CN103948621B - Lentinan oral preparation and preparation method thereof - Google Patents
Lentinan oral preparation and preparation method thereof Download PDFInfo
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Abstract
The invention provides a lentinan oral preparation, which is characterized by comprising lentinan, wherein the lentinan is a pure beta triple helix-forming single lentinan with specific infrared features, weight-average molecular weight of 400,000-800,000 and lentinan content of more than 94wt%. The lentinan oral preparation has effects on resisting tumors and enhancing immunomodulatory, being the same as a lentinan injection preparation, and the preparation method of the oral preparation is simpler and more convenient, shorter in production cycle, lower in cost and wider in application than that of the injection preparation.
Description
Technical field
The present invention relates to a kind of peroral dosage form of lentinan and preparation method thereof, it belongs to field of biology, falls within
Pharmaceutical dosage form is studied.
Background technology
It is well known that pure β, three helical configurations, single lentinan be widely used in tumour radiotherapy and chemotherapy one
Plant immunomodulator.Having for the tumour such as digestive system and lung, mammary gland significantly heighten the effect of a treatment and reduce toxic and side effect.Mushroom is more
Sugared injection (lentinan) preparation process is complicated, and the cycle is tediously long, is more expensive to manufacture, and especially injection is unique administration way
Footpath, it brings Operative risk and trouble to the tumor patient for having various diseases (such as heart, liver, kidney), also increases and treat into
This.
Lentinan (C6H10O5)nIt is pure β, three helical configurations, the single polysaccharide extracted from mushroom fruiting body.Mesh
Before, it is that everybody generally accepts：Effective medicine with antitumor enhancing immunoloregulation function, but in method of administration, have not
Same cognition, a kind of viewpoint is to think that β, three helical configuration lentinans can be formed, and its molecular weight is excessive, can not be by human body
Intestinal cell is absorbed by the body arrival whole body everywhere.What can be passed through by the absorption of human body intestinal canal cell is small molecular weight, it is impossible to formed
The lentinan of β, three helical configurations, therefore, do not possess activity to form drug effect yet.Only weight average molecular weight control 40~
800000 lentinan is made injection, by injection, whole body is reached everywhere with blood, just forms drug effect.And it is present, with
Many scientist's researchs find：The polysaccharide that many Chinese herbal medicines are extracted, it is possible to complete by human body by Clathrin albumen
Absorb, the oral absorption and drug effect that are found to be lentinan provide new scientific basis.Chinese patent CN101244093 is carried
A kind of oral liquid containing lentinan is gone out, the lentinan molecular weight ranges that it contains are the dalton of 2-100 ten thousand, this perfume (or spice)
Mushroom polyoses oral liquid is although effective, but its oral utilization ratio is not high, to reach the clothes that satisfied therapeutic effect needs
Large usage quantity.
The content of the invention
It is an object of the invention to provide the peroral dosage form and its system of a kind of lentinan with high Oral availability
Preparation Method, it has equivalent efficacy with the lentinan injection of antitumor activity.
In order to achieve the above object, the invention provides a kind of peroral dosage form of lentinan, it is characterised in that contain weight
Average molecular weight is 400,000~800,000 pure β, the lentinan of three helical configurations, and its purity is ＞ 96wt%, and the lentinan
In 3500~3300cm-1、2920-2800cm-1、1100-1000cm-1、890cm-1With INFRARED ABSORPTION.
Shown in meaning lentinan molecular formula such as formula (1) of the invention：
Preferably, the Congo red reaction of described lentinan is positive (+).
Present invention also offers the preparation method of the peroral dosage form of above-mentioned lentinan, it is characterised in that specific steps bag
Include：It is in proportion that the weight portion of adhesive 100 is soluble in water, filler or diluent 99-99.9 weight portions are added under agitation
In, stirring, then solid dosage forms is made, wherein, described adhesive includes lentinan 1-0.1 weight portions.
Preferably, described solid dosage forms is tablet, capsule or granule.
Preferably, described filler or diluent be starch, dextrin, lactose, microcrystalline cellulose, mannitol, glucose,
One or more in sorbierite, sucrose (Icing Sugar) and superfine silica gel powder.
