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1. (WO2019000335) STANDARD LIBRARY OF LOW-MOLECULAR-WEIGHT HEPARIN, DALTEPARIN SODIUM, AND PREPARATION METHOD THEREOF
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Pub. No.: WO/2019/000335 International Application No.: PCT/CN2017/090902
Publication Date: 03.01.2019 International Filing Date: 29.06.2017
IPC:
C08B 37/10 (2006.01) ,C12Q 1/00 (2006.01)
C CHEMISTRY; METALLURGY
08
ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
B
POLYSACCHARIDES; DERIVATIVES THEREOF
37
Preparation of polysaccharides not provided for in groups C08B1/-C08B35/110; Derivatives thereof
10
Heparin; Derivatives thereof
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
Q
MEASURING OR TESTING PROCESSES INVOLVING ENZYMES OR MICRO-ORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
1
Measuring or testing processes involving enzymes or micro-organisms; Compositions therefor; Processes of preparing such compositions
Applicants:
辰欣药业股份有限公司 CISEN PHARMACEUTICAL CO., LTD. [CN/CN]; 中国山东省济宁市 高新区同济科技工业园 Tongji Science and Technology Industrial Zone, Jining High-Tech Zone Jining, Shandong 272073, CN
山东辰中生物制药有限公司 SHANDONG CHENZHONG BIOPHARMACEUTICAL CO., LTD. [CN/CN]; 中国山东省济宁市 鱼台县张黄镇工业园 Zhanghuang Industrial Zone, Yutai County Jining, Shandong 272350, CN
Inventors:
周霞 ZHOU, Xia; CN
雷晓刚 LEI, Xiaogang; CN
郭维 GUO, Wei; CN
Agent:
北京超凡志成知识产权代理事务所(普通合伙) CHOFN INTELLECTUAL PROPERTY; 中国北京市 海淀区北四环西路68号左岸工社1215-1218室 Room 1215-1218, Floor 12 Left Bank Community No.68 Beisihuanxilu, Haidian District Beijing 100080, CN
Priority Data:
Title (EN) STANDARD LIBRARY OF LOW-MOLECULAR-WEIGHT HEPARIN, DALTEPARIN SODIUM, AND PREPARATION METHOD THEREOF
(FR) BIBLIOTHÈQUE STANDARD D'HÉPARINE DE FAIBLE MASSE MOLÉCULAIRE, LA DALTÉPARINE SODIQUE, ET SON PROCÉDÉ DE PRÉPARATION
(ZH) 一种低分子肝素达肝素钠标准品库及其制备方法
Abstract:
(EN) The present invention provides a method for preparing a standard library of a low-molecular-weight heparin, dalteparin sodium, and a product thereof. The method uses crude heparin sodium as a raw material and is based on compound enzymatic hydrolysis and a modified nitrite degradation method. After the steps of enzymatic hydrolysis, oxidation, purification by ultrafiltration, purification by ethanol precipitation, degradation, reduction, alkaline oxidation and purification, refining by ultrafiltration, freeze drying, etc., a standard library of a low-molecular-weight heparin, dalteparin sodium, with a particular average molecular weight can be prepared.
(FR) La présente invention concerne un procédé de préparation d'une bibliothèque standard d'une héparine de faible masse moléculaire, la daltéparine sodique, et un produit associé. Le procédé utilise de l'héparine sodique brute comme matière première et est basé sur une hydrolyse enzymatique du composé et un procédé de dégradation de nitrite modifié. Après les étapes d'hydrolyse enzymatique, d'oxydation, de purification par ultrafiltration, de purification par précipitation à l'éthanol, de dégradation, de réduction, d'oxydation alcaline et de purification, de raffinage par ultrafiltration, de lyophilisation, etc, une bibliothèque standard d'une héparine de faible masse moléculaire, la daltéparine sodique, ayant une masse moléculaire moyenne particulière peut être préparée.
(ZH) 本发明公开了一种低分子肝素达肝素钠标准品库的制备方法及其产品,该方法以粗品肝素钠为原料,以符合酶解和改良的亚硝酸盐降解法为基础,经酶解、氧化、超滤除杂、醇沉除杂、降解、还原、碱氧纯化、超滤精制、冻干等步骤制得具有特定平均分子量的低分子肝素达肝素钠标准品库。
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: Chinese (ZH)
Filing Language: Chinese (ZH)