CN113476528A - Composition for inhibiting growth of tumor cells, improving qi and blood functions of human body and delaying senescence - Google Patents
Composition for inhibiting growth of tumor cells, improving qi and blood functions of human body and delaying senescence Download PDFInfo
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Abstract
The invention relates to a composition for inhibiting the growth of tumor cells, improving the qi and blood functions of a human body and delaying senescence. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients in proportion: rhodiola root, kudzu vine root, sea-buckthorn, wolfberry fruit, acanthopanax root and American ginseng. The Chinese medicinal composition has the biological properties of inhibiting the growth of tumor cells, improving the qi and blood functions of a human body and delaying senility. In addition, the related Chinese medicinal composition also has the biological properties of improving anoxia endurance and enhancing immunity. The traditional Chinese medicine composition of the invention has excellent technical effects as described in the specification.
Description
Technical Field
The invention belongs to the technical field of medicines, relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition containing rhodiola rosea and other medicinal materials, and particularly relates to a traditional Chinese medicine composition with biological properties of inhibiting tumor cell growth, improving qi and blood functions of a human body and delaying senescence. In addition, the related Chinese medicinal composition also has the biological properties of improving anoxia endurance and enhancing immunity.
Background
Rhodiola rosea, which is a dry root and rhizome of Rhodiola crenulata (hook.f. et Thoms.) h.ohba, a plant of the family crassulaceae, has been included in the chinese pharmacopoeia, 2015 edition and 2020 edition. In autumn, the flower stems are withered, picked and dug, the rough skin is removed, cleaned and dried in the sun. The rhodiola root is a perennial herb and 10-20 cm high. Thick root, cone shape, fleshy, brownish yellow, root neck with most fibrous root, short rhizome, thick shape, cylindrical shape, covered by most of the tile-shaped arranged scaly leaves. The ecological floating bed grows in a high and cold non-pollution area with the altitude of 1800 and 2500 meters, and the growth environment is severe, so that the ecological floating bed has strong vitality and special adaptability. Can be used as a medicine, can tonify qi, clear away the lung-heat, benefit intelligence and nourish the heart, and is a traditional Chinese medicine with wide effect. It also has good skin caring effect, and can be used as skin care product or edible product. Rhodiola root is mild in nature and sweet and bitter in taste; it enters lung and heart meridians. Has the effects of benefiting qi, activating blood circulation, dredging collaterals and relieving asthma. It is clinically used for treating qi deficiency and blood stasis, chest stuffiness and pains, apoplexy hemiplegia, listlessness and asthma. The first medical book of ancient China, Shennong Ben Cao Jing, listed rhodiola as a medicine top grade, took rhodiola root to lighten body and benefit qi, did not prolong life, was nontoxic and was taken for a long time without hurting people. Has the effects of tonifying kidney, regulating qi and nourishing blood, and is mainly used for treating weakness, chest distress and the like of the whole body; also has effects in promoting blood circulation, stopping bleeding, clearing lung-heat, relieving cough, relieving fever, and stopping leukorrhagia. The Tibetan medicine of the four departments also relates to the record of rhodiola, namely that the rhodiola is mild in nature, astringent in taste, good in moistening lung, capable of tonifying kidney, regulating qi and nourishing blood. It can be used for treating asthenia, chest distress, nausea, and asthenia. The record of "Jingzhu materia Medica": radix Rhodiolae has effects in promoting blood circulation, clearing away lung-heat, relieving cough, relieving fever, and relieving pain, and can be used for treating pneumonia, tracheitis, asthenia, chest distress, difficulty in ventilation, and purple lips and palm. The record of the Ming dynasty Li Shizhen Ben Cao gang mu: rhodiola root, the top grade of the original meridian, eliminates pathogenic factors and evil qi and tonifies various deficiencies is a rare herb in known tonic medicines. The term "Jingtian flavor picric acid in Qianjin pteride Fang" is nontoxic. Mainly treat the symptoms of large heat and sore, fever and vexation, evil and evil, venomous scab and other defects, and the flower owner and the woman can leak red and white, clear the body and improve the eyesight, and can be taken for a long time to refresh the mind and be not old. The Chinese medicine dictionary records: rhodiola root is cold in nature and sweet and astringent in taste. Activate blood and stop bleeding, clear lung heat and relieve cough. It can be used for treating hemoptysis, pneumonia, and cough. Common Tibet Chinese herbal medicine: radix Rhodiolae also has effects of promoting blood circulation, stopping bleeding, clearing lung-heat, relieving cough, relieving fever, and stopping leukorrhagia. It can be used for treating hemoptysis, cough due to pneumonia, and leukorrhagia.
The traditional Chinese medicine composition prepared from rhodiola rosea, kudzu root, sea buckthorn, medlar, acanthopanax and American ginseng has excellent biological effects of improving anoxia endurance and enhancing immunity, and other biological effects of the composition are also expected, such as biological effects of inhibiting tumor cell growth, improving qi and blood functions of a human body, delaying senescence and the like.
In addition, in view of the limitation of the shortage of rhodiola herb resources, it is expected by those skilled in the art to improve the utilization rate of rhodiola herb.
There are many kinds of rhodiola extraction methods, and the conventional method is ethanol aqueous solution extraction or water extraction, and these methods have the disadvantages of high energy consumption and loss of some active substances caused by high-temperature treatment. CN102688276A (CN201210206424.4) discloses a method for microwave wall-breaking assisted extraction of rhodiola rosea injection, which comprises the following preparation steps: the rhodiola rosea medicinal material is moistened through a moistening machine, the medicine is thoroughly permeated, microwave wall breaking is carried out through a tunnel microwave dryer, the microwave power is 20kw, the conveying belt speed is 2m/min, the medicinal material after wall breaking is put into an extraction tank for low-temperature reduced pressure extraction, the extraction temperature is 75-80 ℃, and salidroside extracting solution is obtained. The microwave wall breaking assisted extraction technology is believed to be adopted in the document, dry medicinal materials are moistened by a moistening machine, dehydrated cells absorb water and swell, and microwave energy is absorbed to the maximum extent, so that the cell wall breaking is facilitated, active ingredients in the medicinal materials are rapidly released under negative pressure and low temperature, the extraction time is greatly shortened, the energy consumption is saved, and impurities are obviously reduced. However, the present inventors found that the extraction efficiency of bioactive substances of the extract obtained by the wall-breaking extraction method of rhodiola rosea still needs to be improved.
Therefore, those skilled in the art still expect new methods for preparing pharmaceutical compositions comprising rhodiola, and especially expect new methods for preparing pharmaceutical compositions comprising rhodiola extract, which are expected to have higher extraction rate of active substances and/or better spectrum of active substances, and the pharmaceutical compositions prepared thereby are expected to have excellent biological activity.
Disclosure of Invention
The present invention is intended to provide a novel method for preparing a pharmaceutical composition (also referred to as a chinese medicinal composition or a composition) comprising rhodiola, and particularly, a novel method for preparing a pharmaceutical composition comprising a rhodiola extract, which is expected to have a higher extraction rate of active substances and/or a better spectrum of active substances, and a pharmaceutical composition prepared therefrom having an excellent biological activity. It has been surprisingly found that one or more of the above objects can be achieved by the process of the present invention, and the present invention has been completed based on such findings.
Therefore, the invention provides a traditional Chinese medicine composition in a first aspect, which is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients: 1000 parts of rhodiola rosea, 575-675 parts of kudzu root, 200-300 parts of sea buckthorn, 200-300 parts of wolfberry fruit, 200-300 parts of acanthopanax and 100-150 parts of American ginseng.
The traditional Chinese medicine composition according to the first aspect of the invention is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients: 1000 parts of rhodiola rosea, 600-650 parts of kudzu root, 225-275 parts of sea buckthorn, 225-275 parts of wolfberry fruit, 225-275 parts of acanthopanax and 110-140 parts of American ginseng.
The traditional Chinese medicine composition according to the first aspect of the invention is prepared by the following method:
(1) adding purified water with the weight 6-10 times that of the kudzu root, the sea buckthorn, the acanthopanax and the wolfberry fruit into the kudzu root, decocting and extracting the mixture for 1-3 hours, and taking decoction liquid; adding 5-8 times of purified water into the medicine residues, decocting and extracting for 1-2 hours, and separating decoction; preparing rhodiola rosea extract by using a microwave wall-breaking extraction method;
(2) mixing the decoctions, filtering, and concentrating to obtain a clear paste with a relative density of 1.15-1.20 (50 ℃); spray drying to obtain radix Puerariae mixed extract;
(3) mixing radix Puerariae mixed extract and radix Rhodiolae extract, pre-pulverizing to 100 mesh radix Panacis Quinquefolii fine powder, mixing, optionally adding appropriate amount of adjuvant, mixing, making soft mass with 65% ethanol, making wet granule, and drying to obtain granular Chinese medicinal composition.
