CN101278896A - Chitosan nano silver gel agent and uses thereof - Google Patents

Chitosan nano silver gel agent and uses thereof Download PDF

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CN101278896A
CN101278896A CN 200810016256 CN200810016256A CN101278896A CN 101278896 A CN101278896 A CN 101278896A CN 200810016256 CN200810016256 CN 200810016256 CN 200810016256 A CN200810016256 A CN 200810016256A CN 101278896 A CN101278896 A CN 101278896A
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chitosan
silver
nano
nano silver
gel
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CN101278896B (en
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李长林
谢松梅
邹方明
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山东赛克赛斯药业科技有限公司
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Abstract

The invention relates to a chitosan nano silver gelata used for treating an inflammation in a lower genital tract, cervicitis and cervical erosion of female and empyrosis, scalding, bedsore infection and other skin inflammations such as tinea manus and pedes, and various wound infections, etc. The medicinal raw materials of the chitosan nano silver gelata of the invention are the nano silver and chitosan polymer in respective therapy dose; the nano silver is the nano silver powder or the nano silver colloid; the chitosan polymer is the chitosan and the chitin and one or more than one derivative of the chitosan and the chitin. The product of the invention has the advantages of high efficiency and being nonpoisonous, and has an extremely strong antibacterial action and an excellent therapeutic effect; compared with other nano silver gelata, the chitosan nano silver gelata of the invention has the advantages of perfect sterilizing effect, long-lasting effect and tissue repair function.

Description

壳聚糖纳米银凝胶剂及其应用 Silver and Its Application gels chitosan nano

技术领域 FIELD

本发明涉及一种壳聚糖纳米银凝胶剂,用来治疗女性下生殖道炎症、宫颈炎、宫颈糜烂及烧伤、烫伤、褥疮感染及其他皮肤炎症如手足癣、各种创伤感染等。 The present invention relates to a nano silver chitosan gels used to treat inflammation of the female genital tract, cervicitis, cervical erosion and burns, burns, decubitus and other skin infections such as tinea inflammation, trauma of various infections. 背景技术 Background technique

女性下生殖道炎症、宫颈炎、宫颈糜烂发病率较高,是妇科疾病中的常见病。 The female genital tract inflammation, cervicitis, cervical erosion higher incidence of common gynecological diseases. 目前,市场上治疗产品较多,但治疗效果不理想,复发率较高。 Currently, more therapeutic products on the market, but treatment is not satisfactory, a higher recurrence rate.

烧烫伤、褥疮病人感染的发生率较高,较多的使用抗生素易产生耐药性,难以控制病情。 Burns, higher incidence of pressure ulcers infected patients, more easy to produce antibiotic resistance, it is difficult to control the disease.

皮肤炎症种类较多,治疗难度较大且容易复发,很多皮肤炎症没有特效抗菌药。 More types of skin inflammation, the treatment of large and easy to relapse more difficult, a lot of skin inflammation is no specific antibiotic. 银具有强烈的杀菌效果,可以杀死600多种细菌,并且不会产生耐药性。 Silver has a strong bactericidal effect, can kill more than 600 kinds of bacteria, and do not generate resistance. 其杀菌机理是银与细菌体内巯基酶结合使其失去活性,使细菌死亡;银和细菌细胞壁上暴露的肽聚糖反应,形成可逆性复合物,使它们不能把氧(能量)转运进细胞,阻止病菌的活动, 导致其死亡;银和致病菌的DNA结合,导致DNA结构变性,不能复制,使致病菌失活。 Bactericidal mechanism is silver in combination with sulfhydryl enzyme in bacteria loss of activity, so that dead bacteria; exposed on the bacterial cell wall peptidoglycan and silver, to form a reversible complex, that they can not oxygen (energy) transport into cells, prevent the activities of bacteria, which leads to death; DNA binding silver and pathogens causing DNA denaturation structure, you can not copy the pathogen inactivation. 壳聚糖也具有杀菌作用,在酸性条件下,壳聚糖分子中的氨基带有正电荷,成为NH3+,吸附带有负电荷的细菌,使细菌细胞壁和细胞膜上的负电荷分布不均,干扰细胞壁的合成,打破在自然状态下的细胞壁合成与溶解平衡,使细胞壁趋向于溶解,细胞膜因不能承受渗透压而变形破裂,细胞的内容物如水、蛋白质等渗出,发生细菌溶解而死亡。 Chitosan also has a bactericidal effect, under acidic conditions, the chitosan amino groups in the molecule with a positive charge to become NH3 +, adsorption of negatively charged bacteria, so that the negative charge on the bacterial cell walls and membranes are unevenly distributed, interference cell wall synthesis, broken in a natural state of cell wall synthesis and solution equilibrium, tends to dissolve cell wall, cell membrane because they can not withstand the deformation and fracture of osmotic pressure, water content of cells, proteins and the like exudate, bacteria and death occurs dissolved.

