熄风通脑胶囊稳定性考察

Study on the Stability of Xifeng Tongnao Capsules

目的 :考察熄风通脑胶囊的稳定性。方法:按《中国药典》(2010年版)二部附录原料药与药物制剂稳定性试验指导原则,采用影响因素试验、加速试验和长期试验方法,用高效液相色谱法测定芍药苷的含量,并考察其性状、鉴别、水分、崩解时限及微生物限度。结果:本品对强光较稳定,60℃高温时崩解时间延长,高湿时易吸湿潮解,室温条件下各项指标稳定。结论:本品在贮存及运输过程中应避免高温及潮湿。

Objective： To study the stability of xifeng tongnao capsules. Methods： According to the guiding principle for the stability test of drug substances and pharmaceutical preparations set forth in the appendix of Vol. 11I of the Chinese Pharmacopoeia （2010 edition）, the content of paeonifiorin was determined by HPLC. The characteristics, identification, moisture content, disintegration time limit and microbial limits were observed by the influencing factor test, the accelerated test and long-term test. Results： The samples were stable against strong light or ambient temperature ; The disintegration time was prolonged under high temperature of 60 ℃ ; It was easy to absorb moisture in the condition of high humidity, and all indices were stable under room temperature. Conclusion：Xifeng tongnao capsules should be kept and protected against high temperature and humidity in storage and transportation.