建立一个多策略平台,用于质量控制和质量标记屏幕的Mailuoshutong药丸
Yaojuan Chu1, Xiangyu Zhang2, Lihua Zuo1
1Department of Pharmacy, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China; Henan Engineering Research Center of Clinical Mass Spectrometry for Precision Medicine, Zhengzhou Key Laboratory of Clinical Mass Spectrometry, Zhengzhou 450052, China.
Journal of pharmaceutical and biomedical analysis
|March 1, 2024
概括
使用多策略平台,改善了治疗血栓血管炎消灭症 (TAO) 的Mailuoshutong药片 (MLSTP) 质量控制. 这个平台确定了关键的质量标记,并验证了MLSTP.
科学领域:
- 传统中国医药 传统中国医药
- 药理学 药理学是指药理学的学科.
- 质量控制 质量控制 质量控制
背景情况:
- 阻塞性血管炎 (TAO) 是一种严重的炎症性血管疾病,复发率高,残疾率高.
- 麻醉药丸 (MLSTP) 是一种有效的中国传统药物,但其复杂的成分给质量控制带来了挑战.
- 为MLSTP建立可靠的质量评估指标对于一致的治疗结果至关重要.
研究的目的:
- 开发一个多策略平台来评估Mailuoshutong药片 (MLSTP) 的质量统一性.
- 识别潜在的质量标记物 (Q标记物) 并了解MLSTP在治疗阻塞性血管炎 (TAO) 的治疗机制.
- 为MLSTP建立一个强大的质量控制方法.
主要方法:
- 网络药理学被用来预测MLSTP治疗TAO的关键目标和信号通路.
- 在体内实验中,通过调节PI3K-AKT,VEGF和HIF-1信号通路,验证了MLSTP的治疗作用.
- 超高性能液体染色学 (UPLC) 指纹被用于选潜在的Q标记物,使用网络药理学识别并通过定量分析证实.
主要成果:
- 鉴定出六种潜在的Q标志物:基酸,液素,氨酸,氨酸,氨酸-7-糖化物,柏柏林和氨酸.
- 通过单一标记 (QAMS) 方法对多组件的定量分析成功建立并与外部标准方法 (ESM) 相比验证.
- 该研究表明,MLSTP通过调节TAO治疗中的关键信号通路来证明其有效性.
结论:
- 建立的多策略平台有效地选Q标记者,并加强MLSTP的质量控制.
- 提高MLSTP的质量标准将确保其在TAO临床管理中的有效性和安全性.
- 这种方法为复杂的传统中医药的质量评估提供了可靠的框架.
相关概念视频
01:19Quality Assurance
3.9K
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
3.9K
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
285
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
285
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
403
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
403
01:26Therapeutic Drug Monitoring: Drug Analysis Methods
305
Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
305