CN109223838A - A kind of preparation method and applications of ginkgo leaf extract oral liquid - Google Patents
A kind of preparation method and applications of ginkgo leaf extract oral liquid Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
Abstract
The present invention relates to field of medicaments, and in particular to health product technology field more particularly to a kind of preparation method and applications of ginkgo leaf extract oral liquid.Detailed process are as follows: using the ginkgo biloba p.e and corrigent, antioxidant, seaweed ester sodium, vitamin C and cosolvent of certain proportion parts by weight, be added into ethyl alcohol, be uniformly mixed, adjust pH, ginkgo-leaf oral liquor can be obtained in filtration sterilization packing.The preparation method of ginkgo leaf extract oral liquid disclosed by the invention, the purity extracted to ginkgo leaf extract can be improved, so that the content of the beneficiating ingredients such as flavones is relatively high in obtained ginkgo leaf extract, the principle active component gingkgo flavonoids in ginkgo-leaf oral liquor obtained and terpene lactone are not in degradation over time in the solution simultaneously and stability is good, compliance is good, and ginkgo leaf extract oral liquid obtained can be used for the preparation of health care product；There is good curative effect to human body various diseases.
Description
Technical field
The present invention relates to field of medicaments, and in particular to health product technology field more particularly to a kind of ginkgo leaf extract oral liquid
Preparation method and applications.
Background technique
Ginkgo leaf is a kind of plant with very high medical value, and ginkgo is the ancient tree species in China, it is magical
The tree of medical treatment, pre-Jurassic dinosaur controls terrestrial time within more than 200,000,000 5 thousand years, and ginkgo has been most flouring one of plant.The earth is raw
It orders after variation in 100000000000 years, after the covering of especially the 4th century glacier, the only ginkgo looks that still keep its most original,
It is referred to as " living fossil " in organic evolution history.Its leaf, fruit, seed have higher medical value, and pharmacological action is not
Disconnected to be realized, clinical application range gradually expands.Though ginkgo leaf can promote blood circulation, prevent cardiovascular disease, it cannot be simultaneously
Take it is other control painstaking effort-pipe drug (such as aspirin), ginkgo biloba extract is concentrated granular shape, have it is very strong remove from
By base and antioxidation, glycosides displayed, amino acid and Amino acid synthesis collagen component in ginkgo leaf to human body beauty treatment,
Inhibit melanin growth, skin gloss and elasticity is kept to play no small effect.
The Total Ginkgo Flavone-Glycoides and amarolide of ginkgo leaf extract are soluble in the powerful substance in blood and blood lipid, in them
70% is dissolved in blood by gastrointestinal absorption.30% is absorbed by liver, decomposes blood and blood lipid, decomposition blood vessel rubbish in liver,
Remove " iron rust " on vascular wall.It is excreted by liver metabolism, has broken the limitation of numerous products " only molten not arrange ", comprehensively
Restore the tension and transparent performance of blood vessel.Blood is improved to the support capacity of various tissues and organ, improves microcirculation, changes
System circulation is unsmooth, the defect of transparency difference.
Ginkgo leaf extract also has reparation and protective effect to blood vessel.Can digital preservation vascular wall it is complete, in reparation
Membrane tissue cell.Ginkgo leaf extract supplements human body, restores human elementary balance comprehensively, adjusts body system comprehensively, enhances
Immunity improves memory, restores heart and brain power.
In recent years, especially the country such as Germany, Japan, the U.S., France divides the chemical analysis in ginkgo leaf both at home and abroad
A large amount of research has been carried out from method, has achieved greater advance, representative is to prepare ginkgo with solvent-extracted method
Leaf extract, such as Germany Sehwabe, the dry crude powder in the pharmaceutical factory Flashiman, predominantly ginkgo leaf, extraction process are 60% acetone pumping
It mentions, filters pressing is saturated with ammonium sulfate, is extracted with methyl ethyl ketone with CCL4 degreasing, acetone water layer, is made into after extracting solution pressurization concentration certain
The ethanol solution of concentration adds appropriate Pb(OH) 2 filterings, it is saturated again with sulfate of ammoniac after filtrate concentration, methyl ethyl ketone is extracted, extracting solution
After dry concentration with ethyl alcohol purification be concentrated and dried again ginkgo (GBE) extract (see Deutsche Bundespatent
ED2117429.1767098).Such method, the organic and inorganic chemical mediator used is more, and complex process is at high cost, and easily makes
At residual, the quality of product is influenced.The production technology of domestic ginkgo biloba p.e at present, it is mainly molten using water or alcohols
Agent is extracted, then the mode through macroporous resin adsorption, (Chinese Patent Application No. 94114835.1), but its acquirement rate is low, gained
Extractive content is not also high.