The traditional Chinese medicine composition according to the first aspect of the invention is in the form of capsules, granules, tablets and other preparations. The preparation of the granular Chinese medicinal composition obtained by the above method into preparations in the form of capsules, granules, tablets and the like is easily realized by those skilled in the art according to the prior knowledge.
The traditional Chinese medicine composition according to the first aspect of the invention, wherein in the step (2), the water content of the obtained kudzu root mixed extract is less than 3.5%.
The traditional Chinese medicine composition according to the first aspect of the invention, wherein in the step (2), the water content of the obtained dried granules is less than 3.5%.
The traditional Chinese medicine composition according to the first aspect of the invention is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients: 1000 parts of rhodiola rosea, 315-340 parts of epimedium, 100-120 parts of fructus amomi, 315-340 parts of prepared rehmannia root, 100-120 parts of wolfberry fruit, 63-67 parts of cinnamon, 43-47 parts of clove, 100-120 parts of ginseng fruit and 100-120 parts of Chinese yam.
The traditional Chinese medicine composition according to the first aspect of the invention is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients: 1000 parts of rhodiola rosea, 625 parts of kudzuvine root, 250 parts of sea-buckthorn, 250 parts of medlar, 250 parts of acanthopanax and 125 parts of American ginseng.
The traditional Chinese medicine composition according to the first aspect of the invention is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients: 1000 parts of rhodiola rosea, 675 parts of kudzu root, 200 parts of sea buckthorn, 300 parts of wolfberry fruit, 225 parts of acanthopanax and 150 parts of American ginseng.
The traditional Chinese medicine composition according to the first aspect of the invention is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients: 1000 parts of rhodiola rosea, 575 parts of kudzu root, 300 parts of sea-buckthorn, 200 parts of wolfberry fruit, 275 parts of acanthopanax and 100 parts of American ginseng.
The traditional Chinese medicine composition according to the first aspect of the invention is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients: 1000 parts of rhodiola rosea, 600 parts of kudzu root, 275 parts of sea-buckthorn, 225 parts of wolfberry fruit, 300 parts of acanthopanax and 110 parts of American ginseng.
The traditional Chinese medicine composition according to the first aspect of the invention is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients: 1000 parts of rhodiola rosea, 650 parts of kudzu root, 225 parts of sea-buckthorn, 275 parts of wolfberry fruit, 200 parts of acanthopanax and 140 parts of American ginseng.
According to the first aspect of the invention, the rhodiola rosea extract is prepared by the following method:
(a) taking rhodiola rosea medicinal materials, and moistening the medicinal materials by using a vacuum medicine moistening machine, wherein the ratio of the medicinal materials to water is 1: 1 to 1.5 are, for example, 1: 1-1.4, thoroughly permeating the medicine, and breaking the wall by microwave through a tunnel microwave dryer;
(b) extracting the broken medicinal materials with 3-5 times of water by weight in a water extraction tank for 2 hours, and collecting an extracting solution;
(c) extracting the medicine residues and 2.5-3.5 times of water by weight in the extraction tank again for 1 hour under the same condition, and collecting the extracting solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain radix Rhodiolae extract.
The traditional Chinese medicine composition according to the first aspect of the invention, wherein: moistening the medicines in a vacuum moistening machine under the conditions of vacuum degree of-0.06 Mpa and vacuum softening time of 45 min; adding 0.3-0.5 v/v% of glacial acetic acid and 0.5-1 w/v% of calcium chloride into the water obtained in the step (a); performing microwave wall breaking under the conditions of microwave power of 20kw, conveying belt speed of 2m/min and temperature of 20-25 ℃; microwave wall breaking is carried out until the water content of the medicinal materials is reduced to 8-12%; and/or (b) extracting in an extraction tank under the conditions of vacuum degree of-0.05 to-0.06 Mpa, extraction temperature of 75 to 80 ℃ and steam pressure of 0.06 to 0.09 Mpa.
Further, the second aspect of the present invention provides a method for preparing the Chinese medicinal composition according to any one of the embodiments of the first aspect of the present invention, which comprises the following steps:
(1) adding purified water with the weight 6-10 times that of the kudzu root, the sea buckthorn, the acanthopanax and the wolfberry fruit into the kudzu root, decocting and extracting the mixture for 1-3 hours, and taking decoction liquid; adding 5-8 times of purified water into the medicine residues, decocting and extracting for 1-2 hours, and separating decoction; preparing rhodiola rosea extract by using a microwave wall-breaking extraction method;
(2) mixing the decoctions, filtering, and concentrating to obtain a clear paste with a relative density of 1.15-1.20 (50 ℃); spray drying to obtain radix Puerariae mixed extract;
(3) mixing radix Puerariae mixed extract and radix Rhodiolae extract, pre-pulverizing to 100 mesh radix Panacis Quinquefolii fine powder, mixing, optionally adding appropriate amount of adjuvant, mixing, making soft mass with 65% ethanol, making wet granule, and drying to obtain granular Chinese medicinal composition.
The traditional Chinese medicine composition according to the first aspect of the invention is in the form of capsules, granules, tablets and other preparations. The preparation of the granular Chinese medicinal composition obtained by the above method into preparations in the form of capsules, granules, tablets and the like is easily realized by those skilled in the art according to the prior knowledge.
The method according to the second aspect of the present invention, wherein in the step (2), the water content of the obtained pueraria lobata mixed extract is less than 3.5%.
The process according to the second aspect of the present invention, wherein in step (2), the moisture content of the resulting dried granules is less than 3.5%.
According to the method of the second aspect of the present invention, the rhodiola rosea extract is prepared by the following method:
(a) taking rhodiola rosea medicinal materials, and moistening the medicinal materials by using a vacuum medicine moistening machine, wherein the ratio of the medicinal materials to water is 1: 1 to 1.5 are, for example, 1: 1-1.4, thoroughly permeating the medicine, and breaking the wall by microwave through a tunnel microwave dryer;
(b) extracting the broken medicinal materials with 3-5 times of water by weight in a water extraction tank for 2 hours, and collecting an extracting solution;
(c) extracting the medicine residues and 2.5-3.5 times of water by weight in the extraction tank again for 1 hour under the same condition, and collecting the extracting solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain radix Rhodiolae extract.
The method according to the second aspect of the invention, wherein: moistening the medicines in a vacuum moistening machine under the conditions of vacuum degree of-0.06 Mpa and vacuum softening time of 45 min; adding 0.3-0.5 v/v% of glacial acetic acid and 0.5-1 w/v% of calcium chloride into the water obtained in the step (a); performing microwave wall breaking under the conditions of microwave power of 20kw, conveying belt speed of 2m/min and temperature of 20-25 ℃; microwave wall breaking is carried out until the water content of the medicinal materials is reduced to 8-12%; and/or (b) extracting in an extraction tank under the conditions of vacuum degree of-0.05 to-0.06 Mpa, extraction temperature of 75 to 80 ℃ and steam pressure of 0.06 to 0.09 Mpa.
Furthermore, the third aspect of the present invention provides an application of the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention in preparing a product for improving hypoxia tolerance and immunity, or in preparing a product for inhibiting tumor cell growth, improving qi and blood functions of a human body, and delaying aging.
Further, the fourth aspect of the present invention provides a rhodiola root extract, which is prepared by the following method:
(a) taking rhodiola rosea medicinal materials, and moistening the medicinal materials by using a vacuum medicine moistening machine, wherein the ratio of the medicinal materials to water is 1: 1 to 1.5 are, for example, 1: 1-1.4, thoroughly permeating the medicine, and breaking the wall by microwave through a tunnel microwave dryer;
(b) extracting the broken medicinal materials with 3-5 times of water by weight in a water extraction tank for 2 hours, and collecting an extracting solution;
(c) extracting the medicine residues and 2.5-3.5 times of water by weight in the extraction tank again for 1 hour under the same condition, and collecting the extracting solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain radix Rhodiolae extract.
