Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2000-08-28
2002-04-09
Levy, Neil S. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S489000, C424S744000
Reexamination Certificate
active
06368624
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a tablet prepared from a dried product obtained by pulverization under cooling and subsequent vacuum freeze-drying of a fresh entire aloe leaf, a method for preparing the tablet, and use thereof.
The tablet according to the present invention is useful as a medicine or so-called health food, such as laxative, stomachics, anti-gastrointestinal ulcer drug, anti-inflammatory drug, anti-fungal drug, anti-hyperglycemia drug, anti-burn edema drug for oral administration, or immunomodulator.
BACKGROUND
Aloe has been extensively used as folk medicine. Reference to aloe powders is also made in the Japanese Pharmacopeia.
The present inventors and certain laboratories both in Japan and abroad have succeeded in separating low-, medium- and high molecular weight ingredients contained in aloe.
For example, it is known that Aloe arborescens var. natalensis (referred to as “Kidachi aloe” hereinafter) contains polysaccharides such as aloetin, aloenin, aloeursin or D-mannose, aloemannan or aloe albonacite: aloe vera contains polysaccharides; and that Cape aloe contains anthraquinonic ingredients, such as aloin or aloe-emodin.
In this consideration, attempts have intensively been made to process the aloe into medicines. For the time being, as the officially allowed health food, food products prepared from Kidachi aloe have been commercialized in Japan extensively.
Most of these products, however, are prepared by drying aloe leaves under sun shine or by hot air and, at the time of tableting, several to about ten percents of an additive, such as Avicel (Trade name of micro crystalline cellurose) or corn starch, is added as a binder to facilitate tableting.
DISCUSSION OF THE RELATED ART
It is noted that most ingredients isolated and purified from the aloe and found to be efficaceous to animals by animal experiments, are polysaccharides, glycoproteins or enzymes, all of which may exhibit activity in a stable state only when treated for purification at lower temperatures. For this reason, it is generally thought to be desirable to apply as small a quantity of heat as possible for the preparation of the health food or medicine from aloe.
However, since the products now presented to the market are prepared by drying aloe leaves under sun shine or by circulation of hot air, the above mentioned components, namely the polysaccharides, glycoproteins or enzymes, have been thermally degraded or oxidized in the course of drying.
Further more, the additives for facilitating tableting, such as Avicel or corn starch, are added in an amount of several to tens of percents in the conventional aloe tablet products. Since a small amount of water is added under heating to knead the additives with the dried aloe mass, the resulting product undergoes further thermal degradation by such heating.
SUMMARY OF THE DISCLOSURE
It is therefore an object of the present invention to provide a dried mass or powder, granule, tablet or a medicine of a plant belonging to the genus Aloe of the family Liliaceae, which is free from the above described inconveniences in the conventional preparation of Aloe product.
It is another object of the present invention to provide a method for producing the dried mass or powder, granule, tablet or medicine.
According to the present invention, the above object is accomplished by the following dried mass, granule, tablet, and medicine and a method for producing the dried mass, granule, tablet and medicine.
i) A vacuum freeze-dried mass of a plant belonging to the genus Aloe of the family Liliaceae.
ii) A method for producing a dried mass of a plant belonging to the genus Aloe of the family Liliaceae comprising crushing the plant and freeze-drying the crushed mass in vacuum.
iii) A vacuum freeze-dried granule of a plant belonging to the genus Aloe of the family Liliaceae.
iv) A method for producing a granule of a plant belonging to the genus Aloe of the family Liliaceae comprising molding the dried mass according to item i) under pressure for granulating.
v) A tablet comprising a vacuum freeze-dried mass of a plant belonging to the genus Aloe of the family Liliaceae.
vi) A method for producing a tablet comprising tableting the granule according to item iii).
vii) A tablet according to item v) further comprising nutrient and/or medicinal ingredients.
viii) A method for producing a tablet comprising tableting the granule according to item iii) with nutrient or medically effective ingredients.
ix) A medicine comprising the tablet according to item v) or vii).
The dried mass, granule or the tablet according to the present invention exhibits the following properties:
i) It presents pale green color;
ii) It has a grassy smell;
iii) It has a strongly bitter taste;
iv) It is soluble in water, while being partially insoluble in methanol, ethanol or acetone;
v) In protein determination reactions, it is positive both in bicinchoninic acid (BCA) reaction and in Lowry-Folin reaction;
vi) As to saccharides determination reactions, it is positive in anthrone sulfuric acid reaction and in phenol sulfuric acid reaction;
vii) As to proteolytic enzyme activities, it has activities of carboxypeptidase and trypsin, and it has also protease-inhibitory activity;
viii) It exhibits positive cell agglutination activity with erythrocytes and weakly positive cell agglutination activity with cancer cells; and
ix) It exhibits weakly positive blastogenetic activity with lymphocytes.
The dried mass, granule and the tablet of the plant belonging to the genus Aloe of the family Liliaceae according to the present invention contains efficaceous ingredients endogenously contained in the genus Aloe of the family Liliaceae, such as polysaccharides, glycoproteins and enzymes, in a state substantially free from degradation otherwise caused by heating, such as thermal degradation or oxidation. A variety of physiologically active substances, found to be contained in the plant by animal experiments, such as aloin or aloe carboxypeptidase, are also present without undergoing thermal degradation. Hence, the dried mass, granule and tablet according to the present invention may be used as medicines, such as laxative, stomachics, anti-gastrointestinal ulcer drug, anti-inflammatory drug, anti-fungal drug, anti-hyperglycemia drug, anti-burn edema drug, or immunomodulator, or as a variety of health foods.
The tablet of the present invention may consist of 100% of the above mentioned dried mass, without the necessity of the additive for tableting as an essential constituent, so that a high quality tablet is provided which contains the efficaceous or medicinal ingredients of the plant belonging to the genus Aloe of the family Liliaceae with a high purity.
The tablet of the present invention is easy to swallow, even though it has a strong bitter taste and a flavor displayed by the plant when chewed.
In the present method for producing the dried mass of the present invention, the liquid obtained by crushing the plant belonging to the genus Aloe of the family Liliaceae is freeze-dried in vacuum, without resorting to the step of drying the liquid by heating at a temperature higher than the ambient temperature, therefore, the dried mass containing the above mentioned efficaceous ingredients in the plant is prepared without degrading those ingredients.
According to the method for preparing the granule of the present invention, the dried mass is press molded into the granule, and the granule containing the efficaceous ingredients is produced without thermally degrading these efficaceous ingredients.
In the method for producing the tablet of the present invention, the dried mass is press molded into the granule, and then tableted. Thus, the tablet containing the above mentioned efficaceous ingredients is produced without degrading the efficaceous ingredients in the plant. Since no additive for facilitating tableting is required, the tablet containing the above efficaceous ingredients in higher percentages are produced. Thus the tablet contains up to 100 percent of effective ingredients in the dried mass.
In this
Levy Neil S.
Morrison & Foerster / LLP
Yurika Incorporated
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