CN112076215A - 一种改善生殖道微生态的抗菌组合物及其应用 - Google Patents
一种改善生殖道微生态的抗菌组合物及其应用 Download PDFInfo
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- Medicinal Preparation (AREA)
Abstract
本发明属于医药领域,公开了一种改善生殖道微生态的抗菌组合物及其应用,该抗菌组合物,包括以下组分:氧化还原电位水、稳定剂、pH调节剂、凝胶基质、保湿剂;稳定剂选自卤酸盐和羟基乙叉二膦酸。该抗菌组合物中的稳定剂卤酸盐和羟基乙叉二膦酸能协同稳定氧化还原电位水,凝胶基质的加入进一步提高组合物的整体稳定性,保湿剂的加入有助于抗菌组合物在生殖道中发挥抗菌组合物对有害菌的杀灭效果,同时,保湿剂有助于改善生殖道微生态环境的稳定性。本发明所述抗菌组合物以其氧化电位物理杀菌为主导,对皮肤无刺激,具有无毒、无耐药、无污染,安全性高的特点。
Description
技术领域
本发明属于医药领域,特别涉及一种改善生殖道微生态的抗菌组合物及其应用。
背景技术
女性生殖道感染(RTIS)包括:阴道炎、宫颈炎、盆腔炎,以前者最为常见。目前,妇科抗感染治疗以药物治疗方式为主导,其中以化学药和中成药居多。临床上,根据感染类型采用单一用药或联合用药方案。在过去二十多年中,随着抗生素化学药物的滥用,在杀灭致病菌的同时,耐药性不断产生,使生殖道益生菌、优势菌群受到不同程度的破坏,从而丧失或降低阴道自洁防御功能,导致感染复发率、混合性感染率逐年攀升。近年来,人们致力于研究如何通过益生菌补给制剂来修复生殖道微生态环境,但收效甚微。生殖道微生态环境的重建,已然成为妇科抗感染治疗领域刻不容缓、亟须解决的世界性难题。
女性生殖道内存在大量不致病微生物群,与人体处于共生状态。其生态体系由阴道内的微生态菌群、机体的内分泌调节功能和免疫功能组成,健康妇女阴道内的正常微生物群落与宿主、环境之间相互制约、相互协调。
阴道微环境平衡对维持其自净及宿主健康起着关键性作用。健康妇女阴道兼性厌氧乳杆菌的数量占阴道微生物的95%以上,含菌数也最多(107-108CFU/mL阴道分泌物)。是育龄期正常阴道内的优势菌,也是阴道正常菌群中最重要的益生菌成员,其决定着微生物群生态平衡的核心关键。乳酸杆菌存在广泛,嗜酸性,适宜pH 5.5-6.0生存,耐酸力强,在pH3.0-4.5的环境中仍然能生存。
阴道pH值,是影响阴道微生态平衡、变化的重要因素和重要指标之一。正常育龄期妇女,在无感染的条件下阴道pH值为3.8-4.2。临床上主要通过描述阴道菌群的密集度、多样性、优势菌、机体炎性反应和原因菌等形态学方面,结合pH值、过氧化氢、白细胞酯酶等功能性指标对阴道微生态环境进行全面评价,以诊断微生态是否失调。
临床治疗广泛使用抗生素,抑制致病菌的同时也破坏阴道正常菌群,使优势微生物改变,产生大量耐药性的病原微生物,一旦再次感染,将严重影响抗生素的疗效。因此,生殖道感染治疗应重视生殖道生态环境的调控。由此可见,乳杆菌在维持阴道生态菌群平衡中起重要作用,是女性生殖道的微生物防线。而阴道乳杆菌的减少甚至缺失,可导致阴道菌群失调,阴道清洁度、酸碱度异常,使外源性有害微生物侵入及内源性致病菌大量繁殖,从而导致阴道炎。
因此,希望提供一种改善生殖道微生态环境的抗菌药物,该药物针对破坏生殖道微生态环境的菌群具有明显的杀菌作用,特别是对一些耐药菌有杀菌作用,但对生殖道中的益生菌或共生菌无明显杀灭作用,从而改善生殖道微生态环境。
发明内容
本发明旨在至少解决上述现有技术中存在的技术问题之一。为此,本发明提出一种改善生殖道微生态的抗菌组合物及其应用,本发明制得的抗菌组合物对破坏生殖道微生态的支原体、衣原体、白色念珠菌、对耐甲氧西林的金黄色葡萄球菌具有显著的杀灭作用,但对生殖道中的益生菌或共生菌无明显杀灭作用,从而改善生殖道微生态环境。
