CN110292662A - 一种用于尿路冲洗的抗菌液及其制备方法 - Google Patents
一种用于尿路冲洗的抗菌液及其制备方法 Download PDFInfo
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- urinary tract
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Abstract
本发明公开了一种用于尿路冲洗的抗菌液及其制备方法,其特征在于,所述用于尿路冲洗的抗菌液的组分包括:络合剂、抗菌剂、表面活性剂、生物膜抑制剂、水。本发明络合剂可以防止生物膜或结石等牢固结构的形成,抗菌剂对病原微生物有杀死作用或抑制生长作用,表面活性剂可以促进抗菌剂在水中溶解度,生物膜抑制剂可以防止细菌耐药菌群的形成。
Description
技术领域
本发明属于医疗器械领域,具体涉及一种用于尿路冲洗抗菌液及其制备方法。
背景技术
留置导尿管是临床诊疗中常用的基础技术,广泛应用于尿潴留、排尿困难、手术后引流尿液等,但导尿术极易引发留置导尿管相关性尿路感染(C AUTI)。目前医院大约40%的获得性感染为泌尿道感染,而其中的90%与导尿管有关。近年来人们通过对留置导尿管和细菌生物膜之间的关系研究证明了在CAUTI的发生和发展中,细菌生物膜起到了重要作用。细菌生物膜能在自然环境下建立和生存,比如尿路上皮、前列腺结石和包括导尿管在内的各种临时或永久的人工植入物。
医院内的CAUTI的致病菌包含大量的革兰氏阴性及阳性细菌,比如大肠埃希菌、奇异变形杆菌、铜绿假单胞菌、表皮葡萄球菌、粪肠球菌等,其中大肠埃希菌和奇异变形杆菌是最易在尿路系统中形成细菌生物膜的菌种。
细菌生物膜(biofilm)也称为生物被膜,是指附着于有生命或无生命物体表面被细菌胞外大分子包裹的有组织的细菌群体。生物膜细菌对抗生素和宿主免疫防御机制的抗性很强。生物膜中存在各种主要的生物大分子如蛋白质、多糖、DNA、RNA、肽聚糖、脂和磷脂等物质。生物膜多细胞结构的形成是一个动态过程,包括细菌起始粘附、生物膜发展和成熟扩散等阶段。
插入导尿管后,其内面及外面即形成了细菌生物膜生长形成的靶点,导尿管表面提供了细菌粘附和扩散的环境。细菌在导尿管形成生物膜主要有两种方式,一种为腔外途径,当导尿管插入或在包绕导尿管外边的粘液鞘中移动时,微生物在向上在导尿官腔外直接接种繁殖,大约70%的女性留置导尿管发生的菌尿被认为是腔外途径引起的;一种为腔内途径,主要发生在引流系统的密闭性失败或引流袋污染。一般官腔外的细菌定植感染要早于管腔内的,而且定值黏附数量与菌种类液也较多,导尿管插入时顶端所带入细菌是CAUTI主要发生途径和机制。
大部分留置导管尿路感染表现是无症状菌尿,当感染出现症状时,接下来患者会出现发热、尿道炎、膀胱炎、肾(膀胱)结石等,随着感染的发展,会出现泌尿生殖黏膜损伤,出血或者导尿管、引流系统的梗阻甚至死亡等症状。
一旦人体器官(肾脏、膀胱、输尿管、尿道)以及导尿管内外表面形成细菌生物膜,抗生素以及人体的免疫系统很难对其发挥作用,最终导致尿路感染。因此CAUTI的预防,主要是预防留置导尿管期间表面细菌生物膜形成,目前CAUTI的预防主要是通过以下方式:
1、封闭的引流系统、严格的无菌操作和护理,尽量避免可能感染途径,据报道使用预先密闭的引流系统以及每日会阴清洁可以降低约50%的CAU TI发病率。
2、导尿管表面涂覆抗菌或亲水涂层也可一定程度上抵御细菌在导尿管表面的黏附,降低细菌生物膜形成的能力。
3、CAUTI发生初期也可通过生理盐水或抗菌液等对尿路进行冲洗。
目前临床针对CAUTI的预防虽然采取了一定措施,但截至目前还未见对留置导尿管细菌生物膜形成的预防或去除的系统性研究,特别是导管涂层液或冲洗液成分对预防导尿管生物膜形成的机理及效果研究较少,未见专门用于并有效的留置导尿管涂层液或冲洗液的研究论文或专利。
