scholarly journals Regulatory compliance of herbal medicines – A review

2019 ◽  
Vol 10 (4) ◽  
pp. 3127-3135
Author(s):  
Malathi Seshasayee Konda Ramadoss ◽  
Kailasam Koumaravelou
Keyword(s):  
Medicinal Product ◽  
Herbal Medicines ◽  
Regulatory Compliance ◽  
Global Market ◽  
World Health ◽  
Manufacturing Companies ◽  
Medicinal Products ◽  
Herbal Medicinal Product ◽  
Herbal Medicinal Products ◽  
Herbal Medicinal

Recently, herbal medicinal products (HMP) have gained importance and are extensively used in the prevention and treatment of various ailments. A commercial herbal medicinal product should comply with the regulatory requirements of quality, safety and efficacy. Currently, the standards and regulations of herbal medicinal products are varying from country to country, which poses a challenge to the manufacturing companies to place a standardized herbal product in the global market. Hence a collaborative effort must be taken both by regulatory bodies and the World Health Organization (WHO) to establish harmonized regulations for a herbal medicinal product. An attempt has been made in this review which may pave the way to meet out the constraints and challenges in the manufacturing and marketing of herbal medicinal product worldwide.

scholarly journals Pharmaco-epidemiological research on herbal medicinal products in the paediatric population: data from the PhytoVIS study

2019 ◽  
Vol 179 (3) ◽  
pp. 507-512
Author(s):  
Karen Nieber ◽  
Esther Raskopf ◽  
Johanna Möller ◽  
Olaf Kelber ◽  
Robert Fürst ◽  
...  
Keyword(s):  
Adverse Events ◽  
Common Cold ◽  
Sleep Disturbances ◽  
Skin Diseases ◽  
Herbal Medicines ◽  
Paediatric Population ◽  
Clinical Effects ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Herbal Medicinal

AbstractIn paediatrics, clinical study data are limited, especially on herbal medicinal products. To address this gap, 2063 datasets from the paediatric population were evaluated in the PhytoVIS data base. By screening for paediatric data, information on indication, gender, treatment, co-medication and tolerability were evaluated. The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety. The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events. The data shed light on a still neglected field of phyto-pharmacotherapy by giving information on the use of herbal medicines in an unselected cohort of paediatric patients. The results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.What is Known:• In Germany, about 85% of children receive one or more herbal medicinal products per year.• Despite international initiatives to promote clinical research in paediatrics, there are still many gaps of knowledge in the use of drugs in paediatrics.What is New:• The PhytoVIS project evaluated 2063 data sets from the paediatric population using herbal medicinal products.• The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety, and 84% of the patients rated the therapy as very good or good without adverse events.

Herbalism and the menopause

2002 ◽  
Vol 8 (2) ◽  
pp. 72-74 ◽  
Author(s):  
Edzard Ernst
Keyword(s):  
Herbal Medicines ◽  
Trial Data ◽  
Black Cohosh ◽  
Effective Alternative ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Herbal Medicinal

Herbal medicinal products are often sold as a safe and effective alternative to HRT. Sizeable sets of trial data exist for black cohosh and soy. For other herbal medicines, only isolated trials have emerged, and their number is too low to enable one to arrive at valid conclusions. Collectively the data for black cohosh do not prove efficacy. The evidence for soy is encouraging but not compelling. Neither black cohosh nor soy is associated with major safety problems. Further research is warranted to closer define the role of herbal medicines for the menopause.

scholarly journals The potential of herbal extracts to inhibit SARS-CoV-2: a pilot study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Michela Luisa De Pellegrin ◽  
Anette Rohrhofer ◽  
Philipp Schuster ◽  
Barbara Schmidt ◽  
Philipp Peterburs ◽  
...  
Keyword(s):  
Respiratory Infections ◽  
Quantitative Polymerase Chain Reaction ◽  
Herbal Medicines ◽  
Vero Cells ◽  
Cell Culture Supernatant ◽  
Herbal Extracts ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Herbal Medicinal

