CN102309537A - Anti-fatigue and immunity-enhancing Chinese medicinal composition, its preparation method and application - Google Patents
Anti-fatigue and immunity-enhancing Chinese medicinal composition, its preparation method and application Download PDFInfo
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Abstract
The invention discloses an anti-fatigue and immunity-enhancing Chinese medicinal composition, its preparation method and application. The Chinese medicinal composition of the invention is characterized by comprising the following raw materials by weight: 50-300 parts of American ginseng, 1500-2500 parts of Astragalus, 1000-2000 parts of sea cucumber; or comprising the following weight part of American ginseng, Astragalus extract powder extracted in a ratio of 10:1 and sea cucumber extract powder extracted in a ratio of 10:1, specifically: 50-300 parts of American ginseng, 150-250 parts of Astragalus extract powder, and 100-200 parts of sea cucumber extract powder. The invention also relates to the preparation method of the Chinese medicinal composition. Utilizing an advanced production technology, the method can produce products with accurate active component content, exact effects and reliable functions, as well as anti-fatigue and immunity-enhancing roles. The Chinese medicinal composition provided in the invention can be further applied to preparation of anti-fatigue and immunity-enhancing medicaments.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, particularly a kind of Chinese medicine composition with antifatigue and increasing immune power effectiveness also relates to its preparation method and the application in preparation antifatigue and increasing immune power medicine thereof, belongs to the field of Chinese medicines.
Background technology
Mental tension, fatigue, diet is unbalance, health is aging all can cause immunity degradation.Main cause has following several respects: the one, and the age.Immunity is successively decreased with advancing age, and immune response speed slows down or easy error with advancing age.The 2nd, pressure.Evidence suggests that pressure causes psychentonia, anxiety, melancholy, can reduce lymphocytic mobility.The 3rd, sleep.Immune system is according to the normal running of rule round the clock.If there is not competent sleep, its phagocytosis and cell division can reduce, and lymphocyte quantity and activity are suppressed.The 4th, diet and nutrition.Undernutrition and bad dietary habit are the another factors that causes immune system malfunctioning.
In current society, aging trend is remarkable, and because rhythm of life is accelerated, the heavy life stress of working is big.Much human is under the life stress for a long time, perhaps has various bad living habit and the shortage that causes sleeping; Unbalanced meals are under inharmonic interior environment substance metabolism, and a lot of youngsters also are easy to hypoimmunity, endanger self health.Immunologic function not enough or lowly can produce totally unfavorable influence to body health makes the incidence and mortality raising of multiple infectious disease and non-infective disease.
The easiest crowd who is in the hypoimmunity state is following several kinds: the one, and the old people; Himself immunity system aging and the hypoimmunity that causes; Along with the progress of society, aging society to be formed in the world a lot of countries be admitted facts, and China has the maximum old people of quantity in the world; Develop suitable with it health food, have huge market potential.The 2nd, for a long time in the face of keen competition pressure, the huge crowd of psychological burden, like the operator of enterprises and institutions; Dedication is strong, busy brain worker etc.The 3rd, bad life habits is arranged, unbalanced crowd is taken in nutrition.Therefore, the product of exploitation enhancing immunity to guaranteeing or promoting health, is very important, and the crowd that this demand is arranged also is very widely, this point by the demand of domestic and international enhancing immunity produce market constantly enlarge prove.
According to statistics, since nineteen ninety-six, in the granted health food be that the product of major function accounts for 32.69% with the enhancing immunity, occupy first of the health care, explain that the health-product market capacity of enhancing immunity is bigger.In today with keen competition, can there be the problem of immunity degradation in the crowd big with blue-collar social worker, middle-aged and elderly people, stress and that have a delicate constitution that is engaged in mental work.Therefore, can get more and more to product consumption with " raising immunity " function.
To above-mentioned this situation; The inventor thinks a product with enhancing immunity of exploitation, and it is extensive to have a suitable crowd, the suitable characteristics of social development demand now; Its market demand and market capacity are huge, and its social benefit and economic benefit are also beyond doubt preferably.
It is primary raw material that the present invention selects fine Radix Panacis Quinquefolii, the Radix Astragali and Stichopus japonicus or Radix Astragali extract and Stichopus japonicus extract for use, obtains having better bioactive health product.The production technology of uses advanced of the present invention, the products obtained therefrom active component content is accurate, and is of fine qualities, definite effect, reliable effect is added the huge market demand, must access consumers in general's favor.
Summary of the invention
The present invention is through big quantity research; After the pathogenesis disease of hypoimmunity is understood in depth; According to pharmacological research and clinical test results in the past; Selecting fine Radix Panacis Quinquefolii, the Radix Astragali or Radix Astragali extract and Stichopus japonicus or Stichopus japonicus extract for use is primary raw material, processes the health food with enhancing immunity.
