Developed in response to practitioners desiring a convenient-to-use form of prescription similar to those used in Chinese clinics.
Produced for the Institute for Traditional Medicine by Subhuti Dharmananda based on traditional prescriptions, patents from mainland China, and Clinical research data.
Seven Forests has currently 124 formula contained in the practitioners guide "A Bag of Pearls": Each formula is shown with ingredients, general activities, sample indications, personalising with other formula, and background explanatory notes. Tablets are 700mg in bottling of 100 tablets.
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F O R M U L A AD E S I G N
The origins of the Seven Forests formulas are indicated in the explanatory notes on each formula page. In most cases, at least two or three existing prescriptions were consulted in designing the formula. The formulas consulted in designing th new one include:
1. Traditional prescriptions recorded in Chinese and Japanese medical books and reported in the English language.
2. Patent formulas manufactured in mainland China or Hong Kong that have been exported to the West, usually described in one or more books on the subject.
3. Prescriptions that have been used in a clinic in China and have been reported in a recent medical journal or at an international conference, usually in the context of a research report.
In determining the final formulation, some adjustments to the reference formulas have been made after consuting the above sources and the available Materia Medicas. Often, this process of adjustment involves the addition of one or two herbs not found in the original prescriptions, used here to emphasise or add a particular therapeutic principle that is desired.
As examples of the above three approaches:
Bupleurum 12 Modification of Traditional Formula
Kochia 13 Survey of Formulations
Platycodon 14 New Formulation
P R O D U C T I O NA O F AH E R B AT A B L E T S
The Seven Forests formulas were first produced as tablets in 1987.
The steps in producing bottled herbal tablets are presented in detail:
Herbs, minerals, and animals are gathered in China by traditional methods. Many are found in nature as they have been since the beginning of their use in medicine, but others are cultivated and raised stocks. Some of the items are processed in China before being transferred to the marketplace in Hong Kong, the main site of acquisition. Processing includes selecting appropriate portions of the herb material, and drying, steaming or baking. Herbs that have some toxicity in their natural condition, such as aconite, pinellia, and arisaema, are processed by traditional methods that render them non-toxic. Items traditionally obtained from other national sources, such as frankincense and myrrh from Arabic lands, are traded on the same Hong Kong market as the herbs from mainland China: the Seven Forests crude matereials are obtained from this market area (for extracts, see point 3 following). The supply organisation for crude herbs used in Seven forests formulas, New Century Herbs (San Francisco), sends a representative to Hong Kong on a regular basis to assist in selecting materials from the herb markets. Every attempt is made to use the highest grade of herbs. Experienced herb dealers and pharmacists at New Century Herbs use traditional means, learned in China, to confirm the identity of the materials that are imported.
The imported materials are selected and measured according to the Seven Forests prescriptions by trained professionals at New Century Herbs. These are then prepared for powdering by hand cutting the larger pieces to a reasonable size, drying any overly-moist materials, and removing any undesirable part of the raw materials. Some preprocessing is occasionally done, such as quick-frying, baking, soaking (and then drying), or other traditinal methods. The mixed raw materials are then shipped to a grinding facility. The main facility has been grinding Chinese herbs for more than 20 years. Due to the great variability of moisture content, fibre and texture of the herbs, the task of grinding is quite difficult. The finished powders are shipped to a tableting facility, Formulation Technology Incorporated, after being inspected at New Century Herbs.
Some crude herbs are first prepared by a hot water extraction technique followed by drying. This is done in several facilities, including factories in China and the US. The basic process is simple: the herbs are cooked just as they would be in a decoction, and then the liquid is removed from the herb dregs. Using advanced technology equipment, the water is removed from the extract to yield a powder. The extraction result is reported to ITM in terms of the concentration factor (amount of raw material used to yield an amount of extract) or the minimum level of a marker compound in the herb (eg tanshinones is salvia) or both. The extracts are accompanied by a certificate of identity, with production batch lot numbers. The US supplier of dried extracts is Sun Ten Laboratories, which provides some single herbs added to formulas and some complete formulas (such as Blue Earth Dragon, Bidens 6, and Eclipta Tablets).
The herb powders, any extracts to be added, and supplementary manufacturing materials, are blended together at the tableting factory. The supplementary materials are: natural stearic acid (helps the herbal material to flow into the tableting die), silicon dioxide (regulates material texture), cellulose (to aid in forming the tablet when there are oily components), and gum arabic (causes the compressed material to stick together). the amount of the supplemental materials will vary depending on the nature of the herb formula, such as its oiliness, but is typically only 7-8% of the finished tablet( the minimum amount necessary to form a tablet).
