Background: Oral aphthosis has a negative impact on oral health. This study aimed to assess the effectiveness of gel formulation including diclofenac and propolis in the treatment of oral ulcers. Methods: Participants...Background: Oral aphthosis has a negative impact on oral health. This study aimed to assess the effectiveness of gel formulation including diclofenac and propolis in the treatment of oral ulcers. Methods: Participants included 100 normal individuals with aphthous, excluding those having allergies to any ingredient in the diclofenac formulation. Patients were randomly assigned into two groups: one group received treatment with a combination of diclofenac potassium 3% (10 mg/g, 60 g) and propolis 5% gel (Group II), and the other group received a placebo (Group 1). The patient was evaluated using standard digital photographs and chronic oral mucosal questionnaires on days 1, 3, 5, and 7 after healing. Utilizing the Mann-Whitney U test, the two groups were compared. Each group’s changes were examined using Friedman’s test. Results: There was a statistically dramatic change over time in Group II. After one day, the median total score dropped statistically significantly, and from one to three days with effect size (d) 2.485, Group II demonstrated 48% complete healing and 52% partial healing, while Group I demonstrated 4% partial healing and 96% no change. Effect size (V): 0.995. Conclusions: The combination of diclofenac and propolis provided instant relief and an affordable new regimen for treating oral aphthosis.展开更多
The main purpose of this study is to prepare highly stable diclofenac potassium(DP)pellet with microcrystalline cellulose(MCC)by extrusionespheronization.Using MCC,DP pellets were prepared and the stability was invest...The main purpose of this study is to prepare highly stable diclofenac potassium(DP)pellet with microcrystalline cellulose(MCC)by extrusionespheronization.Using MCC,DP pellets were prepared and the stability was investigated.Related compounds of DP pellets were analyzed by High Pressure Liquid Chromatography(HPLC).After stability test of 60℃/75%RH for 10 d,the values of two main related compounds were 0.94%and 2.17%,respectively.Compatibility tests show that instability of DP was mainly caused by MCC.To improve the stability of DP in presence of MCC,different kinds of stabilizers were investigated.Upon addition of 1.5%(w/w)sodium hydroxide,the primary related compound of pellets was reduced to be 0.159%after stability test of 60℃/75%RH for 50 d.This study demonstrated that MCC induced decomposition of DP upon exposure to moisture could be prohibited by addition of sodium hydroxide.The mechanisms were discussed and residual hydroxyl free radicals in excipients were responsible for decomposition of DP.Finally,this formulation of DP is highly stable with sustained-release behavior.展开更多
Two different salts of diclofenac,diclofenac sodium and diclofenac potassium,in tablet dosage form were tested for their bioavailability and disposition kinetics in a group of eighteen rabbits in normal and experiment...Two different salts of diclofenac,diclofenac sodium and diclofenac potassium,in tablet dosage form were tested for their bioavailability and disposition kinetics in a group of eighteen rabbits in normal and experimentally induced dehydrated conditions with a wash out period of 7 days between both stages of study.Biochemical and physiological parameters were also measured in both normal and dehydrated states.Diclofenac levels in plasma were determined using a validated reversed phase HPLC method.Primary kinetic parameters i.e.AUC0-∞,Cmax,Tmax and other disposition kinetics were obtained with non-compartmental procedure.Biochemical parameters i.e.packed cell volume,plasma glucose and total lipid concentration in dehydrated rabbits increased significantly.Plasma concentration of diclofenac sodium and diclofenac potassium decreased significantly in water deprived rabbits.In comparison,diclofenac potassium in normal and dehydrated state of the same group of rabbits showed a significantly increased plasma concentration when compared with diclofenac sodium.展开更多
