Quality Of Herbal Medicinal Products Research Articles

Quality of herbal medicinal products based on sage and thyme preparations

Quality of herbal medicinal products based on sage and thyme preparations

Potential Hepatotoxins Found in Herbal Medicinal Products: A Systematic Review.

The risk of liver injury associated with the use of herbal medicinal products (HMPs) is well known among physicians caring for patients under a HMP therapy, as documented in case reports or case series and evidenced by using the Roussel Uclaf Causality Assessment Method (RUCAM) to verify a causal relationship. In many cases, however, the quality of HMPs has rarely been considered regarding potential culprits such as contaminants and toxins possibly incriminated as causes for the liver injury. This review aims to comprehensively assemble details of tentative hepatotoxic contaminants and toxins found in HMPs. Based on the origin, harmful agents may be divided according two main sources, namely the phyto-hepatotoxin and the nonphyto-hepatotoxin groups. More specifically, phyto-hepatotoxins are phytochemicals or their metabolites naturally produced by plants or internally in response to plant stress conditions. In contrast, nonphyto-hepatotoxic elements may include contaminants or adulterants occurring during collection, processing and production, are the result of accumulation of toxic heavy metals by the plant itself due to soil pollutions, or represent mycotoxins, herbicidal and pesticidal residues. The phyto-hepatotoxins detected in HMPs are classified into eight major groups consisting of volatile compounds, phytotoxic proteins, glycosides, terpenoid lactones, terpenoids, alkaloids, anthraquinones, and phenolic acids. Nonphyto-hepatotoxins including metals, mycotoxins, and pesticidal and herbicidal residues and tentative mechanisms of toxicity are discussed. In conclusion, although a variety of potential toxic substances may enter the human body through HMP use, the ability of these toxins to trigger human liver injury remains largely unclear.

Challenges in the quality of herbal medicinal products with a specific focus on contaminants.

The complex regulatory framework for the quality of herbal medicinal products, in particular with regard to potential contaminants, consists of legal provisions including Pharmacopoeia requirements, relating to limits as well as in most cases to methods for determination. This review intends to provide an overview on the legal requirements for testing potential contaminants in herbal drugs used for the production of herbal medicinal products. The following issues are described and discussed: For the assessment of pesticide residues, Chapter 2.8.13 of the European Pharmacopoeia and Regulation (EC) 396/2005 applies, for heavy metals the general Pharmacopoeia monograph as well as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3D guideline on elemental impurities. The Pharmacopoeia also includes limits and acceptance criteria for microbiological purity and aflatoxins, respectively. Polycyclic aromatic hydrocarbons are mentioned in Regulation (EC) 1881/2006 for food as well as in a Reflection Paper on herbal medicinal products. For several years, a potential contamination with pyrrolizidine alkaloids was discussed which led to measures being imposed on industry and health authorities. Various examples demonstrate that the evaluation of data from daily analytical practice is extremely useful to gain an overview on the occurrence of residues and/or contaminants in herbal drugs and herbal preparations. Such evaluations might assist manufacturers in their individual risk assessment and the definition of their testing strategies and contribute to guarantee the quality and safety of the marketed products. Annual data evaluations demonstrate that a remarkable decrease of the pyrrolizidine alkaloid content burden in herbal drugs and extracts used for the production of herbal medicinal products has been achieved over the past few years. However, it has also become clear that this issue cannot be completely solved in the near future.

Review: Quality of herbal medicinal products: State of the art of purity assessment

BackgroundThe European Pharmacopoeia as well as further legal provisions contain rules for the assessment of potential residues and contaminants in herbal substances and preparations used for the production of herbal medicinal products, e.g. for the assessment of pesticide residues, heavy metals and other elemental impurities, mycotoxins and microorganisms. As a potential contamination caused by weeds, the occurrence of pyrrolizidine alkaloids is being discussed for several years which lead to measures of health authorities limiting the PA content in herbal medicinal products and to measures of industry consisting of reducing the probability of PA occurrence in medicinal plants and the respective products. ConclusionIn this context and with regard to all kinds of potential residues or contaminants, collection and evaluation of data from daily analytical practice of manufacturers and suppliers is useful for the assessment of the situation and the definition of testing strategies.

