Development and Validation of Chromatographic Method for the Standardization of Homeopathic Formulation of Syzygium Cumini.

BACKGROUND: Syzygium cumini (Lam.), family Myrtaceae, has a long history of use in folk and traditional systems of indigenous medicine. Many homeopathic formulations of Jamun seeds are available in the market for their crucial usage as an anti-diabetic. Despite the popularity of homeopathic products, a lack of standard quality is a significant impediment in their acceptance. The present study aimed to develop and validate a chromatographic method for the standardization of the homeopathic formulation of Syzygium cumini. METHODS: The seeds of Syzygium cumini were studied for physicochemical evaluation and preliminary phytochemical screening. Also, the in-house standard and marketed homeopathic formulations of Syzigium cumini were standardized for pH, total fatty content, total phenolic and flavonoid content, with quantitative high-performance liquid chromatography- photodiode array detector (HPLC-PDA) analysis by using ellagic acid as a marker. RESULTS: The physicochemical characteristics of crude material were found to be within pharmacopeial limits. The phytochemical screening showed the presence of various secondary metabolites. The total phenolic and flavonoid content was higher in the in-house standard than in marketed formulations. A validated quantitative HPLC-PDA analysis showed variations of ellagic acid content in different homeopathic formulations. CONCLUSION: Physicochemical analysis and the HPLC method for quantitative estimation of ellagic acid can be used to standardize a homeopathic formulation of Syzygium cumini.

The quality of selected South African and international homoeopathic mother tinctures.

The high potential variability of chemical composition of the plant material involved in the manufacture of homoeopathic mother tinctures (a common source of homoeopathic medicines), renders both their quality control and assurance a significant challenge (Pande and Pathak, 2006). The absence of significant regulations regarding the quality of Complementary and Alternative Medicines (CAM) in South Africa contributes to this challenge (Gqaleni et al, 2007). In order to assess any quality differences between local and international manufacturers, the following homoeopathic mother tinctures, Artemisia absinthium, Rosmarinus officinalis e foliis recentibus, Salvia officinalis and Sambucus nigra, were chosen on the basis that they can be grown both locally in South Africa and internationally and are prepared according to the German Homoeopathic Pharmacopoeia (GHP), method 3a. Colour analysis was followed by thin layer chromatographic (TLC) analysis on each selected sample and relevant reference sample using both aluminum-backed TLC plates and glass-backed HPTLC plates. Photographs were taken of the resultant chromatograms, active components were identified, comparisons to the reference chromatograms were made and the overall quality of each homoeopathic mother tincture deduced. The quality of all nine of the selected samples manufactured internationally complied with the minimum quality standards set by the GHP. Five out of the six local samples complied with the minimum standards of the GHP._Notwithstanding the minimum GHP standards, the superior number of high quality international samples implies that their quality exceeded that of the locally manufactured tinctures. Greater regulation regarding the quality of these types of products has therefore been identified.

Infection models in basic research on homeopathy.

INTRODUCTION: The objective of this study was to search for effective agents for the treatment of infections in animals or infected cell lines. METHODS: The Homeopathic Basic Research experiments (HomBRex) database (http://www.carstens-stiftung.de/hombrex) on model biological systems in homeopathic research was searched. Eligible experiments were reviewed and analysed. RESULTS: The database contains 48 eligible experiments published from 1832 to 2009. Causative pathogens were bacteria, fungi, viruses, proto- and metazoa. In the experiments, various parameters were observed and a large set of medicines was investigated. In eight of the 48 experiments, at least one of the investigated medicines was selected according to the similia principle. Nosodes and homeopathic complexes were investigated in 8 and 14 experiments respectively. Mice were the most often used host organisms (13 experiments). In 31 experiments at least one homeopathic medicine was found effective for treatment. CONCLUSION: The results of basic research experiments may invigorate new clinical trials that investigate complementary treatments for infectious diseases. However, all experiments reviewed here await replication and no clear-cut conclusion can be drawn regarding the transferability of in vitro results to in vivo outcomes.

Canova, a Brazilian medical formulation, alters oxidative metabolism of mice macrophages.

