Comparative analysis of fractional CO 2 laser, focused ultrasound and simple drug treatment of gynecological vulva white lesions / 中国医师杂志

Objective:To investigate the effects of fractional CO 2 laser, focused ultrasound and simple drug treatment of gynecological vulva white lesions. Methods:A prospective study was conducted on 126 patients with white lesions of the vulva admitted to Hainan Cancer Hospital from August 2018 to December 2020. They were divided into drug group, focused ultrasound group and fractional CO 2 laser group by random number table method, with 42 patients in each group. The drug group was treated with mometasone furoate cream or dexamethasone acetate cream, and the focused ultrasound group was treated with focused ultrasound; the fractional CO 2 laser group was treated with fractional CO 2 laser. The serum interleukin-2 (IL-2), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and human epidermal growth factor (EGF) levels before and after treatment, and Visual Analogue Scale (VAS) and Dermatology Life Quality Index (DLQI) scores of the three groups were compared. Results:Before treatment, there was no significant difference in the levels of IL-2, TNF-α, CRP and EGF among the three groups (all P>0.05). After treatment, the levels of IL-2, TNF-α, CRP and EGF in the three groups were significantly decreased, and the levels of IL-2, TNF-α, CRP and EGF in the focused ultrasound group and fractional CO 2 laser group were lower than those in the drug group, with statistically significant difference (all P<0.05). Before treatment, there was no significant difference in the white lesions, dry pruritus, sexual pain and chapped skin scores of the three groups (all P>0.05); After treatment, scores of all dimensions of the three groups were significantly decreased, and scores of all dimensions of the focused ultrasound group and fractional CO 2 laser were lower than those of the drug group, with statistical significance (all P<0.05). Before treatment, there was no significant difference in the scores of symptoms and feelings, daily activities and interpersonal relationship of the three groups (all P>0.05); After treatment, scores of all dimensions of the three groups were significantly decreased, and scores of all dimensions of the focused ultrasound group and fractional CO 2 laser were lower than those of the drug group, with statistical significance (all P<0.05). Conclusions:Fractional CO 2 laser has a remarkable effect in the treatment of gynecological vulva white lesions, which can reduce the level of inflammatory factors in patients, improve the pain condition, and improve the quality of life.

Study on bioequivalence evaluation of dexamethasone acetate tablets in Chinese healthy volunteers / 中国临床药理学与治疗学

AIM: To assess the bioequivalence of oral dexamethasone acetate tablets between the test and reference formulations in healthy adult Chinese subjects on an empty stomach and after meals. METHODS: A randomized, open, single-dose, two-cycle double crossover bioequivalence study was followed. Twenty-four healthy subjects were included in the fasting group, and 32 healthy subjects were included in the postprandial group, taking 2 tablets (0.75 mg/tablet) of the test formulation (T) or 3 tablets (0.50 mg/tablet) of the reference formulation (R) per cycle for two cycles. The concentrations of dexamethasone acetate in human plasma were determined using liquid chromatography-mass spectrometry, and the pharmacokinetic parameters were calculated according to the non-atrial model using WinNonlin 8.0 software.The bioequivalence of both the test formulation and the reference formulation was evaluated. RESULTS: The pharmacokinetic parameters after oral administration of dexamethasone acetate tablets in a fasted state in subjects with the reference formulation are as follows: Tmax 1.13 (0.50, 4.00) and 1.00 (0.50, 5.00) h, AUC0-t (72.25±21.55) and (69.23±17.76) ng · mL

Simultaneous determination of dexamethasone acetate , camphor and phenol in compound cream by HPLC method / 药学实践杂志

