Establish Quality Parameters Research Articles

Physicochemical and chromatographic method of characterization of Matricaria recutita tinctures

Context: The pharmacological activity of medicinal products containing plant materials depends on their specific components. However, these components are not characterized in their entirety in all cases. Therefore, manufacturing processes must be duly characterized and validated. Aims: To characterize a chamomile (Matricaria recutita) tincture through chemometric analysis of chromatographic data in order to establish quality parameters for its production. Methods: Various chamomile tinctures were manufactured and the precision and robustness of the production process for each was verified. The physicochemical properties of the tinctures were characterized and their chromatographic digital fingerprints analysed through chemometric methods. Results: A good correlation between the physicochemical characterization and the chromatographic analysis was demonstrated. The preparation methodology was proved to be repeatable as long as the source of the plant material is not altered. Conclusions: The principal component multivariate analysis of chromatograms was a helpful and simple tool for the characterization and traceability of the production method.

Surgical Quality of Care in Esophageal Malignancies

Esophagectomy is the primary surgical treatment for localized malignant neoplasms of the esophagus, and while outcomes have shown that substantial improvement has been made, the ceiling for improvement is still high. A total of 2506 publications published from January 2002 to March 2012 were identified from PubMed, MEDLINE and the Cochrane Library using the keywords: 'esophagectomy', 'esophagus', 'neoplasm' and 'cancer' to identify quality key surgical articles in esophagectomy that were broken down into three groups: preoperative, intraoperative and postoperative care. There have been limited preoperative surgical trials, mostly in preoperative antibiotic use, which have led to changes in surgical management. Key and substantial changes have occurred in the intraoperative management for esophageal malignancies around surgical anastomosis technique and anesthesia. Nutritional outcomes still remain a key challenge, and currently there is no established standard of care in the postoperative management of esophagectomy patients. We established quality parameters for leak rates, overall morbidity and mortality, and these form the foundation from which all esophageal surgeons should rank their results. We then utilized the techniques described above to maintain those rates or, better yet, to significantly improve those rates in each surgeons' practice.

Supply chain and Management System based Standardization of Botanicals

In recent years with ever-growing commercialization in the field of herbal medicines, inadvertent contamination, substitution and intentional adulteration with pharmaceutical drugs in herbal plants and products are common practices. The challenges are innumerable and enormous, making the global herbal market potentially unsafe. Generally, quality control and quality assurance activities cover the entire supply chain and include good practices throughout the supply chain from cultivation to the point of use by the consumer. In practice, good manufacturing practices are used to address safety requirement of medicinal plants and herbal medicines primarily during the processing of harvested medicinal plants for conversion into products intended for consumer use. This talk seeks to enlighten physicians, pharmacists, consumers, manufacturers and stake holders in herbal medicine of the need to establish quality parameters for cultivation, collection, handling, processing and production of herbal medicines as well as employ such parameters in ensuring the safety of the global herbal market. The processes of good quality assurance and standardization of herbal medicines and products will also be discussed in detail with regard to WHO guidelines. This presentation will cover current perspectives for addressing all aspects for supply chain quality control and assurance of botanicals from cultivation to consumer use, an attempt has been made for a sequential study of the quality control of herbal medicinal products (HMP) starting from selection of medicinal plants; good agricultural practices (GAP); cultivation; good field collection practices (GFCP); organized and unorganized drugs; source and period of collection; identification; storage chemical standardization; assay; good manufacturing practices (GMP); pharmacological study to clinical approach, with special reference to maintain standardization at each and every stage. Modern techniques used for quality, safety and quality control will be discussed in detail to outline the challenges of standardization with special reference to marker compounds in plant species and their fingerprinting. Practical experiences of laboratory work on inadvertent contamination and substitution as well as intentional adulteration with pharmaceutical drugs in herbal plants and products will been discussed in detail.

Comparative pharmacognostic study and establishment of quality parameters of leaves of two species of Karen: Thevetia peruviana and Nerium indicum

Background: Two species of Karen - Nerium indicum and Thevetia peruviana are found distributed throughout tropical parts of India. Their leaves are used as cardiotonic and diuretic. Objectives: The present investigation deals with the comparative pharmacognostical study of the leaves of the two species and establishment of its quality parameters. Methods: Detailed morphological and qualitative as well as quantitative microscopic study was carried out. This was followed by phytochemical screening of the two species. Results: Leaf surface microscopy of N. indicum leaf shows straight-walled epidermal cells and anomocytic stomata whereas T. peruviana leaf shows wavy-walled epidermal cells and anisocytic stomata. The chief powder characterisics of N. indicum powder are horse-shoe shaped and annular xylem vessels, pericyclic fibres, hooked-top covering trichomes and calcium oxalate rosette crystals, whereas T. peruviana powder shows mainly the presence of rosette crystals, thereby making it easy to differentiate the two leaves. Various quantitative microscopic parameters were also established. Phenolics, cardenolides, and sterols were detected in both the species, but alkaloids were detected only in T. peruviana . Conclusion: The present work can serve as a useful tool in the identification, authentication and standardization of the plant material and distinguishing the two species from each other.

