CN112190707A - anti-HPV recombinant human gel and preparation method thereof - Google Patents

anti-HPV recombinant human gel and preparation method thereof Download PDF

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CN112190707A
CN112190707A CN202010977040.7A CN202010977040A CN112190707A CN 112190707 A CN112190707 A CN 112190707A CN 202010977040 A CN202010977040 A CN 202010977040A CN 112190707 A CN112190707 A CN 112190707A
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黄荣奎
李兰兰
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Henan Youwei Medical Technology Co ltd
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Abstract

The invention provides an anti-HPV recombinant human gel and a preparation method thereof, and relates to the technical field of biomedicine. The anti-HPV recombinant human gel comprises: the raw materials comprise the following components in percentage by weight: 1 to 20 percent of compound yolk immunoglobulin, 0.1 to 5 percent of bacteriostatic agent, 0.5 to 10 percent of lubricant, 0.1 to 10 percent of thickening agent and the balance of purified water. The anti-HPV recombinant human gel and the preparation method thereof provided by the invention have the advantages of small side effect, good curative effect and difficulty in causing poisoning.

Description

anti-HPV recombinant human gel and preparation method thereof
Technical Field
The invention relates to the technical field of biomedicine, in particular to an anti-HPV recombinant human gel and a preparation method thereof.
Background
With changes in life concepts and deterioration of the surrounding environment, genital tract infections are becoming more and more common and frequently occurring in women. The HPV is also called human papilloma virus, is an epitheliotropic virus and is widely distributed in human and animals, and the HPV mainly causes wart lesions of skin and mucous membrane. According to the relation between the HPV and tumorigenesis, the HPV can be divided into high-risk type and low-risk type, wherein the HPV infection of the high-risk type is proved to be the main reason for inducing genital cancer including female cervical cancer; the low risk type mainly causes condyloma acuminatum. According to the statistics of the world health organization, 52.9 ten thousand cervical cancer cases are generated each year around the world, about 25 ten thousand people die of the cervical cancer, and more than 90 percent of the cervical cancer cases come from developing countries. The mortality rate for cervical cancer is second highest in women 25-45 years of age. HPV can cause benign tumors and warts in humans, and both men and women can be infected with HPV. The types of diseases that HPV virus may cause are anal cancer, penile cancer, throat mass, genital condyloma, etc.; women are mostly cervical cancer, vulvar cancer, vaginal cancer, anal cancer, head and neck cancer and the like; in addition, the infection of the male reproductive system is also affected, the male genital candidiasis is often caused by the infection of partners or sexual partners or indirect infection, and the candida infection is further aggravated by overlong prepuce or phimosis and local dampness of part of patients. The effects of HPV on the male reproductive system are mainly condyloma acuminata and genital herpes. Also effects on the female reproductive system as some HPV viral types are classified as "high risk" viruses because they cause cellular variation and can lead to reproductive organ cancer: cervical cancer and vaginal cancer are both possibly caused by HPV. In fact, more than 99% of all cervical cancers are caused by these high risk HPV viruses.
At present, the medicines for treating HPV virus are in the form of ointment, suppository for gynecology and external medicines of effervescent preparations, and also have the medicines for treating HPV virus by using vaccine, but the research and development time is long and the risk is high. In the prior art, most of the therapeutic drugs for treating HPV virus have slow effect, long cure course and high cost.
Chinese patent publication No. CN1456194A discloses an anti-hpv ointment, which contains arsenic (a raw material for preparing arsenic trioxide with high risk of use, which is described as octanoic acid, which has high toxicity and enters lung meridian), red lead (containing lead element, which is easily poisoned by lead), and other toxic substances, and thus has high side effects and is easily poisoned by lead. There are also therapeutic drugs for HPV virus using vaccines, but they are long in development time and high in risk. Aiming at the defects in the prior art, the hpv virus resisting medicine has small side effect and good curative effect and is not easy to cause poisoning. Therefore, there is a need to provide a novel complex against HPV viral infection to solve the above-mentioned drawbacks of the prior art.
Therefore, there is a need to provide a new anti-HPV recombinant human gel and a method for preparing the same to solve the above technical problems.
Disclosure of Invention
In order to solve the technical problems, the invention provides an anti-HPV recombinant human gel which has small side effect and good curative effect and is not easy to cause poisoning and a preparation method thereof.
