中国伤残医学
中國傷殘醫學
중국상잔의학
CHINESE JOURNAL OF TRAUMA AND DISABILITY MEDICINE
2013年
8期
98-100
,共3页
盐酸苯海拉明片%空白颗粒法%有关物质%稳定性
鹽痠苯海拉明片%空白顆粒法%有關物質%穩定性
염산분해랍명편%공백과립법%유관물질%은정성
Diphenhydramine hydrochloride tablet%Blank particle production craft%Related substances%Stability
目的:通过试验优化盐酸苯海拉明片的生产工艺,以提高盐酸苯海拉明片的稳定性,减少有关物质的产生。方法:采用空白颗粒法生产工艺,以高效液相法检测降解物二苯酮及相关杂质。结果:盐酸苯海拉明片质量稳定,含量、有关物质、溶出度均符合规定。结论:盐酸苯海拉明片空白颗粒法生产工艺稳定可行,可用于生产。
目的:通過試驗優化鹽痠苯海拉明片的生產工藝,以提高鹽痠苯海拉明片的穩定性,減少有關物質的產生。方法:採用空白顆粒法生產工藝,以高效液相法檢測降解物二苯酮及相關雜質。結果:鹽痠苯海拉明片質量穩定,含量、有關物質、溶齣度均符閤規定。結論:鹽痠苯海拉明片空白顆粒法生產工藝穩定可行,可用于生產。
목적:통과시험우화염산분해랍명편적생산공예,이제고염산분해랍명편적은정성,감소유관물질적산생。방법:채용공백과립법생산공예,이고효액상법검측강해물이분동급상관잡질。결과:염산분해랍명편질량은정,함량、유관물질、용출도균부합규정。결론:염산분해랍명편공백과립법생산공예은정가행,가용우생산。
Objective:To improve the stability of diphenhydramine hydrochloride tablet and reduce the production of related sub -stances.Methods:Blank granule production craft was adopted and the degradation diphenyl ketone was detected with the high perform -ance liquid chromatography .Results: The quality of diphenhydramine hydrochloride tablet was stable , content , related substances and drug’ s dissolution all come up to the required standard .Conclusion:The blank particle production craft should be stable and suitable for the production of the diphenhydramine hydrochloride tablet .