scholarly journals CURRENT REQUIREMENTS FOR THE QUALITY OF HERBAL MEDICINAL PRODUCTS

2018 ◽  
Vol 8 (3) ◽  
pp. 170-178 ◽  
Author(s):  
E. I. Sakanyan ◽  
E. L. Kovaleva ◽  
L. N. Frolova ◽  
V. V. Shelestova
Keyword(s):  
Russian Federation ◽  
Herbal Medicines ◽  
The State ◽  
Arsenic Content ◽  
Medicinal Products ◽  
Herbal Products ◽  
Herbal Medicinal Products ◽  
The Russian Federation ◽  
Herbal Medicinal

The article provides the results of a comparative analysis of requirements laid out in the State Pharmacopoeia of the USSR, XI ed. (SPh XI) and the State Pharmacopoeia of the Russian Federation, XIII ed. (SPh XIII) concerning  quality evaluation and standardization of herbal substances, herbal medicines and other herbal products. The article discusses requirements  for the criteria of herbal substances and herbal medicines quality control described in general chapters and monographs that were previously in force and that have recently been adopted. The article mentions new herbal substances that were included into the State Pharmacopoeia of the Russian Federation for the first time as well as herbal substances included into the State Pharmacopoeia of the USSR, X ed., not included into SPh XI, but included into SPh XIII. The article analyses the requirements described in the new general chapters that were recently included into SPh XIII: “Herbal substances. Herbal preparations”, “Determination of heavy metals and arsenic content in herbal substances and herbal medicinal  products”, “Determination of water absorption  factor for herbal substances”,  “Buds”, “Cut-pressed granules”. The article suggests ways to improve methods of analysis of herbal substances and herbal medicinal products in view of recent advances in pharmacopoeial analysis and the increasing requirements for its quality.

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 Limits for the Content of Heavy Metals and Arsenic as a Means of Ensuring Safe Use of Herbal Medicinal Products

2021 ◽  
Vol 9 (2) ◽  
pp. 61-68
Author(s):  
M. S. Galenko ◽  
I. V. Gravel ◽  
N. Yu. Velts ◽  
R. N. Alyautdin
Keyword(s):  
Heavy Metals ◽  
Human Body ◽  
Toxic Elements ◽  
Quantitative Methods ◽  
Arsenic Content ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Herbal Medicinal ◽  
Heavy Metals And Arsenic

Herbal medicinal products (HMPs) are widely used in medical practice due to their availability, ease of use, and relatively safe pharmacological profile. However, medicinal plants are capable of accumulating heavy metals and arsenic which can have toxic effect on the human body when found in HMPs. The aim of the study was to summarise and analyse requirements of the Russian and foreign pharmacopoeias for the limits of heavy metals and arsenic in HMPs. National and regional pharmacopoeias have limits for the content of the major toxic elements (lead, cadmium, mercury, chromium, and arsenic) in HMPs. The study showed that the Indian and Japanese pharmacopoeias include only semi-quantitative methods for determination of heavy metals and arsenic, while the Russian and Chinese pharmacopoeias allow for the use of both quantitative and semi-quantitative methods. It was demonstrated that the limits for heavy metals and arsenic are the same for herbal substances and HMPs. The development of consistent approaches to determination of heavy metals and arsenic content, a systematic transition to quantitative methods of analysis, and establishment of individual limits for toxic elements in different HMP dosage forms, will make it possible to achieve the so-called consistent harmonisation, ensure reliable assessment of the content of heavy metals and arsenic, and minimize the risk of their entering human body with HMPs.

scholarly journals DNA metabarcoding to unravel plant species composition in selected herbal medicines on the National List of Essential Medicines (NLEM) of Thailand

