Study On The Preparation Process And The Quality Evaluation Of Yiqing Dispersible Tablet

Yiqing dispersible tablet comes from Yiqing granule of Chinese Pharmacopoeia by modifying the form. Consisting of Radix Scutellariae,Rheum officinale Baill. and Rhizoma Coptidis, Yiqing granule has being effecting in purging fire for removing toxin and cooling blood. In order to adapting clinical demand, its form is now changed into dispersible tablet which disintegrates very quickly and drug in it will dissolve faster, meanwhile, the preparation process and the quality control have been studied completely and systematically.1. The study has been done on pre-clinical pharmacy including determining preparation route, selecting extraction, concentration and dry technology according to the extractum and the contents transferring of baicalin, chrysopanol, Berberine hydrochloride by comprehensive test;Selecting description of the disintegrating agent and the bulking agent and matching and the metod of adding according to disintergrating time limited in the modeling technique。2. Assessing the quality control of medical material including the identification and the content determination, and regulated the content of medical material, calculated by the baicalin of Radix Scutellariae, emodin and chrysopanol of Rheum officinale Baill., and berberine of Rhizoma Coptidis must not be less than 14.5%,0.65%,6.7 %。3. Completing the quality criteria of the finished product especially establishing the method of determination of baicalin, emodin, chrysopanol, and berberine in Yiqing dispersible tablet including the preparation of the sample,chromatographic parameter and methodology tests, and regulated the content of Yiqing, calculated by the baicalin, emodin and chrysopanol, and berberine must not be less than 10.5,1.54,23,3 mg per tablet.4. Establishing its dissolution rate according to the dissolution and the systematic adaptability for the method of determination of baicalin, As a result, the dissolution of baicalin is higher than 80% in duration of 15 minute tests.5. The finger prints of Yiqing dispersible tablet were studied by HPLC including the preparation of the sample,chromatographic parameter and methodology tests , and finally established the common mold of the fingerprints. The similarities of 10 batch of Yiqing dispersible tablet were analyzed with "Computer Aided Similarity Evaluation" software for manifesting the satisfactory semblance among them.