國產(chǎn)阿莫西林口服制劑質(zhì)量評價
發(fā)布時間：2018-09-18 08:50
【摘要】：目的評價國產(chǎn)阿莫西林口服制劑的質(zhì)量現(xiàn)狀及存在問題。方法按照國家評價性抽驗(yàn)計(jì)劃總體要求,采用法定檢驗(yàn)方法結(jié)合探索性研究進(jìn)行樣品檢驗(yàn),統(tǒng)計(jì)分析檢驗(yàn)結(jié)果。結(jié)果法定檢驗(yàn)結(jié)果顯示355批樣品(其中319批膠囊,14批片劑,22批分散片)全部合格;不同廠家不同批次阿莫西林膠囊樣品中雜質(zhì)的種類基本一致,但這些雜質(zhì)在不同廠家產(chǎn)品中分布及含量有較大變化,同時不同劑型的雜質(zhì)譜也不盡相同;不同生產(chǎn)廠家膠囊之間溶出行為差異顯著。結(jié)論目前國產(chǎn)阿莫西林口服制劑的產(chǎn)品質(zhì)量基本能符合現(xiàn)行標(biāo)準(zhǔn)要求;而探索性研究提示現(xiàn)行標(biāo)準(zhǔn)不完善,建議有關(guān)物質(zhì)檢查項(xiàng)下增加阿莫西林噻唑酸、二酮哌嗪(2R)阿莫西林、阿莫西林閉環(huán)二聚體雜質(zhì)等單個雜質(zhì)參與主成份對照法定量,以規(guī)定它們在制劑中的限度;不同廠家的阿莫西林膠囊存在不同的溶出特性。
[Abstract]:OBJECTIVE To evaluate the quality status and problems of domestic amoxicillin oral preparations.METHODS According to the general requirements of national evaluation sampling plan,the samples were examined by statutory method combined with exploratory study,and the results were analyzed statistically.Results The statutory results showed that 355 batches of samples(319 batches of capsules,14 batches of tablets,22 batches of dispersed samples). The impurities in different batches of Amoxicillin Capsules from different manufacturers were basically the same, but the distribution and content of these impurities in the products of different manufacturers were greatly changed, and the impurity mass spectra of different dosage forms were also different. The dissolution behavior of Amoxicillin Capsules from different manufacturers was significantly different. The quality of oral preparations can basically meet the requirements of the current standards, while exploratory studies suggest that the current standards are not perfect, and it is suggested that single impurities, such as amoxicillin thiazolic acid, diketopiazine (2R) amoxicillin, amoxicillin closed-loop dimer impurities, should be added under the relevant substance inspection to participate in the principal component control method to determine their contents in the preparations. The limits of the dissolution of Amoxicillin Capsules from different manufacturers are different.
【作者單位】： 貴州省食品藥品檢驗(yàn)所;
【分類號】：R927
，
本文編號：2247395
[Abstract]:OBJECTIVE To evaluate the quality status and problems of domestic amoxicillin oral preparations.METHODS According to the general requirements of national evaluation sampling plan,the samples were examined by statutory method combined with exploratory study,and the results were analyzed statistically.Results The statutory results showed that 355 batches of samples(319 batches of capsules,14 batches of tablets,22 batches of dispersed samples). The impurities in different batches of Amoxicillin Capsules from different manufacturers were basically the same, but the distribution and content of these impurities in the products of different manufacturers were greatly changed, and the impurity mass spectra of different dosage forms were also different. The dissolution behavior of Amoxicillin Capsules from different manufacturers was significantly different. The quality of oral preparations can basically meet the requirements of the current standards, while exploratory studies suggest that the current standards are not perfect, and it is suggested that single impurities, such as amoxicillin thiazolic acid, diketopiazine (2R) amoxicillin, amoxicillin closed-loop dimer impurities, should be added under the relevant substance inspection to participate in the principal component control method to determine their contents in the preparations. The limits of the dissolution of Amoxicillin Capsules from different manufacturers are different.
【作者單位】： 貴州省食品藥品檢驗(yàn)所;
【分類號】：R927
，
本文編號：2247395
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