今日药学

2021, v.31(07) 526-529

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含盐酸去氧肾上腺素的软胶囊辅料的筛选与评价
Screening and Evaluation of Excipients for Soft Capsules Containing Phenylephrine Hydrochloride

刘晓芬;邱科先;张俊林;
LIU Xiaofen;QIU Kexian;ZHANG Junlin;Anshi Pharmaceutical (Zhongshan) Inc.;

摘要(Abstract):

目的含盐酸去氧肾上腺素的软胶囊辅料的筛选与评价。方法采用高效液相色谱法进行药物稳定性的测定,色谱柱:Agilent Zorbax Plus C_(18)(150 mm×4.6 mm,5μm);流动相:流动相A:含1 g·mL~(-1)辛烷磺酸钠和5 mmol·mL~(-1)乙酸铵的水溶液,流动相B:乙腈-冰醋酸(100∶1,V/V),梯度洗脱;检测波长:270 nm;柱温:30℃。采用高效液相色谱法进行辅料的筛选,色谱柱:Agilent Zorbax XDB-C_(18)(150 mm×4.6 mm,5μm);流动相:60%乙腈;检测波长:355 nm;柱温:30℃。结果聚乙二醇中醛类化合物与盐酸去氧肾上腺素的β-芳基乙胺反应生成异喹啉,影响药物的稳定性。通过对聚乙二醇中醛类化合物的测定,筛选出最优的聚乙二醇来源于Sasol Germany GmbH。结论含盐酸去氧肾上腺素的软胶囊应选择醛类等羰基化合物限度为≤5 ppm的聚乙二醇。
OBJECTIVE To investigate the screening and evaluation of excipients for soft capsules containing phenylephrine hydrochloride. METHODS HPLC was performed for stability teston.Agilent Zorbax Plus C_(18)(150 mm×4.6 mm,5 μm) column was used with the mobile phase consisting of mobile phase A:aqueous solution containing 1 g·mL~(-1) of octanesulfonate sodium and 5 mmol·mL~(-1) ofammonium acetate,ang mobile phase B:acetonitrile-glacial acetic acid(100∶1,V/V).The method was performed by gradient elution. The detection wavelength was 270 nm and column temperature was 30 ℃.A HPLC was performed to screen excipients on a column of Agilent Zorbax XDB-C_(18)(150 mm×4.6 mm,5 μm) with the mobile phase consisting of acetonitrile-water(60∶40,V/V) at detection wavelength of 355 nm and column temperature of 35 ℃. RESULTS The aldehyde compounds in polyethylene glycol reacted with the β-arylethylamine of phenylephrine hydrochloride to form isoquinoline,which affected the stability of the drug.Through the determination of aldehyde compounds in polyethylene glycol,the best excipient was from Sasol Germany GmbH. CONCLUSION Soft capsules containing phenylephrine hydrochloride should choose polyethylene glycol with a limit of content less than 5 ppm to carbonyl compounds such as aldehydes.

关键词(KeyWords): 盐酸去氧肾上腺素;软胶囊;辅料筛选
phenylephrine hydrochloride;soft capsule;screening of excipients

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作者(Author): 刘晓芬;邱科先;张俊林;
LIU Xiaofen;QIU Kexian;ZHANG Junlin;Anshi Pharmaceutical (Zhongshan) Inc.;

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