| 周悦，马晓斐，马丽霞，张佳，庄欣雅，余亦婷，张倩，董洁，陈军，严国俊.基于RTCA技术的复方丹参片体外溶出与一致性评价研究[J].南京中医药大学学报(社会科学版),2021,37(5):730-736. |
| 基于RTCA技术的复方丹参片体外溶出与一致性评价研究 |
| In Vitro Dissolution and Consistency Evaluation of Compound Danshen Tablets Based on RTCA Technology |
| |
| DOI： |
| 中文关键词: 关键词:复方丹参片 体外溶出度 实时细胞电子分析技术 紫外分光光度法 溶出动力学模型 |
| 英文关键词: Compound Danshen Tablets in vitro dissolution real-time cell-based assay UV spectrophotometry dissolution kinetics model |
| 基金项目: |
|
| 摘要点击次数: 424 |
| 全文下载次数: 486 |
| 中文摘要: |
| 目的 基于实时电子分析技术(Real-time cell-based assay，RTCA)，探讨以细胞生物效应评价复方丹参片体外溶出度的可行性。方法 依据大鼠心肌细胞(H9C2)对复方丹参片不同时间的溶出液呈现浓度梯度依赖，利用RTCA技术监测不同时间溶出药液的细胞动态变化，建立一种以细胞指数(Cell index，CI)为指标的溶出动力学模型。同时计算溶出度，与传统紫外分光光度法测定的溶出曲线进行相关性与一致性评价，利用DDSolver软件进行相关性分析。结果 以紫外分光光度法所得到的溶出曲线作为参比，3个不同厂家的复方丹参片溶出曲线差异因子f1均小于15，相似因子f2均大于50。并且2种评价方法下，同一厂家复方丹参片的溶出曲线最佳拟合模型均一致。结论 基于RTCA细胞生物效应评价方法可以基本反映复方丹参片体外溶出度的特征。以细胞指数为指标的溶出度评价方法有望成为中药固体制剂体外溶出度新的检测手段。 |
| 英文摘要: |
| OBJECTIVE Based on real-time cell-based assay (RTCA)， the feasibility of evaluating the in vitro dissolution of Compound Danshen Tablets by cell biological effect was investigated. METHODS According to the concentration gradient dependence of rat cardiomyocytes (H9C2) on the dissolution of Compound Danshen Tablets at different times， RTCA was used to monitor the dynamic changes of cells in different time. Thus， a dissolution kinetic model based on cell index (CI) was established. At the same time， the dissolution rate was calculated to evaluate the correlation and consistency with the dissolution curve determined by traditional UV spectrophotometry. Finally， DDSolver software was used for correlation analysis. RESULTS Taking the dissolution curve obtained by UV spectrophotometry as a reference， the difference factor f1 of the dissolution curve of Compound Danshen Tablets from three different manufacturers was less than 15， and the similarity factor f2 was greater than 50. Under the two evaluation methods， the best fitting model of dissolution curves of Compound Danshen Tablets from the same manufacturer were consistent. CONCLUSION This result showed that the cell biological effect evaluation method based on RTCA could basically reflect the characteristics of in vitro dissolution of Compound Danshen Tablets. The dissolution evaluation method based on the cell index is expected to become a new detection method for the in vitro dissolution of solid preparations of traditional Chinese medicine. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |
