WO2005092344A1 - Preparation medicinale - Google Patents

Preparation medicinale Download PDF

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Publication number
WO2005092344A1
WO2005092344A1 PCT/RU2004/000115 RU2004000115W WO2005092344A1 WO 2005092344 A1 WO2005092344 A1 WO 2005092344A1 RU 2004000115 W RU2004000115 W RU 2004000115W WO 2005092344 A1 WO2005092344 A1 WO 2005092344A1
Authority
WO
WIPO (PCT)
Prior art keywords
patients
treatment
group
study
significant fox
Prior art date
Application number
PCT/RU2004/000115
Other languages
English (en)
Russian (ru)
Inventor
Alexandr Leonidovich Reshetov
Irina Anatolievna Vereschagina
Original Assignee
Zakrytoe Aktsionernoe Obschestvo 'novaya Linia'
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
Application filed by Zakrytoe Aktsionernoe Obschestvo 'novaya Linia' filed Critical Zakrytoe Aktsionernoe Obschestvo 'novaya Linia'
Priority to EA200501366A priority Critical patent/EA013052B1/ru
Priority to PCT/RU2004/000115 priority patent/WO2005092344A1/fr
Publication of WO2005092344A1 publication Critical patent/WO2005092344A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • 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
    • A61P31/04—Antibacterial agents
    • A61P31/06—Antibacterial agents for tuberculosis
    • 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
    • A61P31/08—Antibacterial agents for leprosy
    • 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
    • A61P31/20—Antivirals for DNA viruses
    • A61P31/22—Antivirals for DNA viruses for herpes viruses

