Organic compounds -- part of the class 532-570 series – Organic compounds – Fatty compounds having an acid moiety which contains the...
Reexamination Certificate
2002-04-16
2004-06-01
Carr, Deborah D. (Department: 1621)
Organic compounds -- part of the class 532-570 series
Organic compounds
Fatty compounds having an acid moiety which contains the...
C554S008000, C554S009000, C554S011000, C554S016000, C554S227000, C514S547000
Reexamination Certificate
active
06743930
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to natural pharmaceutical chemistry, especially relates to kernel oils extracted from plant kernels, more especially relates to kernel oils extracted from spine date (
Semen ziziphi spinosae
), flatspine pricklyash and walnut (
Semen persicae
), the process for preparing same, the pharmaceutical composition containing same and the medicinal use thereof.
BACKGROUND OF THE INVENTION
The spine date kernel and the flatspine pricklyash are Chinese traditional medicines for both medical- and food-purpose, which have functions such as nourishing liver, calming heart, constraining sweating, engendering liquid, warming the middle warmer to alleviate pain, killing parasites and relieving itch.
The walnut kernel is one of the Chinese traditional medicines for both medical- and food-purpose, and has functions of nourishing the kidney, warming the lung and moistening the bowel. However, walnut kernel oil has usually been used as an edible oil and has not been reported as a parenteral nutritional agent. The common walnut kernel oil preparation is not advantageous to human absorption, and its medical application is restricted since it is difficult for it to meet the clinic requirements as an intravenous emulsion. The backward technology of extraction and separation in the prior art induces in unqualified chemical and physical properties (such as acid value) and high impurity contents.
In the prior art, the fat emulsions prepared from the soya bean oil, the cotton seed oil and the red flower oil are commonly used to replenish nutrients and energy to human body. The fat emulsion made from soya bean oil is more widely used. However, no work on the improvement of immunological functions, the increase of serum proteins, the inhibition on transplanted tumor, experimental Lewis lung cancer and liver cancer HAC, and the functions of nourishing kidney, warming lung and loosening bowel has not been reported in the studies of the fat emulsion made from the soya bean oil.
Thus, the first aspect of the invention is to provide a kernel oil from kernels of plants which can be used for the preparation of a novel intravenous emulsion having functions of replenishing nutrients, improving immunologic function and increasing serum proteins.
The second aspect of the invention is to provide two special technological processes for the extraction of the kernel oil of the invention.
The third aspect of the invention is to provide a pharmaceutical composition containing the kernel oil of the invention, including intravenous emulsion and oral capsules. Said intravenous emulsion can replenish nutrients, improve immunologic function and increase serum proteins. Also, it has functions of nourishing kidney, warming lung and loosening bowel. In addition, it is not expensive.
The fourth aspect of the invention is to provide the use of the kernel oil of the invention in the preparation of remedies for the treatment of diseases such as tumors, AIDS and hypoimmunity, etc.
SUMMARY OF THE INVENTION
The kernel oil extracted from plant kernels according to the first aspect of the invention comprises triglycerides 90-99.9%, diglycerides 0.01-5%, monoglycerides 0.01-3%, sitosterol 0.1-2.5% and cyclolanosterol 0.01-1%.
One process for extracting the kernel oil of according to the invention comprises the steps of:
1) Crude extraction: the kernel/kernel powder being expressed or extracted with an organic solvent or via supercritical fluid extraction to obtain a crude oil;
2) Decoloring: decoloring the crude oil with an adsorbent decoloring agent to obtain a decolored oil;
3) Caustic refining: dissolving the decolored oil in petroleum ether, adding a stoichiometric amount of NaOH under agitation, standing still and demixing, then washing the organic phase, thus obtaining an emulsion;
4) Demulsifying: adding acetone into the emulsion with agitation, separating layers and achieving the upper layer of oil phase.
