氢溴酸高乌甲素原料药的稳定性研究

目的考察氢溴酸高乌甲素原料药的稳定性，为该药新制剂的研究奠定理论基础。方法依据2005年版《中国药典（二部）》有关规定进行稳定性试验和加速试验，采用高效液相色谱法测定氢溴酸高乌甲素含量。结果氢溴酸高乌甲素原料药于（4500±500）lx放置10d后其含量下降百分率最大（为4．15％），表层颜色由白色转为微红，提示其对光有一定的不稳定性；在60℃条件下放置，第5天、第10天的含量分别下降了0．84％和1．45％；在相对湿度为（90±5）％条件下放置，第5天、第10天的含量分别下降了0．21％和1．27％。结论氢溴酸高乌甲素原料药对湿或热稳定，对光较敏感，新制剂的研究要考虑药物对光的稳定性。

Stability of Raw Medicine of Lappaconitine Hydrobromide

Objective To investigate the stability of raw medicine of lappaconitine hydrobromide so as to provide the theoretical foundation for the development of new preparation. Methods Based on the relevant provisions in Chinese Pharmacopoeia （2000 version） to conduct the stability test. The content of lappaconitine hydrobromide was determined by HPLC method. Results The content of lappaconitine hydrobromide decreased by 4. 15% under （4 500±500）lx for 10 d. The surface color was from white to reddish, suggesting the drug was unstable to the light to some extent. The content of the drug decreased by 0. 84% and 1.45% under 60℃ for 5, 10 d, respectively; which decreased by 0. 21% and 1.27% under （90±5）% RH for 5, 10d, respectively. Conclusion Lappaconitine hydrobromide is stable to humidity or heat, but more sensitive to light, so the stability to light should be paid more attention in the development of new preparation.