CN110151915B - 一种蜂胶口腔护理液及其制备方法 - Google Patents
一种蜂胶口腔护理液及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种蜂胶口腔护理液，其特征在于，以重量百分含量计，包含以下组分：蜂胶提取物0.5％～5％，中药提取物0.5％～5％，食用乙醇0.5％～5％，表面活性剂5~10%，pH调节剂0.1％～1％，甜味剂0.01％～1％，防腐剂0.01～0.05％，余量为水。本发明采用蜂胶提取物与中药提取物复配使用，具有抑菌以及促进创面愈合的作用，制备方法简单，具有很好的使用前景。
Description
技术领域
本发明涉及医药技术领域，尤其涉及一种蜂胶口腔护理液及其制备方法。
背景技术
随着生活水平的不断提高，人们越来越多的关注到自己口腔健康问题。口腔溃疡、牙龈出血以及口腔异味又是口腔问题的主要症结。这些口腔问题大多由于口腔存在的致病菌引起的。致病菌附着在牙齿表面，会引发口腔溃疡、口腔异味等多种口腔问题。为保证口腔健康，常用的清洁手段有：漱口、刷牙、牙签、牙线、超声洁牙等，其中，漱口水，又称口腔清洁护理液，是一种新型的口腔保健用品，漱口水在清除口腔异味、减少口腔细菌、防止龋齿、抗炎镇痛方面有很好的效果，也是口腔科疾病的辅助治疗药品。具有使用方便、便于携带的优点。
蜂胶（propolis）是蜜蜂从植物芽孢或树干破皮伤处采集来的树脂（树胶），并混入蜜蜂上颚腺的分泌物，与蜂蜡、少量花粉等加工而成的一种具有芳香气味和黏性的胶状固体物质。中医药文献记载，蜂胶有润肤生肌、解毒杀虫、祛风止痛以及治疗牙痛等功效。蜂胶及其制剂能抑制金黄色葡萄球菌、链球菌、沙门氏菌、大肠杆菌、绿脓杆菌、白色念珠菌和炭疽杆菌等 20 余种细菌。对主要致龋菌进行体外抑菌试验表明，有显著效果。另外，蜂胶还具有中和细菌毒素的作用，常用不会引起菌群失调症，也不会产生耐药现象蜂胶具有消炎和促进组织愈合的功效，能促进口腔溃疡的愈合，促进组织修复，其化学成分中的花粉、多种维生素、脂肪酸和多糖等具有营养作用， 可提供溃疡愈合所需的营养；醇类、酚类和醛类有腐蚀凝固有机质促进组织再生以及溃疡愈合的作用。
发明内容
（一）发明目的
为解决上述口腔问题，本发明的目的旨在提供一种蜂胶口腔护理液及其制备方法。
（二）技术方案
为实现上述目的，本发明采取的技术方案如下：
本发明一方面提供了一种蜂胶口腔护理液，其特征在于，以重量百分含量计，包含以下组分：
蜂胶提取物0 .5％～5％，中药提取物0 .5％～5％，食用乙醇0 .5％～5％，表面活性剂5~10%，pH调节剂0 .1％～1％，甜味剂0.01％～1％，防腐剂0 .01～0.05％，余量为水。
进一步的，所述蜂胶口腔护理液，其特征在于，以重量百分含量计，包含以下组分：
蜂胶提取物1％～4％，中药提取物1％～4％，食用乙醇1％～4％，表面活性剂6~8%，pH调节剂0.5％～0.8％，甜味剂0 .1％～0.5％，防腐剂0.02～0.04％，余量为水。
进一步可选的，所述蜂胶提取物的总黄酮含量＞35wt%；进一步优选的，所述蜂胶提取物的制备方法如下：
