CN114601750A - 一种用于口腔清洁护理用品的防腐剂组合物及其制备方法与应用 - Google Patents
一种用于口腔清洁护理用品的防腐剂组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明公开一种用于口腔清洁护理用品的防腐剂组合物,按照总重量份100份计,由以下重量份的原料组成:防腐剂A 3~35份,防腐剂B 1~36份,增效剂0.1~15份,稳定剂0.02~10份,溶剂4~70份;其中,所述的防腐剂A为苯甲酸、苯甲酸钠、苯氧乙醇、山梨酸、山梨酸钠中的任意一种或任意几种;防腐剂B为氯苯甘醚、4‑羟基苯甲酸、4‑羟基苯甲酸甲酯、4‑羟基苯甲酸乙酯、4‑羟基苯甲酸丙酯、4‑羟基苯丙酯、脱氢乙酸、脱氢乙酸钠、苯甲醇中的任意一种或任意几种。同时,本发明还公开所述防腐剂组合物的制备方法与应用。本发明提供的用于口腔清洁护理用品的防腐剂组合物稳定性好,防腐性能优异,安全性高。
Description
技术领域
本发明属于日用品辅助制剂制备技术领域,具体涉及一种用于口腔清洁护理用品的防腐剂组合物及其制备方法与应用。
背景技术
口腔清洁护理用品作为一类口腔卫生用品,在使用过程中与口腔密切接触,如果微生物指标不达标,极易引起人体不适。因此国家对口腔清洁护理用品有较高的卫生要求,如口腔清洁护理液的卫生指标中要求菌落总数小于等于500 CFU/mL,霉菌与酵母菌总数小于等于100 CFU/mL,粪大肠菌群、铜绿假单胞菌和金黄色葡萄球菌均不应检出。牙膏的卫生指标与口腔清洁护理液基本相同,要求菌落总数小于等于500 CFU/g,霉菌与酵母菌总数小于等于100 CFU/g,耐热大肠菌群、铜绿假单胞菌和金黄色葡萄球菌均不应检出。口腔清洁护理用品特别是口腔清洁护理液、牙膏、牙粉等非一次性用品,在使用过程中要不断与外界环境接触,如与水、空气、口腔接触等,这就增加了遭受微生物污染的风险,所以不仅要保证其在未开封前卫生指标符合要求,而且在使用过程中,也要保证使用的安全性。这就对产品提出了更高要求,要达到这一点,就要在产品中添加安全且可靠的防腐剂产品。
根据口腔清洁护理用品用原料普遍采用《牙膏用原料规范》要求, 其中许用防腐剂为48种。由于防腐剂均有一定毒性,因此国家对其均有限量要求。但在一定限量下防腐剂的防腐性能有限,因此就需要将多种防腐剂复配使用,从而增强其防腐效果,甚至降低使用量。
发明内容
针对现有技术的缺陷,本发明公开了一种用于口腔清洁护理用品的防腐剂组合物,具有优异的防腐性能,且安全性高。
一种用于口腔清洁护理用品的防腐剂组合物,按照总重量份100份计,由以下重量份的原料组成:
防腐剂A 3~35份,
防腐剂B 1~36份
增效剂 0.1~15份,
稳定剂 0.02~10份
溶剂 4~70份;
其中,所述的防腐剂A为苯甲酸、苯甲酸钠、苯氧乙醇、山梨酸、山梨酸钠中的任意一种或任意几种;
防腐剂B为氯苯甘醚、4-羟基苯甲酸、4-羟基苯甲酸甲酯、4-羟基苯甲酸乙酯、4-羟基苯甲酸丙酯、4-羟基苯丙酯、脱氢乙酸、脱氢乙酸钠、苯甲醇中的任意一种或任意几种;
所述增效剂为增效剂A与增效剂B的组合物,所述增效剂A为纽甜、索马甜、阿力甜、甜菊糖中的任意一种;所述增效剂B为2-羟基丁二酸、吡啶-3-甲酸中的至少一种。
优选地,所述增效剂A与增效剂B的重量比为(0.5-1):(3.5-6.5)。
优选地,所述稳定剂β-环糊精、EDTA-2Na、维生素E醋酸酯、维生素C中的任意一种或任意几种。
优选地,所述溶剂为水或/和醇类溶剂。
优选地,所述醇类溶剂为1,2-丙二醇、1,3-丙二醇、1,3-丁二醇、甲基丙二醇、苯氧乙醇中的任意一种或任意几种。
所述防腐剂组合物的制备方法,包括以下步骤:
(1)将溶剂、防腐剂A和增效剂搅拌,混合均匀;
(2)向其中加入防腐剂B,搅拌混合至得到均一溶液;
(3)加入稳定剂搅拌,混合均匀;
(4)用400目以上的滤布过滤,所得液体即为所述防腐剂组合物。
所述防腐组合物在口腔清洁护理用品中的应用:按照0.01-0.05wt%加入口腔清洁护理用品中。
本发明的优点:
(1)本发明提供的用于口腔清洁护理用品的防腐剂组合物稳定性好,该防腐剂组合物50℃放置4个月,外观无明显变化;
