CN103417584A - Pharmaceutical composition and preparation method and application thereof - Google Patents
Pharmaceutical composition and preparation method and application thereof Download PDFInfo
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- CN103417584A CN103417584A CN2013103670509A CN201310367050A CN103417584A CN 103417584 A CN103417584 A CN 103417584A CN 2013103670509 A CN2013103670509 A CN 2013103670509A CN 201310367050 A CN201310367050 A CN 201310367050A CN 103417584 A CN103417584 A CN 103417584A
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Abstract
A pharmaceutical composition is made of raw materials comprising, by weight, 1-300 parts of chlorogenic acid and 1-50 parts of ganoderma lucidum spores oil. The invention further provides a preparation method of the pharmaceutical composition. The chlorogenic acid and the ganoderma lucidum spores oil which are compatibly adopted in the raw materials interact synergistically, full consideration is given to characteristics of the raw materials in the study of the composition of the chlorogenic acid and the ganoderma lucidum spores oil, and an inclusion technology is applied to product development, so that stable coexistence the oily liquid raw materials of the ganoderma lucidum spores oil and solid materials of eucommia leaves extracted chlorogenic acid is realized. After inclusion by the inclusion technology, liquid medicine is pulverized, easily-oxidized natural products are protected, active ingredients are prevented from being damaged by air, stability can be improved, taste can be improved, and a new choice is provided to clinical applications.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition.
Background technology
Chlorogenic acid (chlorogenic acid), be plant in the aerobic respiration process through the cinnamic acid approach
The class phenylpropanoids that (cinnamic acid pathway) produces, extensively be present in each kind of plant, plays anticorrosion, antibiotic, antiviral effect in growing process, enjoys the good reputation of " plant leukocyte ".Chlorogenic acid is to study one of focus medicine for anticancer, antiviral, anti-AIDS both at home and abroad.
The Cortex Eucommiae is containing one of the highest plant of chlorogenic acid, in Folium Eucommiae contained chlorogenic acid to human body there is antibiotic, antiviral, function of gallbladder promoting, protect the liver, the effects such as blood pressure lowering, stimulating central nervous system system.Chlorogenic acid is all effective in cure to digestive system, blood system and reproductive system.There is more antibiotic, antiviral, antimutagenic and antineoplastic action.Strengthen in addition in addition small intestinal peristalsis, promote bile secretion, function of gallbladder promoting, stop blooding, increase leukocyte, shorten blood clotting and bleeding time and antioxidant activity.Studies have shown that, the hydrolyzate caffeic acid of chlorogenic acid also has the effect of function of gallbladder promoting, leukocyte increasing; It is one of monomer plant amedica of very paying close attention in the world at present to various acute bacterial infection diseases and because the leukopenia due to radiotherapy, chemotherapy has significant curative effect.
Ganoderma is the treasure in the Chinese medicine treasure-house, is the large-scale medicinal fungi that a class has health care.Ganoderma spore oil be with dry spore, after the physical method breaking cellular wall, extract and the oily liposome.Mainly containing the compositions such as triterpenes, sterols, is the aggregation of Ganoderma spore effective ingredient.Efficacy study shows that it has enhancing human body immunity power, hepatoprotective, antiviral, adjusting blood fat and nerve, cardiovascular and respiratory system are had to the improvement of adjusting effect.In addition, Ganoderma spore oil can strengthen the physiologically active of immunocyte, recovers body's immunity, is the material of a kind of effective antitumour and adjusting immunologic function, strengthens the body constitution of tumor patient comprehensively, delays or stop the generation of tumor complication; Coordinate operation, chemicotherapy, can promote postoperative rehabilitation, for the auxiliary treatment after radiotherapy, chemotherapy; For insomnia forgetfulness, the empty Mental fatigue of body, neurasthenia; For hepatopathy, cardiovascular disease, hypertensive auxiliary treatment and prevention.
