by Eric Brand

On the topic of allergens…I am often asked about the fillers used in granules, and whether or not they pose a risk to allergic individuals. In order to answer this question, it is necessary to first explore the issue of fillers in granules in general.

Granule products (concentrated extract powders) are produced by a variety of different techniques. Two methods of making granules are particularly prominent, with the first method more commonly seen in Taiwan and the latter method more commonly seen in mainland China. Different manufacturing techniques require different amounts of filler (or no filler at all), and the filler selected varies from company to company and product to product.

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In both mainland China and Taiwan, granules are made by decocting medicinals in water and then reducing the strained decoction to a concentrate with a combination of low-heat and vacuum technology.

In Taiwan, most companies use older-generation Japanese technology and methods, and reduce the concentrate to a viscous semi-liquid, which is then sprayed onto filler (carrier) to achieve an even, flowing powder. In mainland China, many companies use a newer method of creating a dry extract without the addition of fillers. This latter approach produces a powder that will clump easily if exposed to air, so filler must be added to prevent clumping unless the powder is packaged immediately in gelcaps or single-dose foil packs. (To a certain extent, the technology in use in different areas reflects the different prescribing styles in these regions, but that is a subject for another blog entry.)

The most common fillers (excipients) selected for granules are starch and dextrin. Dextrin is a modified starch that lacks proteins, so it is generally considered hypoallergenic and should be chemically indistinguishable regardless of its source. Some companies use starch derived from corn, others use starch derived from potatoes or other plant products. Potato and rice starch are widely regarded as hypoallergenic. Unfortunately, few granule companies currently list the source of the starch on their products, and virtually no companies that use starch currently reveal how much starch their product contains on their US label. The Taiwanese labels for the same products always list the quantity of starch, but they still do not list the source plant. Despite this lack of transparent labeling on how much of the medicine is inert vs. active, most granule products pose little risk of food allergies.

In addition to starch and dextrin, some granule companies use ground raw herbs as a carrier or filler. This method only works with herbs that can produce a dry, consistent powder; it works with substances like astragalus but it doesn’t work with sticky substances like rehmannia. Adherents of this method like it because the carrier is not completely inert, so the product potentially offers a modest increase in potency over a product that only has an inert starch filler. However, critics of this method point to the fact that the ground crude herb is less hygienic than pharmaceutical starch, and some products have been found to have issues with contamination owing to the inclusion of unprocessed ground herbal material.

How much filler is in granules, anyway?

Like concentration ratios, the quantity of filler varies from product to product and company to company. In Taiwan, granules typically vary between 2:1 and 5:1 in potency, if measured as a source to product ratio. Compound formulas in Taiwan often hover around 2:1 to 5:1 (most between 2:1 and 3:1), while single herbs often hover around a concentration ratio of 4:1 to 5:1. Some herbs can achieve higher concentrations than others, and some require more filler than others. However, while the concentrations vary dramatically, the quantity of filler is often relatively consistent.

I’ve recorded the label data of hundreds of Taiwanese granule products. The highest concentration ratio I’ve ever seen in a Taiwanese finished product is 7:1 (for zhu ru), while the lowest concentration ratio I’ve seen is 0.7:1 (for bai bu). Out of three of the biggest Taiwanese granule producers, two of the companies use approximately 50% filler across the board on all products, while the third company uses about 33% filler in most of its products. Below is a random listing of Taiwanese granule products, their concentration ratios, and percentage of filler. The wide variance in potency from product to product really makes me wish that their US labeling was as transparent as their original Taiwanese labeling.

Granules made in mainland China are far more variable in terms of their quantity of filler. China’s two largest granule companies produce two main products- no-filler, single dose foil packs, and dextrin-added, 5:1 extracts, which are packaged in 100g bottles. The former requires no filler but isn’t suitable for clinics that use 100g bottles and mix powders together, because the powder will tend to clump. Such clinics instead use the latter product, which varies in its dextrin quantity depending on the concentration of the original concentrated source product. For example, one supplier makes corydalis in a 10:1 original concentration, and they then add 50% dextrin to achieve a 5:1 extract. The same company makes dandelion in a 7.5:1 original concentration, which is diluted to 5:1 by adding 25% dextrin. Unfortunately, data on the dextrin quantity is often lacking on the label.

