CN114452307A - Lactobacillus capsule with treatment and prevention effects on vaginitis and preparation method thereof - Google Patents

Lactobacillus capsule with treatment and prevention effects on vaginitis and preparation method thereof Download PDF

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CN114452307A
CN114452307A CN202011248022.1A CN202011248022A CN114452307A CN 114452307 A CN114452307 A CN 114452307A CN 202011248022 A CN202011248022 A CN 202011248022A CN 114452307 A CN114452307 A CN 114452307A
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lactobacillus
parts
powder
capsule
vaginitis
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宿志瑞
崔巍
崔崇军
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Xi'an Zhenghao Biological Pharmaceutical Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • A61K35/741Probiotics
    • A61K35/744Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747Lactobacilli, e.g. L. acidophilus or L. brevis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/722Chitin, chitosan
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
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  • Organic Chemistry (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Pain & Pain Management (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Rheumatology (AREA)
  • Biophysics (AREA)
  • Gynecology & Obstetrics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

The invention relates to a lactobacillus capsule with treatment and prevention effects on vaginitis and a preparation method thereof, wherein the lactobacillus capsule comprises the following components in parts by weight: 20-50 parts of lactobacillus, 10-20 parts of lactobacillus salivarius, 10-20 parts of lactobacillus rhamnosus, 10-20 parts of lactobacillus plantarum, 5-10 parts of chitosan, 1-5 parts of bromelain and 5-10 parts of corn starch. According to the lactobacillus capsule with the functions of treating and preventing vaginitis, provided by the invention, under the requirement of the formula proportion, lactobacillus and chitosan are mutually cooperated, so that on one hand, the vaginal flora environment is improved in a form of additionally adding thalli, pathogenic bacteria are killed, pathogenic bacteria are inhibited, and a beneficial flora environment is constructed, and on the other hand, the growth of lactobacillus is promoted by introducing chitosan nutrient substances, so that the vaginal flora environment is thoroughly improved, the microecological health in vagina is maintained, and the aim of radically treating vaginitis is fulfilled.

