Study And Qulity Evaluation Of Angelicae Sinensis Dispersible Tablet

Recently,much attention has been paid to dispersible tablets and some dispersible tablets of pharmaceutical chemicals have been put on market. However, dispersible tablets of Traditional Chinese Medicine (TCM) has a relatively slow progress and many of dispersible tablets of TCM are still on the stage of experimental and clinical research. Angelicae sinensis, principle active ingredient of which is hydrophobic ferulaic acid, has a good therapeutic effect. When Angelicae sinensis is prepared into dispersible tablets, the capacity of dissolution can be remarkably improved leading to better bioavailability.By pre-formulation research, technical research and formulation screening, Angelicae sinensis dispersible tablets of good quality were prepared and the quality control system of Angelicae sinensis dispersible tablets was established.Firstly, experiments were designed to investigate the characteristics of drug and adjuvants. The results showed that Angelicae sinensis powdered extract had good filling ability and flowability, and Prosolv was selected as bulking agent. Ferulaic acid concentration of Angelicae sinensis extractum was 944.03±7.7182μg/g. Secondly, single factor experiment and orthogonal experiment were applied to select proper adjuvants and their ratio, using disintegration time, dispersal homogeneity and stability of the suspension forming as parameters. The optimized formulation is as follows: Angelicae sinensis powdered extract 50%, Prosolv34%, CCNa10%, Amylum pregelatinisatum5%, Micropowder Silicon Gel1%. Two tablets were prepared by diffierent techniques of wet granulation and tablet direct compression and compared. The disintegration time of the tablets by the latter technique was shorter. It was proved that the technique of tablet direct compression was simple, time and energy saving and was fit for rapid-release-tablets preparing. Thirdly, the system of quality control was established. The mean tablet weight was 200mg and the hardness was about 4.2kg. Tablet weight variation is small, disintegration time and dispersal homogeneity were conforming to the CP. The assaying method of high efficiency liquid chromatography was established with a test index of ferulic acid. The results showed that the method was simple and fast, with a high precision. The content of ferulic acid in Angelicae sinensis was about 500μg/g. The solvent system of the ferulic acid reference in most literatures was methanol, such as methanoic acid (95:5), 50% methanol, 50% alcohol. But the stability of ferulic acid is poor. It will disintegrate while in a environment of light and hot. The solvent which is mentioned above will lead ferulic acid a quick integration. After solvent screening, 5% methanoic acid was the best which could keep reference stabilizing in 48h. Finally, the dissolution assaying method——ultraviolet spectrophotometry was established. The results showed that the method could used to determine the dissolution of Angelicae sinensis dispersible tablet and the method was simple and fast, with a high precision. The curve of accumulation dissolution percentage-time was fitting to Weibull distribution model. The result of variance analysis of T50 and TD showed the dissolution behavior between dispersible tablet and common tablet exist extreme significant deviation. The dissolution percentage of Angelicae sinensis dispersible tablet was up to 80% at the time of 15minutes.