which powders are best?

January 20, 2003

While you are at it, ask for a certificate for the Mercury (Hg) content of Gelatinum Asinii (E Jiao).

>>>Simon can you post a list of all the herbs you found problems with, especially powders.

Alon

January 20, 2003

I allowed this message because it is very informative and does indeed represent

the

japanese model of quality control. the author clearly states his vested

interests up front,

which is all I ask. rather than a promo for a product, I would consider this a

challenge to

meet these excellent and thoughtful standards developed by the japanese

pharmaceutical industry.

Dear All

The recent discussions about the quality control and assaying of

Chinese medicine formulas are very interesting to me. I have been

reading all the messages during the past weeks and now I couldn't help

myself to jump into the discussion. I have told myself not to join the

discussion directly because I work at a Kampo/Chinese medicine

manufacture company. I understand this discussion board does not allow

any comments that have commercial interests, and anything I say will

be considered " conflict of interest " . Well, I will just share my

personal opinions as a practitioner/scientist from the experience I

have worked with Honso Pharmaceutical Co., Ltd., a Japanese Kampo

product manufacturer. I believe what Honso is bringing into the States

is really a new concept of producing quality herbal products

PHARMACEUTICALLY. Perhaps I should credit it as a contribution from

the whole Japanese Kampo industry. However since there is only one

entered the US so far, I will use Honso as a representative figure.

From what I read on Chinese Herbal Medicine board regarding quality

control/assurance, particularly the granule/powder products (Honso

only does granule for practitioners), there are following issues,

among others, that mostly concerned:

1. Variation of amounts of raw herbs that enter a herbal formula

(different manufacturers use different amounts of ingredients for a

similar formula)

2. Variation of methods by which the herbal mixtures are processed

(water boiling, alcohol extract, or direct compress of grinded herbs)

3. Variation of levels of active constituents, in a finished product,

among different manufacturers or among different lots within one

manufacturer (Does a manufacturer's QC department assays the finished

product in every lot and reject the lot if failed the test?)

Japanese Kampo industry has solved most of these problems, at least in

some degree, over the past several decades. Although the selection of

herbal formulas within Kampo system is rather limited, only 210

approved and mostly Han dynasty and Shang Han Lun formulas, the

quality of those available Chinese medicine formulas in Japan has been

constantly stable over the time. It would be worthy of looking into

the Japanese style of manufacturing to see how herbal mixtures (as

oppose to single herb) are semi-standardized and assayed.

To maintain a standard formulation (not only the combination of herbs

but also weight) for a given formula among all producers, Japanese

Ko-Sei-Sho (the Ministry of Health and Welfare) has studied the

history of each Chinese herbal medicine formula. As we all know that

the amounts of each herb in a Chinese herbal formula vary among

practitioners. It is also true on the text books historically.

Therefore comparisons are given to all formulas as to which text book

recorded what amount for an ingredient. As a result, a fixed amount

for each ingredient is published and every manufacturer followed.

Kampo medicine has been passed down generation after generation like

the Chinese medicine did. The most adapted method of preparing herbal

formulas is boiling the sliced raw herbs and taking the water solution

afterward (although we know there are other traditional ways such as,

in Chinese, " Gao " , " Dan " , " Wan " and " San " ). Therefore, the herbal

industries in Japan as well as in China have resembled a similar

process for mass production of herbal formulas. The process usually

includes: raw herbs >>>slicing >>>weighing >>>blending >>>extraction

(water boiling, a heat control system capable of precisely controlling

a boiling condition is used) >>>separation (which separates the solid

residue of crude herbs from its liquid) >>>condensing >>> spray drying

>>>granulation >>>filling and packing >>>product. As granule became

the most accepted dosage form in Japan, all manufacturers produce

herbal formulas in the same fashion above.

The other interesting feature in Kampo products is their packaging.

Almost all prescription granule products are packed in a slick packet

for one dose (three doses a day), which prevents the granules from air

and moisture degradation. The amount of one day dosage is usually 7.5

gram, which is the total weight of the mixture (herbal extract and the

binder such as rice starch and crystalline cellulose etc.). It is

really not an issue on the concentration ratio such as 5:1 or 10:1, as

long as the requested daily amount of herbs can be " carried " within

the 7.5 gram of granule. In Honso's case, we use 5-6:1 concentration

ratio in most formulas. We also disclose fully the formulation

information. Here is an example for Minor Bupleurum Formula

(Sho-saiko-to; Xiao Chai Hu Tang) that is published on our catalog:

The daily dose of 7.5g (3 unit packets) contains 4.20g of Minor

Bupleurum Formula extract powder which is a concentrate of the

following herbs:

Bupleurum Root (Chai hu) 7.0g

Pinellia Tuber (Ban xia) 5.0g

Scutellaria Root (Huang qin) 3.0g

Ginseng (Ren shen) 3.0g

Jujube (Da zao) 3.0g

Licorice (Gan cao) 2.0g

Ginger (Sheng jiang) 1.0g

The most important contribution to Chinese medicine from Japan,

besides the tremendous amounts of research, is what I called

" semi-standardization " of herbal mixtures. As we know, it is easy

nowadays to standardize a single botanical such as assaying silybin

for milk thistle or ephedrine for Ma Huang. However it is difficult to

assay and therefore standardize a mixture of several or sometime 10 to

20 herbs. Most of herbal manufacturers only control the weight of each

ingredient that goes into a formula before extraction. Some control

quality qualitatively by thin layer chromatography (TLC) which only

assures that the required herb is in the product. In Japan, all

prescription herbal formulas are required by Ko-sei-sho to both

qualitatively and quantitatively assay their finished products.

The importance of assaying herbal formulas is obvious. Let's take

Minor Bupleurum formula as an example again. One of the key herbs is

bupleurum (saiko) in the formula, with an active constituent called

Saikosaponin (A. B. C...). The levels of saikosaponins can vary

between 5 to 10 times if the bupleurum is harvested in different areas

from north China to south and to Japan. Therefore if a manufacturer is

only controlling the weight of bupleurum, the efficacy of the product

can be good or none depend upon if the active constituents are at the

right level. From the TCM point of view, although we did not know

saikosaponin thousands of years ago, a good practitioner did pay great

attention to where the herbs were harvested and a good herb seller did

grade raw herb according to their quality. In the modern time, the

only way to assure the best quality herbal formulas that a

practitioner can get is to assay and standardize them.

At Honso, the quality control of a finished herbal formula is

performed under the scrutiny of Ko-sei-sho at two levels on every lot:

first assay each individual herb qualitatively by TLC, and then

measure at least two active constituents quantitatively by HPLC. For

example, minor bupleurum formula is processed as following:

TLC testing: to identify Bupleurum, Ginger, Scutellaria, Jujube,

Ginseng, and Glycyrrhize.

HPLC testing: the specification is as such: 24.7-46.0 mg/day of

Glycyrrhizin, 110.6-205.6 mg/day of Baicalin, and 6.5-19.7 mg/day of

Saikosaponin.

Other testings are routinely performed on each lot according to

Japanese Pharmacopoeia including heavy metals, arsenic, and water

content and microbiological tests.

We have recently conducted a comparison test on Honso?s and other

three leading companies? granule products. The testing samples are

randomly purchased in the US and tested against Honso?s specification

in Honso's QC department (the samples are stored at Honso in case

anybody wants to repeat the test on their own). We have tested Minor

Blue Dragon Formula (Xiao Qing Long Tang), All-Inclusive Great

Tonifying Formula (Shi Quan Da Bu Tang) and Minor Bupleurum Formula

(Xiao Chai Hu Tang) on their active constituents (bioactive markers).

The results show Honso's products come on top of every parameter we

tested. For more detail about this test, please visit our website at

http://honsousa.com/Quality/comparison.htm.

Thank you for letting me to post this message. Again, I have no

intention of commercially promote our product line. If in any way this

message is not suitable to this group please delete it all together

and I will never post any such kinds of messages again.

Dan Wen

Honso USA, Inc.

, Rory Kerr <rorykerr@w...>

wrote:

> I'm trying to decide which desiccated powder company to go with.

I'd

> appreciate some opinions as to the best combination of price and

> quality.

> - Who do you prefer?

> - Who do you avoid?

>

> Thanks.

>

> Rory

> --

January 21, 2003

Thanks for putting this out to the group. I found it very

informative and useful, indeed.

On Monday, January 20, 2003, at 03:35 PM, honsousa <info

wrote:

> I allowed this message because it is very informative and does indeed

> represent the

> japanese model of quality control. the author clearly states his

> vested interests up front,

> which is all I ask. rather than a promo for a product, I would

> consider this a challenge to

> meet these excellent and thoughtful standards developed by the japanese

> pharmaceutical industry.

January 21, 2003

Kampo system is rather limited, only 210approved and mostly Han dynasty and Shang Han Lun formulas, thequality of those available Chinese medicine formulas in Japan has beenconstantly stable over the time. It would be worthy of looking intothe Japanese style of manufacturing to see how herbal mixtures (asoppose to single herb) are semi-standardized and assayed.>>>From what i understand most of the taiwanese companies meet japanise standarts. Is that correct?

Alon

January 21, 2003

For more detail about this test, please visit our website athttp://honsousa.com/Quality/comparison.htm.>>>This link does not work

alon

January 21, 2003

Hi Alon,

Try www.honso.com, maybe can get to the comparison page from there.