Quality Of Herbal Drugs Research Articles

Quality Control and Evaluation of Herbal Product

Abstract: Standardization of herbal formulation is important in order to assess of quality drug. The quality of herbal drug is the considerate all the factor which contribute directly or indirectly to the safety, effectiveness of the product Medicinal plant have been used to improve human health , increasing popularity global as drug , complementary and alternative medicines, food supplement, cosmetic as medical devices. The complexity of herbs and extracts supplied to such a wide range of markets and in different requlatory environment, raise major quality issues, increasing the need for appropriate analytical method for their identification, standardization &also for the detection of adulterants and contamination. Major limitation factors, such as herbal product naming, sampling and sample preparation are also discussed. The use of products of natural origin has remarkably increased in the global market, because of consumer becoming more health-conscious herbal medicines are considered safe by consumers and these product are generally less expensive than allopathic medicines.

Preliminary Phytochemical Screening and Standardization of Pisum sativum

Traditional medicines are widely perceived as natural and safe, that is, not toxic. This is not necessarily true, especially when herbs are taken with prescription drugs, over-the-counter medications, or other herbs, as is very common. World Health Organization determined explicit rules for the assessment of the wellbeing, adequacy and quality of herbal drugs. The current examination was attempted to the standardization of seeds of Pisum sativumand to assess the fundamental phytochemical investigation. In this investigation the dried seeds ofPisum sativumwere assessed for organoleptic characters, physicochemical boundaries of pH, loss on drying, ash values and fundamental phytochemical examination for distinguishing of chemical constituents. The information acquired by the current examination shows all the qualities within the determination of WHO and all these may accommodate in distinguishing of this therapeutic plant and may likewise supportive in forestalling its debasement

Quality Control of Withania somnifera and its Marketed Formulations by Validation through High Performance Thin Layer Chromatography

Withania somnifera is the most valuable herbaceous plant, also known as Ashwagandha used in the traditional systems of Indian medicine having many therapeutic effects. It is obtained from the dried roots and stems of Withania somnifera belonging to family Solanaceae. The active chemical constituents of Withania somnifera are withaferin A, withanolide A, withasomniferin-A, isopelletierine, withasomidienone, tropine, withanone, cuscohygrine, anaferine, hygrine, anahygrine, somniferine, mesoanaferine, etc. It is used as a liver tonic, aphrodisiac, in asthma, emaciation, in bronchitis and ulcers. It has life prolonging, rejuvenating effect & also used for the treatment of insomnia, anxiety, skin disease, nervous exhaustion, impotency, enhancing memory and insulin secretion etc. Marketed formulations of Ashwagandha are Ashwagandharista, Himalaya Ashwagandha, Stresswin, Stresscom, Inlife Ashwagandha capsules, Himalaya massage oil, Ancient Apothecary, KSM 66 Ashwagandha, Vigomax, Baidyanath Ashwagandha Amrita 450 ml, Vital plus, Amrutha kasthuri and Brento etc. To maintain the quality of marketed formulations validation should be done. Different validation parameters such as LOQ, LOD, range & linearity, accuracy, ruggedness and specificity have been studied. Ashwagandha is in demand as a good health promoter is expanding in global market. Many efforts were undertaken to develop a better Withania somnifera variety with a specific chemotype. HPTLC (High performance thin layer chromatography) is most important in evaluating the quantity and quality of herbal drug. This technique is modern & effective form of TLC which is used for qualitative and quantitative analytical determination of analytes. It is the simple, rapid, precise, specific, robust and accurate technique. The effect of different extraction methods on marker compound Withaferin-A & other than Withaferin-A, effect of different climatic zones on phytochemical profile of Withania somnifera, different mobile ........

