Taif University, College of Pharmacy, Department of Clinical Pharmacy, PO Box 11099, Taif, 21944 Saudi Arabia.
Taif University, College of Pharmacy, Department of Pharmacognosy, PO Box 11099, Taif, 21944 Saudi Arabia.
J AOAC Int. 2022 Jun 29;105(4):1153-1161. doi: 10.1093/jaoacint/qsac020.
Inflammatory bowel disease (IBD) is a chronic autoimmune sickness that affects the gastrointestinal tract (GIT). Currently available treatment regimens have various adverse effects and create a financial burden.
This paper presents the development of an oral liquid formulation containing a nanoemulsion (NE) of herbal extracts for the treatment of IBD.
A NE-based formulation was prepared and characterized. Stability studies based on the physical appearance, viscosity, pH, total microbial count, and assay were performed. The antioxidant activity of the individual extract, mixture, and formulation was compared by the DPPH method. In order to assess both the efficacy and the safety of the formulation, a TNBS-induced colitis model was used.
A herbal extract of fennel, anise, chamomile, linseed, and pomegranate fruit peel was used as the oil phase, PEG as a surfactant, Tween 80 as a co-surfactant, and benzalkonium chloride (0.001% w/v) as a preservative in the NE. Average particle size, PDI, viscosity, and pH were 283 nm, 0.33, 48 cp, and 5.9, respectively. Assay of the product by standard marker anethole was 99.6%. It was established that the formulation remains stable at least for 6 months. The antioxidant activity of the combined extract was higher than the individual extracts. The colon mucosa damage index (CMDI) from the formulation was negligible and similar to that of the control group.
The results suggest that it is worthwhile developing the NE of herbal extracts for treating IBD. Additionally, the benefit of selecting a multi-herb extract for NE formulation is demonstrated by the antioxidant activity of the combined extracts.
This study revealed that the NE of the herbal extract is a promising approach for IBD treatment. A patent related to the work is published in the Indian Official Journal of the Patent Office (14/2021).
炎症性肠病（IBD）是一种影响胃肠道（GIT）的慢性自身免疫性疾病。目前可用的治疗方案有各种不良反应，并造成经济负担。
本文介绍了一种含有草药提取物纳米乳（NE）的口服液体制剂的开发，用于治疗 IBD。
制备并表征了基于 NE 的制剂。进行了基于物理外观、粘度、pH 值、总微生物计数和含量测定的稳定性研究。通过 DPPH 法比较了各提取物、混合物和制剂的抗氧化活性。为了评估该制剂的疗效和安全性，使用 TNBS 诱导的结肠炎模型。
使用茴香、八角、洋甘菊、亚麻籽和石榴果皮的草药提取物作为油相，PEG 作为表面活性剂，Tween 80 作为助表面活性剂，苯扎氯铵（0.001%w/v）作为 NE 的防腐剂。平均粒径、PDI、粘度和 pH 值分别为 283nm、0.33、48cp 和 5.9。用标准标志物茴香脑测定产品含量为 99.6%。结果表明，该制剂至少在 6 个月内保持稳定。复方提取物的抗氧化活性高于各提取物。制剂的结肠黏膜损伤指数（CMDI）可忽略不计，与对照组相似。
结果表明，开发用于治疗 IBD 的草药提取物 NE 是值得的。此外，通过比较各提取物的抗氧化活性，表明选择多草药提取物用于 NE 制剂具有优势。
本研究表明，草药提取物的 NE 是治疗 IBD 的一种有前途的方法。与该工作相关的专利已在印度专利局官方公报（14/2021）上公布。
