herb quality - vic perfitt

8/14/2019 Herb Quality - Vic Perfitt

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Will EC Directives stop peoplebuying herb rubbish?

Vic Perfitt MBE

Perceptions of Herb Quality

Monday July 24 2006Ryton Organic Gardens.


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Perceptions of herb quality.A Canadian study showed that none of

the Feverfew products made in the US

contained enough of the activeingredient needed to be effective

75% of US herbal products are of poor

quality. Dr Gail Mahady WHOcollaborating centre.University of IllinoisChicago USA.


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Do we have a problem in the

UK? Valeriana officinalis L.

Valerian wallichii used as an adulterant and

substitute. BPC 1963 Adulterants &substitutes A problem recognised over 40years ago.

Does it still happen today? When the cost ofValeriana wallichii is approx. 33% of the costof Valeriana officinalis L conforming to BPmonograph. What do you think?


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DOES IT MATTER? A resounding yes yes yes.

If you do not know by precise binomial

nomenclature the plant, and its identification,every aspect of the quality of the productbecomes suspect.

Safety becomes compromised immediately.

Efficacy becomes suspect and ineffective dueto application of incorrect specie.


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QUALITY EXAMPLES.Valerian officinalis, Valeriana wallichii,Valeriana edulis (mexicana).

Zanthoxylum clava herculis L. testing ofPowdered dry extract Prickly Ash Barkfor manufacturing a licensed herbal

medicinal product, to ensure correctspecie is being used in the product.


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Then there was Black Cohosh! Newspaper headlines 19.07.2006.Herbal remedy harms the liverHerb pill warningMillions of women alerted to danger of

HRT herb

Source: The Sun.Daily Mail.The Times. MHRA action on safety concerns over

Black Cohosh and liver injury.


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Is Black Cohosh Cimicifuga

racemosa L Nutt hepatotoxic? The link to Cimicifuga racemosa L Nutt

is tenuous.See EMEA statement &

evaluation London 18.07.2006. What about the quality of the products?Are all the Black Cohosh products

produced containing the correct specie? This is the current challenge to the

Herbal industry.


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BLACK COHOSH cont. With the increasing demands for black

cohosh plant material for the production ofmenopausal dietary supplements in theUnited States, the adulteration of blackcohosh,especially with Asian Actaeaspecies,may increase further.Products-contain Asian Actaea species indicates thatblack cohosh products commercially availablein the United States may not be as claimed

Journal of Agriculture & Food ChemistryVolume 54 No 9 2006.


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Black Cohosh cont. To date,in large part,(if not exclusively)

Black Cohosh extracts are produced inChina from specie(s) other than Cimicifugaracemosa. It is also interesting to note thatthe plant itself, Black Cohosh (Cimicifugaracemosa) is not present in China.Theincentive behind this adulteration iseconomic.Several plants from China havebeen identified as an economic adulterant

ChromaDex Inc.Santa Ana.CA.USA


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Black Cohosh cont. A newer problem of adulteration with

extracts from less expensive Asian species

seem to be emerging. Effective enforcementand improvement of regulatory requirementsfor the quality control of these products isnecessary.We have little safety profiles of

Asian Actaea species Journal of Agriculture & Food Chemistry

Volume 54 No 9 2006.


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Will EC Directives stop people

buying herb rubbish? Directive 2004/24/EC amending as regards

traditional herbal medicinal products,Directive 2001/83/EC on the Community coderelating to medicinal products for human use.

Article 1 Definition:- Herbal Medicinalproduct is any medicinal product,exclusively

containing as active ingredients one or moreherbal substances or one or more herbalpreparations, or one or more such herbalsubstances in combination with one or moresuch herbal preparation


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Herbal Substance.Herbal substances are precisely

defined by the plant part used and the

botanical name according to binomialsystem (genus, specie,variety andauthor)

Quality standard as per currentEuropean Pharmacopoeia Ph Eur.monographs or BP.


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Ph.Eur. BP.Monograph

standard examples. Identification test Combination of

Macroscopical, Microscopical,Chromatographic procedures,Chemicalreactions.

Tests.- Foreign Matter, Total Ash, Ashinsoluble in hydrochloric acid, Water solubleextractive, Extractable matter.

Loss on drying. Microbial limits,Pesticideresidues, Mycotoxins.

Assay


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Browse: British Pharmacopoeia 2004 Addendum (electronic) British Pharmacopoeia Volume I & II

Monographs: Medicinal and Pharmaceutical substances ___________Valerian____________________ _________

ValerianGeneral Notices

(Valerian Root, Ph Eur monograph 0453)

Action and use

Sedative.

When Powdered Valerian is prescribed or demanded, material complying with the appropriate requirements below shall be dispensed orsupplied.

Ph Eur

DEFINITIONValerian root consists of the dried, whole or fragmented underground parts ofValeriana officinalis L. s.l., including the rhizome surrounded by

the roots and stolons. It contains not less than 5 ml/kg of essential oil for the whole drug and not less than 3 ml/kg of essential oil for the cut

drug, both calculated with reference to the dried drug and not less than 0.17 per cent of sesquiterpenic acids expressed as valerenic acid

(C15

H22O

2; M

r234), calculated with reference to the dried drug.

CHARACTERS

Valerian root has a characteristic odour.It has the macroscopic and microscopic characters described under identification tests A and B.

IDENTIFICATIONA. The rhizome is yellowish-grey to pale brownish-grey, obconical to cylindrical, up to about 50 mm long and 30 mm in diameter; the base is

elongated or compressed, usually entirely covered by numerous roots. The apex usually exhibits a cup-shaped scar from the aerial parts; stem

bases are rarely present. When cut longitudinally, the pith exhibits a central cavity transversed by septa. The roots are numerous, almost

cylindrical, of the same colour as the rhizome, 1 mm to 3 mm in diameter and sometimes more than 100 mm long. A few filiform fragile

secondary roots are present. The fracture is short. The stolons show prominent nodes separated by longitudinally striated internodes, each 20

mm to 50 mm long, with a fibrous fracture.

B. Reduce to a powder (355). The powder is pale yellowish-grey to pale greyish-brown. Examine under a microscope using chloral hydratesolution R. The powder shows cells containing a pale brown resin or droplets of essential oil; isolated rectangular sclereids with pitted walls 5 urn

to 15 urn thick; reticulately-thickened xylem vessels; occasional fragments of cork cells and epidermal cells, some with root hairs. Examine

under a microscope using a 50 per cent V/V solution ofglycerol R. The powder shows numerous fragments of parenchyma with cells, containing

single or compound starch granules; the single granules are rounded or elongated, 5 urn to 15 Mm in diameter and have sometimes a cleft or

radiate hilum; the compound granules have two to six components with an overall diameter of up to 20 urn.

Crown Copyright 2005


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Pharmaceutical GMP. Good manufacturing practice means the part

of quality assurance which ensures thatmedicinal products are consistently producedand controlled to the quality standardsappropriate to their intended use,theprinciples and guidelines of which arespecified in chapter 2 of Commission Directive

91/356/EEC Rules & Guidance for Pharmaceutical

Manufacturers & Distributors 2002.TSO.


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CONCLUSIONS. Herbal remedies are medicinal products and

should be regulated as such.

Quality, Safety, and Efficacy are imperativesfor medicinal products. Poor quality,(garbage in garbage out) source

of most safety issues with herbal products.

Will EC Directives Stop..they will stopmanufacturers producing rubbish and therebysafe effective herbal medicinal products will

be available to the consumer.

herb quality - vic perfitt

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