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-C18 ODS色谱柱（250mm×4．6mm，5μm），流动相为15％甲醇，检测波长285nm，流速0．8ml／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200ml蒸馏水，溶出方法为小杯法，转速为50r／min，测定滴丸的溶出度。结杲：红景天苷的最大波长为285μm，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。
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,5μm）, 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 40.5-405 μg/ml, the average recovery rate was 100.37 % with RSD 1.52 % and its dissolution parameters obtained were Td = 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.
出处
《新疆医科大学学报》
CAS
2006年第12期1137-1139,共3页
Journal of Xinjiang Medical University
关键词
红景天滴丸
含量测定
溶出度测定
Rhodiola rosea dropping pills
content determination
determination of dissolution rate