Standardization of Ayurvedic Drug- Nyctanthes arbor-tristis, Hippophae salicifolia, Ocimum tenuiflorum and Reinwardtia indica and Combined Herb-Herb

The herbal medicines have reached extensive acceptability as therapeutic agents for various clinical diseases due to global demand. Therefore, standardization is the essential and initial step to drug development. It is for the establishment of consistent biological activity, a consistent chemical profile and biomarker identification. It improves the safety and efficacy of herbal medicine to provide the best herbal medicine to society and increase popularity rather than non-standardized extracts. In addition, it is essential to practice or maintain a quality assurance program for the production and manufacturing of herbal medicine that includes the basis of organoleptic characters and photomicrographs, physicochemical, proximate analysis phytochemical evaluation and quality control analysis and order to assess the quality of drugs, based on the concentration of their active principles. WHO has provided specific guidelines for the assessment of the safety, efficacy and quality of herbal drugs as a prerequisite for global harmonization and of utmost importance. In the present study, the herbal extracts were cleaned, dried in the shade and powdered by passing through the sieve as per the method described in the standard protocol. An overview covering various techniques employed in the extraction and characterization of Nyctanthes arbortristis, Hippophae salicifolia, Ocimum tenuiflorum and Reinwardtia indica, standardization is reported in this study. The obtained data would be very significant for future clinical aspects, as the bioactive molecules present in the extracts may exhibit synergistic effect with other bioactive compound and show a better therapeutic value. Thus, this study provides standardized and therapeutically potential data of active polyherbal formulations for the different ailments.

Light microscopy and scanning electron microscopy: Implications for authentication of misidentified herbal drugs.

Plant-based drugs have reached remarkable acceptability as therapeutic remedy for various diseases due to the adverse effects of contemporary medicines. This increasing popularity of herbal drugs leads to a growing herbal market for the development of plant-based drugs, nutraceuticals, pharmaceuticals and cosmeceuticals. Herbal drug adulteration is a complex problem which currently has undeniable consequences on health and nutrition. Ambiguities in nomenclature, misidentification and resemblance of colour and texture of the crude herbal drugs are the major causes of adulteration. Three different species commercially marketed under the same trade name Halion are Lepidium apetalum, Asparagus officinalis, and Lepidium didymum. The genuine source of Halion is Lepidium apetalum, which is authenticated by using basic and advanced taxonomic techniques. Morphology, anatomy and palynology of the misidentified sources were done using light and scanning electron microscopic techniques for authentication. This study may help to set microscopic techniques as a tool to achieve quality and standardization of the genuine source of the herbal drug. Phytochemical analysis and biological screening is needed for the further establishment of authenticity and quality of herbal drugs.

Herbal Drug Regulatory Landscape: Key Comparison between Russia and India

Herbal drugs as well as the traditional medicines are widely used and are a part of primary healthcare among world population. The demand of herbal drugs is also seen increased in developed nations due to its beneficial effects. As the use of herbal drugs increases worldwide, the possibility of side effects and adverse effects are also more common, which necessitate well structured regulatory control over the globe. But the fact is that the legislative classification and regulatory control of herbals differ among countries and no harmonization exists in regulations. Assurance of the safety, efficacy and quality of herbal drugs remain a key issue in industrialized and developing nations. This review illustrates on how the herbal drugs are defined and to compare the different perceptions of herbal drugs regulations in Russia and India.

Comprehensive HPTLC Fingerprinting for Quality Control of an Herbal Drug - The Case of Angelica gigas Root.

The quality of herbal drugs is usually controlled using several tests recommended in a monograph. HPTLC is the method of choice for identification in many pharmacopoeias. If combined with a suitable reference material for comparison, HPTLC can provide information beyond identification and thus may simplify quality control. This paper describes, as a proof of concept, how HPTLC can be applied to define specifications for an herbal reference material and to control the quality of an herbal drug according to these specifications. Based on multiple batches of cultivated Angelica gigas root, a specific HPTLC method for identification was optimized. This method can distinguish 27 related species. It also can detect the presence of mixtures of A.gigas with two other Angelica species traded as "Dang gui" and is suitable as well for quantitative assessment of samples in a test for minimum content of the sum of decursin and decursinol angelate. The new concept of "comprehensive HPTLC fingerprinting" is proposed: HPTLC fingerprints (images), which are used for identification, are converted into peak profiles and the intensities of selected zones are quantitatively compared to those of the corresponding zones of the reference material. Following a collaborative trial involving three laboratories in three countries, the method was applied to check the quality of further candidates for establishing an appropriate reference material. In conclusion, this case demonstrates that a single HPTLC analysis can provide information about identity, purity, and minimum content of markers of an herbal drug.