5) Adsorption and water-washing: Subjecting the oil phase to be adsorbed with neutral alumina and kaolin sequently, and filtered, then removing the organic solvent from the filtrate in nitrogen atmosphere, and washing the oil phase with worm water, drying, then adsorbing with neutral alumina, thus obtaining a refined oil.
Another process for extracting the kernel oil according to the invention comprises the steps of:
1) Crude extraction: the kernel/kernel powder being expressed or extracted with an organic solvent or via supercritical fluid extraction to obtain a crude oil;
2) Degumming: agitating and heating the crude oil, then adding phosphoric acid to render a complete reaction;
3) Caustic refining: adding NaOH or Na
2
CO
3
solution at the same temperature into the degummed oil to render a complete reaction, then standing still and demixing, thus obtaining a refined oil;
4) Water-washing: washing the caustic-refined oil with pure water to obtain a water-washed oil.
5) Dewatering: adding an adsorbent into the water-washed oil or heating the water-washed oil under vacuum to remove the water, thus obtaining a clear dewatered oil;
6) Decoloring: decoloring the dewatered oil with an adsorbent decoloring agent to obtain a decolored oil;
7) Deodorizing: heating the decolored oil with agitation under vacuum in nitrogen atmosphere to raise the oil temperature to 120-160° C., feeding steam made from pure water into the oil and further heating the oil to 160-260° C. and keeping for 0.5-2 hours, then cutting short the pure water steam, thus removing the moisture from the oil and obtaining deodorized oil.
2. The pharmaceutical composition according to the invention comprises a therapeutically effective amount of the kernel oil extracted from kernels of plants and one or more pharmaceutically acceptable adjuvants.
The invention also provides the use of the kernel oil from kernels of plants in the preparation of remedies for treating tumors, AIDS, hypoimmunity, infantile malnutrition, postoperation and diseases in need of supplementing fat elements.
DETAILED DESCRIPTION OF THE INVENTION
The kernel oil extracted from plant kernels according to the invention is a clear light yellow oily liquid which comprises triglycerides 90-99.9%, diglycerides 0.01-5%, monoglycerides 0.01-3%, sitosterol 0.1-2.5% and cyclolanosterol 0.01-1%.
The lipolysis of said kernel oil gives the following fatty acids: hexadecanoic acid 5-8%, octadecanoic acid 1-3%, octadecenic acid 18-30%, octadecadienoic acid 50-65% and calendic acid 6-14%.
The kernel oil of the invention possesses the following physical properties examined on the basis of fatty oil: relative density 0.920-0.930, refractive index 1.470-1.480, acid value<0.80, iodine value 120.0-155.0, saponification value 180.0-200.0, peroxide value<30.0 meq.kg
−1
, ignited residue 0.01-0.04%, arsenic salts<2 ppm, heavy metals<10 ppm, and mean molecular weight 873.96.
The preferred embodiments of the kernel oils of the invention are those extracted from kernels of spine date, flatspine pricklyash and walnut.
With the walnut kernel as an example, the first process for extracting kernel oils includes the following steps:
Primary extraction—The kernel/kernel powder being expressed or extracted with an organic solvent or via supercritical fluid extraction to obtain a crude walnut kernel oil;
Decoloring—Adding proper amount of petroleum ether into the crude oil and thoroughly mixing it, adding proper amount of activated carbon for injection-purpose, keeping the temperature constant, filtering the mixture, and recovering the petroleum ether, thus obtaining a decolored oil;
Caustic refining—Putting the decolored oil and a proper amount of petroleum ether into a reaction kettle, adding 2% NaOH in an amount calculated on basis of the acid value and the amount of the decolored oil with agitation, standing still, and removing the lower layer of liquid waste, then adding two fold of warm distilled water with agitation, standing still, and removing the lower layer of liquid waste, then washing once more in the same method, duration and water temperature as above, suffici
Carr Deborah D.
Fish & Richardson P.C.
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