密隔离，用尖锐探针探查牙本质过敏区，以10作为最敏感，以0为无敏感，记录患者的过敏程度，作为试验前基线。将患牙过敏区用75％酒精消毒脱脂，干燥，然后将长约1cm的产品糊剂涂满于过敏区，涂敷患处约5分钟，用蒸馏水将残存糊剂冲洗干净，然后用尖锐探针探查牙本质过敏区，记录患者的过敏程度。牙齿敏感为0-2记为显效，3-8记为有效，9-10记为无效。
1.3疗效分析
表3实施例1总体疗效分析
Figure BDA0003165579220000071
表4对比实施例总体疗效分析
Figure BDA0003165579220000072
由表3-4的统计数据可知，本发明对牙齿过敏病患的总体治疗效果显著，总病例数为45例，总有效率达到95.5％。结合表4可知，对比实施例对牙齿敏感的治疗效果不佳，对比实施例1的总有效率为28.8％，对比实施例4的总有效率为46.6％。
2.典型病例
治疗方法同1.2。
典型病例1：张某，男，40岁。过敏程度为9，使用本发明实施例1糊剂涂敷患处约5分钟，冲洗后，敏感程度明显减轻，过敏程度为1。
典型病例2：胡某，女，45岁。过敏程度为8，使用本发明实施例1糊剂涂敷患处约5分钟，冲洗后，敏感程度明显减轻，过敏程度为2。
需要说明的是，发明人对其他实施例及对比实施例也开展了临床试验，但在此不做列举，如后续需要补充数据，亦可提供。

Claims (5)

1.一种缓解牙齿敏感和/或抑制口腔细菌的口腔用糊剂，其特征在于，所述的口腔用糊剂由脱敏活性成分4-12重量份、抑菌活性成分2-3重量份、粘合剂10-25重量份、固体基质50-80重量份、抗氧剂0.5-3重量份、溶剂14重量份组成；
所述的脱敏活性成分为硝酸银和氟化亚锡，二者重量份比为1:1-4；
所述的抑菌活性成分选自氯己 定；
所述的脱敏活性成分和抑菌活性成分的重量比为1:0.1-0.3；
所述的固体基质选自白陶土、滑石粉、碳酸钙、碳酸镁中的一种或多种；
所述的粘合剂选自西黄蓍胶、卡波姆、环糊精、海藻酸钠中的一种或多种；
所述的溶剂为5％的甲基丙烯酸羟乙酯溶液；
所述的抗氧剂选自没食子儿茶素没食子酸酯。
2.根据权利要求1所述的口腔用糊剂，其特征在于，按重量份计算，所述的脱敏活性成分8份、抑菌活性成分2份、粘合剂15份、固体基质60份、抗氧剂1份、溶剂14份。
3.根据权利要求1所 述的口腔用糊剂，其特征在于，所述的硝酸银和氟化亚锡的重量份比为1:3。
4.根据权利要求1所 述的口腔用糊剂，其特征在于，所述的脱敏活性成分和抑菌活性成分的重量比为1:0.25。
5.根据权利要求1所述的口腔用糊剂，其特征在于，所述的固体基质为白陶土；所述的粘合剂为西黄蓍胶。
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