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WO1999037321A1 - Preparation immuno-modulatrice a base d'interleukine 1 et procede de preparation - Google Patents

Preparation immuno-modulatrice a base d'interleukine 1 et procede de preparation Download PDF

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Publication number
WO1999037321A1
WO1999037321A1 PCT/RU1998/000212 RU9800212W WO9937321A1 WO 1999037321 A1 WO1999037321 A1 WO 1999037321A1 RU 9800212 W RU9800212 W RU 9800212W WO 9937321 A1 WO9937321 A1 WO 9937321A1
Authority
WO
WIPO (PCT)
Prior art keywords
πρeπaρaτa
interleukin
inτeρleyκina
preparation
chsα
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/RU1998/000212
Other languages
English (en)
Russian (ru)
Inventor
Sergei Alexandrovich Ketlinsky
Andrei Semenovich Simbirtsev
Alexandr Mitrofanovich Ischenko
Evgeny Vitalievich Mitrofanov
Mikhail Aizerovich Gershanovich
Larisa Valentinovna Filatova
Evgeny Nikolaevich Sventitsky
Jury Tikhonovich Kalinin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
GOSUDARSTVENNY NAUCHNO-ISSLEDOVATELSKY INSTITUT OSOBO CHISTYKH BIOPREPARATOV (GOSNII OCHB)
TOVARISCHESTVO S OGRANICHENNOI OTVETSTVENNOSTIJU TSITOKIN
Original Assignee
GOSUDARSTVENNY NAUCHNO-ISSLEDOVATELSKY INSTITUT OSOBO CHISTYKH BIOPREPARATOV (GOSNII OCHB)
TOVARISCHESTVO S OGRANICHENNOI OTVETSTVENNOSTIJU TSITOKIN
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from RU98107188/13A external-priority patent/RU2128706C1/ru
Application filed by GOSUDARSTVENNY NAUCHNO-ISSLEDOVATELSKY INSTITUT OSOBO CHISTYKH BIOPREPARATOV (GOSNII OCHB), TOVARISCHESTVO S OGRANICHENNOI OTVETSTVENNOSTIJU TSITOKIN filed Critical GOSUDARSTVENNY NAUCHNO-ISSLEDOVATELSKY INSTITUT OSOBO CHISTYKH BIOPREPARATOV (GOSNII OCHB)
Publication of WO1999037321A1 publication Critical patent/WO1999037321A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/20—Interleukins [IL]
    • A61K38/2006—IL-1

