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1. CN112969466 - METHOD FOR PREPARING PROGESTERONE PARTICULATE, PREPARED PROGESTERONE PARTICULATE AND INJECTION THEREOF

Office
China
Application Number 201980071761.7
Application Date 23.12.2019
Publication Number 112969466
Publication Date 15.06.2021
Publication Kind A
IPC
A61K 31/57
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
57substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane, progesterone
C07J 7/00
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
JSTEROIDS
7Normal steroids containing carbon, hydrogen, halogen, or oxygen, substituted in position 17 beta by a chain of two carbon atoms
CPC
A61K 31/57
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
57substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane, progesterone
C07J 7/00
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
JSTEROIDS
7Normal steroids containing carbon, hydrogen, halogen or oxygen substituted in position 17 beta by a chain of two carbon atoms
Applicants SICHUAN KELUN PHARMACEUTICAL RESEARCH INSTITUTE CO., LTD.
四川科伦药物研究院有限公司
HUNAN KELUN PHARMACEUTICAL RESEARCH CO., LTD.
湖南科伦药物研究有限公司
Inventors LIANG XIANGYONG
梁相永
LI MING
李明
SU ZHENGXING
苏正兴
GUO DACHENG
郭大成
YI CONG
易聪
WEI WEI
魏巍
LI DAN
李丹
ZHAO DONG
赵栋
WANG JINGYI
王晶翼
Agents 北京派特恩知识产权代理有限公司 11270
北京派特恩知识产权代理有限公司 11270
Priority Data 2018116186441 28.12.2018 CN
2019107348102 09.08.2019 CN
Title
(EN) METHOD FOR PREPARING PROGESTERONE PARTICULATE, PREPARED PROGESTERONE PARTICULATE AND INJECTION THEREOF
(ZH) 制备黄体酮颗粒物的方法、所得黄体酮颗粒物及其注射剂
Abstract
(EN)
Disclosed is a method for preparing a progesterone particulate, especially a crystal or powder. The method comprises: step 1, dissolving progesterone in a solvent to provide a progesterone solution; step 2, pumping the progesterone solution into a high-speed shearing progesterone precipitation solvent at a predetermined speed to precipitate progesterone; and step 3, separating the precipitate and freeze-drying same to obtain the progesterone particulate, wherein the progesterone particulate being a progesterone crystal or progesterone powder. By using the method of the present invention, a micron-sized progesterone crystal or powder having good stability can be obtained. The progesterone injection prepared by using same not only achieves a sustained release effect of at least 5 days, but also has good stability. The method of the present invention is simple to operate, has low cost, and is easily scaled up for industrial production.

(ZH)
本申请公开了一种制备黄体酮颗粒物,尤其是晶体或粉体的方法,其中所述方法包括:步骤1,使黄体酮溶于溶剂中以提供黄体酮溶液;步骤2,将所述黄体酮溶液以预定速度泵入到高速剪切的黄体酮的析出溶剂中以使黄体酮析出;和步骤3,分离析出物并进行冷冻干燥以获得所述黄体酮颗粒物;其中,所述黄体酮颗粒物为黄体酮晶体或黄体酮粉体。通过本发明的方法可获得微米级的黄体酮晶体或粉体,且稳定性好。采用其制备的黄体酮注射剂不仅实现至少5天的缓释效果,而且稳定性好。本发明的方法操作简单,成本低,易于工业化放大生产。

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