CN107744524B - Iodine-containing tincture antibacterial gel and preparation method thereof - Google Patents
Iodine-containing tincture antibacterial gel and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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Abstract
The invention discloses iodine-containing tincture antibacterial gel and a preparation method thereof, wherein the iodine-containing tincture antibacterial gel comprises the following components in percentage by mass: 0.5 to 10 percent of iodine tincture, 0.1 to 3 percent of macromolecular thickening agent, 0.1 to 5 percent of chitosan or chitin derivative, 0.05 to 2 percent of zinc salt, 10 to 75 percent of alcohol and 20 to 80 percent of pure water. The iodine tincture is complexed with the chitosan/chitin derivative, so that iodine molecules are embedded into the axial center of the spirochete of the chitosan/chitin derivative to form a light yellow or colorless transparent inclusion compound, iodine in the system is more stably present in gel, a wound surface can be protected after the iodine tincture is smeared to form a film, the antibacterial/bactericidal efficacy is continuously exerted, the wound surface healing promoting effect of the chitosan/chitin derivative is exerted, a good healing environment is provided for the wound surface, the irritation and the corrosivity of a product are effectively reduced, yellow dyeing is avoided, and deiodination is not needed after the iodine tincture is used. The invention has strong bacteriostatic action on pathogenic bacteria such as escherichia coli, staphylococcus aureus, candida albicans and the like, and can be applied to the antibiosis/bacteriostasis of bacteria and fungi. It can also be used for inhibiting bacteria caused by mosquito bite, skin pruritus, skin red swelling, and acne.
Description
Technical Field
The invention relates to a bacteriostatic agent and a preparation method thereof, in particular to iodine-containing tincture bacteriostatic gel and a preparation method thereof.
Background
Iodine tincture, also known as iodine tincture, is a well-known sterilizing disinfectant, can efficiently kill pathogenic bacteria, spores, protozoa, molds, fungi, viruses and the like which infect skin, and has the action mechanism of oxidizing the active groups of protoplasm protein of the iodine tincture and combining with amino groups of protein to denature the protein so as to oxidize and inactivate enzyme protein. The iodine ions can rapidly destroy pathogenic bacteria and gradually shrink the affected part to make necrotic tissue fall off, and collagen fiber cells proliferate and repair skin.
Iodine tincture has the defects of strong irritation, strong corrosivity, need of alcohol for deiodination, instability, yellow and ugly skin after being smeared, easy contamination to clothes and the like.
In order to overcome the defects of iodine, a great deal of research work is carried out by scientific researchers. In the 50 s of the 20 th century, people developed iodophor, namely complex iodine, so that the sterilizing effect of iodine can be kept, the irritation and corrosivity of iodine can be reduced, and the utilization of iodine elements by human is improved to a new height.
Specifically, the complex iodine is various amorphous complexes formed by complexing iodine with complexing agents such as surfactants and the like, and has no fixed molecular formula and molecular weight. The complex iodine has different physical and chemical properties, sterilizing effect, safety, stability and the like due to different carriers, formulas and processes and different complexing degrees of various complex iodine. At present, more than 100 types of iodophors are reported in domestic and foreign documents. In developed western countries, povidone iodine (PVP-I) was screened from numerous iodophors in the last 80 years, and is widely used in clinical applications in hospitals, and is listed in pharmacopoeias of america, china, the united kingdom, japan, and the like. Povidone iodine has good killing effect on bacterial propagules (such as staphylococcus aureus, escherichia coli, streptococcus, pseudomonas aeruginosa and the like), mycobacterium tuberculosis, bacteriophage, bacterial spores, fungi, viruses and protozoa, is slightly influenced by environment and organic matters, and is a preferred skin, mucous membrane and surgical operation disinfectant at home and abroad at present.
Although povidone iodine has less volatility, good water solubility, relatively less irritation and is easier to elute than iodine tincture, there are some disadvantages to be improved, such as povidone iodine is a reddish brown liquid, and can stain skin after being applied, and pigmentation is easy to generate; although less irritating than iodine tincture, it can still cause anaphylaxis and irritation to skin and mucous membrane, and can cause obvious absorption, local irritation and burning sensation of iodine when applied externally to pregnant women, lactating mothers and infants; povidone iodine has the effect of dehydrating tissues, so that the wound surface is dry and is not beneficial to wound surface healing; povidone iodine is unstable under illumination and heat and needs to be stored away from light; povidone iodine still has certain corrosiveness, and the metal product can be corroded after being soaked for a long time.
