ABSTRACT
OBJECTIVE:To investigate the similarity of dissolution curves between generic preparations and reference prepara-tions of Bisacodyl enteric-coated tablets in various dissolution mediums,and to provide reference for improving production technolo-gy and internal quality of generic preparations. METHODS:Paddle method was adopted with rotation speed of 75 r/min. The disso-lution test was performed using 1000 mL pH 6.0 phosphate buffer solution,pH 6.8 phosphate buffer solution,water containing 2% sodium lauryl sulfate. HPLC method was used to determine average accumulative dissolution of main components from 3 kinds of generic preparations and reference preparations at different time points to draw out dissolution curves. Similarity factor(f2)meth-od was used to the similarity of dissolution curves. RESULTS:Dissolution curves of reference preparations were basically the same in 3 kinds of dissolution mediums. But the dissolution curve f2 of one generic preparation among 3 manufactures to dissolution curve of reference preparation were ≥50,namely the similarity. CONCLUSIONS:The quality of generic Bisacodyl enteric-coat-ed tablets produced by different manufacturers is obviously different;the generic preparations needs to be further improved in the production technology and internal quality. For domestic generic preparation,it is necessary to strengthen the real-time monitoring of its dissolution curve,to ensure the drug quality.
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OBJECTIVE:To evaluate the dissolution curves similarity of generic and original preparation of Losartan potassium tablets,and to provide reference for improving quality evaluation of the preparation.METHODS:Using hydrochloric acid solution (pH 3.0),phosphate buffer solution(pH 4.5),phosphate buffer solution (pH 6.8) and water as medium,paddle method was adopted for dissolution test with dissolution medium volume of 900 mL and rotation speed of 50 r/min.UV-visible spectrophotometry was adopted to determine accumulative dissolution of generic and original preparation of Losartan potassium tablets with the detection wavelength of 256 um.The similarity of dissolution curves were evaluated by calculating similarity factor(f2).RESULTS:The linear range of losartan potassium was 12.11-35.96 μg/mL (r≥0.999 7).RSDs of precision,stability and reproducibility tests were all lower than 5.0％.The recoveries of 4 dissolution media were 98.66％-100.84％ (RSD=0.77％,n=9),98.91％-100.59％ (RSD=0.49％,n=9),98.33％-101.39％ (RSD=0.85％,n=9),99.46％-101.32％ (RSD=0.55％,n=9).In 4 dissolution media,f2 of the dissolution curves of 3 batches of generic and original preparation of Losartan potassium tablets were all higher than 70.CONCLUSIONS:The dissolution curves of self-made and original preparation of Losartan potassium tablets show good similarity.
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OBJECTIVE:To systematically review the efficacy and safety of the generic and original preparation of atorvas-tatin,and provide evidence-based reference for clinical treatment. METHODS:Retrieved from PubMed,EMBase,Cochrane Li-brary,CJFD,Wanfang Database,VIP and CBM,related randomized controlled trials(RCT)about generic preparation of atorvas-tatin(test group)versus original preparation of atorvastatin(control group)were collected. Meta-analysis was performed by using Rev Man 5.3 software after data extract and quality evaluation. RESULTS:Totally 16 RCTs were included,involving 2 077 pa-tients. Results of Meta-analysis showed,compared with control group,there were no significant differences in reducing total choles-terol (TC) [MD=-0.06,95%CI(-0.14,0.01),P=0.11],triglyceride (TG) [MD=-0.00,95%CI(-0.08,0.08),P=0.99], low-density lipoprotein cholesterol (LDL-C) [MD=-0.07,95%CI(-0.16,0.01),P=0.09],increasing high-density lipoprotein cholesterol(HDL-C)[MD=-0.00,95% CI(-0.03,0.03),P=0.96] and the incidence of major adverse cardiac events(MACE) [OR=1.18,95%CI(0.71,1.97),P=0.52] in test group;in terms of safety,compared with control group,there were no significant differences in the resulting in alanine aminotransferase (ALT) increased [OR=1.08,95%CI(0.51,2.30),P=0.83],the incidences of myalgia [OR=2.46,95%CI(0.70,8.65),P=0.16] and gastrointestinal adverse reactions [OR=1.11,95%CI(0.64,1.95),P=0.71]. CONCLUSIONS:Both the generic and original preparation of atorvastatin can effectively reduce blood lipid levels,with sim-ilar safety.
