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OBJECTIVE:To compare therapeutic efficacy and safety of chlorquinaldol-promestriene and miconazole nitrate for simple vulvovaginal candidiasis (VCC).METHODS:In retrospective analysis,a total of 231 patients with simple VCC were divided into observation group (116 cases) and control group (115 cases).Observation group was given Chlorquinaldol-promestriene vaginal tablet (0.2 g) every night.Control group was given Miconazole nitrate suppositories (200 mg) every night.Both groups received a course of treatment,lasting for 7 d.Clinical efficacies of 2 groups were observed at the first and second recheck.The symptom relief time recurrence and ADR of effective patients were observed.RESULTS:There was no statistical significance in the total response rates of 2 groups at the first reexamination,as well as total response rates of 2 groups and symptom relief time of effective patients at the second reexamination(P＞0.05).At the second reexamination,reoccurrence rate of observation group was significantly lower than that of control group,with statistical significance (P＜0.05).There was no statistical significance in the incidence of ADR between 2 groups(P＞0.05).CONCLUSIONS:Chlorquinaldol-promestriene is similar to miconazole nitrate for VCC in therapeutic efficacy and safety,but chlorquinaldol-promestriene is better than miconazole nitrate in reducing recurrence rate.
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OBJECTIVE:To compare therapeutic efficacy and safety of chlorquinaldol-promestriene and miconazole nitrate for simple vulvovaginal candidiasis (VCC).METHODS:In retrospective analysis,a total of 231 patients with simple VCC were divided into observation group (116 cases) and control group (115 cases).Observation group was given Chlorquinaldol-promestriene vaginal tablet (0.2 g) every night.Control group was given Miconazole nitrate suppositories (200 mg) every night.Both groups received a course of treatment,lasting for 7 d.Clinical efficacies of 2 groups were observed at the first and second recheck.The symptom relief time recurrence and ADR of effective patients were observed.RESULTS:There was no statistical significance in the total response rates of 2 groups at the first reexamination,as well as total response rates of 2 groups and symptom relief time of effective patients at the second reexamination(P＞0.05).At the second reexamination,reoccurrence rate of observation group was significantly lower than that of control group,with statistical significance (P＜0.05).There was no statistical significance in the incidence of ADR between 2 groups(P＞0.05).CONCLUSIONS:Chlorquinaldol-promestriene is similar to miconazole nitrate for VCC in therapeutic efficacy and safety,but chlorquinaldol-promestriene is better than miconazole nitrate in reducing recurrence rate.
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Objective To study the treatment effect of joint nitric acid imidazole and itraconazole on recurrent candida vaginitis.Methods 200 confirmed cases of patients with recurrent candida vaginitis in our hospital during October 2014 to June 2015 were selected and divided into research group and the control group with random indicator method,with 100 cases in each group.The control group were treated by nitric acid imidazole vaginal soft capsule,with vaginal drug delivery,which shoud put suppository in vaginal depths after washing,for one times a night and one soft capsule every time,and a week was a period of treatment.The patients in the research group received basis treatment of the control group adding itraconazole capsules(200mg per day,oral).8 weeks after treatment,the patients in this process were reviewed to analyzed clinical efficacy and adverse reactions occured.Results The total effective rate of the research group was 98%,which of the control group was 73%,the difference was statistically significant(χ2 =25.21,P 0.05 ).Conclusion The curative effect of itraconazole joint miconazole nitratet to recurrent monilial vaginitis is superior to the use of miconazole nitrate alone, with less adverse reaction,and is easy to use.It is worth clinical application.
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Objective:To optimize the preparation technology of ketoconazole and miconazole nitrateβ-cyclodextrin inclusion com-pound. Methods: The weight ratio of β-cyclodextrin to ketoconazole, inclusion temperature and inclusion time as the testing factors, the optimal inclusion technology was screened by orthogonal experiments. Results:The optimum inclusion conditions were as follows:the weight ratio of β-cyclodextrin to ketoconazole was 8 ∶1, the inclusion temperature was 50℃, and the ultrasonic time was 50 min. Conclusion:The optimized β-cyclodextrin inclusion process is simple and convenient to carry out.
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Objective:To study the effect of caprylic/capric acid glycerides (Lab), propylene glycol (PG) and Azone on the transdermal behavior of ketoconazole and miconazole nitrate in compound ketoconazole gel, to screen appropriate penetration enhanc-ers. Methods:Using a RYJ-6A-type transdermal drug diffusion tester, the effects of Lab, PG and Azone at different concentrations on the transdermal behavior of ketoconazole and miconazole nitrate in compound ketoconazole gel were studied. Results:3% PG showed the most obvious penetration enhancement, which could increase the permeation of ketoconazole by 2. 004 times, and increase the pen-etration of miconazole nitrate by 1. 795 times, and the differences were statistically significant (P<0. 05). Conclusion:The penetra-tion effect of 3% PG is obvious, which can be applied in compound ketoconazole gel.
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Objective: To establish a method for the determination of ketoconazole and miconazole nitrate in compound ketocon-azole gels. Methods:An HPLC method was developed. A Hypersil BDS C18 column(416 mm × 200 mm,5μm) was used, the mobile phases consisted of 0. 5% ammonium acetate solution-methanol(containing 0. 2% triethanolamine) (20∶80), the flow rate was 1. 0 ml ·min-1 , the detection wavelength was set at 230nm, the column temperature was 30℃ and the injection volume was 20μl. Results:There was a good linear correlation within the range of 5. 1-510. 0 mg·L-1 for ketoconazole (r=0. 999 9) and 50. 0-500. 0 mg·L-1 for miconazole nitrate (r=0. 999 9), the average recovery for ketoconazole and miconazole nitrate was 100. 3%(RSD=0. 38%, n=6) and 99. 9%(RSD=0. 79%, n=6), respectively. Conclusion:The method is simple, rapid, accurate and sensitive, and can pro-vide a method for controlling the quality of compound ketoconazole gels.
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Objetivo: validar el método para control de la calidad del nitrato de miconazol en una nueva crema al 2 por ciento. Métodos: se realizó la validación según los parámetros exigidos para la categoría I y considerando la metodología y los criterios de aceptación vigentes en Cuba. Una vez validado, se aplicó al análisis de los tres lotes elaborados a escala piloto. Resultados: los resultados fueron satisfactorios, cumpliendo en todos los parámetros los límites establecidos. El método fue lineal, exacto y preciso en el rango de 10 a 30 mg/g y no hubo interferencias de ninguno de los componentes de la nueva formulación. Los lotes presentaron correcta dosificación, sin diferencias estadísticamente significativas entre las réplicas y los lotes analizados. Conclusiones: El método evaluado resulta válido para el objetivo con el cual se propuso(AU)
Objective: to validate a quality control method for a 2 percent new miconazole nitrate cream. Methods: the validation was made following the category I parameters and taking into account the methodology and acceptance criteria in force in Cuba. Once validated, the analysis of the three batches was applied on pilot scale. Results: the results were satisfactory since they fulfilled all the set parameters. The method was linear, accurate and precise in the 10-30 mg/g range. there was no interference from any of the components of the new formulation. The batches presented correct dosing, without any statistically significant differences between replicas and analyzed batches. Conclusions: the evaluated method proved to be valid for the stated purpose(AU)
Subject(s)
Humans , Titrimetry/methods , Validation Studies as Topic , Miconazole/therapeutic use , CubaABSTRACT
The aim of this study was to prepare and evaluate gels incorporating nanostructured lipid carriers (NLC) of Miconazole nitrate (MN) for systemic delivery of the active after topical application. MN has been used as model drugs to be incorporated into nanostructured lipid carriers, once they are very well established as antimycotics for the treatment of topical fungal infections. NLC designed for topical administration of MN, were prepared by the hot high pressure homogenization technique. This MN-NLC was characterized for particle size, entrapment efficiency, and SEM. The lipid nanoparticles were incorporated in gels for convenient topical application and were evaluated forfor particle size, Rheological analysis Texture analysis , In vitro drug release studies and Ex Vitro skin permeation Studies. The preparation of aqueous NLC dispersions with a mean particle size lower than 300 nm has been obtained with uniform size distribution (PI < 0.350). The prepared semi-solid systems showed mean particle size remained lower than 250 nm and PI remained lower than 0.500 after 3 months of storage. An initial rapid release was observed in the case of Marketed gel, whereas MN- NLC Gel depicted a slow initial release with a lag time of 0.5 h and 1 h, respectively. High amount of MN release was facilitated through abdominal skin of rats from marketed gel than MN-NLC Gel. Research work could be concluded as successful development of MN-loaded NLC-bearing hydrogel to increase the encapsulation efficiency of colloidal lipid carriers with advantage of improved performance in terms of stability and provides a sustaining MN topical effect as well as faster relief from fungal infection.
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FJ, with 9.7 times difference between the highest and the lowest. CONCLUSION: Prepared with different base materials, the permeation ability of of the preparation will be different.
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0.05);the cure rates were 55.77%,36.54% and 88.46%,re-spectively;the recurrence rates were 11.54%,25.00% and 1.92%,respectively.CONCLUSION:Scheme A is the preferable one economically,however,taking all the factors into consideration,scheme C is the best one.
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OBJECTIVE:To establish an HPLC method for determination of triamcinolone acetonide(TA), diphenhydramine hydrochloride(DH) and miconazole nitrate(MN) in compound miconazole nitrate cream(MNC). METHODS: The determination was performed on Hypersil ODS2. The mobile phase consisted of methanol-acetonitrile-0.5% ammonium acetate (45∶35∶20) at a flow rate of 1.0 mL?min-1. The UV detection wavelength was 234 nm; the column temperature was 40 ℃ and the inject volume was 20 ?L. RESULTS: The linear ranges for MN, TA and DH were 0.16～0.64 (r=0.999 8), 0.02～0.06 (r=0.999 9) and 0.08～0.24 (r=0.999 2) mg?L-1 respectively, with their average recoveries at 100.0%, 99.6% and 100.7%, RSD at 1.2%, 0.8% and 0.9%(n=3) respectively. CONCLUSION: The HPLC method can be used for the simultaneous determination of the three constituents in CMNC.