验证一种体外模型,以估计牙刷期间牙膏释放的化物量
Mateus Xavier-Queiroz1, Antônio Pedro Ricomini-Filho1, Jaime Aparecido Cury1
1Department of Biosciences, Faculdade de Odontologia de Piracicaba, UNICAMP, Piracicaba, SP, Brazil.
Brazilian dental journal
|December 10, 2025
概括
一个新的体外模型准确地预测了刷牙期间牙膏释放的化物. 这种经过验证的方法评估牙膏化物生物可用性,帮助产品开发和疗效研究.
科学领域:
- 口腔健康 口腔健康
- 材料科学 材料科学 材料科学
- 分析化学 分析化学
背景情况:
- 在刷牙期间有效地从牙膏中释放化物对于预防牙损伤至关重要.
- 现有的方法缺乏临床验证,用于测量牙膏中的体内化物释放量.
- 需要一个可靠的体外模型来预测体内化物生物可用性.
研究的目的:
- 开发和验证一种体外模型,用于评估牙膏释放的化物.
- 为了将体外化物释放测量与牙刷过程中获得的体内数据相关联.
- 为了评估牙膏的风湿性质和化物释放之间的关系.
主要方法:
- 开发了一种体外机械动模型来模拟刷牙.
- 进行了一项交叉体内研究,三名参与者使用不同的牙膏配方 (Na2FPO3/CaCO3和NaF/SiO2).
- 使用离子选择性电极测量了总可溶性化物 (TSF),并使用度计评估了质性 (粘度,歇斯底里面积).
主要成果:
- 在体内和体外全溶性化物 (TSF) 释放之间建立了显著的线性关系.
- 在体内,TSF释放与上切粘度有显著的线性相关性.
- 经过验证的体外模型在模拟牙刷过程中有效估计了化物的生物可用性.
结论:
- 开发的体外模型提供了牙膏化物释放的临床相关评估.
- 风病学性质,特别是上切粘度,是化物生物可用性的重要预测因素.
- 这种经过验证的模型可以帮助开发和质量控制化物释放牙膏.
相关概念视频
In Vitro Drug Release Testing: Overview, Development and Validation
284
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
284
In Vitro Drug Dissolution: Compendial Testing Models II
215
Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
215
In Vitro Drug Dissolution: Compendial Testing Models I
195
Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
195


