Ayurvedic formulations containing benzoic and ascorbic acids as additives: benzene formation during storage and impact of additives on quality parameters.

OBJECTIVES: Ayurvedic formulations are becoming the prior choice of people as health care supplements. The increasing demand for these formulations has led to extensive development of Ayurvedic pharmaceutical industries worldwide. The reaction between the preservatives (sodium benzoates and ascorbic acid) used in these formulations could generate benzene. Benzene is classified as class-1 human carcinogen and responsible for various short and long term health effects. METHODS: In this study, 25 formulations (containing ascorbic acid and sodium benzoate) of various manufacturers available as over the counter products were obtained and their benzene content were determined using gas chromatograph with flame ionization detector. RESULTS: The result showed that 64% of the formulations were free from benzene contamination whereas 36% of formulations were found to be contaminated with benzene. A simple, less time-consuming, economic, and validated gas chromatographic method for estimation of benzene in Ayurvedic formulations was also developed successfully in present study. CONCLUSIONS: The data revealed that the level of benzene was within permissible limits, yet the presence of a carcinogen in the marketed formulations intended for internal use is an alarming situation.

Assessment of compliance level of ICH guidelines for organic volatile impurities in common ayurvedic hepatic formulations.

Background Herbal medicines have been used in the treatment of liver diseases for a long time. In recent years, the use of herbal medicines for protection from other strong antibiotics as well as drugs that can damage the liver during their metabolism in liver and for treatment of liver diseases has increased all over the world. It is important to mention that a number of organic solvents are used at different stages of extraction/formulation development for these traditional preparations in industries/pharmacies. In addition, some of these solvents possess established carcinogenic properties and may enter the formulation as residual solvents. Hence as per ICH guidelines it is mandatory to keep the level of these solvents up to permissible limits. There has been a lot of hue and cry that ayurvedic formulations available in the market are not properly standardized for their quality due to lack of stringent regulations and standards from regulatory authorities. Therefore the aim of present work was to assess the compliance of ICH guidelines for level of organic volatile impurities in common marketed ayurvedic hepatic formulations. Methods In this study, 25 ayurvedic herbal formulations available as OTC product have been assessed for presence of residual solvents using gas chromatography with flame ionization detector. Results This study on 25 fast moving hepatic formulations in the market reflects that no residual solvents were detected in any of the formulations however if present were within prescribed permissible limits of ICH guidelines. The data was also subjected to statistical analysis (F-test and t-test at 95% confidence level). Conclusions Results indicate the safety of these hepatic formulations with respect to residual solvents. In addition presents a simple, linear, specific, accurate, precise and rugged gas chromatographic method for estimation of residual solvents.

Ethanol content in traditionally fermented ayurvedic formulations: Compromised Good Manufacturing Practice regulations - compromised health.

BACKGROUND: A large part of the population of India prefers the traditional medicine (ayurvedic formulations) for primary health care. However, the effective quality control of herbal medicine is still a big challenge. Numerous reports indicate noncompliance with Compromised Good Manufacturing Practice (GMP) guidelines by the manufacturers which may lead to adverse drug reactions or toxic effects. Asava and arishta are the classical herbal dosage forms wherein fermentation occurs during production leading to the generation of ethanol. The presence of ethanol in these preparations may lead to their misuse. The self-generated ethanol is responsible for extraction of active constituents and acts as a self-preservative. As the procedure for preparation for asava and arishta is same, the ethanol content is also expected to be the same irrespective of the manufacturer. OBJECTIVE: The objective of the present study was to assess and compare the ethanol content of some traditionally fermented ayurvedic formulations available in the market. METHOD: In this study, 20 formulations from 3 different manufacturers available as over-the-counter products were obtained and their ethanol contents were determined using gas chromatograph with flame ionization detector. RESULTS: Statistically significant differences were noted in the ethanol content of various ayurvedic formulations. A simple, less time-consuming, economic, and validated gas chromatographic method for estimation of ethanol in fermented ayurvedic formulations was also developed successfully in present study. CONCLUSION: The data generated during study reflected poor compliance of GMP guidelines by the manufacturers and hence the quality is being grossly compromised posing a safety hazard.