发明内容
由于上述现有技术中的不足,本发明通过配制一种留置导尿管抗菌液用于导尿管涂层液或冲洗液,通过抗菌试验以及导尿管在模拟尿液中的生物膜的形成效果,证实,本发明配方抗菌液可有效预防导尿管表面表面细菌生物膜形成。
本发明为实现上述目的提供一种用于尿路冲洗抗菌液及其制备方法,本发明采用了以下技术方案:
一种用于尿路冲洗的抗菌液的组分包括:
络合剂、抗菌剂、表面活性剂、生物膜抑制剂、水。
本技术方案中,络合剂可以防止生物膜或结石等牢固结构的形成,抗菌剂对病原微生物有杀死作用或抑制生长作用,表面活性剂可以促进抗菌剂在水中溶解度,生物膜抑制剂可以防止细菌耐药菌群的形成。
优选地,所述组分的含量如下:
3wt%-10wt%的络合剂、0.1wt%-2wt%的抗菌剂、0.1wt%-2wt%的表面活性剂、0.1wt%-10wt%的生物膜抑制剂,剩下的含量用水补足至100%。
进一步,优选地,包括如下组分和含量:
3wt%的络合剂、0.5wt%的抗菌剂、1wt%的表面活性剂、1.5wt%的生物膜抑制剂,剩下的含量用水补足至100%。
优选地,所述络合剂为金属离子络合剂;
所述表面活性剂为阴离子型表面活性剂、非离子型表面活性剂中的一种或几种。
进一步,优选地,所述金属离子络合剂为柠檬酸盐、磷酸盐、硫代硫酸盐、亚硫酸盐中的一种或几种;
所述抗菌剂为白藜芦醇、金银花抗菌提取液、壳聚糖、含银离子抗菌剂、季铵盐、多肽中的一种或几种;
所述阴离子型表面活性剂包括:硫酸化物、磺酸化物;
所述非离子型表面活性剂包括:聚山梨酯类、聚氧乙烯脂肪酸酯类、聚氧乙烯脂肪醇醚类中的一种或几种;
所述生物膜抑制剂为N-乙酰氨基葡萄糖;
所述水为去离子水。
本技术方案中,柠檬酸钠在医药工业中用作抗血凝剂、化痰药和利尿药;有金属离子络合能力。柠檬酸钠对Ca2+、Mg2+等金属离子具有良好的络合能力,对其他金属离子,如Fe2 +等离子也有很好的络合能力;具有良好的pH调节及缓冲性能,其具有防止结石,溶解结石的作用。
白藜芦醇通过抑制1,3-β-D-葡萄糖合成酶、甘露聚糖-蛋白质复合物、甲壳质合酶或细胞壁鞘类磷脂生物合成等机制,破坏细胞壁或干扰细胞壁的合成,再由破损的细胞壁进入细胞内部,在破坏细胞壁的同时亦可损伤细胞膜,导致细胞内重要物质如钾离子、氨基酸和核苷酸外漏,破坏细胞膜结构的完整性以及膜内的正常代谢,而当药物透过细胞膜进入菌体后,通过干扰核酸、蛋白质等细胞器的合成,出现细胞器的完全破坏以及细胞膜的溶解,进而影响菌体生长代谢。白藜芦醇对葡萄球菌和皮肤癣菌、白色念珠菌有较好的抑菌效果。
乙酰氨基葡萄糖:抗生素在抗细菌感染治疗中,可引起病原菌转变成称之为潜生体(Cryptic growth cell,CGC)的纤细状变化,促成病原菌形成群集而产生生理性耐药。用药的同时也可致体内的常居菌群引起CGC变化,而发生抗生素治疗后的并发慢性病症,导致体内菌群失调,甚至引起肠道功能紊乱形成慢性功能疾病。在抗菌治疗的时候给予N-乙酰-D-氨基葡萄糖的复方制剂可阻止细菌CGC形成,预防抗菌用药后的并发症发生。防止细菌在导尿管表面形成群集,提高抗菌剂的抗菌效果,延缓生物膜的形成。
本发明还提供了一种用于尿路冲洗的抗菌液的制备方法,包括如下制备步骤:
将络合剂、抗菌剂、表面活性剂、生物膜抑制剂加入到水中,磁力搅拌至完全溶解后高压蒸汽灭菌,得到所述用于尿路冲洗的抗菌液。
进一步,所述磁力搅拌的搅拌温度为40~60℃,优选为50℃,搅拌转速为150r/min,搅拌时间为2h。
优选地,所述高压蒸汽灭菌的灭菌温度为121℃,灭菌时间为15min。
本发明的有益效果在于:
1、本发明通过多种配方的组合,实现了一种尿路冲洗抗菌液用于留置导尿管期间对尿路系统的冲洗,通过抗菌试验以及导尿管在模拟尿液中的生物膜的形成效果,证实,本发明配方抗菌液可有效预防导尿管表面细菌生物膜形成。
