盐酸多奈哌齐口崩片的溶出曲线相似性研究

Dissolution similarity of donepezil hydrochloride orally disintegrating tablets

目的考察盐酸多奈哌齐口崩片自研制剂与参比制剂(规格均为5 mg)在4种不同pH介质中溶出行为的相似性。方法以日本卫材公司的盐酸多奈哌齐口崩片为参比制剂,测定自研制剂在4种不同介质中(pH=1.0盐酸溶液、pH=3.0醋酸盐缓冲液、pH=6.8磷酸盐缓冲液和水)的溶出曲线,采用高效液相色谱法检测并用相似因子(f2)法对溶出曲线的相似性进行评价。结果在pH=1.0、3.0、6.8不同介质中,自研制剂与参比制剂15 min时的溶出度均>85%;在水中两者的f2>50。结论自研制剂与参比制剂在4种不同溶出介质中的体外溶出行为相似。

Objective To determine the dissolution similarity of self-prepared and original preparations （5 mg per tablet） in 4 media with different pH values in vitro. Methods Paddle method was used to determine the dissolution of the sample in pH = 1.0 hydrochloric acid, pH = 3.0 acetic acid and sodium acetate buffer solution, pH = 6.8 phosphate buffer solution and water, with oversea listed donepezil hydrochloride orally disintegrating tablets as the reference preparation. High performance liquid chromatography was used to determine the content of the tablets. Similarity factor （f2） was used to evaluate the similarity of dissolution curves. Results In the 4 dissolution media, f~ of donepezil hydrochloride from self-prepared and reference preparations was both more than 50. Conclusion The dissolution of self-prepared and reference preparation is similar in 4 dissolution media.