The efficacy effect of this product is an enhancing immunity, modern pharmacology test and clinical research confirmation, and Radix Panacis Quinquefolii contains ginsenoside, volatile oil, saccharide and various trace elements etc.; Wherein main effective ingredient is the ginsenoside; Have significant enhancing immunity, anticancer, the anti-ageing effect of waiting for a long time; The main effective ingredient astragalus polysaccharides and the various trace elements of the Radix Astragali can act on the panimmunity competent cell, bring into play immunoregulation effect through the secretion that promotes the parts of fine intracellular cytokine; Stichopus japonicus contains the multiple nutritional components of needed by human such as Stichopus japonicus polysaccharide, selenka, and beche-de-mer can be comprehensively apace for human body supplements the nutrients, enhancing immunity; Three kinds of material combinations can be regulated the human immunologic function, enhancing immunity.
Therefore, one of technical problem to be solved by this invention provides a kind of Chinese medicine composition of antifatigue and increasing immune power, it is characterized in that containing each raw material of following weight portion: Radix Panacis Quinquefolii 50-500 part, Radix Astragali 1500-2500 part, Stichopus japonicus 1000-2000 part; Or
The Radix Panacis Quinquefolii that contains following weight portion, Radix Astragali extract powder that extracts according to 10: 1 ratios and the Stichopus japonicus extract powder that extracts according to 10: 1 ratios: Radix Panacis Quinquefolii 50-500 part, Radix Astragali extract powder 150-250 part, Stichopus japonicus extract powder 100-200 part;
Preferably, Chinese medicine composition of the present invention is characterized in that containing each raw material of following weight portion: 200 parts of Radix Panacis Quinquefoliis, 1850 parts of the Radixs Astragali, 1450 parts of Stichopus japonicuss; Or
The Radix Panacis Quinquefolii that contains following weight portion, Radix Astragali extract powder that extracts according to 10: 1 ratios and the Stichopus japonicus extract powder that extracts according to 10: 1 ratios: 200 parts of Radix Panacis Quinquefoliis, 185 parts in Radix Astragali extract powder, 145 parts in Stichopus japonicus extract powder.
Described " extracting according to 10: 1 ratios " is meant that crude drug and final extract weight ratio are 10: 1.Radix Astragali extract powder and Stichopus japonicus extract powder are to extract according to 10: 1 ratios respectively, and for example 10 kilograms Milkvetch Root extracts the powdery product that is condensed into 1 kilogram, is called 10: 1 Radix Astragali extract powder.
Second technical problem to be solved by this invention provides a kind of pharmaceutical preparation of antifatigue and increasing immune power, it is characterized in that said preparation by Chinese medicine composition of the present invention and the adjuvant of pharmaceutically accepting form.Make suitable clinically various preparations according to the pharmaceutical preparation conventional method, especially refer to oral formulations, comprise decoct, capsule, pill, granule, tablet or oral liquid etc.
The 3rd technical problem to be solved by this invention is the method for preparing that Chinese medicine composition thing preparation of the present invention is provided according to the difference of selected raw material:
Pharmaceutical preparation of the present invention can directly add water through conventional decocting for Chinese herbal medicine method, above-mentioned Chinese medicine composition is decocted into Chinese herbs decoction take, and also can further add acceptable accessories and process various other drug preparations.
Pharmaceutical preparation of the present invention, when selecting raw material of Chinese medicine material Radix Panacis Quinquefolii, the Radix Astragali, Stichopus japonicus as raw material for use, its preparation method comprises at first and takes by weighing each composition respectively by proportioning; Chinese crude drug is cleaned pulverizing,, soak decoction 2 hours the Radix Astragali, the Stichopus japonicus cleaned after pulverizing; Filter; Medicinal residues add water and decoct, merge the filtrating that obtains for twice, add 8 times of weight 70% concentration ethanol; It is 1.30 extractum that heating and refluxing extraction 4 hours, filtration, decompression filtrate recycling ethanol, extracting solution are evaporated to relative density.The Radix Panacis Quinquefolii that takes by weighing is pulverized and is sieved, and obtains the fine powder of Radix Panacis Quinquefolii; The fine powder of Radix Panacis Quinquefolii mixes with the extractum of the aforementioned Radix Astragali and Stichopus japonicus, makes suitable clinically various preparations according to the pharmaceutical preparation conventional method, especially refers to oral formulations.
Pharmaceutical preparation of the present invention, when the Radix Astragali extract powder of selecting raw material of Chinese medicine material Radix Panacis Quinquefolii for use, extract according to 10: 1 ratios, Stichopus japonicus extract powder during as raw material, its preparation method comprises Radix Astragali extract powder, Stichopus japonicus extract powder (about 80 orders) further is ground into thinner powder; Cross 100 mesh sieves; Obtain fine powder, add adjuvant, mixing granulation in granulator; After the moisture oven dry; Add adjuvant and carry out granulate, make suitable clinically various preparations, especially refer to oral formulations according to the pharmaceutical preparation conventional method.
