CN1765369A - Nano silver gel and its application - Google Patents
Nano silver gel and its application Download PDFInfo
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- CN1765369A CN1765369A CN 200410085928 CN200410085928A CN1765369A CN 1765369 A CN1765369 A CN 1765369A CN 200410085928 CN200410085928 CN 200410085928 CN 200410085928 A CN200410085928 A CN 200410085928A CN 1765369 A CN1765369 A CN 1765369A
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Abstract
Description
技术领域technical field
本发明涉及一种纳米银凝胶,其包含纳米银溶液及水凝胶。本发明的纳米银凝胶可用来治疗女性下生殖道炎症、子宫颈炎或皮肤受伤区域。The invention relates to a nano-silver gel, which comprises a nano-silver solution and a hydrogel. The nano-silver gel of the invention can be used to treat women's lower reproductive tract inflammation, cervicitis or skin injury area.
背景技术Background technique
银具有公认的抗菌效果,它通过阻断细菌细胞壁输氧活动和抑制细菌DNA复制对各种微生物产生杀灭作用。一般而言,一种抗生素大致可杀死6种不同的抗生体,但是银却可杀死600多种细菌。再加上银是不具毒性的物质,所以银的使用范围相当广且历史悠久。透过高科技纳米技术的方式,使银粒子活性变大,抗菌功能增强,对居家环境及个人卫生的品质有显著的提高。银的纳米级细微颗粒以及纳米银所释放的银离子水溶液,都具有显著的杀菌效果。纳米银在多倍稀释的情况下,对于大肠杆菌、金黄色葡萄球菌、沙门氏杆菌及绿脓杆菌等均有99.99%的抑制功效,其主因为银本身具有的生物作用。Silver has a recognized antibacterial effect. It kills various microorganisms by blocking the oxygen transport activity of bacterial cell walls and inhibiting bacterial DNA replication. Generally speaking, an antibiotic can kill roughly 6 different kinds of organisms, but silver can kill more than 600 kinds of bacteria. In addition, silver is a non-toxic substance, so silver has a wide range of uses and a long history. Through high-tech nanotechnology, the activity of silver particles is enlarged, the antibacterial function is enhanced, and the quality of home environment and personal hygiene is significantly improved. Both nano-scale fine particles of silver and the aqueous solution of silver ions released by nano-silver have significant bactericidal effects. In the case of multiple dilutions, nano-silver has 99.99% inhibitory effect on Escherichia coli, Staphylococcus aureus, Salmonella and Pseudomonas aeruginosa, which is mainly due to the biological effect of silver itself.
活性银离子能吸引细菌体内酶蛋白上的巯基,迅速地结合在一起,并使含巯基的酶失去活性,使细菌死亡。值得注意的是:当细菌被银离子杀死后,银离子又会从死去的细菌上游离出来,再持续对活菌做重复的动作,直至所有细菌被消灭。由此可知,纳米银的功效是属于长效型抗菌剂,效果持久。纳米银利用纳米材料的小尺寸效应和表面效应,使银的杀菌力更加提高。就银离子杀菌机制而言,由于银离子在很低的浓度下就能破坏细菌细胞膜;或可强烈吸引细菌体中B蛋白的巯基,与之迅速结合,降低细菌原生物的酶活性,从而产生抗菌作用;同时通过缓释银离子,可发挥持久的抗菌效果。Active silver ions can attract sulfhydryl groups on the enzyme proteins in bacteria, quickly combine them together, and inactivate the enzymes containing sulfhydryl groups, resulting in the death of bacteria. It is worth noting that when the bacteria are killed by silver ions, the silver ions will be freed from the dead bacteria, and then continue to repeat the action on the live bacteria until all the bacteria are eliminated. It can be seen that the effect of nano-silver is a long-acting antibacterial agent with a long-lasting effect. Nano-silver uses the small size effect and surface effect of nano-materials to further improve the bactericidal power of silver. As far as the bactericidal mechanism of silver ions is concerned, silver ions can destroy bacterial cell membranes at very low concentrations; or they can strongly attract the sulfhydryl group of protein B in bacteria and quickly combine with it to reduce the enzyme activity of bacterial protozoa, thereby producing Antibacterial effect; at the same time, through the slow release of silver ions, it can exert a long-lasting antibacterial effect.
阴道炎和子宫颈炎是发病率较高的女性下生殖道炎,对妇女及其家庭成员的身心健康有很大影响。目前市场上治疗产品虽多,但在剂型、使用方法、疗效等方面都不理想。Vaginitis and cervicitis are female lower genital tract inflammations with a higher incidence rate, which have a great impact on the physical and mental health of women and their family members. Although there are many therapeutic products in the market, they are not ideal in terms of dosage forms, methods of use, and curative effects.
阴道炎症是由细菌、霉菌、衣原体、支原体、病毒、原虫等引起的。阴道感染病源可以上行至子宫腔、输卵管、卵巢及盆腔,从而造成急慢性的子宫内膜炎、输卵管炎、卵巢炎或骨盆腔炎,慢性感染者除发炎症状外,甚至可以引发肠道阻塞及不孕。Vaginal inflammation is caused by bacteria, molds, chlamydia, mycoplasma, viruses, protozoa, etc. The source of vaginal infection can ascend to the uterine cavity, fallopian tubes, ovaries and pelvic cavity, resulting in acute and chronic endometritis, salpingitis, oophoritis or pelvic inflammatory disease. In addition to inflammation symptoms, chronic infection can even cause intestinal obstruction and infertility.
