CN101053588A - Preparation method for compound arabinogalactan film coated tablets - Google Patents
Preparation method for compound arabinogalactan film coated tablets Download PDFInfo
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Abstract
The invention discloses a producing method for compound arabinogalactan film-coated tablets (CAFT), which is characterized in that: having the arabinogalactan, astragalus root, fuling poris cocos as material to produce coated tablets. The arabinogalactan is extracted by Larix gmelinii Rupr. with a basic unit of its main chain 1,3-beta-D-galactose, and a side chain mainly composed of L-arabinose connecting to the main chain by 6-1. The primary chemical components of the astragalus root are astragaloside I, II, III, asragulus polysacharin A, B, C, D, flavone, alkaloid, glucuronic acid, and microelement Selenium and etc.; and the primary chemical components of the fuling poris cocos are beta-pachyman, pachymic acid, poriatin and beta-pachyman catabolic enzyme. Three medicines cooperate to improve the organism immune function.
Description
Technical field
The invention relates to a kind of preparation method of compound arabinogalactan film coated tablets (Compound Arabinogalactan Film-coated Tablets writes a Chinese character in simplified form CAFT).
Background technology
A. arabinogalactan immunocompetence technique background
Arabinogalactan (Arabinogalactan writes a Chinese character in simplified form AG) is a kind of important biological polysaccharide that obtains from trees and plant, has water solublity and bioavailability.The be significantly improved immune response activity of mononuclear cell in the human body immunizing antigen, macrophage, T cell and natural killer cell of arabinogalactan, excite immunizing antigen to produce nonspecific cell killing effect, and produce endogenous interferon IFN and TNF in the inductor.The plain receptors bind of arabinogalactan and specific agglutination is as the immunopotentiating agent with potential curative effect, can be used for controlling hydrothorax, the ascites that various tumors cause, also can be used for pulmonary carcinoma, hepatocarcinoma, esophageal carcinoma, bladder cancer, malignant lymphoma, late gastric cancer and melanomatous treatment.
At present, arabinogalactan by the approval of united states drug and food Watch-dog committee (FDA), is widely used in a plurality of industries such as medicine, food, cosmetics.
B. the Radix Astragali and Poria immunocompetence technical background
(1) Radix Astragali immunocompetence technique background
The Radix Astragali can make the early stage antigen binding cell in immunity back, comprises that antibody secreting cell and B, T lymphocyte and NK cell number obviously raise, and leukocyte and macrophage phagocytic ability and cellular immunization and humoral immunization are all had potentiation.The Radix Astragali can activate the expression that IFN-γ, IL-4 and IgG subclass interferon suppress heme oxygenase-1, and heart is had positive inotropic action, can increase the cardiac output and the every amount of fighting, and to tired and depleted heart, its cardiotonic is more obvious.The Radix Astragali not only can improve patient's hemorheological property, can also reduce platelet adhesion rate, reduces thrombosis, and myocardial cell is had significant protective effect.The Radix Astragali can be expanded renal blood vessels and renal blood flow increasing, reduces the stimulation to juxtaglomerular apparatus, thereby brings high blood pressure down, and recovers cell viability, repairs the nephridial tissue structure, rebulids the effect of kidney blood flow.
(2) Poria immunocompetence technical background
Pachyman energy inducer T lymphocyte produces IL-2 and improves the activity of IL-2, strengthens the active also generation of inducing interferon of the killer cell (LAK) of NK cell and lymphokineactivation.Pachyman can also strengthen the macrophage recognition function, improves the phagocytic rate and the phagocytic index of macrophage, and can increase macrophage release TNF, and the activity of enhance TNF.Pachyman can obviously strengthen the breeder reaction that spleen T lymphocyte stimulates ConA, improves mice peripheral T lymphocyte a-ANAE positive rate; Activate bone-marrow-derived lymphocyte, improve the effect of fuselage state and enhancing anti-infection ability.In addition, the different polysaccharide of Poria (Pachymaran) has very strong anti-tumor activity.Pachyman suppresses dna replication dna, RNA interfering is transcribed or mediated dna ruptures and causes death of neoplastic cells by influencing a plurality of links of division growth of tumor cell.Su-fuling all has obvious enhancing macrophage to produce and induce the ability of tumor necrosis factor in vivo and in vitro.Poria can also influence internal metabolism, and electrolytical balance is had the conciliation effect.