Pharmacognostic study and establishment of quality parameters of stems of Oxystelma esculentum

Background: Oxystelma esculentum is a perennial twiner growing near water logged areas of the Indian sub-continent. It is traditionally used as a diuretic, galactagogue, anthelmintic and antiperiodic. It is also used ethnomedicinally in throat infections, skin diseases and jaundice. Aim: The present investigation deals with detailed pharmacognostic study of the stems of the plant and establishment of its quality parameters. Materials and Methods: This involved macroscopic and microsopcic studies followed by phytochemical screening, using the established chemical tests. Results: The young and old stems of O. esculentum showed significant morphological and microscopical differences. Microscopy of the powdered stems revealed the presence of parenchymatous tissue filled with numerous rosette crystals and laticiferous vessels. Various quantitative microscopic and physico-chemical parameters were established. Both young and old stems were found to contain cardenolides, flavonoids, phenolics, coumarins, steroids and triterpenoids. Conclusion: Such detailed study can be helpful in standardizing the formulations of O. esculentum as well as serve as a guide for isolating novel phytoconstituents from it.

Standardization of herbal medicines - A review

There is increasing awareness and general acceptability of the use of herbal drugs in today’s medical practice. Although, most of these applications are unorthodox, it is however a known fact that over 80% of the world population depends on herbal medicines and product 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 market unsafe. This review seeks to enlighten stakeholders in herbal medicine on 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. The processes of good quality assurance and standardization of herbal medicines and products were also discussed. Key words: Herbal medicine, standardization, quality control.

Impact of different storage conditions on the quality of selected essential oils

Four common essential oils were subjected to different storage conditions in order to reveal the impact of light and temperature on the physico-chemical properties as well as on the chemical composition of the respective oil. For this purpose, aliquots of lavender, pine, rosemary, and thyme oil were stored for up to 72weeks in the presence of atmospheric oxygen at 23°C in the dark as well as at 23°C and 38°C under cool white light, respectively. Alterations were monitored by a set of recently established quality parameters such as peroxide value, pH, and conductivity as well as high-performance liquid chromatography (HPLC) with diode array detection and tandem mass spectrometry. Characteristic changes occurred for each essential oil, revealing individual impacts of extrinsic parameters on the particular sample. Most striking degradation of monoterpenes could be observed in rosemary oil: While α-terpinene was reduced to less than 10% within 3weeks of storage at 38°C under daylight but did not alter during the same period at room temperature in the dark, its amount in pine oil decreased to about 40 and 65%, respectively. Moreover, trends of peroxide values were compared to conductivity and pH in the course of storage. This approach allows to shed light on the storage history thereby providing a more complete view on essential oil quality. Additionally, gas chromatography (GC) analyses coupled to electron ionization mass spectrometry were performed in order to evaluate the informative and complementary character of GC and HPLC with regard to their capability to retrace essential oil modifications upon storage, respectively.

Blood-related proteomics

Blood-related proteomics is an emerging field, recently gaining momentum. Indeed, a wealth of data is now available and a plethora of groups has contributed to add pieces to the jigsaw puzzle of protein complexity within plasma and blood cells. In this review article we purported to sail across the mare magnum of the actual knowledge in this research endeavour. The main strides in proteomic investigations on red blood cells, platelets, plasma and white blood cells are hereby presented in a chronological order. Moreover, a glance is given at prospective studies which promise to shift the focus of attention from the end product to its provider, the donor, in a sort of Kantian "Copernican revolution". A well-rounded portrait of the usefulness of proteomics in blood-related research is accurately given. In particular, proteomic tools could be adopted to follow the main steps of the blood-banking production processes (a comparison of collection methods, pathogen inactivation techniques, storage protocols). Thus proteomics has been recently transformed from a mere basic-research extremely-expensive toy into a dramatically-sensitive and efficient eye-lens to either delve into the depths of the molecular mechanisms of blood and blood components or to establish quality parameters in the blood-banking production chain totally anew.

Chromatographic profiles and identification of new phenolic components of Ginkgo biloba leaves and selected products.

Ginkgo biloba leaves and their extracts are one of the most widely used herbal products and/or dietary supplements in the world. A systematic study of the phenolic compounds is necessary to establish quality parameters. A modified LC-DAD-ESI/MS method was used to obtain chromatographic profiles for the flavonoids and terpene lactones of Ginkgo biloba leaves. The method was used to identify 45 glycosylated flavonols and flavones, 3 flavonol aglycones, catechin, 10 biflavones, a dihydroxybenzoic acid, and 4 terpene lactones in an aqueous methanol extract of the leaves. The extracted G. biloba leaf products contained the same flavonoids as the raw leaves except for the lack of biflavones. The detected glycosylated flavonol contents were equal to or more than 0.0008% of the dry plant material. This is the first report of the presence of more than 20 of these flavonoids in G. biloba.

Fatty acid composition and palynological analysis of bee (Apis) pollen loads in the states of São Paulo and Minas Gerais, Brazil

SUMMARYThe fatty-acid composition and botanical origin of 14 honey bee (Apis mellifera) pollen load samples acquired in shops and apiaries in Minas Gerais and São Paulo states, Brazil, were determined. The fatty acids presented a variable composition among these samples. All samples contained oleic, linoleic and arachidic acid. Only one sample did not contain palmitic acid. The unsaturated fatty-acid level varied from 18.6% to 55.9% of the total fatty-acid composition, suggesting that pollen is a good source of unsaturated fatty acids to the diet. Several pollen types were identified. Eucalyptus (Myrtaceae) and Eupatorium (Asteraceae) pollen types were the most common among those sampled. These data might help the regulatory agencies establish quality parameters for pollen produced in Brazil. There are no additional data available on Brazilian pollen fatty acid composition.

Multicomponent analysis of volatile organic compounds in water by automated purge and trap coupled to gas chromatography–mass spectrometry

The performance of an automated purge and trap concentrator coupled to gas chromatography–mass spectrometric detection was evaluated by analyzing 40 volatile organic compounds of different chemical families. Compounds chosen defined as toxic for the environment and for human health were selected according to Directive 76/464/CEE. The present work includes: (i) the optimization of the purge and trap conditions, (ii) the establishment of quality parameters and in last instance (iii) the analysis of surface waters. The analytical method consisted of a modification of the EPA Method 524.2 in which water was pumped, via an automated AquaTek 70 Liquid Autosampler to a 25-ml purging device, where samples were purged and trapped in a Tenax or Tenax-Silica and Charcoal column. Afterwards, helium was used to desorb the trapped analytes that flow directly into the GC column. Mass spectrometric analysis was carried out in selected ion monitoring and scan modes to ensure quantification and confirmation of the results. Parameters optimized were the sample volume analyzed, bubbling flow-rate and time and temperature of desorption. Optimal conditions lead to mean recoveries of 80%, limits of detection between 0.002 and 0.1 μg/l, linearity from 0.01 to 2.5 μg/l and maximum standard deviation of 10%, using a Tenax trap. This protocol permitted a high precision and sample throughput and was used to determine volatile organic compounds in surface river, effluents and coastal waters of Portugal, on a routine basis.

Amino acids and hexosamines as indicators of organic matter degradation state in North Sea sediments

Sediment cores from six stations in the eastern North Sea were analyzed for protein amino acids, the nonprotein amino acids β-alanine and γ- aminobutyric acid and the hexosamines galactosamine and glucosamine, and bulk parameters (organic carbon, nitrogen, total hydrolyzable amino acids and carbohydrates) in order to establish the degradation state of sedimentary organic matter. The study sites were selected on the basis of their different physical settings and macrofaunal communities so that a broad quality range in the organic matter would likely be covered. To test if the molecular parameters provide a robust matrix for quality determination, we integrated our results with complementary literature data ranging from marine source organisms to deep-sea environments. A principal component analysis based on the mole percent contribution of amino acids show4 that there are systematic variations in the amino acid spectra as a consequence of degradation of organic matter. Comparison with more established quality parameters such as hexosamines confirmed that amino acids reflect the degradation state of the organic matter. The amino acids glycine, serine, and threonine were enriched in the more degraded material, and others, such as phenylalanine, glutamic acid, tyrosine, leucine, and isoleucinc, became depleted with increasing degradation state. Selective preservation of structural compounds (diatom cell walls, chitinous organic matter) vs. preferential breakdown of cell plasma material appears to be the reason for the contrastin,; behavior of these molecular compounds. Some of the essential amino acids for macrofauna nutrition (arginine, methionine, and histidine) occurred in lower concentrations in the North Sea sediments compared to organism tissue and therefore may be limiting to growth of deposit-feeders.

Germanium speciation by LC-HG-ICP/OES

Liquid chromatography-hydride generation-inductively coupled plasma optical emission spectroscopy (LC-HG-ICP/OES) has been used to determine inorganic and organometallic species of germanium. In recent studies these coupled systems has been applied successfully to the speciation of arsenic. To establish separation conditions for germanium two reversed stationary phases and different solvent mixtures for elution, in isocratic or gradient mode have been tested. The reduction of germanium species to the corresponding volatile hydride is a critical step, especially for acidity control, thus the conditions for reduction using different concentrations of acid have been studied systematically. For the conditions established quality parameters as limit of detection (at the μg l−1 level), precision and recovery have been determined for the germanium species considered in a saline matrix.