ДЖАМИОЛКОВСКИ Деннис Д. (US),ФИЦ Бенджамин Д. (US),ЯН Дачуань (US)
申请号：
RU2014126581
公开号：
RU2014126581A
申请日:
2012.11.20
申请国别(地区):
RU
年份:
2016
代理人:
摘要：
1. A method for predicting the behavior in vivo of synthetic absorbable polymers formed from these implants or medical devices having hydrolyzable bonds in the chain, on the basis of tests in vitro, comprising the steps of: (a) carrying out hydrolysis of a known amount of test sample at a known time in absorbance vivo, at a substantially constant pH value and substantially constant test temperature, which is equal to or greater than body temperature, using the known concentration of the titrating base register tion volume of the titrating base versus time (b) record the time required to achieve a constant level of the degree of sample hydrolysis test, wherein the degree of hydrolysis is 70 percent or more (c) repeating steps (a) and (b) under conditions test selected for steps (a) and (b), using at least one distinct test specimen with other known time absorption in vivo (d) construction of the correlation in vivo curve - in vitro, reflecting the dependence of in vivo absorption time of time hydrolyzed for in vitro, registered in step (b) (e) carrying out hydrolysis of a known amount of the test sample with an unknown time absorption in vivo under the test conditions selected for steps (a) and (b), using the known concentration of the titrating base register titrating base volume versus time (f) predicting behavior in vivo using a correlation curve plotted in step (d), and in vitro hydrolysis time recorded in step (e) .2. A method according to Claim. 1, wherein said temperature test locat1. Способ прогнозирования поведения in vivo синтетических абсорбируемых полимеров, образованных из них имплантатов или медицинских устройств, имеющих гидролизуемые связи в цепи, на основании испытания in vitro, включающий следующие стадии:(a) проведение гидролиза известного количества образца для испытания при известном времени абсорбции in vivo, при, по существу, постоянном значении pH и, по существу, постоянной температуре испытаний, которая равна или больше температуры тела, с ис
