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Related substances in pharmaceutical formulations are associated with their safety, efficacy and stability. However, there is no overall study already published on the assessment of related substances in the Compound Ketoconazole and Clobetasol Propionate Cream. In this work, a reliable HPLC-TOF-MS qua-litative method was developed for the analysis of related substances in this preparation with a quick and easy extraction procedure. Besides the active pharmaceutical ingredients, two compounds named ke-toconazole impurity B′ optical isomer and ketoconazole impurity E were identified. Furthermore, a new HPLC method for qualitative and quantitative assessment on related substances and degradation pro-ducts, which were found in the stability test, was established and validated. The single standard to determine multi-components method was applied in the quantitative analysis, which was an effective way for reducing cost and improving accuracy. This study can provide a creative idea for routine analysis of quality control of the Compound Ketoconazole and Clobetasol Propionate Cream.
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Objective:To establish a method for the content determination of two ingredients in ktoconazole and clobetasol propio -nate cream.Methods:HPLC was performed on a Kromasil C 18 column (250 mm ×4.6 mm, 5 μm) with the mobile phase of metha-nol-sodium acetate with gradient elution at a flow rate of 1.0 ml· min-1 .The detection wavelength was 239 nm, the column tempera-ture was 30℃and the injection volume was 10 μl.Results:The linear range was 160.30-1282.40 μg· ml-1 for ketoconazole (r=1.0000) and 4.03-32.24μg· ml-1 for clobetasol propionate (r=1.0000).The average recoveries were 100.9％(RSD=0.52％, n=9) and 100.2％(RSD=0.56％,n=9), respectively.Conclusion:The method is accurate with good specificity and high sensi-tivity, which can be used for the detection of ketoconazole and clobetasol propionate .
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Objective@#To investigate the clinical effect of 0.02% clobetasol propionate cream (CPC) on phimosis in prepubertal children.@*METHODS@#We retrospectively analyzed the clinical data about 237 prepubertal children with phimosis present at the Outpatient Department from June 2012 to December 2015. The patients were aged 2－14 (mean 8.6) years, all treated by topical application of 0.02% CPC to the narrowed opening and adhered part of the foreskin twice a day, in the morning and evening respectively. At the time of CPC application, the foreskin was slightly retracted. We evaluated the therapeutic effect every week from the end of the first week of treatment.@*RESULTS@#Totally, 233 of the patients completed the 8-week treatment, of whom 181 (77.68%) showed full retraction of the foreskin, 28 (12.01%) experienced improvement (disappearance of the phimotic ring), and 24 (10.30%) failed to respond, with a total effectiveness rate of 89.70%. No significant local or systemic adverse reactions were observed during the treatment.@*CONCLUSIONS@#Topical application of 0.02% Clobetasol Propionate Cream is a safe, effective, painless, and inexpensive option for the treatment of phimosis in prepubertal chilodren.
Subject(s)
Adolescent , Child , Child, Preschool , Humans , Male , Administration, Topical , Anti-Inflammatory Agents , Clobetasol , Foreskin , Gels , Outpatients , Phimosis , Drug Therapy , Retrospective Studies , Treatment OutcomeABSTRACT
Objective To compare the effect of compound flumethasone ointment and clobetasol propionate cream on serum and skin lesion Th cell related indicators in patients with eczema. Methods 156 patients with chronic eczema were chosen. According to the type of topical drugs, they were divided into two groups: the flumethasone group and the clobetasol propionate group. The changes of eczema treatment effect, serum and skin lesions Th cell related indicators of the two groups were compared. Results After treatment, the serum interferon-γ (IFN-γ) of the flumethasone group was (27.57 ± 5.67) pg/mL, IL-2 was (36.51 ± 8.03) pg/mL and IL-4 was (26.37 ± 5.29) pg/mL, IL-10 was (25.38 ± 4.64) pg/mL and INF-γof skin lesions was (56.53 ± 21.81) pg/L , IL-2 was (51.69 ± 15.67) pg/L, IL-4 was (159.42 ± 25.64) pg/L and (139.62 ± 24.58) pg/L, significantly lower than those of clobetasol propionate group (P <0.05), but the clinical benefit rate (94.87%) was significantly higher than (80.77%) of clobetasol propionate group (P <0.05). Conclusion Compared with clobetasol propionate cream, the effect of compound flumetasone ointment is more effective in treating eczema, and its mechanism may regulate the expressions of Th cell related cytokines.