不同厂家型号羧甲基淀粉钠对氨磺必利片溶出的影响

Effects of Different Types of Sodium Starch Glycolate from Different Manufacturers on Dissolution of Amisulpride Tablets

本研究比较了不同厂家型号羧甲基淀粉钠(sodium starch glycolate,SSG)对氨磺必利片溶出的影响。采用不同厂家、不同型号的SSG 制备氨磺必利片,并以原研制剂索里昂?为参比,分别于温度(60±2)℃、相对湿度(75±5)%的恒温恒湿箱中放样10d;温度(40±2)℃、相对湿度(75±5)%的恒温恒湿箱中放样3个月。通过崩解时限检查及体外溶出试验,观察到以磷酸盐基团交联的SSG,相对于以羟乙酸盐基团交联的SSG 具有改善崩解和溶出、提高溶出稳定性的作用,用其制得的氨磺必利片与原研制剂的溶出稳定性情况一致。本试验提示,采用磷酸盐基团交联的SSG 可改善由于使用羟乙酸盐基团交联的SSG 造成的氨磺必利片溶出稳定性差的问题。

The aim of this study is to evaluate the influence of sodium starch glycolate (SSG) from different manufacturers with different crosslink modes on dissolution of amisulpride tablets. Several self-made amisulpride tablets prepared by different SSG products and the original amisulpride tablets (Solian?) were stored at (60±2)℃/relative humidity (RH)(75±5)% for 10 d or (40±2)℃/ RH (75±5)% for 3 months. By testing the disintegration time and in vitro dissolution behaviors of above samples, it was found that SSG crosslinked by phosphate group (PG) could improve disintegration and dissolution behaviors of the generics, and increase dissolution stability, compared with SSG crosslinked by glycolate group (GG). The dissolution stability of amisulpride tablets that prepared by SSG crosslinked by PG was in accordance with that of Solian?. The PG crosslinking mode of SSG can improve the slow dissolution rate caused by using SSG crosslinked by GG and the dissolution stability of amisulpride tablets.