CN114533668A - 一种改进中和胃酸药物抑菌效力的方法 - Google Patents
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Abstract
本发明为一种改进中和胃酸药物抑菌效力的方法,所述方法包括向混合液中加入防腐剂A和防腐剂B,所述防腐剂A为醋酸氯己定,所述防腐剂B为苯甲醇。该改进中和胃酸药物抑菌效力的方法,通过苯甲醇和醋酸氯己定的联合作用,可同时有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的生长繁殖,达到可同时抑制五种微生物的生长繁殖的功效,使药物符合抑菌效力规定,增强了铝镁加混悬液抑制微生物生长的能力,使该产品更加安全。
Description
技术领域
本发明涉及生物医药领域,具体地说是一种改进中和胃酸药物抑菌效力的方法。
背景技术
铝镁加混悬液,适应症为中和胃酸药。其适用于治疗胃及十二指肠溃疡或胃酸过多引起的返酸、烧心、疼痛、腹胀、嗳气等症状。
口服溶液剂为了保证在有效期内的微生物符合服用安全要求,通常会加入防腐剂。但目前某市售制剂中,铝镁加混悬液①未添加防腐剂。铝镁加混悬液2添加一种防腐剂,防腐剂为醋酸氯己定,两种市售制剂铜绿假单胞菌的抑菌效力均不合格。
根据分析得知,上述中的铝镁加混悬液②只添加一种防腐剂其本身抑菌能力并不可行;
原因分析⑴:醋酸氯己定pH5-7时呈现有效抗菌活性,铝镁加混悬液该产品包括各种市售制剂pH均为8-10,不在有效范围内,因此其本身抑菌能力并不可行。
原因分析⑵:根据相关文献(细菌对消毒剂耐药性机制的研究进展. 贾宁,陈世平.中华医院感染学杂志.2001)证实,铜绿假单胞菌对醋酸氯己定会产生耐药性。
原因分析⑶:根据实验(实验数据如下表)证实,铜绿假单胞菌对醋酸氯己定会产生耐药性;
由此可知,目前所服用的铝镁加混悬液中单纯使用醋酸氯己定作为防腐剂会使药品的抑菌效力不合格,不能够保证药品的安全性。
发明内容
本发明的目的在于提供一种改进中和胃酸药物抑菌效力的方法,以解决上述背景技术中提出的问题。
为实现上述目的,本发明提供如下技术方案:一种改进中和胃酸药物抑菌效力的方法,所述方法包括向混合液中加入防腐剂A和防腐剂B;
所述防腐剂A为醋酸氯己定;
所述防腐剂B为苯甲醇。
优选的,所述醋酸氯己定的浓度为0.01-0.2%。
优选的,所述苯甲醇的浓度为0.1-2.0%。
优选的,所述混合液包括铝镁加10g、山梨醇溶液5g、微晶纤维素- 羧甲基纤维素1g、水50ml和西甲硅油乳液0.02g。
优选的,还包括有香精0.05g和纯化水100ml。
优选的,所述醋酸氯己定的含量为0.01g,所述苯甲醇的含量为0.1g 一种中和胃酸药物的制备方法,包括以下步骤:
S1:取铝镁加10g,加山梨醇溶液5g搅拌成糊状;
S2:微晶纤维素-羧甲基纤维素1g溶于50ml水制成胶浆,并搅拌至S1 制得的混合液中;
S3:取0.02g西甲硅油乳液搅拌至S2制得的混合液中;
S4:取苯甲醇0.1g、醋酸氯己定0.01g、香精0.05g,搅拌至S3得到的混合液中,并加纯化水至100ml搅匀。
与现有技术相比,本发明的有益效果是:该改进中和胃酸药物抑菌效力的方法,通过苯甲醇和醋酸氯己定的联合作用,可同时有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的生长繁殖,达到可同时抑制五种微生物的生长繁殖的功效,使药物符合抑菌效力规定,增强了铝镁加混悬液抑制微生物生长的能力,使该产品更加安全。
具体实施方式
下面通过实施例详述本发明。
实施例1
S1:取铝镁加10g,加山梨醇溶液5g搅拌成糊状;
S2:微晶纤维素-羧甲基纤维素1g溶于50ml水制成胶浆,并搅拌至S1 制得的混合液中;
S3:取0.02g西甲硅油乳液搅拌至S2制得的混合液中;
S4:取香精0.05g,搅匀在S3得到的混合液中。
实施例2
S1:取铝镁加10g,加山梨醇溶液5g搅拌成糊状;
S2:微晶纤维素-羧甲基纤维素1g溶于50ml水制成胶浆,并搅拌至S1 制得的混合液中;
S3:取0.02g西甲硅油乳液搅拌至S2制得的混合液中;
S4:取苯甲醇0.2g、醋酸氯己定0.02g、香精0.05g,搅拌至S3得到的混合液中,并加纯化水至100ml搅匀。
实施例3
S1:取铝镁加10g,加山梨醇溶液5g搅拌成糊状;
S2:微晶纤维素-羧甲基纤维素1g溶于50ml水制成胶浆,并搅拌至S1 制得的混合液中;
S3:取0.02g西甲硅油乳液搅拌至S2制得的混合液中;
S4:取苯甲醇0.4g、醋酸氯己定0.02g、香精0.05g,搅拌至S3得到的混合液中,并加纯化水至100ml搅匀。
实施例4
S1:取铝镁加10g,加山梨醇溶液5g搅拌成糊状;
S2:微晶纤维素-羧甲基纤维素1g溶于50ml水制成胶浆,并搅拌至S1 制得的混合液中;
S3:取0.02g西甲硅油乳液搅拌至S2制得的混合液中;
S4:取苯甲醇0.2g、醋酸氯己定0.04g、香精0.05g,搅拌至S3得到的混合液中,并加纯化水至100ml搅匀。
实施例5
S1:取铝镁加10g,加山梨醇溶液5g搅拌成糊状;
S2:微晶纤维素-羧甲基纤维素1g溶于50ml水制成胶浆,并搅拌至S1 制得的混合液中;
S3:取0.02g西甲硅油乳液搅拌至S2制得的混合液中;
S4:取苯甲醇0.4g、醋酸氯己定0.04g、香精0.05g,加纯化水至100ml,搅匀在S3得到的混合液中。
实施例6
S1:取铝镁加10g,加山梨醇溶液5g搅拌成糊状;
S2:微晶纤维素-羧甲基纤维素1g溶于50ml水制成胶浆,并搅拌至S1 制得的混合液中;
S3:取0.02g西甲硅油乳液搅拌至S2制得的混合液中;
S4:取苯甲醇1.0g、醋酸氯己定0.05g、香精0.05g,搅拌至S3得到的混合液中,并加纯化水至100ml搅匀。