Preferably, described adhesive also includes glucose, sucrose, HPMC, sodium carboxymethylcellulose, shallow lake
One or more in powder and dextrin.
Present invention also offers the preparation method of the peroral dosage form of another above-mentioned lentinan, it is characterised in that specific
Step includes：By lentinan in pure water heating for dissolving, obtain the lentinan production that lentinan content is 2-3% former
Feed liquid, mixing kettle is delivered to by pure water, is opened and is mixed, and adds lentinan raw materials for production liquid, continues to stir, by gained
Mixed liquor carry out filling, obtain shiitake fungus polyoses oral liquid.
Preferably, before filling, the shiitake fungus polyoses oral liquid in mixing kettle adds sodium acid carbonate, the weight of lentinan
Amount content is 2-500PPM.
Preferably, before filling, in adding sodium acid carbonate, essence and flavor enhancement in lentinan solution at least one
Kind, carbon dioxide is added when filling,.
Preferably, in the oral liquid of described lentinan, the weight content of lentinan is 2PPM~10PPM.
Preferably, the pH of described shiitake fungus polyoses oral liquid is 7~9.
Lentinan in peroral dosage form of the present invention is extracted from mushroom fruiting body, pure β, three spiral structures that treatment is obtained
The single lentinan of type (lentinan).The lentinan orally after be absorbed by the body by enteron aisle, reach be applied to it is antitumor
Chemotherapy, radiotherapy after immunomodulator effect, have and significant heighten the effect of a treatment and reduce toxic and side effect.It is made of the lentinan
The various medicines and health products of peroral dosage form, have possessed antitumor, enhancing immunoregulation effect, have with lentinan injection
Standby same effect.
Compared with prior art, the beneficial effects of the invention are as follows：
1st, the present invention has possessed antitumor, enhancing immunoregulation effect, possesses same effect with lentinan injection,
And the preparation method of peroral dosage form is more simple and convenient than injection, the short manufacturing cycle, low cost, using more extensive.
2nd, the present invention is using pure β, three spiral incense configurations, single and with the lentinan of specific infrared signature, can be with
The bioavilability of lentinan peroral dosage form raw material is greatly improved, reduction takes dosage, convenient use day, and improves patient's
Biddability.
3rd, the more stable holding of energy under alkalescent (pH is 7~9) environment is various effectively using lentinan for the present invention
Configuration, therefore lentinan is made soda, both suit public tastesplay to the gallery demand, the function of lentinan is kept again, no
It is a kind of new functional health drink to lose.
Specific embodiment
The present invention is illustrated with reference to embodiment.Lentinan of the present invention uses Publication No.
The Chinese patent of CN101161112, Patent No. ZL200610116956.3《A kind of method of separating and purifying lentinan》It is real
The method described in example is applied to isolate and purify and obtain.Other auxiliary materials are all from Chemical Reagent Co., Ltd., Sinopharm Group.Its
The weight average molecular weight of middle lentinan is determined with light scattering method；Lentinan purity is determined with sulfuric acid-phynol method；Mushroom is more
Sugared configuration is determined with infrared spectrum and Congo red reaction method.
Embodiment 1
A kind of peroral dosage form of lentinan, containing the pure β as shown in formula (1) that weight average molecular weight is 400,000~800,000,
The lentinan of three helical configurations, its purity is 96.1wt%, and the lentinan is in 3500~3300cm-1、2920-
2800cm-1、1100-1000cm-1、890cm-1With INFRARED ABSORPTION.The Congo red reaction of lentinan is positive (+).Above-mentioned perfume (or spice)
The preparation method of the peroral dosage form of mushroom polysaccharide, concretely comprises the following steps：In high-speed mixing granulating machine, mannitol 99.7g is added, will be upper
The lentinan 0.1g for stating is dissolved in 50mL water, is added in mannitol under agitation, is stirred 12 minutes with 15 hertz of rotating speeds, mistake
20 mesh sieves, pelleting.Particle is dried through drying box, magnesium stearate 0.2g is added, after being well mixed, is transferred on tablet press machine and is pressed
Piece, trimmer weight is 0.1g, is made 1000, obtains final product lentinan oral tablet.The lentinan oral tablet surface of gained
Smooth, in good taste, the bioavilability of lentinan is greatly improved, can be a piece of daily, greatly reduces medication dose.