将蜂胶原料经过风选除杂后，在-18℃下进行冷冻，将冷冻后的蜂胶在4℃下粉碎成颗粒，并过80目筛，然后将所述蜂胶颗粒溶于蜂胶质量8倍量的去离子水中，随后加入蜂胶质量0.05倍的助溶剂聚乙二醇，加热至45℃，搅拌30min至蜂胶颗粒完全溶解，冷却至室温、静置后除去固体得蜂胶溶液，然后将所得蜂胶溶液经孔径为60KD超滤陶瓷膜过滤，得到蜂胶精制液再经减压浓缩干燥得蜂胶粗浸膏；向所得蜂胶粗浸膏中加入其质量0.2%氧化石墨烯和其质量8倍量的95%乙醇水溶液进行回流提取，提取温度为75℃，提取时间为2小时，将提取液过滤，然后减压浓缩滤液回收溶剂至干，即得蜂胶总黄酮提取物，所述减压浓缩的压力为0.03MPa，浓缩温度为55℃。
进一步可选的，所述中药提取物的制备方法如下：
按野菊花：山豆根：薄荷：白芨：蒲黄：花椒质量之比为3:6:2:4:3:1分别称取后，分别粉碎过80目筛，然后混合，混合后加入60~95％v/v的乙醇进行超声提取，所述超声提取的功率为15~60kHz，温度为45~55℃，提取时间为50~70min，提取3次，合并提取液，减压浓缩，并于45~55℃下干燥后粉碎，即得；优选的，所述乙醇浓度为80%v/v，所述超声提取的功率为30kHz，温度为50℃，提取时间为55min，干燥温度为50℃；
进一步可选的，所述食用乙醇体积浓度为60～80％；进一步可选的，所述食用乙醇体积浓度为75％；
进一步可选的，所述表面活性剂由PEG-40氢化蓖麻油和羧甲基纤维素组成，所述PEG-40氢化蓖麻油与羧甲基纤维素的质量比为2:（1~4）；进一步可选的，所述PEG-40氢化蓖麻油与羧甲基纤维素的质量比为2：3；进一步可选的，所述pH调节剂为苹果酸、酒石酸、柠檬酸或柠檬酸钠；
进一步可选的，所述甜味剂为山梨糖醇、木糖醇或甜叶菊苷；
进一步可选的，所述的防腐剂为尼泊金甲酯或尼泊金乙酯。
本发明另一方面还提供了如上任一种所述的蜂胶口腔护理液的制备方法，其特征在于：包括下步骤：S1：按上述重量配比称取各组分，然后取蜂胶提取物、中药提取物与表面活性剂以及食用乙醇充分混合；
S2：向上述溶液中加入pH调节剂、甜味剂、防腐剂，充分搅拌使之混合；
S3：向上述溶液中加入所述蜂胶提取物和中药提取物重量之和的1~5%的活性炭，然后充分搅拌后静置、过滤；
S4：用纯化水补足重量，灭菌，灌装，即得；优选的，所述灭菌为微孔滤膜过滤，所述微孔滤膜的直径为5~10 μm。
有益效果
与现有技术相比，本发明体现的技术优点体现在以下几个方面：
1. 本发明采用了蜂胶提取物，蜂胶是蜜蜂将从植物芽孢或树干上采集的树脂入其上腭腺、蜡腺的分泌物中加工而成的一种具有香气味的胶状固体物。蜂胶中黄酮类化合物、烯萜化合物及酯类化合物对大肠杆菌、 金黄色葡萄球菌致病微生物均有很好的抑制作用，能够损伤细胞壁并改变菌体细胞的通透性，可使金黄色葡萄球菌和大肠杆菌碱性磷酸酶和β-半乳糖酸酶在胞外溶出，且对金黄色葡萄球菌的作用更强。本发明所采用的蜂胶提取物的制备方法，通过加入分散剂以及使用超滤膜，采用物理方法除去了蛋白质、多糖等大分子物质而不引入新的杂质，工艺过程中利用纯物理过程进行澄清、除杂，大幅度的提高了蜂胶提取物中活性成分黄酮的含量，并且很大程度减轻环境污染，提高了产品质量安全；
2. 本发明采用了由野菊花、山豆根、薄荷、白芨、蒲黄以及花椒以固定配比组成的中药提取物，与蜂胶提取物一起，共同发挥抑菌、收敛、止血的功效，能够有效对抗口腔溃疡、出血、炎症等口腔问题。
3. 本发明组合物采用的表面活性剂材料多为生物易降解材料，对于环境十分友好；而且具有无毒、对人体十分安全。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚明了，下面结合具体实施方式，对本发明进一步详细说明。应该理解，这些描述只是示例性的，而并非要限制本发明的范围。显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
