桃核承气缓释片的稳定性研究Δ - 中国药房.PDFVIP

桃核承气缓释片的稳定性研究Δ ＊ # 杜 清 ，刘 文 ，徐 剑，汤 瑾（贵阳中医学院，贵阳 550002） 中图分类号 R283.64；R927.11 文献标志码 A 文章编号 1001-0408（2013）07-0634-03 DOI 10.6039/j.issn. 1001-0408.2013.07.21 摘 要 目的：考察桃核承气缓释片的稳定性，预测其有效期；了解影响其稳定性的因素，为加速试验和长期试验提供依据。方 法：通过经典恒温加速试验和影响因素试验法考察稳定性，采用高效液相色谱法测定制剂中大黄酸和大黄素的含量。结果：大黄 酸的有效期为2.42年，大黄素的有效期为2.40年；强光照射对桃核承气缓释片的稳定性有一定影响，高温和高湿度对其稳定性影 响很小。结论：桃核承气缓释片室温下的有效期为2年。为了有利于制剂的质量、安全性和有效性，生产和贮藏过程中应采用适 当的避光措施。 关键词 桃核承气缓释片；大黄酸；大黄素；经典恒温加速试验；稳定性 Study on the Stability of Taohe Chengqi Sustained-release Tablets DU Qing ，LIU Wen ，XU Jian ，TANG Jin（Guiyang College of TCM ，Guiyang 550002，China ） ABSTRACT OBJECTIVE ：To investigate the stability of Taohe chengqi sustained-release tablets ，predict period of validity ；to in- vestigate the influential factors of the stability ，and to provide reference for accelerated test and long-term test. METHODS ：The sta- bility of it was investigated with classical constant temperature accelerated experiment and influential factor test ，and the contents of rhein and emodin were determined by HPLC. RESULTS ：The validity of rhein was 2.42years ，and that of emodin was 2.40years ； strong light exposure could affect the stability of Taohe chengqi sustained-release tablets ，and high temperature and humidity had lit- tle influence. CONCLUSION ：At room temperature ，the period of validity of Taohe chengqi sustained-release tablets is 2 years. In order to ensure the quality ，safety and validity ，lucifuge measures should be adopted during the production and stroage. KEY WORDS Taohe chengqi sustained-release tablets ；Rhein ；Emodin ；Classical constant temperature accelerated experiment ； Stability 桃核承气汤出自张仲景《伤寒论》，是活血化瘀的名方。 司）；TDL-5A 型低速自动平衡离心机（湖南星科科学仪器公 现代药理研究表明，桃核承气汤具有降低血黏度、血胆固醇、 司）；SK8210HP 型超声波清洗器（上海科导超声仪器有限公 [1] [2] 司）。 纤维蛋白原 ，扩张血管，改善微循环的作用 ；方中大黄能降 低血管阻力、增加血流量、阻滞细胞钙内流、提高心肌对氧的 1.2 药品与试剂