Pharmaceutical Standardization and Physicochemical Characterization of Traditional Ayurvedic Marine Drug: Incinerated Conch Shell (Shankha Bhasma).

Natural resources such as plants, animals and minerals have always been used by mankind to develop drugs and marine world is no exception. Marine by-products like conches, pearls, mother of pearl shells, corals and so forth have been used by traditional Ayurvedic practitioners for centuries. The unique methods of these preparations are scientifically designed to eliminate unwanted impurities and convert them into bioavailable form. In this study, Conch (Xanchus pyrum) was used as a marine resource of calcium carbonate and was converted pharmaceutically from its aragonite form to calcite. All the steps of preparations and changes in the properties therein were documented and validated. Further, traditional as well as modern analytical tools were used to study its physical and chemical characters to develop a monograph. The physical characterization included particle size, X-ray diffraction (XRD), Scanning Electron Microscopy (SEM), Thermogravimetric Analysis (TGA) and Fourier Transform Infra-red (FTIR). Metal composition and heavy metal limits were determined using Inductively Coupled Plasma Optical Emission Spectrometry (ICPOES). This study revealed the rearrangement of aragonite crystals into calcite form by grinding, trituration with aloe vera juice and incineration under controlled conditions. Moreover, the finished product was found to be devoid of organic matrix that is nacre. This study creates a foundation for the development of a master formula for commonly used Shankha Bhasma in Ayurvedic medicines.

[The Indian Ayurveda medicine-a meaningful supplement to psychiatric treatment?] / Indische Ayurveda-Medizin ­ eine sinnvolle Ergänzung psychiatrischer Behandlung?

Ayurveda is a traditional Indian system of medicine that is more than 3000 years old, consisting mostly of a specific diet, oily infusions mainly in the area of the head, enemas, medicinal plants and yoga. It is based on a naturopathic and anthropological belief in association with the hinduistic religion. Ayurveda has been practiced very successfully in India but so far it has only been insufficiently appreciated by western medicine, especially psychiatry. An exception is Scharfetter from Zürich who wrote a review article on this topic in 1976. Nevertheless, it is probable that particularly the immunological mechanisms of psychotic and affective disorders can be influenced by the application of ayurvedic methods; however, the empirical data source, particularly with respect to randomized controlled trials and meta-analyses regarding psychiatric disorder symptoms is limited. Even if Ayurveda is applied in a highly individualized manner, this should be rapidly improved for further evidential assessment. First positive experiences in the neuropsychiatric field in Germany are already available.

Validation of ethnopharmacology of ayurvedic sarasvata ghrita and comparative evaluation of its neuroprotective effect with modern alcoholic and lipid based extracts in ß-amyloid induced memory impairment.

ETHNOPHARMACOLOGICAL RELEVANCE: Sarasvata ghrita (SG), a polyherbal formulation from ayurveda, an ancient medicinal system of India, has been used to improve intelligence and memory, treat speech delay, speaking difficulties and low digestion power in children. AIM OF THE STUDY: Study aimed to validate the ethno use of SG in memory enhancement through systematic scientific protocol. The effect of SG and modern extracts of ingredients of SG was compared on cognitive function and neuroprotection in amyloid-ß peptide 25-35(Aß25-35) induced memory impairment in wistar rats. Further the underlying mechanism for neuroprotective activity was investigated. MATERIALS AND METHODS: SG was prepared as per traditional method, ethanolic extract (EE) was prepared by conventional method and lipid based extract was prepared by modern extraction method. All extracts were standardised by newly developed HPLC method with respect to marker compounds. SG, EE and LE were administered orally to male Wistar rats at doses of 100,200 and 400 mg/kg Body Weight by feeding needle for a period of 21 days after the intracerebroventricular administration of Aß25-35 bilaterally. Spatial memory of rats was tested using Morris water maze (MWM) and Radial arm maze (RAM) test. The possible underlying mechanisms for the cognitive improvement exhibited by SG, EE and LE was investigated through ex-vivo brain antioxidant effect, monoamine level estimation, acetylcholine esterase (AchE) inhibitory effect and Brain-derived neurotropic factor (BDNF) levels estimation. RESULTS: SG, EE and LE were analyzed by HPLC method, results showed that EE extract has high percent of selected phytoconstituents as compared with SG and LE. SG and LE decrease escape latency and searching distance in a dose dependant manner during MWM test. In case of RAM significant decrease in number of errors and increase in number of correct choices indicate an elevation in retention and recall aspects of learning and memory after administration of SG an LE. SG and LE extract can efficiently prevent accumulation of ß-amyloid plaque in hippocampus region. There was increase in SOD, GSH, CAT and NO level and decrease in MDA levels in SG and LE administered animals. SG and LE have found to exhibit AchE inhibitiory activity and significant dose-dependant increase in BDNF level in the plasma. SG and LE significantly increased the levels of noradrenaline, dopamine and 5-hydroxytryptamine in the brain. CONCLUSION: The study validated the neuroprotective activity of SG. The study concludes the extraction efficiency of SG for selected phytoconstituents is less than modern methods. However the neuroprotective activity of SG and LE was found to be greater than EE.

