帅放文,章家伟,王向峰,刘鹏,周宏灏
SHUAI Fangwen,ZHANG Jiawei,WANG Xiangfeng,LIU Peng,ZHOU Honghao

• 1:中南大学临床药理研究所
• 2:湖南省药用辅料工程技术研究中心
• 3:湖南尔康制药股份有限公司

摘要(Abstract)：

目的通过羟丙基淀粉空心胶囊与利福平胶囊内容物的影响因素实验,评价羟丙基淀粉空心胶囊在利福平中的应用。方法样品经过高温、高湿处理5 d,10 d后,用反相高效液相色谱法检测利福平含量,其中流动相为甲醇-乙腈-0.075 mol/L磷酸二氢钾溶液-1.0 mol/L枸橼酸溶液(30∶30∶36∶4),检测波长为254 nm。结果利福平胶囊厂家1和厂家2的含量分别为97.13%,108.95%。影响因素实验后,明胶与羟丙基淀粉胶囊外观、色泽等外观形状均无明显变化且吸湿率均小于5%;样品标示量以及有关物质均满足药典要求。结论羟丙基淀粉空心胶囊可应用与利福平胶囊剂中。
OBJECTIVE To investigate the application of hydroxypropyl starch vacant capsules in Rifampicin through the experiment of affecting factors of hydroxypropyl starch vacant capsule and Rifampin capsule contents. METHODS The content of Rifampicin was detected by reversed-phase high performance liquid chromatography( HPLC) at 254 nm,after treated under the condition of high temperature,high humidity for 5 and 10 d. Methanol-acetonitrile- 0. 075 mol / L potassium dihydrogen phosphate- 1.0 mol / L citric acid( 30 ∶ 30 ∶ 36 ∶ 4) were used as mobile phase. RESULTS The contents of manufacturer 1 and 2 was 97. 13%,108. 95%,respectively. The appearance,colour and lustre had no obvious changes in the experiment. Hygroscopic property of gelatine capsule and vacant capsules from hydroxypropyl starch were less than 5%. The contents of Rifampicin and the related substances all accord with the standard of pharmacopoeia. CONCLUSION Testing results show that hydroxypropyl starch vacant capsule can be used for the preparation of Rifampicin capsule.

关键词(KeyWords)： 影响因素实验;羟丙基淀粉空心胶囊;利福平;明胶空心胶囊;反相高效液相色谱
experiment of affecting factors;gelatine capsule;Rifampicin;vacant capsules from hydroxypropyl starch;reversed phase high performance liquid chromatography

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基金项目(Foundation):

作者(Author): 帅放文,章家伟,王向峰,刘鹏,周宏灏
SHUAI Fangwen,ZHANG Jiawei,WANG Xiangfeng,LIU Peng,ZHOU Honghao

参考文献(References)：

• [1]化学药物制剂研究基本技术指导原则课题研究组.化学药物制剂研究基本技术指导原则[M].2004.
• [2]国家药典委员会.中华人民共和国药典[S].二部.北京:中国医药科技出版社,2010.