Оптимізація методики визначення валепотріатів у складі комплексних серцевих крапель

Multiple chromatographic fingerprinting and its application to the quality control of herbal medicines

High-performance thin-layer chromatography (HPTLC) is a powerful analytical technique which is wonderfully suitable for qualitative and quantitative analytical tasks. HPTLC plays an important role in today’s analytical world, not in competition to HLPC but as a complementary method. Fingerprint analysis approach using HPTLC has become the most potent technique for quality control of herbal medicines because of its simplicity, flexibility and reliability. It can serve as a tool for identification, authentication and quality control of herbal medicines. The development of chromatographic fingerprints plays an important role in the quality control of complex herbal medicines. Phytochemical evaluation is one of the tools for the quality assessment, which include preliminary phytochemical screening, chemo profiling and marker compound analysis using modern analytical techniques. High-performance thin-layer chromatography (HPTLC) has emerged as an important tool for the qualitative, semi-quantitative and quantitative phytochemical analysis of the herbal drugs and formulations which includes developing TLC fingerprinting profiles and estimation of biomarkers. In this chapter, attempts will be made to expand the use of HPTLC and at the same time create interest among prospective researchers in herbal analysis and to focus on the theoretical background of HPTLC and few examples of herbal drugs and formulations analysed by various researchers using HPTLC method.

Historically, practitioners of herbal medicine harvested and prepared their own plants individually, ensuring that these remedies were pure, safe, and effective according to traditional doctrines. With the advent of increasing populations, and an industrial society, it became necessary to mass produce herbal medicines. Over time unscrupulous vendors have included toxic plants, and other contaminants into their products causing toxicity which providing the impetus for governmental standardization and regulation. The quality control of herbal medicines is essential for herbal prescribing as it has a direct impact on their safety and efficacy. Developed countries have specific GMP based regulatory guidelines for the production and quality control of herbal medicines and herbal-based products. The concomitant use of drugs and herbs has necessitated increased surveillance and identification of adverse herb-drug interactions. An outline and examples of herbal medicines/products regulation and known herb-drug interactions in developed countries is provided.

Quality control of herbal medicines

Historically, practitioners of herbal medicine harvested and prepared their own plants individually, ensuring that these remedies were pure, safe, and effective according to traditional doctrines. With the advent of increasing populations, and an industrial society, it became necessary to mass produce herbal medicines. Over time unscrupulous vendors have included toxic plants, and other contaminants into their products causing toxicity which providing the impetus for governmental standardization and regulation. The quality control of herbal medicines is essential for herbal prescribing as it has a direct impact on their safety and efficacy. Developed countries have specific GMP based regulatory guidelines for the production and quality control of herbal medicines and herbal-based products. The concomitant use of drugs and herbs has necessitated increased surveillance and identification of adverse herb-drug interactions. An outline and examples of herbal medicines/products regulation and known herb-drug interactions in developed countries is provided.

As traditional Chinese medicine (TCM) is gradually accepted by many countries, people pay much attention to the quality of herbal medicines. Because of the significant variation in active components in them, the quality control of herbal medicines is a very important issue. Nowadays, high-performance liquid chromatography (HPLC) fingerprint spectra (FPS) are widely used in identification and quality control of herbal medicines. This paper will analyze the methodology and their application in identifying and evaluating herbal medicines by means of HPLC FPS, which includes simple comparing, clustering, principal component analysis (PCA), and similarity analysis methods.

Summary A liquid chromatographic fingerprinting methodology has been established for identification and quality control of traditional herbal medicines. The methodology was developed from four case studies. Samples of Herba Artemisia annua, Herba Artemisia scoparia, Rhizoma Ligusticum chuanxiong (also called Rhizoma chuanxiong), and Rhizoma Ligusticum jeholense (also called Rhizoma ligustici) were investigated. In each case study, sample preparation and chromatographic conditions (column, organic modifier, column temperature, detection wavelength, and mechanism) were varied to obtain good fingerprints, i.e. with the maximum number of peaks. Further optimization was then performed either by reducing the analysis time or increasing efficiency. The case studies led to the development of a general methodology consisting of sample preparation and HPLC fingerprint development. The fingerprints obtained with the developed methodology were then successfully used to distinguish between the two Artemisia species and between the two Ligusticum species. The methodology also was used to obtain fingerprints for a large number of different Vietnamese Mallotus species, and for Citri reticulatae pericarpium samples collected in different regions of China.

