| The ingredients of Xiao'er Qingre Zhike Orally Solution is listed in the Volumeâ… of "2005 Pharmacopoeia of the People's Republic of China". It consists of Herba Ephedrae, Semen Armeniacae Amarum, Gypsum Fibrosum, Radix Glycirrhizae, Radix Scutellariae, Radix Isatidis and Rhizoma Menispermi. Its action is to remove heat, release stagnated !ung-qi, relieve asthma and soothe the sore throat. It is primarily applied to infection by exopathogen of infants, cough and yellow-phlegm et al. In this thesis, using this extract of the ingredient as the model drug, and the preparation technics of the dispersion tablets Of traditional medicine was approached; the quality standard was established; the stability of herbal preparation was studied; in addition, the phannacodynamics was compared with the granule in the market.The completely quality standard of Xiao'er Qingre Zhike Dispersible Tablets (QRZK-DT) was formed in this paper. TLC method was used to identify the four kinds of main materia medica: Herba Ephedrae, Radix Scutellariae, Semen Armeniacae Amarum, Radix Glycirrhizae. The determination of disintegration and friability of tablets were carried out. HPLC was used to assay Ephedrine and it's fast and correct.This research paper focuses on powder dircet compression that is the method of QRZK-DT's preparation. It is useful to perform orthogonal experiment that is to quantify water prior to distilling the herbal medicine in accordance with pharmacopoeia. Because of lower water content and drying process time, the preferance way is vacuum dryness. And the dilutes of the tablet was selected according to the compression work, tensile strength and moisture absorption. Correspondingly, disintegrant was chosen through the water absorption experiment, swelling capacity.However, the combination used of super-disintegrants and microcrystalline cellulose can fulfill at most 3 minites disintegration time when it contain 50% extract. And it is shown that the optimized formualtion was composed of extract50% (w/w), MCC30125% (w/w), Tabletase7012.5% (w/w), L-HPC (Shin-Etsu) 10% (w/w), Magnesium stearate 1.5 %, Erythrol 2% et al。Base of the Extract's pyrogenation experiment, the apparent expire date is 837.2 day. The results of the stability tests showed: QRZK-DT were stable to 3-month acceleration and 3-month room temperature experiment. Besides, the results of ephedrine content determination in the dispersible tablet, disintegration time, friability and TLC were positive.The pharmacodynamics experiments of inhibition of cough, inflammation and fever were done. The results show that QRZK-DT could obviously remove heat, relieve cough and have anti-inflammatory effect. There was no difference between QRZK-DT and the granule in the market. |