（一）实施例
1、实施例1：一种口腔护理液
配方：
| 原料名称 | 添加比例wt% | 备注 |
| 蜂胶提取物 | 0.5 | 总黄酮含量＞40wt% |
| 中药提取物 | 0.5 | |
| 食用乙醇 | 0.5 | |
| PEG-40氢化蓖麻油 | 2 | |
| 羧甲基纤维素 | 3 | |
| 柠檬酸 | 0.1 | |
| 木糖醇 | 0.01 | |
| 尼泊金甲酯 | 0.01 | |
| 水 | 补充至100 |
制备方法包括下步骤：S1：按上述重量配比称取各组分，然后取蜂胶提取物、中药提取物与表面活性剂以及60％体积浓度的食用乙醇充分混合；其中，
所述蜂胶提取物的总黄酮含量＞35%，且所述蜂胶提取物的制备方法如下：将蜂胶原料经过风选除杂后，在-18℃下进行冷冻，将冷冻后的蜂胶在4℃下粉碎成颗粒，并过80目筛，然后将所述蜂胶颗粒溶于蜂胶质量8倍量的去离子水中，随后加入蜂胶质量0.05倍的助溶剂聚乙二醇，加热至45℃，搅拌30min至蜂胶颗粒完全溶解，冷却至室温、静置后除去固体得蜂胶溶液，然后将所得蜂胶溶液经孔径为60KD超滤陶瓷膜过滤，得到蜂胶精制液再经减压浓缩干燥得蜂胶粗浸膏；向所得蜂胶粗浸膏中加入其质量0.2%氧化石墨烯和其质量8倍量的95%乙醇水溶液进行回流提取，提取温度为75℃，提取时间为2小时，将提取液过滤，然后减压浓缩滤液回收溶剂至干，即得蜂胶总黄酮提取物，所述减压浓缩的压力为0.03MPa，浓缩温度为55℃；
其中，所述中药提取物的制备方法如下：按质量比野菊花：山豆根：薄荷：白芨：蒲黄：花椒之比为3:6:2:4:3:1，分别称取以上各味药材，分别粉碎过80目筛，混合后加入体积浓度60％的乙醇进行超声提取，所述超声提取的功率为15kHz，温度为45℃，提取时间为50min，提取3次，合并提取液，减压浓缩，并于45℃下干燥后粉碎，即得；
S2：向上述溶液中加入pH调节剂、甜味剂、防腐剂，充分搅拌使之混合；
S3：向上述溶液中加入所述蜂胶提取物和中药提取物重量之和的1%的活性炭，然后充分搅拌后静置、过滤；
S4：用纯化水补足重量，灭菌，灌装，即得；其中，所述灭菌为微孔滤膜过滤，所述微孔滤膜的直径为10 μm。
2. 实施例2：一种口腔护理液
配方：
| 原料名称 | 添加比例wt% | 备注 |
| 蜂胶提取物 | 5 | 总黄酮含量＞40wt% |
| 中药提取物 | 5 | |
| 食用乙醇 | 5 | |
| PEG-40氢化蓖麻油 | 4 | |
| 羧甲基纤维素 | 6 | |
| 柠檬酸钠 | 1 | |
| 山梨糖醇 | 1 | |
| 尼泊金乙酯 | 0.05 | |
| 水 | 补充至100 |
制备方法包括下步骤：S1：按上述重量配比称取各组分，然后取蜂胶提取物、中药提取物与表面活性剂以及80％体积浓度的食用乙醇充分混合；其中，
