Development of Certified Reference Material Solutions for Phytochemicals in Ginger and Kava.

BACKGROUND: Dietary supplements derived from botanicals are commonly consumed and investigated in biomedical studies for their potential health benefits. Accurate identification and quantification of key chemical constituents from botanical ingredients is necessary for consistent product preparations and reproducible research results. Manufacturers need quantitative reference materials of the chemical constituents of interest to verify the content of ingredients and products. The rigor and reproducibility of biomedical research is enhanced through thorough characterization of the interventions used in mechanistic, clinical, and safety investigations. Quantitative reference materials enable reliable product quality assessments and reproducible research results. OBJECTIVE: Solution-based certified reference material (CRM) mixes were developed as calibrants for phytochemicals in ginger and kava. The kava CRM contained yangonin, desmethoxyyangonin, dihydrokavain, DL-kavain, methysticin, dihydromethysticin, flavokawain A, flavokawain B, and flavokawain C. The ginger CRM contained 6-gingerol, 8-gingerol, 10-gingerol, 6-shogaol, 8-shogaol, and 10-shogaol. METHODS: Each phytochemical was sourced as an isolated compound and assigned a purity factor by a mass balance approach accounting for residual impurities. The solution standard mixes were formulated by gravimetric addition of each phytochemical incorporating the purity factor and diluting with acetonitrile to the target concentrations of 500 µg/mL for the gingerols and shogaols, 250 µg/mL for the kavalactones, and 25 µg/mL for the flavokawains. RESULTS: The concentration accuracy of each component in the solution mixes was analytically verified by ultra high performance liquid chromatography with ultraviolet detection (UHPLC-UV) assay comparison to an independently prepared calibration solution. Each component in the ginger and kava CRMs were within 5 and 7% of the target concentrations, respectively. CONCLUSION: Homogeneous kava and ginger phytochemical solution mixes were produced with accurate constituent concentrations and demonstrated good stability over 2 years. These solution mixes were launched as commercially available CRMs. HIGHLIGHTS: These mixes can be used as accurate concentration stock solutions to prepare calibrators and controls for botanical dietary supplement product testing and standardization.

Screening for the Active Anti-Inflammatory and Antioxidant Polyphenols of Gaultheria procumbens and Their Application for Standardisation: From Identification through Cellular Studies to Quantitative Determination.

Aerial parts, leaves, and stems of Gaultheria procumbens are polyphenol-rich herbal medicines with anti-inflammatory and antioxidant effects. The present study focused on identifying active markers of the G. procumbens extracts in an integrated approach combining phytochemical and biological capacity tests. The target compounds, representing all classes of Gaultheria polyphenols, were pre-selected by LC-ESI-PDA-MS/MS. For unambiguous identification, the key analytes, including a rare procyanidin trimer (cinnamtannin B-1), miquelianin potassium salt, and two new natural products: quercetin and kaempferol 3-O-ß-d-xylopyranosyl-(1→2)-ß-d-glucuronopyranosides, were isolated by preparative HPLC and investigated by spectroscopy (HR-ESI-MS, UV-vis, CD, 1D- and 2D-NMR), thiolysis, flame photometry, optical rotation experiments, and absolute configuration studies. The significant contribution of the pre-selected compounds to the biological effects of the extracts was confirmed in vitro: the analytes significantly and in a dose-dependent manner down-regulated the pro-oxidant and pro-inflammatory functions of human neutrophils ex vivo (inhibited the release of reactive oxygen species, IL-1ß, TNF-α, and neutrophils elastase, ELA-2), inhibited two key pro-inflammatory enzymes (cyclooxygenase, COX-2, and hyaluronidase), and most of them, except gaultherin, exerted potent direct antioxidant activity (ferric reducing antioxidant power and superoxide anion scavenging capacity). Moreover, cellular safety was confirmed for all compounds by flow cytometry. Eventually, as these mechanisms have been connected to the health benefits of G. procumbens, 11 polyphenols were accepted as active markers, and a simple, accurate, reproducible, and fully validated RP-HPLC-PDA method for standardisation of the target extracts was proposed.

Effectiveness of Various Types of Bio-Activators to Quality of Compost Fertilizer.

