.5 Traditional Chinese Drug Open Yu Ning Film Preparation Process And Quality Standards

AIMS: For the researching of the fifth rank new drug from Hypericum perforatum L.,the main aims of this research were evaluating the plant's chemical constituents,studying the mensuration for total flavonoids of Hypericum perforatum L., theextracting method of total flavonoids from Hypericum perforatum L., the preparativetechnique of Kaiyuning tablet, and establishing quality standards of the extrcating andthe tablet.METHODS: In the preparative technique, the extracting method for Hypericumperforatum L. with ethanol, the degreasing condition with n-Propanol and theextracting condition with Ethyl Acetate were selected by using separately L₉(3⁴)orthogonal designs. The volume for dissolving with water was researched. The L₉(3⁴)orthogonal design was carried out to select the optimum purification process ofmacroporous resin. In the studying of Kaiyuning tablet, we were researching manykinds of supplements, adhesives, disintegrants and wetting agents. And then thepreparative process of Kaiyuning tablet was established. The method was determinedfor the quality of total flavonoids of Hypericum perforatum L.In the quality controlstudy of the extracting and the tablet, TLC was used for the identification, the qualityof total flavonoids was determined by UV, qualities of Rutin, Quercetinum andHyperoside were determined by HPLC.RESULTS: Establishing the extracting method of total flavonoids from Hypericumperforatum L., the preparative technique of Kaiyuning tablet, the mensuration for totalflavonoids of Hypericum perforatum L., quality standards of the extrcating and thetablet. The linear range for total flavonoids was 8.24μg/ml～49.44μg/ml (r=0.9992)by UV. The average recovery of total flavonoids of Hypericum perforatum L. was98.22％and RSD was 2.0％. The average recovery of total flavonoids of theextracting was 97.9％and RSD was 2.18％. The average recovery of total flavonoidsof Kaiyuning tablets was 97.1％and RSD was 1.42％. The qualities of Rutin, Hyperoside and Quercetinum were determined by HPLC. The linear range for Rutinwas 0.254～2.54μg (r=0.99994), Hyperoside was 0.262～2.62μg (r=0.99999)and Quercetinum was 0.268～2.680μg (r=0.99999). For the extracting, the averagerecovery of Rutin was 99.09％(RSD=1.29％), Hyperoside was 98.87％(RSD=1.81％)and Queretinum was 99.39％(RSD=0.61％). For Kaiyuning tablets, the averagerecovery of Rutin was 99.84％(RSD=0.26％), Hyperoside was 98.98％(RSD=1.11％)and Queretinum was 99.79％(RSD=0.97％).CONCLUSION: The method was suitalble for the extraction and purification of totalflavonoids from Hypericum perforatum L. The preparative technique of Kaiyuningtablet was stable and reliable. The method for the quality of total flavonoids ofHypericum perforatum L. could control the quality of the herb. Quality standards ofthe extracting from Hypericum perforatum L. and Kaiyuning tablet were accurate andprecise.