Main active substances are Ginkgolides and ginkgolides in ginkgo biloba p.e.It has proven convenient that Ginkgolides have
There is the effects of expansion coronary vasodilator, improve blood vessel distal and Cerebrovascular disorders, reduce cholesterol, is anti-oxidant；Ginkgolides is blood
The strong antagonist of platelet activation factor-PAF has protective effect to myocardial ischemia, cerebral hypoxia ischemia.Ginkgo-leaf oral liquor is with ginkgo
Leaf extract is raw material, there is the effect of activating microcirculation and removing stasis medicinal dredging collateral.For chest impediment and cardialgia caused by obstruction of collaterals by blood stasis, apoplexy, hemiplegia,
The strong language of tongue is stuttering；Treating Stable Angina Pectoris of Coronary Artery Disease, cerebral infarction are shown in above-mentioned patient.
Publication No. CN105685998A, publication date are that on 2 23rd, 2016 Chinese invention patent applications disclose one
The preparation method of kind ginkgo-leaf oral liquor, the described method comprises the following steps, extracts ginkgo leaf, obtains ginkgo biloba p.e；By tangerine
Sub- peeling, deseeding, squeeze orange juice；By orange juice be added ginkgo biloba p.e in, be mixed evenly, then use water constant volume, tune
PH is saved, is sterilized to get ginkgo-leaf oral liquor.The advantageous effect of the invention are as follows: the preparation of ginkgo-leaf oral liquor of the present invention
Method extracts the beneficiating ingredient in ginkgo leaf only with edible ethanol, while the beneficiating ingredient in ginkgo leaf is extracted, no
Other harmful chemical components can be added.In addition, added with orange juice in ginkgo-leaf oral liquor described in the invention, orange juice adds
Enter the bitter taste that can cover ginkgo biloba p.e, the orange juice that ginkgo-leaf oral liquor of the present invention includes is alkalinity food
Object, i.e., often taking oral solution described in the invention has the effect of pre- anti-cancer.But the silver prepared by the invention
Flavone compound in apricot leaf oral solution, less containing terpene lactone, drug effect will be deteriorated accordingly, and the master in ginkgo leaf
Wanting active material is Ginkgolides and ginkgolides, the main active substances amount in the ginkgo leaf extracted by ethyl alcohol compared with
Few, recovery rate is low.
Ginkgo leaf extract preparation is existing based on the solid pharmaceutical preparations such as tablet, capsule, dripping pill, dispersible tablet, granule.Consider
It takes medicine to dysphagia patien, oral ginkgo biloba extract liquid solves this problem in that.Oral ginkgo biloba extract liquid mainly has
Imitating ingredient is gingkgo flavonoids and terpene lactone, has the function of activating microcirculation and removing stasis medicinal, dredging collateral, is used for brain, peripheral vessels
The treatment of the diseases such as blood circulation disorder disease and organic dementia.But extract not readily dissolves, in ginkgo biloba p.e mouth
It takes in liquid, principle active component gingkgo flavonoids and terpene lactone are unstable in the solution, have different degrees of
Degradation, and taste is very bitter, poor compliance, limits its clinical application.Therefore, it is necessary to improve existing oral liquid formulations, mention
Its high stability.
To sum up, the problem of preparing ginkgo leaf extract oral liquid method in the prior art has: extracting to ginkgo leaf extract
Purity is not high, and the content of the beneficiating ingredients such as flavones is relatively low in obtained ginkgo leaf extract, and in ginkgo biloba p.e mouth
It taking in liquid, principle active component gingkgo flavonoids and terpene lactone are unstable in the solution, over time,
Different degrees of degradation is had, and taste is very bitter, poor compliance limits its clinical application.
Therefore, those skilled in the art are badly in need of providing a kind of preparation method of ginkgo leaf extract oral liquid, to improve to silver
The purity that apricot folic acid extracts, the content of the beneficiating ingredients such as flavones is relatively high in obtained ginkgo leaf extract, while to reach
In oral ginkgo biloba extract liquid, principle active component gingkgo flavonoids and terpene lactone in the solution with when
Between passage be not in degradation and the technical effect that stability is good, compliance is good.
Summary of the invention
It is an object of the invention to overcome the deficiencies of the prior art and provide a kind of preparation method of ginkgo leaf extract oral liquid,
To reach the purity for improving and extracting to ginkgo leaf extract, so that the content of the beneficiating ingredients such as flavones is opposite in obtained ginkgo leaf extract
Higher purpose, it is another object of the present invention to the principle active component Gingko yellows reached in ginkgo-leaf oral liquor obtained
Ketone compounds and terpene lactone are in the solution over time not in degradation and stability is good, compliance is good
Purpose.
