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EFSA Journal. European Food Safety... May 2024Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried flower bud of...
Safety and efficacy of a feed additive consisting of a tincture derived from the flowers of (L.) Merr. & L.M. Perry (clove tincture) for all animal species (FEFANA asbl).
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried flower bud of (L.) Merr. & L.M. Perry (clove tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■) solution, with a dry matter content of ~ 1.66%. The product contains on average 0.511% phenolic acids (of which 0.0344% were flavonoids), 0.039% eugenol, 0.00019% methyleugenol and 0.00008% estragole. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of clove tincture is very unlikely to be of safety concern for the target species up to the maximum proposed use level of 50 mg clove tincture/kg complete feed for all animal species, except for horses, for which the proposed use level is 200 mg/kg complete feed. The FEEDAP Panel considers that the use in water for drinking alone or in combination with use in feed should not exceed the daily amount that is considered very unlikely to be of safety concern when consumed via feed alone. No safety concern would arise for the consumer and the environment from the use of clove tincture up to the maximum proposed use levels in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to methyleugenol and estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the flower buds of and their preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.
PubMed: 38756347
DOI: 10.2903/j.efsa.2024.8791 -
EFSA Journal. European Food Safety... Apr 2024Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried fruit of...
Safety and efficacy of a feed additive consisting of a tincture derived from the dried fruit of (Turcz.) Baill. (omicha tincture) for poultry, horses, dogs and cats (FEFANA asbl).
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried fruit of (Turcz.) Baill. (omicha tincture), when used as a sensory additive in feed for horses, cats, dogs, and in feed and in water for drinking for poultry. The product is a water/ethanol (55:45 v/v) solution, with a dry matter content of not more than 4% (w/w) and a content of 0.01%-0.15% (w/w) for the sum of schisandrin and deoxyschisandrin. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that omicha tincture is safe at the following concentrations in complete feed: 16 mg/kg for turkeys for fattening, 12 mg/kg for chickens for fattening and other poultry for fattening or reared for laying/reproduction, 18 mg/kg for laying hens and other laying/reproductive birds, 56 mg/kg for dogs and 47 mg/kg for horses and cats. The additive is considered safe for consumers when used up to the highest safe level in feed for poultry species and horses. Omicha tincture should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of omicha tincture as a flavour in feed for poultry species and horses was not considered to be a risk to the environment. Since it was recognised that the fruit of can influence sensory properties of feedingstuffs, no further demonstration of efficacy was considered necessary for the tincture under assessment.
PubMed: 38601870
DOI: 10.2903/j.efsa.2024.8731 -
EFSA Journal. European Food Safety... Apr 2024Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of C.A.Mey....
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of C.A.Mey. (ginseng tincture), when used as a sensory additive in feed for horses, dogs and cats. The product is a water/ethanol (40:60 v/v) solution, with a dry matter content of no more than 6% and a content of 0.01%-0.5% (w/w) for the sum of the two triterpene saponins ginsenoside Rb1 and ginsenoside Rg1. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the tincture is safe for horses, dogs and cats at the maximum proposed use level of 48.6, 228.7 and 162 mg/kg complete feed, respectively. The Panel also concluded that the additive is considered safe for consumers when used at the proposed conditions of use in feed for horses. Ginseng tincture should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of the ginseng tincture as a flavour in feed for horses was not expected to pose a risk for the environment. Since the roots of and its preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.
PubMed: 38591023
DOI: 10.2903/j.efsa.2024.8730 -
Frontiers in Pharmacology 2024Commercially available cannabidiol (CBD) products are increasingly being used for medicinal purposes, including for the treatment of various neurological conditions,...
Commercially available cannabidiol (CBD) products are increasingly being used for medicinal purposes, including for the treatment of various neurological conditions, but there are growing concerns around adherence to quality control measures that protect consumers. This study was conducted to assess the purity and label accuracy of commercially available CBD products. Commercially available CBD products were chosen from the open stream of commerce in the United States based on formulations as a tincture, gummy, vape, or topical product. Cannabinoid concentrations were analyzed to verify label accuracy including "full spectrum," "broad spectrum," and "CBD isolate" claims on the product label. Analysis for the presence of contaminants included evaluation for heavy metals, pesticides, and residual solvents. Labeled and actual total amounts of CBD and levels of impurities such as heavy metals, residual solvents, and pesticides were measured. A total of 202 CBD products (100 tinctures, 48 gummies, 34 vape products, and 20 topicals) were chosen to represent a broad sample in the United States. Of the products tested (full spectrum, n = 84; broad spectrum, n = 28; CBD isolate, n = 37), 26% did not meet the definition for product type claimed on the packaging. The majority of products (74%) deviated from their label claim of CBD potency by at least 10%. Heavy metals were detected 52 times across 44 of the 202 products tested, with lead being the most prevalent heavy metal. Residual solvents were detected 446 times across 181 of 202 products, with the highest concentrations reported for hexane, m/p-xylene, methanol, and o-xylene. Of 232 pesticides tested, 26 were found 55 times across 30 products. A total of 3% of heavy metals, 1% of residual solvents, and 1% of pesticides violated >1 regulatory threshold. This study demonstrated that the majority of commercially available CBD products tested within the current study are inaccurately labeled. Heavy metals, residual solvents, and pesticides were found in several products, some of which violated regulatory thresholds. Thus, uniform compliance with CBD quality control measures is lacking and raises consumer protection concerns. Improved regulatory oversight of this industry is recommended.
