采用多条溶出曲线评价灯盏花素片的质量

目的: 比较10家不同企业的灯盏花素片在4种介质中的溶出曲线,以评价该制剂的质量. 方法: 浆法,50 r·min^-1,分别在pH 6.0、pH 6.8、pH 7.6磷酸盐缓冲液和0.75%吐温水溶液中测定溶出曲线,并用单点法或f₂因子法进行了比较分析. 结果: A企业样品确定为参比制剂,D、H、J企业样品在4种溶出介质中均与参比制剂溶出过程相似;C、E、G、I企业样品在部分介质中与参比制剂溶出过程相似;B、F企业样品在4种介质中与参比制剂溶出过程均不相似. 结论: 溶出曲线测定可以反映不同企业生产的灯盏花素片质量存在差异,辅料的性质及使用量是影响灯盏花素片溶出过程的主要因素.

Objective: To compare the dissolution profiles of breviscapine tablets from 10 pharmaceutical manufactures in four dissolution mediums,so as to evaluate the drug quality. Methods: Paddle method was adopted at a rotated speed of 50 r·min^-1. The dissolution profiles were determined in pH 6.0,pH 6.8 and pH 7.6 phosphate buffer solutions and 0.75% Tween water solutions,and the results were analyzed by the method of single pointor f₂ factor. Results: The sample from pharmaceutical manufacture A was taken as reference preparation. All dissolution profiles of breviscapine tablets from pharmaceutical manufactures D,H and J were similar to the reference preparation. Among these samples from pharmaceutical manufactures C,E,G and I,only some dissolution profiles were similar to the reference preparation. The dissolution profiles from pharmaceutical manufactures B and F showed significant difference from that of the reference preparation. Conclusion: There are differences among the quality of breviscapine tablets from different manufactures. The properties and dosages of excipients have an important effect on the dissolution profiles of breviscapine tablets.

[1] LIN X(林雄),ZHU KD(褚克丹). Progress of pharmacological study on breviscapine(灯盏花素的药理学研究进展)[J]. Strait Pharm J(海峡药学),2005,17(6):5
[2] XIE MF(谢沫风). How to develop and validate dissolution test on the quality criteria(如何科学、客观地评价口服固体制剂内在品质―纵论我国固体制剂仿制药质量)[J]. Chin J Pharm(中国医药工业杂志),2010,7(14):19
[3] LUO JW(罗金文),LI HL(李会林),ZHOU MH(周明昊). Comparative studies on dissolution profiles of rosiglitazone preparations from different pharmaceutical manufacturers in two dissolution mediums(不同厂家罗格列酮制剂在两种溶出介质中的溶出曲线比较研究)[J]. Chin J Pharm Anal(药物分析杂志),2010,30(11):2194
[4] LI HG(李海刚). Studies on Oral Absorption of Breviscapus and Prepareation on of Self-microemulsion for Oral Administration(灯盏花素口服吸收机制及其自微乳剂的研制)[D]. Guangzhou(广州):Guangzhou University of Chinese Medicine(广州中医药大学),2011
[5] ZHANG QM(张启明),XIE MF(谢沫风),NING BM(宁保明),et al. Evaluation of solid oral products by dissolution profiles in different mediums(采用多条溶出曲线评价口服固体制剂的内在质量)[J]. Chin J Pharm(中国医药工业杂志),2009,40(12):946
[6] YANG L(杨林),HOU XM(侯小梅),GONG SX(龚士学),et al. Quality evaluation of domestic propafenone hydrochloride tablets by multiple dissolution curve(采用多条溶出曲线评价国产盐酸普罗帕酮片的内在质量)[J].Chin J Pharm Anal(药物分析杂志),2014,34(2):372
[7] XIE MF(谢沐风). Evaluation methods of comparability of dissolution curve(溶出曲线相似性的评价方法)[J].Chin J Pharm(中国医药工业杂志),2009,40(4):308
[8] CHEN XC(陈贤春),WU Q(吴清),WANG YR(王玉蓉),et al. Evaluation methods of dissolution profiles(关于溶出曲线比较和评价方法)[J]. Chin Hosp Phama J(中国医院药学杂志),2007,27(5):662
[9] ZHANG D(张迪),YUE QY(岳青阳),ZHANG L(张丽),et al. Comparative studies on dissolution curves of fluconazole capsules from different pharmaceutical manufactures in four dissolution mediums(不同厂家氟康唑胶囊在4种溶出介质中的溶出曲线比较研究)[J]. Chin J Pharm Anal(药物分析杂志),2012,32(8):1495