在中国知识产权局2005.9.28公开的专利《治疗妇女生殖道感染的纳米银抗菌凝胶, 制备方法及应用》(公开号CN1672689)中,公开了用纳米银作为抗菌剂,卡波姆等作为赋形材料的抗菌凝胶。 Intellectual Property Office of China Patent Publication 2005.9.28 "treating RTIs nano-silver antibacterial gel, preparation and application" (Publication No. CN1672689) discloses a nano-silver as an antimicrobial agent, like as carbomer antibacterial gel-forming material. 所用赋形剂均为人工合成化合物,且没有抗菌作用,没有组织修复功能。 Excipients are synthetic compounds used, and no antibacterial effect, without tissue repair.

在中国知识产权局2005.12.21公开的专利《壳聚糖妇科栓及其制备方法》 (CN1709278)中,公开了一种壳聚糖栓剂,主要是将壳聚糖置于熔化的聚氧乙烯单硬脂酸酯内,搅拌均匀,然后将混合液倒入磨具中,然后冷冻至8度以下成型。 In the Chinese Intellectual Property Office patent disclosed 2005.12.21 "chitosan gynecologic suppository and preparation method" (CN1709278), there is disclosed a suppository chitosan, chitosan is mainly placed melted polyoxyethylenemono the stearate, stir, and then the mixture was poured into a grinder, and then chilled to 8 ° or less formed. 此栓剂作为妇科抗菌剂使用,此栓剂中没有纳米银,抗菌效果不强烈。 This gynecology as a suppository antimicrobial agent, this is not a suppository nano silver, the antibacterial effect is not strong. 并且栓剂限制了给药途径,不能用于皮肤病、烧烫伤等的治疗。 The route of administration and suppositories limit, can not be used for treatment of skin diseases, burns and the like.

发明内容 SUMMARY

本发明的目的提供了一种壳聚糖纳米银凝胶剂,具有抗菌效果好,药效持续时间长,没有耐药性,对组织有修复功能。 Object of the present invention there is provided a nano-silver chitosan gels, having good antibacterial effect, long duration of efficacy, there is no resistance, there tissue repair.

本发明的另一目的在于提供上述壳聚糖纳米银凝胶剂在制备治疗女性下生殖道炎症、宫颈炎、宫颈糜烂、烧伤、烫伤、溃疡、褥疮感染或皮肤炎症药物上应用。 Another object of the present invention is to provide the above-described nanosilver chitosan gels genital tract inflammation, applications cervicitis, cervical erosion, burns, burns, ulcers, decubitus or skin infection in the medicament for treating inflammation of women.

本发明是通过以下措施来实现的: The present invention is achieved by the following measures:

本发明的壳聚糖纳米银凝胶剂,其药用原料为药用量的纳米银和壳聚糖类聚合物, 所述的纳米银是纳米银粉或纳米银胶体,所述的壳聚糖类聚合物为壳聚糖和甲壳素及其衍生物的一种或一种以上。 Nanosilver chitosan gel of the present invention, a pharmaceutically acceptable amount of a raw material for the nano silver and chitosan based polymer, the silver nano-silver nano or nano silver colloid, the chitosan polymer is chitosan and chitin and derivatives thereof or more.

上述本发明的壳聚糖纳米银凝胶,其辅料包括有凝胶剂、保湿剂和稀释剂,以及用于溶解壳聚糖类聚合物的助溶酸。 Nanosilver chitosan gel of the present invention, which comprises a gel materials, humectants and diluents, as well as co-solvent for dissolving the chitosan acid polymer.

