CN102151297A - Compound ganoderma lucidum spore soft capsule and preparation method thereof - Google Patents
Compound ganoderma lucidum spore soft capsule and preparation method thereof Download PDFInfo
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- CN102151297A CN102151297A CN 201110097796 CN201110097796A CN102151297A CN 102151297 A CN102151297 A CN 102151297A CN 201110097796 CN201110097796 CN 201110097796 CN 201110097796 A CN201110097796 A CN 201110097796A CN 102151297 A CN102151297 A CN 102151297A
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Abstract
The invention belongs the technical field of health care products, in particular relates to a compound ganoderma lucidum spore soft capsule and a preparation method thereof. A prescription of the compound ganoderma lucidum spore capsule comprises ganoderma lucidum spore powder, ginseng, astragalus, acanthopanax, rhodiola and cinnamon. The preparation method comprises the following steps of: extracting ganoderma lucidum spore powder essential oil and cinnamon essential oil by utilizing a supercritical technology, extracting effective ingredients of the ginseng, the astragalus, the acanthopanax and the rhodiola by using a heat refluxing method, evenly mixing the effective ingredients, and enabling the mixed effective ingredients to pass through a colloid mill to prepare a soft capsule preparation. The compound ganoderma lucidum spore soft capsule has remarkable efficacies of resisting radiation, fatigue, tumors and ageing and improving immunity, can ensure that a person with low functional level can recover to a normal or approximately normal level and has a bidirectional immunoregulation effect. The product disclosed by the invention has sufficient and enriched effective ingredients, attractive appearance, high bioavailability and remarkable curative effect and is an ideal Chinese medicine health care product.
Description
Technical field
The invention belongs to health product technology field, be specifically related to a kind of immunologic function that improves, radioprotective, resisting fatigue has the compound preparation and preparation method thereof of the Chinese medicine Ganoderma of auxiliary treatment effect to tumor.
Background technology
Increase along with population density, rhythm of life is accelerated, increasing the weight of of social pressure, the aggravation of social competition, the existence of environmental pollution, growth in the living standard, make the accumulation of people's negativity emotion add many extraneous inducements, many people are the people of some subhealth states particularly, immunologic function degression, and the M ﹠ M of multiple noninfectious improves.According to World Health Organization's report, world's cancer patient sickness rate, mortality rate have risen 22% than the nineties, also will rise about 50% in 20 years from now on.
Along with growth in the living standard and medical science applied development, world population average life generally prolongs, China's Ministry of Public Health is reported Chinese average life and has been reached eight teens, aging population and reached 1.3 hundred million, the old people many sick, body constitution is poor, cause medical care insurance expense expenditure to rise gradually.
" put prevention first ", " preventing trouble before it happens " is the state basic policy of China's health service and health care, research and development have the raising immunologic function, radioprotective, the antineoplastic compound Chinese medicinal preparation, be vast medical sci-tech worker's urgent task and research focus, from Chinese medicine, research and develop these class health product emphasis of vast pharmaceutical researchers especially.According to Shennong's Herbal record, Ganoderma " alive for evermore fully for a long time ".Last century the seventies, scientist finds that Ganoderma, Ganoderma spore powder have antitumor action, this rapidly in, start the upsurge of Ganoderma, Ganoderma spore powder research in the states such as U.S., Japan and Korea S..People thought always that the ganoderan in Ganoderma, the Ganoderma spore powder was the anti-tumor activity composition in the past, can improve immune function of human body.Up to 90 year later stage, active ingredient in China scientist experiment confirm Ganoderma spore powder can activate cancerous cell Caspaseization enzyme, causes that cancerous cell withers, and can regulate again and press down gene P53, can also active cell channel protein P38, thus antineoplastic action had.Shanghai University, the London Ludwig of department of medial science of Royal Academy ICR, U.S. Scripps grind prove all that also Ganoderma spore powder can specificity suppresses the activity of oncogene, cancer cell specific induction of apoptosis.Japan rising sun river university, Slaan-Keteering DKFZ of American Academy of Sciences confirms: Ganoderma spore powder can make hepatoma carcinoma cell reverse.Experiment showed, that more than Ganoderma spore powder is by having an effect adjusting oncogene and antioncogene, cancer cell specific induction of apoptosis or the reverse of short cancerous tumor cell to a plurality of crucial target spots in the signal.But at present, Ganoderma or Ganoderma spore powder are main to be used separately, and is directly oral, has limited the performance of its effect.
