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CN1220510C - Chinese patent medicine with the functions of replenishing qi and blood and nourishing the heart to calm the mind, its preparation method and quality control method - Google Patents

Chinese patent medicine with the functions of replenishing qi and blood and nourishing the heart to calm the mind, its preparation method and quality control method Download PDF

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CN1220510C
CN1220510C CNB031374271A CN03137427A CN1220510C CN 1220510 C CN1220510 C CN 1220510C CN B031374271 A CNB031374271 A CN B031374271A CN 03137427 A CN03137427 A CN 03137427A CN 1220510 C CN1220510 C CN 1220510C
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CN1460510A (en
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邹节明
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Guilin Sanjin Pharmaceuticals Co Ltd
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GUILIN SANJIN BIOLOGICAL PHARMACEUTICAL CO Ltd SANJIN GROUP
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Abstract

The present invention relates to a Chinese patent medicine with the functions of replenishing qi, tonifying blood and nourishing the heart to calm the mind, a preparation method thereof and a quality control method. The Chinese medicine is prepared from ginseng, tuber fleeceflower root, tokay, gynostemma pentaphylla total glycosides, water-solubility pearl powder, grassleaf sweelflag rhizome, honey, etc.

Description

A kind of Chinese patent medicine of vigorate qi and replenish the blood tranquilizing by nourishing the heart and preparation method thereof method of quality control
Technical field:
The present invention relates to the Chinese medicine of a kind of vigorate qi and replenish the blood, tranquilizing by nourishing the heart, particularly the Chinese medicine made from Chinese crude drugs such as Radix Ginseng, Radix Polygoni Multiflori, Gecko, Herb Gynostemmae Pentaphylli total glycosides, water soluble Margarita ultrafine powder, Rhizoma Acori Graminei, Mel.
Background technology:
QI and blood deficiency causes has a dizzy spell, tired out weak be a kind of common and multiple illness, the reason complexity of primary disease, symptom is various, course of disease delay is obstinate difficult, treats more thornyly, has a strong impact on physical and mental health.Therefore, a safe and effective medicine is that the patient is needed.
In recent years, along with going deep into of clinical research, also occur on the market some the treatment QI and blood deficiency medicine, existing medicine belongs to a bit cures the symptoms, not the disease, some uses expensive composition, some in application process since uncertain therapeutic efficacy cut interrupt the use.
The invention provides a kind of determined curative effect, safe ready, little, the cheap pure traditional Chinese compound medicine of side effect.
Summary of the invention:
The invention provides the Chinese medicine of a kind of vigorate qi and replenish the blood, tranquilizing by nourishing the heart, this Chinese medicine is to be made by Chinese crude drugs such as Radix Ginseng, Radix Polygoni Multiflori, Gecko, Herb Gynostemmae Pentaphylli total glycosides, water soluble Margarita ultrafine powder, Rhizoma Acori Graminei, Mel.
Chinese medicine preparation of the present invention has vigorate qi and replenish the blood, the tranquilizing by nourishing the heart function.Be used for that QI and blood deficiency causes have a dizzy spell, spiritlessness and weakness, the diseases such as spontaneous perspiration, lustreless complexion, severe palpitation, insomnia forgetfulness of breathing hard.Informal dress can improve body resistance against diseases, slow down aging.
Its prescription of Chinese medicine preparation of the present invention consists of:
Radix Ginseng (preferred Radix Ginseng Rubra) 15-45 part Radix Polygoni Multiflori Preparata 100-300 part Gecko 5-20 part
Herb Gynostemmae Pentaphylli total glycosides 0.5-2 part water soluble Margarita ultrafine powder 15-45 part Rhizoma Acori Graminei 15-45 part
Mel 150-450 part
Preferably
Radix Ginseng (preferred Radix Ginseng Rubra) 20-40 part Radix Polygoni Multiflori Preparata 150-250 part Gecko 10-15 part
Herb Gynostemmae Pentaphylli total glycosides 1-1.5 part water soluble Margarita ultrafine powder 20-40 part Rhizoma Acori Graminei 20-40 part
Mel 200-400 part
More preferably
12.5 parts of 30 portions of 200 portions of Geckos of Radix Polygoni Multiflori Preparata of Radix Ginseng (preferred Radix Ginseng Rubra)
30 parts of 30 parts of Rhizoma Acori Graminei of 1.25 parts of water soluble Margarita ultrafine powder of Herb Gynostemmae Pentaphylli total glycosides
300 parts of Mel
In more than forming, every part of representative be weight portion, weight is calculated with crude drug, and as if being unit with the gram, more than composition can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, 1000 bags of granules, oral liquid 1000ml etc. also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time, and oral liquid can be made Different Package such as 5ml/ bottle, 200ml/ bottle, the 100ml/ bottle, the 50ml/ bottle.