Definitions

  • isoniazid anhydride of isotonic acid - HYP
  • the task is resolved by the adjoining medicinal product, including the active substances and the target supplements, the difference is that the consumable is in the process of consuming -
  • a predominantly medicinal product is suitable for use with a medication that may contain isoniazid, rephampin, and pyrazinamide.
  • a predominantly medicament may be made in the form of tablets, combined pills, capsules, syrups and injections.
  • the invention may, however, be introduced in the usual way as either a direct or intrinsic (convenient, internally, internally, internally).
  • the proposed medicament contains active substances in quantities of 0.1 to 4 g.
  • the proposed medicinal products are manufactured in the usual way. ⁇ a ⁇ yadu with a ⁇ ivnym vesches ⁇ v ⁇ m le ⁇ a ⁇ s ⁇ vennye s ⁇ eds ⁇ va m ⁇ gu ⁇ ⁇ i e ⁇ m s ⁇ de ⁇ - zha ⁇ ⁇ bychnye vs ⁇ m ⁇ ga ⁇ elnye vesches ⁇ va, ⁇ inya ⁇ ye in ⁇ e ⁇ n ⁇ l ⁇ gii ⁇ ig ⁇ vle- Nia le ⁇ a ⁇ s ⁇ v, ⁇ a ⁇ ie ⁇ a ⁇ binders ⁇ able ⁇ , na ⁇ lni ⁇ eli, ⁇ nse ⁇ van ⁇ y, vesches ⁇ va, ⁇ azb ⁇ yzgivaemye on ⁇ able ⁇ i, ⁇ egulya ⁇ y ⁇ e ⁇ uches ⁇ i, myagchi ⁇ eli, smachiva ⁇ eli, dis ⁇ e ⁇ ga ⁇ y, e
  • the following medicinal products, together with separate active substances, may contain combinations of various types of active substances.
  • the decay areas were divided in 93.5% of cases, most often they were multiple or with sizes larger than 4 cm in diameter. Bacterial isolation was shared among 42 people (67.7%), which was massive in 53.2% of cases. In 1 patient, drug resistance was found to be common for all useful drugs. In patients with depression, an active syndrome was revealed, which in 42.0% of cases had a pronounced symptom (severe, significant changes in the body, a decrease in body mass).
  • the K-cell was divided into ⁇ into ⁇ and ⁇ with ⁇ and PPD.
  • the specific humorous and cellular response was evaluated at the highest level for good antibodies in the serial reaction ( ⁇ P ⁇ , ⁇ G ⁇ , I ⁇ ) and in.
  • the study of the immune status of sick tuberculosis has shown that in all of them there were some or other disorders of the immune system. For the majority of them, the process occurred on the basis of a reduced, reduced or negative number of lymphomas, initial low rates and a deficiency of the disease. Higher initial indicators ⁇ ( ⁇ 16 + ) are noted, which, apparently, compensates for the deficiency of icaomb-factors. In 40 patients (70.0%), the indicators of immunoglobulins, especially classes ⁇ and ⁇ were reduced.
  • a positive x-ray dynamics of the process was revealed after 1 month in 51, 8% of cases and after 2 months in 42.5% of the study group, and in the group of 35.0% and 30.0% of the total. It was manifested by the absorption of infiltration and part of the housing, a significant decrease in the size of the decay area. The most significant x-ray changes were noted in patients with a pronounced exudative reaction and persistent changes in the immune status.
  • Pe ⁇ en ⁇ sim ⁇ s ⁇ b ⁇ lnymi s ⁇ eds ⁇ va ⁇ iz ⁇ b ⁇ e ⁇ eniyu was ud ⁇ vle ⁇ v ⁇ i ⁇ elnaya, y 3 b ⁇ lny ⁇ in issleduem ⁇ y g ⁇ u ⁇ e observed ⁇ b ⁇ chnaya ⁇ ea ⁇ tsiya as ⁇ zh- n ⁇ y sy ⁇ i, d ⁇ ugi ⁇ ⁇ b ⁇ chny ⁇ ⁇ ea ⁇ tsy not ⁇ mechen ⁇ .
  • the invention is effective and in the presence of severe, impaired disease, when isoniazid is inactive or is inaccessible.
  • Table 1 The dynamics of immunological parameters in patients with pulmonary tuberculosis and the use of a drug ( ⁇ + m)
  • ⁇ ablitsa 2 Dinami ⁇ a immun ⁇ l ⁇ giches ⁇ i ⁇ ⁇ aza ⁇ eley at b ⁇ lny ⁇ ⁇ ube ⁇ ulez ⁇ m leg ⁇ i ⁇ ⁇ i ⁇ imenenii s ⁇ eds ⁇ va ⁇ iz ⁇ b ⁇ e ⁇ eniyu ( ⁇ + m)
  • Cough, shortness of breath 3 points - symptoms are constant; 2 points - more than two times; 1 point - one time; 0 - no symptoms.
  • Benefits 3 - mute; 2 - slimy; 1 - mucous; 0 - no net.
  • the degree of activity of inflammation was evaluated by laboratory data.
  • the effective inflammatory process was considered to be due to an increase in leukemia, an increase in SJE, the presence of an ⁇ / I shift, SSS in the discharge of blood.
  • thermotherapy The mode of thermotherapy was as follows:
  • Table 3 The dynamics of the clinical manifestations of the CGI due to the influence of the invention and the placebo ( ⁇ ⁇ )
  • the body of the body was normalized in the group of patients received by the invention for 3 days, and placebo was the 5th day of therapy.