Quality inconsistency of herbal medicine is an obstacle that limits the extensive use and study of traditional Chinese medicine. Differences in environmental conditions and processing methods of herbal medicine often result in varying clinical outcomes in patients. Standard chemical markers used for the quality control (QC) of herbal medicine are usually the most abundant and characteristic components, which may not be therapeutically relevant or cannot comprehensively reflect the biological quality of the herbs. In view of this, a novel QC method for better assessment of herbal medicine has been developed via bioactivities analysis. Immunological activities of Dictamni Cortex, a typical herbal medicine for the treatment of various inflammatory diseases, from different geographical locations in China, were evaluated. Upon in vitro treatment of their water and ethanol extracts, distinct patterns of inflammatory cytokines including tumor necrosis factor (TNF)-α, interleukin (IL)-10, IL-6, IL-12p70, IL-1β, and chemokine CXCL8 were released from the lipopolysaccharides- and/or phytohaemagglutinin-stimulated human peripheral blood mononuclear cells (PBMC). Thus, in addition to the commonly used morphological, chemical, or DNA markers, the novel high-throughput profiling of inflammatory cytokines and chemokines of PBMC upon treatment with herbal extracts could be an important reference to help for the quality control of herbal medicine in the future.

The medicinal plants are important source for pharmaceutical manufacturing. Medicinal plants & herbal medicines account for a significant percentage of the pharmaceutical market. There is increasing awareness and general acceptability of the use of herbal drugs in today’s medical practice although most of these applications are not scientific. Herbal medicines are not a simple task since many factors influence the biological efficacy and Reproducible therapeutic effect. So it is necessary to improve safety of herbal drugs by developing certain quality control parameters & by following the WHO guidelines for herbal medicines. This review seeks to enlighten the need to establish quality parameters for collection, handling, processing and production of herbal medicine as well as employ such parameters in ensuring the safety of the global herbal market. It is necessary to introduce measures on the regulation of herbal medicines to ensure quality, safety, efficacy of herbal medicines by using modern suitable standards & GMP. The processes of good quality assurance and standardization of herbal medicines and products using various spectroscopic, chromatographic and electrophoretic methods were also discussed. In fact, the research field of quality control of herbal medicines is really an interdisciplinary research. It needs crossover of chemistry, pharmacology, medicine and even statistics to provide a platform for the quality control of traditional herbal medicines and further to discover the novel therapeutics composed of multiple chemical compounds.
 Keywords: Herbal drugs, Adulteration, Standardization, Chromatography, Electrophoresis, HP-LC and GC-MS.

The term “herbal drugs” denotes plants or plant parts that have been converted into Phyto pharmaceuticals by means of simple processes involving harvesting, drying, and storage. A practical addition to the defini-tion is also to include other crude products derived from plants, which no longer show any organic struc-ture, such as essential oils, fatty oils, resins, and gums. There is increasing awareness and general accepta-bility of the use of herbal drugs in today’s medical practice. Although, most of these applications are unor-thodox, it is however a known fact that over 80% of the world population depends on herbal medicines and products for healthy living. This rise in the use of herbal product has also given rise to various forms of abuse and adulteration of the products leading to consumers and manufacturers disappointment and in some instances fatal consequences. The challenge is innumerable and enormous, making the global herbal mar-ket unsafe. Evaluation of herbal drug is an important tool in the formulation of high-quality herbal prod-ucts. This review seeks to enlighten stakeholders in herbal medicine on the need to establish quality param-eters with the help of advanced analytical tools and well-defined standardization methods in ensuring the safety of the global herbal market. The processes of good quality assurance and standardization of herbal medicines and products using various spectroscopic, chromatographic and electrophoresis methods were also discussed. In fact, the research field of quality control of herbal medicines is really interdisciplinary research. It needs crossover of chemistry, pharmacology, medicine and even statistics to provide a platform for the quality control of traditional herbal medicines and further to discover the novel therapeutics com-posed of multiple chemical compounds Medicinal plants are an important source for creating medicines. Medicinal plants and herbal treatments play a major role in the drug industry. As people have started to no-tice more side effects from man-made drugs, many medicines today are made from natural herbs. But herb-al medicines have some problems because they don't have clear standards. The big issue is that there are no fixed rules for the materials used, how they are processed, the final product, the way it's given, and there are no clear rules for checking quality. herbal treatments are commonly used for many health problems. Scientists find it hard to create reliable ways to check the chemicals in these herbs, including measuring the active parts and other main ingredients. Having clear standards is very important to make sure herbal medi-cines work the same every time, have the same chemical makeup, and meet quality rules during produc-tion.