<b>Background and Objective:</b> Plant litter or plants that grow naturally and the plant materials of the cultivated plants are quite abundant both in fresh and dry form. In the case of a plant, litter is not processed and left on the surface of the soil as organic material then the process of decomposition and reshuffle requires a long time. The research aimed to find out the effectiveness of bio-activators on the formation and quality of compost fertilizer. <b>Materials and Methods:</b> The study design was used in a factorial pattern with two factors. The First factor is bio-activator consists of four levels, namely: EM-4, PROMI, Orgadec and (EM-4+PROMI+Orgadec). The second factor is organic matter consists of seven levels, namely: <i>Imperata cylindrica</i>, paddy straw, <i>Gliricidia sepium</i> leaves, (<i>Imperata cylindrica</i> + paddy straw), (<i>Imperata cylindrica</i> + <i>Gliricidia sepium</i> leaves), (paddy straw + <i>Gliricidia sepium</i> leaves), (<i>Imperata cylindrica </i>+ paddy straw + <i>Gliricidia sepium</i> leaves). There were 28 treatments, each treatment was repeated three times to obtain 84 treatment units. <b>Results:</b> The result showed that compost fertilizer with Orgadec bio-activator treatment and PROMI is the best quality (pH compost, water content, P-total, N-total, C-organic, C/N ratio). <b>Conclusion:</b> The compost fertilizer with Orgadec bio-activator is the best quality for this research (pH compost, moisture content, P-total, N-total, C-organic, C/N ratio).

A review of the ethnobotanical value, phytochemistry, pharmacology, toxicity and quality control of Tussilago farfara L. (coltsfoot).

ETHNOPHARMACOLOGICAL RELEVANCE: Tussilago farfara L. (commonly called coltsfoot), known as a vital folk medicine, have long been used to treat various respiratory disorders and consumed as a vegetable in many parts of the world since ancient times. AIM OF THE REVIEW: This review aims to provide a critical evaluation of the current knowledge on the ethnobotanical value, phytochemistry, pharmacology, toxicity and quality control of coltsfoot, thus provide a basis for further investigations. MATERIALS AND METHODS: A detailed literature search was obtained using various online search engines (e.g. Google Scholar, Web of Science, Science Direct, Baidu Scholar, PubMed and CNKI). Additional information was sourced from ethnobotanical literature focusing on Chinese and European flora. The plant synonyms were validated by the database 'The Plant List' (www.theplantlist.org). RESULTS: Coltsfoot has diverse uses in local and traditional medicine, but similarities have been noticed, specifically for relieving inflammatory conditions, respiratory and infectious diseases in humans. Regarding its pharmacological activities, many traditional uses of coltsfoot are supported by modern in vitro or in vivo pharmacological studies such as anti-inflammatory activities, neuro-protective activity, anti-diabetic, anti-oxidant activity. Quantitative analysis (e.g. GC-MS, UHPLC-MRMHR) indicated the presence of a rich (>150) pool of chemicals, including sesquiterpenes, phenolic acids, flavonoids, chromones, pyrrolizidine alkaloids (PAs) and others from its leaves and buds. In addition, adverse events have resulted from a collection of the wrong plant which contains PAs that became the subject of public concern attributed to their highly toxic. CONCLUSIONS: So far, remarkable progress has been witnessed in phytochemistry and pharmacology of coltsfoot. Thus, some traditional uses have been well supported and clarified by modern pharmacological studies. Discovery of therapeutic natural products and novel structures in plants for future clinical and experimental studies are still a growing interest. Furthermore, well-designed studies in vitro particularly in vivo are required to establish links between the traditional uses and bioactivities, as well as ensure safety before clinical use. In addition, the good botanical identification of coltsfoot and content of morphologically close species is a precondition for quality supervision and control. Moreover, strict quality control measures are required in the studies investigating any aspect of the pharmacology and chemistry of coltsfoot.

Safety assessment of homeopathic medicines: The Adonis vernalis paradox and the 'analysis trap' of using different pharmacopeias.