The anti-HPV recombinant human gel provided by the invention comprises: the raw materials comprise the following components in percentage by weight: 1 to 20 percent of compound yolk immunoglobulin, 0.1 to 5 percent of bacteriostatic agent, 0.5 to 10 percent of lubricant, 0.1 to 10 percent of thickening agent and the balance of purified water.
Preferably, the raw materials comprise the following components in percentage by weight: 2 to 15 percent of compound yolk immunoglobulin, 0.2 to 3 percent of bacteriostatic agent, 1 to 5 percent of lubricant, 0.1 to 0.5 percent of thickening agent and the balance of purified water.
Preferably, the raw materials of the compound yolk immunoglobulin comprise the following components: recombinant human collagen, special yolk antibody and yeast beta glucan.
Preferably, the bacteriostatic agent is one or more of polyhexamethylene guanidine, chitosan quaternary ammonium salt and phenoxyethanol.
Preferably, the lubricant is glycerol.
Preferably, the thickener is carbomer.
The preparation method of the anti-HPV recombinant human gel comprises the following steps:
a. adding purified water with the temperature of 40-60 ℃ into stirring equipment, adding Carmholtz into the stirring equipment to dissolve the Carmholtz, stirring for 2.5-4.5h under a heat preservation state, controlling the rotating speed of a stirring blade at 600-800min/r, and preparing gel for later use after stirring;
b. simultaneously adding a bacteriostatic agent, a lubricant and purified water into another stirring device, starting the stirring device, stirring for 1-2h, and controlling the rotating speed of a stirring blade at 500-;
c. after stirring, adding the compound egg yolk immunoglobulin into the stirring equipment with the bacteriostatic agent again, starting the stirring equipment, stirring for 1-2h, and controlling the rotating speed of the stirring blades at 600-;
d. simultaneously adding the gel and the mixed solution prepared in the step into new stirring equipment, starting the stirring equipment at normal temperature, stirring for 2-3h, and controlling the rotating speed of a stirring blade at 800-1000min/r to prepare the anti-HPV recombinant human gel and the preparation method thereof;
e. the prepared anti-HPV recombinant human gel and the preparation method thereof are filled by filling equipment, and the filling container is sterilized.
Preferably, the sterilization mode in the step (e) is ultraviolet sterilization.
Compared with the related technology, the anti-HPV recombinant human gel and the preparation method thereof provided by the invention have the following beneficial effects:
1. the special-shaped yolk antibody is added into the gel, so that the gel has high HPV (human papillomavirus) resistance activity and can well treat HPV; the recombinant human collagen accelerates the rapid repair and regeneration of the erosion tissue and promotes healing; the yeast beta glucan has stronger biological activity of enhancing immunity and repairing cells; the addition of carbomer can adsorb and wrap the inactivated HPV and discharge the HPV out of a body; the addition of the glycerol can adjust the product properties, so that the gel is positioned at the focus position, the acting time is long, and the curative effect is good;
2. the invention uses the compound yolk immunoglobulin as the active component for resisting HPV for the first time, simultaneously gives consideration to other effective components, exerts the multi-component synergistic effect and obtains the product with good quality effect;
3. the product of the invention adopts biological preparation raw materials, and belongs to pure natural antibiotic-free products. Most of the medicaments adopted in the current commonly used medicaments for treating gynecological diseases are antibiotic medicaments, and the medicaments are not only harmful to the organism after being used for a long time, but also can generate drug resistance;
4. the bacteriostatic agent used in the invention is guanidine bacteriostatic agent, is commonly used in vaginal lotion, and has the advantages of no irritation, good bacteriostatic effect and the like. The long-acting bacteriostasis effect is achieved by the combined synergistic effect of a plurality of bacteriostats.
Detailed Description
The present invention will be further described with reference to the following embodiments.
Example 1
anti-HPV recombinant human gels include: the raw materials comprise the following components in percentage by weight: 2 percent of compound yolk immunoglobulin, 0.2 percent of bacteriostatic agent, 1 percent of lubricant, 0.1 percent of thickening agent and the balance of purified water.
The raw materials of the compound yolk immunoglobulin comprise the following components: recombinant human collagen, special yolk antibody and yeast beta glucan.
The bacteriostatic agent is a mixture of polyhexamethylene guanidine, chitosan quaternary ammonium salt and phenoxyethanol.
The lubricant is glycerol.
The thickening agent is carbomer.
The anti-HPV recombinant human gel comprises the following components in percentage by weight: 0.5% of special-shaped yolk antibody, 0.5% of recombinant human collagen, 1% of yeast beta glucan, 0.1% of chitosan quaternary ammonium salt, 0.05% of polyhexamethylene guanidine, 0.05% of phenoxyethanol, 0.1% of carbomer, 1% of glycerol and the balance of purified water.
