CN103417584B - A kind of pharmaceutical composition and its production and use - Google Patents

Abstract

A kind of pharmaceutical composition, it is the preparation that the raw material containing following weight proportioning is prepared from: chlorogenic acid 1 300 parts, Ganoderma spore oil 1 50 parts.Present invention also offers the preparation method of this pharmaceutical composition.Medicine material Content of Chlorogenic Acid of the present invention and Ganoderma spore oil compatibility use, there is the effect of Synergistic, in chlorogenic acid and Ganoderma spore oil prescription are studied, take into full account property of raw material, inclusion technique is applied in product development, it is achieved oily liquids raw material Ganoderma spore oil and stablizing of solid material Folium Eucommiae extract chlorogenic acid coexist.After using inclusion technique inclusion, make liquid medicine powdered, it is achieved the protection of oxidizable natural product, prevent the air destruction to active component, its stability can be improved, mouthfeel can be improved simultaneously, provide a kind of new selection for clinic.

Description

A kind of pharmaceutical composition and its production and use

Technical field

The present invention relates to a kind of pharmaceutical composition.

Background technology

Chlorogenic acid (chlorogenic acid), be plant during aerobic respiration through cinnamic acid approach

A class phenylpropanoids produced by (cinnamic acid pathway), is widely present in various plant In, growing process plays a part anticorrosion, antibacterial, antiviral, enjoys the good reputation of " plant leukocyte ".Chlorogenic acid is Research both at home and abroad is for one of the focus medicine of anticancer, antiviral, anti-AIDS.

The Cortex Eucommiae is one of plant the highest containing chlorogenic acid, in Folium Eucommiae contained chlorogenic acid human body is had antibacterial, antiviral, Function of gallbladder promoting, protect the liver, blood pressure lowering, the effect such as stimulating central nervous system system.Digestive system, blood system and reproductive system are all had by chlorogenic acid Curative effect.There is wide antibacterial, antiviral, antimutagenic and antineoplastic action.The most also strengthen small intestinal peristalsis, promote gallbladder Juice secretion, function of gallbladder promoting, stop blooding, increase leukocyte, shorten blood clotting and bleeding time and antioxidant activity.Research proves, chlorogenic acid Hydrolyzate caffeic acid also have the effect of function of gallbladder promoting, leukocyte increasing；It to various acute bacterial infection diseases and because of radiotherapy, Leukopenia caused by chemotherapy has significant curative effect, is one of current solitary plant medicine the most extremely paid close attention to.

Ganoderma is the treasure in Chinese medicine treasure-house, is a class large-scale medicinal fungi that has health care.Ganoderma spore oil Be with dry spore extract after physical method breaking cellular wall obtained by oily liposome.Mainly contain the composition such as triterpenes, sterols, It it is the aggregation of Ganoderma spore effective ingredient.Efficacy study show its have enhancing human body immunity power, hepatoprotective, antiviral, Regulate blood fat and neural, cardiovascular and respiratory system are had regulation improvement result.Additionally, Ganoderma spore oil can strengthen immunity carefully The physiologically active of born of the same parents, recovers body's immunity, is a kind of effective antitumour and the material of regulation immunologic function, strengthens comprehensively The body constitution of tumor patient, delays or stops the generation of tumor complication；Coordinate operation, chemicotherapy, postoperative rehabilitation can be promoted, be used for Auxiliary treatment after radiotherapy, chemotherapy；For insomnia forgetfulness, body void Mental fatigue, neurasthenia；For hepatopathy, cardiovascular disease, high blood The auxiliary of pressure treats and prevents.

At present, there is not yet the pertinent literature report that chlorogenic acid and Ganoderma spore oil are compounding.

Summary of the invention

The technical scheme is that and provide a kind of pharmaceutical composition, it be by chlorogenic acid and Ganoderma spore oil compounding and Becoming, another technical scheme of the present invention there is provided 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 containing following weight proportioning is prepared from:

Chlorogenic acid 1-300 part, Ganoderma spore oil 1-50 part.

It is further preferred that it is the preparation being prepared from by the raw material of following weight proportioning:

Chlorogenic acid 1-300 part, Ganoderma spore oil 1-50 part.

It is further preferred that it is the preparation being prepared from by the raw material of following weight proportioning:

Chlorogenic acid 100-300 part, Ganoderma spore oil 10-50 part.

