华蟾素胶囊释放度测定方法的研究
|
摘要
目的建立测定华蟾素胶囊释放度的方法。方法采用高效液相色谱法,测定华蟾素胶囊中华蟾酥毒基和酯蟾毒配基的溶出量,色谱柱为Ultimate AQ-C_(18),以乙腈-0.5%磷酸盐缓冲液(50∶50)(用磷酸调节pH值为3.2)为流动相,流速为0.5mL·min~(-1);检测波长为296nm;进样量10μL;柱温为40℃;考察不同的溶出介质、转速下华蟾素胶囊中华蟾酥毒基和酯蟾毒配基的溶出情况。结果建立了以磷酸盐缓冲液(pH值为6.8)100mL为溶出介质,转速为100r·min~(-1)的溶出方法。结论所建立的方法简便,准确,结果可靠,该方法可以用于该制剂的质量控制。
OBJECTIVE To establish a method to assay release of Cinobufacin capsules by HPLC.METHODS The dissolution of cinobufagin and recibufogenin in Cinobufacin capsules was determined by HPLC,The column was Ultimate AQ-C_(18),the mobile phase was acetonitrile-0.5% potassium dihydrogen phosphate(50∶50,v/v)(use the phosphoric acid adjusted to pH=3.2) with a flow rate of 0.5 mL·min~(-1),detection wavelength was 296 nm,column temperature was 40℃,injection volume was 10μL.The dissolubilities of cinobufagin and recibufogenin in Cinobufacin capsules were discussed with different dissolution mediums and difierent rotation speeds.RESULTS The method of dissolution tests for Cinobufacin capsules were established with 100 mL pH 6.8 phosphate buffer as dissolution media and the rotation speed was 100 r·min~(-1).CONCLUSION This method is simple and accurate,the results are reliable and it could be used for quality control of Cinobufacin capsules.
OBJECTIVE To establish a method to assay release of Cinobufacin capsules by HPLC.METHODS The dissolution of cinobufagin and recibufogenin in Cinobufacin capsules was determined by HPLC,The column was Ultimate AQ-C_(18),the mobile phase was acetonitrile-0.5% potassium dihydrogen phosphate(50∶50,v/v)(use the phosphoric acid adjusted to pH=3.2) with a flow rate of 0.5 mL·min~(-1),detection wavelength was 296 nm,column temperature was 40℃,injection volume was 10μL.The dissolubilities of cinobufagin and recibufogenin in Cinobufacin capsules were discussed with different dissolution mediums and difierent rotation speeds.RESULTS The method of dissolution tests for Cinobufacin capsules were established with 100 mL pH 6.8 phosphate buffer as dissolution media and the rotation speed was 100 r·min~(-1).CONCLUSION This method is simple and accurate,the results are reliable and it could be used for quality control of Cinobufacin capsules.
引文
[1]白政忠,刘利群,张丁丁,等.中成药口服固体制剂的系统分类与溶出度方法建立浅析[J].中国药品标准,2015,16(3):163-166.
[2]国家食品药品监督管理局.普通口服固体制剂溶出度试验技术指导原则[S].2009.
[3]国家药典委员会编.中国药典:四部[S].2015年版.北京:中国医药科技出版社,2015,38-40121-122,374-378.
[4]陈瀛澜,郝艳艳,郭夫江,等.蟾酥化学成分及药理活性研究进展[J].中草药,2017,48(12):2579-2588.
[5]孟姝,江婷玉,卜春景,等.中药制剂溶出度的研究进展[J].临床合理用药,2015,8(11):180-181.
[6]陈丽姣,杨冬霞,赵艳.HPLC法测定他米巴罗汀片的溶出度[J].中国药房,2016,27(30):4304-4306.
[7]肖娅,常金花,薛禾菲,等.栀子金花丸中3种成分溶出度的比较[J].中成药,2017,39(10):2076-2080.
[8]孙婷,姜建国,郭永辉.HPLC测定比沙可啶肠溶片体外释放度[J].中国现代应用药学,2017,34(01):81-84.
[9]谢沐风.如何科学、客观地制订溶出度试验质量标准[J].中国医药工业杂志,2012,43(3):A23-A32.
[10]姜红,金少鸿.固体药物制剂的溶出度比较[J].中国药事,2000,14(5):326-328.
[11]金鹏,刘艳,卜媛媛.不同厂家盐酸贝那普利片溶出度考察[J].中国药事,2015,29(2):183-185.
[12]李欣,郑少华,张沛沛,等.不同固体制剂中白杨素的溶出度评价[J].西北药学杂志,2016,31(01):76-79.
[13]李霞,刘放,吴宏富.华蟾素分散片的溶出度测定[J].中国药业,2010,19(24):37-39.
[2]国家食品药品监督管理局.普通口服固体制剂溶出度试验技术指导原则[S].2009.
[3]国家药典委员会编.中国药典:四部[S].2015年版.北京:中国医药科技出版社,2015,38-40121-122,374-378.
[4]陈瀛澜,郝艳艳,郭夫江,等.蟾酥化学成分及药理活性研究进展[J].中草药,2017,48(12):2579-2588.
[5]孟姝,江婷玉,卜春景,等.中药制剂溶出度的研究进展[J].临床合理用药,2015,8(11):180-181.
[6]陈丽姣,杨冬霞,赵艳.HPLC法测定他米巴罗汀片的溶出度[J].中国药房,2016,27(30):4304-4306.
[7]肖娅,常金花,薛禾菲,等.栀子金花丸中3种成分溶出度的比较[J].中成药,2017,39(10):2076-2080.
[8]孙婷,姜建国,郭永辉.HPLC测定比沙可啶肠溶片体外释放度[J].中国现代应用药学,2017,34(01):81-84.
[9]谢沐风.如何科学、客观地制订溶出度试验质量标准[J].中国医药工业杂志,2012,43(3):A23-A32.
[10]姜红,金少鸿.固体药物制剂的溶出度比较[J].中国药事,2000,14(5):326-328.
[11]金鹏,刘艳,卜媛媛.不同厂家盐酸贝那普利片溶出度考察[J].中国药事,2015,29(2):183-185.
[12]李欣,郑少华,张沛沛,等.不同固体制剂中白杨素的溶出度评价[J].西北药学杂志,2016,31(01):76-79.
[13]李霞,刘放,吴宏富.华蟾素分散片的溶出度测定[J].中国药业,2010,19(24):37-39.