Quality Analysis Of Asini Corii Colla And Feining Granule

Tradictional Chinese medicine had a long history and is always regarded as the gem of China. Its therapeutic effect was validated by long period of clinical practice. However, how to carry out deep research on material basis and quality control is what the modernization of TCMs faced with. This thesis took Asini Corii Colla and Feining Granule as the objects, and the main academic contributions are as follows:A RP-HPLC method with precolumn derivatization for the simultaneous determination of 13 amino acids in Asini Corii Colla was established. The 13 amino acids were separated within 36 min with a good linearity (r>0.9977) in the range of the test concentration. The average values of recovery (n=3) were 95.2%-104.4% and the RSD values were less than 5.0%. The method is simple, accurate, and repeatable, which could be applied for the quality control of Asini Corii Colla. It may also serve as a good reference for the determination of amino acids in other Pharmaceuticals.Components B01-B04 of the whole extract of Senecio cannabifolius Less. var. integrifolius. were obtained by liquid-liquid extraction, and they were separated well except that the organic acids occurred in both components B01 and B02. Subcomponents were acquired by preparative HPLC. The chemical profile of the whole extract and the components was thoroughly and systematically investigated by using LC-Q-TOF-MSD, LC-IT-MSD, NMR and comparing with the standard substances. Several compounds were only detected in components. When tested by LPS-induced NO production, the extract exhibited an inhibitory rate of 35.7% at the concentraction of 50 ?g/mL. To dig up the potential effective constituents,15 compounds were tested with the same experimental procedure and 11 of them showed anti-inflammatory activity in varying degrees.On basis of the evaluation of pharmacological activity, a HPLC method was developed for the determination of 10 compounds in Feining granule. The results showed that these 10 compounds had good linearity (R2>0.999) in the range of the test concentration. The average values of recovery of high, median, and low concentrations (n=3) were 95.2%-104.8% and the RSD values were less than 4.3%. The proposed method was subsequently applied for simultaneous determination of 10 constituents in 17 batches, i.e.,9 batches from Senecio cannabifolius Less. and 8 from Senecio cannabifolius var. integrilifolius. There was significant difference between the two varieties by t-test in the contents of homogentisic acid, chlorogenic acid, hyperoside, isoquercitrin, and 3,5-dicaffeoyl quinic acid (p<0.05). While the contents of other compounds in these two twrieties of Feining Granule had few difference. For the limit tests of noxious pyrrolizidine alkaloids, a HPLC-MSD method was established to determine seneciphylline and senecionine in 10 batches of Feining granule, in which 5 from Senecio cannabifolius Less. and 5 from Senecio cannabifolius var. integrilifolius. The contents of the two alkaloids examined, seneciphylline and senecionine, were below the limit (40 ?g/g) in all the tested samples, yet they varied widely in different batches. As for the two varieties, senecionine was only detected in the preparation of Senecio cannabifolius var. integrilifolius.