发明内容Contents of the invention
本发明提供一种纳米银凝胶,优选包含浓度2至100ppm的纳米银溶液及水凝胶,其中纳米银溶液与水凝胶以1∶20至20∶1重量比均匀混合。The invention provides a nano-silver gel, preferably comprising a nano-silver solution and a hydrogel at a concentration of 2 to 100 ppm, wherein the nano-silver solution and the hydrogel are uniformly mixed at a weight ratio of 1:20 to 20:1.
本发明纳米银凝胶中,纳米银溶液浓度为2至100ppm,优选浓度为10至50ppm,最优选浓度为20ppm。In the nano silver gel of the present invention, the concentration of the nano silver solution is 2 to 100 ppm, the preferred concentration is 10 to 50 ppm, and the most preferred concentration is 20 ppm.
本发明纳米银凝胶中,纳米银溶液与水凝胶的重量比为1∶20至20∶1,优选以重量比为1∶10至10∶1混合,最优选重量比为9∶1。In the nano silver gel of the present invention, the weight ratio of the nano silver solution to the hydrogel is 1:20 to 20:1, preferably 1:10 to 10:1, most preferably 9:1.
本发明纳米银凝胶中,该凝胶是纤维素衍生物(甲基纤维素、羟丙基纤维素、羟丙甲基纤维素或羟乙基纤维素)、丙烯酸酯聚合物、丙烯酸酯衍生物、藻酸与黄原酸胶。In the nano silver gel of the present invention, the gel is cellulose derivative (methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose or hydroxyethyl cellulose), acrylate polymer, acrylate derivative substances, alginic acid and xanthan gum.
本发明纳米银凝胶,是以一推拉套筒的凝胶器传递纳米银凝胶,该胶器传递纳米银凝胶的形状呈圆润形。The nano-silver gel of the present invention uses a push-pull sleeve gel device to transfer the nano-silver gel, and the shape of the gel device to transfer the nano-silver gel is round.
本发明纳米银凝胶用于通过各种给药途径处理各种感染的应用,其可治疗女性下生殖道炎症(念珠菌阴道炎、细菌阴道炎、滴虫阴道炎、老年性阴道炎或阴道混合感染)或子宫颈炎(慢性子宫颈炎或子宫颈糜烂)、用于皮肤受伤区域(皮肤发炎、皮肤外伤或烧烫伤,其中皮肤发炎是足癣、股癣、青春痘或粉刺引起皮肤发炎)。Nano-silver gel of the present invention is used for the application of processing various infections by various routes of administration, and it can treat women's lower reproductive tract inflammation (candida vaginitis, bacterial vaginitis, trichomonas vaginitis, senile vaginitis or vaginal Mixed infection) or cervicitis (chronic cervicitis or cervical erosion), for skin injury areas (skin inflammation, skin trauma or burns, where skin inflammation is tinea pedis, jock itch, acne or acne causing skin inflammation) .
本发明纳米银凝胶中加入各种医药用添加剂制成传递剂型可处理包括促进皮肤生长(添加促表皮生长素)、防疤痕产生(添加防疤痕产生成分例如次没食子酸铋或天然植物提取物)、治疗皮肤发炎、皮肤外伤烧烫伤(添加芦荟提取物)。Various pharmaceutical additives are added to the nano silver gel of the present invention to make a delivery dosage form, which can be processed including promoting skin growth (adding epidermal growth-stimulating hormone), preventing scar generation (adding anti-scarring ingredients such as bismuth hypogallate or natural plant extracts) ), treatment of skin inflammation, skin trauma burns (add aloe extract).
附图说明Description of drawings
图1是给药纳米银凝胶至患病处的凝胶器。Fig. 1 is the gel device for administering nano-silver gel to the diseased part.
图2是给药纳米银凝胶至患病处的凝胶器的推筒与凝胶器筒体组合的情形。Fig. 2 is the combination situation of the pusher of the gel device and the gel device barrel for administering the nano-silver gel to the diseased part.
图示代表符号说明:Icons represent symbol descriptions:
10凝胶器10 gels
20凝胶器筒体20 gel cartridges
30推筒30 push cylinder
40弹性塞40 elastic plug
50出口50 exits
60密合盖60 tight cover
70纳米银凝胶70nm silver gel
具体实施方式Detailed ways
本发明提供纳米银与一种由聚合物交联而形成的水凝胶混合,配制技术与配制比例如下,使用由制造商购得的具有杀菌与杀霉菌能力的纳米银颗粒,已公开于US 2002051823。具有小于100nm的纳米银颗粒的组合物已披露于WO 03080231。加入灭菌水调配成20ppm纳米银溶液。再由制造商3M购得TegagelTM水凝胶。将20ppm纳米银溶液与水凝胶以9∶1的重量比配制成本发明的纳米银凝胶。The present invention provides nano-silver mixed with a hydrogel formed by polymer cross-linking. The preparation technology and preparation ratio are as follows, using nano-silver particles purchased by the manufacturer with bactericidal and fungicidal capabilities, which have been disclosed in US 2002051823. Compositions with nanosilver particles smaller than 100 nm have been disclosed in WO 03080231. Add sterilized water to prepare a 20ppm nano silver solution. Tegagel (TM) hydrogels were then purchased from the manufacturer 3M. The nano-silver gel of the present invention was prepared by 20 ppm nano-silver solution and hydrogel in a weight ratio of 9:1.
