CN101244110A - Chinese medicine composition with function of releasing fatigue, reinforcing immunity, and preparation method - Google Patents
Chinese medicine composition with function of releasing fatigue, reinforcing immunity, and preparation method Download PDFInfo
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- CN101244110A CN101244110A CNA2008100448737A CN200810044873A CN101244110A CN 101244110 A CN101244110 A CN 101244110A CN A2008100448737 A CNA2008100448737 A CN A2008100448737A CN 200810044873 A CN200810044873 A CN 200810044873A CN 101244110 A CN101244110 A CN 101244110A
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Abstract
The invention discloses an anti-fatigue and immune-enhancing drug composition and the preparation method, belonging to the technological field of Chinese herbal medicine, comprising extractions from rhodiola root and seed oil from sea buckthorn as the active components, which can be made into various forms of formulation after being added with accessories acceptable in pharmocology; and can be made into soft capsule preparation after being added with vegetable oil, gelatin liquid through processes of pellet making, pellet washing and drying. The soft capsule preparation of the invention, as the preparation of refined extractions, is characterized in that the extractions from the rhodiola root are ethanol extractions from primary medical powder of rhodiola root, comprising 1% to 3% of rhodiola root glycoside as the essential active component, and seed oil from sea buckthorn as the carbon dioxide super-critical extraction from sea buckthorn containing 25.47% to 31.13% of linoleic acid and 4.05% to 4.95% of linolenic acid. The drug composition has the advantages of exact active ingredients, small taking dosage, quick dispersing and absorbing in intestinal, direct effect, high bioavailability, and exact anti-fatigue and immune-enhancing function proved by pharmacodynamic tests.
Description
Technical field
The present invention relates to the field of Chinese medicines, relate in particular to a kind of Chinese medicine composition and preparation method thereof with fatigue alleviating, enhancing immune function of human body.
Background technology
Immune system is the defense mechanism of human body self, functions of immune system is disorderly can bring harm to human body, not only can cause body to produce multiple disease, as various infectious disease, autoimmune disease etc., and can make human body be easy to generate fatigue, even confidential relation is also arranged with human senility.Fatigue typically refers to a kind of asthenia, energy is not enough or used-up sensation, and fatigue is not only a kind of subjective sensation, and fatigue also is a kind of common and non-specific symptom clinically, can be used as the cardinal symptom of numerous disease or simultaneous phenomenon and occurs.Often fatigue easily causes immunity degradation, and is same, and the immunity reduction also is prone to fatigue.When tired and immunologic hypofunction is threatening health of people, more affect the pursuit of people to quality of life.Therefore, use various medicine and health product with fatigue alleviating, raise immunity, treatment and improvement are tired, the low caused disease of body's immunity has great importance.
The medicament of the fatigue alleviating of using, adjusting immunologic function has biological and chemical agents and Chinese medicine or natural medicinal formulations at present.Biological and chemical agents not only has many toxic and side effects, and costs an arm and a leg.The Chinese medicine or the natural drug compound recipe of some energy fatigue alleviating, human body immunity improving function have secular clinical use history, and toxic and side effects is little, for fatigue alleviating and enhancing immunity positive role is arranged also, can effectively stop or slow down disease and transform to bad aspect.But these compound recipes generally need to take in a large number for a long time to play positive effect, and most of compound recipes are not easy to preparation, also be difficult to satisfy the edible safety of product, the Chinese medicine composition of parum drug and centralize the power that really has tangible fatigue alleviating, enhancing human body immunity function is actually rare.
Summary of the invention
The objective of the invention is to: a kind of preparation of being convenient to is provided, has the Chinese medicine composition of obvious fatigue alleviating, enhancing human body immunity function.
Another object of the present invention provides the preparation method of said composition.
To achieve these goals, the invention provides following technical scheme:
A kind of Chinese medicine composition with fatigue alleviating, raise immunity is characterized in that: metering by weight consists predominantly of 30～60 parts of Radix Rhodiolae extracts, 350～450 parts of Fructrs Hippophae seed oil.
Described Radix Rhodiolae extract can extract with following method and obtain: get the Radix Rhodiolae protogenic medicinal powder, cross 20 mesh sieves, add 70% (v/v) alcohol heating reflux and extract twice, add 6 times of amount 70% ethanol for the first time, be heated to 100 ℃ and extracted 2 hours; The ethanol that adds for the second time 4 times of amounts 70%, being heated to 100 ℃ extracted 1.5 hours, merge extracted twice gained medicinal liquid, filter, it is 1.12 extractum that filtrate decompression is condensed into concentration, and spraying drying powder-forming is crossed 80 mesh sieves, obtain rhodioside content and be 1%～3% Radix Rhodiolae extract, this Radix Rhodiolae extract also contains multiple essential amino acids, trace element, vitamin and the volatilization wet goods material of tyrosol, tannin, flavone compound and human body needs.
Described Fructrs Hippophae seed oil can obtain with following method: get seed of Fructus Hippophae, pulverize, cross 40 mesh sieves, through 40 ℃ of freeze-day with constant temperature 12 hours, place CO
2In the extraction cylinder of supercritical extraction equipment, feed CO
2, be that 45 ℃, pressure are 30MPa, CO in temperature
2Flow is extraction 0.5 hour under the condition of 20kg/h, separate obtain that linoleic acid content is 25.47%～31.13%, linolenic acid content is 4.05%～4.95% Fructrs Hippophae seed oil, this Fructrs Hippophae seed oil also contains materials such as flavone compound, abundant vitamin, carotene, catechin, coumarin, plant sterol.
The optimum ratio of Chinese medicine composition of the present invention is mainly by 50 parts of Radix Rhodiolae extracts, 400 parts of compositions of Fructrs Hippophae seed oil.
Chinese medicine composition of the present invention adds that pharmaceutically acceptable carrier or complementary composition can be made into various medicaments.Described medicament can be an oral formulations, as soft capsule, drop pill etc.
Chinese medicine composition of the present invention adds a certain proportion of vegetable oil, and mixing adds the gelatin solution pill, washes ball, drying can be made into soft capsule preparation.
30～60 parts of Chinese medicine composition Radix Rhodiolae extracts of the present invention, 350～450 parts of Fructrs Hippophae seed oil, add 45～55 portions of soybean oils, mixing, adding is by 100～115 parts in gelatin, 40～46 parts of glycerol, 100～115 parts of gelatin solutions of forming of purified water, pill, wash ball, drying can be made into soft capsule preparation.
