The Thai Journal of Pharmaceutical Sciences
Abstract
Acemannan extracted from Aloe vera was well characterized as an acetylated mannose polysaccharide which have promising clinical profile for tissue regeneration. Quality aspect of acemannan is required to develop the herbal extract for practical industrial application and reliable therapeutic use. The research aim is to investigate the qualify attributes of acemannan that have impact on its safety and efficacy. Quality of three production batches of acemannan were evaluated based on ICH quality guidelines and pharmacopeial standard. The quality aspect of acemannan were determined by analytical technique including FT-IR, SEC-HPLC, RP-HPLC, GC, and loss on drying to ensure its identify and purity. The cell proliferation assay was determined to evaluate the potency of acemannan on tissue regeneration. The physicochemical characters of acemannan samples were consistency. Their identities confirmed by IR spectra and retention time. Molecular size distribution has shown that acemannan size below 100 kD may contribute to better activity as seen in cell proliferation assay and can be used to qualify acemannan potency. The purity profile of acemannan has indicates that contamination of impurities including aloin and residual solvent were within acceptable limits. Specification of acemannan as active pharmaceutical ingredient was established and can be applied for commercial use.
Publisher
Faculty of Pharmaceutical Sciences, Chulalongkorn University
First Page
638
Last Page
645
Recommended Citation
Seeleamngam, Siriwan; Sangvanich, Polkit; Thunyakitpisal, Pasutha; and Vongsutilers, Vorasit
(2023)
"Characterization of quality attribute and specification for standardization of acemannan extracted from Aloe vera for tissue regeneration,"
The Thai Journal of Pharmaceutical Sciences: Vol. 46:
Iss.
6, Article 3.
Available at:
https://digital.car.chula.ac.th/tjps/vol46/iss6/3