葛根素胶囊及其体外分析方法的研究 Research on Puerarin Capsule and Its Analysis Methods in Vitro

目的：研究葛根素胶囊的制备和体外分析方法的建立。方法：用紫外分光光度法分析研究不同辅料对葛根素胶囊溶出度的影响。结果：辅料由微晶纤维素、聚乙二醇4000和微粉硅胶组成的处方制备的葛根素胶囊溶出效果最优，45 min体外累积溶出量大于85%。紫外标准曲线线性范围在1.0~10.0 µg/mL内，线性良好；回收率范围为98.60~101.91%，RSD = 1.95%。结论：本文研究的葛根素磷脂胶囊体外溶出度良好，在一定程度上可评估体内生物利用度。建立的紫外分析方法操作简便，快速，具有良好的精密度和准确度，可作为葛根素胶囊的体外分析方法。 Objective: Research on the preparation of puerarin capsule and the establishment of its in vitro Analytical Method. Method: Ultraviolet spectrophotometry method is adopted to analyze the impact of different excipients on dissolution rate of puerarin capsule. Results: The dissolution rate of puerarin capsule is optimal when the excipient formula consists of micro crystal cellulose (MCC), PEG-4000 and micronization silica gel. The in vitro accumulative dissolution rate reaches NLT 85% within 45 minutes. The UV standard curve shows a good linearity range between 1.0 - 10.0 µg/mL and the recovery rate is between 98.60% - 101.91%, RSD = 1.95%. Conclusion: The puerarin phosphatide capsule in this research has a good in vitro dissolution, which can be used as an in vivo assessment of the bioavailability to some extent. The ultraviolet spectrophotometry analytical method is easy to operate, fast, precise and accurate, which can be used as an in vitro analytical method for puerarin capsule.