阅读说明：本技术 一种基于聚六亚甲基胍的消毒用涂膜剂及其制备方法 (Polyhexamethylene guanidine-based film coating agent for disinfection and preparation method thereof ) 是由 房志仲 林培鸿 于 2021-07-09 设计创作，主要内容包括：本发明提供一种基于聚六亚甲基胍的消毒用涂膜剂及其制备方法,所述基于聚六亚甲基胍的消毒用涂膜剂的配方如下：聚六亚甲基胍：0.25-0.5；中药材提取物：0.1-5.0；成膜材料：5.0-15.0；增塑剂：2.0-4.0；保湿剂/致孔剂：10-15；乙醇：20-75；余量为精制水；该基于聚六亚甲基胍的消毒用涂膜剂以多组分形成的复方消毒用涂膜剂,能够扩大杀菌及抗病毒作用,利用成膜材料的成膜特性,涂布在手臂上能够形成一层不溶于水的保护膜,具有隐形手套的作用,同时加入了保湿剂/致孔剂,不影响皮肤的生理功能及手指的正常工作,具有杀菌迅速、维持时间长的特点。(The invention provides a polyhexamethylene guanidine-based film coating agent for disinfection and a preparation method thereof, wherein the formula of the polyhexamethylene guanidine-based film coating agent for disinfection is as follows: polyhexamethylene guanidine: 0.25-0.5; chinese medicinal material extract: 0.1-5.0; film-forming materials: 5.0-15.0; plasticizer: 2.0-4.0; humectant/porogen: 10-15 parts of; ethanol: 20-75 parts of; the balance of refined water; the polyhexamethylene guanidine-based compound film coating agent for disinfection is a compound film coating agent for disinfection formed by multiple components, can expand the effects of sterilization and virus resistance, can form a layer of water-insoluble protective film on an arm by utilizing the film forming property of a film forming material, has the effect of a hidden glove, is added with a humectant/pore forming agent, does not influence the physiological function of skin and the normal work of fingers, and has the characteristics of rapid sterilization and long maintenance time.)

1. The polyhexamethylene guanidine-based film coating agent for disinfection is characterized by comprising the following formula: polyhexamethylene guanidine: 0.25-0.5; chinese medicinal material extract: 0.1-5.0; film-forming materials: 5.0-15.0; plasticizer: 2.0-4.0; humectant/porogen: 10-15 parts of; ethanol: 20-75 parts of; the balance being refined water.

2. The polyhexamethylene guanidine-based disinfecting film coating agent according to claim 1, characterized in that: the film forming material is one or a combination of polyvinyl butyral (PVB), povidone (PVP), polyvinyl alcohol (PVA), ethylene-vinyl acetate copolymer (EVA) and hydroxypropyl methylcellulose, preferably polyvinyl butyral or ethylene-vinyl acetate copolymer, and most preferably polyvinyl butyral.

3. The polyhexamethylene guanidine-based disinfecting film coating agent according to claim 1, characterized in that: the plasticizer is one or a combination of phthalic acid ester, citric acid ester and sebacic acid ester, preferably triethyl citrate, dibutyl phthalate or acetyl tributyl citrate, most preferably triethyl citrate, the phthalic acid ester comprises but is not limited to dibutyl phthalate and benzyl butyl phthalate, the citric acid ester comprises but is not limited to triethyl citrate and acetyl tributyl citrate, and the sebacic acid ester comprises but is not limited to dibutyl sebacate.

4. The polyhexamethylene guanidine-based disinfecting film coating agent according to claim 1, characterized in that: the humectant/pore-forming agent is one or a combination of more of glycerol, propylene glycol or polyethylene glycol-400, preferably glycerol.

5. The polyhexamethylene guanidine-based disinfecting film coating agent according to claim 1, characterized in that: the traditional Chinese medicine extract is a fluid extract obtained by mixing more than one traditional Chinese medicine, extracting by a water extraction-alcohol precipitation method, recovering ethanol and concentrating.

6. The method for preparing a polyhexamethylene guanidine-based film coating agent for disinfection according to any one of claims 1 to 5, comprising the following specific steps:

the method comprises the following steps: taking a proper amount of various raw materials according to a formula for later use;

step two: adding the film forming material into ethanol, stirring to dissolve the film forming material, adding the plasticizer, and uniformly stirring;

step three: dissolving polyhexamethylene guanidine and Chinese medicinal material extract in refined water, adding humectant/pore-forming agent, and stirring;

step four: and (4) adding the liquid obtained in the third step into the liquid obtained in the second step, and uniformly stirring to obtain the polyhexamethylene guanidine-based film coating agent for disinfection.

Technical Field

The invention belongs to the technical field of film coating agents, and particularly relates to a polyhexamethylene guanidine-based film coating agent for disinfection and a preparation method thereof.

