Study On Preparation Process And Quality Standards Of The Fufang Zushima Zhentong Plaster

The Fufang Zushima Zhentong plaster is a modern prescription based on the experienceof Traditional Chinese Medicine (TCM), according to TCM syndrome differentiationtheory and pharmacodynamic studies, and composed of three kinds of herbs that are CortexDaphnes, Rhizoma Curcumae, and Rhizoma Sparganii. It was found to be used in thetreatment of rheumatism, pain of bones, bruises and so on by clinical observation,with theefficacies of expelling the wind and dispelling the cold, relaxing tendons and invigorating thecirculation of blood, dispelling the congestion and relieving pain. The effect was obviouswhile the side effects were little. According to the chemical properties and pharmacologystudies of pharmacodynamic materials, and based on the TCM theory and the provisions ofthe handbook of research on natural medicine, the prescription was made into rubber plasterunder the guidance of modern pharmaceutical technology combine with the productionpractices. And the quality standards of the plaster was also studied for developing a new drugwith high and marked curative effects but fewer toxic reactions, which is convenient and easyto promote for the clinical.In this experiment，according to the efficacy and properties of preparation’s activecomponents，contents of daphnetin and curcumin, dried cream yield were used as indices ofappraisal in the orthogonal design of this experiment combined with single factor method, inorder to get the corresponding optimal processes of extraction using high-performance liquidchromatography.And the results were: Rhizoma Curcumae and Rhizoma Sparganii smashed,Cortex Daphnes grinded and passed40mesh screen, the three kinds of herbs were mixed asprescribed proportion, added10times the amount of70％alcohol to extract three times in theway of refluxing, each time1.5hours, filtered then spared.The appropriate excipients wereselected and their ratios were screened. The production process consists of smelting rubber,drying materials, spreeding, filming and slicing, then the product were gotten. The techniquesof TLC and HPLC was adopted in the studies of qualitative identification and contentdetermination for the product, and the conditions of prescription drugs by TLC and contentdetermination method of daphnetin which is effective ingredient of monarch drug weredetermined. Then it was examined under the relevant contents of rubber plaster in the "ChinaPharmacopoeia"2010Edition, and the preliminary quality standards were established for theplaster. The preliminary stability for this prduct was studied and results were fulfilled in thetext time. Studies show that the extraction, forming processes of Fufang Zushima Zhentong plasterare simple, reasonable and practicable. TLC and determination method are simple, specific.The quality standards of the preparation are stable and controllable.