汉防己甲素微球的稳定性研究

Study on the Stability of Tetrandrine Microsphere

目的:研究汉防己甲素微球的稳定性。方法:采用加速试验和室温留样观察,考察汉防己甲素微球外观性状、载药量、包封率、渗漏率、微生物稳定性等指标。结果:经过六个月的试验,汉防己甲素微球的外观性状、载药量、渗漏率、微生物稳定性无明显改变;但在六个月的加速试验中,包封率则下降,渗漏率增加。结论:汉防己甲素微球室温条件下稳定,但对热不稳定,应低温保存。

Objective:To study the stability of Tetrandrine Microsphere. Methods: Higher speed test and room temperature test were adopted to investigate the indexes,such as properties of appearance,amount of medicine loaded,seal rate,seepage rate,microbial stability,etc.Results:Through the test of six months,properties of appearance,amount of medicine loaded,seal rate,seepage rate,microbial stability have not obviously change. But after testing for 6 months with higher temperature,the seal rate was reduced,and the seepage rate was increased.Conclusions:Tetrandrine microsphere is steady under the room temperature condition,but is unstable to hot,and ought to keep in conformity with low-temperature.