C. the research and development background of arabinogalactan film coated tablets
Contain a large amount of arabinogalactan (10-25%) in larch in Xinanlin area (the Larix gmelinii Rupr.) timber, larch is the chief species in forest zone, northeast, so arabinogalactan is that a class prepares the natural biological goods that raw material sources are abundant, product cost is low.While is as a kind of activity that can improve natural killer cell and macrophage, but activating complement, the immunopotentiating agent of the immunity of enhancing body, the existing arabinogalactan preparation that is used for medical treatment and health care of arabinogalactan appears on the market abroad.
The present invention is according to the similarity of the pathology of immunodeficiency (IDD) in the syndrome of qi deficiency of spleen and lung of traditional medicine and the modern medicine, employing has Chinese medicine astragalus and the Poria and the arabinogalactan composition compound preparation of invigorating the spleen to benefit the lung effect, and arabinogalactan has the non-specific and cellular immune function of raising; The Radix Astragali, Poria have the raising humoral immune function.The present invention has the immunization of adjusting and variant characteristics according to arabinogalactan, the Radix Astragali, three kinds of medicines of Poria, Chinese medicine and western medicine is used in combination, purpose is based on the Western medicine medicine, is equipped with the Chinese medicine with clear and definite pharmacological action and forms prescription, the performance drug synergism; And according to the character and the route of administration of arabinogalactan, the Radix Astragali and Poria, the requirement in conjunction with producing, transport, use, carry and storing is made into pharmaceutical preparation.Strengthen the immune effect of arabinogalactan, improve added value of product, be convenient to the industrialized development of arabinogalactan.
Summary of the invention
Arabinogalactan has the non-specific and cellular immune function of raising; The Radix Astragali, Poria have the raising humoral immune function.The present invention has the immunization of adjusting and variant characteristics according to arabinogalactan, the Radix Astragali, three kinds of medicines of Poria.Three recurrence due to taking drug are joined effectively enhancing human body immunity function.Arabinogalactan is to be extracted by larch in Xinanlin area, and the basic structural unit of its main chain is 1, the 3 β-D galactose that connects, the L-arabinose of side chain to be connected with main chain 6-1; Radix Astragali extractum dry powder, its main chemical compositions is Radix Astragali saponin first a, second, third, astragalus polysaccharides A, B, C, D, flavone, alkaloid, glucuronic acid and trace element-selenium etc.: Poria extract dry powder, its main chemical compositions are the Poria extract dry powder that β-pachyman, pachymic acid, su-fuling, soil are herded acid, eburicoic acid, β-pachyman catabolic enzyme, natural gum, protein, lecithin, choline and inorganic constituents potassium, sodium, magnesium, phosphorus etc.Drug synergism is brought into play in three kinds of composite uses of medicine, and is made into the pharmaceutical dosage form of Film coated tablets.
The invention provides a kind of preparation method of compound arabinogalactan film coated tablets, it is characterized in that: adopt and get refining astragalus, Poria extract dry powder and arabinogalactan by a certain percentage, adding starch fully mixes, certain density ethanol (playing wetting agent) is sprayed into composite mixture, handle through the soft ability of system, one-tenth granule two one-step formings, in 60 ℃ of electric heating constant temperature air dry ovens after the drying, the cut-off footpath is less than 14 purpose granules, add an amount of magnesium stearate mixing, obtain the plain sheet of compound recipe arabinogalactan through the single punch tablet machine tabletting.Pour in the coating pan that 15% Opadry Opadry II film coating liquid is housed after plain sheet sieves, regulate coating machine parameter, drive peristaltic pump, spray gun, carry out film coating.When treating that coating solution has sprayed, close peristaltic pump, spray gun, the coating pan rotating speed that slows down dry 10 minutes, obtains compound recipe arabinogalactan thin membrane coated tablet.