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Santhosh Kumar J. Urumarudappa ◽  
Chayapol Tungphatthong ◽  
Pinidphon Prombutara ◽  
Suchada Sukrong
Keyword(s):  
Species Composition ◽  
Plant Species ◽  
Herbal Medicines ◽  
Essential Medicines ◽  
Medicinal Products ◽  
Herbal Products ◽  
Herbal Medicinal Products ◽  
Traditional Medicines ◽  
Dna Metabarcoding ◽  
Herbal Medicinal

Abstract Traditional medicines are widely traded across the globe and have received considerable attention in the recent past, with expectations of heightened demand in the future. However, there are increasing global concerns over admixture, which can affect the quality, safety, and efficacy of herbal medicinal products. In this study, we aimed to use DNA metabarcoding to identify 39 Thai herbal products on the Thai National List of Essential Medicines (NLEM) and assess species composition and admixture. Among the products, 24 samples were in-house-prepared formulations, and 15 samples were registered formulations. In our study, DNA metabarcoding analysis using ITS2 and rbcL barcode regions were employed to identify herbal ingredients mentioned in the products. The nuclear region, ITS2, was able to identify herbal ingredients in the products at the genus- and family-levels in 55% and 63% of cases, respectively. The chloroplast gene, rbcL, enabled genus- and family-level identifications in 58% and 73% of cases, respectively. In addition, plant species were detected in larger numbers (Family identified, absolute %) in registered herbal products than in in-house-prepared formulations. The level of fidelity increases concerns about the reliability of the products. This study highlights that DNA metabarcoding is a useful analytical tool when combined with advanced chemical techniques for the identification of plant species in highly processed, multi-ingredient herbal products.

scholarly journals DEvELopMENT of TEOHNiQuEs FoR THE DETERMiNATioN oF MoisTuRE (Loss oN DRYING) oF MEDiOiNAL PLANT RAW MATERiALS oF MoRPHoLoGiOAL group “FRUiT” by infrared thermogravimetric method

2019 ◽  
Vol 19 (1-2) ◽  
pp. 13-18
Author(s):  
D. A Zhdanov ◽  
V. B Braslavsky
Keyword(s):  
Medicinal Plant ◽  
Russian Federation ◽  
Raw Materials ◽  
The State ◽  
Moisture Loss ◽  
Anethum Graveolens ◽  
Thermogravimetric Method ◽  
Plant Raw Materials ◽  
The Russian Federation

The article is devoted to the development of new and perspective for the State Pharmacopoeia of the Russian Federation (SP RF) techniques for determining of the moisture (loss on drying) of medicinal plant raw materials of the morphological group “Fruit” and medicinal plant preparations by the use of infrared thermogravimetric (IRTGM) method. The techniques for determination of moisture (loss on drying) IRTGM-method as exemplified by the fruit of the following medicinal plants: Silybum marianum (L.) Gaertn., Rosa cinnamomea L. and Anethum graveolens L. were developed. The comparable results for determining of the moisture (loss on drying) of the medicinal plant raw materials of investigated plants were obtained by means of two methods: IRTGM and pharmacopoeial method, which allow us to recommend the developed techniques for inclusion into the relevant monographs of the State Pharmacopoeia of the Russian Federation.

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.

scholarly journals Comparative Analysis of Heavy Metal and Arsenic Content in Various Herbal Dosage Forms Marketed in Russia

2020 ◽  
Vol 10 (1) ◽  
pp. 41-50
Author(s):  
V. M. Shchukin ◽  
N. E. Kuz’mina ◽  
Yu. N. Shvetsova ◽  
A. I. Luttseva
Keyword(s):  
Sample Preparation ◽  
Inductively Coupled Plasma ◽  
Test Methods ◽  
Dosage Forms ◽  
Arsenic Content ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Current Test ◽  
Herbal Medicinal ◽  
Preparation Techniques