Embodiment 2
A kind of peroral dosage form of lentinan, containing the pure β as shown in formula (1) that weight average molecular weight is 400,000~800,000,
The lentinan of three helical configurations, its purity is 96.1wt%, and the lentinan is in 3500~3300cm-1、2920-
2800cm-1、1100-1000cm-1、890cm-1With INFRARED ABSORPTION.The Congo red reaction of lentinan is positive (+).Above-mentioned perfume (or spice)
The preparation method of the peroral dosage form of mushroom polysaccharide, concretely comprises the following steps：In high-speed mixing granulating machine, add microcrystalline cellulose 40g and
Mannitol 57.9g, above-mentioned lentinan 0.1g and glucose 2g are dissolved in 50mL water, and microcrystalline cellulose is added under agitation
In element and mannitol, stirred 15 minutes with 15 hertz of rotating speeds, cross 20 mesh sieves, pelleting.Particle is dried through drying box, by 20
Mesh sieve whole grain, after being well mixed, the particle after whole grain is transferred in capsule filling machine, and every capsule loads 0.1g, can obtain 1000
Grain lentinan oral capsule.The dissolution of gained capsule is fast, and bioavilability is high, can greatly reduce medication dose.
Embodiment 3
A kind of peroral dosage form of lentinan, containing the pure β as shown in formula (1) that weight average molecular weight is 400,000~800,000,
The lentinan of three helical configurations, its purity is 96.1wt%, and the lentinan is in 3500~3300cm-1、2920-
2800cm-1、1100-1000cm-1、890cm-1With INFRARED ABSORPTION.The Congo red reaction of lentinan is positive (+).Above-mentioned perfume (or spice)
The preparation method of the peroral dosage form of mushroom polysaccharide, concretely comprises the following steps：In fluid bed granulator, microcrystalline cellulose 2700g is added, opened
Compressed air, makes powder fluidising；Above-mentioned lentinan 1g and glucose 299g are dissolved in 500mL water, are pumped under agitation
In fluid bed granulator, top spray is added, boiling granulating 30 minutes, and air outlet controls 70 DEG C, is dried 5 minutes, and material is crossed into 40 mesh sieves
Pelleting, is transferred in particles packing machine, subpackage dress, often wraps 3g, is made 1000 bags, obtains final product lentinan granule.Gained particle
Uniform in size, dissolution is fast, and the bioavilability of lentinan peroral dosage form raw material is greatly improved, can a daily bag, greatly reduce
Medication dose.
Embodiment 4
A kind of peroral dosage form of lentinan, containing the pure β as shown in formula (1) that weight average molecular weight is 400,000~800,000,
The lentinan of three helical configurations, its purity is 96.1wt%., and the lentinan is in 3500~3300cm-1、2920-
2800cm-1、1100-1000cm-1、890cm-1With INFRARED ABSORPTION.The Congo red reaction of lentinan is positive (+).Above-mentioned perfume (or spice)
The preparation method of the peroral dosage form of mushroom polysaccharide, concretely comprises the following steps：Lactose 295g is put into high-speed mixing granulating machine, will be above-mentioned
Lentinan 1g and sodium carboxymethylcellulose 4.8g are dissolved in 500mL water, are added in high-speed mixing granulating machine under agitation, with
15 hertz of speed are stirred 14 minutes, are transferred in oscillating granulator, cross 18 mesh sieves, granulation.Gained particle is done for 70 DEG C by baking oven
Dry half an hour, it is transferred in V-type blender, adds magnesium stearate 0.2g, be well mixed, be transferred in capsule filling machine, adjusts
Loading amount is 0.3g, is made 1000, obtains final product lentinan oral capsule.Gained even particle size, capsule dissolution is fast, and mushroom is more
The bioavilability of sugared peroral dosage form raw material is greatly improved, can be daily one, greatly reduces medication dose.