Said adjuvant is that sucrose, starch, dextrin, microcrystalline Cellulose, Pulvis Talci, magnesium stearate or calcium sulfate are wherein at least a, and preferred, said adjuvant is dextrin and microcrystalline Cellulose.
Described preparation comprises capsule, pill, granule, tablet or oral liquid.
Preferably, described preparation is a tablet.
Tablet has following advantage: (1) dissolution rate and bioavailability are better; (2) dosage is accurate, and the medicine content difference is less in the tablet, and medicament mixed is uniformly dispersed; (3) steady quality, tablet are drying solid, and some easy oxidation deterioration and deliquescent medicine can borrow coating protect, so light, air, moisture etc. are less to its influence; (4) carry, transport, take more convenient; (5) mechanization production degree is high, and output is big, and cost is low, and production standard is prone to reach.
The 4th technical problem to be solved by this invention provides the method that described Chinese medicine composition is processed tablet, it is characterized in that, may further comprise the steps:
(1) raw material pre-treatment: Radix Panacis Quinquefolii; Radix Astragali extract powder and Stichopus japonicus extract powder according to ratio extraction in 10: 1; Pulverize separately is crossed 100 mesh sieves, obtains Radix Panacis Quinquefolii powder respectively; Radix Astragali extract powder (it is higher to compare raw material Radix Astragali extract powder (80 order) degree of grinding) and Stichopus japonicus extract powder (it is higher to compare raw material Radix Astragali extract powder (80 order) degree of grinding) after further pulverizing, subsequent use; Preparation dextrin slurry through being 1: 9 ratio slurry commanding tank of packing into the dextrin of 50-200 weight portion and purified water according to weight ratio, constantly stirs, and is heated to 77-85 ℃ simultaneously, and gelatinizing promptly gets dextrin and starches; Microcrystalline Cellulose was pulverized 100 mesh sieves, subsequent use;
(2) mixing granulation: granulate with efficient wet granulator; Difference weighing Radix Panacis Quinquefolii powder 50-300 weight portion; Stichopus japonicus extract powder 100-200 weight portion after Radix Astragali extract powder 150-250 weight portion after further pulverizing and further the pulverizing is packed in the granulator jointly; Start the mixing stirring paddle, mix and stirred 25 minutes; Behind the mix homogeneously, open the granulation switch, evenly add the dextrin slurry and granulate;
(3) oven dry: wet granular is dried with heated-air circulation oven; The control temperature is at 60--70 ℃ during oven dry, and drying time is 10-15 hour, makes moisture below 3% after the oven dry;
(4) granulate: the granule that makes is selected 12 eye mesh screen granulate with waving granulation machine;
(5) total mixing: the microcrystalline Cellulose of the granule behind the granulate and the 20-60 weight portion of getting ready, mixed 25 minutes in mixer; Mix the back granule and be contained in the clean medicinal plastic bag, airtight;
(6) tabletting: will get granule to be pressed ready and join corresponding punch die with tablet machine and be washed into tablet, be plain sheet, tablet weight variation is controlled at ± 5% scope in;
(7) coating:
Dosing: according to industry conventional method,,, stir, be mixed with concentration and be 10% film coating liquid by adding in an amount of purified water after the proper proportion weighing with each raw material of film coating agent;
The tablet coating: plain sheet is dropped in the coating machine, and regulating EAT is 70 ± 5 ℃, and leaving air temp is 45 ± 5 ℃, and spray material coating reaches about 3.0% of total amount up to coat weight, behind the coating, tablet weight variation is controlled at ± 5% scope in; Tablet behind the coating is sent into the sheet chamber of drying in the air, and the sheet 12 hours of drying in the air promptly gets.
Preferably, available from the logical biotechnology Co., Ltd of prosperous Bioisystech Co., Ltd and Kang Beili in the Shaanxi, wherein Radix Astragali extract is pale brown toner powder respectively for Radix Astragali extract powder and Stichopus japonicus extract powder; Lot number is 100628; Effective ingredient is an astragaloside, and active constituent content is＞0.3%/5%/10%, and the order number is: 80 orders; Analytical method is: HPLC, extract according to 10: 1 ratios; Stichopus japonicus extract is a pale powder, lot number KB20100516, and every bag of 25Kg, according to crude drug: the extract quality ratio is that 10: 1 ratios are extracted, and detection method TLC detects.
Preferably, said film coating agent is made up of the raw material of following weight portion: hypromellose 10-20 part, hyprolose 1-5 part, magnesium stearate 1-2 part, Macrogol 4000 1-5 part, Black Rouge 0.005-0.02 part, red ferric oxide 0.005-0.02 part.