其它可替换Tegagel并包含于本发明中的商用凝胶列于下表:
本发明提供此纳米银凝胶在处理各种感染中的给药途径。在抗生素被广泛运用以前,人们就已经发现银具有抗菌的功效,并用以杀菌,主要是因为微生物会对抗生素产生耐药性(resistence),但对银却不会。本发明所使用的纳米银可应用于卫生产品上,包括但不限于衣物清洁剂、妇女粉刺、面疱的清洁剂、牙膏的浸泡溶液等。同时也可应用于卫生医疗产品,包括但不限于创伤或烧烫伤的部位、细菌或霉菌感染部位(包括妇科感染病如阴道炎(vaginitis))、胃肠道细菌感染以及由性行为传染的疾病的患者。此外,纳米银溶液也可应用在工业产品上,包括但不限于食物特别是水果与蔬菜的保存、饮用水的消毒剂、纸类以及工程填充物的保存(特别是防止霉菌的产生)。The invention provides the administration route of the nano silver gel in treating various infections. Before antibiotics were widely used, people had discovered that silver had antibacterial effects and was used to kill bacteria, mainly because microorganisms would develop resistance to antibiotics, but not to silver. The nano-silver used in the present invention can be applied to hygienic products, including but not limited to clothes cleaners, cleaners for women's acne and pimples, soaking solution for toothpaste, and the like. At the same time, it can also be applied to health and medical products, including but not limited to wounds or burns, bacterial or fungal infections (including gynecological infections such as vaginitis), gastrointestinal bacterial infections, and sexually transmitted diseases of patients. In addition, the nano-silver solution can also be applied to industrial products, including but not limited to the preservation of food, especially fruits and vegetables, disinfectant for drinking water, preservation of paper and engineering fillings (especially to prevent the generation of mold).
本发明所用的纳米银组合物具有广谱杀菌与杀霉菌能力,其可以杀死与阻止细菌或霉菌的增生。这些细菌或霉菌包括大肠杆菌(Escherichiacoli),抗Methicilli71的金黄色葡萄球菌(Staphylococcus aureus),沙眼衣原体(Chlamydia trachomatis),斯图普罗威登菌(Providenciastuartii),,创伤弧菌(Vibrio vulnificus),肺炎杆菌(Pneumobacillus),硝酸盐阴性杆菌(bacillus),金黄色葡萄球菌(Staphylococcus aureus),白色念珠菌(Candida albicans),阴沟气杆菌(Bacillus cloacae),腊肠样杆菌(Bacillusallantoides),Morgan′s bacillus(Salmonella naorgani),Pseudomonasmaltophila,绿脓假单胞菌(Pseudomonas aeruginosa),淋球菌(Neisseriagonorrhoeae),枯草杆菌(Bacillus subtilis),粪产碱杆菌(Bacillus foecalisalkaligenes),溶血链球菌B(Streptococcus hemolyicus B),柠檬酸杆菌(Citrobacter),与丙型副伤塞沙门氏菌(Sahnonella paratyphi C)。The nano-silver composition used in the present invention has broad-spectrum bactericidal and fungicidal capabilities, which can kill and prevent the proliferation of bacteria or mold. These bacteria or molds include Escherichia coli (Escherichiacoli), Methicilli71-resistant Staphylococcus aureus, Chlamydia trachomatis, Providenciastuartii, Vibrio vulnificus, pneumonia Pneumobacillus, nitrate-negative bacillus (bacillus), Staphylococcus aureus, Candida albicans, Bacillus cloacae, Bacillus allantoides, Morgan's bacillus ( Salmonella naorgani), Pseudomonasmaltophila, Pseudomonas aeruginosa, Neisseriagonorrhoeae, Bacillus subtilis, Bacillus foecalisalkaligenes, Streptococcus hemolyicus B, lemon Citrobacter, and Salmonella paratyphi C.
本发明所用的纳米银组合物的抗菌与抗霉菌能力,相较于传统的抗生素,具有不会引发产生具有药物耐药性的细菌或霉菌的优点。Compared with traditional antibiotics, the antibacterial and antifungal properties of the nano silver composition used in the present invention has the advantage of not causing drug-resistant bacteria or molds.
凝胶gel
本发明所用的凝胶来自3M TegagelTM创伤水凝胶。该水凝胶是由聚合物交联而形成,其优点为清澈透明的水凝胶,可协助滋润伤口的处理,并且无刺激性。因Tegagel具有95%的水份,可有效降低伤口神经末梢的疼痛感,且为凝胶形态,容易使用。The gel used in the present invention is from 3M Tegagel ™ Wound Hydrogel. The hydrogel is formed by cross-linking polymers, which has the advantage of being a clear and transparent hydrogel, which can help moisturize the wound treatment and is non-irritating. Because Tegagel has 95% water, it can effectively reduce the pain of nerve endings in the wound, and it is in the form of a gel, which is easy to use.
