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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 establish the method for dissolution determination of Metoprolol tartrate tablets,and to evaluate the similarity of dissolution curves of generics and original drugs. METHODS:The paddle method was adopted with rotational the speed of 50 r/min,using pH 1.2 hydrochloric acid solution,pH 4.5 acetate buffer solution and pH 6.8 phosphate buffer solution as dissolution media. Fiber-optical drug dissolution real-time measurement instrument was used to determine the dissolution curves of generic and original Metoprolol tartrate tablets with optical distance of 10 mm. Similarity factor (f2) method was used to evaluate its similarity. RESULTS:In 3 dissolution mediums,the f2 of generic and original Metoprolon tartrate tablets were 80.5,66.8, 69.4,respectively,which indicated that the dissolution curves showed similarity. CONCLUSIONS:Established real-time dissolution process analysis method is suitabe for the dissolution determination of Metoprolol tartrate tablets. Generic and eriginal show the sim-ilarity in dissolation behavier,so they have good consistency in quality.
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Objective To establish the dissolution curves test method of Ribavirin capsules, and investigate dissolution behavior of domestic Ribavirin capsules.To provide experimental basis for generic drugs quality consistency evaluation.Methods According to the first dissolution method (basket method)stated in appendix Ⅹof Chinese Pharmacopeia(2010 edition),the rotation speed was 50 r/min with dissolution medium volume of 900 mL.The dissolution profiles of Ribavirin capsules in four different mediums( pH 1.2 hydrochloric acid solution,pH 4.5 acetic buffer,pH 6.8 phosphate buffer and water) were determined by HPLC.The determination was performed on C18 column with mobile phase consisted of 4 g/L sodium dihydrogen phosphate solution(pH adjusted to 5.0 ±0.05 using 5% sodium hydroxide solution)-acetonitrile(98:2)at the flow rate of 1.0 mL/min.The detection wavelength was 225 nm,and sample size was 10μL.Results The linear range of ribavirin was 2.5-200μg/mL(r=1).RSD of precision and stability tests were lower than 0.5%.The average recoveries were 101.3%, 100.7%, 100.2%, 100.4% in four mediums.Dissolution behavior of capsules can be more consistent and rapid dissolution in pH4.5 and pH6.8 mediums.But they were quite different in pH1.2 and water mediums, and some of their average dissolution at 15 min could not reach 85%.Conclusion This method is accurate and reliable.There is a difference between domestic Ribavirin capsules dissolution behavior, and the formulation processes have room for improvement.
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Objective:To study the dissolution behavior of panax notoginseng saponins R1 , ginseng saponin Rg1 and ginseng sapo-nin Rb1 in Xuesaitong soft capsules in two different dissolution media. Methods:The dissolution test conditions were confirmed accord-ing to“quality of medical drugs information set” of Japan and the dissolution media were chosen in accordance with the physicochemi-cal properties of Xuesaitong soft capsules, the in vitro dissolution of Xuesaitong soft capsules was inspected respectively in pH 6. 8 phosphate buffer and water. The dissolution rate was determined by HPLC-ELSD, and the similarity of the release curves for the three components was compared with similarity factors ( f2 ) method. Results: The assay displayed a good linearity over the concentration range of 0. 8-16. 0 mg·L-1(r=0. 999 6), 3. 0-60. 0 mg·L-1(r=0. 999 8) and 4. 0-80. 0 mg·L-1(r=0. 999 7) for panax notog-inseng saponins R1 , ginseng saponin Rg1 and ginseng saponin Rb1 , respectively. In pH 6. 8 phosphate buffer and water, f2 of ginseng saponin Rg1 and ginseng saponin Rb1 were both above 50 when compared with panax notoginseng saponins R1 . Conclusion:The meth-od is simple, accurate and reproducible in the dissolution determination of the soft capsules. The dissolution of ginseng saponin Rg1 and ginseng saponin Rb1 has similar characteristics with that of panax notoginseng saponins R1 in Xuesaitong soft capsules.