  • Table 4 Dynamics of indicators of environmental friendliness due to the influence of the invention and the placebo ( ⁇ ⁇ ⁇ )
  • Table 5 The dynamics of the frequency of changes in the distant labs of a large hospital due to the impact of the invention and the placebo.
  • the group that received the mediation of the invention (primary) - 10 people (6 men and 4 women).
  • the average weight is 43.7 ⁇ 3.61.
  • ⁇ en ⁇ gen ⁇ l ⁇ giches ⁇ ie changes ⁇ a ⁇ a ⁇ e ⁇ iz ⁇ valis in ⁇ il ⁇ atsiey leg ⁇ chny ⁇ ⁇ ley ⁇ chag ⁇ v ⁇ g ⁇ in ⁇ m including slivn ⁇ g ⁇ ⁇ a ⁇ a ⁇ e ⁇ a (y ⁇ i ⁇ b ⁇ lny ⁇ ⁇ sn ⁇ vn ⁇ y and ⁇ i ⁇ b ⁇ lny ⁇ ⁇ n ⁇ ln ⁇ y g ⁇ u ⁇ ) and ⁇ dn ⁇ m case ( ⁇ sn ⁇ vnaya g ⁇ u ⁇ a) in ⁇ e ⁇ s ⁇ i- tsialn ⁇ g ⁇ ⁇ a ⁇ a ⁇ e ⁇ a.
  • the main underlying diseases identified in the therapeutic groups are provided by the following:
  • the prerequisite for participating in a clinical trial was an informal written consent of the patient.
  • the patient was ill with treatment by the invention in the dose of 0.2 ⁇ 2 times a day or placebo.
  • the groupization of the therapeutic group was carried out on the table of random numbers by means of a balancing number.
  • the first group (basic) - 12 people were given about 400 mg of the medication to the invention daily; the second group is 8 people placebo.
  • SIGNIFICANT FOX (DR. 26) 18 are contained in a phase of a regular medication of a difficult commission or are not included in the list of "Exclusion of patients from studies.”
  • Immunological and virological exams were conducted in dynamics: before treatment, after 1 week and after 3 weeks before the start of treatment.
  • the study of the immune status included the determination of 6 subpopulations of limfocytes: ⁇ +, ⁇ 4 +, ⁇ 08 +, ⁇ 72 +, ⁇ 016 +, ⁇ +, immunodegulance, the immune system, the functional activity of antibodies (avidity of antibodies).
  • SIGNIFICANT FOX 19 lyuminestsen ⁇ n ⁇ m ⁇ es ⁇ e ⁇ s ⁇ n ⁇ ann ⁇ y a ⁇ ivn ⁇ s ⁇ i ney ⁇ il ⁇ v and ⁇ a ⁇ zhe ⁇ s ⁇ - s ⁇ bn ⁇ s ⁇ i a ⁇ ivi ⁇ va ⁇ sya ( ⁇ e ⁇ itsien ⁇ ⁇ L) ⁇ i in ⁇ ubatsii i ⁇ with 3 ⁇ azvede- niyami vesches ⁇ va ⁇ iz ⁇ b ⁇ e ⁇ eniyu and two .immun ⁇ nymi ⁇ e ⁇ a ⁇ a ⁇ ami ( ⁇ im ⁇ - gene and tsi ⁇ l ⁇ e ⁇ n).
  • ⁇ a ⁇ was d ⁇ s ⁇ ve ⁇ n ⁇ ⁇ vyshen u ⁇ ven ⁇ d ⁇ in syv ⁇ - ⁇ e ⁇ vi have ⁇ l ⁇ viny b ⁇ lny ⁇ ⁇ vyshen u ⁇ ven ⁇ d ⁇ , reduced u ⁇ ven ⁇ d ⁇ have b ⁇ lshins ⁇ va b ⁇ lny ⁇ ⁇ bei ⁇ g ⁇ u ⁇ ⁇ e ⁇ bladala ⁇ du ⁇ tsiya niz ⁇ avidny ⁇ , ⁇ es ⁇ ⁇ un ⁇ tsi ⁇ naln ⁇ ne ⁇ ln ⁇ tsenny ⁇ an ⁇ i ⁇ el, byl ⁇ snizhen ⁇ s ⁇ de ⁇ zhanie ⁇ - lim ⁇ tsi ⁇ v.
  • Table 8 Contents of immunoglobulin classes ⁇ , ⁇ , C, and circulating immune complexes (DIAs) before and during treatment of patients with medical problems
  • the condition of the cellular immunity is v ill with chronic obstructive malidiasis in the course of treatment of the medication
  • Table 12 Dynamics of indicators of internal status in patients with chronic obstructive disease
  • Table 15 The efficacy of phenazide in the treatment of patients with primary pulmonary tuberculosis
  • Table 16 Frequency of the treatment of the bacterium after 3 months of using phenazide for the treatment of painful lung tuberculosis
  • Table 17 Frequency of the cavity after 3 months of use of phenazide in the treatment of painful, destructive pulmonary tuberculosis
  • Gesture ⁇ 37 ⁇ - laboratory strain ⁇ . ⁇ i ⁇ egsi ⁇ z, vys ⁇ vi ⁇ ulen ⁇ - ny, chuvs ⁇ vi ⁇ elny ⁇ ⁇ iv ⁇ ube ⁇ uleznym ⁇ e ⁇ a ⁇ a ⁇ am.
  • the business life of the property after the use of the material was evaluated as a means of access to the property due to the loss of ownership of the property
  • the invention was installed in the absence of culture.
  • mice infected with the foot of a 5000 medicine isolated from a painful or treatable medication are not susceptible to treatment.
  • the invention was administered through an internal gastrointestinal probe in 0.5 ml of a superficial suspension or in 0.2 ml of physiological solution 5 times per week. At the end of the experiment, the animals were killed, so that the paws grew and performed a quantitative bacterial analysis. ⁇ The results of the experiment were judged by the number of microbes that were propagated in the lap after infection.
  • Live mice-hybrids ( ⁇ ⁇ ⁇ 57 ⁇ / 6) , ⁇ , infected with mycobacterium leprosy, taken from a patient with a healthy type of leprosy, were divided into 5 groups of 1-group
