CN109568430A - A kind of preparation method and application of immunopotentiator - Google Patents
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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Abstract
The invention discloses a kind of preparation method and application of immunopotentiator, comprising the following steps: (1) adds water to cook Cortex Phellodendri, rheum officinale, radix scutellariae, Radix Isatidis and the coptis by prescription, obtain decocting liquid, filtrate is obtained by filtration, filtrate is concentrated to get medicinal extract;(2) 95% ethyl alcohol is added makes alcohol content 30 ~ 60%, stirs, and stands, filtration, and recycles ethyl alcohol, is concentrated to get thick paste;(3) auxiliary material is added in thick paste, mixes, is dried to obtain the Immune-enhancing effect preparation.The present invention is based on the preparation processes of existing YANKENING PIAN, concentrate after water in prior art is decocted, carry out secondary processes innovation and promotion, the effective component weight of reservation becomes smaller, improve the rate of transform of extract component, reduce drug daily to measure, be more advantageous to the preparation of various preparations, can integrally promote the quality of the kind.In addition, immunopotentiator of the invention can be used as a kind of new immunopotentiator, it can development and application.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of preparation method and application of immunopotentiator.
Background technique
YANKENING PIAN phonetic name: YanKeNingPian comes from Drug Standard of Ministry of Public Health of the Peoples Republic of China Chinese traditional patent formulation
The 7th, preparation (book number: Z7-104, standard number: WS3-B-1368-93).YANKENING PIAN by traditional Chinese medicine of the five flavours Cortex Phellodendri, radix scutellariae,
The coptis, Radix Isatidis, rheum officinale composition, have clearing heat-fire, the effect of anti-inflammtory anti-dysentery.Modern times are used to treat acute tonsillitis, carefully
Bacterium property pneumonia, acute conjunctivitis, tympanitis, furuncle carbuncle scrofula, acute mastitis, enteritis, bacillary dysentery and acute urethral infection.
Immune is a kind of physiological function of human body, human body by this identification of function " oneself " and " non-oneself " ingredient, thus
It destroys and repels and enter damaging cells caused by the antigenic substance (such as germ) or human body itself of human body and tumour cell
Deng to maintain the health of human body.
Immunopotentiator is to reach a kind of immunotherapy medicaments of enhancing immunity of organisms by different modes.It is immune to increase
Strong agent is mainly used for enhancing antitumor action, the anti-infection ability of body, corrects immune deficiency, such drug can activate it is a kind of or
Panimmunity competent cell, enhancing body specificity and non-specific immune function, make low immune function restore normal.It is right
Crowd or livestock and poultry in hypoimmunity, taking immunopotentiator can be improved its immunity, to prevent the generation of disease.Cause
This, seeks a kind of immunopotentiator that can enhance body and resist pathogenic infection ability, it appears particularly important.
Summary of the invention
To solve the above-mentioned problems, the present invention provides a kind of preparation methods of immunopotentiator.
The technical solution of the present invention is as follows: a kind of preparation method of immunopotentiator, comprising the following steps:
(1) Cortex Phellodendri, rheum officinale, radix scutellariae, Radix Isatidis and the coptis are added water to cook, filtrate is obtained by filtration in decocting liquid, and filtrate is concentrated to give
To medicinal extract;
(2) 95% medical ethanol is added makes alcohol content 30~60%, stirs, and stands, filtration, and recycles ethyl alcohol, is concentrated
Obtain thick paste;
(3) auxiliary material is added in thick paste, mixes, is dried to obtain the Immune-enhancing effect preparation.
In formula: Cortex Phellodendri heat-clearing and damp-drying drug, purging fire for removing toxin;Radix scutellariae has the effect of heat-clearing and damp-drying drug, purging intense heat, removing toxic substances, cooling blood and hemostasis;
The coptis has the effect of heat-clearing and damp-drying drug, purging fire for removing toxin;Radix Isatidis has the effect of clearing heat and detoxicating, cool blood relieving sore-throat;Rheum officinale, which has, to rush down
Under attack product, the effect of clearing heat-fire, removing pattogenic heat from the blood and toxic material from the body, dispelling stasis of blood and stimulating the menstrual flow, removing dampness through diuresis and removing jaundice.
The present invention is based on the preparation processes of existing YANKENING PIAN, the concentrate after water in prior art is decocted, then carry out
Secondary processes are promoted, and handle concentrate using 95% medical ethanol in the present invention, and alcohol content is made to reach 30~60%, recycle second
Alcohol obtains alcohol concentrate thick paste, the 15% of thick paste after the weight of the thick paste can decoct for original water, because having discarded a large amount of alcohol precipitation
It forms sediment, the effective component weight of reservation becomes smaller, improves the rate of transform of extract component, reduce drug and daily measure, more favorably
In the preparation of various preparations, the quality of immunopotentiator can be integrally promoted.
