CN107280992A - 含纳他霉素的水溶性防腐剂组合物及其制备方法与应用 - Google Patents
含纳他霉素的水溶性防腐剂组合物及其制备方法与应用 Download PDFInfo
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- CN107280992A CN107280992A CN201710496800.0A CN201710496800A CN107280992A CN 107280992 A CN107280992 A CN 107280992A CN 201710496800 A CN201710496800 A CN 201710496800A CN 107280992 A CN107280992 A CN 107280992A
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- natamycin
- cyclodextrin
- beta
- water
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Classifications
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Abstract
本发明公开了一种含纳他霉素的水溶性防腐剂组合物及其制备方法与应用,该组合物包括以下重量份的组分:纳他霉素0.5‑5份,防腐剂1‑25份,增溶稳定剂5‑40份,溶剂50‑90份。本发明组合物在较低的添加量下,即对霉菌、酵母菌都具有很好的抑制作用。产品适用性广,使用量小,成本低,所使用的增溶稳定剂为环糊精类药用辅料,很大程度上提高了纳他霉素的溶解度,使组合物水溶性极佳,适合各种场合使用。特别地,本发明的部分防腐剂对纳他霉素具有协同增溶的作用,可提高纳他霉素的溶解度并降低增溶剂的添加量,在保证抑菌效果的同时降低产品成本。
Description
技术领域
本发明涉及一种含纳他霉素的水溶性防腐剂组合物及其制备方法与应用。
背景技术
多年来,由于防霉效果异常出色,化妆品防腐剂碘丙炔醇丁基氨甲酸酯(IPBC)在日化及湿巾领域得到了广泛的应用。但随着我国《化妆品安全技术规范》(2015年版)的正式发布和实施,因其对IPBC限用条件更严格的较大修订,无疑会对IPBC的使用产生重大影响。这就需要有新的防霉产品来替代其应用。
纳他霉素是是一种多烯大环内酯类化合物,由链霉菌生物发酵生产,来源天然,对霉菌、酵母菌有非常出色的抑制作用,一般的MIC值都在1~10ppm。早在1982年美国FDA即批准作为食品防腐剂使用,并归类为GRAS(Generally Recognized as Safe)添加剂。我国批准作为食品防腐剂使用是1996年,已列入食品添加剂使用标准。目前,全世界已有30多个国家批准纳他霉素作为食品防腐剂使用。纳他霉素在一般的溶剂特别是水中的溶解度很低,并且它对细菌几乎没有抑制作用,这在很大程度上限制了它的应用。现有纳他霉素的悬浮液、微乳液制备方法及其复配组合物大多涉及在食品工业、农业等领域的应用。纳他霉素在日化产品、湿巾等领域的应用还处于初始阶段,相关文献报道及专利也较为少见。
为克服现有技术不足,本发明提供一种纳他霉素与日化防腐剂复配的组合物,安全高效,抑菌谱广,水溶性好,方便使用,可添加在湿巾、爽肤水、面膜等含水量大的产品中,也可用于家居洗涤用品的防霉抑菌,弥补了纳他霉素自身的缺陷,扩大了其在日化产品及湿巾中的使用范围。
发明内容
本发明提供一种含有纳他霉素、日化防腐剂、增溶稳定剂及溶剂的组合物,其中通过增溶剂的和部分防腐剂的作用提高了纳他霉素在水中的溶解度,使其可以添加到湿巾、面膜等高含水量的日化产品及家居用品中,并且弥补了纳他霉素对细菌基本无抑制作用的不足,该组合物对常见细菌、霉菌及酵母菌具有优异的抑杀作用,抑菌谱广,效果稳定,使用量低。
本发明技术方案如下:
