论文部分内容阅读
目的评价自制与进口盐酸左西替利嗪片体外溶出行为的相似性。方法依据2010年版《中华人民共和国药典(二部)》标准和参照日本《医疗用药品品质情报集》中的溶出度试验条件,采用紫外分光光度法,分别以水、0.1 mol/L的盐酸、pH=4.0的醋酸盐缓冲液、pH=6.8的磷酸盐缓冲液为溶出介质进行测定,溶出方法为桨法,转速为50 r/min,并通过f2相似因子法评价自制与进口盐酸左西替利嗪片溶出曲线的相似性。结果 3个批号的自制片在不同溶出介质中30 min溶出度均大于90%,与进口片的相似因子大于50%。结论自制片与进口片的溶出曲线相似,提示该试验药品处方合理,生产工艺稳定可靠。
Objective To evaluate the in vitro dissolution behavior of levocetirizine hydrochloride tablets. Methods According to the dissolution test conditions in Pharmacopoeia of the People ’s Republic of China (2010) and reference to Japan’ s “Quality Information Set for Medical Use of Medicines”, UV spectrophotometry was used to separate the samples with water, 0.1 mol / L hydrochloric acid, pH = 4.0 acetate buffer, pH = 6.8 phosphate buffer for the dissolution medium determination, the dissolution method for the paddle method, speed 50 r / min, and by f2 similarity factor evaluation homemade and imported hydrochloric acid left West Alizarin tablets dissolution profile of the similarity. Results The results showed that the dissolution rates of the three batches of self-made tablets in different dissolution media were more than 90% at 30 min, and the similarities with the imported tablets were more than 50%. Conclusion Dissolution curves of self-made tablets and imported tablets are similar, suggesting that the prescription of the test drugs is reasonable and the production process is stable and reliable.