Description

Lactobacillus capsule with treatment and prevention effects on vaginitis and preparation method thereof
Technical Field
The invention relates to the technical field of biological preparations, in particular to a lactobacillus capsule with treatment and prevention effects on vaginitis and a preparation method thereof.
Background
According to statistics, 10 million women all over the world suffer from vaginal discomfort, wherein nearly 90% of white-collar workers over 30 years old have gynecological diseases, while women of childbearing age have a vaginal infection probability of 61%, and about 60% of women need to take 2-3 days per month to treat the vaginal infection.
One of the pathogenesis of bacterial vaginitis is that the environment in the vagina changes, the mutual restriction relationship among microorganisms is disordered, and pathogenic microorganisms rapidly grow and reproduce due to the pathogenic microorganisms and the external reasons. The lactic acid bacteria are important beneficial microorganisms in vaginal secretion, and play an important role in maintaining the stability of the local microbial environment of the vagina and reducing the occurrence of various vaginitis. Lactic acid bacteria, which are the dominant bacteria of the female vaginal microecological system, have recently attracted attention of scholars in terms of important roles in lowering vaginal pH, maintaining vaginal ecological balance, maintaining vaginal cleanliness, and the like.
However, the effective treatment components of the existing vaginal lactobacillus capsules are mainly antibiotic medicines, although the antibiotics have a positive effect on disease control, the large use of the antibiotics can reduce the sensitivity of bacteria to the medicines and increase the drug resistance, and the antibiotics can destroy the normal flora of the vagina while inhibiting pathogenic bacteria.
Disclosure of Invention
In order to solve the defects in the prior art, the invention provides a lactobacillus capsule with the functions of treating and preventing vaginitis and a preparation method thereof.
The embodiment of the invention provides a lactobacillus capsule with treatment and prevention effects on vaginitis, which comprises the following components in parts by weight:
20-50 parts of lactobacillus, 10-20 parts of lactobacillus salivarius, 10-20 parts of lactobacillus rhamnosus, 10-20 parts of lactobacillus plantarum, 5-10 parts of chitosan, 1-5 parts of bromelain and 5-10 parts of corn starch.
In one embodiment of the invention, the medicine preparation further comprises 10-15 parts of solid medicine particles, and the solid medicine particles comprise an adsorbent and a lubricant.
In one embodiment of the invention, the adsorbent comprises compressible starch, lactose, microcrystalline cellulose; the lubricant comprises magnesium stearate, polyethylene glycol, and hydrogenated vegetable oil.
Another embodiment of the present invention provides a method for preparing a lactobacillus capsule having a therapeutic and prophylactic effect on vaginitis, comprising the steps of:
respectively culturing seed solutions of lactobacillus salivarius, lactobacillus plantarum and lactobacillus rhamnosus, and mixing and stirring uniformly with a protective agent to obtain an emulsion;
carrying out emulsion spray drying by a boiling granulation dryer to respectively obtain lactobacillus salivarius powder, lactobacillus plantarum powder and inactivated lactobacillus rhamnosus powder, and weighing the prepared lactobacillus salivarius powder, lactobacillus plantarum powder and lactobacillus rhamnosus powder according to the required weight parts;
weighing chitosan, bromelain and corn starch in required parts by weight, and uniformly mixing with lactobacillus salivarius powder, lactobacillus plantarum powder and lactobacillus rhamnosus powder to obtain a mixture for later use;
weighing the lactobacillus dry powder in the required weight part, uniformly mixing the lactobacillus dry powder with the mixture for later use, and preparing the lactobacillus capsule.
Compared with the prior art, the invention has the beneficial effects that:
according to the lactobacillus capsule with the functions of treating and preventing vaginitis, provided by the invention, under the requirement of the formula proportion, lactobacillus and chitosan are mutually cooperated, so that on one hand, the vaginal flora environment is improved in a form of additionally adding thalli, pathogenic bacteria are killed, pathogenic bacteria are inhibited, and a beneficial flora environment is constructed, and on the other hand, the growth of lactobacillus is promoted by introducing chitosan nutrient substances, so that the vaginal flora environment is thoroughly improved, the microecological health in vagina is maintained, and the purpose of radically treating vaginitis is achieved.
Detailed Description
The present invention will be described in further detail with reference to specific examples, but the embodiments of the present invention are not limited thereto.
The present invention will be described in detail with reference to the following embodiments in order to make the aforementioned objects, features and advantages more comprehensible. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention can be embodied in many different forms than those herein described and one skilled in the art can make similar modifications without departing from the spirit of the invention and it is therefore not limited to the specific embodiments disclosed below.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
Example one
The embodiment provides a lactobacillus capsule with treatment and prevention effects on vaginitis, which comprises the following components in parts by weight: 20-50 parts of lactobacillus, 10-20 parts of lactobacillus salivarius, 10-20 parts of lactobacillus rhamnosus, 10-20 parts of lactobacillus plantarum, 5-10 parts of chitosan, 1-5 parts of bromelain and 5-10 parts of corn starch.
Furthermore, each of the lactic acid bacteria capsules in this embodiment may further include 10 to 15 parts of solid pharmaceutical particles, where the solid pharmaceutical particles include an adsorbent and a lubricant, where the adsorbent is preferably compressible starch, lactose, and microcrystalline cellulose, and the lubricant is preferably magnesium stearate, polyethylene glycols, and hydrogenated vegetable oil. The medicament solid particles are taken as the middle filling materials of the lactic acid bacteria capsule, and gelatin is not taken, so that the effect range of the lactic acid bacteria capsule is not reduced due to the effect of the filling materials of the gelatin and the lactic acid bacteria capsule in the using process of the lactic acid bacteria capsule, and the whole treatment effect is not influenced.
According to the lactobacillus capsule with the effects of treating and preventing vaginitis, provided by the embodiment, under the requirement of the formula proportion of the embodiment, lactobacillus and chitosan are mutually cooperated, so that on one hand, the vaginal flora environment is improved in a form of additionally adding thalli, pathogenic bacteria are killed, pathogenic bacteria are inhibited, and a beneficial flora environment is constructed, and on the other hand, the growth of lactobacillus is promoted by introducing chitosan nutrient substances, so that the vaginal flora environment is thoroughly improved, the microecological health in vagina is maintained, and the purpose of radically treating vaginitis is achieved.
Example two
On the basis of the first embodiment, the embodiment provides a lactobacillus capsule with treatment and prevention effects on vaginitis, and the lactobacillus capsule comprises the following components in parts by weight: 35 parts of lactobacillus, 15 parts of lactobacillus salivarius, 15 parts of lactobacillus rhamnosus, 15 parts of lactobacillus plantarum, 58 parts of chitosan, 3 parts of bromelain and 8 parts of corn starch.
Further, 12 parts of solid medicament particles, lactose as an adsorbent and magnesium stearate as a lubricant.
EXAMPLE III
The embodiment provides a lactobacillus capsule with treatment and prevention effects on vaginitis, which comprises the following components in parts by weight: 20 parts of lactobacillus, 10 parts of lactobacillus salivarius, 10 parts of lactobacillus rhamnosus, 10 parts of lactobacillus plantarum, 5 parts of chitosan, 1 part of bromelain and 5 parts of corn starch.
Further, the solid medicament particles comprise 10 parts of lactose as an adsorbent and magnesium stearate as a lubricant.
Example four
The embodiment provides a lactobacillus capsule with treatment and prevention effects on vaginitis, which comprises the following components in parts by weight: 50 parts of lactobacillus, 20 parts of lactobacillus salivarius, 20 parts of lactobacillus rhamnosus, 20 parts of lactobacillus plantarum, 10 parts of chitosan, 5 parts of bromelain and 10 parts of corn starch.
Further, 15 parts of solid medicament particles, lactose as an adsorbent and magnesium stearate as a lubricant.
EXAMPLE five
On the basis of the first embodiment, the preparation of the lactobacillus capsule having the effect of treating and preventing vaginitis of the embodiment comprises the following steps:
step 1, respectively culturing seed solutions of lactobacillus salivarius, lactobacillus plantarum and lactobacillus rhamnosus, and mixing and stirring the seed solutions with a protective agent uniformly to obtain an emulsion;
step 2, carrying out emulsion spray drying through a boiling granulation dryer to respectively obtain lactobacillus salivarius powder, lactobacillus plantarum powder and inactivated lactobacillus rhamnosus powder, and weighing the prepared lactobacillus salivarius powder, lactobacillus plantarum powder and lactobacillus rhamnosus powder according to the required weight parts;
step 3, weighing chitosan, bromelain and corn starch in required parts by weight, and uniformly mixing with lactobacillus salivarius powder, lactobacillus plantarum powder and lactobacillus rhamnosus powder to obtain a mixture for later use;
and step 4, weighing the lactobacillus dry powder in required parts by weight, uniformly mixing with the mixture for later use, and preparing the lactobacillus capsule.
Further, the above steps of this embodiment may further include:
step 5, on the basis of the step 4, carrying out air flow crushing on the lactose serving as an adsorbent, weighing the lactose in required parts by weight, and uniformly mixing the lactose and the mixture prepared in the step 4;
and 6, adding a lubricant magnesium stearate to the mixture obtained in the step 5, and uniformly mixing to prepare the lactobacillus capsule.
To illustrate the effectiveness of the lactic acid bacteria capsules having therapeutic and prophylactic effects on vaginitis proposed in this example, the following experiments were conducted:
the lactobacillus capsule prepared by the steps is subjected to a foaming amount test, and the specific operation of the test is as follows: taking 10 test tubes (with the inner diameter of 1.5cm) with 25ml scales, precisely adding 2ml of water, placing in a water bath at 37 +/-1 ℃ for 5 minutes, respectively putting one lactobacillus capsule in each tube, sealing, and observing the volume of the maximum foaming amount within 20 minutes, wherein the average volume is not less than 6ml, and the volume of less than 3ml is not more than 2 tablets.
Then, the prepared lactobacillus capsule is subjected to a bacteriostatic test, and the test specifically operates as follows: inoculating Escherichia coli (generation 4) on slant of tryptic soy peptone agar medium, and culturing at 32 deg.C for 23 hr; inoculating Staphylococcus aureus (generation 4) on trypticase soy agar slant, and culturing at 32 deg.C for 23 hr; inoculating Candida albicans (generation 4) on the slant of the agar culture medium, and culturing at 23 deg.C for 3-5 days; the 24h slant culture of the test bacteria was washed with PBS to prepare a bacterial suspension (the required concentration was 100. mu.ml of the test bacteria was dropped on a control sample or 5m1 sample, and the number of recovered bacteria was 1X 104~9×104cfu/mL); taking 0.75g of capsule content as a test solution in 5ml of sterilized PBS; taking the content without lactobacillus, dissolving in 5ml of PBS, and then sterilizing to obtain a control solution; respectively dripping 100 μ L of bacterial suspension into the test solution and the reference solution, and mixing; then diluting 1000 times with appropriate PBS solution, taking 5mL of the diluent, placing in two plates, pouring with 15mL of nutrient agar culture medium (bacteria: Escherichia coli, Staphylococcus aureus) or agar culture medium of Sabouraud's jelly (Zymobacter albicans) cooled to 40-45 deg.C, rotating the plates to make them fully uniform, and turning the plates after agar solidification. Cultured at 32 ℃ for 5 days (bacteria) and at 22 ℃ for 5 days (yeast: Candida albicans), and counted as viable bacterial colonies. Then, bacteriostatic tests were performed on escherichia coli, staphylococcus aureus, and candida albicans, respectively, to obtain the bacteriostatic effects of the lactic acid bacteria capsules shown in table 1.
TABLE 1 bacteriostatic effect of lactic acid bacteria capsules
Figure BDA0002770703090000071
As can be seen from Table 1, the Lactobacillus capsule proposed in this example has strong bacteriostatic effect (bacteriostatic rate is greater than 80%).
The foregoing is a more detailed description of the invention in connection with specific preferred embodiments and it is not intended that the invention be limited to these specific details. For those skilled in the art to which the invention pertains, several simple deductions or substitutions may be made without departing from the spirit of the invention, which should be construed as belonging to the scope of the invention.

Claims (4)

1. The lactobacillus capsule with the effect of treating and preventing vaginitis is characterized by comprising the following components in parts by weight:
20-50 parts of lactobacillus, 10-20 parts of lactobacillus salivarius, 10-20 parts of lactobacillus rhamnosus, 10-20 parts of lactobacillus plantarum, 5-10 parts of chitosan, 1-5 parts of bromelain and 5-10 parts of corn starch.
2. The lactic acid bacteria capsule having the effect of treating and preventing vaginitis recited in claim 1, further comprising 10 to 15 parts of solid pharmaceutical particles, said solid pharmaceutical particles comprising an adsorbent and a lubricant.
3. The lactic acid bacteria capsule for treating and preventing vaginitis recited in claim 2, wherein said adsorbent comprises a compressible starch, lactose, microcrystalline cellulose; the lubricant comprises magnesium stearate, polyethylene glycol, and hydrogenated vegetable oil.
4. A preparation method of a lactobacillus capsule with treatment and prevention effects on vaginitis is characterized by comprising the following steps:
respectively culturing seed solutions of lactobacillus salivarius, lactobacillus plantarum and lactobacillus rhamnosus, and mixing and stirring uniformly with a protective agent to obtain an emulsion;
carrying out emulsion spray drying by a boiling granulation dryer to respectively obtain lactobacillus salivarius powder, lactobacillus plantarum powder and inactivated lactobacillus rhamnosus powder, and weighing the prepared lactobacillus salivarius powder, lactobacillus plantarum powder and lactobacillus rhamnosus powder according to the required weight parts;
weighing chitosan, bromelain and corn starch in required parts by weight, and uniformly mixing with lactobacillus salivarius powder, lactobacillus plantarum powder and lactobacillus rhamnosus powder to obtain a mixture for later use;
weighing the lactobacillus dry powder in the required weight part, uniformly mixing the lactobacillus dry powder with the mixture for later use, and preparing the lactobacillus capsule.
CN202011248022.1A 2020-11-10 2020-11-10 Lactobacillus capsule with treatment and prevention effects on vaginitis and preparation method thereof Pending CN114452307A (en)

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Citations (5)

* Cited by examiner, † Cited by third party
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US20180117100A1 (en) * 2015-04-16 2018-05-03 Kobiolabs, Inc. Lactobacillus sp. strain having ability to inhibit proliferation of virginal pathogenic microorganisms
CN108158995A (en) * 2017-12-29 2018-06-15 广州润虹医药科技股份有限公司 A kind of gynaecology's anti-bacteria foaming agent containing chitosan and preparation method thereof
CN109985069A (en) * 2019-03-29 2019-07-09 杭州远大生物制药有限公司 Probiotic composition and application thereof
CN111000873A (en) * 2019-09-03 2020-04-14 江苏中天药业有限公司 Lactobacillus vaginal effervescent capsule and preparation method thereof
WO2020074547A1 (en) * 2018-10-09 2020-04-16 Tervisetehnoloogiate Arenduskeskus As Lactobacillus crispatus probiotic strains suitable for treating urogenital yeast and bacterial infections

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180117100A1 (en) * 2015-04-16 2018-05-03 Kobiolabs, Inc. Lactobacillus sp. strain having ability to inhibit proliferation of virginal pathogenic microorganisms
CN108158995A (en) * 2017-12-29 2018-06-15 广州润虹医药科技股份有限公司 A kind of gynaecology's anti-bacteria foaming agent containing chitosan and preparation method thereof
WO2020074547A1 (en) * 2018-10-09 2020-04-16 Tervisetehnoloogiate Arenduskeskus As Lactobacillus crispatus probiotic strains suitable for treating urogenital yeast and bacterial infections
CN109985069A (en) * 2019-03-29 2019-07-09 杭州远大生物制药有限公司 Probiotic composition and application thereof
CN111000873A (en) * 2019-09-03 2020-04-14 江苏中天药业有限公司 Lactobacillus vaginal effervescent capsule and preparation method thereof

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李洁;: "乳杆菌活菌胶囊对细菌性阴道炎患者阴道微生态的影响", 河南医学研究, no. 18, pages 3358 - 3359 *

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