CN109381607A - A kind of pharmaceutical composition and its preparation process treated blood disease and merge bacterium infection - Google Patents
A kind of pharmaceutical composition and its preparation process treated blood disease and merge bacterium infection Download PDFInfo
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- CN109381607A CN109381607A CN201811586293.0A CN201811586293A CN109381607A CN 109381607 A CN109381607 A CN 109381607A CN 201811586293 A CN201811586293 A CN 201811586293A CN 109381607 A CN109381607 A CN 109381607A
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- QAOWNCQODCNURD-UHFFFAOYSA-N sulfuric acid Substances OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 1
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- 230000001629 suppression Effects 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- DKVBOUDTNWVDEP-NJCHZNEYSA-N teicoplanin aglycone Chemical compound N([C@H](C(N[C@@H](C1=CC(O)=CC(O)=C1C=1C(O)=CC=C2C=1)C(O)=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)OC=1C=C3C=C(C=1O)OC1=CC=C(C=C1Cl)C[C@H](C(=O)N1)NC([C@H](N)C=4C=C(O5)C(O)=CC=4)=O)C(=O)[C@@H]2NC(=O)[C@@H]3NC(=O)[C@@H]1C1=CC5=CC(O)=C1 DKVBOUDTNWVDEP-NJCHZNEYSA-N 0.000 description 1
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Abstract
The invention discloses a kind of pharmaceutical compositions and its preparation process treated blood disease and merge bacterium infection, and pharmaceutical composition includes Japanese polygala, Cornu Bubali slice, leaf of negundo chastetree, dendrobium nobile, cymose buckwheat rhizome, indigo naturalis, soapberry, semen ziziphi spinosae, ganoderma lucidum, elscholtiza, witloof, cattail pollen；Preparation process includes that alcohol extracting, water are mentioned, semi-bionic extraction method, stifling extracted and purifying resin etc.；In addition, swallowing problem for children's medication, the composition is prepared into granule, syrup, effervescent tablet etc. is conveniently taken.A kind of pharmaceutical composition and its preparation process treated blood disease and merge bacterium infection provided by the invention, merges bacterium infection for treating blood disease, has the function of that quick, cure rate is high, treating both manifestation and root cause of disease.
Description
Technical field
The present invention relates to a kind of pharmaceutical compositions and its preparation process treated blood disease and merge bacterium infection, belong to Chinese medicine
Compounding techniques field.
Background technique
In recent years, due to the use of chemotherapy means continuously improved with immunosuppressor, Children malignances patient is outstanding
It is that the disease-free survival rate of children with acute leukemia constantly rises, but since its immune function is subjected to over the course for the treatment of
Different degrees of damage, in addition child patient developing immune system itself is not perfect enough, it is the risk factor infected, and by
One of the main reason for death caused by infecting is Children malignances death.Neutrophil leucocyte lacks after intense prior chemotherapy,
Atypical clinical manifestations when infecting, it is difficult to early diagnose, the chance of mixed infection is more, and disease progression is rapid, poor prognosis.Cause
This simultaneously to the treatment of Children malignances Chemotherapy in Patients will also improve the immunity of child patient, and prevent and treat thin
The infection of bacterium and fungi.
Summary of the invention
The technical problem to be solved by the invention is to provide a kind of pharmaceutical compositions treated blood disease and merge bacterium infection
The immunity of patient can be improved in object, the composition, and prevents and treat bacterium and fungal infection；
The present invention also provides a kind of preparation process for treating hemopathic pharmaceutical composition, the extraction of the method active component is imitated
Rate is high, content is high；
The present invention also provides a kind of oral preparations for treating hemopathic pharmaceutical composition, swallow and ask for children's medication
Topic, is prepared into granule, syrup for the composition, effervescent tablet etc. is conveniently taken.
In order to solve the above technical problems, the technical solution adopted by the present invention are as follows:
A kind of pharmaceutical composition treated blood disease and merge bacterium infection, the raw material including following parts by weight: Japanese polygala 10
~20 parts, 10~15 parts of Cornu Bubali slice, 10~15 parts of leaf of negundo chastetree, 10~15 parts of dendrobium nobile, 10~15 parts of cymose buckwheat rhizome, indigo naturalis 3~9
Part, 3~9 parts of soapberry, 5~8 parts of semen ziziphi spinosae, 3~8 parts of ganoderma lucidum, 3~5 parts of elscholtiza, 3~5 parts of witloof, 3~5 parts of cattail pollen.
A kind of pharmaceutical composition treated blood disease and merge bacterium infection, the raw material including following parts by weight: melon
15~20 parts of interest, 10~15 parts of Cornu Bubali slice, 10~15 parts of leaf of negundo chastetree, 10~15 parts of dendrobium nobile, 10~15 parts of cymose buckwheat rhizome, indigo naturalis
6~9 parts, 6~9 parts of soapberry, 5~8 parts of semen ziziphi spinosae, 3~5 parts of ganoderma lucidum, 3~5 parts of elscholtiza, 3~5 parts of witloof, 3~5 parts of cattail pollen.