More than form, as if being unit with the gram, can be made into the preparation of 50-1000 taking dose, as tablet, make 1000, each taking dose can be the 1-20 sheet, can take 50-1000 time altogether.As granule, make 125 bags, take the 1-2 bag at every turn, can take 62.5-125 time altogether.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the gram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, and for especial patient, the proportioning of the amount of can corresponding adjustment forming increases or reduce being no more than 100%, and drug effect is constant.
Single medicinal material, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Chinese medicine preparation of the present invention, can add the medicine acceptable carrier when being prepared into medicament, described medicine acceptable carrier can be: starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preparation of the present invention, peroral dosage form preferably, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc., preferably oral liquid.
Preparation of the present invention is determined usage and dosage according to patient's situation in use, but obeys every day three times, each 1-20 agent, as: 1-20 bag or grain or sheet.
Chinese medicine preparation of the present invention prepares by the following method.
(1), preparation Aromatic water: get Radix Ginseng Rubra, Rhizoma Acori Graminei coarse grain, add the water distillation, collected Aromatic water about 1: 1.Remaining aqueous solution filters, and gets filtrate A and medicinal residues.
(2), ethanol extraction: above-mentioned medicinal residues and Gecko merge, and use 50%-90% alcohol heating reflux 0.5-2 hour, filter, and get liquor B and medicinal residues.
(3) water extraction: above-mentioned medicinal residues and Radix Polygoni Multiflori Preparata merge, and add decocting in water and fry in shallow oil 1-3 time, each 1-3 hour, collecting decoction filters, and merges with above-mentioned filtrate A, being concentrated into relative density is 1.05-1.20 (55 degrees centigrade), add above-mentioned liquor B and ethanol, make the alcohol amount of containing reach 50-80%, stir, left standstill 24-72 hour, get supernatant, reclaim ethanol, the clear paste that is concentrated into relative density and is 1.05-1.20 (55 degrees centigrade) is standby.
(3) Mel is refining
Get Mel and add 1-3 times of water dilution, boiled 20-60 minute, scumming and impurity are concentrated to relative density more than 1.20, and is standby.
(4) aqueous Margarita powder
Water intaking dissolubility Margarita powder, it is an amount of to add pure water, and heating for dissolving is standby.
(5) Herb Gynostemmae Pentaphylli total glycosides
Get Herb Gynostemmae Pentaphylli total glycosides, it is an amount of to add pure water, and heating for dissolving is standby.
(6) manufactured goods
Get above-mentioned clear paste, Mel, the water soluble Margarita ultrafine powder aqueous solution is boiled, and filters, and adds Aromatic water, Herb Gynostemmae Pentaphylli total glycosides solution, and mixing such as an amount of correctives, adding water move to total amount is 1000ml, filter, embedding, promptly.
The present invention also provides the method for quality control of Chinese medicine preparation of the present invention, comprising:
(1) discrimination method:
Step is as follows: (1) gets Chinese medicine preparation 20ml of the present invention, adds ethanol 5ml, shakes up, and extracts with ether 20ml jolting, divides and gets ether solution, and evaporate to dryness, residue add chloroform 0.5ml makes dissolving, as need testing solution.Other gets Radix Polygoni Multiflori Preparata control medicinal material 2g, adds methanol 50ml, puts in the water-bath reflux 1 hour, filters, and filtrate evaporate to dryness, residue add water 20ml makes dissolving, adds hydrochloric acid 1ml again, puts in the water-bath heating 30 minutes, and cooling is shone medical material solution in pairs with legal system immediately.Get emodin, physcione reference substance again, chlorination is copied into the mixed solution that every 1ml contains 0.5mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 5 μ l of above-mentioned three kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the carboxymethylcellulose sodium solution, upper solution with toluene-ethyl acetate-formic acid (15: 2: 1) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color; Put in the ammonia smoked after, put under the daylight and inspect, speckle becomes redness.