The inclusion of requirements for independent determination of arsenic, cadmium, mercury, and lead, and the current sample preparation techniques into the State Pharmacopoeia of the Russian Federation (Ph. Rus.) requires the revision of the existing limits for elemental toxicants in herbal substances and herbal medicinal products produced from them.The aim of the study was to analyse the data on elemental toxicant content obtained during quality control of herbal substances (herbs, medicinal herb mixtures, extracts, and tinctures) using current test methods and sample preparation techniques, and to compare the obtained results with the Russian and foreign scientific and specialist literature.Materials and methods: the internal data on the content of critical heavy metals and arsenic in different dosage forms of herbal medicinal products, which were obtained by inductively coupled plasma mass spectrometry after sample preparation by decomposition in closed vessels, were compared with literature data. Results: it was demonstrated that the content of lead, cadmium, and mercury in all the test samples did not exceed the Ph. Rus. limits and was consistent with the analysed literature. The arsenic content in some herbal medicinal products was higher than the established Ph. Rus. limits, but complied with the less stringent Ph. Eur. and USP requirements for herbal substances. The authors investigated the link between the content of elemental toxicants and the place of collection and the part of the plant being tested. It was shown that different types of medicinal plants had a tendency to accumulate particular elements. The authors determined the content of the elements to be controlled in extracts and tinctures. The differences in the Russian and foreign requirements for the content of elemental toxicants may be attributed to the method of obtaining experimental data that form the basis for the setting of limits.Conclusions: the results of the study confirm the validity of the existing limits for elemental toxicants in herbal medicinal products. The authors demonstrated the need to revise the existing limits for arsenic in herbal medicinal products.

scholarly journals Risk of Fungi Associated with Aflatoxin and Fumonisin in Medicinal Herbal Products in the Kenyan Market

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Lucia Keter ◽  
Richard Too ◽  
Nicholas Mwikwabe ◽  
Charles Mutai ◽  
Jennifer Orwa ◽  
...  
Keyword(s):  
Quality Improvement ◽  
Experimental Design ◽  
Medical Research ◽  
Microbial Quality ◽  
Medicinal Products ◽  
Herbal Products ◽  
Herbal Medicinal Products ◽  
Toxigenic Fungi ◽  
Herbal Medicinal ◽  
Fungal Contaminants

Utilization of herbal products is a major concern due to the possibility of contamination by toxigenic fungi that are mycotoxin producers such as Aspergillus species during processing and packaging. Research was carried out to determine the presence of aflatoxins and fumonisins in herbal medicinal products sold in Eldoret and Mombasa towns in Kenya. The study employed both exploratory and laboratory experimental design. The herbal products were purchased from the market and transported to Kenya Medical Research Institute for processing and analysis. Fungal contaminants were determined according to Pharmacopoeia specifications. The toxins were quantified using ELISA based technique. The genus Aspergillus was the most dominant followed by Penicillium. Fungal counts ranged between 1 CFU/g and >1000 cfu/g. Analysis of variance showed that the rate of fungal contaminants for Eldoret and Mombasa samples had significant association (p≤0.001). Aflatoxin levels ranged from 1 to 24 ppb, while fumonisin levels ranged from 1 to >20 ppb. Only 31% of samples met the standards for microbial limits as specified in Pharmacopoeia. There is need for product microbial quality improvement through proper harvesting, processing, storage, and marketing. It is recommended that a policy be enacted to enable regulation of herbal products in Kenya.

scholarly journals Determination of the Marker Diarylheptanoid Phytoestrogens in Curcuma comosa Rhizomes and Selected Herbal Medicinal Products by HPLC-DAD

2018 ◽  
Vol 66 (1) ◽  
pp. 65-70 ◽  
Author(s):  
Bancha Yingngam ◽  
Adelheid Brantner ◽  
Damrongsak Jinarat ◽  
Rawiwun Kaewamatawong ◽  
Wandee Rungseevijitprapa ◽  
...  
Keyword(s):  
Medicinal Products ◽  
Curcuma Comosa ◽  
Herbal Medicinal Products ◽  
Herbal Medicinal
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