Definitions

  • the area of technology whereby the invention is not available The invention is not available in the field of medicine, but in the case of a patient who is immune to the disease,
  • Izves ⁇ n ⁇ is ⁇ lz ⁇ vanie in ⁇ aches ⁇ ve s ⁇ eds ⁇ v, v ⁇ zdeys ⁇ vuyuschi ⁇ immune sis ⁇ emu, ⁇ e ⁇ a ⁇ a ⁇ v ginseng eleu ⁇ e ⁇ a, ⁇ ble ⁇ i ⁇ i, ⁇ vni ⁇ a, mummy, ⁇ lisa and ⁇ ⁇ ( ⁇ And ⁇ ashan ⁇ v ⁇ ⁇ P ⁇ vs ⁇ y P ⁇ yan ⁇ -a ⁇ ma ⁇ iches ⁇ ie ⁇ as ⁇ eniya, M, ⁇ g ⁇ mizda ⁇ 1991 AND WITH S ⁇ l ⁇ va and d ⁇ Di ⁇ as ⁇ uschie and ⁇ ul ⁇ u ⁇ nye ⁇ as ⁇ eniya, ⁇ , ⁇ editsina 1990) U ⁇ azannye ⁇ e ⁇ a ⁇ a ⁇ y ⁇ imenyayu ⁇ sya, ⁇ a ⁇ ⁇ avil ⁇ , ⁇ e ⁇ aln ⁇ as
  • Izves ⁇ n ⁇ is ⁇ lz ⁇ vanie as immun ⁇ m ⁇ dulya ⁇ v tsi ⁇ in ⁇ v in chas ⁇ n ⁇ s ⁇ i al ⁇ a-in ⁇ e ⁇ e ⁇ na P ⁇ e ⁇ a ⁇ a ⁇ vv ⁇ di ⁇ sya b ⁇ ln ⁇ mu vnu ⁇ imyshechn ⁇ or in ⁇ anazaln ⁇ as ae ⁇ z ⁇ ley ⁇ un ⁇ tsi ⁇ ni ⁇ vanie sis ⁇ emy in ⁇ e ⁇ e ⁇ na ⁇ i ⁇ azlichny ⁇ s ⁇ s ⁇ ba ⁇ and d ⁇ za ⁇ administration al ⁇ a-2-in ⁇ e ⁇ e ⁇ na zavisi ⁇ ⁇ a ⁇ ivatsii e ⁇ s ⁇ essii gen ⁇ v gis ⁇ s ⁇ vmes ⁇ im ⁇ s ⁇ i and ⁇ sn ⁇ vn ⁇ m svyazan ⁇ with ⁇ iv ⁇ vi ⁇ usnym deys ⁇ vie
  • IL-1 is an inducible protein, the products of which are mainly the main elements and markers (Sétlinsky S and Dr, Bulletin Sim. 48)
  • the synthesis of IL-1 begins in response to the introduction of microorganisms in any way and in order to prevent tkane and is necessary for the implementation of all the complex processes, which are referred to as
  • ⁇ dna ⁇ e ⁇ s ⁇ e ⁇ imen ⁇ y with in ⁇ e ⁇ ley ⁇ in ⁇ m-1 does not ⁇ iveli ⁇ s ⁇ zdaniyu meditsins ⁇ g ⁇ ⁇ e ⁇ a ⁇ a on eg ⁇ ⁇ sn ⁇ ve, ⁇ ⁇ ⁇ eb ⁇ val ⁇ s ⁇ eshenie ⁇ blemy ⁇ lucheniya s ⁇ abiln ⁇ y ⁇ a ⁇ matsev ⁇ iches ⁇ y ⁇ m ⁇ zitsii, ⁇ bes ⁇ echivayuschey s ⁇ ⁇ ⁇ ann ⁇ s ⁇ immun ⁇ m ⁇ duli ⁇ uyuschi ⁇ sv ⁇ ys ⁇ v IL-1 ⁇ tsesse ⁇ lucheniya g ⁇ v ⁇ y le ⁇ a ⁇ s ⁇ venn ⁇ y ⁇ my and ⁇ i ⁇ anenii in ⁇ echenie ⁇ iemlem ⁇ g ⁇ for ⁇ a ⁇ matsev ⁇ iches ⁇ i ⁇
  • a further one task is to expand the range and use of drugs on the main IL-1 for therapeutic purposes.
  • E ⁇ i and d ⁇ ugie ⁇ esheny problem in ⁇ am ⁇ a ⁇ nas ⁇ yascheg ⁇ iz ⁇ b ⁇ e ⁇ eniya ⁇ ezhde vseg ⁇ blag ⁇ da ⁇ ya is ⁇ lz ⁇ vaniyu in s ⁇ s ⁇ ave zayavlyaem ⁇ g ⁇ ⁇ e ⁇ a ⁇ a ⁇ a chel ⁇ veches ⁇ g ⁇ syv ⁇ chn ⁇ g ⁇ albumin (CHS ⁇ ) ⁇ bes ⁇ echivayuscheg ⁇ s ⁇ anenie immun ⁇ m ⁇ duli ⁇ uyuschi ⁇ lechebny ⁇ sv ⁇ ys ⁇ v in ⁇ e ⁇ ley ⁇ ina-1 ⁇ tsesse ⁇ lucheniya and ⁇ aneniya g ⁇ v ⁇ y le ⁇ a ⁇ s ⁇ venn ⁇ y ⁇ my.
  • the immunocompromised product is in accord with the invention, is a mixture of human black albumin (black) and interleukin-1, in part, it is 1
  • ⁇ zm ⁇ zhn ⁇ ⁇ a ⁇ zhe is ⁇ lz ⁇ vanie b ⁇ lshi ⁇ or menshi ⁇ ⁇ s ⁇ avneniyu with u ⁇ azannymi in ⁇ e ⁇ valami ⁇ liches ⁇ v CHS ⁇
  • ⁇ dna ⁇ is ⁇ lz ⁇ vanie menshi ⁇ ⁇ n ⁇ si ⁇ elny ⁇ ⁇ liches ⁇ v CHS ⁇
  • ⁇ increase ⁇ a ⁇ ivn ⁇ s ⁇ i ⁇ e ⁇ a ⁇ a ⁇ a in ⁇ tsesse izg ⁇ vleniya g ⁇ v ⁇ y ⁇ my and its ⁇ i ⁇ anenii and ⁇ imenenie b ⁇ lshi ⁇ ⁇ liches ⁇ v not ⁇ iv ⁇ di ⁇ ⁇ further v ⁇ z ⁇ as ⁇ aniyu s ⁇ abiln ⁇ s ⁇ i ⁇ e ⁇ a ⁇ a ⁇ a.
  • a IS ⁇ W ⁇ IZYA ⁇ G ⁇ (P ⁇ IL ⁇ 26) IL-4 ⁇ aches ⁇ ve 1be ⁇ a genn ⁇ -inzhene ⁇ n ⁇ g ⁇ ⁇ du ⁇ a, ⁇ luchenn ⁇ g ⁇ ⁇ ul ⁇ ivi ⁇ vaniem ba ⁇ e ⁇ ii ⁇ zs ⁇ e ⁇ sg ⁇ a s ⁇ sh ⁇ amm C600 in chas ⁇ n ⁇ s ⁇ i, ⁇ ⁇ Te n ⁇ l ⁇ gii ⁇ isann ⁇ y in ⁇ a ⁇ en ⁇ e ⁇ ⁇ ° 2045575, 1992, pp ⁇ sleduyuschim release of ⁇ du ⁇ a ⁇ ul ⁇ u ⁇ aln ⁇ y zhid ⁇ s ⁇ i with ⁇ m ⁇ schyu i ⁇ n-gid ⁇ bn ⁇ y ⁇ ma ⁇ g ⁇ a ⁇ ii.
  • freeze-drying method which excludes the possibility of freezing the food and subsequent purification by cooling the product selected at an interval of from -55 to -65 ° C, with an initial pressure of 4-7 Pa after that, at a follow-up to 6 ° C. and holding off at this temperature for 4-5 hours
  • P ⁇ luchenny ⁇ e ⁇ a ⁇ a ⁇ , ⁇ a ⁇ ⁇ azali e ⁇ s ⁇ e ⁇ imen ⁇ y, m ⁇ zhe ⁇ by ⁇ is ⁇ lz ⁇ van ⁇ a ⁇ for na ⁇ uzhn ⁇ g ⁇ ⁇ imeneniya, ⁇ a ⁇ ⁇ d ⁇ zhn ⁇ g ⁇ or for administration in the form vnu ⁇ ivenn ⁇ g ⁇ ⁇ as ⁇ v ⁇ a in iz ⁇ niches ⁇ m ⁇ as ⁇ v ⁇ e ⁇ l ⁇ ida na ⁇ iya, dis ⁇ illi ⁇ vann ⁇ y v ⁇ de, ⁇ as ⁇ v ⁇ a ⁇ glyu ⁇ zy and d ⁇ ugi ⁇ ⁇ a ⁇ matsev ⁇ iches ⁇ i ⁇ iemlemy ⁇ zhid ⁇ s ⁇ ya ⁇ .
  • the product is used in the form of products, applied to the wound dressing, applications or emulsions in oils, where the concentration of interleukin-1 is used for 100%
  • the drug has an immune-stimulating effect by increasing the functional activity of neutral and immune-related disorders.
  • ⁇ liniches ⁇ ie is ⁇ y ⁇ aniya ⁇ dem ⁇ ns ⁇ i ⁇ vali vys ⁇ uyu e ⁇ e ⁇ ivn ⁇ s ⁇ ⁇ imeneniya ⁇ e ⁇ a ⁇ a ⁇ a ⁇ iz ⁇ b ⁇ e ⁇ eniyu in ⁇ aches ⁇ ve immun ⁇ s ⁇ imulya ⁇ a for ⁇ e ⁇ tsii v ⁇ ichny ⁇ immun ⁇ de ⁇ itsi ⁇ ny ⁇ s ⁇ s ⁇ yany at b ⁇ lny ⁇ with gn ⁇ yn ⁇ -se ⁇ iches ⁇ imi ⁇ tsessami ⁇ tsen ⁇ a immunn ⁇ g ⁇ s ⁇ a ⁇ usa ⁇ atsien ⁇ v, ⁇ luchavshi ⁇ ⁇ e ⁇ a ⁇ iyu ⁇ e ⁇ a ⁇ a ⁇ m, ⁇ vedennaya ⁇ sle ⁇ nchaniya ⁇ u ⁇ sa treatment ⁇ azala, ch ⁇ ⁇ e ⁇ a ⁇ a
  • LIS ⁇ Z ⁇ IZYA ⁇ G ⁇ ( ⁇ 26) 6 interleukin-2 the synthesis of which was significantly reduced before the start of treatment compared with normal indicators.
  • the drug also caused an increase in the functional activity of neutral granulomas, and specifically, migration, bactericidal activity and cell phage.
  • the product is in the local capacity of 0.5 l and holds 1, 2 ml of an external solution containing 2.5 mg of Intoleukin-1 and
  • the product is prepared using the method described in Example 1, but before adding the solution to the product, it adds 2.5 gains to the product, which gives an external charge of 7.5 g.
  • Example 3 The biological activity of the claimed product is in the 5th process of the receipt of a ready-made form.
  • the activity distribution method was changed to eight sample models, 10 ampoules per each, and
  • Example 2 The product is prepared, generally obtained, as described in Example 2, which contains 1 mg IL-1 beta, 60 mg is lightly dry, and 3 mg is lightly coated.
  • Example 3 The product is received, as a matter of fact, as described above, as described in Example 1, which contains 1 mkg of IL-1 beta and 20 mb of emergency, but it is not necessary
  • Interleukin-1 beta 1 mcg, dissolved in 1 ml of apirogenic water
  • Interleukin-1 beta 1 mcg, dissolved in 1 ml of apirogenic water and dried
  • the product is substantially in the form of a substantially reduced dry product
  • EXAMPLE 4 In relation to the evaluation of biological activity in a standard commercially available test for mice and human lymphocytes (Simbirtsev et al., Immunology, 1990
  • Table 4 The effect of treatment for the treatment of drugs in patients with atherosclerosis in patients with myelo-depressive disorder caused by the onset of heart disease
  • EXAMPLE 7 Treatment of leukemia caused by the use of citations and irradiation in a patient with a large lymphoma and a gentle administration of the drug