PubMed: 38562466
DOI: 10.3389/fphar.2024.1335441 -
Journal of Ethnopharmacology Jun 2024The Gu Yan Xiao tincture, a blend of traditional Chinese herbs, is traditionally used for osteoarthritis and related pain. This study investigated its mechanism of...
ETHNOPHARMACOLOGICAL RELEVANCE
The Gu Yan Xiao tincture, a blend of traditional Chinese herbs, is traditionally used for osteoarthritis and related pain. This study investigated its mechanism of action in order to rationalize and validate its therapeutic use.
AIM OF THE STUDY
This study analyzed, in a rabbit model of knee osteoarthritis, whether and how Gu Yan Xiao tincture exerts therapeutic benefits by modulating chondrocyte autophagy.
MATERIALS AND METHODS
The active constituents within the GYX tincture were identified using liquid chromatography-mass spectrometry. The rabbit model was established by injecting animals with type II collagenase intra-articularly, and the effects of topically applied tincture were examined on osteoarthritis lesions of the knee using histopathology, micro-computed tomography and x-ray imaging. Effects of the tincture were also evaluated on levels of inflammatory cytokines, matrix metalloproteases, and autophagy in chondrocytes. As a positive control, animals were treated with sodium diclofenac.
RESULTS
The tincture mitigated the reduction in joint space, hyperplasia of the synovium and matrix metalloproteases in serum that occurred after injection of type II collagenase in rabbits. These therapeutic effects were associated with inhibition of mTOR and activation of autophagy in articular chondrocytes. Inhibiting mTOR with rapamycin potentiated the therapeutic effects of the tincture, while inhibiting autophagy with 3-methyladenine antagonized them.
CONCLUSIONS
Gu Yan Xiao tincture mitigates tissue injury in a rabbit model of osteoarthritis, at least in part by inhibiting mTOR and thereby promoting autophagy in chondrocytes. These results rationalize the use of the tincture not only against osteoarthritis but also potentially other diseases involving inhibition of autophagy in bones and joints.
Topics: Animals; Rabbits; Chondrocytes; X-Ray Microtomography; Cartilage, Articular; TOR Serine-Threonine Kinases; Osteoarthritis, Knee; Metalloproteases; Autophagy; Collagenases
PubMed: 38548121
DOI: 10.1016/j.jep.2024.118095 -
Journal of Traditional and... Mar 2024L. is a native plant of South America whose pharmacological properties have not been studied yet.
BACKGROUND
L. is a native plant of South America whose pharmacological properties have not been studied yet.
AIM
To evaluate the cardiovascular and intestinal pharmacological effects of L. leaves tincture (GphT) and the mechanisms involved.
EXPERIMENTAL PROCEDURE
The chromatographic profile of GphT was done. Its effects were evaluated by contractile concentration-response curves (CRCs) obtained from the agonist carbachol or calcium found in isolated rat small intestine, as well as in the relaxant CRCs. Cardiac effects were evaluated on isolated rat hearts exposed to ischemia/reperfusion (I/R). Experiments were performed to evaluate the diuretic activity in conscious rats and the hypotensive effect in anaesthetised rats.
RESULTS
Fifteen flavonoids were identified in GphT by HPLC-UV, including diosmin. GphT induced a non-competitive inhibition in both carbachol and calcium CRCs on rat small intestine. The first was not affected by indomethacin. Moreover, GphT, unlike diosmin, relaxed the contracture produced by a high-potassium solution in a dose-dependently way. Neither propranolol nor l-NAME changed it. GphT did not show diuretic activity but induced hypotension insensitive to l-NAME. While GphT perfusion of isolated hearts increased injury consequent to I/R, oral administration was cardioprotective and reversed by l-NAME. However, diosmin did not improve the post-ischemic recovery.
CONCLUSIONS
This study supports the use of L. tincture as an antispasmodic and hypotensive agent. Moreover, it has been demonstrated to be preventive of post-ischemic cardiac dysfunction. However, diosmin would not be responsible for these effects.
PubMed: 38481545
DOI: 10.1016/j.jtcme.2023.10.005 -
Molecules (Basel, Switzerland) Jan 2024The objective of this study was the optimization of the extraction process and the qualitative and quantitative determination of the bioactive metabolites:...
Extraction Optimization and Qualitative/Quantitative Determination of Bioactive Abietane-Type Diterpenes from Three Species (Common Sage, Greek Sage and Rosemary) by H-qNMR.
