Standardization of Andrographis paniculata, Mitracarpus scaber and Nauclea latifolia Herbal Preparations as per European and Nigerian Drug Regulations
Journal Title: European Journal of Medicinal Plants - Year 2014, Vol 4, Issue 4
Abstract
Background: Herbal drug standardization (HDS) is multidisciplinary with botany and chemistry working together to facilitate decisions on production of herbal medicines. The common reasons for HDS are: i) it creates the need for establishing botanical identity; ii) it is necessary for establishing dosage and iii) it facilitates industrial production and good manufacturing practice (GMP). Aims: To outline the strategies being used to standardize Conavir, Niprd-AM1 and Niprifan and to show that HDS is the ideal strategy for herbal drug development (HDD) from traditional medicines (TMs). Methodology: Relevant data on: i) the regulatory requirements of Europe’s Medicines Evaluation Agency (EMEA) and Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) and ii) on Andrographis paniculata (AP), Mitracarpus scaber (MS) and Nauclea latifolia (NL) were reviewed. Crude herbal drugs (CHDs) from aerial parts each of AP and MS and from roots of NL and the active crude extracts (ACEs) derived from them were studied using standard botanical, phytochemical and physicochemical techniques with the aim of standardizing them for production. The ACEs from AP (Conavir) and from NL (Niprd-AM1) were dry water extracts. The ACE from MS (Niprifan) was a dry ethylacetate extract. Results: The regulatory provisions of NAFDAC for herbal preparations were broadly similar to those of EMEA but the latter proved more explicit in many respects. Furthermore, the results on the CHDs and ACEs adequately meet the requirements of the two agencies. Conclusions: The results here provided and those reported elsewhere collectively furnish the data needed for drawing-up the registration dossiers of AP/Conavir, NL/Niprd-AM1 and MS/Niprifan as per EMEA and NAFDAC requirements. But for purposes of further work, it is needful for the GC-MS studies to be amplified and combined with others, so as to facilitate identification of suitable markers and pave the way for studies requiring bioassays.
Authors and Affiliations
Sunday J. Ameh, Nneka Ibekwe, Aminu Ambi, Obiageri Obodozie, Mujtaba Abubakar, Magaji Garba, Herbert Cocker, Karniyus S. Gamaniel
Keywords
Related Articles
- EP ID EP350076
- DOI 10.9734/EJMP/2014/5457
- Views 97
- Downloads 0
Screening of Ageratum conyzoides Linn. and Alchornea cordifolia (Schumach. & Thonn.) Extracts for Antibacterial Activity
Aim: To investigate the antibacterial activities of Ageratum conyzoides and Alchornea cordifolia as part of the exploration for new and novel bioactive compounds. Study Design: Aqueous and ethanol extracts were prepared...
Antimicrobial and Antioxidant Potentials, and Chemical Constituents of the Leaf Extracts of the Nigerian Piliostigma thonningii (Caesalpiniaceae) Schum
Aims: In this work the 95% ethanol extract of the Nigerian Piliostigma thonningii known traditionally to possess a number of medicinal properties was screened for antimicrobial and antioxidant potentials as well as ident...
Therapeutic Potential of Withania somnifera in CNS Disorders: A Neuropharmacological Review
Context: According to Ayurveda, the oldest and the first documented system of medicine in the world defines medicinal plants as Medhya Rasayana which show properties influencing the brain tissues. Medhya Rasayana can rep...
A 28- Day Oral Toxicity Study of Pseudocedrela kotschyi Methanol Extract in Sprague-Dawley Rats
Aims: To evaluate the safety profile of Pseudocedela kotschyi which is used in traditional medicine for the treatment of epilepsy, malaria, diarrhoea and pains, a 28 day sub chronic toxicity study was conducted was evalu...
An Evaluation of the Sub Acute Toxicity and Haemostatic Effects of Leaves Extract of Achyranthes aspera in Mice and Albino Rats
Background: Achyranthes aspera is used mostly in Nigerian and other folklore medicines to stop bleeding from wounds and in the treatment of other conditions such as dog bite, scorpion bite, gonorrhoea, obstetric disorder...