Safety Of Herbal Drugs Research Articles

Clinical and pharmacological aspects of vervain (Verbena officinalis L.) using in the treatment of respiratory system diseases (literature review)

In the pharmacotherapy of the respiratory system diseases, phytotherapy attracts attention due to the high preventive and therapeutic potential of biologically active substances of medicinal plants. At the same time, verification of the effectiveness and safety of herbal drugs is necessary. That is why scientific research of folk medicine plants including common verbena (Verbena officinalis L.) of the Verbenaceae family has been carried out.
 The aim of the work is the analysis of verified data on the chemical composition of the herb verbena, the results of pharmacological and toxicological studies directed at determining the effectiveness and safety in the treatment of infectious and inflammatory diseases of the respiratory tract.
 The search for verified data using Internet resources, comparative analysis, systematization and generalization of data were carried out.
 The main secondary metabolites that determine the profile of verbena herb biological activity are iridoid glycosides (verbenalin, aucubine and gastatoside), as well as phenylpropanoid glycosides (verbascoside, isoverbascoside and eukovoside). Thus, the antibacterial and antifungal activity of certain verbena extracts against clinically significant strains of bacteria and fungi has been proven. The anti-inflammatory effect of various extracts of the Verbena herb was established on carrageenan-induced and formalin-induced edema models. The antioxidant effect of certain verbena herb fractions has been proven by in vitro methods. It is important at presence of diseases for which oxidative stress is an important pathogenetic factor. The results of clinical studies have confirmed the anti-inflammatory and antibacterial activity of the vervaine herb decoction applied topically in the case of chronic gingivitis. The expediency of verbascoside use for increasing the barrier functions of the oral mucosa, promoting epithelization, reducing pain and other signs of inflammation in oral mucositis against the background of tumour chemotherapy has been substantiated. Toxicological studies have shown that different verbena herb extracts belong to the class of low-toxic or practically non-toxic substances when taken orally.
 Thus, the antimicrobial, anti-inflammatory and antioxidant effects of verbena, as well as its high level of safety, substantiate the prospects for the use of this medicinal plant in the treatment of the respiratory system diseases.

The validated pharmaceutical standard operating procedure and quality control study of the coded polyherbal tablet formulation AYUSH SG-5

In India, Ayurvedic medicine has its own significance and dominance in the Indian Medicine System. The traditional medicine system of India is not well renowned due to the lack of standardization of herbal drugs. To assess the quality, purity, efficacy, potency, and safety of herbal drugs, standardization is the major aspect. Recently, World Health Organization (WHO) and European Medicines Agency (EMEA) have issued guidelines for the quality control of herbal drugs. The aim of the present study is the standardization of the coded polyherbal tablet formulation AYUSH SG-5. A scientific methodology was adopted to perform the standardization parameters like organoleptic parameters, microscopic, macroscopic, physico-chemical analysis, and high-performance thin-layer chromatographic (HPTLC) profiling of AYUSH SG-5. The HPTLC study has exhibited the presence of various phytochemicals such as 6-gingerol in Sunthi ( Zingiber officinale rhizomes), Epicatechin in Vetas (stem bark of Salix alba ), Colchicine in Suranjan ( Colchicum luteum corms), Resveratrol in Chopchini ( Smilax china tuber), Guggulsterone E & Z in Guggul ( Commiphora wightii resin). Based on the results of the present study, a monograph was proposed in the interests of quality control of the AYUSH SG-5. This research will help pharmacists to develop the formulation of AYUSH SG-5 with greater reproducibility and this document could be treated as a pharmaceutical standard operating procedure (SOP) for the production of AYUSH SG-5 in pharmacy. • A polyherbal ayurvedic tablet formulation AYUSH SG-5 for rheumatoid arthritis is prepared. • A scientific methodology was adopted to perform the standardization of AYUSH SG-5. • Organoleptic parameters, microscopic, macroscopic studies performed as per API. • Physico-chemical tests and HPTLC profiling of AYUSH SG-5 was performed. • In HPTLC study, marker compounds like 6-gingirol, Epicatechin, Colchicine, Resveratrol, guggulsterol E & Z in Guggul were identified. • A validated SOP was purposed for preparation and standardization of AYUSH SG-5.

