WO1999040941A1

WO1999040941A1 - A fish scale extract as a calcium supplement

Info

Publication number: WO1999040941A1
Application number: PCT/US1999/003371
Authority: WO
Inventors: John Achkar
Original assignee: Individual
Current assignee: Individual
Priority date: 1998-02-17
Filing date: 1999-02-17
Publication date: 1999-08-19
Anticipated expiration: 2000-08-17
Also published as: WO1999040941A8; AU3296899A

Abstract

The present invention is directed to a calcium rich preparation which is prepared by soaking fish scales in a mixture of carbohydroxilic acid and acidic acid for a defined period of time. This fish scale extract can be used as food supplement to prevent or reduce the risk of bone loss or other calcium deficiencies.

Description

A Fish Scale Extract As A Calcium Supplement

BACKGROUND OF THE INVENTION

1. Field of the Invention This invention relates to a novel material and composition useful as a calcium supplement for humans and other animals. In particular, this invention relates to a fish scale extract containing a special form of calcium which can be applied topically to the skin and absorbed easily by the skin for strengthening bones or preventing other calcium deficiencies .

2. Description of the Related Art

Calcium is the fifth most abundant element in the human body. It plays an important role in many physiological processes, including nerve and muscle functions. Not surprisingly, nutritional and metabolic deficiencies of calcium can have broad-ranging adverse effects. Since about 90% of the body's calcium is found in bone tissues, many of these adverse effects are manifested through deficiencies in the structure, function and integrity of the skeletal system.

The most common metabolic bone disorder is osteoporosis. Osteoporosis can be generally defined as the reduction in the quantity of bone, or the atrophy of skeletal tissue. In general, there are two types of osteoporosis: primary and secondary. "Secondary osteoporosis" is the result of an identifiable disease process or agent. However, approximately 90% of all osteoporosis cases is idiopathic "primary osteoporosis" . Such primary osteoporosis includes postmenopausal osteoporosis, age-associated osteoporosis (affecting a majority of individuals over the age of 70 to 80) , and idiopathic osteoporosis affecting middle-aged and younger men and women.

For some osteoporotic individuals the loss of bone tissue is sufficiently great so as to cause mechanical failure of the bone structure. Bone fractures occur often, for example, in the wrist, hips and spine of women suffering from postmenopausal osteoporosis. Kyphosis (abnormally increased curvature of the thoracic spine) may also result. The mechanism of bone loss in osteoporotics is believed to involve an imbalance in the process of "bone remodeling". Bone remodeling occurs throughout life, renewing the skeleton and maintaining the strength of bone . This remodeling occurs in a series of discrete pockets of activity in the bone, called "osteoclasts" and "osteoblasts" . Osteoclasts (bone dissolving or resorting cells) are responsible for the resorption of a portion of bone within the bone matrix, during the resorption process. After resorption, the osteoclasts are followed by the appearance of osteoblasts (bone forming cells) , which then refill the resorbed portion with new bone.

In a healthy adult, the rate at which the osteoclasts and osteoblasts are formed maintains a balance of bone resorption and bone formation. However, in osteoporotics an imbalance in this remodeling process develops, resulting in loss of bone at a rate faster than the accretion of bone. This imbalance is much more severe, and occurs at a younger age, in osteoporotics as compared to healthy adults.

Many compositions and methods are described in the medical . literature for the prevention or "treatment" of osteoporosis. Many of these compositions and methods attempt to either slow the loss of bone or to produce a net gain in bone mass. See, for example, R. C. Haynes, Jr. et al . , "Agents affecting Calcification", The Pharmacological Basis of Therapeutics, 7th Edition (A. G. Gilman, L. S. Goodman et al . , Editors, 1985) ; and G. D. hedon et al . , "An Analysis of

Current Concepts and Research Interest in Osteoporosis", Current

Advances in Skeletogenesis (A. Ornoy et al . , Editors, 1985).

Estrogen is often used to affect the metabolism of calcium.

