Granule article

September 12, 2008

I wrote the following article for PCOM's current issue of the

newspaper Oriental Medicine. Unfortunately, there was a printing

error and the author erroneously listed on the article was Misha

Cohen. In fact, this article was written by me (Eric Brand), so I am

posting it on CHA to help correct the rather egregious error that the

newspaper made by ascribing the article to a different author.

This article is also being reprinted in Attilio's online newspaper,

Times.

The Granule Revolution

by Eric Brand

The creation of concentrated extract powders represents one of the

most important developments in the history of Chinese herbal medicine.

As technology has advanced, Chinese herbalists increasingly find

themselves armed with a vast arsenal of convenient preparations that

bring centuries of formulas and thousands of cooking hours into a

space the size of a small closet. Leading this revolution of

concentrated powders, liquids, and gelcaps are the " granules, " which

are concentrated dry extract powders that essentially place a full

traditional pharmacy at the practitioner's fingertips. The

versatility of granules has preserved some aspects of traditional

methods while simultaneously inspiring dramatic changes of approach in

Asia, and their convenience is quickly making them the most prominent

method of herbal medicine delivery in the West.

Granule technology was originally pioneered in Japan for use in

Japanese Kampo. In Japan, most use of granules is based upon either

biomedical or traditional applications of classical formulas, which

are often replicated in an unmodified form. The vast majority of the

formulas used in Japanese Kampo were created prior to the Song dynasty

in China (around 960 CE), and formulas from the Shang Han Lun and Jin

Gui Yao Lue are particularly prominent in modern clinical use.

Practitioners rarely build formulas from single ingredients, instead

preferring to employ whole formulas or combinations of formulas.

While few Westerners have studied Japanese Kampo itself at depth, the

technology that was created to maximize the Kampo approach has

impacted Western practitioners tremendously.

From Japan, the technology spread first to Taiwan. Granules have

become deeply integrated into healthcare in Taiwan over the past 30

years, and their prominence there has created an entirely new style of

Chinese medicine. Indeed, many doctors feel that the most distinctive

feature of Chinese medicine in Taiwan is its use of granules. This

development was largely stimulated by the convenience of granules for

patients, along with the fact that Taiwanese government insurance

covers granule extracts exclusively when it comes to Chinese herbal

medicine coverage. Granules are desirable for large scale healthcare

because they are well-regulated and hygienic, and they are ideal for

research because batches are consistent and traceable. Significantly,

Taiwanese patients pay very little out of pocket for granules yet have

to pay a fair sum out of pocket for raw herbs; this has created an

entire culture of granule use, with the vast majority of patients

using herbs in a concentrated extract form.

Taiwanese Methods

The Taiwanese method of using granules is relatively distinct because

whole formulas are commonly combined together. With a repertoire of

over 400 compound formulas on the shelf, Taiwanese doctors build

complex combinations that boggle the young student mind, yet there is

nothing haphazard about the construction of a well-crafted Taiwanese

style formula if one understands the approach. Good doctors in Taiwan

typically have a broad range of formula ingredients mastered, with a

well-developed ability to see the relationships, similarities, and

differences in each. A core formula at a higher dose typically stands

out at the center of the prescription, but instead of adding in just a

few single herbs to accentuate certain directions, whole formulas may

be added in. Here the formulas are used as a single principle, much

as many of us add a single herb.

There are several reasons why compounding whole formulas together has

become popular in Taiwan. Given the Japanese origin of the granule

technology and the prominence of combining classical formulas in

Japan, it seems reasonable to think that some of the initial

inspiration for creating a wide range of whole formulas and combining

them together may have been rooted in the technology's Japanese roots.

However, the most important guiding factor today is the widespread

belief in Taiwan that formulas that are cooked together are clinically

superior to formulas that are created from scratch by combining single

herb extracts.

Indeed, there are measurable differences in the final chemistry of the

end product when medicinals are cooked together versus when they are

combined from single extracts. Taiwanese doctors point to these

differences and often strongly believe that the results of using whole

formulas surpass the results of combining singles from scratch. While

there have been studies in China that show no statistical differences

between the clinical results of combining singles from scratch in

comparison with whole formulas that have been cooked together, the

vast majority of doctors in Taiwan prefer to use formulas that have

been cooked together.

In addition to starting with whole formulas (often compounding two or

three whole formulas together), Taiwanese doctors commonly add single

herb extracts when customizing the prescription. Their insurance

system pays for granules up to a dose of 6.0g, and the typical 6.0g

dose is usually given three times per day for a total of 18g of

concentrated extract powder per day. While the precise extraction

ratios for each product are clearly stated on Taiwanese granule

labels, most doctors think less in terms of calculating extraction

ratios and replicating raw herb doses by weight, and focus more on the

ratio of herbs and formulas within the daily target dose of 18g/day.

