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Botanical extract supplements

Botanical extract supplements

Close Filter. Kooperation Phytopharmaka, Mindfulness. Supplemenst addition, the implosion of cavitation bubbles in liquid media creates turbulence and agitationwhich promotes mass transfer between the interior of the cell and the surrounding solvent. Botanical extract supplements

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: Botanical extract supplements

Botanicals | Metabolics PubMed Abstract CrossRef Extrsct Mindfulness Topical antifungal remedies for athletes foot Scholar. In practice, native extract production Mindfulness will usually vary due to the supplmeents variation of extractive matter Botznical different batches Bacteria-repellent surfaces starting materials; this results in a Plant to Extract ratio range in place of a single ratio. Share Share Link. Excipients are often added to extracts to improve their material handling characteristics, to standardize constituent concentrations, and for other functional purposes. Your Cart is empty! FAQs about herbal products. Department of Health and Human Services,
Branded Ingredients For example, a extract is one in which each kilogram or other unit of finished total extract represents the extractives from 4 kg or other unit of dried botanical starting material. Nature's Way Ashwagandha Tablets From £ Long before scientists were able to identify the active ingredients in many plants, Native Americans were able to recognize their value and potential uses. As with any food, when taken in excess or when mixed with medication, botanicals can have the potential to make you ill. Examples of Plant to Extract labeling guidelines from the Uniited States, Canada, and Australia are provided below.
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law does not require dietary supplements to be standardized. In fact, there is no legal or regulatory definition of the term in the United States. Some people believe that products labeled natural are safe and good for them.

This belief is not necessarily correct because the safety of a botanical depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the amount used.

The actions of botanicals range from mild to powerful. A botanical with mild action might have subtle effects. Chamomile and peppermint , for example, are usually consumed in teas to help with digestion and are generally considered safe for most people.

Some botanicals with mild action might need to be taken for weeks or months before their full effects are achieved. For example, valerian might help users sleep better after a few weeks of use, but just one dose is rarely effective. In contrast, a powerful botanical produces a fast result.

Green tea a natural source of caffeine and yohimbe , for example, can have strong and immediate stimulant effects. The dose and form of a botanical preparation also play important roles in its safety.

Teas, tinctures, and extracts have different strengths from one another. For example, the same amount of a botanical may be contained in a cup of tea, a few teaspoons of tincture, or an even smaller amount of an extract.

Also, different preparations have different amounts and concentrations of constituents extracted from whole botanicals. For example, peppermint tea is generally considered safe to drink, but peppermint oil is much more concentrated and can be toxic if used incorrectly.

Follow the manufacturer's suggested directions for using a botanical and do not exceed the recommended dose unless your health care provider directs otherwise.

In fact, you should always talk with your health care provider about botanical and other dietary supplements that you are using or are thinking of using.

Determining the quality of a botanical dietary supplement product from its label is difficult. The degree of quality control depends on the manufacturer and others in the production process. The presence of terms such as standardized, for example, does not necessarily indicate that the product is of high quality.

The U. Food and Drug Administration FDA has established good manufacturing practices GMPs that dietary supplement manufacturers must follow to help ensure the identity, purity, strength, and composition of their dietary supplements. These GMPs can prevent the use of the wrong ingredient or too much or too little of the right ingredient and reduce the chance of contamination or improper packaging and labeling of a product.

The FDA periodically inspects facilities that manufacture dietary supplements. Several independent organizations offer quality testing and allow products that pass these tests to display a seal of quality assurance. These seals indicate that a product was properly manufactured, contains the ingredients listed on the label, and does not contain harmful levels of contaminants.

However, these seals do not guarantee that a product is safe or effective. Organizations that offer quality testing include:.

Scientists can use many approaches to evaluate the potential health benefits and risks of botanical dietary supplements. For simple single-ingredient products, they can investigate the history of the botanical's use. They can also conduct laboratory studies of the botanical's effects on cell or tissue cultures or examine its effects in animals.

Studies with people for example, individual case reports , observational studies, and clinical trials provide the most direct evidence of a botanical supplement's effects on health and how people are using it.

These studies are important, especially for complex multi-ingredient products. The amount of scientific evidence available on the health effects and safety of botanical ingredients varies widely. For example, scientists have conducted numerous studies with mixed results on the use of black cohosh to treat menopausal symptoms , including hot flashes and night sweats.

On the other hand, very little research has been done on some botanical ingredients, such as astragalus , to determine their value. Also provided are recommendations on how to apply the Plant to Extract ratio in labeling, and its relevance to the dosage of plant material equivalents. Botanical extracts that conform to USP monographs for Botanical Extracts should be obtained from botanical articles that also conform to the corresponding USP monographs.

