基于气相色谱法逆向研究TALICIA缓释胶囊中5种辅料的含量  

Reverse study of five excipients in TALICIA extended-release capsules based on gas chromatography

作　　者：尚伯阳 满金田 白金缘 刘烁 赵旻[1] SHANG Boyang;MAN Jintian;BAI Jinyuan(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;Pfizer Investment Co.,Ltd,Beijing 100010,China;不详)

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]辉瑞投资有限公司,北京100010

出　　处：《中国处方药》2025年第7期34-41,共8页Journal of China Prescription Drug

摘　　要：目的对TALICIA缓释胶囊进行逆向工程研究,确定其辅料处方比例。方法采用气相色谱(GC)法测定TALICIA缓释胶囊中5种辅料(十二烷基硫酸钠、羟丙基纤维素、羟丙基甲基纤维素、玉米淀粉甘露醇混合物、硬脂酸镁)的处方量,并排除其他辅料的干扰。结果测得十二醇的保留时间为10.94 min,质量浓度在0.01~1.60 mg/ml内与各自峰面积呈良好的线性关系;2-碘丙烷及碘丙烷的保留时间分别为7.51 min、4.25 min,质量浓度在0.27~6.13 mg/ml和6.58×10^(-3)~3.86 mg/ml、0.50~6.25 mg/ml内与各自峰面积呈良好的线性关系;甘露醇的保留时间为23.98 min,质量浓度在0.33~20.00 mg/ml内与各自峰面积呈良好的线性关系;硬脂酸甲酯的保留时间为9.94 min,质量浓度在0.05~4.00 mg/ml内与各自峰面积呈良好的线性关系。每1.0 g TALICIA缓释胶囊白色微粒片芯粉末中十二烷基硫酸钠辅料的含量为8.57%,羟丙基纤维素和羟丙基甲基纤维素辅料的总含量为1.14%~6.98%;每1.0 g TALICIA缓释胶囊白色微粒包衣粉末中十二烷基硫酸钠辅料的含量为4.98%;TALICIA缓释胶囊白色微粒中甘露醇的含量为77.19%,玉米淀粉甘露醇混合物的含量为90.59%;硬脂酸镁的含量为1.51%。结论逆向工程研究能有效解析TALICIA缓释胶囊的辅料处方组成及用量,该实验方法准确、快速、可靠,可以作为控制产品质量的有效方法。Objective To conduct a reverse engineering study on TALICIA extended-release capsules and determine their excipient prescription ratios.Methods The prescribed amounts of five excipients(sodium dodecyl sulfate,hydroxypropyl cellulose,hydroxypropyl methylcellulose,mixture of cornstarch and mannitol,magnesium stearate)in TALICIA extended-release capsules were determined by the gas chromatography(GC)method while eliminating interference from other excipients.Results The retention time of dodecanol was measured to be 10.94 min,and the mass concentration showed a good linear relationship with the respective peak area within 0.01-1.60 mg/ml;the retention times of 2-iodopropane and iodopropane were 7.51 min,4.25 min,and the mass concentrations were in the range of 0.27-6.13 mg/ml and 6.58×10^(-3)-3.86 mg/ml,respectively,0.50-6.25 mg/ml showed a good linear relationship with the respective peak areas;the retention time of mannitol was 23.98 min,and the mass concentration showed a good linear relationship with the respective peak areas in the range of 0.33-20.00 mg/ml;the retention time of methyl stearate was 9.94 min,and the mass concentration showed a good linear relationship with the respective peak areas in the range of 0.05-4.00 mg/ml.The content of sodium dodecyl sulfate excipient per 1.0 g of TALICIA extended-release capsule white microparticle core powder was 8.57%,and the total content of hydroxypropyl cellulose and hydroxypropyl methyl cellulose excipient ranged from 1.14%to 6.98%;the content of sodium dodecyl sulfate excipient in the white microparticle coating powder of TALICIA extended-release capsules per 1.0 g of white microparticle was 4.98%;the content of sodium dodecyl sulfate excipient in the white microparticle coating powder of TALICIA extended-release capsules was 4.98%.Mannitol in the white microparticles of TALICIA extended-release capsules was 77.19%,and the content of corn starch mannitol mixture was 90.59%;the content of magnesium stearate was 1.51%.Conclusion The reverse engineering study can e

关 键 词：TALICIA缓释胶囊 逆向工程 处方研究 

分 类 号：R927.2[医药卫生—药学]