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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 evaluate the quality of Breviscapine tablets from the aspects of effectiveness, material basis and safety. Methods: The sample of breviscapine tablets was tested by statutory standard. The dissolution curves of samples of different enterprises in four dissolution media of pH 6.0, 6.8, 7.6 and 0.75% Tween aqueous solution were determined by UV method. Medium, paddle method at 50 rpm, 30 min sampling, and the dissolution rate of the sample was measured by UV method. The content of scutellarin was determined by HPLC-DAD method. The separation and identification of related substances and the determination of the characteristic spectrum were carried out. MS method was used to determine the contents of heavy metals and harmful elements in the samples. The contents of acetone, macroporous resin residue and plasticizer in the film were detected by GC and GC-MS. Results: The samples of 111 batches of breviscapin were tested according to statutory standards. The dissolution curves of breviscapin tablets from different sources were similar. Only one sample had a dissolution of less than 75% Non-main components of the relative content; Preparation of heavy metals and harmful elements, acetone residues and macroporous resin residues did not exceed the limit; film film samples were not detected eight plasticizers. The amount of disintegrant is the key factor that affects the dissolution behavior. Conclusion: Breviscapine tablet overall quality is good.