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1- As dietary supplement
Royal jelly belongs to a group of
products generically described as "dietary supplements" These
are products which are consumed not for their caloric content nor for
pleasure, but to supplement the normal diet with substances in which
it might be lacking. In reality, however, the use of royal jelly
is not so much linked to its high content in "noble" substances, but
to its assumed stimulant and therapeutic value. However, it cannot be
defined as a medicine because the data required for classification in
this category are lacking. If it were declared a medicine, its use
would become dependant on medical prescriptions and the production and
marketing of royal jelly-based products would become the exclusive
domain of the pharmaceutical industry.
A large amount of royal jelly
is sold and consumed as it is harvested. In its unprocessed, natural
state, it is preferred by most producers, because it does not require
any special technology, and by consumers because of its unaltered
"naturalness". The fact that its taste is not very pleasant, instead
of deterring consumers appears to enhance its image as a "medicine".
For those who do not appreciate this particular medicinal aspect,
royal jelly can be mixed with a little honey, sugar syrup or water, or
it may be encapsulated.
Unprocessed royal jelly is usually
packaged in small, dark glass bottles of sizes that correspond
to the duration of a "treatment" e.g. 10, 15 or 20 g. A tiny plastic
spatula is usually included for the "correct" dosage of 250 - 500 mg,
Special isothermal packaging (usually a moulded polystyrene box) is
sometimes used to make the product look even more precious and protect
it perhaps from brief temperature fluctuations.
Producers also sell pure royal jelly
in its original queen cells after having removed the larvae and sealed
the cells. The cells may be sealed with another wax queen cell cup,
with liquid wax or by squeezing the ends of the cell together. The
queen cells thus prepared can be packaged in small plastic boxes or
glass jars together with a small spatula. The main disadvantage of
this type of packaging is that the royal jelly does not keep well (two
weeks in a refrigerator or a few months when frozen immediately) and
only sells well directly from the producer to the consumer. On the
other hand such sales can be extremely profitable and are also
attractive to consumers who can be sure that the product is untreated
and fresh. Given the normal variation in content of queen cells the
net weight must be given for the smallest possible quantity (e.g.
minimum content 250 mg/cell).
Royal jelly sold in any of the
above forms must always be kept at or below 5~ C during storage,
during transportation and in the retail store. Empty packages can be
displayed while full containers are stored in a refrigerator.
2- As ingredient in medicine-like
products
This category of products resembles
medicines as far as their form of presentation is concerned, but in
other respects these products are no different from the dietary
supplements and foods described in the two preceding sections.
However, they require more advanced technology for production and
packaging and make higher demands on product stability as well as
quality control. For the same reasons, many of these applications use
freeze dried royal jelly. Unfortunately, the pricing of these products
does not always reflect the quality of the product and many are
grossly overpriced.
In medicine-like formulations royal
jelly is generally included for its stimulatory effects. However,
it is also used to solve specific health problems. A variety of
formulations are available, often containing ingredients otherwise
used to alleviate particular afflictions. As has been seen in an
earlier section, there is no solid scientific base for any such uses.
Advertising or other popular information should therefore be treated
with great caution and royal jelly should never be used as a
substitute for other treatments unless the treatment has been approved
by a competent physician.
Whether royal jelly is the only
active ingredient, or is mixed with others, the basic forms of
presentation remain the same and are adapted to the desired
applications or consumer preferences. Dosages may be presented in any
of the following ways:
- as a single dose package of dry royal
jelly with separate solvent,
- as a single dose of mixed pulverized
ingredients with or without solvent and in tablet or capsule form,
- as a single or multiple dose liquid
solution for oral administration or injection
Single-dosage packages generally have to
use a filler to bring the dose of the active ingredient (royal
jelly or the ingredient mix) to a volume that can be easily
handled by the consumer. An envelope containing only 250 mg of
freeze-dried royal jelly would look very empty and the powder
it contained might easily be lost. Sugar, salt, aromas, citric acid,
glycine, a.o. may all serve as fillers. As well as being mere fillers,
they often render the product more pleasant to taste. Additional
ingredients mixed with royal jelly are often other food supplements
like plant extracts (ginseng), yeasts, pollen
extracts and others.
Most packages provide the dry phase in a
separate package, envelope or vial and a solvent in an appropriate
container. Not only does this separation allow more effective
treatment of the liquid phase (such as pasteurization or
sterilization) but it also improves storage life and therefore
facilitates shipping and marketing. Some refined packaging contains
the dry phase in a special lid which upon opening releases the powder
into the solvent.
In tablet form, the
principal excipient is usually a powdered sugar plus a binding agent
such as gum arabic. For larger production, tableting machines are
necessary which can sometimes be purchased second-hand at reasonable
prices. Hard and soft gelatine capsules can be used for similar
formulations. The hard capsules can be filled by hand on a small scale
or by machine on a more industrial level, but soft capsules and
gelatine drops need expensive equipment and are usually manufactured
only by larger enterprises or under contract by large enterprises for
third parties.
