CN114469754A - 一种无菌活性胶原面膜贴及其灭菌方法 - Google Patents
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Abstract
本发明提供一种无菌活性胶原面膜贴及其灭菌方法,该面膜贴由胶原、水、辐照保护剂和面膜布组成,并封装于铝塑袋内,所使用的灭菌方法包括:将面膜贴置于‑30~‑10℃的条件下冷冻12~24h,使其中液体成分冷冻结冰;将经冷冻处理的封装面膜在温度为‑10~0℃的条件下进行辐照灭菌,辐照剂量为12‑40kGy;完成灭菌,将面膜贴置于室温环境,逐步恢复至室温。本发明所制备的面膜贴在保持胶原活性的同时,经低温辐照灭菌保证了产品的无菌水平,不含防腐、抑菌成分,保障产品的安全性。
Description
技术领域:
本发明涉及一种无菌活性胶原面膜贴及其灭菌方法。
背景技术:
胶原作为一种细胞外基质,在生物发展过程中占据着关键地位。在各种不同种类胶原之中,Ⅰ型胶原大量在皮肤组织中占比80%左右,来维持皮肤张力和承受拉力,让皮肤饱满充盈,是皮肤中重要组成成分。活性的Ⅰ型胶原呈现独特的三股螺旋结构,具有较好的机械性能、低免疫原性和良好的生物相容性,有利于细胞的存活和生长,还具有保湿和促进表皮细胞生长的性能。因此,活性Ⅰ型胶原可被制为面膜贴产品,用于皮肤护理、保湿及浅表创面修复。但Ⅰ型胶原的螺旋结构容易受热、辐照等因素而被破坏,导致失去胶原活性,因而保持胶原活性是胶原产品生产加工过程中的一项重要内容。
活性的Ⅰ型胶原易受微生物影响而腐败、失效,因此在产品中需控制微生物。面膜产品常见的控制微生物方法是加入防腐剂,使产品微生物符合《化妆品安全技术规范》要求。但防腐剂具有一定的生物毒性,可能引起皮肤尤其是敏感肌皮肤的发红、过敏、瘙痒等症状。近年,研究人员开始采用灭菌方式开发无菌、无防腐面膜贴产品,但常见的灭菌方法如湿热灭菌、高温灭菌、EO灭菌、辐照灭菌均会导致胶原结构的破坏,从而失去活性。
中国专利申请CN109106610A和CN105983094A均提出一种低温辐照方法,用于胶原贴产品的灭菌。该方法需将胶原贴在极低温度(-80℃~-40℃)下冷冻,然后再保持-80℃~-40℃条件下辐照灭菌。但是这种极低温条件需要消耗大量的能量,同时加大在产品辐照前的运输、存储难度,造成产品成本上升。
发明内容:
针对上述现有技术的缺陷,本发明提出一种无菌活性胶原面膜贴及其灭菌方法。本发明所述的面膜贴未添加任何防腐剂,且在无菌标准下仍能保持胶原活性。
根据本发明的第一方面,本发明采用以下技术方案:
一种无菌活性胶原面膜贴,其特征在于,包括:胶原液、辐照保护剂和面膜布,并由铝塑袋承装、密封。
根据本发明的第二方面,本发明采用以下技术方案:
一种无菌活性胶原面膜贴的灭菌方法,其特征在于,无菌活性胶原面膜贴胶包括原液、辐照保护剂和面膜布,并由铝塑袋承装、密封;
所述灭菌方法包括以下步骤:
S1:将面膜贴置于-30~-10℃的条件下冷冻,使其中液体成分冷冻结冰;
S2:将经冷冻处理的封装面膜在温度为-10~0℃的条件下进行辐照灭菌,辐照剂量为12-40kGy;
S3:完成灭菌,将面膜贴置于室温环境,逐步恢复至室温。
本发明的面膜贴不添加防腐剂。所述的胶原液为可以为Ⅰ型胶原水溶液
进一步地,所述的辐照灭菌为γ射线(钴60)辐照或电子束辐照。
进一步地,所述的辐照保护剂为天然黄酮或类黄酮,其含量为胶原液的0.005%~0.1%。
再进一步地,所述的天然黄酮或类黄酮包括异黄酮、黄烷醇、黄烷酮、槲皮素、灯盏花素、甘草素中的一种或多种。
进一步地,所述的胶原液为牛跟腱经脱脂、粉碎、酶解、透析处理得到的活性Ⅰ型胶原水溶液,其中活性Ⅰ型胶原浓度为0.5~6mg/mL。
本发明的无菌活性胶原面膜贴,可用于皮肤护理、保湿及浅表创面修复。
本发明所述面膜贴无菌、活性胶原特性是通过如下原理实现的:
胶原液中添加微量的辐照保护剂,并采用冷冻辐照方式对产品进行灭菌,在辐照保护剂和低温的双重保护下,最大程度地保持胶原活性。
相比于现有技术,本发明具有以下优异性:
(1)天然黄酮或类黄酮具有明显的抗辐射、抗自由基、抗氧化、抗癌防癌、抗菌抗病毒等生物活性作用,本发明将天然黄酮或类黄酮作为辐照保护剂,结合辐照保护剂和冷冻辐照方法,有效保障胶原活性。
(2)本发明使用普通冷冻条件(-30~-10℃)和低温辐照条件(-10~0℃)对产品进行辐照,剂量12~40kGy,无需极低温冷冻环境,降低产品辐照过程的能耗和转运、储存难度,降低成本。
(3)本发明所制备的面膜贴仅含有胶原液、微量辐照保护剂和面膜布,不含防腐剂、抑菌剂、保湿剂等成分,在达到无菌级别的同时保障产品的安全性,适宜各种人群使用。
附图说明
图1为Ⅰ型胶原的SDS-PAGE电泳检测图,其中,A为中检院Ⅰ型胶原标品,B为本发明实施例1中所述的常温辐照后的面膜贴对照组,C为本发明实施例1所述的低温环境(-5℃)辐照后的面膜贴对照组,D为本发明实施例1所述加入辐照保护剂并常温辐照的面膜贴对照组,E为本发明实施例1所述的加入辐照保护剂冷冻后(-15℃)再常温辐照的面膜贴对照组,F为本发明实施例1所制备的未灭菌面膜贴(辐照灭菌前),G为本发明实施例1所制备的无菌活性胶原面膜贴。
具体实施方式:
以下通过介绍本发明的实施例,以进一步阐明本发明实质性特点和显著的进步,但本发明决非限于实施例。
实施例1:
(1)制备面膜贴:将新鲜的牛跟腱经脱脂、粉碎、酶解、透析处理得到的活性Ⅰ型胶原水溶液,其中活性Ⅰ型胶原浓度为1mg/mL。向胶原液中添加0.05%异黄酮,充分搅拌溶解后将溶液灌入到具有面膜布的铝塑袋中,热封铝塑袋即得面膜贴。
(2)辐照灭菌:
S1:将面膜贴置于-15℃的条件下冷冻12h,使其中液体成分冷冻结冰;
S2:将经冷冻处理的封装面膜在温度为-10℃的条件下进行辐照灭菌,辐照剂量为15kGy;
S3:完成灭菌,将面膜贴置于室温环境,逐步恢复至室温。
(3)SDS-PAGE电泳检测:
测试方法:按2020版《中国药典》0541第五法SDS-聚丙烯酰胺凝胶电泳法
取样方法:Ⅰ型胶原标准品1mg加80微升缓冲液作为供试液;各组面膜贴采用挤压方法,将溶液挤出,作为供试品。
制样方法:供试品溶液与缓冲液按比例混匀,置水浴或100℃块状加热器中加热5分钟,冷却至室温。
对照组A:采用中检院提供的Ⅰ型胶原标准品;
对照组B:用1mg/mL的胶原液灌入到具有面膜布的铝塑袋中,热封铝塑袋得面膜贴,将该面膜贴常温辐照(15kGy)后测试;
对照组C:用1mg/mL的胶原液灌入到具有面膜布的铝塑袋中,热封铝塑袋得面膜贴,将该面膜贴在低温环境(-5℃)辐照,辐照剂量15kGy,恢复室温后测试;
对照组D:向1mg/mL的胶原液中添加0.05%异黄酮,然后灌入到具有面膜布的铝塑袋中,热封铝塑袋得面膜贴,将该面膜贴常温辐照(15kGy)后测试;
对照组E:向1mg/mL的胶原液中添加0.05%异黄酮,然后灌入到具有面膜布的铝塑袋中,热封铝塑袋得面膜贴,将该面膜贴冷冻(-15℃)12h后再常温辐照,辐照剂量15kGy,恢复室温后测试;
实验组F:本实施例步骤(1)所制备的面膜贴(未灭菌);
实验组G:经本实施例步骤(1)、(2)所制备的无菌面膜贴。
经SDS-PAGE电泳测试,仅有标准品A和实验组F、G存在条带,并且条带位置相似,表明本实施例所制备的无菌面膜贴具有活性Ⅰ型胶原特性。对照组B~E无电泳条带,表明对照组方法所制备的无菌面膜贴内的Ⅰ型胶原已失活、变性。具体来说,对照组B测试结果表明常温15kGy辐照会破坏Ⅰ型胶原活性;对照组C测试结果表明低温环境(-5℃)15kGy辐照会破坏Ⅰ型胶原活性;对照组D测试结果表明添加0.05%异黄酮后,常温15kGy辐照会破坏Ⅰ型胶原活性;对照组E测试结果表明添加0.05%异黄酮后,冷冻(-15℃)12h后再常温15kGy辐照会破坏Ⅰ型胶原活性;实验组F、G测试结果表明添加0.05%异黄酮后,冷冻(-15℃)12h且低温(-10℃)15kGy辐照,能够保持Ⅰ型胶原活性。
