WO2018082163A1 - 一种抑菌液 - Google Patents

一种抑菌液 Download PDF

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Publication number
WO2018082163A1
WO2018082163A1 PCT/CN2016/111195 CN2016111195W WO2018082163A1 WO 2018082163 A1 WO2018082163 A1 WO 2018082163A1 CN 2016111195 W CN2016111195 W CN 2016111195W WO 2018082163 A1 WO2018082163 A1 WO 2018082163A1
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Prior art keywords
carboxymethyl chitosan
bacteriostatic
molecular weight
average molecular
number average
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PCT/CN2016/111195
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English (en)
French (fr)
Inventor
徐宇帆
徐耀中
高心怡
李萍
肖璠
姜义华
金莎
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上海陶盛生物技术有限公司
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Publication of WO2018082163A1 publication Critical patent/WO2018082163A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/28—Polysaccharides or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/722—Chitin, chitosan
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/23—Carbohydrates
    • A61L2300/232—Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents

Definitions

  • the invention relates to a bacteriostatic liquid, in particular to an antibacterial liquid for a non-woven fabric.
  • Diapers become one of the necessities of infants and the elderly. However, if the existing diapers are not replaced in time or if the weather is hot, the baby's skin may be rash or the skin is inflamed, causing great damage to the baby. In order to solve this problem, some technical solutions are provided in the prior art.
  • the invention patent of 201510143244.X discloses a traditional Chinese medicine composition for a diaper and a preparation method of the diaper, wherein the traditional Chinese medicine composition is composed of honeysuckle, atractylodes, alfalfa, yam, hazelnut, white peony, mint, White fresh skin, yellow cedar, dandelion, paeonol, and windproof composition; the above traditional Chinese medicine composition is cleaned and added with water to be soaked, and the non-woven surface layer of the diaper is infiltrated after being boiled to obtain a liquid medicine.
  • the invention combines the effects of various medicinal materials in traditional Chinese medicine on the diaper, so that the skin of the user's buttocks can directly contact the medicinal ingredient to achieve the effect of prevention and treatment.
  • the invention patent of 2015107034304 discloses a bacteriostatic solution and a preparation method thereof, and a preparation method of the diaper, the bacteriostatic solution, which is composed of the following parts by mass, stearyl ether-21, hard alcohol ether -2 component composition, the antibacterial solution is applied to the surface layer of the non-woven fabric to have a skin-friendly and bacteriostatic effect.
  • an antibacterial liquid for a non-woven fabric wherein the antibacterial liquid is an aqueous solution containing carboxymethyl chitosan, the carboxymethyl group
  • the number average molecular weight of chitosan is from 1,000 to 20,000.
  • the concentration of the aqueous solution of carboxymethyl chitosan is not less than 0.1% by weight. More preferably, the concentration of the aqueous solution of carboxymethyl chitosan is not less than 0.2% by weight. More preferably, the concentration of the aqueous solution of carboxymethyl chitosan is not less than 1.0% by weight.
  • the number average molecular weight in the present invention is determined according to "People's Republic of China Pharmacopoeia (Four Parts)" (2015 edition) General 0401 "UV-visible spectrophotometry” method for the determination of A 525 .
  • the principle is as follows: the acetylacetone reagent reacts with the reducing end groups of standard glucosamine, carboxymethyl chitosan or its hydrolyzate to produce a chromogen; under certain conditions, the absorbance A 525 has a linear relationship with the molar concentration of the corresponding sugar.
  • the multiple of the reducing end group which is increased after hydrolysis than the hydrolysis is the average degree of polymerization n of the carboxymethyl chitosan, and the number average molecular mass of the sugar can be calculated by combining the average molecular mass of the sugar unit in the molecule.
  • the carboxymethyl chitosan is O-carboxymethyl chitosan.
  • the O-carboxymethyl chitosan is a partially carboxymethylated chitosan after decarboxylation of carboxymethyl chitin or substitution of a 6-hydroxyhydrogen of chitosan with a carboxymethyl group.
  • R 1 is CH 2 COONa
  • R 2 is CH 2 COONa or H
  • R 3 is CH 2 COONa or H or COCH 3 .
  • the method for preparing the carboxymethyl chitosan comprises degrading the carboxymethyl chitosan raw material having a higher number average molecular weight by hydrogen peroxide. More preferably, the number average molecular weight of the carboxymethyl chitosan in the carboxymethyl chitosan raw material having a high number average molecular weight is from 300,000 to 700,000. More preferably, the carboxymethyl chitosan starting material having a higher number average molecular weight has a degree of carboxymethyl substitution of from 0.8 to 1.3. More preferably, the carboxymethyl chitosan raw material having a higher number average molecular weight has a carboxymethyl group O substitution degree of 0.7 to 1.0 and a N degree substitution degree of not more than 0.3.
  • the carboxymethyl chitosan raw material having a higher number average molecular weight is obtained by the method disclosed in the invention patent of the domestic application No. 2013105362023, which discloses a method for preparing carboxymethyl chitosan, the method Based on chitin as a raw material, the chitin is first alkalized, and the deacetylation reaction is carried out by using a hot and cold alternating method to produce a chitosan sodium salt and then a base. The carboxylation reaction is carried out under the conditions to obtain a carboxymethyl chitosan product having a high number average molecular weight.
  • the method of the invention has simple process and easy control, avoids the chain scission phenomenon caused by long-term high-temperature reaction in the chitosan molecular chain deacetylation reaction, thereby obtaining a carboxymethyl group with high viscosity, high substitution degree and better water solubility.
  • Chitosan is suitable for large-scale industrial production.
