摘要
目的:对灯盏花素片从有效性、物质基础、安全性方面进行质量评价与分析。方法:运用法定标准检验灯盏花素片样品;采用UV法测定不同企业样品在p H值6.0、6.8、7.6及含0.75%吐温水溶液4种溶出介质中的溶出曲线;以p H 6.8为溶出介质,桨法50转/分,30 min取样,UV法测定样品的溶出度;采用HPLC-DAD法测定野黄芩苷的含量,进行相关物质的分离与鉴定,以及特征图谱的测定;采用ICP-MS法测定样品中重金属及有害元素的含量;采用GC、GC-MS法对样品的丙酮残留、大孔树脂残留和薄膜衣片中塑化剂残留情况进行检测。结果:111批灯盏花素片样品按法定标准检验均合格;不同来源的灯盏花素片溶出曲线相似;仅有1种来源的样品溶出量低于75%;相关物质的检查更能体现样品中非主成分的相对含量;制剂中重金属及有害元素、丙酮残留量和大孔树脂残留量均未超过限度;薄膜衣片样品中均未检出8种塑化剂。崩解剂的加入量是影响溶出行为的关键因素。结论:灯盏花素片总体质量较好。
Objective： To conduct quality evaluation and analysis of Dengzhanhuasu tablets from the aspects of efficacy, material basis and safety. Methods： The samples of Dengzhanhuasu tablets were tested using the legal standards. The dissolution curves of samples from different enterprises were determined by UV method in 4 kinds of dissolution medium at pH 6.0, 6.8, 7.6 and 0.75% Tween solution respectively. The dissolution rate of the samples was determined by UV method in dissolution medium at pH 6.8 and paddle method at 50 rpm, 30 min. The content of scutellarin, the separation and identification of related substances, and the determination of characteristic map were determined by HPLC-DAD. The content of heavy metals and harmful elements in the samples were determined by ICP-MS. The residue of acetone, macroporous resin and plasticizer in film-coated tablets were detected by GC and GC-MS. Results： All 111 batches of samples were qualified according to legal standards. The dissolution curves of Dengzhanhuasu tablets from different manufacturers were similar. Only one sample had a dissolution rate less than 75%. The relative content of nonprincipal components in the sample is better reflected by the inspection of the relevant substances. The content of heavy metals and harmful elements,as well as residue of acetone and macroporous resin in Dengzhanhuasu tablets did not exceed maximum residue limits. Eight types of plasticizers were not found in the film-coated tablets. The quantity of disintegrant was the key factor affecting the dissolution. Conclusion： The overall quality of Dengzhanhuasu tablets is good.
出处
《中国药事》
CAS
2017年第10期1186-1191,共6页
Chinese Pharmaceutical Affairs
关键词
灯盏花素片
有效性
物质基础
安佥陧
Dengzhanhuasu tablets
efficacy
material basis
safety
