Preparation And Quality Evaluation Of Zhitonghuayu Plastics

Objective To screen the best craft for the preparation of Zhitonghuayu Plastics with orthogonal experiental design and provide quality evaluation as well.Methods 1.On the basis of the research of prescription of Zhitonghuayu and the choice of dosage form.Orthogonal test was adopted to investigate effects of the concentration and amount of ethanol,extraction time on ethanol extraction technology of the prescription of Zhitonghuayu with yield of Imperatorin and hydroxysafflor yellow A as comprehensive evaluation index.2.The polyvinyl alcohol(PVA1788)was used as the substrate.The appearance of the Plastics and the coating formation time were taken as evaluation indexes.L9(34)orthogonal test was used to screen the film forming process and the molding process was determined,and HPLC was used to detect the content of imperatorin and hydroxysafflor yellow A,and established the limit.3.Once and multiple dosing skin irritation test was carried out with New Zealand rabbit model.Results 1.Optimum extraction conditions were as follows:15-fold 60%ethanol reflux extraction for 2 hours.2.The best film forming process of Zhitonghuayu Plastics is:PVA1788 9g,glycerin 2ml,CMC-Na 0g;molding process is:12%PVA1788 alcohol solution,Chinese medicine concentrated liquid,glycerin by 75:23:2 ratio of mixing,fully stirring uniform,ultrasound 10 minutes.Content limit coating agent of imperatorin and hydroxysafflor yellow A is not less than 6.26 μg·ml-1 and 25.48μg·ml-1.3.Zhitonghuayu Plastics had no any irritant effect on the New Zealand rabbit skin.Conclusion 1.This optimized process was stable and feasible,it could provide a reference for further development of Zhitonghuayu Plastics.2.We successfully selected the optimized craft with fine plasticity and convenient application.The quality of Zhitonghuayu Plastics can be effectively controlled by HPLC method.3.Zhitonghuayu Plastics is new type of external preparation with high safety.