Herbal Medicine Flashcards

1
Q

what are Herbal Medicinal product?

A

any medicinal product, exclusively containing as active ingredients one or more herbal drugs or one or more herbal drug preparations or in combination

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2
Q

how are herbal drug prepered?

A

they are homogeneous product obtained by subjecting herbal drugs to treatments such as extraction, distillation, expression, fractionation, purification, concentration

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3
Q

give examples of herbal drugs

A

extracts, essential oils, expressed juices, powered herbal drug

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4
Q

Definition “Herbal drug”

A

mainly whole, fragmented or brocken plants or part of plants in an unprecessed state, usually in dried but sometimes fresh

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5
Q

differences between herbal medicinal and medicinal product (API)

A

Herbal medicinal product: API, complex mixture of herbal ingredients e.g in herbal extract

Medicinal product:
API, defined synthetic/partial-synthetic/non-synthetic substance or mixture of synthetic/partial-synthetic/non-systhetic susstances

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6
Q

differences between herbal medicinal and medicinal product (defined content)

A

HMP: defined content of important active substances classes–> Ph.Eur.
MP: defined content of every API

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7
Q

what are herbal extracts?

A

liquid: preprations obtained by extraction
semi-solid: viscous extracts/thick extracts and oleoresins
solid: dry extracts preparations obtained from herbal drugs

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8
Q

standardised extracts?

A

are adjusted to a certain content of an igrendient(S) with kwon therapeutic efficacy (narrow content limit (+/- 10%)

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9
Q

Quantified extracts?

A

are adjusted to a defined range or one or more active lead susbtances, done by mixing batches of extracts

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10
Q

on what does the ratio of the ingredients in a extract depends on?

A

Growing conditions of the plants
the manufacturing process
the stabiliy
the extraction time and the solvent

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11
Q

Growing conditions of the plants

A

plant enviroment and genetic factors could significantly affect the biochemical components

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12
Q

the manufacturing process

A

Maceration and Percolation

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13
Q

the stabiliy

the extraction time and the solvent

A

stability: pH, temperature and light
Solvent: the extract is produced from the herbal drug and ethanl (60 -80 %)

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14
Q

Percolation and Maceration ?

A

Maceration: extraction technique that is condcuted at room temperature grind up the herb, add solvent and let it sit for a month

Percolation: grinding a dried herb, moistening it with some of the solvent, lettting is sit for 12-24 hours

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15
Q

Traditional use (TU)
Well-estabalished use (WEU)
Stand-alone/mixed applciation (SA/MA)

A

TU: must have been used for at least 30 years including at last 15 years within the EU

WEU: Establised at least 10 ears within the EU
SA/MA: Article 8(3) of directive 2011/83/EC

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16
Q

Efficacy of the TU, WEU and SA/MA?

A

TU: Plausible efficacy + safety through experience
WEU: proofed efficacy and level of safety

SA/MA: safety and efficacy data from the company’s onw development or a combination or own studesi and bibliographic data

17
Q

TU: plausible efficacy and safety comes from?

A
through experience from
bibliographic assessment
no medical supervision needed--> indictaion
oral, external or inhalation preparation
specificfied strength and dosage regime
18
Q

WEU: proofed efficacy and level of sadety is from

A

assessment of bibliographic safety and efficacy data

19
Q

what about clinical trials in TU, WEU and SA/MA?

A

TU: No clinical interventional tests and trials on safety and efficacy/insufficent eveidence from clinical trials

WEU: Sufficient data are available in literature –> interventional clincial studuies post-marketing studies

SA/MA: Performance of own clincial trials

20
Q

herbanl drugs used as medicines based on traditional use

A

it means that, eventhough there is insufficent evidence from CT the effectiveness of the HM is plausible, safe used for 15 years

21
Q

herbanl drugs used as medicines based on WEU?

A

HMP: bibliographc data proving scientific eveidence of their effectivesses

22
Q

MA for stand alone application

A

Full dosser (Moduel 1-5)

National procedure
decentralized procedure, mutual recongnition procedure
centralzed procedure, if obligation are fulfilled

23
Q

MA for WEU

A

subsmission Modules 1-3, M4 and 5 are based on bibliographic assessment

NP, DP/MRP, CP

24
Q

MA for TU:

A

simplified registration procedure–> submission modules 1-3,4 and 5 based on reference to the herbal monograph for plausible efficacy and review of safety data–> shows long term experience with safety and efficacy

NP, DP/MRP

25
Q

Do the exercise

A

have you done it?