Herbal Medicine

Question 1

what are Herbal Medicinal product?

Answer 1

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

Question 2

how are herbal drug prepered?

Answer 2

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

Question 3

give examples of herbal drugs

Answer 3

extracts, essential oils, expressed juices, powered herbal drug

Question 4

Definition “Herbal drug”

Answer 4

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

Question 5

differences between herbal medicinal and medicinal product (API)

Answer 5

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

Question 6

differences between herbal medicinal and medicinal product (defined content)

Answer 6

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

Question 7

what are herbal extracts?

Answer 7

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

Question 8

standardised extracts?

Answer 8

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

Question 9

Quantified extracts?

Answer 9

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

Question 10

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

Answer 10

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

Question 11

Growing conditions of the plants

Answer 11

plant enviroment and genetic factors could significantly affect the biochemical components

Question 12

the manufacturing process

Answer 12

Maceration and Percolation

Question 13

the stabiliy

the extraction time and the solvent

Answer 13

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

Question 14

Percolation and Maceration ?

Answer 14

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

Question 15

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

Answer 15

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

Question 16

Efficacy of the TU, WEU and SA/MA?

Answer 16

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

Question 17

TU: plausible efficacy and safety comes from?

Answer 17

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

Question 18

WEU: proofed efficacy and level of sadety is from

Answer 18

assessment of bibliographic safety and efficacy data

Question 19

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

Answer 19

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

Question 20

herbanl drugs used as medicines based on traditional use

Answer 20

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

Question 21

herbanl drugs used as medicines based on WEU?

Answer 21

HMP: bibliographc data proving scientific eveidence of their effectivesses

Question 22

MA for stand alone application

Answer 22

Full dosser (Moduel 1-5)

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

Question 23

MA for WEU

Answer 23

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

NP, DP/MRP, CP

Question 24

MA for TU:

Answer 24

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

Question 25

Do the exercise

Answer 25

have you done it?