CN113476396A - anti-HPV gel and production process thereof - Google Patents
anti-HPV gel and production process thereof Download PDFInfo
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- CN113476396A CN113476396A CN202110661276.4A CN202110661276A CN113476396A CN 113476396 A CN113476396 A CN 113476396A CN 202110661276 A CN202110661276 A CN 202110661276A CN 113476396 A CN113476396 A CN 113476396A
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 18
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 75
- 239000002994 raw material Substances 0.000 claims abstract description 63
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims abstract description 54
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims abstract description 52
- 235000010413 sodium alginate Nutrition 0.000 claims abstract description 52
- 239000000661 sodium alginate Substances 0.000 claims abstract description 52
- 229940005550 sodium alginate Drugs 0.000 claims abstract description 52
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 45
- 239000008213 purified water Substances 0.000 claims abstract description 32
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims abstract description 27
- 229920002125 Sokalan® Polymers 0.000 claims abstract description 27
- 229960001631 carbomer Drugs 0.000 claims abstract description 27
- 229920001519 homopolymer Polymers 0.000 claims abstract description 27
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 claims abstract description 27
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 claims abstract description 27
- 229960002216 methylparaben Drugs 0.000 claims abstract description 27
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims abstract description 25
- 229940057838 polyethylene glycol 4000 Drugs 0.000 claims abstract description 16
- 229960005150 glycerol Drugs 0.000 claims abstract description 14
- 229960004418 trolamine Drugs 0.000 claims abstract description 14
- 238000003756 stirring Methods 0.000 claims description 18
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- 238000001514 detection method Methods 0.000 claims description 10
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- 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
- A61K31/734—Alginic acid
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- 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
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- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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Abstract
The invention discloses an anti-HPV gel and a production process thereof, wherein the gel is prepared from sodium alginate carbomer homopolymer, triethanolamine, glycerol, polyethylene glycol 4000, methylparaben and purified water, S1, the raw materials are prepared, and the raw materials are unpacked and weighed to obtain corresponding parts of sodium alginate, carbomer homopolymer, triethanolamine, glycerol, polyethylene glycol 4000, methylparaben and purified water; the production steps comprise: the gel is pushed into a human body by using a disposable injector to reduce the local HPV load.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to an anti-HPV gel, and a production process of the anti-HPV gel.
Background
Human papillomavirus, a papillomavirus A genus belonging to the papovaviridae family, is a spherical DNA virus that causes the proliferation of the squamous epithelium of the human skin mucosa. It is manifested by symptoms such as common wart and genital wart (condyloma acuminatum). Human papillomavirus (hpv) infection is attracting more and more attention with the rapidly increasing incidence of condyloma acuminatum in venereal diseases and the increasing of cervical cancer, anal cancer and the like.
HPV infects humans primarily by direct or indirect contact with contaminated articles or by sexual transmission. HPV infection is host and tissue specific and can only infect damaged cells of the human skin mucosa. Following HPV infection of these cells, they remain latent in the basal cell in a small amount of free DNA, allowing for immune escape. When the basal cells are continuously differentiated, matured and migrate to the mucosal surface, the HPV viruses proliferate in large quantities. With apoptosis of epithelial cells at the mucosal surface, viral particles are released in large quantities to the epithelial surface, which can further exacerbate infection as a new source of infection.
The existing preventive vaccine can effectively prevent HPV infection, but has no obvious therapeutic effect on patients with existing HPV infection or precancerous lesion, so that the development of therapeutic drugs aiming at HPV infection is necessary.
Disclosure of Invention
The invention aims to solve the defects in the prior art, and provides an anti-HPV gel and a production process thereof, wherein anions carried on the surface of sodium alginate are combined with positive charge regions of HPV capsid protein to block viruses from invading host cells of vaginal mucosa basal layers.
In order to achieve the purpose, the invention provides the following technical scheme:
an anti-HPV gel, the formulation of which is as follows: the components by percentage: 0.05-10% of sodium alginate, 0.5-3% of carbomer homopolymer, 0.05-2% of triethanolamine, 0.5-10% of glycerol, 40000.05-5% of polyethylene glycol, 0.05-5% of methyl paraben and 65-98.8% of purified water.
Preferably, the formula of the anti-HPV gel is as follows: the components by percentage: 10% of sodium alginate, 3% of carbomer homopolymer, 2% of triethanolamine, 10% of glycerol, 40005% of polyethylene glycol, 5% of methyl paraben and 65% of purified water.
Preferably, the formula of the anti-HPV gel is as follows: the components by percentage: 6% of sodium alginate, 2% of carbomer homopolymer, 1% of triethanolamine, 3% of glycerol, 40002% of polyethylene glycol, 2% of methyl paraben and 84% of purified water.
