Quality Controls

1. Introduction

The Quality Controls (QC) applied to the manufacture of the Three Treasures, Women’s Treasure and Little Treasures remain a top priority.

The Three Treasures and Women’s Treasure tablets are made from the concentrated powders of the herbs. The concentrated powders themselves are made by decocting the raw herbs at source thereby greatly enhancing the synergy of the herbs ending with a fine powder that is more concentrated than the raw herbs, i.e. 1 gram of concentrated powder equals at least 5 grams of raw herbs. This process makes the tablets much more readily digestible and assimilable by the small intestine.

The Three Treasures, Woman’s Treasure and Little Treasures are made in GMP approved facilities. The strictest herb selection and identification protocols available are applied.

From extraction and condensation to vacuum drying and flow coating, each step is performed with state-of-the-art equipment and monitored by well-trained staff.

Throughout the process, the herb extracts are submitted to tests to ensure that they meet GMP standards. High Performance Liquid Chromatography (HPLC) is used to ensure consistent levels of active ingredients. All products are analyzed for the presence of heavy metals and harmful bacteria such as salmonella and E coli.

In addition, volatile oils are collected during the extraction process. The oils are reintroduced downstream.

2. What Quality Controls (QC) are the Remedies Subject to After Processing?

Each batch of every product is subject to careful analysis to ensure a consistent and stable amount of active ingredients. QC is reflected in a final certificate, listing all relevant information and test results, which include the following:

  • Botanical name.
  • Organoleptic properties.
  • Standard test concerning solubility, stability, etc.
  • Thin Layer Chromatography (TLC) to (re)confirm identity – by using a chemical “fingerprint” unique to each species.
  • High Performance Liquid Chromatography (HPLC) measures potency by substantiating the presence of active ingredients.
  • Standard tests for bacteria (e.g. salmonella, col-bacteria, total bacteria count), moulds and yeasts.
  • Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) analysis of heavy metal values. This state-of-the-art geophysical technology assures the absolute safety of the remedies, with reference to the limit values of the Japanese and the European pharmacopoeias. This system is sensitive to sub-parts per billion, compared to other systems which detect elements only in sub-parts per million.
  • Gas Chromatography (GC) further ensures safety by testing for over 200 potentially harmful substances such as pesticides, herbicides and fungicides.
  • Herbs susceptible to contamination by aflatoxins are tested separately.

3. Manufacturers

In America, we have two manufacturers:

  1. Far East Summit make the Little Treasure liquids. Click here to review quality control process.
  2. Quali Herb manufacture the Three Treasures and Woman’s Treasure tablets. Click here to review quality control process.

Outside of the US, we have one manufacturer:

  1. Sun Ten based in Taiwan make the Three Treasures and Woman’s Treasure tablets. Click here to review quality control process.

4. Concentration Strength of Tablets

Please note that the new tablets differ from the old ones in three important ways:

  • The concentration is higher
  • The excipients are less
  • The excipients are different

Concentration of Tablets
The concentration ratio of the new tablets is 1:7.5, i.e. 1g of tablet is equivalent to 7.5g of dried herb. In the old tablets, the concentration ratio was 1:4. This means that the new tablets are almost twice as concentrated as the old ones. The implication, of course, is that the dosage should be lower than that used for the old tablets. Thus, if one was previously taking 4 tablets a day, they can now take 2-3; if they were previously taking 6 tablets a day, they can now take 3-4.

The Excipients are Less
Previously, the excipients represented 16% of the weight of each tablets; now they are only 4% of the weight of each tablet.

The Excipients are Different
Previously, the excipients included microcrystalline cellulose, povidone, magnesium stearate, starch, croscarmellose sodium, ethylcellulose. Whenever possible, the starch used as excipient is that from the herbs making up the formula themselves. In addition, only magnesium stearate is used as excipients in a proportion varying from 1% to 4%. Again, this means that the tablets are better digested and assimilated.

Therefore, taking into account the higher concentration, the lower proportion of excipients in each tablets and the different type of excipients used, the new 60-tablet pot is equivalent to a total of 216,000 “active” mg, while the old 100-tablet pot was equivalent to a total of 200,160 “active” mg.

5. Dosage of Three Treasures, Women’s Treasure and Little Treasures

As the new tablets are almost twice as concentrated as the old ones, the dosage should be lower than that used for the old tablets. Thus, if, for example, one was previously taking 4 tablets a day, they can now take 2-3; if they were previously taking 6 tablets a day, they can now take 3-4.