Therefore selecting Ganoderma spore powder in these health product is principal agent, extract wherein the effective ingredient ganoderan and use supercritical liquid extraction technique, extraction contains the quintessence oil of high concentration three terpene components, be equipped with strengthening the body resistance again, radioprotective, the antifatigue Radix Ginseng, the Radix Astragali, Cortex Cinnamomi, Radix Rhodiolae, Chinese medicines such as Radix Et Caulis Acanthopanacis Senticosi, make outward appearance U.S., effect is good, the easy soft capsule preparation that absorbs, multicomponent in all medicines of comprehensive performance, multichannel, many target spots coordinative role, form powerful immune legion, common performance improves immune function of human body, radioprotective, resisting fatigue, the effect of assisting in preventing and treating cancer.
Summary of the invention
The object of the present invention is to provide a kind of can give full play to the Ganoderma spore powder effect, and can with the synergistic compound ganoderma spore soft capsule of other Chinese medicine ingredients preparation and preparation method thereof.
Compound ganoderma spore soft capsule preparation provided by the invention, its prescription comprises Ganoderma spore powder (sporoderm-broken rate reaches more than 98%), Radix Ginseng, the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae, Cortex Cinnamomi, each component is by weight:
Ganoderma spore powder 950 ~ 1050g,
Radix Ginseng 400 ~ 600g,
The Radix Astragali 900 ~ 1100g,
Radix Et Caulis Acanthopanacis Senticosi 400 ~ 600g,
Radix Rhodiolae 900 ~ 1100g,
Cortex Cinnamomi 450 ~ 550g.
The preparation method of above-mentioned compound ganoderma spore soft capsule preparation the steps include:
(1) Chinese medicine ingredients is extracted:
A: Ganoderma lucidum (Leyss. Ex Fr.) Karst. or Ganoderma spore powder, Cortex Cinnamomi, with the supercritical technology extraction, its extraction conditions is: 50 ℃ of temperature respectively--60 ℃, pressure 20 Mpa--30Mpa, time 1.5-3 hour, get quintessence oil, residue is continued to employ.
B: Radix Ginseng, the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae and above-mentioned Ganoderma lucidum (Leyss. Ex Fr.) Karst. or Ganoderma spore powder, cinnamomic residue, with mass concentration is 70% ~ 95% ethanol heating and refluxing extraction, generally extracts 2--3 time each 1-2 hour, decompression and solvent recovery, drying under reduced pressure is ground into fine powder.
(2) soft capsule preparation
40 ℃ of Ganoderma spore quintessence oil, cinnamon essential oils--50 ℃ of insulations are evenly stirred the solid micropowder of Radix Ginseng, the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae and residue extract in described quintessence oil; Cross colloid mill, cross 80 orders--100 mesh sieves, repeat 2--4 time, be prepared into soft capsule; 20 ℃--30 ℃ of placements, granulate, washing dries up finished product packing.
The present invention has several big characteristics: (1) Ganoderma spore powder, Cortex Cinnamomi make active component improve tens of times with wherein fully enrichment such as effective ingredient such as ganoderma lucidum triterpene, cinnamic aldehyde of supercritical technology.(2) use soft capsule technology and colloid mill technology, make the extraction powder play micronized, and be suspended in the quintessence oil, make soft capsule, improved the class of product, accelerated dissolution rate, quickened to absorb, improved bioavailability, overcome the black big, thick of Chinese medicine product, content of beary metal exceeds standard, organic agricultural chemicals transfinites, many disadvantages of organic solvent excess, also overcome take that Ganoderma spore powder produces feel sick, get stuck between the teeth, absorb incomplete shortcoming, prevention effect obtains significantly to improve.
