Bioprospecting Laboratory, Interdisciplinary School of Health Sciences, University of Pune, Pune, India.
Planta Med. 2010 Mar;76(5):481-8. doi: 10.1055/s-0029-1186220. Epub 2009 Oct 20.
Stability testing at preformulation stages is a crucial part of drug development. We studied physicochemical stability and biological activity of Withania somnifera (ashwagandha) dried root aqueous extract during six months real-time and under accelerated storage conditions. The characteristic constituents of ashwagandha roots include withanolides such as withaferin A and withanolide A. We modified and validated the HPLC-DAD method for quantitative measurement of withanolides and fingerprint analysis. The results suggest a significant decline in withaferin A and withanolide A content under real and accelerated conditions. The HPLC fingerprint analysis showed significant changes in some peaks during real and accelerated storage (> 20 %). We also observed incidences of clump formation and moisture sensitivity (> 10 %) under real-time and accelerated storage conditions. These changes were concurrent with a significant decline in immunomodulatory activity (p < 0.01) during the third month of the accelerated storage. Thus, adequate control of temperature and humidity is important for WSE containing formulations. This study may help in proposing suitable guidance for storage conditions and shelf life of ashwagandha formulations.
在配方前阶段进行稳定性测试是药物开发的重要组成部分。我们研究了六个月实时和加速储存条件下睡茄（印度人参）干根水提物的物理化学稳定性和生物活性。根中的特征成分包括醉茄内酯，如醉茄素 A 和醉茄内酯 A。我们修改并验证了 HPLC-DAD 方法，用于定量测量醉茄素和指纹分析。结果表明，在实时和加速条件下，醉茄素 A 和醉茄内酯 A 的含量显著下降。HPLC 指纹分析显示，在实时和加速储存过程中（>20%），一些峰发生了显著变化。我们还观察到在实时和加速储存条件下结块形成和湿度敏感性（>10%）的发生率。这些变化与加速储存第三个月免疫调节活性的显著下降（p<0.01）同时发生。因此，对于含有 WSE 的制剂，控制温度和湿度非常重要。本研究可为提出适合的贮藏条件和印度人参制剂的保质期提供参考。
