WO2017185596A1 - Médicament polyhexaméthylène guanidine destiné au traitement des maladies gastro-intestinales, procédé de préparation et son utilisation - Google Patents

Médicament polyhexaméthylène guanidine destiné au traitement des maladies gastro-intestinales, procédé de préparation et son utilisation Download PDF

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Publication number
WO2017185596A1
WO2017185596A1 PCT/CN2016/099708 CN2016099708W WO2017185596A1 WO 2017185596 A1 WO2017185596 A1 WO 2017185596A1 CN 2016099708 W CN2016099708 W CN 2016099708W WO 2017185596 A1 WO2017185596 A1 WO 2017185596A1
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WO
WIPO (PCT)
Prior art keywords
polyhexamethylene
weight
parts
drug
gastrointestinal diseases
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Application number
PCT/CN2016/099708
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English (en)
Chinese (zh)
Inventor
卫国刚
Original Assignee
卫国刚
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Publication of WO2017185596A1 publication Critical patent/WO2017185596A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K31/74—Synthetic polymeric materials
    • A61K31/785—Polymers containing nitrogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules

Definitions

  • the invention belongs to the technical field of medicines, and in particular relates to a polyhexamethylene guanidine medicine for treating gastrointestinal diseases, a preparation method and application thereof.
  • drugs for treating gastrointestinal diseases caused by bacteria are sulfonamides, quinolones, ciprofloxacin hydrochloride, and oxygen.
  • Antibiotics such as flaroxacin, amoxicillin, and gentamicin sulfate participate in the cell metabolism of bacteria and viruses by means of effective drug components in antibiotics, and disturb or inhibit cell metabolism, thereby achieving sterilization purposes.
  • these drugs After being taken by the human body, these drugs enter the blood and lymph through the visceral mucosal epithelial cells, and are widely distributed and remain in various tissues, thereby exerting toxic and side effects on the normal tissues of the human body while acting on the lesions.
  • long-term use of these drugs will lead to resistance to various types of bacteria, fungi, and viruses, affecting the bactericidal effect and therapeutic effect.
  • Polyhexamethylene oxime environmentally friendly polymer, has a broad spectrum of sterilization, low effective concentration, fast action, stable nature, and good solubility in water. It can be used at room temperature, long-term antibacterial, no side effects, no corrosive, colorless, odorless, non-toxic, non-combustible, non-explosive, safe to use, moderate in price, convenient to transport, and a very effective fungicide. It is currently widely used in the sterilization of medical devices, public environments, home, fabrics, food, milk, and care products. At present, there are no reports on the use of polyhexamethylene hydrazine in the treatment of gastrointestinal diseases in China.
  • the present invention provides a polyhexamethylene guanidine drug for treating gastrointestinal diseases with rapid onset, good curative effect, no toxic side effects, no residual in the body, and no drug resistance.
  • the pharmaceutical preparations can treat human gastrointestinal diseases in the form of liquids, powders, granules, tablets or capsules.
  • a polyhexamethylene guanidine drug for treating gastrointestinal diseases the raw material components include:
  • Microcrystalline cellulose 2-8 parts by weight
  • Magnesium stearate 1-4 parts by weight.
  • the raw material components of the polyhexamethylene oxime drug for treating gastrointestinal diseases include:
  • Microcrystalline cellulose 4-6 parts by weight
  • Magnesium stearate 2-3 parts by weight.
  • the polyhexamethylene hydrazine is one or more of polyhexamethylene gluconate gluconate, polyhexamethylene hydrazine lactic acid, polyhexamethylene sulfonium sulfate, and polyhexamethylene phosphide phosphate. A mixture of proportions.
  • the polyhexamethylene hydrazine is polyhexamethylene ruthenium gluconate, polyhexamethylene hydrazine lactic acid, polyhexamethylene sulfonium sulfate, and polyhexamethylene phosphite phosphate according to a mass ratio of 2-8:2- A mixture of 8:2-8:2-8.
  • the starch is a mixture of one or more of corn starch, tapioca starch, and potato starch in any ratio.
  • the glucose is anhydrous glucose; anhydrous glucose, that is, glucose containing no crystal water, is a colorless crystal or a white crystalline powder, is odorless, sweet, soluble in water, and slightly soluble in ethanol.
  • the microcrystalline cellulose is silicified microcrystalline cellulose; the silicified microcrystalline cellulose is obtained by blending microcrystalline cellulose and colloidal silica in water and drying at 105 ° C for 30 min, and the microcrystalline cellulose should be 94 wt%. -99.9 wt%.
  • a method for preparing the polyhexamethylene oxime drug for treating gastrointestinal diseases comprising the steps of:
  • the polyhexamethylene oxime drug for treating gastrointestinal diseases is obtained.
  • the particle diameter of the drug granule is 50-200 ⁇ m, so that the granule can be directly prepared, or the medicinal granules satisfying the requirements can be tableted by a tableting machine to obtain a polyhexamethylene oxime drug tablet.
  • the agent may also be directly divided into capsules according to a certain amount to obtain a polyhexamethylene oxime drug capsule.
  • the compound liquid of polyhexamethylene hydrazine drug can be applied to oral ulcer spray, eye drops, ear drops Gynecological lotion; polyhexamethylene guanidine drug can also be used to prepare various gynecological gels or gynecological suppositories; polyhexamethylene guanidine drugs can also be used to prepare creams for treating athlete's foot or skin diseases.
