WO2020182181A1 - Utilisation d'un squelette de paroi cellulaire de nocardia rubra dans le traitement de lésions blanches sur la vulve - Google Patents

Utilisation d'un squelette de paroi cellulaire de nocardia rubra dans le traitement de lésions blanches sur la vulve Download PDF

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Publication number
WO2020182181A1
WO2020182181A1 PCT/CN2020/078933 CN2020078933W WO2020182181A1 WO 2020182181 A1 WO2020182181 A1 WO 2020182181A1 CN 2020078933 W CN2020078933 W CN 2020078933W WO 2020182181 A1 WO2020182181 A1 WO 2020182181A1
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Prior art keywords
cell wall
weeks
vulva
nocardia rubra
nocardia
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PCT/CN2020/078933
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English (en)
Chinese (zh)
Inventor
盖波
窦春艳
张轶
张国英
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辽宁格瑞仕特生物制药有限公司
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Priority to CN202311610377.4A priority Critical patent/CN117482118A/zh
Priority to CN202080002084.6A priority patent/CN112040962A/zh
Publication of WO2020182181A1 publication Critical patent/WO2020182181A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/99—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from microorganisms other than algae or fungi, e.g. protozoa or bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/20—Bacteria; Culture media therefor
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12R—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS
    • C12R2001/00—Microorganisms ; Processes using microorganisms
    • C12R2001/01—Bacteria or Actinomycetales ; using bacteria or Actinomycetales
    • C12R2001/365—Nocardia

Definitions

  • the present disclosure relates to the medical field, the microbiological field, and the biopharmaceutical field. Specifically, this application relates to the use of Nocardia rubra cell wall skeleton in the preparation of drugs for treating white lesions of the vulva.
  • Nocardia rubra is a kind of Nocardia.
  • Nocardia rubra cell wall skeleton (hereinafter referred to as Nr-CWS or N-CWS) can be produced by fermentation, cell disruption, and protease degradation of Nocardia rubra cell wall.
  • Nocardia is polymorphous, with spherical, rod-shaped, or filamentous. Bacteria are not motility, some strains are weakly resistant to acid and obligate aerobic. On ordinary agar plates, colonies can be seen after 3 days of culture, and after 7 to 10 days, the colonies bulge and form aerial hyphae with a fluffy surface. The colonies of different strains are yellow, orange, or red. The molar content of G+C in DNA is 60 to 72%. Most Nocardia bacteria are saprophytes and exist in the soil.
  • the Nocardia rubra cell wall skeleton can be commercially available, such as a product produced by Liaoning Grace Biopharmaceutical Co., Ltd. (trade name "Nakejia”), or Fujian Shanhe Pharmaceutical Co., Ltd. , Fujian Guangshengtang Pharmaceutical Co., Ltd., Fujian Institute of Microbiology, etc.
  • Nocardia rubra cell wall skeleton has been used to treat cervical erosion, cervical precancerous lesions (CN101073583A), anti-human papilloma virus (CN1935262A), skin damage (CN101209267A), skin lesions (eczema, neurodermatitis, non-specific dermatitis, Atopic dermatitis, psoriasis) (CN108938674A), acne (CN108295095A), fungal infection, herpes simplex, herpes zoster (CN1879661A).
  • White lesions of the vulva include white lesions of the vulva, leukoplakia or vulvar dystrophy. Because the vulvar mucosa of patients with lichen sclerosus and squamous cell hyperplasia is white, it is called vulvar white lesions (non-tumor-like lesions of the vulvar epithelium).
  • Non-neoplastic epithelial disorders of skin and mucosa non-neoplastic epithelial disorders of skin and mucosa
  • Mild dysplasia Mild dysplasia
  • Moderate dysplasia (moderate dysplasia);
  • Treatments for white lesions of the vulva usually include:
  • Drug therapy Commonly used drugs for lichen sclerosus are pyruvate ointment, compound vitamin A ointment and progesterone ointment, glucocorticoid ointment or immunotherapy. Squamous epithelial hyperplasia of the vulva can be treated with topical corticosteroids to control itching. Treatment is effective for most patients, but long-term medication must be adhered to.
  • Physiotherapy It is suitable for those who are ineffective or severely ill. Microwave treatment, carbon dioxide laser, helium-neon laser, Pomer light, high-frequency electrosurgical knife, local electrocautery therapy, and liquid nitrogen local cryotherapy.
  • the white lesions of the vulva are selected from any one or a combination of the following: lichen sclerosus and squamous cell hyperplasia.
  • the drug or medical device is administered by skin contact or mucosal contact.
  • the drug or medical device includes a pharmaceutically acceptable carrier.
  • a pharmaceutically acceptable carrier Any suitable vector known to those skilled in the art can be used to implement the technical solutions of the present application.
  • the drug is prepared into a dosage form selected from the group consisting of suppositories, ointments, creams, emulsions, suspensions, pastes, gels, lotions, tinctures, oils, tablets, aerosols , Spray, liniment, powder; wherein the ointment is selected from: ointment, plaster, and cream.
  • a method for treating or preventing the recurrence of white lesions of the vulva comprising the steps of: providing a subject with a therapeutically effective amount of Nocardia rubra cell wall skeleton.
  • drugs are applied to the lesions according to the area and severity of the lesions.
  • drugs or medical devices
  • drugs are applied to the lesions according to the area and severity of the lesions.
  • smearing with a drug containing Nocardia rubra cell wall skeleton, or covering the lesion with a patch impregnated with Nocardia rubra cell wall skeleton, or freeze-dried powder containing Nocardia rubra cell wall skeleton Apply directly to the lesion, or apply paste, suppository, lotion, etc. containing Nocardia rubra cell wall skeleton on the lesion.
  • the medicament comprises:
  • the pharmaceutically acceptable carrier is selected from but not limited to: fillers, stabilizers (e.g., trehalose, glycine), flavoring agents (e.g., xylitol), disintegrants (e.g., carboxymethyl) Base cellulose), binders (e.g. gelatin), lubricants (e.g. magnesium stearate).
  • stabilizers e.g., trehalose, glycine
  • flavoring agents e.g., xylitol
  • disintegrants e.g., carboxymethyl Base cellulose
  • binders e.g. gelatin
  • lubricants e.g. magnesium stearate
  • the stabilizer is selected from one or a combination of the following: glycine, lysine, arginine, hydroxyethyl starch, hydroxymethyl starch, trehalose, dextran.
  • the flavoring agent is selected from one or a combination of the following: sucrose, monosaccharides, sodium saccharin, aspartame, sorbitol, xylitol, mannitol.
  • the binder is selected from one or a combination of the following: sodium carboxymethyl cellulose, hypromellose, gelatin.
  • the lubricant is selected from one or a combination of the following: talc, magnesium stearate, and micronized silica gel.
  • the carrier suitable for this application can also be mentioned, such as but not limited to: dextran, lactose, microcrystalline cellulose, trehalose, glycine, xylitol, sodium carboxymethyl cellulose, erythritol Trisitol, gelatin, magnesium stearate, propellant, humectant, solvent, solubilizer, emulsifier, antioxidant, pH adjuster, preservative.
  • non-limiting examples also include: white petrolatum, carbomer, hypromellose, methyl cellulose, sodium hydroxymethyl cellulose, chitosan, sucralfate chitosan, polyvinylpyrrolidone, Polyvinyl alcohol, sodium hyaluronate, dimethyl ether, tetrafluoroethane, hydrofluoroalkane, glycerin, propylene glycol, deionized water, water for injection, distilled water, ethanol, cetyl alcohol, stearyl alcohol, p-aminobenzoic acid, ethyl Amide, isopropanol, Tween, polyoxyethyl hydrogenated castor oil, stearic acid, glyceryl monostearate, triglyceride monostearate, sucrose fatty acid ester, sucrose ester, sucrose acetate isobutyrate Esters, sorbitan tristearate, isopropyl myristate,
  • the pharmaceutically acceptable carrier is dextran.
  • the medicament or medical device of the present application is administered 1-3 times a day, or once a day, or once every two days.
  • a different dose is used, usually 1 ⁇ g/unit dose/each time to 1000 ⁇ g/unit dose/each time.
  • 1 ⁇ g/unit dose/each time usually 1 ⁇ g/unit dose/each time to 1000 ⁇ g/unit dose/each time.
  • the administration cycle lasts from 2 days to 6 months, for example, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 16 weeks, 17 weeks, 18 weeks or longer, and the range between any two of the foregoing values.
  • the Nocardia rubra cell wall skeleton is a commercially available Nocardia rubra cell wall skeleton.
  • the Nocardia rubra cell wall skeleton is obtained in the following manner, which includes or consists of the following steps:
  • Step 3.1), 3.2), 3.3) can be interchanged in order or in parallel,
  • Step 4) and step 5) can interchange the order
  • the average particle size of the pulverization is 10 nm to 1000 nm, preferably 10 nm to 800 nm, more preferably 10 nm to 500 nm;
  • the sub-packing refers to sub-packing into a container
  • the container is selected from: bottles, tubes, bags, bags, plates, ampoules, injection devices, aluminum film packaging, dressings, capsules, and films.
  • Technicians have the ability to adjust the specific parameters and equipment of cultivation, crushing, separation, collection, impurity removal, and sub-packaging according to the subsequent application (for example, external application) of the active ingredients (cell wall and its constituent components), so as to avoid the introduction of the preparation steps that affect the follow-up Applied factors.
  • an organic solvent is used to remove lipids from the fragmented product.
  • nucleases are used to remove DNA and RNA in the fragmented product.
  • a hydrolase is used to degrade the protein in the fragmented product.
  • a surfactant is used to remove the cell membrane in the disrupted product.
  • the average particle size of pulverization is 10 nm to 1000 nm; mention may be made of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190nm ⁇ 10nm, and the range between any two of the above values.
  • particle size for example, Hu Songqing et al., Modern Particle Size Measurement Technology, Modern Engineering, 2002 22:1).
  • the average particle size of the pulverization is 10 nm to 800 nm.
  • the average particle size of the pulverization is 10 nm to 500 nm.
  • the dispensing refers to dispensing into bottles/ampoules. Just before use, add solvent (such as sterile water) to the bottle/ampule.
  • solvent such as sterile water
  • the subject is an animal other than humans, such as farm animals, pets, working animals, ornamental animals, and production animals.
  • the subject is a human.
  • the subject is suspected of having, confirmed to have, has had, or is susceptible to the target disease or its symptoms.
  • the only therapeutically active ingredient in a drug or medical device is a product derived from Nocardia rubra, especially containing Nocardia rubra component (such as protein, nucleic acid, lipid, cell wall and Its components, carbohydrates, metabolites), specifically products containing Nocardia rubra cell wall (more preferably Nocardia rubra skeleton or its composition).
  • Nocardia rubra component such as protein, nucleic acid, lipid, cell wall and Its components, carbohydrates, metabolites
  • Nocardia rubra cell wall can be understood as both a complete cell wall and an incomplete cell wall (for example, broken or partially degraded).
  • the ingredients exhibiting the desired activity are derived from the cell wall of Nocardia rubra (for example, the cell wall itself or its composition). Therefore, various forms such as complete cell walls, broken cell walls, incomplete degradation products of cell walls, components of cell walls, and cell wall extracts are allowed to be used in clinical applications, which are all included in the scope of the present disclosure.
  • the medicine or medical device of the present disclosure can be prepared in the form of a unit dose (or unit preparation).
  • “Optional” means that what is described later can happen, but does not have to happen; it depends on the situation.
  • sub-package means that the product is allowed to be sub-packaged, but it is not required to be sub-packaged; whether the product is sub-packaged or not does not affect the realization of the technical effect.
  • Example 1 Commercially available Nocardia rubra cell wall skeleton
  • Nocardia rubra cell wall skeleton (trade name: Na Kejia) was purchased from Liaoning Grace Biopharmaceutical Co., Ltd., and the approval number was National Medicine Zhunzi S20030009 (2ml/ampule; freeze-dried powder), which contained 60 ⁇ g of active ingredients and 15mg dextran 40.
  • Nucleic acid removal Centrifuge the broken supernatant, add DNase and RNase to the obtained precipitate, and remove nucleic acid according to the operation recommended by the enzyme supplier.
  • Remove protein add common protease (such as trypsin) to the precipitate and remove protein according to the operation recommended by the enzyme supplier.
  • common protease such as trypsin
  • Removal of lipids adding organic reagents (such as but not limited to one or a combination of acetone, ether, and ethanol) to the precipitate, and removing lipids according to conventional operations in the art.
  • organic reagents such as but not limited to one or a combination of acetone, ether, and ethanol
  • the technician can adjust the sequence to make the steps compatible.
  • the precipitate was re-dissolved in water for injection and set aside.
  • it can be sterilized at 115°C for 20-30 minutes as the original solution of the cell wall skeleton (mainly containing the cell wall skeleton and its components).
  • Example 2 Active ingredient 60 ⁇ g to 120 ⁇ g, such as 60 ⁇ g, 70 ⁇ g, 80 ⁇ g, 90 ⁇ g, 100 ⁇ g, 110 ⁇ g, 120 ⁇ g) or the commercially available product of Example 1 on a dressing (such as sterile gauze), Prepared as an external medical device.
  • active ingredient 60 ⁇ g to 120 ⁇ g such as 60 ⁇ g, 70 ⁇ g, 80 ⁇ g, 90 ⁇ g, 100 ⁇ g, 110 ⁇ g, 120 ⁇ g
  • a dressing such as sterile gauze
  • Example 2 active ingredient 60 ⁇ g was prepared into a freeze-dried powder, and it was directly applied to the lesion surface.
  • a lotion preparation method known in the art can also be used, for example:
  • the lotion mostly uses water and ethanol as the dispersion medium; it is made of active ingredients, electrolytes, isotonicity regulators, etc. in the dispersion medium.
  • the oil phase and the water phase may separate, but they can be re-dispersed after shaking.
  • Test example Treatment effect of white lesions of the vulva
  • Gynecological examination normal vulva development, 2 ⁇ 2cm 2 white area on the right labia majora, local skin thickening, married birth, smooth vagina, smooth wall, a small amount of thin vaginal discharge, smooth cervix, no abnormalities, double The attachment is not abnormal;
  • Histopathological examination local anesthesia with Primacaine STA, routine disinfection, take about 0.6 ⁇ 0.6 ⁇ 0.5cm 3 tissue from the left vulvar lesion and suture 2 stitches. The samples were fixed with 10% formalin, sent to pathology, and the stitches were removed one week after the doctor ordered them.

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Abstract

L'invention concerne l'utilisation d'un squelette de paroi cellulaire de Nocardia rubra dans le traitement de lésions blanches sur la vulve. L'invention concerne une composition pharmaceutique, celle-ci comprenant un composant dérivé d'une paroi cellulaire de Nocardia rubra et pouvant efficacement traiter des lésions blanches sur la vulve, parmi lesquelles figurent le lichen scléreux et l'hyperplasie des cellules squameuses.
PCT/CN2020/078933 2019-03-14 2020-03-12 Utilisation d'un squelette de paroi cellulaire de nocardia rubra dans le traitement de lésions blanches sur la vulve WO2020182181A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202311610377.4A CN117482118A (zh) 2019-03-14 2020-03-12 红色诺卡氏菌细胞壁骨架在治疗外阴白色病变中的用途
CN202080002084.6A CN112040962A (zh) 2019-03-14 2020-03-12 红色诺卡氏菌细胞壁骨架在治疗外阴白色病变中的用途

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CN201910191961 2019-03-14
CN201910191961.8 2019-03-14

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WO2020182181A1 true WO2020182181A1 (fr) 2020-09-17

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PCT/CN2020/078932 WO2020182180A1 (fr) 2019-03-14 2020-03-12 Utilisation d'un produit à base de rhodococcus ruber dans le traitement de lésions blanches vulvaires
PCT/CN2020/078933 WO2020182181A1 (fr) 2019-03-14 2020-03-12 Utilisation d'un squelette de paroi cellulaire de nocardia rubra dans le traitement de lésions blanches sur la vulve

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PCT/CN2020/078932 WO2020182180A1 (fr) 2019-03-14 2020-03-12 Utilisation d'un produit à base de rhodococcus ruber dans le traitement de lésions blanches vulvaires

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WO2023246293A1 (fr) * 2022-06-24 2023-12-28 辽宁天安生物制药股份有限公司 Utilisation d'un squelette de paroi cellulaire de nocardia rubra dans le traitement des lésions cervicales

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