Study On Quality Standard Of Yaotong Tablets And Yaotong Capsules

Objective: Establishment of Thin TLC identification and Content Determination Methods of Yaotong Tablets and Yaotong Capsules by Three Chromatographic Techniques: TLC,HPLC and UPLC-MS.To provide references for the improvement of quality control standards for Yaotong tablets and Yaotong capsules.Methods:?TLC was used to increase the identification of Fructus Psoraleae(Psoralen),Alisma(Alisol B 23-acetate),Achyranthes(?-Ecdysone),and Dipsacales(Asperosaponin ?)of the Yaotong capsules in the prescription,On the basis of the current quality standards of Yaotong Tablets and Yaotong Capsules.?Simultaneous determination of Paeoniflorin,Psoralen,Isopsoralen,Cinnamaldehyde of two preparations by HPLC.?HPLC method was used to study the chlorogenic acid,geniposide,and pinoresinol diglucoside of Eucommia ulmoides leaves in two preparations.?UPLC-MS method was used to determination of Geniposide and Pinoresinol diglucoside of Eucommia ulmoides leaves in two preparations.Results:?With the new TLC methods about Fructus Psoraleae(Psoralen),Alisma(Alisol B 23-acete)of two preparations,there are clearly spots at the corresponding positions of the samples and the control herbs and the reference substances,the negative without interference,the separation degree and Rf value is better,but the TLC identification of Achyranthes(?-Ecdysone)have negative interference.The TLC method about Dipsacales(Asperosaponin ?)of Yaotong capsules has the same color spots at the corresponding positions of the samples and the control herbs and the reference substances,Rf value is good and negative without interference.?The Paeoniflorin,Psoralen,Ipsoralen and cinnamicaldehyde showed a good linear relationships in their respective linear range(r>0.9993)of Yaotong tablets and Yaotong capsules,which stability,precision,reproducibility RSD Both are less than2.0%.The average recovery of Yaotong Tablets was 100.47%(RSD=0.99%)?99.88%(RSD=0.51%)?99.95%(RSD=0.82%)?100.34%(RSD=1.37%),and the average recovery of Yaotong capsules was 99.65%(RSD=0.68%)?100.71%(RSD=0.89%)?101.23%(RSD=0.92%)?100.99%(RSD=0.83%)? Using the Chlorogenic acid as an index component of Eucommia ulmoides leaves in prescriptions,Negative samples have interference and interference comes from diastolic.Under HPLC conditions,the content of Geniposidic acid was extremely low and the separation effect was poor,Pinoresinol diglucoside was not detected.?Geniposide and Pinoresinol diglucoside shouwed a good linear relationships in22.55~2255.0 ng(R=0.9996)?47.95~9591.0 ng linear range(r>0.9999)of Yaotong tablets,which stability,precision,reproducibility RSD Both are less than 2.0%.The average recovery of Yaotong Tablets was 99.5%(RSD=1.08)?100.65%(RSD=1.29).Conclusion:The original quality standards of Yaotong tablets and Yaotong capsules were revised to add the TLC of Fructus Psoraleae(Psoralen)and Alisma(Alisol B 23-acetate).In addition,Yaotong capsules also increased the TLC identification of Dipsacales(Asperosaponin ?).Revise the method of determining the original content of Yaotong tablets and Yaotong capsules to HPLC method for the simultaneous determination of Paeoniflorin,Psoralen,Iisopsoralen,Cinnamon aldehyde.The UPLC-MS method was established to determine the contents of geniposide and pinoresinol diglucoside in Yaotong Tablets,which provided a reference for improving the quality control methods of this kind of preparation.