(2)防腐性能优异,按照0.01%~0.05%添加到口腔清洁护理用品中,不影响产品的稳定性及使用性能,可通过防腐挑战试验;且通过使用甜味剂的组合作为增效剂,明显的提高其防腐性能,使得所述增效在提高防腐性能是还能改善口腔清洁护理用品的口感;
(3)安全性高,经毒理安全测试,LD50大于2000mg/kg,结合使用量该组合物对人体极为安全。
具体实施方式
实施例1
一种用于口腔清洁护理用品的防腐剂组合物,按照总重量份100份计,由以下重量份的原料组成:
防腐剂A : 8份苯甲酸和20份苯氧乙醇;
防腐剂B:1份氯苯甘醚和3份4-羟基苯甲酸甲酯;
增效剂:0.5份纽甜和6.5份2-羟基丁二酸;
稳定剂:0.1份β-环糊精;
溶剂:56份1,3-丙二醇和4.9份水;
所述防腐剂组合物的制备方法,包括以下步骤:
(1)将溶剂、防腐剂A和增效剂搅拌,混合均匀;
(2)向其中加入防腐剂B,搅拌混合至得到均一溶液;
(3)加入稳定剂搅拌,混合均匀;
(4)用400目以上的滤布过滤,所得液体即为所述防腐剂组合物。
实施例2
一种用于口腔清洁护理用品的防腐剂组合物,按照总重量份100份计,由以下重量份的原料组成:
防腐剂A : 5份苯甲酸钠和26份苯氧乙醇;
防腐剂B:1份脱氢乙酸和2份4-羟基苯甲酸丙酯;
增效剂:1份索马甜和6份吡啶-3-甲酸;
稳定剂:0.5份维生素E醋酸酯;
溶剂:58.5份甲基丙二醇;
所述防腐剂组合物的制备方法同实施例1。
实施例3
一种用于口腔清洁护理用品的防腐剂组合物,按照总重量份100份计,由以下重量份的原料组成:
防腐剂A : 28份苯氧乙醇;
防腐剂B:5份4-羟基苯甲酸和1份4-羟基苯甲酸丙酯;
增效剂:1份阿力甜和3.5份吡啶-3-甲酸;
稳定剂:0.02份EDTA-2Na;
溶剂:61.48份1,3-丙二醇;
所述防腐剂组合物的制备方法同实施例1。
实施例4
一种用于口腔清洁护理用品的防腐剂组合物,按照总重量份100份计,由以下重量份的原料组成:
防腐剂A : 20份山梨酸;
防腐剂B:12份脱氢乙酸;
增效剂:0.5份甜菊糖,4.5份2-羟基丁二酸;
稳定剂:0.02份EDTA-2Na;
溶剂:39份苯氧乙醇和23.98份1,2-丙二醇;
所述防腐剂组合物的制备方法同实施例1。
实施例5
一种用于口腔清洁护理用品的防腐剂组合物,按照总重量份100份计,由以下重量份的原料组成:
防腐剂A :14份山梨酸和6份苯甲酸;
防腐剂B:11份脱氢乙酸;
增效剂:1份纽甜、1份2-羟基丁二酸和3份吡啶-3-甲酸;
稳定剂:0.02份EDTA-2Na;
溶剂:50份苯氧乙醇,13.98份1,2-丙二醇;
所述防腐剂组合物的制备方法同实施例1。
实施例6
一种用于口腔清洁护理用品的防腐剂组合物,按照总重量份100份计,由以下重量份的原料组成:
防腐剂A :3份山梨酸钠;
防腐剂B:36份脱氢乙酸钠;
增效剂:0.01份纽甜和0.09份2-羟基丁二酸;
稳定剂:0.02份EDTA-2Na,
溶剂:60.88份水;
所述防腐剂组合物的制备方法同实施例1。
实施例7
防腐剂A :35份苯氧乙醇;
防腐剂B:1份脱氢乙酸钠;
增效剂: 0.3份纽甜和1.7份2-羟基丁二酸;
稳定剂:2份EDTA-2Na;
溶剂:60份1,3-丁二醇;
所述防腐剂组合物的制备方法同实施例1。
实施例8
防腐剂A :35份苯氧乙醇;
防腐剂B: 30份苯甲醇和6份4-羟基苯丙酯;
增效剂: 2份纽甜、10份2-羟基丁二酸和3份吡啶-3-甲酸;
稳定剂:10份维生素C;
溶剂:4份1,3-丁二醇;
所述防腐剂组合物的制备方法同实施例1。
对比例1
不含纽甜,其他同实施例1。
对比例2
不含2-羟基丁二酸,其他同实施例1。
对比例3
增效剂为6.5份纽甜和0.5份2-羟基丁二酸,其他同实施例1。
一.稳定性考察
为了考察稳定性,将实施例和对比例制备的防腐剂组合物,在50℃下放置4个月观察,实施例1-8制备的防腐剂外观无明显变化,对比例1-2的防腐剂外观也无明显变化,而对比例3的防腐剂有沉淀析出。
二.防腐挑战实验
自制漱口水,配方如下(总量100%):
制备方法:将薄荷脑加入山梨醇、甘油和丙二醇的混和液中搅拌至溶解完全,最后加入去离子水继续搅拌至清亮,3~5℃放置18~36小时,过滤即得漱口水。
