CN106267167A - A kind of lactalbumin oleic acid complex and carrageenan composition of medicine and its preparation method and application - Google Patents
A kind of lactalbumin oleic acid complex and carrageenan composition of medicine and its preparation method and application Download PDFInfo
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- CN106267167A CN106267167A CN201610664909.6A CN201610664909A CN106267167A CN 106267167 A CN106267167 A CN 106267167A CN 201610664909 A CN201610664909 A CN 201610664909A CN 106267167 A CN106267167 A CN 106267167A
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- medicine
- lactalbumin
- oleic acid
- composition
- acid complex
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/38—Albumins
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- A—HUMAN NECESSITIES
- 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
- A61K31/731—Carrageenans
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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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
Abstract
The invention discloses a kind of lactalbumin oleic acid complex and carrageenan composition of medicine, including the lactalbumin oleic acid complex of 0.01 1 weight portions, the carrageenan of 0.5 1.5 weight portions, the carbomer of 13 weight portions, the glycerol of 15 weight portions, the ethyl hydroxybenzoate of 0.1 0.2 weight portions.This composition of medicine is a kind of in gel, suppository, dressing.It can prevent and treat women human papilloma virus infection, and prevents and treatment female gynecological gram-negative bacterial infections.
Description
Technical field
The present invention relates to a kind of gynaecopathia product, be specifically related to a kind of lactalbumin-oleic acid complex and carrageenan
Composition of medicine and its preparation method and application.
Background technology
HPV is widely present in nature, and the skin of people, digestive tract, respiratory tract etc. all carry HPV.Every sexual intercourse
Women, all may by property be infected by contact with HPV, have the women of 70-80% can infect HPV the most at least one times.The mankind
Various cancers due to the cause of disease complicated, current science and technology is difficult to effectively prevent to find in time, and early treatment, and cervical cancer is
Currently the only can determine that the cause of disease is because infecting HPV virus and falling ill, thus be in all cancers, uniquely can effectively prevent,
Find in time and the cancer of energy early treatment.Vaccine for cervical cancer research based on HPV as target in the world, part vaccine is
Complete I/II clinical trial phase, be ready for deeper into research, but clinical practice still has problems, such as clinical side effects and
Safety to environment, HPV virus strict species specificity, it is impossible to set up animal model evaluation vaccine immune effect and
The safety issue etc. of vaccine self, affects its flow of research.Domestic HPV vaccine is also in the starting stage, and major part research is concentrated
Exploitation in Chinese medicine preparation.But due to the restriction of detection means, the detection of HPV use histopathology, colposcope or
The methods such as PCR, not yet apply to HC2 (HPVDNA second filial generation hybrid capture detection technique), and fail it is carried out quantitative study.
At present, international and domestic all poured into great enthusiasm research and development novel multiple HPV strain all had prevention and
On the medicine of control effect and biological preparation, but the most breakthrough progress.Can effectively prevent and control in the world
The medicine that HPV virus infects lacks the most relatively, and in treatment owing to there is no a specific drug thus the immunoregulation medicament used by
It is significantly controlled in the defect of the aspects such as generally existence cannot prevent HPV infection, curative effect indefinite, expensive effectively
Use clinically, particularly in the developing country of low income.
Chinese patent 201510537630.7 discloses a kind of prevention and controls the bioprotein of human papilloma virus infection
Dressing and invisible film, it uses JB albumen and other additive compounds to make bioprotein dressing and invisible film, reaches effectively to prevent
Problem with the medicine controlling HPV infection.But, its effect in terms for the treatment of simple type and mixed type HPV infection is the most notable.
Summary of the invention
The primary and foremost purpose of the present invention is just to provide a kind of lactalbumin-oleic acid complex and carrageenan composition of medicine and system thereof
Preparation Method and application, it can prevent and treat women human papilloma virus infection, and prevention and treatment female gynecological remove from office orchid
Family name's negative bacterial infections.
For achieving the above object, the present invention adopts the following technical scheme that and implements:
A kind of lactalbumin-oleic acid complex and carrageenan composition of medicine, including the lactalbumin-oil of 0.01-1 weight portion
Acid complex, the carrageenan of 0.5-1.5 weight portion, the carbomer of 1-3 weight portion, the glycerol of 1-5 weight portion, 0.1-0.2 weight
The ethyl hydroxybenzoate of part.This composition of medicine is the one in gel, suppository or dressing.