(2) get discriminating (1) water layer down, with water saturated n-butyl alcohol 20ml, jolting is extracted, and leaves standstill, and branch is got n-butyl alcohol liquid, adds ammonia solution 30ml, shakes up, and n-butyl alcohol liquid evaporate to dryness is got in the placement layering, and residue adds methanol 1ml makes dissolving, as need testing solution.Other gets Radix Ginseng Rubra control medicinal material 1g, adds ethanol 30ml, puts in the water-bath and refluxes 1 hour, filters, and filtrate evaporate to dryness, residue add water 20ml makes dissolving, shines medical material solution in pairs with legal system.Get ginsenoside Rb1, Re, Rg1 reference substance again, add methanol and make the mixed solution that every 1ml contains 0.5mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 2-4 μ l of above-mentioned three kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the carboxymethylcellulose sodium solution, with chloroform-methanol-water (7: 3: 0.5) is developing solvent, launches, and takes out, dry, spray, is put under the daylight and is inspected about 5 minutes of 105 ℃ of bakings with 10% ethanol solution of sulfuric acid.In the test sample chromatograph, with reference substance and the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
(2) inspection method:
Comprise following content:
Relative density is not less than 1.10 (appendix VIIA of Chinese Pharmacopoeia version in 2000).
PH value is 4.0-6.0 (appendix VIIG of Chinese Pharmacopoeia version in 2000).
Meet every regulation relevant under the mixture item (appendix IG of Chinese Pharmacopoeia version in 2000).
(3) content assaying method:
Step is as follows: precision is measured Chinese medicine preparation 20ml of the present invention, puts in the separatory funnel, uses chloroform extraction 2 times, each 10ml, and combined chloroform liquid, standby.Water layer adds 2.5mol/L sulfuric acid solution 30ml, chloroform 30ml, reflux 1 hour, and cooling in the dislocation separatory funnel, divides and gets chloroform layer.Water layer chloroform extraction 3 times, each 20ml, combined chloroform liquid filters, and filter washs with minimum of chloroform, and cleaning mixture is incorporated in the filtrate, water bath method, the residue dissolve with methanol moves in the 5ml measuring bottle, as need testing solution.It is an amount of that other gets the emodin reference substance, and accurate the title decides, and adds methanol and makes the solution that every 1ml contains 0.4mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw need testing solution 10 μ l, reference substance solution 2 μ l and 4 μ l, respectively the cross point in same be on the silica gel g thin-layer plate of adhesive with the carboxymethylcellulose sodium solution, be developing solvent with the upper solution of toluene-ethyl acetate-formic acid (15: 2: 1), exhibition is apart from about 8cm, take out, dry, scan wavelength according to thin layer chromatography (an appendix VIB of Chinese Pharmacopoeia version in 2000 thin layer chromatography scanning): λ s=440nm, λ R=550nm measures test sample trap integrated value and reference substance trap integrated value, calculates, promptly.
Every of Chinese medicine preparation of the present invention contains emodin (C 15H 10O 5) must not be lower than 150 μ g.
Below by effect experiment beneficial effect of the present invention is described.
Test the medicine that used medicine prepares for the method according to the embodiment of the invention 1, experimental result is as follows.
Pharmacodynamics test: the experiment medicine has obvious facilitation to the blood Hb of hemolytic blood deficiency mice, the recovery of RBC value, can obviously prolong pentobarbital sodium threshold dose length of one's sleep, Rats with Spleen-deficiency gastric juice amount, gastric acid, pepsin activity are had obvious facilitation; Can strengthen mice endurance, hypoxia-bearing capability; Can obviously resist the decline of the peripheral blood T lymphocyte percentage that causes by hydrocortisone; Can resist the WBC decline that cyclophosphamide causes, protection ring phosphamide induced mice atrophy of thymus gland; Can improve deficient animal serum IgG content, strengthen immune function of mice; The fruit bat longevity closes test and shows, can prolong life span of drosophila melanogaster.
Acute toxicity test, mice ig administration maximum tolerated dose is greater than 120ml/kg (being equivalent to clinical plan 200 times with daily dose).
Long term toxicity test, with 40,20,10ml/kg (being equivalent to clinical plan 67,33,17 times with daily dose respectively) gavages 60 days for rat continuously, do not see the overt toxicity reaction, obvious pathological changes is not seen in main organs histological examinations such as the heart, liver, lung, kidney, adrenal gland.
Clinical research; Through one Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi, two Affiliated Hospital and the People's Hospital, Guangxi district 120 routine QI and blood deficiency patients are carried out clinical verification, total effective rate is 92.5%.Do not see obvious adverse reaction during the clinical observation.
