摘要
目的对芪天滴丸(黄芪、赤芍、红景天和红花)的稳定性进行研究。方法采用差示扫描量热法(DSC)、X-射线衍射法和扫描电子显微镜(SEM)技术对芪天滴丸的稳定性进行研究。结果 TG曲线说明滴丸在常温下没有导致其质量发生变化的因素;TG/DSC对比分析显示放置两年的芪天滴丸在70°С和430°С左右的吸热峰明显减小;芍药苷对照品、PEG4000、物理混合物和芪天滴丸的比热变化分别为48.470、24.758、9.328、2.058 J/(g.K),相比其他3种物质,滴丸的稳定性最好;滴丸经过0、1、2、3、6个月的加速试验后的X-射线衍射图谱几乎没有变化,无新衍射峰出现,而放置两年的滴丸X-射线衍射图谱有新的衍射峰出现;SEM图揭示滴丸放置两年后存在老化现象。结论这些分析数据提供了芪天滴丸经加速试验后稳定性良好的证据。
AIM To study the stability of Qitian Dripping Pill （Astragali Radix, Paeoniae rubra Radix, Rhod- iolae roseae Radix et Rhizoma, Carthami Flos ）. METHODS Differential scanning calorimetry （ DSC ） , X-ray diffraction （XRD） and scanning electron microscopy （SEM） technology were employed to examine the stability of Qitian Dripping Pill which had been stored for two years. RESULTS Thermogravimetry （TG） curve showed that there was no quality change at room temperature. TG/DSC analysis indicated that the endothermic peak of dripping pills placed for two years at temperature of 70 ~C and 430 ~C decreased. The changes of specific heat in paeoniflor- in reference substance, PEG4000, physical mixture and Qitian Dripping Pill were 48. 470, 24. 758, 9. 328, 2. 058 J/（ g ~ K）, respectively, compared with the other three substances, the stability of Qitian Dripping Pill was good. After 0,1,2,3,6 month in accelerating test there was no remarkable difference in X-ray diffraction pattern of pill, but pill stored for two years had a new diffraction peak. SEM graph revealed that the pill stored for two years ap- peared aging phenomenon. CONCLUSION These analytical data provide evidence that Qitian Dropping Pill pre- pared in the laboratory have good stability in shelf-life.
出处
《中成药》
CAS
CSCD
北大核心
2011年第12期2065-2068,共4页
Chinese Traditional Patent Medicine
基金
新疆维吾尔自治区重大科技攻关项目"芪天滴丸的临床前研究"(20053312004)
关键词
芪天滴丸
稳定性
差示扫描量热法
X-射线衍射法
扫描电子显微镜
Qitian Dropping Pill
stability
differential scanning calorimetry （ DSC ）
X-ray diffraction （XRD）
scanning electron microscopy（SEM）
