File Name: quality control of herbal medicines and related areas .zip
The webinar will cover topics relating to regulation and review process of OTC drugs, Japanese Pharmacopoeia JP , quality management of herbal medicines. Video about medicinal plant resources and overview of the manufacturer storage of the raw materials crude drugs will be shared as well. The aims of the webinar are to provide chances for the participants to refer back to their work. The webinar is not open to the industry or non-regulatory authorities. Participation from many regulatory authorities is welcomed.
The properties of herbal medicines are related to certain classes of compounds such as alkaloids, flavonoids, essential oils, and others. Infrared imaging techniques are becoming more and more attractive to understand the function and the biochemical composition of plant tissue. In this contribution, the principle, technique, and methodology are described, followed by a discussion of quantitative and qualitative application possibilities.
Finally, some hints to helpful regulatory issues are summarized. Herbal medicine is the oldest and most widely used form of medical treatment in the world, and enjoys increasing popularity due to its health-promoting properties .
During the recent decade, the pharmaceutical industry has initiated sophisticated plant screening programs, applying biochemical high-throughput techniques to find new drugs with distinct properties e. Traditionally, separation techniques including thin-layer chromatography TLC , liquid chromatography LC , gas chromatography GC , and capillary electrophoresis CE hyphenated to mass spectrometry MS were employed for the identification, quantification, and structural elucidation of selected compounds being present or deriving from different plant matrices  , .
Spectroscopic analytical techniques using the near-infrared NIR wavelength region of the electromagnetic spectrum have been used in the food industry to monitor and evaluate on one side the composition and on the other side the quality of foods .
Even though the NIR region was the first known nonvisible part of the electromagnetic spectrum and was discovered in by Herschel, it was not until the s that the first applications of NIR spectroscopy for analytical chemistry were developed. NIR spectroscopy is characterized by low molar absorptivity and scattering. In the beginning, the NIR region was regarded as having little potential for analytical work.
In recent times, it has become one of the most promising techniques for molecular spectroscopy. Affordable and powerful computers have further supported the implementation of applications in several fields, including medical, textile, polymer, and pharmaceutical applications . Vibrational spectroscopic imaging has become an essential tool for tissue analyses in life science, and can support NIR spectroscopic studies in a synergistic manner, because it allows depiction of the spatial distribution of potent ingredients.
It is a modern analytical technique enabling the detection and characterization of molecular components of plant tissue samples down to a resolution of approximately 1. It is based on the absorption of Infrared IR radiation by vibrational transitions in covalent bonds, and enables global analysis of samples, with resolution close to the cellular level.
With this nondestructive analytical method, it is possible to obtain, on one hand, qualitative and quantitative information on heterogeneous samples, and on the other hand, unique chemimorphological information about the tissue status on the other hand. This characteristic of vibrational spectroscopic imaging represents an extremely important benefit for further interpretation of the present current tissue status. This contribution highlights the fundamental principles of NIR and imaging spectroscopy, its applicability, regulatory issues, advantages, synergistic combination, and limitations in herbal medicine research.
IR radiation is the region of the electromagnetic spectrum between the visible VIS and the microwave wavelength . The result is often a crowded spectrum with overlapping peaks. Although NIR-intensities are 10 to times lower than for MIR, highly sensitive spectrometers can be built through several means including the use of efficient detectors.
The light recorded by the detector contains compositional information, which can be unraveled by a computer to report multiple analyses almost instantaneously. NIR spectroscopy can provide simultaneous, rapid, and nondestructive qualitative and quantitative analysis of major components in many organic substances . The physical principle describing the observed effects in both the MIR and NIR regions is the model of the harmonic and an-harmonic oscillator.
In MIR, this vibration follows the equation for the harmonic oscillator, whereas in NIR, the equation for the an-harmonic oscillator is valid, describing the excitation into higher energy states. Chemometrics, a mathematical, statistical, multivariate analytical MVA tool, is applied for further treatment of recorded spectra. An NIR spectrophotometer consists of a light source e.
One of the most frequently cited benefits of analysis by NIR spectroscopy is that little or no sample preparation prior to analysis is required. Spectrophotometers are conveniently classified into dispersive and nondispersive instruments. For example, in a dispersive filter instrument, the monochromator is a wheel holding a number of absorption or interference filters, with the disadvantage of limited resolution .
