CN111714563A - Composition for improving anoxia endurance and preparation method thereof - Google Patents
Composition for improving anoxia endurance and preparation method thereof Download PDFInfo
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- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- A61K9/282—Organic compounds, e.g. fats
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Abstract
The invention provides a composition for improving anoxia endurance and a preparation method thereof, wherein the traditional Chinese medicine composition mainly comprises 1-30 parts of astragalus membranaceus, 1-12 parts of wolfberry fruits, 1-6 parts of American ginseng and 1-6 parts of rhodiola rosea. The preparation method comprises the following steps: (A) adding 8-14 times of water into the medicinal materials, decocting and extracting for 1-3 times, each time for 0.5-2.0 hours, filtering, and combining extracting solutions to obtain a filtrate; (B) and (3) concentrating the obtained filtrate under reduced pressure at 55-85 ℃ until the relative density is 1.10-1.30, drying under reduced pressure at 55-85 ℃ to obtain dry extract, crushing the dry extract and sieving. The extraction process of the composition provided by the invention is simple to operate, and experiments show that the composition has a remarkable function of improving the anoxia tolerance.
Description
Technical Field
The invention relates to the field of medicines, foods or health-care products, in particular to a composition for improving anoxia endurance and a preparation method thereof.
Background
Oxygen is very important for maintaining the life activity of an organism, and oxygen deficiency firstly damages central nerves, so that cerebral edema and even irreversible necrosis of neurons are caused; hypoxia causes the reduction of cardiac function and microcirculation disturbance, and finally causes the insufficiency of blood supply of important organs of the whole body; hypoxia can affect the oxidative respiration function of mitochondria, so that the electron transfer rate of a respiratory chain is reduced, oxidative phosphorylation is decoupled, and the energy supply of an organism is finally affected; a large amount of free radicals are generated in the absence of oxygen, so that the function of cells is seriously damaged; hypoxia can trigger apoptosis.
At present, many medicines and supplements for improving anoxia endurance are available, but the varieties have large toxic and side effects and are inconvenient to take, and people are looking for a product which is simple to prepare and convenient to take and can improve anoxia endurance.
Disclosure of Invention
In view of the above, the present invention is intended to provide a composition, a pharmaceutical product, a food or a health product for improving anoxia tolerance and a preparation method thereof.
Specifically, the composition can be directly ground into powder, or can be an extract prepared by a conventional means or other forms, and comprises, by weight, 1-30 parts of astragalus membranaceus, 1-12 parts of wolfberry fruits, 1-6 parts of American ginseng and 1-6 parts of rhodiola rosea. The raw material medicaments can be directly ground into powder, or can be extracts or other forms prepared by conventional means.
Further, the composition comprises, by weight, 2-30 parts of astragalus membranaceus, 2-12 parts of wolfberry fruits, 2-6 parts of American ginseng and 2-6 parts of rhodiola rosea.
Further, the composition comprises 3-5 parts by weight of astragalus membranaceus, 3-5 parts by weight of wolfberry fruits, 2-3 parts by weight of American ginseng and 2-3 parts by weight of rhodiola rosea.
Preferably, the composition comprises 4 parts by weight of astragalus, 4 parts by weight of wolfberry fruit, 2 parts by weight of American ginseng and 2 parts by weight of rhodiola rosea. Or the composition comprises 5 parts by weight of astragalus, 5 parts by weight of wolfberry fruit, 3 parts by weight of American ginseng and 3 parts by weight of rhodiola rosea.
The invention also provides a medicament, food or health-care product containing the traditional Chinese medicine composition for improving anoxia endurance.
Further, the medicine, food or health care product also comprises acceptable auxiliary materials or additives.
Further, the adjuvant or additive can be one or more of maltodextrin, lactose, dextrin, corn starch, microcrystalline cellulose, croscarmellose sodium, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, silicon dioxide, and magnesium stearate.
The invention also provides a preparation method of any one of the compositions, which comprises the following steps:
(A) adding 8-14 times of water into the medicinal materials, decocting and extracting for 1-3 times, each time for 0.5-2.0 hours, filtering, and combining extracting solutions to obtain a filtrate;
(B) and (3) concentrating the obtained filtrate under reduced pressure at 55-85 ℃ until the relative density is 1.10-1.30, drying under reduced pressure at 55-85 ℃ to obtain dry extract, and sieving the dry extract after crushing to obtain the compound.
The invention also provides a preparation method of the medicine, food or health-care product for improving anoxia endurance, which is selected from tablets, and comprises the following steps: adding 10 times of water into 4 parts of astragalus, 4 parts of medlar, 2 parts of American ginseng and 2 parts of rhodiola rosea, decocting and extracting for 3 times, each time for 1.0 hour, filtering, combining extracting solutions obtained in three times, concentrating under reduced pressure at 65 +/-5 ℃, concentrating to the relative density of 1.20-1.30, drying under reduced pressure at 65 +/-5 ℃ to obtain dry extract, crushing the dry extract by using a universal crusher, sieving by using a 100-mesh sieve, adding auxiliary materials, uniformly mixing, granulating, drying, granulating, mixing, tabletting and coating to obtain the traditional Chinese medicine composition.
Under the condition of oxygen deficiency, the body functions are weakened, and the body functions can be enhanced by tonifying qi in the theory of traditional Chinese medicine. According to the traditional Chinese medicine compatibility principle, astragalus mongholicus has the effects of tonifying qi and invigorating yang, promoting the production of body fluid and nourishing blood, wolfberry fruits have the effects of nourishing liver and kidney, replenishing vital essence and improving eyesight, rhodiola rosea has the effects of tonifying qi and activating blood, and American ginseng has the effects of tonifying qi and nourishing yin. The radix astragali and the American ginseng are combined, so that apoptosis can be inhibited, and hypoxia injury can be alleviated; the combination of the medlar and the rhodiola rosea can benefit essence, activate blood, increase the content of hemoglobin, improve the oxygen carrying capacity of the organism and improve the utilization rate of oxygen.
Animal function experiments show that the composition provided by the invention can obviously prolong the survival time of mice with normal-pressure hypoxia tolerance and sodium nitrite poisoning resistance, and has the function of obviously improving hypoxia tolerance.
The preparation method of the composition provided by the invention combines and extracts the astragalus, the medlar, the American ginseng and the rhodiola rosea, the extraction process is simple to operate, the decoction is reduced, the error is reduced, the time is saved, and compared with the respective extraction of the raw materials, the extraction process is complex and the effective compatibility can not be realized to play the drug effect; the drying method of the composition preparation is reduced pressure drying, the drying process is simple, and the equipment is easy to obtain; in addition, the preparation of the composition has better particle fluidity and compressibility, meets the product requirements, is suitable for continuous tabletting production, and is proved by animal function experiments to be capable of obviously prolonging the survival time of mice in an oxygen deficiency resistance experiment under normal pressure and a sodium nitrite poisoning experiment, thereby showing that the composition has the function of obviously improving the oxygen deficiency tolerance.
Detailed Description
The present invention will now be described in more detail with reference to specific embodiments thereof so that the aspects and advantages of the invention may be better understood. However, the contents of the specific embodiments described below are for illustrative purposes only and are not limiting of the present invention.
The pharmacodynamic experiment part adopts the function of improving anoxia endurance in the technical Specification for health food inspection and evaluation (2003 edition) issued by the ministry of health to study.
It should be noted that, if the specific conditions are not specified, the procedures are carried out according to the conventional conditions or the conditions recommended by the manufacturer, and the raw materials or auxiliary materials used, and the reagents or equipment used are not specified by the manufacturer, and are conventional products commercially available. All percentages, ratios, proportions, or parts are by weight unless otherwise specified.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In addition, any methods and materials similar or equivalent to those described herein can be used in the practice of the present invention.
The components used in the invention, such as astragalus, medlar, American ginseng and rhodiola root, are all commercially available traditional Chinese medicinal materials, and the auxiliary materials are all commercially available medicinal auxiliary materials.
And (3) raw and auxiliary material inspection and requirement:
astragalus root: is a dried root of Astragalus membranaceus Bge Astragalus membrane aceus (Fisch.) of Leguminosae family or Astragalus membranaceus Bge Astragalus membrane aceus (Fisch.) of Hsiao or Astragalus membranaceus Bge, and should meet the relevant regulations under the item of Astragalus membranaceus of pharmacopoeia of the people's republic of China 2015 edition.
Wolfberry fruit: is a dry mature fruit of Lycium barbarum L. of Solanaceae, and should meet the related regulation of Lycium barbarum item in the 2015 edition of pharmacopoeia of the people's republic of China.
American ginseng: is the dry root of American ginseng Panax quinquefolium L. in Araliaceae, and should meet the related regulations under the American ginseng item in the 2015 edition of pharmacopoeia of the people's republic of China.
Rhodiola root: is the dry root or rhizome of Rhodiola crenulata Rhodiola crenulate (hook.f. et Thoms.) H.Ohba, and meets the related regulation of Rhodiola rosea in the 2015 edition of pharmacopoeia of the people's republic of China.
Auxiliary materials such as maltodextrin, lactose, dextrin and the like meet the requirements of the four parts of the pharmacopoeia of the people's republic of China in 2015 edition.
Example 1 an orthogonal design of a composition for enhancing hypoxia tolerance
Taking 4 parts by weight of astragalus, 4 parts by weight of medlar, 2 parts by weight of American ginseng and 2 parts by weight of rhodiola root, and taking water as an extraction solventUsing L9 (3)4) Orthogonal table was used for orthogonal test, and water addition amount (8 times, 10 times, 12 times), extraction time (0.5h, 1.0h, 1.5h), extraction frequency (1 time, 2 times, 3 times) were selected as 3 factors to be examined, and each factor was at 3 levels. See table below:
TABLE 1 factor level table
TABLE 2 orthogonal experimental design
The process evaluation indexes comprise total saponin content, crude polysaccharide content, salidroside content, and determination of 3 index component contents. The total saponin content, the crude polysaccharide content and the salidroside content in the test No. 1-9 are measured according to the technical Specification for health food inspection and evaluation, and the comprehensive evaluation index M is obtained by comprehensively calculating according to three single indexes.
TABLE 3 results of orthogonal testing of extraction Process
TABLE 4 analysis of variance
And (3) considering by taking the comprehensive score as an index, wherein the influence of each factor on the extraction process is extremely poor, and the R value is as follows: the factors C > B > A and C have significant influence, the factor A, B has no significant influence, A1 is more than A2 and less than A3, B1 is more than B2 and less than B3, and C1 is more than C2 and less than C3, so the optimal extraction process is A3B3C3, namely the dosage of the solvent is 12 times, the extraction time is 1.5h, and the extraction times are 3 times. As the orthogonal test method does not have A3B3C3 in combination, the extraction times are relatively more, the time consumption is long, the industrial production is facilitated, and the comprehensive score of the A2B2C3 combination is the highest, the schemes A3B3C3 and A2B2C3 are selected for process verification (the input amount of medicinal materials is increased by 1 time).
TABLE 5 verification of different extraction procedures
The crude polysaccharide content, the puerarin content and the total saponin content obtained by combining the A3B3C3 and the A2B2C3 are higher, the A3B3C3 combination is slightly higher than the A2B2C3 combination, but the relative average deviation before the two combinations is less than 5%, which indicates that the two combinations have no significant influence on the crude polysaccharide content, the puerarin content and the total saponin content. Therefore, from the perspective of industrial production, time is saved, energy consumption is reduced, and the A2B2C3 combination is selected as the optimal extraction process, namely, the dosage of the solvent is 10 times, the extraction time is 1.0h, and the extraction times are 3 times.
Example 2
666.67g of astragalus mongholicus, 666.67g of wolfberry fruit, 333.33g of American ginseng and 333.33g of rhodiola rosea are taken, 12 times of water is added for decoction and extraction for 3 times, 1.5 hours each time, filtration is carried out, three extracting solutions are combined, decompression concentration is carried out at 65 +/-5 ℃, the concentrating is carried out until the relative density is 1.20-1.30, decompression drying is carried out at 65 +/-5 ℃ to obtain dry extract, the dry extract is ground and sieved by a 100-mesh sieve to obtain dry extract powder. Weighing a proper amount of dry paste powder, adding a proper amount of auxiliary materials, uniformly mixing, adding a proper amount of 95% ethanol, stirring to prepare a proper soft material, granulating by using a 16-mesh screen, drying at 60 +/-5 ℃, controlling the moisture of the granules to be 4.0-6.0%, grading by using a 16-mesh screen, adding a proper amount of auxiliary materials after grading, uniformly mixing, tabletting, coating and preparing into 1000 tablets.