The question of dosage is a very complex one for which there are no hard and fast rules. In many cases, it is a matter of trial and error; patients often find their own “correct” level of dosage. Even for drugs, the question of dosage is far from being as “scientific” and accurate as we are led to believe. Reaction to a drug varies considerably and unpredictably between individuals as plasma concentrations commonly vary by a factor of 5 or more.

One of the criticisms often levelled at herbal remedies is that, because they are not standardised, there is no way of saying how much of the remedy’s active constituents a patient is taking, and therefore no way of adjusting the dose accurately. There are two basic faults in this argument: first of all, with drugs, too, finding the correct dosage is often a matter of trial and error due to individual variations in reaction; secondly, and most importantly, herbal remedies containing whole plants act in a physiological rather than chemical way, more like a food than a drug. Thus, adjusting the dosage of individual active constituents is not necessary: it is precisely when active constituents are isolated that herbal remedies cause side-effects and adverse reactions in the same way as drugs. For example, ephedrine causes many more side-effects than Ma Huang Herba Ephedrae, glycyrrhizinic acid causes many more side-effects (water and sodium retention) than Gan Cao Radix Glycyrrhizae uralensis, etc.

Furthermore, since herbal remedies are intrinsically safer than drugs, the therapeutic range is far broader than for drugs. Indeed, the harmful dosage of herbs is so high that it would be impossible to ingest in one day. There are, in fact, reports of adverse reactions to herbal remedies in people who used them (unsuccessfully) in suicide attempts.

Of course, there are toxic plants for which the dosage is crucial and the therapeutic range quite narrow (e.g. Lei Gong Teng Radix Tripterigii wilfordii, Huang Yao Zi Semen Dioscoreae bulbiferae, Ma Qian Zi Semen Strychni nux-vomica, etc.) but the Three Treasures and Women’s Treasure ranges do not contain any of these toxic herbs.

Many factors influence dosage, and I am going to discuss them one by one: it should be stressed that all the following factors need to be taken into account in every case.

The Full or Empty Character of the Condition
In Empty patterns the dosage can be lower than in Full patterns. Thus, for all the formulae in the Clearing category and the Nourishing and Clearing category, the dosage should be higher than for those in the Nourishing category.

Chronic vs Acute Conditions
In acute cases, the dosage should be higher. For example, if we are using Expel Wind-Heat for a severe invasion of Wind-Heat with fever, swollen tonsils, pronounced aches, etc., then the patient can take 9 or even more tablets in 24 hours. In contrast, there is no point in treating a chronic condition with a high dose, because it can change only slowly.

Age of the Patient
Old people and children need lower doses. A newborn baby should not be treated at all and it is preferable not to treat any baby under 6 months of age unless absolutely imperative. Infants and children up to 6 years old should have a third of a dose; children between 6 and 14 half a dose; after that, a full dose.

A simple formula to calculate the dosage for children is as follows:
Age / Age + 12 x dose

For example, if an adult dose is 6 grams per day, the dosage for a 6-year-old would be:
6 / 6 + 12 x 6 grams = 1.99 grams

The dosage should also be reduced in the elderly: approximately half a dose after 70 and a third of a dose after 80.

Condition and Body-build of the Patient
The weaker the patient, the lower the dose. Thus, a frail old lady should have a lower dose than a large, corpulent man.

The Condition Itself
The dosage should be adjusted also according to the severity of symptoms. For example, the dosage of Chemo- and Radio-Support should be varied according to the severity of the adverse reactions to chemo- or radio-therapy. For example, an average dose for these remedies might be about 4-6 tablets a day, but if the adverse reactions to the therapy are severe this dosage can be increased.

The Digestive System
The weaker the patient’s digestive system, the lower the dose. This is a very important consideration: Western patients have weaker digestive systems than Chinese people and are easily upset by herbal tablets (more than by decoctions). If a patient experiences a digestive upset, make sure that he or she is taking the tablets after food and with hot water.

It is prudent not to prescribe any formulae during the first three months of pregnancy. From the fourth month onwards, formulae can be prescribed, unless, of course, they are specifically forbidden in pregnancy. This is indicated under “Caution and contraindications” within the explanation for each formula.