Study On The Preparation Of Zhuzigantai Dispersible Tablets

Investigated the preparation technique and the optimum formulation of Zhuzigantai dispersible tablets by orthogonal experimental design,and developed the methods for determination the content of glycyrrhizin and corilagin.Extract conditions were studied by testing the total extraction of Phyllanthus amarus and the glycyrrhizin content using orthogonal experimental design. The optimal extraction condition of Phyllanthus amarus was extracted with 10 times amount of 75% alcohol, refluxing 2 hours at first, and then with 8 times amount of 75% alcohol, refluxing 2 hours. And the optimum process for the extraction of Sweritia mileensis T.N.Ho et W.L.Shih,Astragalus membranaceus and Glycyrrhiza uralensis Fisch was as follow: These herbal medicines were crushed, decocted 2 times with 10 and 8 times water, for 4 and 3 hours respectively.The best amounts of MCC, cCMC-Na, PVPP, using in the dispersible tablets, were be investigated by orthogonal design. The optimum dispersible tablet compositions were: MCC 50%, cCMC-Na 10% and PPVP 5%.The dissolution of that tablets was fast, could be completely form into suspension in one minute, which could screen through the No. 2 mesh. The stability of Zhuzigantai dispersible tablets is very good in the condition with 40℃and 75% relative humidity.Established the HPLC methods for determination of glycyrrhizin and corilagin contents. The determination of glycyrrhizin was performed on a RP-C18 column using methol-0.2mol/L ammonium acetate and glacial acetic acid(67:33:1) as mobile phase. The wavelength was 250nm, and the flow rate was 1.0ml/min. The determination of corilagin was performed on a RP-C18 column using methol-0.4% acetic acid as mobile phase. The wavelength was 268nm, and the flow rate was 1.0ml/min. the proposed methods are simple, reproducible and sensitive. The content of glycyrrhizin of three batch products is 8.29mg, 8.41mg, 8.27mg per tablet respectively and the content of corilagin of three batch products is 5.31mg, 5.24mg, 5.20mg per tablet respectively.