所述蜂胶提取物的总黄酮含量＞35%，且所述蜂胶提取物的制备方法如下：将蜂胶原料经过风选除杂后，在-18℃下进行冷冻，将冷冻后的蜂胶在4℃下粉碎成颗粒，并过80目筛，然后将所述蜂胶颗粒溶于蜂胶质量8倍量的去离子水中，随后加入蜂胶质量0.05倍的助溶剂聚乙二醇，加热至45℃，搅拌30min至蜂胶颗粒完全溶解，冷却至室温、静置后除去固体得蜂胶溶液，然后将所得蜂胶溶液经孔径为60KD超滤陶瓷膜过滤，得到蜂胶精制液再经减压浓缩干燥得蜂胶粗浸膏；向所得蜂胶粗浸膏中加入其质量0.2%氧化石墨烯和其质量8倍量的95%乙醇水溶液进行回流提取，提取温度为75℃，提取时间为2小时，将提取液过滤，然后减压浓缩滤液回收溶剂至干，即得蜂胶总黄酮提取物，所述减压浓缩的压力为0.03MPa，浓缩温度为55℃；
其中，所述中药提取物的制备方法如下：按质量比野菊花：山豆根：薄荷：白芨：蒲黄：花椒之比为3:6:2:4:3:1，分别称取以上各味药材，分别粉碎过80目筛，混合后加入95％v/v的乙醇进行超声提取，所述超声提取的功率为60kHz，温度为55℃，提取时间为70min，提取3次，合并提取液，减压浓缩，并于55℃下干燥后粉碎，即得；
S2：向上述溶液中加入pH调节剂、甜味剂、防腐剂，充分搅拌使之混合；
S3：向上述溶液中加入所述蜂胶提取物和中药提取物重量之和的5%的活性炭，然后充分搅拌后静置、过滤；
S4：用纯化水补足重量，灭菌，灌装，即得；其中，所述灭菌为微孔滤膜过滤，所述微孔滤膜的直径为10 μm。
3.实施例3：一种口腔护理液
配方：
| 原料名称 | 添加比例wt% | 备注 |
| 蜂胶提取物 | 1 | 总黄酮含量＞40wt% |
| 中药提取物 | 1 | |
| 食用乙醇 | 1 | |
| PEG-40氢化蓖麻油 | 2.4 | |
| 羧甲基纤维素 | 3.6 | |
| 苹果酸 | 0.5 | |
| 甜叶菊苷 | 0.1 | |
| 尼泊金甲酯 | 0.02 | |
| 水 | 补充至100 |
制备方法：
制备方法包括下步骤：S1：按上述重量配比称取各组分，然后取蜂胶提取物、中药提取物与表面活性剂以及75％体积浓度的食用乙醇充分混合；其中，
所述蜂胶提取物的总黄酮含量＞35%，且所述蜂胶提取物的制备方法如下：将蜂胶原料经过风选除杂后，在-18℃下进行冷冻，将冷冻后的蜂胶在4℃下粉碎成颗粒，并过80目筛，然后将所述蜂胶颗粒溶于蜂胶质量8倍量的去离子水中，随后加入蜂胶质量0.05倍的助溶剂聚乙二醇，加热至45℃，搅拌30min至蜂胶颗粒完全溶解，冷却至室温、静置后除去固体得蜂胶溶液，然后将所得蜂胶溶液经孔径为60KD超滤陶瓷膜过滤，得到蜂胶精制液再经减压浓缩干燥得蜂胶粗浸膏；向所得蜂胶粗浸膏中加入其质量0.2%氧化石墨烯和其质量8倍量的95%乙醇水溶液进行回流提取，提取温度为75℃，提取时间为2小时，将提取液过滤，然后减压浓缩滤液回收溶剂至干，即得蜂胶总黄酮提取物，所述减压浓缩的压力为0.03MPa，浓缩温度为55℃；
其中，所述中药提取物的制备方法如下：按质量比野菊花：山豆根：薄荷：白芨：蒲黄：花椒之比为3:6:2:4:3:1，分别称取以上各味药材，分别粉碎过80目筛，混合后加入体积浓度80％的乙醇进行超声提取，所述超声提取的功率为30kHz，温度为50℃，提取时间为55min，提取3次，合并提取液，减压浓缩，并于50℃下干燥后粉碎，即得；
S2：向上述溶液中加入pH调节剂、甜味剂、防腐剂，充分搅拌使之混合；
S3：向上述溶液中加入所述蜂胶提取物和中药提取物重量之和的3%的活性炭，然后充分搅拌后静置、过滤；
S4：用纯化水补足重量，灭菌，灌装，即得；其中，所述灭菌为微孔滤膜过滤，所述微孔滤膜的直径为10 μm。
4.实施例4：一种口腔护理液
