Title:
METHOD FOR PRODUCING AND PREPARING COMPOUND AMINO ACID (15) DIPEPTIDE (2) INJECTION
Document Type and Number:
WIPO Patent Application WO/2023/273484
Kind Code:
A1
Abstract:
A method for producing and preparing a compound amino acid (15) dipeptide (2) injection, comprising the following steps: adding water for injection to 70-80% of the total amount, continuously filling same with nitrogen, and heating same to 80℃ or above; feeding same using a closed feeding tank, and stirring and dissolving same, wherein citric acid, leucine, valine, threonine, tryptophan, arginine, alanine, isoleucine, phenylalanine, methionine, lysine acetate, histidine, proline, serine and aspartic acid are firstly fed; cooling same to at most 60℃, and adding glutamic acid, glycyl glutamyl and glycyl tyrosine; stirring and dissolving same, adding water for injection to the total amount, and then adding citric acid to adjust the pH value to 5.5-6.0; filling a three-layer co-extruded infusion membrane bag with the liquid medicine, and sealing the bag; and performing hot-press sterilization on the filled sample, and packaging same, wherein the dissolved oxygen amount and residual oxygen amount of the liquid medicine are controlled in the preparation process. The production and preparation method is beneficial for guaranteeing the quality stability of the product in the validity period and the safety of clinical medication.
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Inventors:
CAI ZUOQING (CN)
LIU SICHUAN (CN)
LIU WENJUN (CN)
YUAN NANNAN (CN)
WANG YUNCHUAN (CN)
LIU SICHUAN (CN)
LIU WENJUN (CN)
YUAN NANNAN (CN)
WANG YUNCHUAN (CN)
Application Number:
PCT/CN2022/084967
Publication Date:
January 05, 2023
Filing Date:
April 02, 2022
Export Citation:
Assignee:
SICHUAN KELUN PHARMACEUTICAL (CN)
International Classes:
A61K9/08; A61J1/10; A61J1/14; A61J3/00; A61K31/198; A61K31/401; A61K31/405; A61K31/4172; A61K47/12; A61P3/02
Foreign References:
| CN113384523A | 2021-09-14 | |||
| CN105770852A | 2016-07-20 | |||
| CN110693827A | 2020-01-17 | |||
| CN103142992A | 2013-06-12 | |||
| CN110404048A | 2019-11-05 | |||
| CN103948588A | 2014-07-30 |
Other References:
WEI MEI: "How to ensure the quality of compound amino acid injection", STRAIT PHARMACEUTICAL JOURNAL = HAIXIA YAOXUE, ZHONGGUO YAOXUEHUI, FUJIAN, CN, vol. 24, no. 9, 1 January 2012 (2012-01-01), Fujian, CN , pages 14 - 16, XP093017964, ISSN: 1006-3765
ZHANG JIUYUN, ZHANG JIAYING, WANG LIQIANG : "Optimization of the Preparation Process of Compound Amino Acid (15) Double Peptide (2) Injection", FUJIAN MEDICAL JOURNAL., vol. 42, no. 1, 1 January 2020 (2020-01-01), pages 138 - 140, XP093017974, ISSN: 1002-2600
邹意琼等 (ZOU, YIQIONG ET AL.),: "关于注射剂中添加活性炭的思考 (Non-official translation: Thoughts on Adding Activated Carbon to Injections),", 健康大视野 (CHINA HEALTH VERSION),, no. 13, 31 July 2020 (2020-07-31), XP009542130
LI LI, QIN YARU, MA BINGYUAN, CUI HONGYAN, QIAO PING, JIANG HE, ZHANG MING: "Direct and simultaneous determination of methionine sulfoxide and pyroglutamic acid impurities in Compound Amino Acid Injection-18 AA by ion-pair reversed-phase HPLC", SEPARATION SCIENCE PLUS, vol. 1, no. 7, 1 July 2018 (2018-07-01), pages 483 - 489, XP093018072, ISSN: 2573-1815, DOI: 10.1002/sscp.201800059
ZHANG JIUYUN, ZHANG JIAYING, WANG LIQIANG : "Optimization of the Preparation Process of Compound Amino Acid (15) Double Peptide (2) Injection", FUJIAN MEDICAL JOURNAL., vol. 42, no. 1, 1 January 2020 (2020-01-01), pages 138 - 140, XP093017974, ISSN: 1002-2600
邹意琼等 (ZOU, YIQIONG ET AL.),: "关于注射剂中添加活性炭的思考 (Non-official translation: Thoughts on Adding Activated Carbon to Injections),", 健康大视野 (CHINA HEALTH VERSION),, no. 13, 31 July 2020 (2020-07-31), XP009542130
LI LI, QIN YARU, MA BINGYUAN, CUI HONGYAN, QIAO PING, JIANG HE, ZHANG MING: "Direct and simultaneous determination of methionine sulfoxide and pyroglutamic acid impurities in Compound Amino Acid Injection-18 AA by ion-pair reversed-phase HPLC", SEPARATION SCIENCE PLUS, vol. 1, no. 7, 1 July 2018 (2018-07-01), pages 483 - 489, XP093018072, ISSN: 2573-1815, DOI: 10.1002/sscp.201800059
Attorney, Agent or Firm:
CHENGDU XINGZHI PATENT AGENCY (ORDINARY PARTNERSHIP) (CN)
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