CN114601814A - Probiotic and peptide nano controlled release tablet for improving vaginal environment and preparation method thereof - Google Patents
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Abstract
The invention discloses a probiotic and peptide nano controlled release tablet for improving vaginal environment, which comprises a core material and a first embedding wall, wherein the core material comprises: lactobacillus crispatus, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus formaticus, Lactobacillus plantarum, Pediococcus acidilactici, pearl peptide and elastin peptide, the first coating wall comprises: resistant dextrin, xylitol; the invention also discloses a preparation method of the probiotic and peptide nano controlled release tablet for improving the vaginal environment, and the invention can release the medicament at a preset time or a constant speed, and the release is stable.
Description
Technical Field
The invention relates to the technical field of medicines. More particularly, the invention relates to a probiotic and peptide nano controlled release tablet for improving vaginal environment and a preparation method thereof.
Background
Vaginitis is one of the common clinical gynecological diseases at present, has high morbidity, and has the clinical symptoms of leukorrhagia, pruritus vulvae, vaginal sting and the like, can be repeatedly attacked, and seriously affects the physical and psychological health of patients. At present, when the vaginitis is clinically treated, the mainly applied medicine is an antibacterial medicine, but long-term application may cause unbalance of flora in the vagina of a patient or the appearance of drug-resistant bacteria, so that the difficulty of disease treatment is further increased. The balance of the flora is disrupted due to antibiotic abuse and the emergence of drug-resistant strains is triggered, thus causing the occurrence of drug-resistant bacterial vaginitis.
Bacterial Vaginosis (BV) is a disease with imbalance of vaginal microbial flora, is the most common type of vaginitis of women of childbearing age, has incidence rate related to factors such as age groups, and has incidence rate of 4.96-36.00% in China. BV patients are generally characterized by a reduction in the bacteria of the genus Lactobacillus and an increase in the number of several pathogenic bacteria, the majority of which are strictly anaerobic. These pathogens are relatively weak in pathogenic capacity, so that BV is caused not only by the appearance of these pathogens but by uncontrolled proliferation of these pathogens.
A large amount of probiotics such as lactobacillus exist in human vagina, when the amount of the probiotics is reduced due to the change of external environment (such as the use of antibiotics), harmful bacteria can be propagated in a large amount, and bacterial vaginitis can often happen when the amount of the harmful bacteria reaches a certain degree. Exogenous probiotic bacteria are supplemented to treat bacterial vaginitis, and the probiotic bacteria are used for inhibiting the propagation and growth of harmful bacteria to form a novel treatment method for the bacterial vaginitis. The lower genital tract flora of healthy women of childbearing age is mainly Lactobacillus of Lactobacillaceae. In the lower genital tract, lactobacillus, as a dominant flora, can inhibit the growth of pathogenic microorganisms and conditionally pathogenic microorganisms by producing lactic acid, hydrogen peroxide, bacteriostatic peptides, and regulating immunity, which is very important for maintaining the reproductive health of women.
At present, probiotic preparations for regulating the micro-ecology of female genital tracts are mainly capsules and tablets, and domestic clinical application adopts externally applied viable bacteria capsules for vagina, which are single lactic acid bacteria preparations. The foreign vaginal microecological preparation is orally taken and externally applied, the dosage form is mainly capsules, and the preparation also comprises tablets and the like, and most of the preparation is a compound viable bacteria preparation of two or more lactic acid bacteria. The probiotics and the peptide are prepared into a sustained and controlled release preparation, so that the administration frequency can be reduced, the compliance of the medicament is increased, the stability of blood concentration is increased, and the adverse reaction of the medicament is reduced, so that the sustained and controlled release preparation of the medicament has great significance. Particularly, the controlled release type, since it allows the drug to be released at a predetermined time or constant rate.
Disclosure of Invention
An object of the present invention is to solve at least the above problems and to provide at least the advantages described later.
It is still another object of the present invention to provide a probiotic and peptide nano controlled-release tablet for improving vaginal environment and a method for preparing the same, which can release the drug at a predetermined time or constant rate with stable release.
To achieve these objects and other advantages and in accordance with the purpose of the invention, there is provided a probiotic and peptide nano controlled-release tablet for improving vaginal environment, comprising a core material and a first embedding wall, the core material comprising: lactobacillus crispatus, lactobacillus acidophilus, lactobacillus bulgaricus, lactobacillus formaticus, lactobacillus plantarum, pediococcus acidilactici, pearl peptide and elastin peptide, wherein the first packaging material wall comprises: resistant dextrin and xylitol.
Preferably, the pellet core also comprises ethyl cellulose, sodium dodecyl sulfate, polyethylene glycol, pure water, isopropanol and microcrystalline cellulose.
Preferably, the mass fractions of each component of the core material in the total mass of the probiotics and the peptide nano controlled release tablet are respectively as follows: 0.5-2% of lactobacillus crispatus, 0.5-2% of lactobacillus acidophilus, 1.5-3% of lactobacillus bulgaricus, 0.2-1% of lactobacillus formaticus, 0.2-1% of lactobacillus plantarum, 0.2-1% of pediococcus acidilactici, 0.1-0.2% of pearl peptide and 0.1-0.3% of elastin peptide.
Preferably, the mass fractions of each component of the first embedding wall in the total mass of the probiotics and the peptide nano controlled release tablet are respectively as follows: 10-15% of resistant dextrin and 20-35% of xylitol.
Preferably, the mass fraction of the ethyl cellulose in the total mass of the probiotics and the peptide nano controlled release tablet is 1-3%, the mass fraction of the sodium dodecyl sulfate in the total mass of the probiotics and the peptide nano controlled release tablet is 1-3%, and the mass fraction of the polyethylene glycol in the total mass of the probiotics and the peptide nano controlled release tablet is 2-5%.
A preparation method of probiotic and peptide nano controlled release tablets for improving vaginal environment comprises the following specific steps:
s1, dispersing the ethyl cellulose into the mixed solution of the pure water and the isopropanol, then adding the sodium dodecyl sulfate and the polyethylene glycol, stirring and homogenizing to obtain a suspension;
s2, adding the lactobacillus crispatus, the lactobacillus acidophilus, the lactobacillus bulgaricus, the lactobacillus formaticus, the lactobacillus plantarum, the pediococcus acidilactici, the pearl peptide and the elastin peptide into the suspension to obtain a mixture, stirring the mixture, dispersing the mixture by a high-pressure homogenizer, and then grinding the mixture on a nano grinder to ensure that the average particle size of the mixture is less than or equal to 1000nm to obtain probiotic and peptide suspension;
s3, wrapping the probiotic and peptide suspension with the microcrystalline cellulose pill core by adopting a fluidized bed technology to obtain a core material containing the probiotic and the peptide;
s4, embedding the core material containing the probiotics and the peptides in the first embedding wall to obtain the probiotic and peptide nano controlled release tablet.
Preferably, the dispersing conditions of the high-pressure homogenizer in step S2 are: the temperature of the mixture is 26-28 ℃, the flow rate of the mixture is 100-200mL/min, and the homogenizing pressure is 1000-1500 bar.
Preferably, the conditions of the fluidized bed technique in step S3 are: the temperature of the probiotic and peptide suspension is 26-28 ℃, the atomization pressure is 0.6-1.0 bar, the liquid spraying rate is 30-40 g/min, and the liquid spraying time is 50-120 min.
Preferably, in step S4, the core material containing the probiotics and the peptides is embedded in the first embedding wall to obtain a first embedding object, and a second embedding wall is embedded outside the first embedding object to obtain the probiotic and peptide nano controlled-release tablet, wherein the second embedding wall is chitosan.
Preferably, the weight ratio of the chitosan to the first embedding wall is: 10-20: 100.
the invention at least comprises the following beneficial effects:
the resistant dextrin and the xylitol are used as a first embedding wall to be embedded on the outer side of the core material, so that the drug can be released at a preset time or a constant speed, and the release is stable.
Additional advantages, objects, and features of the invention will be set forth in part in the description which follows and in part will become apparent to those having ordinary skill in the art upon examination of the following or may be learned from practice of the invention.
