Preparation Of Control Extract From Stem And Leaf Of Scutellaria Baicalensis And Its Application In Quality Control Of Chinese Medicinal Materials

Objective:1.To study the preparation methods and quality standards of the control extracts from stems and leaves of Scutellaria baicalensis;2.To establish the quality standards of the control extracts from stems and leaves of Scutellaria baicalensis;3.To study the feasibility of quality control of Scutellaria baicalensis stem and leaf control extracts instead of reference substances and control medicines.Methods:1.Taking the total flavonoids from stems and leaves of Scutellaria baicalensis as the determination index,orthogonal design L₉?3⁴?was used to study the effects of ethanol recycling on the extraction rate of total flavonoids,and to optimize the extraction process parameters;Macroporous adsorption resin was used to investigate the operation parameters of crude extract purification.Box-Behnken response surface methodology was used to analyze and establish a mathematical model to optimize the purification process parameters of crude extracts;11 batches of extracts from stems and leaves of Scutellaria baicalensis were calibrated by the same method,including character,identification,examination,fingerprint,content determination and stability.2.According to the technical requirements for the development of national drug standard substances,11 batches of Scutellaria baicalensis stem and leaf medicinal materials were studied in terms of their names,origins,properties,identification,inspection,extracts,content determination,meridian attribution,function,usage,dosage and storage.3.Scutellaria baicalensis stem and leaf control extract was used as a substitute for the reference substance to identify the stem and leaf of Scutellaria baicalensis by TLC.Results:1.Ethanol reflux method is more efficient for the preparation of crude extracts from stems and leaves of Scutellaria baicalensis.The result of orthogonal optimization is A₃B₂C₂:16 times 60%ethanol extraction,reflux twice,reflux 1 hour each time;Design-Expert 10.0.3 software was used to obtain the quadratic multiple regression equation between the yield of total flavonoids from stems and leaves of Scutellaria baicalensis and single factor variables.The analysis of variance showed that A?ethanol concentration?,B?flow rate?and C?elution volume??P<0.01?were all significant items,while elution flow rate?D??0.01<P<0.05?was significant items.The purification process was determined to be 80%ethanol concentration,1.5 mL·min^-11 flow rate,5 BV elution volume and 4 mL·min^-11 elution flow rate.The optimized method was used to purify the stem and leaf of Scutellaria baicalensis to prepare the control extract.The total flavonoid content of the three batches of the control extract was 66.93%,66.86%,66.71%,the average was 66.83%,the theoretical value was67.19%,and RSD was 0.38%,which indicated that the predicted value was close to the true value.With scutellarin as control,the TLC identification of each batch of extracts showed blue spots at the same location.Moisture must not exceed 6.0%,the total ash content should not exceed 3.0%,the similarity of fingerprints should not be less than 0.95,the content of scutellarin(C₂₁H₁₈O₁₂)should not be less than 6.0%.Samples were taken at the end of 0,1,3and 6 months respectively,and three batches of control extracts were tested,which were in accordance with the regulations,and no abnormalities were found.2.The name,origin,character,meridian tropism,function,usage,dosage and storage of Scutellaria baicalensis stem and leaf were described in detail.The microscopic and TLC identification items of the powder of medicinal materials were established.Water content should not exceed 13.0%.The total ash content shall not exceed 12.0%.The leachate should be determined by 50%ethanol hot-dipping method,not less than 23.0%.The content of scutellarin(C₂₁H₁₈O₁₂)should not be less than 0.70%.3.Scutellaria baicalensis stem and leaf control extract replaced the control substance and the control medicinal materials,showing blue spots in the same position.Conclusion:1.The control extract of the stem and leaf of Scutellaria baicalensis was stable and controllable.2.The established standards can provide reference for the quality control of Scutellaria baicalensis stems and leaves.3.Preliminary validation of the feasibility of the control extract of the stem and leaf of Scutellaria baicalensis for quality control of medicinal materials.