【摘要】 目的:探讨蔷薇红景天滴丸的溶出度及红景天苷含量的测定方法,为制剂的质量控制提供依据。方法:用高效液相色谱法测定滴丸中红景天苷的含量,用小杯法考察该制剂溶出度。采用Chromarsil-C18ODS色谱柱(250 mm×4.6 mm,5μm),流动相为15%甲醇,检测波长285 nm,流速0.8 ml/min,柱温35℃,进样量10μl,测定红景天苷的含量;采用RCZ-1A型药物溶出仪,溶出介质为200 ml蒸馏水,溶出方法为小杯法,转速为50 r/min,测定滴丸的溶出度。结果:红景天苷的最大波长为285 nm,线性范围为40.5~405μg/ml,平均回收率为100.37%,RSD为1.52%,溶出参数分别为Td=4.30,T50=3.03。结论:高效液相色谱法简便快速、准确、可靠,重现性好,专属性好,可作为红景天苷的含量测定和溶出度测定的有效方法。更多还原

【Abstract】 Objective: To reach the objective of quality control through determination on Rhodiola content of Rhodiola rosea dropping pills and its dissoluteion rate.Methods: The Rhodiola content of the dropping pills was determined by HPLC and its dissolution rate was determined by small glass method.（1） Determination of rhodiola content: use Chromarsil-C₁₈ ODS column（250×4.6 mm,5 μm）,fluid phase was 15% methanol,the detection was set at 285 nm,flow rate was 0.8 ml/min,column temperature was 35℃,injection amount was 10 μl.（2） Determination of dissolution rate: use RCZ-1A dissolution apparatus,solvent was 200 ml water,method was small glass method,rotation speed was 50 r/min.Results: The detection was set at 285 nm,the calibration cure is linear between 40.5⁴05 μg/ml,the average recovery rate was 100.37% with RSD 1.52% and its dissolution parameters obtained were T_d=4.30,T₅₀=3.03 respectively.Conclusions: This methods were convenient and fast,reliable,extract,its recurrence was fine.It can be the effective method of content and dissolution determination of Hongjingtian dropping pills.更多还原