因此,本发明的第一方面提供一种改善生殖道微生态的抗菌组合物。
具体的,一种改善生殖道微生态的抗菌组合物,包括以下组分:氧化还原电位水、稳定剂、pH调节剂、凝胶基质、保湿剂;所述稳定剂选自卤酸盐和羟基乙叉二膦酸。
优选的,所述卤酸盐选自碘酸钾、氯酸钾或溴酸钾中的至少一种。
优选的,所述凝胶基质选自纤维素衍生物类凝胶基质或非离子型凝胶基质中的至少一种。该凝胶基质对人体无毒无残留,且有助稳定组合物。
进一步优选的,所述纤维素衍生物类凝胶基质选自羟丙基纤维素、羟乙基纤维素、羟丙甲纤维素、乙基纤维素、羧甲基纤维素钠或甲基纤维素中的至少一种。
进一步优选的,所述非离子型凝胶基质选自泊洛沙姆、聚乙烯醇、聚乙二醇400、聚乙二醇2000、聚乙二醇4000、聚乙二醇6000、丙二醇或山梨醇中的至少一种。
优选的,所述保湿剂选自于液体石蜡、甘油、透明质酸、乳酸钠、丙二醇、聚乙二醇中的至少一种。
优选的,所述pH调节剂为磷酸和磷酸盐的混合物。
进一步优选的,所述磷酸盐选自磷酸钠、磷酸二氢钠和磷酸氢二钠中的至少一种。磷酸盐不仅具有调节pH的作用,还有助于辅助稳定剂,提高氧化还原电位水的稳定性。
优选的,所述氧化还原电位水是电解质量分数为0.5-0.1%的氯化钠溶液制得。
优选的,所述氧化还原电位水的有效氯浓度为20-90mg/L,氧化还原电位(ORP)为800-1100mV;进一步优选的,所述氧化还原电位水的有效氯浓度为30-70mg/L,氧化还原电位(ORP)为850-1150mV。选用合适有效氯含量和氧化还原电位的氧化还原电位水,有助于提高组合物对白色念珠菌、对耐甲氧西林的金黄色葡萄球菌的杀菌效果。
优选的,所述氧化还原电位水的pH值为3.0-5.5;进一步优选的,所述氧化还原电位水的pH值为3.5-4.5。
优选的,一种改善生殖道微生态的抗菌组合物,按重量份数计,包括以下组分:氧化还原电位水85-98份、稳定剂0.1-4份、pH调节剂0.5-6份、凝胶基质0.5-6份、保湿剂0.5-6份。
进一步优选的,一种改善生殖道微生态的抗菌组合物,按重量份数计,包括以下组分:氧化还原电位水88-94份、稳定剂0.5-3份、pH调节剂0.5-6份、凝胶基质0.5-3份、保湿剂0.02-2份。
优选的,所述组合物的pH值为3.0-5.5,氧化还原电位为800-1100mV,有效氯(主要是次氯酸或次氯酸根)为30-90mg/L。当所述组合物的pH值、氧化还原电位、有效氯选择合适的范围,更有利于组合物对生殖道中致病菌进行杀灭以及改善整个生殖道的微生态环境。
优选的,所述组合物的剂型为医学上任意可接受的剂型,优选喷雾凝胶剂。
本发明还提供一种改善生殖道微生态的抗菌组合物的制备方法,包括以下步骤:
将氧化还原电位水与稳定剂搅拌混合,再加入凝胶基质、保湿剂、pH调节剂,搅拌,静置、除气泡,制得所述组合物。
一种药物,包括本发明所述的改善生殖道微生态的抗菌组合物和辅料。
优选的,所述药物的剂型为医学上任意可接受的剂型,优选凝胶剂或喷雾剂。
优选的,所述辅料包括赋形剂、崩解剂或润滑剂中的至少一种,赋形剂、崩解剂或润滑剂可根据实际药物的剂型进行选择。
本发明所述改善生殖道微生态的抗菌组合物在制备治疗阴道疾病的药物中的应用。
本发明所述抗菌组合物可选择性杀灭致病菌,最大程度维持乳杆菌等益生菌的优势占据地位。此作用机理是基于女性生殖道致病菌多为厌氧菌,厌氧菌的ORP(氧化还原电位)耐受生存范围为0-800mv,本发明通过精确设置抗菌组合物的OPR为800-1100mV,超出致病厌氧菌的生存范围,从而达到杀灭的目的;而由于优势益生菌-乳杆菌属于兼性厌氧菌(既厌氧又需氧),即便是在pH为3.0-4.5、ORP大于800mV的环境中仍然生长旺盛,具有耐酸性、高耐受力的特质。同时,本发明通过pH值在3.5-4.2之间,与正常育龄女性生殖道的pH值基本持平,以维护生殖道的微酸性环境不受破坏。通过以上机理,最大限度保留乳杆菌的优势占据和恢复性生长,从而有效实现阴道自洁生理机能,改善生殖道微生态环境,减少炎症的变异和复发。
