The Solution and Solid State Stability and Excipient Compatibility of Parthenolide in Feverfew
The Solution and Solid State Stability and Excipient Compatibility of Parthenolide in Feverfew
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DOI：
10.1208/pt0804105
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发表时间：
2007-10-01
影响因子：
3.3
通讯作者：
Augsburger, Larry L.
中科院分区：
文献类型：
--
作者：
Jin, Ping;Madieh, Shadi;Augsburger, Larry L.
本研究的目的是评价白菊水溶液和白菊粉末（固体）的稳定性，并探讨常用辅料与白菊中白菊苷的配伍性。用不同pH缓冲液稀释小白菊提取物溶液，以研究小白菊中的银胶菊苷的溶液稳定性。将小白菊提取物粉末在40 ° C/0%（类似于75%相对湿度（RH））或31%RH/5（类似于50 ° C）下储存，以研究温度和相对湿度对小白菊固体状态下的银胶菊稳定性的影响。将小白菊粉末提取物和不同赋形剂的二元混合物储存在50 ℃/75%RH下用于赋形剂相容性评价。银胶菊在小白菊溶液中的降解符合典型的一级反应。当环境pH在5至7的范围内时，孤雌菊相对稳定，当pH小于3或大于7时变得不稳定。白菊在固态下的降解不符合任何明显的反应模型。水分含量和温度都对降解速率有重要影响。经过6个月的存储，白菊中的parthenoprotein保持恒定在5摄氏度/31%RH。然而，类似于40%的小白菊，如果储存在50摄氏度/31%RH下，小白菊可以降解。当湿度从0%变化到75%RH时，在40 ℃下贮藏6个月后，小白菊中孤雌菊的降解率从18%增加到32%。在为期3周的筛选研究中，野甘菊中的银胶菊在应激条件下与常用辅料具有良好的相容性。
The objectives of this research were to evaluate the stability of parthenolide in feverfew solution state and powdered feverfew (solid state), and explore the compatibility between commonly used excipients and parthenolide in feverfew. Feverfew extract solution was diluted with different pH buffers to study the solution stability of parthenolide in feverfew. Powdered feverfew extract was stored under 40 degrees C/0%similar to 75% relative humidities (RH) or 31% RH/5 similar to 50 degrees C to study the influence of temperature and relative humidity on the stability of parthenolide in feverfew solid state. Binary mixtures of feverfew powered extract and different excipients were stored at 50 degrees C/75% RH for excipient compatibility evaluation. The degradation of parthenolide in feverfew solution appears to fit a typical first-order reaction. Parthenolide is comparatively stable when the environmental pH is in the range of 5 to 7, becoming unstable when pH is less than 3 or more than 7. Parthenolide degradation in feverfew in the solid state does not fit any obvious reaction model. Moisture content and temperature both play important roles affecting the degradation rate. After 6 months of storage, parthenolide in feverfew remains constant at 5 degrees C/31% RH. However, similar to 40% parthenolide in feverfew can be degraded if stored at 50 degrees C/31% RH. When the moisture changed from 0% to 75% RH, the degradation of parthenolide in feverfew increased from 18% to 32% after 6-month storage under 40 degrees C. Parthenolide in feverfew exhibits good compatibility with commonly used excipients under stressed conditions in a 3-week screening study.