To achieve the goals above, the present invention provides the following technical scheme that
A kind of preparation method of ginkgo leaf extract oral liquid, includes the following steps:
(1) 100 parts by weight of ginkgo leaf are weighed, the ethyl alcohol Soakage extraction three times for being 45-60% with mass concentration takes extracting solution to be concentrated
Ethyl alcohol is recycled, concentrate dilutes after being diluted with purified water through being centrifuged crude separation, then with purified water, and cooling natural subsidence is subtracted
Press dry it is dry after, it is spare；
(2) take step (1) to spare ginkgo leaf 20-60 parts by weight and corrigent 11-18 parts by weight, antioxidant 5-15 weight
Part, seaweed ester sodium 15-35 parts by weight, 20-40 parts of vitamin C and cosolvent 3-10 parts by weight, being added into mass concentration is
It in 30-60 parts of ethyl alcohol of 80%, stirs to dissolve, adding appropriate purified water stirring is uniformly mixed it, obtains mixed solution
A；
(3) pH value of step (2) resulting mixed solution A is adjusted to 4.5-6.5 with buffer acidity mediator agent, then with pure
Change water constant volume, crosses 0.25um filtering with microporous membrane and sterilize and dispense, ginkgo leaf extract oral liquid can be obtained.
Further, the step (2) is as follows: taking step (1) to spare ginkgo leaf 30-40 parts by weight and flavoring
Agent 13-15 parts by weight, antioxidant 10-12 parts by weight, seaweed ester sodium 25-30 parts by weight, vitamin C 28-32 parts by weight and hydrotropy
Agent 5-7 parts by weight are added into the ethyl alcohol 45-50 parts by weight that mass concentration is 80%, stir to dissolve, and add appropriate
Purified water stirring is uniformly mixed it, obtains mixed solution A.
Further, the corrigent in the step (2) is in sorbierite, mannitol, stevioside or lemon extract
One or more.
Further, the antioxidant in the step (2) is selected from one or more of sodium pyrosulfite or thiocarbamide.
Further, the cosolvent in the step (2) is selected from calcium lactate, sodium benzoate, p-aminobenzoic acid, urine
One or more of element, nicotinic acid amide or acetamide.
Further, the buffer acidity mediator agent in the step (3) is in potassium citrate, lactic acid or tartaric acid
One or more.
Further, the buffer acidity mediator agent in the step (3) is selected from one of lactic acid or tartaric acid
Or it is several.
Preferably, use buffer acidity mediator agent by the pH of step (2) resulting mixed solution A in the step (3)
Value is adjusted to 5-6.
Further, sterilising temp is 100 DEG C in the step (3), sterilization time 45min.
Ginkgo leaf extract oral liquid made from above-mentioned preparation method can be applied in the preparation of health care product.
Compared with prior art, the invention has the benefit that the present invention provides a kind of preparation of ginkgo leaf extract oral liquid
The purity extracted to ginkgo leaf extract can be improved in method, so that the beneficiating ingredients such as flavones contain in obtained ginkgo leaf extract
Measure it is relatively high, while using made from the preparation method of ginkgo leaf extract oral liquid provided by the invention in ginkgo-leaf oral liquor
Principle active component gingkgo flavonoids and terpene lactone be not in over time in the solution degradation and
Stability is good, compliance is good.In addition, can be used for health care using ginkgo leaf extract oral liquid made from preparation method disclosed by the invention
The preparation of product；Have the function of activating microcirculation and removing stasis medicinal, dredging collateral using ginkgo leaf extract oral liquid made from preparation method of the present invention,
It can be used for the treatment of the diseases such as brain, peripheral vessels blood circulation disorder disease and organic dementia；And in ginkgo biloba p.e
Main active substances are that Ginkgolides and ginkgolides content are high, and recovery rate is high, so that oral solution is to caused by obstruction of collaterals by blood stasis
The strong language of chest impediment and cardialgia, apoplexy, hemiplegia, tongue is stuttering；The pain therapies effect such as Treating Stable Angina Pectoris of Coronary Artery Disease, cerebral infarction is obvious.
And preparation method is simple, and it is easily operated.
Specific embodiment
A kind of preparation method of the ginkgo leaf extract oral liquid of embodiment 1, includes the following steps:
(1) 100 parts by weight of ginkgo leaf are weighed, the ethyl alcohol Soakage extraction three times for being 55% with mass concentration takes extracting solution concentration and recovery
Ethyl alcohol, concentrate dilute after being diluted with purified water through being centrifuged crude separation, then with purified water, and it is dry to carry out decompression for cooling natural subsidence
It is spare after dry；
(2) take step (1) to spare 14 parts by weight of 35 parts by weight of ginkgo leaf and corrigent, 11 parts by weight of antioxidant, seaweed
6 parts by weight of 28 parts by weight of ester sodium, 30 parts of vitamin C and cosolvent are added into 48 parts by weight of ethyl alcohol that mass concentration is 80%
In, it stirs to dissolve, adding appropriate purified water stirring is uniformly mixed it, obtains mixed solution A；
(3) pH value of step (2) resulting mixed solution A is adjusted to 5.5 with buffer acidity mediator agent, then uses purified water
Constant volume, crossing 0.25um filtering with microporous membrane in temperature is 100 DEG C, and sterilization time sterilizes and dispenses under conditions of being 45min
Obtain ginkgo leaf extract oral liquid.