上述本发明的壳聚糖纳米银凝胶,所述的凝胶剂为卡波姆、聚卡波菲、纤维素及其衍生物和聚乙二醇的一种或一种以上;所述的保湿剂为甘油、丙二醇和山梨醇的一种或一种以上;所述的助溶酸为硫酸、硝酸、磷酸、醋酸、甲酸、盐酸、1,2,3,4-丁烷四羧斷BTCA)和柠檬酸(CA)的一种或一种以上。 Nanosilver chitosan gel of the present invention, the gelling agent as a carbomer, polycarbophil, cellulose and derivatives thereof and polyethylene glycol or one or more; the as a moisturizing agent glycerol, sorbitol or propylene glycol and one or more; the solubilizing acid is sulfuric acid, nitric acid, phosphoric acid, acetic acid, formic acid, hydrochloric acid, 1,2,3,4-butane tetracarboxylic off BTCA one or more) and a citric acid (CA) of.

上述本发明的壳聚糖纳米银凝胶,所述的纳米银重量含量为lppm-1000,000ppm, 优选为10ppm-2000ppm纳米银粒径在l-100nm之间;所述的壳聚糖类聚合物浓度为0.1mg-990mg/g, 1尤选为10mg-600mg/g 。 Nanosilver chitosan gel of the present invention, the content by weight of nano-silver lppm-1000,000ppm, preferably 10ppm-2000ppm nano silver particle size is between l-100nm; said chitosan based polymer concentration was 0.1mg-990mg / g, 1, especially preferably from 10mg-600mg / g.

上述本发明的壳聚糖纳米银凝胶,所述纳米银胶体的分散剂是聚乙二醇、纤维素及其衍生物、聚乙烯吡咯烷酮及其衍生物、聚酰胺及其衍生物、粘土、胶原蛋白和果胶的一种或一种以上。 Nanosilver chitosan gel of the present invention, the nano silver colloid dispersing agents are polyethylene glycols, cellulose and derivatives thereof, polyvinylpyrrolidone and derivatives thereof, polyamides and derivatives, clays, one or more collagen and pectin.

本发明还提供一种上述壳聚糖纳米银凝胶在制备治疗女性下生殖道炎症、宫颈炎、 宫颈糜烂、烧伤、烫伤、溃疡、褥疮感染或皮肤炎症药物上应用。 The present invention further provides an above-described nanosilver chitosan gel genital tract inflammation, applications cervicitis, cervical erosion, burns, burns, ulcers, decubitus or skin infection in the medicament for treating inflammation of women.

本发明的凝胶剂中,所述的壳聚糖类聚合物为壳聚糖和甲壳素及其衍生物,来源于虾、蟹的外壳、昆虫外皮、真菌、蝇蛆外壳中等,但来源不受限制。 Gels according to the present invention, the chitosan polymer is chitosan and chitin and derivatives thereof, from shrimp, crab shell, the outer skin of insects, fungi, maggot housing medium, but the source is not Restricted. 甲壳素、壳聚糖可以有其他名称。 Chitin, chitosan may have a different name. 壳聚糖是甲壳素的脱乙酰基衍生物,脱乙酰基部位、程度可以不同,但通称为壳聚糖。 Chitosan is a deacetylated chitin derivative, deacetylation location, extent may be different, but known as chitosan.

本发明的壳聚糖纳米银凝胶剂中,壳聚糖可以用甲壳素、甲壳素衍生物及它们的降解产物、与其他化合物发生交联生产的交联物代替,如壳聚糖与淀粉的交联物等, 但与壳聚糖等交联的其他化合物不限于淀粉;壳聚糖也可以用甲壳素、甲壳素衍生物及它们的降解产物之间的交联产物代替。 Crosslinked chitosan was replaced nanosilver gel of the present invention, the chitosan may be chitin, chitin derivatives and their degradation products, with other crosslinkable compound produced, such as chitosan and starch other compounds crosslinked crosslinked, etc., but are not limited to starch and chitosan; chitin chitosan can also be used, a crosslinked product between a chitin derivative and their degradation products in place. 交联产物可以用物理方法交联,也可用交联剂交联,使用交联剂时,交联剂种类不受限制。 Crosslinked product may be cross-linked by physical methods, can also be used crosslinking agent, crosslinking agent is used, the kind of the crosslinking agent is not limited. 交联反应时,还可以使用催化剂,催化剂种类不受限制。 When the crosslinking reaction, a catalyst may be used, the type of catalyst is not limited.

