CN101411778A - Chinese medicine effective component composition and method for preparing the same - Google Patents
Chinese medicine effective component composition and method for preparing the same Download PDFInfo
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- CN101411778A CN101411778A CNA2007100561631A CN200710056163A CN101411778A CN 101411778 A CN101411778 A CN 101411778A CN A2007100561631 A CNA2007100561631 A CN A2007100561631A CN 200710056163 A CN200710056163 A CN 200710056163A CN 101411778 A CN101411778 A CN 101411778A
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Abstract
The invention discloses a traditional Chinese medicine effective part composition capable of treating malignant tumor, improving immunologic function, and having safe use. The composition contains total alkaloids of Solanum nigrum, general ginsenoside, and total saponins of Astragalus. The invention also discloses a method for preparing the medicine composition.
Description
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind ofly to treat malignant tumor, improve immunologic function, effective ingredient in Chinese compositions safe in utilization, the feature of said composition is to contain Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins, and the present invention also provides this preparation of drug combination method.
Background technology
Modern society's cancer (malignant tumor) has become one of subject matter that threatens human life's health, The World Health Organization's report shows, incidence trend according to present cancer, the year two thousand twenty whole world cancer morbidity will be than present increase by 50%, and the annual newly-increased cancer patient's number in the whole world will reach 1,500 ten thousand people.The medical profession urgent needs is cancer treatment drugs safely and effectively.
Herba Solani Nigri total alkaloids of the present invention derives from single medical material---Herba Solani Nigri.Herba Solani Nigri is the Solanaceae nightshade, and the effect of heat-clearing and toxic substances removing, promoting blood circulation to remove blood stasis, inducing diuresis to remove edema, eliminating phlegm and stopping cough is arranged.Obtained the extensive concern of Chinese scholars in recent years as the Herba Solani Nigri of Chinese medicine, carried out a large amount of research, no matter obtained comparatively objectively information, especially at anti-tumor aspect, be that single medicinal material or its compound preparation are being done a large amount of work aspect basis and the clinical medicine.Herb of Herba Solani Nigri contains glycoside steroid alkaloid, Herba Solani Nigri polysaccharide, mineral, vitamin, pigment, aminoacid etc., also contain ester, carboxyl compound, sterol, phenoloid (its main component is yellow beta-unsaturated esters) in the extract in the Herba Solani Nigri berry, contain saponin in addition.And the chemical constituent that oncotherapy plays a crucial role is mainly Herba Solani Nigri total alkaloids (comprising solasonine, solamargine etc.), be polysaccharide secondly.
Radix Ginseng total saponins of the present invention is the total saponins that extracts from the dry root of Araliaceae Radix Ginseng (Panax ginseng C.A.Mey.).Radix Ginseng is traditional rare Chinese medicine, has that strongly invigorating primordial QI, multiple arteries and veins take off admittedly, an invigorating the spleen to benefit the lung, the function of promoting the production of body fluid, calming the nerves.Modern pharmacological research shows that Radix Ginseng has multiple pharmacologically active.Medical science and pharmacological research prove that Radix Ginseng total saponins is one of main effective ingredient of Radix Ginseng, and it is the major physiological active substance of Radix Ginseng, mainly contains ginsenoside Rg1 and ginsenoside Re etc.
Radix Astragali total saponins of the present invention is the total saponins that extracts from the dry root of leguminous plant Radix Astagali or Radix Astragali.The Radix Astragali has invigorating QI to consolidate the body surface resistance, expelling pus and toxin by strengthening QI, diuresis, the effect of granulation promoting; Also have the enhance immunity system, resist disease, health invigorating, resisting oxidation and delaying senility, antiviral, anticancer effect.
By retrieval, do not see Herba Solani Nigri total alkaloids is arranged, Chinese medicine preparation that Radix Ginseng total saponins and Radix Astragali total saponins carry out the prescription preparation.We are in conjunction with documents and materials, the utilization modern scientific method, study at aspects such as preparation technology, quality standard, drug effect, toxicity and stability, with Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins is that raw material is made pharmaceutical preparation and is used for treatment of cancer, can play the human body immunity improving function when having obvious antitumaous effect, improve the effect of life quality.
