CN112891323B - anti-HIV external disinfectant and preparation method thereof - Google Patents
anti-HIV external disinfectant and preparation method thereof Download PDFInfo
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- CN112891323B CN112891323B CN202110052954.7A CN202110052954A CN112891323B CN 112891323 B CN112891323 B CN 112891323B CN 202110052954 A CN202110052954 A CN 202110052954A CN 112891323 B CN112891323 B CN 112891323B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7015—Drug-containing film-forming compositions, e.g. spray-on
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K47/32—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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
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Abstract
The invention relates to an anti-HIV external disinfectant and a preparation method thereof, belonging to the field of external disinfection. The anti-HIV external disinfectant comprises: anti-HIV active ingredient, film forming material, lubricant and organic solvent; the anti-HIV active ingredient is selected from an integrase inhibitor or a fusion inhibitor. After the anti-HIV external disinfectant is used, a protective film can be formed on hands or gloves of medical staff and used for killing HIV viruses attached to the surfaces of the hands/gloves, and meanwhile, when the anti-HIV external disinfectant is used for forming a break or encountering liquids such as blood, body fluid and the like of HIV patients in occupational exposure, the anti-HIV external disinfectant can be stretched to form a protective film to cover the break, so that the risk of HIV infection is reduced or avoided better.
Description
Technical Field
The invention belongs to the field of external disinfection, and in particular relates to an anti-HIV external disinfectant and a preparation method thereof.
Background
In the medical work of collecting and treating aids patients, sometimes medical staff may be in an exposed environment contacted with blood of aids patients, for example, skin break may be caused by injury of instruments when aids patients are operated, and at this time, if the wound is contacted with blood of aids patients, infection risk is likely to be faced, so that disinfection and protection work needs to be done before contact or operation is started. At the same time, some condom breaks and leaks can also infect aids.
In the prior art, there are some known topical disinfection products, such as:
the invention patent application 201710173128.1 provides a disinfectant for external use, which comprises the following components in parts by weight: 5-15 parts of dittany bark, 5-10 parts of kuh-seng, 10-15 parts of garden balsam stem, 15-30 parts of fructus cnidii, 10-15 parts of bletilla striata, 6-12 parts of fructus kochiae, 0.5-10 parts of cortex pseudolaricis and 3-10 parts of Japanese ampelopsis, and mainly solves the problem that the existing skin disinfection preparation has poor effect on pathogenic fungi and suppurative cocci.
The invention patent application 201811429309.7 provides an external disinfection anti-allergic skin care agent, which comprises the following components in percentage by weight: 0.1 to 1.5 percent of antibacterial agent; tween 600.01-0.05%; 1-2% of licorice extract; 1-3% of kuh-seng extracting solution; 1-3% of gentian extract; 0.5-1% of N-laurylazepan-2-one; 0.5-0.8% of preservative; 0.5-1% of PEG-40 hydrogenated castor oil; 88.15-95.39% of water. The external disinfectant antiallergic skin care agent can rapidly take effect on the conditions of contact allergy, cosmetic allergy, anaphylactic reaction caused by mosquito bites, and the like.
However, there is no special anti-HIV external disinfectant protective agent in the art, which is specially used for medical staff to reduce occupational exposure, prevent occupational exposure, or reduce infection of HIV after occupational exposure, and simultaneously reduce HIV infection during sexual behaviors.
Disclosure of Invention
According to the above-mentioned shortcomings and needs of the art, the present invention aims to provide an external disinfectant for anti-HIV, which can form a protective film on the hands or gloves of medical staff after use, and is used for killing HIV viruses attached to the surfaces of the hands/gloves, and can form a break or can be stretched to form a protective film to cover the break after encountering the liquid such as the blood, body fluid, etc. of HIV patients during occupational exposure, thereby better reducing or avoiding the risk of HIV infection.
The technical scheme of the invention is as follows:
an anti-HIV topical disinfectant, comprising: anti-HIV active ingredient, film forming material, lubricant and organic solvent; the anti-HIV active ingredient is selected from an integrase inhibitor or a fusion inhibitor.
The anti-HIV external disinfectant is characterized by comprising the following components: the raw materials in parts by weight are as follows: 0.1-0.3 part of active ingredient for resisting HIV, 1-5 parts of film forming material, 15-30 parts of lubricant and 1-15 parts of organic solvent.
3. An anti-HIV topical disinfectant according to claim 1 or 2, selected from any one of the following formulas:
0.1 part of active ingredient for resisting HIV, 1 part of film forming material, 15 parts of lubricant and 1 part of organic solvent;
0.3 parts of active ingredient for resisting HIV, 5 parts of film forming material, 30 parts of lubricant and 15 parts of organic solvent;
0.01 part of active ingredient for resisting HIV, 2.5 parts of film forming material, 18 parts of lubricant and 13 parts of organic solvent;
0.01 part of active ingredient for resisting HIV, 0.5 part of film forming material, 17 parts of lubricant and 12 parts of organic solvent;
0.2 parts of active ingredient for resisting HIV, 1 part of film forming material, 25 parts of lubricant and 11 parts of organic solvent;
0.1 part of active ingredient for resisting HIV, 4 parts of film forming material, 28 parts of lubricant and 14 parts of organic solvent;
0.2 parts of active ingredient for resisting HIV, 3 parts of film forming material, 29 parts of lubricant and 13 parts of organic solvent;
0.1 part of active ingredient for resisting HIV, 4 parts of film forming material, 18 parts of lubricant and 4 parts of organic solvent;
0.2 parts of active ingredient for resisting HIV, 5 parts of film forming material, 19 parts of lubricant and 5 parts of organic solvent;
0.1 part of active ingredient for resisting HIV, 2 parts of film forming material, 22 parts of lubricant and 8 parts of organic solvent;
0.3 parts of active ingredient for resisting HIV, 4 parts of film forming material, 20 parts of lubricant and 6 parts of organic solvent;
0.2 part of active ingredient for resisting HIV, 1 part of film forming material, 25 parts of lubricant and 11 parts of organic solvent.
The film-forming material is selected from: polyvinyl alcohol (PVA), povidone, polyvinyl formal, polyvinyl butyral, chitosan, sodium hyaluronate, polyvinyl pyrrolidone;
preferably, the polyvinyl alcohol is PVA124;
the lubricant is selected from: glycerol, propylene glycol, perfume, sucralose, hydroxyethyl cellulose, dimethyl silicone oil, vegetable lubricating oil, paraffin oil, silicone oil, water-soluble oil, and hyaluronic acid;
the organic solvent is selected from the group consisting of: ethanol, acetone and propylene glycol.
The integrase inhibitor is selected from kufukang or bituwei; the fusion inhibitor is selected from Ai Bowei tai (Ai Kening).
The anti-HIV external disinfectant is characterized by further comprising: and (3) a plasticizer.
The weight part of the plasticizer is 0.4-0.6 part.
The plasticizer is selected from: dibutyl phthalate, glycerol, and propylene glycol.
The anti-HIV external disinfectant is characterized by further comprising: an auxiliary agent; the auxiliary agent is selected from the group consisting of: benzalkonium bromide, iodophor, nano silver ion liquid, or bromothalol;
the weight portion of the auxiliary agent is 0.01-0.05 portion.
In the long-term medical working practice, the inventor of the invention is in long-term contact with various infectious patients (especially AIDS patients) to perform orthopedic operations on the patients, and the patients are often at risk of occupational exposure and infection, so the inventor is always striving to find an external disinfectant which is suitable for external use and can continuously exert the anti-HIV effect in the long-term operation process. After the existing anti-HIV medicine, film forming materials and organic solvents are prepared into an external coating agent in the early stage, a layer of medicine film capable of effectively resisting HIV virus can be formed on the surface of skin or gloves, but the external coating agent can form a complete protective film under the condition that the skin has no wound or the gloves have no break, the protective film can be correspondingly broken through once the skin or the gloves have break, a certain infection risk exists, the anti-HIV long-acting performance and the effective response time of the external coating agent are not ideal, the anti-HIV effect is slow, and the anti-HIV duration is short. After the lubricant is mixed in by accident, the external disinfectant obtained by mixing the external film coating agent and the lubricant is coated on the surface of skin or the surface of a glove to form a film, even if a break appears, the film near the break can recover ductility again when encountering liquid and extend to the whole break surface to form a protective film again, thereby greatly reducing the risk of infection caused by the break. Meanwhile, the invention also discovers that the mixed liquid of the film coating agent added with the lubricant and the anti-HIV active medicine, namely, the disinfectant disclosed by the invention, not only can form a layer of protective film rapidly after being coated, but also can rapidly kill HIV virus sprayed on the surfaces of gloves/skins, and has the effect of inhibiting HIV in vitro for a long time, and the rapid inhibition of the virus activity and no virus survival can be ensured by reapplication of the HIV virus after half an hour to 8 hours after the coating. The different formulations of the disinfectant are also suitable for disinfection of hepatitis B, hepatitis C, syphilis, tuberculosis, cloth diseases and the like.
Drawings
The protective film observed at the glove break of fig. 1: the left image is a protective film electron microscope photograph formed within 1 minute after a glove coated with the HIV external disinfectant provided by one embodiment of the present invention using chitosan as a film forming material is punctured, and the right image is a protective film electron microscope photograph formed within 1 minute after a glove coated with the HIV external disinfectant provided by another embodiment of the present invention using polyvinyl alcohol as a film forming material is punctured.
Detailed Description
The invention will be described in further detail with reference to the drawings and the detailed description, which do not limit the scope of the invention.
The anti-HIV active ingredients of the present invention are commercially available, for example, jiefukang, bituo-Wei, ai Bowei Tai.
The invention provides an anti-HIV external disinfectant. In all embodiments of the present invention, the anti-HIV topical disinfectant has the following common features: the anti-HIV external disinfectant comprises: active ingredients for anti-HIV, film forming materials, lubricants and organic solvents; the active ingredient for anti-HIV is selected from integrase inhibitors or fusion inhibitors.
In some specific embodiments, the anti-HIV topical disinfectant comprises: the raw materials in parts by weight are as follows: 0.1-0.3 part of active ingredient for resisting HIV, 1-5 parts of film forming material, 15-30 parts of lubricant and 1-15 parts of organic solvent.
In more specific embodiments, the anti-HIV topical disinfectant is selected from any one of the formulations in table 1 below:
TABLE 1
The experimental procedure for anti-HIV effect in table 1 above included:
the anti-HIV external disinfectant provided by any embodiment of the invention is coated on the surface of a glove or a condom, after the disinfectant is dried, an anti-HIV protective film is formed, the glove is punctured, a proper amount of HIV virus liquid is respectively applied to the break and other positions of the glove, after the virus is wiped, the break is placed under an electron microscope to observe whether the protective film is formed, and meanwhile, the survival number of the HIV virus at the break and other positions to which the virus liquid is applied is measured by using a virus culturing and identifying method.
The virus culturing and identifying method includes immersing the hand/glove surface and glove break in HIV virus culture liquid completely within 1 min after the hand/glove surface and glove break, immersing the hand/glove surface for half an hour, 1 hour and 8 hours after the hand/glove surface is punctured into HIV virus culture liquid completely, culturing for 24h, and detecting whether the HIV virus survived in the culture liquid by using AIDS detection test paper.
The HIV virus culture solution is bovine serum.
In some preferred embodiments, the film-forming material is selected from the group consisting of: polyvinyl alcohol (PVA), povidone, polyvinyl formal, polyvinyl butyral, chitosan, sodium hyaluronate, polyvinyl pyrrolidone;
preferably, the polyvinyl alcohol is PVA124;
the lubricant is selected from: glycerol, propylene glycol, perfume, sucralose, hydroxyethyl cellulose, dimethyl silicone oil, vegetable lubricating oil, paraffin oil, silicone oil, water-soluble oil, and hyaluronic acid;
the organic solvent is selected from the group consisting of: ethanol, acetone, propylene glycol; the ethanol is preferably 75% ethanol.
Each of the above components is commercially available.
In more specific embodiments, the integrase inhibitor is selected from the group consisting of pefurukast and bituyveromyces; the fusion inhibitor is selected from Ai Bowei tai;
ai Bowei tai is preferred.
In other embodiments, the anti-HIV topical disinfectant further comprises: and (3) a plasticizer.
Specifically, the plasticizer is 0.4-0.6 parts by weight.
In a preferred embodiment, the plasticizer is selected from the group consisting of: dibutyl phthalate, glycerol, and propylene glycol.
In some embodiments, the anti-HIV topical disinfectant further comprises: an auxiliary agent; the auxiliary agent is selected from the group consisting of: benzalkonium bromide, iodophor, nano silver ion liquid, hydrogel, or bromorod.
The weight portion of the auxiliary agent is 0.01-0.05 portion. The adjuvant has the function of assisting disinfection and can help kill other pathogens besides HIV.
Specifically, the benzalkonium bromide is a benzalkonium bromide solution with the mass volume ratio of 0.01-0.02%.
Iodophors are commercially available or are mixtures of polyvinylpyrrolidone with 2% elemental iodine by mass to volume.