Compound ganoderma preparation of the present invention has invigorating primordial QI, beneficial vital essence, and sharp joint, the effect of hard muscles and bones can be used for resisting fatigue, antioxidation, defying age, radioprotective, antitumor, can eliminate the poison of radiotherapy, chemotherapy and pay effect, increases immunity, improves sleep; Especially to the various rehabilitations after being ill of middle-aged and elderly people, improve immunologic function, health invigorating all benefits.
The specific embodiment
According to amounts of components of the present invention, select following 3 groups of prescriptions:
Prescription 1: Ganoderma spore powder 1000g, Radix Ginseng 500g, Radix Astragali 1000g, Radix Et Caulis Acanthopanacis Senticosi 500g, Cortex Cinnamomi 500g, Radix Rhodiolae 1000g.
Prescription 2: Ganoderma spore powder 1050g, Radix Ginseng 600g, Radix Astragali 1100g, Radix Et Caulis Acanthopanacis Senticosi 550g, Cortex Cinnamomi 550g, Radix Rhodiolae 1100g.
Prescription 3: Ganoderma spore powder 900g, Radix Ginseng 400g, Radix Astragali 900g, Radix Et Caulis Acanthopanacis Senticosi 450g, Cortex Cinnamomi 450g, Radix Rhodiolae 900g.
As stated above, be prepared into 3 kinds of lucid ganoderma complex preparations.After testing, the quality index of the lucid ganoderma complex preparation of the present invention's preparation is as follows:
(1) functional component index:
Table 1. functional component index
The project indicator
Total polysaccharides (mg/100g) 〉=1600mg
Rhodioside (mg/100g) 〉=350mg.
(2) physical and chemical index:
Table 2. physical and chemical index
The project indicator
Moisture %≤7
Ash %≤9
Arsenic (in As) mg/kg≤1.0
Plumbous (in Ph) mg/kg≤1.0
Hydrargyrum (in Hg) mg/kg≤0.3
Collapse time limit min≤60 that are situated between
Oxidation number % 2
Acid value 40.
(3) microbiological indicator
Table 3. microbiological indicator
The project indicator
Total plate count cfu/g≤1000
Coliform MpA/1000≤40
Mycete cfu/g≤25
Yeast cfu/g≤25
Pathogenic bacterium must not detect.
(4) mensuration of total polysaccharides
The preparation of reference substance solution: take by weighing through 105 ℃ of anhydrous glucose that are dried to constant weight in right amount, put in the 100ml measuring bottle, add water 80ml, make its whole dissolvings, thin up shakes up to scale again, makes the solution that every 1ml contains 50mg, promptly gets reference substance solution.
The about 0.1g of content under this product content uniformity item is got in the preparation of need testing solution, puts in the round-bottomed flask, the 100ml that adds diethyl ether put in the water-bath reflux 1 hour, filtered while hot, and filtering residue is with a small amount of ether washing 2 times, residue and filter paper are put in the round-bottomed flask, added water 150ml, put in the boiling water bath reflux 1 hour, filtered while hot, residue small amount of thermal water washing 4 times, each 10ml, merging filtrate and washing liquid are put coldly, are transferred in the 250ml measuring bottle, add water to scale, shake up, promptly get need testing solution.