  • the higher molecular weight carboxymethyl chitosan dissolves at a pH in the range of 4.5 to 14.0.
  • the carboxymethyl chitosan having a higher number average molecular weight can be dissolved in an acidic solution having a pH of 4.5 to 6.5.
  • the carboxymethyl chitosan has a pH range of 7.0 to 14.0, and the carboxymethyl chitosan having a higher number average molecular weight obtained by the above patent method has a wider pH range and broadens its application. field.
  • the hydrogen peroxide degradation process comprises: adding hydrogen peroxide to the carboxymethyl chitosan having a higher number average molecular weight under stirring to carry out a degradation reaction, and adding a base during the degradation reaction so that the pH of the reaction system is 8.0 to 8.5.
  • the viscosity of the reaction system is 80 to 120 cp
  • sodium sulfite is added to stop the reaction.
  • the reaction temperature is 25 to 45 °C. The degraded carboxymethyl chitosan is obtained by the above degradation reaction.
  • the method for preparing the carboxymethyl chitosan comprises subjecting the carboxymethyl chitosan after hydrogen peroxide degradation to acid precipitation washing.
  • the acid precipitation washing refers to adjusting the carboxymethyl chitosan material after degradation by hydrogen peroxide to pH 6-7, adding ethanol to pale yellow crystals, and repeatedly washing with alcohol, drying and drying to obtain a carboxyl group. Chitosan.
  • the invention discloses a use of the bacteriostatic liquid as described above in the preparation of a sanitary care product.
  • the personal hygiene care product comprises a nonwoven fabric layer formed with a bacteriostatic solution as described above to form a bacteriostatic layer.
  • the nonwoven fabric layer on the personal hygiene care product comprises a diaper for infants and the elderly, a sanitary napkin for women, a non-woven wipe, and a nonwoven fabric layer for use on the mask.
  • the present invention also discloses a personal hygiene care product comprising a nonwoven fabric layer, wherein the nonwoven fabric layer forms a bacteriostatic layer using the bacteriostatic liquid described above.
  • the test shows that the above-mentioned carboxymethyl chitosan has anti-allergic effect in addition to the known antibacterial function, and can be directly or mixed with other additives to prepare various antibacterial liquids and various dosage forms.
  • carboxymethyl chitosan has anti-allergic effect in addition to the known antibacterial function, and can be directly or mixed with other additives to prepare various antibacterial liquids and various dosage forms.
  • carboxymethyl chitosan having a number average molecular weight of 2000 was prepared.
  • the carboxymethyl chitosan raw material having a higher number average molecular weight is degraded with hydrogen peroxide, and the number average molecular weight of the carboxymethyl chitosan raw material having a higher number average molecular weight is 30 W, and the carboxymethyl substitution degree is 0.8 to 1.3.
  • O is a carboxymethyl group having a degree of substitution of 0.7 to 1.0, and the N-position substitution degree is not more than 0.3.
  • the process of hydrogen peroxide degradation is as follows: the hydrogen peroxide is added to the carboxymethyl chitosan with higher number average molecular weight under the stirring condition for degradation reaction, and the pH of the reaction system is 8.0 until the viscosity of the reaction system is The reaction was stopped by adding sodium sulfite at 80 cp. In the degradation reaction, the reaction temperature is room temperature.
  • the preparation method of the carboxymethyl chitosan comprises acid precipitation washing of carboxymethyl chitosan after hydrogen peroxide degradation.
  • the acid precipitation washing refers to adjusting the carboxymethyl chitosan material after degradation by hydrogen peroxide to pH 7, adding ethanol to pale yellow crystals, repeatedly washing with alcohol, drying and drying to obtain a carboxymethyl shell. Glycans.
  • carboxymethyl chitosan having a number average molecular weight of 8,000 was used.
  • the carboxymethyl chitosan raw material having a higher number average molecular weight is degraded with hydrogen peroxide, and the carboxymethyl group having a higher number average molecular weight is used.
  • the chitosan raw material has a number average molecular weight of 40 W and a carboxymethyl substitution degree of 0.8 to 1.3, wherein O is a carboxymethyl group substitution degree of 0.7 to 1.0, and the N-site substitution degree is not more than 0.3.
  • the process of hydrogen peroxide degradation is as follows: the hydrogen peroxide is added to the carboxymethyl chitosan with higher number average molecular weight under stirring, and the degradation reaction is carried out.
  • the pH of the reaction system is 8.2 until the viscosity of the reaction system is The reaction was stopped by adding sodium sulfite at 80 cp.
  • the reaction temperature is room temperature.
  • the preparation method of the carboxymethyl chitosan comprises acid precipitation washing of carboxymethyl chitosan after hydrogen peroxide degradation.
  • the acid precipitation washing refers to adjusting the carboxymethyl chitosan material after degradation by hydrogen peroxide to pH 6, adding ethanol to pale yellow crystals, repeatedly washing with alcohol, drying and drying to obtain a carboxymethyl shell. Glycans.
  • carboxymethyl chitosan having a number average molecular weight of 15,000 was used.
  • the carboxymethyl chitosan raw material having a higher number average molecular weight is degraded with hydrogen peroxide, and the number average molecular weight of the carboxymethyl chitosan raw material having a higher number average molecular weight is 55 W and the carboxymethyl substitution degree is 0.8 to 1.3.
  • O is a carboxymethyl group having a degree of substitution of 0.7 to 1.0, and the N-position substitution degree is not more than 0.3.
  • the process of hydrogen peroxide degradation is as follows: the hydrogen peroxide is added to the carboxymethyl chitosan with higher number average molecular weight under stirring, and the degradation reaction is carried out.
  • the pH of the reaction system is 8.2 until the viscosity of the reaction system is The reaction was stopped by adding sodium sulfite at 120 cp.
  • the reaction temperature is room temperature.
  • the preparation method of the carboxymethyl chitosan comprises acid precipitation washing of carboxymethyl chitosan after hydrogen peroxide degradation.
  • the acid precipitation washing refers to adjusting the carboxymethyl chitosan material after degradation by hydrogen peroxide to pH 6, adding ethanol to pale yellow crystals, repeatedly washing with alcohol, drying and drying to obtain a carboxymethyl shell. Glycans.
  • carboxymethyl chitosan having a number average molecular weight of 20,000 was used.
  • the carboxymethyl chitosan raw material having a higher number average molecular weight is degraded with hydrogen peroxide, and the number average molecular weight of the carboxymethyl chitosan raw material having a higher number average molecular weight is 70 W and the carboxymethyl substitution degree is 0.8 to 1.3.
  • O is a carboxymethyl group having a degree of substitution of 0.7 to 1.0, and the N-position substitution degree is not more than 0.3.
  • the process of hydrogen peroxide degradation is: adding hydrogen peroxide to the carboxymethyl chitosan with higher number average molecular weight under stirring conditions.
  • the degradation reaction was carried out, and the pH of the reaction system was adjusted to 8.4 by adding a base during the degradation reaction until the viscosity of the reaction system was 100 cp, and sodium sulfite was added to stop the reaction.
  • the reaction temperature is room temperature.
  • the preparation method of the carboxymethyl chitosan comprises acid precipitation washing of carboxymethyl chitosan after hydrogen peroxide degradation.
  • the acid precipitation washing refers to adjusting the carboxymethyl chitosan material after degradation by hydrogen peroxide to pH 6.5, adding ethanol to pale yellow crystals, and repeatedly washing with alcohol, drying and drying to obtain a carboxymethyl shell. Glycans.
  • the carboxymethyl chitosan prepared in Examples 1 to 4 was used as a test sample to carry out a skin anti-metamorphosis animal test. That is, after the animal was induced to contact with 2,4-dinitrochlorobenzene (DNCB) skin, the test sample was observed to have anti-metamorphosis effect on the skin. Specifically, after the guinea pig skin is induced to contact with the DNCB skin, a metamorphosis (allergic) state is generated, and the test sample is applied at the same time, and the anti-metamorphosis effect of the low molecular weight carboxymethyl chitosan-90 on the guinea pig skin is observed by the excitation contact.
  • DNCB 2,4-dinitrochlorobenzene
  • Test sample 1. Low molecular weight carboxymethyl chitosan in Examples 1-4
  • DNCB 4-dinitrochlorobenzene
  • Test animals 30 white guinea pigs, male and female half body weight: 250g-300g
  • Test wet temperature 20 °C ⁇ 2 ° C, relative humidity 60 ⁇ 70%
  • test sample groups Thirty healthy white guinea pigs were selected, and the test skins of 8 cm ⁇ 4 cm on both sides of the spine were shaved. The animals were divided into test sample groups, and the positive control group and the blank control group were divided into 3 groups, 10 animals in each group.
  • test sample was applied to the right side of the sample group animal in the same manner once a day for 28 days.
  • Test concentration 1.0% means that 1.0 wt% of an aqueous solution of carboxymethyl chitosan was used.
  • the carboxymethyl chitosan of Examples 1 to 4 all had anti-allergic effects on white guinea pig skin.
  • the carboxymethyl chitosan prepared in Examples 1 to 4 was used as a test sample, and a human body experiment, specifically a skin acupuncture experiment, was carried out, and the protocol was as follows.
  • Example 1 The low molecular weight carboxymethyl chitosan of Example 1 was dissolved in water to form a 0.2 wt% aqueous solution of carboxymethyl chitosan, and 2 ml was taken for human experiment, and 0, 3, 30, 60.90, 120, 150 minutes after application. After the measurement of the itching sensation in the test site, the redness and blister area are shown in Table 1:
  • Example 2 The low molecular weight carboxymethyl chitosan of Example 2 was dissolved in water to form a 0.2 wt% aqueous solution of carboxymethyl chitosan, and 2 ml was taken for human experiment, 0, 3, 30, 60.90, 120, 150 minutes after application. After the measurement of the itching sensation in the test site, the redness and blister area are shown in Table 2:
  • Blister area (positive control) 100 87 77 69 67 28 20 Blister area (sample) 100 67 51 40 32 17 8
  • Example 3 The low molecular weight carboxymethyl chitosan of Example 3 was dissolved in water to form a 0.2 wt% aqueous solution of carboxymethyl chitosan, and 2 ml was taken for human experiment, and 0, 3, 30, 60.90, 120, 150 minutes after application. After the measurement of the itching sensation in the test site, the redness and blister area are shown in Table 3:
  • the low molecular weight carboxymethyl chitosan of Example 4 was dissolved in water to form a 0.2 wt% aqueous solution of carboxymethyl chitosan, and 2 ml was taken for human experiment, and 0, 3, 30, 60.90, 120, 150 minutes after application. After the measurement of the itching sensation in the test site, the redness and blister area are shown in Table 4:
  • Blister area (positive control) 100 89 72 65 61 33 17 Blister area (sample) 100 60 52 40 28 17 4
  • the carboxymethyl chitosan prepared in Examples 1 to 4 was dissolved in water to form an aqueous solution of carboxymethyl chitosan, that is, an antibacterial solution.
  • the concentration of the aqueous solution of carboxymethyl chitosan is not less than 0.1% by weight.
