HU, YU FANG,胡宇方,LIN, CHUN CHOU,林春绸,林春綢,LI, CHENG YU,李承禹
申请号：
TW104138713
公开号：
TW201618755A
申请日:
2015.11.20
申请国别(地区):
TW
年份:
2016
代理人:
摘要：
The present invention provides a process for preparing an antioxidant-free pharmaceutical solution for injection, which comprises the following steps: (a) dissolving an active ingredient and a pharmaceutically acceptable excipient in a solvent for injection within a container to prepare an solution for injection； (b) placing the container containing the solution for injection in a pressure reducing device to reduce the pressure at a controlled temperature, wherein the pressure of the gas in the headspace in the container is reduced to be lower than the atmospheric pressure but higher than the boiling pressure of the solution for injection at the controlled temperature where the controlled temperature is higher than the freezing point of the solution for injection； or the pressure of the gas in the headspace in the container is reduced to be lower than the atmospheric pressure where the controlled temperature is lower than the freezing point of the solution for injection； (c) sealing the container. The antioxidant-free pharmaceutical solution for injection prepared by the process of the present invention has good long-term stability.本發明提供一種製備不含抗氧化劑的藥物注射溶液的方法，該方法包括下列步驟：(a)在一容器中將活性成分和藥學上可接受賦形劑溶解於注射用介質以製備注射溶液；(b)將該含有注射溶液的容器置於一減壓裝置內，於控制溫度下進行減壓，其中當控制溫度高於注射溶液的凝固點，使該容器內頂部空間氣體壓力降低至低於大氣壓力並高於注射溶液於該控制溫度下沸騰的壓力間，或者當控制溫度低於注射溶液的凝固點，使該容器內頂部空間氣體壓力降低至低於大氣壓力，以及(c)密封該容器。根據本發明方法所製備的不含抗氧化劑的藥物注射溶液具有良好的長期穩定性。