本发明所使用的凝胶,其最佳使用方式为能提供并维持一潮湿的复原环境。由于患部周围的潮湿度提高了,凝胶可以协助清洁与移除坏死组织或菌体。凝胶也可用于创伤或烧烫伤部位。凝胶的另一优点为移除时不会对部位造成损伤,并且其柔顺的触感能提高患者的依从性。The gel used in the present invention is optimally used to provide and maintain a moist recovery environment. Due to the increased humidity around the affected area, the gel can assist in cleansing and removal of dead tissue or bacteria. The gel can also be used on wounds or burns. Another advantage of the gel is that it does not cause damage to the site when it is removed, and its soft touch improves patient compliance.
给药途径Route of administration
本发明的给药途径优选为外敷,以溶液、乳液或是软膏方式应用。本发明可应用于皮肤、伤口、眼部、鼻或嘴部以预防、处理各种感染。本发明的组合物可以公知方法应用,其中之一是以戴手套的手施用。其它特殊的伤口处理方式也可一起在患部应用。本发明提供长效抗微生物的功效。The administration route of the present invention is preferably external application in the form of solution, emulsion or ointment. The present invention can be applied to skin, wound, eyes, nose or mouth to prevent and treat various infections. The compositions of the present invention can be applied by known methods, one of which is gloved hand application. Other special wound treatment methods can also be applied to the affected area together. The present invention provides long-lasting antimicrobial efficacy.
将本发明的组合物用于处理眼部感染时,本发明的组合物可以溶液或药膏的方式,以标准方式施用于下眼睑,或将本组合物制成眼药水,以标准方式施用于眼部。When the compositions of the present invention are used to treat ocular infections, the compositions of the present invention can be applied to the lower eyelid in a standard manner as a solution or ointment, or the composition can be formulated as eye drops and applied to the eye in a standard manner. department.
将本发明的组合物用于处理嘴部发炎包括牙龈炎时,本发明的组合物可以溶液或药膏的形式,以类似海绵或牙膏的方式施用。本组合物亦可以溶液的形式注入体内的空腔处理感染。When the composition of the present invention is used to treat inflammation of the mouth, including gingivitis, the composition of the present invention can be applied in the form of a solution or ointment, in a manner similar to a sponge or toothpaste. The composition may also be injected into a cavity in the body in the form of a solution to treat infections.
本发明的组合物以外敷方式给药时有几项优点。第一,本发明不含任何可能使患者不适的抗生素。其次,本发明不会使细菌或霉菌产生耐药性。此外,纳米银相对于其它金属粒子,不会在患者的皮肤或衣服上染色。The compositions of the present invention have several advantages when administered topically. First, the present invention does not contain any antibiotics that may make patients uncomfortable. Secondly, the present invention will not cause bacteria or molds to develop drug resistance. In addition, nanosilver does not stain the patient's skin or clothing, unlike other metal particles.
本发明的组合物可另外添加其它常见的医药用添加剂,例如促表皮生长素(EGF)。促表皮生长素是一种重要的生长素,它是50-60个氨基酸分子组成的肽链,链中含有6个半胱氨酸分子。半胱氨酸分子间形成稳定的双硫键,使整条肽链成为三个环联部分的活性物质。促表皮生长素能促进表皮细胞生长繁殖,加速受伤表皮细胞的修复,抑制胃酸分泌,在医药上有很广的用途。促表皮生长素在组织培养时,能促进人体皮肤上皮细胞、角膜上皮细胞和哺乳动物上皮细胞生长。促表皮生长素也常应用于化妆品,能促进皮肤组织、角膜上皮组织及胃上皮细胞的生长繁殖,加速角膜创伤的修复,增强表皮细胞的蛋白质、RNA的合成和细胞代谢。The composition of the present invention can additionally add other common pharmaceutical additives, such as epidermal growth-stimulating factor (EGF). Epidermal growth-stimulating hormone is an important auxin, which is a peptide chain composed of 50-60 amino acid molecules, and the chain contains 6 cysteine molecules. Stable disulfide bonds are formed between cysteine molecules, making the entire peptide chain an active substance with three ring-connected parts. Epidermal growth-stimulating hormone can promote the growth and reproduction of epidermal cells, accelerate the repair of injured epidermal cells, inhibit gastric acid secretion, and has a wide range of uses in medicine. Epidermal growth-stimulating hormone can promote the growth of human skin epithelial cells, corneal epithelial cells and mammalian epithelial cells in tissue culture. Epidermal growth-stimulating hormone is also often used in cosmetics, which can promote the growth and reproduction of skin tissue, corneal epithelial tissue and gastric epithelial cells, accelerate the repair of corneal trauma, and enhance the protein and RNA synthesis and cell metabolism of epidermal cells.
实施例Example
实施例一纳米银凝胶的制作方法The preparation method of embodiment 1 nanometer silver gel
由制造商购得纳米银颗粒,加入灭菌水调配成20ppm纳米银溶液。再由制造商3M购得TegagelTM水凝胶。将20ppm纳米银溶液与水凝胶以重量比9∶1配制成本发明的纳米银凝胶70。将纳米银凝胶70充填至凝胶器10后,凝胶器筒体20与推筒30接触端以弹性塞40密合,凝胶器筒体20的出口50以密合盖60密合,使用时将推筒30推弹性塞40,让凝胶从出口50送至患者的病变部位。Nano-silver particles were purchased from the manufacturer, and sterilized water was added to prepare a 20ppm nano-silver solution. Tegagel (TM) hydrogels were then purchased from the manufacturer 3M. The
实施例二纳米银凝胶治疗阴道炎与子宫颈炎Embodiment two nano-silver gel treatment vaginitis and cervicitis
医院妇产科自2003年8月至2004年1月,采用纳米银妇女外用抗菌凝胶治疗各种阴道炎子宫颈炎。From August 2003 to January 2004, the obstetrics and gynecology department of the hospital used nano-silver antibacterial gel for external use for women to treat various vaginitis and cervicitis.
