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Objective To compare the efficacy of vidarabine monophosphate and ribavirin for treating hand-foot-mouth disease (HFMD) in children.Methods 120 children with HFMD and admitted to a hospital from April 2013 to April 2015 were randomly divided into observation group and control group,60 cases in each group,observation group treated with vidarabine monophosphate,control group treated with ribavirin,the therapeutic efficacy between two groups were compared.Results After treatment,the negative conversion rate of intestinal virus EV and EV71,as well as Coxsackie virus A16(CA16) in observation group were 87.0％,85.7％,and 93.1％ respectively,in control group were 64.0％,69.8％,and 78.6％ respectively,difference between two groups was statistically significant (all P＜0.05).The average length of hospital stay in observation group was shorter than control group ([4.5 ± 1.3] days vs [6.2 ± 1.2] days,P＜0).05),symptom(fever,stomatitis,skin rash) control time in observation group were all shorter than control group(all P＜0.05).Whether patients with or without complication,therapeutic effect of the observation group was better than that of control group;myocardial enzyme data,C reactive protein (CRP),and white blood cell(WBC) in observation group were all lower than control group(all P＜0.05).Conclusion Efficacy of vidarabine monophosphate for treating children with HFMD is better than ribavirin,but it needs further study.
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OBJECTIVE:To investigate the stability of Vidarabine monophosphate for injection combined with Aciclovir injec-tion. METHODS:HPLC method was adopted. The content variations of two drugs in mixture were determined within 8 h at 5 ℃, 25℃,35℃under dark and light. The changes in appearance,property,pH value and insoluble particles(within 24 h)were inves-tigated before and after compatibility. RESULTS:There were no significant changes in appearance and pH value at 5 ℃,25 ℃, 35 ℃ under dark,and insoluble particles were in line with Chinese Pharmacopoeia(2010 edition),and the relative content of vida-rabine monophosphate and aciclovir were above 99%(compared with 0 h)within 8 h. Under the light conditions,as the tempera-ture raised and the extension of storage time,the content of vidarabine monophosphate did not significantly decrease,but that of aciclovir had declined significantly(4 h and after 4 h),while pH value also had a certain degree of rise;the insoluble particles had no obvious change. CONCLUSIONS:The mixture of vidarabine monophosphate and aciclovir in 0.9% Sodium chloride injections is stable under dark conditions within 8 h;it is suggested that the mixture should be used up within 4 h after mixing and protect from light to guarantee the safety of drug use in the clinic.
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OBJECTIVE:To establish a method for the determination of ethanol,acetonitrile,dichloromethane,ethyl acetate, pyridine in vidarabine monophosphate. METHODS:Headspace GC was performed on the column of Agilent DB-624,programmed temperature,inlet temperature was 200 ℃,the detector was flame ionization detector,detecting temperature was 250 ℃,nitrogen was carrier gas,flow rate was 3 ml/min,split ratio was 1∶1,the top bottles equilibrium temperature was 100 ℃,and equilibrium time was 45 min,injection volume was 1 ml. external standard was used for quantitative analysis. RESULTS:The peaks of five re-sidual solvents could be completely separated from the other peaks respectively,The linear rang was 24.7-296.3 μg/ml for ethanol (r=0.999 6)、1.9-23.2 μg/ml for acetonitrile(r=0.999 0),2.8-33.6 μg/ml for dichloromethane(r=0.998 0),24.7-295.9 μg/ml for ethyl acetate(r=0.999 5),1.0-11.9 μg/ml for pyridine(r=0.998 6);RSDs of precision and reproducibility tests were lower than 4.35%;recoveries were 102.4%(RSD=2.0%,n=9)、102.1%(RSD=3.4%,n=9)、105.5%(RSD=4.8%,n=9)、100.3%(RSD=4.8%, n=9)、98.3%(RSD=4.0%,n=9). The minimum quantifation limit was 0.304 4-0.988 0 μg/ml and the minimum detection limit was 0.101 5-0.329 3 μg/ml. CONCLUSIONS:The method is simple,accurate and reproducible,and can be used for the determination of residual solvents in vidarabine monophosphate.
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Objective To explore effect of vidarabine monophosphate combined with astragalus injection on serum cardiac troponin I ( cTnI), interleukin 1β(IL-1β), interleukin-10 (IL-10) and tumor necrosis factor-α(TNF-α) in children with hand-foot-and-mouth disease.Methods 60 cases with hand-foot-and-mouth disease from March 2013 to March 2015 in the hospital were selected and divided into two groups treated by different therapy, 30 cases in each group.The control group received conventional treatment + ribavirin injection, and experimental group received vidarabine monophosphate combined with astragalus injection on the basis of conventional treatment, one time per day.All patients were treated for a course of 7 days.The serum cTnI,IL-1β,IL-10 and TNF-αlevels were compared before and after treatment.Results After treatment, the serum cTnI, IL-1β, IL-10 and TNF-αlevels in two groups decreased than those of pre-treatment (P<0.05), the above indicators of experimental group were lower than those of control group (P<0.05).Conclusion The combination of vidarabine monophosphate and astragalus injection could significantly decrease serum cTnI, IL-1β, IL-10 and TNF-αlevels in children with hand-foot-and-mouth disease.
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Objective To study optimal compatibility scheme of vidarabine monophosphate for injection combined with aciclovir injection. Methods L18(35) of orthogonal design was used with five factors: temperature, illumination,storage time,solvent and solvent dosage;the insoluble particles were observed by GWJ-4 type particle analyzer.The content of vidarabine monophosphate and aciclovir was detected by HPLC.Optimization of the best scheme of vidarabine monophosphate for Injection combined with aciclovir injection was studied.Results The regression equation of vidarabine monophosphate and aciclovir were A=3.78 ×104C+2.32, r=0.9997(n=5)and A=7.11 ×105C-4.65, r=0.9995(n=5),The results showed that the relationship between the range of 200-900μg/mL(vidarabine monophosphate) and the range of 1000-4500μg/mL(aciclovir) was good.The optimal compatibility conditions are the follows:temperature of 25,as far as possible away from light;Vidarabine monophosphate for injection 1 (0.1 g/branch) and 1 acyclovir injection (10 mL:0.5 g) mixed with 100 mL 0.9% sodium chloride injection,and dropping out within 4 h after compatibility. Conclusion The optimal compatibility scheme has good repeatability,injection solution stability is good.It prouides scientific reference for the safty of clinical rational drug use.
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Objective:To establish an HPLC method for the determination of the related substances in vidarabine monophosphate for injection. Methods:The known impurities vidarabine and adenine in vidarabine monophosphate for injection were analyzed by an external standard method on a Kromasil 100-5 C18 column(250 mm × 4. 6 mm,5μm)with the mobile phase consisting of water(contai-ning 10 mmol·L-1 tetrabutyl ammonium hydroxide and 10 mmol·L-1 potassium dihydrogen phosphate)-methanol(80:20)at a flow rate of 1. 0 ml·min-1,the detection wavelength was set at 258nm,the column temperature was at 30℃,and the sample size was 20μl. Meanwhile,the unknown impurities were examined by a self-control method. Results:Good linear relationships of vidarabine and adenine were obtained within the range of 0.0765 ~1.530 7μg·ml-1(r =0.999 9)and 0.078 0 ~1.560 0 μg·ml-1(r =0. 999 9). The corresponding average recovery was 99. 8% with RSD of 0. 2%(n=9)for vidarabine and 97. 0% with RSD of 1. 2%(n=9)for adenine. Conclusion:The method can be used to determine the related substances in vidarabine monophosphate for injec-tion.