  • Table 19 The useful activity of DDS, the inventive material and the disposable drug depending on the mode
  • ⁇ e ⁇ s ⁇ e ⁇ imen ⁇ e were is ⁇ lz ⁇ vany mouse ⁇ ( ⁇ S ⁇ C 57 ⁇ / 6) za ⁇ azhennye mi ⁇ ba ⁇ e ⁇ iyami le ⁇ y, vzya ⁇ ymi of le ⁇ my b ⁇ ln ⁇ g ⁇ left- ⁇ ma ⁇ znym ⁇ i ⁇ m le ⁇ y.
  • mice The infected mice were divided into groups:
  • mice 1 group - end-to-end (to mice daily, in addition to output, they introduced 0.5 ml of extreme suspension);
  • 2, 3, 4 groups received a response of 100 mcg of DDS, a substance by the invention or a consumable substance of the invention, by 0.5 ml of suspension, a week is 5;
  • Groups 5, 6, 7 received a corresponding amount of 50, 100, 200 micrograms of a suitable form of material when they were supplied with 0.2 ml of a weekly discharged unit;
  • Table 20 Convenient activity of a particular form of the substance, depending on the dose and the administration mode
  • Tests were conducted on the effect of a substance on an invention on an active activity of lymphocytes in the case of acute redness at a painful treatment after 3 months after the onset.
  • the invention discloses an immunomodulatory effect on the inhibitory activity of the lymphocytes.
  • a reduction in the incidence of lymphadenitis after treatment was given only by responding to an optimal dose of ⁇ ⁇ ⁇ / ⁇ .
  • a simple analysis of the patient’s response to each individual patient test ifies to the stimulation of a reduced function of the patient and the result of a higher immunity
  • Table 21 The proactive activity of mononucleates in the case of obstructive patients who are undergoing treatment
  • the method of obtaining active medicament of a medical device and the method of obtaining a medicinal product is illustrated by the following methods.
  • EXAMPLE 1 Method for the production of an active substance of a medicinal product
  • EXAMPLE 2 Obtaining a medicinal form in the form of a table
  • the diameter of the balls is 5mm.
  • the mass of balls per 100 g of ready-made meat is 500 g.
  • the medicament for gelatinous capsules of 0.1 g and only 0.2 g is produced by the use of a manual device in the case of an accident in the case of an accident.
  • Composition material of the invention - 0.1 g and 0.2 g without fillers and conservatives.
  • the product is placed on the side of the cassette, distributes the space on the platform and further in the process.
  • Yellow capsules are made up of: quinine epa - 0.05%, titanium dioxide - 1.0%, gelatin - up to 100%. Capsules of the substance are reserved for medical use in Russia.
  • Example 5 The preparation of a medicinal form in the form of a suspension (syrup).
  • Example 6 Preparation of a medicinal product in the form of injections.
  • the medicinal product for injections is a waste medicine that includes an active drug and pharmaceuticals.
  • the claimed amount of the claimed medicament is 7000 mg / kg, while the phenazide is 2000 mg / kg. Because the phenazide is 3.5 times higher,
  • declared medication may be used for resistant diseases, as well as for longer periods of time and longer.
  • a modern treatment concept for painful tuberculosis implies, along with the basic chemotherapy, the appointment of different immune modulators, which increase the incidence of the disease.
  • the claimed medicinal product is stable in the process of storage. It does not change the appearance, physical characteristics and biological properties during a few years, for example, 3 years or more.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Virology (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne un médicament qui comprend une substance active et des additifs à but spécifique. On utilise en tant que substance active le (2,4-dihydroxyl-6-méthyl-5- pyrimidyl)-(4-pyridin-carbonyl-hydrazinyl) sulphone correspondant à la formule (III) ou ses sels pharmaceutiquement acceptables, ou ses isomères en quantités efficaces. En outre, le médicament de l'invention peut contenir au moins un moyen antituberculeux tel que l'isonioside, la rephampicine ou le pyrazinamide. Le médicament de l'invention peut s'utiliser sous forme de comprimés, de cachets combinés, de capsules, de sirop ou d'injections.
PCT/RU2004/000115 2004-03-26 2004-03-26 Preparation medicinale WO2005092344A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EA200501366A EA013052B1 (ru) 2004-03-26 2004-03-26 Лекарственное средство
PCT/RU2004/000115 WO2005092344A1 (fr) 2004-03-26 2004-03-26 Preparation medicinale

