Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-12-18
2004-09-28
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S774000
Reexamination Certificate
active
06797285
ABSTRACT:
TECHNICAL FIELD
The invention relates to leaves of
Cajanus Cajan
(
L
.)Millsp. and extract ,and pharmaceutical formulations thereof. The invention also relate to new uses of leaves of
Cajanus Cajan
(
L
.)Millsp. and extract, especially in pharmaceutical filed. The invention belongs to field of Chinese Traditional Medicine.
BACKGROUND OF THE INVENTION
Cajanus Cajan
(
L
.)Millsp. is a subtropical bush plant, which belongs to adjonus genus of popilionaccae family, grows in south part of China, and also is called as Liudou, Niudou, Dourong or Liudian in Chinese. The plant has effects of clearing away heat and detoxicating, promoting blood circulation and relieving blood stasis, antisepsis, relieving inflammatory. Its root has effects of clearing away heat and detoxicating, stopping bleeding and relieving pain, and killing parasites. The tender leaves of it can be used in treating aphtha when chewed in mouth; the juice pressed from its tender leaves can be used in treating jaundice; the pulp obtained by pounding its tender leaves have the function of eliminating slough and promoting tissue regeneration on wound; the decoction of its leaves can be effective in cough and diarrhea. CN 11 74052A disclosed medical use of
Cajanus Cajan
(
L
.)Millsp., however, it is not clear to obtain active component of the plant because it was used in combination with other components and wasn't extracted. Therefor, its use is limited.
DESCRIPTION OF THE INVENTION
It is an object of the invention to provide an extract from leaves of
Cajanus Cajan
(
L
.)Millsp., so-called its active component.
It is a further object of this invention to provide a process for the preparation of such extract.
It is also a object of this invention to provide an pharmaceutical formulation comprising leaves of
Cajanus Cajan
(
L
.)Millsp. or its extract as active component.
It is another object of this invention to provide new use of leaves of
Cajanus Cajan
(
L
.)Millsp. or its extract, that is new use in the preparation of pharmaceutical formulations.
The extract of leaves of
Cajanus Cajan
(
L
.)Millsp. can be obtained as follows:
(1) The Purification and Preparation of Crude Materials
Cajanus Cajan
(
L
.)Millsp.
[preparation] :The tender leaves and branches of
Cajanus Cajan
(
L
.)Millsp. is collected, removed impurity and old branches, cleaned and dried in the shade. They are cut into about 5 cm small parts and put in clean container for later use.
(2) Extraction, Concentrating and Drying of Drugs
These treated
Cajanus Cajan
(
L
.)Millsp. are put in multi-function extractor. Water is added in 10-fold amount of drugs, and then these drugs are immersed for about 0.5 to 2 hours. The mixture is decocted 14 times for 1-2 hours each times. After filtered, the filtrates is drew immediately into a vacuum concentrator(atmospheric pressure is −0.08 Mpa and temperature is 60° C.) and concentrated to relative density of 1.05-1.15 (detected at 60° C.). After filtered with 80 mush filter cloth, the filtrates is filtered by continuous centrifugation, and then the centrifugal fluid is dried by spray-drying process to obtain dried extract powder, that is the active component extract according to the invention which is put in clean and air-tight container.
In order to produce extract according to the invention, the preferable process includes the following steps. These treated
Cajanus Cajan
(
L
.)Millsp. are put in multi-function extractor. After water is added in 10-fold amount of drugs and these drugs are immersed for about 1 hour, the mixture is decocted 3 times for 1.5 hours each times. After filtered, the filtrates is drew immediately into a vacuum concentrator and concentrated under the condition of −0.08 Mpa and 60° C. to relative density of 1.05-1.15 (detected at 60° C.). After filtered with 80 mush filter clothes, the filtrates is filtered by continuous centrifugation at 15,000 r.p.m with the flow amount of 50L/hour, and then the centrifugal fluid is dried by spray-drying process under the condition of 180° C. at entrance, 4 seconds of dried time and 80° C. at exit. The resultant dried extract powder is put in clean and air-tight container.
