WO2020143397A1 - Utilisation d'un squelette de paroi cellulaire de nocardia rubra dans le traitement d'un ulcère aphteux récurrent - Google Patents

Utilisation d'un squelette de paroi cellulaire de nocardia rubra dans le traitement d'un ulcère aphteux récurrent Download PDF

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Publication number
WO2020143397A1
WO2020143397A1 PCT/CN2019/125597 CN2019125597W WO2020143397A1 WO 2020143397 A1 WO2020143397 A1 WO 2020143397A1 CN 2019125597 W CN2019125597 W CN 2019125597W WO 2020143397 A1 WO2020143397 A1 WO 2020143397A1
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WIPO (PCT)
Prior art keywords
nocardia
cell wall
weeks
wall skeleton
red
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PCT/CN2019/125597
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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 CN201980010488.7A priority Critical patent/CN111683670A/zh
Publication of WO2020143397A1 publication Critical patent/WO2020143397A1/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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis

Definitions

  • the present application relates to the use of Nocardia red cell wall skeleton in the preparation of a medicament for treating recurrent aphthous ulcer.
  • Nocardia rubra is a type of Nocardia.
  • the cell wall skeleton of Nocardia red (hereinafter referred to as Nr-CWS or N-CWS) can be prepared after fermentation, cell disruption, and protease degradation of the Nocardia red bacteria.
  • Nocardia are in many forms, spherical, rod-shaped, or filamentous.
  • the bacteria have no motility, and some strains are weakly acid-resistant and obligate aerobic. On ordinary agar plates, colonies were visible after 3 days of cultivation, and after 7 to 10 days, the colonies bulged to form aerial hyphae, and the surface was fluffy. The colonies of different strains are yellow, orange, or red.
  • the G+C molar content of DNA is 60 to 72%. Most Nocardia are saprophytes and are present in the soil.
  • the cell wall skeleton of Nocardia rubra may be commercially available, for example, a product produced by Liaoning Grestel Biopharmaceutical Co., Ltd. (trade name "Nakejia”), or Fujian Shanhe Pharmaceutical Co., Ltd. , Fujian Guangshengtang Pharmaceutical Co., Ltd., Fujian Institute of Microbiology, etc.
  • the Nocardia red cell wall skeleton has been used to treat cervical erosion, cervical precancerous lesions (CN101073583A), anti-human papillomavirus (CN1935262A), skin damage (CN101209267A), skin lesions (eczema, neurodermatitis, non-specific dermatitis, Atopic dermatitis, psoriasis) (CN108938674A), acne (CN108295095A), fungal infections, herpes simplex, herpes zoster (CN1879661A).
  • Recurrent aphthous ulcers are small and painful ulcers of the oral mucosa. They have the characteristics of periodicity, recurrence and self-limitation. Most recurrent aphthous ulcers occur on the lips, cheeks, and tongue margins. Modern medicine believes that ulcers will heal on their own within 7 to 10 days. The problem is that many patients often have repeated illnesses. The etiology and pathogenic mechanism of recurrent aphthous ulcers are still unclear.
  • the trigger may be local trauma, mental stress, changes in food, drugs, hormone levels, and lack of vitamins or trace elements.
  • the diagnosis of recurrent aphthous ulcers can refer to the "Guidelines for the diagnosis and treatment of recurrent aphthous ulcers" formulated by the Professional Committee of Oral Mucosal Diseases of the Chinese Stomatological Association.
  • Recurrent aphthous ulcers mainly include:
  • the lesions are sensitive or there are congested areas of needle-tip size or slightly larger; in the short term, a round or oval shape with a diameter of about 2 to 4 mm and a shallow ulcer with a clear boundary is formed.
  • the center is slightly recessed, and the surface is covered with a light yellow pseudomembrane; the mucosa around the ulcer is congested and flushed.
  • the number of ulcers is generally around 2 to 3. After the ulcer is formed, there is more severe burning pain.
  • the ulcer can heal gradually in about 7 to 10 days without leaving scars. But after an intermittent period of varying lengths, it can recur.
  • stomatitis type aphthous ulcers are also known as stomatitis type aphthous ulcers. Except for the small area and the large number of ulcers (up to 20 to 30), the remaining phenotypes are similar to those of mild recurrent aphthous ulcers. The ulcers are scattered and widely distributed, and the mucosa is congested obviously. There is severe pain, accompanied by headache, fever, or local lymphadenopathy.
  • recurrent necrotizing mucosal peri-gland inflammation or peri-glandular aphthous ulcer is the most severe type. Ulcers often occur individually, and rarely 2 or more. It is more common in the inner lip and the mucous membrane in the corner of mouth.