  • the drying temperature is 80-120 ° C, and the drying time is 30-240 min.
  • the polyhexamethylene oxime drug is used in the preparation of a medicament for treating gastrointestinal diseases.
  • the polyhexamethylene oxime drug for treating gastrointestinal diseases according to the present invention, by using polyhexamethylene hydrazine as a medicinal component, and adding a suitable ratio of starch, glucose, lactose, microcrystalline cellulose and hard Magnesium oleate, the final preparation of polyhexamethylene hydrazine drug, enters the gastrointestinal tract and directly interacts with the pathogen, attracts and envelops the pathogen through positive and negative charges, cuts off the nutrient intake channel of the pathogen and effectively inhibits the division of the pathogen And the polymer film formed by polyhexamethylene hydrazine can block the respiratory passage of the pathogen and cause the bacteria to quickly suffocate and die; according to the above treatment mechanism, first, the polyhexamethylene hydrazine is not directly involved in the cell metabolism of the pathogenic cells.
  • polyhexamethylene oxime is used as a macromolecular polymer, it will not be digested. Absorption of tube mucosal epithelial cells, thereby avoiding the use of antibiotics in the prior art, which tends to cause drug components to remain in various tissues,
  • the polyhexamethylene oxime has a strong covering protection ability on the digestive tract mucosa, repairs and improves the defense function of the mucosal barrier against the attack factor, and has a balanced normal flora and local analgesic effect.
  • the polyhexamethylene oxime drug of the present invention does not have resistance to various bacteria, fungi and viruses by means of a special sterilizing mechanism, and the bactericidal effect is not affected by bacteria, fungi or viruses.
  • the effect is quick on action and good in curative effect.
  • the polyhexamethylene sulfonium drug enters the body and is not absorbed by the cells, and is directly excreted through the stomach and intestines, and does not remain in the body, and has no toxic and side effects.
  • 1 g is represented by 1 part by weight.
  • the present embodiment provides a polyhexamethylene guanidine drug for treating gastrointestinal diseases, and the raw material components include:
  • Anhydrous glucose 25 parts by weight
  • Lactose 45 parts by weight
  • Microcrystalline cellulose 2 parts by weight
  • Magnesium stearate 4 parts by weight.
  • a method for preparing the polyhexamethylene oxime drug for treating gastrointestinal diseases comprising the steps of:
  • the polyhexamethylene oxime drug for treating gastrointestinal diseases can be obtained.
  • the present embodiment provides a polyhexamethylene guanidine drug for treating gastrointestinal diseases, and the raw material components include:
  • Anhydrous glucose 35 parts by weight
  • Lactose 40 parts by weight
  • Microcrystalline cellulose 8 parts by weight
  • Magnesium stearate 1 part by weight.
  • a method for preparing the polyhexamethylene oxime drug for treating gastrointestinal diseases comprising the steps of:
  • the polyhexamethylene oxime drug for treating gastrointestinal diseases can be obtained.
  • the present embodiment provides a polyhexamethylene guanidine drug for treating gastrointestinal diseases, and the raw material components include:
  • Potato starch 16 parts by weight
  • Anhydrous glucose 28 parts by weight
  • Silicified microcrystalline cellulose 4 parts by weight
  • Magnesium stearate 3 parts by weight.
  • a method for preparing the polyhexamethylene oxime drug for treating gastrointestinal diseases comprising the steps of:
  • step (3) After the granules of step (2) are dried at 100 ° C for 120 minutes, the gastrointestinal diseases can be treated. Diseased polyhexamethylene guanidine drug.
  • the present embodiment provides a polyhexamethylene guanidine drug for treating gastrointestinal diseases, and the raw material components include:
  • Anhydrous glucose 32 parts by weight
  • Magnesium stearate 2 parts by weight.
  • a method for preparing the polyhexamethylene oxime drug for treating gastrointestinal diseases comprising the steps of:
  • the polyhexamethylene oxime drug for treating gastrointestinal diseases can be obtained.
  • the present embodiment provides a polyhexamethylene guanidine drug for treating gastrointestinal diseases, and the raw material components include:
  • Anhydrous glucose 30 parts by weight
  • Silicified microcrystalline cellulose 5 parts by weight
  • Magnesium stearate 2.5 parts by weight.
  • a method for preparing the polyhexamethylene oxime drug for treating gastrointestinal diseases comprising the steps of:
  • the polyhexamethylene oxime drug for treating gastrointestinal diseases can be obtained.
  • the present inventors observed the polyhexamethylene oxime drug of the present invention for 100 patients with clinical gastrointestinal diseases, including 52 males and 48 females, the youngest being 19 years old, the largest being 78 years old, and 23 cases of acute gastroenteritis. There were 42 cases of gastric ulcer and 35 cases of gastrointestinal symptoms.
  • Treatment of diarrhea twice daily, 0.4-0.6 grams each time, taking 1-3 days;
  • the patient's symptoms of discomfort were improved, and after 5 days of continuous treatment, the patient was cured, and the patient's gastroduodenal ulcer, acute gastroenteritis, stomach bleeding No more recurrence, no symptoms of pale complexion, pale hands and feet, dizziness, headache, and no want to eat.

