目的 制訂潑尼松緩釋片中潑尼松及其體外釋放度的測定方法。方法 采用高效液相色譜法，C₁₈色譜柱（250 mm×4.6 mm，5 μm）；流動相：乙腈–水（24∶76）；UV檢測器檢測波長：240 nm；體積流量：1.0 mL/min；柱溫：30 ℃。對潑尼松緩釋片3批樣品和1批參比制劑進行了潑尼松的測定。采用pH 6.8磷酸鹽緩沖液500 mL作為釋放介質(zhì)，以第二法（槳法）裝置，轉(zhuǎn)速為75 r/min，分別在3、3.5、4、4.5、5、7 h取樣，采用高效液相色譜法測定潑尼松緩釋片中潑尼松的體外釋放度。結(jié)果 潑尼松的線性范圍為5～100 μg/mL。平均回收率為99.69%，RSD值為0.78%。潑尼松緩釋片自制樣品與參比制劑中潑尼松的測定結(jié)果一致。樣品在3.5 h內(nèi)無釋放、7 h內(nèi)釋放基本完成；自制樣品與參比制劑的體外釋放度結(jié)果一致，且批間重現(xiàn)性良好。結(jié)論 建立的潑尼松緩釋片中潑尼松和體外釋放度測定方法簡便、快速，易于操作。樣品和參比制劑中潑尼松測定和體外釋放度測定結(jié)果均一致。

Objective To establish a method for the determination of prednisone in Prednisone Sustained-release Tablets and its release in vitro.Methods The separation by HPLC method was performed on C₁₈ column (250 mm×4.6 mm, 5 μm) with mobile phase of acetonitrile - water (24:76). The UV detection wavelength was set at 240 nm. The flow rate was 1.0 mL/min, and the column temperature was 30 ℃. The contents of prednisone in 3 batches of Prednisone Sustained-release Tablets samples and 1 batch of reference preparation were determined. Phosphate buffer (pH 6.8) 500 mL was used as the release medium, the second method (paddle method) device was carried on, and the speed was 75 r/min. The samples were collected at 3, 3.5, 4, 4.5, 5, and 7 h, and the in vitro release of prednisone in Prednisone Sustained-release Tablets was determined by HPLC method.Results The content of prednisone had good linear range of 5 μg/mL to 100 μg/mL. The average recovery was 99.69% with RSD value of 0.78%. The determination results of prednisone in the self-made Prednisone Sustained-release Tablets sample and the reference preparation were consistent. The sample was not released within 3.5 h, but it was released within 7 h.In vitro releases of the self-made samples were consistent with those of the reference preparations, and the reproducibility between batches was good.Conclusion The established method for the determination and its in vitro release of prednisone in Prednisone Sustained-release Tablets is simple, rapid, and easy to operate. Determination andin vitro release of prednisone in samples and reference preparations were consistent.

R977