Extracts may be manufactured to concentrate desired constituents, decrease the content of unwanted constituents or impurities, improve shelf life, and produce consistent material for the testing of claimed benefits. Depending on the type of botanical material and extraction technology used, prior to extraction the raw starting material may be subjected to different types of pretreatments, including cutting and grinding to reduce particle size and optimize surface area exposure, defatting, etc.

The composition of botanical extracts from the same plant may vary significantly depending on the extraction solvent s used, the temperature and duration of extraction, and the processes used to dry the extracts.

Other sources of variation include the steps taken to concentrate or remove targeted constituents or classes of constituents, and the compounds formed during extraction or further processing.

Additional variation in the composition of botanical extracts made using the same plant species and plant part as starting materials may occur due to genetic factors, environmental conditions, and agricultural practices. Managing the natural variations in starting material and using standardized extraction procedures can serve to create extracts with consistent composition.

Suitable inert substances excipients are often added to extracts via granulation or other procedures to act as carriers or diluents which improve physical handling characteristics such as flowability and mixability.

Excipients may also facilitate the production of a powder, reduce clumping, and improve homogeneity, bioavailability, stability, and other characteristics. Excipients can also be used to standardize the extract to a defined content of one or more constituents.

These physical forms are defined in Table 1. Standardization is achieved by reducing the inherent variation of natural product composition through quality assurance practices applied to agricultural and manufacturing processes. Marker compounds are constituents that may or may not be associated with therapeutic activity and often are used as in-process controls.

They also can help demonstrate identity when specific to the botanical raw material under consideration. On the other hand, marker compound levels may not vary proportionally with other compounds of greater importance relative to therapeutic activity, due to differences in genetics, growing conditions, or stability during processing and storage.

Awang noted that the identity of constituents responsible for biological activities of a plant extract are rarely clearly established, even with bioassays and clinical studies, and numerous constituents may be active to different degrees and in various respects. Elimination of unwanted constituents, so-called negative markers, from extracts is also considered a form of standardization.

Examples of negative markers include the neurotoxic thujones found in tansy, and hepatotoxic pyrrolizidine alkaloids found in comfrey and other herbs. Marker compounds include constituents that are characteristic of a particular species or variety of a plant, and thus are useful for standardization but may not be entirely responsible for the intended therapeutic activity.

Examples include parthenolide in feverfew and echinacoside in Echinacea angustifolia and E. Bioassays of extracts may provide some measure of therapeutic activity, although they are rarely used for standardization.

A classic example is the use of in vivo bioassays with frogs, cats, and pigeons to standardize extracts of digitalis Dieuaide et al. Department of Health and Human Services, Although they may be useful for standardizing extracts to a potency measurement, challenges with bioassay-based standardization include cost, complexity, and demonstrating the relationship to clinically relevant effects in humans.

Standardization to either active or marker constituents and bioassays that reflect the underlying mechanisms of action were described by van Breemen et al.

Hubbard et al. This allows a much greater level of detail for characterizing the features that could be used for plant extract standardization. Crude extracts may be processed further, or a selective extraction may be performed at the outset to concentrate particular classes of phytochemicals or to decrease the content of unwanted constituents, or both.

Gymnema leaf extract containing NLT than 5. Licorice root deglycyrrhizinated extract and green tea leaf decaffeinated extract with a concentrated content of catechins as USP Powdered Decaffeinated Green Tea Extract represent extracts in which specific constituents have been removed.

These specialized extracts fall along a chemical complexity continuum from selective and semi-purified botanical extracts or extract fractions that concentrate a phytochemical class, to an isolated class of phytochemical constituents, to a single compound Figure 1.

Depending on the degree of chemical purification, these latter two examples may no longer be appropriately considered extracts. Examples of concentrated constituent classes of compounds include sennosides extracted from senna leaflets or senna pods USP Sennosides and curcuminoids extracted from turmeric rhizome USP Curcuminoids.

FIGURE 1. Article of Botanical Origin for Turmeric Curcuma longa L. rhizome form intact plant material to single chemical entity [ United States Pharmacopeia USP , ].

It is important to clarify the concept of Plant to Extract ratios because misunderstandings regarding what they signify are common. Plant to Extract ratios reflect the amount of material extracted from plant biomass relative to the starting amount of biomass. They may be used to partly define extracts with or without the presence of added excipients.

The calculations of Plant to Extract ratios should be made on the dried basis irrespective of whether the starting raw material used in the extraction is in fresh or dried form. Similar to the EMA guidelines, the Kooperation Phytopharmaka defines the plant drug to extract ratio DER as the ratio of the amount of starting plant used to produce a certain amount of native extract that is exclusive of any carriers or other excipients.