The rhodiola rosea extract according to the fourth aspect of the present invention, wherein: moistening the medicines in a vacuum moistening machine under the conditions of vacuum degree of-0.06 Mpa and vacuum softening time of 45 min; adding 0.3-0.5 v/v% of glacial acetic acid and 0.5-1 w/v% of calcium chloride into the water obtained in the step (a); performing microwave wall breaking under the conditions of microwave power of 20kw, conveying belt speed of 2m/min and temperature of 20-25 ℃; microwave wall breaking is carried out until the water content of the medicinal materials is reduced to 8-12%; and/or (b) extracting in an extraction tank under the conditions of vacuum degree of-0.05 to-0.06 Mpa, extraction temperature of 75 to 80 ℃ and steam pressure of 0.06 to 0.09 Mpa.
Further, the fifth aspect of the present invention provides a method for preparing a rhodiola rosea extract, which comprises the following steps:
(a) taking rhodiola rosea medicinal materials, and moistening the medicinal materials by using a vacuum medicine moistening machine, wherein the ratio of the medicinal materials to water is 1: 1 to 1.5 are, for example, 1: 1-1.4, thoroughly permeating the medicine, and breaking the wall by microwave through a tunnel microwave dryer;
(b) extracting the broken medicinal materials with 3-5 times of water by weight in a water extraction tank for 2 hours, and collecting an extracting solution;
(c) extracting the medicine residues and 2.5-3.5 times of water by weight in the extraction tank again for 1 hour under the same condition, and collecting the extracting solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain radix Rhodiolae extract.
The method according to the fifth aspect of the invention, wherein: moistening the medicines in a vacuum moistening machine under the conditions of vacuum degree of-0.06 Mpa and vacuum softening time of 45 min; adding 0.3-0.5 v/v% of glacial acetic acid and 0.5-1 w/v% of calcium chloride into the water obtained in the step (a); performing microwave wall breaking under the conditions of microwave power of 20kw, conveying belt speed of 2m/min and temperature of 20-25 ℃; microwave wall breaking is carried out until the water content of the medicinal materials is reduced to 8-12%; and/or (b) extracting in an extraction tank under the conditions of vacuum degree of-0.05 to-0.06 Mpa, extraction temperature of 75 to 80 ℃ and steam pressure of 0.06 to 0.09 Mpa.
In the above-described steps of the preparation method of the present invention, although the specific steps described therein are distinguished in some detail or in language description from the steps described in the preparation examples of the detailed embodiments below, those skilled in the art can fully summarize the above-described method steps in light of the detailed disclosure throughout the present disclosure.
Any embodiment of any aspect of the invention may be combined with other embodiments, as long as they do not contradict. Furthermore, in any embodiment of any aspect of the invention, any feature may be applicable to that feature in other embodiments, so long as they do not contradict. The invention is further described below.
All documents cited herein are incorporated by reference in their entirety and to the extent such documents do not conform to the meaning of the present invention, the present invention shall control. Further, the various terms and phrases used herein have the ordinary meaning as is known to those skilled in the art, and even though such terms and phrases are intended to be described or explained in greater detail herein, reference is made to the term and phrase as being inconsistent with the known meaning and meaning as is accorded to such meaning throughout this disclosure.
The traditional Chinese medicine composition is prepared from rhodiola rosea, kudzu root, sea buckthorn, wolfberry fruit, acanthopanax and American ginseng.
The rhodiola root has the functions of benefiting qi, activating blood circulation, dredging collaterals and relieving asthma. Can be used for treating qi deficiency, blood stasis, thoracic obstruction, cardiodynia, apoplexy, hemiplegia, listlessness, and asthma. Clear lung heat to relieve cough. It can be used for treating hemoptysis, pneumonia, and cough. Invigorating qi, clearing away lung-heat, improving intelligence, nourishing heart, astringing, stopping bleeding, removing blood stasis, and relieving swelling. Can be used for treating qi deficiency, asthenia, aversion to cold, short breath, asthenia, cough due to lung heat, hemoptysis, leucorrhea diarrhea, and traumatic injury.
Salidroside can inhibit tumor cell proliferation by interfering cell metabolism and changing properties of cell coat, and also can improve T lymphocyte transformation rate and phagocyte activity, enhance immunity, inhibit tumor growth, increase leukocyte, and resist microwave radiation. Rhodiola rosea extract with salidroside as main ingredient can restore immune system to normal by improving T-cell immunity, enhance immunity, and further improve resistance of organism to accumulated toxin due to gradual development of infection; the rhodiola rosea is used for eliminating melancholy, is used for improving the mental state of people and becomes a valuable medicine for people living in countries and seasons which cannot be irradiated by enough sunlight due to the prolonged period of months; rhodiola rosea extract is used for protecting cardiovascular system, and has been shown to alleviate cardiovascular tissue damage and dysfunction caused by stress, prevent the decrease of cardiac contractility due to ambient stress in a scrabble state and contribute to stabilization of contractility.
The wall-breaking extraction method of the reference literature in the preparation of the rhodiola rosea extract comprises the steps of firstly moistening the medicinal materials by using a vacuum medicine moistening machine, then carrying out microwave wall-breaking in a microwave dryer, and then putting the medicinal materials into an extraction tank for extraction. The vacuum herbal medicine infiltrating machine has the working principle that air in gaps of medicinal material fibers is pumped out by vacuum, water rapidly enters plant cell tissues through capillaries under the negative pressure condition, and the purpose of infiltrating is to make dehydrated plant cells absorb water and swell, so that conditions are created for subsequent processes. The principle of using microwave drying equipment to break the cell wall is that the dried material absorbs microwave energy in a microwave drying equipment field and is converted into heat, moisture is evaporated through the heat, and the cell wall is broken in the process of discharging the moisture from inside to outside, so that the purposes of drying the material and breaking the cell wall are achieved. The microwave drying equipment comprises: tunnel type microwave drying equipment, box type microwave drying equipment and vacuum type microwave drying equipment. When the polar medium is not added with an electric field, the dipoles of the polar medium do disorder movement, and the whole body is electrically neutral; when an external electric field is applied, the dipoles in the medium are rearranged in a directional manner, namely, one end with positive electricity tends to the negative electrode, and the other end with negative electricity tends to the positive electrode, so that the dipoles which move disorderly and are not regularly arranged become polarized molecules with certain orientation and regular arrangement, and meanwhile, the external electric field gives potential energy to the dipoles. The stronger the polarization of the medium, the more energy the medium stores, and if the direction of the electric field is changed, the direction of the dipole arrangement is changed. During the transformation, due to the thermal movement of the molecules, the interaction between adjacent molecules and the pole-changing effect of the polar molecules, a friction-like effect is generated, so that the polar molecules acquire energy and are expressed in the form of thermal energy, and the temperature of the medium is increased. During microwave drying, microwave energy is transmitted into the material and absorbed by water, the microwave energy is instantaneously converted into heat energy to simultaneously heat the inside and the outside of the material, so that the pressure of water vapor in the inner layer is suddenly increased, the water vapor is driven to be discharged to the surface layer to cause cell wall rupture, the inner layer of the material firstly appears a drying layer and gradually expands towards the outer layer, and the drying sequence from inside to outside is completely different from that of the conventional drying process.
The sea buckthorn used in the composition has the effects of strengthening spleen and promoting digestion, relieving cough and eliminating phlegm, activating blood and dissolving stasis, and nourishing yin and promoting the production of body fluid, and is clinically used for treating spleen deficiency and anorexia, food retention and abdominal pain, cough with excessive phlegm, chest stuffiness and pain, blood stasis and amenorrhea, and traumatic injury and swelling.
The American ginseng used in the composition has the effects of tonifying qi and nourishing blood, nourishing yin and tonifying kidney, strengthening spleen and nourishing stomach, delaying senescence and beautifying, and is clinically used for resisting fatigue, resisting aging and shock, improving thinking, improving memory and endocrine, enhancing human immunity and improving cardiovascular function.
The medlar used by the composition has the effects of nourishing kidney, moistening lung, tonifying liver and improving eyesight, and is clinically used for treating liver and kidney yin deficiency, soreness and weakness of waist and knees, dizziness, blurred vision, hyperdacryosis, consumptive disease, cough, diabetes and spermatorrhea.
The kudzu root used by the composition has the effects of relieving muscles and fever, promoting eruption, promoting the production of body fluid to quench thirst, and invigorating yang and relieving diarrhea, and is clinically used for exterior syndrome fever, neck and back pain, measles without adequate eruption, fever thirst, yin deficiency and thirst quenching, heat diarrhea and dysentery, and spleen deficiency and diarrhea.
The acanthopanax used by the composition has the effects of tonifying qi and spleen, tonifying kidney and soothing nerves, and is clinically used for treating spleen-kidney yang deficiency, soreness and weakness of waist and knees, weakness and hypodynamia, insomnia, dreaminess and inappetence.
