目的 建立考察苯丙氨酯片溶出過(guò)程的方法，比較不同廠家的生產(chǎn)工藝及質(zhì)量。方法 以對(duì)照品法，利用FODT-601FX光纖藥物溶出度實(shí)時(shí)測(cè)定儀實(shí)時(shí)監(jiān)測(cè)苯丙氨酯片的溶出過(guò)程，并采用相似因子（f₂）對(duì)溶出曲線進(jìn)行一致性評(píng)價(jià)。結(jié)果 選擇0.5 mm探頭，260 nm為測(cè)定波長(zhǎng)，苯丙氨酯濃度在20～130 μg/mL與吸光度具有良好的線性關(guān)系，r=0.999 9。考察了市售的5個(gè)廠家（A～E廠）11個(gè)批次的苯丙氨酯產(chǎn)品在水中的溶出曲線，除D廠外各批次苯丙氨酯片的溶出度檢查結(jié)果均符合日本橙皮書的規(guī)定，但各廠家苯丙氨酯片的溶出曲線存在一定差異，選取樣品C1作為參比制劑，有A、C2、C3、E樣品的溶出曲線與C1相似（50≤f₂≤100），而B、D廠樣品的溶出曲線與C1明顯不同（f₂<50）。結(jié)論 光纖法溶出度能客觀反映苯丙氨酯片溶出全過(guò)程，監(jiān)測(cè)的5個(gè)廠家生產(chǎn)的苯丙氨酯片存在藥品溶出過(guò)程不相似以及部分廠家內(nèi)在質(zhì)量差異較大的問(wèn)題。

Objective To compare the differences in intrinsic qualities of products by observing dissolving-out process of phenporbamate tablets from different manufacturers. Methods The fiber-optic real-time dissolution detector was used and conditions adopted for dissolution were in accordance with detecting conditions of phenporbamate tablets dissolution, and similar factor method (f₂) was also used to evaluate differences of dissolution values of different manufacturer's phenporbamate tablets. Results Phenporbamate tablets was monitored at light path 0.5 mm and wave length 260 nm, and its absorbability was better with concentration at range of 20-130 μg/mL, r=0.999 9. Phenporbamate tablets from 11 different batches and 5 different manufacturers (A-E) conformed to the national drug standards (except D), but differences were found in the dissolution curves of those drugs. C1 was used as the reference preparation, only samples A, C2, C3 and E had similar dissolution process with C1's dissolution process (50 ≤ f₂ ≤ 100). However, both samples B and D had clear differences in their dissolution when compared to the dissolution process of C1 (f₂ < 50). Conclusion Fiber optic dissolution test system can objectively reflect the whole dissolving process of phenporbamate tablets.

廣西食品藥品安全科研項(xiàng)目（KY2017-03）