Summary of the invention
The purpose of this invention is to provide that a kind of anti-malignant tumor is evident in efficacy, the effective ingredient in Chinese composition and method of making the same of enhancing human body immunity function.This drug regimen is a raw material with Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins.
The present invention is achieved through the following technical solutions:
1. the preparation of Herba Solani Nigri total alkaloids:
Get herb of Herba Solani Nigri and fruit, add 50%～90% alcoholic solution and extract 2～3 times, each 6～8 times of amounts reclaim ethanol, be concentrated into relative density 1.25, the 0.1mol/l acid solution that adds 2～4 times of amounts in the concentrated solution fully stirs cold preservation, filter, filtering residue washs 1～3 time with hydrochloric acid solution, and merging filtrate and cleaning mixture are with low pole or middle polarity resin absorption.First water flushing resin column/bed is closely neutral to effluent behind the resin absorption; Closely colourless with 0.1mol/l alkaline solution flushing resin column/bed again, closely colourless to contain alcohol amount 10%～40% ethanol liquid flushing resin column/bed again to effluent to effluent.Discard.Carry out eluting with 50～90% ethanol again, show colourless, collect eluent, reclaim ethanol, transfer pH value to 8～10, leave standstill cold preservation, collecting precipitation with the alkaline solution of 0.5～1.5mol/l to there not being the alcohol flavor to eluent.Naturally dry, promptly get Herba Solani Nigri total alkaloids.
Above-described alkaline solution is selected from sodium hydroxide, calcium hydroxide, potassium hydroxide, magnesium hydroxide and ammonia spirit; Described acid solution is selected from acetic acid, hydrochloric acid, sulphuric acid and citric acid solution; Described eluting organic solvent is or two or three mixed phase that form with arbitrary proportion of methanol, ethanol, n-butyl alcohol, chloroform, benzene.
2. the preparation of Radix Ginseng total saponins:
The Radix Ginseng powder is broken into coarse powder, in the boiling water of 12～24 times of weight, decocts 2～3 times, each 1～2 hour.Merge each time extracting solution, being concentrated into 50 ℃～90 ℃ relative densities is 1.00～1.20.Concentrated solution adds ethanol, makes that ethanol content reaches 65%～75% in the solution, filters.With decompression filtrate recycling ethanol, and the pH value to 7 of regulator solution～15 placements, filter, filtrate is passed through macroporous adsorptive resins, with 10%～30% ethanol-eluting resin column, discard eluent,, collect eluent with 50%～90% concentration ethanol eluting, eluent is by large hole cation exchanger resin and macroporous anion exchange resin, the effluent decompression recycling ethanol, concentrate drying gets dry powder.Dry powder with 20%～～90% dissolve with ethanol solution, is mixed with 5% total saponins solution, adds 1% medicinal carbon, reflux 30min～2h, filtered while hot, fine straining again, decompression filtrate recycling ethanol concentrates and is dried to dry powder, Radix Ginseng total saponins.
3. the preparation of Radix Astragali total saponins:
With the Chinese crude drug Radix Astragali is raw material, comprises steps such as extraction, desaccharide, decolouring, purification.It is characterized in that the Radix Astragali is pulverized, in the normal pressure extraction element, the water hot reflux is extracted more than 2 times; The assembling section extracting solution, filter, clear liquid adds on the macroporous adsorptive resins, with 10 times of deionized-distilled water eluting saccharide parts with upper volume, carry out eluting with 5 times of sodium hydroxide, potassium hydroxide or calcium hydroxide aqueous solutions of 0.05%～0.5% again with upper volume, continue and decolour with 5 times of ethanol elutions of 20%～50 with upper volume, again with 70%～90% ethanol elution astragaloside, eluent is concentrated to small size, centrifugal precipitation, the promptly highly purified astragaloside of obtaining; In mother solution, add ethanol to concentration of alcohol and be 70%～90%, centrifugal, get supernatant, the precipitation behind the concentrate drying after astragaloside mixes, obtains Radix Astragali total saponins.
4. above-mentioned Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins is even with the regulation mixed, promptly get effective ingredient in Chinese compositions of the present invention.
Effective ingredient in Chinese compositions of the present invention is characterised in that, contains Herba Solani Nigri total alkaloids 2～4 weight portions, Radix Ginseng total saponins 1～3 weight portion, Radix Astragali total saponins 1～2 weight portion.Wherein preferred proportion is Herba Solani Nigri total alkaloids 3 weight portions, Radix Ginseng total saponins 2 weight portions, Radix Astragali total saponins 1 weight portion.
Press practice of pharmacy, can become the various clinical pharmaceutical dosage form as antitumor drug Herba Solani Nigri total alkaloids of the present invention, Radix Ginseng total saponins, Radix Astragali total saponins preparation of compositions, comprise the dosage form of oral formulations or parenterai administration.Described oral formulations is tablet, capsule, granule, powder, pill, suspensoid, oral liquid etc.; Described parenterai administration dosage form is injection, infusion solution, freeze dried injection etc.
Adjuvant in the antitumor drug combination preparation of the present invention is meant conventional excipient, as: solvent, cosolvent, disintegrating agent, correctives, binding agent, coloring agent, antiseptic etc.
The specific embodiment
Embodiment 1Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins preparation of compositions
(1) method one:
1. the preparation of Herba Solani Nigri total alkaloids:
Get herb of Herba Solani Nigri and fruit and add 80% alcoholic solution extraction 3 times, each 8 times of amounts, reclaim ethanol, be concentrated into relative density 1.25, add the 0.1mol/l hydrochloric acid solution of 3 times of amounts in the concentrated solution, fully stir, cold preservation is filtered, and filtering residue washs 2 times with hydrochloric acid solution, merging filtrate and cleaning mixture are with low pole or middle polarity resin absorption.First water flushing resin column/bed is closely neutral to effluent behind the resin absorption; Closely colourless with 0.1mol/l ammonia spirit flushing resin column/bed again, closely colourless to contain alcohol amount 20% ethanol liquid flushing resin column/bed again to effluent to effluent.Discard.Carry out eluting with 70% ethanol again, show colourless, collect eluent, reclaim ethanol, transfer pH value to 9, leave standstill cold preservation, collecting precipitation with the sodium hydroxide solution of 1.0mol/l to there not being the alcohol flavor to eluent.Naturally dry, promptly get Herba Solani Nigri total alkaloids.
Above-described alkaline solution is selected from sodium hydroxide, calcium hydroxide, potassium hydroxide, magnesium hydroxide and ammonia spirit; Described acid solution is selected from acetic acid, hydrochloric acid, sulphuric acid and citric acid solution; Described eluting organic solvent is or two or three mixed phase that form with arbitrary proportion of methanol, ethanol, n-butyl alcohol, chloroform, benzene.
2. the preparation of Radix Ginseng total saponins:
The Radix Ginseng powder is broken into coarse powder, in the boiling water of 15 times of weight, decocts 2 times each 1.5 hours.Merge each time extracting solution, being concentrated into 80 ℃ of relative densities is 1.10.Concentrated solution adds ethanol, makes that ethanol content reaches 70% in the solution, filters.With decompression filtrate recycling ethanol, and the placement of the pH value to 10 of regulator solution, filter, filtrate is passed through macroporous adsorptive resins, use 20% ethanol-eluting resin column, discard eluent,, collect eluent with 70% concentration ethanol eluting, eluent is by large hole cation exchanger resin and macroporous anion exchange resin, the effluent decompression recycling ethanol, concentrate drying gets dry powder.With dry powder 70% dissolve with ethanol solution, be mixed with 5% total saponins solution, add 1% medicinal carbon, reflux 1h, filtered while hot, fine straining again, decompression filtrate recycling ethanol concentrates and is dried to dry powder, Radix Ginseng total saponins.