According to the biological effects of the medicinal materials, the composition has the effects of inhibiting the growth of tumor cells, improving the qi and blood functions of a human body and delaying senescence.
The process of the invention and the products obtained exhibit excellent technical effects as described in the context herein.
Detailed Description
The present invention will be further described by the following examples, however, the scope of the present invention is not limited to the following examples. It will be understood by those skilled in the art that various changes and modifications may be made to the invention without departing from the spirit and scope of the invention. The present invention has been described generally and/or specifically with respect to materials used in testing and testing methods. Although many materials and methods of operation are known in the art for the purpose of carrying out the invention, the invention is nevertheless described herein in as detail as possible. The following examples further illustrate the invention without limiting it. In the present invention, rhodiola rosea medicinal materials used in various experiments were measured to have a salidroside content of 0.7143% by [ HPLC1 method ], i.e., 1000g of dried medicinal materials contained 7.143g of salidroside, unless otherwise specified. In the present invention, rhodiola root crude drugs used in various experiments were previously washed and pulverized into granules that can pass through a No. one sieve, as not otherwise specified. When referring to the recovery of salidroside, it is calculated from the ratio of the weight of salidroside in the extract to the weight of salidroside in the equivalent dosed amount of drug material, as not otherwise indicated. The vacuum herbal medicine infiltrating machine used in the embodiment of the invention is RYJ-100 model, the tunnel microwave dryer is QX-30HM7 model, the extraction tank is TNH-20 model, and other types of equipment can be used as long as the same working parameters as those of the invention are set.
The [ HPLC1 method ] for determining the salidroside content in various materials of the invention is operated as follows:
performing high performance liquid chromatography (China pharmacopoeia 2020 edition four ministry of general regulation 0512);
chromatographic conditions and system applicability test: octadecylsilane chemically bonded silica is used as a filling agent; taking methanol-water (15: 85) as a mobile phase, and detecting the wavelength at 275 nm;
the number of theoretical plates is not less than 2000 calculated according to salidroside peak;
preparation of control solutions: taking a proper amount of salidroside reference substance, precisely weighing, and adding methanol to obtain solution containing 0.5mg per 1 ml;
preparing a test solution (when the test is a medicinal material): taking 0.5g of sample powder passing through a third sieve, precisely weighing, placing in a conical flask with a plug, precisely adding 10ml of methanol, sealing the plug, weighing, ultrasonically treating for 30 minutes, cooling, weighing again, supplementing the lost weight with methanol, shaking up, filtering, and taking the subsequent filtrate;
preparation of test solution (when the test is various extracts): precisely weighing a sample corresponding to 0.5g of rhodiola rosea medicinal material, placing the sample into a conical flask with a plug, precisely adding 10ml of methanol, sealing the plug, weighing, ultrasonically treating for 30 minutes, cooling, weighing again, supplementing the lost weight with methanol, shaking up, filtering, and taking a subsequent filtrate to obtain the rhodiola rosea medicinal material;
the determination method comprises the following steps: precisely sucking 10 μ l of each of the reference solution and the sample solution, respectively, injecting into a liquid chromatograph, measuring, converting the sample into dry product, and calculating the amount of salidroside in the sample.
Example 1: preparing rhodiola root extract
(1) Taking 1kg of rhodiola rosea medicinal material, moistening the medicinal material by using a vacuum moistening machine (the vacuum degree is-0.06 Mpa, the vacuum softening time is 45min), wherein the ratio of the medicinal material to water (0.4 v/v% glacial acetic acid and 0.75 w/v% calcium chloride are added in the water) is 1: 1.2, completely permeating the medicinal materials, and performing microwave wall breaking (until the water content of the medicinal materials is reduced to 8-12%) by a tunnel microwave dryer (the microwave power is 20kw, the conveying speed is 2m/min, and the temperature is 20-25 ℃);
(2) extracting the wall-broken medicinal materials with a 4-time weight of water in an extraction tank (vacuum degree is-0.05 to-0.06 Mpa, extraction temperature is 75 to 80 ℃, and steam pressure is 0.06 to 0.09Mpa) for 2 hours, and collecting an extracting solution (HPLC 1 method) to obtain 5.307g of salidroside in the extracting solution, wherein the recovery rate is 74.3 percent;
(3) extracting the medicine residues and 3 times of water in the same condition in an extraction tank for 1 hour again, and collecting the extracting solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain 128.3g radix Rhodiolae extract (water content 3.25%, [ HPLC1 method ]) with salidroside content 5.957g and salidroside recovery rate 83.4%.
Example 2: preparing rhodiola root extract
(1) Taking 1kg of rhodiola rosea medicinal material, moistening the medicinal material by using a vacuum moistening machine (the vacuum degree is-0.06 Mpa, the vacuum softening time is 45min), wherein the ratio of the medicinal material to water (0.3 v/v% glacial acetic acid and 1w/v% calcium chloride are added in the water) is 1: 1.4, completely permeating the medicinal materials, and performing microwave wall breaking (until the water content of the medicinal materials is reduced to 8-12%) by a tunnel microwave dryer (the microwave power is 20kw, the conveying speed is 2m/min, and the temperature is 20-25 ℃);
(2) extracting the wall-broken medicinal materials with a 5-time weight of water in an extraction tank (vacuum degree is-0.05 to-0.06 Mpa, extraction temperature is 75 to 80 ℃, and steam pressure is 0.06 to 0.09Mpa) for 2 hours, and collecting an extracting solution (HPLC 1 method is adopted, the content of salidroside in the extracting solution is 5.463g, and the recovery rate is 76.4%);
(3) extracting the residues and 2.75 times of water again in the extraction tank under the same condition for 1 hr, and collecting the extractive solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain rhodiola extract 126.5g (water content 3.11%, [ HPLC1 method ]) with salidroside content 6.072g, and salidroside recovery rate 85.0%.
Example 3: preparing rhodiola root extract
(1) Taking 1kg of rhodiola rosea medicinal material, moistening the medicinal material by using a vacuum moistening machine (the vacuum degree is-0.06 Mpa, the vacuum softening time is 45min), wherein the ratio of the medicinal material to water (0.5 v/v% glacial acetic acid and 0.5 w/v% calcium chloride are added in the water) is 1: 1, thoroughly permeating the medicinal materials, and performing microwave wall breaking (until the water content of the medicinal materials is reduced to 8-12%) by a tunnel microwave dryer (the microwave power is 20kw, the conveying speed is 2m/min, and the temperature is 20-25 ℃);
(2) extracting the wall-broken medicinal materials with 3 times of water in an extraction tank (vacuum degree is-0.05 to-0.06 Mpa, extraction temperature is 75 to 80 ℃, and steam pressure is 0.06 to 0.09Mpa) for 2 hours, and collecting an extracting solution (the content of salidroside in the extracting solution is 5.256g by HPLC1 method, and the recovery rate is 73.6%);
(3) extracting the residues and 3.25 times of water in the same condition in an extraction tank for 1 hr, and collecting the extractive solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain rhodiola extract 134.6g (water content 4.31%, [ HPLC1 method ]) with rhodiola glycoside content 5.936g and rhodiola glycoside recovery rate 83.1%.
Example 4: preparing rhodiola root extract
(1) Taking 1kg of rhodiola rosea medicinal material, moistening the medicinal material by using a vacuum moistening machine (the vacuum degree is-0.06 Mpa, the vacuum softening time is 45min), wherein the ratio of the medicinal material to water (0.45 v/v% glacial acetic acid and 0.65 w/v% calcium chloride are added in the water) is 1: 1.1, completely permeating the medicinal materials, and performing microwave wall breaking (until the water content of the medicinal materials is reduced to 8-12%) by a tunnel microwave dryer (the microwave power is 20kw, the conveying speed is 2m/min, and the temperature is 20-25 ℃);
(2) extracting the wall-broken medicinal materials with 3.5 times of water in an extraction tank (vacuum degree is-0.05 to-0.06 Mpa, extraction temperature is 75 to 80 ℃, and steam pressure is 0.06 to 0.09Mpa) for 2 hours, and collecting an extracting solution (HPLC 1 method is adopted to measure the salidroside content in the extracting solution to be 5.264g, and the recovery rate is 73.7%);
(3) extracting the residues and 3.5 times of water in the same condition in an extraction tank for 1 hr, and collecting the extractive solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain rhodiola extract 127.6g (water content 3.73%, [ HPLC1 method ]) with rhodiola glycoside content 5.973g, and rhodiola glycoside recovery rate 83.6%.