Drawings
FIG. 1 is a flow chart of a method for preparing a controlled release nano tablet of probiotics and peptides for improving vaginal environment according to one embodiment of the present invention;
FIG. 2 is a graph showing the cumulative elution amounts of examples 1 to 6 according to one embodiment of the present invention.
Detailed Description
The present invention is further described in detail below with reference to examples so that those skilled in the art can practice the invention with reference to the description.
The application provides a probiotic and peptide nano controlled release tablet for improving vaginal environment, which comprises a core material and a first embedding wall, wherein the core material comprises: lactobacillus crispatus, lactobacillus acidophilus, lactobacillus bulgaricus, lactobacillus formaticus, lactobacillus plantarum, pediococcus acidilactici, pearl peptide and elastin peptide, wherein the first packaging material wall comprises: the resistant dextrin and the xylitol are used for embedding lactobacillus crispatus, lactobacillus acidophilus, lactobacillus bulgaricus, lactobacillus formaticus, lactobacillus plantarum, pediococcus acidilactici, pearl peptide and elastin peptide, so that the medicament can be released at a preset time or a constant speed and is released stably.
In other embodiments, ethyl cellulose, sodium lauryl sulfate, polyethylene glycol, purified water, isopropyl alcohol, and microcrystalline cellulose pellets are also included.
In other embodiments, the mass fractions of each component of the core material in the total mass of the probiotics and the peptide nano controlled release tablet are respectively as follows: 0.5-2% of lactobacillus crispatus, 0.5-2% of lactobacillus acidophilus, 1.5-3% of lactobacillus bulgaricus, 0.2-1% of lactobacillus formaticus, 0.2-1% of lactobacillus plantarum, 0.2-1% of pediococcus acidilactici, 0.1-0.2% of pearl peptide and 0.1-0.3% of elastin peptide.
In other embodiments, the mass fractions of each component of the first embedding wall in the total mass of the probiotics and the peptide nano controlled release tablet are respectively as follows: 10-15% of resistant dextrin and 20-35% of xylitol.
In other embodiments, the ethyl cellulose accounts for 1-3% of the total mass of the probiotic and peptide nano controlled release tablet, the sodium dodecyl sulfate accounts for 1-3% of the total mass of the probiotic and peptide nano controlled release tablet, and the polyethylene glycol accounts for 2-5% of the total mass of the probiotic and peptide nano controlled release tablet.
As shown in fig. 1, the embodiment of the present application provides a method for preparing a probiotic and peptide nano controlled-release tablet for improving vaginal environment, which comprises the following specific steps:
s1, dispersing the ethyl cellulose into the mixed solution of the pure water and the isopropanol, then adding the sodium dodecyl sulfate and the polyethylene glycol, stirring and homogenizing to obtain a suspension;
s2, adding the lactobacillus crispatus, the lactobacillus acidophilus, the lactobacillus bulgaricus, the lactobacillus formaticus, the lactobacillus plantarum, the pediococcus acidilactici, the pearl peptide and the elastin peptide into the suspension to obtain a mixture, stirring the mixture, dispersing the mixture by a high-pressure homogenizer, and then grinding the mixture on a nano grinder to ensure that the average particle size of the mixture is less than or equal to 1000nm to obtain probiotic and peptide suspension;
s3, wrapping the probiotic and peptide suspension with the microcrystalline cellulose pill core by adopting a fluidized bed technology to obtain a core material containing the probiotic and the peptide;
s4, embedding the core material containing the probiotics and the peptides in the first embedding wall to obtain the probiotic and peptide nano controlled release tablet.
In other embodiments, the dispersing conditions of the high-pressure homogenizer in step S2 are: the temperature of the mixture is 26-28 ℃, the flow rate of the mixture is 100-200mL/min, and the homogenizing pressure is 1000-1500 bar.
In other embodiments, the conditions of the fluidized bed technique in step S3 are: the temperature of the probiotic and peptide suspension is 26-28 ℃, the atomization pressure is 0.6-1.0 bar, the liquid spraying rate is 30-40 g/min, and the liquid spraying time is 50-120 min.