Coating solution can prepare as follows described in the preparation method of the present invention: adopt Opadry Opadry II coating powder as coating material, the 90g coating powder is dissolved in ethanol, and to make 75% alcoholic solution A standby.In magnetic stirrer, add 510g ultrafiltration pure water, start magnetic stirrer, treat that the water surface forms whirlpool, solution A is added in the entry along the whirlpool direction slowly, joining day is no less than 5 minutes, the mixing speed that slows down then to whirlpool just disappears, and continues to stir 45 minutes, obtains 15% Opadry Opadry II film coating liquid.
Refining astragalus described in the preparation method of the present invention, Poria extract dry powder can prepare as follows: get each 50 of raw materials, be crushed to certain particle size, adopt decocting method to extract after adding a certain amount of water logging bubble certain hour, each 1.5 hours extraction times, merge extractive liquid,, be concentrated into 1: 1, obtain the Radix Astragali or Poria crude extract.Adopt the chitosan sedimentation method to carry out the purification of crude extract,, add the chitosan clarifier for preparing, add 2.5g in every Hydrargyri Oxydum Rubrum liquid, continue the slow 10min of stirring, leave standstill 24h, promptly get sample solution in 60 ℃ of quick stirrings down.The sample solution vacuum drying gets dry extract, pulverizes the back and crosses 80 mesh sieves, obtains the refined dry extract powder.
Chitosan clarifier can prepare as follows described in the preparation method of the present invention: take by weighing chitosan 1g, add 1% aqueous acetic acid 100ml, magnetic agitation to chitosan dissolves fully.
It is Main Ingredients and Appearance that the present invention has prepared first with the arabinogalactan, and the Radix Astragali, Poria are the compound arabinogalactan film coated tablets of auxiliary element.The present invention carries out the biological effect evaluation to the compound arabinogalactan film coated tablets agent first.The present invention adopts many index comprehensives point system that the Forming Quality of the plain sheet of compound recipe arabinogalactan is estimated, outward appearance, weight differential, hardness, disintegration with tablet are index, comprehensive each single index testing result of Forming Quality is to the effect of mouldability, index is marked, carry out overall merit with Forming Quality, filter out the prescription that meets the requirement of tablet Forming Quality.The present invention is the effect that index is investigated the film coating protection against the tide with the water content.The biological effect evaluation is carried out in the compound arabinogalactan film coated tablets agent, preparation type selecting effect is estimated.
The compound arabinogalactan film coated tablets of the present invention's preparation is characterised in that: 1) the compound recipe arabinogalactan of this method preparation is a pharmacodynamic raw materials with arabinogalactan, the Radix Astragali, Poria compatibility.2) dosage form of the compound recipe arabinogalactan of this method preparation is a Film coated tablets.3) compound recipe arabinogalactan temperature in preparation process of this method preparation is not higher than 60 ℃.
Advantage of the present invention: 1) having prepared first with the arabinogalactan is Main Ingredients and Appearance; The Radix Astragali, Poria are the compound arabinogalactan film coated tablets of auxiliary element.2) to have prepared first with arabinogalactan, the Radix Astragali, Poria be the Film coated tablets dosage form of main ingredient compatibility in the present invention.3) the present invention carries out the biological effect evaluation to the compound arabinogalactan film coated tablets agent first, and preparation type selecting effect is estimated.