Example 5: preparing rhodiola root extract
(1) Taking 1kg of rhodiola rosea medicinal material, moistening the medicinal material by using a vacuum moistening machine (the vacuum degree is-0.06 Mpa, the vacuum softening time is 45min), wherein the ratio of the medicinal material to water (0.35 v/v% glacial acetic acid and 0.85 w/v% calcium chloride are added in the water) is 1: 1.3, completely permeating the medicinal materials, and performing microwave wall breaking (until the water content of the medicinal materials is reduced to 8-12%) by a tunnel microwave dryer (the microwave power is 20kw, the conveying speed is 2m/min, and the temperature is 20-25 ℃);
(2) extracting the wall-broken medicinal materials with a 4.5-fold weight of water in an extraction tank (the vacuum degree is-0.05 to-0.06 Mpa, the extraction temperature is 75 to 80 ℃, and the steam pressure is 0.06 to 0.09Mpa) for 2 hours, and collecting an extracting solution (the content of salidroside in the extracting solution is 5.164g measured by an HPLC1 method, and the recovery rate is 72.3%);
(3) extracting the residues and 2.5 times of water in the same condition in an extraction tank for 1 hr, and collecting the extractive solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain rhodiola rosea extract 143.2g (water content 4.36%, [ HPLC1 method ]) with salidroside content 5.984g, and salidroside recovery rate 83.8%.
Example 6: preparing radix RhodiolaeExtract of plant
(1) Taking 1kg of rhodiola rosea medicinal material, moistening the medicinal material by using a vacuum moistening machine (the vacuum degree is-0.06 Mpa, the vacuum softening time is 45min), wherein the ratio of the medicinal material to water (0.4 v/v% glacial acetic acid is added in the water) is 1: 1.2, completely permeating the medicinal materials, and performing microwave wall breaking (until the water content of the medicinal materials is reduced to 8-12%) by a tunnel microwave dryer (the microwave power is 20kw, the conveying speed is 2m/min, and the temperature is 20-25 ℃);
(2) extracting the wall-broken medicinal materials with a 4-time weight of water in an extraction tank (vacuum degree is-0.05 to-0.06 Mpa, extraction temperature is 75 to 80 ℃, and steam pressure is 0.06 to 0.09Mpa) for 2 hours, and collecting an extracting solution (HPLC 1 method) to obtain 3.943g of salidroside in the extracting solution, wherein the recovery rate is 55.2 percent;
(3) extracting the medicine residues and 3 times of water in the same condition in an extraction tank for 1 hour again, and collecting the extracting solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain 129.2g of rhodiola rosea extract (water content 4.14%, [ HPLC1 method ]) with rhodiola glycoside content 4.843g and yield 67.8%.
Example 7: preparing rhodiola root extract
(1) Taking 1kg of rhodiola rosea medicinal material, moistening the medicinal material by using a vacuum medicine moistening machine (the vacuum degree is-0.06 Mpa, the vacuum softening time is 45min), wherein the ratio of the medicinal material to water (0.75 w/v% of calcium chloride is added in the water) is 1: 1.2, completely permeating the medicinal materials, and performing microwave wall breaking (until the water content of the medicinal materials is reduced to 8-12%) by a tunnel microwave dryer (the microwave power is 20kw, the conveying speed is 2m/min, and the temperature is 20-25 ℃);
(2) extracting the wall-broken medicinal materials with a 4-time weight of water in an extraction tank (vacuum degree is-0.05 to-0.06 Mpa, extraction temperature is 75 to 80 ℃, and steam pressure is 0.06 to 0.09Mpa) for 2 hours, and collecting an extracting solution (HPLC 1 method is adopted to measure the salidroside content in the extracting solution to be 4.125g, and the recovery rate is 57.7%);
(3) extracting the medicine residues and 3 times of water in the same condition in an extraction tank for 1 hour again, and collecting the extracting solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain 136.6g radix Rhodiolae extract (water content 4.14%, [ HPLC1 method ] with salidroside content of 4.652g, and salidroside recovery rate of 65.1%.
Example 8: preparing rhodiola root extract
This example 8 was prepared as a comparative example with reference to the method of the example of CN 102688276A.
(1) Taking 1kg of rhodiola rosea medicinal material, and moistening the medicinal material by using a vacuum medicine moistening machine (the vacuum degree is-0.06 Mpa, the vacuum softening time is 45min), wherein the ratio of the medicinal material to water is 1: 1.2, completely permeating the medicinal materials, and performing microwave wall breaking (until the water content of the medicinal materials is reduced to 8-12%) by a tunnel microwave dryer (the microwave power is 20kw, the conveying speed is 2m/min, and the temperature is 20-25 ℃);
(2) extracting the wall-broken medicinal materials with a 4-time weight of water in an extraction tank (vacuum degree is-0.05 to-0.06 Mpa, extraction temperature is 75 to 80 ℃, and steam pressure is 0.06 to 0.09Mpa) for 2 hours, and collecting an extracting solution (the content of salidroside in the extracting solution is 4.027g measured by an HPLC1 method, and the recovery rate is 56.4%);
(3) extracting the medicine residues and 3 times of water in the same condition in an extraction tank for 1 hour again, and collecting the extracting solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain rhodiola extract 131.6g (water content 3.74%, [ HPLC1 method ]) with rhodiola glycoside content 4.748g and rhodiola glycoside recovery rate 66.5%.
As is clear from the results of examples 1 to 8, in the vacuum drug-moistening step of the method of the present invention, the recovery rate of salidroside in the extract can be significantly improved by adding both glacial acetic acid and calcium chloride to the water used for moistening, and the recovery rate of salidroside is low when neither glacial acetic acid nor calcium chloride is added or only either is added.
Test example 1: biological activity of rhodiola rosea extract
In this test example 1, the biological properties of some of the preparations herein, in particular, the properties of resistance to oxygen deficiency, fatigue, cold, immunity and the like, were examined by referring to the methods carried by the heronshen literature (heronshen, et al, pharmacodynamic studies of rhodiola sachets, journal of chinese medical information, 2003, 10 (3): 28).
As not otherwise stated, the mice used in the test were 5-6 week-old male Balb/c mice weighing 18-22 g, purchased from the Experimental animals center of Sichuan university. The full-automatic biochemical analyzer is model BS-280 of Mirey.
Reagent testing: rhodiola rosea extracts obtained in examples 1 to 8; rhodiola rosea oral liquid (B20070002, Tibetan medicine group, the concentration of salidroside is 0.564mg/ml measured by the invention [ HPLC1 method ]); cyclophosphamide (H20160467, Baxter Oncology GmbH) for injection.
Administration dose: the rhodiola rosea extract and the rhodiola rosea oral liquid are converted into salidroside, the dosage of the salidroside is 3.5 mg/kg of mouse weight, the dosage is about 10-12 times of the dosage for human use, and is equivalent to the dosage in the Hojunsheng literature; the extract is dissolved with water to obtain a concentration of 0.2ml liquid medicine per mouse, and the rhodiola oral liquid is also diluted with the same oral volume. Cyclophosphamide is formulated with water for injection.
Test 11: influence of rhodiola rosea extract on decompression hypoxia of normal mice
The experimental mice are randomly divided into groups shown in the following table according to weight, each group comprises 20 animals, each group is administered with stomach irrigation for 1 time (3.5mg salidroside/kg mouse weight) every day, the blank control group is administered with purified water for 6 days continuously, the experiment is carried out 30min after the last administration, 4 mice in each group are placed in a sealed glass container of a pressure-reducing and oxygen-lacking device every time, the vacuum pump reduces the pressure to 350mmHg, the normal pressure is recovered when half of the experimental animals die, the time is recorded, the survival rate of the animals in each group is counted, and the survival rate of the animals in each group is counted according to X2The test was statistically analyzed, and the results were: the survival percentage of the blank control group was 20.0%, the survival percentage of the extract group of example 1 was 75.0%, the survival percentage of the extract group of example 6 was 45.0%, the survival percentage of the extract group of example 7 was 50.0%, the survival percentage of the extract group of example 8 was 45.0%, and the survival percentage of the rhodiola oral liquid group was 40.0%.
Test 12: influence of rhodiola rosea extract on normal mouse hypoxia under normal pressure
The experimental mice were randomly divided into groups shown in the following table according to body weight, each group was 10 animals, each group was administered 1 time per day (3.5mg salidroside/kg mouse body weight) by intragastric administration, the blank control group was administered purified water for 6 days continuously, 30min after the last administration was performed, the mice were individually placed in 250ml wide-mouth bottles filled with 5g sodium lime, the bottles were capped, vaseline was applied to ensure sealing, the time of hypoxic death of the mice was observed and recorded, the time of hypoxic death of the mice in the administration group and the control group was compared, and the results are shown in table 1 below.
