The Three Treasures Newsletters
SPRING 2003
THE THREE TREASURES AND WOMEN'S TREASURE
QUALITY CONTROLS
1. INTRODUCTION
The present newsletter is dedicated to the Quality Controls (QC)
applied to the manufacture of the Three Treasures and Women's Treasure
remedies. Most Western governments today are demanding tighter controls
over the quality of Chinese herbal products. Regulatory authorities
such as the Medicines Control Agency in the UK and the Food and
Drug Administration in the USA in particular demand that Chinese
herbal remedies be free from (or within internationally-admitted
levels) heavy metals (e.g. mercury, lead, cadmium, arsenic), aristolochic
acid, pesticides, aflatoxins and, of course, Western drugs. Unfortunately,
Chinese-made patent remedies are still regularly found to contain
aristolochic acid, heavy metals and sometimes Western drugs such
as steroids. For example, of 2609 samples of traditional Chinese
medicines collected from eight hospitals in Taiwan, 23.7% contained
pharmaceutical adulterants, most commonly caffeine, paracetamol,
indomethacin, hydrochlorothiazide and prednisolone. NSAI drugs have
been found and benzodiazepines have been found in many Chinese patent
medicines.1
To ensure the continuous availability, safety and efficacy of our
remedies, QC remain a top priority for the Three Treasures and Women's
Treasure product lines.
First of all, it should be remembered
that the Three Treasures and Women's
Treasure tablets are not made from ground-up
raw herbs but from the concentrated
powders of the herbs. The concentrated
powders themselves are made by decocting
the raw herbs and then removing the
fluid to end up 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 (and in
the case of the Kaiser powders, the
concentration is even higher). This process
makes the tablets much more readily
digestible and assimilable by the small
intestine.
We have recently changed manufacturer
for the powders that make up the Three
Treasures and Women's Treasure tablets.
The Three Treasures and Women's Treasure
remedies are now made in Taiwan according
to standards exceeding those of Good
Manufacturing Practice (GMP).
The processing
plant iis a GMP (Good Manufacturing Practices)
approved facility. From extraction and
condensation to vacuum drying and flow
coating, each step is performed with
state-of-the-art equipment and monitored
by a well-trained staff.
Throughout the process, the herb
extracts are submitted to tests to ensure that they
meet GMP standards as well as the company's own even
higher expectations. The site laboratory uses equipment
such as High Performance Liquid Chromatography (HPLC)
to assure consistent levels of active ingredients.
All products are analyzed for the presence of heavy
metals and harmful bacteria such as salmonella and
E coli.
The company's modern scientific
processing methods and rigorous quality control set
them apart from all other sources of Chinese herbs
for the following reasons:
| • |
The remedies are
manufactured to a standard exceeding
GMP standards. |
| • |
Volatile oils are
collected during the extraction
process. The oils are reintroduced
downstream in a closed system. |
| • |
The strictest herb selection
and identification protocols available
are applied. Their ID protocol
is in a constant state of upgrade. |
| • |
The presence of
heavy metals in herbs is detected
it in terms of parts per billion. |
It is important also to point out that we have changed an important
aspect of the manufacturing process. While previously individual
powders were imported from Taiwan and then mixed and tableted in
the UK to make a specific formula, now the raw herbs making up a
remedy are decocted together at source to form the powdered formula
directly, thereby greatly enhancing the synergy of the herbs.
1Fugh-Berman A, Herb-drug
interactions, in The Lancet, Vol. 355, No. 9198, 8 January 2000,
p. 13438.
2. HOW ARE THE THREE TREASURES
AND WOMEN'S TREASURE REMEDIES PRODUCED?
a) Raw materials - only the finest and freshest
herbs are bought. The raw herbs are then inspected for conformity
and species verification by experienced botanists in Taiwan and
Europe.
b) Extraction - volatile oils are removed, to
be introduced later on. All the herbs for a single remedy are
then decocted together, rather than separately, thereby greatly
strengthening the synergy of the herbs. This is done in a closed
and controlled environment.
c) Evaporation - the collected volatile oils
are reintroduced and the liquid extract is further concentrated
d) Granulation - this takes place is a completely
enclosed chamber, protected against cross-contamination. The concentrate
is sprayed on starch particles of the same herbs and is vacuum-dried
at low temperature.
e) Formulation - the modified formulae, now in
their dry granular form, are then bottled and sealed. Labelling
takes place in the U.K under GMP standards.
3. 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. |
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 |
a) 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.
b) 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.
c) 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 AND WOMEN'S TREASURE
REMEDIES
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 considereably 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
|
x dose. |
Age + 12 |
|
For example, if an adult dose is 6 grams per day, the dosage for
a 6-year-old would be:
6
|
x 6 grams |
= 1.99 grams |
6 + 12 |
|
|
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.
Pregnancy
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.
WEBSITES:
www.giovanni-maciocia.com
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