Most herbal powders cannot be easily compressed into tablets directly, and must first be granulated. This is accomplished by moistening the herbal material (which include the gummy binder) with water and making slabs that are dried slowly in a low temperature oven. The slabs are then ground through a large-mesh scree. The granulated material is compressed into tablets by modern high-pressure machines that accurately measure the desired amount of raw material into the mold.
The herb tablets are coated with a thin layer of processed cellulose. The coating makes the tablet smoother for easier swallowing and helps to retain the freshness of the product, but does not inhibit digestion of the tablet (the tablets are tested for their ability to quickly break down in water and in gastric-like fluid). A few batches of formula are made with vegetable shellac in place of processed cellulose. This done when the herb powder consistency is such that a stable tablet and coating may be difficult to attain with the cellulose. This is the main reason for variability in tablet appearance; if tablets from different batches are broken open and the interior colours compared, they will usually be quite similar even if the surface appears lighter (cellulose coating) or darker (shellac coating).
Seven Forests tablets are packaged in high-quality plastic bottles that retain product freshness. The standard packaging size is 100 tablets per bottle; more than half of the products are also made in 250 tablet size.
Most bottles are labelled with suggested use of 2-3 tablets three times a day. This is an accurate, but conservative, description for amounts to be used by average adults.
Each label is stamped with a lot number and expiration date (sometimes, the bottom of the bottle is stamped instead). The expiration date stamped on products is four years after they are bottled. The expiration date is the last date when ITM will ship the products from its facilities. The unopened bottle stored at moderate temperatures is expected to be fully usable for at least one year, and usually two years, after the expiration date. In other words, ITM does not ship a product that has less than one year of valid shelf life. The lot number is to be used in tracing the production records and to recover product in case therre are any problems discovered after completion of the manufacturing process. ITM has a strict policy limiting product returns to insure that it is always providing the most recently produced batch of product.
Each individual and organisation involved with producing th final Seven Forests formula is responsible for maintaining the highest possible quality control over their aspect of the production. The individuals and organisations working with ITM have been selected based on their expertise, reliability, and continued high performance. Because Seven Forests formulas are provided as natural supplements rather than drugs, they are not routinely subjected to laboratory testing (eg microbiological evaluation, chemical analysis, etc), as might be done for registered drug products. The US factories where the Seven Forests materials are produced are all subject to routine visits by the Food and Drug Administration and/or the State Health Department to assure that Good Manufacturing Practices (GMP) are being followed. Batches of raw materials used to make the tablets are tracked by a system of lot number and the identity of all items obtained as powders (eg extracts rather than whole pieces of crude herbs) is confirmed by a certificate provided by the suppliers. Extracts produced in China are supervised by individuals known to ITM to assure the product identity, quality of manufacture, and purity of the imported material. Finished products (tablets) are randomly inspected to check on the appearance, taste, smell, and other qualititative aspects, and samples from each batch are retained at the tablet factory for comparison purposes. Tablets that appear somewhat different than previous batches are sent to ITM for inspection and are not packaged unless the variation is approved as being within normal limits.
Place of Manufacture
Manufacturing the tablets in the US helps assure that no undesirable ingredients are included. No wheat, soy, corn, or other additives that are commonly avoided, have been included in the tablet manufacturing, so there is no need to worry about unintentional ingestion of allergens (check ingredients of formulas to make sure that herb components are not of concern). The ingredients used are hypoallergenic; the binders, flow agents, and coating materials are not protein substances and are not known to cause allergy reactions. The heavy metals found in some Chinese products, reflecting the traditional Chinese practice of including cinnabar or calomel (which contain mercury) are realgar (which contains arsenic) to certain pills accoriding to the original prescription or for the purpose of enhancing their effects. Seven Forests formulas DO NOT utilise any such ingredients. The heavy metals are not a natural component of ordinary Chinese herbs. Several of the Sevn Forests formulas and raw materials from which they are produced were tested for lead content. The amounts present are quite small and do not pose any known hazard.. Endangered species restrictions are monitored by the herb suppliers and by importers of the finished materials, and items of concern are removed from the products Materials that are listed as potentially endangered and requiring certification to have them imported have such certification at the import point (ITM is not directly involved in this process). Herb ingredients that have been deemed potentially toxic, such as aristolochic acid, have been removed from the formulas and ITM monitors the literature for information about new concerns (for example, the Western herb kava kava, included in two White Tiger range of formulas, has been mentioned as a possible cause of rare hepatic reactions, and this situation is monitored by ITM).