It is further preferred that it is the preparation being prepared from by the raw material of following weight proportioning:

Chlorogenic acid 100-200 part, Ganoderma spore oil 10-30 part.

It is further preferred that it is the preparation being prepared from by the raw material of following weight proportioning:

Chlorogenic acid 160 parts, Ganoderma spore oil 25 parts.

Wherein, the Ganoderma spore oil used is more than two grades, the golden yellow or translucent oily liquids of brownish red, has spirit The Ganoderma lucidum spore distinctive faint scent of oil.Precipitate is had to produce at low temperatures or solidification, total triterpene contents >=15%；Triglyceride is 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, adds pharmaceutically acceptable auxiliary The preparation that material or complementary composition are prepared from.

Described preparation is buccal lozenge or oral formulations；Preferably, described buccal lozenge is buccal tablet, oral cavity patch Sheet, collutory；Described oral formulations is: tablet, effervescent tablet, capsule, oral liquid, powder.

Wherein, described buccal tablet is the raw material by following weight proportioning and adjuvant 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 in lactose, glucose, Sorbitol, mannitol, maltose alcohol, xylitol One or more；Described correctives is selected from sucrose, aspartame, stevioside, fructose, vitamin C, protein sugar, orange One or more mixing in taste correctives；Described diluent is selected from starch, microcrystalline Cellulose, mannitol Plant or multiple；Described disintegrating agent selected from Sodium Hydroxymethyl Stalcs, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, One or more in microcrystalline Cellulose, pre-paying starch；Lubricant is in magnesium stearate, calcium stearate, stearic acid, Pulvis Talci One.

It is further preferred that described buccal tablet is the raw material by following weight proportioning and adjuvant is prepared from:

Chlorogenic acid 160 parts, Ganoderma spore oil Benexate Hydrochloride 140 parts, 390 parts of mannitol, lactose 365 parts, pre-pay Change starch 100 parts, hydroxypropylcellulose 70 parts, orange taste correctives 5 parts, aspartame 3 parts, PVP K30 45 parts, magnesium stearate 3 Part.

Wherein, described orange taste correctives i.e. bitterness correctives, model: 98AF1415.Manufacturer is: gloomy fragrance essence color Scientific and technological (Chinese) company limited of element, agency is Guangzhou Tian Run pharmaceutcal corporation, Ltd.

Present invention also offers a kind of method preparing described pharmaceutical composition, wherein, described buccal tablet is by following Prepared by step:

A, weigh raw material and adjuvant；

B, first with beta-schardinger dextrin-, Ganoderma spore oil is prepared as clathrate；

C, mixing, soft material processed, pelletize, be dried, granulate, tabletting, obtain tablet.

Present invention also offers this pharmaceutical composition, in preparation, there is raising body non-specific immunity and raising machine Body is to the purposes in the medicine of the Scavenging activity of oxygen-derived free radicals or health product.

Medicine material Content of Chlorogenic Acid of the present invention and Ganoderma spore oil compatibility use, and have the effect of Synergistic, green former During acid and Ganoderma spore oil prescription are studied, take into full account property of raw material, inclusion technique is applied in product development, it is achieved oily Liquid charging stock Ganoderma spore oil and stablizing of solid material Folium Eucommiae extract chlorogenic acid coexist.After using inclusion technique inclusion, Make liquid medicine powdered, it is achieved the protection of oxidizable natural product, prevent the air destruction to active component, can be improved it steady Qualitative, mouthfeel can be improved simultaneously, provide a kind of new selection for clinic.

Detailed description of the invention

Embodiment 1 drug port of the present invention buccal tablet adjuvant screening test

This product raw material contains more extract, poor fluidity, tabletting after needing to pelletize, and carries out adjuvant according to these features Screening.

Mannitol no hygroscopicity, absorbs heat during dissolving, and there is comfort sense in oral cavity, the most commonly used in chewable tablet；Lactose is without moisture absorption Property, compressibility is good, stable in properties, and most drug not chemically reactive, in blocks bright and clean attractive in appearance, can improve tablet surface light Slip.Using mannitol and lactose as filler, mix with the raw material drafting every consumption, respectively with water, 70% ethanol, 90% ethanol, as adhesive, carries out the screening of adhesive.

