CN100431419C - 一种用于足部消毒的生物制剂 - Google Patents
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Abstract
一种用于足部消毒的生物制剂,包括重量百分比含量为0.0001-0.1%的溶葡萄球菌酶和医药学上可接受的载体。所说的载体包括水、凝胶用基质或乳膏剂用基质。该制剂中还含有重量百分比含量为0.001-5%的溶菌酶,0.5-50%的蛋白质稳定剂,润肤剂以及适量的乳化剂。该制剂杀菌效果强,杀菌谱广;稳定性强,无耐药性,无毒无刺激。
Description
技术领域
本发明涉及一种生物型杀菌制剂,具体的说,是涉及一种用于足部消毒的生物制剂。
背景技术
足部细菌感染是日常生活中常见现象。足部皮肤和身体其他部位的皮肤一样,每天都在不停地新陈代谢,随时都有皮屑脱落。皮屑就会与汗和灰尘等混杂起来积蓄在脚趾缝及皮肤皱襞里,容易寄生霉菌、红色毛藓菌、金黄色葡萄球菌、白色念珠菌及变形杆菌等。
白天,包裹在鞋袜中的足部温度和湿度增大,细菌的生长和繁殖加速;此外接触被细菌污染的拖鞋、毛巾、浴盆等,容易造成感染;某些免疫力低下的特定人群,如慢性卧床病人,糖尿病人及其他免疫缺损病患者等,足部细菌感染高到90%以上;总之,足部是人体最易发生感染的部位之一。
足部细菌感染的主要症状包括出现丘疹鳞屑或角化发生,水疱型和糜烂潮湿型等现象。足癣或继发感染还会造成淋巴水肿,严重的感染性淋巴水肿需要通过手术治疗。因此,控制真菌感染是预防淋巴水肿的最有效和简便的措施之一。
目前市场上治疗足部感染的产品主要有二类:一类是抗真菌药物,如复方水杨酸酊剂、硝酸咪康唑、复方雷琐辛擦剂,1%克霉唑霜,糜枯矾粉和脚气粉;另一类是含氯的消毒产品。其中后者,对皮肤粘膜,特别是受损皮肤的刺激性很强。而前者容易产生耐药性,往往在第一次使用时见效快速,但是容易复发,而且一旦复发,则效果明显减弱。其次,这两类产品对皮肤有一定的化学伤害,容易造成局部皮肤干燥,还往往有异味。综目前市场上更缺乏适合免疫力低下的特定人群的,能长期使用,无耐药性和霉副作用的产品。
发明内容
本发明需要解决的技术问题在于提供一种用于足部消毒的生物制剂,以克服现有技术存在的毒副作用大,对皮肤和粘膜刺激性强,且易产生耐药性、易复发的缺陷。
本发明提供了一种用于足部杀菌、护肤的生物制剂,该制剂包括重量百分比含量为0.0001-0.1%的溶葡萄球菌酶和医药学上可接受的载体。
其中的溶葡萄球菌酶为野生类型、重组产生、突变异种或保留抗葡萄球菌细胞壁肽聚糖的含甘氨酸交联键的任何重组或有关的酶中的一种或一种以上;溶葡萄球菌酶来源于Staphylococus Simulans分泌于胞外的蛋白产物,其基因的核酸组成有1486个核苷酸;蛋白分子量6803Da,由244个氨基酸组成,WO0129201(Expression of recombinant muture lysostaphin)和DE4425645(New lysostaphin gene with deletion in pro-segment repeatregion)分别报道了重组的溶葡萄球菌酶和突变的溶葡萄球菌酶,但是其杀菌活性保持不变。溶葡萄球菌酶的杀菌机理是通过专一性的切断胞壁肽聚糖中的甘氨酸键,达到快速杀死致病菌的效果。所用的溶葡萄球菌酶是上海高科生物工程有限公司通过基因重组技术产生,由枯草杆菌扩增分泌的,其酶的比活性范围为300-1200单位/毫克;
所说的载体包括水、凝胶用基质或乳膏剂用基质。
凝胶用基质包括甘油明胶、淀粉、纤维素衍生物、聚乙二醇中的一种或一种以上;
乳膏剂用基质包括羟类、油脂类或类脂中的一种或一种以上以及乳化剂;
其中:
羟类包括凡士林、固体石蜡、液体石蜡或硅酮等中的一种;
油脂类包括花生油、棉子油或氢化植物油等中的一种;
类脂包括羊毛脂、蜂蜡或胆固醇等中的一种。
乳膏剂包括天然乳化剂或合成乳化剂中的一种或一种以上,其中的天然乳化剂如阿拉伯胶、动物胶、海藻酸盐、卵磷脂等;合成乳化剂如纤维素衍生物、硬脂酸甘油酯、蔗糖脂肪酸酯类、吐温(Tween)等,其加入量为乳膏剂用基质重量的2~15%。
该制剂中还含有重量百分比含量为0.001-5%的溶菌酶,溶菌酶为细菌胞壁溶解酶、酵母菌胞壁溶解酶、霉菌胞壁溶解酶中的一种或一种以上;所用的溶菌酶是从蛋清中提取的活性成分,是符合中国药典标准的原料药,溶菌酶是通过作用于胞壁中的β-1,4糖苷键或β-1,3葡聚糖而杀死细菌。不仅可协同溶葡萄球菌酶增强杀菌功能,同时可以增强溶葡萄球菌酶的生物稳定性。
为了增强溶葡萄球菌酶的存放稳定性,需要加入重量百分比含量为0.5-50%的蛋白质稳定剂,本发明中所使用的蛋白质稳定剂是聚乙二醇类物质或壳聚糖、甲壳素、N-乙酰-D-氨基等药用高分子化合物,可以包裹蛋白质或多肽,免受其他物质的破坏,从而增强蛋白质或多肽的稳定性。
同时为了使该制剂对皮肤有一定的护理作用,加入制剂总量0.5~20%的润肤剂以及适量的乳化剂,优选的润肤剂包括水溶性改性硅油、阳离子改性硅油、氨基改性硅油和氨基复合改性硅油中的一种或一种以上,乳化剂为天然乳化剂或合成乳化剂中的一种或一种以上,其中的天然乳化剂如阿拉伯胶、动物胶、海藻酸盐、卵磷脂等;合成乳化剂如纤维素衍生物、硬脂酸甘油酯、蔗糖脂肪酸酯类、吐温(Tween)等,加入量为制剂重量的2~10%。
当载体为水时,即为水剂;当载体为凝胶用基质时,即为凝胶剂;当载体为乳膏剂用基质时,即为乳膏剂。
该制剂具有如下特点:
1.杀菌效果强,杀菌谱广;
该制剂对革兰氏阳性菌和革兰氏阴性菌以及部分病毒和真菌均有效,尤其是金黄色葡萄球菌、红色毛藓菌、绿脓杆菌、白色念珠菌等,体外实验作用5分钟即可达到99.9%的杀菌率,如果作用10分钟甚至20分钟,可使杀菌率达到100%。(如表1-4)。
2.两种生物酶复配,稳定性强,54℃存放2周杀菌活性不变;
本发明是将溶葡萄球菌酶和溶菌酶进行复配,不仅保留了各自的杀菌活性,而且因为各种成分之间可以互相作用,实验证明,复配后不仅杀菌活性较三者各自的杀菌活性大大增强(10-40倍于三者杀菌效果的简单叠加),而且使生物酶的稳定性增强,再加上其他的蛋白质稳定剂,54℃存放2周后(相当于常温保存两年),该制剂对红色毛藓菌的杀菌活性保持不变,仍在99.9%以上,作用20分钟即可达100%。(如表5)。
3.为纯生物制剂及医学上可接受的载体,克服了传统化学类制剂对足部真菌感染久治不愈,易复发,细菌容易产生耐药性的缺点。
4.本制剂为纯生物制剂,足部皮肤,且没有任何毒副作用。经上海市疾病预防控制中心消毒科进行的急慢性毒理试验结果显示,该制剂为无毒无刺激的产品。
本发明还提供了该生物制剂的制备方法,在无菌室中,将各种组分充分混匀,即可。该制剂可用于预防和治疗由真菌或细菌感染引起的脚气、脚藓、灰指甲、皮肤藓等。
其基本特点为:
一.杀菌力强,杀菌谱广
1.对金黄色葡萄球菌的杀灭效果
足部消毒剂原液、50%、25%的稀释液,分别作用5min、10min、20min,对金黄色葡萄球菌的杀灭效果分别为99.99%、99.92%、99.96%。
表1对金黄色葡萄球菌的杀灭效果
注:阳性对照组平均菌数及范围为7.25×105cfu/片(7.15-7.35×105cfu/片)
阴性对照组:中和剂、PBS、培养基无细菌生长。
2.对白色念珠菌的杀灭效果
足部消毒剂原液、50%的稀释液,分别作用5min、20min,对白色念珠菌的平均杀灭率分别为99.97%、99.94%。