一种含纳他霉素的水溶性防腐剂组合物,以重量份计其原料包括:纳他霉素0.5-5份,防腐剂1-25份,增溶稳定剂5-40份,水50-90份;其中,
所述增溶稳定剂包括羟丙基-β-环糊精、羟丙基-γ-环糊精、甲基-β-环糊精、羟丁基-β-环糊精、羧甲基-β-环糊精等中的一种或几种的混合物;
所述防腐剂包括布罗波尔、醋酸氯己定、葡萄糖酸氯已定、西吡氯铵、苄索氯铵、月桂基三甲基氯化铵、咪唑烷基脲、重氮咪唑烷基脲等中的一种或几种的混合物。
优选地,所述含纳他霉素的水溶性防腐剂组合物,以重量份计其原料包括:纳他霉素1-4份,防腐剂5-22份,增溶稳定剂10-30份,水50-80份。
进一步优选地,所述含纳他霉素的水溶性防腐剂组合物,以重量份计其原料包括:纳他霉素1.5-3.5份,增溶稳定剂15-25份,防腐剂10-25份,溶剂50-70份。
进一步优选地,本发明所述含纳他霉素的水溶性防腐剂组合物其原料总重量为100份。
优选地,所述防腐剂为咪唑烷基脲、重氮咪唑烷基脲中的一种或两种。
一般地,本发明所述含纳他霉素的水溶性防腐剂组合物为液态制剂(即水剂);可按本领域常规方法制备;例如按配比将各原料混匀即可。
进一步地,本发明所述含纳他霉素的水溶性防腐剂组合物还可以制成固态制剂(例如固态粉末)。可按本领域常规方法制备。
具体地,本发明提供所述含纳他霉素的水溶性防腐剂组合物还可以制成固态制剂(固态粉末)的制备方法,包括:按配比将纳他霉素和水加入容器后搅拌均匀,升温至50-80℃,再按配比加入增溶稳定剂和防腐剂,搅拌至全部溶解(可作为液态制剂),干燥(冷冻干燥或喷雾干燥),即得。
本发明所述各原料均可市售购得。
本发明还包括上述含纳他霉素的水溶性防腐剂组合物用于个人护理品、家居洗涤用品或湿巾等的用途。
本发明还包括含有上述含纳他霉素的水溶性防腐剂组合物的个人护理品、家居洗涤用品或湿巾等产品。
本发明所述纳他霉素与防腐剂水溶性组合物在个人护理品、家居洗涤用品或湿巾等产品中的添加量一般为0.1-0.3%(重量比)。
本发明所述含纳他霉素的水溶性防腐剂组合物可用于各种个人护理品、家居洗涤用品,特别是加入到含水量较高的产品中起到防腐作用。本发明所述的个人护理品、家居洗涤用品等包括但不限于膏霜、乳液、洗面奶、啫喱、洗发水、沐浴露、洗手液、牙膏、爽肤水、洗涤剂、洗衣液、湿巾类等产品。
本发明组合物在较低的添加量下,即对细菌、霉菌、酵母菌都具有很好的抑制作用。产品适用性广,使用量小,成本低,所使用的增溶稳定剂为环糊精类药用辅料,很大程度上提高了纳他霉素的溶解度,使组合物水溶性极佳,适合各种场合使用。特别地,发明中添加了日化防腐剂,其中咪唑烷基脲类能够起到协同增溶的作用,更加增大了纳他霉素在水溶液中的溶解度,并能降低增溶剂的使用量,降低生产成本。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。实施例中未注明具体技术或条件者,按照本领域内的文献所描述的技术或条件,或者按照产品说明书进行。所用试剂或仪器未注明生产厂商者,均为可通过正规渠道商购买得到的常规产品。
本发明中所使用纳他霉素含量为95.7%,购自北京东方瑞德生物技术有限公司。
如未特殊指明,以下所述%均指重量百分比。
实施例1-10
含纳他霉素的水溶性防腐剂组合物,其为液态制剂,其组分包括纳他霉素、防腐剂、增溶稳定剂和水;各组分用量配比见表1。
制备方法包括:按配比将纳他霉素和水加入容器后搅拌均匀,升温至50-80℃,再按配比加入增溶稳定剂和防腐剂,搅拌至全部溶解,即得。
实施例11-20
含纳他霉素的水溶性防腐剂组合物,其为固态制剂,由实施例1各含纳他霉素的水溶性防腐剂组合物干燥(冷冻干燥或喷雾干燥)制得。
表1纳他霉素与防腐剂水溶性配方各组分含量(重量份)
实验例1
分别考察实施例4(即配方4#)、实施例5(即配方5#)、实施例6(即配方6#)、实施例7(即配方7#)纳他霉素与各组合物常温下(25℃)在水中溶解性。
实验方法:分别称取以上实验样品,加入100g水中,充分混匀;然后分别在常温放置72小时、4℃冷藏放置24小时后观察。以纳他霉素为对照样品。结果见表2。
