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QC of Herbal Medicines

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Hi All, and Hi Don,

 

Hats off to Don for a great mail on QC!

 

I have taken the liberty of cross-posting that mail to three sister-

lists [PA-L, PVA-L and VBMA] with the following introduction:

 

Hi All, Another list ( ) has

a great debate ongoing on Quality Control (QC) of single herbs,

formulas and granules.

 

This debate is highly relevant to VBMA (and to some PA-Ls & PVA-

Ls) because the individual dose of a remedy should relate directly

to the main active ingredients in THAT remedy, be it a single herb,

formula or granule.

 

I take the liberty of cross-posting a mail from Don Wen of Company

X [actual name of the company is deleted in case his mail might be

misconstrued as a spam to elicit business with his company!!].

 

Don works for a large Japanese Kampo firm. He has summarised

the approach adopted in Japan (under the direction of the Ko-Sei-

Sho (Ministry of Health and Welfare) of the Japanese Government)

to ensure QC and batch-to-batch stability of Kampo products.

 

Don's points are MOST important. They highlight the inevitable QC

problems inherent in using raw single herbs or herbal formulas, not

least being the impossibility of adequate sampling and analysis of

those products at the PACKAGING stage (i.e. just before release

from the factory).

 

A close reading of Don's mail suggests that the SAFEST & best-

quality herbals MUST be batch-produced in LARGE amounts by

extraction and drying procedures, with QC at the END of the

process and not at the start or intermediate stages.

 

Extracts produced from huge mixes have MUCH less inherent

variability than use of raw ingredients, whose active ingredients can

vary by a factor of 5 to 10 (or more) between lots.

 

I shudder to think what bottle-to-bottle variability in active

ingredients might be for herbal remedies formulated at home by

individual practitioners who source their raw ingredients from a

variety of local and postal sources!!

 

Best regards, Phil

 

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

 

Congratulations again Don. You have given us all much food for

thought!

 

 

Best regards,

 

 

WORK : Teagasc Staff Development Unit, Sandymount Ave., Dublin 4, Ireland

WWW :

Email: <

Tel : 353-; [in the Republic: 0]

 

HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

WWW : http://homepage.eircom.net/~progers/searchap.htm

Email: <

Tel : 353-; [in the Republic: 0]

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Thank you very much for your support. It would be interesting to see

how your audients respond to the message, particularly from the other

part of the world. Dan Wen

 

, " "

<@e...> wrote:

> Hi All, and Hi Don,

>

> Hats off to Don for a great mail on QC!

>

> I have taken the liberty of cross-posting that mail to three sister-

> lists [PA-L, PVA-L and VBMA] with the following introduction:

>

> Hi All, Another list ( ) has

> a great debate ongoing on Quality Control (QC) of single herbs,

> formulas and granules.

>

> This debate is highly relevant to VBMA (and to some PA-Ls & PVA-

> Ls) because the individual dose of a remedy should relate directly

> to the main active ingredients in THAT remedy, be it a single herb,

> formula or granule.

>

> I take the liberty of cross-posting a mail from Don Wen of Company

> X [actual name of the company is deleted in case his mail might be

> misconstrued as a spam to elicit business with his company!!].

>

> Don works for a large Japanese Kampo firm. He has summarised

> the approach adopted in Japan (under the direction of the Ko-Sei-

> Sho (Ministry of Health and Welfare) of the Japanese Government)

> to ensure QC and batch-to-batch stability of Kampo products.

>

> Don's points are MOST important. They highlight the inevitable QC

> problems inherent in using raw single herbs or herbal formulas, not

> least being the impossibility of adequate sampling and analysis of

> those products at the PACKAGING stage (i.e. just before release

> from the factory).

>

> A close reading of Don's mail suggests that the SAFEST & best-

> quality herbals MUST be batch-produced in LARGE amounts by

> extraction and drying procedures, with QC at the END of the

> process and not at the start or intermediate stages.

>

> Extracts produced from huge mixes have MUCH less inherent

> variability than use of raw ingredients, whose active ingredients can

> vary by a factor of 5 to 10 (or more) between lots.

>

> I shudder to think what bottle-to-bottle variability in active

> ingredients might be for herbal remedies formulated at home by

> individual practitioners who source their raw ingredients from a

> variety of local and postal sources!!

>

> Best regards, Phil

>

> >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

>

> Congratulations again Don. You have given us all much food for

> thought!

>

>

> Best regards,

>

>

> WORK : Teagasc Staff Development Unit, Sandymount Ave., Dublin 4,

Ireland

> WWW :

> Email: <@e...>

> Tel : 353-; [in the Republic: 0]

>

> HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

> WWW : http://homepage.eircom.net/~progers/searchap.htm

> Email: <@e...>

> Tel : 353-; [in the Republic: 0]

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, " honsousa <info@h...> " <

info@h...> wrote:

> Thank you very much for your support. It would be interesting to see

> how your audients respond to the message, particularly from the other

> part of the world. Dan Wen

 

Dan

 

It appears than honso products daily dose packets (3 per day) are made from

about 25-30 grams of raw herb on average if I correctly understand your

product info. this is pretty standard kampo dose range, though much lower

than TCM doses. However it is definitely within the normal textbook dose

range, albeit at the lower end. I was wondering if your company has any data

comparing the amount of standardization constituents in the finished product

versus a simple decoction and versus other product types such as tincture,

liquid extract and pills. It is interesting to see comparisons between your

company and other makers of powdered extracts, but I think it would be very

illuminating if your company could provide some data that showed the actual

level of marker constituents in certain product types, such as liquid extracts

and pills.