Embodiment 5
A kind of peroral dosage form of lentinan, containing the pure β as shown in formula (1) that weight average molecular weight is 400,000~800,000,
The lentinan of three helical configurations, its purity is 96.1wt%, and the lentinan is in 3500~3300cm-1、2920-
2800cm-1、1100-1000cm-1、890cm-1With INFRARED ABSORPTION.The Congo red reaction of lentinan is positive (+).Above-mentioned perfume (or spice)
The preparation method of the peroral dosage form of mushroom polysaccharide, concretely comprises the following steps：Above-mentioned lentinan 5g is weighed, in 90 DEG C of heating stirring dissolvings
To in 2.5L pure water, after all dissolving has no insoluble particle, continue heating stirring 30 minutes, it is ensured that all dissolvings, uniformly
Distribution, obtains the lentinan solution that lentinan content is 2%, and by drinking pure water standard, the drinking pure water of production is passed through
It is 997.5L to measure, and in injection dispensing mixing kettle, opens and mixes, and will dissolve uniform 2.5L lentinans solution injection
In dispensing mixing kettle, and sodium acid carbonate 700g is added, regulation PH is 7.5, is stirred 30 minutes, stops stirring, by auto-filling
Production line filtering, sterilizing, filling 498 mushroom drinks of trial production are had to by 200ml/, wherein, the weight content of lentinan
It is 5PPM, pH is 7.5.
Embodiment 6
A kind of peroral dosage form of lentinan, containing the pure β as shown in formula (1) that weight average molecular weight is 400,000~800,000,
The lentinan of three helical configurations, its purity is 96.1wt%, and the lentinan is in 3500~3300cm-1、2920-
2800cm-1、1100-1000cm-1、890cm-1With INFRARED ABSORPTION.The Congo red reaction of lentinan is positive (+).Above-mentioned perfume (or spice)
The preparation method of the peroral dosage form of mushroom polysaccharide, concretely comprises the following steps：Above-mentioned lentinan 3g is weighed, in 90 DEG C of heating stirring dissolvings
To in 1.5L pure water, after all dissolving has no insoluble particle, continue heating stirring 30 minutes, it is ensured that all dissolvings, uniformly
Distribution, obtains the lentinan solution that lentinan content is 2%, by drinking pure water standard, the drinking pure water of production, warp
It is 28.5L to measure, and in input 50L dispensing mixing kettles, opens and mixes, and will dissolve uniform lentinan solution injection mixed
Close in kettle and add sodium acid carbonate 21g, regulation pH is 7.5, is stirred 30 minutes, stops stirring, and conveying solution is filling after filtering
Into oral liquid bottle, per 10ml/ bottle sterilized again, gland, pack 2962 bottlenecks take lentinan health drink, wherein, perfume
The weight content of mushroom polysaccharide is 100PPM, and pH is 7.5.
Embodiment 7
A kind of peroral dosage form of lentinan, containing the pure β as shown in formula (1) that weight average molecular weight is 400,000~800,000,
The lentinan of three helical configurations, its purity is 96.1wt%, and the lentinan is in 3500~3300cm-1、2920-
2800cm-1、1100-1000cm-1、890cm-1With INFRARED ABSORPTION.The Congo red reaction of lentinan is positive (+).Above-mentioned perfume (or spice)
The preparation method of the peroral dosage form of mushroom polysaccharide, concretely comprises the following steps：Above-mentioned lentinan 10g is weighed, it is molten in 90 DEG C of heating stirrings
Solution after all dissolving has no insoluble particle, continues heating stirring 30 minutes in 5L pure water, it is ensured that all dissolvings, uniformly
Distribution, obtains the lentinan solution that lentinan content is 2%, and by drinking pure water standard, the drinking pure water of production is passed through
It is 2795L to measure, and in injection dispensing mixing kettle, opens and mixes, and adds 3kg sodium acid carbonates stirring and dissolving 10 minutes, will
Dissolve in uniform 5L lentinans solution injection dispensing mixing kettle, stirred 30 minutes, stopped stirring, given birth to by auto-filling
Producing line, filtering, sterilizing, by 280ml/ only, plus carbon dioxide, produce filling 9982 mushrooms soda water drink as a trial, wherein, mushroom
The weight content of polysaccharide is 3.6PPM, and pH is 8.2.