Assay method: measure reference substance solution, each 2.0ml of need testing solution, put in the tool plug test tube, each adds 4% stupid phenol solution 1.0ml, and mixing adds sulphuric acid 7.0ml rapidly, shakes up, and puts in 40 ℃ of water-baths and is incubated 3 ~ 5 minutes, takes out; Put in the ice-water bath 5 minutes, and took out; With water is blank, according to spectrophotography (appendix VA of Chinese Pharmacopoeia version in 2010), goes out to measure trap at the 490nm wavelength.Calculate promptly.Calculating formula is:
Total polysaccharides content (%)=(((Cs * Ax)/As) * extension rate/example weight) * 100%,
In the formula: Cs is a reference substance solution concentration, and As is the trap of reference substance solution, and Ax is the trap of need testing solution.
(5) mensuration of rhodioside
Chromatographic condition:
Chromatographic column: the ODSC of Dikma company
18Post (4.6 * 250nm * 5 μ m)
Mobile phase: methanol-water (both mass ratio 15:85)
Flow velocity: 1.0ml/min
Detect wavelength: 275nm.
The preparation of reference substance solution: it is an amount of to take by weighing the rhodioside reference substance, adds dissolve with methanol, makes the solution that every 1ml contains 0.5mg, promptly gets reference substance solution.
The preparation of need testing solution: get the content 0.5g under this product content uniformity item, put in the tool plug conical flask, add methanol 10ml, close plug shakes up, and claims to decide weight; Ultrasonic 30 minutes, put coldly, claim to decide weight again; Supply the weight that subtracts mistake with methanol, shake up, filter, discard filtrate just, get subsequent filtrate, promptly get need testing solution.
Assay method: draw each 10 μ l of reference substance solution and need testing solution respectively, inject chromatograph of liquid, measure, promptly.Calculating formula is:
C
i%=(((Cs * Ax)/As) * extension rate/example weight) * 100%,
In the formula:
Ai is the peak area of test sample;
As is the peak area of reference substance;
Ci is the concentration of test sample;
Cs is the concentration of reference substance.
(6) other indexs
Measure by Chinese Pharmacopoeia and GB requirement prescriptive procedure respectively.
Compound ganoderma spore soft capsule enhancing immunity function test conclusion of the present invention:
Per os gives 18 ~ 22g male and female mice 1100,366.7 and 183.3mg/kg(be equivalent to respectively to be grown up 30 times, 10 times, 5 times of per kg body weight per day recommended intake every day) this product, 30 days, every result of the test was as follows:
(1) cellular immune function test.ConAi inducing mouse splenocyte changes test (mtt assay).
Each dosage group optical density difference all is higher than the solvent control class value, and increases with dosage, and middle and high dosage group has statistical significant difference (P＜0.05), and middle and high dosage group has the mouse lymphocyte of enhancing multiplication capacity.
(2) the tardy paraphilia reaction of the inductive mice of dinitrofluorobenzene (DNFB) (DTH), each dosage group mouse ear profile swelling degree all is higher than the solvent control class value, and increase with dosage, each dosage group all has statistical significant difference (P＜0.05, P＜0.01).This product can strengthen the tardy paraphilia reaction of mice that DNFB causes.
(3) Turnover of Mouse Peritoneal Macrophages is engulfed chicken red blood cell test (dripping the sheet method), the monokaryon of each dosage group mice-macrophage phagocytic percentage rate and phagocytic index all are higher than the contrast class value, middle and high dosage group phagocytic rate and each dosage group phagocytic index all have significant difference (P＜0.05, P＜0.01).This product has the effect that strengthens the Turnover of Mouse Peritoneal Macrophages phagocytic activity.
(4) antibody-producting cell detects (jer ne improves slide method): each dosage group plaque number average is higher than the solvent control class value, and middle and high dosage group plaque number has been compared significant difference (P＜0.05, P＜0.01) with the contrast class value.The middle and high dosage group of this product has the ability that mice produces antibody-producting cell that strengthens.
(5) serum hemolysin test.Each dosage group mice serum half hemolysis value (HC
50) all being higher than matched group, high dose group has significant difference (P＜0.05).This product has the mice of enhancing to produce the serum hemolysin ability.