  • the above animal test is human test data and the results show that the carboxymethyl chitosan of the present invention not only has antibacterial function, but also has anti-allergic and anti-inflammatory and anti-itching effects; and because of the small molecule carboxymethyl shell in the present invention
  • the antibacterial liquid formed by the aqueous solution of the polysaccharide has a natural component, does not contain hormones or other stimulating chemical components, and has good skin-friendliness and biocompatibility.
  • non-woven fabrics for personal hygiene care products including non-woven fabrics for personal hygiene products including for infants and the elderly.
  • a nonwoven fabric is formed, the personal hygiene care product comprising a nonwoven fabric layer, and the nonwoven fabric layer is formed into a bacteriostatic layer using the bacteriostatic liquid described above.
  • the carboxymethyl chitosan of Example 1 was dissolved in water to form a 1 wt% aqueous solution of carboxymethyl chitosan.
  • the antibacterial phase difference is 17 times.
  • the carboxymethyl chitosan of Example 2 was dissolved in water to form a 1 wt% aqueous solution of carboxymethyl chitosan.
  • the antibacterial phase difference is 62 times.
  • the carboxymethyl chitosan of Example 3 was dissolved in water to form a 1 wt% aqueous solution of carboxymethyl chitosan.
  • the antibacterial phase difference is 4 times.
  • the above aqueous solution of carboxymethyl chitosan is convenient not only in use and preparation, but also has antibacterial, anti-allergic, anti-inflammatory and anti-itch effects, colorless and odorless, and is a natural small molecular substance, biocompatibility and skin-friendly. It is very good in the use of non-woven fabrics for diapers, diapers for women and non-woven wipes for infants and the elderly, and can effectively prevent the users of the above-mentioned products from appearing during use. Skin problems such as redness and itching.
  • the above-mentioned antibacterial liquid is used in the process of preparing a non-woven fabric, and the surface layer of the non-woven fabric is infiltrated or sprayed with the antibacterial liquid to form a surface layer of the non-woven fabric to form a bacteriostatic layer, thereby achieving good suppression.
  • the effect of bacteria is to meet the needs of users.