Test 13: cold resistance test
The test mice are randomly divided into groups shown in the following table according to weight, each group comprises 10 animals, each group is subjected to intragastric administration for 1 time every day (3.5mg salidroside/kg mouse weight), a blank control group is subjected to constant-volume purified water for 6 days, the mice are placed in a low-temperature freezer (-15 to-18 ℃) 40min after the last administration, 1 mouse in each cage of a special iron cage is placed, timing is started, the death condition of the mice is observed after 30min, the survival time of each mouse in each group is recorded until all mice die, comparison among the groups is carried out, and the result of the low-temperature resistant survival time (min) is shown in the following table 1.
Test 14: fatigue resistance test
The test mice are randomly divided into groups shown in the following table according to the weight, each group comprises 10 animals, each group is administered with stomach irrigation for 1 time (3.5mg salidroside/kg mouse weight) every day, the blank control group is administered with purified water with equal volume for 6 days continuously, and the mice are put into a water tank for swimming test 30min after the last administration, the water depth is 30cm, and the tail weight of each mouse is 10% of the weight at the water temperature of 15-16 ℃. The duration of swimming (time from putting into water until the head did not float out of the water for 10 s) was recorded for each mouse, and the results of anti-fatigue swimming time (min) are shown in table 1 below.
Test 15: effect of rhodiola rosea extract on phagocytic function of reticuloendothelial cells in normal mice (carbon particle outline cleaning method)
The test mice were randomly divided into groups shown in the following table by weight, 10 animals of each group were administered with positive drug cyclophosphamide by intraperitoneal injection daily (5mg/kg body weight/day), the other groups were administered with intragastric administration 1 time daily (3.5mg salidroside/kg body weight), the blank control group was administered with purified water of equal volume continuously for 8 days, the experiment was performed 30min after the last administration, each mouse was intravenously injected with chinese ink (diluted with purified water in a ratio of 1: 5) 0.1ml/10g body weight, 20 μ l of blood was taken from the retroorbital plexus of the mice after injection for 1min (t1) and 2min (t2), 2ml of Na2CO3 solution of 0.1% concentration was added thereto and shaken, the optical density values (OD1 and OD2) were measured at 580nm on a biochemical analyzer, the clearance index K (logOD 1-2)/(2-1)), the clearance index (K) results are shown in Table 1 below.
Test 16: effect of rhodiola rosea extract on serum hemolysin antibody level of normal mice
The test mice were randomly divided into groups shown in the following table by weight, each group containing 10 animals, each group was administered 1 time per day by gavage (3.5mg salidroside/kg body weight of mice), the blank control group was administered purified water for 10 days continuously, and each mouse was immunized by intraperitoneal injection of 0.2ml of 5% suspension of chicken red blood cells (CRBC suspension, homemade) into the abdominal cavity before the administration on day 2. The experiment was performed 0.5h after the last dose in each group of animals. The mouse eyes are picked to take blood, the blood is centrifuged, the blood serum is separated, the blood serum is diluted by 100 times, 1ml of diluted blood serum is taken and added into a reaction tube, 0.5ml of 0.5 percent CRBC suspension is added, then 0.5ml of complement solution (10 percent, 3 guinea pig mixed blood serum) is added into ice water, the solution in the reaction tube is shaken evenly and placed into a thermostatic water bath with the temperature of 37 ℃ for reaction for 30min, the shaking is carried out for 2 times in the reaction process, the reaction tube is taken out in the ice water after the reaction is finished to stop the reaction, the centrifugation is carried out, and the supernatant is taken and is used for color comparison at 540nm of a biochemical analyzer. The absorbance (OD) of the supernatant represents the level of mouse serum hemolysin antibody, and the results of the absorbance (OD) of the supernatant are shown in table 1 below, wherein the clearance index (K) of the cyclophosphamide group is 0.0118 ± 0.0051, and the absorbance (OD) of the supernatant is 0.132 ± 0.035.
Table 1: the rhodiola root extract has the effects of normal mouse hypoxia at normal pressure, low temperature survival resistance, fatigue resistance, normal mouse reticuloendothelial cell phagocytosis function and serum hemolysin antibody level (
n＝10)
Note: p <0.05, P <0.01 compared to the blank control group.
As described above, it is apparent from the results of examples 1 to 8 that the recovery rate of salidroside in the extract can be significantly improved by adding both glacial acetic acid and calcium chloride to the water used for drug wetting in the vacuum drug wetting step of the method of the present invention, and the recovery rate of salidroside is low when neither glacial acetic acid nor calcium chloride is added or only either is added. In experimental example 1, when the extracts of examples 1 to 8 and the commercially available rhodiola rosea oral liquid were used as reagents for biological activity examination, although the dosages of the administered drugs were the same in terms of salidroside, the biological activity of the extracts of examples 1 to 5 was significantly better than that of other extracts, which is a surprising and complete finding that, although the dosages of the administered drugs were the same in terms of salidroside, other substances that may produce biological activity were present in the extracts obtained by different methods, i.e., the mass spectra of the active substances were different, and thus the biological activity was different. These results also show that by using the method of the present invention to prepare the rhodiola extract, the concentration of salidroside in the extract is higher, and the biological activity of the active substance spectrum is stronger, therefore, when the rhodiola extract obtained by the present invention is used to prepare the pharmaceutical composition, the dosage of the rhodiola medicinal material can be reduced, but the biological activity is not weakened; or the obtained composition can show more excellent biological activity under the condition of keeping the feeding amount in the existing product preparation process.
The excellent biological activity of the extracts of the embodiments 1 to 5 can obviously prolong the time of the normal pressure hypoxia tolerance of the mouse, obviously increase the capability of the decompression hypoxia tolerance of the mouse, obviously improve the survival rate of the mouse, obviously improve the cold resistance capability, obviously prolong the swimming time of the mouse, obviously improve the phagocytic function of mononuclear reticulocytes of the mouse of a normal mouse immune hypofunction model, and obviously improve the serum hemolysin antibody level of the mouse of a normal mouse immune hypofunction model. Therefore, the rhodiola rosea extract obtained by the method has more advantageous effects of resisting anoxia, cold, fatigue and hypoimmunity.
Example 11: preparation of a composition comprising rhodiola
In this embodiment, a capsule is prepared, and the prescription ratio of the medicinal materials is: 1000g of rhodiola rosea, 625g of kudzu root, 250g of sea-buckthorn, 250g of wolfberry fruit, 250g of acanthopanax and 125g of American ginseng.
The preparation method comprises the following steps:
(1) adding 8 times of purified water into the kudzuvine root, the sea buckthorn, the acanthopanax and the medlar, decocting and extracting for 2 hours, and separating decoction liquid; adding 6 times of purified water into the medicine residues, decocting and extracting for 1.5 hours, and separating decoction;
(2) mixing the decoctions, filtering, and concentrating to obtain a clear paste with a relative density of 1.15-1.20 (50 ℃); spray drying (water content less than 3.5%) to obtain radix Puerariae mixed extract;
(3) mixing radix Puerariae mixed extract and radix Rhodiolae extract obtained in example 1, pre-pulverizing into 100 mesh radix Panacis Quinquefolii fine powder, mixing, adding appropriate amount of starch to 1400g, mixing, making soft mass with 65% ethanol, making wet granule, and drying (water content less than 3%) to obtain granule;
(4) packaging the obtained granules into hollow capsules, wherein each capsule contains 0.3g of the granules to obtain capsules called rhodiola rosea and American ginseng capsules of the Tibetan region of the Central department.
The content of salidroside in the capsule was 426mg per 100g measured by HPLC1 method.
In the present invention, concentration similar to that in the above step (2) is vacuum concentration under reduced pressure, under the concentration conditions of: the vacuum pressure is 0.083mpa, and the temperature is 45-55 ℃. In the present invention, as not otherwise specified, the operating conditions like the spray drying in the above step (2) are: the air inlet temperature is about 180 ℃, and the air outlet temperature is about 120 ℃. In the present invention, drying like in the above step (3) is ventilation air drying under 50 to 60 ℃ conditions, as not otherwise specified.