3. the preparation of Radix Astragali total saponins:
With the Chinese crude drug Radix Astragali is raw material, comprises steps such as extraction, desaccharide, decolouring, purification.It is characterized in that the Radix Astragali is pulverized, in the normal pressure extraction element, the water hot reflux is extracted 3 times; The assembling section extracting solution, filter, clear liquid adds on the macroporous adsorptive resins, with the deionized-distilled water eluting saccharide part of 15 times of volumes, 0.1% sodium hydroxide solution with 10 times of volumes carries out eluting again, and 30% the ethanol elution that continues with 10 times of volumes decolours, again with 70% ethanol elution astragaloside, eluent is concentrated to small size, centrifugal precipitation, the promptly highly purified astragaloside of obtaining; In mother solution, add ethanol to concentration of alcohol and be 70%, centrifugal, get supernatant, the precipitation behind the concentrate drying after astragaloside mixes, obtains Radix Astragali total saponins.
4. above-mentioned Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins is even with the mixed of 3:2:1, promptly get effective ingredient in Chinese compositions of the present invention (1).
(2) method two:
1. the preparation of Herba Solani Nigri total alkaloids:
Get herb of Herba Solani Nigri and fruit and add 70% alcoholic solution extraction 3 times, each 7 times of amounts, reclaim ethanol, be concentrated into relative density 1.15, add the 0.1mol/l hydrochloric acid solution of 2.5 times of amounts in the concentrated solution, fully stir, cold preservation is filtered, and filtering residue washs 3 times with hydrochloric acid solution, merging filtrate and cleaning mixture are with low pole or middle polarity resin absorption.First water flushing resin column/bed is closely neutral to effluent behind the resin absorption; Closely colourless with 0.1mol/l sodium hydroxide solution flushing resin column/bed again, closely colourless to contain alcohol amount 30% ethanol liquid flushing resin column/bed again to effluent to effluent.Discard.Carry out eluting with 75% ethanol again, show colourless, collect eluent, reclaim ethanol, transfer pH value to 9, leave standstill cold preservation, collecting precipitation with the sodium hydroxide solution of 1.0mol/l to there not being the alcohol flavor to eluent.Naturally dry, promptly get Herba Solani Nigri total alkaloids.
Above-described alkaline solution is selected from sodium hydroxide, calcium hydroxide, potassium hydroxide, magnesium hydroxide and ammonia spirit; Described acid solution is selected from acetic acid, hydrochloric acid, sulphuric acid and citric acid solution; Described eluting organic solvent is or two or three mixed phase that form with arbitrary proportion of methanol, ethanol, n-butyl alcohol, chloroform, benzene.
2. the preparation of Radix Ginseng total saponins:
The Radix Ginseng powder is broken into coarse powder, in the boiling water of 20 times of weight, decocts 2 times each 2 hours.Merge each time extracting solution, being concentrated into 85 ℃ of relative densities is 1.15.Concentrated solution adds ethanol, makes that ethanol content reaches 75% in the solution, filters.With decompression filtrate recycling ethanol, and the placement of the pH value to 9 of regulator solution, filter, filtrate is passed through macroporous adsorptive resins, use 15% ethanol-eluting resin column, discard eluent,, collect eluent with 60% concentration ethanol eluting, eluent is by large hole cation exchanger resin and macroporous anion exchange resin, the effluent decompression recycling ethanol, concentrate drying gets dry powder.With dry powder 65% dissolve with ethanol solution, be mixed with 5% total saponins solution, add 1% medicinal carbon, reflux 1.5h, filtered while hot, fine straining again, decompression filtrate recycling ethanol concentrates and is dried to dry powder, Radix Ginseng total saponins.
3. the preparation of Radix Astragali total saponins:
With the Chinese crude drug Radix Astragali is raw material, comprises steps such as extraction, desaccharide, decolouring, purification.It is characterized in that the Radix Astragali is pulverized, in the normal pressure extraction element, the water hot reflux is extracted 2 times; The assembling section extracting solution, filter, clear liquid adds on the macroporous adsorptive resins, with the deionized-distilled water eluting saccharide part of 12 times of volumes, 0.2% sodium hydroxide solution with 6 times of volumes carries out eluting again, and 40% the ethanol elution that continues with 8 times of volumes decolours, again with 80% ethanol elution astragaloside, eluent is concentrated to small size, centrifugal precipitation, the promptly highly purified astragaloside of obtaining; In mother solution, add ethanol to concentration of alcohol and be 80%, centrifugal, get supernatant, the precipitation behind the concentrate drying after astragaloside mixes, obtains Radix Astragali total saponins.