A kind of preparation process for treating blood disease and merging the pharmaceutical composition of bacterium infection, comprising the following steps:
S01 take above-mentioned parts by weight include dry semen ziziphi spinosae, soapberry, Japanese polygala, ganoderma lucidum raw material I, wherein semen ziziphi spinosae
It is crushed with soapberry, Japanese polygala, after ganoderma lucidum crushes, 85% alcohol reflux for being equivalent to 6~10 times of amounts of I gross dry weight of raw material is added
It extracts 2 times, 1~2h, extracting solution merge every time, filtering, and are concentrated into no alcohol taste, obtain filtrate I；The filter residue obtained after filtering is again
6~10 times of amount pure water refluxing extraction 2 times for being equivalent to I gross dry weight of raw material are added, every time 2~3h, extracting solution merges, and is obtained by filtration
Filtrate II；Filtrate I adds 1~2 times of amount pure water for being equivalent to I gross dry weight of raw material, and adjusts PH to 8~9, after stirring 3~4h,
PH value is adjusted to neutrality, macroreticular resin is crossed, stands at least 2 hours after loading, be washed with water 3~5BV removal of impurities, 60~80% ethyl alcohol
3~5BV is eluted, 60~80% ethanol eluates are collected, after being concentrated into 0.1~0.2 times of amount of I gross dry weight of raw material, spray drying,
Obtain saponin(e position；
S02 take above-mentioned parts by weight include dry leaf of negundo chastetree, cymose buckwheat rhizome, indigo naturalis, elscholtiza, cattail pollen raw material II, wherein it is green
Black pigment used by women in ancient times to paint their eyebrows and cattail pollen are fitted into gauze packet, after leaf of negundo chastetree, cymose buckwheat rhizome, elscholtiza crush, water are added and enzyme, heating stirring are warming up to 25~35
DEG C, insulated and stirred extracts 24~36h, and the additional amount of water is equivalent to 6~10 times of amounts of II gross dry weight of raw material, and the additional amount of enzyme is suitable
It after the 0.2%~0.4% of II gross dry weight of raw material, enzymatic hydrolysis, heats up, is separated by solid-liquid separation, obtains filtrate III；
It includes the raw material III of dry dendrobium nobile, witloof that S03, which takes above-mentioned parts by weight, and raw material III crushed 40 meshes, be placed in
On the gauze of food steamer, after fumigating 30~60min in water vapour, the pure of 10~20 times of amounts for being equivalent to III gross dry weight of raw material is added
Water refluxing extraction 2~3 times, 1~3h, filtering, merging filtrate obtain filtrate IV every time；
S04 is by the filtrate II in S01, filtrate III in S02, and the filtrate IV in S03 merges and mixes, and is concentrated into relatively close
The medicinal extract that degree is 1~1.2, is added 95% ethanol solution and is sufficiently stirred in medicinal extract, until alcohol content is 85%~90%, it is quiet
Set 12~for 24 hours after, centrifugation obtains supernatant and precipitating；Water is added to redissolve obtained precipitating, amount of water is equivalent to the 2 of Sediment weight
~3 times, upper macroporous resin column is collected water elution, is concentrated into 0.1~0.15 times for being equivalent to precipitating with 4~6BV water elution,
Be added 95% ethyl alcohol to alcohol content be 85%~90%, stand 12~for 24 hours after, polysaccharide precipitation is centrifuged to obtain, by polysaccharide precipitation nothing
Water-ethanol washs 2~3 times, is dried in vacuo up to polysaccharide position；Supernatant is concentrated into no alcohol taste, crosses macroporous resin column, after loading
At least 2 hours are stood, 3~5BV removal of impurities is washed with water, 20~30% 3~5BV of ethanol elution collect 20~30% ethanol elutions
Liquid, after being concentrated into 0.1~0.2 times of amount of medicinal extract gross weight, spray drying obtains flavones position；
S05 by cornu bubali powder-refining with water to superfine powder, and with saponin(e position, polysaccharide position, after the mixing of flavones position drug is dry
Powder.
A kind of preparation process treating hemopathic pharmaceutical composition, the enzyme include cellulase, hemicellulose
At least two in plain enzyme, protease and yeast enzyme.
A kind of preparation process treating hemopathic pharmaceutical composition, the enzyme be cellulase, yeast enzyme and
Protease, the mass ratio of the cellulase, yeast enzyme and protease are (1~2): (1~3): 1.
A kind of preparation process treating hemopathic pharmaceutical composition, the macroreticular resin be AB-8, D101,
Any one in MCI and HPD100.
A kind of application treating hemopathic pharmaceutical composition and merging in bacterium infection preparation in blood disease, by institute
It states dry powder drug addition auxiliary material and oral preparation is made.
A kind of application treating hemopathic pharmaceutical composition and merging in bacterium infection preparation in blood disease, it is described
Oral preparation is granule, syrup, any one in effervescent tablet.
Japanese polygala is the herb or root of Polygalaceae polygala Japanese polygala, is grown on hillside or wilderness, is mainly distributed on
China northeast, North China, southwest and the Yangtze river basin.Japanese polygala bitter, micro-pungent, it is mild-natured, it can kobadrin, intelligence promoting and tranquilization, Huoxue San "
The stasis of blood, Popular Utilization are very universal.Clinic, which is applied alone, can treat osteomyelitis, arthritis, insomnia etc., significant in efficacy.It is made from it
Compound is mainly used for treating infection of the upper respiratory tract etc., and clinical efficacy is definite, has no obvious toxic-side effects.
Indigo naturalis be the processed dried powder obtained of the leaf or cauline leaf of acanthaceous vegetable acanthaceous indigo or cruciferae isatis,
Agglomerate or particle have the effect of clearing heat and detoxicating, blood cooling and ecchymoses removing, purging intense heat arresting convulsion, are used for febrile virulent maculae, blood-head tells nosebleed, and children shy
Epilepsy.Modern research shows that the effective component in indigo naturalis is indigo, indigo red.
Cymose buckwheat rhizome system buckwheat herbaceos perennial, cymose buckwheat rhizome medicinal material are used as medicine with dry rhizome, have it is clearing heat and detoxicating,
The effect of apocenosis Eradicates stasis of blood, thinks that it has the effect of moistening lung kidney tonifying, invigorating the spleen to arrest diarrhea, wind-damp dispelling in China's folk tradition medication, often
For treating lung abscess, morbilli, pneumonia, the treatment of the diseases such as circumtonsillar abscess.
Cornu bubali is bitter in taste, salty, cold, clearing heat and cooling blood, and detoxify ecchymose removing ".Clinic is usually used in high fever high fever, coma headache, spot
The diseases such as rash bleeding.It is similar with the ingredient of rhinoceros horn, it is identical containing cholesterine, similar essential amino acid and major part
Keratin, thus have effects that approximate pharmacological action and.
Soapberry is Sapindaceae Sapindus defoliation small arbor, is distributed widely in Southeast Asian countries, Japan, TaiWan, China
And Huaihe River areas to the south, there is very extensive utility value.It brings down a fever with cough-relieving, resolving sputum, treatment；Also have simultaneously a variety of
Bioactivity, such as antimicrobial, antitumor, platelet aggregation-against, anti-pain and anti-inflammatory.