Example 3
Taking 40kg of astragalus, 40kg of wolfberry fruit, 20kg of American ginseng and 20kg of rhodiola rosea, adding 10 times of water, decocting and extracting for 3 times, each time for 1.0 hour, filtering, combining three extracting solutions, concentrating under reduced pressure at 65 +/-5 ℃, concentrating to the relative density of 1.20-1.30, drying under reduced pressure at 65 +/-5 ℃ to obtain dry extract, and crushing the dry extract into fine powder passing through a 100-mesh screen by using a universal crusher to obtain dry extract powder.
Mixing: dry paste powder and auxiliary materials are weighed according to the formula and put into a wet mixing granulator to be mixed for 5 minutes.
Preparing a soft material: adding appropriate amount of 95% ethanol, and stirring to obtain soft material.
And (3) granulating: the prepared soft material is granulated by a swing granulator with a 16-mesh screen.
And (3) drying: drying the wet granules at 60 +/-5 ℃, controlling the moisture of the granules to be 4.0-6.0%, and cooling to room temperature.
Straightening: granulating the dry granules by a swing type granulator through a 16-mesh screen,
mixing: and (4) adding the granules and the auxiliary materials into a three-dimensional motion mixer in sequence after finishing the granules, and mixing for 30 minutes.
Tabletting: adjusting a tablet press, adding the mixed granules, adjusting the filling amount, and gradually pressurizing until the tablet weight, hardness, appearance, disintegration time limit and the like meet the requirements.
Coating: preheating the plain tablets in a coating pan, continuously spraying the film coating liquid on the plain tablets until the weight of the tablet cores is increased by 2-3%, stopping spraying the liquid, gradually and systematically cooling, and completely drying the tablets to obtain the film coated tablets. And closing the coating machine, taking out the coated tablets, placing the coated tablets in a stainless steel disc, and cooling to room temperature.
The microbial limit and the pollutant limit of the tablets produced in the embodiment meet the requirements of GB 16740. The weight difference should meet the regulations of the general rule of preparation in the four parts of pharmacopoeia of the people's republic of China.
Example 4 efficacy test of the composition of the present invention for improving hypoxia tolerance
Negative control group: distilled water was administered and the mice were gavaged with 0.1mL/10 g.BW.
Experimental groups: the sample prepared in example 3 was administered to a human at a recommended daily dose of 12g crude drug/60 kgBW. Three dose groups were tested, namely: the crude drug/kg & BW dosage groups of 2.0, 4.0 and 6.0g are 10 times, 20 times and 30 times of the recommended intake of human body, respectively, the samples are prepared into the crude drug/mL of the required concentration of 0.2, 0.4 and 0.6g by using distilled water as a solvent, and the crude drug/mL is continuously infused into the stomach for 30 days by mouth at the ratio of 0.1mL/10g & BW per day.
Normal pressure hypoxia-resistant experiment: the method comprises the steps of continuously feeding tested samples with different concentrations through the mouth of each dosage group, feeding solvents with the same volume to a control group, respectively placing each group of mice into 250mL ground bottles (1 per bottle) containing 5g of soda lime 1 hour after the last gastric lavage, sealing the bottle mouths with vaseline, tightly covering the bottles to prevent gas leakage, immediately timing, and observing the death time of the mice due to oxygen deficiency by taking the respiratory arrest as an index.
Sodium nitrite poisoning survival experiment: the animals in each group were injected with 200mg/kg & BW by intraperitoneal injection of sodium nitrite (injection amount of 0.1mL/10g) 1 hour after the last gavage, and the survival time of the animals was immediately counted.
The results are shown in tables 6 and 7.
TABLE 6 mouse results of the hypoxia tolerance test at atmospheric pressure
As can be seen from Table 6, the survival time of the three dose groups was prolonged to different extents, and the normal pressure survival time of the medium and high dose groups was more prolonged than that of the negative control group.