1.材料与方法1. Materials and methods
病人来源:Patient source:
2002.8~2004.1,计下生殖道炎症患者92例,其中阴道炎47例,混合感染3例。患者年龄18-51岁,平均31.2岁。From August 2002 to January 2004, there were 92 patients with lower genital tract inflammation, including 47 cases of vaginitis and 3 cases of mixed infection. The age of the patients ranged from 18 to 51 years old, with an average of 31.2 years old.
2.试验材料2. Test material
实施例一所制备的纳米银凝胶。The prepared nano-silver gel of embodiment one.
3.诊断标准3. Diagnostic criteria
阴道炎根据临床表现和病原菌检查确诊;子宫颈糜烂按照曹泽毅主编的《中华妇产科学》,根据糜烂面积分为轻度、中度和重度,根据糜烂表面分为单纯型、颗粒型和乳突型。Vaginitis is diagnosed based on clinical manifestations and pathogenic bacteria examination; cervical erosion is divided into mild, moderate and severe according to the area of erosion according to "Chinese Obstetrics and Gynecology" edited by Cao Zeyi, and divided into simple type, granular type and mastoid according to the surface of erosion type.
4.治疗方法4. Treatment
每晚睡前清洗下阴后,患者利用给凝胶器(见图1)将抗菌凝胶推入阴道深部,每晚1支,连用6天。阴道炎患者治疗结束后3天复查,子宫颈炎患者治疗结束后7天复查。询问患者自觉症状改善情况、复查阴道、子宫颈充血情况并对分泌物进行相应的实验和检查。After cleaning the lower part of the vagina before going to bed every night, the patient pushes the antibacterial gel into the deep part of the vagina with a gel applicator (see Figure 1), taking 1 stick every night for 6 consecutive days. Patients with vaginitis will be re-examined 3 days after treatment, and patients with cervicitis will be re-examined 7 days after treatment. Inquire about the improvement of the patient's subjective symptoms, reexamine the congestion of the vagina and cervix, and conduct corresponding experiments and inspections on the secretions.
5.疗效评定标准5. Curative effect evaluation standard
(a)阴道炎(包括念珠菌性阴道炎和滴虫性阴道炎)(a) Vaginitis (including candidal vaginitis and trichomonas vaginitis)
痊愈:症状体征消失,白带减少,白带实验室检查阴性;Recovery: Symptoms and signs disappear, leucorrhea decreases, and leucorrhea laboratory tests are negative;
显效:症状体征明显好转,尚未完全消失,白带实验室检查阴性;Significantly effective: the symptoms and signs have improved significantly, but have not completely disappeared, and the leucorrhea laboratory test is negative;
好转:症状体征减轻,白带实验室检查阳性(作无效统计);Take a turn for the better: symptoms and signs alleviate, leucorrhea lab test is positive (do invalid statistics);
无效:症状体征无改善,白带实验室检查阳性。Ineffective: no improvement in symptoms and signs, and the leucorrhea laboratory test was positive.
(b)细菌性阴道炎(b) bacterial vaginosis
痊愈:症状体征消失,阴道分泌物pH值<4.5,胺试验阴性,未见线索细胞(clue cells);Recovery: symptoms and signs disappeared, vaginal secretion pH <4.5, amine test was negative, no clue cells were seen;
显效:症状体征明显好转但尚未完全消失,阴道分泌物pH值<4.5或胺试验阴性,未见线索细胞;Significantly effective: the symptoms and signs are obviously improved but not completely disappeared, the pH value of the vaginal secretion is <4.5 or the amine test is negative, and no clue cells are seen;
好转:症状体征有所减轻,阴道分泌物pH值<4.5或胺试验阴性,找到线索细胞(作无效统计);Improvement: Symptoms and signs have been relieved, vaginal secretion pH value <4.5 or amine test is negative, and clue cells are found (invalid statistics);
无效:症状体征、阴道分泌物实验室检查均无明显改善。Ineffective: There was no significant improvement in symptoms, signs, and laboratory examinations of vaginal secretions.
阴道炎症的有效率计算:有效率=(痊愈+显效)/治疗例数×100%。Effective rate calculation of vaginal inflammation: effective rate=(cured+marked effect)/number of treated cases×100%.
(c)子宫颈糜烂(c) cervical erosion
痊愈:症状体征消失,糜烂面消失,子宫颈光滑;Recovery: Symptoms and signs disappear, the erosion surface disappears, and the cervix is smooth;
显效:症状体征明显好转,尚未完全消失,糜烂面积缩小1/2,重度转为中度、中度转为轻度;Significantly effective: the symptoms and signs have improved significantly, but have not completely disappeared, the erosion area has shrunk by 1/2, and the severe has turned into moderate, and the moderate has turned into mild;
有效:症状体征好转,尚未完全消失,糜烂面积缩小<1/2,或乳突型转化为颗粒型、颗粒型转化为单纯型;Effective: Symptoms and signs have improved, but have not completely disappeared, and the erosion area has shrunk by <1/2, or the mastoid type has transformed into a granular type, and the granular type has transformed into a simple type;
无效:症状体征无好转,糜烂面积无变化。Ineffective: no improvement in symptoms and signs, no change in erosion area.