配方：
| 原料名称 | 添加比例wt% | 备注 |
| 蜂胶提取物 | 4 | 总黄酮含量＞40wt% |
| 中药提取物 | 4 | |
| 食用乙醇 | 4 | |
| PEG-40氢化蓖麻油 | 3.2 | |
| 羧甲基纤维素 | 4.8 | |
| 酒石酸 | 0.8 | |
| 木糖醇 | 0.5 | |
| 尼泊金甲酯 | 0.04 | |
| 水 | 补充至100 |
制备方法同实施例3。
5. 实施例5：一种口腔护理液
配方：
| 原料名称 | 添加比例wt% | 备注 |
| 蜂胶提取物 | 2 | 总黄酮含量＞40wt% |
| 中药提取物 | 2 | |
| 食用乙醇 | 3 | |
| PEG-40氢化蓖麻油 | 2.8 | |
| 羧甲基纤维素 | 4.2 | |
| 柠檬酸 | 0.6 | |
| 木糖醇 | 0.3 | |
| 尼泊金甲酯 | 0.03 | |
| 水 | 补充至100 |
制备方法同实施例3。
（二）实验例
1. 抑菌活性实验
1.1实验对象：按照本发明实施例1~5制备的漱口水
1.2实验方法：
以金黄色葡萄球菌为例，分别用1mL 无菌移液管移取0.5mL实施例1~5制备的漱口水，浸泡灭菌的滤纸片，摇匀，静置一段时间后，取出置于涂抹大肠杆菌悬液的固体培养基上，分散均匀。然后将培養皿放在恒温培养箱一段时间后取出观察并测量抑菌圈直径。并且按照同样的方法，对实施例1~5对于变形链球菌、乳酸杆菌、牙龈卟啉单胞菌的抑菌活性进行测定。测试结果显示在表1中。
1.3 实验结果
表1
口腔中主要有4类致病菌，牙龈卟啉单胞菌是一种非酵解糖的革兰氏阴性厌氧球杆菌，是牙周致病菌之一。牙龈卟啉单胞菌一旦失控，会导致牙龈从牙齿上脱落下来；葡萄球菌是一群革兰氏阴性球菌，常堆积成葡萄串状，多数为非致病菌，少数可导致疾病，引发口腔炎症；乳酸杆菌是指能使糖类发酵产生乳酸的细菌，是一群生活在机体内益于宿主健康的微生物，酸牛奶中就含有乳酸杆菌。乳酸杆菌发酵糖产生大量乳酸，易造成龋洞。本发明制备的漱口水对于口腔常见细菌均具有良好的抗菌活性，并且对于变形链球菌的活性更好。
2. 口腔溃疡实验
2.1实验对象：实施例5制备的口腔护理液
2.2 实验方法：
2.2.1造模：用乙醚将大鼠麻醉后，用镊子夹破一块大鼠口腔粘膜皮肤，在夹破粘膜皮下注射金黄色葡萄球菌液，隔日形成周围有黄色渗出物的溃疡面。
2.2.2给药：取造模成功的大鼠36只，雌雄各半，体重200g左右，称重后随机分成3组，每组12只。分为空白组、阳性对照组以及给药组。每组每天均给药两次。空白组直接给以不含药物的医用纱布片贴敷于溃疡面；阳性对照组给予蘸取维生素B12的医用纱布片进行贴敷；治疗组给予蘸取实施例5制备的口腔护理液进行贴敷。第一天给药前，用游标卡尺分别测量每只大鼠的溃疡面直径。连续给药，观察10天，于第11天再次用游标卡尺测量未痊愈大鼠的溃疡面直径。以平均愈合直径作为指标采用t检验评价疗效。实验结果见表2。另外，统计溃疡面完全愈合大鼠只数，计算治愈率，统计结果见表3。
2.3 实验结果：由统计以及观察结果可知，本发明制备的口腔护理液具有显著的治疗口腔溃疡的功效，表2中反映出了使用本品后溃疡面的愈合情况，表3反映出了本品治愈口腔溃疡的情况，与阳性对照药相比，本发明技术方案制备的口腔护理液效果更好。
表2
| 组别 | 只数 | 平均愈合直径（mm/d） |
| 空白组 | 12 | 0.38±0.20 |
