CN1634121A - Dripping pills of ganoderma lucidum polysaccharide and polystictus versicolor polysaccharide - Google Patents
Dripping pills of ganoderma lucidum polysaccharide and polystictus versicolor polysaccharide Download PDFInfo
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- CN1634121A CN1634121A CN 200410083986 CN200410083986A CN1634121A CN 1634121 A CN1634121 A CN 1634121A CN 200410083986 CN200410083986 CN 200410083986 CN 200410083986 A CN200410083986 A CN 200410083986A CN 1634121 A CN1634121 A CN 1634121A
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Abstract
The invention relates to a pharmaceutical composition oral preparation which contains polysaccharide of Ganoderma lucidum or krestin as the active component, wherein the medicinal composition can be used for treating various diseases, and has the functions of immunological regulation, anticancer and antisenescence. The medicinal composition also contains a finite proportion of medicinal carrying agent as the substrate.
Description
Technical field
The present invention relates to a kind ofly be used for the treatment of multiple disease, and have immunoloregulation function, and pharmaceutical composition obviously anticancer, anti-aging effects, particularly a kind of is the drug composition oral preparation of active component with ganoderan or krestin.
Background technology
Show that with pharmacology analysis ganoderan and krestin all have curative effect in various degree to diseases such as chronic bronchitis, coronary heart disease, angina pectoris, chronic hepatitis, neurasthenia, palpitation and dizziness through clinical in a large number; Especially making people interested is that they also have immunoloregulation function, and obvious anticancer and activity of fighting against senium.
[ganoderan]
1. immunoloregulation function: in order to explore the ganoderan immune regulation mechanism, Li Mingchun etc. adopt cAMP content in cell culture and the competitive protein binding analysis Turnover of Mouse Peritoneal Macrophages, the result shows that ganoderan can cause that cAMP concentration raises in the Turnover of Mouse Peritoneal Macrophages.So think, ganoderan raises by causing in the Turnover of Mouse Peritoneal Macrophages cAMP concentration, thereby causes PKA activation, activating macrophage.This is likely GLB
7Strengthen the immune function of mice important channel.
2. antitumor action: the telomerase opinion is to propose a kind of new Ganoderma anticancer mechanism after by institute of materia medica, Shanghai experimentation recent years.Ganoderma extract can cause the cancerous cell telomerase to lose activity, and impels cancerous cell natural apoptosis after division.It is the Zhang Yaozheng of Dalian Medical Univ professor research topic that short differentiation is discussed, and research discloses cancerous cell can open up non-lethal treatment tumor new approaches, new way again to normal cell differentiation, reverse under short differentiation agent effect.
The foreign scholar also necessarily studies the Ganoderma anticancer property, and usefulness alcohol extraction effective component of glossy ganoderma such as Hu Hongbo, Nam-ShikAHN carry out clinical experiment to the thymic carcinoma patient to be found, extract can the anticancer growth.Many foreign scholars carry out a large amount of zooperies and show, Ganoderma extract can reach 50% conversion ratio to the cancer curative effect.In Japan is specifically designed to partner treatment with chemotherapy and radiation, can heightens the effect of a treatment and accelerate the state of an illness and recover.
3. anti-aging effects: research in recent years thinks that aging mainly is because interior free yl causes the peroxidating of biomembrane lipid, causes membrane structure damage and functionally inactive to cause.Li Mingchun etc. adopt laser scanning co-focusing microscope technology, the equal one GLB of dynamic monitoring ganoderan
7To Turnover of Mouse Peritoneal Macrophages M reactive oxygen free radical content influence, experiment shows, ganoderan can reduce mouse peritoneal M reactive oxygen free radical and produce, and can cause mouse peritoneal M reactive oxygen free radical output by antagonism PMA, from cellular level proof ganoderan anti-aging effects.The ganoderan anti-aging effects also shows others, as: can improve DNA polymerase activity, thereby promote the synthetic and cell proliferation of immunocyte DNA, play anti-aging effects.