Regulatory agencies have to ensure the end-user safety of botanically derived homeopathic medicines prepared with diluted starting materials derived even from toxic plants. In the case of plant-derived homeopathic products, assessment must consider the particular characteristics of an extract and its component molecules, even if diluted. The identification and quantification of these molecules have a crucial role in risk assessment, as it allows complete toxicological evaluation in a regulatory perspective. Different results can be achieved using different approaches and references supported by the same regulatory framework, as different methods of preparation used, assays and test analysis performed in compliance with different referent pharmacopoeias. All these facts can introduce a bias in the safety assessment and the paradoxical outcome for homeopathic Adonis vernalis underlines the need for caution. The case also demonstrates the relevance of considering the analytical method for assessment of all herbal medicinal products or herbal supplements, with the purpose of finding the total amount of toxicants as a good approach.

[Research and development of certified reference material of swertioside].

The standard sample of natural products is an essential standard reference to determine the quality of the product in the quality control of natural products. To develop a certified reference material(CRM) of swertioside according to the Work Guideline for Reference Materials(3): Reference Material-General Principles and Statistical Method for Certification(GB/T 15000.3-2008), swertioside was purified from whole plant of Swertia mussotii by extraction, isolation and Prep-HPLC to obtain certified reference material of swertioside. The structure of swertioside was identified by IR, UV, high-resolution MS, NMR. Thin layer chromatography, optical rotation, elemental analysis and melting point was carried out for the identification. The purity of the prepared sample was tested from different chromatographic elution conditions, thin layer chromatography and HPLC-MS. Swertioside was divided into 140 bottles, with 10 mg per bottle after homogeneity test, stability test and quantitative analysis. This CRM is 7-O-[α-L-rhamnopyranosyl-(1→2)-ß-D-xylopyranosyl]; the homogeneity of the 95% confidence interval was good; the certified purity value was 98.66%, with a relative expanded uncertainty of 0.38%; the storage period was 36 months at 0-8 ℃. Therefore, the CRM of sakuranetin reached the technical requirements of CRM, and was accepted by SAC. Swertioside is successfully developed and can be used for determining content, evaluating test methods, detecting relevant products and controlling quality.

Analysis of the similarities and differences between Auclandia and Vladimirae rhizomes by chemical profiling and chemometric analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Aucklandiae Radix (AR) and Vladimiriae Radix (VR), as traditional Chinese medicine, have been included in many editions of Chinese Pharmacopoeia with similar efficacy such as promoting qi and relieving pain, which are used to treat chest, hypochondriac, abdominal fullness and pain, diarrhea and tenesmus. In most conditions, VR is used to be a substitute of AR or a local habit. However, whether VR could substitute for AR to play a same role in the formulation and clinical applications needs further study. AIM OF THE STUDY: In this study, similarities and differences between AR and VR would be assessed, and possible reasons that may influence the efficacy of the AR and VR would be explained from the perspective of chemical composition. MATERIALS AND METHODS: HPLC-PDA was used to obtain the data of 10 batches of AR and VR, and to establish chemical fingerprint and chemometric analysis. UPLC-ESI-Q-TOF-MS was used to identify the structure of chemical compounds which contributed to the differences between AR and VR. RESULTS: The chemical fingerprint analysis results showed that 20 peaks in common for AR and 26 peaks in common for VR both presented a good similarity (>0.9), and 15 peaks in common for AR and VR also showed a good similarity (>0.9). Nevertheless, chemometric showed AR was distinct from VR and three chemical compounds, which leading to their differences, were identified by UPLC-ESI-Q-TOF-MS. The three chemical compounds were 3ß-acetoxy-11ß-guaia-4 (15),10 (14)-diene-12,6α-olide, 10α,14-epoxy-11ß-guaia-4 (15)-ene-12,6α-olide and costunolide, respectively. CONCLUSION: In general, AR and VR were highly similar, but their differences were deserved to be paid attention to. This research could provide reference for quality control and set a foundation for clinical applications of AR and VR.

What is and what should never be: artifacts, improbable phytochemicals, contaminants and natural products.

The scope of this review is to sensitize the natural product chemists to the underestimated problem related to artifact, comprising contaminants and improbable natural compounds. This review wants to give an overview about the various facets of this problem and to provide some hints to avoid incurring these situations. It does not pretend to report exhaustively about all the cases available in literature. The issue of artifacts has always existed and is quite impossible to completely eliminate because the results of phytochemical analysis are known only at the end of the work and in many cases there is not the possibility to compare the results. Therefore, it is important to take the necessary precautions during the workout in order to minimize the possibility that an unexpected event may occur. In second instance, anyone involved in these studies should increase the level of self-criticism with respect to the obtained experimental results.

