非洛地平缓释片的制备及体外释放行为研究
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摘要
目的制备非洛地平缓释片,并对其进行体外释放行为研究。方法以聚氧乙烯40氢化蓖麻油为增溶剂,羟丙基甲基纤维素(HPMC)和羟丙基纤维素(HPC)为缓释材料制备非洛地平缓释片。通过单因素对处方进行初步筛选,以正交试验筛选出最佳处方,考察自制制剂和参比制剂在不同释放介质中的释放行为,并进行f_2相似因子比较。结果选择HPC(JXF)用量为15%,HPMC(E50)用量为30%,HPMC(E10M)用量为10%时,制备的非洛地平缓释片与参比制剂在不同的释放介质中相似因子f_2均在50以上。结论自制非洛地平缓释片体外释放行为与参比制剂相似。
Objective To prepare felodipine sustained-release tablets and determine its in vitro release. Methods Polyoxyethylene 40 hydrogenated castor oil was used as the solubilizing agent, and HPMC and HPC were used as the sustained-release materials to prepare felodipine sustained-release tablets. The prescriptions were screened by single factors, and the best prescriptions were screened by the orthogonal test. The release behaviors of self-made preparations and reference preparations in different release media were investigated, and f_2 similar factors were compared. Results When the selected amount of HPC(JXF) was 15%, HPMC(E50) dosage was30%, and HPMC(E10 M) dosage was 10%, the similar factor f_2 of the prepared felodipine sustained-release tablets and the reference preparation in different release media were above 50. Conclusion The in vitro release behaviors of self-made felodipine sustained-release tablets are similar to those of the reference preparation.
Objective To prepare felodipine sustained-release tablets and determine its in vitro release. Methods Polyoxyethylene 40 hydrogenated castor oil was used as the solubilizing agent, and HPMC and HPC were used as the sustained-release materials to prepare felodipine sustained-release tablets. The prescriptions were screened by single factors, and the best prescriptions were screened by the orthogonal test. The release behaviors of self-made preparations and reference preparations in different release media were investigated, and f_2 similar factors were compared. Results When the selected amount of HPC(JXF) was 15%, HPMC(E50) dosage was30%, and HPMC(E10 M) dosage was 10%, the similar factor f_2 of the prepared felodipine sustained-release tablets and the reference preparation in different release media were above 50. Conclusion The in vitro release behaviors of self-made felodipine sustained-release tablets are similar to those of the reference preparation.
引文
[1]李丹,宫建,孙晓辉,等.住院高血压患者的药物利用度研究[J].中南药学,2017,10(15):1470-1472.
[2]杜丽娜.非洛地平[J].临床药物治疗杂志,2004,2(1):46-50.
[3]朱雨秋,郭圣荣.非洛地平缓释片的研制及体外释放研究[J].药学实践杂志,2011,29(2):101-108.
[4]吴琼珠,禹道春,戴永健,等.非洛地平缓释片的释放度研究[J].解放军药学学报,2001,17(4):192-193.
[5]穆殿平,杨金荣,吉佩忠,等.非洛地平缓释制剂体外释放度比较[J].中国医院药学杂志,2003,23(11):657-659.
[6]梁竹,王宝德,于燕莉,等.不同产品非洛地平缓释片药动学比较[J].中国临床药理与治疗学,2005,10(5):551-554.
[7]Vogt M,Kunath K,Dressman JB. Dissolution improvement of four poorly water soluble drugs by cogrinding with commonly used excipients[J]. Eur J Pharm Biopharm,2008,68(2):330-337.
[8]徐志谦,马宜雪,董伦,等.非洛地平固体分散体缓释片的研制与优化[J].西南师范大学学报,2017,42(8):90-95.
[9]靖博宇,郑霞,何仲贵.非洛地平缓释片体外释药因素分析及释放度比较[J].海峡药学,2011,23(6):33-36.
[10]Cao QR,Chai JS,Liu Y,et al. A formulation approach for development of HPMC-based sustained release tablets for tolterodine tartrate with a low release variation[J]. Drug Dev Ind Pharm,2013,39(11):1720-1730.
[11]Qazi F,Shoaib MH,Yousuf RI,et al. Formulation development and evaluation of Diltiazem HCl sustained release matrix tablets using HPMC K4M and K100M[J]. Pak J Pharm Sci,2013,26(4):653-663.
[12]刘阿敏,丁斌,王磊,等.盐酸他喷他多缓释片的研制及体外释放考察[J].安徽医药,2015,19(11):2069-2074.
[13]刘晓娟,孙玉琦,张亚秋,等.盐酸曲美他嗪缓释片的研制及其体外释药特性考察[J].中国新药杂志,2012,21(5):567-570.
[14]Qiu YH,Garren J,Samara E,et al. Once-a-day controlled-release dosage form of divalproex sodium II:Development of a Predictive in vitro drug release method[J]. J Pharm Sci,2003,92(11):2317-2325.
[2]杜丽娜.非洛地平[J].临床药物治疗杂志,2004,2(1):46-50.
[3]朱雨秋,郭圣荣.非洛地平缓释片的研制及体外释放研究[J].药学实践杂志,2011,29(2):101-108.
[4]吴琼珠,禹道春,戴永健,等.非洛地平缓释片的释放度研究[J].解放军药学学报,2001,17(4):192-193.
[5]穆殿平,杨金荣,吉佩忠,等.非洛地平缓释制剂体外释放度比较[J].中国医院药学杂志,2003,23(11):657-659.
[6]梁竹,王宝德,于燕莉,等.不同产品非洛地平缓释片药动学比较[J].中国临床药理与治疗学,2005,10(5):551-554.
[7]Vogt M,Kunath K,Dressman JB. Dissolution improvement of four poorly water soluble drugs by cogrinding with commonly used excipients[J]. Eur J Pharm Biopharm,2008,68(2):330-337.
[8]徐志谦,马宜雪,董伦,等.非洛地平固体分散体缓释片的研制与优化[J].西南师范大学学报,2017,42(8):90-95.
[9]靖博宇,郑霞,何仲贵.非洛地平缓释片体外释药因素分析及释放度比较[J].海峡药学,2011,23(6):33-36.
[10]Cao QR,Chai JS,Liu Y,et al. A formulation approach for development of HPMC-based sustained release tablets for tolterodine tartrate with a low release variation[J]. Drug Dev Ind Pharm,2013,39(11):1720-1730.
[11]Qazi F,Shoaib MH,Yousuf RI,et al. Formulation development and evaluation of Diltiazem HCl sustained release matrix tablets using HPMC K4M and K100M[J]. Pak J Pharm Sci,2013,26(4):653-663.
[12]刘阿敏,丁斌,王磊,等.盐酸他喷他多缓释片的研制及体外释放考察[J].安徽医药,2015,19(11):2069-2074.
[13]刘晓娟,孙玉琦,张亚秋,等.盐酸曲美他嗪缓释片的研制及其体外释药特性考察[J].中国新药杂志,2012,21(5):567-570.
[14]Qiu YH,Garren J,Samara E,et al. Once-a-day controlled-release dosage form of divalproex sodium II:Development of a Predictive in vitro drug release method[J]. J Pharm Sci,2003,92(11):2317-2325.