4. above-mentioned Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins is even with the mixed of 2:1:1, promptly get effective ingredient in Chinese compositions of the present invention (2).
(3) method three:
1. the preparation of Herba Solani Nigri total alkaloids:
Get herb of Herba Solani Nigri and fruit and add 75% alcoholic solution extraction 2 times, each 8 times of amounts, reclaim ethanol, be concentrated into relative density 1.10, add the 0.15mol/l hydrochloric acid solution of 3 times of amounts in the concentrated solution, fully stir, cold preservation is filtered, and filtering residue washs 3 times with hydrochloric acid solution, merging filtrate and cleaning mixture are with low pole or middle polarity resin absorption.First water flushing resin column/bed is closely neutral to effluent behind the resin absorption; Closely colourless with 0.1mol/l ammonia spirit flushing resin column/bed again, closely colourless to contain alcohol amount 20% ethanol liquid flushing resin column/bed again to effluent to effluent.Discard.Carry out eluting with 70% ethanol again, show colourless, collect eluent, reclaim ethanol, transfer pH value to 10, leave standstill cold preservation, collecting precipitation with the magnesium hydroxide solution of 1.0mol/l to there not being the alcohol flavor to eluent.Naturally dry, promptly get Herba Solani Nigri total alkaloids.
Above-described alkaline solution is selected from sodium hydroxide, calcium hydroxide, potassium hydroxide, magnesium hydroxide and ammonia spirit; Described acid solution is selected from acetic acid, hydrochloric acid, sulphuric acid and citric acid solution; Described eluting organic solvent is or two or three mixed phase that form with arbitrary proportion of methanol, ethanol, n-butyl alcohol, chloroform, benzene.
2. the preparation of Radix Ginseng total saponins:
The Radix Ginseng powder is broken into coarse powder, in the boiling water of 20 times of weight, decocts 2 times each 2 hours.Merge each time extracting solution, being concentrated into 75 ℃ of relative densities is 1.2.Concentrated solution adds ethanol, makes that ethanol content reaches 80% in the solution, filters.With decompression filtrate recycling ethanol, and the placement of the pH value to 11 of regulator solution, filter, filtrate is passed through macroporous adsorptive resins, use 25% ethanol-eluting resin column, discard eluent,, collect eluent with 60% concentration ethanol eluting, eluent is by large hole cation exchanger resin and macroporous anion exchange resin, the effluent decompression recycling ethanol, concentrate drying gets dry powder.With dry powder 80% dissolve with ethanol solution, be mixed with 5% total saponins solution, add 1% medicinal carbon, reflux 1h, filtered while hot, fine straining again, decompression filtrate recycling ethanol concentrates and is dried to dry powder, Radix Ginseng total saponins.
3. the preparation of Radix Astragali total saponins:
With the Chinese crude drug Radix Astragali is raw material, comprises steps such as extraction, desaccharide, decolouring, purification.It is characterized in that the Radix Astragali is pulverized, in the normal pressure extraction element, the water hot reflux is extracted 4 times; The assembling section extracting solution, filter, clear liquid adds on the macroporous adsorptive resins, with the deionized-distilled water eluting saccharide part of 20 times of volumes, 0.1% sodium hydroxide solution with 12 times of volumes carries out eluting again, and 25% the ethanol elution that continues with 15 times of volumes decolours, again with 80% ethanol elution astragaloside, eluent is concentrated to small size, centrifugal precipitation, the promptly highly purified astragaloside of obtaining; In mother solution, add ethanol to concentration of alcohol and be 75%, centrifugal, get supernatant, the precipitation behind the concentrate drying after astragaloside mixes, obtains Radix Astragali total saponins.
4. above-mentioned Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins is even with the mixed of 4:2:1, promptly get effective ingredient in Chinese compositions of the present invention (3).
Embodiment 2The preparation of injection
(1) the effective ingredient in Chinese preparation of compositions method of Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins is with embodiment 1.