PROFIL KELAINAN KULIT PADA PASIEN DERMATITIS ATOPIK ANAK DAN DEWASA

Dermatitis atopik merupakan peradangan kulit berupa dermatitis kronis residif, disertai rasa gatal, dan dapat mengenai atau menyerang bagian tubuh tertentu. Anak-anak lebih sering terkena dermatitis atopik dan 50% menghilang saat remaja tetapi terkadang menetap dan muncul saat dewasa, atau bahkan baru mulai muncul saat usia dewasa. Tujuan penelitian ini untuk mengetahui profil kelainan kulit pada pasien dermatitis atopik anak dan dewasa.
 Penelitian ini merupakan penelitian deskriptif observasional dengan desain retrospektif. Sampel penelitian ini yaitu pasien anak dan dewasa yang didiagnosis dermatitis atopik di URJ Kulit dan Kelamin RSI Jemursari Surabaya tahun 2014-2015. Pengumpulan data dilakukan dengan menggunakan data sekunder yang diperoleh dari rekam medis pasien.
 Hasil yang diperoleh pada penelitian ini adalah 44 orang (15 pasien anak, 29 pasien dewasa pada pasien anak didapatkan 10 tempat predileksi lesi dan total yang didapatkan yaitu 22 tempat predileksi dengan tempat predileksi lesi yang paling banyak pada kaki (27,3%). Sedangkan pada 29 sampel pada pasien dewasa, didapatkan 22 tempat predileksi lesi dan total yang didapatkan yaitu 52 tempat predileksi dengan tempat predileksi lesi yang paling banyak adalah Lengan sebanyak 7 orang (13,5%)
 Pasien Anak yang mengalami Dermatitis Atopik didapatkan hampir setengahnya tempat predileksi lesi pada kaki dan jenis lesinya macula eritema. Sedangkan pada pasien Dewasa sebagian kecil tempat predileksi lesi pada lengan dengan jenis lesi pada macula eritema.

Advanced techniques of conservation and cultivation

Since ancient times, various plants are being traditionally used, as medicine throughout the world. These plants are cultivated as well as collected from wild. Some important medicinal plants, which have source of wild, are difficult for collection. The best way to provide the plants needed for medicinal purposes is to cultivated rather than collecting them from wild. Now a days, some medicinal species are in risk of disappearing due to man-made and natural calamities. So there is need of conservation of medicinal plants to maintain sustainable development by protecting and using biological resources in ways that do not diminish the world’s variety of genes , species, habitats and ecosystems. Medicinal plants can be cultivated by cutting, layering, grafting and budding and conservation mainly included activities like collection, propagation, characterization, evaluation and eradication, storage and division. On the other hand, some modern techniques have been also established for the better growth and maintenance of medicinal plants such as In-Situ & Ex-Situ conservation, Germplasm technique, cryopreserpation technique, tissue culture technique. This review gives information about various cultivation methods to reduces misidentification and adulteration of medicinal herbs and also shows importance of modern techniques of conservation, management and sustainable utilization of medicinal plants for human health care. This information will definitely useful for quality of herbal medicinal products and reduced uncertain therapeutic effects.

Comparative In Vitro Dissolution of Two Commercially Available Er-Zhi-Wan Herbal Medicinal Products.