Macrophages play a significant role in the host defence mechanism. When activated they can produce reactive oxygen species (ROS) as well as related reactive nitrogen species (RNS). ROS are produced via NAD(P)H oxidase which catalyzes superoxide (O2-) formation. It is subsequently converted to hydrogen peroxide (H2O2) by either spontaneous or enzyme-mediated dismutation. Nitric oxide synthase (NOS) catalyzes nitric oxide (NO) formation. Canova (CA) is a Brazilian medication produced with homeopathic techniques, composed of Aconitum, Thuya, Bryonia, Arsenicum, Lachesis in distilled water containing less than 1% ethanol. Previous studies demonstrated that CA is neither toxic nor mutagenic and activates macrophages decreasing the tumor necrosis factor-alpha (TNFalpha) production. In this assay we showed that macrophages triggered with Canova increased NAD(P)H oxidase activity as well as that of iNOS, consequently producing ROS and NO respectively. Cytochrome oxidase and peroxisomes activities were inhibited by NO. As NO and O2- are being produced at the same time, formation of peroxynitrite (ONOO-) may be occurring. A potential explanation is provided on how treatment with Canova may enhance immune functions which could be particularly important in the cytotoxic actions of macrophages. CA can be considered as a new adjuvant therapeutic approach to known therapies.

Regulation of homeopathic drug products.

PURPOSE: The regulation of homeopathic drug products is discussed. SUMMARY: Homeopathy is a system of medicine based on the observation that high doses of pharmacologically active substances cause symptoms when administered to healthy individuals. These same substances, when prepared in very dilute form, may relieve similar symptoms in conditions resulting from different etiologies. Unlike dietary supplements, homeopathic drugs are subject to the Food, Drug, and Cosmetic Act and regulations issued by FDA. Instead of the new-drug-approval process, premarket approval for homeopathic drugs is by way of monograph approval by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Monographs are published in the Homeopathic Pharmacopoeia of the United States (HPUS). The criteria for inclusion in the HPUS require that a homeopathic drug product be determined by HPCUS to be safe and effective and to be prepared according to the specifications of the HPUS general pharmacy section. The long history and established nature of homeopathic drug regulation may provide a model for the regulation of dietary supplements. CONCLUSION: Homeopathic drugs in the United States are subject to well-defined regulatory processes that more closely resemble those that apply to allopathic medications than to dietary supplements.

The structure of the Organon.

The Organon of Medicine is the seminal text of Homeopathy. However, its grammar and structure make it obtuse and remote to both new students and veterans. We propose a demarcation of the Organon into sections, exposing the didactic structure of the Organon, and display this demarcation in concise graphic form. It is hoped that this representation will improve accessibility and understanding of the Organon for readers at all levels.

The puzzle of homeopathy.

Homeopathy is a branch of Western medicine that has mostly been rejected by Western orthodoxy for the last 200 years because of conceptual and scientific clashes. Homeopathy uses microdoses of potential toxins to provoke defense and self-regulatory responses, rather than the more orthodox approach of blocking body reactions. This approach hints at its clinical scope: it can help, at times resolve, conditions that are intrinsically reversible rather than mechanical problems, deficiencies, or irreversible breakdowns in body functions where it is only palliative. In recent years, there has been a renaissance of interest. Public demand has soared, and with it professional interest. Approximately 20% of Scotland's general practitioners have completed basic training. This is partly occasioned by public interest in complementary medicine and a sympathy with the more mind-body approach of homeopathy, and partly by recent scientific evidence. Some homeopathic dilutions are so extreme they are dismissed by critics as only placebo. Yet trials and meta-analyses of controlled trials are pointing toward real effects, mechanism of action unknown. Clinical outcome studies suggest useful clinical impact and excellent safety. There seems to be a potential to enhance patient care by integrating the two systems.

[The legal status of homeopathic medicines. Quality requirements, registration and permit procedures]. / Der rechtliche Status homöopathischer Arzneimittel. Qualitätsanforderungen, Registrierung und Zulassungsverfahren.

Homeopathic medicaments which are ready for application have to be approved or registered before they can be made available. This procedure is regulated by the "Arzneimittelgesetz (AMG)", a law regulating licensing and registration of medicaments. The commission in charge of the registration and licensing of homeopathic medicaments is the "Aufbereitungskommission D" of the German "Bundesgesundheitsamt (BGA)", the Board of Public Health. Application forms are dealt with on the basis of controlled and non-controlled clinical studies, application observations, and case studies, as well as specialized literature. The commission is trying to do justice to the particular features of the special field of homeopathy.

[Drugs for special therapies. Demonstration of the effectiveness of homeopathy drugs]. / Arzneimittel der besonderen Therapierichtungen. Wirksamkeitsnachweise am Beispiel von Homöopathika.

The drugs employed in special types of therapy-phytotherapy, homeopathy, anthroposophic medicines--are being used more and more frequently. In view of the fact that they are equated by law with chemical-synthetic drugs, they must meet the criteria of quality and harmlessness. With respect to effectiveness, the specific peculiarities of these special types of therapy have to be taken into account, and this is illustrated taking homeopathic agents as an example.