Preferably, a kind of lactalbumin-oleic acid complex and carrageenan composition of medicine, including the milky white egg of 0.5 weight portion
In vain-oleic acid complex, the carrageenan of 1 weight portion, the carbomer of 2 weight portions, the glycerol of 5 weight portions, the Ni Bo of 0.15 weight portion
Gold ethyl ester.
In certain embodiments, a kind of lactalbumin-oleic acid complex also includes 1-2 weight portion with carrageenan composition of medicine
Triethanolamine, the water of 87.3-96.39 weight portion.
The preparation method of a kind of lactalbumin-oleic acid complex and carrageenan composition of medicine: include following operating procedure:
1): weigh each raw material according to proportioning, carbomer is stirred in the water of 80-85 DEG C to the most swelling, after add OK a karaoke club
Glue, stirring, to being completely dissolved, while hot through 0.22 μm membrane filtration sterilizing, obtains No. 1 solution；
2): be dissolved in the water by ethyl hydroxybenzoate, through 0.22 μm membrane filtration sterilizing, No. 2 solution are obtained；
3): add to No. 2 solution under agitation No. 1 solution mixes, add triethanolamine, adjust pH to 5.6, obtain 3
Number solution；
4): under room temperature, lactalbumin-oleic acid complex is dissolved in qs glycerin by stirring at low speed, go out through 0.22 μm membrane filtration
Bacterium, obtains No. 4 solution；
5): under uniform temperature stirs, No. 4 solution are added in No. 3 solution and mixes, use sterilized triethanolamine solution
Adjust pH to 5.6；
6): finally adding water to 100 parts and stir evenly and i.e. obtain composition of medicine, composition of medicine is gel.
This composition of medicine can be used for preventing and treating women human papilloma virus infection, and is used for preventing and treating women
Gynecological's gram-negative bacterial infections.
The present invention is also claimed composition of medicine of the present invention in preparation prevention and treatment women human papillomavirus sense
Dye, and it is used for the application preventing and treating in the medicine of female gynecological gram-negative bacterial infections.
Nineteen ninety-five, Hakansson et al. has been surprisingly found that when studying breast milk antibacterial activity, containing a species specificity in breast milk
The material of inducing apoptosis of tumour cell, and its molecular weight is the most close with lactalbumin, but simple lactalbumin can not be drawn
Play the apoptosis of tumor cell, therefore the material of this inducing cell apoptosis is called lactalbumin polymer.Several years subsequently,
The Nomenclature Composition and Structure of Complexes of this polymer is conducted in-depth research by Svensson and Svanborg et al., determines this polymer
For lactalbumin-oleic acid complex, and synthesize the thing of this inducing apoptosis of tumour cell the most in vitro in 2000
Matter.2003, Sweden scientific research personnel carried out lactalbumin-oleic acid complex to 40 example cutaneous papilloma patients
(HAMLET) Therapy study, using placebo as comparison, observes therapeutic outcome after being administered 3 weeks.The patient 1 of HAMLET treatment group
After individual month, cutaneous papilloma volume averagely reduces 75%, and placebo patients only reduces 15%～20%.Then to before
Placebo patients uses HAMLET treatment, cutaneous papilloma volume-diminished 82% after being administered 1 month.Meanwhile, connect all
By HAMLET treatment patient carry out 2 years by a definite date it has been observed that total cure rate is up to 82%.
Lactalbumin-oleic acid complex has the antiviral activity of wide spectrum.This complex does not has shadow to vagina normal flora
Ring, be highly suitable in vaginal products using.It addition, the carrageenan selected is except discharging body by the HPV absorption of inactivation, parcel
Outward, itself also having the antiviral activity of wide spectrum, and women human papillomavirus is had inhibition, therefore this product is suitable for
In blocking HPV infection and propagation；After the cervical lesions preventing and treating HPV infection to cause, genital tracts and treatment
Recurrence, safely and effectively prevents the generation of cervical cancer.It is high that this composition of medicine has HPV infection negative conversion rate, easy to use, and safety is without secondary
The features such as effect.
Specifically, this composition of medicine has a characteristic that
1, this composition of medicine compares other anti-HPV infection product, has negative conversion rate the highest, this maximum feature of good effect.
2, composition of medicine applies also for the HPV infection women at any age, can be with Reusability.Cervical cancer can be prevented again
HPV infection can be treated, including chronic cervicitis, epithelium of cervix uteri dysplasia, including CIN I, II, III degree etc., prevent and treat dual-purpose.
3, the anti-HPV infection of wide spectrum, not only infects effectively to HPV16 and HPV18, equally has protection to other type and makees
With.
4, without any may material excitatory to vagina.
5, easy to use, safety has no side effect, without pain.