Nowadays, people pay much attention to the quality of herbal medicines. Because of the significant variation in active components in them, the quality control of herbal medicines is a very important issue. High-performance liquid chromatography (HPLC) is widely used in identification and quality control of herbal medicines. A new, simple, sensitive, selective, and precise high-performance liquid chromatography (HPLC) was developed for the determination and identification of frangulin A content in “Frangula syrup”, “Frangula decoction” and “solution of aqueous-alcoholic extract from the bark of Frangula alnus” was developed and validated. The stationary phase was inert sil C18 column. The mobile phase consisting of acetonitrile (HPLC Grade) and potassium dihydrogen phosphate buffer (pH 2.5) in a gradient flow was used. The column was equilibrated with the mobile phase (flow rate 1.0 ml/min); the UV detection was set at 420 nm. Various optimizations were performed to examine the frangulin A content in herbal medicines and their preparation including retention time, spike authentic standard, change of wavelength, change of mobile phase composition and blank test. Using HPLC analysis we obtained the results of the quantitative determination of content of frangulin A in decoction, syrup and water-alcohol extract of Frangula alnus Mill. bark. The content of frangulin A in decoction amounted to 6,45 µg/20 l, in syrup amounted to 3,72 µg/20 l, in water-alcohol extract amounted to 7,9 l /20 µg .

Herbal preparations, particularly those from traditional Chinese or Indian medicine, are becoming increasingly popular in Europe and the USA. Their application is often based on long-term historic use rather than on scientific evidences; thus, analytical tools to assure their efficacy, safety and consistency are in great demand. This review evaluates the importance of CE for quality control of herbal medicinal products during the last five years. After briefly describing the general characteristics of natural products analysis by CE, numerous applications on medicinal plants or herbal products are summarized. These examples not only reflect the enormous variability of CE with respect to buffer systems and detection modes employed, but also indicate an increasing importance of this separation technique for quality control purposes compared with more established ones such as HPLC.

Pretreatments of chromatographic fingerprints for quality control of herbal medicines