4. other effect: Luo Shaohong etc. irritate excess of the stomach to the hyperglycemia mice and find when testing, and reach 100mg/kg when above irritating stomach dosage, can obviously reduce hyperglycemia mouse blood sugar level, no dose-effect relationship.When 200mg/kg dosage, can reduce normal mouse blood glucose, the effect of obvious stimulation insulin secretion is arranged, and can obviously strengthen the hyperglycemia mice the glucose tolerance, visible ganoderan has remarkable effect of lowering blood sugar.Zhang Guoliangs etc. are to the mice discovery that experimentizes, and ganoderan causes the Mouse Liver of liver injury model to have restitution to being infected by BCG.Domesticly also begin to adopt ganoderan composite treatment treatment chronic hepatitis B, reaching the chronic persistent hepatitis cure rate is 71.43%, and the chronic active hepatitis cure rate is 53.33% good result.Gold spring flowers etc. are by discovery that big mice is experimentized, ganoderan can obviously prolong clotting time of mice, reduce TG content in the hyperlipemia in mice serum, obviously prolong rats thrombus in vivo formation time suppresses blood stasis rats in vitro thrombosis and reduces the blood stasis specific viscosity.As seen, ganoderan also helps to improve the heart and brain blood circulation, and the control diseases of cardiovascular and cerebrovascular systems is played good action.
5. the ganoderan structure is formed: at present, show through many researcher lot of experiments, in being separated to more than 200 kind of ganoderan, wherein major part is β-type glucosan, minority is α-type glucosan, polysaccharide chain is made of three strands of monosaccharide chains, it is a kind of helical form spatial configuration thing, its spatial configuration is similar with DNA, RNA, between the spiral layers mainly with the hydrogen bond stationary positioned, molecular weight is present in Ganoderma mycelium, sporophore cell wall inwall, in liquid culture fermentation liquid and the solid culture culture medium mostly from hundreds of to hundreds thousand of.It generally all is D-glucose, D-galactose, D-mannose, D-xylose, L-fucose, L-rhamnose, L-arabinose that ganoderan monosaccharide is formed.
(give birth to Dongming, the horse Oriolus chinensis diffusus. the ganoderan Review Study. 2004 the 7th phases of grain and oils and fats are P.44.)
[krestin]
(Coriolus versicolor Polysaccharide CVPS) is the polysaccharide that proposes to krestin from the variegated Coriolous Dersicolor (Fr.) Quel fungus of basidiomycetes, also can separate obtaining from the mycelium of artificial culture.Pharmacological evaluation shows, multiple biological activity such as it has antitumor, antiulcer, protect the liver.
1. hepatoprotective effect: give mouse stomach manyzoned polypore sporophore polysaccharide 1g/kg, respectively contaminate 1 time with 0.13%CC14 respectively, can significantly reduce the mice serum glutamate pyruvate transaminase at 4h, 10h, 26h.Give mouse stomach manyzoned polypore sporophore polysaccharide 250mg/kg, 7d can significantly reduce subacute hepatitis mice serum glutamate pyruvate transaminase and liver homogenate glutamate pyruvate transaminase continuously.Give mouse stomach manyzoned polypore sporophore polysaccharide 300mg/kg, 14d continuously can obviously prolong the survival period of ascitic type liver cancer mice, obviously reduces cancerous cell number in the ascites, significantly the mitotic index of anticancer.
2. anti-aging effects: only inject 1.5% krestin 0.2ml/ to mouse peritoneal, continuous 4d, can improve the activity of the selenium glutathion peroxidase of each tissue of mice body, improve body defence active oxygen damage ability, its potentiation and its antineoplastic immune regulating action to active oxygen enzymatic purge mechanism is closely related, significant.Use discovering of blocker, krestin all occurs in transcriptional level to the influence of selenium glutathion peroxidase and the expression of non-selenium glutathion peroxidase, and synthesizing of certain novel protein may participate in inducing process.The damage that krestin causes oxidized low density lipoprotein has obvious protective effect.The external mouse peritoneal selenium glutathion peroxidase mRNA content that krestin is handled of low dose of tert-butyl hydroperoxide does not have obvious influence, but can induce normal mouse peritoneal macrophage selenium glutathion peroxidase mRNA.Krestin can strengthen the resistance of macrophage respiratory burst function to the tert-butyl hydroperoxide damage.