Pharmacognostic and Physicochemical Standardization of Nigella sativa and Allium cepa Seeds

Standardization is the code of conduct in order to ensure the proper identification, authentication and also for the standardization of crude herbal drugs. The quality of herbal drugs is the sum of all factors which contribute directly or indirectly to the safety, effectiveness and acceptability of the product. Towards authentication and quality assurance of medicinal plants, pharmacognostic, physicochemical studies of Nigella sativa and Allium cepa seeds were performed. The macroscopic and physicochemical parameters like ash value, loss on drying, foaming index, swelling index, extractive values and fluorescence analysis were carried out as per WHO guidelines. The findings of Pharmacognostic and physicochemical studies can be used as markers in the identification and standardization of Nigella sativa and Allium cepa seeds as a herbal remedy and also towards monograph development on the plant. Further it assists in validating this raw material for use in herbal formulations in the upcoming era.

Comprehensive quality evaluation of medical Cannabis sativa L. inflorescence and macerated oils based on HS-SPME coupled to GC–MS and LC-HRMS (q-exactive orbitrap®) approach

There are at least 554 identified compounds in C. sativa L., among them 113 phytocannabinoids and 120 terpenes. Phytocomplex composition differences between the pharmaceutical properties of different medical cannabis chemotype have been attributed to strict interactions, defined as ‘entourage effect’, between cannabinoids and terpenes as a result of synergic action. The chemical complexity of its bioactive constituents highlight the need for standardised and well-defined analytical approaches able to characterise the plant chemotype, the herbal drug quality as well as to monitor the quality of pharmaceutical cannabis extracts and preparations. Hence, in the first part of this study an analytical procedures involving the combination of headspace-solid-phase microextraction (HS-SPME) coupled to GC–MS and High Resolution Mass-Spectrometry LC-HRMS (Orbitrap®) were set up, validated and applied for the in-depth profiling and fingerprinting of cannabinoids and terpenes in two authorised medical grade varieties of Cannabis sativa L. inflorescences (Bedrocan® and Bediol®) and in obtained macerated oils. To better understand the trend of all volatile compounds and cannabinoids during oil storage a new procedure for cannabis macerated oil preparation without any thermal step was tested and compared with the existing conventional methods to assess the potentially detrimental effect of heating on overall product quality.

Current Status of Herbal Drug Standards in the Indian Pharmacopoeia.

The benefits of herbal drugs were well understood way back. They have been used for the promotion of health and medical purposes - in disease conditions. It is a conventional belief that herbal drugs have no side effects, are cheaper and locally available. Among Indian systems of medicines, herbs/herbal formulations are used to a larger extent. The quality control of the marketed herbs/herbal formulations is important for acquiring optimum therapeutic benefit as well as for expanding global outreach. Therefore, herbal drug standards are important. Reference standards, the Indian Pharmacopoeia Reference Substances especially the botanical reference substances and the phytochemical reference substances are required for comparison of quality of herbal drugs. The Indian Pharmacopoeia Commission has initiated the process of providing Indian Pharmacopoeia Reference Substances to the stakeholders. Therefore, this article provides an overview of the history and the status of herbal drug standards in the current and forthcoming issues of Indian Pharmacopoeia. In Indian Pharmacopeia, efforts have been made for the harmonization of standards with international counterparts wherever possible. Copyright © 2017 John Wiley & Sons, Ltd.

Quality Standards for Herbal Drugs and Herbal Drug Preparations - Appropriate or Improvements Necessary?