Preferably, the formula of the anti-HPV gel is as follows: the components by percentage: 0.05% of sodium alginate, 0.5% of carbomer homopolymer, 0.05% of triethanolamine, 0.5% of glycerol, 40000.05% of polyethylene glycol, 0.05% of methyl paraben and 98.8% of purified water.
The invention provides a production process of anti-HPV gel, which comprises the following steps:
s1, preparing materials, namely, de-wrapping the raw materials and weighing corresponding parts of sodium alginate, carbomer homopolymer, triethanolamine, glycerol, polyethylene glycol 4000, methyl paraben and purified water;
s2, primary treatment, grinding and sieving the sodium alginate in the raw material;
s4, adding raw materials at a time, sequentially and slowly adding sodium alginate, carbomer homopolymer, polyethylene glycol 4000 and methyl paraben into a reaction kettle, and stirring the mixed solution to keep the uniformity of the mixed raw materials when adding;
s5, preliminary detection, wherein after the raw materials are mixed in the step S4, sampling detection is carried out to detect whether the components are mixed uniformly;
s6, adding the raw materials for the second time, sequentially and slowly adding triethanolamine and glycerol into the reaction kettle, and uniformly stirring to complete the mixing of the raw materials;
s7, detecting again, and sampling and detecting the mixed raw materials in the S6;
s8, filling a finished product, namely filling, internally wrapping and externally wrapping the prepared raw materials to complete the production of the anti-HPV gel;
s9, detecting finished products, and sampling and detecting the multi-packaged anti-HPV gel to ensure that the quality of the anti-HPV gel reaches the standard.
Preferably, in S2, the sodium alginate is ground by a ball mill when ground, a 400-mesh screen is used when sieved, and the amount is confirmed again after sieving.
Preferably, in the step S3, the temperature of the purified water is raised to 40 ℃ and kept for 30 minutes, and then the raw materials are added to ensure the uniformity of the water temperature.
Preferably, in the step S4, before adding the sodium alginate, the carbomer homopolymer, the polyethylene glycol 4000 and the methyl paraben, the water temperature is raised to 50 ℃, and after adding the raw materials, the stirring is continued for at least 30 minutes.
The invention has the technical effects and advantages that: the anti-HPV gel provided by the invention is prepared from sodium alginate, carbomer homopolymer, triethanolamine, glycerol, polyethylene glycol 4000, methyl paraben and purified water, and the product is mainly characterized in that anions carried on the surface of the sodium alginate are combined with positive charge regions of HPV capsid protein to block viruses from invading host cells of vaginal mucosa basal layers, so that the aim of blocking HPV infection is fulfilled.
Drawings
FIG. 1 is a process flow diagram of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
An anti-HPV gel, the formulation of which is as follows: the components by percentage: 10% of sodium alginate, 3% of carbomer homopolymer, 2% of triethanolamine, 10% of glycerol, 40005% of polyethylene glycol, 5% of methyl paraben and 65% of purified water.
Referring to fig. 1, the process for producing an anti-HPV gel includes the steps of:
s1, preparing materials, namely, de-wrapping the raw materials and weighing corresponding parts of sodium alginate, carbomer homopolymer, triethanolamine, glycerol, polyethylene glycol 4000, methyl paraben and purified water;
s2, carrying out primary treatment, grinding and sieving sodium alginate in the raw materials, grinding the sodium alginate by using a ball mill when grinding the sodium alginate, using a 400-mesh screen when sieving the sodium alginate, and confirming the weight of the sodium alginate again after sieving the sodium alginate;
s3, mixing raw materials, adding purified water into a reaction kettle, heating the purified water to 40 ℃, preserving heat for 30 minutes, adding the raw materials to ensure the uniformity of water temperature, stirring the purified water when heating water, keeping the uniformity of water temperature and preserving heat;
s4, adding the raw materials at a time, raising the water temperature to 50 ℃, continuously stirring for at least 30 minutes after adding the raw materials, sequentially and slowly adding the sodium alginate, the carbomer homopolymer, the polyethylene glycol 4000 and the methyl paraben into the reaction kettle, and stirring the mixed solution when adding the raw materials to keep the mixing uniformity of the raw materials;
s5, preliminary detection, wherein after the raw materials are mixed in the step S4, sampling detection is carried out to detect whether the components are mixed uniformly;
s6, adding the raw materials for the second time, sequentially and slowly adding triethanolamine and glycerol into the reaction kettle, and uniformly stirring to complete the mixing of the raw materials;
s7, detecting again, and sampling and detecting the mixed raw materials in the S6;
s8, filling a finished product, namely filling, internally wrapping and externally wrapping the prepared raw materials to complete the production of the anti-HPV gel;
s9, detecting finished products, and sampling and detecting the multi-packaged anti-HPV gel to ensure that the quality of the anti-HPV gel reaches the standard.