The preparation method of the anti-HPV recombinant human gel comprises the following steps:
a. adding purified water of 40-60 ℃ into stirring equipment, adding Carmholtz into the stirring equipment to dissolve the Carmholtz, stirring for 2.5 hours under a heat preservation state, controlling the rotating speed of a stirring blade at 600min/r, and preparing gel for later use after stirring;
b. simultaneously adding a bacteriostatic agent, a lubricant and purified water into another stirring device, starting the stirring device, stirring for 1, and controlling the rotating speed of a stirring blade to be 500 min/r;
c. after stirring, adding the compound egg yolk immunoglobulin into the stirring equipment with the bacteriostatic agent again, starting the stirring equipment, stirring for 1h, and controlling the rotating speed of the stirring blades at 600min/r to prepare a mixed solution;
d. simultaneously adding the gel and the mixed solution prepared in the step into a new stirring device, starting the stirring device at normal temperature, stirring for 2h, and controlling the rotating speed of a stirring blade at 800min/r to prepare the anti-HPV recombinant human gel and the preparation method thereof;
e. the prepared anti-HPV recombinant human gel and the preparation method thereof are filled by filling equipment, and the filling container is sterilized.
The sterilization mode in the step (e) is ultraviolet sterilization.
Example 2
anti-HPV recombinant human gels include: the raw materials comprise the following components in percentage by weight: 10% of compound yolk immunoglobulin, 1.2% of bacteriostatic agent, 3% of lubricant, 0.3% of thickening agent and the balance of purified water.
The raw materials of the compound yolk immunoglobulin comprise the following components: recombinant human collagen, special yolk antibody and yeast beta glucan.
The bacteriostatic agent is a mixture of polyhexamethylene guanidine, chitosan quaternary ammonium salt and phenoxyethanol.
The lubricant is glycerol.
The thickening agent is carbomer.
The anti-HPV recombinant human gel comprises 1% of special-shaped yolk antibody, 2% of recombinant human collagen, 7% of yeast beta glucan, 1% of chitosan quaternary ammonium salt, 0.1% of polyhexamethylene guanidine, 0.1% of phenoxyethanol, 0.3% of carbomer, 3% of glycerol and the balance of purified water.
The preparation method of the anti-HPV recombinant human gel comprises the following steps:
a. adding purified water of 40-60 ℃ into stirring equipment, adding Carmholtz into the stirring equipment to dissolve the Carmholtz, stirring for 3.5 hours under a heat preservation state, controlling the rotating speed of a stirring blade at 700min/r, and preparing gel for later use after stirring;
b. simultaneously adding a bacteriostatic agent, a lubricant and purified water into another stirring device, starting the stirring device, stirring for 1.5h, and controlling the rotating speed of a stirring blade at 550 min/r;
c. after stirring, adding the compound egg yolk immunoglobulin into the stirring equipment with the bacteriostatic agent again, starting the stirring equipment, stirring for 1.5h, and controlling the rotating speed of the stirring blades at 700min/r to prepare a mixed solution;
d. simultaneously adding the gel and the mixed solution prepared in the step into a new stirring device, starting the stirring device at normal temperature, stirring for 2.5h, and controlling the rotating speed of a stirring blade at 900min/r to prepare the anti-HPV recombinant human gel and the preparation method thereof;
e. the prepared anti-HPV recombinant human gel and the preparation method thereof are filled by filling equipment, and the filling container is sterilized.
Preferably, the sterilization mode in the step (e) is ultraviolet sterilization.
Example 3
anti-HPV recombinant human gels include: the raw materials comprise the following components in percentage by weight: 15% of compound yolk immunoglobulin, 3% of bacteriostatic agent, 5% of lubricant, 0.5% of thickening agent and the balance of purified water;
the raw materials of the compound yolk immunoglobulin comprise the following components: recombinant human collagen, special yolk antibody and yeast beta glucan.
The bacteriostatic agent is a mixture of polyhexamethylene guanidine, chitosan quaternary ammonium salt and phenoxyethanol.
The lubricant is glycerol.
The thickening agent is carbomer.
The anti-HPV recombinant human gel comprises 3% of a special-shaped yolk antibody, 2% of recombinant human collagen, 10% of yeast beta glucan, 2% of chitosan quaternary ammonium salt, 0.5% of polyhexamethylene guanidine, 0.5% of phenoxyethanol, 0.5% of carbomer, 5% of glycerol and the balance of purified water.