The most specific embodiments of the invention are as follows:
example 71 topical disinfectant: 15-30 g of glycerol or dimethyl silicone oil (i.e. lubricant), 0.4-0.6g of fat-forming agent or plasticizer, 0.1-0.3 part of guanidine salt bactericide (i.e. auxiliary agent), 1-15g of nursing agent (i.e. organic solvent) and 0.03g of organic acid-base regulator; film former (i.e., film forming material) pvp2.5g, ai Bowei tai (Ai Kening) (i.e., anti-HIV active ingredient) 10mg (or one tenth of the amount of kufukang or bituwei orally) and the balance deionized water.
Example 72 condom lubricant (i.e. external disinfectant of the invention specific to condoms): 0.1-0.5 g of sodium hyaluronate (i.e. film forming material), 15-30 g of glycerin or simethicone (i.e. lubricant), 0.01-0.05 g of brobol (i.e. auxiliary agent), 10mg of Ai Bowei tai (Ai Kening) (i.e. anti-HIV active ingredient) in terms of 100ml of liquid, 1-15g of organic solvent and the balance of deionized water. The condom lubricant has the effects of nourishing yin and lubricating, has no irritation to mucous membrane, has no uncomfortable feeling to human body, and has no side effect.
It was confirmed that examples 71 and 72 also obtained anti-HIV effects as shown in Table 1.
Table 1 of the anti-HIV effect of the example section of the present invention, column 1: the anti-HIV effect (within 1 minute) refers to the anti-HIV response time of the external disinfectant, namely, the anti-HIV effect response time can quickly kill HIV virus sprayed to the surfaces of gloves or condoms within 1 minute, and the ranges from 2 to 4 are: the "anti-HIV effect (long-acting inhibition effect)" refers to the data of the anti-HIV long-acting inhibition effect of the external disinfectant of the present invention, that is, after the external disinfectant of the present invention is applied for half an hour, 1 hour and 8 hours, the effect of rapidly killing the inhibitory activity can be achieved within 1 minute by reapplying the HIV virus liquid on the glove/condom surface, and the number of viruses on the glove surface can be made to be 0.
Claims (17)
1. An anti-HIV topical disinfectant, comprising: the raw materials in parts by weight are as follows: 0.1-0.3 part of anti-HIV active ingredient, 1-5 parts of film forming material, 15-30 parts of lubricant and 1-15 parts of organic solvent; the anti-HIV active ingredient is selected from integrase inhibitors or fusion inhibitors; the film-forming material is selected from: polyvinyl alcohol (PVA), povidone, polyvinyl formal, polyvinyl butyral, chitosan, sodium hyaluronate, polyvinyl pyrrolidone; the anti-HIV external disinfectant is a film coating agent; the integrase inhibitor is selected from kufukang or bituwei; the fusion inhibitor is selected from Ai Bowei tai.
2. The anti-HIV topical disinfectant according to claim 1, wherein the disinfectant is selected from any one of the following formulas:
0.1 part of active ingredient for resisting HIV, 1 part of film forming material, 15 parts of lubricant and 1 part of organic solvent;
0.3 parts of active ingredient for resisting HIV, 5 parts of film forming material, 30 parts of lubricant and 15 parts of organic solvent;
0.2 parts of active ingredient for resisting HIV, 1 part of film forming material, 25 parts of lubricant and 11 parts of organic solvent;
0.1 part of active ingredient for resisting HIV, 4 parts of film forming material, 28 parts of lubricant and 14 parts of organic solvent;
0.2 parts of active ingredient for resisting HIV, 3 parts of film forming material, 29 parts of lubricant and 13 parts of organic solvent;
0.1 part of active ingredient for resisting HIV, 4 parts of film forming material, 18 parts of lubricant and 4 parts of organic solvent;
0.2 parts of active ingredient for resisting HIV, 5 parts of film forming material, 19 parts of lubricant and 5 parts of organic solvent;
0.1 part of active ingredient for resisting HIV, 2 parts of film forming material, 22 parts of lubricant and 8 parts of organic solvent;
0.3 parts of active ingredient for resisting HIV, 4 parts of film forming material, 20 parts of lubricant and 6 parts of organic solvent;
0.2 part of active ingredient for resisting HIV, 1 part of film forming material, 25 parts of lubricant and 11 parts of organic solvent.
3. The anti-HIV topical disinfectant according to claim 1 or 2, wherein the polyvinyl alcohol is PVA124;
the lubricant is selected from: glycerol, propylene glycol, hydroxyethyl cellulose, dimethyl silicone oil, vegetable lubricating oil, paraffin oil, silicone oil, water-soluble oil, and hyaluronic acid;
the organic solvent is selected from the group consisting of: ethanol, acetone and propylene glycol.