本发明壳聚糖纳米银凝胶剂中,该凝胶剂有一定的黏度,凝胶剂的黏度大于50mPa-S。 Chitosan nano silver gels of the present invention, the gelling agent has a viscosity of certain viscosity, the gelling agent is greater than 50mPa-S. 本发明的制备方法: The method of the present invention are prepared:

本发明壳聚糖纳米银凝胶剂,其制备方法为:将壳聚糖溶解于稀酸溶液中,充分溶胀后加入搅拌器中,将纳米银(粉状或溶胶状)加入搅拌器中,加入稀释剂使纳米银、壳聚糖含量达到要求,充分搅拌使纳米银壳聚糖混合均匀,形成凝胶状;即形成本发明的壳聚糖纳米银凝胶,然后分装即可。 Chitosan gels of the present invention, nano-silver, which is prepared as follows: chitosan is dissolved in dilute acid solution, to the mixer after sufficiently swollen, the nanosilver (powder or sol) to the mixer, nano silver added diluent, the content of chitosan meet the requirements, sufficiently stirred nanosilver chitosan mixed, form a gel; i.e., nano silver chitosan gel formed according to the present invention, can be aliquoted. 另一种制备方法为:将壳聚糖、稀酸溶液、纳米银(粉状或溶胶状)、稀释剂加入搅拌器中,充分搅拌使壳聚糖充分溶胀后, 形成凝胶状;即形成本发明的壳聚糖纳米银凝胶,然后分装。 Another preparation method: chitosan, dilute acid solution, nanosilver (powder or sol), a diluent to the mixer, thoroughly stirred after fully swollen chitosan, gelatinous form; i.e., formed nanosilver chitosan gel of the present invention, and packaging.

凝胶制好后可以装在给凝胶器中,给凝胶器由套管、助推杆组成,套管顶端有保护帽。 After a good gel system can be installed in a vessel to gel, the gel is given by the sleeve, the push rod co-composition, the protective cap from the top of the sleeve. 凝胶器外型较细长、顶端圆润,适合阴道给药。 Gel is more elongated shape, rounded tip, suitable for vaginal administration. 凝胶剂预装入套管内,使用时将推杆与套管组合,通过推杆将壳聚糖纳米银凝胶直接推入阴道内。 Gels preloaded into the cannula, in combination with the pusher sleeve by the push rod chitosan nanosilver gel directly pushed into the vagina during use.

凝胶制好后也可以装入铝塑软管内,用于烧伤、烫伤、褥疮感染、其他皮肤炎症的治疗、各种创伤感染治疗等。 May be made after a good gel loaded into the plastic hose, for burns, burns, bedsores infection, treatment of other skin inflammation, treatment of various wound infection.

本发明的抗菌机理有如下几个原因- Antibacterial mechanism of the present invention for several reasons -

1. 壳聚糖分子在酸性条件下,其氨基成为带正电荷的-NH3+,吸附带负电荷的细 1. chitosan under acidic conditions, which become positively charged amino group -NH3 +, the adsorption of negatively charged fine

胞壁,使壳聚糖吸附在细胞膜表面形成一层高分子膜,改变了细胞膜的选择透过性, 阻止营养物质向细胞内的运输,致使细胞质流失、细胞质壁分离,从而起到抑菌杀菌作用。 Cell wall, form a chitosan adsorbed polymer film cell membrane, the selected membrane to change permeability, prevents the transport of nutrients within the cells, resulting in loss of cytoplasm, cytoplasmic separation wall, and thus play a bactericidal bacteriostatic effect.

2. 壳聚糖通过渗入进细胞体内,吸附细胞体内带有阴离子的细胞质,并发生絮凝作用扰乱细胞正常的生理活动,从而杀灭细菌。 2. chitosan penetrate into cells in vivo by adsorption with the cell body cytoplasm anion, and disrupting the cells normal physiological activity flocculation effect, thus killing the bacteria.

