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目的:了解贝诺酯片溶出度与人体内血药浓度的相关性,建立溶出度测定法。方法:用1％十二烷基硫酸钠溶液为溶剂,桨法测定,45min时取样,紫外分光光度法测定贝诺酯片溶出度;贝诺酯片人体内血药浓度是以对二甲氨基苯甲醛为内标,用HPLC法分别测定血浆中扑热息痛与水杨酸的含量,数理统计贝诺酯片溶出度与人体内药代动力学参数的相关性。结果:贝诺酯片溶出度与人体内药代动力学参数AUC、C_(max)相关性显著[相关系数(r)分别为0.968与0.985(n=5),查表r_(0.01,3)=0.959]。结论:建立的贝诺酯片溶出度测定法可有效地控制药品的质量。
OBJECTIVE: To understand the correlation between the dissolution of benofenate tablets and the plasma concentration in human body and to establish a dissolution assay. Methods: 1% sodium dodecyl sulfate solution was used as the solvent and the paddle method was used to determine the dissolution rate of benofenate tablets at 45 min. The concentration of Benoteproside tablets in the human body was determined by the UV- Benzaldehyde was used as internal standard, and the contents of paracetamol and salicylic acid in plasma were determined by HPLC respectively. The correlation between the dissolution of bensene tablets and the pharmacokinetic parameters in human body was analyzed by mathematical statistics. Results: The dissolution of benofenate tablets was significantly correlated with the pharmacokinetic parameters AUC and C max of human body [r = -0.968 and 0.985 (n = 5, respectively] = 0.959]. Conclusion: The established dissolution assay of benofenate tablets can effectively control the quality of medicines.