Aforesaid method for preparing, the weight of preferred said each raw material is:
Wherein said film coating agent is made up of each raw material of following weight:
Process 1000 in tablet altogether, the 0.7g/ sheet.
The 5th technical problem to be solved by this invention provides the application of described Chinese medicine composition in preparation antifatigue and increasing immune power medicine.
Three kinds of primary raw materials of these article all have the enhancing human body immunity function, improve T lymphocyte, NK cytoactive, strengthen the peritoneal macrophage phagocytic function, promote body specific immunity and non-specific immunity.The Radix Panacis Quinquefolii and the Radix Astragali or Radix Astragali extract Combined application have the effect of Synergistic, and Stichopus japonicus or Stichopus japonicus extract play auxiliary effect, and three kinds of material combinations can mediator's body immunity function, enhancing immunity.
Polysaccharide and saponin all are its important functional components in three kinds of raw materials.For this reason, the present invention has carried out the functional component detection in literature research with to this product after, the functional component of confirming product is total saponins (being about 9.4mg/g) and crude polysaccharides (being about 0.012g/g).
The physical and chemical index of this product has adopted the up-to-date regulation of GB/T5009; Microbiological indicator has adopted the up-to-date regulation of GB/T 4789; Used simultaneously " health care (function) food the universal standard " (GB16740-1997), " prepackaged food label general rule " (GB7718-2004) and Packaging-Pictorial Marking for Handling of Goods (GB/T 191-2008) etc.For guaranteeing product quality, standard-required, the composition inspection method of the relevant raw material in also the consulted and carried out Pharmacopoeia of the People's Republic of China (2010 editions), the Ministry of Public Health " health food check and assessment technique standard " (2003 editions).In the net content metering, also with reference to the method for " content of prepackaged goods with fixed net metering test rule " (JJF 1070-2005) regulation.
These article mature preparation process, the production testing process meets national relevant regulations.The steady quality of product is reliable.
Description of drawings
Fig. 1 processes the production technology sketch of tablet for Chinese medicine composition of the present invention.
The specific embodiment
Below in conjunction with specific embodiment the present invention is further specified, it should be understood that these embodiment only are used for the purpose of illustration, never limit protection scope of the present invention.
Former, adjuvant is originated and is used foundation:
This products material all derives from regular company, see shown in the table 1, and according to the standard of my company, through quality inspection department after the assay was approved, permission is put into production.
The purchase source of table 1 raw material used herein
Radix Astragali extract powder and Stichopus japonicus extract powder are respectively available from the logical biotechnology Co., Ltd of prosperous Bioisystech Co., Ltd and Kang Beili in the Shaanxi; Wherein Radix Astragali extract is pale brown toner powder, and lot number is 100628, and effective ingredient is an astragaloside; Active constituent content is＞0.3%/5%/10%; The order number is: 80 orders, and analytical method is: HPLC, extract according to 10: 1 ratios; Stichopus japonicus extract is a pale powder, lot number KB20100516, and every bag of 25Kg, according to crude drug: the extract quality ratio is that 10: 1 ratios are extracted, and detection method TLC detects.
The Chinese medicine crude drug Radix Astragali, Stichopus japonicus are commercially available common Chinese medical material.
After raw material (Radix Panacis Quinquefolii, the Radix Astragali, Radix Astragali extract, Stichopus japonicus, Stichopus japonicus extract) was bought, as inner packing, irradiation sterilization was carried out in unification in the airtight clean bag of packing into.
Radiation parameter: 1. irradiation dose 4.0KGY; 2. exposure time is 2 hours; 3. unevenness≤2.5; 4. environmental condition: 25 ℃ of temperature, relative humidity 60%.
Main production equipments is as shown in table 2:
Table 2 main production equipments used in the present invention
The preparation of embodiment 1 granule
(1) raw material pre-treatment: Radix Panacis Quinquefolii, Radix Astragali extract powder and Stichopus japonicus extract powder, pulverize separately is crossed 100 mesh sieves, and is subsequent use; Is 1: 9 ratio slurry commanding tank of packing into the dextrin of 80g and purified water according to mass ratio, constantly stirs, and is heated to 85 ℃ simultaneously, and the dextrin slurry is processed in gelatinizing; Microcrystalline Cellulose was pulverized 100 mesh sieves, and was subsequent use;
(2) mixing granulation: granulate with efficient wet granulator, according to prescription weighing Radix Panacis Quinquefolii powder 80g respectively, Radix Astragali extract powder 250g and Stichopus japonicus extract powder 200g pack in the granulator jointly, start the mixing stirring paddle, mix stirring 25 minutes; Behind the mix homogeneously, open the granulation switch, evenly add 80g dextrin slurry by formula proportion and granulate;
(3) oven dry: wet granular is dried with heated-air circulation oven; The control temperature is at 70 ℃ during oven dry, and drying time is 10 hours, and making moisture after the oven dry is 2%;
(4) granulate: the granule that makes is selected 12 eye mesh screen granulate with waving granulation machine;
(5) total mixing: granule behind the granulate and the 60g microcrystalline Cellulose of getting ready by the formula proportion weighing, in mixer, mixed 25 minutes, process granule.