| 给药组 | 12 | 0.66±0.16 |
| 阳性对照药组 | 12 | 0.56±0.12 |
表3
| 组别 | 10天后完全愈合只数 | 治愈率 |
| 空白组 | 4 | 33.3% |
| 给药组 | 11 | 91.7% |
| 阳性对照药组 | 10 | 83.3% |
应当理解的是，本发明的上述具体实施方式仅仅用于示例性说明或解释本发明的原理，而不构成对本发明的限制。因此，在不偏离本发明的精神和范围的情况下所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。此外，本发明所附权利要求旨在涵盖落入所附权利要求范围和边界、或者这种范围和边界的等同形式内的全部变化和修改例。
Claims (3)
1.一种蜂胶口腔护理液，其特征在于，以重量百分含量计，包含以下组分：蜂胶提取物0.5％～5％，中药提取物0 .5％～5％，食用乙醇0 .5％～5％，表面活性剂5~10%，pH调节剂0.1％～1％，甜味剂0.01％～1％，防腐剂0.01～0.05％，余量为水；
其中，所述蜂胶提取物的总黄酮含量＞35wt%，且蜂胶提取物的制备方法如下：将蜂胶原料经过风选除杂后，在-18℃下进行冷冻，将冷冻后的蜂胶在4℃下粉碎成颗粒，并过80目筛，然后将所述蜂胶颗粒溶于蜂胶质量8倍量的去离子水中，随后加入蜂胶质量0.05倍的助溶剂聚乙二醇，加热至45℃，搅拌30min至蜂胶颗粒完全溶解，冷却至室温、静置后除去固体得蜂胶溶液，然后将所得蜂胶溶液经孔径为60KD超滤陶瓷膜过滤，得到蜂胶精制液再经减压浓缩干燥得蜂胶粗浸膏；向所得蜂胶粗浸膏中加入其质量0.2%氧化石墨烯和其质量8倍量的95%乙醇水溶液进行回流提取，提取温度为75℃，提取时间为2小时，将提取液过滤，然后减压浓缩滤液回收溶剂至干，即得蜂胶总黄酮提取物，所述减压浓缩的压力为0.03MPa，浓缩温度为55℃；
其中，所述中药提取物的制备方法包括以下步骤：按野菊花：山豆根：薄荷：白芨：蒲黄：花椒质量之比为3:6:2:4:3:1分别称取后，分别粉碎过80目筛，然后混合，混合后加入60~95％v/v的乙醇进行超声提取，所述超声提取的功率为15~60kHz，温度为45~55℃，提取时间为50~70min，提取3次，合并提取液，减压浓缩，并于45~55℃下干燥后粉碎，即得；
其中，所述表面活性剂由PEG-40氢化蓖麻油和羧甲基纤维素组成，且所述PEG-40氢化蓖麻油与羧甲基纤维素的质量比为2:（1~4）。
2.根据权利要求1所述的蜂胶口腔护理液，其特征在于，以重量百分含量计，包含以下组分：
蜂胶提取物1％～4％，中药提取物1％～4％，食用乙醇1％～4％，表面活性剂6~8%，pH调节剂0.5％～0.8％，甜味剂0 .1％～0.5％，防腐剂0.02～0.04％，余量为水。
3.一种如权利要求1~2任一项所述蜂胶口腔护理液的制备方法，其特征在于，包括下步骤：S1：按上述重量配比称取各组分，然后取蜂胶提取物、中药提取物与表面活性剂以及食用乙醇充分混合；
S2：向上述溶液中加入pH调节剂、甜味剂、防腐剂，充分搅拌使之混合均匀；
S3：向上述溶液中加入所述蜂胶提取物和中药提取物重量之和的1~5%的活性炭，然后充分搅拌后静置、过滤；
S4：用纯化水补足重量，灭菌，灌装，即得。
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