Standards for quality control as defined in the European Pharmacopoeia contribute significantly to a consistent and high quality of herbal drugs, herbal drug preparations, and herbal medicinal products. The minimum content of single plant constituents is considered of high relevance. Therefore, nearly all monographs on herbal drugs or herbal drug preparations contain an obligatory assay.However, a critical evaluation of the data published for such assayed constituents reveals that in most cases these constituents have to be considered as purely analytical markers without correlation to quality or efficacy. Examples where the assay does not meet its objective support the need to adapt current quality standards. Moreover, the trend to increase the content of certain constituents may lead to significant modifications to traditional manufacturing processes.In order to initiate a scientific discussion, the role of the assay in the context of quality requirements, quality documentation in the manufacturing process, safety, and efficacy is discussed and possible alternatives to the single marker assay are examined.

Macroscopic authentication of Chinese materia medica (CMM): A UK market study of seeds and fruits

This small-scale macroscopic and quantitative authentication study, the first of its kind in the UK and elsewhere, assesses the identity and purity (excluding pesticides and heavy metals) of a selection of Chinese materia medica (CMM) seeds and fruits on the UK market. 25 fruit and seed CMM were chosen based on their inclusion in the Chinese Pharmacopoeia (2010, referred hereafter as ‘official species’), maximum dimension of 10mm, and regular use in Traditional Chinese Medicine (TCM) practice in the UK according to UK practitioners. In 2012 samples were obtained from six TCM wholesale traders and eight retail dispensaries in southeast England. Macroscopic identity and purity testing was undertaken drawing on expertise at the Royal Botanic Gardens, Kew and its collection of vouchered CMM reference drugs, herbarium specimens and published identification texts. Of the 25 CMM requested from suppliers, 23 were obtained, represented by 211 samples. 191 samples were identified as being sourced from the correct drug; 20 were identified as sourced from unofficial species. Of the 191 correct samples, 5 displayed major contamination by other plant material, stones, earth, etc. (defined as >5% of sample volume), and 12 had minor contamination (2–5%). 95% of samples derived from medicinally cultivated plants were sourced from an official species, 5% were contaminated; in contrast, 78% of wild-sourced CMM samples were sourced from an official species, and 14% showed contamination. These results aim to guide the further development of good practice in TCM herbal drug quality control, for which suggestions are provided.

Pharmacognostic and Preliminary Phytochemical Evaluation of Centipeda minima and Bauhinia purpurea Leaves

Centipeda minima and Bauhinia purpurea are used as traditional medicinal plant for ailment of various diseases. The present study was aimed to evaluate the Pharmacognostic and Phytochemical screening of Centipeda minima and Bauhinia purpurea. The Pharmacognostic evaluation (total ash, acid insoluble ash, water soluble ash, water soluble extractive and alcohol soluble extractive) and fluorescence analysis of leaves powder were performed. Preliminary phytochemical investigation was carried out of the crude extracts of Centipeda minima and Bauhinia purpurea leaves using solvents of different polarity. The Pharmacognostic characters of Centipeda minima and Bauhinia purpurea have been done for standardization of crude drug. The results of preliminary phytochemical revealed the presence of flavonoids, tannins, phenolic compounds, alkaloids, glycosides, fats and carbohydrates in Centipeda minima and Bauhinia purpurea leaves. These studies provided referential information in regard to its identification parameters assumed significantly in the way of acceptability of herbal drugs in present scenario of lack of regulatory laws to control quality of herbal drugs.

Phytochemical Screening and Thin Layer Chromatography of Ficus carica Leaves Extract

Ficus carica leaves are traditionally used in the treatment of various diseases namely vitiligo, diabetes, coughs, asthma, constipation and gingivitis. The aim of the present study was a preliminary phytochemical and thin layer chromatography (TLC) analysis of the various extracts of Ficus carica leaves. Phytochemical analysis was carried out using the standard phytochemical assays. TLC analysis of the chloroform and ethanol extract of the leaves was carried out using the solvent system Ethanol: Chloroform (9:1) and Ethanol: Hexane (3:7), respectively. The findings of the preliminary phytochemical screening revealed the presence of various chemical compounds like alkaloids, glycosides, flavonoids, carbohydrates, tannins, phenols, fixed oil and fats. The three Rf value (0.59, 0.78 & 0.94) and six Rf value (0.05, 0.21, 0.34, 0.51, 0.65 & 0.87) were found in TLC plate of chloroform and ethanol extracts, respectively. These studies provided referential information in regard to its identification parameters assumed significantly in the way of acceptability of herbal drugs in present scenario of lack of regulatory laws to control quality of herbal drugs.

