在传统中医药制剂中的多组分溶解试验方法的建立,基于体外-体外相关性
Pengcheng Guo1, Qizheng Wang1, Xiaoqiang Xiang2
1Department of Pharmaceutics, School of Pharmacy, Fudan University & Key Laboratory of Smart Drug Delivery, Ministry of Education, Shanghai 201203, China.
Pharmaceuticals (Basel, Switzerland)
|August 29, 2024
概括
通过使用多个质量标志物,开发出了为元胡志通片 (YZTs) 配备的全新综合溶解系统. 该系统准确地预测药物的性能,有助于YZT的质量控制.
科学领域:
- 制药科学 制药科学
- 药理动力学 药理动力学
- 传统中国医药 传统中国医药
背景情况:
- 华中药片 (YZT) 需要强有力的质量控制方法.
- 建立体外和体内相关性 (IVIVC) 对于预测药物性能至关重要.
- 传统中医药 (TCM) 制剂在溶解测试中提出了独特的挑战.
研究的目的:
- 建立一个基于IVIVC.IVIVC的多组件综合溶解评估系统,用于YZT.
- 确定关键质量标记物 (Q标记物) 的最佳溶解条件.
- 开发一种可靠的YZT质量控制方法.
主要方法:
- 在各种条件下测试五种Q标记物的溶解 (四胺,α-烯胺,原胺,科里达林,拜坎吉利辛).
- 在 beagle 狗的药理动力学研究.
- 数字解卷用于构建IVIVC模型.
- 使用生物制药分类系统 (BCS) 整合Q标记数据.
主要成果:
- 所有五种Q标记物都被归类为BCS I化合物.
- 特定的Q标记物在不同的溶解条件下 (例如,方法,各种介质) 显示出良好的相关性.
- 使用乙缓冲体中的BCS I Q标记物的综合方法显示出最佳的相关性.
- 开发的系统准确地预测了YZT的药理动力学数据.
结论:
- 建立的多组件集成溶解系统有效地预测了YZT的药理动力学行为.
- 该系统为YZT的质量控制提供了一种经过验证的方法.
- 这项研究为TCM制剂的溶解评估提供了一个有希望的策略.
相关概念视频
01:15Theories of Dissolution: Diffusion Layer Model
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Dissolution, the process by which drug particles dissolve in a solvent, is explained by the diffusion layer model, a theoretical framework that simulates the absorption of oral drugs and allows us to analyze experimental data.
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
714
01:16Methods for Studying Drug Absorption: In vitro
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In vitro experiments are crucial for understanding the transport and absorption of drugs through biological materials. These studies employ varied methods such as the diffusion cell method, the everted sac technique, and the everted ring technique.
The diffusion cell method uses a two-compartment cell, including a donor compartment with the drug solution, which simulates the environment where the drug is applied, and a receptor compartment with a buffer solution, which simulates the environment...
The diffusion cell method uses a two-compartment cell, including a donor compartment with the drug solution, which simulates the environment where the drug is applied, and a receptor compartment with a buffer solution, which simulates the environment...
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01:20Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
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Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
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