  • the ulcer is similar to the mild recurrent aphthous ulcer, but its diameter gradually expands to 1 to 2 cm and develops deeper into the mucosal glands.
  • the ulcer is purplish red or dark red, with irregular edges, swollen petals, and a central depression.
  • the bottom is uneven, slightly hard, small nodules, red around the ulcer, local severe pain and may be accompanied by local lymphadenopathy, fever, etc.
  • the course of the disease is often more than a few months. Scars remain after healing, and in severe cases, tissue defects may form.
  • the current conventional treatment methods are:
  • systemic therapy has a certain effect, but the effect is slow and the relapse treatment is ineffective; or the use of immunosuppressive agents (such as thalidomide) (MurielHello et al. Use of Thalidomide for Severe Recurrent Aphthous Stomatitis: A Multicenter Cohort Analysis Medicine .Volume 89, 2010, 176-182), prednisone, dexamethasone, etc., but the side effects are larger and the effect is slower; or treatment with immunomodulators. Because the etiology and pathogenic mechanism are not yet clear, the systemic treatment effect is not ideal, and it is easy to relapse after healing.
  • immunosuppressive agents such as thalidomide
  • Nocardia red cell wall skeleton in the preparation of a medical device for treating recurrent aphthous ulcer or its recurrence.
  • the medical device is an accessory, bandage, film, or patch.
  • the recurrent aphthous ulcer is selected from any one or combination of the following: mild recurrent aphthous ulcer, herpes-type recurrent aphthous ulcer, and severe recurrent aphthous ulcer.
  • the drug or medical device is administered via mucosal contact.
  • the drug or medical device comprises 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 solution of the present application.
  • the medicament is prepared in a dosage form selected from the group consisting of ointment, cream, emulsion, suspension, paste, gel, lotion, tincture, oil, tablet, aerosol, spray Agent, liniment, powder; wherein, the paste is selected from: ointment, plaster, cream.
  • a method of treating recurrent aphthous ulcers comprising the step of providing a therapeutically effective amount of Nocardia red cell wall skeleton to a subject.
  • drugs are applied to the lesions for differences in the area and depth of the ulcer.
  • drugs or medical devices
  • smearing with a drug containing the Nocardia red cell wall skeleton, or covering the lesion with a patch impregnated with the Nocardia red cell wall skeleton, or a lyophilized powder containing the Nocardia red cell wall skeleton Apply directly on the ulcer surface, apply a paste containing Nocardia red cell wall skeleton on the ulcer surface, etc.
  • the drug is a buccal tablet.
  • it is prepared by directly lyophilizing powder at room temperature.
  • 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 Sodium cellulose), binders (eg gelatin), lubricants (eg magnesium stearate).
  • stabilizers e.g. trehalose, glycine
  • flavoring agents e.g. xylitol
  • disintegrants e.g. carboxymethyl Sodium cellulose
  • binders eg gelatin
  • lubricants eg magnesium stearate
  • the stabilizer is selected from one or a combination of glycine, lysine, arginine, hydroxyethyl starch, hydroxymethyl starch, trehalose, dextran.
  • the flavoring agent is selected from one or a combination of sucrose, monosaccharide, 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: talc, magnesium stearate, micronized silica gel.
  • carriers suitable for the present application such as but not limited to: dextran, lactose, microcrystalline cellulose, trehalose, glycine, xylitol, sodium carboxymethyl cellulose, erythritol, 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, hydrofluoroalkanes, glycerin, propylene glycol, deionized water, water for injection, distilled water, ethanol, cetyl alcohol, stearyl alcohol, p-aminobenzoic acid, ethyl alcohol Amide, isopropanol, Tween, polyoxyethyl hydrogenated castor oil, stearic acid, glyceryl monostearate, triglyceryl monostearate, fatty acid sucrose ester, sucrose ester, sucrose acetate isobutyrate Ester, sorbitan tristearate, isopropyl myri
  • the pharmaceutically acceptable carrier is dextran.
  • each dose is administered twice a day, or once a day, or once every two days; each dose, depending on the area and depth of the patient's ulcer, different doses are used, usually 1 ⁇ g to 1000 ⁇ g/unit dose/each time . Specifically, for example, 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120 , 130, 140, 150, 160, 170, 180, 190, 200 ⁇ g/unit dose/each time, and the range between any two of the aforementioned values.
  • the administration lasts from 2 days to 2 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 Week, 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 red cell wall skeleton is a commercially available Nocardia red cell wall skeleton.
  • the Nocardia rubra cell wall skeleton is obtained in the following manner, which includes or consists of the following steps:
  • Steps 3.1), 3.2), 3.3) can exchange order or parallel,
  • Step 4) and step 5) can exchange 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 packaging refers to packaging into containers
  • the container is selected from: bottle, tube, bag, bag, plate, ampoule, injection device, aluminum film packaging, dressing, pouch, film.
  • Technicians have the ability to adjust the specific parameters and equipment of cultivation, crushing, separation, collection, removal of impurities, and sub-packaging according to the subsequent application of active ingredients (cell walls and their constituents) (such as external application), so as not to introduce influences on the subsequent steps in the preparation steps Factors of application.
  • an organic solvent is used to remove lipids in the broken product.
  • nucleases are used to remove DNA and RNA from the broken products.
  • hydrolytic enzymes are used to degrade proteins in the broken products.
  • a surfactant is used to remove cell membranes in the disrupted product.
  • the crushed average particle size 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.
  • There are many test methods for particle size (Hu Songqing et al., Modern Particle Size Measurement Technology, Modern Engineering, 22:1, 2002).
  • 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. Before use, add a solvent (such as sterile water) to the bottle/ampule.
  • a solvent such as sterile water
  • the subject is an animal other than a human, such as for farm animals, pets, working animals, ornamental animals, and production animals.
  • the subject is a human.
  • the subject is suspected of having, diagnosed with, already suffering from, or susceptible to the target disease or its symptoms.
  • the only therapeutic (or prophylactic) active ingredient in a drug or medical device is a product derived from Nocardia rubra, in particular, contains Nocardia rubra component (eg protein, nucleic acid, Products such as lipids, cell walls and their constituents, carbohydrates, metabolites), specifically, products containing Nocardia red cell wall (more preferably Nocardia red skeleton or its composition).
  • Nocardia rubra component eg protein, nucleic acid, Products such as lipids, cell walls and their constituents, 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 ingredient showing the desired activity comes from the cell wall of Nocardia rubra (eg, the cell wall itself or its composition). Therefore, in clinical applications, various forms such as intact cell walls, broken cell walls, incomplete degradation products of cell walls, components of cell walls, extracts of cell walls, and the like are all included within the scope of the present disclosure.
  • the technician understands that other cell wall components adsorbed, combined, and carried on the network-like entity are not excluded.
  • the pharmaceutical or medical device of the present disclosure can be prepared in the form of unit dose (or unit preparation).
  • Example 1 Commercially available Nocardia red cell wall skeleton
  • the red Nocardia cell wall skeleton (trade name: Na Kejia) was purchased from Liaoning Gresto Biopharmaceutical Co., Ltd., and approved the number S20030009 (2ml/ampule; lyophilized powder), which contains 60 ⁇ g of active ingredient and 15mg dextran 40.
  • Nucleic acid removal Centrifuge the broken supernatant, add DNase and RNase to the obtained precipitate, and remove the nucleic acid according to the operation recommended by the enzyme supplier.
  • Protein removal Add common protease (such as trypsin) to the precipitate, and remove the protein according to the operation recommended by the enzyme supplier.
  • protease such as trypsin
  • Delipidation Add organic reagents (such as but not limited to one or a combination of acetone, diethyl ether, and ethanol) to the precipitate, and remove lipids according to routine operations in the art.
  • organic reagents such as but not limited to one or a combination of acetone, diethyl ether, and ethanol
  • the technician can adjust the order to make the steps compatible.
  • the precipitate is reconstituted in water for injection and is ready for use.
  • it can be sterilized at 115°C for 20-30 minutes as a stock solution of the cell wall skeleton (mainly including the cell wall skeleton and its constituent 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 commercial product of Example 1 on a dressing (such as sterile gauze), Prepared as a medical device for external use.
  • 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 is prepared as a lyophilized powder and applied directly to the ulcer surface.
  • Test case Treatment effect of recurrent aphthous ulcer
  • the pharmaceutically acceptable carrier was administered according to the same administration protocol, and the therapeutic benefits of the ulcer surface were not shown after follow-up (data not shown here).

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Abstract

L'invention concerne l'utilisation d'un squelette de paroi cellulaire de Nocardia rubra dans le traitement d'un ulcère aphteux récurrent. L'ulcère aphteux récurrent est choisi parmi l'un quelconque ou une combinaison des éléments suivants : un ulcère aphteux récurrent doux, un ulcère aphteux récurrent herpétique et un ulcère aphteux récurrent grave. On peut voir qu'après administration médicamenteuse, la cicatrisation des ulcères, l'hyperémie et les symptômes de douleur disparaissent.
PCT/CN2019/125597 2019-01-09 2019-12-16 Utilisation d'un squelette de paroi cellulaire de nocardia rubra dans le traitement d'un ulcère aphteux récurrent WO2020143397A1 (fr)

Priority Applications (1)

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CN201980010488.7A CN111683670A (zh) 2019-01-09 2019-12-16 红色诺卡氏菌细胞壁骨架在治疗复发性阿弗他溃疡中的用途

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CN201910017739 2019-01-09
CN201910017739.6 2019-01-09

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114712404A (zh) * 2021-06-29 2022-07-08 辽宁格瑞仕特生物制药有限公司 红色诺卡氏菌细胞壁骨架作为中性粒细胞调节剂的用途
EP4056682A4 (fr) * 2020-01-21 2023-01-18 Liaoning Greatest Bio-Pharmaceutical Co., Ltd. Utilisation d'un squelette de paroi cellulaire de nocardia rubra en médecine régénérative

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1879661A (zh) * 2005-06-16 2006-12-20 沈阳胜宝康生物制药有限公司 红色诺卡氏菌细胞壁骨架在制备抗真菌感染的药物中的用途
CN101209267A (zh) * 2006-12-29 2008-07-02 沈阳胜宝康生物制药有限公司 红色诺卡氏菌细胞壁骨架在制备治疗皮肤损伤和疮疡的药物中的用途
JP2010265327A (ja) * 2010-08-25 2010-11-25 Hokkaido Univ 癌抗原非特異的な標的化ｔ細胞の製造方法及び医薬
WO2012083884A1 (fr) * 2010-12-23 2012-06-28 辽宁纳可佳生物制药有限公司 Procédé pour améliorer les fonctions des cellules dendritiques par utilisation du squelette de la paroi cellulaire de nocardia rubra
CN102895264A (zh) * 2012-11-15 2013-01-30 福建广生堂药业股份有限公司 红色诺卡氏菌细胞壁骨架口含片及其制备方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1879661A (zh) * 2005-06-16 2006-12-20 沈阳胜宝康生物制药有限公司 红色诺卡氏菌细胞壁骨架在制备抗真菌感染的药物中的用途
CN101209267A (zh) * 2006-12-29 2008-07-02 沈阳胜宝康生物制药有限公司 红色诺卡氏菌细胞壁骨架在制备治疗皮肤损伤和疮疡的药物中的用途
JP2010265327A (ja) * 2010-08-25 2010-11-25 Hokkaido Univ 癌抗原非特異的な標的化ｔ細胞の製造方法及び医薬
WO2012083884A1 (fr) * 2010-12-23 2012-06-28 辽宁纳可佳生物制药有限公司 Procédé pour améliorer les fonctions des cellules dendritiques par utilisation du squelette de la paroi cellulaire de nocardia rubra
CN102895264A (zh) * 2012-11-15 2013-01-30 福建广生堂药业股份有限公司 红色诺卡氏菌细胞壁骨架口含片及其制备方法

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4056682A4 (fr) * 2020-01-21 2023-01-18 Liaoning Greatest Bio-Pharmaceutical Co., Ltd. Utilisation d'un squelette de paroi cellulaire de nocardia rubra en médecine régénérative
CN114712404A (zh) * 2021-06-29 2022-07-08 辽宁格瑞仕特生物制药有限公司 红色诺卡氏菌细胞壁骨架作为中性粒细胞调节剂的用途

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