TABLE 7 survival test results for mouse sodium nitrite poisoning
As can be seen from Table 7, the survival time of mice in the three dose groups after sodium nitrite poisoning is prolonged to different degrees, and the survival time of mice in the medium and high dose groups after sodium nitrite poisoning is more obviously prolonged compared with that of the negative control group.
The experimental result shows that the sample can obviously prolong the survival time of mice after normal pressure hypoxia tolerance and sodium nitrite poisoning, and the result shows that the composition has the function of improving the hypoxia tolerance according to the judgment standard of health food inspection and evaluation technical specification.
Finally, it should be noted that: it should be understood that the above examples are only for clearly illustrating the present invention and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. It is not necessary or necessary to exhaustively enumerate all embodiments herein, and obvious variations or modifications can be made without departing from the scope of the invention.
Claims (10)
1. The composition for improving anoxia endurance is characterized by comprising, by weight, 1-30 parts of astragalus membranaceus, 1-12 parts of wolfberry fruits, 1-6 parts of American ginseng and 1-6 parts of rhodiola rosea.
2. The composition of claim 1, wherein the Chinese medicinal composition comprises 2-30 parts of astragalus, 2-12 parts of wolfberry fruit, 2-6 parts of American ginseng and 2-6 parts of rhodiola rosea.
3. The composition of claim 1, wherein the Chinese medicinal composition comprises 3-5 parts of astragalus, 3-5 parts of wolfberry fruit, 2-3 parts of American ginseng and 2-3 parts of rhodiola rosea.
4. The composition of claim 1, wherein the Chinese medicinal composition comprises 4 parts of astragalus, 4 parts of wolfberry fruit, 2 parts of American ginseng and 2 parts of rhodiola.
5. A pharmaceutical, food or health product comprising the composition for improving anoxia tolerance according to any one of claims 1 to 4.
6. The medicament, food or health product of claim 5, further comprising acceptable excipients or additives.
7. The drug, food or health product according to claim 5, wherein the adjuvant or additive is selected from one or more of maltodextrin, lactose, dextrin, corn starch, microcrystalline cellulose, croscarmellose sodium, low substituted hydroxypropyl cellulose, carboxymethyl starch sodium, silicon dioxide, and magnesium stearate.
8. A process for preparing a composition according to any one of claims 1 to 4, comprising:
(A) adding 8-14 times of water into the medicinal materials, decocting and extracting for 1-3 times, each time for 0.5-2.0 hours, filtering, and combining extracting solutions to obtain a filtrate;
(B) and (3) concentrating the obtained filtrate under reduced pressure at 55-85 ℃ until the relative density is 1.10-1.30, drying under reduced pressure at 55-85 ℃ to obtain dry extract, crushing the dry extract and sieving.
9. The method according to claim 8, wherein the amount of water is 10 times, the number of extraction times is 3, and the extraction time is 1.0 hour.
10. A process for the preparation of a medicament, food or nutraceutical according to claims 5 to 7, which is selected from the group consisting of tablets, comprising: adding 10 times of water into 4 parts of astragalus, 4 parts of medlar, 2 parts of American ginseng and 2 parts of rhodiola rosea by weight, decocting and extracting for 3 times, each time for 1.0 hour, filtering, combining extracting solutions obtained in three times, concentrating under reduced pressure at 65 +/-5 ℃, concentrating to the relative density of 1.20-1.30, drying under reduced pressure at 65 +/-5 ℃ to obtain dry extract, crushing the dry extract by using a universal crusher, sieving by using a 100-mesh sieve, adding auxiliary materials, mixing uniformly, granulating, drying, finishing, mixing and tabletting.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101263907A (en) * | 2008-04-25 | 2008-09-17 | 北京市科威华食品工程技术有限公司 | Common stonecrop herb fatigue-resistance health care beverage and preparation thereof |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101263907A (en) * | 2008-04-25 | 2008-09-17 | 北京市科威华食品工程技术有限公司 | Common stonecrop herb fatigue-resistance health care beverage and preparation thereof |
Non-Patent Citations (2)
| Title |
|---|
| 刘琳等: "提高缺氧耐受力的红景天保健胶囊的实验评价 ", 《食品工业》 * |
| 刘琳等: "提高缺氧耐受力的红景天保健胶囊的研制", 《食品与发酵科技》 * |
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