The specific embodiment
Example 1
The employing mass ratio is 1: 1 a ratio, get the Radix Astragali, Poria extract dry powder and the arabinogalactan of refining 80 mesh sieves, adding starch with 10% quality proportioning fully mixes, with concentration is that 60% ethanol (playing wetting agent) sprays into composite mixture, handle through the soft ability of system, one-tenth granule two one-step formings, drying is after 60 minutes in 60 ℃ of electric heating constant temperature air dry ovens, the cut-off footpath is less than 20 purpose granules, add the magnesium stearate mixing with 1% quality proportioning, obtain the plain sheet of compound recipe arabinogalactan through the single punch tablet machine tabletting.Pour in the coating pan that 15% Opadry Opadry II film coating liquid is housed after plain sheet sieves, regulate coating machine parameter, drive peristaltic pump, spray gun, carry out film coating.When treating that coating solution has sprayed, the coating pan rotating speed that slows down dry 10 minutes, obtains compound recipe arabinogalactan thin membrane coated tablet.The plain sheet outward appearance of compound recipe arabinogalactan complete bright and clean, color is equal, colourless numb speckle is abnormal; Weight differential 0.9168%; Hardness 6.2kg; Disintegration 7min.Under 37 ℃, relative humidity 75% condition, adopt dry weight-loss method to detect its moisture, the result shows that film-coat has good moistureproof ability.
Example 2
The employing mass ratio is 1: 1 a ratio, get the Radix Astragali, Poria extract dry powder and the arabinogalactan of refining 80 mesh sieves, concentration is that 70% ethanol (playing wetting agent) sprays into composite mixture, handle through the soft ability of system, one-tenth granule two one-step formings, drying is after 60 minutes in 60 ℃ of electric heating constant temperature air dry ovens, the cut-off footpath adds the magnesium stearate mixing less than 14 purpose granules with 2% quality proportioning, obtains the plain sheet of compound recipe arabinogalactan through the single punch tablet machine tabletting.All the other operations are with example 1, in this example the plain sheet outward appearance of compound recipe arabinogalactan complete bright and clean, color is equal, the coloured numb speckle of idol is abnormal; Weight differential 0.8527%; Hardness 4.6kg; Disintegration 7mi; Has good moistureproof ability.
Example 3
The compound arabinogalactan film coated tablets acute toxicity test.Choose 20 of healthy Kunming mouses, carry out acute toxicity test.In 1 week, death and toxic reaction all do not appear in 20 mices after the administration, and any unusual performance is not also arranged.Animal appearance, activity, appetite are normal, and no abnormal secretions and defecation are unusual.Dosage has been Cmax and the maximum volume that experiment can reach in the experiment.In adult's 60 kilograms of days of average weight dosage 3 grams, it is 0.13 * 2=0.26 gram that average weight 20 gram mices on average gavaged the crude drug amount in 24 hours, and maximum tolerated dose is 260 times.
Example 4
The compound arabinogalactan film coated tablets long term toxicity test.Choose 60 of healthy rats, be divided into 3 groups of low dosage (1g/kg) and high dose (4g/kg), matched groups at random.The 1st, 2 group gavages compound arabinogalactan film coated tablets solution 4g/kg respectively, and 1g/kg, matched group give the equal-volume distilled water, and 8 o'clock every mornings were pressed the heavy gastric infusion of animal body, and volume is fixed as 2ml/100g, and administration is seven days weekly, continuously 42d.Carry out long term toxicity test.
The arabinogalactan preparation sees Table 1 to the experimental result that influences of rat body weight, and each treated animal is movable normal at experimental session, the outward appearance hair luster, and feces is no abnormal, none death, rat body weight increases with age growth.
The arabinogalactan preparation shows that to the result of study of routine blood test continuous application compound arabinogalactan film coated tablets 28d does not have obvious influence to rat hemoglobin, erythrocyte, leukocyte count and lymph, acidophilia, reticulocyte.
The arabinogalactan preparation shows the influence of rats'liver renal function test, and continuous application compound arabinogalactan film coated tablets 28d is to rat blood serum ALT, AKP, and BUN and Crea content do not have obvious influence.
The arabinogalactan preparation to continuous gastric infusion 28d after, internal organs outward appearances such as the heart of each treated animal, liver,spleen,kidney, lung are normal, the proportion of every 100g body weight (except that spleen) and matched group no significant difference.Special pathological change is seen in equal end by pathological anatomy and histopathologic examination, retains the tissue morphology structure of the above-mentioned internal organs of animal and does not see obvious pathological changes.
The influence of table 1 pair rat body weight (X ± SD n=20) (g)
| Matched group | Low dose group | High dose group | |
| Before the administration after the administration after the administration in 7 days after the administration in 14 days after the administration in 21 days 28 days | 147.8±17.5 172.7±29.3 185.4±26.7 208.2±35.4 222.58±34.3 | 145.1±12.4 163.1±18.9 174.3±21.6 199.0±18.7 210.3±22.1 | 146.7±18.4 173.6±25.7 183.5±26.7 209.8±39.7 223.4±33.6 |
The t check, each experimental group and matched group be P＞0.05 relatively
Example 5
Compound arabinogalactan film coated tablets is to the influence of mice non-specific immunity.Selecting body weight for use is 30 of the Kunming mouses of 20 ± 2g, and male and female half and half are divided into five groups at random, 10 every group.Every Mus lumbar injection chicken erythrocyte suspension 1ml after 14 days.Determination experiment group, matched group and blank are organized macrophage phagocytic percentage rate and the phagocytic index of mice, represent the macrophage phagocytic ability of mice with phagocytic percentage or phagocytic index.
Arabinogalactan is a matched group, compound recipe arabinogalactan sugar Film coated tablets preparation is that the experimental result that the medication group is engulfed chicken red blood cell to Turnover of Mouse Peritoneal Macrophages shows, with the compound arabinogalactan film coated tablets preparation is medication group (64 ± 6%, 1.53 ± 0.43) Turnover of Mouse Peritoneal Macrophages is engulfed chicken red blood cell percentage rate and phagocytic index all apparently higher than matched group (40410%, 0.50 ± 0.17) and blank group (34 ± 9%, 0.33 ± 0.15), significant difference.
Example 6
Compound arabinogalactan film coated tablets is to the influence of the humoral immune function of mice body.Selecting body weight for use is the Kunming mouse of 20 ± 2g, and male and female half and half are divided into five groups at random, 10 every group.Continuously gastric infusion is 14 days, and administration the 2nd day is with every 0.2ml of 20%SRBC (about 4 * 10
8Individual SRBC) lumbar injection immune mouse, immunity took off cervical vertebra and put to death mice after 4 days, took out spleen, calculated the hemolysis plaque number.
Experimental result shows, the formation of hemolysis plaque that with compound recipe arabinogalactan sugar Film coated tablets preparation is medication group (4580 ± 1860) is apparently higher than with the arabinogalactan dropping pill formulation being matched group (2043 ± 580) and blank (1579 ± 427), the significant difference (P＜0.01) organized.With sheep red blood cell (SRBC) (SRBC) lumbar injection sensitized mice, then produce antibody after a couple of days, under complement participates in, can make the SRBC dissolving, produce plaque.Thereby can detect antibody with this and form quantity reflection humoral Immunological State.The hemolysis barren spot experiment result shows that compound arabinogalactan film coated tablets can significantly improve the humoral immune function of body.Compare significant difference with the reference matched group with blank group, its effect is better than using separately the arabinogalactan drop pill.
Example 7
Compound arabinogalactan film coated tablets is to mouse immune regulating action mechanism.Selecting body weight for use is 30 of the Kunming mouses of 20 ± 2g, adopts the immunoregulation effect mechanism of arabinogalactan preparation to the experimental analysis and the research arabinogalactan preparation of the excretory influence of mouse boosting cell interleukin-2 (IL-2).Experimental result shows that administration group IL-2 activity (24507 ± 403) is apparently higher than matched group (19038 ± 495) and blank group (18706 ± 688), significant difference (P＜0.01).
IL-2 can stimulate the growth of NK cell and strengthen its molten cytosis, produces the activated killer cell of so-called lymphokine (LAK).IL-2 can also act on human B cell, both can be used as somatomedin, is again the synthetic stimulus object of antibody.This shows that IL-2 also has obvious facilitation to body's immunological function.Experimental result shows that compound arabinogalactan film coated tablets has obvious facilitation to mouse boosting cell IL-2 secretion, thereby can think that excretory the increasing of IL-2 that compound arabinogalactan film coated tablets causes is it to one of mechanism of the immunoloregulation function of body.
One of function is to stimulate the differentiation of T lymphopoiesis.Arabinogalactan can promote the release of il-1 (IL-1), and the prompting compound arabinogalactan film coated tablets also may promote the secretion of il-1 (IL-1).
Pachyman has facilitation to immune function of mice, and another effective ingredient su-fuling makes the performance of Poria effect will depend on the effect of other drug in the prescription to the inhibitory action that body fluid and the cellular immunization of mice all has suitable intensity in the Poria.The content of the Radix Astragali is 50% in this Chinese prescription of Radix Astragali Poria, near the limit that suppresses immunologic function, but this prescription cooperate with arabinogalactan make Film coated tablets after, but make said preparation that the facilitation of immunologic function is significantly higher than arabinogalactan and use separately.Explanation thus, the Radix Astragali, Poria can strengthen the immunologic enhancement of arabinogalactan, and the three is shared to have cooperative effect.
Claims (4)
1. the compound arabinogalactan film coated tablets of the present invention preparation, its preparation process feature is: adopt and get refining astragalus, Poria extract dry powder and arabinogalactan by a certain percentage, adding starch fully mixes, certain density ethanol (playing wetting agent) is sprayed into composite mixture, handle through the soft ability of system, one-tenth granule two one-step formings, in 60 ℃ of electric heating constant temperature air dry ovens after the drying, the cut-off footpath is less than 20 purpose granules, add an amount of magnesium stearate mixing, obtain the plain sheet of compound recipe arabinogalactan through the single punch tablet machine tabletting.Plain sheet is carried out comprehensive grading, reach requirement after, pour into after sieving in the coating pan that 15% Opadry Opadry II film coating liquid is housed, regulate coating machine parameter, drive peristaltic pump, spray gun, carry out film coating.When treating that coating solution has sprayed, close peristaltic pump, spray gun, the coating pan rotating speed that slows down dry 10 minutes, obtains compound recipe arabinogalactan thin membrane coated tablet.
2. the dosage form of claim 1 described compound recipe arabinogalactan is a Film coated tablets.
3. the described compound arabinogalactan film coated tablets of claim 1 is a pharmacodynamic raw materials with arabinogalactan, the Radix Astragali, Poria compatibility.
4. the described many index comprehensives point system that the Forming Quality of the plain sheet of compound recipe arabinogalactan is estimated of claim 1, be that a kind of outward appearance with tablet, weight differential, hardness, disintegration are index, comprehensive each single index testing result of Forming Quality is to the effect of mouldability, index is marked, carry out overall merit with this Forming Quality, filter out the method for the prescription that meets the requirement of tablet Forming Quality tablet.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101288680B (en) * | 2008-05-12 | 2011-04-13 | 江阴天江药业有限公司 | Preparation method of instant tuckahoe granule |
| CN103766881A (en) * | 2012-10-26 | 2014-05-07 | 苏州市洋海电子有限公司 | Traditional Chinese medicine health product |
| CN108530547A (en) * | 2018-02-26 | 2018-09-14 | 华南农业大学 | A kind of arabogalactan KMCP and preparation method thereof and the application in preparing immunomodulator |
-
2007
- 2007-04-20 CN CN 200710072063 patent/CN101053588A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101288680B (en) * | 2008-05-12 | 2011-04-13 | 江阴天江药业有限公司 | Preparation method of instant tuckahoe granule |
| CN103766881A (en) * | 2012-10-26 | 2014-05-07 | 苏州市洋海电子有限公司 | Traditional Chinese medicine health product |
| CN108530547A (en) * | 2018-02-26 | 2018-09-14 | 华南农业大学 | A kind of arabogalactan KMCP and preparation method thereof and the application in preparing immunomodulator |
| CN108530547B (en) * | 2018-02-26 | 2021-01-19 | 华南农业大学 | Arabinogalactan KMCP, its preparation method and application in preparing immunomodulator |
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Open date: 20071017 |