Résumé
This study was aimed to compare the pharmacokinetics (PK) of Shengmai injection and Shenmai injection with a single injection administration using a constant speed in subjects with stable angina pectoris.A total of 20 subjects with stable angina pectoris were divided into two groups.Each group was administered with Shengmai and Shenmai injection.The liquid chromatography-mass spectrometry (LC/MS) was adopted to determine concentrations of ginsenosides in plasma at different time points.PK parameters were calculated for comparison.The results showed that after a single intravenous infusion of Shengmai and Shenmai injection,the Cm.of ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1 and ginsenoside Rc in Shenmai group were higher than those of the Shengmai group with statistical significance (P ≤0.05).There were differences on the T1/2 of ginsenoside Rg1,AUC0-144h and CL of ginsenoside Rc,as well as Tmax of ginsenoside Rd (P ≤ 0.05).However,there was no significant difference shown on other PK parameters.It was concluded that after a single Shengmai or Shenmai injection,there were PK differences of ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1 and ginsenoside Rc in the human body.The clinical medication selection should be based on syndrome differentiation and treatment of patients.
Résumé
OBJECTIVE: To study the stability of dexamethasone sodium phosphate(DSP) eye drops and predict its validity duration.METHODS: The content of DSP in eye drops was determined by HPLC and its validity duration was predi-cated using initial average rate method.RESULTS: The linear concentration range of DSP was 18～70 ?g?mL-1(r=0.999 9) with an average recovery rate of 99.74%(RSD=0.37%).The content of DSP in the eye drops decreased as its storing temperature increased and the storing time prolonged,but its pH was stable. The validity duration of the eye drops was computed to be 70 days at 25 ℃ and 438 days at 4 ℃.CONCLUSION: This eye drops were stable at 4 ℃.