Optimum ratio by the prepared soft capsule preparation of Chinese medicine composition of the present invention is: 50 parts of Radix Rhodiolae extracts, 400 parts of Fructrs Hippophae seed oil, 50 parts of soybean oils, 115 parts in gelatin, 46 parts of glycerol, 115 parts of purified water.
The preparation method of Chinese medicine composition soft capsule preparation of the present invention is:
1. the preparation of gelatin solution: accurately take by weighing gelatin, glycerol, purified water in proportion, get in the purified water addingization glue jar, add glycerol and stir, open and be steam heated to 70～85 ℃, under stirring, add gelatin, mix homogeneously, heat preservation for standby use;
2. the preparation of content:
Get the Radix Rhodiolae protogenic medicinal powder, cross 20 mesh sieves, add 70% (v/v) alcohol heating reflux and extract twice, add 6 times of amount 70% ethanol for the first time, be heated to 100 ℃ and extracted 2 hours; The ethanol that adds for the second time 4 times of amounts 70% is heated to 100 ℃ and extracted 1.5 hours, merges extracted twice gained medicinal liquid, filters, and it is 1.12 extractum that filtrate decompression is condensed into concentration, and spraying drying powder-forming is crossed 80 mesh sieves, and is standby;
Get seed of Fructus Hippophae, pulverize, cross 40 mesh sieves,, place CO through 40 ℃ of freeze-day with constant temperature 12 hours
2In the extraction cylinder of supercritical extraction equipment, feed CO
2, be that 45 ℃, pressure are 30MPa, CO in temperature
2Flow is extraction 0.5 hour under the condition of 20kg/h, separate Fructrs Hippophae seed oil, standby;
Radix Rhodiolae extract, Fructrs Hippophae seed oil, soybean oil are pressed the formula proportion mix homogeneously, filter;
3. pill: the gelatin solution that will make is put in the gelatin solution storage tank of pellet processing machine, and the content for preparing is put into liquor tank, starts pellet processing machine, and debugging is the back pill accurately;
4. whole ball is with dry: evenly the stall with goods spread out on the ground for sale is on gauze earlier for the soft gelatin capsule that oozes, and in the blowing of low temperature below 10 ℃, cold wind typing back places in the drying baker cleaning qualified soft gelatin capsule, more than dry 24h under 25～30 ℃ the temperature with 95% ethanol flush away soft gelatin capsule surface oil reservoir.
Chinese medicine composition provided by the present invention can be used for preparing the health food or the medicine of fatigue alleviating, raise immunity.
Technical scheme of the present invention is based on motherland's medical science to fatigue, the pathogenetic understanding and the Therapeutic Principle of immunologic hypofunction, achieve with reference to modern pharmacological research, from the numerous medicine of motherland's medicine treasure-house, filter out " sweet in the mouth, little hardship; puckery, cool in nature ", plant amedica Radix Rhodiolae with " nourishing vigour; benefiting vital QI for tranquillizing " effect, " sour in the mouth, warm in nature ", Fructus Hippophae with " promoting blood circulation to remove blood stasis, the chest stuffiness relieving reduces phlegm; spleen reinforcing is good for the stomach " effect, form the one warm cold of two medicines, compatibility mutually by the theory of Chinese medical science prescription, the property of medicine is gentle more partially, the monarch and his subjects are orderly, maximize favourable factors and minimize unfavourable ones, and can bring into play the effect of QI invigorating and blood regulating.
Radix Rhodiolae is a Crassulaceae rhodiola herbaceos perennial, application as medical material and healthy food material has long history, first medical science ancient books and records of Ancient Times in China Shennong's Herbal is classified as in the book on Chinese herbal medicine Radix Rhodiolae top grade, " the main life of supporting is with Ying Tian; nontoxic; as to obey clothes of a specified duration more and do not hurt sb.'s feelings " has the effect of " QI invigorating of making light of one's life by commiting suicide, do not prolong life always ".The tradition Tibetan medicine thinks that Radix Rhodiolae is flat and is slightly cold, can the kidney invigorating, lung moistening, can be used for the treatment of diseases such as general weakness, uncomfortable in chest, nausea and vomiting, physical weakness, women leucorrhea.Modern study to Radix Rhodiolae shows that the main effective ingredient of Radix Rhodiolae is rhodioside and tyrosol, contains multiple essential amino acids, trace element, vitamin and the volatilization wet goods material of tannin, flavone compound and human body needs in addition; Radix Rhodiolae can significantly improve the ability that body utilizes oxygen, reduces the oxygen consumption of cell, improves human body anoxia, removes anerobic glycolysis product such as lactic acid etc., and significant anoxia enduring and antifatigue effect are arranged.
Fructus Hippophae is one of plant the most ancient on the earth, is traditional Tibetan medicine, mongolian medicine and Chinese medicine, and ancients claim that Fructus Hippophae is " a holy fruit ".Carry according to " Chinese herbal medicine is used in Tibet always ", Fructus Hippophae has the function of " spleen reinforcing is good for the stomach for promoting blood circulation to remove blood stasis, the chest stuffiness relieving that reduces phlegm ".Modern study shows, Fructus Hippophae contains abundant vitamin, carotene, catechin, coumarin, plant sterol, flavonoid, unsaturated fatty acid, organic acid, human essential amino acids and nearly 20 kinds of trace element, bioactive ingredients such as Fructus Hippophae total flavones, unsaturated fatty acid all has in various degree regulating power to immune too many levels, humoral immunization and cellular immunization are had tangible adjusting and potentiation, can strengthen the human body resistance against diseases.
In addition, for reducing dose and increasing active constituent content, the present invention has replaced Fructus Hippophae extractum with Fructrs Hippophae seed oil, has replaced the Radix Rhodiolae crude drug with Radix Rhodiolae extract, by this two kind of plant extract composition of prescription, can play the effect of better fatigue alleviating and raise immunity.Because Fructrs Hippophae seed oil is fat-soluble oil-like extracts, and the good airproof performance of soft capsule skin, airborne moisture, oxygen and light have been isolated, can reduce influence to content and effective ingredient, can guarantee the stability of medicament, make it give full play to drug effect, so the dosage form optimization software capsule preparation of pharmaceutical composition of the present invention.
Compared with prior art, the invention has the beneficial effects as follows: Radix Rhodiolae extract of the present invention contains the rhodioside of high level, can significantly improve the ability that body utilizes oxygen, reduces the oxygen consumption of cell, improve human body anoxia, significant anoxia enduring and antifatigue effect are arranged; Fructrs Hippophae seed oil is to adopt supercritical carbon dioxide extraction method to extract the crude vegetal that obtains from the Fructus Hippophae pit, be rich in unsaturated fatty acid, especially two of needed by human body kinds of most important polyunsaturated fatty acid---linoleic acid plus linolenic acids, these polyunsaturated fatty acid all have in various degree regulating power to immune humoral immunization and cellular immunization, and have good fatigue alleviating effect.The mutual compatibility of Radix Rhodiolae extract and Fructrs Hippophae seed oil, the energy Synergistic can play the effect of good fatigue alleviating and raise immunity.Soft capsule preparation of the present invention is that primary raw material is prepared from by Radix Rhodiolae extract and Fructrs Hippophae seed oil, be the extract preparation, effective ingredient is definite, taking dose is little, dispersion is fast in intestinal, absorption is fast, and effect is direct, the bioavailability height, through pharmacodynamics test, the result shows that pharmaceutical composition of the present invention has the effect of definite fatigue alleviating and raise immunity.
The specific embodiment
The present invention is described in further detail below in conjunction with specific embodiment.
Embodiment 1
Take by weighing raw material (gram) by following proportioning:
Radix Rhodiolae extract 50, Fructrs Hippophae seed oil 400, soybean oil 50, gelatin 115, glycerol 46, purified water 115.
The preparation method of the soft capsule preparation of Chinese medicine composition of the present invention is as follows:
1. the preparation of gelatin solution: get in the purified water addingization glue jar, add glycerol and stir, open and be steam heated to 70～85 ℃, under stirring, add gelatin, mix homogeneously, heat preservation for standby use;
2. the preparation of content: get Fructrs Hippophae seed oil, soybean oil, Radix Rhodiolae extract,, fully stir evenly, filter through mixing after the assay was approved;
3. pill: the gelatin solution that will make is put in the gelatin solution storage tank, and temperature is controlled at about 60 ℃; The content for preparing is put into liquor tank, 10～20 ℃ of room temperatures, 40～50 ℃ of water dropper temperature; Beginning should regulate rubber weight and the thickness uniformity during drop pill, make meet certain requirement after, formally production again;
4. whole ball is with dry: the earlier even stall with goods spread out on the ground for sale of the soft gelatin capsule that oozes is on gauze, dry at low temperature below 10 ℃, the cold wind typing is back with 95% ethanol flush away soft gelatin capsule surface oil reservoir, at 15～25 ℃, relative humidity is under 20%～30% the condition more than the dry 24h, packs the soft capsule preparation that promptly gets Chinese medicine composition of the present invention after quality examination.
Make 978 of Chinese medicine composition composition soft capsules of the present invention (content 0.5g/ grain) as stated above, yield rate 97.8%.
The capsule shell proportioning of Chinese medicine composition soft capsule preparation of the present invention gets through a large amount of experiment sievings, prepares soft capsule by proportioning provided by the present invention, finished product rate height, good stability.The test method of described capsule shell optimum ratio is:
In the selection course of capsule skin prescription, gelatin: the ratio that purified water was taked conventional 1: 1 is added, and the qualification rate during with softgel shell hardness, disintegration, one-tenth ball is screened the glycerol consumption that influences capsule cortex amount as investigating index, and concrete grammar is as follows:
Take by weighing gelatin, glycerol, purified water preparation capsule skin by following proportioning, the qualification rate when the softgel shell hardness of investigation capsule skin, disintegration, one-tenth ball:
1. gelatin: glycerol: purified water=1: 0.3: 1
2. gelatin: glycerol: purified water=1: 0.35: 1
3. gelatin: glycerol: purified water=1: 0.4: 1
4. gelatin: glycerol: purified water=1: 0.45: 1
Experimental result is as shown in table 1: 1. institute's pill softgel shell is harder for scheme, and disintegration time is longer, and becomes the ball qualification rate lower; Scheme 2. institute's pill softgel shell is hard partially and become the ball qualification rate on the low side; Scheme 4. behind the pelleting capsule shells softer, in storage with the capsule adhesion takes place in transit easily; Scheme 3. institute's pill softgel shell degree and disintegration time is all more suitable, becomes ball qualification rate height, and is relatively comprehensive, selects for use scheme 3., determines that finally the prescription ratio of gelatin, glycerol, purified water in the medicinal composition soft capsule of the present invention is: 1: 0.4: 1.
Table 1
| Scheme | Softgel shell hardness | Disintegration | Become the ball qualification rate |
| ① | Harder, can leakage of oil | 29min | 92％ |
| ② | Hard partially | 27min | 95％ |
| ③ | Suitable | 20min | 99％ |
| ④ | Softer | 16min | 94％ |
Radix Rhodiolae extract in the Chinese medicine composition of the present invention, Fructrs Hippophae seed oil can prepare as follows:
1. the preparation of Radix Rhodiolae extract: get the Radix Rhodiolae protogenic medicinal powder, cross 20 mesh sieves, add 70% (v/v) alcohol heating reflux and extract twice, add 6 times of amount 70% ethanol for the first time, be heated to 100 ℃ and extracted 2 hours; The ethanol that adds for the second time 4 times of amounts 70% is heated to 100 ℃ and extracted 1.5 hours, merges extracted twice gained medicinal liquid, filters, and it is 1.12 extractum that filtrate decompression is condensed into concentration, and spraying drying powder-forming is crossed 80 mesh sieves, obtains Radix Rhodiolae extract.
With reference to " VID high performance liquid chromatography of Chinese pharmacopoeia version in 2005, the content of measuring rhodioside in the Radix Rhodiolae extract is 1%～3%, its method is:
Get Radix Rhodiolae extract 600mg in the 100mL volumetric flask, add the ultrasonic 15min of 70mL methanol, take out natural cooling, add methanol constant volume, shake up,, get need testing solution with the filtering with microporous membrane of 0.45um to 100mL; Precision takes by weighing rhodioside and the Rosavin reference substance that is dried to constant weight through phosphorus pentoxide, adds methanol and makes the solution that every 1mL contains 0.15mg respectively, in contrast product solution; Accurate above-mentioned reference substance solution and each 10 μ L of need testing solution of drawing inject chromatograph of liquid and detect.Chromatographic condition is: chromatographic column is C
18Stainless steel column (5 μ m, 4.6 * 150mm), be mobile phase with water and ethanol, flow velocity is 1.0mL/min, and it is 276nm that rhodioside detects wavelength, and it is 254nm that Rosavin detects wavelength, 30 ℃ of column temperatures, sensitivity is 0.005AUFS, theoretical cam curve is not less than 3000 by rhodioside.Detection finishes and calculates content of effective by external standard method, promptly gets the content of the rhodioside of Radix Rhodiolae extract of the present invention.
2. the preparation of Fructrs Hippophae seed oil: get seed of Fructus Hippophae, pulverize, cross 40 mesh sieves,, place CO through 40 ℃ of freeze-day with constant temperature 12 hours
2In the extraction cylinder of supercritical extraction equipment, feed CO
2, be that 45 ℃, pressure are 30MPa, CO in temperature
2Flow is extraction 0.5 hour under the condition of 20kg/h, separates obtaining Fructrs Hippophae seed oil.
With reference to Ministry of Public Health " health food functional component and sanitary index inspection specification " (2003 editions), measure that linolenic acid, linoleic content are respectively in the Fructrs Hippophae seed oil: linoleic acid content is 25.47%～31.13%, linolenic acid content is 4.05%～4.95%, and its method is:
Get Fructrs Hippophae seed oil and extract oils and fats by the method for stipulating among the GB/T5009.6, take by weighing oils and fats 100mg and magnetic stir bar and put into the 50mL volumetric flask in the lump, add 4mL 0.5mol/l potassium hydroxide alcoholic solution, top connects reflux condensing tube, and be fixed on the magnetic stirring apparatus, by the condensing tube nitrogen that in solution, imports suitable for reading, open magnetic stirring apparatus, heating makes reactant liquor keep 65 ± 5 ℃, stirring and refluxing 15min, add the 5mL normal hexane from condensing tube top and continue to stir 5min, remove condensing tube, add the 5mL saturated sodium-chloride water solution, shook several minutes, be transferred to and divide dried up and organic facies in the 25mL separatory funnel, add 3mL normal hexane wash water phase again, separate, abandon water, merge organic facies and be settled to 10mL, get need testing solution; Precision takes by weighing the alpha-linolenic acid methyl ester of 0.0250g and the gamma-Linolenic acid standard substance of 0.0250g, uses n-hexane dissolution respectively, and standardize solution is in the 25mL volumetric flask, and mixing is mixed with the standard control solution of 1.0mg/ml; Accurate above-mentioned reference substance solution and each 10 μ L of need testing solution of drawing, inject gas chromatograph detects.Chromatographic condition is: chromatographic column is FFAP (modified poly (ethylene glycol) 20M, 30m * 0.25mm, i.d.0.25 μ m), post oven temperature, degree: 215 ℃, and injector temperature: 250 ℃, detector temperature: 260 ℃, nitrogen: 50mL/min, shunting in 30: 1; Hydrogen 45mL/min; Air: 500mL/min.Testing result is calculated linoleic acid or linolenic content by external standard method, is scaled the linoleic acid plus linolenic acid amount of analysing in the Fructrs Hippophae seed oil again, promptly gets linolenic acid, linoleic acid content in the Fructrs Hippophae seed oil of the present invention.
Embodiment 2
Take by weighing raw material (kilogram) by following proportioning:
Radix Rhodiolae extract 3, Fructrs Hippophae seed oil 45, soybean oil 4.5, gelatin 11.5, glycerol 4.6, purified water 11.5
Get in the purified water addingization glue jar, add glycerol and stir, open and be steam heated to 70～85 ℃, under stirring, add gelatin, mix homogeneously, heat preservation for standby use; Get Fructrs Hippophae seed oil, soybean oil, Radix Rhodiolae extract,, fully stir evenly, filter through mixing after the assay was approved; The gelatin solution that has made is put in the gelatin solution storage tank, and temperature is controlled at about 60 ℃; The content for preparing is put into the liquor tank pill, 10～20 ℃ of room temperatures, 40～50 ℃ of water dropper temperature start pellet processing machine, and debugging is the back pill accurately; The earlier even stall with goods spread out on the ground for sale of the soft gelatin capsule that oozes is on gauze, dry at low temperature below 10 ℃, the cold wind typing is back with 95% ethanol flush away soft gelatin capsule surface oil reservoir, at 15～25 ℃, relative humidity is under 20%～30% the condition more than the dry 24h, packs the soft capsule preparation that promptly gets Chinese medicine composition of the present invention after quality examination.
Make 96500 of Chinese medicine composition composition soft capsules of the present invention (content 0.5g/ grain) as stated above, yield rate 96.5%.
Embodiment 3
Take by weighing raw material (kilogram) by following proportioning:
Radix Rhodiolae extract 6, Fructrs Hippophae seed oil 35, soybean oil 5.5, gelatin 10, glycerol 40, purified water 10
Get purified water, glycerol, gelatin, mix homogeneously is mixed with the gelatin solution heat preservation for standby use; Get Fructrs Hippophae seed oil, soybean oil, Radix Rhodiolae extract, mixing filters; The gelatin solution that has made is put in the gelatin solution storage tank, and temperature is controlled at about 60 ℃, and the content for preparing is put into liquor tank, pill, and 10～20 ℃ of room temperatures, 40～50 ℃ of water dropper temperature start pellet processing machine, and debugging is the back pill accurately; The earlier even stall with goods spread out on the ground for sale of the soft gelatin capsule that oozes is on gauze, dry at low temperature below 10 ℃, the cold wind typing is back with 95% ethanol flush away soft gelatin capsule surface oil reservoir, at 15～25 ℃, relative humidity is under 20%～30% the condition more than the dry 24h, packs the soft capsule preparation that promptly gets Chinese medicine composition of the present invention after quality examination.
Make 96100 of Chinese medicine composition composition soft capsules of the present invention (content 0.5g/ grain) as stated above, yield rate 96.1%.
Embodiment 4
Take by weighing Radix Rhodiolae extract 50g, Fructrs Hippophae seed oil 400g adds vegetable oil 50g, and the mixing heat fused splashes in the liquid coolant, absorbs liquid coolant with filter paper after the contraction condensation, promptly gets the dropping pill formulation of Chinese medicine composition of the present invention.
Pharmaceutical composition pharmacodynamic study of the present invention
The pharmacodynamics test of soft capsule content is further illustrated the beneficial effect of pharmaceutical composition of the present invention in 4 by the following examples.
(1) anti-fatigue effect test
Test example one mice swimming with a load attached to the body test
With male mice in kunming, body weight is 18～22g, wound laboratory animal science service portion provides by Changsha Kaifu District east, laboratory animal production licence number SCXK (Hunan) 2006-0001, be divided into 5 groups at random, each organizes 10, promptly edible vegetable oil matched group, edible rhodiola root extract group (hereinafter to be referred as the Radix Rhodiolae group), pharmaceutical composition low dose group of the present invention (0.167g/kgbw), middle dosage group (0.333g/kgbw), high dose group (0.999g/kgbw) (be equivalent to respectively human body recommended dose 5,10,30 times).When basic, normal, high dosage is subjected to the test solution preparation, take by weighing soft capsule content 1.67g, 3.33g, the 9.99g of pharmaceutical composition of the present invention respectively, with edible vegetable oil to 100mL, when being subjected to the test solution preparation, the Radix Rhodiolae extract group gets Radix Rhodiolae extract 0.99g, add edible vegetable oil to 100mL, matched group gives isopyknic edible vegetable oil.Give animal subject respectively and irritate stomach, irritate stomach every day once, irritate the long-pending 0.1mL/10gbw of being of body of stomach.Continuous irrigation stomach 30 days, behind the last administration 30min, at the bear a heavy burden sheet lead of 5% body weight of mouse tail root, place the swimming case to swim mice, swimming case depth of water 30cm, 25 ℃ ± 1.0 ℃ of water temperatures, the record mice swimming with a load attached to the body time (s), be that mice begins to the dead time from swimming, the swimming with a load attached to the body time of record is carried out statistical procedures with Excel, Spss software, the result is as shown in table 2:
The middle and high dosage group of pharmaceutical composition of the present invention mice is compared with control group mice, and its swimming with a load attached to the body time all obviously prolongs, and difference has significance (P
1＜0.05 or P
1＜0.01), show that pharmaceutical composition of the present invention has the effect that prolongs the mice swimming with a load attached to the body time, the Radix Rhodiolae group can prolong the mice swimming with a load attached to the body time, but difference does not have significance (P
1＞0.05); The middle and high dosage group of pharmaceutical composition of the present invention mice is compared with Radix Rhodiolae extract group mice, and its swimming with a load attached to the body time all obviously prolongs, and difference has significance (P
2＜0.05 or P
1＜0.01), illustrates that pharmaceutical composition provided by the invention than single Radix Rhodiolae extract preparation/Fructrs Hippophae seed oil preparation, has good synergistic function.
Table 2 pharmaceutical composition of the present invention is to the influence of mice swimming with a load attached to the body time
| Group | Number of animals (only) | Swimming time (s) | The P value | |
| P 1 | P 2 | |||
| Dosage group high dose group in the matched group Radix Rhodiolae group low dose group | 10 10 10 10 10 | 266.0±108.9 285.0±112.7 375.5±137.7 423.0±154.1 449.5±99.3 | --- 0.197 0.150 0.024 0.007 | --- --- 0.137 0.021 0.008 |
Test example two pharmaceutical compositions of the present invention are to the influence of tired mice serum carbamide
With male mice in kunming, body weight is 18～22g, is divided into 5 groups at random, and each organizes 10, promptly edible vegetable oil matched group, Radix Rhodiolae group, the basic, normal, high dosage group of pharmaceutical composition of the present invention, give animal subject respectively and irritate stomach, irritate stomach every day once, irritate the long-pending 0.1mL/10gbw of being of body of stomach.Continuous irrigation stomach 30 days, behind the last administration 30min, in temperature is not swimming with a load attached to the body 90min in 30 ℃ the water, dial the eyeball blood sampling behind the rest 60min, with the blood sample collected in 4 ℃ leave standstill 3h after the centrifugal 15min of 2000rpm, get serum and measure serum urea with automatic clinical chemistry analyzer, the record test data also carries out statistical procedures, the result is as shown in table 3, result of the test shows in the pharmaceutical composition of the present invention, the high dose group mice is compared with control group mice, serum urea content is starkly lower than matched group, and difference has significance (P＜0.05), illustrates that pharmaceutical composition of the present invention has to reduce the effect that tired mice carbamide produces; The Radix Rhodiolae group has the tired mice carbamide of certain minimizing generation effect, but difference does not have significance (P
1＞0.05); The middle and high dosage group of pharmaceutical composition of the present invention mice is compared with Radix Rhodiolae extract group mice, and its swimming with a load attached to the body time all obviously prolongs, and difference has significance (P
2＜0.05), illustrates that pharmaceutical composition provided by the invention than single Radix Rhodiolae extract preparation/Fructrs Hippophae seed oil preparation, has good synergistic function.
Table 3 pharmaceutical composition of the present invention is to the influence of tired mice serum carbamide
| Group | Number of animals (only) | Serum urea (mmol/L) | The P value | |
| P 1 | P 2 | |||
| Dosage group high dose group in the matched group Radix Rhodiolae group low dose group | 10 10 10 10 10 | 9.73±0.66 9.51±0.97 9.47±1.01 8.60±1.08 8.16±1.81 | --- 1.032 0.863 0.023 0.001 | --- 0.73 0.022 0.002 |
The influence that test example three pharmaceutical compositions of the present invention change tired mice blood lactic acid
With male mice in kunming, body weight is 18～22g, is divided into 5 groups at random, and each organizes 10, promptly edible vegetable oil matched group, Radix Rhodiolae extract group, the basic, normal, high dosage group of pharmaceutical composition of the present invention, give animal subject respectively and irritate stomach, irritate stomach every day once, irritate the long-pending 0.1mL/10gbw of being of body of stomach.Continuous irrigation stomach 30 days, from the angular vein clump 20 μ L that take a blood sample, not bearing a heavy burden then in temperature is to stop behind the swimming 10min in 30 ℃ the water, respectively at motion back 0min and the same blood sampling 20 μ L of 20min behind the last administration 30min, measure blood lactic acid, blood lactic acid testing cassete is provided by Britain RANDOX company; And be calculated as follows blood lactic acid area under curve:
Blood lactic acid area under curve=1/2 * (the blood lactic acid value of blood lactic acid value before the swimming+swimming back 0min) * 10+1/2 * (the blood lactic acid value of the blood lactic acid value of swimming back 0min+swimming back 20min) * 20
The record test data also carries out statistical procedures, the results are shown in Table 4.
The influence that table 4 pharmaceutical composition of the present invention changes mice blood lactic acid
| Group | Number of animals (only) | Blood lactic acid value (mmol/L) before the motion | Motion back 0min blood lactic acid value (mmol/L) | Motion back rest 20min blood lactic acid (mmol/L) | Blood lactic acid area under curve | The P value | |
| P 1 | P 2 | ||||||
| Dosage group high dose group in the matched group Radix Rhodiolae group low dose group | 10 10 10 10 10 | 3.41±0.48 3.49±0.43 3.69±0.41 3.56±0.46 3.50±0.49 | 7.70±0.57 7.63±0.51 7.60±0.41 7.39±0.53 6.71v0.43 | 5.95±0.97 5.85±0.77 5.87±0.64 5.90±0.88 5.54±0.89 | 192.09±16.26 191.33±14.73 191.20±10.98 187.36±16.10 173.84±12.90 | --- 1.135 0.998 0.799 0.019 | --- --- 0.978 0.8 0.018 |
Above result shows that pharmaceutical composition high dose group mice of the present invention compares with matched group, and blood lactic acid area under curve is starkly lower than matched group, and difference has significance (P＜0.05), illustrates that high dose group has the effect that reduces mice blood lactic acid area under curve; The Radix Rhodiolae group has the effect of certain reduction mice blood lactic acid area under curve, but difference does not have significance (P
1＞0.05); Pharmaceutical composition high dose group mice of the present invention is compared with Radix Rhodiolae extract group mice, and its swimming with a load attached to the body time all obviously prolongs, and difference has significance (P
2＜0.05), illustrates that pharmaceutical composition provided by the invention than single Radix Rhodiolae extract preparation, has good synergistic function.
Above result of the test shows, per os gives the pharmaceutical composition of the present invention 30 days of mice 0.167g/kg.bw, 0.333g/kg.bw, 0.999g/kg.bw dosage, 0.333g/kg.bw, 0.999g/kg.bw dosage can significant prolongation mice the swimming with a load attached to the body time, significantly reduce serum urea level behind the mouse movement, 0.999g/kg.bw dosage can obviously reduce the blood lactic acid area under curve of mice, P＜0.05 or P＜0.01 illustrates that pharmaceutical composition provided by the invention has the alleviating physical fatigue function; Per os gives the Radix Rhodiolae extract 30 days of mice 0.999g/kg.bw dosage, have certain significant prolongation mice the swimming with a load attached to the body time, reduce serum urea level behind the mouse movement, reduce the effect of the blood lactic acid area under curve of mice, but do not have significance; Pharmaceutical composition high dose group mice of the present invention is compared with Radix Rhodiolae extract group mice, and its swimming with a load attached to the body time all obviously prolongs, and serum urea content obviously reduces, and blood lactic acid area under curve obviously reduces, and difference has significance (P
2＜0.05), illustrates that pharmaceutical composition provided by the invention than single Radix Rhodiolae extract preparation, has good synergistic function.
(2) raise immunity test
Test example four delayed allergies (DTH) (the sufficient sole of the foot thickens method)
With male mice in kunming, body weight is 18～22g, wound laboratory animal science service portion provides by Changsha Kaifu District east, laboratory animal production licence number SCXK (Hunan) 2006-0001, be divided into 5 groups at random, each organizes 10, promptly edible vegetable oil matched group, edible seed of Fructus Hippophae line of oils, pharmaceutical composition low dose group of the present invention (0.167g/kgbw), middle dosage group (0.333g/kgbw), high dose group (0.999g/kgbw) (be equivalent to respectively human body recommended dose 5,10,30 times).When basic, normal, high dosage is subjected to the test solution preparation, take by weighing soft capsule content 1.67g, 3.33g, the 9.99g of pharmaceutical composition of the present invention respectively, with edible vegetable oil to 100mL, when being subjected to the test solution preparation, gets the seed of Fructus Hippophae line of oils Fructrs Hippophae seed oil 8g, add edible vegetable oil to 100mL, matched group gives isopyknic edible vegetable oil.Give animal subject respectively and irritate stomach, irritate stomach every day once, irritate the long-pending 0.1mL/10gbw of being of body of stomach, continuous irrigation stomach 30 days, behind the last administration 30min, every mouse peritoneal injection 2% (v/v) SRBC 0.2mL sensitization, measure left back sufficient sole of the foot thickness after 4 days, then measuring point subcutaneous injection 20% (v/v) SRBC (the every Mus of 20 μ L/), measure left back sufficient sole of the foot portion thickness in injection back 24h, same position is measured three times, averages, and represents the degree of DTH with sufficient sole of the foot thickness difference (swelling degree of the paw) before and after attacking.With Excel, Spss software test data is carried out statistical procedures, the result is as shown in table 5:
The middle and high dosage group of pharmaceutical composition of the present invention mice is compared with control group mice, and its swelling degree of the paw is apparently higher than matched group, and difference has significance (P
1＜0.05), shows that pharmaceutical composition of the present invention has the effect that strengthens the mice delayed allergy; Seed of Fructus Hippophae line of oils mice swelling degree of the paw is higher than matched group (P
1＞0.05), illustrates that Fructrs Hippophae seed oil has the tardy allergic effect of certain enhancing mice; The middle and high dosage group of pharmaceutical composition of the present invention mice is compared with seed of Fructus Hippophae line of oils mice, and its swelling degree of the paw obviously increases, and difference has significance (P
2＜0.05), illustrates that pharmaceutical composition provided by the invention than single Fructrs Hippophae seed oil preparation, has good synergistic function.
Table 5 pharmaceutical composition of the present invention is to the influence of mice delayed allergy (DTH)
| Group | Number of animals (only) | Injection back 24h swelling degree of the paw (mm) | The P value | |
| P 1 | P 2 | |||
| Dosage group high dose group in the matched group seed of Fructus Hippophae line of oils low dose group | 10 10 10 10 10 | 0.251±0.059 0.269±0.053 0.289±0.066 0.331±0.054 0.334±0.058 | --- 0.437 0.361 0.014 0.010 | --- --- 0.357 0.016 0.012 |
Test example five antibody-producting cells detect (Jerne improves slide method)
With male mice in kunming, body weight is 18～22g, be divided into 5 groups at random, each organizes 10, promptly edible vegetable oil matched group, edible seed of Fructus Hippophae line of oils, the basic, normal, high dosage group of pharmaceutical composition of the present invention gives animal subject respectively and irritates stomach, irritates stomach every day once, irritate the long-pending 0.1mL/10gbw of being of body of stomach, continuous irrigation stomach 30 days.Get Sanguis caprae seu ovis with normal saline washing 3 times, the centrifugal 10min of 2000rpm is made into the cell suspension of 2% (v/v), every Mus lumbar injection 0.2mL with hematocrit SRBC with normal saline.The mice of immunity after 4 days put to death, get spleen, tear up gently, use Hank ' s liquid to make cell suspension, 200 eye mesh screens filter, wash, centrifugal 2 times, at last with cell suspension in 5mL Hank ' s liquid.With after the culture medium heating for dissolving of top layer with 2 times of concentration of equivalent, pH value is that 7.4 Hank ' s liquid mixes, the packing small test tube, every pipe 0.5mL, the volume ratio that adds in pipe with the preparation of SA liquid is 10%SRBC 50 μ L, splenocyte suspension 20 μ L again, be poured on the slide of brushing the thin layer agarose behind the mixing rapidly, treat after agarose solidifies flat button of slide to be placed on the slide frame, put into CO2 gas incubator incubation 1.5h, to join with the complement (1: 10) of SA liquid dilution and continue incubation 1.5h in the slide groove, counting hemolysis plaque number.The record test data also carries out statistical procedures, result's following (seeing Table 6):
Per os gives the BAICAO vigor soft capsule 30 days of mice various dose, and middle and high dosage group mouse antibodies cell number is apparently higher than matched group, and difference has significance (P＜0.01); The middle and high dosage group of pharmaceutical composition of the present invention mice is compared with control group mice, and the antibody-producting cell number is apparently higher than matched group, and difference has significance (P＜0.01), illustrates that pharmaceutical composition of the present invention has the effect that improves mouse antibodies cellulation number; Pharmaceutical composition high dose group mouse antibodies cellulation number of the present invention is higher than seed of Fructus Hippophae line of oils mice, and difference has significance (P
2＜0.05), illustrates that pharmaceutical composition provided by the invention than single Fructrs Hippophae seed oil preparation, has good synergistic function.
Table 6 pharmaceutical composition of the present invention is to the influence of mouse antibodies cellulation number
| Group | Number of animals (only) | Hemolysis plaque number (* 10 3/ full spleen) | The P value | |
| P 1 | P 2 | |||
| Dosage group high dose group in the matched group seed of Fructus Hippophae line of oils low dose group | 10 10 10 10 10 | 25.3±9.3 32.4±10.5 48.8±13.2 42.4±13.0 25.3±9.3 | --- 0.531 0.391 0.073 0.006 | --- --- 0.378 0.068 0.005 |
The six mice carbon clearance tests of test example
With male mice in kunming, body weight is 18～22g, be divided into 5 groups at random, each organizes 10, promptly edible vegetable oil matched group, edible seed of Fructus Hippophae line of oils, the basic, normal, high dosage group of pharmaceutical composition of the present invention gives animal subject respectively and irritates stomach, irritates stomach every day once, irritate the long-pending 0.1mL/10gbw of being of body of stomach, continuous irrigation stomach 30 days.Behind the last administration 30min, mouse tail vein injection is with the india ink of 4 times of normal saline dilutions, every 10g body weight injection 0.1mL, and timing immediately after prepared Chinese ink injects is after injecting prepared Chinese ink the 2nd, 10min gets blood 20 μ L from the angular vein clump respectively, joins 2mL Na
2O
3In the solution, shake up.With Na
2O
3Solution at 600nm wavelength place colorimetric photometry density value (OD), is put to death mice with 722 type spectrophotometers as blank, gets liver, spleen, weighs, and is calculated as follows phagocytic index:
Phagocytic rate %=engulfs macrophage number * 100 of macrophage number/counting of chicken bonus share born of the same parents
The macrophage number of chicken red blood cell sum/counting that phagocytic index=quilt is engulfed
The record test data also carries out statistical procedures, result's following (seeing Table 7):
The high dose group mice phagocytic index of pharmaceutical composition of the present invention has significance (P＜0.01) apparently higher than control group mice difference, illustrates that pharmaceutical composition of the present invention has the effect of enhancing mouse monokaryon-macrophage phagocytic function; Seed of Fructus Hippophae line of oils mice phagocytic index is higher than matched group (P
1＞0.05), illustrates that Fructrs Hippophae seed oil has the effect of certain enhancing mouse monokaryon-macrophage phagocytic function; Pharmaceutical composition high dose group mice phagocytic index of the present invention is higher than seed of Fructus Hippophae line of oils mice, and difference has significance (P
2＜0.05), illustrates that pharmaceutical composition provided by the invention than single Fructrs Hippophae seed oil preparation, has good synergistic function.
Table 7 pharmaceutical composition of the present invention is to the influence of mouse antibodies cellulation number
| Group | Number of animals (only) | Phagocytic index (a) | The P value | |
| P 1 | P 2 | |||
| Dosage group high dose group in the matched group seed of Fructus Hippophae line of oils low dose group | 10 10 10 10 10 | 5.922±1.177 5.810±1.107 5.700±1.081 6.154±0.661 6.823±1.337 | --- 0.932 0.741 0.204 0.009 | --- --- 0.731 0.137 0.008 |
The mensuration (determination of lactate dehydrogenase method) of test example seven NK cytoactives
With male mice in kunming, body weight is 18～22g, be divided into 5 groups at random, each organizes 10, promptly edible vegetable oil matched group, edible seed of Fructus Hippophae line of oils, the basic, normal, high dosage group of pharmaceutical composition of the present invention gives animal subject respectively and irritates stomach, irritates stomach every day once, irritate the long-pending 0.1mL/10gbw of being of body of stomach, continuous irrigation stomach 30 days.Behind the last administration 30min, to be tried the dislocation of mice cervical vertebra and put to death, the aseptic spleen of getting is made splenocyte suspension, use Hank ' s liquid to wash 3 times, abandon supernatant cytoplasm is upspring, added aquesterilisa 0.5mL splitting erythrocyte 20 seconds, add 2 times of Hank ' s liquid 0.5mL, the centrifugal 10min of 1000rpm, the RPMI1640 complete culture solution that contains 10% calf serum with 1mL is resuspended, and with the blue dyeing counting of platform phenol (viable count should more than 95%), adjusting cell concentration be 2 * 10
7Individual/mL, this is the effector lymphocyte; Getting the well-grown YAC-1 cell of back 24h that goes down to posterity is 4 * 10 with RPMI1640 complete culture solution adjustment cell concentration
5Individual/mL, this is a target cell.Get each 100 μ L of target cell and effector lymphocyte (imitating the target ratio is 50: 1), add in U type 96 well culture plates; Target cell nature release aperture adds target cell and each 100 μ L of culture fluid, and the maximum release aperture of target cell adds target cell and each 100 μ L of 2.5%Trinton; Above-mentioned every three parallel holes of all establishing, in 37 ℃, cultivate 4h in 5% CO2 gas incubator, then with 96 well culture plates with the centrifugal 5min of 1500rpm, every hole is drawn supernatant 100 μ L and is placed flat 96 well culture plates, adds LDH substrate liquid 100 μ L simultaneously, according to room temperature reaction 3～10min, every hole adds the HCL30 μ L of 1mol/L, measures optical density (OD) at microplate reader 490nm place, is calculated as follows the NK cytoactive:
NK cytoactive={ (reacting hole OD-nature release aperture OD)/(maximum release aperture OD-nature release aperture OD) } * 100%
The record test data also carries out statistical procedures, result's following (seeing Table 8):
The middle dosage group NK cells in mice activity of pharmaceutical composition of the present invention is apparently higher than control group mice, and difference has significance (P＜0.01), illustrates that pharmaceutical composition of the present invention has the effect that strengthens the single NK cytoactive of mice; Pharmaceutical composition high dose group NK cells in mice activity of the present invention is higher than seed of Fructus Hippophae line of oils mice, and difference has significance (P
2＜0.05), illustrates that pharmaceutical composition provided by the invention than single Fructrs Hippophae seed oil preparation, has good synergistic function.