Hypericum perforatum: Synthesis of Active Principles during Flowering and Fruitification-Novel Aspects of Biological Potential.

St. John's wort is a widely used medicinal plant. The quality of herbal drug, which is in most of the cases collected from nature, varies. Therefore, the aim of the present study was detailed chemical characterization of Hypericum perforatum subsp. perforatum samples collected in close time intervals during flowering and fruitification with the purpose to state the phenological stage characterized by maximum levels of active principles. The antioxidant potential and potential to inhibit biologically important enzymes, as well as the cytotoxicity and genotoxicity of the sample collected during the full flowering period, were evaluated. Data showed that the optimal period for the achieving of maximum level of active principles is the phenophase between floral budding and flowering stage. Significant antioxidant potential and the ability to inhibit biologically important enzymes (especially α-glucosidase) were recorded. The extract exhibited no genotoxicity in subcytotoxic concentrations, while increased cytotoxicity recorded in cotreatment with bleomycin on malignant cell lines was especially significant.

Chemical characterization and chemotaxonomy of Hypericum hirsutum L. 1753 from Vojvodina (Serbia)

The genus Hypericum includes over 500 widely distributed species. The main representative is St. John?s wort (Hypericum perforatum L. (1753), Hypericaceae), the only approved biological source of Hyperici herba by WHO and EMEA monographs. It is frequently used in the form of oil macerate for treatment of burns, scars, eczema and gas?trointestinal disorders, as well as in the form of water and alcoholic extracts as clinically proved antidepressant. Available data suggest that the amounts of secondary metabolites in the plant vary depending on ecological factors of the habitat, and consequently affect the quality of herbal drug. The reports show that other species of the genus have similar chemical profile as H. perforatum. But, there are also Hypericum species in which some of the secondary metabolites of interest occur in higher quantities than in H. perforatum. As previous data suggest, Hypericum hirsutum L. 1753, could be such example. Therefore, the aim of this study was to chemically characterize water-alcoholic extracts of H. hirsutum samples, collected at four localities in Vojvodina (Republic of Serbia) by liquid chromatography (HPLC-DAD). The obtained results suggest a good match (in a term of a presence of investigated compounds) of previously published results describing chemical profile of H. perforatum water-alcoholic extracts with examined H. hirsutum extracts. Also, chemotaxonomic analysis showed variations in quantity of secondary metabolites in the examined extracts. This opens the door to further investigation of H. hirsutum as a new source of bioactive secondary metabolites and additional markers in Hypericum chemotaxonomy.

Comparative study of Passiflora taxa leaves: I. A morpho-anatomic profile

Determining the authenticity and quality of plant raw materials used in the formulation of herbal medicines, teas and cosmetics is essential to ensure their safety and efficacy for clinical use. Some Passiflora species are officially recognized in the pharmaceutical compendia of various countries and have therapeutic uses, particularly as sedatives and anxiolytics. However, the large number of Passiflora species, coupled with the fact that most species are popularly known as passion fruit, increases the misidentification problem. The purpose of this study is to make a pharmacognostic comparison between various Passiflora species to establish a morpho-anatomical profile that could contribute to the quality control of herbal drug products that contain passion fruit. This was conducted by collecting samples of leaves from twelve Passiflora taxa (ten species and two forms of P. edulis): P. actinia, P. alata, P. amethystina, P. capsularis, P. cincinnata, P. edulis f. flavicarpa, P. edulis f. edulis, P. incarnata, P. morifolia, P. urnifolia, P. coccinea and P. setacea, from different locations and their morpho-anatomical features were analyzed using optical microscopy and scanning electron microscopy. Microscopic analysis allowed to indicate a set of characters that can help to differentiate species. These include midrib and petiole shape, midrib and petiole vascular pattern, medium vein shape, presence of trichomes, presence of blade epidermal papillae and sclerenchymatic cells adjoining the vascular bundles. These characters could be used to assist in the determination of herbal drug quality and authenticity derived from a species of Passiflora.