It should be noted that Blue Poppy’s extract products do not use any fillers at all. Thus, while the fillers used pose virtually no risk of allergic reactions, the very issue of starch and filler does not apply to Blue Poppy’s products. The reason for this is that Blue Poppy’s products are produced as a dry, concentrated extract without filler, which is immediately packaged in vacuum-sealed bottles of gelcaps. Filler is not required with this delivery method, because the loose powder does not need to be exposed to air over a prolonged period of time. Additionally, Blue Poppy’s products are presently the only products on the market that explicitly list their concentration ratios.

Personally, I feel that open labeling of concentration ratios and quantities of filler should be a mandatory aspect of granule labeling, but at present it seems that few companies are willing to provide this information to their customers. Too many practitioners remain uninformed about proper dosage, so we don’t demand transparent labeling as a group. Unfortunately, this apathy on the part of the masses makes it much harder for those who want the numbers to get the data. Imagine if biomedical drugs were sold in another country with a clear label that stated the quantity of filler and the quantity of active ingredients, and then big pharma omitted this information when exporting to the US…

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Below is a random sampling of some concentration ratios from Taiwanese labels (all products listed come from label data of prominent Taiwanese brands sold in the US):

Ma zi ren wan (Brand "A") Two parts of 5.5:1 concentrate and one part starch.
4.5g of the final powder contains the equivalent of 4g huo ma ren, 2g
bai shao, 2g zhi shi, 2g hou po, 2.5 xing ren, and 4g da huang.

Ma zi ren wan (Brand "B") one part 4.25:1 concentrate and one part starch.
4.0g of the final powder contains the equivalent of 2.5g huo ma ren,
1g bai shao, 1g zhi shi, 2g da huang, 1g hou po, and 1g xing ren.

As you can see, these two formulas have very different concentrations.
One is nearly twice as strong as the other. Oddly enough, the
stronger one is cheaper at the store. Note that neither is 5:1 in
its final stage. Brand B is 2.15:1. Brand A is 3.66:1.

Now just a random survey of other formulas:

Yin qiao san= Two parts of 7.5g concentrate to one part filler. About
4.95:1 at the end, very close to 5:1.
6g of final product contains 5g jin yin hua, 5g lian qiao, 2g dan zhu
ye, 2g jing jie, 2g lu gen, 3g jie geng, 3g niu bang zi, 3g ze xie, 3g
bo he, 2.5 gan cao, 2.5g dan dou chi.

Yi guan jian= One part 4.33g extract mixed with one part filler.
About 2.17:1 at the end, close to only 2:1.

Xiao Feng San= One part 5:1 extract mixed with one part filler. About
2.5:1 at the end.

Huo Xiang Zheng Qi San= One part 6.7:1 extract mixed with one part
filler. About 3.35:1 at the end.

Xiao Yao San= 10.5g contains 5.9g of 4.7:1 concentrate mixed with 4.6g
starch. About 2.6:1 at the end.

Si Wu Tang= One part 5:1 extract mixed with one part filler. About
2.5:1 at the end.

Gui Pi Tang= One part 5.2:1 extract mixed with one part filler. About
2.6:1 at the end.

Some data on single herbs:

For every 1 gram of final product, unless explicitly listed, the products below have 0.5 grams of starch and the extract of:
Zhu ru= 7 g
Bai he=2.7 g
Zi hua di ding= 3.75 g
Zi Wan= 1.4 g (this one has 60% starch instead of the normal 50%)
Zi su ye=3 g (this one has 57% starch)
Dang gui= 2 g
Du huo= 2 g
Ze lan= 3.5 g
Shu di= 2.5 g
Man Jing Zi= 4.5 g
Bai bu= 0.7 g
Di long= 3.8 g
Di gu pi= 3.8 g
Di yu= 3.5 g
Xuan shen= 3 g
Sheng di= 3 g
Sheng jiang = 3.5 g
Xian he cao= 2 g
Dong gua zi= 5.5 g
Ban zhi lian= 3.5 g
Ban xia= 3.42 g
Shi wei=3.5 g
Shi hu= 2.5 g
Yu zhu=2 g
Gan cao= 2.5 g
Bai mao gen= 3 g
Bai xian pi= 3.5 g
Bai hua she she cao= 5 g
Bai guo= 3.8 g
Bai jie zi= 3.5 g
Bai dou kou= 6.25 g