Compatibility of Hollow Hydroxypropyl Starch Capsules with Drug Particles of Ofloxacin
SHUAI Fang-wen1,2,3, ZHANG Jia-wei2,3, WANG Xiang-feng2,3, WANG Xiao-qing2,3, ZHOU Hong-hao1*
1. Institute of Clinical Pharmacology, Central South University. Changsha 410078, China; 2. Engineering Technology Research Center of pharmaceutical excipients of Hunan Provincial, Changsha 410331, China; 3. Hunan ER-KANG Pharmaceutical Co., Ltd., Changsha 410331, China
Abstract��OBJECTIVE To investigate the compatibility of hollow hydroxypropyl starch capsules with drug particles of ofloxacin. METHODS The capsules were placed in conditions of high temperature of 40 �� or high humidity of (75��5)% RH for 5 and 10 d, respectively. The contents and related substances were determined by high performance liquid chromatography(HPLC), and the changes in the drug appearance and colors were observed. RESULTS After being stored under the conditions of high temperature and high humidity for 5 and 10 d, the contents of ofloxacin were in the range of 90%-110%, and no new impurities were detected, which conformed to the quality standard of ofloxacin capsules in the Chinese Pharmacopoeia 2010 edition. CONCLUSION There is good compatibility between ofloxacin and hollow hydroxypropyl starch capsules, which is consistent with the test results of gelatin capsules.
˧����,�¼�ΰ,�����,��С��,�ܺ��. �DZ�����ۿ��Ľ���������ɳ�ǽ���ҩ������������Կ���[J]. �й�ҩѧ��־, 2015, 50(13): 1130-1133.
SHUAI Fang-wen, ZHANG Jia-wei, WANG Xiang-feng, WANG Xiao-qing, ZHOU Hong-hao. Compatibility of Hollow Hydroxypropyl Starch Capsules with Drug Particles of Ofloxacin. Chinese Pharmaceutical Journal, 2015, 50(13): 1130-1133.
QIAN Y N.Research status ofloxacin and its clinical application.Anhui Med(����ҽѧ), 1995,15(2):54-55. SONALI S B, SANDIP B, AMRITA N, et al.Interactions and incom-patibilities of pharmaceutical excipients with active pharmaceutical ingredients .Excip Food Chem,2010,1(3):3-26. LU L H, WANG F, ZHANG J, et al.Determination of levofloxacin mesylate for injection related substances by HPLC .J Ind Sci(�ӱ���ҵ�Ƽ�),2006,23(5):271-273. Ch. P(2010). Vol ��(�й�ҩ��2010��. ����). 2010:821-823. ALIEN J. Drug-induced photosensitivity.Clin Pharm, 1993, 12(8): 580-587. UMEZAWA N. Participation of reactive oxygen species in phototoxicity induced bu quinolone antibacterial agent. Arch Biochem Biophys, 1997, 342(2): 275-281.
2015, Vol. 50 
