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Objective:To compare the dissolution of compound fructus forsythiae, paracetamol and chlorphenamine maleate cap-sules from different manufacturers.Methods: The dissolution test was carried out by a basket method in 900 ml dissolution medium with the rotating speed at 100 r·min-1. The dissolution profiles of compound fructus forsythiae,paracetamol and chlorphenamine mal-eate capsules from different manufacturers in four dissolution media including hydrochloric acid solution, pH 4.5 acetate buffer solu-tion,water and pH 6.8 phosphate buffer solution were determined,and the dissolution curves were compared by a similar factor meth-od. Results:The cumulative dissolution of compound fructus forsythiae,paracetamol and chlorphenamine maleate capsules from seven manufacturers was all over 70% in 30 min in hydrochloric acid solution,while failed to dissolve well in pH 4.5 acetate buffer solution, water and pH 6.8 phosphate buffer solution. All the dissolution curves in the 4 dissolution media were different among the batches. Conclusion:The quality of compound fructus forsythiae,paracetamol and chlorphenamine maleate capsules from various manufacturers is much different. Promising dissolution should be guaranteed,at the same time,the stability needs to be improved.
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Objective To prepare generic irbesartan tablets and to evaluate its consistency of dissolution tests.Methods Using the original drugs (irbesartan) as reference drug,the single factor experiments were applied to investigating the type and amount of adhesive,tablet hardness,water content of tablets,and coating weight.ZRS-8G Dissolution Tester was used to conduct the dissolution tests which were carried on four different dissolution media.Then the similar factor (f2) was adopted to evaluate the similarity of dissolution between the original drug and generic drug.Results As the stabilizer,3％ HPMC-E5 was more stable than 5％ PVP K30.It had no difference of dissolution between original and generic drugs when the amount of adhesive,tablets hardness and water content were within the range of investigation.And the coating weight was 2％ to 3％.Moreover,the f2 values of original drug and generic drug were all greater than 50 in different dissolution media.Conclusion Thef2 results indicate a similarity in the dissolution behavior of reference drug and generic irbesartan tablets prepared by the single factor experiments.And the preparation process of generic irbesartan tablets is stable.
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Objective:To explore the chemical and biological assay pattern for the quality control and evaluation of Chinese mate-ria medica solid preparations ( CMMSP) . Methods:Compound berberine tablets were used as the model drug, the inhibition against sensitive strains of the dissolution solution at different time points was studied with water as the dissolution medium, and the cumulative dissolution of compound berberine tablets was obtained based on the bacterial inhibitory rate. The dissolution of hydrochloric acid ber-berine was also determined by HPLC, and a f2 similar factor method was used to evaluate the relevance of the two methods. Results:The antimicrobial test showed that berberine was sensitive to escherichia coli,staphylococcus aureus, bacillus subtilis, micrococcus luteus and candida albicans etc, and among them, the antibacterial circle edge of bacillus subtilis was clear with higher sensitivity. The disso-lution curve of compound berberine tablets determined by HPLC as the reference, the similarity factor f2 of bio-dissolution curve of com-pound berberine tablets from 7 different manufactures was greater than 50, which suggested that the dissolution determination method based on biological titer determination could comprehensively reflect the bioavailability of compound berberine tablets. Conclusion:The biological activity evaluation method for dissolution is expected to be one of the effective means for in vitro dissolution test of CMMSP.
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Objective:To compare the dissolution of domestic terazosin hydrochloride tablets and capsules to provide reference for clinical use. Methods:The dissolution of the products from different manufacturers was investigated respectively in 4 kinds of media:pH 1. 0 hydrochloric acid solution,pH 4. 5 phosphate buffer solution,pH 6. 8 phosphate buffer solution and water. The dissolution tests were carried out by a paddle method at the stirring speed of 50 r·min-1 and an HPLC method was used to determine the dissolution rate. The dissolution behavior of the samples from different manufacturers was compared by a similar factor method. Results:The do-mestic tablets showed higher similarity with the reference formula, and the dissolution behavior of the capsules had significant differ-ence. Conclusion:The calculation method for the specification in some manufacturers is different from that of the reference prepara-tion, which leads to the difference between the testing preparation and the reference preparation, and should be paid attention in clini-cal use.
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Objective: To explore the chemical-biological assay pattern for quanlity control and evaluation of Chinese materia medica solid preparations (CMMSP). Methods: MTT assay was used to obtain the characteristic cell inhibitory rate on LX-2 hepatic stellate cells by Compound Biejia Ruangan Tablet (CBRT) dissolving solutions in PBS dissolution medium with pH 7.4 for different time periods. From these results, the cumulative dissolution of CBRT was obtained based on the cell inhibitory rate. The dissolution rates of paeoniflorin, phillyrin, and ginsenosides Rg1 were determined by HPLC method. A novel approach of self-defined weighting coefficient based on the quality had been created to establish the integrated dissolution rate model. Then f2 similar factor method was used to evaluate the relevance of these two methods. Results: The f2 values for paeoniflorin, phillyrin, ginsenosides, and the integration dissolution were 43, 58, 61, and 59, respectively. It was indicated that the dissolution of multicomponent integration could fully reflect the biological potency of all parties. Conclusion: The biological activity-multicomponents integrated evaluation method of dissolution is expected to be one of the effective means for in vitro dissolution test of CMMSP.