Preferably, Cortex Phellodendri, rheum officinale, radix scutellariae, Radix Isatidis and the coptis are added water to cook three times in the step (1), every time 2
Hour, merge each decocting liquid.
Preferably, the density of the medicinal extract is 1~1.3g/cm-3(temperature is 60 DEG C).
Preferably, the density of the medicinal extract is 1.2g/cm-3(temperature is 60 DEG C).
Preferably, the Immune-enhancing effect preparation is chewable tablets, capsule, granule or tablet.
The present invention also provides a kind of immunopotentiators being prepared by above-mentioned preparation method.
Thymus gland and spleen are the important maincenters and peripheral immune organ of body, and thymus gland is the master that T lymphocyte is reached maturity
Place is wanted, and spleen is the main place that bone-marrow-derived lymphocyte is reached maturity.Thymus index and spleen index can directly reflect immune organ
Developmental condition and body immune level.By animal packet and its immunization method, using thymus index and spleen index as index,
It confirms that Immune-enhancing effect preparation of the invention has immunological enhancement, can restore to cause immunodeficient mouse through hydrochloric acid dexamethasone
Thymus gland and spleen, significantly improve mouse spleen index and thymus index.
Macrophage can swallow up, destroy damaged tissue, facilitate the rehabilitation course of human body.Although they are in damage position
Point plays key effect, once but task completion, it is necessary to it withdraws as early as possible, terminates inflammatory reaction, open a way for regenerative process.Continue
Existing macrophage is unfavorable for organized renewing.The present invention is thin by enzyme-linked immunosorbent assay (ELISA method) detection macrophage
The secreting, expressing of palpebral edema tumor necrosis factor (TNF-α), macrophages in vitro (RAW264.7) activation inhibition assay result show
This Immune-enhancing effect preparation has good inhibiting effect to macrophage activation, mouse macrophage can be inhibited excessively to discharge swollen
Tumor necrosis factor (TNF-α), the treatment for illnesss such as chronic airway inflammations bring new hope.Therefore immune increasing of the invention
Strong agent can be used as a kind of new immunopotentiator, applied to enhancing human immunity.
Compared with prior art, the beneficial effects of the present invention are embodied in:
The present invention is based on the preparation processes of existing YANKENING PIAN, then carry out secondary processes innovation and promotion, reservation it is effective
Ingredients Weight becomes smaller, and improves the rate of transform of extract component, reduces drug and daily measures, and is more advantageous to the system of various preparations
It is standby, it can integrally promote the quality of the kind.In addition, the immunopotentiator in the present invention can be used as a kind of new Immune-enhancing effect
Agent, can development and application.
Specific embodiment
Beneficial effects of the present invention are further illustrated below by experimental example and embodiment.
Experimental example 1
Immune-enhancing effect agent formulation is subjected to mouse immune humidification, specific experiment is as follows:
Selection mouse experiment is pharmacological basis, immune organ weight test method(s): clinically causes mouse with hydrochloric acid dexamethasone
Immune deficiency wins spleen and thymus gland, and weighing calculates spleen index and thymus index;Using Microsoft Office Excel
2003 statistical softwares, 12.0 statistical system of SPSS for windows, experimental data is with mean+standard deviationIt indicates,
Mathematics statistics is carried out using independent samples t-test.
Mouse immune experiment:
Dosage:
Normal group (physiological saline): concentration 9mg/mL;
Model group (dexamethasone sodium phosphate injection): 4 are dissolved in 20mL water (every dexamethasone containing 5mg), concentration
For 1mg/mL, every injection 0.3mL;
Positive controls (levamisol): 68mg is dissolved in 20ml water, concentration 3.4mg/mL;
Immunopotentiator high dose group: 3.2g is dissolved in 20ml water, concentration 0.16g/mL;
Immunopotentiator low dose group: 1.6g is dissolved in 20ml water, concentration 0.08g/mL.
Animal packet, modeling and administration:
50 6~8 week old cleaning grade kunming mices are randomly divided into 5 groups, every group 10 (half male and half female), every counterpoise
30g, be divided into 5 groups: Normal group (physiological saline 9mg/mL), model group (dexamethasone 1mg/mL), positive controls are (left-handed
Imidazoles 3.4mg/mL), immune formulation sample high dose group (160mg/mL), immune formulation sample low dose group (80mg/mL).
Gastric infusion: successive administration 8 days, control group and model group gave physiological saline, remaining administration corresponding reagent.1st
It starts, every afternoon gastric infusion 0.2mL.By the 3rd day, in addition to Normal group, remaining group morning was using intraperitoneal injection
Dexamethasone (10mg/Kgd-1) 0.3mL, afternoon gastric infusion 0.2mL.8th day, last gastric infusion for 24 hours after, first claim
Mice weights are taken, then cervical dislocation puts to death mouse, wins spleen and thymus gland, blots surface bloodstain, is weighed with electronic balance wet
Weight.Calculate spleen index and thymus index.