Efficacy and Safety of Oral Herbal Drugs Used as Adjunctive Therapy for Melasma: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

Background Melasma is an acquired disorder of facial pigmentation. Its etiology is multifactorial; thus, the management is usually challenging. As a complementary therapy, herbal drugs are often used in the management of melasma. This work was aimed to investigate the efficacy and safety of herbal drugs on melasma in female patients. Methods This study followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search was conducted, and all randomised controlled trials (RCTs) on the use of oral herbal drugs as complementary therapy for melasma in female patients were included. A meta-analysis was conducted according to the guidelines of the Cochrane Collaboration using Review Manager 5.4. Results Ten eligible trials, with 1015 female melasma patients, were included. All of the included RCTs had some concerns for risk of bias for different reasons, especially for that most of included trials were unblinded. Pooled data suggested phytotherapy plus routine therapy had significantly better efficacy on melasma than routine therapy, in terms of response rate (OR: 4.49, 95% CI: 3.25 to 6.20, p < 0.00001), reduction of skin lesion score (SMD: −0.56, 95% CI: −0.79 to −0.33, p < 0.00001), and improvement of serum E2 levels (SMD: −1.58, 95% CI: −2.62 to −0.55, p 0.003). In addition, there was no significant difference in the incidence of AEs between phytotherapy plus routine therapy and routine therapy (OR: 0.92, 95% CI: 0.53 to 1.58; p 0.76). Overall, herbal drugs used as an adjunct to routine therapy significantly enhanced the efficacy for the treatment of melasma but with a comparable safety profile. Conclusion These findings have implications for recommending herbal drugs as a viable complementary treatment option for melasma.

Uncovering the Anti-Lung-Cancer Mechanisms of the Herbal Drug FDY2004 by Network Pharmacology.

With growing evidence on the therapeutic efficacy and safety of herbal drugs, there has been a substantial increase in their application in the lung cancer treatment. Meanwhile, their action mechanisms at the system level have not been comprehensively uncovered. To this end, we employed a network pharmacology methodology to elucidate the systematic action mechanisms of FDY2004, an anticancer herbal drug composed of Moutan Radicis Cortex, Persicae Semen, and Rhei Radix et Rhizoma, in lung cancer treatment. By evaluating the pharmacokinetic properties of the chemical compounds present in FDY2004 using herbal medicine-associated databases, we identified its 29 active chemical components interacting with 141 lung cancer-associated therapeutic targets in humans. The functional enrichment analysis of the lung cancer-related targets of FDY2004 revealed the enriched Gene Ontology terms, involving the regulation of cell proliferation and growth, cell survival and death, and oxidative stress responses. Moreover, we identified key FDY2004-targeted oncogenic and tumor-suppressive pathways associated with lung cancer, including the phosphatidylinositol 3-kinase-Akt, mitogen-activated protein kinase, tumor necrosis factor, Ras, focal adhesion, and hypoxia-inducible factor-1 signaling pathways. Overall, our study provides novel evidence and basis for research on the comprehensive anticancer mechanisms of herbal medicines in lung cancer treatment.

Determination of synthetic pharmaceutical adulterants in herbal weight gain supplements sold in herb shops, Tehran, Iran.

BackgroundNowadays with the growing popularity of herbal remedies across the world, large sections of population rely on herbal drug practitioners for their primary care. Therefore there is a need to ensure about the safety of herbal drugs and to detect adulteration with undeclared active pharmaceutical ingredients. Herbal drugs are used as first-line drug therapy in some instances. Unfortunately even if there are claims as to be natural, undeclared active pharmaceutical ingredients have been detected in these supplements.ObjectivesThe purpose of the present study was to analyse herbal weight gain drugs collected from herb shops located in Tehran, Iran to detect hidden pharmaceutical ingredients using UHPLC and GC/MS instrumentations.MethodsSixty herbal drugs advertised as weight gain supplements were gathered from herb shops Tehran province, Iran. All samples were analysed from analytical toxicology point of view to detect undeclared active pharmaceutical ingredients. Method was validated for quantitative analysis of cyproheptadine and dexamethasone.ResultsMethod validity parameters showed good results for quantitative analysis of pharmaceutical ingredients. Cyproheptadine, dexamethasone, sildenafil, tramadol, caffeine and acetaminophen were detected in herbal weight gain drugs. Analysed dosage forms contained cyproheptadine and dexamethasone in concentrations higher than therapeutic doses. Quantitative analysis of contaminated drugs showed that the content of pharmacologic ingredients were 0.2–67 and 5.5–10.1 mg/tablet or capsule for cyproheptadine and dexamethasone respectively.ConclusionsDespite natural supplements producers’ claim, herbal weight gain drugs were not natural at all. Undeclared active pharmaceutical ingredients can predispose patients to health problems and even life-threatening situations. Graphical ᅟ

DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR QUANTITATIVE ESTIMATION OF NUCIFERINE FROM LOTUS LEAVES

Nelumbo nucifera Gaertn (Family: Nelumbonaceae), commonly known as lotus, is an aquatic perennial plant. The lotus leaves are used to treat fever, hematemesis, hyperlipidaemia and obesity. The leaves are rich in alkaloids such as nuciferine, roemerine, pronuciferine and N-nornuciferine. The present study describes simple, accurate, precise, robust RP-HPLC method to detect and quantitate nuciferine as a marker from lotus leaves. The marker was resolved using Hemochrom Intsil C-18 column, with mobile phase methanol:10mm phosphate buffer (85:15), pH adjusted to 4 (using orthophosphoric acid) at a flow rate of 1 mL/min. Retention time of nuciferine was 5.60±0.2 minutes at 272 nm. Linear responses were obtained in concentration range of 1 - 9 ppm for nuciferine with correlation coefficient (r2) of 0.9996. The developed method was applied for quantitation of marker from lotus leaves. This method can be used to evaluate nuciferine containing extracts, thus conforming to the need of ensuring quality and safety of herbal drugs.

Cushing in a Leaf: Endocrine Disruption From a Natural Remedy

Information regarding the safety of herbal drugs is often not reported. We describe the case of a 65-year-old woman referred to us for a iatrogenic hypercortisolism, who denied any previous steroid consumption. She reported only a chronic application of a phytocosmetic cream, containing ethanol extract of the Cardiospermum halicacabum (CH) plant. Adrenal insufficiency occurred after the cream application was stopped. CH is used in traditional and Western medicine for its documented anti-inflammatory properties. Once the presence of synthetic glucocorticoids was ruled out in the phytocosmetic product, we investigated whether and how its chronic application could have caused the iatrogenic hypercortisolism. Liquid chromatography high-resolution mass spectrometry (LC-HRMS) was performed to exclude the presence of known glucocorticoids in the cream. ELISA assay and Western blot analysis were employed to assess ACTH secretion and the glucocorticoid receptor expression respectively in murine ACTH-secreting pituitary adenoma cells AtT-20/D16v-F2, treated with dexamethasone, CH tincture, and mifepristone alone or in combination. To detect specific interaction of CH extract with the glucocorticoid receptor, we performed a dual-luciferase reporter assay in HEK293 cells. In AtT-20/D16v-F2 cells, CH extract showed to significantly reduce basal and CRH-induced ACTH secretion and the glucocorticoid receptor expression, similarly to dexamethasone; these effects were counteracted by mifepristone. In HEK293 cells, dexamethasone significantly induced luciferase activity after 24- and 36-hour treatment and CH tincture only after 36 hours; these effects were antagonized by mifepristone. CH extract displays a glucocorticoid-like activity, by means of a direct binding to the glucocorticoid receptor.

Herbal drug standardization and its implication – A current need of time

In recent years more people throughout world are turning to use medicinal plant products in healthcare system. The use of herbal drugs has been increased all over the world due to their huge therapeutic effect and less adverse effects as compared to other medicines. Worldwide need of alternative medicine has resulted in growth of natural product markets and interest in traditional systems of medicine. Herbal drug technology is used for converting botanicals materials into medicines, where standardization and quality control with proper integration of modern scientific techniques and traditional knowledge is important. Mostly herbal drugs are effective but due to adulteration and lack of standardization, the effectiveness of the herbal drug is decreased. So there is need of development of standardization parameters. In the standardization of the herbal drug the physical, chemical, biological, analytical parameters are carried out. It assures the quality, purity and safety of herbal drug. Reason of these studies involve the safe and accurately selection and handling of crude materials, ensure efficacy and stability of finished product. Implication of standardization of herbal drug is essential because of increasing demand for developing an herbal dosage form which improve patient convince and compliance.

