HEBRANT, JEAN,LIDARSSI, TERRY,DE SCHRYVER, CHRISTOPHE,KRESS, ROBERT KARL
申请号：
EP07447042.8
公开号：
EP2011452B1
申请日:
2007.07.06
申请国别(地区):
EP
年份:
2014
代理人:
摘要：
Intramuscular and bioresorbable injectable preparation, for carrying out a muscular implant in human or animal, in an oily sterilized solution form, comprises: medium-chain triglycerides (MCT), preferably plant origin； optionally benzyl alcohol； and optionally alpha-tocopherol. An independent claim is included for a process for preparing intramuscular injectable preparation, comprises weighing and mixing raw materials, triglyceride, benzyl alcohol and tocopherol； controlling concentration of benzyl alcohol； prefiltration and/or filtration on sterilizing filter, preferably 22 mu m； intermediate stocking in container of contention； distribution in ampoules or syringes, preferably 5 ml, before heating at 220[deg] C and cooling with sterilized air； heating sealed ampoules in autoclave at 120[deg] C for 20 minutes； inspection (100%) of ampoules for detecting leakage, presence of particles and rift； eliminating non-compliant ampoules； primary packaging； secondary packaging； storing quarantine； and controlling and approbation of lots. ACTIVITY : Neuroprotective； Muscular-Gen； Neuroleptic. MECHANISM OF ACTION : None given.