3. the effect of raise immunity: krestin can obviously increase
60The mice serum lysozyme content and the spleen index of immunologic hypofunction due to the Co irradiation.Krestin reduces the caused by cyclophosphamide murine interleukin the rebound significantly effect, can significantly increase phagocytic index and engulf coefficient.Krestin can significantly improve the level of mouse boosting cell interleukin II, lymphotoxin and interferon gamma, can significantly strengthen the ability of Turnover of Mouse Peritoneal Macrophages secreting tumor necrosis factor and interleukin 1.Polysaccharide-peptide can promote efficiently expressing through inductive human peripheral leucocytes Jie plain 6 of phytohemagglutinin, comparatively obvious to induce cultivation 48h, transcribing of interleukin-6 mRNA also shows obvious accelerating effect simultaneously, and this may be that it promotes the mechanism that interleukin-6 efficiently expresses.Krestin can improve normal mouse and cyclophosphamide and cause that immunosuppressed mice lymhocyte transformation rate, sheep red blood cell (SRBC) coagulation antibody are tired, splenocyte produces hemolytic antibody ability and NK cell and macrophage anti-tumor activity.Krestin can improve mice colony stimulating factor activity, and colony stimulating factor mRNA content is raise.Krestin can be strengthened the inductive macrophage apoptosis of nitric oxide, induces nitric oxide synthase gene to express, and can strengthen the inducing action of interferon gamma and lipopolysaccharide.After Turnover of Mouse Peritoneal Macrophages and O-LDL co-cultivation 24h that krestin was handled, cellular morphology is not seen bigger change, and after stimulating with lipopolysaccharide, tumor necrosis factor and nitric oxide generation are than matched group height.Krestin has amplification effect to total cell of T and complementary or induced T lymphocyte.It is more than 2 times of matched group that krestin can make mice endotoxin removing coefficient k, and the prompting krestin has the function of obvious enhancing body reticuloendothelial system, and control has positive effect to hepatopathy.
4. tumor-inhibiting action: krestin is in vitro tests, and is effective to AH-13 cell, Jitian's sarcoma cell, AH-130 cell and Chinese mugwort Li Shi ascites cells; Animal vivo test is effective to tumor strains such as S-180, Chinese mugwort Li Shi ehrlich ascites carcinoma, leukemia-P388, MC-sarcoma, adenocarcinoma-755, ascites hepatocarcinoma-AH-13, AH-7974, AH-66F and yoshida sarcomas.Krestin is to the inhibitory rate 84.4% of melanoma B 16.A little less than the effect slightly of the acute T leukemic lymphoblastoid of human body cell strain Jurkat inhibition of proliferation, suppression ratio is 70%; And be 58% to human body glands of large intestine JEG-3 LS-180 inhibition of proliferation rate; To human breast cancer cell MCF7 no obvious inhibitory action in experimental concentration.Krestin has obvious inhibitory action to human body chronic myeloid leukemia cells strain K 562 and human body glands of large intestine JEG-3 SW620, and when drug level was 200 μ g/mL, suppression ratio surpassed 60%; During 500 μ g/mL, suppression ratio reaches 90%.
(Niu Xiaohui, Ji Fenglan, Zhang Wei, Xu Huibo, Sun Xiaobo, Yang Shirong. the krestin Advance on Pharmacological Activities. Chinese science and technology core periodical (2004) 02-P.57-60)
5. chemical constituent: extraction separation goes out krestin from the wild manyzoned polypore sporophore of Changbaishan area, through further separation and purification, obtains polysaccharide I and II, and molecular weight is respectively 110000 and 10000.(its ratio is 1: 0.41: 0.33: 0.27) to contain glucose, fucose, mannose and galactose among the I; Except that containing above-mentioned 4 kinds of sugar, also has rhamnose (ratio is 1: 0.076: 0.075: 0.036: 0.075) among the II.The main sugar chain structure all belongs to the glucosan that β (1 → 3) connects.