Leaf of negundo chastetree is the leaf of Verenaceae Vitex species Vitex negundo var cannabifolia, has the effects of wind-dispelling dampness elimination, eliminating phlegm and relieving asthma, removing toxic substances,
Cough, asthma is cured mainly, is had a stomachache, abdominal pain, summer-heat and damp dysentery, tinea pedis swelling, rubella itch etc..The average matter of its effective component Vitexina
Measuring score is 0.109%.
Dendrobium nobile is the general name of the fresh or dry stem of a variety of medicinal plants of orchid family Dendrobium.It is mainly used for consumption of body fluid caused by febrile disease, dry
The treatment of the various diseases such as polydipsia, after being ill abnormal heat.Modern pharmacology research shows that dendrobium nobile has anti-oxidant, anti-aging, improves liver
Function treatment cataract, enhances human immunity, is hypoglycemic, antithrombotic, antitumor, anti-mutagenesis, antibacterial, promoting the effects of digestion.
Semen ziziphi spinosae is the dry mature seed of rhamnaceae plant wild jujube, alias jujube kernel, jujube nucleus.It is sweet in flavor, mild-natured, there is calming heart
Calm the nerves, arrest sweating promotes the production of body fluid, nourishing the liver function.Restlessness of asrhenia type and insomnia is cured mainly, seized with terror secondary, polydipsia of palpitating with fear, the diseases such as abnormal sweating.
Elscholtiza is conventional Chinese medicine, has the function of delivering driving away summer heat, dampness removing row water, for summer-heat damp cold, fever with aversion to cold is lossless,
The diseases such as abdominal pain, vomiting and diarrhoea.
Witloof is compositae plant, has the effect of clear liver and gallbladder, stomach strengthening and digestion promoting, inducing diuresis to remove edema, is usually used in jaundice with damp-heat pathogen, stomach
Pain deficiency of food and edema and little urine.
Cattail pollen is Typhaceae plant typha angustata, typha angustifolia, common cattail or its pollen for belonging to various plants.Cattail pollen
With hemostasis, dissolving stasis, diuresis and other effects.Cattail pollen is usually used in treating blood strangury and dry pain, double tongue, aphtha, tumbling and swelling, ear, bleeding from five sense organs or subcutaneous tissue, standby
Dysentery, hematochezia, traumatic hemorrhage, menostasis abdominal pain, dysmenorrhea etc..
Ganoderma lucidum is the drying and ripening spore of On Polyporaceae red sesame, has invigorating qi for tranquilization, strengthening spleen and tonifying lung effect, for adjusting
Immune, antitumor, adjusting blood lipid is saved, blood glucose is reduced, adjusts nervous system and cardiovascular system etc..
Chen Chun, Xue Hongman, Fang Jianpei wait Children malignances patient's neutrophil leucocyte to lack facing for phase nosocomial infection
Bed analysis Chinese Journal of Nosocomiology, 2006,16 (2): 1367-69., document report, children with hematological diseases merge bacterium sense
Dye, mainly most common with respiratory tract infection, infection rate 45.4%；Secondly to be complicated by infection on the basis of mucosal erosion after chemotherapy,
Infection rate is 18.4%；Bacteremia is 12.6%；Skin infection includes that perianal infection is 8.0%；Enteric infection is 6.9%；It secretes
Urinary tract infection is 5.7%；Central catheterization infection 1.7%.Pathogen is mainly gram-positive bacteria (accounting 31.5%), leather
Lan Shi negative bacterium (accounting 55.4%), fungi (accounting 13.1%).
Aiming at the problem that children with hematological diseases merges bacterium infection, we select Japanese polygala, and soapberry, leaf of negundo chastetree is as antibacterial
Sterilization component is equipped with cornu bubali, and indigo naturalis, cattail pollen is as clearing heat and cooling blood, and detoxify ecchymose removing ingredient, can effectively treat caused by infection
Inflammation, fever, the symptoms such as swelling and pain, cough；Improve the basis that immunity is resistant to infection, and The spleen and stomach provide the material basis of the acquired, invigorating the spleen and
Stomach is the basic of raising immunity, and it is strengthening the spleen and stomach ingredient combination semen ziziphi spinosae, dendrobium nobile, ganoderma lucidum that we, which select elscholtiza, cymose buckwheat rhizome, witloof,
Equal heart-nourishing tranquilizers, gather removing toxic substances resolving sputum altogether, care for shield the foundation of acquired constitution, improve the effect of feelings will.
The method that the present invention is mentioned using water after first alcohol extracting, successively by saponin(e in semen ziziphi spinosae, soapberry and Japanese polygala and more
Sugar deduction point is taken out, and later separation purification procedures are reduced；By alkaline hydrolysis method, make saponin constituent be converted to effective glycosides or
Person's aglycon ingredient, enhances the therapeutic effect of drug.Leaf of negundo chastetree, cymose buckwheat rhizome, indigo naturalis, elscholtiza, cattail pollen are added by water using enzymatic isolation method
It is extracted with enzyme insulated and stirred, flavones ingredient can be made to be more easier to be released, to improve flavone compound
Yield.Dendrobium nobile and witloof powder are placed in steam using vapor fumigating system and fumigated, so that dry crude drug cell is logical originally
Permeability enhancing improves polysaccharide yield so that polysaccharide compound is more conducive to being precipitated；In addition alcohol is carried out to polysaccharide position
Heavy, purifying resin, alcohol precipitation improves the purity at polysaccharide position.Macroporous resin purification is used for multiple times in the present invention, not only improving has
The purity at position is imitated, and greatly reduces the total ash of dry powder drug, total ash is made to meet the regulation of relevant criterion.
Detailed description of the invention
Fig. 1 is the process of the preparation process of pharmaceutical composition for treating blood disease merging bacterium infection of the invention a kind of
Figure.
Specific embodiment
For realize the present invention technological means, technical characteristic, reach purpose and effect is easy to understand, below with reference to
The present invention is further explained for attached drawing.
