不同介质中盐酸氨溴索胶囊溶出曲线相似性比较的研究

Study on Hydrochloride Capsule Dissolution Curve Similarity Comparison in Different Medium

目的:评价自制盐酸氨溴索胶囊与市售原研品盐酸氨溴索片体外溶出行为的相似性。方法:分别考查自制试验制剂盐酸氨溴索胶囊和参比制剂盐酸氨溴索片在水、盐酸溶液(9→1000)、p H4.5醋酸盐缓冲液与p H6.8磷酸盐缓冲液等4种溶出介质中的体外溶出行为,以紫外-可见分光光度法进行测定,并采用f2相似因子法评价受试制剂和市售参比制剂溶出曲线的相似性。结果:在4种介质中,自制样品与参比制剂相似因子f2均在50~100之间。结论:在这4种介质中,自制试验制剂与参比制剂溶出行为相似,说明受试制剂的处方工艺合理。

Objective： Evaluation of Ambroxol hydrochloride capsule and branded goods sold Ambroxol hydrochloride in vitro dissolution behavior of similarity. Examining homemade test preparation. Methods： Ambroxol hydrochloride capsule and reference preparation Ambroxol hydrochloride tablets in water, hydrochloric acid solution（9→ 1000） p H4.5 acetate buffer and p H6.8 phosphate buffer in vitro dissolution behavior of 4 kinds of dissolution medium, by ultraviolet-visible spectrophotometry for determination of f2 similarity factor method is used to estimate preparations and commercially available reference subjects dissolution curve similarity. Results： In 4 kinds of medium, the homemade sample similar to the reference preparation factor f2 were between 50 and 100. Conclusion： in the 4 kinds of medium, homemade test preparation and reference preparation dissolution behavior, showed the prescription of preparation technology is reasonable.