痔舒宁中空栓的制备及质量控制  

Preparation and Quality Control of Zhishuning Hollow Suppositories

作　　者：张倩 王来成 王为 印晓星 王涛 王晖 卢文洁 吕冬梅 ZHANG Qian;WANG Laicheng;WANG Wei;YIN Xiaoxing;WANG Tao;WANG Hui;LU Wenjie;LV Dongmei(Department of Pharmacy,Affiliated Hospital of Xuzhou Medical University,Xuzhou 221006;College of Pharmacy,Xuzhou Medical University,Xuzhou 221004)

机构地区：[1]徐州医科大学附属医院药学部,徐州221006 [2]徐州医科大学药学院,徐州221004

出　　处：《药学与临床研究》2018年第5期351-354,374,共5页Pharmaceutical and Clinical Research

摘　　要：目的:制备痔舒宁中空栓并建立其质量控制方法。方法:以半合成脂肪酸甘油酯为基质制备中空栓,采用理化鉴别法及薄层色谱分析法对痔舒宁中空栓所含组分进行定性分析;采用高效液相色谱法对盐酸曲马多进行含量测定。结果:该制剂的一般检查项目均符合药典规定,薄层鉴别中供试品均斑点清晰,分离度好,且阴性对照无干扰;含量测定中,曲马多在50～300μg·mL^(-1)范围内线性关系良好(r=0.999 9),平均回收率为99.92%(RSD 1.68%,n=6),3批制剂检测平均含量99.23 mg/枚。结论:按照《中国药典》2015版及相关文献质量标准对痔舒宁中空栓进行质量检测,结果均符合规定。Objective:To prepare Zhishuning hollow suppositories and control the quality.Method:The hollow suppositories were prepared with semisynthetic fatty acid glyceride as the matrix.Physical and chemical identification and thin layer chromatography were used for qualitative identification of components contained in the Zhishuning hollow suppositories.The content of tramadol hydrochloride in the suppositories was determined by HPLC.Result:The results of general examination items of the preparation complied with the provisions of the ChP.The TLC spots were fairly clear,and the negative controls showed no interference.Tramadol was linearly determined in the range of 50-300μg·mL-1(r=0.9999),the average recovery of tramadol was 99.92%(RSD=1.68%,n=6).The average content of tramadol tested in 3 batches of the products was 99.23 mg per suppository.Conclusion:The quality of Zhishuning comply with the regulations in the 2015 edition of the ChP and relevant literature.

关 键 词：痔舒宁中空栓 薄层色谱法 高效液相色谱法 曲马多 

分 类 号：R943[医药卫生—药剂学]