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Abstract

一种抑菌液，为含有羧甲基壳聚糖的水溶液，所述羧甲基壳聚糖的数均分子量为1000～20000。试验表明，羧甲基壳聚糖除了具有已知的抗菌功能外，具有抗过敏的功效，可将之直接或与其他添加剂混合制成各种抑菌液及各种剂型，用于无纺布上。其不仅方便使用，而且抑菌抗过敏效果好，并且无色无味，能够很有效的避免个人卫生护理用品如婴儿和老人用的纸尿布、女性用的卫生巾以及无纺布湿纸巾使用的无纺布上，避免了使用者在使用过程中出现的红肿、瘙痒的皮肤问题。

Description

一种抑菌液 技术领域
本发明涉及一种抑菌液，具体涉及一种用于无纺布的抑菌液。
背景技术
纸尿裤成为婴儿和老人必需品之一，然而现有的纸尿裤在使用时如果不及时更换或者由于天气炎热等情况容易导致婴儿的皮肤起红疹或者皮肤发炎，给婴儿带来很大伤害。为了解决这一问题，现有技术中提供了一些技术方案。
国内申请号为201510143244.X的发明专利公开了一种用于纸尿裤的中药组合物以及纸尿裤的制备方法，其中所述中药组合物，由金银花、白术、茯苓、淮山、薏仁、白蒺藜、薄荷、白鲜皮、黄柏、蒲公英、丹皮、防风组成；将上述中药组合物清洗干净并添加水浸泡，并煎煮获得药液后浸润纸尿裤的无纺布面层。此发明中结合中医中各种药材功效将其用于纸尿裤上可以使得使用者臀部的皮肤直接接触药效成分，达到预防与治疗一体的效果。国内申请号为2015107034304的发明专利公开了一种抑菌溶液及其制成的纸尿裤以及纸尿裤的制备方法，这种抑菌溶液，其由以下质量份，硬脂醇醚-21、硬质醇醚-2等组分组成，将这种抑菌溶液用于无纺布的面层起到亲肤和抑菌的效果。
然而采用中药成分时制备过程复杂，且中药一般会有味道，并不受市场上一部分消费者欢迎；采用对比文件2中的抑菌液其抗菌效果有，但是并没有抗过敏效果，使用者在使用时也仍然容易出现皮肤问题。
发明内容
鉴于以上所述现有技术的缺点，本发明的目的在于提供一种用于无纺布的抑菌液。
为了实现上述目的或者其他目的，本发明是通过以下技术方案实现的。
一种用于无纺布的抑菌液，所述的抑菌液为含有羧甲基壳聚糖的水溶液，所述羧甲基 壳聚糖的数均分子量为1000～20000。
优选地，所述羧甲基壳聚糖水溶液的浓度为不小于0.1wt％。更优选地，所述羧甲基壳聚糖水溶液的浓度为不小于0.2wt％。更优选地，所述羧甲基壳聚糖水溶液的浓度为不小于1.0wt％。
本发明中所述数均分子量是按照《中华人民共和国药典(四部)》(2015年版)通则0401“紫外-可见分光光度法”方法测定A525。其原理为：乙酰丙酮试剂与标准氨基葡萄糖、羧甲基脱乙酰壳多糖或其水解液的还原性端基反应产生色原；一定条件下，吸光度A525与相应糖的摩尔浓度具有线性关系。水解后比水解前增加的还原性端基的倍数就是该羧甲基脱乙酰壳多糖的平均聚合度n，结合分子中糖单元平均分子质量可以计算出该糖的数均分子质量。
更优选地，所述羧甲基壳聚糖为O-羧甲基脱乙酰壳多糖。所述O-羧甲基脱乙酰壳多糖为羧甲基甲壳素脱乙酰化后或壳聚糖的6-羟基氢被羧甲基取代后的部分羧甲基化的脱乙酰壳多糖。
更为具体地，所述O-羧甲基脱乙酰壳多糖的结构式如下所示：
Figure PCTCN2016111195-appb-000001
其中R1为CH2COONa；R2为CH2COONa或H；R3为CH2COONa或H或COCH3。
优选地，所述羧甲基壳聚糖的制备方法包括将数均分子量较高的羧甲基壳聚糖原料通过双氧水降解。更为优选地，所述数均分子量较高的羧甲基壳聚糖原料中羧甲基壳聚糖的数均分子量30～70万。更为优选地，所述数均分子量较高的羧甲基壳聚糖原料中羧甲基取代度为0.8～1.3。更为优选地，所述数均分子量较高的羧甲基壳聚糖原料中羧甲基O位取代度为0.7～1.0，N位取代度不超过0.3。
所述数均分子量较高的羧甲基壳聚糖原料为由国内申请号为2013105362023的发明专利公开的方法制备获得，其公开了一种制备羧甲基壳聚糖的方法，所述的方法是以甲壳素为原料，先将甲壳素碱化，使用冷热交替法进行脱乙酰化反应，生产壳聚糖钠盐，再在碱 性条件下进行羧化反应，获得数均分子量较高的羧甲基壳聚糖产品。本发明方法工艺简单且易于控制，避免了壳聚糖分子链脱乙酰化反应时因长期高温反应出现的断链现象，从而获得了一种高粘度、高取代度和水溶性更好的羧甲基壳聚糖，适合大规模工业化生产。所述分子量较高的羧甲基壳聚糖溶解的pH范围为4.5～14.0。所述的数均分子量较高的羧甲基壳聚糖可以溶解在pH为4.5～6.5的酸性溶液中。与传统工艺获得的羧甲基壳聚糖溶解的pH范围为7.0～14.0相比，上述专利方法获得的数均分子量较高的羧甲基壳聚糖溶解的pH范围更宽，拓宽了其应用领域。
优选地，双氧水降解的工艺为：将双氧水在搅拌条件下加入数均分子量较高的羧甲基壳聚糖中进行降解反应，降解反应过程中加碱使得反应体系的pH为8.0～8.5，直至反应体系的粘度为80～120cp时加入亚硫酸钠停止反应。更优选地，降解反应中，反应温度为25～45℃。由上述降解反应即获得降解后的羧甲基壳聚糖。
更优选地，所述羧甲基壳聚糖的制备方法包括对双氧水降解后的羧甲基壳聚糖进行酸析洗涤。所述酸析洗涤是指用酸调整双氧水降解后的羧甲基壳聚糖料体至pH为6～7，加入乙醇至淡黄色晶体析出，再用酒精反复洗涤，甩干，干燥获得羧甲基壳聚糖。
本发明公开了一种如上述所述的抑菌液在制备卫生护理用品上的用途。