(2) preparation of aqueous injection: take by weighing Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins compositions 10g, with the water for injection dissolving, accent pH value to 7 filters, sterilization, and check, packing gets 1000 of aqueous injection.
(3) preparation of infusion solution: take by weighing Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins compositions 10g, after an amount of water for injection dissolving, hydrochloric acid with 0.1mol/l is regulated pH value to 6～7, stirs 30 minutes, adds certain active carbon, continue to stir half an hour, filter, behind the 0.22 μ m filter membrane, add an amount of water for injection excessively, stir fill, promptly get infusion solution.
(4) preparation of lyophilized injectable powder: take by weighing Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins compositions 10g, add 1000ml water for injection, 80 ℃～90 ℃ insulated and stirred after the dissolving, add the mannitol of 100g fully, stir and make dissolving; Regulate pH value to 6～7, aseptic fine straining quantitatively is sub-packed in the pipe-produced glass bottle, lyophilization, promptly.
Embodiment 3The preparation of solid preparation
(1) the effective ingredient in Chinese preparation of compositions method of Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins is with embodiment 1.
(2) preparation of tablet: take by weighing Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins compositions 10g, pharmaceutic adjuvant starch, magnesium stearate 100g.Mix homogeneously is pulverized, and sieves, granulate, and drying, tabletting, check, packing gets 10000 in tablet.
(3) preparation of capsule: take by weighing Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins compositions 100g, medical starch 1000g, mix homogeneously, the capsule of packing into No. 2, every contains pharmaceutical composition 100mg.
(4) preparation of powder: take by weighing Herba Solani Nigri total alkaloids, Radix Ginseng total saponins and Radix Astragali total saponins compositions 1000g, starch 1000g, mix homogeneously, packing makes every bag to contain pharmaceutical composition 100mg promptly.
Claims (7)
1, a kind of have treatment malignant tumor, human body immunity improving function, an effective ingredient in Chinese compositions safe in utilization, it is characterized in that being made up of following components by part by weight:
Herba Solani Nigri total alkaloids 2～4 weight portions
Radix Ginseng total saponins 1～3 weight portion
Radix Astragali total saponins 1～2 weight portion.
2, effective ingredient in Chinese compositions according to claim 1, wherein the weight portion of each component is respectively:
Herba Solani Nigri total alkaloids 3 weight portions
Radix Ginseng total saponins 2 weight portions
Radix Astragali total saponins 1 weight portion.
3, effective ingredient in Chinese compositions according to claim 1, wherein its preparation method of Herba Solani Nigri total alkaloids is as follows:
Get herb of Herba Solani Nigri and fruit, add 50%～90% alcoholic solution and extract 2～3 times, each 6～8 times of amounts reclaim ethanol, be concentrated into relative density 1.25, the 0.1mol/l acid solution that adds 2～4 times of amounts in the concentrated solution fully stirs cold preservation, filter, filtering residue washs 1～3 time with hydrochloric acid solution, and merging filtrate and cleaning mixture are with low pole or middle polarity resin absorption.First water flushing resin column/bed is closely neutral to effluent behind the resin absorption; Closely colourless with 0.1mol/l alkaline solution flushing resin column/bed again, closely colourless to contain alcohol amount 10%～40% ethanol liquid flushing resin column/bed again to effluent to effluent.Discard.Carry out eluting with 50～90% ethanol again, show colourless, collect eluent, reclaim ethanol, transfer pH value to 8～10, leave standstill cold preservation, collecting precipitation with the alkaline solution of 0.5～1.5mol/l to there not being the alcohol flavor to eluent.Naturally dry, promptly get Herba Solani Nigri total alkaloids.
Above-described alkaline solution is selected from sodium hydroxide, calcium hydroxide, potassium hydroxide, magnesium hydroxide and ammonia spirit; Described acid solution is selected from acetic acid, hydrochloric acid, sulphuric acid and citric acid solution; Described eluting organic solvent is or two or three mixed phase that form with arbitrary proportion of methanol, ethanol, n-butyl alcohol, chloroform, benzene.