有效率=(痊愈+显效+有效)/治疗例数×100%。Effective rate=(cured+markedly effective+effective)/number of treated cases×100%.
(d)不良反应(d) Adverse reactions
治疗过程中应密切监视不良反应,并详细记录所出现的不良反应。Adverse reactions should be closely monitored during treatment, and adverse reactions that occur should be recorded in detail.
6.检验结果6. Test results
(a)阴道炎(a) Vaginitis
47例阴道炎中,38例痊愈,治愈率80.9%;7例显效,总有效率95.7%,详见表1。Of the 47 cases of vaginitis, 38 cases were cured, with a cure rate of 80.9%; 7 cases were markedly effective, with a total effective rate of 95.7%.
表1纳米银妇女外用抗菌凝胶治疗阴道炎的效果
(b)子宫颈炎(b) Cervicitis
42例子宫颈糜烂中,轻度15例,有效率93.3%;中度17例,有效率82.4%;重度10例,有效率80%;总有效率85.7%,详见表2。Among the 42 cases of cervical erosion, 15 cases were mild, with an effective rate of 93.3%; moderate cases, 17 cases, with an effective rate of 82.4%; severe cases, 10 cases, with an effective rate of 80%; the total effective rate was 85.7%, see Table 2 for details.
表2纳米银妇女外用抗菌凝胶治疗子宫颈炎的效果
(c)混合感染(c) mixed infection
观察病例中,有3例为混合感染,其中1例同时有细菌性阴道炎、滴虫性阴道炎、中度子宫颈糜烂。经1个疗程6天的治疗,细菌性阴道炎显效,滴虫性阴道炎痊愈,子宫颈糜烂转为轻度(疗效判定为显效);1例为细菌性阴道炎、念珠菌性阴道炎、重度子宫颈糜烂的患者。治疗6天,症状明显改善,细菌性阴道炎痊愈、念珠菌转阴,子宫颈仅见充血;另1例患者同时感染了阴道毛滴虫和支原体(Mycoplasma);用纳米银凝胶治疗6天后,滴虫和支原体均转阴。Among the observed cases, 3 were mixed infections, and 1 of them had bacterial vaginosis, trichomonal vaginitis, and moderate cervical erosion at the same time. After a course of 6 days of treatment, the bacterial vaginosis was markedly effective, the trichomonal vaginitis was cured, and the cervical erosion turned to mild (the curative effect was judged to be markedly effective); 1 case was bacterial vaginosis, candida vaginitis, Patients with severe cervical erosion. After 6 days of treatment, the symptoms improved significantly, the bacterial vaginosis was cured, Candida turned negative, and only hyperemia was seen in the cervix; another patient was infected with Trichomonas vaginalis and Mycoplasma at the same time; after 6 days of treatment with nano-silver gel, Both trichomonas and mycoplasma turned negative.
(d)不良反应(d) Adverse reactions
2例患者诉外阴瘙痒感,停用后无异常发现。Two patients complained of genital itching, and no abnormalities were found after discontinuation.
7.讨论7. Discussion
(a)纳米银妇女外用抗菌凝胶的有效成分纳米银,能广效抗菌,对细菌、真菌、滴虫等多种病原体都有抑制或杀灭作用。一般病人使用6支凝胶后,外阴瘙痒或灼痛感明显好转,分泌物减少,异味消失。治疗结束后复查,对多种阴道炎都有确切的疗效。治愈率80.9%,总有效率95.7%。(a) Nano-silver The active ingredient of the antibacterial gel for external use for women, nano-silver, has broad-spectrum antibacterial effects, and can inhibit or kill various pathogens such as bacteria, fungi, and trichomonas. Generally, after using 6 gels, the itching or burning sensation of the vulva is obviously improved, the secretion is reduced, and the peculiar smell disappears. After the treatment, the re-examination has a definite curative effect on various vaginitis. The cure rate is 80.9%, and the total effective rate is 95.7%.
(b)纳米银具有促进组织修复与再生的功效。纳米银凝胶对子宫颈炎有明显疗效,特别是对感染因素引起的单纯型子宫颈糜烂。对其他因素引起的子宫颈糜烂,使用后症状明显改善,子宫颈充血减轻,分泌物减少,有利于进行第二疗程治疗或进一步做物理治疗。(b) Nano-silver has the effect of promoting tissue repair and regeneration. Nano-silver gel has obvious curative effect on cervicitis, especially on simple cervical erosion caused by infection factors. For cervical erosion caused by other factors, the symptoms are obviously improved after use, cervical congestion is relieved, and secretions are reduced, which is conducive to the second course of treatment or further physical therapy.