The preparation of embodiment 2 capsules
(1) raw material pre-treatment: Radix Panacis Quinquefolii, Radix Astragali extract powder and Stichopus japonicus extract powder, pulverize separately is crossed 100 mesh sieves, and is subsequent use; The dextrin of 137g and purified water according to 1: 9 ratio of mass ratio slurry commanding tank of packing into, are constantly stirred, be heated to 77 ℃ simultaneously, the dextrin slurry is processed in gelatinizing; Microcrystalline Cellulose was pulverized 100 mesh sieves, and was subsequent use;
(2) mixing granulation: granulate with efficient wet granulator, according to prescription weighing Radix Panacis Quinquefolii powder 280g respectively, Radix Astragali extract powder 150g and Stichopus japonicus extract powder 100g pack in the granulator jointly, start the mixing stirring paddle, mix stirring 25 minutes; Behind the mix homogeneously, open the granulation switch, evenly add 137g dextrin slurry by formula proportion and granulate;
(3) oven dry: wet granular is dried with heated-air circulation oven; The control temperature is at 60 ℃ during oven dry, and drying time is 15 hours, and making moisture after the oven dry is 3%;
(4) granulate: the granule that makes is selected 12 eye mesh screen granulate with waving granulation machine;
(5) total mixing: granule behind the granulate and the 20g microcrystalline Cellulose of getting ready by the formula proportion weighing, in mixer, mixed 25 minutes, process granule, incapsulate, process 1000, promptly get.
The preparation of embodiment 3 tablets
As shown in Figure 1:
(1) raw material pre-treatment: Radix Panacis Quinquefolii, Radix Astragali extract powder and Stichopus japonicus extract powder, pulverize separately is crossed 100 mesh sieves, and is subsequent use; The dextrin of 105g and purified water according to 1: 9 ratio of mass ratio slurry commanding tank of packing into, are constantly stirred, be heated to 80 ℃ simultaneously, the dextrin slurry is processed in gelatinizing; Microcrystalline Cellulose was pulverized 100 mesh sieves, and was subsequent use;
(2) mixing granulation: granulate with efficient wet granulator, according to formula proportion weighing Radix Panacis Quinquefolii powder 200g respectively, Radix Astragali extract powder 185g and Stichopus japonicus extract powder 145g pack in the granulator jointly, start the mixing stirring paddle, mix stirring 25 minutes; Behind the mix homogeneously, open the granulation switch, the dextrin slurry that evenly adds 105g by formula proportion is granulated;
(3) oven dry: wet granular is dried with heated-air circulation oven; The control temperature is at 65 ℃ during oven dry, and drying time is 13 hours, makes moisture 2% after the oven dry;
(4) granulate: the granule that makes is selected 12 eye mesh screen granulate with waving granulation machine;
(5) total mixing: granule behind the granulate and the microcrystalline Cellulose of getting ready by the 44g of prescription weighing, mixed 25 minutes in mixer; Mix the back granule and be contained in the clean medicinal plastic bag, airtight, wait for initial survey;
(6) tabletting: through after the assay was approved, join corresponding punch die with tablet machine and be washed into tablet, be plain sheet getting granule to be pressed ready, tablet weight variation is controlled at ± 5% scope in;
(7) coating
Dosing: each raw material of film coating agent is added in the 200g purified water after by following prescription weighing, stir, be mixed with concentration and be 10% film coating liquid;
The tablet coating: plain sheet is dropped in the coating machine, and regulating EAT is 70 ℃, and leaving air temp is 45 ℃; Spray material coating reaches about 3.0% of total amount up to coat weight, behind the coating; Process 1000 in tablet altogether, 0.7g/ sheet, tablet weight variation be controlled at ± 5% scope in; Tablet behind the coating is sent into the sheet chamber of drying in the air, and the sheet 12 hours of drying in the air promptly gets.
As the further packing of the tablet that obtains can be proceeded following steps:
The content uniformity inspection:
The regulation of pressing in the Pharmacopoeia of the People's Republic of China (2005 editions) an one " rules of preparations " is carried out, and meets the requirement of " content of prepackaged goods with fixed net metering test rule " (JJF 1070-2005), and its minus deviation is controlled at below 5%.After the content uniformity passed examination, gained is qualified finished product.
The packing of product:
1, inner packing: 60 slices/bottle; Use inner packaging material to pack as high-density polyethylene bottle; Meet " requirement of used for packing foods polyethylene formation article sanitary standard " (GB 9687-1988) standard; Bottle seal uses polystyrene film, need meet " used for packing foods polystyrene molding article sanitary standard " (GB/T 5737-1995) standard.(following production routine moves on to outside the clear area and carries out)
2, outer package: 80 bottles/case, use packaging material to be corrugated case, meet " corrugated case " (GB6543-1986) standard.