将实施例1、实施例3以及对比例1-2提供的防腐剂组合物均分别按照质量比0.01%、0.03%、0.05%加入自制漱口水中,按照美国药典USP27(51)微生物防腐功效测试标准进行微生物挑战测试,测试用微生物菌种如下:(1)细菌:铜绿假单胞菌(Pseudomonasaeruginosa)CGMCC1.2464、大肠埃希氏菌(Escherichia coli)ATCC 44102、金黄色葡萄球菌(Staphylococcus aureus)CGMCC 1.0089;(2)真菌:白假丝酵母(Candida albicans)CGMCC 2.2086、黑曲霉(Aspergillus niger) CGMCC 3.3928。结果见表1-4。
表1 实施例1防腐挑战结果
从表1可见,实施例1的防腐剂组合物在添加0.01%时,第7天细菌总数2.2×103cfu/g,真菌总数1.2×103 cfu/g。第14天细菌总数3.6×102 cfu/g,真菌总数4.1×102cfu/g。第14天细菌、真菌总菌落数均低于起始菌落数的10-3,第21天细菌、真菌总菌落数分别为50 cfu/g,20 cfu/g,第28天细菌、真菌总菌落数均<10 cfu/g,说明实施例1样品的防腐体系对微生物有优良抑杀作用,通过挑战试验;添加0.03%、0.05%防腐剂组合物的自制漱口水从第7天起,样品中的细菌和真菌均小于10 cfu/g,说明该样品的防腐体系对微生物有特强的抑杀作用,通过挑战试验。
表2 实施例3防腐挑战结果
从表2可见,实施例3的防腐剂组合物在添加0.01%时,第7天细菌总数为1.1×103cfu/g,真菌总数为2.8×103 cfu/g,第14天细菌总数为1.1×102cfu/g,真菌总数2.1×102 cfu/g。第14天细菌、真菌总菌落数均低于起始菌落数的10-3,第21天,第28天细菌、真菌总菌落数持续下降,第28天细菌、真菌总菌落数均小于10。说明该样品的防腐体系对微生物的抑杀作用好,通过挑战试验。添加0.03%、0.05%的防腐剂组合物的样品从第7天起,样品中的细菌、真菌均小于10 cfu/g,说明该样品的防腐体系对微生物有特强抑杀作用,通过挑战试验。
表3 对比例1防腐挑战结果
表4 对比例2防腐挑战结果
由表3,表4,可知,对比例1和对比例2的防腐剂在添加量为0.01%、0.03%、0.05%时对自制漱口水防腐效能很差第28天时细菌总数和真菌总数减少均较少,均不能通过挑战试验。
Claims (7)
1.一种用于口腔清洁护理用品的防腐剂组合物,其特征在于:按照总重量份100份计,由以下重量份的原料组成:
防腐剂A 3~35份,
防腐剂B 1~36份
增效剂 0.1~15份,
稳定剂 0.02~10份
溶剂 4~70份;
其中,所述的防腐剂A为苯甲酸、苯甲酸钠、苯氧乙醇、山梨酸、山梨酸钠中的任意一种或任意几种;
防腐剂B为氯苯甘醚、4-羟基苯甲酸、4-羟基苯甲酸甲酯、4-羟基苯甲酸乙酯、4-羟基苯甲酸丙酯、4-羟基苯丙酯、脱氢乙酸、脱氢乙酸钠、苯甲醇中的任意一种或任意几种;
所述增效剂为增效剂A与增效剂B的组合物,所述增效剂A为纽甜、索马甜、阿力甜、甜菊糖中的任意一种;所述增效剂B为2-羟基丁二酸、吡啶-3-甲酸中的至少一种。
2.根据权利要求1所述防腐剂组合物,其特征在于:所述增效剂A与增效剂B的重量比为(0.5-1):(3.5-6.5)。
3.根据权利要求2所述防腐剂组合物,其特征在于:所述稳定剂为β-环糊精、EDTA-2Na、维生素E醋酸酯、维生素C中的任意一种或任意几种。
4.根据权利要求3所述防腐剂组合物,其特征在于:所述溶剂为水或/和醇类溶剂。
5.根据权利要求4所述防腐剂组合物,其特征在于:所述醇类溶剂为1,2-丙二醇、1,3-丙二醇、1,3-丁二醇、甲基丙二醇、苯氧乙醇中的任意一种或任意几种。
6.根据权利要求1所述防腐剂组合物的制备方法,其特征在于:包括以下步骤:
(1)将溶剂、防腐剂A和增效剂搅拌,混合均匀;
(2)向其中加入防腐剂B,搅拌混合至得到均一溶液;
(3)加入稳定剂搅拌,混合均匀;
(4)用400目以上的滤布过滤,所得液体即为所述防腐剂组合物。
7.权利要求1所述防腐组合物在口腔清洁护理用品中的应用,其特征在于:所述应用为按照0.01-0.05wt%加入口腔清洁护理用品中。
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