UNASSIGNED:Benjakul(BJK)是五种植物草药成分的组合,在泰国传统医学中广泛用作抗炎药物。本研究旨在开发一种用于临床的含有BJK的新型局部微乳剂。
未经鉴定:通过转相温度(PIT)方法制备微乳液。评估物理化学性质和稳定性以确定最佳配方。然后对稳定的BJK负载的微乳剂配方进行体外抗炎活性研究,皮肤细胞毒性,药物渗透,和稳定性。
UNASSIGNED:两种含有肉豆蔻酸异丙酯(ME1-BJK和ME2-BJK)的新型制剂通过了药典稳定性测试。BJK成分完全溶解在油相中,并掺入微乳液基料Transcutol®和Labrasol®,避免使用酒精,两种微乳制剂均显示出高抗炎活性,IC50值为3.41±0.36和3.95±1.73μg/mL,分别。然而,ME1-BJK的溶出度通过亲脂性和亲水性膜显示出优异的释放曲线,在4小时时的最高累积量为25.13%和38.06%,分别。所有测试的BJK提取物制剂在高达50μg/mL的浓度下没有表现出明显的皮肤细胞毒性。在加速条件下储存六个月后,抗炎活性无明显变化.
UNASSIGNED:成功开发了一种新型且稳定的负载BJK的微乳液制剂,具有出色的释放和稳定性能。进一步的临床研究,以评估疼痛减轻,水肿,并且在动物模型中使用该制剂的皮肤刺激正在进行中。
UNASSIGNED: Benjakul (BJK) is a combination of five botanical herbal constituents widely used in Thai traditional medicine as an anti-inflammatory remedy. This study aimed to develop a novel topical microemulsion containing BJK for clinical use.
UNASSIGNED: The microemulsions were produced by a phase inversion temperature (PIT) methodology. Physicochemical properties and stability were evaluated to determine an optimal formula. The stable BJK-loaded microemulsion formulas were then subjected to in vitro studies for their anti-inflammatory activity, skin cell toxicity, drug permeation, and stability.
UNASSIGNED: Two novel formulations containing isopropyl myristate (ME1-BJK and ME2-BJK) passed the compendial stability test. BJK constituents were completely dissolved in the oil phase and incorporated into the microemulsion base Transcutol® and Labrasol® avoiding the use of alcohol, both microemulsion formulations demonstrated high anti-inflammatory activity with IC50 values of 3.41 ± 0.36 and 3.95 ± 1.73 μg/mL, respectively. However, dissolution of ME1-BJK showed a superior release profile through both lipophilic and hydrophilic membranes with the highest accumulated amount at 4 h of 25.13% and 38.06%, respectively. All tested formulations of BJK extract demonstrated no apparent skin cell toxicity at concentrations up to 50 μg/mL. After six-month storage under accelerated conditions, there were no significant changes in anti-inflammatory activity.
UNASSIGNED: A novel and stable BJK-loaded microemulsion formulation was successfully developed with excellent release and stability properties. Further clinical research to evaluate pain reduction, edema, and skin irritation using this formulation in animal models is ongoing.