Embodiment 1:
As shown in Figure 1, a kind of pharmaceutical composition treated blood disease and merge bacterium infection, the original including following parts by weight
Material: 10 parts of Japanese polygala, 15 parts of Cornu Bubali slice, 10 parts of leaf of negundo chastetree, 10 parts of dendrobium nobile, 15 parts of cymose buckwheat rhizome, 6 parts of soapberry, 9 parts of indigo naturalis,
5 parts of semen ziziphi spinosae, 5 parts of ganoderma lucidum, 5 parts of elscholtiza, 5 parts of witloof, 5 parts of cattail pollen.
A kind of preparation process for treating blood disease and merging the pharmaceutical composition of bacterium infection, it is characterised in that: packet
Include following steps:
S01 take above-mentioned parts by weight include dry semen ziziphi spinosae, soapberry, Japanese polygala, ganoderma lucidum raw material I, wherein wild jujube
Benevolence, soapberry crushing, Japanese polygala, after ganoderma lucidum crushes, 85% alcohol reflux that 6 times of amounts for being equivalent to I gross dry weight of raw material are added is mentioned
It takes 2 times, each 2h, extracting solution merges, and filtering is concentrated into no alcohol taste, obtains filtrate I；The filter residue obtained after filtering adds phase
When in 10 times of amount pure water refluxing extraction 2 times of I gross dry weight of raw material, each 2h, extracting solution merges, and filtrate II, filtrate I is obtained by filtration
1 times of amount pure water for being equivalent to I gross dry weight of raw material is added, and adjusts PH to 8, after stirring 4h, adjusts pH value to neutrality, mistake
HPD100 macroreticular resin stands at least 2 hours after loading, is washed with water 5BV removal of impurities, and 60~80% ethanol elution 5BV collect 60
~80% ethanol eluate, after being concentrated into 0.1 times of amount of I gross dry weight of raw material, spray drying obtains saponin(e position；
The assay at saponin(e position:
The preparation of standard curve: precision weighs the ginsenoside Rb1 reference substance 5.0mg of dry constant weight, moves to 10mL capacity
Bottle, with dehydrated alcohol constant volume, is configured to the reference substance solution of 0.5mg/mL.Precision absorption ginsenoside Rb1's reference substance solution 0,
0.1,0.2,0.3,0.4,0.5,0.6ml has in plug rub oral examination tube in 10mL, and reagent is volatilized in 60 DEG C of baking ovens, 5% (matter is added
Measure percentage) vanillic aldehyde~glacial acetic acid solution 0.2mL and perchloric acid 0.8mL, it shakes up, 60 DEG C of heating water bath 20min, in ice-water bath
Cooling 3min, is added glacial acetic acid 5mL, shakes up, and retinue reagent makees blank, and absorbance value is measured at 545nm with spectrophotometer,
Using ginsenoside Rb1's concentration as abscissa, absorption angle value is ordinate, draws standard curve, and obtaining regression equation is y=
23.895x-0.0688 R2=0.9990.
Precision draws the saponin(e position 5.012mg being prepared in S01, moves to 10mL volumetric flask and is placed in 10mL tool plug ground
In test tube, operated according to " preparation of standard curve ", by above-mentioned standard curve, the content for acquiring saponin(e substance accounts for saponin(e portion
The 78.9% of position.
S02 take above-mentioned parts by weight include dry leaf of negundo chastetree, cymose buckwheat rhizome, indigo naturalis, elscholtiza, cattail pollen raw material II, wherein it is green
Black pigment used by women in ancient times to paint their eyebrows and cattail pollen are fitted into gauze packet, after leaf of negundo chastetree, cymose buckwheat rhizome, elscholtiza crush, water are added and enzyme, heating stirring are warming up to 25 DEG C,
Insulated and stirred is extracted for 24 hours, and the additional amount of water is equivalent to 10 times of II gross dry weight of raw material, the enzyme be cellulase, yeast enzyme and
Protease, the mass ratio of the cellulase, yeast enzyme and protease are 1:1:1, and it is total that total additional amount of enzyme is equivalent to raw material II
The 0.2% of dry weight after enzymatic hydrolysis, heats up, is separated by solid-liquid separation, obtains filtrate III；
What S03 took above-mentioned parts by weight includes the raw material III of dry dendrobium nobile, witloof, and raw material III crushed 40 meshes, set
In on the gauze of food steamer, after fumigating 60min in water vapour, the pure water refluxing extraction 3 for being equivalent to 10 times of amounts of raw material III is added
Secondary, each 3h is filtered, and merging filtrate obtains filtrate IV；
S04 is by the filtrate II in S01, filtrate III in S02, and the filtrate IV in S03 merges and mixes, and is concentrated into relatively close
The medicinal extract that degree is 1.2, is added 95% ethanol solution and is sufficiently stirred in medicinal extract, until alcohol content is 85%, after standing for 24 hours,
Centrifugation, obtains supernatant and precipitating；Water is added to redissolve obtained precipitating, amount of water is equivalent to 3 times of Sediment weight, upper D101 macropore
Resin column is concentrated into 0.1 times for being equivalent to Sediment weight with 4BV water elution, and 95% ethanol solution to alcohol content is added and is
90%, after standing 12h, it is centrifuged to obtain polysaccharide precipitation, polysaccharide precipitation is washed 2 times with dehydrated alcohol, is dried in vacuo up to polysaccharide portion
Position.Supernatant is concentrated into no alcohol taste, crosses AB-8 macroporous resin column, stands at least 2 hours after loading, is washed with water 5BV and cleans, and 20
~30% ethanol elution 5BV collects 20~30% ethanol eluates, after being concentrated into 0.1 times of amount of medicinal extract gross weight, spray drying,
Obtain flavones position.
