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Abstract The present study is aimed to formulate steroidal oral mucoadhesive gels of dexamethasone sodium phosphate and betamethasone sodium phosphate. Six gel formulations each of dexamethasone sodium phosphate and betamethasone sodium phosphate prepared using two different polymers carboxymethyl cellulose sodium and hydroxypropyl methylcellulose, in variable proportions. All the formulations subjected for assessment of various physicochemical parameters and mechanical properties. The formulations BSP5 and DSP5, both containing 1.25 % carboxymethyl cellulose sodium, 1.25 % hydroxypropyl methylcellulose, exhibiting mucoadhesive strength of 12.300 ± 0.004 and 12.600 ± 0.01, adhesiveness of 28.04 ± 00 and 30.02 ± 00, cohesiveness of 28.04 ± 00 and 30.02 ± 00, drug release of 86.869 ± 0.380 % and 88.473 ± 0.457 % respectively were considered as promising ones and were further subjected for stability studies and in vivo study in male albino rats. Formulation DSP5 upon oral application for 4 months in arecoline induced oral submucous fibrosis rats, showed more than 80 % reduction in fibrosis as compared with BSP5 which showed nearly 50 % reduction. These results were concluded on the basis of histopathological profile and weight gain among the experimental animals during in vivo study. Hence, DSP5 by minimizing the painful injuries and morbidities justifies being suitable noninvasive model for OSMF treatment.
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Animais , Masculino , Ratos , Fibrose Oral Submucosa/tratamento farmacológico , Betametasona/análise , Dexametasona/análise , Físico-Química/classificação , Benchmarking/métodos , Géis/classificação , Adesividade , Liberação Controlada de FármacosRESUMO
Objective To investigate the extraction methods for active components from oral ulcer film and optimize the determination methods of active components dexamethasone sodium phosphate and metronazole. Methods Different extraction solvents(methanol, water and 70% methanol aqueous) were applied to extract the active components dexamethasone sodium phosphate and metronazole from oral ulcer film, which contents were quantified by a HPLC method. Results the extraction solvent water had the best efficacy and more simpler compared to the other two solvents. Clotriazole showed a good linear relationship within 5.014 5-200.5800 μg/ml (r=0.999 8), and the average extraction recovery was (104.23±0.63)%, and for dexamethasone sodium phosphate, a good linear relationship was obtained in the range of 0.482-16.328 μg/ml (r=0.9999), and the average extraction recovery was (103.97±1.02)%. Conclusion The water extraction method established in this study was simple and efficient, which showed features of simplicity, accuracy and repeatable.
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OBJECTIVE:To provide reference for promoting the rational use of Dexamethasone sodium phosphate injection in the clinic. METHODS:Special comment criteria and evaluation rules was formulated,medical records of 1273 inpatients receiving Dexamethasone sodium phosphate injection were collected from our hospital during Jul. 2014-Jun. 2015. Rationality of drug use was evaluated and analyzed retrospectively. RESULTS:The most use amount and case number of Dexamethasone sodium phosphate injection were in the departments of blood/oncology,obstetrics,emergency minimally invasive surgery,gastrointestinal surgery,emergency trauma of orthopedics and thyroid breast surgery;while much less were in departments of new pediatrics, infection and rehabilitation. There were 138 cases of irrational use of Dexamethasone sodium phosphate injection found in special comment, and the total irrational use rate was 10.84％ . The types of irrational use included inappropriate indication (contraindication,59.42％),inappropriate drug combination(18.84％),inappropriate drug selection (15.94％),inappropriate usage and dosage(3.62％)and inappropriate drug dosage forms or drug delivery methods(2.17％),etc. The irrational use rate of Dexamethasone sodium phosphate injection monthly declined steadily by month from 30.35％ in Jul. 2014 to 7.81％ in Jun. 2015 through the special comment;then a consensus of 5 points for the drug use formed in our hospital. CONCLUSIONS:There are irrational situations in the clinical use of Dexamethasone sodium phosphate injection in our hospital,especially in the cases of inappropriate indications. The rationality of the drug can be improved by the development of the special comment. This work should continue to be carried out in the future and perfected.
