Quality Evaluation and Study of Dissolution Determination for Compound Norethisterone Tablet / 中国药房

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.

Preparation and Dissolution Rate of Gliquidone Solid Dispersion / 中国药房

OBJECTIVE: To prepare gliquidone solid dispersion and to investigate its dissolution rate. METHODS: The gliquidone solid dispersion was prepared by dissolvent- fusion method and dissolvent method with PEG- 6000( PEG) and PVP K30( PVP) as carriers. RESULTS: The results of in vitro dissolubility test showed that the higher the carrier ratio, the faster the drug dissolution. The in vitro dissolubility of solid dispersions was faster with PVP than with PEG as carrier. The dissolution rate of the gliquidone- PVP ( 1∶ 7) solid dispersion reached as high as above 70% in 10 minutes, which was superior to that of its bulk drug. CONCLUSION: The gliquidone solid dispersion has been prepared successfully.