Objective To optimize the prescription of Dronedarone Hydrochloride Tablets, and to evaluate its dissolubility. Methods The main factors, such as the filler proportion of lactose and starch, concentration of 5%adhesive povidone K30 ethanol solution, content of solubilizing agent Poloxamer 188, and content of disintegrant polyvinylpolypyrrolidone were optimized by L9(34) orthogonal test with dissolubility of dronedarone hydrochloride as index. Dronedarone Hydrochloride Tablets (Multaq) from Sanofi-Aventis were selected as reference preparation, and the similarity of dissolubility curves were evaluated by the similarity factor (f2) method. Results The optimized prescription of Dronedarone Hydrochloride Tablets was as follows:filler proportion of lactose and starch was 2∶1, ethanol concentration of 5%adhesive povidone K30 was 40%, content of solubilizing agent Poloxamer was 2%, and content of disintegrant polyvinylpolypyrrolidone was 3%. In various dissolution media with different pH values, the dissolubility curves of Dronedarone Hydrochloride Tablets between self-prepared preparations and reference Multaq were compared, and similar factors f2 were above 50. Conclusion The dissolution behaviors of self-prepared preparations and reference Multaq in various dissolution media with different pH values are similar.

Objective To establish an HPLC method for determining fenofibrate in Fenofibrate Sustained-release Tablets. Methods HPLC was carried out on a Dikma C18 column(200 mm × 4.6 mm, 5 μm) with methanol- water(90∶10) as mobile phase. The detection wavelength was set at 288 nm. The injection volume was 20 μL at the flow rate of 1.0 mL/min. The temperature of column was set at 25 ℃. Results There were good linear relationship of fenofibrate in the range of 2 — 12 μg/mL(r = 0.999 9). The limits of detection and quantitation were 10 and 30 ng/mL, respectively. The average recoveries was 99.86% with RSD value of 0.72%(n = 9). Conclusion The method is accurate and simple for quality control of fenofibrate in Fenofibrate Sustained-release Tablets.

Objective:To study the method of preparing ginkgolides sustained-release tablets and investigate its vitro release characteristics.Method:the release of ginkgolides A(GA) and ginkgolides B(GB) was used as indicators to evaluate and optimize the formulation.The effets of hydroxypropyl methyl cellulose(HPMC) type and amount,the lactose amount,low-substituted hydroxypropyl cellulose(L-HPC) amount and carboxymethyl starch sodium(CMS-Na) amount on release behavior in vitro were observed in single-factor testing method.Then the formula-tion was optimized by orthogonal design test to determine the best preparation technological conditions.Result:The sustained-release tablets which were taken once a day,were prepared with HPMCK4M as matrix,low-substituted hydroxypropyl cellulose as disintegrant,microcrystalline cellulose and lactose as fillers.The tablets released 30% in 2 h,60% in 6 h,and exceeding 90% in 12 h,meeting the requirements for sustained-release.Conclusion:Ginkgolides sustained-release tablets prepared in this method has good behavior of release characteristics.The shape of tablets and compressibility were good.The preparative technology is also simple with low producing cost.

The method of preparing Ginkgolides gastric floating sustained-release tablet was studied and the releasing characteristics in vitro were also investigated.The floating and releasing performance in vitro were used as indicators to evaluate and optimize the formulation.Effects of hydroxypropyl methyl cellulose(HPMC) type and amount,sodium bicarbonate amount and stearic acid amount on release behavior in vitro were observed in single-factor testing method.Then the formulation was optimized by orthogonal design test to determine the best preparation technological conditions.The result showed that gastric floating sustained-release tablets,which were prepared with HPMCK4M as matrix,stearic acid as floating assistant,sodium bicarbonate as gas-producer,and microcrystalline cellulose and lactose as fillers,was taken once a day.And the tablet was released 35% in 2 h,60% in 6 h,exceeding 85% in 12 h.The releasing rate met requirements for gastric floating sustained-release.It is concluded that ginkgolides gastric floating sustained-release tablets prepared in this method has good release characteristics.The tablets are in good shape and compressibility.The preparative technology is also simple with low manufacture cost.