title: Rational quality assessment procedure for less-investigated herbal medicines: Case of a Congolese antimalarial drug with an analytical report.
abstract: Herbal medicines are the most globally used type of medical drugs. Their high cultural acceptability is due to the experienced safety and efficiency over centuries of use. Many of them are still phytochemically less-investigated, and are used without standardization or quality control. Choosing SIROP KILMA, an authorized Congolese antimalarial phytomedicine, as a model case, our study describes an interdisciplinary approach for a rational quality assessment of herbal drugs in general. It combines an authentication step of the herbal remedy prior to any fingerprinting, the isolation of the major constituents, the development and validation of an HPLC-DAD analytical method with internal markers, and the application of the method to several batches of the herbal medicine (here KILMA) thus permitting the establishment of a quantitative fingerprint. From the constitutive plants of KILMA, acteoside, isoacteoside, stachannin A, and pectolinarigenin-7-O-glucoside were isolated, and acteoside was used as the prime marker for the validation of an analytical method. This study contributes to the efforts of the WHO for the establishment of standards enabling the analytical evaluation of herbal materials. Moreover, the paper describes the first phytochemical and analytical report on a marketed Congolese phytomedicine.
authors.affiliation: Institute of Organic Chemistry, University of Würzburg, Am Hubland, 97074 Würzburg, Germany; Faculty of Pharmaceutical Sciences, University of Kinshasa, B.P. 212, Kinshasa XI, Congo.
authors.forename: Dieudonné Tshitenge
authors.initials: DT
authors.lastname: Tshitenge
authors.affiliation: Institute of Organic Chemistry, University of Würzburg, Am Hubland, 97074 Würzburg, Germany.
authors.forename: Karine Ndjoko
authors.initials: KN
authors.lastname: Ioset
authors.affiliation: Faculty of Pharmaceutical Sciences, University of Kinshasa, B.P. 212, Kinshasa XI, Congo.
authors.forename: José Nzunzu
authors.initials: JN
authors.lastname: Lami
authors.affiliation: Faculty of Pharmaceutical Sciences, University of Kinshasa, B.P. 212, Kinshasa XI, Congo.
authors.forename: Josaphat
authors.initials: J
authors.lastname: Ndelo-di-Phanzu
authors.affiliation: Institute of Organic Chemistry, University of Würzburg, Am Hubland, 97074 Würzburg, Germany; Faculty of Pharmaceutical Sciences, University of Kinshasa, B.P. 212, Kinshasa XI, Congo.
authors.forename: Jean-Pierre Koy Sita
authors.initials: JP
authors.lastname: Mufusama
authors.affiliation: Institute of Organic Chemistry, University of Würzburg, Am Hubland, 97074 Würzburg, Germany. Electronic address: bringman@chemie.uni-wuerzburg.de.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Bringmann
mesh_terms: D000962:Antimalarials / Q000592:standards*; D002851:Chromatography, High Pressure Liquid; D015023:Democratic Republic of the Congo; D005960:Glucosides / Q000592:standards; D029001:Herbal Medicine / Q000592:standards*; D010636:Phenols / Q000592:standards; D064209:Phytochemicals / Q000592:standards*; D008517:Phytotherapy; D010946:Plants, Medicinal / Q000737:chemistry; D011786:Quality Control; D012015:Reference Standards; D059808:Polyphenols
chemical_list: D000962:Antimalarials; D005960:Glucosides; D010636:Phenols; D064209:Phytochemicals; C058956:acteoside; D059808:Polyphenols; C064683:isoacteoside
keywords: Acteoside; Acteoside (PubChem CID: 5,281,800); Authentication; Fingerprinting; Herbal medicine; Isoacteoside (PubChem CID: 6,476,333); Pectolinarigenin-7-O-glucoside (PubChem CID: 44,258,439); SIROP KILMA; Stachannin A (PubChem CID: 44,258,461); Validation