(Dan Youliang, Zhuan Zhiquan, Li Bohua, Sun Xiaohong. the krestin progress. Chinese herbal medicine 1998 the 29th volume the 5th phase-P.349-351)
From above data as can be seen, ganoderan has similar characteristic and purposes with krestin.Be used for clinical ganoderan at present, the krestin peroral dosage form has oral liquid, capsule etc., oral liquid is taken usually and is not easily, metering also is difficult to accurately.And the capsule supplementary product consumption is big, and relative cost is also higher, has increased the certain economic burden to the patient; Aborning owing to there is granulation process, also causes environmental pollution easily, and bring certain influence simultaneously to the direct labor.
Summary of the invention
The objective of the invention is to remedy the deficiencies in the prior art, provide a kind of drug loading big, release fast, quick produce effects, the bioavailability height, easy to use flexible, cheap, and free of contamination aborning ganoderan drop pill and krestin drop pill.
Adopt following preparation method can obtain ganoderan drop pill involved in the present invention and krestin drop pill.With the ganoderan is active constituents of medicine, mixes mutually with pharmaceutically suitable carrier as substrate according to certain ratio, forms through specific prepared again.Specific as follows:
[prescription]
1. ganoderan---the process experimentation proves, in isolated more than 200 kinds of ganoderans, wherein major part is β-type glucosan, and minority is α-type glucosan, and polysaccharide chain is made of three strands of monosaccharide chains, it is a kind of helical form spatial configuration thing, its spatial configuration is similar with DNA, RNA, and mainly with the hydrogen bond stationary positioned, molecular weight is from hundreds of to hundreds thousand of between the spiral layers, be present in Ganoderma mycelium, sporophore cell wall inwall mostly, in liquid culture fermentation liquid and the solid culture culture medium.It generally all is D-glucose, D-galactose, D-mannose, D-xylose, L-fucose, L-rhamnose, L-arabinose that ganoderan monosaccharide is formed;
2. krestin---contain polysaccharide I and II, molecular weight is respectively 110000 and 10000.(its ratio is 1: 0.41: 0.33: 0.27) wherein to contain glucose, fucose, mannose and galactose among the polysaccharide I; Except that containing above-mentioned 4 kinds of sugar, also has rhamnose (ratio is 1: 0.076: 0.075: 0.036: 0.075) among the polysaccharide II.The main sugar chain structure all belongs to the glucosan that β (1 → 3) connects.
3. substrate---Polyethylene Glycol
1500～20000, any one or two or more mixture in the pharmaceutic adjuvant such as stearic acid, sodium stearate, glycerin gelatine, polyoxyethylene stearate 40 esters, Lac, polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium, sodium lauryl sulphate;
According to the weight portion meter (g, kg), ganoderan: substrate=1: 1～1: 9.
[preparation method]
1. according to weight portion meter (g, kg), ratio with 1: 1～1: 9, accurately take by weighing ganoderan or krestin and substrate, mix homogeneously, place in the heating container heating while stirring, until obtaining containing ganoderan and substrate, or the pharmaceutical composition fused solution of krestin and substrate and/or emulsion and/or suspension are standby;
2. adopt the drop pill machine (for example TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production) of self-control or industrial general, and the temperature control system of adjustment drop pill machine, make the water dropper storage tank temperature heating of drop pill machine and remain on (60～100) ℃, error＜2%; The temperature of condensing agent cooling and remain on (40～-15) ℃, error＜5% in the condensation column;
3. treating that the temperature of condensing agent in the storage tank of dropping-pill machine head and the condensation column is stable respectively is in above second step during desired state of temperature, to contain ganoderan and substrate, or the pharmaceutical composition fused solution of krestin and substrate and/or emulsion and/or suspension insert in the water dropper storage tank of drop pill machine under the state of insulation, splashes into by water dropper with suitable speed and shrink shaping in the condensing agent naturally.
Condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
4 drop pill that will shrink molding by the outlet of drop pill machine take out, and remove the surface condensation agent, are drying to obtain.
Beneficial effect
The peroral dosage form that is used for clinical ganoderan, krestin at present has oral liquid, capsule etc., and oral liquid is taken usually and is not that easily, metering also is difficult to accurately.And the capsule supplementary product consumption is big, and relative cost is also higher, has increased the certain economic burden to the patient; Aborning owing to there is granulation process, also causes environmental pollution easily, and bring certain influence simultaneously to the direct labor.
Ganoderan involved in the present invention, krestin drop pill, utilize substrate such as surfactant polyethylene to make solid dispersion with ganoderan, krestin, make medicine be molecule, colloid or microcrystalline state and be dispersed in the substrate, the total surface area of medicine is increased.And substrate is hydrophilic, and medicine is had wetting action, can make that medicine is rapidly molten to loose into microgranule or solution, thereby makes the dissolving of medicine and absorb and accelerate, thereby has improved bioavailability, has brought into play efficient, quick-acting effects.Compare with other conventional oral formulations, ganoderan involved in the present invention, krestin drop pill have following beneficial effect:
1. the drop pill that utilizes the solid dispersion technology preparation and get can adopt sublingual administration, and effective ingredient is fully contacted with mucomembranous surface, absorbs by mucomembranous epithelial cell, directly enters blood circulation.Especially sublingual administration administration contacts promptly with saliva and to dissolve rapidly, is absorbed by oral mucosa, directly enters blood circulation without gastrointestinal tract and liver, not only avoided the liver sausage first pass effect, and it is rapid to have brought into play onset, bioavailability height, the advantage that side effect is little.
2. drop pill production technology, equipment involved in the present invention are simple, cycle is short, the automaticity height, the production efficiency height, usually production cost is with below 50% of kind tablet, can reduce patient's drug cost greatly, thereby reduce patient's financial burden, make Most patients all have the ability to use this new pharmaceutical preparation.
3. this preparation is by after solid drugs and substrate heating, being melt into liquid state, splash in the not miscible condensed fluid and make, and the stability of drug height, not facile hydrolysis, oxidation is not subject to the influence of crystal formation, thereby guaranteed drug quality, increased stability.
4. ganoderan involved in the present invention, krestin drop pill, main production process is all carried out under liquid state, and no dust pollution helps labor protection and environmental protection.
The specific embodiment
Now with the test and the result thereof of several groups of specific embodiments, be described further with regard to the preparation method of ganoderan drop pill of the present invention and krestin drop pill.
[ganoderan drop pill prescription]
1. ganoderan---adopt the product of Qingyuan County gold source fungus polysaccharide goods Co., Ltd, polyoses content is 30.8%, moisture 5.3%, and character is a chocolate brown powder;
2 substrate---Polyethylene Glycol
1500～20000, in the pharmaceutic adjuvant such as stearic acid, sodium stearate, glycerin gelatine, polyoxyethylene stearate 40 esters, Lac, polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium, sodium lauryl sulphate any one;
3 according to the weight portion meter (g, kg), ganoderan: substrate=1: 1～1: 9.
[result of the test]
In order to observe ganoderan and different substrates at 1: 1,1: 3, prepared ganoderan drop pill was in qualitative difference during proportioning such as 1: 9, and respectively according to 1: 1,1: 3,1: 9 ratio was with ganoderan and Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as stearic acid, sodium stearate, polyoxyethylene stearate 40 esters, glycerin gelatine, Lac, polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium, sodium lauryl sulphate matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 * 15 pharmaceutical compositions that ganoderan and different substrates constituted, and obtain that 3 * 15 groups of different experimental results see Table 1 respectively, table 2, table 3.