3. 银与微生物内巯基酶结合使后者失活,阻断微生物的能量代谢及细胞壁合成, 起到杀灭细菌、病毒及真核微生物的作用。 3. The silver binding enzyme microbial sulfhydryl inactivating the latter, blocking the energy metabolism of microorganisms and cell wall synthesis, a kill bacteria, viruses and eukaryotic microorganism effects.

4. 银和细菌细胞壁上暴露的肽聚糖反应,形成可逆性复合物,使它们不能把氧(能量)转运进细胞,阻止病菌的活动,导致其死亡。 The reaction peptidoglycan exposed on the bacterial cell wall and 4. silver, reversible complexes are formed, so that they can not oxygen (energy) transport into cells, blocking the activity of bacteria, resulting in death.

5. 银和致病菌的DNA结合,与DNA碱基结合的银离子彼此形成交叉链接,导致DNA结构变性,抑制其复制,使致病菌失活。 The silver pathogens and DNA binding, binding silver ions to the DNA bases formed cross-linked with each other, resulting in DNA structure degeneration, inhibition of the replication of the pathogen inactivation.

本发明的产品还有组织修复功能,银能促进上皮再生和组织修复,从而促进伤口和糜烂愈合。 Products are tissue repair of the present invention, silver can promote epithelial regeneration and tissue repair to promote wound healing and erosion. 壳聚糖具有活化细胞功能、激活免疫细胞、在受伤的肌体内能诱导特殊细胞,促进伤口修复、增加伤口愈合能力,本发明的产品没有耐药性。 Chitosan activated cell function, activation of immune cells, can be induced in a particular cell body injuries, wound repair, wound healing increases, the product of the present invention is not resistance. .

本发明的产品,用于治疗女性下生殖道炎症、宫颈炎、宫颈糜烂等具有显著优异的疗效。 Product of the invention for use in treating genital tract inflammation, cervicitis, cervical erosion having remarkably excellent effect of the female. 本发明的凝胶剂可以通过阴道直接给药,纳米级银粒径小,比表面积大,增加了与病菌接触机会,增强了杀菌效果。 Gel of the present invention can be directly administered vaginally, small nano silver particle, a large surface area ratio, an increase of bacteria in contact with the opportunity to enhance the sterilization effect. 壳聚糖通过其带电荷的NH3+与细菌细胞壁的阴离子结合,杀灭革兰氏阴性菌、阳性菌,并且壳聚糖有组织修复功能,可以促进伤口的愈合,修复糜烂面。 NH3 + chitosan by the bacterial cell wall which charged anionic binding, killing Gram-negative bacteria, positive bacteria, organized repair and chitosan, can promote wound healing, repair erosion surface. 纳米银广谱抗菌,对革兰氏阴性菌、革兰氏阳性菌、真菌、 滴虫等都有强烈的抑制、杀灭作用。 Broad-spectrum antibacterial nano-silver, have a strong inhibition of the Gram-negative bacteria, gram-positive bacteria, fungi, trichomonas, etc., kill. 本发明的产品,还具有缓释作用,壳聚糖为大分子多糖,对纳米银有缓释功能,能延长纳米银的释放,治疗效果更显著。 Product of the invention, further having a sustained release, chitosan polysaccharide macromolecules, sustained-release function of nano-silver, nano-silver can be prolonged release of therapeutic effect is more pronounced. 本发明的凝胶剂无毒性、无过敏性、无刺激性,并且具有组织修复功能,能促进糜烂面的愈合。 Gel of the present invention is non-toxic, non-allergenic, non-irritating, and has a tissue repair, can promote healing of the erosion surface. 所以本发明的产品起效快、治疗效果好、没有毒副作用、治疗持续时间长、能增强组织修复能力、不影响阴道正常菌群和酸碱度、杀菌作用不受pH值影响。 So the product of the invention rapid onset of treatment effect, no toxic side effects, the treatment of long duration, can enhance tissue repair, does not affect the normal vaginal flora and pH, sterilization is not affected by pH.