Herbal hepatotoxicity in traditional and modern medicine: actual key issues and new encouraging steps.

Plants are natural producers of chemical substances, providing potential treatment of human ailments since ancient times. Some herbal chemicals in medicinal plants of traditional and modern medicine carry the risk of herb induced liver injury (HILI) with a severe or potentially lethal clinical course, and the requirement of a liver transplant. Discontinuation of herbal use is mandatory in time when HILI is first suspected as diagnosis. Although, herbal hepatotoxicity is of utmost clinical and regulatory importance, lack of a stringent causality assessment remains a major issue for patients with suspected HILI, while this problem is best overcome by the use of the hepatotoxicity specific CIOMS (Council for International Organizations of Medical Sciences) scale and the evaluation of unintentional reexposure test results. Sixty five different commonly used herbs, herbal drugs, and herbal supplements and 111 different herbs or herbal mixtures of the traditional Chinese medicine (TCM) are reported causative for liver disease, with levels of causality proof that appear rarely conclusive. Encouraging steps in the field of herbal hepatotoxicity focus on introducing analytical methods that identify cases of intrinsic hepatotoxicity caused by pyrrolizidine alkaloids, and on omics technologies, including genomics, proteomics, metabolomics, and assessing circulating micro-RNA in the serum of some patients with intrinsic hepatotoxicity. It remains to be established whether these new technologies can identify idiosyncratic HILI cases. To enhance its globalization, herbal medicine should universally be marketed as herbal drugs under strict regulatory surveillance in analogy to regulatory approved chemical drugs, proving a positive risk/benefit profile by enforcing evidence based clinical trials and excellent herbal drug quality.

Development of chemo-genetic fingerprints and pharmacological evaluation of Lannea coromandelica Linn.

Correct identification of medicinal plants by phytochemical and genetic fingerprints is a fast growing tool to ensure reproducible medicinal quality of herbal drugs. Due to advances in molecular biology techniques, copious highly informative DNA-based methods have been developed for the identification of medicinal plants. In our current study, HPTLC and Restricted Fragment Length Polymorphism (RFLP) techniques were employed to develop fingerprinting of Lannea coromandelica (L. coromandelica) and filariciadal activity of ethyl acetate extract was assessed by motility inhibition and MTT reduction assay with concentrations range 1000 to 25 µg/ml. The HPTLC analysis of ethyl acetate extract was carried out using hexane: ethyl acetate: formic acid: methanol (5:4:1:0.5 v/v/v/v) for fingerprinting and quantification of ellagic acid and quercetin. The HPTLC method was found to give compact spots for Rf= 0.54, ellagic acid; Rf= 0.91, quercetin. The HPTLC method was validated as per the International Conference on Harmonization guidelines. A polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) analysis of the matK gene was developed to discriminate L. coromandelica from others. Only the 578-bp PCR product from L. coromandelica could be digested with restricted enzyme (SsspI) into two fragments of 364 and 214-bp. Inhibitory concentration (IC50) for the plant extract was found to be 284.5 µg/ml. In the motility assay, complete inhibition of motility was observed for all concentrations. Hence, our study could be valuable for inventing strategies for quality control parameter and primary screening of new potential filaricides of L. coromandelica.

Pharmacognostic Evaluation of Leaves and Stem of Murraya koenigii

Murraya koenigii has been widely used as medicine in indigenous system of medicine. It is used as an analgesic, febrifuge, stomachic, carminative and for the treatment of dysentery skin eruption. The present study was planned for details pharmacognostical studies of Murraya koenigii leaves and stem. Macroscopical characters and microscopical characters of leaves and stem were perceived. The Physicochemical properties (total ash, acid insoluble ash, water soluble ash, water soluble extractive, methanol soluble extractive, moisture content and foaming index) of bark powder were studied. The values of physicochemical can also be used for standardization of Murraya koenigii. These studies provided referential information in regard to its identification parameters assumed significantly in the way of acceptability of herbal drugs in present scenario of lack of regulatory laws to control quality of herbal drugs.