Thymus index and spleen index K value: K (mg/g)=organ weight/mouse weight.
1 mouse thymus index of table and spleen index
Compared with normal group:△△P < 0.01,△P<0.05;Compared with model group: P < 0.05 * * P < 0.01, *.
Test result is shown: immunopotentiator causes immunodeficient mouse thymus gland to have proliferation function hydrochloric acid dexamethasone, with
Model group compares: high low dose group has extremely significant difference (P < 0.01);Immunopotentiator causes immune lack to hydrochloric acid dexamethasone
Sunken mouse spleen has proliferation function, compared with model group: high low dose group has extremely significant difference (P < 0.01).
By above it is demonstrated experimentally that immunopotentiator, which has the function of, enhances immune function of mice.Mouse thymus after modeling
Severe atrophy, and positive drug and immune formulation sample can make mouse thymus restore normal;Mouse spleen severe atrophy after modeling,
And positive drug and immune formulation sample can make mouse spleen restore normal, there is good application prospect.
Experimental example 2
Enzyme-linked immunosorbent assay (ELISA method) detects the secreting, expressing of macrophage tumor necrosis factor (TNF-α).
TNF-α be it is a kind of can direct killing tumour cell and the cell factor to normal cell without overt toxicity, be institute so far
It was found that one of the strongest bioactie agent of direct killing function of tumor, but excessive secretion TNF-α can cause chronic airway scorching
The illnesss such as disease.Specific experiment is as follows:
Screening model: macrophage (RAW264.7) activation inhibits model.
Screening technique: enzyme-linked immunosorbent assay (ELISA method) detects macrophage tumor necrosis factor (TNF-α)
Secreting, expressing.
Screening sample: immunopotentiator.
Modular concept: macrophage can activate under correlative factor stimulation, and secreting, expressing TNF-α.By lipopolysaccharides (LPS)
It is added in macrophage and cultivates after a certain period of time, add sample to be tested, be incubated for culture after a certain period of time, cell supernatant is taken to survey
Determine the content of TNF-α, activation inhibiting effect of the judgement sample to cell.(note: TNF-α in vivo, it is outer can be thin to some tumours
Born of the same parents or cell line play lethal effect, and a variety of normal cells of in vitro culture then acellular poison effect.It, can benefit according to this feature
With TNF-α sensitivity target cell measurement TNF-α activity)
Calculation formula: activation index=sample sets TNF-α content/normal group TNF-α content
Activate inhibiting rate (%)=[(LPS activation index-sample activation index)/LPS activation index] * 100
The selection result: 2 are shown in Table.
2 macrophage of table (RAW264.7) activates suppression result
The results showed that activation inhibiting rate of the sample in 0.2 μ g/mL of low concentration also has 28.82 ± 2.17, illustrate immune
Reinforcing agent has good inhibiting effect to macrophage activation, and macrophage tumor necrosis factor (TNF-α) can be effectively suppressed
Excessive secretion expression.
Metering depends on effect to be achieved, treatment time and administration mode;In terms of the former preparation YANKENING PIAN of people
Amount and effective dose are reference, these dosage are equivalent to the ingredient of sample activity containing immune formulation 65mg in adult oral dose daily.
Embodiment 3
A kind of preparation method of immunopotentiator, comprising the following steps:
(1) by Cortex Phellodendri 413.8g, rheum officinale 82.8g, radix scutellariae 310.3g, Radix Isatidis in YANKENING PIAN prescription in ministry standard
310.3g and coptis 20.7g are added water to cook three times, and 2 hours every time, collecting decoction filtered, and filtrate is condensed into medicinal extract, medicinal extract density
For 1.2g/cm-3(temperature is 60 DEG C), cooling, yield 53%;
(2) 95% medical ethanol is added makes alcohol content 50%, stirs, and stands, and ethyl alcohol is recycled in filtration, and alcohol liquid is condensed into
Thick paste, yield 7.6%;
(3) in terms of the granule of the 65mg containing reactive compound, the thick paste 65mg in step (2) is taken, dextrin is separately added into
1835mg, sucrose 8100mg, routinely granule is made in technology.
