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止咳枇杷糖浆中辅料的研究

Research of excipients in Zhike Pipa Tangjiang
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摘要 目的建立止咳枇杷糖浆中蔗糖、防腐剂等辅料的含量测定方法。方法HPLC-ELSD法测定止咳枇杷糖浆中蔗糖、果糖、葡萄糖含量;HPLC法测定苯甲酸钠、山梨酸钾、羟苯甲酯、羟苯乙酯的含量,用建立的方法对5家企业23批止咳枇杷糖浆中蔗糖及其还原糖以及4种防腐剂进行测定。结果蔗糖、果糖、葡萄糖进样量分别在0.6528-9.792μg、1.3056-7.8336μg、1.3144-7.8864μg内呈良好的线性关系,平均回收率分别为102.8%、99.4%、100.2%;苯甲酸钠、山梨酸钾、羟苯甲酯、羟苯乙酯进样量分别在0.2114-4.2280μg、0.1047-2.0940μg、0.1011-2.0220μg、0.1062-2.124μg内呈良好的线性关系,未检出除苯甲酸钠外其他防腐剂的添加,苯甲酸钠回收率为96.5%。结论该研究建立的方法稳定可靠、专属性强、简便高效,为止咳枇杷糖浆中辅料的质量控制提供了参考。 Objective To establish a method for determining the content of excipients such as sucrose and preservatives in Zhike Pipa Tangjiang.Methods HPLC-ELSD method was used to determine the contents of sucrose,fructose,and glucose;HPLC method was used to determine the contents of benzoic acid,potassium sorbate,methylparaben,and ethylparaben.The established method was used to determine sucrose and its reducing sugars,and four preservatives,in 23 batches of Zhike Pipa Tangjiang from 5 enterprises.Results The linear ranges of sucrose,fructose,and glucose were 0.6528-9.792μg,1.3056-7.8336μg,and 1.3144-7.8864μg.The average recoveries were 102.8%,99.4%,and 100.2%.The linear ranges of sodium benzoate,potassium sorbate,methylparaben,and ethylparaben were 0.2114-4.2280μg,0.1047-2.0940μg,0.1011-2.0220μg,0.1062-2.124μg,respectively.No addition of preservatives were detected except sodium benzoate.The average recoveries of sodium benzoate was 96.5%.Conclusion The method developed is stable,reliable,highly specific and simple which provides a reference for the quality control of Zhike Pipa Tangjiang.
作者 陈思妮 李铮 常馨月 任禹轩 傅欣彤 Chen Sini;Li Zheng;Chang Xinyue;Ren Yuxuan;Fu Xintong(Beijing Institute for Drug Control,Beijing 102206,China)
出处 《首都食品与医药》 2026年第5期160-163,共4页 Capital Food Medicine
关键词 止咳枇杷糖浆 蔗糖 抑菌剂 高效液相色谱法 含量测定 Zhike Pipa Tangjiang sucrose preservatives HPLC content determination
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