The group practices of table 1 ganoderan and different substrates (1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | ????50.0 | ????71 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????84 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????50.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????50.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????50.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????50.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Stearic acid | ????50.0 | ????55 | ????＜30 | ????＞10 | + |
| Sodium stearate | ????50.0 | ????72 | ????＜30 | ????＞10 | + |
| Glycerin gelatine | ????50.0 | ????58 | ????＜30 | ????＞10 | + |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????87 | ????＜30 | ????＜10 | +++ |
| Lac | ????50.0 | ????52 | ????＜30 | ????＞10 | + |
| The polyoxyethylene monostearate | ????50.0 | ????73 | ????＜30 | ????＞10 | + |
| Polyethers | ????50.0 | ????84 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????50.0 | ????73 | ????＜30 | ????＞10 | ++ |
| Sodium lauryl sulphate | ????50.0 | ????70 | ????＜30 | ????＞10 | ++ |
Result by table 1 can see: when extractum or dry powder: during substrate=1: 1, part test rounding rate wherein, the ball method of double differences is different and index such as hardness is all undesirable, and dissolve scattered time limit institute is influenced not obvious.
The group practices of table 2 ganoderan and different substrates (1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | ????25.0 | ????78 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????25.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????25.0 | ????95 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Stearic acid | ????25.0 | ????68 | ????＜30 | ????＞10 | + |
| Sodium stearate | ????25.0 | ????70 | ????＜30 | ????＞10 | ++ |
| Glycerin gelatine | ????25.0 | ????66 | ????＜30 | ????＞10 | + |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Lac | ????25.0 | ????65 | ????＜30 | ????＞10 | + |
| The polyoxyethylene monostearate | ????25.0 | ????74 | ????＜30 | ????＞10 | ++ |
| Polyethers | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????85 | ????＜30 | ????＜10 | ++ |
| Sodium lauryl sulphate | ????25.0 | ????75 | ????＜30 | ????＞10 | ++ |
Result by table 2 can see: when extractum or dry powder: during substrate=1: 3, the rounding rate, the ball method of double differences is different and index such as hardness is better than the data of table 1 slightly.
The group practices of table 3 ganoderan and different substrates (1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | ????10.0 | ????89 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 4000 | ????10.0 | ????95 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????10.0 | ????95 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????10.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????96 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Stearic acid | ????10.0 | ????82 | ????＜30 | ????＜10 | ++ |
| Sodium stearate | ????10.0 | ????82 | ????＜30 | ????＞10 | ++ |
| Glycerin gelatine | ????10.0 | ????70 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Lac | ????10.0 | ????73 | ????＜30 | ????＞10 | ++ |
| The polyoxyethylene monostearate | ????10.0 | ????87 | ????＜30 | ????＜10 | ++ |
| Polyethers | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????10.0 | ????87 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????83 | ????＜30 | ????＜10 | +++ |
Result by table 3 can see: when extractum or dry powder: during substrate=1: 9, it is desirable that every index all is tending towards.
[krestin drop pill prescription]
1. krestin---adopt the product of Qingyuan County gold source fungus polysaccharide goods Co., Ltd, polyoses content is 32.9%, moisture 4.8%, and character is a chocolate brown powder;
2 substrate---Polyethylene Glycol
1500～20000, in the pharmaceutic adjuvant such as stearic acid, sodium stearate, glycerin gelatine, polyoxyethylene stearate 40 esters, Lac, polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium, sodium lauryl sulphate any one;
3 according to the weight portion meter (g, kg), ganoderan: substrate=1: 1～1: 9.
[result of the test]
In order to observe krestin and different substrates at 1: 1,1: 3, prepared krestin drop pill was in qualitative difference during proportioning such as 1: 9, and respectively according to 1: 1,1: 3,1: 9 ratio was with krestin and Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as stearic acid, sodium stearate, polyoxyethylene stearate 40 esters, glycerin gelatine, Lac, polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium, sodium lauryl sulphate matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 * 15 pharmaceutical compositions that krestin and different substrates constituted, and obtain that 3 * 15 groups of different experimental results see Table 4 respectively, table 5, table 6.