Farmacovigilância de drogas vegetais e seus derivados: uma ação necessária e já iniciada para a segurança do paciente, no contexto do uso racional de medicamentos

In antiquity, the treatment of diseases affecting humans was usually performed medicinal plants. Since the industrial revolution in the nineteenth century, this alternative treatment method has fallen into disuse. In recent decades, however, it has been used again because of factors such as lack of access to doctors and pharmacists and the high cost of synthetic drugs services. Consequently, the number of reports of adverse events related to plant drugs has increased. Its use is common in primary care, and most users believe that it is a safe treatment method. The toxicity of medicines or drugs that contain plants is a matter of public health because they can trigger adverse reactions such as severe poisoning and can interact with conventional drugs. There are few data on the safety of herbal drugs, and most of them have not been subjected to clinical phase studies. Monitoring of unwanted effects through the implementation of a pharmacovigilance system that includes the medicinal plant species is required. However, in Brazil, the safety assessment of herbal drugs and their derivatives is only beginning. It is therefore necessary to take actions to ensure that an effective and robust system is structured.

Herbal-drug-associated Adverse Events Reported in the Internet Newspaper Articles

Objectives: The aim of this study was to understand the characteristics of herbal-drug-associated adverse events (AEs) reported in the internet newspaper articles and to take a countermeasure against the safety issue of herbal drugs. Methods: We searched the internet newspaper articles published from 2010 to 2014 in the 3 major portal sites in Korea, NAVER, DAUM, and GOOGLE. Search terms were the Korean words equivalent of ‘herbal drug’ and ‘side effects’. Informations on the type and characteristics of suspected herbal drugs, AEs, and the patient records were extracted from the articles reporting the herbal-drug-associated AE occurred in Korea. Results: From 8,806 articles, a total of 36 AEs were found. The most frequently reported age group was 20s, and women outnumbered men. Obesity was the most common cause of administration. Doctors of Korean medicine clinic were the most commonly referred prescribers and purchasing route (11 cases). The most frequently mentioned medicinal herb was Ephedra sinica (7 cases) and the most commonly reported AEs were abdominal pain (8 cases), dizziness (6 cases), diarrhea (5 cases), and vomiting (5 cases) were followed in order. Ten cases were judged as serious AEs, and the others were not. Conclusions: Current customers demand health care providers to offer them sufficient information on the safety of herbal drugs. To satisfy their requirements, physicians of Korean medicine should be able to explain, predict, prepare, recognize, and deal with the herbal-drug-associated AEs. We propose an establishment of pharmacovigilance system for herbal medicine, in which doctors of Korean medicine are participated as important personnel, to collect and analyze the related AEs and offer credible information on the safety of herbal drug.

HERBAL DRUGS IN PEDIATRIC RHINOSINUSITS TREATMENT

The article referred to the use of herbal drugs in treatment of acute rhinosinusitis in children. Topical aspects of the etiology, pathogenesis, clinical manifestations and diagnosis of acute rhinosinusitis in children are disscussed. The advantages of application of herbal drugs in such pathology are discussed indications for these drugs and possible side effects. The results of research of the efficacy and safety of herbal drugs for the treatment and prevention of acute sinusitis in children are adduced .

REVIEW ON STANDARDIZATION OF HERBAL CHURNA

In the last some years, the use of herbal drugs has been increased all over the world due to their huge therapeutic effect and less adverse effects as compared to other medicines . The rising use of herb al drug by the human is forcing the driving force to evaluate the health claim of these agents and to develop standards of quality, purity, safety and e fficacy of the drug. Mostly herbal drugs are effective but due to adulteration and lack of standardization, the effectiveness of the herbal drug is decreased. So there is need of development of standardization parameters. In the standardization of th e herb al drug the physical, chemical, biological , analytical parameters a re carried out. It assures the quality, purity and safety of herbal drug.

Heavy Metal Contamination of Herbal Drugs: Implication for Human Health-A Review

Interest in the use of medicinal plants in treatment of diseases in Africa has increased tremendously over the past decade. Ingestion of contaminated medicinal plants and herbal medicinal products is regarded as potential source of heavy metal toxicity to both man and animals. Heavy metals are often not well defined in medicine, but include all toxic metals. They are released into the environment by both natural and a variety of anthropogenic sources. The presence of heavy metals in plant tissues is primarily dependent upon their availability and concentration in the soil. They can also be deposited directly on plant surfaces from the atmosphere. Heavy metals are persistent in nature due to their long biological half-life. The major heavy metals of health concern are arsenic, cadmium, lead and mercury. They are the redox inactive metals and show their toxic effects via bonding to sulphydryl groups of proteins and depletion of glutathione - an antioxidant. In order to ensure quality and safety of herbal drugs, cultivation and collection of medicinal plants in the immediate vicinity of industrial sites which utilize these metals and their compounds, and sites where these metals have been improperly disposed is highly discouraged; because plants from these areas are prone to high concentration of heavy metals, hence, increases human risk of contamination when taken. In addition,

CHILDHOOD COUGH — RATIONAL APPROACH TO TREATMENT

Questions of rational approach to treatment of childhood diseases accompanied by cough are discussed in this article. The author emphasized the necessity of taking into account special features of the disease, mechanisms of action of used drugs and their undesirable effects, as well as individual characteristics of a patient. High efficacy and safety of herbal drugs in treatment of respiratory disorders in children is shown. An algorithm of choice of drugs influencing on cough is offered.