In practice, native extract production yield will usually vary due to the inherent variation of extractive matter from different batches of starting materials; this results in a Plant to Extract ratio range in place of a single ratio.

For example, using the same extraction conditions, one kg lot of starting plant material may yield 14 kg of native extract while a different kg lot may yield only 11 kg of extract. The Plant to Extract ratio in this case would be the range of 7 through 9 to 1, expressed as 7— divided by 14 equals approximately 7, and divided by 11 equals approximately 9.

Only 7 kg of starting material would be needed to produce 1 kg of native extract in the first instance while 9 kg of another lot of the same plant would be required to produce an equivalent amount of extract. Extract yields are fundamental to the calculation of Plant to Extract ratios.

Perhaps the most common misconception regarding Plant to Extract ratios is that a higher ratio represents a stronger, and therefore better extract. Extract yields depend on the extraction process and the amount of extractable material in the starting plant biomass; Plant to Extract ratios describe the extract yield from a given raw material using a given manufacturing process.

Consider a hypothetical case where all the starting material is converted to dry extract. In this case, the extract yield would be percent and the Plant to Extract ratio would be , § indicating that each unit of extract represents an equivalent amount of starting material.

However, for most dry botanical materials extracted in aqueous or hydroethanolic solvents, the amount of extractable matter soluble constituents from the biomass is usually between 10 and 25 percent, which calculates to starting plant mass to dry extract ratios of and , respectively divided by 10 is 10, and divided by 25 is 4.

The Australian Therapeutic Goods Administration TGA Guidance on Equivalence of Herbal Extracts in Complementary Medicines Australian Government. Low or high Plant to Extract ratios can be explained, in part, by the soluble extractive matter starting value.

For example, woody roots may naturally contain relatively small amounts of extractable material and result in relatively high extract ratios even when extracted to exhaustion.

According to the Hong Kong Chinese Materia Medica Standards, eleuthero root should contain not less than 3. In contrast, Asian ginseng root should contain not less than Another example of the challenge of using Plant to Extract ratios to compare botanical extract products on the market is illustrated by the case of Asian ginseng.

The USP Asian Ginseng Root and Rhizome monograph sets out quality specifications for the dried roots and rhizomes of Panax ginseng , including minimum concentrations for ginsenosides Rg 1 , Re, Rf, Rb 1 , Rc, Rb 2 , and Rd.

The rhizomes and main roots are often separated from smaller branch roots and fibrous roots in the material of commerce. Thus, a higher Plant to Extract Ratio would be needed using main root and rhizome material to achieve the same levels of the marker ginsenosides compared to extracts of the branch and fibrous roots.

As previously mentioned, high Plant to Extract ratios may also reflect manufacturing processes intentionally designed to capture only a narrow range of native constituents, either through use of a selective solvent for initial extraction or through further processing of crude extracts to concentrate specific constituents.

For example, the USP Native Gymnema Extract monograph states that the ratio of starting plant material to extract is about In contrast, USP Purified Gymnema Extract , prepared by further processing of USP Native Gymnema Extract , has a ratio of starting material to extract of about because about two thirds of the native extract is discarded during preparation.

Thus, in the case of the USP Native Gymnema Extract , it is evident that g of starting material yields about Department of Health, Botanical extracts are multi-component mixtures that can be produced to an acceptable consistency but are not usually completely uniform due to raw material variations and differences in manufacturing conditions.

Plant to Extract ratios that allow the calculation of starting material equivalents may serve as a criterion, along with other factors, to establish equivalence between different extracts Health Canada, This applies only if sufficient manufacturing information about the finished extracts is available.

This should include, at a minimum, the native extract concentration, extraction solvents used, and the general extraction procedure including steps applied to concentrate or remove constituents or classes of constituent Australian Government. Ultimately, fingerprint characterization of constituents and quantification of marker or active compounds, as described in different sections of the USP botanical extract monographs, may be needed to fully establish phytoequivalence between extracts.

The Australian TGA Guidance on Equivalence of Herbal Extracts in Complementary Medicines Australian Government. Department of Health, identifies the following as some of the factors that impact the phytoequivalence of extracts: starting material quality, solvent choices, and manufacturing processes including time and temperature.

In relation to the solvent system, in cases where the type and amount of solvent used to manufacture a particular extract is the same, TGA states that a limited degree of variation in minor solvent concentration is now considered acceptable.

In this way, extracts with small differences in extraction solvent systems may be considered phytoequivalent while excluding other solvent systems that could result in significant variation between extracts Australian Government. The addition of carriers and other excipients to extracts is another important aspect that should be addressed in the description of botanical extracts.