The assay at flavones position:
The preparation of standard curve: accurately weighing the rutin standard items 10mg for being dried to permanent quality, molten with 50% ethanol solution
Solution, and is settled to 50mL, obtains rutin standard solution, and precision draws rutin standard solution 0,2,4,6,8,10mL in the capacity of 50mL
In bottle, adds distilled water to be diluted to 10mL, 5%NaNO is then added2Solution 2mL, shakes up, and stands 6min；Again plus 10%Al (NO3)3
Solution 2mL, shakes up, and stands 6min；It is eventually adding 4%, NaOH solution 20mL, scale is settled to distilled water, shakes up, is stood
15min sets spectrophotometer and measures absorbance value at 510nm.Using the concentration of control substance of Rutin as abscissa, absorbance value is
Ordinate draws standard curve, obtains regression equation y=1.116x-0.0661, R2=0.9991.
Precision weighs flavones position 5.004mg obtained in above-mentioned S04, is placed in 50mL volumetric flask, according to " standard curve
Preparation " operation, by above-mentioned standard curve, the content for acquiring Flavonoid substances accounts for the 89.1% of flavones position.
The assay at polysaccharide position:
The preparation of standard curve: it is dried to permanent quality by 105 DEG C of dextrose standard sample, standard items 10mg is weighed, is made into
The standard solution of 0.04mg/mL.It pipettes standard solution 0mL, 0.2mL, 0.4mL, 0.8mL, 1mL, 1.2mL and is placed in 50mL colorimetric cylinder
In, add water to be settled to 2mL, it is that 6% phenol 1mL and concentrated sulfuric acid 5mL sets spectrophotometer at 490nm that mass fraction, which is then added,
Survey its absorbance.Using the concentration of dextrose standard sample as abscissa, absorbance value is ordinate, draws standard curve, must return
Equation y=3.8642x-0.0523, R2=0.9993.
Precision weighs polysaccharide position 2.010mg obtained in above-mentioned S04, is placed in 100mL volumetric flask, according to " standard is bent
The preparation of line " operation, by above-mentioned standard curve, the content for acquiring polysaccharose substance accounts for the 91.3% of polysaccharide position.
S05 by cornu bubali powder-refining with water to superfine powder, and with saponin(e position, polysaccharide position, after the mixing of flavones position drug is dry
Powder.
It is granule that the oral preparation, which is made, in dry powder drug addition auxiliary material.
Embodiment 2:
A kind of pharmaceutical composition treated blood disease and merge bacterium infection, the raw material including following parts by weight: Japanese polygala 20
Part, 10 parts of Cornu Bubali slice, 11 parts of leaf of negundo chastetree, 15 parts of dendrobium nobile, 10 parts of cymose buckwheat rhizome, 3 parts of soapberry, 6 parts of indigo naturalis, 8 parts of semen ziziphi spinosae, spirit
8 parts of sesame, 3 parts of elscholtiza, 3 parts of witloof, 3 parts of cattail pollen.
A kind of preparation process for treating blood disease and merging the pharmaceutical composition of bacterium infection, it is characterised in that: packet
Include following steps:
S01 take above-mentioned parts by weight include dry semen ziziphi spinosae, soapberry, Japanese polygala, ganoderma lucidum raw material I, wherein semen ziziphi spinosae
And soapberry crushing, Japanese polygala, after ganoderma lucidum crushes, 85% alcohol reflux that 10 times of amounts for being equivalent to I gross dry weight of raw material are added is mentioned
It takes 2 times, each 1h, extracting solution merges, and filtering is concentrated into no alcohol taste, obtains filtrate I；The filter residue obtained after filtering adds phase
When in 8 times of amount pure water refluxing extraction 2 times of I gross dry weight of raw material, each 2h, extracting solution merges, and filtrate II, filtrate I is obtained by filtration
2 times of amount pure water for being equivalent to I gross dry weight of raw material are added, and adjust PH to 9, after stirring 3h, pH value is adjusted to neutrality, crosses AB-8
Macroreticular resin stands at least 2 hours after loading, is washed with water 3BV removal of impurities, and 60~80% ethanol elution 3BV collect 60~80%
Ethanol eluate, after being concentrated into 0.2 times of amount of I gross dry weight of raw material, spray drying obtains saponin(e position；
Precision draws the saponin(e position 5.015mg being prepared in S01, moves to 10mL volumetric flask and is placed in 10mL tool plug ground
In test tube, is operated according to " preparation of standard curve " in embodiment 1, by above-mentioned standard curve, acquire containing for saponin(e substance
Amount accounts for the 82.2% of saponin(e position.
S02 take above-mentioned parts by weight include dry leaf of negundo chastetree, cymose buckwheat rhizome, indigo naturalis, elscholtiza, cattail pollen raw material II, wherein it is green
Black pigment used by women in ancient times to paint their eyebrows and cattail pollen are fitted into gauze packet, after leaf of negundo chastetree, cymose buckwheat rhizome, elscholtiza crush, water and enzyme are added, the enzyme is cellulase, ferment
Female enzyme and protease, the mass ratio of the cellulase, yeast enzyme and protease are 2:2:1, and heating stirring is warming up to 35 DEG C, are protected
36h is extracted in temperature stirring, and the additional amount of water is equivalent to 6 times of II gross dry weight of raw material, and the additional amount of enzyme is equivalent to II gross dry weight of raw material
0.4%, after enzymatic hydrolysis, heat up, be separated by solid-liquid separation, obtain filtrate III；
It includes the raw material III of dry dendrobium nobile, witloof that S03, which takes above-mentioned parts by weight, and raw material III crushed 40 meshes, be placed in
On the gauze of food steamer, after fumigating 30min in water vapour, 20 times of amount pure water refluxing extractions for being equivalent to III gross dry weight of raw material are added
2 times, each 2h, filtering, merging filtrate obtains filtrate IV；
S04 is by the filtrate II in S01, filtrate III in S02, and the filtrate IV in S03 merges and mixes, and is concentrated into relatively close
The medicinal extract that degree is 1, is added 95% ethanol solution and is sufficiently stirred in medicinal extract, until alcohol content is 90%, after standing for 24 hours, from
The heart obtains supernatant and precipitating；Water is added to redissolve obtained precipitating, amount of water is equivalent to 2 times of Sediment weight, upper D101 macropore tree
Rouge column collects water elution with 6BV water elution, and is concentrated into and is equivalent to 0.1 times of Sediment weight, and 95% ethyl alcohol is added to containing
Alcohol amount is 85%, after standing 15h, is centrifuged to obtain polysaccharide precipitation, polysaccharide precipitation is washed 3 times with dehydrated alcohol, is dried in vacuo to obtain the final product
Polysaccharide position, supernatant are concentrated into no alcohol taste, cross HPD100 macroporous resin column, stand at least 2 hours after loading, be washed with water
3BV removal of impurities, 20~30% ethanol elution 3BV collect 20~30% ethanol eluates, after being concentrated into 0.2 times of amount of medicinal extract gross weight,
Spray drying, obtains flavones position.
