舒气安神丸的稳定性分析  

Analysis on stability of Shuqi anshen pills

作　　者：李彩霞 刘光斌 毛和平 

机构地区：[1]酒钢医院药学部,甘肃嘉峪关735100

出　　处：《现代医药卫生》2015年第16期2417-2420,共4页Journal of Modern Medicine & Health

摘　　要：目的考察舒气安神丸的稳定性和有效期。方法对该院试生产的舒气安神丸进行吸湿性试验、引湿性试验、影响因素试验、加速试验及长期试验,考察其外观性状、微生物限度和含量等。结果舒气安神丸在相对湿度(RH)为(92.5±5.0)%条件下10 h吸湿质量增加18.16%,在RH为(75.0±5.0)%条件下10 h吸湿质量增加8.27%,其在湿度较大的情况下具有较强的吸湿性。引湿性试验结果显示,舒气安神丸有引湿性,质量增加9.60%。影响因素试验、加速试验、长期试验的各考察项目均符合规定:外观性状符合规定、鉴别项斑点清晰、水分9.0%以下、溶散时限60 min以下、丹酚酸B含量0.3%以上、微生物限度符合规定。结论舒气安神丸贮存时要注意防潮,其稳定性良好,有效期确定为24个月。Objective To investigate the stability and expiration date of Shuqi anshen pills. Methods The moisture absorption test,hygroscopicity test,influencing factor test,accelerated test and long-term test of Shuqi anshen pills produced by this hospital were conducted for investigating the appearance,microbial limit,content,etc. Results The mass increase of Shuqi anshen pills in the moisture absorption test under the condition of the relative humidity（RH）（92.5±5.0）% for 10 h reached 18.16%,which under the condition of RH（75.0±5.0）% for 10 h hygroscopic reached 8.27%,indicating that the preparation had stronger moisture absorption in the case of larger humidity. The hygroscopicity test results showed that Shuqi anshen pills had hygroscopici-ty,the mass increase reached 9.60%. The influence factor test,accelerated test and long-term test all met the stipulations：the appearance conformed to the stipulation,the identifying spots were clear,the moisture content was less than 9.0%,the dissolved time was below 60 min,the salviandic acid B content was more than 0.3% and the microbial limit conformed to the stipulation. Conclusion Shuqi anshen pills should be stored for caution on moisture,which has good stability and its expiration date is determined to be 24 months.

关 键 词：药物稳定性 湿度 温度 药用制剂 中草药 舒气安神丸 

分 类 号：R286.75[医药卫生—中药学]