实施例2:
(1)制备面膜贴:将新鲜的牛跟腱经脱脂、粉碎、酶解、透析处理得到的活性Ⅰ型胶原水溶液,其中活性Ⅰ型胶原浓度为6mg/mL。向胶原液中添加0.1%甘草素,充分搅拌溶解后将溶液灌入到具有面膜布的铝塑袋中,热封铝塑袋即得面膜贴。
(2)辐照灭菌:
S1:将面膜贴置于-10℃的条件下冷冻12h,使其中液体成分冷冻结冰;
S2:将经冷冻处理的封装面膜在温度为0℃的条件下进行辐照灭菌,辐照剂量为12kGy;
S3:完成灭菌,将面膜贴置于室温环境,逐步恢复至室温。
实施例3:
(1)制备面膜贴:将新鲜的牛跟腱经脱脂、粉碎、酶解、透析处理得到的活性Ⅰ型胶原水溶液,其中活性Ⅰ型胶原浓度为0.5mg/mL。向胶原液中添加0.1%灯盏花素,充分搅拌溶解后将溶液灌入到具有面膜布的铝塑袋中,热封铝塑袋即得面膜贴。
(2)辐照灭菌:
S1:将面膜贴置于-30℃的条件下冷冻12h,使其中液体成分冷冻结冰;
S2:将经冷冻处理的封装面膜在温度为-10℃的条件下进行辐照灭菌,辐照剂量为40kGy;
S3:完成灭菌,将面膜贴置于室温环境,逐步恢复至室温。
实施例4:
(1)制备面膜贴:将新鲜的牛跟腱经脱脂、粉碎、酶解、透析处理得到的活性Ⅰ型胶原水溶液,其中活性Ⅰ型胶原浓度为3mg/mL。向胶原液中添加0.005%黄烷醇,充分搅拌溶解后将溶液灌入到具有面膜布的铝塑袋中,热封铝塑袋即得面膜贴。
(2)辐照灭菌:
S1:将面膜贴置于-20℃的条件下冷冻12h,使其中液体成分冷冻结冰;
S2:将经冷冻处理的封装面膜在温度为-5℃的条件下进行辐照灭菌,辐照剂量为15kGy;
S3:完成灭菌,将面膜贴置于室温环境,逐步恢复至室温。
本领域的技术人员容易理解,以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。
Claims (8)
1.一种无菌活性胶原面膜贴,其特征在于,包括:胶原液、辐照保护剂和面膜布,并由铝塑袋承装、密封。
2.如权利要求1所述的一种无菌活性胶原面膜贴,其特征在于,所述的辐照保护剂为天然黄酮或类黄酮,其含量为胶原液的0.005%~0.1%。
3.根据权利要求2所述的一种无菌活性胶原面膜贴,其特征在于,所述的天然黄酮或类黄酮包括异黄酮、黄烷醇、黄烷酮、槲皮素、灯盏花素、甘草素中的一种或多种。
4.根据权利要求1所述的一种无菌活性胶原面膜贴,其特征在于,所述的胶原液为牛跟腱经脱脂、粉碎、酶解、透析处理得到的活性Ⅰ型胶原水溶液,其中活性Ⅰ型胶原浓度为0.5~6mg/mL。
5.一种无菌活性胶原面膜贴的灭菌方法,其特征在于,无菌活性胶原面膜贴胶包括原液、辐照保护剂和面膜布,并由铝塑袋承装、密封;
所述灭菌方法包括以下步骤:
S1:将面膜贴置于-30~-10℃的条件下冷冻,使其中液体成分冷冻结冰;
S2:将经冷冻处理的封装面膜在温度为-10~0℃的条件下进行辐照灭菌,辐照剂量为12-40kGy;
S3:完成灭菌,将面膜贴置于室温环境,逐步恢复至室温。
6.根据权利要求5所述的无菌活性胶原面膜贴的灭菌方法,其特征在于,所述的辐照灭菌为γ射线(钴60)辐照或电子束辐照。
7.根据权利要求5所述的无菌活性胶原面膜贴的灭菌方法,其特征在于,所述的辐照保护剂为天然黄酮或类黄酮,其含量为胶原液的0.005%~0.1%。
8.根据权利要求7所述的无菌活性胶原面膜贴的灭菌方法,其特征在于,所述的天然黄酮或类黄酮包括异黄酮、黄烷醇、黄烷酮、槲皮素、灯盏花素、甘草素中的一种或多种。
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