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Objective To study the clinical significance of dexamethasone (DT) in the combined spinal and epidural anesthesia for delivery of elderly parturient women. Methods 134 elderly parturient women were selected as the research object, and randomly divided into two groups. 69 cases in DT group received intramuscular injection of dexamethasone and combined anesthesia, while 65 cases in INN group received intramuscular injection of tramadol (INN) and combined spinal and epidural anesthesia. The anesthetic effect of the two groups were observed. Results After treatment, the interleukin (IL-6), myeloperoxidase (MPO), tumor necrosis factor-α (TNF-α) and methane dicarboxylic aldehyde (MDA) in DT group were significantly higher than INN group (P<0.05). The five kinds of immunoglobulins levels (IgA, IgD, IgE, IgG and IgM) in DT group were higher than those in INN group (P<0.05). The heart rate (HR) in DT group was lower and mean arterial pressure (MAP) was higher than that in INN group(P<0.05). There was 1 cases of macrosomia, 2 cases of premature delivery in DT group, the adverse pregnancy outcomes was 4.35%(3/69). there was 1 cases of macrosomia, 1 cases of congenital deformity, 1 cases of premature delivery and 1 case of postterm delivery in DT group, the adverse pregnancy outcomes was 5.80%(4/69), with no significant difference between two groups. Conclusion Dexamethasone combined with anesthesia is very effective for delivery of elderly parturient women which shows very good anti-inflammatory and immunoregulation.
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OBJECTIVE:To establish a method for the simultaneous determination of ornidazole and dexamethasone sodium phosphate in Compound ornidazole film. METHODS:HPLC was performed on the column of Inertsil ODS-3 with mobile phase of methanol-20 mmol/L phosphate buffer(pH was adjusted to 7.40 with glacial acetic acid)(55∶45,V/V)at a flow rate of 1.0 ml/min, column temperature was 30 ℃,detection wavelength was 242 nm and volume injection was 10 μl. RESULTS:The linear range were 1-100μg/ml for both ornidazole(r=0.999 7)and dexamethasone sodium phosphate(r=0.999 9);RSDs of precision,stabili-ty and reproducibility tests were lower than 2.0%;recoveries were 96.50%-99.80%(RSD=1.02%,n=9) and 96.50%-99.60%(RSD=0.99%,n=9). CONCLUSIONS:The method is specific with good precision and stability and high accuracy,and can be used for the simultaneous determination of ornidazole and dexamethasone sodium phosphate in Compound ornidazole film.
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OBJECTIVE: To investigate the compatibility of dexamethasone sodium phosphate injection and ondansetron hydrochloride injection. METHODS: The dexamethasone sodium phosphate injection and ondansetron hydrochloride injection were dissolved with 5% glucose injection and 0.9% sodium chloride injection respectively at commonly used concentrations in clinic. The contents of dexamethasone sodium phosphate and ondansetron hydrochloride were determined by HPLC at 0, 3, 6, and 24 h after the preparation of solution. Meanwhile, the pH and number of indiscerptible particles in these solutions were also determined. RESULTS :The mixtures of the two drugs were highly stable within 24 h, without obvious change in pH and color. The numbers of insoluble particles greater than 10 and 25 μm were acceptable. CONCLUSION: Dexamethasone sodium phosphate injection is compatible with ondansetron hydrochloride injection.
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Objective To investigate the compatibility of Shuanghuanglian Injection mixed with Cefazolin Sodium for Injection, Dexamethasone Sodium Phosphate Injection and Ribavirin Injection. Methods Under room temperature, the changes of appearance were determined by pH meter and particle counter for Shuanghuanglian Injection mixed with Cefazolin Sodium for Injection, Dexamethasone Sodium Phosphate Injection and Ribavirin Injection. Results There were no evident changes in appearance and pH of Shuanghuanglian Injection mixed with Cefazolin Sodium for Injection, Dexamethasone Sodium Phosphate Injection and Ribavirin Injection. The number of particles (diameter≥25 μm) of Shuanghuanglian Injection mixed with Cefazolin Sodium for Injection and Dexamethasone Sodium Phosphate Injection was increased after 0.5 h. Conclusion Shuanghuanglian Injection can be mixed with Cefazolin Sodium for Injection, Dexamethasone Sodium Phosphate Injection and Ribavirin Injection for bigeminy, while should not for multitherapy.
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Objective To study the stability of Qingkailing injection, Qingkailing and dexamethasone sodium phosphate injection in compatibility of 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, glucose and sodium chloride injection. Methods Such changes as appearance, pH, and insoluble particulate were observed at the room temperature after mixing together of the Qing Kai Ling Injection, Qingkailing and dexamethasone sodium phosphate injection with 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, glucose and sodium chloride injection. Results Dexamethasone sodium phosphate did not affect the stability of the Qingkailing. The PH value of Qingkailing stayed at 6.4～7.0 after being mixed with four kinds of solutions. The compatibility solutions had no significant change in appearance, met to the requirements of the Chinese Pharmacopoeia insoluble particle detection specification Conclusion Qing Kai Ling Injection, Qing Kai Ling and dexamethasone sodium phosphate injection can be used together with solvent compatibility of 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, glucose and sodium chloride injection within 8 h.