In other embodiments, the embedding of the core material comprising probiotic bacteria and peptides in the first embedding wall in step S4 results in a first embedding, embedding a second embedding wall at the outer side of the first embedding object to obtain the probiotic and peptide nano controlled release tablet, wherein the second embedding wall is chitosan, because the chitosan is characterized by being insoluble in water but soluble in acid, and the vagina is in an acid state, namely, the first embedded object embedded by the chitosan does not influence the dissolution of the first embedded object in the vagina, but the chitosan is not easy to dissolve when meeting water outside, thereby playing the role of protecting the first embedded object, meanwhile, the added chitosan also reduces the slow release speed of the first embedded object in the vagina, further slows down the release speed of the probiotics and the peptide nanometer, makes the release of the probiotics and the peptide nanometer more stable, and further improves the conversion rate and the utilization rate of the probiotics and the peptide nanometer.
In other embodiments, the weight ratio of the chitosan to the first embedding wall is: 10-20: 100.
example 1
The probiotic and peptide nano controlled release tablet for improving the vaginal environment comprises the following components in percentage by weight when the total weight of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is 1000 mg: 20mg of lactobacillus crispatus, 20mg of lactobacillus acidophilus, 30mg of lactobacillus bulgaricus, 10mg of lactobacillus formaticus, 10mg of lactobacillus plantarum, 10mg of pediococcus acidilactici, 2mg of pearl peptide, 3mg of elastin peptide, 150mg of resistant dextrin, 350mg of xylitol, 30mg of ethyl cellulose, 30mg of sodium dodecyl sulfate, 50mg of polyethylene glycol, pure water, isopropanol and a microcrystalline cellulose pill core, wherein the pure water, the isopropanol and the microcrystalline cellulose pill core are prepared according to requirements.
A preparation method of probiotic and peptide nano controlled release tablets for improving vaginal environment comprises the following specific steps:
s1, dispersing the ethyl cellulose into the mixed solution of the pure water and the isopropanol, then adding the sodium dodecyl sulfate and the polyethylene glycol, stirring and homogenizing to obtain a suspension;
s2, adding the lactobacillus crispatus, the lactobacillus acidophilus, the lactobacillus bulgaricus, the lactobacillus formaticus, the lactobacillus plantarum, the pediococcus acidilactici, the pearl peptide and the elastin peptide into the suspension to obtain a mixture, stirring the mixture, dispersing the mixture by a high-pressure homogenizer, and then grinding the mixture by a nano grinder to ensure that the average particle size of the mixture is less than or equal to 1000nm to obtain probiotic and peptide suspension, wherein the dispersion conditions of the high-pressure homogenizer are as follows: the temperature of the mixture is 26-28 ℃, the flow rate of the mixture is 100-200mL/min, and the homogenizing pressure is 1000-1500 bar;
s3, wrapping the microcrystalline cellulose pill core with the probiotic and peptide suspension by adopting a fluidized bed technology to obtain a core material containing probiotics and peptides, wherein the temperature of the probiotic and peptide suspension is 26-28 ℃, the atomization pressure is 0.6-1.0 bar, the liquid spraying rate is 30-40 g/min, and the liquid spraying time is 50-120 min;
s4, embedding the core material containing the probiotics and the peptides in the first embedding wall to obtain the probiotic and peptide nano controlled release tablet.
Example 2
When the total weight of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is 1000mg, the resistant dextrin is 140g, the xylitol is 330g, and the rest components and the weight are the same as those in the embodiment 1, and meanwhile, the preparation method of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is also the same as that in the embodiment 1.
Example 3
When the total weight of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is 1000mg, the resistant dextrin is 130g, the xylitol is 310g, and the rest components and the weight are the same as those in the embodiment 1, and meanwhile, the preparation method of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is also the same as that in the embodiment 1.
Example 4
When the total weight of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is 1000mg, the total weight of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is 120g of resistant dextrin, 290g of xylitol and the balance of the components and the weight are the same as those in example 1, and the preparation method of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is also the same as that in example 1.