Abstract Background Herbal medicinal products have a long-standing history of use in the therapy of common respiratory infections. We sought to assess the potential of five validated herbal extracts regarding their ability to restrict SARS-CoV-2 replication in vitro: Bronchipret thyme-ivy (BRO TI), Bronchipret thyme-primrose (BRO TP), Imupret (IMU), Sinupret extract (SINx) and Tonsipret (TOP). Methods Vero cells were incubated with different concentrations of herbal extracts and infected with SARS-CoV-2 for 48 hours. The inhibition of viral replication was assessed by determination of the viral RNA load in the cell culture supernatant using quantitative polymerase chain reaction (qPCR). Results SARS-CoV-2 RNA load was reduced by non-cytotoxic concentrations of BRO-TP (up to approximately 1,000-fold) and, to a lesser extent, IMU and TOP (approximately 10-fold). Conclusions Some herbal extracts showed a promising in vitro effectiveness against SARS-CoV-2, suggesting an antiviral potential of herbal medicinal products. The potential of herbal medicines to restrict SARS-CoV-2 and to treat COVID-19 should be investigated further in a clinical setting.

scholarly journals Determination of Anthracene Derivatives in Herbal Medicines

2021 ◽  
Vol 11 (2) ◽  
pp. 104-114
Author(s):  
O. V. Evdokimova ◽  
A. V. Beketova ◽  
M. N. Lyakina
Keyword(s):  
Comparative Analysis ◽  
Herbal Medicines ◽  
Quality Standards ◽  
Test Methods ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Herbal Preparations ◽  
Anthracene Derivatives ◽  
Herbal Medicinal

The relevance of this study stems from the need for alignment of test methods used for identification and assay of anthracene derivatives in herbal preparations and herbal medicinal products. The aim of the study was to analyse Russian and international quality standards and to identify the most specific and sensitive test methods that could be used for herbal medicines containing anthracene derivatives. The comparative analysis of requirements in the Identification, Determination of major classes of bioactive compounds, and Assay parts of the Russian and foreign pharmacopoeial monographs for herbal preparations and herbal medicinal products containing anthracene derivatives, demonstrated that the main test method used for identification is thin layer chromatography, while assays most often rely on spectrophotometry. The so-called “consistent standardisation” principle is implemented in the Russian quality standards as regards alignment of methods used for anthracene derivative determination in herbal preparations (i.e. active pharmaceutical ingredients, APIs) and herbal medicinal products containing these APIs. The comparative analysis of requirements in the Russian and foreign quality standards for herbal medicines containing anthracene derivatives demonstrated the need for elaboration of two general chapters: Qualitative analysis of anthracene derivatives in herbal medicines and Quantitative analysis of anthracene derivatives in herbal medicines.

scholarly journals Dissolution test of herbal medicines containing Paullinia cupana: validation of methods for quantification and assessment of dissolution

2011 ◽  
Vol 47 (2) ◽  
pp. 269-277 ◽  
Author(s):  
Sandra Alves de Sousa ◽  
Henrique Pascoa ◽  
Edemilson Cardoso da Conceição ◽  
Suzana Ferreira Alves ◽  
Danielle Guimarães Almeida Diniz ◽  
...  
Keyword(s):  
Condensed Tannins ◽  
Herbal Medicines ◽  
Dosage Forms ◽  
Dissolution Behavior ◽  
Therapeutic Action ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Dissolution Studies ◽  
Paullinia Cupana ◽  
Herbal Medicinal

"Guaraná" (Paullinia cupana) is used as a physical activity enhancer and stimulator due to its methylxanthines and condensed tannins. The aim of this work was to evaluate the dissolution behavior of five herbal medicines in the form of capsules and tablets containing guaraná. Assay and dissolution methods were validated and results obtained allowed simultaneous marker quantification with precision, accuracy, selectivity and robustness. Findings showed that 100% of the herbal medicinal products analyzed did not provide satisfactory results concerning the presence of four markers, 60% had three markers (caffeine, catechin and epicatechin), while 40% had only caffeine at tested dosage forms. In addition, after 30 minutes, only capsule A showed at least 80% of the dissolved markers. In other capsules, marker dissolution did not exceed 60% whereas 60% of the samples had some characteristic pharmacotechnical problems. These results evidence the need for rigorous quality control to help ensure the therapeutic action of these drugs. To this end, dissolution studies are an essential tool for quality assurance of herbal medicines.

