OBJECTIVE:To establish a method for the dissolubility determination of Manidipine Hydrochloride tablet and eval-uate the quality consistency of generic and original preparation. METHODS:HPLC was performed on the column of Waters Sym-metry C18 column with mobile phase of potassium phosphate monobasic solution (potassium phosphate monobasic 6.8 g was well-mixed with water 1 000 ml,and pH was adjusted to 4.6 by potassium hydroxide solution)-acetonitrile (49∶51,V/V) at flow rate of 1.0 ml/min,detection wavelength was 228 nm,column temperature was 25℃,and the injection volume was 20μl. The dis-solution mediums were 0.1 mol/L hydrochloric acid solution,acetic acid-sodium acetate buffer solution(pH 4.0)and phosphate buf-fer solution [pH 6.8,adding into 0.5% sodium dodecyl sulfonate(SDS)],volume of dissolution medium was 900 ml and rotating rate was 50 r/min,and the dissolubility of Manidipine hydrochloride tablet generic and original preparation was investigated and the similarity of dissolution profile was evaluated by calculating similar factor (f2). RESULTS:The linear range of manidipine hydro-chloride was 0.625-20 μg/ml;RSDs of instrument precision and stability tests were lower than 2.0%;recoveries of 3 dissolution mediums were 92.86%-102.97%(RSD=1.9%,1.8% and 2.7%,n=9),respectively. The dissolubility of 3 batches of Manidipine hydrochloride tablet generic and original preparations was higher than 85% in 0.1 mol/L hydrochloric acid solution in 15 min;f2 was >50 in acetic acid-sodium acetate buffer solution (pH 4.0) and phosphate buffer solution (pH 6.8,adding into 0.5% SDS). CONCLUSIONS:The method is suitable for the dissolubility determination of Manidipine hydrochloride tablet;meanwhile,the dis-solution profile in vitro of Manidipine hydrochloride tablet generic and original preparations has similarities,so the quality consis-tency is good.

Objective:To investigate the impact of a pain management model based on clinical pathway (CP) refinement on postoperative pain relief, recovery, and cognitive function in patients undergoing orthopedic joint surgery.Methods:A total of 150 orthopedic joint surgery patients admitted to Handan Central Hospital from February 2018 to January 2021 were selected. They were randomly divided into an observation group (treated with a pain management model based on CP refinement) and a control group (treated with conventional pain management) using a random number table method, with 75 patients in each group. We compared the differences in pain relief, recovery, cognitive function, and postoperative complication rates between two groups of patients.Results:The Visual Analogue Scale (VAS) scores of the observation group patients at 2, 6, 12, and 24 hours after surgery were lower than those of the control group, and the differences were statistically significant (all P<0.05). 24 hours after surgery, the Japanese Orthopaedic Association (JOA) scores of both groups of patients decreased compared to before treatment, and the angle of straight leg elevation test increased compared to before treatment (all P<0.05). In addition, the JOA scores of the observation group were lower than those of the control group, and the angle of straight leg elevation test was greater than that of the control group, with statistical significance (all P<0.05). 24 hours after surgery, the Mini-mental State Examination (MMSE) scores of both groups of patients increased (all P<0.05), and the MMSE scores of the observation group were higher than those of the control group, with statistical significance (all P<0.05). The incidence of postoperative nausea and vomiting in the observation group was significantly lower than that in the control group, and the difference was statistically significant (all P<0.05). Conclusions:The analgesic model based on CP refined management has improved the postoperative analgesic effect, recovery, and cognitive function of patients undergoing orthopedic joint surgery. It is recommended to promote it clinically.