The group practices of table 4 krestin and different substrates (1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | ????50.0 | ????69 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????82 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????50.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????50.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????50.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????50.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Stearic acid | ????50.0 | ????53 | ????＜30 | ????＞10 | + |
| Sodium stearate | ????50.0 | ????70 | ????＜30 | ????＞10 | + |
| Glycerin gelatine | ????50.0 | ????55 | ????＜30 | ????＞10 | + |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Lac | ????50.0 | ????58 | ????＜30 | ????＞10 | + |
| The polyoxyethylene monostearate | ????50.0 | ????76 | ????＜30 | ????＞10 | + |
| Polyethers | ????50.0 | ????85 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????50.0 | ????74 | ????＜30 | ????＞10 | ++ |
| Sodium lauryl sulphate | ????50.0 | ????70 | ????＜30 | ????＞10 | ++ |
The group practices of table 5 krestin and different substrates (1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | ????25.0 | ????79 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????25.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????25.0 | ????95 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????95 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Stearic acid | ????25.0 | ????70 | ????＜30 | ????＞10 | + |
| Sodium stearate | ????25.0 | ????71 | ????＜30 | ????＞10 | ++ |
| Glycerin gelatine | ????25.0 | ????69 | ????＜30 | ????＞10 | + |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Lac | ????25.0 | ????66 | ????＜30 | ????＞10 | + |
| The polyoxyethylene monostearate | ????25.0 | ????74 | ????＜30 | ????＞10 | ++ |
| Polyethers | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????86 | ????＜30 | ????＜10 | ++ |
| Sodium lauryl sulphate | ????25.0 | ????74 | ????＜30 | ????＞10 | ++ |
The group practices of table 6 krestin and different substrates (1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | ????10.0 | ????88 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 4000 | ????10.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????10.0 | ????95 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????10.0 | ????95 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Stearic acid | ????10.0 | ????81 | ????＜30 | ????＜10 | ++ |
| Sodium stearate | ????10.0 | ????82 | ????＜30 | ????＞10 | ++ |
| Glycerin gelatine | ????10.0 | ????68 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Lac | ????10.0 | ????70 | ????＜30 | ????＞10 | ++ |
| The polyoxyethylene monostearate | ????10.0 | ????88 | ????＜30 | ????＜10 | ++ |
| Polyethers | ????10.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????10.0 | ????86 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????80 | ????＜30 | ????＜10 | +++ |
Can be seen by table 4,5,6 result: every quality index is similar substantially to ganoderan.
(annotate: the hardness method for expressing in the subordinate list, adopt drop pill is placed on the glass plate, press...with one's finger it, observe its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.)
Claims (6)
1. one kind is used for the treatment of multiple disease, and have immunoloregulation function, and pharmaceutical composition obviously anticancer, anti-aging effects---ganoderan drop pill, be active constituents of medicine with the ganoderan, be prepared from pharmaceutically suitable carrier as substrate, wherein:
The extraction mixture of 1.1 ganoderan---Ganoderma, the polysaccharide chain of effective ingredient wherein for constituting by three strands of monosaccharide chains, it is a kind of helical form spatial configuration thing, its spatial configuration is similar with DNA, RNA, between the spiral layers mainly with the hydrogen bond stationary positioned, molecular weight is present in Ganoderma mycelium, sporophore cell wall inwall, in liquid culture fermentation liquid and the solid culture culture medium mostly from hundreds of to hundreds thousand of; It generally all is D-glucose, D-galactose, D-mannose, D-xylose, L-fucose, L-rhamnose, L-arabinose that ganoderan monosaccharide is formed;
1.2 substrate---Polyethylene Glycol
1500～20000, any one or two or more mixture in the pharmaceutic adjuvant such as stearic acid, sodium stearate, glycerin gelatine, polyoxyethylene stearate 40 esters, Lac, polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium, sodium lauryl sulphate;
1.3 according to the weight portion meter (g, kg), ganoderan: substrate=1: 1～1: 8.