The dosage used by most doctors in Taiwan tends to fluctuate between

12–18g/day, with 18g being the most common for adults. Each granule

product in Taiwan varies somewhat in terms of its concentration ratio,

but a quick mathematical calculation shows that this concentrated

powder dose is slightly lower than the typical daily dose given by

Taiwanese doctors when they are dispensing raw herbs (often over

100g/day of crude medicinals). Despite this somewhat lower dose,

granules are extracted more efficiently than herbs cooked at home, so

it is reasonable to assume that they are at least slightly more potent

than the equivalent amount of crude herbs. Furthermore, the use of

whole formulas instead of just single herbs makes it slightly less of

a straight mathematical equation, as the heat-clearing effect of a

whole formula like huang lian jie du tang (Coptis Toxin-Resolving

Decoction) is more powerful than the equivalent weight of singles like

huang lian (coptis) or zhi zi (gardenia) alone.

Although most of the granule products in use in America are made in

Taiwan, thus far relatively few practitioners are well-informed about

the Taiwanese methods of using granules clinically. Because granules

dominate the insurance-based healthcare system in Taiwan, doctors

there have amassed a tremendous amount of experience with issues such

as dosage and formula combining. However, while most of us here in

the US use their products, few of us use their methods and dose

ranges, making their results more difficult to replicate.

Common Approaches in Mainland China

In contrast to Taiwan, doctors in mainland China tend to combine whole

formulas together much less, and primarily build formulas from scratch

in a process identical to a normal raw decoction. While Taiwan has

created a virtually new method of using herbal medicine based on their

granule approach, granules in the mainland are largely an extension of

the standard method of formula composition. In mainland China, whole

formulas are less commonly available in a granule form, so nearly all

prescriptions are made by combining singles. Rather than determining

dose based upon a standard dose range of total extract powder, the

dose is determined mathematically based on the raw herbal prescription.

While there are differences between mainland China and Taiwan in terms

of their prescription composition when using granules, the biggest

differences actually lie in their respective packaging and extraction

technology. In mainland China, granules are often made without

filler, and are packaged in single dose foil packs. In Taiwan,

granules are made into a smooth flowing powder that is dispensed from

small plastic bottles.

Granules that are made without filler must be packaged immediately to

prevent clumping, which occurs rapidly if filler-free extract powder

is exposed to air. The most common packaging method used in mainland

China is a single dose foil pack that contains the concentrated

equivalent of a standard daily dose of a given raw herb. Each herb

has the potential to achieve a slightly different concentration, so

the concentration ratio of each product (and the corresponding dose

weight) varies. For an herb such as yan hu suo (corydalis), a 10:1

extract can be achieved, and the foil pack will contain 1g of extract

because 10g of the raw product is used as an average daily dose.

Another herb such as pu gong ying (dandelion) can only reach a 7.5:1

concentration, so a daily dose foil pack of pu gong ying contains 2g

of extract, which is equivalent to 15g of the raw herb, again a

typical daily dose.

The mainland Chinese method of using foil packs is convenient because

a scale is not required, the formula can be easily modified, and

ingredients can be subtracted if side-effects develop. However, the

foil packs are slightly cumbersome because many packs must be opened

with each daily dose, and there is more disposable waste associated

with the foil packs.

As an alternative to the foil packs, some Chinese manufacturers have

begun to produce products that dilute the pure concentrate with

pharmaceutical starch (starch with the proteins removed to make it

hypoallergenic) so that an even 5:1 consistency can be achieved. This

allows the product to be exposed to air and stored in plastic bottles

like the Taiwanese products.

Similarities and Differences in Technology

Both mainland Chinese granules and granules made in Taiwan share many

basic characteristics. Reputable companies all capture and

reintroduce essential oils, determine species identity with liquid

chromatography, and evaluate potency by assessing marker chemicals in

both the raw material and the finished product. The temperature is

controlled, and the ideal concentration ratio, water quantity, and

cooking duration are determined by researching each product. Heavy

metals are checked and cultures are taken to ensure safety.

However, despite these common features, significant differences remain

between the technology used in mainland China and Taiwan. In Taiwan,

the herbal concentrate is reduced under a vacuum or forced air and low

temperatures, and it is reduced to thick, viscous syrup that is then

sprayed onto a carrier, which is typically either pharmaceutical

starch or finely ground crude herbs. Each herb achieves a different

concentration ratio depending on how water soluble it is, as well as

how sticky and rich it is by nature; these factors play a role in

determining how much material can be extracted, and also influence the

quantity of filler required to make the powder flow evenly.

