摘要
目的：研制能增加用药部位药物浓度的依沙吖啶凝胶。方法：用ＣＭＣＮａ作凝胶基质，按制剂学原理制备了依沙吖啶凝胶，建立了酸碱度、卫生学、含量测定等质控方法，进行了加速试验和自然室温留样考察。结果：ｐＨ值６．５～６．８，卫生学检查符合规定，含量测定平均回收率９９．３４％，ＲＳＤ＝０．７４％（ｎ＝５），并且凝胶稳定无变化。结论：制备该凝胶工艺简单，所得制剂质量可控，性质稳定，可满足临床用药需求。
OBJECTIVE:To develop a gel of ethacridine,which can increase the density at the local part of the drugs used.METHODS:Using CMC Na as the gel stroma,the gel of ethacridine lactate has been developed.RESULTS:The pH value is 6.5 ～ 6.8 .And it is up to the standard through the hygienical test.In the test of content,the average rate of recovery is 99.34% and RSD = 0.74% ( n =5).After going through the centrifugation in high speed,thermostability and cold test,and the test to stay in natural temperature,no changes in gel have been found.CONCLUSIONS:Gel can be easily developed.The quality is able to be controlled and the stability kept.Gel is a useful medicine for the clinic.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
1999年第3期153-155,共3页
Chinese Journal of Hospital Pharmacy
关键词
依沙吖啶
凝胶
质量控制
稳定性
Ethacridine Lactate,gel,quality control,stability