In a scanning monochromator instrument, a grating or a prism is used to separate the individual frequencies of the radiation. In Fourier transform FT spectrophotometers, interferometers are used to generate modulated light, and time domain signal of the light reflected or transmitted by the sample can be converted into a spectrum via a fast transformation . In most cases, a Michelson or polarization interferometer is used. As alternatives, laser-based systems that do not require a monochromator or acousto-optic tuneable filter instruments using a diffraction-based optical band-pass filter can be used .
The first IR microscopes were built during the s and s, but these microscopes were slow. It was in the s that the subsequent development of microprocessor-controlled motorized stages made raster scan mapping convenient. Enhanced spatial resolution, which is enabled by the substitution of synchrotron radiation for a thermal source, was a significant instrumental advance.
These developments allowed simultaneous measurements and significantly increased data acquisition rates. From the physical point of view, diffraction, refraction, reflection, and absorption effects are playing a considerable role. Advantages of FTIR spectroscopic microscopes are microspatial chemical mapping or imaging of complex heterogeneous samples with a resolution down to approximately 1.
Schematic view of a mid-infrared reflective microscope, which can operate in either reflectance or transmission mode. MCT, mercury cadmium telluride. During the last couple of years, hyperspectral imaging systems have become popular . The cube is recorded by stepwise moving of the object of interest under the camera by means of an actuator, while at each step a line is scanned.
In combination with attenuated total reflection ATR spectroscopy, the maximal resolution of 1. This sampling technique offers a convenient, fast, and inexpensive route for analysis of static samples. It allows information about the spatial distribution of the chemical species within the sample to be obtained. The operator can choose between three different types of FTIR mapping techniques:.
Point mapping provides several different areas of a sample to be analyzed consecutively. Line mapping defines a series of spectra obtained along one dimension, where chemical changes that occur along this dimension are investigated.
In FTIR imaging, the whole area of interest is sampled simultaneously and allows a large number of spectra to be acquired with fine spatial detail over an area . However, obtained imaging data are challenging, and a key issue is how to extract relevant information from the huge amount of data.
In FTIR microscopy, one can choose between two different sampling techniques: transmission IR beam passes through the sample and reflection IR beam reflects from the sample surface. In transmission measurements, the IR beam passes through the sample and the transmitted light is recorded by a detector, which is placed behind the sample following the law of Lambert—Beer.
Transmission analysis requires the sample to be partly transparent. Samples can be placed on substrates transparent to the wavelength range of the probing radiation e.
In reflection measurements, the IR beam reflects from the sample surface and the reflected light is recorded by a detector. This sampling technique allows rapid examination of the distribution of organic compounds on a complex surface of solid samples. There are two reflection measurement sampling techniques in FTIR microscopy:.
In diffuse refection measurements, the incoming radiation interacts with the sample and is scattered by interaction with the particles. A fraction of this light is reflected by the sample and recorded by the detector. In the NIR range, DR is widely used for the image analysis of thick nontransparent samples in various noninvasive applications e. In ATR measurements, the IR radiation enters a prism made of a high refractive index IR transmitting material, and is totally internally reflected.
This reflectance creates an evanescent wave. The wave extends beyond the surface of the crystal into the sample held in intimate contact with the crystal and in regions of the IR spectrum where the sample absorbs energy. With this sampling technique, the IR beam typically penetrates from 0. Main advantages of ATR imaging measurements are minimal or no sample preparation. Additionally, samples with high water contents can be analysed more efficiently than in conventional transmission mode.
For detailed information about detector theory, technology, and current developments, the interested reader is referred to the cited literature.
Data processing techniques for imaging data will be discussed in the next chapter. The NIR spectrum is represented by a huge number of partially overlapping overtones and combination vibrations, therefore appears to be much more complicated than the MIR spectrum.
Therefore, it is in many cases impossible to correctly assign the corresponding vibration bands. For this reason, multivariate statistical analysis MVA is a powerful mathematical tool enabling the extraction of the required information from the spectrum .
The most frequently applied chemometrical procedures include principal component analysis PCA for reducing the number of variables facilitating both qualitative and quantitative analysis. Data pretreatment minimizes inhomogeneities originating from the recording of the spectra, and enables elimination of baseline shifts.