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne un médicament polyhexaméthylène guanidine destiné au traitement des maladies gastro-intestinales. Le médicament polyhexaméthylène guanidine final est préparé à l'aide de la polyhexaméthylène guanidine comme composant actif, et en ajoutant de l'amidon, du glucose, du lactose, de la cellulose microcristalline et du stéarate de magnésium sous un rapport en poids approprié. La préparation médicinale peut être utilisée pour traiter les maladies gastro-intestinales dans les corps humains sous la forme d'un liquide, d'une poudre, d'une particule, d'un comprimé ou d'une capsule.
PCT/CN2016/099708 2016-04-25 2016-09-22 Médicament polyhexaméthylène guanidine destiné au traitement des maladies gastro-intestinales, procédé de préparation et son utilisation WO2017185596A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201610261767.9 2016-04-25
CN201610261767.9A CN105726491A (zh) 2016-04-25 2016-04-25 治疗肠胃疾病的聚六亚甲基胍药物及其制备方法和应用

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WO2017185596A1 true WO2017185596A1 (fr) 2017-11-02

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105726491A (zh) * 2016-04-25 2016-07-06 卫国刚 治疗肠胃疾病的聚六亚甲基胍药物及其制备方法和应用
CN110538158A (zh) * 2019-09-10 2019-12-06 郑州百瑞动物药业有限公司 一种水产用长效缓释双层片状消毒剂及其制备方法

Citations (4)

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CN103705536A (zh) * 2014-01-03 2014-04-09 卫望奎 一种盐酸聚六亚甲基胍的药物配方及制备方法
CN104839458A (zh) * 2015-06-11 2015-08-19 卫国刚 聚六亚甲基胍药物饲料添加剂
CN105030684A (zh) * 2015-07-20 2015-11-11 卫国刚 聚六亚甲基胍药物粉剂、胶囊的配方及制备方法
CN105726491A (zh) * 2016-04-25 2016-07-06 卫国刚 治疗肠胃疾病的聚六亚甲基胍药物及其制备方法和应用

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050063926A1 (en) * 2003-09-23 2005-03-24 Bathina Harinath B. Film-forming compositions for protecting animal skin
CN105125574A (zh) * 2015-07-20 2015-12-09 卫国刚 聚六亚甲基胍畜禽药物粉剂的配方及其制备工艺
CN105213420A (zh) * 2015-10-26 2016-01-06 卫国刚 丙酸聚六亚甲基胍肠胃道药物制剂

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103705536A (zh) * 2014-01-03 2014-04-09 卫望奎 一种盐酸聚六亚甲基胍的药物配方及制备方法
CN104839458A (zh) * 2015-06-11 2015-08-19 卫国刚 聚六亚甲基胍药物饲料添加剂
CN105030684A (zh) * 2015-07-20 2015-11-11 卫国刚 聚六亚甲基胍药物粉剂、胶囊的配方及制备方法
CN105726491A (zh) * 2016-04-25 2016-07-06 卫国刚 治疗肠胃疾病的聚六亚甲基胍药物及其制备方法和应用

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