Embodiment 4
A kind of preparation method of immunopotentiator, comprising the following steps:
(1) by Cortex Phellodendri 413.8g, rheum officinale 82.8g, radix scutellariae 310.3g, Radix Isatidis in YANKENING PIAN prescription in ministry standard
310.3g and coptis 20.7g are added water to cook three times, and 2 hours every time, collecting decoction filtered, and filtrate is condensed into medicinal extract, medicinal extract density
For 1.2g/cm-3(temperature is 60 DEG C), cooling, yield 47%;
(2) 95% medical ethanol is added makes alcohol content 60%, stirs, and stands, and ethyl alcohol is recycled in filtration, and alcohol liquid is condensed into
Thick paste, yield 8.1%;
(3) in terms of the capsule of the 65mg containing reactive compound, the thick paste 65mg in step (2) is taken to be separately added into cornstarch
230mg, talcum powder 3mg and calcium monohydrogen phosphate 2mg, routinely capsule is made in technology.
Embodiment 5
A kind of preparation method of immunopotentiator, comprising the following steps:
(1) by Cortex Phellodendri 413.8g, rheum officinale 82.8g, radix scutellariae 310.3g, Radix Isatidis in YANKENING PIAN prescription in ministry standard
310.3g and coptis 20.7g are added water to cook three times, and 2 hours every time, collecting decoction filtered, and filtrate is condensed into medicinal extract, medicinal extract density
For 1.2g/cm-3(temperature is 60 DEG C), cooling, yield 49%;
(2) 95% medical ethanol is added makes alcohol content 55%, stirs, and stands, and ethyl alcohol is recycled in filtration, and alcohol liquid is condensed into
Thick paste, yield 7.3%;
(3) in terms of the tablet of the 65mg containing reactive compound, take the thick paste 65mg in step (2) be separately added into starch 213mg,
Magnesium stearate 2mg and sodium carboxymethyl starch 20mg, routinely tablet is made in technology.
Embodiment 6
A kind of preparation method of immunopotentiator, comprising the following steps:
(1) by Cortex Phellodendri 413.8g, rheum officinale 82.8g, radix scutellariae 310.3g, Radix Isatidis in YANKENING PIAN prescription in ministry standard
310.3g and coptis 20.7g are added water to cook three times, and 2 hours every time, collecting decoction filtered, and filtrate is condensed into medicinal extract, medicinal extract density
For 1.2g/cm-3(temperature is 60 DEG C), cooling, yield 46%;
(2) 95% medical ethanol is added makes alcohol content 45%, stirs, and stands, and ethyl alcohol is recycled in filtration, and alcohol liquid is condensed into
Thick paste, yield 6.9%;
(3) in terms of the chewable tablets of the 65mg containing reactive compound, the thick paste 65mg in step (2) is taken to be separately added into dextrin
100mg, starch 200mg, mannitol 65mg, sorbierite 65mg, magnesium stearate 5mg, routinely chewable tablets is made in technology.
The above described is only a preferred embodiment of the present invention, being not intended to limit the present invention in any form, appoint
What is to the above embodiments according to the technical essence of the invention any simply to repair without departing from technical solution of the present invention content
Change, equivalent variations and modification, all of which are still within the scope of the technical scheme of the invention.
Claims (8)
1. a kind of preparation method of immunopotentiator, which comprises the following steps:
(1) Cortex Phellodendri, rheum officinale, radix scutellariae, Radix Isatidis and the coptis are added water to cook, obtains decocting liquid, filtrate is obtained by filtration, filtrate is concentrated to give
To medicinal extract;
(2) 95% medical ethanol is added makes alcohol content 30 ~ 60%, stirs, and stands, filtration, and recycles ethyl alcohol, and alcohol liquid is concentrated
Obtain thick paste;
(3) auxiliary material is added in thick paste, mixes, is dried to obtain the Immune-enhancing effect preparation.
2. a kind of preparation method of immunopotentiator as described in claim 1, which is characterized in that in the step (1) by Cortex Phellodendri,
Rheum officinale, radix scutellariae, Radix Isatidis and the coptis add water to cook three times, 2 hours every time, merge each decocting liquid.
3. a kind of preparation method of immunopotentiator as described in claim 1, which is characterized in that the Cortex Phellodendri is 413.8g, greatly
Huang is 82.8g, radix scutellariae 310.3g, Radix Isatidis are 310.3g and the coptis is 20.7g.
4. a kind of preparation method of immunopotentiator as described in claim 1, which is characterized in that the density of the medicinal extract is 1 ~
1.3g/cm-3(temperature is 60 DEG C).
5. a kind of preparation method of immunopotentiator as claimed in claim 4, which is characterized in that the density of the medicinal extract is
1.2g/cm-3(temperature is 60 DEG C).
6. a kind of preparation method of immunopotentiator as described in claim 1, which is characterized in that the Immune-enhancing effect preparation is nozzle
Chew piece, capsule, granule or tablet.
7. a kind of immunopotentiator obtained by any preparation method of claim 1 ~ 6.
8. immunopotentiator is as the application in medicament for immunity enhancement.
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