Exfactory inspection: require to carry out exfactory inspection according to enterprise's mark.Inspection item are organoleptic indicator, whole physical and chemical index, whole microbiological indicator, net content and allowed minus deviation index.
Warehouse-in is stored: according to company standard, product warehousing is stored after the assay was approved.
The efficacy effect of raw material, consumption and safety evaluatio are as shown in table 3.
The efficacy effect of table 3 raw material, consumption and safety
Annotate: safe dose derive from 2010 version " Chinese Pharmacopoeia (one one) " regulation.
Usage: every day 2 times, 2/inferior.
The preparation of embodiment 4 tablets
(1) raw material pre-treatment: Radix Panacis Quinquefolii, the Radix Astragali and Stichopus japonicus are cleaned, and dry, and be subsequent use; Microcrystalline Cellulose was pulverized 100 mesh sieves, and was subsequent use;
(2) take by weighing each raw material respectively by following weight portion: Radix Panacis Quinquefolii 200g, Radix Astragali 1850g and Stichopus japonicus 1450g;
(3) soak decoction 2 hours to the Radix Astragali that weighs up, Stichopus japonicus, filter, medicinal residues add water and decoct; Merge the filtrating that obtains for twice; Add 8 times of weight 70% concentration ethanol, it is 1.30 extractum that heating and refluxing extraction 4 hours, filtration, decompression filtrate recycling ethanol, extracting solution are evaporated to relative density; The Radix Panacis Quinquefolii 200g crushing screening that takes by weighing obtains the fine powder of Radix Panacis Quinquefolii;
(4) fine powder of Radix Panacis Quinquefolii mixes with extractum, adds an amount of starch mixing, and drying is pulverized, and the microcrystalline Cellulose by the 44g of prescription weighing with getting ready mixed 25 minutes in mixer;
(5) tabletting: through after the assay was approved, join corresponding punch die with tablet machine and be washed into tablet, be plain sheet getting granule to be pressed ready, tablet weight variation is controlled at ± 5% scope in;
(6) coating
Dosing: each raw material of film coating agent is added in the 200g purified water after by following prescription weighing, stir, be mixed with concentration and be 10% film coating liquid;
The tablet coating: plain sheet is dropped in the coating machine, and regulating EAT is 70 ℃, and leaving air temp is 45 ℃; Spray material coating reaches about 3.0% of total amount up to coat weight, behind the coating; Process 1000 in tablet altogether, 0.7g/ sheet, tablet weight variation be controlled at ± 5% scope in; Tablet behind the coating is sent into the sheet chamber of drying in the air, and the sheet 12 hours of drying in the air promptly gets.
The tablet that embodiment 3 is prepared is used for the test of the following index
The check of Test Example 1 toxicology
Monitoring of hygiene inspection center has been carried out toxicological assessment according to " the health food check and assessment technique standard " of version in 2003 to submitted sample (tablet that embodiment 3 prepares) through Jilin Province; Sample receives inspection to be numbered Ji and defends searching SP201008006 number, and testing result is following:
1, acute toxicity test: each treated animal of duration of test is not seen poisoning symptom, and death toll is zero, female, male mice: LD
50＞21.5g/kgBW.Explain that product of the present invention belongs to nontoxic level.
2, genetic toxicity test (Salmonella reversion test, bone marrow cell micronucleus test, mouse sperm deformity test): testing result is all negative, does not see the genetoxic effect.
3, rat 30d feeding trial: each item indexs such as routine blood test, blood biochemistry index, organ coefficient and body weight, weightening finish, food-intake, food utilization are not all seen harmful effect.Histopathology is observed, and liver,spleen,kidney, stomach, duodenum, testis, ovary are not all seen significant pathological change.
Test Example 2 function of enhancing immunity evaluations
Monitoring of hygiene inspection center has been carried out the function of enhancing immunity evaluation according to " the health food check and assessment technique standard " of version in 2003 to submitted sample through Jilin Province, and sample receives inspection to be numbered Ji and defends searching SP201008006 number, and testing result is following:
Per os gives the tablet 30 days that the Chinese medicine composition of the present invention of mice various dose processes, and can improve half hemolysis value, the mouse antibodies cellulation number of mice, promptly increases humoral immune function, sees table 4,5; Can strengthen the delayed allergy of mice, promptly increase cellular immune function; Can improve the carbon of mouse monokaryon-macrophage and clean up ability, see table 6; To the ability that body weight gain, internal organs/body weight ratio, the inductive mouse spleen lymphocyte conversion capability of ConA, the Turnover of Mouse Peritoneal Macrophages of mice are engulfed chicken red blood cell, the NK cytoactive does not have influence.Judge the effect that tablet that Chinese medicine composition of the present invention is processed has function of enhancing immunity thus.
