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1. CN1791424 - Sustained-release fine granular preparation of human growth hormone and process for producing the same

Office
China
Application Number 200480013106.X
Application Date 15.06.2004
Publication Number 1791424
Publication Date 21.06.2006
Grant Number 100360181
Grant Date 09.01.2008
Publication Kind C
IPC
A61K 38/27
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
27Growth hormone (Somatotropin)
A61K 9/14
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
A61K 47/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
02Inorganic compounds
A61K 47/04
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
02Inorganic compounds
04Non-metals; Compounds thereof
A61P 5/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
5Drugs for disorders of the endocrine system
A61P 43/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
43Drugs for specific purposes, not provided for in groups A61P1/-A61P41/108
CPC
A61K 9/0019
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
A61K 9/1611
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605Excipients; Inactive ingredients
1611Inorganic compounds
A61K 9/1694
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1682Processes
1694resulting in granules or microspheres of the matrix type containing more than 5% of excipient
A61K 9/19
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
19lyophilised ; , i.e. freeze-dried, solutions or dispersions
A61K 38/27
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
27Growth hormone [GH] (Somatotropin)
A61P 43/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
43Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Applicants Japan Science & Tech. Corp.
独立行政法人科学技术振兴机构
独立行政法人物质·材料研究机构
格兰尼探索研究所
Inventors Ogawa Yasuaki
小川泰亮
Fujii Takao
藤井隆雄
Miyamoto Yoko
宫本阳子
Niimi Jun
新美纯
Ikoma Toshiyuki
生驹俊之
Tanaka Junzo
田中顺三
Agents chen cuan
中国国际贸易促进委员会专利商标事务所
Priority Data 2003173410 18.06.2003 JP
Title
(EN) Sustained-release fine granular preparation of human growth hormone and process for producing the same
(ZH) 人体生长激素的缓释性微粒制剂及其制造方法
Abstract
(EN) It is intended to provide a sustained release fine granular preparation of human growth hormone having both of biodegradability and sustained-release performance with the use of an organic solvent in a minimized amount, ensuring the release of human growth hormone over 3 days or longer, showing regulated initial burst release, being able to have human growth hormone at a content of 10% or more, allowing the quantitative adsorption/encapsulation of sustained-release fine granules of human growth hormone up to 20%, and having favorable dispersion and needle penetration properties, and a process for producing the same. This preparation comprises a porous apatite derivative, human growth hormone and a water-soluble divalent metal compound.
(ZH)

本发明提供如下的人体生长激素的缓释性微粒制剂及其制造方法,即,可以极力避免有机溶剂的使用而同时具有生物体内分解性及缓释性能,延续3天或以上地缓慢释放人体生长激素,抑制了初期爆发性释放,人体生长激素含有率也在10%或以上,最大可以定量地吸附封入20%的人体生长激素,并且分散性、穿针性也良好。其包括多孔性磷灰石衍生物、人体生长激素及水溶性2价金属化合物。


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