Toxicological screening and DNA sequencing detects contamination and adulteration in regulated herbal medicines and supplements for diet, weight loss and cardiovascular health.

Use of herbal medicines and supplements by consumers to prevent or treat disease, particularly chronic conditions continues to grow, leading to increased awareness of the minimal regulation standards in many countries. Fraudulent, adulterated and contaminated herbal and traditional medicines and dietary supplements are a risk to consumer health, with adverse effects and events including overdose, drug-herb interactions and hospitalisation. The scope of the risk has been difficult to determine, prompting calls for new approaches, such as the combination of DNA metabarcoding and mass spectrometry used in this study. Here we show that nearly 50% of products tested had contamination issues, in terms of DNA, chemical composition or both. Two samples were clear cases of pharmaceutical adulteration, including a combination of paracetamol and chlorpheniramine in one product and trace amounts of buclizine, a drug no longer in use in Australia, in another. Other issues include the undeclared presence of stimulants such as caffeine, synephrine or ephedrine. DNA data highlighted potential allergy concerns (nuts, wheat), presence of potential toxins (Neem oil) and animal ingredients (reindeer, frog, shrew), and possible substitution of bird cartilage in place of shark. Only 21% of the tested products were able to have at least one ingredient corroborated by DNA sequencing. This study demonstrates that, despite current monitoring approaches, contaminated and adulterated products are still reaching the consumer. We suggest that a better solution is stronger pre-market evaluation, using techniques such as that outlined in this study.

[Quality evaluation of Magnoliae Officinalis Cortex based on combinative method of fingerprint,quantitative analysis of multicomponents and chemometrics].

This study aims to establish a combinative method based on fingerprint,assay of multi-component and chemometrics for quality evaluation of Magnoliae Officinalis Cortex. Twenty batches of samples were determined by UPLC and a common mode of fingerprint was established. The similarities between fingerprints of 20 batches of samples were over 0. 90 and the common mode were evaluated. Eight components were identified as syringing, magnocurarine, magnoflorine, magnoloside B, magnoloside A, honokiol,magnolol,and piperitylmagnolol by comparison with reference substances and their content in samples were simultaneously determined.Based on the results,the fingerprint had good consistency between the same origin and minor diversity between the different sources.Piperitylmagnolol and peak 13 could be used as a distinction with the different sources. According to content of 8 components,Fisher discriminant analysis model was established and different source sample was classified pursuant to the discriminant fraction. It is indicated that simultaneous quantification of multi components coupled with chemometrics analysis could be a well-acceptable strategy to identify and evaluate the quality of Magnoliae Officinalis Cortex.

A review of the phytochemistry and pharmacological activities of Magnoliae officinalis cortex.

ETHNOPHARMACOLOGICAL RELEVANCE: Magnoliae Officinalis Cortex (the dried bark of Magnolia officinalis), a widely used traditional Chinese medicine, is also known as 'Houpo' (Chinese: ). Magnoliae Officinalis Cortex has a wide range of pharmacological effects and has been used to treat conditions such as abdominal distention, vomiting, diarrhea, food accumulation, Qi stagnation, constipation, phlegm and fluid retention and cough resulting from asthma. AIMS OF THE REVIEW: The present paper reviews advances in research relating to the botany, ethnopharmacology, phytochemistry, pharmacology and toxicology of Magnoliae Officinalis Cortex. Prospects for future investigation and application of this herb are also discussed. MATERIALS AND METHODS: Information on Magnoliae Officinalis Cortex was obtained from published materials, including ancient and modern books; PhD and MSc dissertations; monographs on medicinal plants; the pharmacopoeia of different countries and electronic databases, such as SCI finder, PubMed, Web of Science, ACS, Science Direct, Wiley, Springer, Taylor, AGRIS, Europe PMC, EBSCO host, CNKI, WanFang DATA, J-STAGE and Google Scholar. RESULTS: More than 200 chemical compounds have been isolated from Magnoliae Officinalis Cortex, including lignans, phenylethanoid glycosides, phenolic glycosides, alkaloids, steroids and essential oils. The plant has been reported to have pharmacological effects on the digestive system, nervous system and cardiovascular and cerebrovascular systems, as well as antibacterial, anti-tumour, analgesic, anti-inflammatory and anti-oxidative effects. CONCLUSIONS: Magnoliae Officinalis Cortex is an essential traditional Chinese medicine with pharmacological activities that mainly affect the digestive system, nervous system and cardiovascular and cerebrovascular systems. This review summarises its botany, ethnopharmacology, phytochemistry, pharmacology and toxicology. These information suggest that we should focus on the development of new drugs related to Magnoliae Officinalis Cortex, including specific constituents, so that Magnoliae Officinalis Cortex can exert greater therapeutic potential. Meanwhile, it is important to pay attention to the rational use of Magnolia resources, avoiding over-harvesting which could lead to lack of resources. We should also pursue research on Magnolia substitutes and develop resources such as Magnoliae Officinalis Flos and Magnolia Leaf.