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We evaluated the use of a combination of vitamins B1, B6, and B12 with dexamethasone in the treatment of the signs and symptoms of inflammatory neuropathy of the upper and lower limbs, in an open-label clinical trial. Patients were submitted to a 9-day treatment period with three doses of study medication at three day intervals, and a series of clinical and laboratory assessments, prior to the first dose of study medication and at each of the following three visits to the study center. Efficacy evaluations at each study visit included a 100mm VAS pain scale and global and satisfaction surveys completed by the patient and the investigating physician. Safety evaluations included a comparison of changes in laboratory evaluations at each visit and the incidence, severity, duration, and outcome of adverse events. A total of sixty-one patients were enrolled in the trial. A clinically significant improvement in all of the efficacy measures was observed from the pre-treatment to end-of-study evaluations. No clinically significant alterations in clinical assessments were observed during the treatment period. Based on the results of this clinical study, we conclude that the combination of dexamethasone with the B-vitamins is safe and effective in the treatment of the signs and symptoms of inflammatory neuropathy.
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OBJECTIVE:To establish a HPLC method for the simultaneously determination of three components in Bikeling nasal spray. METHODS: The column we used was Hypersil ODS and the mobile phase was 0.1%mtriethylamine(adjust pH3.2 with phosphate acid)-acetonitrile (75∶25). The detective wavelength was 256nm and the sample size was 10?L. RESULTS: The linear rangs of ofloxacin, ephedrine hydrochloride and dexamethasone sodium phosphate were 32～320?g?mL-1(r=0.999 9),64～640?g?mL-1(r=1.000 0) and 4～40?g?mL-1(r=1.000 0)respectively, and the average recoveries were 100.05%(RSD=0.32%), 100.17%(RSD=0.48%) and 99.85%(RSD=1.67%),respectively. CONCLUSION: The method was simple and accurate and can be used for the quality control of Bikeling nasal spray
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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 ℃.
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OBJECTIVE: To establish a RP-HPLC method for the simultaneous determination of chloramphenical,dexamethsone sodium phosphate and deoxyepinephrine in luxindi eye drops.METHODS: The determination was performed on Kromasil C18 column and the mobile phase consisted of methanol-water(containing 0.2% triethylamine and 0.15% octane sulfonic acid sodium,pH was adjusted to 3.8 with phosphoric acid,40∶60) with flow rate at 1.0 mL?min-1.The detective wavelength was set at 230 nm;the sample size was 20 ?L and the column temperature was set at room temperature.RESULTS: The linear ranges of chlormphenical,dexamethasone sodium phosphate and deoxyepinephrine were 125～1 000(r=0.999 3),25～200(r=0.999 6) and 12.5～100(r=0.999 2) mg?L-1,respectively,with the average recoveries rate at 99.53%,100.0% and 99.24%,and RSD at 0.51%,0.90% and 0.72%,respectively.CONCLUSIONS: This method is simple,rapid and accurate,and it is applicable for the content determination of this preparation.
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OBJECTIVE:To prepare compound ofloxacin gel and to establish its quality control method.METHODS:Ofloxacin was used as principal agent to be mixed with dexamethasone sodium phosphate,carbomer 940 was taken as base material,the content of ofloxacin and dexamethasone were determined by HPLC method.RESULTS:The linear detection concentration ranges of ofloxacin and dexamethasone were 20～300?g/ml and 5～50?g/ml,respectively,the average recovery rates of which were (99.8?0.5)%(RSD=0.84%)and (100.6?0.8)%(RSD=0.87%),respectively.CONCLUSION:The preparation is stable in quality,the prepare technique is simple and the quality control is reliable.