Another form of presentation is in
vials with a liquid solution of royal jelly. These are simple
to prepare and can use fresh unprocessed royal jelly, but they present
preservation problems both with regard to microbiological activity and
the long-term stability of the royal jelly. The addition of a little
alcohol or propolis extract increases protection against microbial
growth. Such preparations are distributed widely and are now being
imported mostly from Asia by Europe, the USA and some Latin American
countries . One of the more common formulations contains honey, royal
jelly and an alcohol extract of ginseng. Since these products are not
regulated as food or as medicines, they are not required to list all
ingredients, particularly the different preservatives which are
necessary in these liquid formulations.
The production of injectable royal
jelly preparations must be left to qualified laboratories in order
to avoid problems with contamination and toxicity. There are patents
that protect the production of royal jelly extracts for human use (by
injection), but up to now there is no actual production or use for
these "medicines", at least in Western Europe.
The medicinal or pseudo-medicinal use of
royal jelly is much more popular in Asia and Eastern Europe,
where rules on medicinal formulations and applications are very
different from those in Western Europe and North America. In Africa,
very little use of royal jelly has been reported, either as a
food supplement or as medicine.
3- As ingredient in cosmetics
Except in Asia, probably the largest use
of royal jelly is in cosmetics. Royal jelly is included
in many dermatological preparations, but mostly in those used for skin
refreshing, and skin regeneration or rejuvenation. It is also used
in creams or ointments for healing burns and other wounds.
It is usually included in very small dosages (0.05 to 1 %) but
it is likely that it deteriorates relatively quickly. No precise data
on loss of effectiveness are available. The freeze-dried form of royal
jelly is usually preferred because of ease of handling. A royal
jelly/lactose paste mixed at 00C is said to stabilize royal
jelly (Rubinsstein, 1954). The paste can then be added to cosmetic
preparations.
4- Others
The only other known uses for royal jelly
are in animal nutrition. In particular, royal jelly has occasionally
been used (fresh or freeze-dried) to stimulate race horses. For
experimental purposes it is also used as a food for rearing mites and
insects.
Storage
Royal jelly has a limited
shelf-life. Early beliefs in the extreme instability of royal jelly
activity, based on the alleged rapid loss of the "queen determination"
factor have not been confirmed. Since neither the mode of activity nor
the actual effects of royal jelly are known, there are no data
available on changes in its biological effectiveness on humans after
long term storage.
Information is, however, available on
changes in composition due to long term storage, such as a higher acid
titre, a large unsoluble protein fraction, less free amino acids, less
glucose oxidase and others (Takenaka et., 1986 and Karaali et al,
1988). Such changes make it appear likely that also biological
activity is influenced by storage. Refrigeration and freezing delay
and reduce the chemical changes. Although freeze-dried jelly is the
most staable form of royal jelly, some changes still take place.
On the basis of the above, we can
conclude that refrigeration of royal jelly at 0~ to 5 0C is
a minimum precaution. Still better is storage, whenever possible, at
temperatures below -170C, which is attainable in most
household freezers. Since royal jelly is an emulsified product and not
cellular tissue, freezing presents no particular problem and common
household freezers can be used.
As there are no criteria for establishing
"safety" limits for product activity, storage and shelf-life should be
kept as brief as possible. For products sold in Europe, the average
recommended storage time after production is 18 months under
refrigeration. For products stored at - 170 C, storage can be
extended to 24 months. After defrosting and packaging, the product
should not be stored in a refrigerator for more than 12 months.
Freeze dried royal jelly and royal
jelly based products are generally stored at room temperature,
sometimes for several years. Freeze-dried royal jelly is certainly
more stable than the fresh product, but it was reported that only
during the first two months of storage at room temperature no signs
were observed of any deterioration (Okada et al., 1977). Therefore,
also in this case cold storage is recommended to minimize changes and
products should be kept on the shelf for as short a time as possible.
The storage recommendations for fresh and
dried royal jelly are valid in the same way for all wet or dry
products to which royal jelly has been added. Contrary to many
recommendations on packages, these products should be stored in the
same manner as the pure, fresh jelly.
In 1956, a French patent was granted for
a method of stabilizing royal jelly by mixing it with an easily
assailable, adsorbent substance such as a carbohydrate or protein. A
homogenized paste of 10 g fresh royal jelly with 100 g of lactose,
mixed at 00C was proposed by Jean (1956). However,
no evaluation or verification of increased shelf-life is available.
Such support substances, often sugars but also glycine are frequently
used to increase the volume of single doses of freeze-dried royal
jelly, to make handling easier for both packers (weighing of very
small quantities is both difficult and imprecise) and customers. |