表2对白色念珠菌的杀灭效果
注:阳性对照组平均菌数及范围为6.00×105cfu/片(5.80-6.20×105cfu/片)
阴性对照组:中和剂、PBS、培养基无细菌生长。
3.对大肠杆菌的杀灭效果
足部消毒剂原液、50%、25%的稀释液,分别作用2min、10min、20min,对大肠杆菌的平均杀灭率分别为99.93%、99.99%、99.98%。
表3对大肠杆菌的杀灭效果
注:阳性对照组平均菌数及范围为7.00×105cfu/片(6.80-7.20×105cfu/片)
阴性对照组:中和剂、PBS、培养基无细菌生长。
4.对红色毛癣菌的杀灭效果
足部消毒剂原液、75%、50%的稀释液,分别作用5min、10min、20min,对红色毛癣菌的平均杀灭率分别为99.90%、99.97%、99.99%。
表4对红色毛藓菌的杀灭效果
注:阳性对照组平均菌数及范围为1.86×106cfu/片(1.82-1.89×106cfu/片)
阴性对照组:中和剂、PBS、培养基无细菌生长。
二.稳定性好
表5存放14天后对红色毛藓菌的杀灭效果
注:阴性对照组无细菌生长。
三.无毒副作用
急性经口毒性试验:小鼠LD50>5000mg/kg,属实际无毒级;
皮肤刺激试验:属无刺激性;
蓄积毒性试验:蓄积系数K>5,属弱蓄积性;
微核试验:无致微核作用。
具体实施方式
实施例1
溶葡萄球菌酶0.0001克,溶菌酶5克,聚乙二醇1000 20克,壳聚糖1克,水补足100克。
无菌搅拌器内加入适量的蒸馏水,然后分别加入上述比例的其他组分,充分搅拌混匀,再加蒸馏水至100克,混匀,灌装即可。
实施例2
溶葡萄球菌酶0.1克,溶菌酶0.001克,聚乙二醇1000 20克,壳聚糖5克,凡士林3克,吐温2克,聚氧乙烯硬脂酸酯30克。
将上述组分按照比例分别加入无菌容器中,搅拌均匀,作成乳膏状,可直接涂抹在患处。
实施例3
溶葡萄球菌酶0.001克,溶菌酶0.01克,甲壳素5克,淀粉5克,聚乙二醇1500 20克。
将上述组分按照比例分别加入无菌容器中,如需要,可加入适量的水,搅拌均匀,可制成凝胶状,直接涂抹在患处。
Claims (5)
1.一种用于足部消毒的生物制剂,其特征在于,包括重量百分比含量为0.0001-0.1%的溶葡萄球菌酶、制剂总量0.5~20%的润肤剂以及适量的乳化剂和医药学上可接受的载体,所说的载体为水、凝胶用基质或乳膏剂用基质;
凝胶用基质为甘油、明胶、淀粉、纤维素衍生物、聚乙二醇中的一种或一种以上;
乳膏剂用基质为羟类、油脂类或类脂中的一种或一种以上以及乳化剂,羟类为凡士林、固体石蜡、液体石蜡或硅酮中的一种;油脂类为花生油、棉子油或氢化植物油中的一种;类脂为羊毛脂、蜂蜡或胆固醇中的一种;乳化剂为天然乳化剂或合成乳化剂中的一种或一种以上;
润肤剂为阳离子改性硅油、氨基改性硅油和氨基复合改性硅油中的一种或一种以上。
2.根据权利要求1所述的用于足部消毒的生物制剂,其特征在于,溶葡萄球菌酶为野生类型、重组产生、突变异种或保留抗葡萄球菌细胞壁肽聚糖的含甘氨酸交联键的任何重组或有关的酶中的一种或一种以上。
3.根据权利要求1所述的用于足部消毒的生物制剂,其特征在于,该制剂中还含有重量百分比含量为0.001-5%的溶菌酶。
4.根据权利要求1所述的用于足部消毒的生物制剂,其特征在于,该制剂中还含有重量百分比含量为0.5-50%的蛋白质稳定剂,蛋白质稳定剂包括聚乙二醇类物质或壳聚糖、甲壳素或N-乙酰-D-氨基。
5.根据权利要求1所述的用于足部消毒的生物制剂,其特征在于,该制剂为水剂、凝胶剂或乳膏剂。
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