4, effective ingredient in Chinese compositions according to claim 1, wherein the preparation method of Radix Ginseng total saponins is as follows:
The Radix Ginseng powder is broken into coarse powder, in the boiling water of 12～24 times of weight, decocts 2～3 times, each 1～2 hour.Merge each time extracting solution, being concentrated into 50 ℃～90 ℃ relative densities is 1.00～1.20.Concentrated solution adds ethanol, makes that ethanol content reaches 65%～75% in the solution, filters.With decompression filtrate recycling ethanol, and the pH value to 7 of regulator solution～15 placements, filter, filtrate is passed through macroporous adsorptive resins, with 10%～30% ethanol-eluting resin column, discard eluent,, collect eluent with 50%～90% concentration ethanol eluting, eluent is by large hole cation exchanger resin and macroporous anion exchange resin, the effluent decompression recycling ethanol, concentrate drying gets dry powder.Dry powder with 20%～90% dissolve with ethanol solution, is mixed with 5% total saponins solution, adds 1% medicinal carbon, reflux 30min～2h, filtered while hot, fine straining again, decompression filtrate recycling ethanol concentrates and is dried to dry powder, Radix Ginseng total saponins.
5, effective ingredient in Chinese compositions according to claim 1, its feature is as follows in the preparation method of Radix Astragali total saponins:
With the Chinese crude drug Radix Astragali is raw material, comprises steps such as extraction, desaccharide, decolouring, purification.It is characterized in that the Radix Astragali is pulverized, in the normal pressure extraction element, the water hot reflux is extracted more than 2 times; The assembling section extracting solution, filter, clear liquid adds on the macroporous adsorptive resins, with 10 times of deionized-distilled water eluting saccharide parts with upper volume, carry out eluting with 5 times of sodium hydroxide, potassium hydroxide or calcium hydroxide aqueous solutions of 0.05%～0.5% again with upper volume, continue and decolour with 5 times of ethanol elutions of 20%～50 with upper volume, again with 70%～90% ethanol elution astragaloside, eluent is concentrated to small size, centrifugal precipitation, the promptly highly purified astragaloside of obtaining; In mother solution, add ethanol to concentration of alcohol and be 70%～90%, centrifugal, get supernatant, the precipitation behind the concentrate drying after astragaloside mixes, obtains Radix Astragali total saponins.
6, a kind of preparation that is effective ingredient with the described effective ingredient in Chinese compositions of claim 1, it is characterized in that this effective ingredient in Chinese compositions and one or more pharmaceutical excipients, or can be prepared into oral drug preparation or non-intestinal pharmaceutical preparation with the other drug of this drug regimen prescription.
7, preparation according to claim 6 is characterized in that described oral drug preparation is tablet, capsule, granule, powder, pill, suspensoid, oral liquid etc.; Described parenterai administration dosage form is injection, infusion solution, freeze dried injection etc.; Described pharmaceutical excipient is solvent, disintegrating agent, correctives, binding agent, coloring agent, antiseptic etc.; The medicine that described other compatibility is used, referring to the described compositions of the claim 1 of effective dose is certain medicine material, again compatibility other allowed the Chinese medicine or the chemical drugs that share.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100561631A CN101411778A (en) | 2007-10-15 | 2007-10-15 | Chinese medicine effective component composition and method for preparing the same |
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| CNA2007100561631A CN101411778A (en) | 2007-10-15 | 2007-10-15 | Chinese medicine effective component composition and method for preparing the same |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104503271A (en) * | 2014-11-20 | 2015-04-08 | 江西汇仁药业有限公司 | Chinese patent medicine production process control method |
| CN110423262A (en) * | 2019-05-23 | 2019-11-08 | 齐齐哈尔医学院 | A kind of Astragalus Root P.E preparation method rich in Astragaloside IV |
-
2007
- 2007-10-15 CN CNA2007100561631A patent/CN101411778A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104503271A (en) * | 2014-11-20 | 2015-04-08 | 江西汇仁药业有限公司 | Chinese patent medicine production process control method |
| CN110423262A (en) * | 2019-05-23 | 2019-11-08 | 齐齐哈尔医学院 | A kind of Astragalus Root P.E preparation method rich in Astragaloside IV |
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