Normalization algorithms can eliminate differences in intensity caused by different sample positioning. Performing the first or second derivative of the original spectrum can reduce spectral noise. Calibration development can mathematically describe the covariation between certain variables or find a mathematical function regression model by which the values of the dependent variables are calculated from values of the measured variables .
The calibration procedure of the NIR spectrometer can be summarized in five steps: 1 choice of a representative sample set; 2 recording of the NIR spectra; 3 measurement of the reference values; 4 multivariate modelling to generate a relationship between the recorded spectra and the reference values; and 5 validation of the system. The choice of the highest suitable regression model is based on the calculation of the following values:.
BIAS, i. PRESS predicted residual error sum square is the sum of the square of the deviation between predicted and reference values. The PRESS value of the validation set should be as small as possible and similar to that of the calibration set.
Standard error of estimation SEE , i. Standard error of prediction SEP , i. The analysis of IR imaging data sets includes denoising, baseline correction, normalization, suppression of anomalous pixels, image compression, and univariate and multivariate analysis .
Available software programs improve the quality of information extracted from the large data sets, reduce the dimensionality to more practical levels, allow different imaging data sets to be aligned and compared, and address data management, including determination of statistical significance and relative abundance between particular chemical species.
It has been reported that data analysis of IR imaging results consists of several steps:. To analyze the spectral and spatial information contained in an image, various techniques also known as multivariate image analysis MIA have been introduced. In contrast to univariate image analysis, MIA uses all of the information contained in the hyperspectral image.
Unlabeled IR spectral data can be separated into different clusters based on their characteristics in an unsupervised way. Clustering, also called unsupervised classification of FTIR microscopic data, can be performed such that spectra within the same cluster are as similar as possible and spectra in different clusters are as dissimilar as possible where different types of cells may be separated within biological tissue.
There are many clustering techniques that have been applied for hyperspectral images, such as hierarchical clustering, KM clustering, and FCM clustering, which increase the information content of FTIR imaging data dramatically .
For detailed information about statistical classification, the interested reader is referred to the cited literature. The ad- and disadvantages of NIR spectroscopy are summarized in the following. The advantages and disadvantages of imaging spectroscopy are summarized in the following.
In this chapter, we discuss the potential of NIR spectroscopy for the quantitative characterization of herbal medicine and its constituents, including secondary metabolites and leading compounds.
The following section summarizes the potential of NIR spectroscopy for the classification of the origin of natural products and verification of authenticity.
The properties of herbal medicines are related to certain classes of compounds such as alkaloids, flavonoids, essential oils, and others. Infrared imaging techniques are becoming more and more attractive to understand the function and the biochemical composition of plant tissue. In this contribution, the principle, technique, and methodology are described, followed by a discussion of quantitative and qualitative application possibilities. Finally, some hints to helpful regulatory issues are summarized. Herbal medicine is the oldest and most widely used form of medical treatment in the world, and enjoys increasing popularity due to its health-promoting properties . During the recent decade, the pharmaceutical industry has initiated sophisticated plant screening programs, applying biochemical high-throughput techniques to find new drugs with distinct properties e.
Section 36 of the Therapeutic Goods Act allows the Minister for Health to determine Manufacturing Principles that are to be applied in the manufacture of therapeutic goods. Good Manufacturing Practice GMP describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality. It is strongly recommended you download this document to your own computer and open it from there. This recommendation summarises the interpretations an inspector adopts during an inspection of the manufacture of sterile medicinal products. It reflects the most important changes introduced in the revised Annex 1, but is not intended to address all changes in the revision. How to access a pdf document.
Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. Hennell Published Medicine. Abstract The past decade has seen an unprecedented growth in the popularity of complementary medicines in Western countries. As the popularity of complementary medicines continues to grow, serious concerns have been raised about their quality and safety.
Herbal medicine also Herbalism is the study of pharmacognosy and the use of medicinal plants. Plants have been the basis for medical treatments through most of human history, and such traditional medicine is still widely practiced today. Although herbalism may apply modern standards of effectiveness testing to herbs and medicines derived from natural sources, few high-quality clinical trials and standards for purity or dosage exist.
December 9, Science focus: Top 10 most read nutrition research of Tomatoes offer affordable source of Parkinson's disease drug. Science Daily.
The authors of this thematic issue provide a comprehensive summary of most recent knowledge and references on quality control in wide fields. Quality control is essential for natural products like natural medicine and related food products. In this issue fifteen chapters have been included, discussing in detail various aspects of quality control. It will certainly prove useful not only for phytoc It will certainly prove useful not only for phytochemical researchers, but also many scientists working in numerous fields. Much effort has been invested by the contributors to share current information. By Zhang Zhen and Bi Kaishun.
already been isolated and all possible chemical modifications in these substances had. Quality Control of Herbal Medicines and Related Areas.
A survey on the plants used for reproductive disease was carried out during the period At least 29 of these NPs were found to be bioactive. Medicinal plants naturally synthesize and accumulate some secondary metabolites, like alkaloids, sterols, terpenes, flavonoids, saponins, glycosides, cyanogeniCS, tannins, resins. Medical cannabis, or medical marijuana MMJ , is cannabis and cannabinoids that are prescribed by physicians for their patients. I have an earlier post in the January archives with lots of good information on Apple Cider Vinegar For Rabbits check it out. In this project a total of 64 medicinal plants belonging to 39 families and 58 genera and species have been documented, which are being used by the local communities for the treatment of different human sicknesses. Nalini Mohan said that medicinal plants will be distributed to every household in the State and as a.
Приближаясь к пиджаку защитного цвета, он не обращал внимания на сердитый шепот людей, которых обгонял. Прихожане могли понять нетерпение этого человека, стремившегося получить благословение, но ведь существуют строгие правила протокола: подходить к причастию нужно, выстроившись в две линии. Халохот продолжал двигаться. Расстояние между ним и Беккером быстро сокращалось. Он нащупал в кармане пиджака пистолет.
Ежедневно тысячи сообщений и разговоров перехватывались и посылались экспертам АНБ для дешифровки. Разведданные, поставляемые агентством, влияли на процесс принятия решений ФБР, ЦРУ, а также внешнеполитическими советниками правительства США. Беккер был потрясен.
Да будет. - Хейл вроде бы затрубил отбой. - Теперь это не имеет значения. У вас есть ТРАНСТЕКСТ.
Эти аргументы она слышала уже много. Гипотетическое будущее правительство служило главным аргументом Фонда электронных границ. - Стратмора надо остановить! - кричал Хейл. - Клянусь, я сделаю. Этим я и занимался сегодня весь день - считывал тексты с его терминала, чтобы быть наготове, когда он сделает первый шаг, чтобы вмонтировать этот чертов черный ход.
Она протянула руку, поманив его к. - Без воска? - тихо спросила она, обнимая. - Без воска.
Беккер достал из кармана бумажник. - Конечно, я буду счастлив тебе заплатить. - И он начал отсчитывать купюры. Глядя, как он шелестит деньгами, Меган вскрикнула и изменилась в лице, по-видимому ложно истолковав его намерения.
- Если бы Танкадо подозревал некий подвох, он инстинктивно стал бы искать глазами убийцу. Как вы можете убедиться, этого не произошло. На экране Танкадо рухнул на колени, по-прежнему прижимая руку к груди и так ни разу и не подняв глаз.
В парке. Это было убийство - Ermordung. - Беккеру нравилось это немецкое слово, означающее убийство.
ГЛАВА 41 В кладовке третьего этажа отеля Альфонсо XIII на полу без сознания лежала горничная. Человек в очках в железной оправе положил в карман ее халата связку ключей. Он не услышал ее крика, когда ударил ее, он даже не знал, кричала ли она вообще: он оглох, когда ему было всего двенадцать лет от роду.
Отключи ТРАНСТЕКСТ. Давай выбираться отсюда. Внезапно Стратмор сбросил оцепенение. - Иди за мной! - сказал .
Тремя пролетами ниже Дэвид Беккер висел на вытянутых руках над Апельсиновым садом с наружной стороны Гиральды, словно упражняясь в подтягивании на оконном выступе. Когда Халохот поднимался по лестнице, Беккер, спустившись на три пролета, вылез через один из проемов и повис на руках. Сделал он это как раз вовремя - убийца промчался мимо в ту же секунду.
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