目的 評(píng)價(jià)國產(chǎn)氯雷他定片的質(zhì)量現(xiàn)狀。方法 采用法定標(biāo)準(zhǔn)方法結(jié)合探索性研究對(duì)樣品進(jìn)行評(píng)價(jià)，統(tǒng)計(jì)分析檢驗(yàn)結(jié)果。結(jié)果 按法定標(biāo)準(zhǔn)檢驗(yàn)248批樣品，均符合規(guī)定，合格率為100%；探索性研究建立的HPLC法能有效分離氯雷他定及其5個(gè)雜質(zhì)。采用生物藥劑學(xué)分類系統(tǒng)（BCS）Ⅱ類藥物的兩點(diǎn)測(cè)定法分析樣本的溶出度能區(qū)分氯雷他定片質(zhì)量的優(yōu)劣。結(jié)論 本品按各執(zhí)行標(biāo)準(zhǔn)檢驗(yàn)，總體合格率較好，通過探索性研究擬定的方法有助于揭示產(chǎn)品的質(zhì)量問題，引導(dǎo)企業(yè)進(jìn)行制劑工藝改進(jìn)，提高藥品質(zhì)量。

Objective To evaluate the quality status of loratadine tablets.Methods Using statutory testing methods and combine with the exploratory research to evaluate the quality of loratadine tablets by statistical analysis of the results.Results The statutory standard methods showed 248 batches of loratadine tablets samples were qualified, the qualified rate was 100%. Exploratory studies have shown that the improved HPLC method of related substances could be separated from loratadine and five impurities with a good resolution. Adopting two points for biopharmaceutics classification system (BCS)Ⅱ drugs' assessment could distinguish the quality of the dissolution of loratadine tablets.Conclusion At present the most products quality of loratadine tablets can meet the current specifications. The exploratory research suggests that the new-established method can be used to improve the quality specification and is suitable for controlling the quality of this drug. The quality of domestic-made preparations needs to be improved.

廈門市重大科技項(xiàng)目（3502Z20121035）