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Cette invention concerne une préparation qui consiste en un mélange comprenant de la sérum-albumine humaine ainsi que de l'interleukine 1 bêta selon un rapport en poids de 20-60: 1. Cette préparation peut également contenir du lactose selon une dose de 1 à 3 mg par νg de préparation. Comme l'ont montré les expériences, cette préparation permet de stimuler la leucopoïèse dans des conditions où celle-ci est fortement inhibée par une leucopénie toxique, y compris une neutropénie fébrile, liée à l'utilisation de cytostatiques distincts ou de leurs combinaisons pendant le traitement de tumeurs malignes. Cette préparation possède une action curative efficace dans le cas de la leucopénie déclenchée par l'action d'un rayonnement ionisant, et possède des propriétés de protection radiologique. Cette préparation possède une action immuno-stimulante fortement exprimée, et peut être utilisée afin de traiter des conditions de déficit immunitaire secondaires déclenchées par des interventions chirurgicales ou des traumatismes.
PCT/RU1998/000212 1998-01-22 1998-06-30 Preparation immuno-modulatrice a base d'interleukine 1 et procede de preparation Ceased WO1999037321A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
RU98100791 1998-01-22
RU98100791 1998-01-22
RU98107188/13A RU2128706C1 (ru) 1998-04-23 1998-04-23 Иммуномодулирующий препарат "беталейкин"
RU98107188 1998-04-23