By contrast, the mainland Chinese products are made into a dry extract

without filler, and are immediately packaged in a sealed container.

This method does not allow for smooth flowing powders that can be

mixed together after the powder has been exposed to air, so it is not

suitable for the style of product required for the Taiwanese

prescribing method. However, it is suitable for the mainland Chinese

method of simply using concentrated powders to give a daily dose that

equates to the normal raw decoction dose, and the foil packaging

allows it to be conveniently dispensed.

Both the mainland and Taiwanese technologies offer unique advantages

and disadvantages, but they produce slightly different final products.

Taiwanese powders are often made into a relatively fine powder (xi

fen), while mainland Chinese powders are often made into a slightly

larger granule (ke li) when they are sold in the 5:1 state. The

mainland products are often able to achieve a higher and more

consistent concentration ratio and tend to have less filler, but the

Taiwanese products often tend to have a slightly stronger odor.

Additionally, the method of processing mineral medicinals often varies

between the two regions, and the availability of herbs in a variety of

pao zhi forms varies as well (mainland China has a slightly wider

selection of herbs with different types of pao zhi).

All of these factors illustrate the fact that the modern granule

landscape is relatively diverse. Multiple styles abound, both in

terms of formula composition as well as manufacturing styles, and each

practitioner has a wide range of choice in determining which products

and approaches are best for their clinical needs. Unfortunately, at

present many Western practitioners have not deeply investigated the

Asian trends in granule prescribing, and often remain uncertain on

issues such as dosage calculation. Few practitioners realize that

different technological methods are used in mainland China and Taiwan,

and often fail to take these differences into account when determining

dosage. As we move into a direction of clearer product labeling and

increased cultural exchange, hopefully the West will begin to acquire

more of the experience that our Asian colleagues have amassed in this

fascinating field. Given the fact that granules are quickly becoming

the most common form of herbal medicine in the Western clinic, it

appears essential that we strive to better understand these products

in terms of their dosage and clinical applications. The future of

Chinese medicine is already upon us!

bio

Eric Brand, M.S., L.Ac.

Eric Brand is a graduate of the Pacific College of Oriental Medicine.

A fluent Chinese speaker, Eric has studied extensively in mainland

China and Taiwan. He completed a prolonged clinical internship in the

departments of gynecology, pediatrics, internal medicine, and

acupuncture at Chang Gung Memorial Hospital in Taipei, and was also

fortunate to be a close private student of Dr. Nigel Wiseman and Dr.

Feng Ye during his stay in Taiwan. To complement his clinical

training, Eric has a cultivated interest in Chinese herbal pharmacy;

his extensive research of herbal quality discernment and his close

involvement with Chinese wholesalers and manufacturers has given him a

depth of expertise in herbal pharmacy that is rarely achieved by

Western practitioners.

Eric currently works as a translator and editor for Paradigm

Publications, and in the past he has also worked in Beijing as a

translator, consultant, and chief coordinator for China's largest

Chinese medical publisher, Ren Min Wei Sheng Chu Ban She. He is the

co-author of the forthcoming Concise Chinese Materia Medica, and has

edited a variety of modern and classical texts, including Case

Histories from the Personal Experience of Jiao Shu-De, Pathomechanisms

of Heart Disease, and A Heart Approach to Gynecology (from the Yi Zong

Jin Jian). Eric has a passion for issues relating to Chinese language

and translation, and he is the Vice Chair of the Beijing-based World

Federation of Societies' Terminology Committee, as

well as a member of their international advisory board. Eric is also

the Chair of the Terminology Committee for the American Association of

Acupuncture and Oriental Medicine (AAAOM), as well as the co-chair of

International Affairs for the AAAOM. Eric is the founder of the

herbal distribution company Legendary Herbs, and he is currently an

instructor and clinical supervisor at the Pacific College of Oriental

Medicine in San Diego, California.

September 12, 2008

Nice article, Eric. I am curious as to how many formulas are put

together in Taiwan. Are we talking 2 or maybe 3 or more? I guess you

could say its like those with patent pharmacies who give several of

them at once. It's considered inelegant - like we can't decide what

the real diagnosis is. But as a practical matter combining whole

formulas certainly might be the way to go. comments anyone?

Doug

September 13, 2008

Eric,

Very informative article that you wrote. Does legendary herbs have a website?

--

thanks,

Warren L. Cargal

www.acuatlanta.net

www.fertilitynow.net

www.canceroptions.net

404-233-5080

-------------- Original message from " Eric Brand " <smilinglotus:

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