The specific embodiment:
Further specify the present invention by the following examples
Embodiment 1:
The preparation of oral liquid
Prescription:
Radix Ginseng (preferred Radix Ginseng Rubra) 30g Radix Polygoni Multiflori Preparata 200g Gecko 12.5g
Herb Gynostemmae Pentaphylli total glycosides 1.25g water soluble Margarita ultrafine powder 30g Rhizoma Acori Graminei 30g
Mel 300g
More than seven flavor crude drugs make 1000ml (every 10ml contain crude drug 6 gram) altogether
Preparation technology:
(1), preparation Aromatic water: get Radix Ginseng Rubra, Rhizoma Acori Graminei coarse grain, add the water distillation, collected Aromatic water about 1: 1.Remaining aqueous solution filters, and gets filtrate A and medicinal residues.
(2), ethanol extraction: above-mentioned medicinal residues and Gecko merge, and with 70% alcohol heating reflux 1 hour, filter, must liquor B and medicinal residues.
(3) water extraction: above-mentioned medicinal residues and Radix Polygoni Multiflori Preparata merge, and add decocting in water and fry in shallow oil 2 times, each 1 hour, collecting decoction filters, and merges with above-mentioned filtrate A, being concentrated into relative density is 1.05 (55 degrees centigrade), add above-mentioned liquor B and ethanol, make to contain alcohol amount and reach 60%, stir, left standstill 24 hours, get supernatant, reclaim ethanol, the clear paste that is concentrated into relative density and is 1.05 (55 degrees centigrade) is standby.
(3) Mel is refining
Get Mel and add 3 times of water dilutions, boiled 60 minutes, scumming and impurity are concentrated to relative density more than 1.20, and is standby.
(4) aqueous Margarita powder
Water intaking dissolubility Margarita powder adds pure water 100ml, and heating for dissolving is standby.
(5) Herb Gynostemmae Pentaphylli total glycosides
Get Herb Gynostemmae Pentaphylli total glycosides, add pure water 100ml, heating for dissolving, standby.
(6) manufactured goods
Get above-mentioned clear paste, Mel, the water soluble Margarita ultrafine powder aqueous solution is boiled, and filters, and adds Aromatic water, Herb Gynostemmae Pentaphylli total glycosides solution, and an amount of correctives mixing, adding water move to total amount is 1000ml, filter, embedding, promptly.
Embodiment 2:
The preparation of capsule
Prescription:
Radix Ginseng (preferred Radix Ginseng Rubra) 30g Radix Polygoni Multiflori Preparata 200g Gecko 12.5g
Herb Gynostemmae Pentaphylli total glycosides 1.25g water soluble Margarita ultrafine powder 30g Rhizoma Acori Graminei 30g
Mel 300g
More than seven flavor crude drugs make 1000 (every contain crude drug 0.6 gram) altogether
Preparation technology:
(1), preparation Aromatic water: get Radix Ginseng Rubra, Rhizoma Acori Graminei coarse grain, add the water distillation, collected Aromatic water about 1: 1.Remaining aqueous solution filters, and gets filtrate A and medicinal residues.
(2), ethanol extraction: above-mentioned medicinal residues and Gecko merge, and with 70% alcohol heating reflux 1 hour, filter, must liquor B and medicinal residues.
(3) water extraction: above-mentioned medicinal residues and Radix Polygoni Multiflori Preparata merge, and add decocting in water and fry in shallow oil 2 times, each 1 hour, collecting decoction filters, and merges with above-mentioned filtrate A, being concentrated into relative density is 1.05 (55 degrees centigrade), add above-mentioned liquor B and ethanol, make to contain alcohol amount and reach 60%, stir, left standstill 24 hours, get supernatant, reclaim ethanol, the clear paste that is concentrated into relative density and is 1.05 (55 degrees centigrade) is standby.
(3) Mel is refining: get Mel and add 1 times of water dilution, boiled 60 minutes, scumming and impurity are concentrated to relative density more than 1.20, and is standby.
(4) manufactured goods: get above-mentioned clear paste, Mel, water soluble Margarita ultrafine powder, Aromatic water, Herb Gynostemmae Pentaphylli total glycosides, and 100g starch, the 50g dextrin mixes, and granulates, and the oven dry back adds magnesium stearate 10g, the capsule of packing into No. 1.

Claims (9)

1, a kind of Chinese traditional compound medicine is characterized in that, it is made by the Chinese medicine of following component,
Radix Ginseng or Radix Ginseng Rubra 15-45 part Radix Polygoni Multiflori Preparata 100-300 part Gecko 5-20 part
Herb Gynostemmae Pentaphylli total glycosides 0.5-2 part water soluble Margarita ultrafine powder 15-45 part Rhizoma Acori Graminei 15-45 part
Mel 150-450 part.