Table 4 Chinese medicine composition of the present invention is to the influence of mouse antibodies cellulation number
P: each experimental group and negative control group be * relatively: compare＜0.05 with negative control group
Visible by table 4, per os gives the tablet 30 days that the Chinese medicine composition of the present invention of mice various dose processes, and the result shows that the tablet that the Chinese medicine composition of the present invention of high dose is processed generates the number effect of being significantly improved to the mouse antibodies cell.
Table 5 Chinese medicine composition of the present invention is to mice half hemolysis value HC
50Influence
P: each experimental group and negative control group be * relatively: compare＜0.05 with negative control group
Visible by table 5, per os gives the tablet 30 days that the Chinese medicine composition of the present invention of mice various dose processes, and the result shows that the tablet that the Chinese medicine composition of the present invention of high dose is processed can improve the mice half hemolysis value.
Table 6 Chinese medicine composition of the present invention is cleaned up the influence of function to the carbon of monokaryon-macrophage
P: each experimental group and negative control group be * relatively: compare＜0.05 * * with negative control group: compare＜0.01 with negative control group
Visible by table 6, per os gives the tablet 30 days that the Chinese medicine composition of the present invention of mice various dose processes, and the result shows that the tablet that the Chinese medicine composition of the present invention of middle and high dosage is processed can improve the carbon of mouse monokaryon-macrophage and clean up function.
Test Example 3 functional components, stable, hygienical evaluation
Monitoring of hygiene inspection center has been carried out functional component, stable, hygienical evaluation according to " health food check and assessment technique standard ", the Q/DLLK010-2010 of version in 2003 to submitted sample through Jilin Province; Sample receives inspection to be numbered Ji and defends searching SP201008006 number, and testing result is following:
Functional component through this product of check is total saponins (being about 9.4mg/g) and crude polysaccharides (being about 0.012g/g).
The content that stable learn, hygienical evaluation shows wherein Gamma Hexaochlorocyclohexane, clofenotane, arsenic, lead, hydrargyrum is all below detection limit; The equal coincidence detection standard of total plate count: GB/T4789.2-2010, coliform: GB/T4789.3-2003, mycete: GB/T4789.15-2010, yeast: GB/T4789.15-2003; Pathogenic bacterium (duodenum 12 road pathogenic bacterium and pathogenic coccus) detection is comprised: Salmonella: GB/T4789.4-2010, shigella: GB/T4789.5-2003, staphylococcus aureus: GB/T4789.10-2010, Hemolytic streptococcus: GB/T4789.11-2003 detects, and the above pathogenic bacterium of result are all undetected.
The above is merely the preferred embodiments of the present invention, only is illustrative for the purpose of the present invention, and nonrestrictive; Those of ordinary skills understand, and in spirit that claim of the present invention limited and scope, can carry out many changes to it, revise, even equivalence change, but all will fall in protection scope of the present invention.
Claims (10)
1. the Chinese medicine composition of an antifatigue and increasing immune power is characterized in that containing each raw material of following weight portion: Radix Panacis Quinquefolii 50-300 part, Radix Astragali 1500-2500 part, Stichopus japonicus 1000-2000 part; Or
The Radix Panacis Quinquefolii that contains following weight portion, Radix Astragali extract powder that extracts according to 10: 1 ratios and the Stichopus japonicus extract powder that extracts according to 10: 1 ratios: Radix Panacis Quinquefolii 50-300 part, Radix Astragali extract powder 150-250 part, Stichopus japonicus extract powder 100-200 part.
2. Chinese medicine composition as claimed in claim 1 is characterized in that containing each raw material of following weight portion: 200 parts of Radix Panacis Quinquefoliis, 1850 parts of the Radixs Astragali, 1450 parts of Stichopus japonicuss; Or
The Radix Panacis Quinquefolii that contains following weight portion, Radix Astragali extract powder that extracts according to 10: 1 ratios and the Stichopus japonicus extract powder that extracts according to 10: 1 ratios: 200 parts of Radix Panacis Quinquefoliis, 185 parts in Radix Astragali extract powder, 145 parts in Stichopus japonicus extract powder.
3. the pharmaceutical preparation of an antifatigue and increasing immune power is characterized in that being made up of the adjuvant of claim 1 or 2 described Chinese medicine compositions and pharmaceutically acceptance.
4. pharmaceutical preparation as claimed in claim 3 is characterized in that described preparation is decoct, capsule, pill, granule, tablet or oral liquid.
5. pharmaceutical preparation as claimed in claim 4 is characterized in that described preparation is a tablet.