Detailed description of the invention
In order to make objects and advantages of the present invention clearer, below in conjunction with embodiment, the present invention is carried out specifically
Bright.Should be appreciated that following word only in order to describe one or more specific embodiments of the present invention, not to the present invention
The protection domain of concrete request carries out considered critical.
Embodiment 1: composition of medicine
This composition of medicine is by the lactalbumin of 0.5 weight portion-oleic acid complex, the carrageenan of 1 weight portion, 2 weight portions
Carbomer, the glycerol of 5 weight portions, the ethyl hydroxybenzoate of 0.15 weight portion, the triethanolamine of 1 weight portion, the water of 90.35 weight portions
Composition.
Preparation method:
1): weigh each raw material according to proportioning, 2 parts of carbomers are stirred to the most swelling in 20 parts of water of 80 DEG C, after add 1
Part carrageenan, stirring, to being completely dissolved, while hot through 0.22 μm membrane filtration sterilizing, obtains No. 1 solution；
2): be dissolved in 5 parts of water by 0.15 part of ethyl hydroxybenzoate, through 0.22 μm membrane filtration sterilizing, No. 2 solution are obtained；
3): add to No. 2 solution under agitation No. 1 solution mixes, add 0.5 part of triethanolamine, adjust pH extremely
5.6, obtain No. 3 solution；
4): under room temperature, 0.5 part of lactalbumin-oleic acid complex is dissolved in 5 parts of glycerol by stirring at low speed, through 0.22 μm film mistake
Filter sterilization, obtains No. 4 solution；
5): under uniform temperature stirs, No. 4 solution are added mixing in No. 3 solution, with 0.5 part of sterilized three ethanol
Amine aqueous solution adjusts pH to 5.6；
6): finally adding water to 100 parts and stir evenly and i.e. obtain composition of medicine, composition of medicine is gel.
Embodiment 2: composition of medicine
This composition of medicine is by the lactalbumin of 0.01 weight portion-oleic acid complex, the carrageenan of 0.5 weight portion, 1 weight portion
Carbomer, the glycerol of 1 weight portion, the ethyl hydroxybenzoate of 0.1 weight portion, the triethanolamine of 1 weight portion, 96.39 weight portions
Water forms.
Preparation method:
1): weigh each raw material according to proportioning, 1 part of carbomer is stirred to the most swelling in 20 parts of water of 85 DEG C, after add
0.5 part of carrageenan, stirring, to being completely dissolved, while hot through 0.22 μm membrane filtration sterilizing, obtains No. 1 solution；
2): be dissolved in 5 parts of water by 0.1 part of ethyl hydroxybenzoate, through 0.22 μm membrane filtration sterilizing, No. 2 solution are obtained；
3): add to No. 2 solution under agitation No. 1 solution mixes, add 0.5 part of triethanolamine, adjust pH extremely
5.6, obtain No. 3 solution；
4): under room temperature, 0.01 part of lactalbumin-oleic acid complex is dissolved in 5 parts of glycerol by stirring at low speed, through 0.22 μm film
Filtration sterilization, obtains No. 4 solution；
5): under uniform temperature stirs, No. 4 solution are added mixing in No. 3 solution, with 0.5 part of sterilized three ethanol
Amine aqueous solution adjusts pH to 5.6；
6): finally adding water to 100 parts and stir evenly and i.e. obtain composition of medicine, composition of medicine is gel.
Embodiment 3: composition of medicine
This composition of medicine is by the lactalbumin of 1 weight portion-oleic acid complex, the carrageenan of 1.5 weight portions, 3 weight portions
Carbomer, the glycerol of 5 weight portions, the ethyl hydroxybenzoate of 0.2 weight portion, the triethanolamine of 2 weight portions, the water group of 87.3 weight portions
Become.
Preparation method:
1): weigh each raw material according to proportioning, 3 parts of carbomers are stirred to the most swelling in 20 parts of water of 85 DEG C, after add
1.5 parts of carrageenans, stirring, to being completely dissolved, while hot through 0.22 μm membrane filtration sterilizing, obtains No. 1 solution；
2): be dissolved in 5 parts of water by 0.2 part of ethyl hydroxybenzoate, through 0.22 μm membrane filtration sterilizing, No. 2 solution are obtained；
3): add to No. 2 solution under agitation No. 1 solution mixes, add 1 part of triethanolamine, adjust pH to 5.6,
Obtain No. 3 solution；
4): under room temperature, 1 part of lactalbumin-oleic acid complex is dissolved in 5 parts of glycerol by stirring at low speed, through 0.22 μm membrane filtration
Sterilizing, obtains No. 4 solution；
5): under uniform temperature stirs, No. 4 solution are added mixing in No. 3 solution, with 1 part of sterilized triethanolamine
Solution adjusts pH to 5.6；
6): finally adding water to 100 parts and stir evenly and i.e. obtain composition of medicine, composition of medicine is gel.