表2纳他霉素与防腐剂组合物溶解性
表2中,4#与5#对比可看出在不加环糊精类增溶剂的情况下,咪唑烷基脲类对纳他霉素没有增溶效果或效果不明显,说明咪唑烷基脲类只有在与环糊精配合使用时才显示出对纳他霉素具有协同增溶作用;其余各实验样品在试验条件下均可在水中完全溶解且在各储存条件下不析出,说明本发明所得组合物具有良好的水溶性。为保证抑菌效果,纳他霉素在日化产品中的添加量一般应在0.005~0.03%(以活性物计),本发明组合物完全可以满足实际应用的需要。
实验例2
考察咪唑烷基脲类对纳他霉素在水溶液中的增溶协同作用,对比添加与不添加咪唑烷基脲及添加量不同时的组合物(配方3#、6#、7#、8#、9#、10#)在制备成固体粉末后各组分含量,结果见表3。
表3咪唑烷基脲类对纳他霉素的增溶作用
纳他霉素(%) | 重氮咪唑/咪唑烷基脲% | 其他防腐剂(%) | 增溶剂(%) | |
3# | 7.5 | —— | 17.5 | 75 |
6# | 5 | 35 | 10 | 50 |
7# | 7 | 40 | 3 | 50 |
8# | 10 | 52.5 | —— | 37.5 |
9# | 10 | —— | 10 | 80 |
10# | 10 | 50 | —— | 40 |
表3中,3#与7#对比可以看出在加入重氮咪唑/咪唑烷基脲的组合中,纳他霉素的溶解量较未加者要高且增溶剂的加入量少,说明重氮咪唑/咪唑烷基脲对纳他霉素具有增溶样作用;6#与7#对比可说明在增溶剂加量不变的情况下,增加重氮咪唑/咪唑烷基脲的量可提高纳他霉素在水中的溶解度,即其具有协同增溶作用;9#与10#对亦可明显看出重氮咪唑/咪唑烷基脲可以部分替代环糊精的增溶作用。按当前原料的市场价格核算成本,环糊精的售价要高于重氮/咪唑烷基脲4至5倍,因此,将咪唑烷基脲类与纳他霉素进行复配可降低增溶剂的添加量,即可降低组合物成本;同时由于咪唑烷基脲类防腐剂对细菌的抑菌效果较真菌要好,与纳他霉素只对真菌有抑菌效果形成互补,两者结合可扩大各自的抑菌谱,成为一种广谱的防腐剂。
实验例3
抗(抑)菌试验(Ⅰ)——最低抑菌浓度(MIC值)测定。
通过悬液法测定实施例2(即配方2#)纳他霉素与防腐剂组合物最低抑菌浓度(MIC值),并与纳他霉素和重氮咪唑烷基脲及市售一款防腐剂的MIC值做对比,结果见表4。
表4最低抑菌浓度(MIC值)
*号代表无抑制作用。
由表4可以看出相较于纳他霉素和咪唑烷基脲各自的抑菌谱和抑菌浓度,组合物在对细菌和真菌的抑菌谱和抑菌效果方面均有显著优势,即重氮咪唑烷基脲弥补了纳他霉素对细菌抑制无效的缺点,而组合物提高了重氮咪唑烷基脲对真菌的抑制作用,二者组合的抑菌效果可以与当前市场中广泛使用的重氮咪唑烷基脲和IPBC的组合相媲美。
实验例4
防腐效能测试(挑战性试验Ⅰ)。
参考美国化妆品香料香精协会(CTFA)推荐的防腐体系效能评价方法,进行28天单次接菌挑战性试验。
1.试验菌株:细菌(大肠杆菌E.coli、金黄色葡萄球菌S.aureus、铜绿假单胞菌P.Aeruginosa);真菌(黑曲霉A.niger、白假丝酵母菌C.albicans)。采用混合菌接种,细菌混合菌悬浊液107CFU/mL;真菌混合菌悬浊液106CFU/mL。
2.试验样品:按配方(EDTA二钠0.05%、1,3-丁二醇6%、芦芭胶8%、爱尔兰海草胶4%、燕麦蛋白1%、AMC1%、CO401%、透明质酸0.01%、香精0.1%、防腐剂适量、去离子水加至100%)配制爽肤水配方,其中防腐体系分别按下表5中A、B、C所述配方含量添加(并以防腐体系编号作为样品编号),以考察不同防腐体系的抑菌效果。
表5配方各防腐体系添加量(重量百分含量)
3.样品接种:分别称取上述湿巾液A、B、C、D100克各2份,分别加入1mL细菌混合悬浊液和1mL真菌混合悬浊液,混合均匀,将样品于室温(22.5±2.5℃)保存,并分别于0、2、7、14、21、28天检测化妆品中的菌落数,以判断防腐效能。
4.试验结果