6. prepare the method for the described pharmaceutical preparation of claim 5, it is characterized in that, the preparation of described tablet may further comprise the steps:
(1) raw material pre-treatment: Radix Panacis Quinquefolii, Radix Astragali extract powder and Stichopus japonicus extract powder, pulverize separately is crossed 100 mesh sieves, obtains Radix Panacis Quinquefolii powder respectively, and Radix Astragali extract powder and Stichopus japonicus extract powder after further pulverizing are subsequent use; Preparation dextrin slurry through being 1: 9 ratio slurry commanding tank of packing into the dextrin of 50-200 weight portion and purified water according to weight ratio, constantly stirs, and is heated to 77-85 ℃ simultaneously, and gelatinizing promptly gets dextrin and starches; Microcrystalline Cellulose was pulverized 100 mesh sieves, subsequent use;
(2) mixing granulation: granulate with efficient wet granulator; Difference weighing Radix Panacis Quinquefolii powder 50-300 weight portion; Stichopus japonicus extract powder 100-200 weight portion after Radix Astragali extract powder 150-250 weight portion after further pulverizing and further the pulverizing is packed in the granulator jointly; Start the mixing stirring paddle, mix and stirred 25 minutes; Behind the mix homogeneously, open the granulation switch, evenly add the dextrin slurry and granulate;
(3) oven dry: wet granular is dried with heated-air circulation oven; The control temperature is at 60--70 ℃ during oven dry, and drying time is 10-15 hour, makes moisture below 3% after the oven dry;
(4) granulate: the granule that makes is selected 12 eye mesh screen granulate with waving granulation machine;
(5) total mixing: the microcrystalline Cellulose of the granule behind the granulate and the 20-60 weight portion of getting ready, mixed 25 minutes in mixer; Mix the back granule and be contained in the clean medicinal plastic bag, airtight;
(6) tabletting: will get granule to be pressed ready and join corresponding punch die with tablet machine and be washed into tablet, be plain sheet, tablet weight variation is controlled at ± 5% scope in;
(7) coating:
Dosing: each raw material of film coating agent is added in an amount of purified water after by suitable proportioning weighing, stir, be mixed with concentration and be 10% film coating liquid;
The tablet coating: plain sheet is dropped in the coating machine, and regulating EAT is 70 ± 5 ℃, and leaving air temp is 45 ± 5 ℃, and spray material coating reaches about 3.0% of total amount up to coat weight, behind the coating, tablet weight variation is controlled at ± 5% scope in; Tablet behind the coating is sent into the sheet chamber of drying in the air, and the sheet 12 hours of drying in the air promptly gets.
7. method for preparing as claimed in claim 6 is characterized in that said film coating agent comprises each raw material of following weight portion: hypromellose 10-20 part, hyprolose 1-5 part, magnesium stearate 1-2 part, Macrogol 4000 1-5 part, Black Rouge 0.005-0.02 part, red ferric oxide 0.005-0.02 part.
8. method for preparing as claimed in claim 6 is characterized in that the weight of described each raw material is:
Wherein said film coating agent is made up of each raw material of following weight:
Process 1000 in tablet altogether, the 0.7g/ sheet.
9. the application of the described Chinese medicine composition of claim 1-2 in preparation antifatigue and increasing immune power medicine.
10. the application of the described pharmaceutical preparation of claim 3-5 in preparation antifatigue and increasing immune power medicine.
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| CN103829238A (en) * | 2014-02-17 | 2014-06-04 | 大连圣弘医药有限公司 | Blood lipid lowering health food and preparation method thereof |
| CN107279990A (en) * | 2017-05-23 | 2017-10-24 | 辽宁阿里郎生物工程股份有限公司 | A kind of foreign beche-de-mer capsules and preparation method thereof |
| CN109393283A (en) * | 2018-12-26 | 2019-03-01 | 同药集团大同制药有限公司 | Using Radix Astragali as the preparation method of the anti-Fatigue Composition of major ingredient |
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| CN1582965A (en) * | 2003-08-20 | 2005-02-23 | 焦红军 | Double ginseng capsules and their preparation |
| CN101756185A (en) * | 2008-10-22 | 2010-06-30 | 于树丽 | American ginseng astragalus buccal tablet |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1582965A (en) * | 2003-08-20 | 2005-02-23 | 焦红军 | Double ginseng capsules and their preparation |
| CN101756185A (en) * | 2008-10-22 | 2010-06-30 | 于树丽 | American ginseng astragalus buccal tablet |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103829238A (en) * | 2014-02-17 | 2014-06-04 | 大连圣弘医药有限公司 | Blood lipid lowering health food and preparation method thereof |
| CN107279990A (en) * | 2017-05-23 | 2017-10-24 | 辽宁阿里郎生物工程股份有限公司 | A kind of foreign beche-de-mer capsules and preparation method thereof |
| CN109393283A (en) * | 2018-12-26 | 2019-03-01 | 同药集团大同制药有限公司 | Using Radix Astragali as the preparation method of the anti-Fatigue Composition of major ingredient |
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