At present, there is not yet the composite pertinent literature report of chlorogenic acid and Ganoderma spore oil.
Summary of the invention
Technical scheme of the present invention has been to provide a kind of pharmaceutical composition, and it is by chlorogenic acid and Ganoderma spore oil is composite forms, and another technical scheme of the present invention has been to provide preparation method and the purposes of this pharmaceutical composition.
The invention provides a kind of pharmaceutical composition, it is the preparation that the raw material that contains the following weight proportioning is prepared from:
Chlorogenic acid 1-300 part, Ganoderma spore oil 1-50 part.
Further preferably, it is the preparation that the raw material by the following weight proportioning is prepared from:
Chlorogenic acid 1-300 part, Ganoderma spore oil 1-50 part.
Further preferably, it is the preparation that the raw material by the following weight proportioning is prepared from:
Chlorogenic acid 100-300 part, Ganoderma spore oil 10-50 part.
Still more preferably, it is the preparation that the raw material by the following weight proportioning is prepared from:
Chlorogenic acid 100-200 part, Ganoderma spore oil 10-30 part.
Still more preferably, it is the preparation that the raw material by the following weight proportioning is prepared from:
160 parts of chlorogenic acids, 25 parts of Ganoderma spore oils.
Wherein, the Ganoderma spore oil used is for more than secondary, and the translucent oily liquids of golden yellow or brownish red, have the distinctive faint scent of Ganoderma spore oil.There is at low temperatures precipitate produce or solidify total triterpene contents >=15%; Triglyceride total amount >=60%; Iodine number >=55%; Acid value is up to 15mg KOH/g; Moisture≤2%.Arsenic<0.5mg/Kg; Lead<1mg/Kg; Hydrargyrum<0.1mg/Kg; Cadmium (Cd)≤0.5mg/kg.Total number of bacteria<1000/g; Total number of molds<50/g; Coliform<30/g; Pathogenic bacterium must not detect.
Pharmaceutical composition of the present invention is to be active component by chlorogenic acid, Ganoderma spore oil, the preparation that adds pharmaceutically acceptable adjuvant or complementary composition to be prepared from.
Described preparation is buccal lozenge or oral formulations; Preferably, described buccal lozenge is buccal tablet, mouth paster, collutory; Described oral formulations is: tablet, effervescent tablet, capsule, oral liquid, powder.
Wherein, described buccal tablet is that raw material and adjuvant by the following weight proportioning is prepared from:
Chlorogenic acid 1-300 part, Ganoderma spore oil 1-50 part, excipient 1-850 part, correctives 1-10 part, disintegrating agent 1-70 part, binding agent 1-50 part, lubricant 1-5 part.
Wherein, described filler is selected from one or more in lactose, glucose, Sorbitol, mannitol, maltose alcohol, xylitol; Described correctives is selected from one or more the mixing in sucrose, aspartame, stevioside, fructose, vitamin C, protein sugar, orange flavor correctives; Described diluent is selected from one or more in starch, microcrystalline Cellulose, mannitol; Described disintegrating agent is selected from one or more in Sodium Hydroxymethyl Stalcs, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, pre-paying starch; Lubricant is a kind of in magnesium stearate, calcium stearate, stearic acid, Pulvis Talci.
Further preferably, described buccal tablet is that raw material and adjuvant by the following weight proportioning is prepared from:
160 parts of chlorogenic acids, 140 parts of Ganoderma spore oil Benexate Hydrochlorides, 390 parts, mannitol, 365 parts of lactose, 100 parts of pre-paying starch, 70 parts of hyprolose, 5 parts of correctivess of orange flavor, 3 parts of aspartames, 45 parts of PVP K30s, 3 parts of magnesium stearate.
Wherein, described orange flavor correctives is the bitterness correctives, model: 98AF1415.Manufacturer is: gloomy fragrance essence pigment science and technology (China) company limited, agency is sky, Guangzhou demulcen industry company limited.
The present invention also provides a kind of method for preparing described pharmaceutical composition, and wherein, described buccal tablet is to be prepared by following steps:
A, take raw material and adjuvant;
B, first with beta-schardinger dextrin-, Ganoderma spore oil is prepared into to clathrate;
C, mixing, soft material processed, granulation, drying, granulate, tabletting, obtain tablet.
The present invention also provides this pharmaceutical composition to have the body of raising non-specific immunity and improve body to the medicine of the removing ability of oxygen-derived free radicals or the purposes in health product in preparation.
Medicine material Content of Chlorogenic Acid of the present invention and Ganoderma spore oil compatibility are used, effect with Synergistic, in chlorogenic acid and the research of Ganoderma spore oil prescription, take into full account property of raw material, inclusion technique is applied in product development, realizes stable the coexisting of oily liquids raw material Ganoderma spore oil and solid material Folium Eucommiae extract chlorogenic acid.After adopting the inclusion technique enclose, make the liquid medicine powdered, realize the protection of easy oxidation natural product, prevent the destruction of air to active component, can improve its stability, can improve mouthfeel, for clinical, provide a kind of new selection simultaneously.
The specific embodiment
Embodiment 1 drug port buccal tablet of the present invention adjuvant screening test
This product raw material contains more extract, poor fluidity, and tabletting after needing to granulate, carry out the screening of adjuvant according to these characteristics.
The mannitol no hygroscopicity, absorb heat during dissolving, and there is comfort sense in oral cavity, the most commonly used in chewable tablet; The lactose no hygroscopicity, compressibility is good, and stable in properties is with most drug chemically reactive not, bright and clean attractive in appearance in flakes, can improve the tablet surface slickness.Using mannitol and lactose as filler, mixed with the raw material of drafting every consumption, using respectively water, 70% ethanol, 90% ethanol as adhesive, carry out the screening of adhesive.
The adjuvant screening trial test formula of this product, as follows:
Wet granulation, according to the list of references consumption, carry out the screening of binding agent, and result is as follows:
Table 1 binding agent screening test
Because Ganoderma spore oil is liquid, be difficult for mix homogeneously while directly feeding intake without pretreatment, the uniformity of dosage units of Ganoderma triterpenoids is poor after measured, and be exposed to for a long time in environment and contact easy oxidation with air, the bad smell become sour occurs, therefore, its pretreatment need be fed intake after beta-cyclodextrin inclusion compound.
Consider the unstable structure that chlorogenic acid contains Polyphenols and ester, and preliminary pre-test result, selecting the PVP90% ethanol is binding agent.
The present invention intends being prepared into the oral cavity tablet, and hardness is larger, to reduce friability, guarantees that product is at transportation, the integrity while depositing.Consider that the target group may adopt containing the mode of changing and take this product, add therein a small amount of disintegrating agent to accelerate containing changing and tablet dissolved speed while chewing, thereby selected mouthfeel and compressibility hyprolose preferably.Hyprolose energy and various compatibility of drugs, have good inertia, is binding agent and the disintegrating agent of solid preparation, is specially adapted to " interior addition ", can obviously improve the hardness of tablet, accelerates disintegrate and release.
The chlorogenic acid monomer of principal agent for extracting from Folium Eucommiae in formula, mouthfeel is more sour and astringent, adds appropriate aspartame, orange flavor correctives to cover; Add magnesium stearate commonly used in chewable tablet as lubricant, increase mobility of particle, prevent the generation of sticking.
The research of Ganoderma spore oil clathrate process:
Adopt saturated water solution method to carry out the preparation of clathrate.Take Ganoderma spore oil, add in 95% ethanol and stir evenly, tepor makes to dissolve, splash in the beta-schardinger dextrin-saturated aqueous solution of 60～70 ℃, more than stirring 1h, stop heating and continue again to stir 3 hours, obtain white precipitate. standing 12 hours of room temperature, filter, precipitate three times with absolute ethanol washing, to surperficial oil stains-less, will be deposited in 60 ℃ of dryings, cross 60 mesh sieves, obtain.
