Research On Quality Control Methods Of Wudi Medicinal Liquor And Wudidan Capsule

The Wudi medicinal liquor consists of 39 medical materials which are Radix Astragali,Radix Angelicae Sinensis,Radix Rehmanniae preparata,Radix Paeoniae Rubra,Resina Draconis,Radix Ginseng,Rhizoma Chuanxiong,Herba Cistanches and so on.It is the nineteenth one of the Ministry of health drug standards that contains the standard of this liquor which only has the TLC methods of cinnamaldehyde and Chuanxiong and hasn’t determination of content.Wudidan capsule consists of 20 medical materials such as Radix Astragali,Cortex Eucommiae,Herba Cistanches,Rhizoma Chuanxiong,Resina Draconis,Radix Notoginseng.The capsule standard is contained in twentieth volumes of the Ministry of health drug standards,which consists of only identification and detection.Both Wudi medicinal liquor and Wudidan Capsule have the efficacy of tonifying qi-blood,nourishing liver and kidney,strengthening the muscles and bones,stopping swelling and pain,removing rheumatism.They are mainly used for rheumatism that caused by insufficiency of the liver and kidney,sprain and backache leg pain.At present it is less about the research on quality control methods about Wudi medicinal liquor and Wudidan Capsule,so it is important to establish the quality control methods of them.Resina Draconis is the major medicine of Wudi medicinal liquor and Wudidan Capsule which is the resin of Dracaena cochinchinensi s(Lour.)S.C.Chen,there is removing blood stasis,promoting wound healing and muscle function.Resina Draconis contains flavonoids,saponin,phenols,organic acids,esters and volatile oil,among which Loureirin A and B as the representation of the two hydrogen chalcone composition are the main effective compositions of promoting blood circulation and removing blood stasis.This study established TLC methods of Radix Astragali,Radix Paeoniae Rubra,Radix Ginseng and HPLC method for the determination of Loureirin A and Loureirin B in Wudi medicinal liquor;established the TLC Radix Notoginseng in Wudidan capsule and the HPLC method of the determination of Loureirin A and Loureirin B,established the fingerprint research method of Resina Draconis,and LC-MS method of qualitative and quantitative research on the 6 components of the Radix Notoginseng.To provide a scientific basis for the quality control of the two traditional Chinese medicines.Part one Research on quality control methods of Wudi medicinal liquorObjective: To establish the quality control methods of Wudi medicinal liquor.Methods:The Radix Astragali,Radix Paeoniae Rubra,Radix Ginseng were identified by TLC and content determination of Loureirin A and Loureirin B by HPLC.The chromatographic column was Boston Green ODS C18(4.6 x 250mm;5μm),the mobile phase was acetonitrile-0.1% phosphoric acid solution with gradient elution,flow rate was 1.0mL min-1,the detection wavelength was 278 nm,the column temperature was 30℃.Results: The TLC identification exhibited same colour spots on the same location with control solution.On the research of assay,Loureirin A showed a good linear relationship in the range of0.0 2168~2.1680μg,the regression equation was Y=76.7149X+0.3893,R2=0.9999.Loureirin B showed a good linear relationship in the range of 0.01038~1.0380μg,the regression equation was Y=55.0714X+0.1357,R2=0.9998.The precision,repeatability and stability of the method were satisfying.The average recovery was in the range of 99~101%,RSD<2%.Conclusion: the methods established in this study have good specificity and can be used to control the quality of the product.Part two Research on quality control methods of Wudidan Capsule Objective: To establish the quality control methods of Wudidan Capsule.Methods:The Radix Notoginseng,Radix Astragali were identified by TLC and content determination of Loureirin A and Loureirin B by HPLC.The chromatographic column was Boston Green ODS C18(4.6 x 250mm;5μm),the mobile phase was acetonitrile-0.1% phosphoric acid solution with gradient elution,flow rate was 1.0mL·min-1,the detection wavelength was 278 nm,the column temperature was 30℃.The fingerprint research method of Resina Draconis was also HPLC which The chromatographic column was Thermo AcclaimTM 120 C18(4.6 x 250mm;5μm),the mobile phase was acetonitrile-0.1% phosphoric acid solution with gradient elution,flow rate was 1.0mL·min-1,the detection wavelength was 278 nm,the column temperature was 40℃.UPLC-MS was used to research the illegally added in Radix Notoginseng,The column was Waters BEH C18(1.7 μm,2.1 × 100 mm),the mobile phase was acetonitrile-water with gradient elution,flow rate of 0.5mL ·min-1,the column temperature was 40℃.Ion source mass spectrometry conditions for electrical spray(ESI source),monitoring model for negative ion multiple reaction monitoring mode,desolvation gas temperature was 500 ℃,capillary voltage:3.10 kV,cone voltage: 60 V.Results: The TLC identification exhibited same colour spots on the same location with control solution.On the research of assay,Loureirin A showed a good linear relationship in the range of 0.02168~2.1680μg,the regression equation was Y=76.7149X+0.3893,R2=0.9999.Loureirin B showed a good linear relationship in the range of 0.01038~1.0380μg/mL,the regression equation was Y=55.0714X+0.1357,R2=0.9998.The precision,repeatability and stability of the method were satisfying.The average recovery was in the range of 98~101%,RSD<2%.The Fingerprint of Resina Draconis in wudidan capsule was established,there were nine characteristic peaks,similarity above 0.9.An UPLC-MS method was established for the study of the illegally added in Radix Notoginseng.After the detection,found no illegal adding.Conclusion: This method is accurate and reliable,and it can be used to control the quality of the Wudidan Capsule.