The preparation method of the anti-HPV recombinant human gel comprises the following steps:
a. adding purified water of 40-60 ℃ into stirring equipment, adding Carmholtz into the stirring equipment to dissolve the Carmholtz, stirring for 4.5 hours under a heat preservation state, controlling the rotating speed of a stirring blade at 800min/r, and preparing gel for later use after stirring;
b. simultaneously adding a bacteriostatic agent, a lubricant and purified water into another stirring device, starting the stirring device, stirring for 2 hours, and controlling the rotating speed of a stirring blade at 600 min/r;
c. after stirring, adding the compound egg yolk immunoglobulin into the stirring equipment with the bacteriostatic agent again, starting the stirring equipment, stirring for 2h, and controlling the rotating speed of the stirring blades at 800min/r to prepare a mixed solution;
d. simultaneously adding the gel and the mixed solution prepared in the step into a new stirring device, starting the stirring device at normal temperature, stirring for 3h, and controlling the rotating speed of a stirring blade at 1000min/r to prepare the anti-HPV recombinant human gel and the preparation method thereof;
e. the prepared anti-HPV recombinant human gel and the preparation method thereof are filled by filling equipment, and the filling container is sterilized.
Preferably, the sterilization mode in the step (e) is ultraviolet sterilization.
Comparative example
anti-HPV recombinant human gels include: the raw materials comprise the following components in percentage by weight: 1% of compound yolk immunoglobulin, 1.2% of bacteriostatic agent, 3% of lubricant, 0.3% of thickening agent and the balance of purified water.
The raw materials of the compound type yolk immunoglobulin comprise the following components of special type yolk antibody.
The bacteriostatic agent is a mixture of polyhexamethylene guanidine, chitosan quaternary ammonium salt and phenoxyethanol.
The lubricant is glycerol.
The thickening agent is carbomer.
The anti-HPV recombinant human gel comprises 1% of special-shaped yolk antibody, 1% of chitosan quaternary ammonium salt, 0.1% of polyhexamethylene guanidine, 0.1% of phenoxyethanol, 0.3% of carbomer, 3% of glycerol and the balance of purified water.
The preparation method of the anti-HPV recombinant human gel comprises the following steps:
a. adding purified water of 40-60 ℃ into stirring equipment, adding Carmholtz into the stirring equipment to dissolve the Carmholtz, stirring for 3.5 hours under a heat preservation state, controlling the rotating speed of a stirring blade at 700min/r, and preparing gel for later use after stirring;
b. simultaneously adding a bacteriostatic agent, a lubricant and purified water into another stirring device, starting the stirring device, stirring for 1.5h, and controlling the rotating speed of a stirring blade at 550 min/r;
c. after stirring, adding the compound egg yolk immunoglobulin into the stirring equipment with the bacteriostatic agent again, starting the stirring equipment, stirring for 1.5h, and controlling the rotating speed of the stirring blades at 700min/r to prepare a mixed solution;
d. simultaneously adding the gel and the mixed solution prepared in the step into a new stirring device, starting the stirring device at normal temperature, stirring for 2.5h, and controlling the rotating speed of a stirring blade at 900min/r to prepare the anti-HPV recombinant human gel and the preparation method thereof;
e. the prepared anti-HPV recombinant human gel and the preparation method thereof are filled by filling equipment, and the filling container is sterilized.
Preferably, the sterilization mode in the step (e) is ultraviolet sterilization.
The sample prepared by the embodiment of the invention has the following using effects: volunteers were divided on average into 3 groups of 120 persons each.
Observing volunteers in the group, cleaning the vagina with warm boiled water every night, and coating 3g of the gel prepared in example 2 around labia and inside the vagina;
the control group uses commercial common HPV medicament as control, and the dosage is 3g each time; each group was administered for 4 weeks and then first and second rechecks 12 weeks later;
the contrast group takes the medicament prepared in the comparative example as a contrast, and the dosage is 3g each time; each group was given 4 weeks after the first follow-up and 12 weeks after the second follow-up.
The results are shown in Table 1.
Figure RE-GDA0002777487750000071
TABLE 1 comparison of clinical efficacy of two groups of patients
As can be seen from the table above, the gel prepared by the invention has the advantages of high cure rate and good curative effect; the comparative example shows that the effective rate is obviously reduced without using the recombinant human collagen and the yeast beta glucan of the invention.