实施例7
S1:取铝镁加10g,加山梨醇溶液5g搅拌成糊状;
S2:微晶纤维素-羧甲基纤维素1g溶于50ml水制成胶浆,并搅拌至S1 制得的混合液中;
S3:取0.02g西甲硅油乳液搅拌至S2制得的混合液中;
S4:取苯甲醇1.0g、醋酸氯己定0.02g、香精0.05g,搅拌至S3得到的混合液中,并加纯化水至100ml搅匀。
实施例8
S1:取铝镁加10g,加山梨醇溶液5g搅拌成糊状;
S2:微晶纤维素-羧甲基纤维素1g溶于50ml水制成胶浆,并搅拌至S1 制得的混合液中;
S3:取0.02g西甲硅油乳液搅拌至S2制得的混合液中;
S4:取苯甲醇2.0g、醋酸氯己定0.1g、香精0.05g,搅拌至S3得到的混合液中,并加纯化水至100ml搅匀。
实施例9
S1:取铝镁加10g,加山梨醇溶液5g搅拌成糊状;
S2:微晶纤维素-羧甲基纤维素1g溶于50ml水制成胶浆,并搅拌至S1 制得的混合液中;
S3:取0.02g西甲硅油乳液搅拌至S2制得的混合液中;
S4:取苯甲醇2.0g、醋酸氯己定0.2g、香精0.05g,搅拌至S3得到的混合液中,并加纯化水至100ml搅匀。
对上述实施例1至9,得出结果为:
实施例1中,不能有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的产生;
实施例2中,能有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的产生;
实施例3中,能有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的产生;
实施例4中,能有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的产生;
实施例5中,能有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的产生;
实施例6中,能有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的产生;
实施例7中,能有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的产生;
实施例8中,能有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的产生;
实施例9中,能有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的产生。
实验数据总结表:
由此可得知,在铝镁加混悬液中加入醋酸氯己定和苯甲醇为1:5至 1:20的比例时,醋酸氯己定在0.01-0.2w/v%的浓度范围,苯甲醇在 0.1-2.0w/v%的浓度范围时,可同时有效抑制铜绿假单胞菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉的生长繁殖,符合抑菌效力规定。
同时还根据实验得出,单独使用醋酸氯己定时,铜绿假单胞菌不符合规定;单独使用苯甲醇时,铜绿假单胞菌和大肠埃希菌不符合规定。
以上仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以权利要求的保护范围为准。
Claims (7)
1.一种改进中和胃酸药物抑菌效力的方法,其特征在于:所述方法包括向混合液中加入防腐剂A和防腐剂B;
所述防腐剂A为醋酸氯己定;
所述防腐剂B为苯甲醇。
2.根据权利要求1所述的改进中和胃酸药物抑菌效力的方法,其特征在于:所述醋酸氯己定的浓度为0.01-0.2%。
3.根据权利要求1所述的改进中和胃酸药物抑菌效力的方法,其特征在于:所述苯甲醇的浓度为0.1-2.0%。
4.根据权利要求1所述的改进中和胃酸药物抑菌效力的方法,其特征在于:所述混合液包括铝镁加10-20g、山梨醇溶液5-10g、微晶纤维素-羧甲基纤维素1-5g、水50ml和西甲硅油乳液0.02-0.1g。
5.根据权利要求4所述的改进中和胃酸药物抑菌效力的方法,其特征在于:还包括有香精0.05g。
6.根据权利要求1所述的改进中和胃酸药物抑菌效力的方,其特征在于:所述醋酸氯己定的含量为0.01-0.2g,所述苯甲醇的含量为0.1-2.0g。
7.一种中和胃酸药物的制备方法,其特征在于:包括以下步骤:
S1:取铝镁加10g,加山梨醇溶液5g搅拌成糊状;
S2:微晶纤维素-羧甲基纤维素1g溶于50ml水制成胶浆,并搅拌至S1制得的混合液中;
S3:取0.02g西甲硅油乳液搅拌至S2制得的混合液中;
S4:取苯甲醇0.1g、醋酸氯己定0.01g、香精0.05g,搅拌至S3得到的混合液中,并加纯化水至100ml搅匀。
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US20100092577A1 (en) * | 2007-03-29 | 2010-04-15 | Pier Luigi Guasti | Topical compositions containing magaldrate |
WO2016084078A1 (en) * | 2014-11-25 | 2016-06-02 | Sharon Laboratories Ltd. | Antimicrobial preservative compositions |
CN114028331A (zh) * | 2021-11-03 | 2022-02-11 | 北京鑫开元医药科技有限公司 | 镁加铝混悬液及其制备工艺 |
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