Lentinan anti-tumor experiment：
Experiment is classified with lentinan peroral dosage form：
| Title | Formulation |
| Embodiment 1 | Lentinan content is 0.1mg/100mg oral tablets |
| Embodiment 2 | Lentinan content is 0.1mg/100mg oral capsules |
| Embodiment 3 | Lentinan content is 1mg/3g bag oral granular formulations |
| Embodiment 4 | Lentinan content is 1mg/0.3g oral capsules |
| Embodiment 5 | Lentinan content is 1mg/200ml oral liquids |
| Embodiment 6 | Lentinan content is 1mg/10ml health drinks |
| Embodiment 7 | Lentinan content is 1mg/280ml soda water |
Lentinan peroral dosage form anti-tumor experiment consumption
| Title | Daily formulation consumption | Medication cycle |
| Lentinan for injection injection | 0.025mg/0.1ml | It is discontinued 2 days after 5 days weekly, is used in conjunction 3 weeks |
| Embodiment 1 | 0.025mg/25mg | It is discontinued 2 days after 5 days weekly, is used in conjunction 3 weeks |
| Embodiment 2 | 0.025mg/25mg | It is discontinued 2 days after 5 days weekly, is used in conjunction 3 weeks |
| Embodiment 3 | 0.025mg/75mg | It is discontinued 2 days after 5 days weekly, is used in conjunction 3 weeks |
| Embodiment 4 | 0.025mg/7.5mg | It is discontinued 2 days after 5 days weekly, is used in conjunction 3 weeks |
| Embodiment 5 | 0.025mg/5ml | It is discontinued 2 days after 5 days weekly, is used in conjunction 3 weeks |
| Embodiment 6 | 0.025mg/0.25ml | It is discontinued 2 days after 5 days weekly, is used in conjunction 3 weeks |
| Embodiment 7 | 0.025mg/7ml | It is discontinued 2 days after 5 days weekly, is used in conjunction 3 weeks |
Body weight is taken in the female of 25g ± 1g, without pregnant ICR healthy mices.
After taking mouse subcutaneous transplanting S180 ascites cells, after determining administration, administration group and blank control group
Data statistics illustrate the antitumor activity of lentinan all kinds preparation.
Add aqua sterilisa to be configured to every 1ml 0.25mg containing lentinan solution with lentinan injection to be supplied as injection
Medicine.
6 groups, every group 10 are randomly divided into by Mouse Weight order.
Since mouse subcutaneous transplanting S180 tumour cells second day, medication group is started to supply medicine daily, dosage is note
Penetrate many with contained mushroom in lentinan injection 0.1ml (0.025mg lentinans), all kinds of preparations of lentinan peroral dosage form
Sugar is 0.025mg, after tumour transplatation 25 days, kills whole mouse, takes out tumour, gravimetry.
The exemplary embodiment lock of meter mark each group mouse：Blank control group (WC), administration group (WT)
The inhibiting rate of tumour is sought according to the following formula：
Tumor control rate (%)=(WC-WT)/WC*100%
The comparing that lentinan oral formulations influence with lentinan injection on tumor control rate
| Mouse medication group | Take out the average weight of tumour | Tumor control rate | Effective order |
| Blank control group | 9.2g | ||
| Lentinan for injection injection | 0.8g | 91% | 1 |
| Embodiment 1 | 1.29g | 86% | 8 |
| Embodiment 2 | 1.05g | 89% | 4 |
| Embodiment 3 | 1.17g | 87% | 7 |
| Embodiment 4 | 1.1g | 88% | 6 |
| Embodiment 5 | 0.96g | 90% | 3 |
| Embodiment 6 | 0.88g | 90% | 2 |
| Embodiment 7 | 1.03g | 89% | 5 |
Lentinan oral formulations are with lentinan injection drug effect to existence time effects experiment calibrating：
Take 4~5 week old Kunming mouses, male and female dual-purpose, random point 6 groups, every group 12, by S180 knurl liquid physiological saline
Cell concentration is diluted to for 5*106The cell suspension of/0.2ml, ip injections.