Example 5
When the total weight of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is 1000mg, the resistant dextrin is 110g, the xylitol is 270g, the rest components and the weight are the same as those in the embodiment 1, and meanwhile, the preparation method of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is also the same as that in the embodiment 1.
Example 6
When the total weight of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is 1000mg, the resistant dextrin is 100g, the xylitol is 250g, and the rest components and the weight are the same as those in the embodiment 1, and meanwhile, the preparation method of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is also the same as that in the embodiment 1.
Example 7
When the total weight of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is 1000mg, the total weight of the probiotic and peptide nano controlled release tablet is 150g by weight, 350g by weight of xylitol and 50g by weight of chitosan, and the rest components and the weight are the same as those in the embodiment 1, meanwhile, the preparation method of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is the same as that in the embodiment 1, and simultaneously, after the core material containing the probiotic and the peptide is embedded in the first embedding wall in the step S4, a first embedding object is obtained, a second embedding wall is embedded on the outer side of the first embedding object, and the second embedding wall is chitosan, so that the probiotic and peptide nano controlled release tablet is obtained.
Example 8
When the total weight of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is 1000mg, the total weight of the probiotic and peptide nano controlled release tablet is 150g by weight, 350g by weight of xylitol and 100g by weight of chitosan, and the balance of the components and the weight are the same as those in the embodiment 1, meanwhile, the preparation method of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is the same as that in the embodiment 1, and simultaneously, after the core material containing the probiotic and the peptide is embedded in the first embedding wall in the step S4, a first embedding object is obtained, a second embedding wall is embedded on the outer side of the first embedding object, and the second embedding wall is chitosan, so that the probiotic and peptide nano controlled release tablet is obtained.
Comparative example 1
When the total weight of the probiotic and peptide nano controlled release tablet for improving the vaginal environment is 1000mg, resistant dextrin and xylitol are removed by weight, the rest components and the weight are the same as those in example 1, and the steps of the preparation method of the probiotic and peptide nano controlled release tablet for improving the vaginal environment are the same as those in example 1.
The melting time limit test (0922 melting time limit test method in the four parts of the 15 th edition of Chinese pharmacopoeia) and the dissolution test (100 rpm/min pH4.5 acetate buffer + 3% SDS-paddle method) were carried out in the above examples and comparative examples, and the results are shown in Table 1 below, and the cumulative dissolution amounts in examples 1 to 6 are shown in FIG. 2.
TABLE 1
As can be seen from fig. 2, the cumulative elution amount of the drug increases with the increase of the weight of the first embedding wall, and as can be seen from table 1, compared with comparative example 1, the increase of the first packing wall can ensure the effect of continuous effect, and meanwhile, the probiotic and peptide nano controlled release tablet for improving the vaginal environment has high elution rate, can play a slow release effect and has certain bio-adhesion, so that the tablet can continuously and quickly take effect, is not easy to fall off from the vagina, ensures the treatment effect and does not pollute clothes and trousers. Example 8 shows that embedding chitosan on the outer side of the first inclusion complex further improves the dissolution rate of the drug and improves the utilization rate and conversion rate of the drug, compared with example 1.
While embodiments of the invention have been described above, it is not limited to the applications set forth in the description and the embodiments, which are fully applicable in various fields of endeavor to which the invention pertains, and further modifications may readily be made by those skilled in the art, it being understood that the invention is not limited to the details shown and described herein without departing from the general concept defined by the appended claims and their equivalents.
Claims (10)
1. The probiotic and peptide nano controlled-release tablet for improving the vaginal environment is characterized by comprising a core material and a first embedding wall, wherein the core material comprises: lactobacillus crispatus, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus formaticus, Lactobacillus plantarum, Pediococcus acidilactici, pearl peptide, elastin peptide, the first coating wall includes: resistant dextrin and xylitol.
2. The probiotic and peptide nano controlled-release tablet for improving the vaginal environment according to claim 1, further comprising ethyl cellulose, sodium lauryl sulfate, polyethylene glycol, purified water, isopropyl alcohol and a microcrystalline cellulose pellet core.