The adjuvant screening trial test formula of this product, as follows:

Wet granulation, according to list of references consumption, carries out the screening of binding agent, and result is as follows:

Table 1 binding agent screening test

Owing to Ganoderma spore oil is liquid, the most preprocessed it is difficult to mix homogeneously when directly feeding intake, Ganoderma triterpenoids after measured Uniformity of dosage units poor, and be exposed in environment oxidizable with air contact for a long time, the bad smell become sour occur, therefore, Its pretreatment need to be fed intake after beta-cyclodextrin inclusion compound.

Contain the unstable structure of Polyphenols and ester, and preliminary pre-test result in view of chlorogenic acid, select PVP90% second Alcohol liquid is binding agent.

The present invention intends being prepared as oral cavity tablet, and hardness is relatively big, to reduce friability, it is ensured that product is in transport, when depositing Integrity.The mode containing changing may be used to take this product in view of target group, add a small amount of disintegrating agent wherein to add Fast containing tablet dissolution velocity when changing and chew, thus have selected mouthfeel and the preferable hydroxypropylcellulose of compressibility.Hydroxypropylcellulose Can there is good inertia with various compatibility of drugss, be binding agent and the disintegrating agent of solid preparation, be particularly well-suited to " inside add Method ", the hardness of tablet can be significantly improved, accelerate disintegrate and release.

In formula, principal agent is the chlorogenic acid monomer extracted from Folium Eucommiae, and mouthfeel is more sour and astringent, add appropriate aspartame, Orange taste correctives is to cover；Magnesium stearate conventional in addition chewable tablet, as lubricant, increases mobility of particle, prevents sticking Generation.

The research of Ganoderma spore oil clathrate process:

Saturated water solution method is used to carry out the preparation of clathrate.Weigh Ganoderma spore oil, add in 95% ethanol and stir evenly, micro- Temperature makes dissolving, instills in the beta-schardinger dextrin-saturated aqueous solution of 60～70 DEG C, stirs more than 1h, and it is little that stopping heating being further continued for stirring 3 Time, obtaining white precipitate. room temperature stands 12 hours, filters, and precipitates three times with absolute ethanol washing, to surface oil stains-less, will precipitation It is dried at 60 DEG C, crosses 60 mesh sieves, to obtain final product.

Select Ganoderma spore oil and beta-schardinger dextrin-rate of charge, beta-schardinger dextrin-and the rate of charge of water, inclusion temperature, mixing time 4 main because of rope, with volatile oil recovery rate, utilization rate and containing ratio as index, has carried out L₉(3⁴) orthogonal test, factor level It is shown in Table 2.

Table 2 factor level table

The orthogonal experiments of table 3 Ganoderma spore oil beta-cyclodextrin inclusion compound

According to design, having carried out 9 groups of tests altogether, result of the test is shown in Table 3, and it is D ＞ A ＞ that clathrate process factor affects size C ＞ B, analyzes through directly perceived, and best of breed is A₂B₂C₃D₁.Compare through extreme difference, C₂With C₃Inclusion rate and clathrate yield k value difference Less, show that inclusion time 3h Yu 6h is little on the impact of inclusion result, consider time factor, therefore select C₂Level.Really Fixed condition is A₂B₂C₂D₁, i.e. spore oil: beta-schardinger dextrin-(g:g)=1:6, temperature/DEG C=60, time/h=3, beta-schardinger dextrin-: water/g: ml=1:4。

The checking of clathrate process

According to the optimal conditions determined, clathrate process is carried out three batches of Product Validations.

Weighing Ganoderma spore oil 0.5kg, add in 95% ethanol 3L and stir evenly, tepor makes dissolving, is slowly added into 60～70 DEG C In 12L aqueous solution containing beta-schardinger dextrin-3kg, stirring 3h, stop heating and be further continued for stirring 3 hours, obtain white precipitate, room temperature stands 12 hours, filter, precipitate three times with absolute ethanol washing, to surface oil stains-less, 60 DEG C will be deposited in and be dried, and cross 60 mesh sieves, i.e. ?.

Table 4 three batch sample is verified

Numbering	Clathrate yield (%)	Inclusion rate (%)	Clathrate abnormal smells from the patient
				1	94.22	91.55	Pure in smell, oil-free tapinoma-odour
2	94.57	90.48	Pure in smell, oil-free tapinoma-odour
				3	95.14	91.06	Pure in smell, oil-free tapinoma-odour

By table 4 the result it can be seen that this technology stability is good, it is adaptable to Ganoderma spore oil inclusion.

