發(fā)布時間：2018-05-26 06:38

  本文選題：鹽酸頭孢他美酯 + 口服固體制劑　； 參考：《中國藥房》2017年13期

【摘要】：目的:為提高鹽酸頭孢他美酯口服固體制劑質(zhì)量的均一性、穩(wěn)定性及其質(zhì)量控制標準提供參考。方法:采用法定檢驗方法對105批鹽酸頭孢他美酯制劑(片劑、膠囊劑、干混懸劑和分散片)的性狀、鑒別、重量差異或裝量差異、水分、微生物限度、有關(guān)物質(zhì)、溶出度和含量等進行常規(guī)檢驗,并對檢驗結(jié)果進行分析;另對其雜質(zhì)來源、溶出度一致性評價、樣品剩余有效期與有關(guān)物質(zhì)及含量的相關(guān)性等進行探索性研究。結(jié)果:法定檢驗結(jié)果顯示,105批樣品中103批合格(合格率98.1%),不合格項目為性狀及有關(guān)物質(zhì),其他項目均符合相關(guān)規(guī)定;分散片的有關(guān)物質(zhì)測定方法與其他劑型差別較大。探索性研究結(jié)果表明,制劑中的有關(guān)物質(zhì)來源于原料以及生產(chǎn)和貯存過程中發(fā)生的降解反應;與國產(chǎn)參比片劑與膠囊劑比較,其他廠家產(chǎn)品溶出度的相似因子(f2)大多小于50;鹽酸頭孢他美酯制劑的有關(guān)物質(zhì)、含量與剩余有效期未見相關(guān)性。結(jié)論:105批國產(chǎn)鹽酸頭孢他美酯口服固體制劑質(zhì)量基本合格;片劑、膠囊和干混懸劑現(xiàn)行檢驗標準基本可行,但分散片的檢驗標準亟需提高。
[Abstract]:Objective: to improve the quality uniformity, stability and quality control of ceftamet hydrochloride oral solid preparation. Methods: 105 batches of ceftamet hydrochloride preparations (tablets, capsules, dry suspension and dispersible tablets) were determined by using the method of legal examination, including identification, weight difference or volume difference, moisture content, microbial limit and related substances. The dissolution and content of the samples were tested by routine methods, and the results were analyzed. The sources of impurities, the consistency evaluation of dissolution, the correlation between the remaining validity period of samples and the related substances and contents were also studied. Results: the results of legal examination showed that 103 of 105 samples were qualified (the qualification rate was 98.1%), the unqualified items were characters and related substances, the other items were in accordance with the relevant regulations, and the determination methods of related substances in dispersible tablets were quite different from those of other dosage forms. The results of exploratory study showed that the related substances in the preparation originated from raw materials and degradation reactions during production and storage, and were compared with those of domestic reference tablets and capsules. Most of the similar factors (F _ 2) of other products were less than 50, and there was no correlation between the content of ceftamet hydrochloride and the remaining period of validity. Conclusion the quality of 105-batches of domestic ceftamet hydrochloride oral solid preparations is basically up to standard, the present standard of tablets, capsules and dry suspensions is basically feasible, but the standard of dispersible tablets needs to be improved.
【作者單位】： 廣西壯族自治區(qū)食品藥品檢驗所;
【分類號】：R927.1

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