Disclosure of Invention
In view of the above problems, the present invention aims to provide a pale yellow or colorless transparent iodine tincture antibacterial gel which can continuously exert antibacterial/bacteriostatic effects, effectively reduce irritation, and does not stain skin.
The gel contains broad-spectrum antibacterial iodine tincture components and chitosan/chitin derivative components for promoting wound healing, and due to good film forming property and slow release property of the chitosan/chitin derivative, a layer of protective film can be formed on a wound surface after the chitosan/chitin derivative is coated, the effective antibacterial/bactericidal component iodine is slowly released, the antibacterial/bactericidal efficacy is continuously exerted, overhigh local iodine concentration can be avoided, iodine corrosivity is avoided, the lower frequency use frequency of the gel compared with other antibacterial products can achieve better effect, and the gel has better safety. Meanwhile, the gel plays the moisturizing performance of the chitosan/chitin derivative, promotes cell growth and promotes wound healing, provides a good environment for wound repair, and effectively promotes wound healing.
The invention also aims to provide a preparation method of the iodine tincture-containing antibacterial gel.
The invention comprises iodine tincture, high molecular thickener, chitosan/chitin derivative, zinc salt, alcohol and water, wherein iodine tincture is complexed with chitosan/chitin derivative, and iodine acts with hydroxyl of chitosan/chitin derivative, so that iodine molecules are embedded into the axial center of spirochete of chitosan/chitin derivative to form a light yellow or colorless transparent inclusion compound, iodine in the system is more stable in gel, the wound surface can be protected after being coated and formed into a film, the bacteriostasis/sterilization effect is continuously exerted, the wound surface healing promotion effect of chitosan/chitin derivative is exerted, a good healing environment is provided for the wound surface, the irritation and corrosivity of the product are effectively reduced, yellow dyeing is avoided, and deiodination is not needed after the use.
The specific technical scheme of the invention is as follows:
an iodine-containing tincture antibacterial gel comprises the following components in percentage by mass: 0.5 to 10 percent of iodine tincture, 0.1 to 3 percent of macromolecular thickening agent, 0.1 to 5 percent of chitosan or chitin derivative, 0.05 to 2 percent of zinc salt, 10 to 75 percent of alcohol and 20 to 80 percent of pure water.
The iodine tincture is prepared by mixing iodine, potassium iodide, alcohol and pure water according to a certain proportion, wherein the mass ratio of the iodine to the potassium iodide is (0.5-10): 1, the volume percentage concentration of the alcohol is 10-75%.
The macromolecular thickener is one or more of hydroxyethyl methylcellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, carboxymethyl hydroxyethyl cellulose, hydroxypropyl cellulose, carbomer or xanthan gum.
The chitosan or chitin derivative is one or more of carboxylated chitosan, benzoylated chitosan, cyanoethyl chitosan, hydroxypropyl chitin, hydroxyethyl chitosan, hydroxyethyl chitin, carboxymethyl chitosan, carboxymethyl chitin, carboxyethyl chitosan, carboxyethyl chitin, succinyl chitosan, succinyl chitin, sulfonated chitosan, sulfonated chitin, benzaldehyde schiff base of chitosan, N-ethyl chitosan, N-succinylated chitosan, N-maleylated chitosan, N-phthaloylated chitosan and N-acetylated chitosan.
The zinc salt is one or more of zinc lactate, zinc gluconate, zinc acetate, zinc borate, zinc amino acid, zinc glycyrrhizate, zinc citrate, zinc borate, zinc chloride, zinc acetate, and zinc borate.