Tablet formulation screening and technical study

Because chlorogenic acid is to light, heat, wet more sensitive, with mannitol and the reducing sugar lactose that can increase stability in prescription For excipient, with the ethanol solution of PVP K30 as binding agent, hydroxypropyl cellulose is disintegrating agent, reach to shorten Granulation time, Pelleting temperature is low, reduce drying temperature, drying time is short, the rapid effect of slice, thin piece disintegrate.

Weigh supplementary material and cross 60 mesh sieve mix homogeneously respectively, add 85% ethanol solution of 10% PVP K30, soft material processed, 20 mesh sieves are pelletized, and 60 DEG C are dried, make moisture with outward appearance, mouthfeel and hardness as inspection target.The results are shown in Table 5.

4 prescriptions of table 5 filler screening design

From result, prescription 1 is complete with mannitol as excipient, the puckery punching of material, slice, thin piece rough surface, and hardness is relatively Greatly.Prescription 2 on the basis of prescription 1 with mannitol-lactose (1:1) as excipient, slice, thin piece smooth in appearance is complete, and hardness is moderate, mouth Feel sweeter.Prescription 3 is finely adjusted according to prescription 2 result, reduces mannitol consumption, adds pre-paying starch, slice, thin piece outward appearance on a small quantity Preferably, but hardness is smaller, and mouth is tasted grittiness.Prescription 4 adjusts lactose and mannitol ratio on the basis of prescription 3, slice, thin piece outward appearance, Good mouthfeel, hardness is moderate, in pelletization.Above-mentioned 4 prescription tablet weight variations are big, should be poor with mobility, compressibility green Ortho acid addition is correlated with, and need to suitably adjust addition.

On the basis of the prescription 4 of Preliminary screening, lactose and mannitol ratio in raw material and excipient ratios, excipient, viscous Mixture concentration optimizes further, and factor level table is shown in Table 6.

Table 6 factor level table

Set each experiment Central Plains supplementary product consumption, mixing according to table 6 quadrature factor water-glass, add the bonding of respective concentration Agent, soft material processed, with " gently pinching agglomerating, light pressure is the most broken " as soft material determination methods, record adhesive uses volume；By soft material in 60 DEG C air dry oven is dried, to moisture be 3% time, cross No. 2 sieve granulate and i.e. obtain dried granule, be mixed into 0.3% Lubricant, tabletting and get final product.

Use dried granule angle of repose, granule yield, sheet outward appearance and hardness as evaluation index, real to each horizontal factor Test and mark, by above-mentioned four indices score be added obtain each horizontal factor experiment total score be evaluated, with investigate each because of The element impact on tablet molding.Orthogonal experiments is shown in Table 7.

Table 7SPSS designs orthogonal experiments

Sequence number	A	B	C	D	Total score
						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

SPSS software is used to carry out statistical analysis, result such as following table.

Table 8 orthogonal statistical analysis result of the test

A.R side=0.893(adjusts R side=0.772)

Result shows, chlorogenic acid has pole significant difference, for affecting sheet with clathrate ratio (A) and adhesive concentration (D) The major influence factors of agent molding；Raw material has significant difference from the different of excipient ratios (B), for affecting the secondary of tablet molding Want influence factor.

Table 9 and table 10 result show, chlorogenic acid and clathrate ratio are that 160:140 is better than other two ratios；10% stick Mixture concentration is better than the adhesive of other two concentration.

Table 9 chlorogenic acid and the Estimation of Mean table of clathrate ratio

The Estimation of Mean table of table 10 adhesive concentration

Estimation of Mean to raw material Yu excipient, result shows, raw material and excipient ratios are to be better than other during 300:850 Two ratios.

Table 11 raw material and the Estimation of Mean table of excipient ratios

In the Estimation of Mean of mannitol and galactose ratio, mannitol and galactose ratio be better than during 300:280 other two Individual ratio.Result see table.

Table 12 mannitol and galactose ratio Estimation of Mean

Therefore, by the impact on tablet molding of the variance analysis each factor, with chlorogenic acid: clathrate=160:140, bonding Agent concentration is 10%, raw material: excipient=300:850, mannitol: lactose=300:280 is optimum selection.

