目的 對氨苯喋啶片101批樣品進(jìn)行法定標(biāo)準(zhǔn)檢驗及探索性研究，對該品種的質(zhì)量狀況作出總體分析及評價。方法 法定標(biāo)準(zhǔn)檢驗依據(jù)《中國藥典》2010年版二部，其質(zhì)量標(biāo)準(zhǔn)設(shè)定有性狀、化學(xué)反應(yīng)鑒別、溶出度、重量差異、UV法測定含量。探索性研究參照BP2010年版氨苯蝶啶原料項下有關(guān)物質(zhì)檢測方法，采用優(yōu)化后的HPLC法考察各企業(yè)提供的氨苯蝶啶原料及101批片劑中的有關(guān)物質(zhì)；采用HPLC法測定5個企業(yè)的樣品在4種不同pH值介質(zhì)中的溶出曲線，并與日本橙皮書中氨苯喋啶片溶出曲線進(jìn)行比較；建立了溶出度測定的非標(biāo)方法，并對全部樣品進(jìn)行檢驗；為考察輔料及各有關(guān)物質(zhì)對氨苯蝶啶含量測定的影響，建立了HPLC法測定氨苯蝶啶片含量的方法。結(jié)果 法定標(biāo)準(zhǔn)檢驗：101批樣品，5批次不符合規(guī)定，不合格率為5%，不合格項目均為溶出度檢查。探索性研究：有關(guān)物質(zhì)研究表明制劑中的雜質(zhì)來源于原料，檢驗101批樣品，均檢出已知雜質(zhì)B、C和一個未知雜質(zhì)，均未檢出已知雜質(zhì)A；溶出曲線及溶出度研究比較了該制劑在4種不同pH值介質(zhì)中的溶出曲線，5家生產(chǎn)企業(yè)制劑溶出曲線與日本橙皮書上的相似性差異大，有3家生產(chǎn)企業(yè)的自身批間均一性相對較好；含量測定結(jié)果說明輔料及各有關(guān)物質(zhì)對氨苯蝶啶含量測定基本無影響。結(jié)論 各生產(chǎn)企業(yè)氨苯蝶啶片的質(zhì)量參差不齊，總體質(zhì)量狀況與日本藥品有差距，建議進(jìn)一步進(jìn)行生物等效性研究，改進(jìn)制劑工藝，提高質(zhì)量。

Objective The quality overall analysis and evaluation were made through the combination of mandatory standard inspection and exploratory research of 101 batches of Triamterene Tablet samples. Methods Mandatory standard inspection: pursuant to the Chinese Pharmacopoeia 2010, the quality standard consisted of properties, chemical reaction identification, dissolution rate, weight variation, and UV spectrometry content. Exploratory research: with reference of Triamterene raw material relative testing method of BP 2010, the optimized HPLC method was employed to inspect the relative materials of producers provided triameterene raw materials and 101 batches of Triamterene Tablets. The PHLC method was employed to achieve the dissolution curves of five producers provided Triamterene samples in four media with different pH values . The comparison among those dissolution curves with the ones of Japan Orangebook was made accordingly. The non-standard method of Triamterene was established and applied to inspect all samples. To investigate the influence of auxiliary materials and relevant materials in triamterene, the PHLC was developed for the determinatin of triamterene content in Triamterene Tablets. Results Mandatory standard inspection: among 101 batches of sample, five batches were inconformity, the fraction defective was about 5%, the unqualified item was dissolution inspection. Exploratory research: in the relevant material research, 101 batches of sample were inspected, all samples were detected with known impurity B, C, and a unknown impurity, no known impurity A found. Dissolution curve and dissolution rate research: to compare the dissolution curves of preparations in four media with different pH value, the dissolution curves from five producers’ preparation have the apparent similar difference with the ones of Japan Orangebook, while the inter-batch uniformity of three producers’ products was relative good. The result of the content inspection indicated that the auxiliary materials and relevant materials were with no apparent influence on the triamterene content inspection. Conclusion The quality of Triamterene Tablets from the individual producer are uneven, while the overall quality is lower than that of Japanese product. It is suggested to enhance the pharmaceutical bioequivalence study, innovate the pharmaceutical technology, and to improve the quality accordingly.