Spices: Potential Therapeutics for Alzheimer's Disease.

India has traditionally been known to all over the world for spices and medicinal plants. Spices exhibit a wide range of pharmacological activities. In contemporary, Indian spices are used to rustle up delicious delicacies. However, the Indian spices are more than just adjuvant which adds aroma and fragrance to foods. A few spices are very widely used and grown commercially in many countries, contain many important chemical constituents in the form of essential oil, oleoresin, oleogum, and resins, which impart flavor, pungency, and color to the prepared dishes, simultaneously exerts diverse therapeutic benefits. Ayurveda, the traditional systems of medicine in India has many evidences for the utilization of spices to cure various diseases. Some of the activities have been scientifically proven. Among various indications central nervous system disorders are of prime importance and it has been evident in traditional books and published reports that spices in fact protect and cure neuronal ailments. Likewise there are many spices found in India used for culinary purpose and have been found to have reported specific activities against brain disorders. About 400 B.C., Hippocrates rightly said "Let food be thy medicine and medicine thy food." This review focuses on the importance of spices in therapeutics and the till date scientific findings of Indian spices in CNS pharmacology and explores the potential of Indian spices to cure CNS disorders.

"Getting the water-carrier to light the lamps": Discrepant role perceptions of traditional, complementary, and alternative medical practitioners in government health facilities in India.

The government of India has, over the past decade, implemented the "integration" of traditional, complementary and alternative medical (TCAM) practitioners, specifically practitioners of Ayurveda, Yoga and Naturopathy, Unani, Siddha, Sowa-rigpa, and Homoeopathy (collectively known by the acronym AYUSH), in government health services. A range of operational and ethical challenges has manifested during this process of large health system reform. We explored the practices and perceptions of health system actors, in relation to AYUSH providers' roles in government health services in three Indian states - Kerala, Meghalaya, and Delhi. Research methods included 196 in-depth interviews with a range of health policy and system actors and beneficiaries, between February and October 2012, and review of national, state, and district-level policy documents relating to AYUSH integration. The thematic 'framework' approach was applied to analyze data from the interviews, and systematic content analysis performed on policy documents. We found that the roles of AYUSH providers are frequently ambiguously stated and variably interpreted, in relation to various aspects of their practice, such as outpatient care, prescribing rights, emergency duties, obstetric services, night duties, and referrals across systems of medicine. Work sharing is variously interpreted by different health system actors as complementing allopathic practice with AYUSH practice, or allopathic practice, by AYUSH providers to supplement the work of allopathic practitioners. Interactions among AYUSH practitioners and their health system colleagues frequently take place in a context of partial information, preconceived notions, power imbalances, and mistrust. In some notable instances, collegial relationships and apt divisions of responsibilities are observed. Widespread normative ambivalence around the roles of AYUSH providers, complicated by the logistical constraints prevalent in poorly resourced systems, has the potential to undermine the therapeutic practices and motivation of AYUSH providers, as well as the overall efficiency and performance of integrated health services.