Prepared Formulas as Practical Alternatives

No Need for a Spoonful of Sugar: Prepared Herbal Formulas as Practical Alternatives to Decoctions

Although cooked water-based extractions (decoctions: 湯 tāng) are widely taught in TCM schools and commonly used in the administration of traditional Chinese herbal medicine, many TCM herbalists in the US report that patients are often reticent to take herbs in this way. Decoctions require attentive cooking unless one has an automatic decocting machine, and the odor of the herbs can permeate one’s home and disturb others in the dwelling. The often bitter, sometimes fishy, sometimes astringent taste of many formulas can be a major turn-off. Decoctions are also not particularly convenient for on-the-go lifestyles. However, preference for pleasant tastes and not having time to watch a pot boil is not a modern phenomenon. As such, many alternative dosage forms have evolved through the centuries, from crude honey pills to high-tech dripping pills and everything in between.

Pills, pills, and more pills

Pills, known as wán jì (丸劑) in Chinese, have been utilized since the time of the Shang Han Lun. Pills are familiar to patients and often appreciated since the preparation of a decoction is not necessary. This can result in increased patient compliance, particularly to those who may have an aversion to the taste of decoctions. They are also easily stored, have a long shelf-life, and are convenient for travel during a patient’s busy day-to-day life.

Before pills can be absorbed in the digestive system, they require disintegration and dissolution and therefore, generally, have a slower onset and longer duration of action than liquid decoctions. Additionally, some herbal ingredients should not be decocted since they may be damaged by heat treatment, or if they are highly aromatic, or if they are more toxic when decocted and therefore should only be taken in pill form. For practitioners, classical or traditional formulas in pill form can allow for an immediate prescription that the patient can take home. This can also provide an opportunity to see what effect the prepared formula has on the patient before the herbalist creates a custom formula tailored for the patient’s specific syndrome(s).

Unfinished Teapills

There are a variety of pill forms based on how they are prepared. The simplest pills are made from finely ground, crushed, or pulverized herbs. Often, herbs can be purchased in powder form (Mayway carries most of our Plum Flower® herbs in powder form), otherwise, a mortar and pestle and a high-quality herb powder grinding machine (rather than a blender or food processor) will be required.

The most common type of pill in Chinese herbology is one that is made with a liquid, called a “Water Pill” (shuǐ wán 水丸). Finely ground herbs are mixed with a liquid sufficient to make a dough-like consistency. Pure water is a common solvent, although a grain-based alcohol or wine, vinegar, or the juice from fresh herbs can also be used. The dough is cut, and the pieces are formed into relatively small balls, somewhat smaller than a baby pea (2-5 mm, about 150 mg). This type of pill is easy to swallow, disintegrates quickly, and is easily digested and absorbed. These pills tend to be fragile, easily break apart upon drying out, and do not travel well.

Honey Pills (mì wán 蜜丸) are made with finely ground herbs mixed with honey. The honey is warmed to make it easier to work with and added to the herbs to make a paste. Occasionally, a small amount of beeswax and sesame oil is added to the honey. The sesame oil assists in reducing the stickiness of the honey and keeping the pills moist. The beeswax acts as an additional binder. Honey pills are usually larger than water pills, often as large as 15-25 mm. Sometimes, honey pills are referred to as a bolus and may come wrapped in cellophane or placed in a wax or plastic “egg”. They are often cut into pieces before ingesting them to make the pill(s) easier to swallow. Honey, in addition to serving as a binder to maintain the integrity of the pill, is itself a tonifying herb, which also moistens and lubricates. For a patient who is vegan, instead of using honey, it is possible to make a facsimile using mucilaginous herbs in place of the honey such as red jujube (Dà zặo) or slippery elm (Ulmus rubra).

Paste Pills (hú wán 糊丸) are produced by thoroughly mixing the fine herbal powder with rice or wheat flour (with water) or by using cooked rice or mashed, cooked noodles. The resultant dough is formed into pills. Paste pills break up in the digestive system more slowly, allowing for a more gradual absorption and a prolonged duration of action. The use of rice or wheat is considered more tonifying and less harsh to the Spleen Qi since these pills are well tolerated and do not cause gastrointestinal adverse effects.

Another option is to place finely ground herbs into capsules instead of making pills. Filling capsules can be time consuming, but one can suggest that the patient purchase a capsule maker and bulk capsules (which can be found here), especially if they are going to be taking herbs for some time. Capsules come in two major varieties. Gelatin caps are made from a combination of glycerin and collagen, which is derived from the skin, bones, organs, and connective tissues of animals including beef, pork, and fish. Vegetarian capsules are derived from a polymer of cellulose called Hypromellose, which comes primarily from wood pulp. Size 0 capsules hold ~400 mg and 00s hold ~650 mg, so one issue may be the number of capsules that are required to provide an effective dose.

In fact, all the routes of administration described above may require large amounts of pills and capsules necessary to achieve a therapeutic effect. Even a relatively small formula comprised of 50 grams of herbs might require over 300 pills or 75, size 00 capsule per day! Some additional disadvantages to this type of pills and capsules that are made with powdered whole herbs are due to the fact that “whole”, powdered herbs include non-herbal components that may accompany the herbs. For example, while Mayway has clearly defined specifications with limits for each of our Plum Flower® herbs and conducts laboratory testing to ensure quality, there are heavy metals, such as lead, mercury, cadmium, and arsenic in the herbs that have been absorbed by the roots from the soil in which they are grown. Pesticides may be applied to soils in which the herbs are grown and/or to the herbs at various stages in the growth, harvesting, and drying of the herbs. Lastly, herbs can be exposed to various microbials such as coliform bacteria, yeasts, and molds during their handling, even at the final stage of preparation if strict handwashing and sanitation protocols are not followed.

Teapills on Manufacturing Line

To overcome these disadvantages, Lanzhou Foci Pharmaceutical Company, founded in 1929, invented a type of pill made from concentrate, appropriately named “Concentrated Pills” (nóng suō wán 濃縮丸). To help our customers better understand them and to further differentiate them from pharmaceutical drugs, in the 1990s here at Mayway we started to call this type of pill a “Teapill.” We wanted to emphasize that they were made from a “tea”, more precisely, a decoction. A large batch of herbs are cooked together in stainless steel cooker that includes a volatile chemical recovery system, strained, and then concentrated and condensed using a low temperature vacuum process. (See a video describing how teapills are made.) The condensed liquid is added to a small portion of powdered herbs from the formula to create a paste that is cut and then rolled into pills. These pills are mixed with very small amounts of activated charcoal, hydrated magnesium silicate, and China wax as excipients to maintain the integrity and shelf-life of the pills. Some producers of pills made from concentrates use starch or the dried dregs of the powdered dregs as excipients.

One large advantage to teapills is that since they are made from extracted concentrates, the number of pills required to provide an effective dose is much lower than pills made from ground powders. The standard dose for teapills is 8 pills, three times per day. Based on the results of quality testing by Mayway Herbs, the heavy metals and pesticides largely remain in the dregs and are only present in not detectable or very low levels in the finished teapills. Since these pharmaceutical grade pills are produced using Good Manufacturing Practices, sanitation is assured. The major disadvantage to teapills is that since they are ready-made, one cannot create a custom formula. However, many customers have reported excellent clinical success prescribing a combination of formulas, reminding us that the best medicine is what your patient is willing to take.

A relatively recent innovation in Chinese herbology is the Dripping Pill (dī wán 滴丸). Dripping Pills are prepared by blending an herbal extract and a matrix under low thermal conditions and dripping the mixture into a cooling liquid in which the droplets are insoluble. This process of pill formation results in a solid-dispersoid in a pill shape. Both the herbal extract and the matrix molecules turn into very fine, tiny crystals. These crystals are easily absorbed with a higher bioavailability, rapid biological activity, and lower adverse effects compared with conventional dosage forms such as tablets and capsules. Only a few herbal products are available in this form, especially in the US.

Extracted Granules/Powders

Extract Powders

Another choice when your patient will not accept herbs to be decocted is to offer them a powder or granule herbal extract. Please see a couple of previously written articles on Mayway’s website discussing this topic. The first is a deep dive regarding the nature of these excellent herbal products and the second is an article on dosing considerations. A significant advantage to extract powders is that although they are available as classic formulas, they can also be tailored for your patient’s specific needs based on their syndrome differentiation using single herb extract granules.

One thing to point out is that extract powders and granules are analogous to instant coffee. Essentially, they are dried decoctions, so when you reconstitute them with warm water, the result is a decoction. Of course, your patient does not have to cook these at home, but if there is still an aversion to the taste, then placing the extract powder in capsules is a very viable solution. Since Mayway’s published standard dose for extract powders is 9 grams per day, this is only 23, 400 mg (size 0) capsules per day.

Our herbal dispensary here at Mayway Herbs can make any formula for you in extract powder form, encapsulate, and ship the prescription to you to dispense or drop-ship it directly to your patient. (Learn more about our dispensary service)

Tablets

Finally, some discussion regarding tablets (yào piàn 药片), another modern dosage form. Tablets can be made by compressing finely ground herbs with binders and other excipients. This form will require the relatively large doses described above regarding analogously composed pills (wán). Alternatively, tablets can be produced from extract granules that are made with dextrin or malto-dextrin, which are also compressed into the die-cast tablet shape. Tablets may be dyed or have a wax, sugar, or enteric coating to mask the flavor of harsh-tasting herbs or to ensure that the tablet survives until it is in the intestines before disintegrating. Of course, tablets made from extract granules will be relatively more potent that those made from powdered raw herbs. It is important to understand that tablets made from extract granules are nearly identical and should be dosed similarly to encapsulated extract granules.

The Safety and Efficacy of Chinese Prepared Herbal Formulas

Based on comments heard at a recent national conference of acupuncturists, I would be remiss if I did not address the belief held by some that Chinese prepared formulas are ineffective and unsafe to use. First, effectiveness is related to the form of the formula with products comprised of extracted herbs being significantly more potent than those made from powdered herbs. Teapills and extract powders/granules are roughly equivalent in their potency since both are made from extracted herbal formulas, and should have similar effects to those from decoctions. Determining the proper dosage for a patient is critical and requires monitoring a patient’s response to the therapy.

However, one legitimate concern comes from the prevalence of counterfeit products that are sold which mimic established brands. Not only are the names of the formulas copied (or facsimiles using alternate romanization of Chinese characters), but in many cases, even the packaging is purposefully confusingly similar. The counterfeiting of Min Shan® brand from Lanzhou Foci Pharmaceutical Co. was one of the motivations behind Mayway Herbs creating our Plum Flower® line of teapills in the early 1990s. Makers of counterfeit products used to be called “mountain bandit factories”, but China has recently initiated reforms in the licensing of herbal products and many companies that engaged in counterfeiting are now defunct. Look for products that are produced by companies certified by GMPs (Good Manufacturing Practices). All of Mayway’s manufacturers comply with stringent Chinese GMPs and have also been internationally certified by the Australian Therapeutic Goods Administration (TGA). TGA standards are among the highest in the world, since dietary and herbal supplements sold there are subject to the same guidelines as pharmaceutical drugs. In addition, all manufacturers used by Mayway have been inspected by the US FDA.

An additional factor in diminishing trust with Chinese prepared herbal medicines is adulteration. This issue can range from products which do not contain the herbs listed on the label (and maybe nothing more than starch or cellulose) to products which contain prescription or OTC (over the counter) pharmaceutical drugs. Since herbal products are classified by FDA as dietary supplements, products containing drugs are illegal in the US. FDA requires adherence to strict labeling regulations which obviate the selling of herbal products which do not contain the listed ingredients. Importantly, the FDA requires that the identity of every ingredient listed on the label must be authenticated by species and part used by at least two scientifically valid methods. The easy solution to both of these two problems is to only buy Chinese prepared herbal medicines from reputable US importers rather than unknown brands sold in grocery or herb stores.

The final concern regarding Chinese prepared herbal medicines is contamination. Primarily, the concern of contamination is in reference to microbials, heavy metals, and pesticides. An herb company’s quality assurance program should include specifications of limits regarding these contaminates and a robust testing program to ensure those limits are maintained. Every company from whom you buy should provide a signed Certificate of Analysis (CofA) conducted by an ISO/IEC 17025 certified laboratory for every batch of every product that they sell. Testing documents that never change or do not list a batch number on a company’s website are dubious. If a bona fide C of A is not available to you as their customer, buy your herbal products from a company who will provide the documentation. Plum Flower® and Bamboo Pharmacy™ products are genuine, unadulterated, and quality-tested, and we have the documentation to back it up! To see a more in-depth discussion of these issues, read our article discussing Product Safety.

Hopefully, understanding these herb formula options will increase your patient’s compliance with taking Chinese herbs. While pills and capsules made from finely ground raw herbs can be easily be made in your clinic (or kitchen), the most effective herbal products are those that have been extracted, namely teapills and extract powders, both of which are the featured products from Mayway Herbs.

References

  • Bensky, D. & Barolet, R., Formulas & Strategies, Eastland Press: 1990.
  • Blasch, P., Prescription for Herbal Healing, Avery, 2002.
  • Chen, J.K. & Chen, T., Chinese Herbal Formulas and Applications, Art of Medicine Press, 2009.
  • Fratkin, J., Chinese Herbal Patent Medicines: The Clinical Desk Reference, Shya Publications, 2001.
  • Maclean, Will, Clinical Manual of Chinese Herbal Patent Medicines, Pangolin Press: 2003.
  • Santillo, H., Natural Healing with Herbs, Hohm Press, 1993.
  • Tierra, M., The Way of Herbs, Pocket Books, 1998.
  • Wrinkle, A. et al., A Practitioner’s Formula Guide, Elemental Essentials Press: 2008.

Bio: Skye Sturgeon, DAOM, L.Ac.

Skye is the Quality Assurance Manager and Special Consultant for Mayway, USA. Skye was the former Chair of Acupuncture & East Asian Medicine and core faculty member at Bastyr University, core faculty member and Faculty Council Chair at the American College of Traditional Chinese Medicine, and President and Senior Professor of the Acupuncture & Integrative Medicine College, Berkeley. Before making Chinese medicine his career choice, Skye held various positions in the Natural Foods Industry for 12 years and prior to that was a clinical biochemist and toxicologist.
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