Precision weighs flavones position 5.026mg obtained in above-mentioned S04, is placed in 50mL volumetric flask, according in embodiment 1
" preparation of standard curve " operation, by above-mentioned standard curve, the content for acquiring Flavonoid substances accounts for flavones position
88.3%.
Precision weighs polysaccharide position 2.013mg obtained in above-mentioned S04, is placed in 100mL volumetric flask, according to embodiment 1
In " preparation of standard curve " operation, by above-mentioned standard curve, the content for acquiring polysaccharose substance accounts for polysaccharide position
90.3%.
S05 by cornu bubali powder-refining with water to superfine powder, and with saponin(e position, polysaccharide position, after the mixing of flavones position drug is dry
Powder.
Effervescent tablet is made in dry powder drug addition auxiliary material.
Embodiment 3:
A kind of pharmaceutical composition treated blood disease and merge bacterium infection, the raw material including following parts by weight: Japanese polygala 15
Part, 10 parts of Cornu Bubali slice, 15 parts of leaf of negundo chastetree, 10 parts of dendrobium nobile, 10 parts of cymose buckwheat rhizome, 9 parts of soapberry, 3 parts of indigo naturalis, 5 parts of semen ziziphi spinosae, spirit
5 parts of sesame, 5 parts of elscholtiza, 5 parts of witloof, 5 parts of cattail pollen.
S01 take above-mentioned parts by weight include dry semen ziziphi spinosae, soapberry, Japanese polygala, ganoderma lucidum raw material I, wherein wild jujube
Benevolence, soapberry crushing, Japanese polygala, after ganoderma lucidum crushes, 85% alcohol reflux that 8 times of amounts for being equivalent to I gross dry weight of raw material are added is mentioned
It takes 2 times, each 2h, extracting solution merges, and filtering is concentrated into no alcohol taste, obtains filtrate I；The filter residue obtained after filtering adds phase
When in 10 times of amount pure water refluxing extraction 2 times of I gross dry weight of raw material, each 2h, extracting solution merges, and filtrate II, filtrate I is obtained by filtration
1 times of amount pure water for being equivalent to I gross dry weight of raw material is added, and adjusts PH to 8.5, after stirring 4h, adjusts pH value to neutrality, mistake
D101 macroreticular resin stands at least 2 hours after loading, is washed with water 4BV removal of impurities, 60~80% ethanol elution 5BV, collect 60~
80% ethanol eluate, after being concentrated into 0.15 times of amount of I gross dry weight of raw material, spray drying obtains saponin(e position；
Precision draws the saponin(e position 5.016mg being prepared in S01, moves to 10mL volumetric flask and is placed in 10mL tool plug ground
In test tube, is operated according to " preparation of standard curve " in embodiment 1, by above-mentioned standard curve, acquire saponin(e substance
Content accounts for the 77.9% of saponin(e position.
S02 take above-mentioned parts by weight include dry leaf of negundo chastetree, cymose buckwheat rhizome, indigo naturalis, elscholtiza, cattail pollen raw material II, wherein it is green
Black pigment used by women in ancient times to paint their eyebrows and cattail pollen are fitted into gauze packet, after leaf of negundo chastetree, cymose buckwheat rhizome, elscholtiza crush, water and enzyme are added, the enzyme is cellulase, ferment
Female enzyme and protease, the mass ratio of the cellulase, yeast enzyme and protease are 1:3:1, and heating stirring is warming up to 30 DEG C, are protected
30h is extracted in temperature stirring, and the additional amount of water is equivalent to 8 times of II gross dry weight of raw material, and the additional amount of enzyme is equivalent to II gross dry weight of raw material
0.3%, after enzymatic hydrolysis, heat up, be separated by solid-liquid separation, obtain filtrate III；
It includes the raw material III of dry dendrobium nobile, witloof that S03, which takes above-mentioned parts by weight, and raw material III crushed 40 meshes, be placed in
On the gauze of food steamer, after fumigating 50min in water vapour, the pure water reflux that 15 times of amounts for being equivalent to III gross dry weight of raw material are added is mentioned
It takes 2 times, each 2h, filters, merging filtrate obtains filtrate IV；
S04 is by the filtrate II in S01, filtrate III in S02, and the filtrate IV in S03 merges and mixes, and is concentrated into relatively close
The medicinal extract that degree is 1.1, is added 95% ethanol solution and is sufficiently stirred in medicinal extract, until alcohol content is 87%, after standing 20h,
Centrifugation, obtains supernatant and precipitating；Water is added to redissolve obtained precipitating, amount of water is equivalent to 3 times of Sediment weight, upper MCI macropore
Resin column collects water elution with 5BV water elution, is concentrated into 0.15 times for being equivalent to precipitating, and addition mass concentration is 95% second
Alcohol to alcohol content is 90%, after standing 15h, is centrifuged to obtain polysaccharide precipitation, polysaccharide precipitation is washed 2 times with dehydrated alcohol, and vacuum is dry
Dry up to polysaccharide position, supernatant is concentrated into no alcohol taste, crosses AB-8 macroporous resin column, stands at least 2 hours after loading, then use water
5BV removal of impurities is washed, 20~30% ethanol elution 5BV collect 20~30% ethanol eluates, are concentrated into 0.1 times of amount of medicinal extract gross weight
Afterwards, it is spray-dried, obtains flavones position；
Precision weighs flavones position 5.006mg obtained in above-mentioned S04, is placed in 50mL volumetric flask, according in embodiment 1
" preparation of standard curve " operation, by above-mentioned standard curve, the content for acquiring Flavonoid substances accounts for the 87.6% of flavones position.