Comprehensive orthogonal experiments, determines the end formulation of this product, as follows:

Study on the stability

Taking material by the prescription after optimizing, Ganoderma spore oil is prepared as Benexate Hydrochloride, remaining solid material all mistakes 60 mesh sieves.After supplementary material mix homogeneously, add 85% ethanol solution soft material of 10% PVP K30, then soft material is forced The mode of extruding is pelletized by the sieve aperture of 20 mesh, by prepared wet granular at 60 DEG C of dry 3h, dry granule is crossed 20 mesh sieve granulate, Add magnesium stearate and carry out tabletting.

3 prepared batch samples are placed in temperature 38 DEG C ± 1 DEG C, the climatic chamber of relative humidity 75% are accelerated steady Qualitative test, the results are shown in Table 13.

Table 13 accelerated stability test result

Test confirms the chlorogenic acid buccal tablet steady quality prepared by this technique, rational technology.

Beneficial effects of the present invention is proved below by way of concrete pharmacodynamics test.

Test example 1 pharmaceutical composition of the present invention Content of Chlorogenic Acid-Ganoderma spore oil compatibility and the alone impact on immunologic function Contrast

Experiment packet and dose design

Table 14 experiment packet arranges table with dosage

1) chicken red blood cell phagocytosis test

Take kunming mice and be randomly divided into 7 groups according to sex body weight, often group 12.Each group is all by design dosage 0.4ml/ above 20g gastric infusion every day once, continuous 4 weeks, claims weekly twice body weight, adjusts dosage with this.It is administered latter 30 minutes in last, The each Mus lumbar injection 5% chicken erythrocyte suspension 1.0ml/ of each group is only.Inject latter 6 hours, animal is taken off cervical vertebra and puts to death, note through peritoneum Enter normal saline 2ml, and gently rub mouse web portion, then cut an aperture in peritoneum central authorities, draw abdominal cavity washing liquid, drip in microscope slide On, put incubation 30 minutes in 37 DEG C of incubators, with normal saline flushing, methanol is fixed, and Ji's nurse Sa dyes, oil Microscopic observation 100 Macrophage phagocytic chicken red blood cell number.And calculate phagocytic percentage and phagocytic index with following equation.Result of the test is shown 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, alone group is compared with negative group, have pole significant difference (P ＜ 0.01)；Compatibility group and feminine gender group ratio Relatively, there is pole significant difference (P ＜ 0.001), compare with alone group and have significant difference (P ＜ 0.05).

2) carbon clearance test

Take kunming mice and be randomly divided into 7 groups according to sex body weight, often group 10.Each group all designs dosage by table 14 above 0.4ml/20g by daily single, continuous 4 weeks, claims weekly twice body weight, adjusts dosage with this.After last is administered 1h, respectively Group mouse tail vein injection india ink (1:4) 0.1ml 10g^-1, 1min (t after injection₁) and 5min (t₂) eye socket takes Blood 20 μ l, adds and fills 4ml0.1%Na₂CO₃In solution, scan at 400-700nm, in maximum absorption wavelength (576nm) place ratio Color.Animal takes off at cervical vertebra after death, takes liver, spleen is weighed, and calculates phagocytic index K=(logOD₁-logOD₂)/(t₂-t₁), correction gulps down Bite index α=[body weight/(liver weight+spleen weight)] × K^1/3.Result of the test is shown in Table 16.

The result of table 16 carbon clearance test

Compared with negative control group, * P ＜ 0.05, * * P ＜ 0.01

Result shows, compatibility group compares with negative group, and K value has significant difference P ＜ 0.05, α value to have pole significant difference (P ＜ 0.01)；Alone group is compared with negative group and there was no significant difference.

Table 15,16 results show, in chicken red blood cell phagocytosis test, alone group all can increase very significantly with compatibility group Turnover of Mouse Peritoneal Macrophages is to the phagocytic percentage of chicken red blood cell and phagocytic index；In carbon clearance is tested, compatibility group can be bright The aobvious phagocytic index K improving mouse macrophage and the positive phagocytic index α of effect.Result of the test explanation 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 internal radical metabolism

Experiment packet and dose design

Table 17 experiment packet arranges table with dosage

Test method: C₅₇BL/6 mice is divided 8 groups at random by body weight, often group 10.Dosage 0.4ml/20g is designed every by table 14 Day gastric infusion once, continuous 4 weeks, claims weekly twice body weight, adjusts dosage with this.In testing last day, animal is implemented Femoral artery takes blood, centrifugal collection serum.Use TBA colorimetry and xanthine oxidase, by test kit description operation sample-adding, Measure at UV2300 UV detector and at 532nm and 550nm wavelength, survey absorbance, calculate MDA content and SOD vigor.