Objective To establish a HPLC method for simultaneously determining the content of dexamethasone ace-tate ,camphor and phenol in compound cream .Methods The separation was performed on a SHIADZU-GL Inertsil? ODS-3 RP C18 analytical column with the mobile phase consisting of methanol-water (60:40) .The flow rate was 1 .0 ml/min .The detection wave length was 285 nm and the column temperature was 40 ℃ .Results Dexamethasone acetate ,camphor and phe-nol showed good linearity (r> 0 .9995 , n= 7) within the concentration range of 4 .024-40 .24 ,101 .7-2033 and 10 .38-425 .2 μg/ml ,respectively . The average recovery of dexamethasone acetate ,camphor and phenol was 101 .2％ (RSD was 0.56％ ) ,99 .89％ (RSD was 0 .72％ ) ,100 .2％ (RSD was 0 .97％ ) ,respectively .Moreover ,the RSDs were less than 1 .5％ in the repeated tests .Conclusion The method was simple ,quick and accurate .It is suitable for the quality control of dexametha-sone acetate camphor and phenol cream .

Dexamethasone acetate microemulsions: formulation and effect on skin permeability / 药学学报

The present project was designed to optimize the microemulsion (ME) formulation of oil in water (O/W) for dexamethasone acetate (DA), and examine its impact on DA percutaneous permeation. The saturated solubility of DA in different oils, surfactants and co-surfactants was tested. The ratio of surfactant to co-surfactant was selected by constructing pseudo three phase diagrams to investigate the maximal microemulsion area. In vitro permeation studies of DA from microemulsion and suspension were performed to optimize the formulation further. Differential scanning calorimetry (DSC) and attenuated total reflection flourier transformed infrared spectroscopy (ATR-FTIR) were performed to investigate the mechanism of microemulsion action on skin. The optimized formulation was composed of oleic acid/Labrasol/propylene glycol/water with 8/45/15/32(w/w), and the DA loading was 0.75% (w/w). The permeation enhancement of microemusion was 6.00-fold as that of suspension, and the DA from microemulsion retained in the skin was 4.79-fold as that of suspension. DSC and ATR-FTIR results suggested that microemulsion could affect the intercellular lipid lamellae and keratin of the stratum corneum. The barrier function of stratum corneum was disordered by the microemulsion so that the dermal drug delivery was enhanced. Therefore, the optimized microemulsion enhanced DA percutaneous permeation significantly through the interaction of microemulsion with skin, microemulsion is a promising approach for DA percutaneous delivery.

Determination of the antibacterial agent content of compound dexamethasone acetate cream and its antibacterial effect evaluation / 中国生化药物杂志

Objective To establish a HPLC method to determine the antiseptics in compound dexamethasone acetate cream and evaluate the usage rationality of antimicrobial preservatives. Methods The content of ethyl hydroxybenzoate was calculated by external standard with HPLC.The effectiveness of antimicrobial preservatives was measured according to the preservative effectiveness test in ChP(2015edition) by inoculating 5 kinds of test microorganisms including Pseudomonas aeruginosa,Escherichia coli,Staphylococcusaureus,Candida albicans and Aspergillusniger.Results The linear ranges of ethyl hydroxybenzoate was 6.63-132.6 μg/mL ( r =0.999 7 ) .The average recoveries was 99.2%.The samples from different batche had different antimicrobial effectiveness due to the content of ethyl hydroxybenzoate.Conclusion The described method can be used in the determination of the preservatives of ethyl hydroxybenzoate in compound dexamethasone acetate cream.At present the use of antibacterial agent is arbitrary, it is necessary to strengthen research and supervision.

Dermatopharmacokinetics of different formulation and preparation of dexamethasone acetate creams in nude mouse / 中国药学杂志