Select 4 of rate of charge, enclose temperature, the mixings time of Ganoderma spore oil and beta-schardinger dextrin-rate of charge, beta-schardinger dextrin-and water to take volatile oil recovery rate, utilization rate and containing ratio as index mainly because of rope, carried out L
9(3
4) orthogonal test, factor level is in Table 2.
Table 2 factor level table
The orthogonal experiments of table 3 Ganoderma spore oil beta-cyclodextrin inclusion compound
According to design, carried out altogether 9 groups of tests, result of the test, in Table 3, is D>A>C>B on clathrate process factor impact size, through intuitive analysis, best of breed is A
2B
2C
3D
1.Through extreme difference relatively, C
2With C
3Inclusion rate and clathrate yield k value difference less, show that enclose time 3h and 6h are little on enclose result impact, consider time factor, therefore select C
2Level.Determine that condition is A
2B
2C
2D
1, i.e. spore oil: beta-schardinger dextrin-(g:g)=1:6, temperature/℃=60, time/h=3, beta-schardinger dextrin-: water/g:ml=1:4.
The checking of clathrate process
According to definite optimal conditions, clathrate process is carried out to three batches of Product Validations.
Take Ganoderma spore oil 0.5kg, add in 95% ethanol 3L and stir evenly, tepor makes to dissolve, slowly add 60～70 ℃ containing in the 12L aqueous solution of beta-schardinger dextrin-3kg, stir 3h, stop heating and continue again to stir 3 hours, obtain white precipitate, standing 12 hours of room temperature, filter, and with absolute ethanol washing, precipitates three times, to surperficial oil stains-less, to be deposited in 60 ℃ of dryings, cross 60 mesh sieves, obtain.
Table 4 three batch sample checkings
| Numbering | Clathrate yield (%) | Inclusion rate (%) | The clathrate abnormal smells from the patient |
| 1 | 94.22 | 91.55 | Abnormal smells from the patient is pure, without oily tapinoma-odour |
| 2 | 94.57 | 90.48 | Abnormal smells from the patient is pure, without oily tapinoma-odour |
| 3 | 95.14 | 91.06 | Abnormal smells from the patient is pure, without oily tapinoma-odour |
By table 4 the result, can be found out, this technology stability is good, is applicable to the Ganoderma spore oil enclose.
Tablet formulation screening and technical study
Because of chlorogenic acid to light, heat, wet more responsive, in prescription, with mannitol and the reducing sugar lactose that can increase stability, be excipient, the alcoholic solution of PVP K30 of take is binding agent, hydroxypropyl cellulose is disintegrating agent, reach the granulation time that shortens, pelleting temperature low, reduce that bake out temperature, drying time are short, slice, thin piece disintegrate effect rapidly.
Take supplementary material and cross respectively 60 mesh sieve mix homogeneously, add 85% alcoholic solution of 10% PVP K30, soft material processed, 20 mesh sieves are granulated, and 60 ℃ of dryings make moisture take outward appearance, mouthfeel and hardness as investigating index.The results are shown in Table 5.
4 prescriptions of table 5 filler screening design
From result, write out a prescription and 1 take mannitol fully as excipient, the puckery punching of material, the slice, thin piece rough surface, and hardness is larger.It is excipient that prescription 2 be take mannitol-lactose (1:1) on 1 basis at prescription, and the slice, thin piece smooth in appearance is complete, and hardness is moderate, and mouthfeel is sweeter.Prescription 3 is finely tuned according to prescription 2 results, reduces the mannitol consumption, adds pre-paying starch on a small quantity, and the slice, thin piece outward appearance is better, but hardness is smaller, and mouth is tasted grittiness is arranged.Prescription 4 is adjusted lactose and mannitol ratio on prescription 3 bases, slice, thin piece outward appearance, good mouthfeel, and hardness is moderate, in pelletization.Above-mentioned 4 prescription tablet weight variations are large, and chlorogenic acid addition that should be poor to mobility, compressibility is relevant, need suitably adjustment addition.
On prescription 4 bases of Preliminary screening, in raw material and excipient ratios, excipient, lactose and mannitol ratio, binder concn are further optimized, and the factor level table is in Table 6.
Table 6 factor level table
Set and respectively to test the Central Plains supplementary product consumption according to table 6 quadrature factor water-glass, mix, add the adhesive of respective concentration, soft material processed, as the soft material determination methods, record adhesive use volume with " gently pinch agglomerating, light press broken "; Soft material is carried out to drying in 60 ℃ of air dry ovens, while to moisture, being 3%, cross No. 2 sieve granulate obtain dry after granule, sneak into 0.3% lubricant, tabletting and get final product.
Adopt dry after granule angle of repose, granule yield, sheet outward appearance and hardness as evaluation index, each horizontal factor experiment is marked, the total points that the addition of above-mentioned four indices score is obtained to each horizontal factor experiment is estimated, to investigate the impact of each factor on the tablet molding.Orthogonal experiments is in Table 7.
Table 7SPSS design orthogonal experiments
| Sequence number | A | B | C | D | Total points |
| 1 | 3 | 2 | 3 | 1 | 5.89 |
| 2 | 3 | 3 | 1 | 2 | 10.22 |
| 3 | 2 | 1 | 3 | 2 | 12.87 |
| 4 | 2 | 3 | 2 | 1 | 18.88 |
| 5 | 2 | 2 | 1 | 3 | 14.94 |
| 6 | 1 | 3 | 3 | 3 | 13.89 |
| 7 | 1 | 1 | 1 | 1 | 8.20 |
| 8 | 3 | 1 | 2 | 3 | 14.65 |
| 9 | 1 | 2 | 2 | 2 | 12.70 |
| 10 | 3 | 2 | 3 | 1 | 8.64 |
| 11 | 3 | 3 | 1 | 2 | 14.37 |
| 12 | 2 | 1 | 3 | 2 | 14.39 |
| 13 | 2 | 3 | 2 | 1 | 16.31 |
| 14 | 2 | 2 | 1 | 3 | 16.42 |
| 15 | 1 | 3 | 3 | 3 | 16.0 |
| 16 | 1 | 1 | 1 | 1 | 9.0 |
| 17 | 3 | 1 | 2 | 3 | 14.75 |
| 18 | 1 | 2 | 2 | 2 | 9.62 |
Adopt SPSS software to carry out statistical analysis, result is as following table.
Table 8 quadrature statistical analysis result of the test
A.R side=0.893(adjusts R side=0.772)
The result demonstration, chlorogenic acid and clathrate ratio (A) and adhesive concentration (D) have utmost point significant difference, for affecting the major influence factors of tablet molding; Raw material and excipient ratios (B) different have significant difference, for affecting the minor effect factor of tablet molding.
Table 9 and the demonstration of table 10 result, chlorogenic acid and clathrate ratio are that 160:140 is better than other two ratios; 10% adhesive concentration is better than the adhesive of other two concentration.
The Estimation of Mean table of table 9 chlorogenic acid and clathrate ratio
The Estimation of Mean table of table 10 adhesive concentration
To the Estimation of Mean of raw material and excipient, the result demonstration, raw material and excipient ratios are better than other two ratios while being 300:850.
The Estimation of Mean table of table 11 raw material and excipient ratios
In the Estimation of Mean of mannitol and lactose ratio, mannitol and lactose ratio are better than other two ratios while being 300:280.The results are shown in following table.
Table 12 mannitol and lactose ratio Estimation of Mean
Therefore, the impact by each factor of variance analysis on the tablet molding, take chlorogenic acid: clathrate=160:140, adhesive concentration is 10%, raw material: excipient=300:850, mannitol: lactose=300:280 is optimum selection.
