ABSTRACT
OBJECTIVE:To evaluate the relative bioavailability of2kinds of preparations of cefaclor capsules.METH?ODS:The subjects'blood concentrations were determined by HPLC at different time after administered randomly crossover with single oral dose of cefaclor testing preparation or reference preparation.The actual values of C max and T max were adopted;AUC was calculated by trapezoid planimetry;the bioequiavailability of the2preparations were evaluated by two-sides and one-side t-test.RESULTS:The AUC 0～4 of the testing preparation and reference preparation were respectively(13.44?3.06)(?g?h)/ml and(14.19?3.28)(?g?h)/ml;their respective AUC 0～∞ were(13.80?3.08)(?g?h)/ml and(14.62?3.33)(?g?h)/ml;their respective C max were(11.65?2.39)?g/ml and(12.37?2.41)?g/ml;their respective t max were(0.57?0.24)h and(0.66?0.19)h.The relative bioavailability of testing preparation was(95.62?13.51)%.CON?CLUSION:The2preparations are bioequivalent.
ABSTRACT
Objective: To investigate effects of different excipients and its compounds on extract granulating made by spray drying and to find the best compound of making granule. Methods: Taking difficulty of granulating; obtaining rate, granule dissolution rate, hygroscopicity as assessing index, evaluating effects of different excipients and its compounds on granulating and finding the best compound. Results: Different excipients and its compounds could significantly decrease the hygroscopicity of extract. Different compounds could sharply affect difficulty of granulating, obtaining rate and granule disdoultion while lightly affecting the hygroscopicity. Conclusion: When critical relative moisture is controlled under 65%, the following two compounds can be selected: (1) extract sucrose silion dioxide (500∶115∶25). (2) extract sucrose microcrystalline cellulosec silion dioxide.
ABSTRACT
OBJECTIVE:To establish a RP-HPLC method for the determination of baicalin and jasminoidin in Qingkailing Injection.METHODS:It was performed on DiamonsilTM C18 column with acetonitrile-20 mmol?L-1 sodium dihydrogen phosphate solution (20:80)as mobile phase.The flow rate was 1.0 mL?min-1.The detection wavelength was 238 nm.RESULTS:The liner range of baicalin was 1～50?g?mL-1,(r=0.999 5)and the average recovery was 100.75%(RSD=1.75%);The liner range of jasminoidin was 0.1～10?g?mL-1(r=0.999 7)and the average recovery was 100.63%(RSD=1.35%).CONCLUSION:This method is rapid,simple,accurate and sensitive.It can be used for quality control of Qingkailing Injection.