RESUMO
The aim of this work was to perform solubility studies for fexofenadine hydrochloride and establish dissolution conditions for this drug in oral suspension dosage form. The solubility study was executed through the shake-flask method, below 37 ºC±1 ºC, at 100 rpm stirring for 12 h in three buffer solutions: hydrochloric acid pH 2.0, acetate pH 4.5 and phosphate pH 6.8. The dissolution test was developed in vessels containing 900 mL of the same buffer, employing the paddle apparatus in speed of 25 and 50 rpm, below 37 ºC±0.5 ºC. The drug was classified as low solubility according to the Biopharmaceutics Classification System, since the dose/solubility ratio was higher than 250 mL in all media tested (326.55 mL in buffer pH 2.0; 2,456.33 mL in buffer pH 4.5 and 1,021.16 mL in buffer pH 6.8). The dissolution test showed that a release of 85% in 30 min could be established. The rotation speed of 25 rpm, media volume of 900 mL and insertion of the samples through weighted syringes are adequate. The buffered media pH 2.0 could be chosen as dissolution media.
Assuntos
Solubilidade , Suspensões/farmacologia , Dissolução/métodos , Biofarmácia , Preparações Farmacêuticas/análise , Cromatografia Líquida de Alta Pressão/métodos , Formas de DosagemRESUMO
Objective To investigate the effect of compound glycyrrhizin combined with fexofenadine hydrochloride in the treatment of chronic urticaria and its effect on plasma histamine.Methods 100 patients with chronic urticaria were selected as study objects,and they were divided into the control group(50 cases) and observation group(50 cases) according to the random number table method.The control group was treated with fexofenadine hydrochloride,while the observation group was treated with compound glycyrrhizin on the basis of the control group.The clinical effect and plasma histamine level were compared between the two groups.Results The effective rate of the observation group was 96.0%,which was significantly higher than 84.0% of the control group(χ2=7.951,P<0.05).After treatment,the plasma histamine content of the observation group was (2.38±0.26)ng/mL,which was lower than (3.10±0.29)ng/mL of the control group,and the difference between the two groups was statistically significant(t=6.084,P<0.05).Conclusion The compound glycyrrhizin combined with fexofenadine hydrochloride in the treatment of chronic urticaria can reduce the symptoms of the patients,reduce the number and size of the patients and effectively control the clinical symptoms of the patients.And it can effectively reduce the level of plasma histamine in patients with good clinical effect and application value,it is worth to be promoted in clinical.
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Objective To study clinical effects of the fexofenadine hydrochloride Tablets and BCG-PSN in the treatment of chronic urticaria. Methods 122 patients with chronic urticaria treated in Yiwu skin disease hospital from January 2016 to March 2017 were selected and randomly divided into the control group and the experimental group, 61 patients for each group. The control group was given Fexofenadine Hydrochloride Tablets treatment, the experimental group was given BCG-PSN on the basic treatment of the control group. The patients in the experimental group and the control group were treated for 3 months. The treatment effect and adverse reactions were compared between two groups. Results After the corresponding treatment, the number of invalid cases in the experimental group was 10. In the control group, 21 cases were ineffective. The effective rate of the experimental group was 63.93%, which was significantly higher than 32.97% of the control group with statistical significance (P<0.05). There were no obvious adverse reactions in the two groups, and there was no significant difference in the incidence of adverse reactions. After treatment, the integral score of the experimental group was (3.20±0.42), significantly lower than that of the control group (3.98±0.37), with statistical significance (P<0.05). Conclusion fexofenadine hydrochloride Tablets combined with BCG-PSN for the treatment of chronic urticaria could significantly improve clinical symptoms of patients with good efficacy, high safety and clinical application significance.
RESUMO
Objective To study clinical effects of the fexofenadine hydrochloride Tablets and BCG-PSN in the treatment of chronic urticaria. Methods 122 patients with chronic urticaria treated in Yiwu skin disease hospital from January 2016 to March 2017 were selected and randomly divided into the control group and the experimental group, 61 patients for each group. The control group was given Fexofenadine Hydrochloride Tablets treatment, the experimental group was given BCG-PSN on the basic treatment of the control group. The patients in the experimental group and the control group were treated for 3 months. The treatment effect and adverse reactions were compared between two groups. Results After the corresponding treatment, the number of invalid cases in the experimental group was 10. In the control group, 21 cases were ineffective. The effective rate of the experimental group was 63.93%, which was significantly higher than 32.97% of the control group with statistical significance (P<0.05). There were no obvious adverse reactions in the two groups, and there was no significant difference in the incidence of adverse reactions. After treatment, the integral score of the experimental group was (3.20±0.42), significantly lower than that of the control group (3.98±0.37), with statistical significance (P<0.05). Conclusion fexofenadine hydrochloride Tablets combined with BCG-PSN for the treatment of chronic urticaria could significantly improve clinical symptoms of patients with good efficacy, high safety and clinical application significance.
RESUMO
Objective To evaluate the efficacy of fexofenadine hydrochloride tablets at tapering doses for the treatment of chronic spontaneous urticaria. Methods After receiving evaluation of medical history and undergoing autologous serum skin test (ASST), 80 patients with chronic spontaneous urticaria were randomly divided into two groups:conventional dose group administrating fexofenadine hydrochloride tablets 120 mg/d for 12 consecutive weeks, tapering dose group administrating fexofenadine hydrochloride tablets 120 mg/d for the first 4 weeks followed by dose tapering of fexofenadine hydrochloride tablets by 30 mg at the 5th and 9th weeks. The urticaria activity score(UAS) and dermatology life quality index(DLQI)were evaluated before the treatment(baseline)as well as after 4?, 8?and 12?week treatment, and the total dose of fexofenadine hydrochloride was calculated. Results A total of 76 patients completed the 12?week treatment, including 37 patients in the conventional dose group and 39 patients in the tapering dose group. After 4?, 8?and 12?week treatment, a significant decrease was observed in the UAS in the conventional dose group(0.64 ± 0.82, 0.37 ± 0.68 and 0.27 ± 0.56 vs. 4.08 ± 0.79, all P0.05). After 8?and 12?week treatment, symptoms were controlled in 71.79%(28/39)and 82.05%(32/39)of patients in the tapering dose group, respectively, with the total dose of fexofenadine hydrochloride being significantly lower in the tapering dose group than in the conventional dose group (both P<0.001). Conclusion After 4- 8 weeks of treatment with fexofenadine hydrochloride, the tapering dose regimen and conventional dose regimen show similar clinical efficacy in patients with chronic spontaneous urticaria.
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A simple, rapid and precise reverse phase liquid chromatographic (RP-HPLC) method was developed and subsequently validated for simultaneous estimation of Ambroxol hydrochloride and Fexofenadine hydrochloride in bulk drug and in a synthetic mixture. The method is based on High Performance Liquid Chromatography (HPLC) on a reversed – phase column, Hypersil ODS C18 (Hypersil ODS 250 x 4.6 mm, 5, Make: Thermo Scientific) prepacked column. The separation was carried out using a mobile phase containing a buffer and acetonitrile (56:44 v/v), was pumped at a flow rate of 0.8 mL/min, column temperature at 35º C using UVdetection at 225 nm. Both the drugs were well resolved on the stationary phase and the retention times were around 2.424 minute for Ambroxol hydrochloride and 3.753 minute for Fexofenadine hydrochloride. The method was validated and shown to be linear for both the drugs. The correlation coefficients for Ambroxol hydrochloride and Fexofenadine hydrochloride are 0.9994 and 0.9992 respectively.