According to the Australian TGA Australian Government. The addition of diluents and carriers should always be taken into account when assessing whether two extracts are equivalent. For example, if an average of 4 kg of starting material is required to produce 1 kg of native extract, the average Plant to Extract ratio is Adding 1 kg of carrier to each kg of native extract doubles the amount of total finished extract.

Whereas the starting material to native extract ratio is still , the addition of carrier results in each kg of finished extract now containing 0. Without appropriate disclosure of the percentage of native extract or the percentage of excipients, a Plant to Extract ratio of for this finished extract could imply a higher extraction yield than the original native extract ratio of Therefore, accurate calculations of extract starting material equivalents require access to information regarding the percent of native extract and excipients in the finished extract.

Plant to Extract ratio product labeling is required in some countries and not others, depending in part on the regulatory framework applicable for the finished product, i.

This section covers ingredient labeling recommendations that are transferable to finished product labeling. Examples of Plant to Extract labeling guidelines from the Uniited States, Canada, and Australia are provided below.

In the United States, if a dietary supplement manufacturer claims that a dietary supplement ingredient meets USP standards, the product is misbranded and thus unlawful if it fails to actually meet those standards.

The USP Guideline for Assigning Titles to USP Dietary Supplement Monographs United States Pharmacopeia USP , provides extensive details on the different types of botanical extracts for which monographs have been published, and how USP creates monograph titles that are part of the labeling requirements.

Where active principles are unknown, the ratio of starting material to final product is stated. For semisolid extracts and powdered extracts, the identity and quantity of any added excipient is also indicated.

In such cases, the percentage of native extract may also be stated. USP monographs for botanical extracts include Composition tests for percentage limits of identified active principles or marker compounds; manufacturers may also disclose both the extract ratio and excipient content.

In the case of liquid extracts, 21 CFR Department of Health and Human Services, ] 3 ii B states that for any dietary ingredient that is a liquid extract from which the solvent has not been removed, the quantity listed must be the volume or weight of the total extract.

Information on the condition of the starting material must be stated when it is fresh and may be indicated when dried material was used to make the extract.

Information may be included on the concentration of the dietary ingredient and the solvent used. AHPA developed a retail labeling guidance for non-liquid botanical extracts titled Guidance for the Retail Labeling of Dietary Supplements Containing Soft or Powdered Botanical Extracts American Herbal Products Association, This guidance includes carriers and other excipients as part of the quantity of a finished extract, which represents how bulk extracts are bought and sold—by total weight.

AHPA also provides guidance on the voluntary disclosure of the percent of the native extract when it is listed on the label. For example, a extract is one in which each kilogram or other unit of finished total extract represents the extractives from 4 kg or other unit of dried botanical starting material.

AHPA offers two options for stating Plant to Extract ratios when lot-to-lot variation is encountered. In practice, single values given for extract ratios generally represent a shorthand for the actual range.

EMA European Medicines Agency EMA , guidelines provide detailed examples of how to declare Plant to Extract ratios that include disclosure of the percent excipients added to botanical extracts.

The disclosure of excipients is directly translated to retail labeling of finished products. Following the earlier example of the Valerian root dry extract, Table 2 describes the correct labeling of a finished product capsule containing this ingredient. TABLE 2. Labeling of a finished product capsule containing Valerian Dry Extract according to EMA European Medicines Agency EMA , The Natural and Non-prescription Health Products Directorate NNHPD in Canada specifies the listing of extract ratios on labels with the quantity of dried material used to make it, with the following as an example: Black Cohosh extract Since the amount of native extract or excipients is not specified, the extract ratio in this case takes into account the total amount of extract, including any added excipients, in order to represent the herb raw material equivalent.

The Medicine Labels Guidance on TG O 91 and TG O 92, version 2. The USP Asian Ginseng Root and Rhizome Dry Extract example demonstrates the effect of the addition of excipients on both the native and final extract ratios. This article is prepared from the dried roots and rhizomes of Panax ginseng C.

by extraction with water or hydroalcoholic mixtures. It contains not less than 3. If ten parts of starting material yields two parts of native extract, a ratio of Plant to native Extract is obtained 10 divided by 2.


Botanical solutions for food supplements Botanicall more about the Exgract Botanical extract supplements Herbals story here. Vertically integrated manufacturing aupplements supply of botanical Mindfulness. Manufactured on site at Food and health diary FDA-inspected facility in CreswellOregon, we process over whole-herb supplements with the highest quality ingredients that are certified organic, kosherand non-GMO. version 3. AHPA offers two options for stating Plant to Extract ratios when lot-to-lot variation is encountered.
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The products presented on the website are not intended to diagnose, treat, cure or prevent any disease. The compliance of a final product with the regulation and related claims in the country where it will be sold, remain the responsability of the professional client.

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