Analysis of phosphodiesterase type 5 inhibitors as possible adulterants of botanical-based dietary supplements: extensive survey of preparations available at the Czech market.

Popularity of natural-based preparations supporting the sexual potency significantly increased in recent years, which also led to the increase of illegal use of phosphodiesterase type 5 inhibitor (PDE-5) in sexual performance enhancement products. In this study, a rapid U-HPLC‒HRMS/MS method has been developed to simultaneously determine 59 PDE-5 inhibitors and their analogues. Within the development of sensitive method for analysis of 59 PDE-5 inhibitors and their analogues, both sample preparation procedure, as well as separation / detection conditions have been optimized. Extraction efficiency of particular extraction solvents, influence of different mobile phase additives on target analytes separation, as well as impact of various settings of mass analyzer on sensitivity of detection were examined. Data were collected in the 'full MS/data dependent MS/MS' acquisition mode (full MS-dd-MS/MS). Before the U-HPLC‒HRMS/MS method was used for analysis of real samples, proper validation had been conducted. The precision of the method expressed as the relative standard deviation (RSD) was ≤4.2% and ≤5.2% at spiking concentrations 5 µg/g and 0.25 µg/g, respectively. The limits of quantification were in the range 0.25 - 0.05 µg/g and the recovery ranged between 71 and 90%. The optimized method was successfully applied for analysis of 64 real samples, and 10 of them were proved to contain both registered or unregistered synthetic PDE-5 inhibitors. Additionally, the acquired U-HPLC‒HRMS/MS fingerprints were demonstrated to serve as an efficient tool for revealing of other type of possible fraud in products labeling. Retrospective mining of markers of herbs declared on dietary supplements packaging allowed to assess the trueness / untruth in the declaration of medical herbs composition.

An indirect competitive enzyme-linked immunosorbent assay toward the standardization of Pueraria candollei based on its unique isoflavonoid, kwakhurin.

Kwakhurin (Kwa) is a plant secondary metabolite solely present in Pueraria candollei var. mirifica (P. candollei), which has long been used as a Thai traditional herb for estrogen replacement therapy. Recently, health hazards have arisen in Japan regarding P. candollei-derived products containing potent estrogenic compounds. Therefore, the development of standardization methods for P. candollei materials is an urgent problem requiring resolution. The enzyme-linked immunosorbent assay (ELISA) is an effective analytical technique because it enables the development of sensitive and specific assays of the target compound through antigen-antibody reaction. Here, we produced a monoclonal antibody against Kwa (MAb 11F) by immunizing Kwa-bovine serum albumin (BSA) conjugates prepared using an N,N'-carbonyldiimidazole (CDI) mediated method. Stability and cross-reactivity tests of MAb 11F revealed that the MAb 11F is stable for at least 4 months at 4 °C and is highly specific to Kwa. The detectable concentration range of an indirect competitive ELISA (icELISA) using MAb 11F exhibited values of 1.53-48.8 ng/mL with the limit of detection (LOD) of 1.13 ng/mL. Validation analyses revealed that the developed icELISA is precise, accurate, and reliable enough to be applied to P. candollei-derived samples and products for their standardization.

Development of quality standard and phytochemical analysis of Carica papaya Linn leaves.

Carica papaya Linn is the member of Caricaceae family of Kingdom Plantae. The study was executed for the development of qualitative standards of male and female leaves of the plant. The study included evaluation of macroscopial, physico-chemical and preliminary phytochemical parameters to authorize the purity and authenticity of leaf of Carica papaya Linn based on guidelines provided by WHO. Qualitative phytochemical screening of extracts revealed the existence of alkaloids, flavonoids, tannins, phenolic compounds, glycosides including cardiac glycosides, proteins and carbohydrate in different extracts of Carica papaya Linn which are majorly rich in female leaves as compared to male. Mean ash values, acid insoluble ash, water soluble ash, foaming index, swelling index and moisture contents were also evaluated which are more or less similar. FTIR profile of the samples were also generated that confirmed distinct peak values with respective functional groups exhibited by Carica papaya male and female plant. The current research reflected that female and male plant showed variations in phyto-constituents. This data will be utilized for additional Pharmacological and Instrumental evaluation of the plant which can not only be beneficial in discriminating and refining the type as well as nature of various phytochemicals present in Carica papaya male and female leaves but also establish the quality standards for future researches.

From Plant Compounds to Botanicals and Back: A Current Snapshot.

This work aims at giving an updated picture of the strict interaction between main plant biologically active compounds and botanicals. The main features of the emerging class of dietary supplements, the botanicals, are highlighted. Focus is also on the definition of actual possibilities of study approach and research strategies. Examples of innovative directions are given: assessment of interaction of bioactive compounds, chemometrics and the new goal of biorefineries. Current models of existing databases, such as plant metabolic pathways, food composition, bioactive compounds, dietary supplements, and dietary markers, are described as usable tools for health research. The need for categorization of botanicals as well as for the implementation of specific and dedicated databases emerged, based on both analytical data and collected data taken from literature throughout a harmonized and standardized approach for the evaluation of an adequate dietary intake.

Identification, Isolation and Determination of Biomarkers for Quality Control of Bush Tea (Athrixia phyllicoides).

Athrixia phylicoides, known as "bush tea", grows abundantly in South Africa. An infusion of the leaves is used as a beverage and to treat a multitude of health conditions. The aim of this study was to investigate the chemical variation within A. phylicoides and to identify characteristic compounds for quality control. Samples from 12 locations in South Africa were analysed using ultra-performance liquid chromatography. Hierarchical cluster analysis of the aligned ultra-performance liquid chromatography-time-of-flight mass spectrometry data indicated two groups on the resulting dendrogram, representing 48 samples. Five marker compounds, identified through visual inspection and the construction of a discriminant analysis model, were evident on the ultra-performance liquid chromatography-MS profiles. Four of these compounds were isolated and identified, three as hydroxy methoxyflavones and the fourth as a coumarate, using nuclear magnetic resonance spectroscopy. An ultra-performance liquid chromatography-photodiode array method was developed and validated for the determination of the marker compounds using the isolates as standards. The limits of detection for the four compounds ranged from 0.92 - 2.50 µg/mL. Their recoveries at three concentration levels (1.00, 10.0, and 100 µg/mL) were between 97.0 and 101%, while acceptable intra- and inter-day precision was obtained as reflected by percentage relative standard deviation values below 2.24%. The concentrations of all the marker compounds were found to be higher in samples corresponding to Group 1 of the dendrogram than in those from Group 2. This may be attributable to differences in altitude, climate, and some edaphic factors. Identification of these marker compounds will make a valuable contribution towards the quality control and sustainable commercialisation of bush tea.

Integrated analytical assets aid botanical authenticity and adulteration management.

This article reviews and develops a perspective for the meaning of authenticity in the context of quality assessment of botanical materials and the challenges associated with discerning adulterations vs. contaminations vs. impurities. Authentic botanicals are by definition non-adulterated, a mutually exclusive relationship that is confirmed through the application of a multilayered set of analytical methods designed to validate the (chemo)taxonomic identity of a botanical and certify that it is devoid of any adulteration. In practice, the ever-increasing sophistication in the process of intentional adulteration, as well as the growing number of botanicals entering the market, altogether necessitate a constant adaptation and reinforcement of authentication methods with new approaches, especially new technologies. This article summarizes the set of analytical methods - classical and contemporary - that can be employed in the authentication of botanicals. Particular emphasis is placed on the application of untargeted metabolomics and chemometrics. An NMR-based untargeted metabolomic model is proposed as a rapid, systematic, and complementary screening for the discrimination of authentic vs. potentially adulterated botanicals. Such analytical model can help advance the evaluation of botanical integrity in natural product research.

Study of Sedative Tea Phytocomplex within the Framework of Studies Aimed at Creation of a Rectal Dosage Form with Antihistaminic Effect.

We designed a new complex drug with antiallergic effect containing, in addition to the main component loratadine, a phytocomplex for an extra therapeutic effect. A collection of plants with sedative activity is chosen and the optimal agent for extraction of bioactive compounds (40% ethanol) and optimal degree of plant fragmentation are determined. Chemical composition of the sedative tea is evaluated by reverse phase HPLC. The marker components of the species are detected: xanthohumol and isoxanthohumol - Humulus lupulus cone components, Mentha piperita rosmarinic acid, and scutellareine, Menyanthes trifolia element - quercetin-3-rutinoside, and caffeic acid. Standardization of the species by the absolute graduation method in conversion to quercetin-3-rutinoside is suggested.

Selection of chemical markers for the quality control of medicinal plants of the genus Cecropia.

CONTEXT: Several Cecropia (Cecropiaceae) species are traditionally used in Latin America for the treatment of a variety of diseases including diabetes, arterial hypertension, asthma, bronchitis, anxiety, and inflammation. At present, a number of commercial products based on these plants have been introduced into the market with very little information on methods for guaranteeing their quality and safety. OBJECTIVE: This work proposes potential chemical markers for the quality control of the raw materials of Cecropia obtusifolia Bertol., Cecropia peltata L., Cecropia glaziovii Snethl., Cecropia pachystachya Trécul, and Cecropia hololeuca Miq. METHODS: The Herbal Chemical Marker Ranking System (Herb MaRS) developed by the National Institute of Complementary Medicine (NICM) at the University of Western Sydney was used for selecting chemical markers for the quality control of selected medicinal species of Cecropia. This review covers the period from 1982 to 2016. RESULTS: Chlorogenic acid, flavonoidal glycosides (orientin, isoorientin, vitexin, isovitexin, and rutin), catechin, epicatechin, procyanidins (B2, B5, and C1), steroids (ß-sitosterol), and triterpenoids (α-amyrin, pomolic, tormentic and ursolic acids) were selected as chemical markers for the quality control of the leaves. CONCLUSION: It is necessary to establish comprehensive standards for guaranteeing quality, safety and efficacy of herbal drugs. The selection of adequate chemical markers for quality control purposes requires a good knowledge about the chemical composition of medicinal plants and their associated biological properties. To the best of our knowledge this review article is the first to address the identification and quantitative determination of the chemical markers for the genus Cecropia.

Rational quality assessment procedure for less-investigated herbal medicines: Case of a Congolese antimalarial drug with an analytical report.

Herbal medicines are the most globally used type of medical drugs. Their high cultural acceptability is due to the experienced safety and efficiency over centuries of use. Many of them are still phytochemically less-investigated, and are used without standardization or quality control. Choosing SIROP KILMA, an authorized Congolese antimalarial phytomedicine, as a model case, our study describes an interdisciplinary approach for a rational quality assessment of herbal drugs in general. It combines an authentication step of the herbal remedy prior to any fingerprinting, the isolation of the major constituents, the development and validation of an HPLC-DAD analytical method with internal markers, and the application of the method to several batches of the herbal medicine (here KILMA) thus permitting the establishment of a quantitative fingerprint. From the constitutive plants of KILMA, acteoside, isoacteoside, stachannin A, and pectolinarigenin-7-O-glucoside were isolated, and acteoside was used as the prime marker for the validation of an analytical method. This study contributes to the efforts of the WHO for the establishment of standards enabling the analytical evaluation of herbal materials. Moreover, the paper describes the first phytochemical and analytical report on a marketed Congolese phytomedicine.