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Objective To investigate the release feature of dexamethasone sodium phosphate from thermosensitive in situ gels in vitro. Methods Rotation rheometer was used to measure the changes of viscosity with temperature. The membraneless model was applied in assessing corrosion behavior of gel using a thermostatic shaker (50 r/min) at an amplitude of 2.5 cm, taking phosphate buffered solution (pH 7.2) as releasing media. The release behavior was investigated by HPLC on a C18 reverse column DiamonsilTM (250 mm?4.6 mm, 5 ?m). The mobile phase consisted of triethylamine solution-methanol-acetonitrile (38∶28∶34), pumped at 1.0 ml/min, and the detection wavelength was set at 242 nm. Results When the temperature was near to the sol-gel transition temperature, the viscosity rose suddenly. Taking dexamethasone sodium phosphate (2 ml, pH 7.2) as media, the gel dissolution and drug release rate followed the zero order kinetics, and the cumulative gel dissolution (Q1) and cumulative drug release (Q2) equations were Q1=0.8238t (r=0.999, P
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OBJECTIVE:To establish a method for the simultaneous determination of chloramphenicol and dexamethasone sodium phosphate in ear drops by HPLC METHODS:Chloramphenicol and dexamethasone sodium phosphate were separated with a mobile phase of methanol-phosphate buffer solution(0 34% KH2PO4 solution)(60∶40,v/v,1 0ml/min)on Kromasil C8 column and detected at 240nm RESULTS:Good linearity appeared in the concentration of chloramphenicol 100～500?g/ml,r=0 9 999,the recovery was 98 5%～100 8%,RSD≤1 5%;and good linearity showed in the concentration of dexamethasone sodium phosphate 16～80?g/ml,r=0 9 990,the recovery was 98 8%～100 6%,RSD≤2 0% CONCLUSION:This method can simultaneously detect both ingredients in the ear drops
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OBJECTIVE:To establish a RP-HPLC method for content determination of Dexamethasone Sodium Phos-phate in Compound Baifu Pellicles.METHODS:A X-Terra RP 18 column was used,the mobile phase was Methanol-0.34%KH 2 PO 4 solution-triethylamine(52∶48∶0.2),detecting wavelength was242nm and the flow rate was0.7ml/min.RE-SULTS:Dexamethasone Sodium Phosphate was in the good linear range when the sample size was between0.0403?g～2.016?g(r=0.9999,n=3).The average recovery rate was99.85%(RSD=3.00%,n=6).CONCLUSIONS:The established method is convenient,accurate,replicable,which can be applied to quality control of Compound Baifu Pellicles.
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BACKGROUND AND OBJECTIVES: Tonsillectomy is a very common surgical procedure in otolaryngology. Steroid is often given to decrease postoperative morbidity from the procedure. This study was designed to determine the intraoperative and postoperative efficacy of the intravenous administration of dexamethasone sodium phosphate, the long-acting steroid, before or after tonsillectomy. MATERIALS AND METHODS: Sixty children aged between 3 to 15 years were divided into three groups. Twenty children received intravenous dexamethasone sodium phosphate (1 mg/kg up to 15 mg) before undergoing sharp dissection tonsillectomy (group I). Another twenty children received it after operation (group II). The third group was control and did not receive the intravenous dexamethasone sodium phosphate (group III). Intraoperatively blood loss, surgical and anesthesia time were checked. After the operation, each child was evaluated for pain, oral intake, vomiting, body temperature, and bleeding. RESULTS: There were no statistically significant differences noted in blood loss, surgical time, anesthesia time, pain score, oral intake, vomiting, and postoperative bleeding among the three groups of patients. CONCLUSION: The results showed that a single dose of the intravenous dexamethasone sodium phosphate did not affect the postoperative morbidity in children undergoing sharp dissection tonsillectomy.
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Criança , Humanos , Administração Intravenosa , Anestesia , Perda Sanguínea Cirúrgica , Temperatura Corporal , Dexametasona , Hemorragia , Otolaringologia , Sódio , Tonsilectomia , VômitoRESUMO
Dexamethasone sodium phosphate (DSP) is increasingly used in the treatment of ocular inflammatory diseases by systemic, periocular, and recently, intravitreal injection. We have developed a method for the determination of vitreous levels of DSP by reverse phase HPLC. In this method, co-elution of vitreous proteins with DSP is resolved by a prior sample clean-up procedure using Waters Sep-Pak C18 cartridge; the protein is separated and eluted with water while DSP, paraben and prednisone are eluted with methanol. DSP in the resulting sample is then separated by reverse phase HPLC and quantified by UV absorption at 254 nm. The recovery of DSP through the sample clean-up is 68.9 +/- 3.0%. DSP quantitation is linear from 0.1 mg to 1.0 mg per 1.0 ml vitreous. This method provides a simple, sensitive and reliable technique for determining the vitreous levels of DSP.