Homeopathic drug standardization through biological evaluations: An untrodden avenue

There is a dearth of chemico-analytical or instrumental methods for standardization and quality control of higher dilutions of homeopathic drugs. Aim: This review highlights the challenges in standardization of anti-inflammatory homeopathic drugs and suggests a battery of biological assays for their standardization. Methods: We retrieved a total 57 scientific reports from the experimental studies and scientific reviews published between January 1999 and June 2014 related to anti-inflammatory homeopathic drugs and their high dilutions. These comprised of 18 reports on preclinical evaluation, 15 on source materials, 9 on isolated constituents and 15 studies on in-vitro experiments. Few recent citations which supported the initial studies were added later during the compilation of the manuscript. Conclusion: Standardization and quality control of homeopathic mother tinctures and high dilutions warrants an urgent attention. As biological activities are observed to be attributed to the high dilutions which are practically devoid of active ingredients, their standardization may be done through the suggested battery of biological investigations. It is suggested that the current methods of standardization of homeopathic drugs need to be upgraded to include sensitive, reproducible and relevant biological assays so that the end users are assured of the quality, efficacy, and safety of homeopathic dilutions...

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

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.