OBJECTIVE: To study the dermatopharmacokinetics of dexamethasone acetate by administering three different formulation and preparationcreams on skin of nude mouse and discuss the application prospect of the method. METHODS: At 0, 0.25, 0.75, 1.75, 3, 5, 8, 12, 24 h after administered dexamethasone acetate cream about 0.025 g on the back of the nude mice, the excess formulation was gently removed. Then mice were sacrificed at the chosen contact time points. Skin samples were immediately excised from the fixed area of skin and weighed. Both compounds were precipitated from skin homogenate with methanol. The concentrations of dexamethasone acetate in skin were analyzed by using LC-ESI-MS method. The pharmacokinetics parameters were calculated and the percutaneous absorption process in skin of nude mouse was evaluated. RESULTS: This determination method does not interfere with endogenous substances. Calibration curves were linear over the range of 0.052 4-5.24 μg · mL-1. The mean recovery was in the ranges of 89.95%-95.97%. The intra-run relative standard deviations were less than 15%. All the results showed there were no stability related problems during the samples' routine analysis. DMSO can increase the AUC value of dexamethasone acetate, coarse granularity and crystal of cream may decrease the AUC value of dexamethasone acetate. CONCLUSION: This method is fast, sensitive, accurate with good recovery, reproducibility and low detection limited, which can be successfully applied to determine the concentration of dexamethasone acetate in skin and study the dermatopharmacokinetics of nude mouse. This in vivo time-share sampling method can be used in preclinical evaluation and screening the dermatopharmacokinetics of topical drugs.

Determination of dexamethasone acetate in Kelaweiding liniment by HPLC / 药学实践杂志

Objective To establish the quantitative determination method of dexamethasone acetate in Kelaweiding lini‐ment by HPLC .Methods Column:Diamonsil‐C18 (150 mm × 4 .6 mm ,5 μm) ,mobile phase:methanol‐water‐glacialaceticacid (80:20:0 .5) ,flow rate:1 .0 ml/min ,UV detection wavelength:240 nm ,injection volume :20 μl ,column temperature:30 ℃ . Results The standard curve was linear within the range of 2 .00‐64 .00μg/ml ,linear equation was Y=0 .405 2X+0 .804 2(r=0 .999 9) .The average recovery was 99 .3% with RSD 0 .93% (n=9) .Conclusion This method was simple ,stable and could be used to assay dexamethasone acetate in Kelaweiding liniment .

Pharmacodynamic and Pharmacokinetic Studies of β-Cyclodextrin:Dexamethasone Acetate Complexes in Mice

The aim of this study was to evaluate the in vivo activity of the anti-inflammatory and analgesic effects of a suspension of the complex composed of dexamethasone acetate (DMA) with β-cyclodextrin in comparison to a suspension of the pure DMA. Solid complexes prepared by different methods were evaluated in pharmacodynamics and pharmacokinetics studies. The pharmacodynamic effect was investigated although the capacity of the inhibited the inflammation. Models of abdominal constriction, carrageenan-induced paw oedema and formalin induced licking were used. The study of the pharmacodynamic comparison of free DMA and products of β-CD:DMA demonstrated no significant difference in the majority of the tests performed. Plasma concentrations of DMA and DMA:β-CD were assayed by HPLC. A significant (p > 0.05) decrease in the relative bioavailability was obtained with the suspension containing the DMA:β-CD complex as measured by DMA plasma levels. The area under the curve (AUC) of the suspension of DMA was higher than that obtained with the suspension of the complexes. The pharmacokinetic evaluation of dexamethasone carried out on mice in the present study showed that complexed DMA with β-cyclodextrin modifieds some parameters related to the phases of absorption and elimination of this drug.

Determination of Methoxsalen and Dexamethasone Acetate in Compound Methoxsalen Lotions by HPLC / 中国药师

Objective:To establish an HPLC method for the determination of methoxsalen and dexamethasone acetate in compound methoxsalen lotions. Methods:An HPLC method was used. The determination was performed on a Sunfire C18 (250 mm × 4. 6 mm,5μm ) column with the mobile phase of acetonitrile-water ( 60∶40 ) at the flow rate of 1. 0 ml·min-1 . The column temperature was kept at 30℃, the detection wavelength was set at 240nm and the injection volume was 20μl. Results:Methoxsalen and dexamethasone acetate showed good linear relationship within the range of 12.71-101.68 mg·L-1(r=0.999 9) and 10.03-80.25 mg·L-1(r=0. 999 7) with the average recovery of 99. 32%(RSD=0. 11%, n=9 ) and 99. 63%(RSD=0. 20%,n=9) , respectively. Conclu-sion:The method is simple, accurate and repeatable, and suitable for the determination of methoxsalen and dexamethasone acetate in compound methoxsalen lotions.

