ABSTRACT
Objective To investigate the effect of postoperative analgesia by using loxoprofen sodium on dental implant patients at different time points. Methods A total of 400 patients with dental implant treatment were divided into two groups by random number table method. The experimental group was firstly given loxoprofen sodium tablets (60 mg) in 30 minutes preoperatively, and the control group was firstly given on three hours after surgery (60 mg). Local anesthesia was used to all dental implant surgery. Using the Wong-Baker Smile Assessment method in operation and Numerical Rating Scale (NRS) in postoperative respectively to assess pain level in surgery and 3 h, 6 h, 12 h and 24 h after surgery. Results The percentages of painless patients of the experimental group and the control group in operation were 99%(198/200) and 97%(194/200), and there was no significant difference between them (χ2=2.041, P>0.05); the percentages of painless patients of the experimental group at 3 h, 6 h, 12 h after surgery were 60.5%(121/200), 79.0%(158/200), 83.5%(167/200), and the control group were 47.0%(94/200), 64.5%(129/200), 71.5%(143/200), and there was significant difference between the control group and the experimental group (χ2=14.255,15.447, 11.165, P=0.007, 0.004, 0.011); however, in the two groups, there was no significant difference at 24 h after surgery, the experimental group was 93.0% (186/200), the control group was 89.5% (179/200) (χ2=2.468, P>0.05). Conclusions Preoperative administration with loxoprofen sodium tablets can significantly reduce the risk of postoperative pain, and could be used as a conventional implant surgery analgesic program.
ABSTRACT
OBJECTIVE:To improve the determination method for the contents of main components and related substances in Loxoprofen sodium tablets. METHODS:RP-HPLC method was adopted. The determination was performed on Inspire C18 column with mobile phase consisted of acetonitile-0.01 mol/L potassium dihydrogen phosphate(containing 0.2% triethylamine,phosphoric acid adjusted to 3.0±0.1,62 : 38,V/V)at the flow rate of 1.0 mL/min. The column temperature was 40 ℃,and the detection wave-length was set at 221 nm. The sample size was 20 μL. RESULTS:The peak of loxoprofen sodium was well separated with the peak of its related substances(R>1.5). The linear range of loxoprofen sodium ranged 30.0-90.0 μg/mL(r=0.9998). The detection lim-it of loxoprofen was 0.3 μ g/mL. RSDs of precision,stability and repeatability tests were <1.0% . The average recovery rates ranged 99.00%-99.87%(RSD=0.33%,n=9). CONCLUSIONS:This method is accurate,simple,rapid and suitable for the quali-ty control of Loxoprofen sodium tablets.
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Objective:To prepare loxoprofen sodium sustained release pellets, and investigate the in vitro drug release behavior. Methods:Loxoprofen sodium loaded pellets were prepared by extrusion-spheronization technology, and the sustained release pellets were prepared with Eudragit RL 30D and Eudragit RS 30D as the sustained release coating film materials. The drug release behavior of loxoprofen sodium sustained release pellets in vitro was studied. Results:Eudragit RL 30D and Eudragit RS 30D with the ratio of 20 ∶80 was used as the sustained release coating film materials, the coating weight was 20%, the plasticizer content was 10%, and the content of talc was 45%. The in vitro release of loxoprofen sodium from the sustained release pellets was steady and entire in 12 h. Conclusion:The release behavior of loxoprofen sodium sustained release pellets is quite satisfactory. And the preparation technology may be used in the industrial production.
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Objective:To study the preparation and quality control of loxoprofen sodium patches and develop an HPLC method for the determination of loxoprofen sodium. Methods:Loxoprofen sodium patches were prepared with CMC-Na and PVP as the adjuvants, and an HPLC method was used to determine the content of loxoprofen sodium. Results:The linear range of loxoprofen sodium was 4-24μg·ml-1(r=0. 999 7), the average recovery was 99. 99%(RSD=0. 99%, n=6). Conclusion:The preparation method is reason-able, simple and stable. The developed HPLC method is specific to determine the content of loxoprofen.
ABSTRACT
The aim of the study was to optimize the coating formulation of sustained release pellets of loxoprofen sodium by the central composite design-response surface methodology(RSM plus CCD).In the formulation design using RSM plus CCD,independent variables were the ratio of HPMC to EC(X_1) in the sustained coating formulation and polymer load(weight gain,X_2) were selected as in dependent variables,and in vitro accumulated releases from the pellets at 1,4,and 8 h were dependent variables.Multilinear,two and three order quadratic models were used to estimate the relationship between the dependent and the independent variables,and to delineate RSM and overlay contour plots in order to select the optimal formulations in compliance to the hypothesized in vitro releases (%) at 1,4,and 8 h.The results showed that the relationship between dependent and independent variables was best fitted to three-order quadratic equation.The regression equation generated for the hypothesized in vitro cumulative releases(%) at 1,4,and 8 h were Q_(1h) =227.699 2-30.785 9X_1-43.395 4X_2 + 0.917 4X_1~2 +1.820 3X_2~2 +6.803 9X_1X_2-0.131 5X_1~2X_2-0.268 2X_1X_2~2,Q_(4h) =408.254 0-47.427 8X_1-75.229 2X_2 +3.304 0X_2~2 +12.357 3X_1X_2-0.111 8X_1~2X_2-0.5425X_1X_2~2,Q_(8h) =303.539 0-30.417 6X_1-45.114 0X_2 +2.064 4X_2~2 +6.865 0X_1X_2-0.3341X_1X_2~2,respectively.In the optimized coating formulation,the ratio of HPMC to EC was 4.0% and the polymer load 9.0%.Bias between observed and predicted values in vitro accumulated releases were negligible,indicating the high predictability of the selected models.Therefore,RSM plus CCD is applicable in the optimization of the coating formulation of loxoprofen sodium sustained-release pellets.