本发明的产品除了治疗妇女下生殖道炎症,也可治疗各种感染,如皮肤感染等。 Product of the invention in addition to the treatment of inflammation of the lower genital tract of women, but also to treat various infections, such as skin infections. 本产品还可用于化妆品,壳聚糖在稀的弱酸中生成阳离子,形成高分子电解质,具有很高的吸湿和保湿作用,而且还有抗菌作用,对皮肤没有刺激性。 This product can also be used in cosmetics, chitosan generated in dilute weak acid cation, the polymer electrolyte, having a high hygroscopic and moisturizing effect, but also the antibacterial effect, non-irritating to the skin. 螨虫常引起面部皮肤红肿,少量纳米银可以渗透皮肤杀灭病原菌,减轻炎症反应,壳聚糖可以保湿修复皮肤。 Mites often cause facial skin irritation, a small amount of nano-silver can penetrate the skin to kill pathogenic bacteria, reduce inflammation, chitosan can repair the skin moisturizer. 本发明的产品对细菌、真菌、病毒或寄生虫等引起的炎症均有强烈的抑制、杀灭作用。 Product of the invention has a strong inhibition of inflammation bacteria, fungi, viruses or parasites caused killing effect.

临床实验证明,本发明的产品高效、无毒,具有极强的抗菌作用和优异的治疗效果,与其他纳米银凝胶剂相比,杀菌效果强烈、作用持久并且具有组织修复功能。 Clinical experiments show that the product of the present invention is effective, non-toxic, has strong antibacterial effect and an excellent therapeutic effect, compared with other nanosilver gel, strong bactericidal effect, and has a lasting effect tissue repair. 附图说明 BRIEF DESCRIPTION

图1为给凝胶器的助推杆与套管的分体结构示意图。 Figure 1 is a co-gel is a schematic partial structure push rod sleeve. 图2为给凝胶器的组装后的结构示意图。 FIG 2 is a schematic view of the assembled unit to the gel. 图中,l套管,2助推杆,3胶塞,4凝胶剂,5保护帽。 FIG, l sleeve, the push rod co-2, plug 3, 4 gels, protective cap 5. 具体实施方式 Detailed ways

实施例l:壳聚糖纳米银凝胶剂的制作方法 The method of making nano-silver chitosan gels: Example l embodiment

自制纳米银,采用聚乙烯吡咯烷酮溶液分散成胶体,纳米银含量40000ppm, 纳米银胶体:5g。 Nanosilver made using colloidal solution of polyvinylpyrrolidone is dispersed nano silver content 40000ppm, nano silver colloid: 5g. 壳聚糖:10g 卡波姆:3g Chitosan: 10g Carbomer: 3g

乙二醇:2ml Glycol: 2ml

蒸馏水:79g Distilled water: 79g

醋酸:lml Acetic acid: lml

将上述原料置于搅拌器中充分搅拌,得壳聚糖纳米银凝胶剂,纳米银含量 The raw material was placed sufficiently stirred in a stirrer to obtain chitosan gel nano-silver, nano silver content

2000ppm;壳聚糖的浓度为100mg/g。 2000 ppm; chitosan concentration of 100mg / g. 制备完成后分装至给凝胶器中或铝塑管中。 After preparation was dispensed into a gel vessel or a plastic tube.

上述制备的壳聚糖纳米银凝胶,可以用于治疗女性下生殖道炎症、宫颈炎、宫颈糜烂、烧伤、烫伤、渍疡、褥疮感染或皮肤炎症。 Nanosilver gel chitosan prepared as described above, it may be used for the treatment of genital tract inflammation, cervicitis, cervical erosion, burns, burns, ulcer, bedsore infection or inflammation of the skin under the female.

治疗宫颈炎等症的具体用法与用量为:如图1和图2所示,给凝胶器由套管l、助 DETAILED Dosage and treatment of embolism cervicitis: 1 and 2, the gel is given by the sleeve L, co-2

推杆2组成,套管1的中部有一胶塞3,胶塞前部密封有凝胶剂4,套管的顶端有保护帽5。 Composition plunger 2, the sleeve 1 has a central plug 3, the front stopper with a sealing gel portion 4, the top of the sleeve 5 with a protective cap. 凝胶器外型较细长、顶端圆润,适合阴道给药。 Gel is more elongated shape, rounded tip, suitable for vaginal administration. 凝胶剂预装入套管内,使用时将推杆2与套管1组合,通过推杆将壳聚糖纳米银凝胶直接推入阴道内。 The pre-gel into the sleeve, the push rod 2 and the sleeve 1 is used in combination, chitosan by pusher nanosilver gel directly pushed into the vagina. 每次用量3g, 每天1次。 The amount of time 3g, 1 per day. 治疗烧伤、烫伤等症的具体用法与用量为:将凝胶剂涂于患处,每天1次。 Treatment of burns, scald embolism and an amount of the specific use of: a gel applied to the affected area once a day. 实施例2 壳聚糖纳米银凝胶剂的制作方法自制纳米银粉:lmg 壳聚糖:60g 甘油:2g 卡波姆:3g 蒸馏水:32g 醋酸:3ml Production Example 2 chitosan gels made of nano silver nano silver: lmg chitosan: 60g Glycerol: 2g Carbomer: 3g Distilled water: 32g acetate: 3ml