Aqua sterilisa is added to be configured to every 1ml 0.25mg containing lentinan solution as lentinan with lentinan injection
Injection.
0.1ml (lentinan containing 0.025mg) lentinan injection is injected to each test group mouse respectively, other are each
Contained lentinan is 0.025mg during medication group takes peroral dosage form, once a day, is used in conjunction 3 weeks, observes all kinds of preparations to lotus
The influence of knurl mouse survival time.
Lentinan oral formulations and influence of the lentinan injection drug effect to life span
| Mouse medication group | Averagely in the time of depositing | Existence time delay is sequentially |
| Blank control group | 30.5 | |
| Lentinan for injection injection | 66.2 | 1 |
| Embodiment 1 | 61.5 | 5 |
| Embodiment 2 | 59.2 | 8 |
| Embodiment 3 | 60.4 | 6 |
| Embodiment 4 | 61.8 | 4 |
| Embodiment 5 | 60 | 7 |
| Embodiment 6 | 63.5 | 2 |
| Embodiment 7 | 62 | 3 |
Result shows：Blank control group is differed significantly with medicinal group, and oral formulations differ effect with injection and fail to understand
It is aobvious.
Claims (4)
1. a kind of peroral dosage form of lentinan, it is characterised in that contain pure β, three spirals that weight average molecular weight is for 400,000 ~ 800,000
The lentinan of configuration, its purity is>96wt%, and the lentinan is in 3500 ~ 3300cm-1、2920-2800cm-1、1100-
1000cm-1、890cm-1With INFRARED ABSORPTION；The Congo red reaction of described lentinan is positive（+）；Its preparation process bag
Include：By lentinan in pure water heating for dissolving, obtain lentinan content be 2-3% lentinan raw materials for production liquid, will
Pure water is delivered to mixing kettle, opens and mixes, and adds lentinan raw materials for production and sodium acid carbonate, continues to stir, by institute
Mixed liquor carry out it is filling, obtain shiitake fungus polyoses oral liquid lentinan weight content be 2ppm ~ 500ppm.
2. the peroral dosage form of lentinan as claimed in claim 1, it is characterised in that the molecular formula of described lentinan
For：
。
3. the preparation method of the peroral dosage form of the lentinan described in claim 1, it is characterised in that specific steps include：Will
Lentinan heating for dissolving in pure water, obtains the lentinan raw materials for production liquid that lentinan content is 2-3%, will be pure
Water is delivered to mixing kettle, opens and mixes, and adds lentinan raw materials for production and sodium acid carbonate, continues to stir, by gained
Mixed liquor carry out it is filling, obtain shiitake fungus polyoses oral liquid lentinan weight content be 2ppm ~ 500ppm.
4. the preparation method of the peroral dosage form of lentinan as claimed in claim 3, it is characterised in that before filling,
Sodium acid carbonate is additionally added in mixing kettle, at least one in essence and flavor enhancement adds carbon dioxide, lentinan mouthful when filling
Take in liquid, the weight content of lentinan is 2-10ppm.
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| CN107468655B (en) * | 2017-08-21 | 2020-02-18 | 无限极（中国）有限公司 | Lentinan particles and preparation method thereof |
| CN108107010A (en) * | 2017-12-21 | 2018-06-01 | 无限极（中国）有限公司 | A kind of method for detecting lentinan content |
| CN108066302B (en) * | 2017-12-28 | 2020-09-11 | 无限极（中国）有限公司 | Preparation method of fast-dispersing solid preparation and fast-dispersing solid preparation prepared by same |
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| CN102190739A (en) * | 2010-03-12 | 2011-09-21 | 南京易亨制药有限公司 | Process for extracting lentinan and method for measuring molecular weight distribution of lentinan |
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| 香菇多糖制剂的生产技术研究;朱新鹏;《现代商贸工业》;20081231(第12期);393-394 * |
| 香菇多糖口服液的研制;李健 等;《食品工业科技》;20051231(第5期);76-78 * |
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