Precision weighs polysaccharide position 2.004mg obtained in above-mentioned S04, is placed in 100mL volumetric flask, according to embodiment 1
In " preparation of standard curve " operation, by above-mentioned standard curve, the content for acquiring polysaccharose substance accounts for polysaccharide position
89.1%.
S05 by cornu bubali powder-refining with water to superfine powder, and with saponin(e position, polysaccharide position, after the mixing of flavones position drug is dry
Powder.
Syrup is made in dry powder drug addition auxiliary material.
Pharmacological research:
1, to the influence of caused by cyclophosphamide immunologic hypofunction immune function of mice
Test selects mouse 60, is randomly divided into 6 groups, and every group 10, weight 18-22g, half male and half female, Example 1,
2, dry powder drug made from 3, the CMC-Na aqueous dissolution for being 0.5% with mass percentage, is given by dosage ig shown in table 1
Medicine, 1 time a day, continuous 7 days, after administration in the 2nd day, in addition to control group, remaining each group mouse peritoneal injected cyclophosphamide
100mg/kg.It after last dose 1h, weighs in, then cervical dislocation puts to death mouse, and thymus gland and spleen are taken after dissect, calculates dirty
Device coefficient, experimental result are as follows:
Influence of the table 1 to caused by cyclophosphamide immunologic hypofunction immune function of mice
P < 0.05 * * P < 0.01, * compared with model group；##P < 0.01 compared with the control group, #P < 0.01
The results show that compared with the control group, model group thymus gland coefficient, Spleen coefficient are substantially reduced, show immunocompromised mould
Type is formed, and compared with model group, 1.6g/kg 0.8g/kg dosage can significantly improve thymus gland coefficient in embodiment 1,2,3, real
Spleen coefficient can be significantly improved by applying 1.6g/kg dosage in example 2.
2, antibacterial experiment in vitro is studied
Bacteriostatic test method: agar diffusion method is used, the suppression of the bacteriostatic diameter loop diameter qualitative analysis drug of drug is measured
Bacterium effect.Agar diffusion method waits honeysuckle carbon dioxide supercritical extraction object referring to paper, Su Xiangping, Gong great Chun, Zhang Yaxiong
In Vitro Bacteriostasis treasure's traditional Chinese medical science traditional Chinese medicines when studying, 2009,20 (4): 832-834. is often put down plus 0.1mL bacterium solution, is coated with entire training
Support primary surface, 37 ° of absorption 30min.It is positive uniformly to place the aseptic inoculation ring that 4 diameters are about 6mm.Again with pipettor in hole
Add the medical fluid 0.1mL of embodiment 1, embodiment 2, embodiment 3, culture for 24 hours, observes and records inhibition zone in 37 ° of constant incubators
The presence or absence of and diameter (be repeated 2 times, do 4 holes every time, seek the average value of diameter).By the size of antibacterial circle diameter as judgement
The standard of susceptibility height, antibacterial circle diameter be greater than 20mm be it is extremely quick, 15~20mm be Gao Min, 10~14mm be in quick, 10mm
The following are muting sensitive, no inhibition zone is unwise.
The preparation of bacterium solution: respectively by staphylococcus aureus, Escherichia coli, White staphylococcus, Pseudomonas aeruginosa, withered grass bar
Bacterium, candida albicans switching are activated in nutrient agar slopes, and bacterial strain after activation is inoculated in respectively in steamed beef soup, 37 DEG C of cultures
It is spare with 80 times of sterile saline dilution after 12h.
The preparation of medical fluid: embodiment 1, embodiment 2, each 100mg of dry powder drug in embodiment 3 are weighed, water is added to be configured to
The medical fluid of 10mg/ml.
As a result as follows:
2 antibacterial experiment in vitro result of study of table
The result shows that the medical fluid of embodiment 1,2,3 is to the antibacterial of the antibacterial ring size of staphylococcus aureus and White staphylococcus
Diameter is all greater than 15mm, is all larger than to the inhibition zone diameter of Escherichia coli or close to 15mm, has high quick effect；To green pus bar
Bacterium, hay bacillus, candida albicans inhibition zone diameter be all larger than or close to 10mm, have in quick effect.
The above is only a preferred embodiment of the present invention, it should be pointed out that: for the ordinary skill people of the art
For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered
It is considered as protection scope of the present invention.
Claims (8)
1. a kind of pharmaceutical composition treated blood disease and merge bacterium infection, it is characterised in that: the raw material including following parts by weight:
10 ~ 20 parts of Japanese polygala, 10 ~ 15 parts of Cornu Bubali slice, 10 ~ 15 parts of leaf of negundo chastetree, 10 ~ 15 parts of dendrobium nobile, 10 ~ 15 parts of cymose buckwheat rhizome, indigo naturalis 3 ~ 9
Part, 3 ~ 9 parts of soapberry, 5 ~ 8 parts of semen ziziphi spinosae, 3 ~ 8 parts of ganoderma lucidum, 3 ~ 5 parts of elscholtiza, 3 ~ 5 parts of witloof, 3 ~ 5 parts of cattail pollen.
2. a kind of pharmaceutical composition treated blood disease and merge bacterium infection according to claim 1, it is characterised in that: packet
Include the raw material of following parts by weight: 15 ~ 20 parts of Japanese polygala, 10 ~ 15 parts of Cornu Bubali slice, 10 ~ 15 parts of leaf of negundo chastetree, 10 ~ 15 parts of dendrobium nobile, gold
10 ~ 15 parts of buckwheat, 6 ~ 9 parts of indigo naturalis, 6 ~ 9 parts of soapberry, 5 ~ 8 parts of semen ziziphi spinosae, 3 ~ 5 parts of ganoderma lucidum, 3 ~ 5 parts of elscholtiza, 3 ~ 5 parts of witloof,
3 ~ 5 parts of cattail pollen.