The preparation method comprises the following steps: (1) adding pure water and alcohol into a reaction container, adding zinc salt, stirring and dissolving, then adding a high-molecular thickening agent, heating to 30-45 ℃, stirring at a low speed for 2-6 hours, and stirring at a high speed for 30-60 min or emulsifying at a high speed for 10-40 min; (2) adding chitosan or chitin derivatives, stirring at low speed for 2-6 hours at 30-45 ℃, stirring at high speed for 30-60 min or emulsifying for 10-40 min, standing for 5-7 hours, and naturally cooling to room temperature; (3) slowly adding iodine tincture solution, stirring or emulsifying at high speed for 10-60 min, stirring at low speed for 30-60 min, keeping out of the sun, sealing in a container, standing and decolorizing to obtain the iodine tincture antibacterial gel.
The invention takes iodine tincture and chitosan/chitin derivative as main effective components to prepare faint yellow or colorless transparent gel, the iodine tincture is complexed with the components in the gel to enable the gel to be faint yellow or colorless transparent gel, the chitosan/chitin derivative has the efficacy of promoting wound healing and good film-forming property, and the gel becomes a film after being smeared, thereby not only protecting the wound from external pollution and continuously playing the role of antibiosis/bacteriostasis, forming a microenvironment beneficial to wound healing to promote wound healing to heal, but also solving the problems that the iodine tincture needs alcohol deiodination, corrosion, high irritation, yellow dyeing and the like, and improving the safety and efficacy of the product. Compared with povidone iodine, the color of the invention is lighter, the gel is almost colorless and transparent, the aesthetic degree of the product is greatly improved, and after the invention is smeared, a layer of protective film can be formed on the surface of skin, the functions of antibiosis and healing promotion can be continuously exerted while the wound surface is protected, the lower frequency use frequency can achieve better effect, and the irritation is lower and the safety is higher. The invention has strong bacteriostatic action on pathogenic bacteria such as escherichia coli, staphylococcus aureus, candida albicans and the like, and can be applied to the antibiosis/bacteriostasis of bacteria and fungi. And can be used for inhibiting bacteria of skin discomfort symptoms caused by bacteria, fungi, etc., relieving skin tinea, preventing wound infection, and promoting wound healing. It can also be used for inhibiting bacteria caused by mosquito bite, skin pruritus, skin red swelling, and acne.
Detailed Description
The present invention is described in detail below with reference to specific embodiments so that the advantages and features of the present invention can be more easily understood by those skilled in the art, thereby making the scope of the present invention more clearly defined.
Example 1:
weighing 35L of pure water into a vacuum emulsifying machine, adding 60L of 95% alcohol, stirring, adding 0.1kg of zinc gluconate, stirring, adding 0.5kg of hydroxyethyl cellulose after dissolution, heating to 35-40 ℃, stirring at a low speed for 3-5 hours, emulsifying at a high speed for 5-20 minutes, adding 3kg of hydroxypropyl chitosan (pH 6-8, degree of substitution is more than or equal to 60 percent, Qingdao Honghai biotechnology limited company), stirring at 35-40 ℃ for 2-3 hours, and emulsifying at a high speed for 10-30 minutes to uniformly mix the two. Standing for 5-7 hours to naturally cool to room temperature, then adding 0.6L of iodine tincture solution (self-made iodine tincture solution, the mass ratio of iodine to potassium iodide is 2: 1, and the volume percentage concentration of alcohol is 60%), emulsifying at high speed for 10min, stirring at low speed for 30min-60min, placing into a container, sealing, keeping dark, and standing for about 7 days for decolorization to obtain iodine tincture antibacterial gel A.
Example 2:
weighing 43L of pure water in a vacuum emulsifying machine, adding 50L of 95% alcohol, stirring, adding 0.2kg of zinc acetate, stirring, dissolving, adding 1kg of hydroxypropyl cellulose, heating to 35-40 ℃, stirring at a low speed for 3-5 hours, emulsifying at a high speed for 5-20min, adding 2kg of carboxymethyl chitin (pH 6-8, degree of substitution is more than or equal to 80%) and stirring at 35-40 ℃ for 2-3 hours, emulsifying at a high speed for 10-30min, and uniformly mixing the two. Standing for 5-7 hours to naturally cool to room temperature, then adding 2L of iodine tincture (self-made iodine tincture solution, the mass ratio of iodine to potassium iodide is 4: 1, and the volume percentage concentration of alcohol is 50%), emulsifying at high speed for 15min, stirring at low speed for 30min-60min, placing into a container, sealing, keeping dark, standing for about 15 days, and decolorizing to obtain iodine tincture antibacterial gel B.