目的优化双氯芬酸钾口腔黏附片处方。方法采用32满因子设计试验考察因素A(卡波姆和羟丙甲基纤维素的总量在处方中所占的比例)和因素B(卡波姆与羟丙甲基纤维素的质量比)对黏附时间和体外30、180、480 m in的累积释放度的影响,试验数据分...目的优化双氯芬酸钾口腔黏附片处方。方法采用32满因子设计试验考察因素A(卡波姆和羟丙甲基纤维素的总量在处方中所占的比例)和因素B(卡波姆与羟丙甲基纤维素的质量比)对黏附时间和体外30、180、480 m in的累积释放度的影响,试验数据分别采用线性方程和二次多项式拟合,根据最佳数学模型绘制效应面和等高线图,通过重叠等高线图确定最优处方。结果2个影响因素和4个评价指标之间存在定量关系,最优处方:卡波姆和羟丙甲基纤维素的总量在处方中占30%,卡波姆与羟丙甲基纤维素的质量比为0.75∶1。优化处方各指标的预测值和目标值较接近。结论采用因子设计-重叠等高线图法完成了双氯芬酸钾口腔黏附片的多目标同步优化。展开更多
文摘Background: Oral aphthosis has a negative impact on oral health. This study aimed to assess the effectiveness of gel formulation including diclofenac and propolis in the treatment of oral ulcers. Methods: Participants included 100 normal individuals with aphthous, excluding those having allergies to any ingredient in the diclofenac formulation. Patients were randomly assigned into two groups: one group received treatment with a combination of diclofenac potassium 3% (10 mg/g, 60 g) and propolis 5% gel (Group II), and the other group received a placebo (Group 1). The patient was evaluated using standard digital photographs and chronic oral mucosal questionnaires on days 1, 3, 5, and 7 after healing. Utilizing the Mann-Whitney U test, the two groups were compared. Each group’s changes were examined using Friedman’s test. Results: There was a statistically dramatic change over time in Group II. After one day, the median total score dropped statistically significantly, and from one to three days with effect size (d) 2.485, Group II demonstrated 48% complete healing and 52% partial healing, while Group I demonstrated 4% partial healing and 96% no change. Effect size (V): 0.995. Conclusions: The combination of diclofenac and propolis provided instant relief and an affordable new regimen for treating oral aphthosis.
文摘The main purpose of this study is to prepare highly stable diclofenac potassium(DP)pellet with microcrystalline cellulose(MCC)by extrusionespheronization.Using MCC,DP pellets were prepared and the stability was investigated.Related compounds of DP pellets were analyzed by High Pressure Liquid Chromatography(HPLC).After stability test of 60℃/75%RH for 10 d,the values of two main related compounds were 0.94%and 2.17%,respectively.Compatibility tests show that instability of DP was mainly caused by MCC.To improve the stability of DP in presence of MCC,different kinds of stabilizers were investigated.Upon addition of 1.5%(w/w)sodium hydroxide,the primary related compound of pellets was reduced to be 0.159%after stability test of 60℃/75%RH for 50 d.This study demonstrated that MCC induced decomposition of DP upon exposure to moisture could be prohibited by addition of sodium hydroxide.The mechanisms were discussed and residual hydroxyl free radicals in excipients were responsible for decomposition of DP.Finally,this formulation of DP is highly stable with sustained-release behavior.
文摘Two different salts of diclofenac,diclofenac sodium and diclofenac potassium,in tablet dosage form were tested for their bioavailability and disposition kinetics in a group of eighteen rabbits in normal and experimentally induced dehydrated conditions with a wash out period of 7 days between both stages of study.Biochemical and physiological parameters were also measured in both normal and dehydrated states.Diclofenac levels in plasma were determined using a validated reversed phase HPLC method.Primary kinetic parameters i.e.AUC0-∞,Cmax,Tmax and other disposition kinetics were obtained with non-compartmental procedure.Biochemical parameters i.e.packed cell volume,plasma glucose and total lipid concentration in dehydrated rabbits increased significantly.Plasma concentration of diclofenac sodium and diclofenac potassium decreased significantly in water deprived rabbits.In comparison,diclofenac potassium in normal and dehydrated state of the same group of rabbits showed a significantly increased plasma concentration when compared with diclofenac sodium.
文摘目的优化双氯芬酸钾口腔黏附片处方。方法采用32满因子设计试验考察因素A(卡波姆和羟丙甲基纤维素的总量在处方中所占的比例)和因素B(卡波姆与羟丙甲基纤维素的质量比)对黏附时间和体外30、180、480 m in的累积释放度的影响,试验数据分别采用线性方程和二次多项式拟合,根据最佳数学模型绘制效应面和等高线图,通过重叠等高线图确定最优处方。结果2个影响因素和4个评价指标之间存在定量关系,最优处方:卡波姆和羟丙甲基纤维素的总量在处方中占30%,卡波姆与羟丙甲基纤维素的质量比为0.75∶1。优化处方各指标的预测值和目标值较接近。结论采用因子设计-重叠等高线图法完成了双氯芬酸钾口腔黏附片的多目标同步优化。
