卡波姆在重组IFN_α2b片剂中缓释作用的研究  

Effect of slow release of carbopol in the tablet of recombinant IFN_α2b

作　　者：程晓耕[1] 张淑洁[1] 肖艳玲[1] 

机构地区：[1]长春生物制品研究所,长春130062

出　　处：《药品评价》2005年第6期425-426,共2页Drug Evaluation

摘　　要：目的研究Carbopol(CP)在IFN片剂中的缓释作用。方法在IFN片剂和IFN溶液中加入0.1～4.0%不同浓度的CP,按IFN活性测定法测定各溶液的IFN活性。再按溶出度检查法检查当CP百分含量为0.1、0.5、1.0、2.0的各浓度在10min、30min、60min、120min时IFN释放的活性单位,计算总活性单位数量。最后再按常规法进行脆碎度检查。结果CP浓度在2%以内的IFN片剂和不加CP的IFN片剂和溶液其活性基本相同。不含CP的IFN片剂在10min内IFN即完全释放,含2%以下CP浓度的片剂IFN可在片剂中逐渐释放,释放时间可长达120min,释放数量恒定;含CP的IFN片剂脆碎度检查符合药典有关项下的规定。结论含2%以下浓度的片剂对活性无影响,可以零级速率释放IFN,比原片剂释药时间延长12倍。加入CP后片剂质量得到提高。Objective To study the effect of slow release of Carbopol （abbreviated to CP） in the IFN tablet. Methods Added CP with the concentrations of 0.1-4.0% to IFN tablet and solution. According to the assay of IFN, the titer of IFN in the above solutions was detected. Then in terms of the assay of dissolution, the titer of IFN released from the tablet with the CP concentrations of 0.1,0.5,1.0 and 2.0 at the time of 10min, 30min, 60min and 120min. Then the sum of the titer of IFN was obtained. The friability assay of the tablet was done. Results The titer of IFN was same between the tablet contained under 2% CP and the one without CP. IFN was completely released from the tablet without CP within 10min. While IFN was graduall the concentration under 2% CP and the release time was 120min y released from the tablet with long and release quantity was stable. Assay of friability of the CP tablet meet the requirements of Chinese Pharmacopoeia. Conclusion CP with the concentration of under 2% in IFN tablet was nothing to titer of IFN. IFN can be released from the CP tablet with the rate of zero grade and its release time was extent for 12 times, Tablet quality of the CP tablet was improved.

关 键 词：卡波姆 重组干扰素α2b 缓释制剂 

分 类 号：R94[医药卫生—药剂学]