Embodiment 4: clinical effectiveness
(1) anti-HPV virus combination Drug therapy simple type and the clinical effectiveness of mixed type HPV infection.
Observe anti-HPV virus combination medicine (embodiment 1, embodiment 2, embodiment 3) treatment simple type and the sense of mixed type HPV
The clinical effectiveness of dye.The group 1 anti-HPV virus combination Medications Example 1 of employing on probation, group 2 on probation employing uses anti-HPV virus combination
Medications Example 2, the group 3 anti-HPV virus combination Medications Example 3 of employing on probation, matched group uses Chinese patent
201510537630.7 embodiment 1 bioprotein dressing.As table 1 below result shows: single high-risk HPV infection person uses anti-HPV
Virus combination medicine (embodiment 1, embodiment 2, embodiment 3) after 3 months negative conversion rate be 72.0%, 76.0%, 68.0% respectively,
Matched group is 52.0%；After 6 months, group on probation is all turned out cloudy, and matched group is 76.0%.Mixed type high-risk HPV infection person uses anti-
HPV virus combination medicine (embodiment 1, embodiment 2, embodiment 3) after 3 months negative conversion rate be 52.0% respectively, 48.0%,
44.0%, comparison is 24.0%, and after 6 months, group negative conversion rate on probation is respectively 84.0%, 88.0%, 80.0%, compares and is
56.0%%.
Table 1 anti-HPV virus gel dressing treatment simple type and the clinical effectiveness of mixed type HPV infection.
(2) anti-HPV virus combination medicine is to condyloma acuminatum and the curative effect of low risk HPV infection.
Observe anti-HPV virus combination medicine (embodiment 1, embodiment 2, embodiment 3) condyloma acuminatum and low risk HPV are felt
The curative effect of dye.Genitals patients with condyloma acuminatum, after using naturopathy to remove excrescence, posterior fornix is built-in and external genital is smeared
Treatment.The group 1 anti-HPV virus combination Medications Example 1 of employing on probation, group 2 on probation employing uses anti-HPV virus combination medicine to implement
Example 2, the group 3 anti-HPV virus combination Medications Example 3 of employing on probation, matched group naturopathy does not do any treatment after removing excrescence.
Efficacy determination: 1. recovery from illness: cervical HPV-DNA turns out cloudy, genitals condyloma acuminatum is without recurrence；The most effective: cervical HPV-DNA checks knot
Fruit declines；The most invalid: cervical HPV-DNA check is the most down or up, genital wart recurrent exerbation.Result such as table 2 below shows:
After 150 example condyloma acuminatum and low risk HPV infection patient use one course for the treatment of of anti-HPV virus combination medicine, all fully recover, cervix uteri
HPV-DNA turns out cloudy, and genitals condyloma acuminatum is without recurrence.Matched group recovery from illness number of cases only has 5 examples, effective number of cases to be 20 examples, invalid example
Number is 25 examples.
Table 2 anti-HPV virus combination medicine is to condyloma acuminatum and the curative effect of low risk HPV infection.
| Total cases | Recovery from illness number of cases | Effectively number of cases | Invalid number of cases | |
| Group 1 on probation | 50 | 50 | 0 | 0 |
| Group 2 on probation | 50 | 50 | 0 | 0 |
| Group 3 on probation | 50 | 50 | 0 | 0 |
| Matched group | 50 | 5 | 20 | 25 |
(3) the anti-HPV virus combination medicine curative effect to cervical erosion
Observe the anti-HPV virus combination medicine (embodiment 1, embodiment 2, the embodiment 3) curative effect to cervical erosion.Cervix uteri is rotten
The rotten patient group on probation 1 anti-HPV virus combination Medications Example 1 of employing, group 2 on probation employing uses anti-HPV virus combination medicine real
Executing example 2, the group 3 anti-HPV virus combination Medications Example 3 of employing on probation, efficacy determination: 1. recovery from illness: cervix uteri is smooth, rotten to the corn face disappears
Lose；The most effective: rotten to the corn area reduces > 50% or II degree transfer I degree to, III degree transfers II degree to；The most effective: rotten to the corn area reduce <
50%, rotten to the corn area be obviously reduced but improvement less than I degree or rotten to the corn area is without being obviously reduced and granular pattern becomes simple type, nipple
Type becomes granular pattern；The most invalid: before and after treatment, rotten to the corn face is unchanged or has development.Result such as table 3 below shows: anti-HPV virus group
Composite medicine is more than 90% to the effective percentage of cervical erosion.
