摘要
目的 建立高效液相色谱串联电喷雾检测器(HPLC-CAD)同时测定参麦颗粒中3种糖类成分含量的方法,结合色度值分析参麦颗粒色泽与糖类含量的相关性,为参麦颗粒处方制法中辅料蔗糖用量和温度控制提供依据;参考世界卫生组织(WHO)及《中国居民膳食指南(2022)》中游离糖的控制指标,评估参麦颗粒中辅料蔗糖的每日摄入量,为患者健康提供指导。方法 采用HPLC法测定30批参麦颗粒的糖类成分(果糖、葡萄糖、蔗糖)含量,计算游离糖的每日摄入量及供能比;采用Adobe Photoshop对来自同一光源下的参麦颗粒进行色度值(L^(*)、a^(*)、b^(*))的测定,对色度值及糖类成分进行相关性分析、聚类分析及偏最小二乘法-判别分析(PLS-DA)。结果 参麦颗粒各厂家辅料蔗糖用量均超过处方规定量,相关性分析结果显示果糖和葡萄糖的含量与色度值L^(*)呈极显著负相关,与a^(*)呈极显著正相关;可根据参麦颗粒颜色初步判断果糖和葡萄糖的含量,颜色越深,颗粒越偏红、偏蓝,含量越高。30批样品按不同厂家分别聚为三类,表明不同厂家生产的参麦颗粒颜色和糖类成分含量有差异显著,颜色越深,蔗糖降解越严重。30批参麦颗粒样品的蔗糖供能比均超过WHO及《中国居民膳食指南(2022)》中建议的10%,建议厂家开发无糖剂型。结论 所建立的糖类含量测定方法准确稳定,重复性好,为处方制法合理性提供参考,为制粒过程温度控制提供依据;通过控制蔗糖日摄入量,为患者健康状况提供指导。
Objective To establish a method for simultaneous determination of three kinds of carbohydrate in Shenmai Granules by high performance liquid chromatography tandem charged aerosol detector(HPLC-CAD),and to analyse the correlation between carbohydrate and chromatic value of Shenmai Granules,so as to provide a basis for the amount of sucrose and temperature control in the formulation of Shenmai Granules.According to the control indexes of free sugars in the World Health Organization(WHO)and the Dietary Guidelines for Chinese Residents(2022),the daily intake of sucrose in Shenmai Granules was evaluated to provide guidance for patients′health.Methods Determination of carbohydrate(fructose,glucose,sucrose)in 30 batches of Shenmai Granules by HPLC,and the daily intake and energy supply ratio of free sugars were calculated.Adobe Photoshop was used to measure the Carbohydrate(L^(∗),a^(∗),b^(∗))of Shenmai Granules from the same light source.Carry out correlation analysis,cluster analysis and partial least squares discriminant analysis(PLS-DA)on chromatic value and carbohydrate.Results The amount of sucrose of excipients in Shenmai Granules manufacturers exceeded the prescribed quantity.Correlation analysis results showed that the contents of fructose and glucose in Shenmai Granules were significantly negatively correlated with the value of L^(∗),and significantly positively correlated with the value of a^(∗).The content of fructose and glucose can be preliminarily determined according to the color of Shenmai Granules.The darker the color,the redder and bluer the granules,and the higher the content.30 batches of samples are grouped into three categories according to different manufacturers,which shows that the chromatic value and carbohydrate of Shenmai Granules produced by different manufacturers are different.The darker the color,the more serious the sucrose degradation.The sucrose energy supply ratio of 30 batches of Shenmai Granules samples exceeded 10% recommended by WHO and the Dietary Guidelines for Chinese Residents(2022),suggesting that enterprises develop sugar-free dosage forms.Conclusion The established method for the determination of sugar content was accurate,stable and reproducible,which provided reference for the reasonableness of the formulation method and the basis for the temperature control of the granulation process.And to provide guidance for patients′health status by controlling their daily intake of sucrose.
作者
雷蓉
刘亚茹
苏建
刘永利
LEI Rong;LIU Yaru;SU Jian;LIU Yongli(Hebei Institute for Drug and Medical Device Control,Hebei Key Laboratory of Traditional Chinese Medicine Quality Evaluation and Standard Research,Shijiazhuang 050227,China;Hebei Medical University,Shijiazhuang 050017,China)
出处
《药学研究》
CAS
2023年第8期574-578,604,共6页
Journal of Pharmaceutical Research
基金
中国药品监督科学行动计划第二批重点项目——中药有效性安全性评价及全过程质量控制研究项目(No.NMPAJGKX-2023-024)。
关键词
参麦颗粒
色度值
果糖
葡萄糖
蔗糖
一致性评价
化学模式识别
Shenmai Granules
Chromatic value
Fructose
Glucose
Sucrose
Consistency evaluation
Chemical pattern recognition
作者简介
雷蓉,女,硕士,工程师,研究方向:中药质量控制方法与质量评价研究,E-mail:honaaa@126.com;通信作者:刘永利,男,硕士,主任药师,硕士生导师,研究方向:中药质量控制方法与质量评价研究,Tel:0311-85212007,E-mail:liuyongli2008@126.com。