Comprehensive orthogonal experiments, determine the end formulation of this product, as follows:
Study on the stability
Get material by the prescription after optimizing, Ganoderma spore oil is prepared into Benexate Hydrochloride, and all the other solid materials are all crossed 60 mesh sieves.After the supplementary material mix homogeneously, the 85% alcoholic solution soft material processed that adds 10% PVP K30, then granulate by the mode of forcing extruding soft material by 20 purpose sieve apertures, by the wet granular that makes at 60 ℃ of dry 3h, dry granule is crossed to 20 mesh sieve granulate, add magnesium stearate to carry out tabletting.
3 batch samples that make are placed in to 38 ℃ ± 1 ℃ of temperature, carry out accelerated stability test in the climatic chamber of relative humidity 75%, the results are shown in Table 13.
Table 13 accelerated stability test result
Test confirms the chlorogenic acid buccal tablet steady quality made by this technique, and technique is reasonable.
Below prove beneficial effect of the present invention by concrete pharmacodynamics test.
Test example 1 pharmaceutical composition Content of Chlorogenic Acid of the present invention-Ganoderma spore oil compatibility and the alone impact on immunologic function contrast
Experiment grouping and dosage design
Table 14 experiment grouping arranges table with dosage
1) chicken red blood cell phagocytosis test
Get kunming mice and be divided at random 7 groups according to the sex body weight, 12 every group.Above each organized all by design dosage 0.4ml/20g gastric infusion every day once, and continuous 4 weeks, claim weekly body weight twice, adjust dosage with this.After the last administration 30 minutes, each only organized each Mus lumbar injection 5% chicken erythrocyte suspension 1.0ml/.Inject latter 6 hours, the de-cervical vertebra of animal is put to death, through peritoneum saline injection 2ml, and gently rub mouse web portion, then cut an aperture in peritoneum central authorities, draw the abdominal cavity washing liquid, drip on microscope slide, put in 37 ℃ of incubators incubation 30 minutes, with normal saline flushing, methanol is fixed, the dyeing of Ji's nurse Sa, 100 macrophage phagocytic chicken red blood cell numbers of oily Microscopic observation.And calculate phagocytic percentage and phagocytic index with following formula.Result of the test is in Table 15.
Table 15 chicken red blood cell phagocytosis test result
With feminine gender group ratio
*P<0.01
* *P<0.001; With alone group of ratio
△P<0.05,
△ △P<0.01.
Result shows, organizes relatively with negative, utmost point significant difference (P<0.01) is arranged for alone group; Compatibility group and negative group relatively, have utmost point significant difference (P<0.001), with alone group significant difference (P<0.05) is relatively arranged.
2) carbon clearance test
Get kunming mice and be divided at random 7 groups according to the sex body weight, 10 every group.Above each group all is administered once by table 14 design dosage 0.4ml/20g every day, and continuous 4 weeks, claim weekly body weight twice, adjust dosage with this.After last administration 1h, each organizes mouse tail vein injection india ink (1:4) 0.1ml10g
-1, respectively at 1min (t after injection
1) and 5min (t
2) eye socket gets blood 20 μ l, add and fill 4ml0.1%Na
2CO
3In solution, in the scanning of 400-700nm place, in maximum absorption wavelength (576nm), locate colorimetric.After the de-cervical vertebra of animal is put to death, get liver, spleen is weighed, and calculates phagocytic index K=(logOD
1-logOD
2)/(t
2-t
1), proofread and correct phagocytic index α=[body weight/(liver weight+spleen weight)] * K
1/3.Result of the test is in Table 16.
The result of table 16 carbon clearance test
Compare * P<0.05, * * P<0.01 with negative control group
Result shows, compatibility group and negative the group relatively, and the K value has significant difference P<0.05, and the α value has utmost point significant difference (P<0.01); Alone group is compared there was no significant difference with negative group.