相对于现有技术,本发明的有益效果如下:
(1)本发明所述抗菌组合物中的稳定剂卤酸盐和羟基乙叉二膦酸能协同稳定氧化还原电位水,凝胶基质的加入进一步提高组合物的整体稳定性,保湿剂的加入有助于抗菌组合物在生殖道(阴道)中发挥所述抗菌组合物对有害菌的杀灭效果,同时,保湿剂有助于改善生殖道微生态环境的稳定性。
(2)本发明采用医药级亲水的凝胶基质和保湿剂制备抗菌组合物,该凝胶基质和保湿剂对人体无毒无残留,且有助于稳定组合物,使组合物有效期可达到3年。
(3)本发明所述抗菌组合物以其氧化电位物理杀菌为主导,对皮肤无刺激,具有无毒、无耐药、无污染,安全性高的特点。
(4)本发明所述抗菌组合物采用亲水的凝胶基质作为载体,不仅有效提高透皮吸收率,加速显效;同时还增加治疗介质在生殖道的滞停时间,使治疗作用更持久。从而避免了常见传统妇科洗液给药外流,作用时间短的弊端。
具体实施方式
为了让本领域技术人员更加清楚明白本发明所述技术方案,现列举以下实施例进行说明。需要指出的是,以下实施例对本发明要求的保护范围不构成限制作用。
以下实施例中所用的原料、试剂或装置如无特殊说明,均可从常规商业途径得到,或者可以通过现有已知方法得到。
实施例1:改善生殖道微生态的抗菌组合物的制备
一种改善生殖道微生态的抗菌组合物的制备,包括以下步骤:
取85份的氧化还原电位水(pH值为3.1,氧化还原电位为1069mV,有效氯为78mg/L),加入0.5份羟基乙叉二膦酸、0.5份碘酸钾后,搅拌溶解,在搅拌下加入5份的羟丙基纤维素,加料完毕后,继续搅拌至羟丙基纤维素充分混匀,加入1份甘油,搅拌,再加入1份pH调节剂(磷酸和磷酸钠),静置、除气泡,即得改善生殖道微生态的抗菌组合物,经检测,所制得的改善生殖道微生态的抗菌组合物的pH值为3.2,氧化还原电位为1055mV,有效氯为75mg/L。
实施例2:改善生殖道微生态的抗菌组合物的制备
一种改善生殖道微生态的抗菌组合物的制备,包括以下步骤:
取91份氧化还原电位水(pH值为4.0,氧化还原电位为1015mV,有效氯为74mg/L),加入0.5份羟基乙叉二膦酸、0.1份溴酸钾后,搅拌溶解,在搅拌下加入0.1份羟乙基纤维素,加料完毕后,继续搅拌至羟乙基纤维素充分混匀,加入1份甘油和1份透明质酸,搅拌,加入0.3份pH调节剂(磷酸和磷酸二氢钠),静置、除气泡,即得改善生殖道微生态的抗菌组合物,经检测,所制得的改善生殖道微生态的抗菌组合物的pH值为4.1,氧化还原电位为1010mV,有效氯为72mg/L。
实施例3:改善生殖道微生态的抗菌组合物的制备
一种改善生殖道微生态的抗菌组合物的制备,包括以下步骤:
取90份氧化还原电位水(pH值为3.8,氧化还原电位为1098mV,有效氯为68mg/L),加入0.5份羟基乙叉二膦酸和1份氯酸钾后,搅拌溶解,在搅拌下加入9.47份羧甲基纤维素钠,加料完毕后,继续搅拌至羧甲基纤维素钠充分混匀,加入1份乳酸钠和1份透明质酸,搅拌,加入0.03份pH调节剂(磷酸和磷酸氢二钠),静置、除气泡,即得改善生殖道微生态的抗菌组合物,经检测,所制得的改善生殖道微生态的抗菌组合物的pH值为4.0,氧化还原电位为1058mV,有效氯为66mg/L。
实施例4:改善生殖道微生态的抗菌组合物的制备
一种改善生殖道微生态的抗菌组合物的制备,包括以下步骤:
取93份氧化还原电位水(pH值为4.8,氧化还原电位为985mV,有效氯为71mg/L),加入0.5份羟基乙叉二膦酸和1份氯酸钾后,搅拌溶解,在搅拌下加入1.6份聚乙二醇6000,加料完毕后,继续搅拌,加入1.2份乳酸钠和2份透明质酸,搅拌,加入0.5份pH调节剂(磷酸和磷酸氢二钠),静置、除气泡,即得改善生殖道微生态的抗菌组合物,经检测,所制得的改善生殖道微生态的抗菌组合物的pH值为5.0,氧化还原电位为976mV,有效氯为69mg/L。