The physiological profile of qi and blood functions in humans is described in detail in CN109223803A (2018114123575), the entire content of which is incorporated herein by reference. The effect of the composition capsule of example 11 on improving qi and blood functions and delaying aging in humans was examined with reference to the method of test example 4 of CN109223803A (2018114123575). 163 subjects who were included in the test, 57 men, 106 women, and the ages of 44 to 67 years, were evaluated by a combination of observation, inquiry, and complaint within a duration of 1 month before the start of the test, and of these 163 subjects, 146 were exhibited by qi deficiency, 138 were exhibited by blood deficiency, and 151 were exhibited by aging. The subjects took capsules of example 11 of the present invention 3 times a day, 4 capsules at a time, for 45 days, and the diet and daily life during the administration period were maintained substantially the same as before the administration. After the medication is finished, comprehensively evaluating through combination of observation, inquiry and self-complaint: 3 people with no change in qi deficiency and the rest people with qi deficiency disappear (the significant improvement rate of qi deficiency reaches 98.2%), 6 people with no change in blood deficiency and the rest people with blood deficiency disappear (the significant improvement rate of blood deficiency reaches 95.7%), 11 people with no change in aging and the rest people with significantly reduced aging (the aging delay rate reaches 92.7%). These results show that the composition of the present invention has excellent effects of improving qi and blood functions of human body and delaying aging of human body.
The tumor cell growth inhibition assay was performed as follows with reference to the method of CN107519310A (2017108852380): referring to the Zhanghong literature, the anti-tumor effect of the capsule in example 11 was studied by establishing three animal models of mouse liver cancer H22, Lewis lung cancer and melanoma B16, randomly grouping mice, administering 0.5% sodium carboxymethylcellulose to the control group, 30mg/kg Cyclophosphamide (CTX) to the positive group, and 1g capsule (corresponding to 1g rhodiola root) to the example 11 group. The positive medicine is administrated by intraperitoneal injection every other day for 1 time, and the rest groups are administrated by intragastric administration for 1 time every day for 10 days continuously. The weight of the mice is recorded every day, and the weight of the mice and the weight of the tumor are weighed after the last dose is taken, and the tumor inhibition rate is calculated. As a result: example 11 capsules have 37.6%, 43.1% and 33.4% of inhibition rates on liver cancer H22, Lewis lung cancer and melanoma B16; under the condition of parallel test, the tumor inhibition rates of cyclophosphamide on three tumors are respectively 78.4%, 82.2% and 77.6%. Shows excellent effect of inhibiting the growth of tumor cells.
Example 12: preparation of a composition comprising rhodiola
In this embodiment, a capsule is prepared, and the prescription ratio of the medicinal materials is: 1000g of rhodiola rosea, 675g of kudzu root, 200g of sea-buckthorn, 300g of medlar, 225g of acanthopanax and 150g of American ginseng.
The preparation method comprises the following steps:
(1) adding 10 times of purified water into the kudzuvine root, the sea buckthorn, the acanthopanax and the medlar, decocting and extracting for 1 hour, and separating decoction; adding 5 times of purified water into the medicine residues, decocting and extracting for 2 hours, and separating decoction;
(2) mixing the decoctions, filtering, and concentrating to obtain a clear paste with a relative density of 1.15-1.20 (50 ℃); spray drying (water content less than 3.5%) to obtain radix Puerariae mixed extract;
(3) mixing radix Puerariae mixed extract and radix Rhodiolae extract obtained in example 1, pre-pulverizing into 100 mesh radix Panacis Quinquefolii fine powder, mixing, adding appropriate amount of starch to 1400g, mixing, making soft mass with 65% ethanol, making wet granule, and drying (water content less than 3%) to obtain granule;
(4) packaging the obtained granules into hollow capsules, wherein each capsule contains 0.3g of the granules to obtain capsules called rhodiola rosea and American ginseng capsules of the Tibetan region of the Central department.
The content of salidroside in each 100g of the capsule was 418mg as determined by HPLC1 method.
Example 13: preparation of a composition comprising rhodiola
In this embodiment, a capsule is prepared, and the prescription ratio of the medicinal materials is: 1000g of rhodiola rosea, 575g of kudzu root, 300g of sea-buckthorn, 200g of wolfberry fruit, 275g of acanthopanax and 100g of American ginseng.
The preparation method comprises the following steps:
(1) adding purified water with the weight 6 times of that of the kudzuvine root, the sea buckthorn, the acanthopanax and the medlar into the kudzuvine root, decocting and extracting the mixture for 3 hours, and separating decoction; adding 8 times of purified water into the medicine residues, decocting and extracting for 1.5 hours, and separating decoction;
(2) mixing the decoctions, filtering, and concentrating to obtain a clear paste with a relative density of 1.15-1.20 (50 ℃); spray drying (water content less than 3.5%) to obtain radix Puerariae mixed extract;
(3) mixing radix Puerariae mixed extract and radix Rhodiolae extract obtained in example 1, pre-pulverizing into 100 mesh radix Panacis Quinquefolii fine powder, mixing, adding appropriate amount of starch to 1400g, mixing, making soft mass with 65% ethanol, making wet granule, and drying (water content less than 3%) to obtain granule;
(4) packaging the obtained granules into hollow capsules, wherein each capsule contains 0.3g of the granules to obtain capsules called rhodiola rosea and American ginseng capsules of the Tibetan region of the Central department.
The content of salidroside in the capsule was 431mg per 100g measured by HPLC1 method.
Example 14: preparation of a composition comprising rhodiola
In this embodiment, a capsule is prepared, and the prescription ratio of the medicinal materials is: 1000g of rhodiola rosea, 600g of kudzu root, 275g of sea-buckthorn, 225g of wolfberry fruit, 300g of acanthopanax and 110g of American ginseng.
The preparation method comprises the following steps:
(1) adding 7 times of purified water into the kudzuvine root, the sea buckthorn, the acanthopanax and the medlar, decocting and extracting for 2.5 hours, and separating decoction; adding 7 times of purified water into the medicine residues, decocting and extracting for 1 hour, and separating decoction;
(2) mixing the decoctions, filtering, and concentrating to obtain a clear paste with a relative density of 1.15-1.20 (50 ℃); spray drying (water content less than 3.5%) to obtain radix Puerariae mixed extract;
(3) mixing radix Puerariae mixed extract and radix Rhodiolae extract obtained in example 1, pre-pulverizing into 100 mesh radix Panacis Quinquefolii fine powder, mixing, adding appropriate amount of starch to 1400g, mixing, making soft mass with 65% ethanol, making wet granule, and drying (water content less than 3%) to obtain granule;
(4) packaging the obtained granules into hollow capsules, wherein each capsule contains 0.3g of the granules to obtain capsules called rhodiola rosea and American ginseng capsules of the Tibetan region of the Central department.
The content of salidroside in the capsule was 422mg per 100g measured by HPLC1 method.
Example 15: preparation of a composition comprising rhodiola
In this embodiment, a capsule is prepared, and the prescription ratio of the medicinal materials is: 1000g of rhodiola rosea, 650g of kudzu root, 225g of sea-buckthorn, 275g of wolfberry fruit, 200g of acanthopanax and 140g of American ginseng.
The preparation method comprises the following steps:
(1) adding 9 times of purified water into the kudzuvine root, the sea buckthorn, the acanthopanax and the medlar, decocting and extracting for 1.5 hours, and separating decoction; adding 6 times of purified water into the medicine residues, decocting and extracting for 1.5 hours, and separating decoction;
(2) mixing the decoctions, filtering, and concentrating to obtain a clear paste with a relative density of 1.15-1.20 (50 ℃); spray drying (water content less than 3.5%) to obtain radix Puerariae mixed extract;
(3) mixing radix Puerariae mixed extract and radix Rhodiolae extract obtained in example 1, pre-pulverizing into 100 mesh radix Panacis Quinquefolii fine powder, mixing, adding appropriate amount of starch to 1400g, mixing, making soft mass with 65% ethanol, making wet granule, and drying (water content less than 3%) to obtain granule;
(4) packaging the obtained granules into hollow capsules, wherein each capsule contains 0.3g of the granules to obtain capsules called rhodiola rosea and American ginseng capsules of the Tibetan region of the Central department.
The content of salidroside in the capsule was 419mg per 100g measured by HPLC1 method.
All references cited in this specification, including without limitation all papers, publications, patents, patent applications, presentations, texts, reports, manuscripts, brochures, books, internet articles, journal articles, periodicals, and the like, are hereby incorporated by reference into this specification in their entirety. The discussion of the references herein is intended merely to summarize the assertions made by their authors and no admission is made that any reference constitutes prior art. Applicants reserve the right to challenge the accuracy and pertinency of the cited references.