4. An anti-HIV topical disinfectant according to any one of claims 1 to 3, further comprising: and (3) a plasticizer.
5. The anti-HIV topical disinfectant according to claim 4, wherein the plasticizer is 0.4 to 0.6 parts by weight.
6. The anti-HIV topical disinfectant according to claim 5, wherein the plasticizer is selected from the group consisting of: dibutyl phthalate, glycerol, and propylene glycol.
7. An anti-HIV topical disinfectant according to any one of claims 1 to 6, further comprising: an auxiliary agent; the auxiliary agent is selected from the group consisting of: benzalkonium bromide, iodophor, nano silver ion liquid, or bromothalol.
8. The anti-HIV topical disinfectant according to any one of claims 1 to 6, wherein the adjuvant is 0.01 to 0.05 parts by weight.
9. The preparation method of the anti-HIV external disinfectant is characterized by comprising the following raw materials in parts by weight: 0.1-0.3 part of anti-HIV active ingredient, 1-5 parts of film forming material, 15-30 parts of lubricant and 1-15 parts of organic solvent; the anti-HIV active ingredient is selected from integrase inhibitors or fusion inhibitors; the film-forming material is selected from: polyvinyl alcohol, povidone, polyvinyl formal aldehyde, polyvinyl butyral, chitosan, sodium hyaluronate, polyvinylpyrrolidone; the anti-HIV external disinfectant is a film coating agent; the integrase inhibitor is selected from kufukang or bituwei; the fusion inhibitor is selected from Ai Bowei tai.
10. The method for preparing an anti-HIV external disinfectant according to claim 9, wherein the anti-HIV active ingredient, film forming material, lubricant and organic solvent are mixed according to the following weight portions:
0.1 part of active ingredient for resisting HIV, 1 part of film forming material, 15 parts of lubricant and 1 part of organic solvent;
0.3 parts of active ingredient for resisting HIV, 5 parts of film forming material, 30 parts of lubricant and 15 parts of organic solvent;
0.2 parts of active ingredient for resisting HIV, 1 part of film forming material, 25 parts of lubricant and 11 parts of organic solvent;
0.1 part of active ingredient for resisting HIV, 4 parts of film forming material, 28 parts of lubricant and 14 parts of organic solvent;
0.2 parts of active ingredient for resisting HIV, 3 parts of film forming material, 29 parts of lubricant and 13 parts of organic solvent;
0.1 part of active ingredient for resisting HIV, 4 parts of film forming material, 18 parts of lubricant and 4 parts of organic solvent;
0.2 parts of active ingredient for resisting HIV, 5 parts of film forming material, 19 parts of lubricant and 5 parts of organic solvent;
0.1 part of active ingredient for resisting HIV, 2 parts of film forming material, 22 parts of lubricant and 8 parts of organic solvent;
0.3 parts of active ingredient for resisting HIV, 4 parts of film forming material, 20 parts of lubricant and 6 parts of organic solvent;
0.2 part of active ingredient for resisting HIV, 1 part of film forming material, 25 parts of lubricant and 11 parts of organic solvent.
11. The method for preparing an anti-HIV topical disinfectant according to claim 9, wherein the polyvinyl alcohol is PVA124;
the lubricant is selected from: glycerol, propylene glycol, hydroxyethyl cellulose, dimethyl silicone oil, vegetable lubricating oil, paraffin oil, silicone oil, water-soluble oil, and hyaluronic acid;
the organic solvent is selected from the group consisting of: ethanol, acetone and propylene glycol.
12. The method for preparing an anti-HIV topical disinfectant according to any one of claims 9 to 11, wherein the anti-HIV topical disinfectant further comprises: and (3) a plasticizer.
13. The method for preparing an anti-HIV external disinfectant according to claim 12, wherein the plasticizer is 0.4 to 0.6 parts by weight.
14. The method of preparing an anti-HIV topical disinfectant according to claim 12, wherein the plasticizer is selected from the group consisting of: dibutyl phthalate, glycerol, and propylene glycol.
15. The method for preparing an anti-HIV topical disinfectant according to any one of claims 9 to 11, wherein the anti-HIV topical disinfectant further comprises: and (5) an auxiliary agent.
16. The method for preparing an anti-HIV topical disinfectant according to claim 15, wherein the adjuvant is selected from the group consisting of: benzalkonium bromide, iodophor, nano silver ion liquid, or bromothalol.
17. The method for preparing an anti-HIV external disinfectant according to claim 15, wherein the auxiliary agent is 0.01 to 0.05 parts by weight.
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| Publication number | Publication date |
|---|---|
| CN112891323A (en) | 2021-06-04 |
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