3. described in any item a kind of preparations treated blood disease and merge the pharmaceutical composition of bacterium infection according to claim 1 ~ 2
Technique, it is characterised in that: the following steps are included:
S01 take above-mentioned parts by weight include dry semen ziziphi spinosae, soapberry, Japanese polygala, ganoderma lucidum raw material I, wherein semen ziziphi spinosae and nothing
Suffer from son crushing, Japanese polygala, after ganoderma lucidum crushes, 85% alcohol reflux that 6 ~ 10 times of amounts for being equivalent to I gross dry weight of raw material are added extracts 2
Secondary, 1 ~ 2h, extracting solution merge every time, filtering, and are concentrated into no alcohol taste, obtain filtrate I；The filter residue obtained after filtering adds phase
When in 6 ~ 10 times of amount pure water refluxing extraction 2 times of I gross dry weight of raw material, filtrate II is obtained by filtration in 2 ~ 3h, extracting solution merging every time；
Filtrate I adds 1 ~ 2 times of amount pure water for being equivalent to I gross dry weight of raw material, and adjusts PH to 8 ~ 9, stir 3 ~ 4h after, adjust pH value to
Neutrality crosses macroreticular resin, stands at least 2 hours after loading, is washed with water 3 ~ 5BV removal of impurities, and 60 ~ 80% 3 ~ 5BV of ethanol elution are received
Collect 60 ~ 80% ethanol eluates, after being concentrated into 0.1 ~ 0.2 times of amount of I gross dry weight of raw material, spray drying obtains saponin(e position；
S02 take above-mentioned parts by weight include dry leaf of negundo chastetree, cymose buckwheat rhizome, indigo naturalis, elscholtiza, cattail pollen raw material II, wherein indigo naturalis
It is fitted into gauze packet with cattail pollen, after leaf of negundo chastetree, cymose buckwheat rhizome, elscholtiza crush, water is added and enzyme, heating stirring are warming up to 25 ~ 35 DEG C,
Insulated and stirred extracts 24 ~ 36h, and the additional amount of water is equivalent to 6 ~ 10 times of amounts of II gross dry weight of raw material, and the additional amount of enzyme is equivalent to original
Expect the 0.2% ~ 0.4% of II gross dry weight, after enzymatic hydrolysis, heats up, be separated by solid-liquid separation, obtain filtrate III；
It includes the raw material III of dry dendrobium nobile, witloof that S03, which takes above-mentioned parts by weight, and raw material III crushed 40 meshes, be placed in food steamer
Gauze on, after fumigating 30 ~ 60min in water vapour, the pure water reflux for being equivalent to 10 ~ 20 times of III gross dry weight of raw material amounts is added
It extracts 2 ~ 3 times, 1 ~ 3h, filtering, merging filtrate obtain filtrate IV every time；
S04 is by the filtrate II in S01, filtrate III in S02, and the filtrate IV in S03 merges and mixes, and being concentrated into relative density is
1 ~ 1.2 medicinal extract is added 95% ethanol solution and is sufficiently stirred in medicinal extract, until alcohol content is 85% ~ 90%, standing 12 ~
After for 24 hours, centrifugation obtains supernatant and precipitating；Water is added to redissolve obtained precipitating, amount of water is equivalent to 2 ~ 3 times of Sediment weight, on
Macroporous resin column collects water elution with 4 ~ 6BV water elution, is concentrated into 0.1 ~ 0.15 times for being equivalent to precipitating, and 95% second is added
Alcohol to alcohol content be 85% ~ 90%, stand 12 ~ for 24 hours after, be centrifuged to obtain polysaccharide precipitation, polysaccharide precipitation washed 2 ~ 3 with dehydrated alcohol
It is secondary, it is dried in vacuo up to polysaccharide position；Supernatant is concentrated into no alcohol taste, crosses macroporous resin column, stands at least 2 hours after loading,
It is washed with water 3 ~ 5BV removal of impurities, 20 ~ 30% 3 ~ 5BV of ethanol elution collect 20 ~ 30% ethanol eluates, are concentrated into medicinal extract gross weight
After 0.1 ~ 0.2 times of amount, spray drying obtains flavones position；
S05 by cornu bubali powder-refining with water to superfine powder, and with saponin(e position, polysaccharide position, flavones position mixing after dry powder drug.
4. a kind of preparation process for treating hemopathic pharmaceutical composition according to claim 3, which is characterized in that described
Enzyme includes at least two in cellulase, hemicellulase, protease and yeast enzyme.
5. a kind of preparation process for treating hemopathic pharmaceutical composition according to claim 3, it is characterised in that: described
Enzyme is cellulase, yeast enzyme and protease, and the mass ratio of the cellulase, yeast enzyme and protease is (1 ~ 2): (1 ~ 3):
1。
6. a kind of preparation process for treating hemopathic pharmaceutical composition according to claim 3, it is characterised in that: described
Macroreticular resin is any one in AB-8, D101, MCI and HPD100.
7. a kind of preparation process for treating hemopathic pharmaceutical composition according to claim 3, it is characterised in that: by institute
It states dry powder drug addition auxiliary material and oral preparation is made.
8. a kind of preparation process for treating hemopathic pharmaceutical composition according to claim 7, it is characterised in that: described
Oral preparation is granule, syrup, any one in effervescent tablet.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109745454A (en) * | 2019-03-21 | 2019-05-14 | 苏州大学附属儿童医院 | A kind of application of Chinese medicine composition in treatment hemolytic anemia |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102772672A (en) * | 2012-08-24 | 2012-11-14 | 西双版纳增靓生物科技有限公司 | Dendrobium candidum ganoderma lucidum capsule |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102772672A (en) * | 2012-08-24 | 2012-11-14 | 西双版纳增靓生物科技有限公司 | Dendrobium candidum ganoderma lucidum capsule |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109745454A (en) * | 2019-03-21 | 2019-05-14 | 苏州大学附属儿童医院 | A kind of application of Chinese medicine composition in treatment hemolytic anemia |
| CN109745454B (en) * | 2019-03-21 | 2021-11-12 | 苏州大学附属儿童医院 | Application of traditional Chinese medicine composition in treatment of hemolytic anemia |
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