在接种的0、2、7、14、21和28天取样检测,其结果见表6:
表6组合物微生物挑战性试验结果
表6结果显示,A组与B组相比在真菌挑战中均为两天降至10以下,说明组合物对真菌的抑制作用可与添加IPBC的体系一样好;A组与C组相比,说明组合物对真菌的抑菌效果要好于单一使用加量咪唑烷基脲的防腐体系;而D组体系对细菌无抑制作用、对真菌抑制作用强则符合纳他霉素本身的特性。上表6显示出纳他霉素与防腐剂的水溶性组合物在很低的添加量下即可取得良好的抑菌效果。
虽然,上文中已经用一般性说明及具体实施方案对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (10)
1.一种含纳他霉素的水溶性防腐剂组合物,其特征在于,以重量份计其原料包括:纳他霉素0.5-5份,防腐剂1-25份,增溶稳定剂5-40份,水50-90份;其中,
所述增溶稳定剂包括羟丙基-β-环糊精、羟丙基-γ-环糊精、甲基-β-环糊精、羟丁基-β-环糊精、羧甲基-β-环糊精中的一种或几种的混合物;
所述防腐剂包括布罗波尔、醋酸氯己定、葡萄糖酸氯已定、西吡氯铵、苄索氯铵、月桂基三甲基氯化铵、咪唑烷基脲、重氮咪唑烷基脲中的一种或几种的混合物。
2.根据权利要求1所述的组合物,其特征在于,以重量份计其原料包括:纳他霉素1-4份,防腐剂5-22份,增溶稳定剂10-30份,水50-80份;
优选地,所述含纳他霉素的水溶性防腐剂组合物,以重量份计其原料包括:纳他霉素1.5-3.5份,增溶稳定剂15-25份,防腐剂10-25份,溶剂50-70份。
3.根据权利要求1或2所述的组合物,其特征在于,所述防腐剂为咪唑烷基脲、重氮咪唑烷基脲中的一种或两种。
4.根据权利要求1-3任一项所述的组合物,其特征在于,所述含纳他霉素的水溶性防腐剂组合物其原料总重量为100份。
5.根据权利要求1所述的组合物,其特征在于,以重量份计其原料包括:
纳他霉素0.5份,布罗波尔1.0份,羟丙基-β-环糊精10份,水88.5份;或
纳他霉素1.0份,重氮咪唑烷基脲19.0份,羟丙基-γ-环糊精5.0份,水75.0份;或
纳他霉素1.5份,月桂基三甲基氯化铵1.5份,醋酸氯己定2.0份,羟丙基-γ-环糊精10.0份,甲基-β-环糊5.0份,水80.0份;或
纳他霉素2.0份,葡萄糖酸氯己定2.0份,咪唑烷基脲16.0份,羟丁基-β-环糊精10份,甲基-β-环糊精10份,水60.0份;或
纳他霉素2.0份,咪唑烷基脲38.0份,水60.0份;或
纳他霉素2.5份,苄索氯铵5.0份,重氮咪唑烷基脲17.5份,羟丙基-γ-环糊精15份,羧甲基-β-环糊精10份,水50.0份;或
纳他霉素3.5份,西吡氯铵1.5份,重氮咪唑烷基脲20.0份,羟丙基-β-环糊精20份,羧甲基-β-环糊精5份,水50.0份;或
纳他霉素4.0份,咪唑烷基脲21.0份,羟丁基-β-环糊精10份,甲基-β-环糊5份,水60.0份;或
纳他霉素5.0份,醋酸氯己定5.0份,羧甲基-β-环糊精20份,羟丁基-β-环糊精10份,羟丙基-β-环糊精10份,水50.0份;或
纳他霉素5.0份,重氮咪唑烷基脲25.0份,羟丁基-β-环糊精20份,水50.0份。
6.根据权利要求1-5任一项所述的组合物,其特征在于,其为液态制剂或固态制剂。
7.权利要求1-6任一项所述组合物的制备方法,其特征在于,按配比将纳他霉素和水加入容器后搅拌均匀,升温至50-80℃,再按配比加入增溶稳定剂和防腐剂,搅拌至全部溶解,制成液态制剂;或者进一步干燥制成固态制剂。
8.权利要求1-6任一项所述的组合物用于个人护理品、家居洗涤用品或湿巾的用途。
9.含有权利要求1-6任一项所述的组合物的个人护理品、家居洗涤用品或湿巾产品。
10.根据权利要求8所述的用途或权利要求9所述的个人护理品、家居洗涤用品或湿巾,其中所述含纳他霉素的水溶性防腐剂组合物的添加量为0.1-0.3%(重量比)。
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