scholarly journals Occurrence of Potential Bacterial Pathogens and Their Antimicrobial Susceptibility Patterns Isolated from Herbal Medicinal Products Sold in Different Markets of Gondar Town, Northwest Ethiopia

2016 ◽  
Vol 2016 ◽  
pp. 1-11
Author(s):  
Abdela Yesuf ◽  
Yitayih Wondimeneh ◽  
Teklay Gebrecherkos ◽  
Feleke Moges
Keyword(s):  
Drug Resistance ◽  
Multiple Drug Resistance ◽  
Scale Up ◽  
Shigella Dysenteriae ◽  
World Health ◽  
Multiple Drug ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Gondar Town ◽  
Herbal Medicinal

Background. The World Health Organization estimates that about 80% of the world’s population uses herbal medicine to treat various illnesses as means of primary healthcare. However, during preparation, herbal plants may be exposed to contamination by potential pathogens, and this may lead to infections. The aim of this study was to determine bacterial contamination of herbal medicinal products and to assess the antibiotic susceptibility pattern of the isolated bacteria. Methods. A cross-sectional study was conducted from January 1 to May 25, 2013, at Gondar Town. A total of 55 samples used as oral, local, and intranasal routes of administration were collected from the herbalists. Results. In the present study the total aerobic bacterial count ranges from zero to 2.41×109 CFU/g with mean count of 1.99×108 CFU/g or mL while the total coliform count showed an average of 1.05×108 CFU/g or mL with a range of zero to 2.1×109 CFU/g. The most common bacteria isolated were Bacillus spp. followed by Enterobacter spp., Shigella dysenteriae, and Salmonella spp. Multiple drug resistance was not uncommon and it was found that 125 (83.4%) of the isolates were resistant to two or more antibiotics. Conclusion. Herbal medicinal preparations were highly contaminated with pathogenic microorganisms with high microbial load. Most of the isolates have multiple drug resistance. Using those contaminated herbal medicines may lead to infection of other health related risks. Therefore, this warrants urgent training of herbalists and management scale-up for quality and safety of medicinal plants.

scholarly journals Methods to Ensure Microbiological Safety of Organically Produced Medicinal Plants: A Review

HortScience ◽  
2006 ◽  
Vol 41 (2) ◽  
pp. 292-295 ◽  
Author(s):  
James W. Rushing
Keyword(s):  
Functional Foods ◽  
Herbal Medicines ◽  
Future Research ◽  
Review Of Literature ◽  
Human Pathogens ◽  
Medicinal Products ◽  
Over The Counter ◽  
Herbal Medicinal Products ◽  
Microbiological Safety ◽  
Herbal Medicinal

The production, handling, processing and marketing of over-the-counter medicinal products manufactured from plants is virtually unregulated. This can include dietary supplements, functional foods and nutraceuticals, any of which may contain botanical constituents. Of particular concern is the possible presence of human pathogens in products offered at retail. A review of literature is presented. Options for sterilizing herbal medicinal products, including fumigation, irradiation and heat treatments, are presented. Experiences of the spice industry are discussed as they relate to the development of similar protocols for herbal medicines. Methods used to ensure microbiological safety must be evaluated for their effect on the medicinally active constituents in the plant material. Very little data of this nature are available. Avenues for future research are proposed.

scholarly journals Underestimating the Toxicological Challenges Associated with the Use of Herbal Medicinal Products in Developing Countries

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Vidushi S. Neergheen-Bhujun
Keyword(s):  
Developing Countries ◽  
Adverse Reactions ◽  
Case Reports ◽  
Toxicity Testing ◽  
Scientific Data ◽  
World Health ◽  
Medicinal Products ◽  
Care Needs ◽  
Herbal Medicinal Products ◽  
Herbal Medicinal

Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.

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