Impact of socio‐demographic factors, knowledge and attitude on the use of herbal drugs in pregnancy

Herbal drugs are often promoted as 'natural' and 'safe'. These claims may especially attract pregnant women who are often concerned about their unborn child's well-being. Few studies have assessed the use of herbal drugs in pregnancy and the factors related to this use. To investigate the impact of socio-demographic factors, knowledge and attitude on the use of herbal drugs in pregnancy. A total of 400 postpartum women at Ulleval University Hospital in Oslo, Norway were interviewed within 3 days after giving birth by using a structured questionnaire in the period from February to June 2001. In all, 36% of the women reported herbal use during their pregnancy. Both women who had used herbal drugs in pregnancy and those not, had a positive attitude toward the use of herbal drugs in pregnancy. Echinacea was the most well known herb among both groups of women. The factors associated with the use of herbal drugs in pregnancy were: prior use of herbs, high knowledge about herbal drugs and age between 26 and 35 years. There was a non-significant higher frequency of herbal drugs use in pregnancy among women with a higher education level. The widespread use and positive attitude toward herbal drugs in pregnancy indicates an increased need for documentation about both the efficacy and safety of herbal drugs in pregnancy. Women between 26 and 35 years with a prior history of herbal drug use and high knowledge about herbs, are more prone to using herbal drugs in pregnancy.

Use of herbal drugs in pregnancy: a survey among 400 Norwegian women.

To investigate the use of herbal drugs by pregnant women. We interviewed 400 postpartum women at Ullevål University Hospital in Oslo, Norway about the use of herbal drugs, within 3 days after giving birth by using a structured questionnaire in the period from February to June 2001. We found that 36% of the pregnant women had used herbal drugs during pregnancy with an average of 1.7 products per woman. The proportion of women using herbal drugs increased throughout the first, second and third pregnancy trimester. The most commonly used herbs were echinacea, iron-rich herbs, ginger, chamomile and cranberry. Among the women having used herbal drugs in pregnancy, 39% had used herbal drugs that were considered possibly harmful or herbs where information about safety in pregnancy was missing. Herbal galactagogues had been used by 43% of the women who had breastfed a prior child during their breast-feeding period. Use of herbal drugs in pregnancy had most commonly been recommended by family or friends. The widespread use of herbal drugs during pregnancy indicates an increased need for documentation about the safety of herbal drugs in pregnancy. To meet the needs of pregnant women, it is necessary for health care personnel to have knowledge about herbal drugs during pregnancy.

Online quality control with raman spectroscopy in pharmaceutical tablet manufacturing

In India, Ayurvedic medicine has its own significance and dominance in the Indian Medicine System. The traditional medicine system of India is not well renowned due to the lack of standardization of herbal drugs. To assess the quality, purity, efficacy, potency, and safety of herbal drugs, standardization is the major aspect. Recently, World Health Organization (WHO) and European Medicines Agency (EMEA) have issued guidelines for the quality control of herbal drugs. The aim of the present study is the standardization of the coded polyherbal tablet formulation AYUSH SG-5. A scientific methodology was adopted to perform the standardization parameters like organoleptic parameters, microscopic, macroscopic, physico-chemical analysis, and high-performance thin-layer chromatographic (HPTLC) profiling of AYUSH SG-5. The HPTLC study has exhibited the presence of various phytochemicals such as 6-gingerol in Sunthi (Zingiber officinale rhizomes), Epicatechin in Vetas (stem bark of Salix alba), Colchicine in Suranjan (Colchicum luteum corms), Resveratrol in Chopchini (Smilax china tuber), Guggulsterone E & Z in Guggul (Commiphora wightii resin). Based on the results of the present study, a monograph was proposed in the interests of quality control of the AYUSH SG-5. This research will help pharmacists to develop the formulation of AYUSH SG-5 with greater reproducibility and this document could be treated as a pharmaceutical standard operating procedure (SOP) for the production of AYUSH SG-5 in pharmacy.

Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents).

This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs). Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.