(6) peripheral blood leucocyte counting test: respectively organize the leukocyte number average after the irradiation and be less than the negative control group leukocyte count, the radiation damage model is set up.Shone back 14 days, middle dosage group and radiation model control group compare, and leukocyte count increases, and difference has significance (P＜0.05).This product can increase the total white blood cells of mice after the radiation.
To sum up do experiment, product of the present invention had both had the enhancing cellular immune function, had the mouse humoral immune of enhancing function again, also has enhancing mouse monokaryon-macrophage phagocytic function, and certain radiation resistance is arranged.Clinical practice proof this product not only can improve body immunity, can also resist the radiation effects of radiotherapy, chemotherapy etc., is anticancer simply auxiliary treatment health product.
Claims (6)
1. a compound ganoderma spore soft capsule is characterized in that its prescription comprises Ganoderma spore powder, Radix Ginseng, the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae, Cortex Cinnamomi, and each component is by weight:
Ganoderma spore powder 950 ~ 1050g,
Radix Ginseng 400 ~ 600g,
The Radix Astragali 900 ~ 1100g,
Radix Et Caulis Acanthopanacis Senticosi 400 ~ 600g,
Radix Rhodiolae 900 ~ 1100g,
Cortex Cinnamomi 450 ~ 550g.
2. ask 1 described compound ganoderma spore soft capsule according to the right ticket, it is characterized in that the weight proportion of each component is: Ganoderma spore powder 1000g, Radix Ginseng 500g, Radix Astragali 1000g, Radix Et Caulis Acanthopanacis Senticosi 500g, Cortex Cinnamomi 500g, Radix Rhodiolae 1100g.
3. compound ganoderma spore soft capsule according to claim 1 is characterized in that the weight proportion of each component is: Ganoderma spore powder 1050g, Radix Ginseng 600g, Radix Astragali 1100g, Radix Et Caulis Acanthopanacis Senticosi 500g, Cortex Cinnamomi 550g, Radix Rhodiolae 1100.
4. compound ganoderma spore soft capsule according to claim 1 is characterized in that the weight proportion of each component is: Ganoderma spore powder 900g, Radix Ginseng 400g, Radix Astragali 900g, Radix Et Caulis Acanthopanacis Senticosi 450g, Cortex Cinnamomi 450g, Radix Rhodiolae 900g.
5. compound ganoderma spore soft capsule according to claim 1 is characterized in that functional component is as follows: rhodioside 〉=350mg/100g, total polysaccharides 〉=1600mg/100g.
6. according to the preparation method of the described compound ganoderma spore soft capsule of one of claim 1-4, it is characterized in that concrete steps are:
(1) Chinese medicine ingredients is extracted:
A: Ganoderma lucidum (Leyss. Ex Fr.) Karst. or Ganoderma spore powder, Cortex Cinnamomi, with the supercritical technology extraction, extraction conditions is respectively: 50 ℃-60 ℃ of temperature, pressure 20 Mpa--30Mpa, time 1.5-3 hour, get quintessence oil, residue is continued to employ;
B: Radix Ginseng, the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae and above-mentioned Ganoderma lucidum (Leyss. Ex Fr.) Karst. or Ganoderma spore powder, cinnamomic residue are 70% ~ 95% ethanol heating and refluxing extraction with concentration, extracts 2--3 time, and each 1-2 hour, decompression and solvent recovery, drying under reduced pressure is ground into fine powder;
(2) soft capsule preparation
40 ℃ of Ganoderma spore quintessence oil, cinnamon essential oils--50 ℃ of insulations are evenly stirred the solid micropowder of Radix Ginseng, the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi, Radix Rhodiolae and residue extract in described quintessence oil; Cross colloid mill, cross 80 orders--100 mesh sieves, repeat 2--4 time, be prepared into soft capsule; 20 ℃--30 ℃ of placements, granulate, washing dries up finished product packing.
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