 

It would be a great service to the field if we could make an accurate

comparison between product types. Right now, your data is persuasive to

powder users that you have a quality product of this type. However, there is

nothing to persuade liquid and pill users that your product type is superior (or

inferior) to their current choice. I suspect many products on the market are

not

cost effective when measured by this standard. typically your product was

about 1.5-3 times stronger than your competitors according to your in house

data. I am curious what the difference in strength, if any, there would between

your products and the recommended daily dose of various pills (like the 8 TID

little black pills fom china) or several droppers (or less ) of various liquid

extracts and simple tinctures. I remain openminded that the data will

contradict my assumptions. I know some of you will say this is irrelevant and

inaccurate way to assess herb quality, but its not irrelevant to me, many of my

colleagues and pretty much the entire rest of the industrialized world outside

the US. So I guess companies will need to decide if they want the business of

people like me or not.

 

Since I cannot afford to do such testing myself at this time, I will be

soliciting

information from companies. I want companies that are able to produce

satisfactory documentation on this matter to be listed on the CHA website if

that seems a reasonable thing to do. the listing will not be an indictment of

any nonlisted products, merely a positive listing of products that meet certain

international standards derived from the EU and Japan. All standards and

testing requirements will be posted on the webpage. Products will be

categorized according to what level of standards they meet. those that only

show PRESENCE of " markers " or concentration ratios will be classed different

than those that also show LEVELS of " markers " . I can say already that

companies like Blue Poppy, Golden Flower, K'an, KPC, Peoples Herbs and

Mayway already meet many, if not all, of these standards, but very few

companies publish data on the levels of markers. We need to see that data, if

it exists, in order to give the product our highest seal of approval.

 

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, " honsousa <info@h...> " <

info@h...> wrote:

> Thank you very much for your support. It would be interesting to see

> how your audients respond to the message, particularly from the other

> part of the world. Dan Wen

 

Dan

 

It appears than honso products daily dose packets (3 per day) are made from

about 25-30 grams of raw herb on average if I correctly understand your

product info. this is pretty standard kampo dose range, though much lower

than TCM doses. However it is definitely within the normal textbook dose

range, albeit at the lower end. I was wondering if your company has any data

comparing the amount of standardization constituents in the finished product

versus a simple decoction and versus other product types such as tincture,

liquid extract and pills. It is interesting to see comparisons between your

company and other makers of powdered extracts, but I think it would be very

illuminating if your company could provide some data that showed the actual

level of marker constituents in certain product types, such as liquid extracts

and pills.

 

It would be a great service to the field if we could make an accurate

comparison between product types. Right now, your data is persuasive to

powder users that you have a quality product of this type. However, there is

nothing to persuade liquid and pill users that your product type is superior (or

inferior) to their current choice. I suspect many products on the market are

not

cost effective when measured by this standard. typically your product was

about 1.5-3 times stronger than your competitors according to your in house

data. I am curious what the difference in strength, if any, there would between

your products and the recommended daily dose of various pills (like the 8 TID

little black pills fom china) or several droppers (or less ) of various liquid

extracts and simple tinctures. I remain openminded that the data will

contradict my assumptions. I know some of you will say this is irrelevant and

inaccurate way to assess herb quality, but its not irrelevant to me, many of my

colleagues and pretty much the entire rest of the industrialized world outside

the US. So I guess companies will need to decide if they want the business of

people like me or not.

 

Since I cannot afford to do such testing myself at this time, I will be

soliciting

information from companies. I want companies that are able to produce

satisfactory documentation on this matter to be listed on the CHA website if

that seems a reasonable thing to do. the listing will not be an indictment of

any nonlisted products, merely a positive listing of products that meet certain

international standards derived from the EU and Japan. All standards and

testing requirements will be posted on the webpage. Products will be

categorized according to what level of standards they meet. those that only

show PRESENCE of " markers " or concentration ratios will be classed different

than those that also show LEVELS of " markers " . I can say already that

companies like Blue Poppy, Golden Flower, K'an, KPC, Peoples Herbs and

Mayway already meet many, if not all, of these standards, but very few

companies publish data on the levels of markers. We need to see that data, if

it exists, in order to give the product our highest seal of approval.

 

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I can say already that companies like Blue Poppy, Golden Flower, K'an, KPC, Peoples Herbs and Mayway already meet many, if not all, of these standards, but very few companies publish data on the levels of markers. We need to see that data, if it exists, in order to give the product our highest seal of approval.>>>That would be very nice

Alon

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Some people who are interested in this subject might want to (re)read p.

23-4 of Bensky's Formulas & Strategies, 'Editor's Note on Prepared

Medicines'.

 

I had a teacher who wrote big formulas (150-200gm raw / day) and another

who wrote small Rx (~50-60 gm raw / day). In the years I followed them,

I believe they both obtained great results. However, when I tried to

emulate them, I made many more (noticable) mistakes with the big

formulas. I still get good results with smaller formulas, and mistakes

are much less noticable with the smaller dosages... Though I'm sure I

still make my share!

 

Geoff

 

> __________

> Thu, 23 Jan 2003 19:33:52 -0000

> " < " <

> Re: QC of Herbal Medicines

>

> , " honsousa <info@h...> " <

> info@h...> wrote:

> > Thank you very much for your support. It would be interesting to see

> > how your audients respond to the message, particularly from

> the other

> > part of the world. Dan Wen

>

> Dan

>

> It appears than honso products daily dose packets (3 per day)

> are made from

> about 25-30 grams of raw herb on average if I correctly

> understand your

> product info. this is pretty standard kampo dose range,

> though much lower

> than TCM doses. However it is definitely within the normal

> textbook dose

> range, albeit at the lower end.

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