具体实施方式
下面结合具体实施例来进一步描述本发明,但这些实施例仅是范例性的,并不对本发明的范围构成任何限制。本技术领域的普通技术人员应该理解的是,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
实施例1
本发明公开了一种用于尿路冲洗的抗菌液,其组分和含量包括:
3%-10%的络合剂、0.1%-2%的抗菌剂、0.1%-2%的表面活性剂、0.1%-10%的生物膜抑制剂,剩下的含量用水补足至100%。
具体地,络合剂为柠檬酸钠;抗菌剂为白藜芦醇;表面活性剂为十二烷基硫酸钠;生物膜抑制剂为N-乙酰氨基葡萄糖;水为去离子水。
本实施例中,络合剂可以防止生物膜或结石等牢固结构的形成,抗菌剂对病原微生物有杀死作用或抑制生长作用,表面活性剂可以促进抗菌剂在水中溶解度,N-乙酰氨基葡萄糖可以防止细菌耐药菌群的形成。
柠檬酸钠在医药工业中用作抗血凝剂、化痰药和利尿药;有金属离子络合能力。柠檬酸钠对Ca2+、Mg2+等金属离子具有良好的络合能力,对其他金属离子,如Fe2+等离子也有很好的络合能力;具有良好的pH调节及缓冲性能,其具有防止结石,溶解结石的作用。
白藜芦醇通过抑制1,3-β-D-葡萄糖合成酶、甘露聚糖-蛋白质复合物、甲壳质合酶或细胞壁鞘类磷脂生物合成等机制,破坏细胞壁或干扰细胞壁的合成,再由破损的细胞壁进入细胞内部,在破坏细胞壁的同时亦可损伤细胞膜,导致细胞内重要物质如钾离子、氨基酸和核苷酸外漏,破坏细胞膜结构的完整性以及膜内的正常代谢,而当药物透过细胞膜进入菌体后,通过干扰核酸、蛋白质等细胞器的合成,出现细胞器的完全破坏以及细胞膜的溶解,进而影响菌体生长代谢。白藜芦醇对葡萄球菌和皮肤癣菌、白色念珠菌有较好的抑菌效果。
乙酰氨基葡萄糖:抗生素在抗细菌感染治疗中,可引起病原菌转变成称之为潜生体(Cryptic growth cell,CGC)的纤细状变化,促成病原菌形成群集而产生生理性耐药。用药的同时也可致体内的常居菌群引起CGC变化,而发生抗生素治疗后的并发慢性病症,导致体内菌群失调,甚至引起肠道功能紊乱形成慢性功能疾病。在抗菌治疗的时候给予N-乙酰-D-氨基葡萄糖的复方制剂可阻止细菌CGC形成,预防抗菌用药后的并发症发生。防止细菌在导尿管表面形成群集,提高抗菌剂的抗菌效果,延缓生物膜的形成。
实施例2
本具体实施例公开了还提供了一种用于尿路冲洗的抗菌液的制备步骤,所述步骤如下:
将络合剂、抗菌剂、表面活性剂、生物膜抑制剂加入到水中,磁力搅拌至完全溶解后高压蒸汽灭菌,得到用于尿路冲洗的抗菌液。
实施例3
本具体实施例在实施例1、2的基础上公开了本发明一种用于尿路冲洗的抗菌液的制备方法及其在人工尿液中以及导尿管表面细菌黏附或生物膜形成情况:
抗菌液配置:3g柠檬酸钠、1g十二烷基硫酸钠、0.5g白藜芦醇、1.5gN-乙酰氨基葡萄糖加入到94ml去离子水中,磁力搅拌(转速150r/min,温度55℃,时间2h)至完全溶解,高压蒸汽灭菌(温度121℃,时间15min),即制得抗菌液;
菌液制备:分别挑取大肠埃希菌和奇异变形杆菌菌种单菌落接种至人工尿液(含或不含抗菌液)中,经24℃培养两天,作为原菌液备用。
细菌培养:
剪取12段10cm长普通硅胶导尿管,分别放入含大肠埃希菌和奇异变形杆菌的人工尿液、10%抗菌液的无菌试管内,再将胶塞塞紧防止漏液或污染,在37℃条件下培养1天、3天、7天。观察人工尿液中以及导尿管表面细菌黏附或生物膜形成情况,其细菌黏附情况如表1所示,生物膜形成情况如表2所示。
表1人工尿液中导管细菌培养澄清度观察
由表1可知,大肠埃希菌和奇异变形杆菌在含抗菌液的人工尿液中,无法正常繁殖,抗菌液对大肠埃希菌以及奇异变形杆菌有较好的杀灭作用以及可以抑制菌群的形成。
表2导尿管表面生物膜厚度检测(扫描电镜观察)
