[關(guān)鍵詞]
[摘要]
目的 采用近紅外光譜技術(shù)檢測腰痛寧膠囊粉末的混合均勻度,確定混合終點。方法 使用近紅外光譜儀采集腰痛寧膠囊藥粉混合過程圖譜,通過計算機分析軟件,進行藥粉混合均勻度的趨勢分析,同時采集不同混合時間的樣品,以士的寧、馬錢子堿的含量變化為指標(biāo),監(jiān)控生產(chǎn)過程中不同混合時間、取樣點中樣品的成分變化情況,以驗證確認混合終點。結(jié)果 經(jīng)過大量的試驗數(shù)據(jù)的統(tǒng)計、分析、驗證,腰痛寧膠囊藥粉在混合0.5 h已接近均勻,1 h時已經(jīng)混合均勻并穩(wěn)定,與近紅外的光譜趨勢相一致。結(jié)論 此方法簡便、可靠,可以用于腰痛寧膠囊生產(chǎn)中混合均勻度的趨勢分析,確定混合終點。
[Key word]
[Abstract]
Objective To detect mixture uniformity of Yaotongning Capsule by near-infrared (NIR) spectroscopy and to make sure the mixing end. Methods NIR spectra of Yaotongning Capsule powder in the mixing process were collected. Through computer analysis software, trend of powder mixing uniformity was analyzed. Samples collected at different mixing time were used to monitor the component change and confirm the mixing end with the changes of strychnine and brucine as indexes. Results Through extensive statistics, analysis, and validation, Yaotongning Capsule powder mixed for 0.5 h was close to uniform, and 1 h was homogeneous and stable, which was consistent with the trend of NIR spectroscopy. Conclusion This method is simple and reliable, and could be used for the trend analysis in Yaotongning Capsule manufacturing process and determination of the mixing end.
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[基金項目]