Treatments using fluoride have also been described. However, the utility of such agents may be limited, due to possible adverse side effects. See . A. Peck, et al . , Physician's Resource Manual on Osteoporosis (1987) , published by the National Osteoporosis Foundation (incorporated by reference herein) . Nutritional therapies for osteoporosis or prevention for other calcium deficiencies have also been proposed. Many calcium-containing compounds and compositions have been described for use as nutritional supplements. Many commercial preparations are also available, typically containing calcium carbonate. Calcium chloride, calcium gluceptate, calcium gluconate, calcium lactate, calcium phosphate, calcium citrate, and other calcium salts have also been described for use in calcium supplements. The use of calcium citrate, for example, is described in French Patent 2,219,778, Monteau, published Sep. 27, 1974; and World Patent Publications 86/04814 and 86/04815, Pak et al . , both published Aug. 28, 1986. Food supplements containing calcium citrate malate are described in Japanese Patent Document 56/97, 248, Kawai, published Aug. 5, 1981.

The utility of these known supplements varies. Unlike agents (such as estrogen) which affect the metabolism of bone, calcium nutritional supplements have been thought to provide a source for calcium. Not every calcium compound can be absorbed and metabolized by the body. Applicant believes that the degree of calcium adsorption depends on the forms of the calcium compounds. Insofar as applicant knows, no prior art teaches or suggests calcium in a form of an acid extract from a natural product to be used as a absorbable calcium supplement .

It is now discovered that an extract from fish scales contains a special form of calcium complex that is useful as food supplement or a portion of a food supplement to provide the users with more calcium than they otherwise have available from their normal diets. This fish scale extract can be easily absorbed by the human body through the skin. Many commercial calcium supplement preparations also contain vitamin D to facilitate calcium absorption, as in the instance of milk. It is well known that vitamin D plays an active role in calcium homeostasis and is a major regulator of the concentration of Ca²⁺ in plasma.

The concept of topical application of calcium supplements has never been suggested or reported. However, topical application of calcium supplement can be unique and useful as an alternative route to provide the body with calcium supplementation, particularly if the calcium is in a form that can be readily absorbed by the skin. The fish scale extract in the present invention is one of those forms. It should be noted that vitamin D is also synthesized in the skin, suggesting that vitamin D may directly or indirectly interact with calcium to facilitate the absorption of calcium from the skin or otherwise participate calcium metabolism after the absorption.

SUMMARY OF THE INVENTION

An object of the present invention is to provide a calcium complex in which calcium is associated with one or more of other organic molecules. In particular, the calcium complex is obtained by extracting it from fish scales with an acidic solution containing a mixture of a hydrocarboxylic acid and acetic acid. Another object of the present invention is to provide a fish scale extract prepared by soaking the fish scales in a mixture of equal amounts of a hydrocarboxylic acid and acetic acid or a mixture of equal amounts of lemon juice and vinegar.

Another object of the present invention is to provide a fish scale extract prepared by soaking the fish scale in a mixture of a hydrocarboxylic acid and acetic acid or a mixture of lemon juice and vinegar at a ratio of 3 to 1.

A further object of the present invention is to provide a food supplement for preventing or reducing calcium deficiency or the risk of bone loss such as occurs in osteoporosis and related disorders .

Other objects and features of the present invention will become apparent from the following detailed description.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

Turning now to the first embodiment, the materials used in the extraction process comprise fish scales, a hydrocarboxylic acid or acetic acid, or preferably, a mixture of the two. The fish scales may be collected from any type of fish in any amount. Preferably, for a preparation of 500 ml, 1 oz of fish scales are required. The fish scales are first briefly, lightly sprayed with fresh water and then they are soaked in an organic acidic solution. Preferably, the substance coating each of the fish scales is not removed by spraying. Any organic acidic solutions, preferably, acetic acid and a hydrocarboxylic acid such as citric acid or tartaric acid may be used for soaking the fish scales. The acidic solution may be prepared at a concentration of about 0. IN to about IN or at a concentration which is comfortable to the skin. A buffer system such as PBS at a pH of about 2-3 or another value that is comfortable to the skin may also be employed in place of the acid. The ratio of the hydrocarboxylic acid and acetic acid may vary depending on the intended use. Once the acidic solution is formed, the fish scales are introduced into the solution in such a way that the fish scales are completely immersed in the solution. The container that contains the fish scales soaked in the acidic solution is then covered and kept preferably at room temperature for at least 12 hours, preferably about 5 days, during which the calcium or calcium complex continuously comes out of the fish scales. Most preferably, the fish scales may be maintained in the solution until an equilibrium of the calcium concentration between the fish scales and the acidic solution is established so that the calcium concentration is maintained at a constant level. This process may be accelerated by heating the solution. The presence and concentration of the calcium in the solution can be readily determined by a person skilled in the art. Alternatively, food products such as lemon or lime juice and vinegar may be used to substitute the hydrocarboxylic acid and acetic acid. In such case, about 1 oz of the fish scales are soaked in about 500 ml of lemon or lime juice, or in about 500 ml of vinegar, preferably white vinegar or red wine vinegar, or in a mixture including about 200 ml of lemon or lime juice and about 300 ml of vinegar, for at least 12 hours, preferably about 5 days .