2. one kind is used for the treatment of multiple disease, and have immunoloregulation function, and pharmaceutical composition obviously anticancer, anti-aging effects---krestin drop pill, be active constituents of medicine with the ganoderan, be prepared from pharmaceutically suitable carrier as substrate, wherein:
2.1 krestin---contain polysaccharide I and II, molecular weight is respectively 110000 and 10000, (its ratio is 1: 0.41: 0.33: 0.27) wherein to contain glucose, fucose, mannose and galactose among the polysaccharide I, among the polysaccharide II except that containing above-mentioned 4 kinds of sugar, also have rhamnose (ratio is 1: 0.076: 0.075: 0.036: 0.075), the main sugar chain structure of polysaccharide I and polysaccharide II all belongs to the glucosan that β (1 → 3) is connected.
2.2 substrate---Polyethylene Glycol
1500～20000, any one or two or more mixture in the pharmaceutic adjuvant such as stearic acid, sodium stearate, glycerin gelatine, polyoxyethylene stearate 40 esters, Lac, polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium, sodium lauryl sulphate;
2.3 according to the weight portion meter (g, kg), ganoderan: substrate=1: 1～1: 9.
3. as claim 1 or the described any drop pill of claim 2, it is characterized in that: described substrate is Polyethylene Glycol
4000～20000
4. as claim 1 or the described any drop pill of claim 2, it is characterized in that: described substrate is polyoxyethylene stearate 40 esters or polyethers or carboxymethyl starch sodium or sodium lauryl sulphate.
5. as claim 1 or the described any drop pill of claim 2, it is characterized in that: described substrate is polyoxyethylene stearate 40 esters, polyethers, carboxymethyl starch sodium, sodium lauryl sulphate, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000In two or more mixture in pharmaceutically suitable carrier.
6. any drop pill described in claim 1～5, it is characterized in that: the proportioning of ganoderan or krestin and described substrate is 1: 3～6.
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| CN 200410083986 CN1634121A (en) | 2004-10-15 | 2004-10-15 | Dripping pills of ganoderma lucidum polysaccharide and polystictus versicolor polysaccharide |
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| CN 200410083986 CN1634121A (en) | 2004-10-15 | 2004-10-15 | Dripping pills of ganoderma lucidum polysaccharide and polystictus versicolor polysaccharide |
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| TWI386485B (en) * | 2005-07-28 | 2013-02-21 | Nikken Sohonsha Corp | Tramete versicolor and its extract and use thereof |
| US20130108586A1 (en) * | 2011-11-01 | 2013-05-02 | Jimmy Lu | Composition and method of delivery of l-arabinose and select compounds |
| CN103599167A (en) * | 2013-11-07 | 2014-02-26 | 杨曼茹 | Medicament for treating lung cancer |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| TWI386485B (en) * | 2005-07-28 | 2013-02-21 | Nikken Sohonsha Corp | Tramete versicolor and its extract and use thereof |
| CN101361764B (en) * | 2008-09-01 | 2011-10-05 | 北京世纪博康医药科技有限公司 | Composition containing brown alga polysaccharide sulfuric ester and glossy ganoderma polysaccharide and use thereof |
| US20130108586A1 (en) * | 2011-11-01 | 2013-05-02 | Jimmy Lu | Composition and method of delivery of l-arabinose and select compounds |
| CN103599167A (en) * | 2013-11-07 | 2014-02-26 | 杨曼茹 | Medicament for treating lung cancer |
| CN103599167B (en) * | 2013-11-07 | 2015-11-25 | 杨曼茹 | A kind of medicament for the treatment of pulmonary carcinoma |
| CN107158045A (en) * | 2017-06-08 | 2017-09-15 | 王丽荣 | Clever water dust ball and preparation method thereof |
| CN107115353A (en) * | 2017-06-26 | 2017-09-01 | 济源希健生物医药科技发展有限公司 | A kind of coriolan of the methylselenocysteinefrom containing L and preparation method thereof |
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