Table 15,16 results show, in the chicken red blood cell phagocytosis test, alone group all can increase phagocytic percentage and the phagocytic index of Turnover of Mouse Peritoneal Macrophages to chicken red blood cell very significantly with the compatibility group; In the carbon clearance test, the compatibility group can obviously improve phagocytic index K and the positive phagocytic index α of effect of mouse macrophage.Result of the test illustrates chlorogenic acid and Ganoderma spore oil, the especially compatibility of the two, can increase the phagocytic function of macrophage, strengthens the non-specific immunity of mice.
2. compatibility and the alone impact on radical metabolism in body
Experiment grouping and dosage design
Table 17 experiment grouping arranges table with dosage
Test method: C
57The BL/6 mice is divided 8 groups at random by body weight, 10 every group.Press table 14 design dosage 0.4ml/20g gastric infusion every day once, continuous 4 weeks, claim weekly body weight twice, adjust dosage with this.In last day of test, animal is implemented to femoral artery and get blood, centrifugal collection serum.Adopt TBA colorimetry and xanthine oxidase, press test kit description operation application of sample, at UV2300 uv-spectrophotometric instrument, measure 532nm and 550nm wavelength place survey absorbance, calculate MDA content and SOD vigor.
Result of the test is in Table 18.
Table 18 radical metabolism result of the test
Compare * P<0.05, * * * P<0.001 with the feminine gender group; Compare △ P<0.001 with the blank group;
Result shows: 1. alone group is compared with negative group, and SOD is active significantly to raise, and significant difference (P<0.05) is arranged; The compatibility group significantly raises with the activity that negative group compares SOD, and significant difference (P<0.001) is arranged, and can improve the removing ability of body to oxygen-derived free radicals; Relatively, the activity of SOD also has rising to a certain degree, and significant difference (P<0.05) is arranged for interferon group and model group, but effect is weaker than the compatibility group, with alone group suitable.2. the compatibility group compares with negative group, and in serum, the content of MDA obviously descends, and significant difference (P<0.05) is arranged, show that the compatibility group can be by improving the activity of the radical metabolism enzymes such as SOD, remove oxygen-derived free radicals, suppress lipid peroxidation, reduce the content of MDA in mice serum.
Above test confirms, the compatibility group has and improves the body non-specific immunity and improve the removing ability of body to oxygen-derived free radicals, is better than alone group, and take the ratio of chlorogenic acid and Ganoderma spore oil in 100～200:10～30 as good.
Claims (13)
1. a pharmaceutical composition is characterized in that: it is the preparation that the raw material that contains the following weight proportioning is prepared from:
Chlorogenic acid 1-300 part, Ganoderma spore oil 1-50 part.
2. pharmaceutical composition according to claim 1 is characterized in that: it is the preparation that the raw material by the following weight proportioning is prepared from:
Chlorogenic acid 1-300 part, Ganoderma spore oil 1-50 part.
3. pharmaceutical composition according to claim 2 is characterized in that: it is the preparation that the raw material by the following weight proportioning is prepared from:
Chlorogenic acid 100-300 part, Ganoderma spore oil 10-50 part.
4. pharmaceutical composition according to claim 3 is characterized in that: it is the preparation that the raw material by the following weight proportioning is prepared from:
Chlorogenic acid 100-200 part, Ganoderma spore oil 10-30 part.
5. pharmaceutical composition according to claim 4 is characterized in that: it is the preparation that the raw material by the following weight proportioning is prepared from:
160 parts of chlorogenic acids, 25 parts of Ganoderma spore oils.
6. according to the described pharmaceutical composition of claim 1-5 any one, it is characterized in that: total triterpene contents in described Ganoderma spore oil >=15%; Triglyceride total amount >=60%; Iodine number >=55%; Acid value is up to 15mg KOH/g; Moisture≤2%; Arsenic<0.5mg/Kg; Lead<1mg/Kg; Hydrargyrum<0.1mg/Kg; Cadmium (Cd)≤0.5mg/kg; Total number of bacteria<1000/g; Total number of molds<50/g; Coliform<30/g.