优选地，所述个人卫生护理用品包括无纺布层，所述无纺布层采用如上述所述的抑菌液形成抑菌层。
优选地，个人卫生护理用品上的无纺布层包括用于婴儿和老人用的尿不湿、女性用的卫生巾、无纺布湿纸巾和面膜上使用的无纺布层。
本发明还公开了一种个人卫生护理用品，所述个人卫生护理用品包括无纺布层，所述无纺布层采用上述所述的抑菌液形成抑菌层。试验表明，本发明中上述所述羧甲基壳聚糖除了具有已知的抗菌功能外，具有抗过敏的功效，可将之直接或与其他添加剂混合制成各种抑菌液及各种剂型，用于无纺布上。其不仅方便使用，而且抑菌抗过敏效果好，并且无色无味，能够很有效的避免无纺布使用者在使用过程中出现的皮肤问题。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露 的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。
在进一步描述本发明具体实施方式之前，应理解，本发明的保护范围不局限于下述特定的具体实施方案；还应当理解，本发明实施例中使用的术语是为了描述特定的具体实施方案，而不是为了限制本发明的保护范围。下列实施例中未注明具体条件的试验方法，通常按照常规条件，或者按照各制造商所建议的条件。
当实施例给出数值范围时，应理解，除非本发明另有说明，每个数值范围的两个端点以及两个端点之间任何一个数值均可选用。除非另外定义，本发明中使用的所有技术和科学术语与本技术领域技术人员通常理解的意义相同。除实施例中使用的具体方法、设备、材料外，根据本技术领域的技术人员对现有技术的掌握及本发明的记载，还可以使用与本发明实施例中所述的方法、设备、材料相似或等同的现有技术的任何方法、设备和材料来实现本发明。
实施例1
本实施例中为制备数均分子量为2000的羧甲基壳聚糖。
采用数均分子量较高的羧甲基壳聚糖原料用双氧水降解，所述数均分子量较高的羧甲基壳聚糖原料的数均分子量为30W、羧甲基取代度为0.8～1.3，其中，O为羧甲基取代度为0.7～1.0，N位取代度不超过0.3。
双氧水降解的工艺为：将双氧水在搅拌条件下加入数均分子量较高的羧甲基壳聚糖中进行降解反应，降解反应过程中加碱使得反应体系的pH为8.0，直至反应体系的粘度为80cp时加入亚硫酸钠停止反应。降解反应中，反应温度为室温。
所述羧甲基壳聚糖的制备方法包括对双氧水降解后的羧甲基壳聚糖进行酸析洗涤。所述酸析洗涤是指用酸调整双氧水降解后的羧甲基壳聚糖料体至pH为7，加入乙醇至淡黄色晶体析出，再用酒精反复洗涤，甩干，干燥获得羧甲基壳聚糖。
实施例2
本实施例中采用数均分子量为8000的羧甲基壳聚糖。
采用数均分子量较高的羧甲基壳聚糖原料用双氧水降解，所述数均分子量较高的羧甲基 壳聚糖原料的数均分子量为40W、羧甲基取代度为0.8～1.3，其中，O为羧甲基取代度为0.7～1.0，N位取代度不超过0.3。
双氧水降解的工艺为：将双氧水在搅拌条件下加入数均分子量较高的羧甲基壳聚糖中进行降解反应，降解反应过程中加碱使得反应体系的pH为8.2，直至反应体系的粘度为80cp时加入亚硫酸钠停止反应。降解反应中，反应温度为室温。
所述羧甲基壳聚糖的制备方法包括对双氧水降解后的羧甲基壳聚糖进行酸析洗涤。所述酸析洗涤是指用酸调整双氧水降解后的羧甲基壳聚糖料体至pH为6，加入乙醇至淡黄色晶体析出，再用酒精反复洗涤，甩干，干燥获得羧甲基壳聚糖。
实施例3
本实施例中采用数均分子量为15000的羧甲基壳聚糖。
采用数均分子量较高的羧甲基壳聚糖原料用双氧水降解，所述数均分子量较高的羧甲基壳聚糖原料的数均分子量为55W、羧甲基取代度为0.8～1.3，其中，O为羧甲基取代度为0.7～1.0，N位取代度不超过0.3。
双氧水降解的工艺为：将双氧水在搅拌条件下加入数均分子量较高的羧甲基壳聚糖中进行降解反应，降解反应过程中加碱使得反应体系的pH为8.2，直至反应体系的粘度为120cp时加入亚硫酸钠停止反应。降解反应中，反应温度为室温。
所述羧甲基壳聚糖的制备方法包括对双氧水降解后的羧甲基壳聚糖进行酸析洗涤。所述酸析洗涤是指用酸调整双氧水降解后的羧甲基壳聚糖料体至pH为6，加入乙醇至淡黄色晶体析出，再用酒精反复洗涤，甩干，干燥获得羧甲基壳聚糖。
实施例4
本实施例中采用数均分子量为20000的羧甲基壳聚糖。
采用数均分子量较高的羧甲基壳聚糖原料用双氧水降解，所述数均分子量较高的羧甲基壳聚糖原料的数均分子量为70W、羧甲基取代度为0.8～1.3，其中，O为羧甲基取代度为0.7～1.0，N位取代度不超过0.3。
双氧水降解的工艺为：将双氧水在搅拌条件下加入数均分子量较高的羧甲基壳聚糖中进 行降解反应，降解反应过程中加碱使得反应体系的pH为8.4，直至反应体系的粘度为100cp时加入亚硫酸钠停止反应。降解反应中，反应温度为室温。
所述羧甲基壳聚糖的制备方法包括对双氧水降解后的羧甲基壳聚糖进行酸析洗涤。所述酸析洗涤是指用酸调整双氧水降解后的羧甲基壳聚糖料体至pH为6.5，加入乙醇至淡黄色晶体析出，再用酒精反复洗涤，甩干，干燥获得羧甲基壳聚糖。
一、动物试验
将实施例1～4中制备的羧甲基壳聚糖作为试验样品，进行皮肤抗变态动物试验。即动物经2，4一二硝基氯苯(DNCB)皮肤诱导接触后，观察试验样品对皮肤抗变态作用。具体地为：通过豚鼠皮肤经DNCB皮肤诱导接触后，产生变态(过敏)状态，同时涂抹试验样品，经激发接触，观察试验低分子量羧甲基壳聚糖-90对豚鼠皮肤的抗变态作用。
1.试验材料：
试验样品：1.实施例1～4中低分子量羧甲基壳聚糖
