目的 考察雷貝拉唑鈉腸溶片的溶出度，評價(jià)其體外溶出一致性。方法 采用高效液相色譜法測定雷貝拉唑鈉腸溶片含量，并進(jìn)行專屬性、回收率、精密度、穩(wěn)定性等方法學(xué)考察，以原研藥為參比制劑，采用籃法考察國產(chǎn)雷貝拉唑鈉腸溶片在pH 1.2、6.8、8.0三種溶出介質(zhì)中的溶出度并繪制溶出曲線，其中在pH8.0溶出介質(zhì)中考察了轉(zhuǎn)速（100、75 r/min）對藥物溶出行為的影響，以f₂相似因子法比較溶出曲線的相似性。結(jié)果 色譜條件為色譜柱：Diamonsil C₁₈（150 mm×4.6 mm，5 μm）；流動相：0.015 mol/L磷酸氫二鈉溶液（磷酸調(diào)節(jié)pH值至7.0）-乙腈55：45；體積流量1 mL/min；柱溫30℃；檢測波長290 nm；進(jìn)樣量20 μL。方法學(xué)驗(yàn)證結(jié)果均符合檢測要求。國產(chǎn)雷貝拉唑鈉腸溶片在pH 1.2溶出介質(zhì)中溶出曲線與參比制劑一致，在pH 6.8溶出介質(zhì)中僅有1個(gè)廠家的溶出曲線與參比制劑相似，在pH 8.0溶出介質(zhì)中有2個(gè)廠家的溶出曲線與參比制劑相似，且不同轉(zhuǎn)速對藥物的溶出行為無明顯影響，其余廠家溶出曲線與參比制劑均有較大差異，且在3種溶出介質(zhì)中沒有與參比制劑溶出曲線均相似的廠家。結(jié)論 國產(chǎn)雷貝拉唑鈉腸溶片仿制藥與參比制劑的體外溶出行為不一致。

Objective The dissolution of domestic rabeprazole sodium enteric-coated tablets was investigated and the in vitro dissolution consistency was evaluated. Methods A method for the determination of rabeprazole sodium enteric-coated tablets was established using high performance liquid chromatography. The original drug was used as a reference preparation, and the dissolution of the domestic rabeprazole sodium enteric-coated tablets in three dissolution media of pH 1.2, 6.8 and 8.0 was investigated by the basket method. Then, the dissolution curves were drawn according to the dissolution results, and the similarity of the dissolution curves were compared by f₂ similarity factor method. The effect of rotational speed on drug dissolution behavior was also investigated in pH 8.0 dissolution medium. Results The chromatographic conditions were as follows:chromatographic column:diamonsil C₁₈ (150 mm×4.6 mm, 5 μm); mobile phase:0.015 mol/L disodium hydrogen phosphate solution (adjusted to pH 7.0 by phosphoric acid)-acetonitrile 55:45; volume flow rate 1 mL/min; column temperature 30 ° C; detection wavelength 290 nm; injection volume 20 μL. The results of methodology validation met the detection requirements. The dissolution curve of domestic rabeprazole sodium enteric-coated tablets in the dissolution medium at pH 1.2 was consistent with that of the original drug, while the dissolution curve of only one manufacturer in pH 6.8 dissolution medium of was similar to that of the original drug. In pH 8.0 dissolution medium, the dissolution curves of two manufacturers were similar to those of the original drug, and the dissolution behavior was not significantly affected by different rotation speeds. The dissolution curves of the other manufacturers are significantly different from the original drug, and no manufacturer has similar dissolution curves with the original drug in the three media. Conclusion The dissolution behavior of domestic rabeprazole sodium enteric-coated tablets is inconsistent with that of the original drug.

R927.11

北京醫(yī)衛(wèi)健康公益基金資助項(xiàng)目（YWJKJJHKYJJ-A825）