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/RU2004/000115 WO2005092344A1 (fr) 2004-03-26 2004-03-26 Preparation medicinale

Publications (1)

Publication Number Publication Date
WO2005092344A1 true WO2005092344A1 (fr) 2005-10-06

Family

ID=35055975

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU2004/000115 WO2005092344A1 (fr) 2004-03-26 2004-03-26 Preparation medicinale

Country Status (2)

Country Link
EA (1) EA013052B1 (fr)
WO (1) WO2005092344A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2136668C1 (ru) * 1997-10-07 1999-09-10 Голощапов Николай Михайлович N,n'-(сульфонилди-1,4-фенилен)бис(n'',n''- диметилформамидин)1,2,3,4-тетрагидро-6-метил-2,4- диоксо-5-пиримидинсульфонат, стимулирующий клеточный метаболизм и обладающий иммунотропной и антимикобактериальной активностью
RU2141322C1 (ru) * 1997-08-12 1999-11-20 Голощапов Николай Михайлович Иммуномодулятор с антимикобактериальной активностью "изофон", способ его получения и применения
RU2191015C2 (ru) * 1999-11-05 2002-10-20 Общество с ограниченной ответственностью "Центр бифункциональных иммуномодуляторов" Динатриевая соль n-(6-метил-2,4-диоксо-1,2,3,4-тетрагидро-5h-пиримидинсульфон)-n'- изоникотиноилгидразида, проявляющая антимикробную и иммунотропную активность, и лекарственное средство на ее основе

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2141322C1 (ru) * 1997-08-12 1999-11-20 Голощапов Николай Михайлович Иммуномодулятор с антимикобактериальной активностью "изофон", способ его получения и применения
RU2136668C1 (ru) * 1997-10-07 1999-09-10 Голощапов Николай Михайлович N,n'-(сульфонилди-1,4-фенилен)бис(n'',n''- диметилформамидин)1,2,3,4-тетрагидро-6-метил-2,4- диоксо-5-пиримидинсульфонат, стимулирующий клеточный метаболизм и обладающий иммунотропной и антимикобактериальной активностью
RU2191015C2 (ru) * 1999-11-05 2002-10-20 Общество с ограниченной ответственностью "Центр бифункциональных иммуномодуляторов" Динатриевая соль n-(6-метил-2,4-диоксо-1,2,3,4-тетрагидро-5h-пиримидинсульфон)-n'- изоникотиноилгидразида, проявляющая антимикробную и иммунотропную активность, и лекарственное средство на ее основе

Also Published As

Publication number Publication date
EA013052B1 (ru) 2010-02-26
EA200501366A1 (ru) 2006-08-25

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