Publications (1)

Publication Number Publication Date
WO1999037321A1 true WO1999037321A1 (fr) 1999-07-29

Family

ID=26653948

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU1998/000212 Ceased WO1999037321A1 (fr) 1998-01-22 1998-06-30 Preparation immuno-modulatrice a base d'interleukine 1 et procede de preparation

Country Status (1)

Country Link
WO (1) WO1999037321A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4455302A (en) * 1973-10-24 1984-06-19 Robertson Harry J Medical protein hydrolysate, process of making the same and processes of utilizing the protein hydrolysate to aid in healing traumatized areas
WO1995024917A1 (fr) * 1994-03-15 1995-09-21 Unilever Plc Composition de traitement de la peau
US5494663A (en) * 1984-12-25 1996-02-27 Dainippon Pharmaceutical Co., Ltd. Treatment of microbial infection with interleukin 1 polypeptides
US5543140A (en) * 1986-03-14 1996-08-06 Otsuka Pharmaceutical Co., Ltd. Method and use of IL-1α
RU2073522C1 (ru) * 1995-07-20 1997-02-20 Олег Васильевич Рубальский Лекарственный препарат противовирусного действия
WO1997033606A1 (fr) * 1996-03-15 1997-09-18 The General Hospital Corporation MORT CELLULAIRE PROGRAMMEE ET INTERLEUKINE-1$g(b)

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4455302A (en) * 1973-10-24 1984-06-19 Robertson Harry J Medical protein hydrolysate, process of making the same and processes of utilizing the protein hydrolysate to aid in healing traumatized areas
US5494663A (en) * 1984-12-25 1996-02-27 Dainippon Pharmaceutical Co., Ltd. Treatment of microbial infection with interleukin 1 polypeptides
US5543140A (en) * 1986-03-14 1996-08-06 Otsuka Pharmaceutical Co., Ltd. Method and use of IL-1α
WO1995024917A1 (fr) * 1994-03-15 1995-09-21 Unilever Plc Composition de traitement de la peau
RU2073522C1 (ru) * 1995-07-20 1997-02-20 Олег Васильевич Рубальский Лекарственный препарат противовирусного действия
WO1997033606A1 (fr) * 1996-03-15 1997-09-18 The General Hospital Corporation MORT CELLULAIRE PROGRAMMEE ET INTERLEUKINE-1$g(b)

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