Simultaneous Content Determination of Gatifloxacin Dexamethasone Acetate Ear Drops by HPLC / 中国药师

Objective:To developed an HPLC method for the simultaneous content determination of gatifloxacin dexamethasone ac-etate ear drops. Methods:The promising chromatographic separation was achieved on a Phenomenex C18 (250 mm × 4. 6 mm, 5 μm) column. Using gradient elution method, the optimized mobile phase consisted of methanol as the solvent A, and 0. 05% triethylamine solution (adjusting pH to 3. 0 with acetic acid) as the solvent B. The flow rate was 1. 0 ml·min-1, the column temperature was 30℃and the UV detection was carried out at 240 nm. Results: The compounds were separated well, the linearity between the peak areas and the concentrations was observed within the range of 1. 2-60. 0 mg·L-1 for gatifloxacin, and 0. 8-40. 0 mg·L-1 for dexamethasone acetate. The mean recovery of gatifloxacin and dexamethasone acetate was 101. 31% ( RSD =1. 17%) and 99. 71% ( RSD =1. 01%) , respectively. Conclusion: The method is specific and stable in the determination of gatifloxacin dexamethasone acetate ear drops.

Development and validation of HPLC method for analysis of dexamethasone acetate in microemulsions / Desenvolvimento e validação de método de HPLC para análise de acetato de dexametasona em microemulsões

A simple, rapid, accurate and sensitive method was developed for quantitative analysis of dexamethasone acetate in microemulsions using high performance liquid chromatography (HPLC) with UV detection. The chromatography parameters were stainless steel Lichrospher 100 RP-18 column (250 mm x 4 mm i.d., 5 μm particle size), at 30 ± 2 ºC. The isocratic mobile phase was methanol:water (65:35; v/v) at a flow rate of at 1.0 mL.min-1. The determinations were performed using UV-Vis detector set at 239 nm. Samples were prepared with methanol and the volume injected was 20 μL. The analytical curve was linear (r² 0.9995) over a wide concentration range (2.0-30.0 μg.mL-1). The presence of components of the microemulsion did not interfere in the results of the analysis. The method showed adequate precision, with a relative standard deviation (RSD) smaller than 3 percent. The accuracy was analyzed by adding a standard drug and good recovery values were obtained for all drug concentrations used. The HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for quantification of dexamethasone in microemulsions. The analytical procedure is reliable and offers advantages in terms of speed and low cost of reagents.

Um método simples, rápido, preciso e sensível foi desenvolvido para a análise quantitativa de acetato de dexametasona em microemulsões usando cromatografia líquida de alta eficiência (CLAE). Os parâmetros cromatográficos foram: coluna cromatográfica Lichrospher 100 RP-18, (250 mm x 4 mm i.d., 5 μm partícula tamanho), com temperatura de coluna de 30 ± 2 ºC. A fase móvel foi composta de metanol: água (65:35; v/v) com fluxo isocrático de 1 mL.min-1 e volume de injeção de 20 μL. As determinações foram realizadas utilizando detector UV-Vis no comprimento de onda de 239 nm. A curva analítica mostrou-se linear (r² 0,999) em uma ampla faixa de concentração (2,0-30,0 μg.mL-1). A presença de componentes da microemulsão não interferiu nos resultados da análise. O método mostrou precisão adequada, com desvio padrão relativo menor que 3 por cento. A exatidão foi analisada pela adição de padrões do fármaco e valores de recuperação dentro dos limites recomendáveis foram obtidos para todas as concentrações estudadas. O método por CLAE mostrou especificidade e seletividade com linearidade dentro da faixa de concentração utilizada e precisão e exatidão que tornam o método adequado para a análise de dexametasona em microemulsões. O procedimento analítico é fidedigno e oferece vantagens em termos de velocidade e custo de reativos.