The table 3 anti-HPV virus combination medicine curative effect to cervical erosion
(4) the anti-HPV virus combination medicine curative effect to cervical polyp
Observe the anti-HPV virus combination medicine (embodiment 1, embodiment 2, the embodiment 3) curative effect to cervical polyp.Cervix uteri ceases
Meat patient uses naturopathy to be administered after removing excrescence or Wicresoft, the group 1 anti-HPV virus combination Medications Example 1 of employing on probation, examination
With the group 2 anti-HPV virus combination Medications Example 2 of employing, the group 3 anti-HPV virus combination Medications Example 3 of employing on probation.Such as table 4 below
Result shows: anti-HPV virus combination medicine is more than 90% to the effective percentage of cervical polyp.
The table 4 anti-HPV virus combination medicine curative effect to cervical polyp
| Number of cases | Recovery from illness | Invalid | Total effective rate | |
| Group 1 on probation | 30 | 28 | 2 | 93.34% |
| Group 2 on probation | 30 | 29 | 1 | 96.67% |
| Group 3 on probation | 30 | 28 | 2 | 93.34% |
Claims (6)
1. lactalbumin-oleic acid complex and carrageenan composition of medicine, it is characterised in that include the breast of 0.01-1 weight portion
Albumin-oleic acid complex, the carrageenan of 0.5-1.5 weight portion, the carbomer of 1-3 weight portion, the glycerol of 1-5 weight portion,
The ethyl hydroxybenzoate of 0.1-0.2 weight portion.
A kind of lactalbumin-oleic acid complex the most according to claim 1 and carrageenan composition of medicine, it is characterised in that
Including the lactalbumin-oleic acid complex of 0.5 weight portion, the carrageenan of 1 weight portion, the carbomer of 2 weight portions, 5 weight portions
Glycerol, the ethyl hydroxybenzoate of 0.15 weight portion.
A kind of lactalbumin-oleic acid complex the most according to claim 2 and carrageenan composition of medicine, it is characterised in that
Also include the triethanolamine of 1-2 weight portion, the water of 87.3-96.39 weight portion.
4., according to a kind of lactalbumin-oleic acid complex described in any one of claim 1-3 and carrageenan composition of medicine, it is special
Levying and be, this composition of medicine is the one in gel, suppository or dressing.
5. a kind of lactalbumin-oleic acid complex as described in any one of claim 1-4 and the preparation of carrageenan composition of medicine
Method, it is characterised in that comprise the following steps:
1): weigh each raw material according to proportioning, carbomer is stirred in the water of 80-85 DEG C to the most swelling, after add carrageenan, stir
Mix to being completely dissolved, while hot through 0.22 μm membrane filtration sterilizing, obtain No. 1 solution；
2): be dissolved in the water by ethyl hydroxybenzoate, through 0.22 μm membrane filtration sterilizing, No. 2 solution are obtained；
3): No. 2 solution are added under agitation in No. 1 solution mix, add triethanolamine, adjust pH to 5.6, obtain No. 3 molten
Liquid；
4): under room temperature, lactalbumin-oleic acid complex is dissolved in qs glycerin by stirring at low speed, through 0.22 μm membrane filtration sterilizing,
Obtain No. 4 solution；
5): under uniform temperature stirs, No. 4 solution are added in No. 3 solution and mixes, adjust pH with sterilized triethanolamine solution
To 5.6；
6): finally adding water to 100 parts and stir evenly and i.e. obtain composition of medicine, composition of medicine is gel.
6. the composition of medicine described in any one of claim 1-5 in preparation prevention and treats women human papilloma virus infection, with
And the application in the medicine of prevention and treatment female gynecological gram-negative bacterial infections.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021051685A1 (en) * | 2019-09-20 | 2021-03-25 | 江西善行生物科技有限公司 | Compound formulation for removing hpv |
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| CN1960747A (en) * | 2004-02-26 | 2007-05-09 | 哈姆雷特药品公司 | Lactalbumin for inhibiting angiogenesis |
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| CN103372202A (en) * | 2012-07-23 | 2013-10-30 | 任发政 | Lactoprotein/fatty acid-containing composition, and preparation method and application thereof |
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| WO2021051685A1 (en) * | 2019-09-20 | 2021-03-25 | 江西善行生物科技有限公司 | Compound formulation for removing hpv |
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