由表2可知,大肠埃希菌和奇异变形杆菌可在导尿管(未添加抗菌液的人工尿液)表面形成细菌生物膜,并且随着时间的延长,生物膜逐渐变厚变硬;添加抗菌液组可有效抑制导尿管表面细菌生物膜的形成。
表3抗菌液对模拟尿道结石的溶蚀作用
从表3可知,本发明配方抗菌液对草酸钙以及磷酸镁铵有一定的溶蚀作用,可推测,本发明配方抗菌液对尿路系统中已形成的结石具备一定的溶石功效。
实施例4
本具体实施例在实施例1、2的基础上公开了本发明一种用于尿路冲洗的抗菌液的制备方法:
抗菌液配置:10g乙二胺四甲叉磷酸钠、2g十二烷基硫酸钠、2g金银花抗菌提取液、10gN-乙酰氨基葡萄糖加入到76ml去离子水中,磁力搅拌(转速150r/min,温度55℃,时间2h)至完全溶解,高压蒸汽灭菌(温度121℃,时间15min),即制得抗菌液。
表4导尿管表面生物膜厚度检测(扫描电镜观察)
由表4可知,该配方下抗菌液具备较好的防止导尿管表面细菌生物膜形成的效果。
实施例5
本具体实施例在实施例1、2的基础上公开了本发明一种用于尿路冲洗的抗菌液的制备方法:
抗菌液配置:3g柠檬酸钠、0.1g十二烷基硫酸钠、0.1g白藜芦醇、0.1gN-乙酰氨基葡萄糖加入到96.7ml去离子水中,磁力搅拌(转速150r/min,温度55℃,时间2h)至完全溶解,高压蒸汽灭菌(温度121℃,时间15min),即制得抗菌液。
表5导尿管表面生物膜厚度检测(扫描电镜观察)
由表5可知,该配方下抗菌液具备一定的防止导尿管表面细菌生物膜形成的效果。
以上所述实施例仅表达了本发明的实施方式,其描述较为具体和详细,但并不能因此而理解为对本发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (8)
1.一种用于尿路冲洗的抗菌液,其特征在于,所述抗菌液的组分包括:
络合剂、抗菌剂、表面活性剂、生物膜抑制剂、水。
2.如权利要求1所述的一种用于尿路冲洗的抗菌液,其特征在于,所述组分的含量如下:
3wt%-10wt%的络合剂、0.1wt%-2wt%的抗菌剂、0.1wt%-2wt%的表面活性剂、0.1wt%-10wt%的生物膜抑制剂,剩下的含量用水补足至100%。
3.如权利要求1所述的一种用于尿路冲洗的抗菌液,其特征在于,包括如下组分和含量:
3wt%的络合剂、0.5wt%的抗菌剂、1wt%的表面活性剂、1.5wt%的生物膜抑制剂N-乙酰氨基葡萄糖,剩下的含量用水补足至100%。
4.如权利要求1所述的一种用于尿路冲洗的抗菌液,其特征在于:
所述络合剂为金属离子络合剂;
所述表面活性剂为阴离子型表面活性剂、非离子型表面活性剂中的一种或几种。
5.如权利要求4所述的一种用于尿路冲洗的抗菌液,其特征在于:
所述金属离子络合剂为柠檬酸盐、磷酸盐、硫代硫酸盐、亚硫酸盐中的一种或几种;
所述抗菌剂为白藜芦醇、金银花抗菌提取液、壳聚糖、含银离子抗菌剂、季铵盐、多肽中的一种或几种;
所述阴离子型表面活性剂包括:硫酸化物、磺酸化物;
所述非离子型表面活性剂包括:聚山梨酯类、聚氧乙烯脂肪酸酯类、聚氧乙烯脂肪醇醚类中的一种或几种;
所述生物膜抑制剂为N-乙酰氨基葡萄糖;
所述水为去离子水。
6.一种用于尿路冲洗的抗菌液的制备方法包括如权利要求1~5所述的一种用于尿路冲洗的抗菌液,其特征在于,包括如下制备步骤:
将络合剂、抗菌剂、表面活性剂、生物膜抑制剂加入到水中,磁力搅拌至完全溶解后高压蒸汽灭菌,得到所述用于尿路冲洗的抗菌液。
7.如权利要求6所述的一种用于尿路冲洗的抗菌液的制备方法,其特征在于:
所述磁力搅拌的搅拌温度为40~60℃,搅拌转速为100~300r/min,搅拌时间为2h。
8.如权利要求6所述的一种用于尿路冲洗的抗菌液的制备方法,其特征在于:
所述高压蒸汽灭菌的灭菌温度为121℃,灭菌时间为15min。
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