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1. (WO2018121510) GEL OF SODIUM HYALURONATE CROSS-LINKED BY POLYETHYLENE GLYCOL EPOXY DERIVATIVE FOR INJECTION AND PREPARATION METHOD THEREOF
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Pub. No.: WO/2018/121510 International Application No.: PCT/CN2017/118542
Publication Date: 05.07.2018 International Filing Date: 26.12.2017
IPC:
C08G 65/48 (2006.01) ,C08J 3/075 (2006.01) ,C08L 71/02 (2006.01) ,C08L 5/08 (2006.01)
C CHEMISTRY; METALLURGY
08
ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
G
MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
65
Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule
34
from hydroxy compounds or their metallic derivatives
48
Polymers modified by chemical after-treatment
C CHEMISTRY; METALLURGY
08
ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
J
WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H142
3
Processes of treating or compounding macromolecular substances
02
Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques
03
in aqueous media
075
Macromolecular gels
C CHEMISTRY; METALLURGY
08
ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
L
COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
71
Compositions of polyethers obtained by reactions forming an ether link in the main chain; Compositions of derivatives of such polymers
02
Polyalkylene oxides
C CHEMISTRY; METALLURGY
08
ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
L
COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
5
Compositions of polysaccharides or of their derivatives not provided for in group C08L1/ or C08L3/142
08
Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
Applicants:
北京键凯科技股份有限公司 JENKEM TECHNOLOGY CO., LTD. (BEIJING) [CN/CN]; 中国北京市 海淀区西小口路66号中关村东升科技园C-1楼三层 Building C-1, 3/F Zhongguancun Dongsheng Science Park, 66 Xi Xiaokou Road, Haidian District Beijing 100192, CN
Inventors:
魏真 WEI, Zhen; CN
林美娜 LIN, Meina; CN
赵宣 ZHAO, Xuan; CN
Agent:
北京布瑞知识产权代理有限公司 BEIJING BRIGHT IP AGENCY CO., LTD.; 中国北京市 朝阳区广顺北大街5号院内32号B228 B228 No. 32, Inside the No. 5 Yard, Guangshun North Street, Chaoyang District Beijing 100102, CN
Priority Data:
201611246123.929.12.2016CN
201711399574.021.12.2017CN
Title (EN) GEL OF SODIUM HYALURONATE CROSS-LINKED BY POLYETHYLENE GLYCOL EPOXY DERIVATIVE FOR INJECTION AND PREPARATION METHOD THEREOF
(FR) GEL POUR INJECTION D'HYALURONATE DE SODIUM RÉTICULÉ PAR UN DÉRIVÉ ÉPOXY DE POLYÉTHYLÈNEGLYCOL ET PROCÉDÉ DE PRÉPARATION CORRESPONDANT
(ZH) 一种注射用多元甘醇环氧衍生物交联的透明质酸钠凝胶及其制备方法
Abstract:
(EN) A gel of sodium hyaluronate cross-linked by a polyethylene glycol epoxy derivative for injection and a preparation method thereof are provided. The polyethylene glycol epoxy derivative is preferably a compound having a single molecular weight, and a molecule of the compound includes a plurality of ether bonds, and has high water solubility, such that the compound is easily cross-linked with polysaccharides. In addition, since the number of repeating units of polyethylene glycol is more easily adjusted, the chain length thereof is more easily regulated. Therefore, the function of the sodium hyaluronate gel prepared by polyethylene glycol as a cross-linking agent is more easily regulated. The advantages of the cross-linked gel of sodium hyaluronate include low toxicity, low residue, low pushing force, good plasticity, good enzyme resistance, and long in-vivo time. A moderate inactivation process of the cross-linking agent is further disclosed. In the gel, unreacted epoxy groups can be hydrolyzed under a carbonate buffering system of pH 8-9, in order to effectively reduce the difficulty of removing impurities from the cross-linked gel of sodium hyaluronate, avoiding the use of toxic BDDE as a cross-linking agent in the art.
(FR) L'invention concerne un gel pour injection d'hyaluronate de sodium réticulé par un dérivé époxy de polyéthylèneglycol et un procédé de préparation correspondant. Le dérivé époxy de polyéthylèneglycol est de préférence un composé présentant un poids moléculaire unique et une molécule du composé comprend une pluralité de liaisons éther et présente une solubilité élevée dans l'eau, de telle sorte que le composé est facilement réticulé par des polysaccharides. De plus, étant donné que le nombre de motifs récurrents de polyéthylèneglycol est plus facilement ajusté, la longueur de chaîne correspondante est plus facilement régulée. Par conséquent, la fonction du gel d'hyaluronate de sodium préparé par le polyéthylèneglycol en tant qu'agent de réticulation est plus facilement régulée. Les avantages du gel réticulé d'hyaluronate de sodium comprennent une faible toxicité, un faible résidu, une faible force de poussée, une bonne plasticité, une bonne résistance enzymatique et une longue durée in vivo. L'invention concerne en outre un procédé d'inactivation modérée de l'agent de réticulation. Dans le gel, les groupes époxy n'ayant pas réagi peuvent être hydrolysés sous un système tampon de carbonate de pH de 8-9, afin de réduire efficacement la difficulté d'élimination des impuretés du gel réticulé d'hyaluronate de sodium, ce qui évite l'utilisation de BDDE toxique qui est un agent de réticulation dans l'état de la technique.
(ZH) 一种注射用多元甘醇环氧衍生物交联的透明质酸钠凝胶及其制备方法,所述的多元甘醇环氧衍生物,其优选为单一分子量的化合物,其分子中存在多个醚键,水溶性好,更易与多糖发生交联反应,同时由于多甘醇重复单元数较易调整,长度较易控制,其作为交联剂制备的透明质酸钠凝胶性能较易调控;所述的交联的透明质酸钠凝胶毒性低、少残留、挤推力小、塑形性好、耐酶性好、体内保留时间长。还公开了一种温和的交联剂灭活技术,将凝胶中未反应的环氧基团在pH=8-9的碳酸盐缓冲体系中水解反应,可有效降低交联透明质酸钠凝胶的除杂难度,避免现有技术中交联方法使用BDDE的毒性问题。
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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)