Example 3:
weighing 53L of pure water into a vacuum emulsifier, adding 40L of 95% alcohol, stirring, adding 1kg of zinc acetate, stirring, dissolving, adding 2kg of carboxymethyl hydroxyethyl cellulose, heating to 35-40 ℃, stirring at a low speed for 3-5 hours, emulsifying at a high speed for 5-20min, adding 2kg of sulfonated chitosan (self-made, pH 6-8, and the degree of substitution is more than or equal to 60%), stirring at 35-40 ℃ for 2-3 hours, emulsifying at a high speed for 10-30min, and uniformly mixing the two. Standing for 5-7 hours to naturally cool to room temperature, then adding 5L of iodine tincture (self-made iodine tincture solution, the mass ratio of iodine to potassium iodide is 5: 1, and the volume percentage concentration of alcohol is 40%), emulsifying at high speed for 20min, stirring at low speed for 30min-60min, placing into a container, sealing and standing for about 20 days to decolorize, and obtaining the iodine tincture antibacterial gel C.
Example 4: iodine tincture antibacterial gel antibacterial effect
The iodine tincture bacteriostasis gel A, B, C prepared in examples 1-3 is subjected to bacteriostasis performance measurement according to a test method of bacteriostasis performance of dissoluble antibacterial (bacteriostasis) products in appendix C of GB 15979-2002 disposable sanitary article sanitation Standard, and the result shows that the iodine tincture bacteriostasis gel A, B, C has strong bacteriostasis on escherichia coli, staphylococcus aureus and candida albicans. Specific results are shown in table 1.
TABLE 1 bacteriostatic effect of iodine tincture bacteriostatic gel on test bacteria
Note: negative control was grown aseptically.
Example 5:
the iodine tincture antibacterial gel A, B, C prepared in the examples 1-3 is subjected to irritation evaluation according to one-time damaged skin irritation test, multiple complete skin irritation test, vaginal mucosa irritation test and skin allergy test in disinfection product toxicology test technical specification 2002 edition 2.3, and the results show that the three iodine tincture antibacterial gels have no irritation to damaged skin, complete skin and vaginal mucosa, have no skin allergy and have good safety.
Example 6: healing promoting effect of iodine tincture antibacterial gel
Wistar rats were used as test animals, 40 rats, male and female, and 250 g. + -. 20g body weight. The test was divided into 4 groups: povidone iodine control group, iodine tincture antibacterial gel A group, iodine tincture antibacterial gel B group, and iodine tincture antibacterial gel C group, each group contains 10 iodine tincture antibacterial gel C groups. 2% (weight percent, the same applies below) pentobarbital sodium is intraperitoneally injected at 30mg/kg of body weight for anesthesia, the back of a rat is fixed on an operation frame upwards, hairs with the area of 1cm multiplied by 2cm are shaved off from the back by a razor blade, and a 1.5cm long incision with the depth of 1mm is made at the hair removal part of the back by a sterilized blade. Each test group was subjected to the following treatments: (1) the wound surface of a rat of the control group is coated and covered by povidone iodine solution of the control group; (2) iodine tincture antibacterial gel A test group rats coated iodine tincture gel at the incision to completely cover the wound surface; (3) iodine tincture antibacterial gel B test group rats coated iodine tincture gel at the incision to completely cover the wound surface; (4) iodine tincture antibacterial gel C test group rats coated iodine tincture gel at the incision to completely cover the wound. And (3) wrapping the rats in each group after operation by using sterile gauze, normally feeding the rats, changing the medicine every day, and observing the wound healing condition of the rats so as to evaluate the influence of the iodine tincture antibacterial gel on the wound healing of the rats. The results are shown in Table 2.
TABLE 2 results of healing promotion test of iodine tincture antibacterial gel
| Group of | Animal group (only/group) | Average number of days to heal wound |
| Povidone-iodine control group | 10 | 9.5 days |
| Iodine tincture antibacterial gel A | 10 | 6 days |
| Iodine tincture antibacterial gel B | 10 | 5.5 days |
| Iodine tincture antibacterial gel C | 10 | 5.5 days |
Test results prove that the iodine tincture antibacterial gel has a wound healing promoting effect which is obviously superior to that of povidone iodine.