The extract of leaves of
Cajanus Cajan
(
L
.)Millsp. can be formulated into pharmaceutical formulations for clinic use such as tablets, pills, powders, capsules, oral liquids and so on by standard methods, in which the extract is present as active component at effective therapeutic amount, in generally range from 0.01 to 99.9%, preferably, 1 to 90%, more preferably from 5 to 80%, most preferably from 10 to 70%. Alternatively, dried leaves of
Cajanus Cajan
(
L
.)Millsp. can be ground to powder as active component to formulated into clinic pharmaceutical formulations by standard methods.
The capsule of leaves of
Cajanus Cajan
(
L
.)Millsp. can be produced by mixing the extract optionally with excipient such as starch and filling into capsule. It is confirmed by tests that leaves of
Cajanus Cajan
(
L
.)Millsp. or extract thereof have the following novel medical uses.
1. The Use of Leaves of
Cajanus Cajan
(
L
.)Millsp. or Extract Thereof for Manufacture of a Medicament for the Treatment of Osteoporosis
In order to observe the effect of the capsule of leaves of
Cajanus Cajan
(
L
.)Millsp on experimental osteoporosis, the osteoporosis model is made by tretinoin. The result indicated that the capsule notably increased levels of calcium and phosphorus in serum, decreased the level of alkaline phosphatase, and enhanced BMC and BMD in rats. From the observation on pathological section, it is showed that the capsule significantly improved the quality of bone trabecula, reduced the numbers of osteoclast and promoted the growth of osteoblast and thereby prevented and treated osteoporosis.
2. The Use of Leaves of
Cajanus Cajan
(
L
.)Millsp. or Extract Thereof for Manufacture of a Medicament for the Treatment of Ischemic Necrosis of Caput Femoris
After established the New Zealand rabbit model of ischemic necrosis of caput femoris by horse serum-hormone, the capsule at high, middle and low dosages was administrated to the animals separately, normal control group and model control group were set simultaneously. The result showed that the capsule had notable effect on treatment of hormone-induced ischemic necrosis of caput femoris after detecting the density of bone tissue in proximal end of femur, observing by magnifying X-ray photo, pathologic examination by light microscope, observing under television microscope and dynamic measurement for metabolism of bone tissue.
3. The Effect of Leaves of
Cajanus Cajan
(
L
.)Millsp. or Extract Thereof on the Improvement of Hemorrheology
The test of microcirculation in rat mesentery demonstrated that the capsule can significantly increase velocity of blood flow, infinitesimal calculus of velocity and state of blood flow. The index of hemorrheology for rat acute hypostasis model displayed that the capsule can enhance the specific viscosity of total blood and plasma and decrease blood sedimentation.
4. The Use of Leaves of
Cajanus Cajan
(
L
.)Millsp. or Extract Thereof for Manufacture of a Medicament for Anti-inflammatory and Analagecization
The tests of dimethylbenzene induced inflammation on mice pinna and cotton ball granuloma on mice showed that the capsule can alleviated notably ear tumefaction reduced by dimethylbenzene and cotton ball granuloma. Tests of torsion method and hot plate method on mice showed that the capsule declined clearly the number of torsion mice, prolonged the period of the first torsion, increased percent of analgesis, and increased threshold value of pain on mice.
5. The Use of Leaves of
Cajanus Cajan
(
L
.)Millsp. or Extract Thereof for Manufacture of a Medicament for Enhancement of Immune Function
Mice were induced by prednisone acetate to low immune function. In these models, the capsule according to the invention not only have the trend of enhancing phagocytic function of mononuclear leukocyte in mice, but also increased markedly the weight of immune organs such as thymus, spleen and the level of h
Fish & Richardson P.C.
Oh Simon J.
Page Thurman K.
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