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OBJECTIVE:To establish a method for the dissolution determination of Dronedarone hydrochloride tablet,and eval-uate the quality consistency of its generic and original preparations. METHODS:UV spectrometry was performed on the column of 288 nm,dissolution media of Phosphate buffer solution (pH4.5),0.1 mol/L Hydrochloric acid solution [adding into 0.5% sodium dodecyl sulfate(SDS)],Phosphate buffer solution [pH6.8,adding into 0.5%SDS] and water,volume of dissolution medium was 1 000 ml,rotation speed was 75 r/min,the dissolution of generic and original preparations of Dronedarone hydrochloride tablet was detected,and the similarity of dissolution curve was evaluated by calculating the similarity factor (f2). RESULTS:The linear range of dronedarone hydrochloride was 2.147-25.764 μg/ml;RSDs of precision,stability and reproducibility tests were lower than 2.0%;recoveries 4 dissolution media were 99.53%-101.05%(RSD=0.48%,n=9),98.95%-100.05%(RSD=0.39%,n=9), 99.54%-100.20%(RSD=0.24%,n=9)and 98.54%-100.06%(RSD=0.44%,n=9). In the 4 dissolution media,f2 of the dissolu-tion curve of 3 batches of generic and original preparations of Dronedarone hydrochloride tablet was 56,60,63,68,68,52,59, 67,65,68,76,62,respectively. CONCLUSIONS:The method is suitable for the dissolution determination of Dronedarone hydro-chloride tablet;meanwhile,the in vitro dissolution curves of generic and original preparations of Dronedarone hydrochloride tablet show similarity,so the quality consistency is good.
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OBJECTIVE:To establish a method for the dissolubility determination of Manidipine Hydrochloride tablet and eval-uate the quality consistency of generic and original preparation. METHODS:HPLC was performed on the column of Waters Sym-metry C18 column with mobile phase of potassium phosphate monobasic solution (potassium phosphate monobasic 6.8 g was well-mixed with water 1 000 ml,and pH was adjusted to 4.6 by potassium hydroxide solution)-acetonitrile (49∶51,V/V) at flow rate of 1.0 ml/min,detection wavelength was 228 nm,column temperature was 25℃,and the injection volume was 20μl. The dis-solution mediums were 0.1 mol/L hydrochloric acid solution,acetic acid-sodium acetate buffer solution(pH 4.0)and phosphate buf-fer solution [pH 6.8,adding into 0.5% sodium dodecyl sulfonate(SDS)],volume of dissolution medium was 900 ml and rotating rate was 50 r/min,and the dissolubility of Manidipine hydrochloride tablet generic and original preparation was investigated and the similarity of dissolution profile was evaluated by calculating similar factor (f2). RESULTS:The linear range of manidipine hydro-chloride was 0.625-20 μg/ml;RSDs of instrument precision and stability tests were lower than 2.0%;recoveries of 3 dissolution mediums were 92.86%-102.97%(RSD=1.9%,1.8% and 2.7%,n=9),respectively. The dissolubility of 3 batches of Manidipine hydrochloride tablet generic and original preparations was higher than 85% in 0.1 mol/L hydrochloric acid solution in 15 min;f2 was >50 in acetic acid-sodium acetate buffer solution (pH 4.0) and phosphate buffer solution (pH 6.8,adding into 0.5% SDS). CONCLUSIONS:The method is suitable for the dissolubility determination of Manidipine hydrochloride tablet;meanwhile,the dis-solution profile in vitro of Manidipine hydrochloride tablet generic and original preparations has similarities,so the quality consis-tency is good.