7. according to the described pharmaceutical composition of claim 1-6 any one, it is characterized in that: it is to be active component by chlorogenic acid, Ganoderma spore oil, the preparation that adds pharmaceutically acceptable adjuvant or complementary composition to be prepared from.
8. pharmaceutical composition according to claim 7, it is characterized in that: described preparation is buccal lozenge or oral formulations; Preferably, described buccal lozenge is buccal tablet, mouth paster, collutory; Described oral formulations is: tablet, effervescent tablet, capsule, oral liquid, powder.
9. pharmaceutical composition according to claim 8, it is characterized in that: described buccal tablet is to be prepared from by the raw material of following weight proportioning and adjuvant:
Chlorogenic acid 1-300 part, Ganoderma spore oil 1-50 part, excipient 1-850 part, correctives 1-10 part, disintegrating agent 1-70 part, binding agent 1-50 part, lubricant 1-5 part.
10. pharmaceutical composition according to claim 9, it is characterized in that: described filler is selected from one or more in lactose, glucose, Sorbitol, mannitol, maltose alcohol, xylitol; Described correctives is selected from one or more the mixing in sucrose, aspartame, stevioside, fructose, vitamin C, protein sugar, orange flavor correctives; Described diluent is selected from one or more in starch, microcrystalline Cellulose, mannitol; Described disintegrating agent is selected from one or more in Sodium Hydroxymethyl Stalcs, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, pre-paying starch; Lubricant is a kind of in magnesium stearate, calcium stearate, stearic acid, Pulvis Talci.
11. pharmaceutical composition according to claim 10 is characterized in that: described buccal tablet is to be prepared from by the raw material of following weight proportioning and adjuvant:
160 parts of chlorogenic acids, 140 parts of Ganoderma spore oil Benexate Hydrochlorides, 390 parts, mannitol, 365 parts of lactose, 100 parts of pre-paying starch, 70 parts of hyprolose, 5 parts of correctivess of orange flavor, 3 parts of aspartames, 45 parts of PVP K30s, 3 parts of magnesium stearate.
12. a method for preparing the described pharmaceutical composition of claim 9-11 any one is characterized in that: described buccal tablet is to be prepared by following steps:
A, take raw material and adjuvant;
B, first with beta-schardinger dextrin-, Ganoderma spore oil is prepared into to clathrate;
C, mixing, soft material processed, granulation, drying, granulate, tabletting, obtain tablet.
13. the described pharmaceutical composition of claim 1-11 any one has the body of raising non-specific immunity and improves body to the medicine of the removing ability of oxygen-derived free radicals or the purposes in health product in preparation.
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Citations (3)
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| CN1381261A (en) * | 2002-05-15 | 2002-11-27 | 余隆成 | Liquid immunopotentiator for baby |
| CN101474236A (en) * | 2008-01-01 | 2009-07-08 | 陈剑伟 | Ganoderma lucidum wall-broken spore powder capsule |
| CN102429949A (en) * | 2011-11-28 | 2012-05-02 | 四川九章生物化工科技发展有限公司 | Liver-protecting medicine or health care product composition and preparation method and application thereof |
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| CN1381261A (en) * | 2002-05-15 | 2002-11-27 | 余隆成 | Liquid immunopotentiator for baby |
| CN101474236A (en) * | 2008-01-01 | 2009-07-08 | 陈剑伟 | Ganoderma lucidum wall-broken spore powder capsule |
| CN102429949A (en) * | 2011-11-28 | 2012-05-02 | 四川九章生物化工科技发展有限公司 | Liver-protecting medicine or health care product composition and preparation method and application thereof |
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| 胡瞬等: "灵芝孢子油的研究进展", 《安徽农业科学》 * |
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| CN103417584B (en) | 2016-09-21 |
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