Standardization of Andrographis paniculata, Mitracarpus scaber and Nauclea latifolia Herbal Preparations as per European and Nigerian Drug Regulations.

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.