2. 2、4一二硝基氯苯(阳性对照)：2、4一二硝基氯苯(DNCB)用医用凡士林配成1％DNCB凡士林油膏供诱导接触使用，配成0.5％DNCB凡士林油膏供激发接触使用。
3.复方醋酸地塞米松乳膏：(样品对照)华润三九医药1504042H
试验动物：白色豚鼠30只，雌雄各半体重：250g-300g
本院动物使用许可证号：SYXK(沪)2014-0018
上海甲干生物科技有限公司生产许可证号：SCXK(沪)2010-0028
2.试验条件：
试验湿温度20℃±2℃，相对湿度60～70％
3.试验方法：
选取健康白色豚鼠30只，剃去脊柱二侧8cm×4cm范围的试验皮肤被毛备用，将动物分为试验样品组，阳性对照组及空白对照组共3个组，每组10只动物。
(1)诱导接触：将1％DNCB凡士林油膏0.2g左右，涂在试验样品组和阳性对照组动物的左侧，再在第7d和第14d以同样方法重复一次。
(2)涂抹试验品：在诱导接触涂抹同时，用同样方法，将试验样品涂抹在样品组动物的右侧，每天一次，连续涂抹28天。
(3)激发接触：末次诱导后14d，将约0.2g的0.5％DNCB凡士林油膏，涂于各组的动物的右侧试验区，观察接触24h后试验区皮肤的反应。
4.评判标准：
当试验组动物出现皮肤红斑反应值为≥1时，判为该动物出现皮肤变态阳性反应。
5.试验结果：
羧甲基脱乙酰壳聚糖皮肤激发接触24h后皮肤变态反应值
Figure PCTCN2016111195-appb-000002
(0)无红斑 (1)轻微红斑 (2)明显红斑 (3)中—重度红斑 (1)为阳性反应。
试验浓度：1.0％，是指采用1.0wt％的羧甲基壳聚糖水溶液。
6.试验结果评判：
实施例1～4中的羧甲基壳糖均对白色豚鼠皮肤有缓解抗变态作用。
二、人体实验
将实施例1～4中制备的羧甲基壳聚糖作为试验样品，进行人体实验，具体为皮肤针刺实验，方案为如下所述。
测定参数：
1皮肤红肿度：视觉评分(从5到1；由严重变为不严重)
2痒感：受试者主观感觉(从5到1；由严重变为不严重)
3水疱面积的减小：测面积法
用特定的试验刀片在皮肤试验部位滴加盐酸组胺(10mg/ml)；
5分钟后，皮肤会产生严重的水疱以及痒感；
应用本发明实施例1～4中低分子量的羧甲基壳聚糖的水溶液2ml，所述低分子量的羧甲基壳聚糖的水溶液的浓度为0.2wt％。
采用实施例1中低分子量的羧甲基壳聚糖溶于水中形成0.2wt％的羧甲基壳聚糖水溶液，取2ml进行人体实验，在应用后的0,3，30,60.90,120,150分钟后测定试验部位的痒感，红肿度和水疱面积见表1所示：
表1
时间(min) 0 3 30 60 90 120 150
红肿(阳性) 3.5 3.5 3.4 2.8 2.2 0.9 0.6
红肿(样品) 3.2 3.0 2.7 1.4 0.9 0.5 0.2
痒感(阳性) 3.8 3.8 3.6 2.7 1.3 1 0.4
痒感(样品) 3.9 1.6 1.4 0.9 0.3 0 0
水疱面积(阳性对照) 100 85 74 67 63 25 15
水疱面积(样品) 100 60 55 42 31 21 5
采用实施例2中低分子量的羧甲基壳聚糖溶于水中形成0.2wt％的羧甲基壳聚糖水溶液，取2ml进行人体实验，在应用后的0,3，30,60.90,120,150分钟后测定试验部位的痒感，红肿度和水疱面积见表2所示：
表2
时间(min) 0 3 30 60 90 120 150
红肿(阳性) 4.0 3.8 3.7 2.9 2.5 1.9 1.3
红肿(样品) 3.8 2.9 2.7 1.4 0.9 0.5 0.2
痒感(阳性) 3.8 3.7 3.5 2.7 1.1 0.8 0.3
痒感(样品) 3.9 1.8 1.6 0.7 0.1 0 0
水疱面积(阳性对照) 100 87 77 69 67 28 20
水疱面积(样品) 100 67 51 40 32 17 8
采用实施例3中低分子量的羧甲基壳聚糖溶于水中形成0.2wt％的羧甲基壳聚糖水溶液，取2ml进行人体实验，在应用后的0,3，30,60.90,120,150分钟后测定试验部位的痒感，红肿度和水疱面积见表3所示：
表3
时间(min) 0 3 30 60 90 120 150
红肿(阳性) 3.8 3.7 3.5 2.7 2.4 1.8 1.1
红肿(样品) 3.5 2.9 2.5 1.5 0.7 0.4 0.2
痒感(阳性) 3.9 3.8 3.6 2.7 1.3 1 0.4
痒感(样品) 3.8 2.2 1.3 0.8 0.2 0 0
水疱面积(阳性对照) 100 89 70 61 46 28 17
水疱面积(样品) 100 60 52 40 32 15 4
采用实施例4中低分子量的羧甲基壳聚糖溶于水中形成0.2wt％的羧甲基壳聚糖水溶液，取2ml进行人体实验，在应用后的0,3，30,60.90,120,150分钟后测定试验部位的痒感，红肿度和水疱面积见表4所示：
表4
时间(min) 0 3 30 60 90 120 150
红肿(阳性) 3.8 3.5 3.3 2.9 1.5 1.0 0.5
红肿(样品) 3.5 3.0 2.2 1.3 0.8 0.4 0.1
痒感(阳性) 3.8 3.8 3.6 2.7 1.3 1 0.4
痒感(样品) 3.9 2.0 1.7 0.8 0.1 0 0
水疱面积(阳性对照) 100 89 72 65 61 33 17
水疱面积(样品) 100 60 52 40 28 17 4
,根据上述动物实验和人体实验的结果可以均表明所述低分子量羧甲基壳聚糖具有良好的抗过敏效果。
将实施例1～4中制备的羧甲基壳聚糖溶于水中，形成羧甲基壳聚糖水溶液即抑菌液。所述羧甲基壳聚糖水溶液的浓度不小于0.1wt％。
上述动物试验是人体试验数据和结果表明，本发明中羧甲基壳聚糖不仅具有抗菌功能，而且还具有抗过敏及消炎和止痒的功效；并且由于本发明中由小分子羧甲基壳聚糖的水溶液形成的抑菌液具有天然成分，其并不含有激素类或其他刺激类化学成分，具有良好的亲肤性和生物相容性。
可将之直接或与其他添加剂混合制成各种抑菌液及各种剂型，用于个人卫生护理用品用无纺布上，所述个人卫生护理用品用无纺布包括用于婴儿和老人用的尿不湿、女性用的卫生巾以及无纺布湿纸巾上使用的无纺布，在制备所述个人卫生护理用品的工艺中，将无纺布的面层浸润或喷洒所述抑菌液。
由此形成一种无纺布，所述个人卫生护理用品包括无纺布层，所述无纺布层采用上述所述的抑菌液形成抑菌层。
实施例5
采用实施例1中的羧甲基壳聚糖溶于水中形成1wt％的羧甲基壳聚糖水溶液。
10cm×10cm的尿不湿布片上喷洒上述羧甲基壳聚糖水溶液0.43g，室温放置过夜晾干，加入尿液10g，36℃恒温培养。稀释倍数100倍后，测试获得的菌落数为100CFU/g。
空白对照试验中，10cm×10cm的尿不湿布片上喷洒0.85g纯水，室温放置过夜晾干，加入加入尿液10g，36℃恒温培养。稀释倍数100倍后，菌落数为1700CFU/g。
抗菌相差倍数为17倍。
实施例6
采用实施例2中的羧甲基壳聚糖溶于水中形成1wt％的羧甲基壳聚糖水溶液。
10cm×10cm的尿不湿布片上喷洒上述羧甲基壳聚糖水溶液0.43g，室温放置过夜晾干，加入尿液10g，36℃恒温培养。稀释倍数100倍后，测试获得的菌落数为10200CFU/g。
空白对照试验中，10cm×10cm的尿不湿布片上喷洒0.85g纯水，室温放置过夜晾干，加入尿液10g，36℃恒温培养。稀释倍数100倍后，菌落数为640000CFU/g。
抗菌相差倍数为62倍。
实施例7
采用实施例3中的羧甲基壳聚糖溶于水中形成1wt％的羧甲基壳聚糖水溶液。
10cm×10cm的尿不湿布片上喷洒上述羧甲基壳聚糖水溶液0.43g，室温放置过夜晾干，加入尿液10g，36℃恒温培养。稀释倍数100倍后，测试获得的菌落数为3040000CFU/g。
空白对照试验中，10cm×10cm的尿不湿布片上喷洒0.85g纯水，室温放置过夜晾干，加入尿液10g，36℃恒温培养。稀释倍数100倍后，菌落数为14000000CFU/g。
抗菌相差倍数为4倍。
上述羧甲基壳聚糖的水溶液其不仅在使用和制备时方便，而且具有抑菌抗过敏、消炎和止痒效果好，无色无味，且其为天然小分子物质，生物相容性和亲肤性好，在用于婴儿和老人用的尿不湿、女性用的卫生巾以及无纺布湿纸巾上使用的无纺布上时能够很有效的避免上述用品的使用者在使用过程中出现的红肿、瘙痒等的皮肤问题。
将上述所述抑菌液用在制备无纺布的工艺中，将无纺布的面层浸润或喷洒所述抑菌液以使得无纺布的面层形成抑菌层，从而达到良好的抑菌效果，满足使用者的使用需求。
以上所述，仅为本发明的较佳实施例，并非对本发明任何形式上和实质上的限制，应当指出，对于本技术领域的普通技术人员，在不脱离本发明方法的前提下，还将可以做出若干改进和补充，这些改进和补充也应视为本发明的保护范围。凡熟悉本专业的技术人员，在不脱离本发明的精神和范围的情况下，当可利用以上所揭示的技术内容而做出的些许更动、修饰与演变的等同变化，均为本发明的等效实施例；同时，凡依据本发明的实质技术对上述实施例所作的任何等同变化的更动、修饰与演变，均仍属于本发明的技术方案的范围内。

Claims (10)

  1. 一种的抑菌液，其特征在于：所述的抑菌液为含有羧甲基壳聚糖的水溶液，所述羧甲基壳聚糖的数均分子量为1000～20000。
  2. 根据权利要求1所述的抑菌液，其特征在于：所述抑菌液还包括以下特征中的一种或多种：
    所述羧甲基壳聚糖水溶液的浓度为不小于0.1wt％；
    所述羧甲基壳聚糖为O-羧甲基脱乙酰壳多糖。
  3. 根据权利要求1所述的抑菌液，其特征在于：所述羧甲基壳聚糖的制备方法包括将数均分子量较高的羧甲基壳聚糖原料通过双氧水降解，所述数均分子量较高的羧甲基壳聚糖原料中羧甲基壳聚糖的数均分子量30～70万。
  4. 根据权利要求2所述的抑菌液，其特征在于：所述数均分子量较高的羧甲基壳聚糖原料中羧甲基取代度为0.8～1.3。
  5. 根据权利要求2所述的抑菌液，其特征在于：双氧水降解的工艺为：将双氧水在搅拌条件下加入数均分子量较高的羧甲基壳聚糖中进行降解反应，降解反应过程中加碱使得反应体系的pH为8.0～8.5，直至反应体系的粘度为80～120cp时加入亚硫酸钠停止反应。
  6. 根据权利要求2所述的抑菌液，其特征在于：所述羧甲基壳聚糖的制备方法包括对双氧水降解后的羧甲基壳聚糖进行酸析洗涤。
  7. 根据权利要求5所述的抑菌液，其特征在于：所述酸析洗涤是指用酸调整双氧水降解后的羧甲基壳聚糖料体至pH为6～7，加入乙醇至淡黄色晶体析出，再用酒精反复洗涤，甩干，干燥获得羧甲基壳聚糖。
  8. 一种如权利要求1～7任一项所述的抑菌液在制备卫生护理用品上的用途。
  9. 如权利要求8所述的用途，其特征在于：所述个人卫生护理用品包括无纺布层，所述无纺布层采用权利要求1～8所述的抑菌液形成抑菌层。
  10. 如权利要求9所述的用途，其特征在于：个人卫生护理用品上的无纺布层包括用于婴儿和老人用的尿不湿、女性用的卫生巾、无纺布湿纸巾和面膜上使用的无纺布层。
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