3. The probiotic and peptide nano controlled-release tablet for improving the vaginal environment according to claim 2, wherein the mass fractions of each component of the core material in the total mass of the probiotic and peptide nano controlled-release tablet are respectively: 0.5-2% of lactobacillus crispatus, 0.5-2% of lactobacillus acidophilus, 1.5-3% of lactobacillus bulgaricus, 0.2-1% of lactobacillus formaticus, 0.2-1% of lactobacillus plantarum, 0.2-1% of pediococcus acidilactici, 0.1-0.2% of pearl peptide and 0.1-0.3% of elastin peptide.
4. The probiotic and peptide nano controlled-release tablet for improving the vaginal environment according to claim 3, wherein the mass fractions of each component of the first embedding wall in the total mass of the probiotic and peptide nano controlled-release tablet are respectively as follows: 10-15% of resistant dextrin and 20-35% of xylitol.
5. The probiotic and peptide nano controlled-release tablet for improving the vaginal environment according to claim 4, wherein the ethyl cellulose accounts for 1-3% of the total mass of the probiotic and peptide nano controlled-release tablet, the sodium dodecyl sulfate accounts for 1-3% of the total mass of the probiotic and peptide nano controlled-release tablet, and the polyethylene glycol accounts for 2-5% of the total mass of the probiotic and peptide nano controlled-release tablet.
6. The method for preparing the probiotic and peptide nano controlled-release tablet for improving the vaginal environment according to claim 5, is characterized by comprising the following specific steps:
s1, dispersing the ethyl cellulose into the mixed solution of the pure water and the isopropanol, then adding the sodium dodecyl sulfate and the polyethylene glycol, stirring and homogenizing to obtain a suspension;
s2, adding the lactobacillus crispatus, the lactobacillus acidophilus, the lactobacillus bulgaricus, the lactobacillus formaticus, the lactobacillus plantarum, the pediococcus acidilactici, the pearl peptide and the elastin peptide into the suspension to obtain a mixture, stirring the mixture, dispersing the mixture by a high-pressure homogenizer, and then grinding the mixture on a nano grinder to ensure that the average particle size of the mixture is less than or equal to 1000nm to obtain probiotic and peptide suspension;
s3, wrapping the probiotic and peptide suspension with the microcrystalline cellulose pill core by adopting a fluidized bed technology to obtain a core material containing the probiotic and the peptide;
s4, embedding the core material containing the probiotics and the peptides in the first embedding wall to obtain the probiotic and peptide nano controlled release tablet.
7. The method for preparing a probiotic and peptide nano controlled-release tablet for improving vaginal environment of claim 6, wherein the dispersion conditions of the high pressure homogenizer in step S2 are as follows: the temperature of the mixture is 26-28 ℃, the flow rate of the mixture is 100-200mL/min, and the homogenizing pressure is 1000-1500 bar.
8. The method for preparing the controlled release nano tablet of probiotics and peptides for improving vaginal environment as claimed in claim 6, wherein the conditions of the fluidized bed technology in step S3 are as follows: the temperature of the probiotic and peptide suspension is 26-28 ℃, the atomization pressure is 0.6-1.0 bar, the liquid spraying rate is 30-40 g/min, and the liquid spraying time is 50-120 min.
9. The method of claim 6, wherein the step S4 comprises embedding the core material containing probiotics and peptides in the first embedding wall to obtain a first embedding material, embedding a second embedding wall outside the first embedding material to obtain the controlled-release tablets, wherein the second embedding wall is chitosan.
10. The method for preparing the probiotic and peptide nano controlled-release tablet for improving the vaginal environment according to claim 9, wherein the weight ratio of the chitosan to the first embedding wall is as follows: 10-20: 100.
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CN111011867A (en) * | 2019-12-25 | 2020-04-17 | 光明乳业股份有限公司 | Probiotic embedded particle and preparation method thereof |
CN111296844A (en) * | 2020-03-09 | 2020-06-19 | 徐州一统食品工业有限公司 | A composition for improving vaginal health |
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