Background

A pharmaceutical preparation, GUAN JIAO LU (plastics coating agent), is an external preparation prepared by dissolving or dispersing medicine in solvent of film-forming material, and applying on affected part to form film. The product is applied to the affected part, and the solvent is volatilized to form a film, which has protective effect on the affected part and can gradually release the medicine to achieve therapeutic effect. The environment-friendly high molecular polymer disinfectant, polyhexamethylene guanidine, has the excellent performances of broad-spectrum sterilization, quick action, low effective concentration, high action speed, stable property and easy water solubility; can be used at normal temperature, and has long-term antibacterial effect, no adverse side effect, no corrosiveness, no color, no odor, and no toxicity; the material is non-combustible, non-explosive and safe to use; the price is moderate; the polyhexamethylene guanidine bactericide is convenient to transport and is the best bactericide, and the principle of polyhexamethylene guanidine sterilization is that the polyhexamethylene guanidine bactericide is combined with fatty acid in cell membrane phospholipid by acting on a membrane system of cell walls and cytoplasm of bacteria and fungi, so that cytoplasmic membranes of the bacteria and fungi are quickly punctured, the core of germ cells is broken, and living substances in germ bodies flow out, so that the sterilization effect is achieved. Can be used in combination with other bactericides to exert excellent disinfection effect. Since polyhexamethylene guanidine has a nonspecific bactericidal pattern, the possibility that the bacteria will develop resistance to it is very small.

The Chinese medicinal materials of flavescent sophora root, cnidium fruit, rhubarb, broom cypress fruit and stemona root, etc. have been proved to have the functions of sterilization and virus inhibition in and out of human body.

Ethanol is a common medical disinfectant, has the sterilization effect of denaturing protein of pathogens such as bacteria and the like, and is characterized by quick action.

However, the prior art has not provided a film-forming preparation which can rapidly sterilize and has a sustained bacteriostatic action. Under the current severe environment of epidemic prevention, a film coating agent with a continuous disinfection and sterilization effect is urgently needed to be used as an auxiliary and substitute product of other personal hygiene products, and therefore, the invention provides a polyhexamethylene guanidine-based disinfection film coating agent and a preparation method thereof.

Disclosure of Invention

The polyhexamethylene guanidine-based disinfection coating agent is a compound disinfection coating agent formed by multiple components, can expand the sterilization and antivirus effects, can form a layer of water-insoluble protective film on an arm by utilizing the film forming property of a film forming material, has the effect of a hidden glove, is added with a humectant/pore forming agent, does not influence the physiological function of the skin and the normal work of fingers, and has the characteristics of rapid sterilization and long maintenance time.

In order to achieve the purpose, the invention is realized by the following technical scheme: a polyhexamethylene guanidine-based disinfectant coating agent comprises the following formula: polyhexamethylene guanidine: 0.25-0.5; chinese medicinal material extract: 0.1-5.0; film-forming materials: 5.0-15.0; plasticizer: 2.0-4.0; humectant/porogen: 10-15 parts of; ethanol: 20-75 parts of; the balance being refined water.

As a preferred embodiment of the present invention, the film-forming material is one or a combination of several of polyvinyl butyral (PVB), povidone (PVP), polyvinyl alcohol (PVA), ethylene-vinyl acetate copolymer (EVA) and hypromellose, preferably polyvinyl butyral or ethylene-vinyl acetate copolymer, and most preferably polyvinyl butyral.

As a preferred embodiment of the present invention, the plasticizer is one or a combination of phthalic acid ester, citric acid ester and sebacic acid ester, preferably triethyl citrate, dibutyl phthalate or acetyl tributyl citrate, most preferably triethyl citrate, the phthalic acid ester includes but is not limited to dibutyl phthalate and benzyl butyl phthalate, the citric acid ester includes but is not limited to triethyl citrate and acetyl tributyl citrate, and the sebacic acid ester includes but is not limited to dibutyl sebacate.

As a preferred embodiment of the present invention, the humectant/pore-forming agent is one or a combination of several of glycerin, propylene glycol or polyethylene glycol-400, preferably glycerin.

As a preferred embodiment of the invention, the Chinese medicinal material extract is prepared from one or more of radix sophorae flavescentis, fructus cnidii, rheum officinale, fructus kochiae and fructus schisandrae chinensis.

A preparation method of a polyhexamethylene guanidine-based disinfectant coating agent comprises the following specific steps:

the method comprises the following steps: taking a proper amount of various raw materials according to a formula for later use;

step two: adding the film forming material into ethanol, stirring to dissolve the film forming material, adding the plasticizer, and uniformly stirring;

step three: dissolving polyhexamethylene guanidine and Chinese medicinal material extract in refined water, adding humectant/pore-forming agent, and stirring;

step four: and (4) adding the liquid obtained in the third step into the liquid obtained in the second step, and uniformly stirring to obtain the polyhexamethylene guanidine-based film coating agent for disinfection.

The invention has the beneficial effects that:

1. the polyhexamethylene guanidine-based compound film coating agent for disinfection is a compound film coating agent for disinfection formed by multiple components, can expand the effects of sterilization and virus resistance, can form a layer of water-insoluble protective film on an arm by utilizing the film forming property of a film forming material, has the effect of a hidden glove, is added with the humectant/pore forming agent, does not influence the physiological function of the skin and the normal work of fingers, and has the characteristics of rapid sterilization and long maintenance time.

2. The polyhexamethylene guanidine-based film coating agent for disinfection is uniformly coated on the skin of hands and bodies, can form a protective film within 1-2 minutes, achieves the effect of quick sterilization, has a continuous bacteriostatic action, does not influence the normal physiological function of the skin, has no irritation to the skin, and is convenient to use.

3. The polyhexamethylene guanidine-based film coating agent for disinfection disclosed by the invention is prepared by jointly applying polyhexamethylene guanidine, a traditional Chinese medicine extract, polyvinyl butyral and ethanol, has the characteristics of quickly forming a protective film on an arm, quickly sterilizing and maintaining a long-acting effect, and has excellent moisturizing, lubricating and pore-causing properties of glycerin, propylene glycol and polyethylene glycol, so that the normal physiological function of skin is not influenced, and the skin is not irritated.

Drawings

FIG. 1 is a flow chart of a method for preparing polyhexamethylene guanidine-based disinfectant coating agents.

Detailed Description

In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific embodiments.

Referring to fig. 1, the present invention provides a technical solution:

example 1

Adding 10 g of polyvinyl butyral (PVB) into 80 g of ethanol, stirring and dissolving, adding 3.0 g of triethyl citrate, stirring and dissolving to prepare a solution 1; putting 0.5 g of polyhexamethylene guanidine into 5 g of refined water, adding 5 g of mixed extract of radix sophorae flavescentis, fructus cnidii, rheum officinale, fructus kochiae and radix stemonae and 10 g of glycerol, and stirring to dissolve to prepare a solution 2; adding the solution 2 into the solution 1, stirring uniformly, and supplementing the balance of refined water to 100 g to obtain the disinfectant film coating agent combining the polyhexamethylene guanidine and the traditional Chinese medicine extract.

Example 2

Adding 3 g of ethylene-vinyl acetate copolymer (EVA) into 80 g of ethanol, stirring for dissolving, and adding 4 g of acetyl tributyl citrate to prepare a solution 1; putting 0.5 g of polyhexamethylene guanidine into 5 g of refined water, adding 5 g of mixed extract of radix sophorae flavescentis, fructus cnidii, rheum officinale, fructus kochiae and radix stemonae and 10 g of propylene glycol, and stirring to dissolve to prepare a solution 2; adding the solution 2 into the solution 1, stirring uniformly, and supplementing the balance of refined water to 100 g to obtain the disinfectant film coating agent combining the polyhexamethylene guanidine and the traditional Chinese medicine extract.

Sterilization test of the disinfectant coating agent: the disinfecting film coatings of the above examples 1-2 have average killing log values of > 5.00 when applied to staphylococcus aureus, escherichia coli, candida albicans, pseudomonas aeruginosa, and the like for 2-3 minutes at 19-21 ℃.

Bacteriostatic test of the film coating agent for disinfection: the coating agents of the embodiments 1 and 2 are uniformly coated on corresponding culture media, and the effects of inhibiting the growth of bacteria are shown when the killing effects on staphylococcus aureus, escherichia coli, candida albicans, pseudomonas aeruginosa and the like are observed within 1, 2, 3 and 4 hours;

preparing a flat plate by using a trypticase soy peptone agar culture medium, coating the coating agents of the embodiments 1 and 2 on the surface of the culture medium after solidification, dropwise adding staphylococcus aureus and pseudomonas aeruginosa liquid 1 drop on the surface of the film after 0 hour, 1 hour, 2 hours and 4 hours respectively after the bacteriostatic agent forms the film, culturing at 30-35 ℃, and observing the growth condition of a bacterial colony, wherein the specific formula is as follows:

TABLE 1 summary of the results of the bacteriostatic tests of the disinfectant film-forming agents

And (4) conclusion: the film coating agent for disinfection forms a film on the surface of a trypticase soy peptone agar medium, prevents bacteria from contacting with the medium, inhibits the growth of the bacteria, does not generate bacterial colonies, and has the same bacteriostatic experiment effect in 2 hours as the result in 1 hour and 4 hours.

Stability test of film coating agent for disinfection: the result of the accelerated test of the film coating agent of the embodiment 1-2 according to the drug stability test item in the 'Chinese pharmacopoeia' 2020 edition shows that the content of polyhexamethylene guanidine and the content of ethanol decrease rate are both less than 5% after being placed for 6 months under the test condition of 40 +/-2 ℃, and the product validity period is predicted to be more than 2 years.

While there have been shown and described what are at present considered the fundamental principles and essential features of the invention and its advantages, it will be apparent to those skilled in the art that the invention is not limited to the details of the foregoing exemplary embodiments, but is capable of other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.