【摘要】：通過對(duì)那西肽預(yù)混劑檢驗(yàn)與研究,對(duì)其質(zhì)量進(jìn)行分析,并對(duì)現(xiàn)有標(biāo)準(zhǔn)進(jìn)行修訂。依據(jù)現(xiàn)有標(biāo)準(zhǔn),對(duì)那西肽預(yù)混劑進(jìn)行常規(guī)檢驗(yàn),對(duì)標(biāo)準(zhǔn)進(jìn)行了修訂并確定質(zhì)量控制關(guān)鍵點(diǎn);根據(jù)文獻(xiàn)檢索和調(diào)研等情況,開展了含量均勻度、那西肽組分A、含量測(cè)定等3個(gè)方面的探索研究。建議取消標(biāo)準(zhǔn)中關(guān)于性狀的規(guī)定;調(diào)整了p H值的規(guī)定限度范圍為6.0~8.0;補(bǔ)充建立了那西肽組分A的測(cè)定方法,擬規(guī)定限度為不小于88.0%;以N,N-二甲基甲酰胺為溶劑,修訂了那西肽預(yù)混劑含量測(cè)定方法。
[Abstract]:Through the test and research of naciditide premix, the quality of nacitide premix was analyzed, and the existing standards were revised. According to the existing standards, the conventional test of naciditide premix was carried out, and the standard was revised and the key points of quality control were determined. According to the literature retrieval and investigation, the content uniformity, Naxi peptide component A and content determination were explored and studied. It is suggested that the stipulation on traits in the standard should be abolished, the limit range of pH value should be adjusted to 6.0 鈮，

本文編號(hào)：2474415