The application of the anti-HPV gel comprises a disposable injector, wherein the finished product gel is firstly unpacked and then is sucked into the disposable injector, and the disposable injector is used for injecting the gel into a human body and is applied to the anti-HPV.
Example 2
An anti-HPV gel, the formulation of which is as follows: the components by percentage: 6% of sodium alginate, 2% of carbomer homopolymer, 1% of triethanolamine, 3% of glycerol, 40002% of polyethylene glycol, 2% of methyl paraben and 84% of purified water.
The production process of the anti-HPV gel comprises the following steps:
s1, preparing materials, namely, de-wrapping the raw materials and weighing corresponding parts of sodium alginate, carbomer homopolymer, triethanolamine, glycerol, polyethylene glycol 4000, methyl paraben and purified water;
s2, carrying out primary treatment, grinding and sieving sodium alginate in the raw materials, grinding the sodium alginate by using a ball mill when grinding the sodium alginate, using a 400-mesh screen when sieving the sodium alginate, and confirming the weight of the sodium alginate again after sieving the sodium alginate;
s3, mixing raw materials, adding purified water into a reaction kettle, heating the purified water to 40 ℃, preserving heat for 30 minutes, adding the raw materials to ensure the uniformity of water temperature, stirring the purified water when heating water, keeping the uniformity of water temperature and preserving heat;
s4, adding the raw materials at a time, raising the water temperature to 50 ℃, continuously stirring for at least 30 minutes after adding the raw materials, sequentially and slowly adding the sodium alginate, the carbomer homopolymer, the polyethylene glycol 4000 and the methyl paraben into the reaction kettle, and stirring the mixed solution when adding the raw materials to keep the mixing uniformity of the raw materials;
s5, preliminary detection, wherein after the raw materials are mixed in the step S4, sampling detection is carried out to detect whether the components are mixed uniformly;
s6, adding the raw materials for the second time, sequentially and slowly adding triethanolamine and glycerol into the reaction kettle, and uniformly stirring to complete the mixing of the raw materials;
s7, detecting again, and sampling and detecting the mixed raw materials in the S6;
s8, filling a finished product, namely filling, internally wrapping and externally wrapping the prepared raw materials to complete the production of the anti-HPV gel;
s9, detecting finished products, and sampling and detecting the multi-packaged anti-HPV gel to ensure that the quality of the anti-HPV gel reaches the standard.
The application of the anti-HPV gel comprises a disposable injector, wherein the finished product gel is firstly unpacked and then is sucked into the disposable injector, and the disposable injector is used for injecting the gel into a human body and is applied to the anti-HPV.
Example 3
An anti-HPV gel, the formulation of which is as follows: the components by percentage: 0.05% of sodium alginate, 0.5% of carbomer homopolymer, 0.05% of triethanolamine, 0.5% of glycerol, 40000.05% of polyethylene glycol, 0.05% of methyl paraben and 98.8% of purified water.
The production process of the anti-HPV gel comprises the following steps:
s1, preparing materials, namely, de-wrapping the raw materials and weighing corresponding parts of sodium alginate, carbomer homopolymer, triethanolamine, glycerol, polyethylene glycol 4000, methyl paraben and purified water;
s2, carrying out primary treatment, grinding and sieving sodium alginate in the raw materials, grinding the sodium alginate by using a ball mill when grinding the sodium alginate, using a 400-mesh screen when sieving the sodium alginate, and confirming the weight of the sodium alginate again after sieving the sodium alginate;
s3, mixing raw materials, adding purified water into a reaction kettle, heating the purified water to 40 ℃, preserving heat for 30 minutes, adding the raw materials to ensure the uniformity of water temperature, stirring the purified water when heating water, keeping the uniformity of water temperature and preserving heat;
s4, adding the raw materials at a time, raising the water temperature to 50 ℃, continuously stirring for at least 30 minutes after adding the raw materials, sequentially and slowly adding the sodium alginate, the carbomer homopolymer, the polyethylene glycol 4000 and the methyl paraben into the reaction kettle, and stirring the mixed solution when adding the raw materials to keep the mixing uniformity of the raw materials;
s5, preliminary detection, wherein after the raw materials are mixed in the step S4, sampling detection is carried out to detect whether the components are mixed uniformly;
s6, adding the raw materials for the second time, sequentially and slowly adding triethanolamine and glycerol into the reaction kettle, and uniformly stirring to complete the mixing of the raw materials;
s7, detecting again, and sampling and detecting the mixed raw materials in the S6;
s8, filling a finished product, namely filling, internally wrapping and externally wrapping the prepared raw materials to complete the production of the anti-HPV gel;
s9, detecting finished products, and sampling and detecting the multi-packaged anti-HPV gel to ensure that the quality of the anti-HPV gel reaches the standard.