In vitro dissolution test is an essential tool to assess the quality of herbal medicinal products in the solid dosage forms for oral use. Our work aimed to evaluate the dissolution behavior of Er-Zhi-Wan, in the formulations of water-honeyed pill and formula granule. Different media (water, 30% EtOH, 0.1 M HCl, acetate buffer, pH 4.5 and phosphate buffer, pH 6.8) were used following United States Pharmacopoeia and Chinese Pharmacopeia. An ultra-high performance liquid chromatography method was developed and validated to detect simultaneously six active ingredients for quantification and dissolution study (salidroside, specnuezhenide, nuezhenoside, luteolin, apigenin, oleanolic acid). As we observed, contents of main active ingredients were close in the two formulations for daily dose. In each medium, more ingredients dissolved from formula granule with higher Ymax and Ka. The mean dissolution time of the most ingredients in granule was significantly shorter than that in pill in acetate buffer, pH 4.5 and phosphate buffer, pH 6.8. Furthermore, salidroside, specnuezhenide and luteolin dissolved more than 80% in 30 min from formula granule, which indicated higher solubility along the intestinal tract according to biopharmaceutics classification system. The dissolution test developed and validated was adequate for its purposes and could be applied for quality control of herbal medicine. This work also can be used to provide necessary information on absorption for its biopharmaceutical properties.

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union

In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply to herbal products based on clinical evidence and traditional herbal medicinal products. The basic principle is that the quality of herbal medicinal products is intrinsically associated with the quality standard of the herbal substances and/or herbal preparations. Furthermore, the herbal substance or herbal preparation in its entirety is regarded as the active substance. Consequently, a mere determination of the content of marker(s) or constituents with known therapeutic activity is not sufficient for the quality control of herbal medicinal products. Specific quality requirements include thorough product characterisation, adherence to the Good Agricultural and Collection Practices, good manufacturing practices and validated manufacturing process, e.g., raw material testing, in-process testing, fingerprint characterisation etc. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation.

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union

In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation.Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives.Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community.The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply to herbal products based on clinical evidence and traditional herbal medicinal products. The basic principle is that the quality of herbal medicinal products is intrinsically associated with the quality standard of the herbal substances and/or herbal preparations. Furthermore, the herbal substance or herbal preparation in its entirety is regarded as the active substance. Consequently, a mere determination of the content of marker(s) or constituents with known therapeutic activity is not sufficient for the quality control of herbal medicinal products.Specific quality requirements include thorough product characterisation, adherence to the Good Agricultural and Collection Practices, good manufacturing practices and validated manufacturing process, e.g., raw material testing, in-process testing, fingerprint characterisation etc. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation.

Dissection of differences and similarities of botanical drugs in European Union, US and Canada

Because of the unique nature and treatment concept of traditional Chinese medicines (TCMs), TCMs have been respected again since 70s of last century. The regulatory agencies of some developed countries (the FDA, EMA and Health Canada etc) have published new guidance/guidelines/directives in recent years, such as the botanical drug product guidance of the FDA, the evidence for quality of finished natural health products guidance of the Health Canada and the guideline on quality of herbal medicinal products/ traditional herbal medicinal products of the EMA etc. All of the regulatory agencies are willing to scientifically evaluate the herbal medicines and accept it as therapeutic product. This paper analyzed the history of herbal medicine regulation and the similarities and differences of the regulatory requirements of the European Union, the United States and Canada, proposed possible future direction of the international development of Chinese medicine from the perspective of global regulatory affairs.

Quality of herbal medicinal products and food supplements – EU regulation and practical experience

Quality of herbal medicinal products and food supplements – EU regulation and practical experience

The Quality of Commercially Available Herbal Products

Herbal products are believed to be safe as they are naturally occurring, however, this is a misconception. Currently, there are many herbal products which are not manufactured under the Good Manufacturing Practice (GMP) guidelines and hence the quality of the product is not controlled. Quality can be assessed by evaluation of data on levels of either active constituent(s) or chemical markers indicative of origin of plant material. Assessment of published data on levels of quality of herbal medicinal products revealed that only a percentage of the total number of products investigated were found to contain the levels of markers as stated on the label, and others had widely varying levels of constituents. Thus few products complied with acceptable quality control standards. Herbal products are increasingly self-prescribed for the treatment of minor ailments. Patients relying on herbal products for therapeutic effects may expose themselves to either low doses of active constituents causing insufficient effects or alternatively take higher levels than expected, with the increased risk of toxicity or adverse effects, or be affected by the inadvertent inclusion of unexpected components with associated potential health risks.

New frontiers in the quality of herbal medicinal products (HMPs)

New frontiers in the quality of herbal medicinal products (HMPs)

Pathways to Plausibility: When Herbs Become Pills

Herbal medicine has long been contrasted to modern medicine in terms of a holistic approach to healing, vitalistic theories of health and illness, and an emphasis on the body’s innate self-healing capacities. At the same time, since the early twentieth century, the cultivation, preparation and mass production of herbal medicines have become increasingly industrialized, scientificized and commercialized. What is more, phytochemical efforts to identify and isolate particular ‘active ingredients’ from whole-plant extracts have intensified, often in response to increasing regulatory scrutiny of the safety and quality of herbal medicinal products. In this article, I examine whether describing these developments in terms of a biomedical ‘colonization’ of herbal medicine, as has been common, allows us to sufficiently account for the mundane collaborative efforts of herbalists, botanists, phytochemists, pharmacologists, toxicologists and clinicians to standardize and develop certain herbal remedies. By focusing on recent efforts to industrialize and scientifically develop a ‘Western’ (St John’s Wort) and a Vietnamese (Heantos) herbal remedy, I suggest that herbal medicine has come to be not so much colonized as normalized, with herbalists, phytochemists and pharmacologists working to develop standardized production procedures, as well as to identify ‘plausible’ explanations for the efficacy of these remedies.

Integration of herbal medicine into modern medical practices: issues and prospects.

The integration of herbal medicine into modern medical practices including cancer treatments must take into account the interrelated issues of quality, safety, and efficacy. Quality is the paramount issue because it can affect the efficacy and/or safety of the herbal products being used. Current product quality ranges from very high to very low due to intrinsic, extrinsic, and regulatory factors. Intrinsically, species differences, organ specificity, diurnal and seasonal variations can affect the qualitative and quantitative accumulation of active chemical constituents in the source medicinal plants. Extrinsically, environmental factors; field collection methods such as cultivation, harvest, post-harvest transport and storage; manufacturing practices; inadvertent contamination and substitution; and intentional adulteration are contributing factors to the quality of herbal medicinal products. Source plant materials that are contaminated with microbes, microbial toxins, environmental pollutants, or heavy metals; or finished products that are adulterated with foreign toxic plants or synthetic pharmaceutical agents can lead to adverse events. Substandard source materials or finished products will yield therapeutically less effective agents. Herbal medicine quality can also be attributed to regulatory practices. In a number of countries, herbal medicines are unregulated, which has led to product quality differences. Product quality improvement may be achieved by implementing control measures from the point of medicinal plant procurement under good agricultural practices (GAPs) and the manufacture of the finished botanical products under good manufacturing practices (GMPs), plus post-marketing quality assurance surveillance. The lack of pharmacological and clinical data on the majority of herbal medicinal products is a major impediment to the integration of herbal medicines into conventional medical practices. For valid integration, pharmacological and especially, clinical studies, must be conducted on those plants lacking such data. Adverse events, including drug-herb interaction must also be monitored to promote a safe integration of efficacious herbal medicine into conventional medical practices.

Morphogenetic variability of faradiol monoesters in marigold Calendula officinalis L.

The main compounds of lipophilic extracts of flower heads of marigold (Calendula officinalis L.) are triterpendiol esters, mainly faradiol laurate, faradiol myristate and faradiol palmitate. These faradiol-3-O-monoesters have been quantified for the first time by means of reversed phase HPLC with internal standardisation in different parts of C. officinalis plants, namely ray florets, disk florests, involucral bracts, receptacles, levaes and seeds. The amounts of the esters were highest in ray florets, approximately 10 times lower in disk florets than in the ray florets, and approximately 10 times lower in involucral bracts than in the disk florets. In the leaves only traces of the esters could be detected, and in the receptacles no esters could be detected at all. Quantification in the seed was not possible using this method because of interfering fatty compounds. Concerning the faradiol esters, the dried ray and disk florets only should be preferred as primary products for remedies as demanded in the recently published supplement of the Pharmacopoiea Europaea (1999). Breeding work should focus on varieties with a greater number of ray florets in order to improve the quality of herbal medicinal products derived from marigoid.