Objective: To study stability of deslanoside injection. Methods: The stability of deslanoside injection was investigated through acid destruction,alkaline destruction,oxidative destruction,light destruction,high-temperature processing at 121 ℃,accelerated test,and long-term test.Change trends of main content and impurity content of deslanoside injection were determined by HPLC.The Agilent ZORBAX-SB C18 column was used with gradient elution,taking acetonitrile-methanol (232:148) as mobile phase A and water as mobile phase B.The flow rate was 1.0 mL·min-1.The wavelength of detector was 220 nm. Results: Deslanoside injection was unstable under conditions of acid destruction,alkaline destruction,oxidative destruction,and light destruction,high-temperature processing at 121 ℃,the content of its impurities obviously increased under all of these conditions.In accelerated test,after being stored for 0,1,2,3,and 6 months,the average main content of 3 batches of deslanoside injection declined to 99%,97%,95%,92%,88%.In long-term test,after being stored for 0,3,6,9,12,18,24 months,the average main content of 3 batches of deslanoside injection declined to 99%,98%,97%,96%,94%,92%,89%. Conclusion: Sterilization temperature and time should be well controlled for deslanoside injection which should be tightly closed and kept out of light at a low temperature.Besides,rational expiration date should be specified for deslanoside injection.
[1] Goldsmith S R, Simon A B, Miller E.Effect of digitalis on norepinephrine kinetics in congestive heart failure[J].
J Am Coll Cardiol, 1992, 20(4):858
[2] Tsutamoto T, Wada A, Macda K,
et al.Digitalis increases brain natriuretic peptide in patient with severe congestive heart failure[J].
Am Heart J, 1997, 134(5) part 1:910
[3] Cokkinos D V, Tsartsalis G D, Heimonas E T,
et al.Comparison of the inotropic action of digitalis and isoproterenol in younger and older individuals[J].
Am Heart J, 1980, 100(6)part 1:802
[4] MA Shu-hua(马淑骅), HU Jian-jiang(胡剑江), WANG Yu-min (王玉敏),
et al.Comparison on the cardiotonic effect of Astragalus injection in the rats of two different acute heart failure models(黄芪注射液对两种急性心衰模型的强心作用比较)[J].
China J Basic Med Tradit Chin Med(中国中医基础医学杂志), 2011, 17(4):390
[5] Muniz-Junqueira M I, Mota L M, Aires R B,
et al.Digitalis inhibits and furosemide does not change the in vitro phagocytic function of neutrophils of healthy subjects[J].
Int Immunopharmacol, 2003, 3(10-11):1439
[6] Helke C J, Yuhaniak P A, Kellar K J,
et al.Effect of deslanoside on brain and spinal cord levels of serotonin and 5-hydroxy-indoleacetic acid tryptophan hydroxylase activity[J].
Biochem Pharmacol, 1978, 27(20):2459
[7] LI Ge-yuan(李舸远), CHEN Dong-ya(陈东亚), CAI Mei-ming(蔡美明).Impurity study of deslanoside injection(去乙酰毛花苷注射液杂质研究).[J]
Pharm Clin Res(药学与临床研究), 2011, 19(6):508
[8] Mathur AK, Sinha JN, Bhargava K P.Mechanism of deslanoside induced bradyarrhythmias[J].
J Mol Cell Cardiol, 1978, 10(1):58
[9] Helke C J, Quest J A, Gallis R A.Effects of serotonin antagonists on digitalis-induced ventricular arrhythmias[J].
Eur J Pharmacol, 1978, 47(4):443
[10] Helke C J, Kellar K J, Gills R A.Effect of arrhythmogenic doses of deslanoside on the uptake of monoamines in brain tissue and in cardiac tissue[J].
Eur J Pharmacol, 1978, 52(1):47
[11] ChP 2010.Vol Ⅱ(中国药典2010年版.二部)[S]2010:81
[12] HOU Yu-rong(侯玉荣), QIAN Wen(钱文).Determination of the content of deslanoside related substances in deslanoside injection by HPLC(HPLC法测定去乙酰毛花苷的含量及其有关物质)[J].
Pharm Clin Res(药学与临床研究), 2008, 16(3):238