将上述原料置于搅拌器中充分搅拌,得壳聚糖纳米银凝胶剂,纳米银含量10ppm; 壳聚糖浓度为600mg/g。 The raw material was placed sufficiently stirred in a stirrer to obtain chitosan gel nano-silver, nano silver content of 10 ppm; chitosan concentration of 600mg / g. 制备完成后分装至给凝胶器中或铝塑管中。 After preparation was dispensed into a gel vessel or a plastic tube.

用法与用量同实施例1。 Dosage in Example 1. 实施例3 ,壳聚糖纳米银凝胶剂的制作方法 3, method for manufacturing the silver gel chitosan nanoparticles Example

自制纳米银粉:5g 甲壳素:lg 聚乙二醇:3g Silver Nano made: 5g chitin: lg of polyethylene glycol: 3g

蒸馏水:9L5g 磷酸:0.5ml Distilled water: 9L5g phosphate: 0.5ml

将上述原料置于搅拌器中充分搅拌,得壳聚糖纳米银凝胶剂,纳米银含量 The raw material was placed sufficiently stirred in a stirrer to obtain chitosan gel nano-silver, nano silver content

50000ppm;壳聚糖浓度为10mg/g。 50000 ppm; chitosan concentration of 10mg / g. 制备完成后分装至给凝胶器中或铝塑管中。 After preparation was dispensed into a gel vessel or a plastic tube.

用法与用量同实施例1。 Dosage in Example 1. 实施例4:壳聚糖纳米银凝胶剂的制作方法 Example 4: Method of chitosan gel nanosilver

自制纳米银:20mg Homemade nanosilver: 20mg

羧甲基壳聚糖:80g 卡波姆:2g Carboxymethyl chitosan: 80g Carbomer: 2g

乙二醇:lml Glycol: lml

蒸镏水:13g Distilled water: 13g

盐酸:4ml Hydrochloric acid: 4ml

将上述原料置于搅拌器中充分搅拌,得壳聚糖纳米银凝胶剂,纳米银含量200ppm; 羧甲基壳聚糖的浓度为800mg/g。 The raw material was placed sufficiently stirred in a stirrer to obtain chitosan gel nano-silver, nano silver content of 200 ppm; carboxymethyl chitosan concentration was 800mg / g. 制备完成后分装至给凝胶器中或铝塑管中。 After preparation was dispensed into a gel vessel or a plastic tube. 用法与用量同实施例1。 Dosage in Example 1.

测试例1 Test Example 1

对实施例l一4的产品进行体外抗菌实验,实验结果如表1所示。 L of the product of Example 4 is an embodiment of antibacterial experiments, the experimental results shown in Table 1. 表1 实施例1-4的体外抗菌实验结果 Table 1 In vitro antibacterial test results of Examples 1-4

<table>table see original document page 8</column></row> <table>测试例2 <Table> table see original document page 8 </ column> </ row> <table> Test Example 2

对实施例l-4的产品按照《中华人民共和国药典》2005年版二部附录XD中的方法进行了纳米银缓释实验,结果如表2所示。 Of the product of Example l-4 were sustained nanosilver experiment according to "Chinese Pharmacopoeia", 2005 edition Appendix XD Method, the results shown in Table 2.

表2 实施例1-4产品的体外缓释实验 Table In vitro release experiments of Examples 1-4 Product 2

<table>table see original document page 8</column></row> <table>测试例3 <Table> table see original document page 8 </ column> </ row> <table> Test Example 3

实施例1-4产品促进细胞增殖实验,结果如表3所示。 Examples 1-4 experimental products to promote cell proliferation, the results shown in Table 3.

