Quality Control of a Boldo Tisanes Brand Commercialized in Costa Rica Following the Central American Technical Regulation for Natural Products

Abstract

One of the medicinal species used as raw material for the tisanes preparation is the boldo leaf (Peumus boldus). This plant is commonly used as treatment for a variety of conditions, such as digestive and hepatobiliary disorders. It is traditionally known for its choleretic, cholagogue, diuretic, and digestive properties, among others. The objectives of this work were to evaluate the quality of four batches of boldo tisanes of a brand commercialized in Costa Rica through various physicochemical and microbiological tests established in the Central American Technical Regulation (RTCA) 11.03.56.09, and to identify the reproducibility of the quality parameters for the four batches employed. For this reason, the following tests were done: labeling, organoleptic characteristics, foreign matter determination, minimum fill, lead limit, arsenic limit, loss on drying, total ash, microbial enumeration, and specific microorganisms (E. coli and Salmonella sp). The four analyzed batches were in compliance for all assays, except the labeling test, since in all cases only 2 of the 4 items established for the primary packaging (batch number and expiration date) and 3 of the 19 items indicated for the secondary packaging (qualitative-quantitative composition, interactions, and adverse effects) were not found. In addition, the batch 2 had a browner color compared to the others, not complying with the organoleptic test specifications, specifically the color. This is reaffirmed by obtaining a greater percentage of branches in its composition during the foreign matter test. For these reasons, greater controls must be made on the raw material used for the product preparation to achieve reproducibility between the quality characteristics required for the different batches.

A Rapid Continuous Flow Injection Analysis Method Development for Diphenhydramine Hydrochloride

“…Functionally, Diphenhydramine serves as an antihistamine, effectively alleviating symptoms associated with allergies, hay fever, and the common cold (Majdan et al, 2018). Its pharmaceutical formulations are available in various forms such as oral tablets, syrup, or injectables administered intramuscularly or intravenously (Stefanny et al, 2020). Positioned within the first generation of antihistamines, Diphenhydramine is instrumental in managing allergic reactions (Paul et al, 2022).…”