After the fish scales have been sufficiently soaked in the solutions as described above, considerable amount of calcium or calcium complexes from the fish scales are dissolved or associated with the compounds in the acidic solution to form complexes. This preparation may then be filtered by a mesh or a screen so as to separate the fish scales from the fish scale extract that contains calcium associated with one or more other organic molecules.

The extract so prepared is then suitable for an immediate use or may be further modified as a food supplement. For example, an extract cocktail may be formed by adding some other substances such as garlic and honey, etc. into the extract. Alternatively or additionally, vitamin D may be added to the extract. For an extract containing about 500mg of calcium, about 200 International Units of vitamin D may be added. The extract may also serve as a major component for a pharmaceutical composition. In another embodiment, the fish scale extract may be dried by any suitable means, such as lyophilization for the purpose of storage or shipment. The dried fish scale extract may be resuspended or dissolved in a pH neutral solution, or manufactured in the form of capsules or tablets. In case of an immediate application after the extraction, the extract may be administered topically or orally. For an oral administration, the extract can be taken alone or combined with other foods . At least a teaspoon of the extract or its modification may be employed daily depending on the user's needs and for as long as the user desires. Preferably, the extract or its modification is administered three times a day and preferably one tea spoon at each time. For a topical application, the extract or its modification may be applied directly to various areas of the skin such as the face or the chest at least once a day or as often as the user desires or depending on the user's symptoms.

The extract, when administered either orally or topically, may be useful to prevent, or reduce the risk of, the occurrence of bone loss such as osteoporosis or other calcium deficiencies .

EXAMPLE

Twenty identical plastic, acid resistant containers were prepared. Ten portions of equal amount of fish scales were distributed into each of the ten containers, leaving the other ten containers empty for later use. Then sufficient lemon juice and vinegar were prepared in separate containers to be used as stock solutions. 100 ml of lemon juice or vinegar or a mixture of the two were measured according to the following ratios and were poured them into each of the ten containers containing the fish scales :

containers 1 and 2 100 ml of lemon juice alone containers 3 and 4 75 ml of lemon juice + 25 ml of vinegar containers 5 and 6 50 ml of lemon juice + 50 ml of vinegar containers 7 and 8 25 ml of lemon juice + 75 ml of vinegar containers 9 and 10: 100 ml of vinegar alone The containers containing fish scales and solutions as prepared above were covered and thoroughly mixed for a few minutes . Then the containers were allowed to stay for at least two days at room temperature to produce fish scale extracts. The fish scale extracts so prepared were then transferred into each of the ten empty containers by filtering out the fish scales, respectively, and properly labeling the corresponding containers. The filtered fish scale extracts were allowed to stand for at least one week until the insoluble particles precipitated. The supernatants were then removed from the containers as much as possible by syringe, aspiration or any other suitable way that are apparent to one of ordinary skill in the art without disturbing the precipitates . After the removal of the supernatants, the precipitates are dried until the moisture is completely removed. The dried precipitates are measured by weight, as shown in Table I:

TABLE I

Container lemon juice (ml) vinegar (ml) dried Precipitates (gm) *

1&2 100 0 5 gm

3&4 75 25 6 gm

5&6 50 50 8 gm

7&8 25 75 2 gm

9&10 0 100 1 gm

* Each number is an average of the duplicates.

In above example, although any ratio of lemon juice and vinegar may be used to prepare the fish scale extracts, a mixture of equal amounts of lemon juice and vinegar is preferred.

Thus, while there have shown and described and pointed out fundamental novel features of the invention as applied to preferred embodiments thereof, it will be understood that various omissions and substitutions and changes in the form and details of the devices illustrated, and in their operation, may be made by those skilled in the art without departing from the spirit of the invention. For example, it is expressly intended that all combinations of those elements and/or method steps which perform substantially the same function in substantially the same way to achieve the same results are within the scope of the invention. It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto.