Objective: To evaluate the best experimental system of the seven kinds of plasma for the assay of heparin. Methods: Coagulometer was used in the assay of activated partial thromboplastin time (APTT) as the British Pharmacopoeia (BP2008). Different plasma used in biological assay of heparin was evaluated by clotting time and the average recovery rate of heparin standard. Results: The reliability tests of the assays on fresh rabbit plasma, fresh sheep plasma, frozen sheep plasma, fresh pig plasma, frozen pig plasma, fresh rat plasma and frozen human plasma were all passed. The linear regression was significant (P<0.01). The parallel deviation, the conic curve and the reverse conic curve were not significant (P>0.05). The average recovery rates (%, n=3) of heparin on the seven kinds of plasma were 99.41±1.02, 100.47±3.48, 100.71±0.89, 100.94±0.71, 102.40±0.22, 100.84±1.06 and 101.55±3.16. The average FL% (%, n=3) were 2.63±0.21, 5.03±1.33, 4.90±0.37, 10.55±1.32, 4.04±0.79, 10.69±4.18, 7.81±0.35. Conclusion: Both the assays of heparin on fresh rabbit plasma and frozen sheep plasma are stable, accurate and precise. Fresh rabbit plasma and frozen sheep plasma are much better to be the experimental system of the biological assay of heparin than others.
1Drug Specifications Promulgated by the Ministry of Public Health,PR China,Vol 8(卫生部药品标准第八册),1993.21
2ChP(中国药典).2005.VolⅠ(一部):152,200,106,150,76
3CHEN Wei-lin(陈蔚琳),LOU De-bao(漏德宝).Study on quality control of Yindong-liyan oral solution(银冬利咽口服液的质量控制研究).Pharm Care Res(药学服务与研究),2007,7(2):120
4LI Jing(李菁).Study on quality standard for moluo capsule(摩罗胶囊质量标准的研究).Food Drug(食品与药品),2009,11(1):39
5 HUANG Wen-hua(黄文华),ZHAO Bin(赵斌),XIE Chao-liang(谢朝良),et al.Study on quality standard for Hongjinchan granules(红金蝉颗粒质量标准研究).Chin Tradit Pat Med(中成药),2008,30(12):1797
6 ZHANG Yi-ping(张一萍),XU Wei-xian(徐伟贤),CHEN Jin-rong(陈锦荣).Identification method of Ganjie Liyan granules by TLC(甘桔利咽颗粒的薄层色谱鉴别).Strait Pharm J(海峡药学),2008,20(1):58
7WANG Tian-zhi(王天志),LI Yong-mei(李永梅).Flos Loniceraes research progress(金银花的研究进展).West China J Pharm Sci(华西药学杂志),2000,15(4):292
8 CHEN Hui-jin(陈慧瑾),CHEN Xiao-wen(陈晓文),WU Fei-hua(吴飞华),et al.Determination of the content of chlorogenic acid in the Shuanghua Hansu solution by HPLC(高效液相色谱法测定双花含漱液中绿原酸的含量).Mod J Integr Tradit Chin West Med(现代中西医结合杂志),2009,18(5):558
9WANG Yue-ru(王跃茹),WANG Li(王利),CHEN Wei-dong(陈卫东),et al.Determination of chlorogenic acid in Qingfeiyin by HPLC(HPLC法测定清肺饮中绿原酸的含量).Anhui Med Pharm J(安徽医药),2009,13(2):156
10CHEN Lu(程璐),XU Hong-feng(徐宏峰),ZHANG Geng(张耕),et al.Determination of chlorogenic acid in Yanshuyin mistura with HPLC(高效液相色谱法测定咽舒饮合剂中绿原酸的含量).Her Med(医药导报),2009,28(1):105
11ZHOU Yi(周轶).Determination on the content of chlorogenic acid in Lianhua Qingwen capsule(连花清瘟胶囊中绿原酸的含量测定).Guiding J Tradit Chin Med Pharm(中医药导报),2009,15(4):95