薄膜包衣对头孢氨苄胃内漂浮片的影响

Effect of film coating on cephalexin gastric-floating tablets

目的：考察薄膜包衣对头孢氨苄胃内漂浮片释药特性和起漂性能的影响。方法：采用3种不同型号欧巴代（Opadry、Omdry Ⅱ和OpadryAMB）膜材和3种渗透性的丙烯酸树脂[Eudragit RL 30D、RS 30D和RL 30D／RS 30D（1：1）]对头孢氨苄胃内漂浮片包衣，分别以Oparary和Eudragit RL 30D／RS 30D（1：1）对4，6，9，12kg硬度的片剂包衣，增重1％-3％，考察上述包衣条件对头孢氨苄胃内漂浮片释放特性和起漂性能的影响。结果：3种不同型号欧巴代包衣、不同包衣增重及4种硬度片芯包衣的片剂与未包衣片相比，释放特性无明显变化，起漂时间均大于15min，比未包衣前显著延长；6—9kg硬度片芯以渗透性适宜的Eudragit RL 30D／RS 30D（1：1）包衣，增重1％-2％均能保证15min内起漂，释药特性与未包衣前无明显变化。结论：对水具有渗透性、能束缚二氧化碳气体并具有一定抗张强度的衣材是胃内漂浮片优选的包衣材料.

Aim：To study the influence of the film coating on the release profile and floating lag time of cephaelxin gastric-floating tablets. Methods： The floating tablets with various hardness from 4 kg to 12 kg was coated with Opadry , Opadry Ⅱ, Opadry AMB, Eudragit RL 30D, RS 30D or RL 30D/RS 30D（ 1 ： 1 ）with increases in tablets weight ranging from 1% to 3 %. Results： The tablets, coated with each of three kinds of Opadry, with various increases in tablets weight or hardnesses, showed the release of cephalexin similar to the uncoated tablets. But the coated tablets had floating lag time 15 minutes later than that of the uncoated tablets. If cephalexin tablets with hardness of 6 - 9 kg were coated with Eudragit RL 30D/RS 30D （ 1 ： 1 ） with coating increases in tablet weight ranging 1%-2%, there was no evidence that the coating retarded the release, and the tablets floated within 15 minutes. Conclusion： The application of the selected polymers forming the coating film of suitable tensile strength and high water and low CO2 permeabilities allows the initiation of the rapid floating process rapidly and leads to no changes to the release profiles of the tablets.