Result of the test is shown in Table 18.

Table 18 radical metabolism result of the test

* P ＜ 0.05, * * * P ＜ 0.001 is compared with negative group；△ P ＜ 0.001 is compared with blank group；

Result shows: the most alone group is compared with negative group, and SOD activity is notable to be raised, and has significant difference (P ＜ 0.05)； Compatibility group compares the notable rising of activity of SOD with negative group, has significant difference (P ＜ 0.001), can improve body to oxygen freely The Scavenging activity of base；Interferon group compares with model group, and the activity of SOD also has a certain degree of rising, has significant difference (P ＜ 0.05), but effect is weaker than compatibility group, suitable with alone group.2. compatibility group compares with negative group, and in serum, the content of MDA is bright Aobvious decline, has significant difference (P ＜ 0.05), shows that compatibility group can be by improving the activity of the radical metabolism enzymes such as SOD, clearly Deoxygenation free radical, anti-lipid peroxidation reacts, and reduces the content of MDA in mice serum.

More than testing confirmation, compatibility group has raising body non-specific immunity and improves body to oxygen-derived free radicals Scavenging activity, is better than alone group, and is preferred in 100～200:10～30 with the ratio of chlorogenic acid with Ganoderma spore oil.

Claims (10)

1. a pharmaceutical composition, it is characterised in that: it is the preparation being prepared from by the raw material of following weight proportioning:

Chlorogenic acid 160 parts, Ganoderma spore oil 25 parts, wherein, Ganoderma spore oil uses beta-schardinger dextrin-to be prepared as clathrate.

Pharmaceutical composition the most according to claim 1, it is characterised 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；Large intestine Flora < 30/g.

Pharmaceutical composition the most according to claim 1 and 2, it is characterised in that: it is to be alive by chlorogenic acid, Ganoderma spore oil Property composition, adds pharmaceutically acceptable adjuvant or preparation that complementary composition is prepared from.

Pharmaceutical composition the most according to claim 3, it is characterised in that: described preparation is buccal lozenge or oral system Agent.

Pharmaceutical composition the most according to claim 4, it is characterised in that: described buccal lozenge is buccal tablet, oral cavity patch Sheet, collutory；Described oral formulations is: tablet, capsule, oral liquid, powder.

Pharmaceutical composition the most according to claim 5, it is characterised in that: described tablet is effervescent tablet.

Pharmaceutical composition the most according to claim 5, it is characterised in that: in described buccal tablet, auxiliary is filler, rectifys Taste agent, diluent, disintegrating agent and lubricant；Described filler is selected from lactose, glucose, Sorbitol, mannitol, Fructus Hordei Germinatus One or more in sugar alcohol, xylitol；Described correctives is selected from sucrose, aspartame, stevioside, fructose, dimension life One or more mixing in element C, protein sugar, orange taste correctives；Described diluent is selected from starch, microcrystalline cellulose One or more in element, mannitol；Described disintegrating agent selected from Sodium Hydroxymethyl Stalcs, crospolyvinylpyrrolidone, low take For one or more in hydroxypropyl cellulose, microcrystalline Cellulose, pregelatinized Starch；Lubricant be magnesium stearate, calcium stearate, One in stearic acid, Pulvis Talci.

Pharmaceutical composition the most according to claim 5, it is characterised in that: described buccal tablet is by following weight proportioning Raw material and adjuvant are prepared from:

Chlorogenic acid 160 parts, Ganoderma spore oil Benexate Hydrochloride 140 parts, 390 parts of mannitol, lactose 365 parts, pregelatinated form sediment 100 parts of powder, hydroxypropylcellulose 70 parts, orange taste correctives 5 parts, aspartame 3 parts, PVP K30 45 parts, magnesium stearate 3 parts.

9. the method for the pharmaceutical composition prepared described in claim 8, it is characterised in that: described buccal tablet is by following Prepared by step:

A, weigh raw material and adjuvant；

B, first with beta-schardinger dextrin-, Ganoderma spore oil is prepared as clathrate；

C, mixing, soft material processed, pelletize, be dried, granulate, tabletting, obtain tablet.

10. the pharmaceutical composition described in claim 1-8 any one has raising body non-specific immunity in preparation With improve body to the purposes in the medicine of the Scavenging activity of oxygen-derived free radicals or health product.