ABSTRACT
OBJECTIVE：To investigate the in vitro quality consistency of domestic Nitroglycerin table t imitative preparation and reference preparation （original drug ）. METHODS ：The contents of nitroglycerin and related substances in 1 batch of Nitroglycerin tablet reference preparation （manufacturer A ）and 4 batches of imitative preparation （manufacturer B ，C，D，E） were determined according to Nitroglycerin Tablet Import Drugs Registration Standard JX 20010267. The paddle method of dissolution determination method was adopted ，with the rotating speed of 50 r/min. HPLC method was adopted to determine the dissolution amount of 5 batches of above preparations in 4 kinds of dissolution mediums （pH 1.2 hydrochloric acid solution ，pH 4.0 acetate buffer solution ，pH 6.8 phosphate buffer solution ，water） within 10 min.The accumulative dissolution rate was calculated，and dissolution curves of samples were drawn.The similarity of the dissolution curves was evaluated by calculating similarity factor （f2）of 2，5，8 min accumulative dissolution rate. RESULTS ：The contents of nitroglycerin in the preparations from manufacturer A ，B，C，D，E were 99.8％，98.3％，94.0％，93.3％，96.7％，respectively（n＝2）；the contents of related substance were 0.46％，0.55％，0.63％，0.72％，0.49％，respectively（n＝2）. Using reference preparation of manufacturer A as control，f2 of imitative preparation from manufacturer B ，C，D，E were 74，28，25，67 in pH 1.2 hydrochloric acid solution ；76， 26，28，84 in pH 4.0 acetate buffer solution ；79，39，35，71 in pH 6.8 phosphate buffer solution ；69，32，37，62 in water ， respectively. CONCLUSIONS ：The method is suitable for in vitro quality consistency evaluation of Nitroglycerin table timitative preparation. Compared with reference preparation ，the contents of main components in the imitative preparations from manufacturer C，D are lower ；in vitro dissolution curves of those imitative preparation are not similar to reference preparation .
ABSTRACT
Objective To establish a method for determining the dissolution of isoniazid tablet in vitro and evaluate the dissolution profiles.Methods The paddle method was used for the dissolution test and the rotation rate was set at 50 r/min.The hydrochloric acid solution (pH 1.2),acetate buffer solution (pH 4.5),phosphate buffer solution (pH 6.8) and water (900 mL) were used as the dissolution media.HPLC was used for the determination of dissolution quantity.Results There was a good linear relationship between the quality concentration of i soniazid and peak area in the range of 0.1981-0.9904μg (r =0.9993).The average recovery was 100.2％.Precision,reproducibility,and specificity tests were good.Among the determination of 16 manufactures,the dissolution profiles in water of four manufactures were not similar with Sandoz reference preparation.Conclusion The HPLC method is simple.The accuracy and specificity of determination of isoniazid dissolution are improved.There is significant difference in the dissolution profiles between different manufactures.The method can be used for the determination of dissolution curves for isoniazid tablets.
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.
ABSTRACT
Objective: To establish the Guanxin Suhe Pill (GXSHP)-HPLC internal standard quantified fingerprints method (ISQFM) for selecting the reference preparation of GXSHP by ISQFM and providing the quality control method of reference preparation. Methods: Agilent Poroshell 120 SB C18 column (150 mm × 4.6 mm, 2.7 μm), 0.2% ethylic acid-water, and 0.2% ethylic acid-methanol were used as the mobile phases that were eluted with liner program. The flow rate was 0.5 mL/min, the UV absorbance was monitored at 275 nm by injecting 5 μL of the sample solution each time, and the column temperature was maintained at (25.00 ± 0.15)°C. The ISQFM was used to identify the quality and select the reference preparation. Results: The 36 common peaks were marked by choosing IS as the referential peaks and the quality of 12 batches of GXSHPs was identified by the ISQFM. The identification results were that the quality of five batches (S3, S5-S7, and S9) were best, four batches (S4, S8, S10, and S11) were better, two batches (S1 and S2) were good, and one batch (S12) was lower than good, according to the results of this method, S3, S5-S7, and S9 could be used as the reference preparation of GXSHPs. Conclusion: This method could reduce the use of reference substances and improve the accuracy of the measured results. The reference preparation of GXSHPs, which is selected by this method, could be used for the quality control of large quantities of GXSHPs with the great significance in practical production.