In conclusion, the special-shaped yolk antibody is added into the gel, so that the gel has high anti-HPV activity, can well treat HPV, and can accelerate the rapid repair and regeneration of erosive tissues and promote healing by recombining human collagen; the yeast beta glucan has stronger biological activity of enhancing immunity and repairing cells; the addition of carbomer can adsorb and wrap the inactivated HPV and discharge the HPV out of a body; the addition of glycerol can regulate product properties, so that the gel is positioned at the focus position for a long time and has good curative effect. The composite yolk immunoglobulin is used as an anti-HPV active component for the first time, other effective components are considered at the same time, the multi-component synergistic effect is exerted, and the obtained product has good quality effect. The product adopts biological preparation raw materials, and belongs to pure natural antibiotic-free products. Most of the medicines adopted in the current commonly used medicines for treating gynecological diseases are antibiotic medicines, and the medicines are used for a long time, so that certain damage is caused to the organism, and meanwhile, the organism can generate drug resistance. The bacteriostatic agent is guanidine bacteriostatic agent, is commonly used in vaginal lotion, and has the advantages of no irritation, good bacteriostatic effect and the like. The long-acting bacteriostasis effect is achieved by the combined synergistic effect of a plurality of bacteriostats. Although the existing suppository commonly used in gynecology can be retained in the vagina for a long time, the contact time and the contact area are good, but the suppository easily absorbs water in the vagina to cause dryness, and has certain stimulation and inconvenient use. The invention is a water-like gel, not only has the advantages of the suppository, but also avoids the disadvantages of the suppository, and has better patient compliance.
The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications of equivalent structures and equivalent processes, which are made by the present specification, or directly or indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims (8)

1. The anti-HPV recombinant human gel is characterized by comprising the following raw materials in percentage by weight: 1 to 20 percent of compound yolk immunoglobulin, 0.1 to 5 percent of bacteriostatic agent, 0.5 to 10 percent of lubricant, 0.1 to 10 percent of thickening agent and the balance of purified water.
2. The anti-HPV recombinant human gel according to claim 1, characterized in that the raw materials thereof comprise the following components and the weight percentages thereof: 2 to 15 percent of compound yolk immunoglobulin, 0.2 to 3 percent of bacteriostatic agent, 1 to 5 percent of lubricant, 0.1 to 0.5 percent of thickening agent and the balance of purified water.
3. The anti-HPV recombinant human gel according to claim 1, wherein the raw materials of the compound type yolk immunoglobulin comprise the following components: recombinant human collagen, special yolk antibody and yeast beta glucan.
4. The anti-HPV recombinant human gel according to claim 1, wherein the bacteriostatic agent is one or more of polyhexamethylene guanidine, chitosan quaternary ammonium salt and phenoxyethanol.
5. The anti-HPV recombinant human gel according to claim 1, wherein said lubricant is glycerol.
6. The anti-HPV recombinant human gel according to claim 1, wherein the thickener is carbomer.
7. The method for preparing anti-HPV recombinant human gel according to any one of claims 1 to 6, characterized in that it comprises the following steps:
a. adding purified water with the temperature of 40-60 ℃ into stirring equipment, adding Carmholtz into the stirring equipment to dissolve the Carmholtz, stirring for 2.5-4.5h under a heat preservation state, controlling the rotating speed of a stirring blade at 600-800min/r, and preparing gel for later use after stirring;
b. simultaneously adding a bacteriostatic agent, a lubricant and purified water into another stirring device, starting the stirring device, stirring for 1-2h, and controlling the rotating speed of a stirring blade at 500-;
c. after stirring, adding the compound egg yolk immunoglobulin into the stirring equipment with the bacteriostatic agent again, starting the stirring equipment, stirring for 1-2h, and controlling the rotating speed of the stirring blades at 600-;
d. simultaneously adding the gel and the mixed solution prepared in the step into new stirring equipment, starting the stirring equipment at normal temperature, stirring for 2-3h, and controlling the rotating speed of a stirring blade at 800-1000min/r to prepare the anti-HPV recombinant human gel and the preparation method thereof;
e. the prepared anti-HPV recombinant human gel and the preparation method thereof are filled by filling equipment, and the filling container is sterilized.
8. The method for preparing anti-HPV recombinant human gel according to claim 7, wherein the sterilization in step (e) is ultraviolet sterilization.
CN202010977040.7A 2020-09-16 2020-09-16 anti-HPV recombinant human gel and preparation method thereof Pending CN112190707A (en)

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