Table 8 pharmaceutical composition of the present invention is to the active influence of NK cells in mice
| Group | Number of animals (only) | NK cytoactive (%) | NK cytoactive square root arcsine conversion value | The P value | |
| P 1 | P 2 | ||||
| Dosage group high dose group in the matched group seed of Fructus Hippophae line of oils low dose group | 10 10 10 10 10 | 21.1±12.6 20.3±11.7 22.2±10.6 38.1±8.8 27.4±8.2 | 26.6±8.5 26.7±6.3 27.6±7.4 38.0±5.3 31.3±5.2 | --- 0.879 0.978 1.002 0.285 | --- --- 0.923 0.354 0.036 |
Above result of the test shows, per os gives the pharmaceutical composition of the present invention 30 days of mice 0.167g/kg.bw, 0.333g/kg.bw, 0.999g/kg.bw dosage, 0.333g/kg.bw, 0.999g/kg.bw dosage can strengthen the mice delayed allergy, improve the antibody-producting cell number of mice, 0.999g/kg.bw dosage can strengthen the ability of mouse monokaryon-macrophage carbon clearance, 0.333g/kg.bw dosage can strengthen the NK cells in mice activity; Pharmaceutical composition high dose group mice of the present invention is compared with seed of Fructus Hippophae line of oils mice, can significantly strengthen the mice delayed allergy, significantly improve the antibody-producting cell number of mice, significantly strengthens the ability (P of mouse monokaryon-macrophage carbon clearance
2＜0.05), illustrates that pharmaceutical composition provided by the invention than single Fructrs Hippophae seed oil preparation, has good synergistic function.
Pharmaceutical composition toxicologic study of the present invention
Get Chinese medicine composition soft capsule content of the present invention, the acute oral toxicity test result: the maximum tolerated dose of male and female Kunming mouse all greater than 21500mg/kg.bw, is belonged to non-poisonous material; The result is all negative for three genetic toxicity tests (Salmonella reversion test, PCEMNR micronucleus test, mouse sperm deformity test), illustrates that Chinese medicine composition of the present invention has no side effect.
Claims (5)
1, a kind of Chinese medicine composition with fatigue alleviating, raise immunity is characterized in that measuring by weight, consists predominantly of 30～60 parts of Radix Rhodiolae extracts, 350～450 parts of Fructrs Hippophae seed oil.
2, the Chinese medicine composition with fatigue alleviating, raise immunity according to claim 1 is characterized in that measuring by weight, consists predominantly of 50 parts of Radix Rhodiolae extracts, 400 parts of Fructrs Hippophae seed oil.
3, a kind of Chinese medicine composition soft capsule preparation with fatigue alleviating, raise immunity is characterized in that the proportioning raw materials of said preparation is:
30～60 parts of Radix Rhodiolae extracts, 350～450 parts of Fructrs Hippophae seed oil, 45～55 parts of soybean oils, 100～115 parts in gelatin, 44～46 parts of glycerol, 100～115 parts of purified water.
4, the medicine Chinese medicine composition soft capsule preparation with fatigue alleviating, raise immunity according to claim 4 is characterized in that the proportioning raw materials of said preparation is:
50 parts of Radix Rhodiolae extracts, 400 parts of Fructrs Hippophae seed oil, 50 parts of soybean oils, 115 parts in gelatin, 46 parts of glycerol, 115 parts of purified water.
5, according to claim 3 or 4 described preparation methoies, it is characterized in that comprising the steps: with Chinese medicine composition soft capsule preparation of fatigue alleviating, raise immunity
1. the preparation of gelatin solution: accurately take by weighing gelatin, glycerol, purified water in proportion, get in the purified water addingization glue jar, add glycerol and stir, open and be steam heated to 70～85 ℃, under stirring, add gelatin, mix homogeneously, heat preservation for standby use;
2. the preparation of content:
Get the Radix Rhodiolae protogenic medicinal powder, cross 20 mesh sieves, add 70% alcohol heating reflux and extract twice, add 6 times of amount 70% ethanol for the first time, be heated to 100 ℃ and extracted 2 hours; Add for the second time 4 times of amount 70% ethanol, be heated to 100 ℃ and extracted 1.5 hours, merge extracted twice gained medicinal liquid, filter, it is 1.12 extractum that filtrate decompression is condensed into concentration, and spraying drying powder-forming is crossed 80 mesh sieves, and is standby;
Get seed of Fructus Hippophae, pulverize, cross 40 mesh sieves,, place CO through 40 ℃ of freeze-day with constant temperature 12 hours
2In the extraction cylinder of supercritical extraction equipment, feed CO
2, be that 45 ℃, pressure are 30MPa, CO in temperature
2Flow is extraction 0.5 hour under the condition of 20kg/h, separate Fructrs Hippophae seed oil, standby;
Radix Rhodiolae extract, Fructrs Hippophae seed oil, soybean oil are pressed the formula proportion mix homogeneously, filter;
3. pill: the gelatin solution that will make is put in the gelatin solution storage tank of pellet processing machine, and the content for preparing is put into liquor tank, starts pellet processing machine, and debugging is the back pill accurately;
4. whole ball is with dry: evenly the stall with goods spread out on the ground for sale is on gauze earlier for the soft gelatin capsule that oozes, and in the blowing of low temperature below 10 ℃, cold wind typing back places the qualified soft gelatin capsule of cleaning in the drying baker with 95% ethanol flush away soft gelatin capsule surface oil reservoir, under 25～30 ℃ temperature more than the 24h.
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