The objective of this study was the optimization of the extraction process and the qualitative and quantitative determination of the bioactive metabolites: 12--methylcarnosic acid (12MCA), carnosic acid (CA), carnosol (CS), 7--methyl--rosmanol (7MER) and rosmanol (RO) in infusions, decoctions, turbulent flow extracts, tinctures and oleolites from three species: L. (common sage, ), Mill. (Greek sage, ) and Spenn (syn L.) (rosemary, ), using Quantitative Proton Nuclear Magnetic Resonance Spectroscopy (H-qNMR). Regarding the aqueous extracts, decoctions appeared to be richer sources of the studied metabolites than infusions among the three plants. For , the turbulent flow extraction under heating was the most efficient one. The optimum time for the preparation of decoctions was found to be 5 min for and and 15 min for . It is noteworthy that tinctures were not stable in time due to decomposition of the abietane-type diterpenes CA and CS because of the polar solvent used for their preparation. Contrary to this finding, the oleolites of appeared to be very stable. Olive oil as a solvent for extraction was very protective for the contained abietane-type diterpenes. A preliminary stability study on the effect of the storage time of the on the abietane-type diterpenes content showed that the total quantity of abietanes decreased by 16.51% and 40.79% after 12 and 36 months, respectively. The results of this investigation also demonstrated that H-qNMR is very useful for the analysis of sensitive metabolites, like abietane-type diterpenes, that can be influenced by solvents used in chromatographic analysis.
Topics: Abietanes; Rosmarinus; Salvia; Greece; Plant Extracts; Solvents; Diterpenes
PubMed: 38338370
DOI: 10.3390/molecules29030625 -
Plants (Basel, Switzerland) Jan 2024Galenic preparations of German chamomile are used to treat mild skin diseases, inflammation, and spasms, and they have also been reported to have anxiolytic and sedative...
Galenic preparations of German chamomile are used to treat mild skin diseases, inflammation, and spasms, and they have also been reported to have anxiolytic and sedative effects. The medicinal use of chamomile is well known in ethnomedicine. After obtaining its galenic preparations, there is lots of waste left, so it is expedient to develop waste-free technologies. The aims of this study were to gain knowledge of the ethnomedical status of chamomile in the past and present, develop methods for preparing essential oils and dry extracts from German chamomile flowers using complex processing, reveal the phytochemical composition of such extracts, and verify the analgesic and soporific activity of the extracts. Two methods for the complex processing of German chamomile flowers were developed, which allowed us to obtain the essential oil and dry extracts of the tincture and aqueous extracts as byproducts. A total of 22 phenolic compounds (7 hydroxycinnamic acids, 13 flavonoids, and 2 phenolic acids) were found in the dry extracts by using UPLC-MS/MS. In total, nine main terpenoids were identified in the chamomile oil, which is of the bisabolol chemotype. During the production of chamomile tincture, a raw material-extractant ratio of 1:14-1:16 and triple extraction are recommended for its highest yield. In in vivo studies with mice and rats, the extracts showed analgesic activity and improvements in sleep. The highest sedative and analgesic effects in rodents were found with the dry extract prepared by using a 70% aqueous ethanol solution for extraction at a dose of 50 mg/kg. The developed methods for the complex processing of German chamomile flowers are advisable for implementation into the pharmaceutical industry to reduce the volume of waste during the production of its essential oil and tincture, and to obtain new products.
PubMed: 38337883
DOI: 10.3390/plants13030350 -
Scientific Reports Jan 2024Supercritical carbon dioxide (scCO) has been suggested as a good substitution to environmentally harmful water-based tincturing. The present study describes the...
Supercritical carbon dioxide (scCO) has been suggested as a good substitution to environmentally harmful water-based tincturing. The present study describes the successful synthesis of some biologically active dispersion tinctures for supercritical carbon dioxide tincturing of polyester fabric. The coupling of 1-cyanoacetylpiperidine (1) with the diazonium salt of aryl amine derivatives (2a-d) produced 1-((aryldiazenyl) cyanoacetyl piperidines (3a-d). To create the derivatives of 4-(phenyldiazenyl)-5-(piperidin-1-yl)-1H-pyrazol-3-amine (5a), the propane nitriles (3a-d) were condensed with hydrazine hydrate. However, the unexpected 3-aminopyrazol-5-ol yellow-red dispersion dyes (4a-d) were identified as the reaction results. The MS, IR, and NMR spectra were used to describe the novel dyes, and the results exactly matched the suggested structures. The antibacterial test, which was conducted using the AATCC method, revealed that some of the compounds (3a-d) and (4a-d) had impressive antibacterial capabilities against the researched +ve and gram -ve bacteria. For eight dyestuffs, the dyeability, color strength, and color fastness of the tincturing process were evaluated. The evaluation focused on determining color uptake using a gauge for color strength (K/S). All dyes displayed excellent rubbing, washing, and light fastness (color change and staining grade of 4-5).
Topics: Amines; Anti-Bacterial Agents; Azo Compounds; Carbon Dioxide; Coloring Agents; Pyrazoles; Staining and Labeling
PubMed: 38212595
DOI: 10.1038/s41598-023-48740-y