Simultaneous Determination of Sulfadiazine and Dexamethasone Acetate in Compound Nasal Ointment by HPLC / 中国药房

OBJECTIVE: To establish an HPLC method for simultaneous determination of the content of sulfadiazine and dexamethasone acetate in compound nasal ointment.METHODS: The determination was performed on Inertsil C8-3 column with column temperature set at 40 ℃;the mobile phase consisted of methanol-acetonitrile-water(72∶3∶25) with a flow rate of 1.0 mL?min-1.The detective wavelength was set at 240 nm and the sample size was 20 ?L.RESULTS: The linear ranges for sulfadiazine and dexamethasone acetate were 74.65～746.5(r=0.999 9) and 1.495～14.95 ?g?mL-1(r=0.999 7),respectively.The average recoveries were 100.72%(RSD=1.7%) and 100.41%(RSD=1.6%),respectively.CONCLUSION: This method is rapid,simple,accurate and reliable and suitable for the determination of the content of sulfadiazine and dexamethasone acetate in compound nasal ointment.

Determination of Dexamethasone Acetate in Compound Tretinoin Ointment by RP-HPLC / 中国药房

OBJECTIVE: To develop a method for determination of the content of Dexamethasone acetate in Compound tretinoin ointment by RP-HPLC. METHODS: The separation was performed on C18 column with methanol: water (70∶30) as a mobile phase, wavelength of UV detector at 240nm. RESULTS: The linear range of Dexamethasone acetate was within 0.028 3～0.849 0?g(r=0.999 9). The average recovery of Dexamethasone acetate was 101.13%, with RSD at 1.28%. CONCLUSION: The method is simple, rapid and capable of producing good separation results. It can be applied to the quality control of Compound tretinoin ointment.

Simultaneous Content Determination of Metronidazole,Tetracaine Hydrochloride and Dexamethasone Acetate in Metronidazole Compound Powder by HPLC / 中国药房

OBJECTIVE:To establish HPLC method for the simultaneous content determination of metronidazole,tetra-caine hydrochloride and dexamethasone acetate in metronidazole compound.METHODS:The content determination was per-formed on column C 18 ;the mobile phase consisted methanol-water-triethylamine(65∶35∶0.36),the detection wavelength of both metronidazole and tetracaine hydrochloride was310nm,and240nm for dexamethasone acetate,the flow rate was1ml/min and the column temperature was25℃.RESULTS:The linear ranges of metronidazole,tetracaine hydrochloride and dexameth_ asone acetate were0.412?g～2.06?g(r=0.9999),0.191?g～0.956?g(r=0.9999)and0.121?g～0.604?g(r=0.9998),respectively,and their average recoveries were100.69%(RSD=1.28%),101.37%(RSD=0.23%)and102.40%(RSD=0.89%),respectively.CONCLUSION:The method was simple,accurate,reproducible,and suitable for the quality control of metronidazole compound.

Content Determination of Compound Ofloxacin Ear Drops by HPLC Simultaneously / 中国药房

OBJECTIVE:To develop a HPLC method for simultaneous determinatio n of ofloxacin and dexamethasone ac?etate in compound ofloxacin ear drops.METHODS:The analysis was carried on a XDB-C 8 ,the mobile phase was composed of methanol-potassium dihydrogen phosphate(0.02mol/L)by gradient elution,the flow rate was1.0ml/min,the column tem?perature was30℃and the detection wavelength was at240nm.RESULTS:The detectable concentrations of ofloxacin and dexamethasone acetate showed good linear correlation in the ranges of100～500?g/ml and10～30?g/ml respectively,the av?erage recoveries of ofloxacin and dexamethasone acetate were100.6%(RSD=0.46%,n=9)and101.3%(RSD=0.72%,n=9)respectively.CONCLUSION:The method is accurate and reproducible and can be used for determination of ofloxacin and dexamethasone acetate in compound ofloxacin ear drops.