s. PHYTOPHARM 2012 M 114 Obzory po kliniceskoj farmacologii i lekarstvennoj terapii [Reviews of clinical pharmacology and drug therapy] ТОМ 10/2012/2 COULD VIBRATIONAL SPECTROSCOPY REVOLUTIONISE QUALITY CONTROL OF HERBAL MEDICINES? © Viljoen Alvaro, Vermaak Ilze Department of Pharmaceutical Sciences, Faculty of Science, Tshwane University of Technology, Private Bag X680, Pretoria 0001, South Africa Vibrational spectroscopy includes near infrared (NiR) mid-infrared (MiR) and Raman spectroscopy. These methods in combination with multivariate data analysis have proved to be powerful analytical techniques and have been implemented in various industries such as the petrochemical, agricultural and food industries. The quality of herbal medicines is of great concern as many consumers now choose herbal medicines over Western medicines and cases of mistaken identity (substitutions) or adulteration with other species with sometimes dire health consequences or loss of consumer trust in the product due to ineffectiveness has been reported. The quality of herbal medicines is assessed both qualitatively (authentication) and quantitatively through the quantification of specific biomarkers. Traditional analytical methods used to determine quality such as high performance liquid chromatography and mass spectrometry are destructive, expensive and time-consuming. Vibrational spectroscopy methods have major advantages over these methods in that it is simple, rapid, relatively cheap and non-destructive. Various examples of quality control methods developed using vibrational spectroscopy techniques will be described for medicinally and commercially important plant species: to discriminate between closely related plant species (e. g. Agathosma betulina and A. crenulata; Pelargonium reniforme and P. sidoides), a case of mistaken identity (Eriocephalus punctulatus and E. tenuifolius) and as a quantification tool for biomarkers (e. g. pulegone, diosphenol, isomenthone etc. in A. betulina essential oils). hyperspectral imaging uses the platform of vibrational spectroscopy and multivariate data analysis but adds an extra data dimension opening up a range of novel applications in the quality control of herbal medicines such as authentication using whole dried fruits (e. g. Illicium anisatum and I. verum). from these examples it is evident, the revolution has already begun. THE METABOLISM OF LIGNANS FROM FRUCTUS SCHISANDRA © Yin Jun , Cao Yun-Feng , Yang Ling 2 School of Traditional Chinese Medicines, Shenyang Pharmaceutical University, Shenyang 110016, China Laboratory of Pharmaceutical Resource Discovery, Dalian Institute of Chemical Physics, Chinese Academy of Sciences, Dalian 116023, China After metabolites from dibenzocyclooctadiene lignans (Schizandrin, deoxyschizandrin and schisantherin A) of Schisandra chinensis incubated with human liver microsomes were isolated by hPlC and their structures were identified by lC–MS, h-NMR and C-NMR, the study combined correlation analysis, chemical inhibition studies, assays with recombinant CyPs and enzyme kinetics indicated that CyP3A4 was the main hepatic isoform. Three metabolites were isolated by hPlC and their structures were identified to be 8 (R)-hydroxylschizandrin, 2-demethyl-8 (R)-hydroxyl-schizandrin, 3-demethyl-8 (R)-hydroxyl-schizandrin, Rat and minipig liver microsomes were applied to evaluate species differences, and the results showed little difference among the mentioned species. Speculated that deoxyschizandrin might undergo hydroxylation in hlMs, and schizandrin could represent the corresponding metabolite. The data also show that deoxyschizandrin metabolism to form schizandrin specially mediated by CyP3A4, is the principal route of disposition in humans. The specificity, high affinity, and high turnover make deoxyschizandrin hydroxylation an excellent probe drug for CyP3A4 activity in vitro. The metabolic pathway of schisantherin A validated the inhibitory mechanism against CyP3A4 undergoes demethylenenation in the human liver microsomes. iC 50 drift and dynamics test indicate that schisantherin A is inhibitor which shows dependency to NAdP and time, which illustrates that the methylene of schisantherin A produced active intermediate during the catalyzed reaction, thereby presents forceful inhibitory effect against CyP3A4. The lignans containing methylenedioxy abundant in fructus Schisandra probably reduce clinical value thereof. in mice liver microsomes, schisantherin A, schizandrol b and schizandrin b showed strong inhibition against metablism schizandrin and deoxschizandrin. Our research results indicate that why deoxyschizandrin presented forceful anti-multidrug resistance in vitro but reduced or vanished in vivo, and the extract of fructus Schisandra containing deoxyschizandrin presents forceful anti-multidrug resistance in vivo.

Relevance. Improving methods for quality control of medicines, including those of plant origin, is one of the urgent tasks of modern pharmaceutical science and practice. The growing interest in herbal medicine stimulates not only the expansion of the diversity of raw materials and the development of new drugs, but also the constant improvement of approaches and methods for controlling their quality. The purpose of the study is to develop a methodology for the use of specific in vitro enzyme biotest systems (IBTS) in complex laboratory quality control of herbal medicines for additional assessment of their biological activity, which determines therapeutic effectiveness, in addition to physical, physicochemical, and chemical indicators. Material and methods. We used in silico (PASS), in vitro (specific enzyme biotest systems) and in vivo (experimental models) methods. Results. A method has been developed for the use of specific in vitro enzyme biotest systems (IBTS) in complex laboratory quality control of medi-cines, as well as methods of physical, physico-chemical, and chemical analysis to assess their biological properties, which determine the therapeutic effectiveness of medicines. Conclusions. Specific enzyme biotest systems make it possible to identify the specific biological activity of research objects and confirm the feasibil-ity of their use in an in vitro quality control system for herbal medicines at different stages of their life cycle, as demonstrated by the example of ex-tracts from native and biotechnological raw materials, as well as experimental dosage forms, developed at FGBNU VILAR, and comparison drugs.