Although embodiments of the present disclosure have been described using specific terms, devices, and methods, such description is for illustrative purposes only. The words used are words of description rather than limitation. It is to be understood that variations and modifications may be effected by one of ordinary skill in the art without departing from the spirit and scope of the disclosure as set forth in the appended claims. Additionally, it should be understood that aspects of the various embodiments may be interchanged both in whole or in part. The spirit and scope of the appended claims should not be limited to the description of the preferred versions contained therein.
Claims (10)
1. A traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials and optional pharmaceutic adjuvants: 1000 parts of rhodiola rosea, 575-675 parts of kudzu root, 200-300 parts of sea buckthorn, 200-300 parts of wolfberry fruit, 200-300 parts of acanthopanax and 100-150 parts of American ginseng.
2. The traditional Chinese medicine composition according to claim 1, characterized in that:
the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients in proportion: 1000 parts of rhodiola rosea, 600-650 parts of kudzu root, 225-275 parts of sea buckthorn, 225-275 parts of wolfberry fruit, 225-275 parts of acanthopanax and 110-140 parts of American ginseng;
the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients in proportion: 1000 parts of rhodiola rosea, 315-340 parts of epimedium, 100-120 parts of fructus amomi, 315-340 parts of prepared rehmannia root, 100-120 parts of wolfberry fruit, 63-67 parts of cinnamon, 43-47 parts of clove, 100-120 parts of ginseng fruit and 100-120 parts of Chinese yam;
the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients in proportion: 1000 parts of rhodiola rosea, 625 parts of kudzu root, 250 parts of sea-buckthorn, 250 parts of wolfberry fruit, 250 parts of acanthopanax and 125 parts of American ginseng;
the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients in proportion: 1000 parts of rhodiola rosea, 675 parts of kudzu root, 200 parts of sea buckthorn, 300 parts of wolfberry fruit, 225 parts of acanthopanax and 150 parts of American ginseng;
the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients in proportion: 1000 parts of rhodiola rosea, 575 parts of kudzu root, 300 parts of sea-buckthorn, 200 parts of wolfberry fruit, 275 parts of acanthopanax and 100 parts of American ginseng;
the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients in proportion: 1000 parts of rhodiola rosea, 600 parts of kudzu root, 275 parts of sea-buckthorn, 225 parts of wolfberry fruit, 300 parts of acanthopanax and 110 parts of American ginseng;
the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials and optional pharmaceutical excipients in proportion: 1000 parts of rhodiola rosea, 650 parts of kudzu root, 225 parts of sea-buckthorn, 275 parts of wolfberry fruit, 200 parts of acanthopanax and 140 parts of American ginseng;
it is in the form of capsule, granule, or tablet.
3. The Chinese medicinal composition according to claim 1, which is prepared by the following method:
(1) adding purified water with the weight 6-10 times that of the kudzu root, the sea buckthorn, the acanthopanax and the wolfberry fruit into the kudzu root, decocting and extracting the mixture for 1-3 hours, and taking decoction liquid; adding 5-8 times of purified water into the medicine residues, decocting and extracting for 1-2 hours, and separating decoction; preparing rhodiola rosea extract by using a microwave wall-breaking extraction method;
(2) mixing the decoctions, filtering, and concentrating to obtain a clear paste with a relative density of 1.15-1.20 (50 ℃); spray drying to obtain radix Puerariae mixed extract (water content less than 3.5%);
(3) mixing radix Puerariae mixed extract and radix Rhodiolae extract, pre-pulverizing to 100 mesh radix Panacis Quinquefolii fine powder, mixing, optionally adding appropriate amount of adjuvant, mixing, making soft mass with 65% ethanol, making wet granule, and drying (water content less than 3.5%) to obtain granular Chinese medicinal composition.
4. The Chinese medicinal composition according to claim 3, wherein the rhodiola rosea extract is prepared by the following method:
(a) taking rhodiola rosea medicinal materials, and moistening the medicinal materials by using a vacuum medicine moistening machine, wherein the ratio of the medicinal materials to water is 1: 1 to 1.5 are, for example, 1: 1-1.4, thoroughly permeating the medicine, and breaking the wall by microwave through a tunnel microwave dryer;
(b) extracting the broken medicinal materials with 3-5 times of water by weight in a water extraction tank for 2 hours, and collecting an extracting solution;
(c) extracting the medicine residues and 2.5-3.5 times of water by weight in the extraction tank again for 1 hour under the same condition, and collecting the extracting solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain radix Rhodiolae extract.
5. The Chinese medicinal composition according to claim 4, wherein in the step (a), the medicinal materials are moistened in a vacuum moistening machine under the conditions of vacuum degree of-0.06 Mpa and vacuum softening time of 45 min; adding 0.3-0.5 v/v% of glacial acetic acid and 0.5-1 w/v% of calcium chloride into the water obtained in the step (a); performing microwave wall breaking under the conditions of microwave power of 20kw, conveying belt speed of 2m/min and temperature of 20-25 ℃; microwave wall breaking is carried out until the water content of the medicinal materials is reduced to 8-12%; and/or (b) extracting in an extraction tank under the conditions of vacuum degree of-0.05 to-0.06 Mpa, extraction temperature of 75 to 80 ℃ and steam pressure of 0.06 to 0.09 Mpa.
6. A process for preparing a Chinese medicinal composition as claimed in any one of claims 1 to 5, which comprises the steps of:
(1) adding purified water with the weight 6-10 times that of the kudzu root, the sea buckthorn, the acanthopanax and the wolfberry fruit into the kudzu root, decocting and extracting the mixture for 1-3 hours, and taking decoction liquid; adding 5-8 times of purified water into the medicine residues, decocting and extracting for 1-2 hours, and separating decoction; preparing rhodiola rosea extract by using a microwave wall-breaking extraction method;
(2) mixing the decoctions, filtering, and concentrating to obtain a clear paste with a relative density of 1.15-1.20 (50 ℃); spray drying to obtain radix Puerariae mixed extract (water content less than 3.5%);
(3) mixing radix Puerariae mixed extract and radix Rhodiolae extract, pre-pulverizing to 100 mesh radix Panacis Quinquefolii fine powder, mixing, optionally adding appropriate amount of adjuvant, mixing, making soft mass with 65% ethanol, making wet granule, and drying (water content less than 3.5%) to obtain granular Chinese medicinal composition.
7. The method according to claim 6, wherein the rhodiola rosea extract is prepared by the following method:
(a) taking rhodiola rosea medicinal materials, and moistening the medicinal materials by using a vacuum medicine moistening machine, wherein the ratio of the medicinal materials to water is 1: 1 to 1.5 are, for example, 1: 1-1.4, thoroughly permeating the medicine, and breaking the wall by microwave through a tunnel microwave dryer;
(b) extracting the broken medicinal materials with 3-5 times of water by weight in a water extraction tank for 2 hours, and collecting an extracting solution;
(c) extracting the medicine residues and 2.5-3.5 times of water by weight in the extraction tank again for 1 hour under the same condition, and collecting the extracting solution; mixing the two extracting solutions, filtering, and concentrating to obtain clear paste with the relative density of 1.15-1.20 (50 ℃); spray drying to obtain radix Rhodiolae extract.
8. The method of claim 7, wherein: moistening the medicines in a vacuum moistening machine under the conditions of vacuum degree of-0.06 Mpa and vacuum softening time of 45 min; adding 0.3-0.5 v/v% of glacial acetic acid and 0.5-1 w/v% of calcium chloride into the water obtained in the step (a); performing microwave wall breaking under the conditions of microwave power of 20kw, conveying belt speed of 2m/min and temperature of 20-25 ℃; microwave wall breaking is carried out until the water content of the medicinal materials is reduced to 8-12%; and/or (b) extracting in an extraction tank under the conditions of vacuum degree of-0.05 to-0.06 Mpa, extraction temperature of 75 to 80 ℃ and steam pressure of 0.06 to 0.09 Mpa.
9. Use of the Chinese medicinal composition of any one of claims 1 to 5 in preparing a product for inhibiting the growth of tumor cells, improving qi and blood functions of a human body and delaying aging.
10. Use of the traditional Chinese medicine composition of any one of claims 1 to 5 in preparation of products for improving anoxia tolerance and enhancing immunity.
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| CN102688276A (en) * | 2012-06-21 | 2012-09-26 | 通化玉圣药业股份有限公司 | Extraction method for rhodiola rosea injection with assistance of microwave cell disruption |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102688276A (en) * | 2012-06-21 | 2012-09-26 | 通化玉圣药业股份有限公司 | Extraction method for rhodiola rosea injection with assistance of microwave cell disruption |
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| Title |
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| 格尔木医苑林: "藏药介绍：央科藏域红天胶囊", 《微信公众号》 * |
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