Abstract
Plants have been used since antiquity to treat and prevent diseases. Plantain (Plantago lanceolata L.) is traditionally used for the treatment of the common cold and associated symptoms such as cough. This study was designed to evaluate the oral toxicity of plantain leaf extract-containing syrup. In preparation of the toxicological examination and to ensure the quality of the herbal preparation, analytical methods were developed and validated, and stability testing was performed. Physicochemical and microbial quality, thin layer chromatography patterns and high performance liquid chromatography fingerprints complied with the specifications during the entire period of stability testing. The marker substance, acteoside, remained within the stability-defining limits of 90%–110% for quantitative determinations. No hint of toxicity emerged from 14-day repeat dose toxicity testing in rats. The animals were given doses of 3, 6, or 12 mL of syrup per kg body weight by gavage twice daily. All animals showed normal appearance and behavior. Body and organ weights at the end of the study were similar to those in the control group. Overall, P. lanceolata syrup was found to be stable and non-toxic under the test conditions.
Highlights
Herbal medicinal products are enjoying increasing popularity
Authentication and identification of the extract was carried out by thin layer chromatography [19,20], following the method defined for Plantaginis lanceolatae herba of the European Pharmacopoeia
An high-performance liquid chromatography (HPLC) method was developed and validated according to the definitions of ICH guideline Q2 (Validation of analytical procedures) [21] for the quantification of plantain extract in plantain syrup, as a precondition for stability studies, which by themselves served as a foundation for the performance of a repeated-dose toxicity study
Summary
Herbal medicinal products are enjoying increasing popularity. Many plant-derived products used for therapeutic purposes do not meet the current standards for herbal drugs and are not fully evaluated for their quality, safety and efficacy [1]. Agency (EMA) is setting standards for the establishment of an appropriate quality of natural remedies. The regulatory concern is that plants are not necessarily safe only because they are natural, as many potentially toxic constit4uents may be present in plant material, naturally or as contaminants. The development of herbal medicinal products requires tests for quality and safety [2]. Species of the botanical gender Plantago (Plantaginaceae) with its approximately 275 taxa [3]
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