According to the Chinese medicine preparation of claim 1, it is characterized in that 2, it is made by the Chinese medicine of following component,
Radix Ginseng or Radix Ginseng Rubra 20-40 part Radix Polygoni Multiflori Preparata 150-250 part Gecko 10-15 part
Herb Gynostemmae Pentaphylli total glycosides 1-1.5 part water soluble Margarita ultrafine powder 20-40 part Rhizoma Acori Graminei 20-40 part
Mel 200-400 part.
According to the Chinese medicine preparation of claim 1, it is characterized in that 3, it is made by the Chinese medicine of following component,
12.5 parts of 200 portions of Geckos of 30 parts of Radix Polygoni Multiflori Preparatas of Radix Ginseng or Radix Ginseng Rubra
30 parts of 30 parts of Rhizoma Acori Graminei of 1.25 parts of water soluble Margarita ultrafine powder of Herb Gynostemmae Pentaphylli total glycosides
300 parts of Mel.
4, the Chinese medicine preparation of claim 1 is tablet, capsule, oral liquid, buccal tablet, granule, electuary, pill, powder, suspensoid, injection, solution, drop or drop pill.
5. the Chinese medicine preparation of claim 4 is oral liquids.
6. the Chinese medicine preparation of claim 1 prevents and/or treats application in the medicine of QI and blood deficiency disease in preparation.
7, the preparation method of the Chinese medicine preparation of claim 1 is characterized in that, through following steps,
(1), preparation Aromatic water: get Radix Ginseng Rubra, Rhizoma Acori Graminei coarse grain, add the water distillation, collected Aromatic water about 1: 1, remaining aqueous solution filters, and gets filtrate A and medicinal residues;
(2), ethanol extraction: above-mentioned medicinal residues and Gecko merge, and use 50%-90% alcohol heating reflux 0.5-2 hour, filter, and get liquor B and medicinal residues;
(3) water extraction: above-mentioned medicinal residues and Radix Polygoni Multiflori Preparata merge, and add decocting in water and fry in shallow oil 1-3 time, each 1-3 hour, collecting decoction filters, and merges with above-mentioned filtrate A, being concentrated into relative density is 1.05-1.20,55 degrees centigrade, adds above-mentioned liquor B and ethanol, make the alcohol amount of containing reach 50-80%, stir, left standstill 24-72 hour, get supernatant, reclaim ethanol, being concentrated into relative density is 1.05-1.20,55 degrees centigrade, clear paste standby;
(4) Mel is refining: get Mel and add 1-3 times of water dilution, boiled 20-60 minute, scumming and impurity are concentrated to relative density more than 1.20, and is standby;
(5) aqueous Margarita powder: water intaking dissolubility Margarita powder, it is an amount of to add pure water, and heating for dissolving is standby;
(6) Herb Gynostemmae Pentaphylli total glycosides: get Herb Gynostemmae Pentaphylli total glycosides, it is an amount of to add pure water, and heating for dissolving is standby;
(7) manufactured goods: get above-mentioned clear paste, Mel, the water soluble Margarita ultrafine powder aqueous solution is boiled, and filters, and adds Aromatic water, Herb Gynostemmae Pentaphylli total glycosides solution, and mixing such as an amount of correctives, adding water move to total amount is 1000ml, filters embedding.
According to the preparation method of claim 7, it is characterized in that 8, correctives is stevioside or citric acid described in the step (7).
9, the method for quality control of any one Chinese medicine preparation of claim 1-5 comprises discriminating, checks and assay that for discrimination method, step is as follows:
(1) the weighting profit requires the preparation 20ml of 1-6, adds ethanol 5ml, shakes up, and extracts with ether 20ml jolting, divides and gets ether solution, and evaporate to dryness, residue add chloroform 0.5ml makes dissolving, as need testing solution; Other gets Radix Polygoni Multiflori Preparata control medicinal material 2g, adds methanol 50ml, puts in the water-bath reflux 1 hour, filters, and filtrate evaporate to dryness, residue add water 20ml makes dissolving, adds hydrochloric acid 1ml again, puts in the water-bath heating 30 minutes, and cooling is shone medical material solution in pairs with legal system immediately; Get emodin, physcione reference substance again, chlorination is copied into the mixed solution that every 1ml contains 0.5mg, in contrast product solution; According to appendix VIB test of thin layer chromatography Chinese Pharmacopoeia version in 2000, draw each 5 μ l of above-mentioned three kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the carboxymethylcellulose sodium solution, with 15: 2: 1 upper solution of toluene-ethyl acetate-formic acid is developing solvent, launch, take out, dry, put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color; Put in the ammonia smoked after, put under the daylight and inspect, speckle becomes redness;
(2) get discriminating (1) water layer down, with water saturated n-butyl alcohol 20ml, jolting is extracted, and leaves standstill, and branch is got n-butyl alcohol liquid, adds ammonia solution 30ml, shakes up, and n-butyl alcohol liquid evaporate to dryness is got in the placement layering, and residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Radix Ginseng Rubra control medicinal material 1g, adds ethanol 30ml, puts in the water-bath and refluxes 1 hour, filters, and filtrate evaporate to dryness, residue add water 20ml makes dissolving, shines medical material solution in pairs with legal system; Get Ginsenoside Rb l, Re, Rgl reference substance again, add methanol and make the mixed solution that every 1ml contains 0.5mg, in contrast product solution; According to appendix VIB test of thin layer chromatography Chinese Pharmacopoeia version in 2000, draw each 2-4 μ l of above-mentioned three kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the carboxymethylcellulose sodium solution, with chloroform-methanol-water is developing solvent at 7: 3: 0.5, launches, and takes out, dry, spray, is put under the daylight and is inspected about 5 minutes of 105 ℃ of bakings with 10% ethanol solution of sulfuric acid; In the test sample chromatograph, with reference substance and the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
For inspection method, comprise following content:
Check the relative density of the preparation of claim 1-6, should be not less than appendix VIIA of 1.10 Chinese Pharmacopoeias version in 2000;
The pH value of checking the preparation of claim 1-6 should be appendix VIIG of 4.0-6.0 Chinese Pharmacopoeia version in 2000;
The preparation of checking claim 1-6 should meet relevant every regulation under an appendix IJ of Chinese Pharmacopoeia version in 2000 the mixture item;
For content assaying method, step is as follows:
The preparation 20ml that precision is measured claim 1-6 puts in the separatory funnel, uses chloroform extraction 2 times, each 10ml, and combined chloroform liquid, standby; Water layer adds 2.5mol/L sulfuric acid solution 30ml, chloroform 30ml, reflux 1 hour, and cooling in the dislocation separatory funnel, divides and gets chloroform layer; Water layer chloroform extraction 3 times, each 20ml, combined chloroform liquid filters, and filter washs with minimum of chloroform, and cleaning mixture is incorporated in the filtrate, water bath method, the residue dissolve with methanol moves in the 5ml measuring bottle, as need testing solution; It is an amount of that other gets the emodin reference substance, and accurate the title decides, and adds methanol and makes the solution that every 1ml contains 0.4mg, in contrast product solution; According to appendix VIB test of thin layer chromatography Chinese Pharmacopoeia version in 2000, draw need testing solution each 10 μ l, reference substance solution 2 μ l and 4 μ l, respectively the cross point in same be on the silica gel g thin-layer plate of adhesive with the carboxymethylcellulose sodium solution, with 15: 2: 1 upper solution of toluene-ethyl acetate-formic acid is developing solvent, exhibition is taken out apart from about 8cm, dries, scan wavelength according to an appendix VIB of thin layer chromatography Chinese Pharmacopoeia version in 2000 thin layer chromatography scanning: λ S=440nm, λ R=550nm measures test sample trap integrated value and reference substance trap integrated value, calculates, that is, every in the preparation of claim 6 contains emodin C 15H 10O 5Must not be lower than 150 μ g.
CNB031374271A 2003-06-20 2003-06-20 Chinese patent medicine with the functions of replenishing qi and blood and nourishing the heart to calm the mind, its preparation method and quality control method Expired - Lifetime CN1220510C (en)

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CN100387986C (en) * 2004-02-11 2008-05-14 上海市中药研究所 A kind of quality control method of Zhenju Jiangya tablet
CN102604803A (en) * 2012-03-28 2012-07-25 钟定良 Preparation method for ginseng-polygonum multiflorum nourishing solution
CN106596806A (en) * 2016-12-19 2017-04-26 山东省中医药研究院 Method of simultaneously preparing emodin and physcion from radix polygoni multiflori praeparata intelligence reinforcing capsule
CN111773233A (en) * 2020-08-11 2020-10-16 黄大帅 Foot bath health-care traditional Chinese medicine composition for calming nerves and improving sleep and preparation method thereof

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