Sobczak Agnieszka, Zieliński Piotr, Jelińska Anna, Gostyńska-Stawna Aleksandra
Chair and Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, Rokietnicka 3, 60-806 Poznan, Poland.
Molecules. 2025 Jan 12;30(2):278. doi: 10.3390/molecules30020278.
Intravenous nanoemulsions (NEs) are gaining attention as potential delivery systems for poorly water-soluble substances like cannabidiol (CBD). This study aimed to develop novel NEs based on CBD-enriched hemp oils and evaluate their physiochemical properties.
The stability of hemp oils enriched with various concentrations of CBD (0.5%, 1.0%, and 1.5%) with and without the addition of α-tocopherol was determined, and the most stable oils were subsequently incorporated into NEs. In order to determine the CBD content in the obtained CBD-enriched oils and NEs, as well as to conduct stability tests, a new HPLC method was developed and validated.
The HPLC method demonstrated very good linearity, precision, accuracy, specificity, and robustness, enabling reliable assessment of the quality of newly developed formulations. The formulated NEs were characterized by droplet size of below 200 nm and polydispersity index PDI ≤ 0.14 satisfactory for intravenous application.
This research presents a preliminary study on the development of CBD-enriched hemp oil-based NEs that showed promising potential for further investigation. A new HPLC-DAD method was appropriate to register changes in CBD concentration in various matrices, including CBD-hemp oil and intravenous NEs during their preparation and storage. Additionally, the effect of certain emulsifiers used in NE formulations on the course of the chromatographic analysis of CBD was examined, providing valuable insights concerning the application of the provided methodology in future formulation analysis.
静脉注射纳米乳剂（NEs）作为大麻二酚（CBD）等难溶性物质的潜在给药系统正受到关注。本研究旨在开发基于富含CBD的大麻油的新型纳米乳剂，并评估其理化性质。
测定添加和不添加α-生育酚的情况下，富含不同浓度CBD（0.5%、1.0%和1.5%）的大麻油的稳定性，随后将最稳定的油纳入纳米乳剂中。为了测定所获得的富含CBD的油和纳米乳剂中的CBD含量，并进行稳定性测试，开发并验证了一种新的高效液相色谱法。
高效液相色谱法显示出非常好的线性、精密度、准确度、特异性和稳健性，能够可靠地评估新开发制剂的质量。所制备的纳米乳剂的特征在于液滴尺寸低于200nm，多分散指数PDI≤0.14，适用于静脉注射。
本研究对基于富含CBD的大麻油的纳米乳剂的开发进行了初步研究，显示出进一步研究的有前景的潜力。一种新的高效液相色谱-二极管阵列检测法适用于记录各种基质中CBD浓度的变化，包括CBD-大麻油和静脉注射纳米乳剂在制备和储存过程中的变化。此外，还研究了纳米乳剂配方中使用的某些乳化剂对CBD色谱分析过程的影响，为该方法在未来制剂分析中的应用提供了有价值的见解。