(c)一种病原体感染后可以引起阴道生态条件发生改变,造成局部防御机能下降,导致其它病原体的继发感染,此时单用一种药物治疗较难获得良好疗效。在研究中,3例阴道混合感染的患者,单用纳米银妇女外外用抗菌凝胶,经6天一个疗程的治疗,患者症状消失或明显改善,多种病原体均转阴。(c) A pathogen infection can cause changes in the ecological conditions of the vagina, resulting in a decrease in local defense function and secondary infection by other pathogens. At this time, it is difficult to obtain good curative effect with a single drug treatment. In the study, 3 patients with mixed vaginal infection were treated with nanosilver external antibacterial gel for women alone. After a course of 6 days of treatment, the symptoms of the patients disappeared or improved significantly, and many pathogens were turned negative.
实施例三纳米银凝胶治疗女性下生殖道炎症Example 3 Nano silver gel treatment of women's lower reproductive tract inflammation
医院妇产科于2004年1至3月,采用实施例一的纳米银凝胶治疗女性下生殖道炎症60例,疗效总结如下:The obstetrics and gynecology department of the hospital used the nano-silver gel of Example 1 to treat 60 cases of female lower genital tract inflammation from January to March 2004. The curative effects are summarized as follows:
1.病例选择、诊断标准及治疗方法1. Case selection, diagnostic criteria and treatment methods
(a)病例选择:(a) Case selection:
随机选择在门诊就诊的下生殖道炎症患者60例,其中子宫颈糜烂30例,阴道炎(病)30例。均为初诊,并均未使用过任何药物治疗,年龄为22至48岁。Randomly select 60 cases of patients with lower reproductive tract inflammation in the outpatient clinic, including 30 cases of cervical erosion and 30 cases of vaginitis (disease). All were newly diagnosed and had never used any drug treatment. They were aged from 22 to 48 years old.
(b)子宫颈糜烂诊断标准:(b) Diagnostic criteria for cervical erosion:
轻度糜烂:子宫颈糜烂面小于整个宫颈面积的1/3。Mild erosion: The erosion surface of the cervix is less than 1/3 of the entire cervix.
中度糜烂:子宫颈糜烂面占整个宫颈面积的1/2~2/3。Moderate erosion: cervical erosion accounts for 1/2 to 2/3 of the entire cervical area.
重度糜烂:子宫颈糜烂面大于整个宫颈面积的2/3。Severe erosion: the erosion surface of the cervix is greater than 2/3 of the entire cervix.
根据糜烂面积的深浅程度分为:单纯型、颗粒型、乳突型。According to the depth of the erosion area, it can be divided into: simple type, granular type, and mastoid type.
(c)阴道炎(病)诊断标准:(c) Diagnostic criteria for vaginitis (disease):
念珠菌性阴道炎:外阴瘙痒,白带增多呈豆腐渣样或凝乳状,白带镜检念珠菌阳性。Candida vaginitis: genital itching, increased leucorrhea in the form of bean curd residue or curd, and the leucorrhea is positive for candida in microscopic examination.
滴虫性阴道炎:外阴瘙痒,白带增多呈淡黄泡沫样,白带镜检阴道毛滴虫阳性。Trichomonal vaginitis: genital itching, leucorrhea increased in the form of light yellow foam, leucorrhea microscopic examination of Trichomonas vaginalis was positive.
细菌性阴道炎:外阴瘙痒,白带增多有鱼腥臭味,白带稀释液胺试验阳性(即细菌性阴道炎快速检测卡阳性)。Bacterial vaginosis: vulvar itching, increased leucorrhea with fishy smell, positive leucorrhea diluent amine test (positive bacterial vaginosis rapid test card).
(d)治疗方法:(d) Treatment:
受试者每晚睡前清洗外阴后,自行用给凝胶器(请见图1)将纳米银凝胶推入阴道深部,每晚1次,6天为一疗程。治疗结束后3至7天复查,包括症状、体症和实验室检查。After cleaning the vulva every night before going to bed, the subjects used the gel applicator (see Figure 1) to push the nano-silver gel into the deep part of the vagina, once a night, and 6 days was a course of treatment. Review 3 to 7 days after treatment, including symptoms, signs and laboratory tests.
2.疗效判断标准2. Efficacy Judgment Criteria
(a)子宫颈糜烂(a) cervical erosion
痊愈:症状体征消失,糜烂面消失,宫颈光滑。Recovery: Symptoms and signs disappeared, the erosion surface disappeared, and the cervix was smooth.
显效:症状体征明显减轻,糜烂面缩小1/2,重度转为中度,中度转为轻度。Significantly effective: symptoms and signs are significantly relieved, the erosion surface is reduced by 1/2, severe to moderate, and moderate to mild.
有效:症状体征部分减轻,糜烂面缩小<1/2,或乳突型转为颗粒型,颗粒型转为单纯型。Effective: Symptoms and signs are partially alleviated, the erosion surface is reduced by <1/2, or the mastoid type is transformed into a granular type, and the granular type is transformed into a simple type.
无效:症状体征无减轻,糜烂面无变化。Ineffective: no relief of symptoms and signs, no change in the erosion surface.
有效率=(痊愈+显效+有效)/治疗例数×100%。Effective rate=(cured+markedly effective+effective)/number of treated cases×100%.
(b)阴道炎(病)(b) Vaginitis (disease)
痊愈:症状体征消失,白带减少并且镜检病原体(或胺试验)阴性。Recovery from illness: symptoms and signs disappear, leucorrhea decreases and microscopic examination of pathogens (or amine test) is negative.
显效:症状体征明显减轻,白带减少并且镜检病原体(或胺试验)阴性。Significantly effective: symptoms and signs are significantly relieved, leucorrhea is reduced and microscopic examination of pathogens (or amine test) is negative.
好转:症状体征部分减轻,白带镜检病原体(或胺试验)阳性。Improvement: Symptoms and signs were partially alleviated, and the pathogen (or amine test) of the leucorrhea was positive.
无效:症状体征无减轻,白带镜检病原体(或胺试验)阳性。Ineffective: no relief of symptoms and signs, pathogens (or amine test) of leucorrhea are positive.
有效率=(痊愈+显效)/治疗例数×100%。Effective rate=(cured+marked effect)/number of treated cases×100%.
3.结果3. Results
(a)子宫颈糜烂治疗结果:30例子宫颈糜烂患者中,轻度18例,有效率为94%;中度10例,有效率为70%;重度2例,1例有效。治疗子宫项颈糜烂的总有效率为83%,详见表3。(a) Treatment results for cervical erosion: Among the 30 patients with cervical erosion, 18 were mild, with an effective rate of 94%; 10 were moderate, with an effective rate of 70%; 2 were severe, and 1 was effective. The total effective rate in the treatment of cervical erosion is 83%. See Table 3 for details.
表3纳米银妇用抗菌凝胶对子宫颈糜烂的治疗效果
(b)阴道炎(病)治疗结果:30例阴道炎(病)患者中,念珠菌性阴道炎16例,有效率为88%;滴虫性道炎6例,有效率为100%;细菌性阴道炎8例,有效率为88%。治疗阴道炎(病)的总有效率90%,详见表4。(b) vaginitis (disease) treatment result: among 30 routine vaginitis (disease) patients, 16 cases of candida vaginitis, the effective rate is 88%; 6 cases of trichomonal vaginitis, the effective rate is 100%; 8 cases of vaginitis, the effective rate was 88%. The total effective rate of treating vaginitis (disease) is 90%, see Table 4 for details.
表4纳米银妇女外用抗菌凝胶对阴道炎(病)的治疗效果
其它结果:以子宫颈糜烂的深浅程度来观察治疗效果,为单纯型疗效最好;另外,有5例患者称治疗期间阴道有排出少许咖啡色分泌物的情况,但无阴道刺激感等不适。Other results: The treatment effect was observed based on the depth of cervical erosion, and the simple type had the best effect; in addition, 5 patients reported a little brown discharge from the vagina during treatment, but no discomfort such as vaginal irritation.
本发明已详细说明并举例说明,以使熟习此项技术者能实施并加以利用,任何替代、变更与修改均应在不脱离本发明的精神与范围内进行。The present invention has been described in detail and illustrated so that those skilled in the art can implement and utilize it. Any substitutions, changes and modifications should be made without departing from the spirit and scope of the present invention.
熟习此项技术者很快便会发现本发明很容易便可达到目标,并得到本文中所述的结果及优点。细胞株、胚胎、动物及其制造过程和方法仅为示范性的优选实施例代表,并非要限制发明的范围。熟悉本领域的技术人员将会想到对本发明进行修改及其它用途,这些修改均应包含在本发明的精神内并仅限于权利要求范围内。Those skilled in the art will quickly find that the present invention readily achieves its objectives and obtains the results and advantages described herein. Cell lines, embryos, animals and their manufacturing processes and methods are merely representative of exemplary preferred embodiments, and are not intended to limit the scope of the invention. Modifications and other uses of the present invention will occur to those skilled in the art, and these modifications should be included in the spirit of the present invention and limited only by the scope of the claims.
熟悉本领域的技术人员显然很容易在不脱离本发明的精神与范围内对本发明进行变更与修改。Those skilled in the art can easily make changes and modifications to the present invention without departing from the spirit and scope of the present invention.
本说明书所述的所有专利及出版物均为本领域中和发明有关的常规技术。本说明书所述及的专利与发表文章可说明熟悉有关本发明领域的技术人员具有的技术程度。All patents and publications mentioned in this specification are conventional techniques in the field related to the invention. The patents and publications mentioned in this specification are indicative of the level of skill of those familiar with the fields to which the invention pertains.
本文所述的发明附图可在没有任何要件或限制下施行,而非特定本文所披露者。所使用的名词及表达仅为说明目的使用,而非用于限制,且不是要利用这些名词及表达来排除任何所示及所述或其部分特征的均等物,而是认为各种变更修改仍可能在发明申请专利范围内。因此,应该了解虽然已利用优选实施例及选择性的特征来具体披露本发明,但熟悉本领域的技术人员可能会根据其中所披露的构想加以修改及变更,这些修改与变更应当在本发明所附权利要求书所定义的范围内。The drawings of the inventions described herein may operate without any requirements or limitations other than those specifically disclosed herein. The terms and expressions used are used for the purpose of description only, not for limitation, and it is not intended to exclude any equivalents shown and described or parts thereof, and various changes and modifications are considered to be May be within the scope of the invention patent application. Therefore, it should be understood that although preferred embodiments and optional features have been used to specifically disclose the present invention, those skilled in the art may make modifications and changes based on the ideas disclosed therein, and these modifications and changes should be included in the scope of the present invention. within the scope defined in the appended claims.
下列权利要求书提到其它实施例。The following claims refer to other embodiments.
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