复方谷氨酰胺肠溶胶囊中L谷氨酰胺释放度的应用分析  

Determination of L-glutamine release degree in compound glutamin entersoluble capsules

作　　者：金玉[1] 郑长青[1] 

机构地区：[1]中国医科大学附属盛京医院消化内科,辽宁沈阳110021

出　　处：《沈阳药科大学学报》2014年第1期51-54,共4页Journal of Shenyang Pharmaceutical University

摘　　要：目的采用高效液相色谱法测定复方谷氨酰胺肠溶胶囊中L-谷氨酰胺在盐酸溶液及磷酸盐缓冲液中的释放度。方法采用HPLC法。流动相为质量浓度0．8g·L-己烷磺酸钠磷酸溶液（取己烷磺酸钠0．8g溶于1000mL双蒸水中，并加入磷酸0．5mL）-甲醇（体积比9：1），流速为1．0mL·min^-1，进样量为20止，检测波长为225nm。结果以谷氨酰胺质量浓度在0．05-1．0 g·L^-1内与峰面积呈良好的线性关系（r=0．9999）。复方谷氨酰胺肠溶胶囊中L-谷氨酰胺在盐酸溶液中释放度低于5％，在磷酸盐缓冲液中45、60．3和90min释放度分别为70．4％、76％和92．6％，提示复方谷氨酰胺肠溶胶囊在缓冲液中的释放符合《中华人民共和国药典》相关要求。结论该方法灵敏度和精密度高，重现性好。同时测定的药物释放度符合《中华人民共和国药典》相关要求。： Objective To determine the concentration and release degree of L-glutamine in glutamin entersol- uble capsules in hydrochloric acid solution and phosphate buffer by HPLC method. Methods High perform- ance liquid chromatograph was used in the study. Mobile phase was sodium hexanesulfonate solution （ sodium hexanesulfonate 0. 8 g was added into 1 000 mL of double distilled water followed by the addition of 0. 5 mL of phosphate ） -methanol （ V： V=9：1 ） ;the flow rate was set at 1.0 mL·min^-1 ,the sample amount was 20 μL, the detection wavelength was set at 225 nm. Results The peak area had good linearity with concentration in the range from 0. 05 to 1.0 g· L ^- 1 （ r = 0. 999 9 ）. L-glutamine release from glutamin entersoluble capsules in acid was lower than 5% ; however, the rates were 70. 4%, 76% and 92. 6% in PBS at 45 min,60.3 min and 90 min post initiating of release test respectively, which indicates that glutamin entersoluble capsules releasing was in accordance with the pharmacopoeia regarding releasing degrees of the en- teric preparation requirements. Conclusions The HPLC method has high sensitivity and accuracy, good reproducibility, and do not need to gradient elution. The determined drug release rate is in accordance with Chinese pharmacopoeia requirements.

关 键 词：高效液相色谱法 复方谷氨酰胺肠溶胶囊 L-谷氨酰胺 释放度 

分 类 号：R917[医药卫生—药物分析学]