拉米夫定片原辅料相容性的研究  

Compatibility of lamivudine and related excipients

作　　者：吴文华 王丽娜 WU Wen-hua;WANG Li-na(Anhui Center For Drug Evaluation&Inspection,Hefei 230051;Hefei Administration for Market Regulation,Hefei 230041)

机构地区：[1]安徽省药品审评查验中心,合肥230051 [2]合肥市市场监督管理局,合肥230041

出　　处：《中南药学》2021年第6期1144-1147,共4页Central South Pharmacy

摘　　要：目的考察拉米夫定片原料药与各种辅料的相容性,以更好地控制和提高拉米夫定片的质量。方法将拉米夫定原料药与各种辅料混合后,通过稳定性影响因素试验,采用《中国药典》2015年版二部拉米夫定片有关物质检查方法,考察拉米夫定性状、有关物质、含量的变化。结果在高湿试验条件下,拉米夫定与微晶纤维素、羧甲基淀粉钠、欧巴代产生了新杂质胞嘧啶,杂质Ⅰ和其他杂质有新增,总杂质量增加,在高温和光照条件下均未有变化。结论拉米夫定片的原辅料在高湿条件下存在相容性风险,提示生产企业应优化处方,提高产品安全性。Objective To determine the compatibility of the raw and accessory in lamivudine tablets to control and improve product quality.Methods Lamivudine was mixed with various excipients,then the mixture was investigated by the accerlerated stability test.According to the determination methods for the relative substances in lamivudine tablets described in Chinese pharmacopoeia(the second part,2015 edition),the changes of external properties,relative substances and contents in the tablets to evaluate the compatibility of the raw material and accessories.Results Under the conditions of high humidity,the mixture of lamivudine with microcrystalline or sodium carboxymethyl starch or Opadry had new impurities,impurityⅠand other relative substances were increased,the total impurities were increased too.Conclusion The compatibility risk between lamivudine and related excipients suggests that the manufacturers should optimize the prescription and improve the product safety.

关 键 词：拉米夫定 辅料 相容性 

分 类 号：R94[医药卫生—药剂学]