实施例5:改善生殖道微生态的抗菌组合物的制备
一种改善生殖道微生态的抗菌组合物的制备,包括以下步骤:
取94份氧化还原电位水(pH值为4.5,氧化还原电位为1073mV,有效氯为65mg/L),加入0.1份氯酸钾和0.1份羟基乙叉二膦酸后,搅拌溶解,在搅拌下加入5份聚乙二醇4000,加料完毕后,继续搅拌至聚乙二醇4000充分混匀,加入1.2份丙二醇和2份透明质酸,搅拌,加入2份pH调节剂(磷酸和磷酸二氢钠),静置、除气泡,即得改善生殖道微生态的抗菌组合物,经检测,所制得的改善生殖道微生态的抗菌组合物的pH值为4.5,氧化还原电位为1053mV,有效氯为63mg/L。
产品效果测试
1.组合物加速老化条件下稳定性测试
取实施例2制得的组合物,置于密闭容器中,在37±2℃环境温度下进行存放,进行加速老化测试,在第10个月末取样检测pH、氧化还原电位和有效氯,分别为:pH值为4.3,氧化还原电位为1001mV,有效氯为65mg/L。表明实施例2制得的组合物的稳定性极好,在常温下的保质期可达3年。
2.抗菌性能测试
取实施例1-5制得的组合物,测试其对支原体、衣原体、白色念珠菌、对耐甲氧西林金黄色葡萄球菌的抗菌性能,发现实施例1-5制得的组合物,测试其对支原体、衣原体、白色念珠菌、对耐甲氧西林金黄色葡萄球菌的杀灭率都为99.99%(杀灭率的测试按照《消毒技术规范》进行)。
3.治疗患有女性生殖道炎症疾病的效果
选取分别患有细菌性阴道炎、假丝酵母菌阴道病和混合性阴道炎、反复型阴道炎患者各15名,用实施例3制得的抗菌组合物治疗,每天一次给药,3周后统计患者的康复情况(康复情况具体分为:显效:完全无瘙痒、灼痛等症状,且停止给药后,90天无复发;有效:只有轻微瘙痒症状;一般效果:有轻微瘙痒和轻微灼痛等症状,但可以忍受;无效:瘙痒、灼痛等症状无缓解),结果如表1所示。
表1
从表1可以看出,使用实施例3制得的抗菌组合物治疗细菌性阴道炎、假丝酵母菌阴道病和混合性阴道炎、反复型阴道炎患者,治疗效果好,特别是对假丝酵母菌阴道病和混合性阴道炎的治疗效果最佳,访问患有假丝酵母菌阴道病和混合性阴道炎患者用药后的感受,患者表示初次用药后,5min内迅速缓解骚痒、灼痛等症状,具有显效快等特点。
Claims (10)
1.一种改善生殖道微生态的抗菌组合物,其特征在于,包括以下组分:氧化还原电位水、稳定剂、pH调节剂、凝胶基质、保湿剂;所述稳定剂选自卤酸盐和羟基乙叉二膦酸。
2.根据权利要求1所述的抗菌组合物,其特征在于,所述凝胶基质选自纤维素衍生物类凝胶基质或非离子型凝胶基质中的至少一种。
3.根据权利要求1所述的抗菌组合物,其特征在于,所述保湿剂选自于石蜡、甘油、透明质酸、乳酸钠、丙二醇、聚乙二醇中的至少一种。
4.根据权利要求1所述的抗菌组合物,其特征在于,所述氧化还原电位水的有效氯浓度为20-90mg/L,氧化还原电位为800-1100mV。
5.根据权利要求1所述的抗菌组合物,其特征在于,所述氧化还原电位水的pH值为3.0-5.5。
6.根据权利要求1所述的抗菌组合物,其特征在于,按重量份数计,包括以下组分:氧化还原电位水85-98份、稳定剂0.1-4份、pH调节剂0.5-6份、凝胶基质0.5-6份、保湿剂0.5-6份。
7.根据权利要求1-6中任一项所述的抗菌组合物,其特征在于,所述组合物的pH值为3.0-5.5,氧化还原电位为800-1100mV,有效氯为30-90mg/L。
8.权利要求1-7中任一项所述的抗菌组合物的制备方法,其特征在于,包括以下步骤:
将所述氧化还原电位水与稳定剂搅拌混合,再加入凝胶基质、保湿剂和pH调节剂,搅拌,静置,制得所述组合物。
9.一种药物,其特征在于,包括权利要求1-7中任一项所述的组合物和辅料。
10.权利要求1-7中任一项所述的组合物在制备治疗阴道疾病的药物中的应用。
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