Simultaneous Determination of Chloromycetin and Dexamethasone Acetate in Jiefu Cream by HPLC / 中国药房

OBJECTIVE:To determine the contents of chloromycetin and dexamethasone acetate in Jiefu cream.METHODS:A reversed-phase HPLC was established for the determination with C18 column as stationary phase.The mobile phase consisted of acetonitrile and 0.05%mol/L phosphate buffer solution(40∶60),the detection wavelength was 240nm.RESULTS:Chlorom-ycetin had a good linearity (r=0.9 998) in the range of 0.1～0.3mg/ml,the mean recovery was 100.6% with a RSD of 1.3%.Dexamethasone acetate had a good linearity(r=0.9 998) in the range of 0.02～0.08mg/ml,the mean recovery was 101.1% with a RSD of 1.7%.CONCLUSION:The method is simple,sensitive and accurate.

Theophylline,prednisone acetate and dexamethasone acetate illegally mixed into traditional Chinese medicinal preparation for antitussive and antiasthmastics by UPLC-MS / 中成药

AIM: To establish a quick,accurate,sensitive method for analysis of theophylline,prednisone acetate and dexamethasone acetate illegally added into traditional Chinese medicinal preparation for antitussive and antiasthmastics by UPLC-MS. METHODS: The UPLC-MS/MS method was used.Electrospay ionization(ESI) source was applied and operated in the positive and negative ion mode.Theophylline,prednisone acetate and dexamethasone acetate illegally added into traditional Chinese medicinal preparations were identified. RESULTS: Both theophylline and prednisone acetate were found in formulations. CONCLUSION: The method is selective and sensitive and can be used to detect the theophylline,prednisone acetate and dexamethasone acetate illegally added into traditional Chinese medicinal preparations.

Simultaneous determination of camphor and menthol in Compound Dexamethasone Acetate Cream by GC / 中成药

AIM: To establish the capillary GC method for separating and determining both camphor and menthol in Compound Dexamethasone Acetate Cream. METHODS: The methyl salicylate was used as internal substance and the sample solution was prepared by extracting with anhydrous ethanol at(60 ?C.) The GC test conditions consisted of Agilent HP-INNOWAX(30 m?0.320 mm?0.25 ?m) as the stationary phase,nitrogen as the carrier gas,split ratio of 25.0(∶)1.The flow rate was 1.5 mL/min,column temperature was at 145?C,inlet temperature was(200 ?C),FID detection was(250 ?C),injection volume was 0.6 ?L. RESULTS: The linearities of camphor and menthol were good,in the range of 0.303-3.030 g/L with r=0.999 9 for camphor and in the range (0.306)-(3.060) g/L with r=0.999 9 for menthol.The average recoveries of high,middle and low three concentrations for menthol were 100.6%,100.2%, 99.7%;RSD was 0.58%,0.65%,0.88% and for camphor were 100.3%,(99.8%),(97.8%);RSD was 0.43%,0.78%,1.0%. CONCLUSION: This method is convenient,rapid,accurate and reproducible,and can be used for quality control of Compound Dexamethasone Acetate Cream.

Preparation and Quality Control of Dexamethasone Acetate Borneol Cream / 中国药房

OBJECTIVE:To prepare dexamethasone acetate borneol cream and to establish its quality control method.METHODS:Dexamethasone acetate borneol cream was prepared by grinding method;dexamethasone acetate and phenol were identified by TLC,and the content of the principal agent was determined by ultraviolet spectrophotometry.RESULTS:The prepared cream fitted the description of China Pharmacopeia(2005 edition) in identification and tests etc.The linear range of dexamethasone acetate was 12.06～28.14 ?g?mL-1(r=0.999 7),and the average recovery rate of 98.52%(RSD=0.66%).CONCLUSION:The preparation is reasonable in compounding,simple and feasible in techniques,and its quality is stable and controllable.

Preparation and Quality Control of Dibing Gel / 中国药房

OBJECTIVE:To prepare Dibing gel and establish its quality control method.METHODS:The0.5%Carbopol940was taken as the base of gel.The content of dexamethasone acetate was determined by HPLC.The stability and the skin irritation test were studied,too.RESULTS:The calibration curve of dexamethasone acetate was linear in the range of20～120?g/ml.The average recovery of dexamethasone acetate was101.1%,RSD=0.92%.The preparation was stable and had no irritation to skin.CONCLUSION:The gel was resonable in formulation,convenient in preparation technique,and simple and accurate in method of quality control.