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目的测定抗疏健骨胶囊中三种指标成分的体外溶出度,为抗疏健骨胶囊的质量评价研究奠定基础。方法采用高效液相色谱法测定淫羊藿苷、β-蜕皮甾酮和丹酚酸B三种指标成分在不同转速、溶出介质、溶出方法中的累积溶出率。结果通过对溶出方法、转速、溶出介质的考察,建立了适合抗疏健骨胶囊多指标成分溶出度检查方法:以0.5%的SDS水溶液作为溶出介质,以转速100 r/min的桨法为溶出方法。结论 3种成分在90 min时的溶出几乎达到饱和状态。相同条件下,同时刻淫羊藿苷、β-蜕皮甾酮和丹酚酸B三种成分中的溶出度比较的结果为:丹酚酸B>β-蜕皮甾酮>淫羊藿苷,淫羊藿苷、β-蜕皮甾酮和丹酚酸B的T50分别为10.56 min、9.57 min和9.05 min,T d分别为13.34 min、12.10 min和11.44 min,三种成分的溶出效果以丹酚酸B最佳,淫羊藿苷最差。
OBJECTIVE To determine the in vitro dissolution of three components in Shuzhongjian Capsule, and lay the foundation for the quality evaluation of Shuzhongjiao Capsule. Methods The cumulative dissolution rates of icariin, β-ecdysterone and salvianolic acid B in different speed, dissolution medium and dissolution method were determined by high performance liquid chromatography. Results According to the dissolution method, speed and dissolution medium, the method of dissolution test for multi-index components of anti-Shujianjiao capsule was established. Dissolution was performed with 0.5% SDS aqueous solution as dissolution medium and paddle method with speed of 100 r / min method. Conclusion The dissolution of the three components almost reaches the saturation state at 90 min. Under the same conditions, at the same time icariin, β-ecdysterone and salvianolic acid B dissolution of the three components of the results compared: Salvianolic acid B> β-ecdysterone> icariin, prostitution T50 of icariin, β-ecdysterone and salvianolic acid B were 10.56 min, 9.57 min and 9.05 min, respectively, and T d was 13.34 min, 12.10 min and 11.44 min, respectively. The dissolution efficiencies of three components were salvianolic acid B best, icariin worst.