表3 实施例1-4产品的细胞增殖实验 Table 1-4 Cell Proliferation Experimental Example 3 Product

<table>table see original document page 8</column></row> <table> <Table> table see original document page 8 </ column> </ row> <table>

Claims (7)

1. 一种壳聚糖纳米银凝胶剂,其特征在于:其药用原料为药用量的纳米银和壳聚糖类聚合物,所述的纳米银是纳米银粉或纳米银胶体,所述的壳聚糖类聚合物为壳聚糖和甲壳素及其衍生物的一种或一种以上。 A nano-silver chitosan gels, characterized in that: a pharmaceutically acceptable amount of a raw material of nano silver and chitosan based polymer, the nano-silver nano silver or a colloidal nano silver, the chitosan based polymer described later as a chitosan and chitin and derivatives thereof or more.
2、 根据权利要求1所述的壳聚糖纳米银凝胶,其特征在于:其辅料包括有凝胶剂、保湿剂和稀释剂,以及用于溶解壳聚糖类聚合物的助溶酸。 2, the chitosan nanosilver gel according to claim 1, characterized in that: a gel which comprises excipients, humectants and diluents, as well as co-solvent for dissolving the chitosan acid polymer.
3、 根据权利要求2所述的壳聚糖纳米银凝胶,其特征在于:所述的凝胶剂为卡波姆、 聚卡波菲、纤维素及其衍生物和聚乙二醇的一种或一种以上;所述的保湿剂为甘油、 丙二醇和山梨醇的一种或一种以上;所述的助溶酸为硫酸、硝酸、磷酸、醋酸、甲酸、盐酸、1,2,3,4-丁垸四羧酸和柠檬酸的一种或一种以上。 3, nano-silver chitosan gel according to claim 2, wherein: the gelling agent is a carbomer, polycarbophil, cellulose and derivatives thereof and a polyethylene glycol or one or more species; according as a humectant glycerol, propylene glycol and sorbitol or more; the solubilizing acid is sulfuric acid, nitric acid, phosphoric acid, acetic acid, formic acid, hydrochloric acid, 2,3 a 4-butoxy embankment acid and citric acid or one or more.
4、 根据权利要求1或2所述的壳聚糖纳米银凝胶,其特征在于:所述的纳米银重量含量为l卯m-1000,000卯m,纳米银粒径在l-100nm之间;所述的壳聚糖类聚合物浓度为0.1mg-990mg/g。 4. The nano-silver chitosan gel of claim 1 or claim 2, wherein: said nano-silver weight content of l d d m-1000,000 m, nano silver particle size of l-100nm between; said chitosan based polymer concentration of 0.1mg-990mg / g.
5、 根据权利要求4所述的壳聚糖纳米银凝胶,其特征在于:所述的纳米银重量含量为10ppm-2000ppm,纳米银粒径在l-100nm之间;所述的壳聚糖类聚合物浓度为10mg陽600mg/g。 5, according to claim nanosilver chitosan gel according to claim 4, wherein: said nano-silver weight content of 10ppm-2000ppm, nano silver particle size is between l-100nm; said chitosan male-based polymer concentration of 10mg 600mg / g.
6、 根据权利要求1或2所述的壳聚糖纳米银凝胶,其特征在于:所述纳米银胶体的分散剂是聚乙二醇、纤维素及其衍生物、聚乙烯吡咯烷酮及其衍生物、聚酰胺及其衍生物、粘土、胶原蛋白和果胶的一种或一种以上。 6. nanosilver chitosan gel of claim 1 or claim 2, wherein: said nano silver colloid dispersing agents are polyethylene glycols, cellulose and derivatives thereof, polyvinylpyrrolidone and derivatives thereof It was one or more polyamides and derivatives, clay, collagen, and pectin.
7、 一种权利要求1所述的壳聚糖纳米银凝胶在制备治疗女性下生殖道炎症、宫颈炎、 宫颈糜烂、烧伤、烫伤、溃疡、褥疮感染或皮肤炎症药物上应用。 7, the chitosan nanosilver gel of Claim 1 for treating inflammation in the female genital tract, applications cervicitis, cervical erosion, burns, burns, ulcers, decubitus or skin infection inflammation drugs.
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