OBJECTIVE:To evaluate the inherent quality differences of different batches of Compound norethisterone tablet from different domestic enterprises by researching its in vitro dissolution,to provide reference for improving relevant standards in pharmacopoeia and optimizing production processes in drug manufacturers. METHODS:Orthogonal test was adopted to screen its dissolving conditions,small glass method was finally confirmed by detecting rotating speed,sampling time and dissolution medi-um,sampling determination was conducted with the dissolution medium of 0.5% sodium dodecyl sulfonate and rotating speed of 50 r/min and 45 min. And HPLC was adopted to simultaneously determine the in vitro dissolution of norethindrone and ethinyl estra-diol,then AV value method was adopted to detect the similarity of dissolution profiles of 8 batches of products from 2 domestic en-terprises. RESULTS:The dissolution profiles and similarity of AV value method showed the cumulative dissolution of 8 batches of Compound norethisterone tablet from 2 domestic enterprises had no significant difference at different time points,overall similarity was relatively high;but the ethinyl estradiol had certain difference,overall similarity was relatively low. CONCLUSIONS:The dif-ference of dissolution profiles of Compound norethisterone tablet may has effect on the drug efficacy,the production process and quality in domestic enterprises should be managed strictly. Meanwhile,the current method of dissolution is weak to distinguish from the quality,which needs to be improved urgently.

OBJECTIVE:To study transfer rate of asperosaponinⅥ in standard decoction of Dipsacus asper decoction pieces. METHODS:The content of asperosaponin Ⅵ in Dipsacus asper decoction pieces and its standard decoction was determined by HPLC. The determination was performed on SinoChrom ODS-AP with mobile phase consisted of acetonitrile-water(30∶70,V/V)at the flow rate of 1.0 mL/min. The detection wavelength was set at 212 nm,and column temperature was 30℃. The sample size was 10 μL. By the ingredients content obtained,the transfer rate of asperosaponin Ⅵ was calculated during decoction piece to standard decoction. RESULTS:The linear range of asperosaponin Ⅵ was 0.484-4.84 μ g(r＝0.999 9). RSDs of precision,stability and reproducibility tests were all lower than 2%. The limits of quantification and detection were 0.3 and 0.1 μ g,respectively. The average recoveries in D. asper decoction pieces and standard decoction were 95.13% -100.22%(RSD＝1.78%,n＝6), 97.07%-100.08%(RSD＝0.98%,n＝6). RSD of durability test was lower than 1%.The transfer rate of asperosaponin Ⅵ in standard decoction of D. asper decoction pieces ranged 26.3%-49.5%. CONCLUSIONS:The method is simple,accurate,precise, stable,reproducible and durable,and can be used for transfer rate of asperosaponin Ⅵ in standard decoction of D. asper decoction pieces.