Title:
ETAMSYLATE INJECTION AND PREPARATION METHOD THEREFOR
Document Type and Number:
WIPO Patent Application WO/2021/227405
Kind Code:
A1
Abstract:
An etamsylate injection and a preparation method therefor. The preparation steps are as follows: preparing saturated solutions of etamsylate, edetate disodium, sodium metabisulfite and sodium chloride for later use; dissolving mannitol, potassium chloride and calcium chloride in 10 ml of water for injection to obtain a trace element solution for later use; uniformly mixing the saturated solutions of etamsylate, edetate disodium, sodium metabisulfite, sodium chloride with the trace element solution to obtain a concentrated raw material solution; putting the concentrated raw material solution into a concentrated preparation tank, adsorbing, and filtering until the concentrated solution is clear; putting the concentrated solution into a diluted preparation tank, adding water for injection, adsorbing, and filtering to obtain a diluted solution; performing three-stage filtration treatment on the diluted solution to obtain a finished product stock solution; supplementing water for injection into the finished product stock solution until the weight of the final solution is reached; sealing; sterilizing for 10 min; detecting whether visible suspending foreign matters and particles exist in sterilized ampoule bottles or not, and measuring the amount thereof; and storing.
Inventors:
ZHAO TING (CN)
LIU CHANGJIANG (CN)
WU SHUANGJUN (CN)
DUAN YIJIE (CN)
ZHAO HAIQIAO (CN)
LIU CUNLING (CN)
YIN CAIXIA (CN)
WANG ZHENGWEN (CN)
LIU CHANGJIANG (CN)
WU SHUANGJUN (CN)
DUAN YIJIE (CN)
ZHAO HAIQIAO (CN)
LIU CUNLING (CN)
YIN CAIXIA (CN)
WANG ZHENGWEN (CN)
Application Number:
PCT/CN2020/127765
Publication Date:
November 18, 2021
Filing Date:
November 10, 2020
Export Citation:
Assignee:
SHANDONG FANGMING PHARM GROUP (CN)
International Classes:
A61K9/08; A61K31/205; A61K47/02; A61K47/10; A61K47/18; A61K47/20; A61P7/04
Foreign References:
| CN111437253A | 2020-07-24 | |||
| CN106963729A | 2017-07-21 | |||
| CN109010266A | 2018-12-18 | |||
| CN107308105A | 2017-11-03 | |||
| CN108926538A | 2018-12-04 | |||
| EP3167881A1 | 2017-05-17 |
Attorney, Agent or Firm:
JI 'NAN FANGYU PATENT AGENCY OFFICE (GENERAL PARTNERSHIP) (CN)
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