In conclusion, the examples 4 to 6 prove that the iodine tincture antibacterial gel has excellent antibacterial effect and no irritation, and can effectively promote the healing of the wound surface, so that the iodine tincture antibacterial gel has wide application prospect as a novel antibacterial gel for promoting the healing.
Claims (3)
1. The iodine-containing tincture antibacterial gel is characterized by comprising the following components in percentage by mass: 0.5 to 10 percent of iodine tincture, 0.1 to 3 percent of macromolecular thickening agent, 0.1 to 5 percent of chitosan derivative or chitin derivative, 0.05 to 2 percent of zinc salt, 10 to 75 percent of alcohol and 20 to 80 percent of pure water; the chitosan derivative or the chitin derivative is one or more of carboxylated chitosan, benzoylated chitosan, cyanoethyl chitosan, hydroxypropyl chitin, hydroxyethyl chitosan, hydroxyethyl chitin, carboxymethyl chitosan, carboxymethyl chitin, carboxyethyl chitosan, carboxyethyl chitin, succinyl chitosan, succinyl chitin, sulfonated chitosan, sulfonated chitin, benzaldehyde schiff base of chitosan, N-ethyl chitosan, N-succinylated chitosan, N-maleylated chitosan, N-phthaloylated chitosan and N-acetylated chitosan;
the iodine-containing tincture antibacterial gel is prepared by the following method: (1) adding pure water and alcohol into a reaction container, adding zinc salt, stirring and dissolving, then adding a high-molecular thickening agent, heating to 30-45 ℃, stirring at a low speed for 2-6 hours, and stirring at a high speed for 30-60 min or emulsifying at a high speed for 10-40 min; (2) adding chitosan derivative or chitin derivative, stirring at low speed for 2-6 hr at 30-45 deg.C, stirring at high speed for 30-60 min or emulsifying for 10-40 min, standing for 5-7 hr, and naturally cooling to room temperature; (3) slowly adding iodine tincture solution, stirring or emulsifying at high speed for 10-60 min, stirring at low speed for 30-60 min, keeping out of the sun, sealing in a container, standing and decolorizing to obtain the iodine tincture antibacterial gel.
2. Bacteriostatic gel according to claim 1, characterized in that the polymeric thickener is one or more of hydroxyethyl methylcellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, carboxymethyl hydroxyethyl cellulose, hydroxypropyl cellulose, carbomer or xanthan gum.
3. Bacteriostatic gel according to claim 1, characterized in that the zinc salt is one or more of zinc lactate, zinc gluconate, zinc acetate, zinc borate, zinc amino acid, zinc glycyrrhizate, zinc citrate, zinc chloride.
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| CN112426561A (en) * | 2020-10-26 | 2021-03-02 | 上海迪派生物科技有限公司 | Hydrogel with continuous antibacterial ability |
| CN115105624B (en) * | 2022-08-26 | 2022-11-08 | 广东海洋大学 | Marine polysaccharide-based efficient antibacterial film dressing and preparation method thereof |
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| CN1685829A (en) * | 2005-04-30 | 2005-10-26 | 武汉大学 | Preparation method of chitin/zinc compound bactericide |
| CN102886062A (en) * | 2011-07-21 | 2013-01-23 | 武汉市三鼎医用生物制品有限公司 | Iodinated chitosan biological antibacterial gel |
| CN104958778A (en) * | 2015-06-23 | 2015-10-07 | 青岛博益特生物材料股份有限公司 | Antibacterial healing promoting material for oral cavities and application of antibacterial healing promoting material |
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| CN1685829A (en) * | 2005-04-30 | 2005-10-26 | 武汉大学 | Preparation method of chitin/zinc compound bactericide |
| CN102886062A (en) * | 2011-07-21 | 2013-01-23 | 武汉市三鼎医用生物制品有限公司 | Iodinated chitosan biological antibacterial gel |
| CN104958778A (en) * | 2015-06-23 | 2015-10-07 | 青岛博益特生物材料股份有限公司 | Antibacterial healing promoting material for oral cavities and application of antibacterial healing promoting material |
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