2=1)。此方法檢測鹽酸川芎嗪在升華干燥12 h后含量減少9%,24 h其含量減少40%以上,48 h幾乎完全損失。結(jié)論 鹽酸川芎嗪在冷凍干燥過程中隨時(shí)間延長會(huì)因升華而使含量損失加重。;Objective To study the stability of tetramethylpyrazine hydrochloride in the process of freeze-drying preparation, and to provide a basis for freeze-drying powder injections which contain tetramethylpyrazine hydrochloride. Methods To determinate the content of tetramethylpyrazine hydrochloride by High Performance Liquid Chromatography (HPLC). It was the chromatographic conditions that mobile phase constitution was methanol-water, and methanol:water= 45:55, flowing rate was 1.0 mL/min; and column temperature was 40℃, sample volume:10 μL. Detecting wavelength was set at 295 nm, and the content of tetramethylpyrazine hydrochloride at different sublimation-drying was detected at 0 h, 12 h, 24 h and 48 h. Results Tetramethylpyrazine hydrochloride showed good linear relationship between the concentration of 10.5 μg/mL and 168 μg/mL, and the regression equation was Y=25.837X + 10.669 (R2=1). The content of tetramethylpyrazine hydrochloride reduced respectively 9% and 50% at 12 h and 24 h during the course of sublimation-drying, and almost completely lost at 48 h. Conclusion The content of tetramethylpyrazine hydrochloride lost more with the extension of the course of freeze-drying process."/>

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首頁 > 過刊瀏覽>2018年第41卷第1期 >2018,41(1):100-103. DOI:10.7501/j.issn.1674-6376.2018.01.018
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鹽酸川芎嗪在冷凍干燥工藝中的穩(wěn)定性研究

Experimental study of the change of content of tetramethylpyrazine hydrochloride in the process of freeze-drying preparation

發(fā)布日期:2018-03-17
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