The application of the anti-HPV gel comprises a disposable injector, wherein the finished product gel is firstly unpacked and then is sucked into the disposable injector, and the disposable injector is used for injecting the gel into a human body and is applied to the anti-HPV.
Table 1 the formulation composition when carried out according to examples 1-3 gives the following table:
in summary, the following steps: the anti-HPV gel provided by the invention is prepared from sodium alginate, carbomer homopolymer, triethanolamine, glycerol, polyethylene glycol 4000, methyl paraben and purified water, and the product is mainly characterized in that anions carried on the surface of the sodium alginate are combined with positive charge regions of HPV capsid protein to block viruses from invading host cells of vaginal mucosa basal layers, so that the aim of blocking HPV infection is fulfilled.
Finally, it should be noted that: although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that modifications may be made to the embodiments or portions thereof without departing from the spirit and scope of the invention.
Claims (8)
1. An anti-HPV gel, characterized by: the formula of the anti-HPV gel is as follows: the components by percentage: 0.05-10% of sodium alginate, 0.5-3% of carbomer homopolymer, 0.05-2% of triethanolamine, 0.5-10% of glycerol, 78-5% of polyethylene glycol 40000.05, 0.05-5% of methyl paraben and 65-98.8% of purified water.
2. An anti-HPV gel according to claim 1, characterized in that: the formula of the anti-HPV gel is as follows: the components by percentage: 10% of sodium alginate, 3% of carbomer homopolymer, 2% of triethanolamine, 10% of glycerol, 40005% of polyethylene glycol, 5% of methyl paraben and 65% of purified water.
3. An anti-HPV gel according to claim 1, characterized in that: the formula of the anti-HPV gel is as follows: the components by percentage: 6% of sodium alginate, 2% of carbomer homopolymer, 1% of triethanolamine, 3% of glycerol, 40002% of polyethylene glycol, 2% of methylparaben and 84% of purified water.
4. An anti-HPV gel according to claim 1, characterized in that: the formula of the anti-HPV gel is as follows: the components by percentage: 0.05% of sodium alginate, 0.5% of carbomer homopolymer, 0.05% of triethanolamine, 0.5% of glycerol, 40000.05% of polyethylene glycol, 0.05% of methyl paraben and 98.8% of purified water.
5. The process for the production of an anti-HPV gel according to any one of claims 1 to 4, characterized in that: the method comprises the following steps:
s1, preparing materials, namely, de-wrapping the raw materials and weighing corresponding parts of sodium alginate, carbomer homopolymer, triethanolamine, glycerol, polyethylene glycol 4000, methyl paraben and purified water;
s2, primary treatment, grinding and sieving the sodium alginate in the raw material;
s4, adding raw materials at a time, sequentially and slowly adding sodium alginate, carbomer homopolymer, polyethylene glycol 4000 and methyl paraben into a reaction kettle, and stirring the mixed solution to keep the uniformity of the mixed raw materials when adding;
s5, preliminary detection, wherein after the raw materials are mixed in the step S4, sampling detection is carried out to detect whether the components are mixed uniformly;
s6, adding the raw materials for the second time, sequentially and slowly adding triethanolamine and glycerol into the reaction kettle, and uniformly stirring to complete the mixing of the raw materials;
s7, detecting again, and sampling and detecting the mixed raw materials in the S6;
s8, filling a finished product, namely filling, internally wrapping and externally wrapping the prepared raw materials to complete the production of the anti-HPV gel;
s9, detecting finished products, and sampling and detecting the multi-packaged anti-HPV gel to ensure that the quality of the anti-HPV gel reaches the standard.
6. The process for the production of an anti-HPV gel according to claim 5, wherein: in S2, sodium alginate was ground using a ball mill, sieved using a 400-mesh sieve, and the amount thereof was confirmed again after sieving.
7. The process for the production of an anti-HPV gel according to claim 5, wherein: in the step S3, the temperature of the purified water is raised to 40 ℃, the purified water is kept for 30 minutes, and then the raw materials are added to ensure the uniformity of the water temperature.
8. The process for the production of an anti-HPV gel according to claim 5, wherein: in the S4, before adding the sodium alginate, the carbomer homopolymer, the polyethylene glycol 4000 and the methylparaben, the water temperature is raised to 50 ℃, and after adding the raw materials, the stirring is continued for at least 30 minutes.
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