Corrigent in the step (2) is sorbierite.
Antioxidant in the step (2) is sodium pyrosulfite.
Cosolvent in the step (2) is sodium benzoate.
Buffer acidity mediator agent in the step (3) is tartaric acid.
Embodiment 2
The difference from embodiment 1 is that: step (1) is taken in the step (2) to spare 30 parts by weight of ginkgo leaf and is rectified
13 parts by weight of taste agent, 10 parts by weight of antioxidant, 25 parts by weight of seaweed ester sodium, 5 parts by weight of 28 parts of vitamin C and cosolvent, by it
It is added in 45 parts by weight of ethyl alcohol that mass concentration is 80%, stirs to dissolve, adding appropriate purified water stirring keeps its mixing equal
It is even, obtain mixed solution A.
Embodiment 3
The difference from embodiment 1 is that: step (1) is taken in the step (2) to spare 40 parts by weight of ginkgo leaf and is rectified
15 parts by weight of taste agent, 12 parts by weight of antioxidant, 30 parts by weight of seaweed ester sodium, 7 parts by weight of 30 parts of vitamin C and cosolvent, by it
It is added in 50 parts by weight of ethyl alcohol that mass concentration is 80%, stirs to dissolve, adding appropriate purified water stirring keeps its mixing equal
It is even, obtain mixed solution A.
Embodiment 4
The difference from embodiment 1 is that: step (1) is taken in the step (2) to spare 20 parts by weight of ginkgo leaf and is rectified
11 parts by weight of taste agent, 5 parts by weight of antioxidant, 15 parts by weight of seaweed ester sodium, 3 parts by weight of 20 parts of vitamin C and cosolvent, by it
It is added in 30 parts by weight of ethyl alcohol that mass concentration is 80%, stirs to dissolve, adding appropriate purified water stirring keeps its mixing equal
It is even, obtain mixed solution A.
Embodiment 5
The difference from embodiment 1 is that: step (1) is taken in the step (2) to spare 60 parts by weight of ginkgo leaf and is rectified
18 parts by weight of taste agent, 15 parts by weight of antioxidant, 35 parts by weight of seaweed ester sodium, 10 parts by weight of 40 parts of vitamin C and cosolvent, will
It is added in 60 parts by weight of ethyl alcohol that mass concentration is 80%, stirs to dissolve, and adding appropriate purified water stirring makes its mixing
Uniformly, mixed solution A is obtained.
Embodiment 6
The difference from embodiment 1 is that: the corrigent in the step (2) is mannitol.
Embodiment 7
The difference from embodiment 1 is that: the corrigent in the step (2) is stevioside and lemon extract.
Embodiment 8
The difference from embodiment 1 is that: the antioxidant in the step (2) is the thiocarbamide and pyrosulfurous acid that weight ratio is 1:1
Sodium.
Embodiment 9
The difference from embodiment 1 is that: the cosolvent in the step (2) is calcium lactate.
Embodiment 10
The difference from embodiment 1 is that: the cosolvent in the step (2) is the nicotinic acid amide and acetamide that weight ratio is 1:2.
Embodiment 11
The difference from embodiment 1 is that: the buffer acidity mediator agent in the step (3) is the lactic acid that weight ratio is 1:3
And potassium citrate.
Comparative example 1
The difference from embodiment 1 is that: step (1) is taken in the step (2) to spare 17 parts by weight of ginkgo leaf and is rectified
8 parts by weight of taste agent, 3 parts by weight of antioxidant, 10 parts by weight of seaweed ester sodium, 1 parts by weight of 18 parts of vitamin C and cosolvent, by itself plus
Enter in 28 parts by weight of ethyl alcohol that mass concentration is 80%, stir to dissolve, adding appropriate purified water stirring keeps its mixing equal
It is even, obtain mixed solution A.
Comparative example 2
The difference from embodiment 1 is that: step (1) is taken in the step (2) to spare 65 parts by weight of ginkgo leaf and is rectified
22 parts by weight of taste agent, 18 parts by weight of antioxidant, 36 parts by weight of seaweed ester sodium, 17 parts by weight of 43 parts of vitamin C and cosolvent, will
It is added in 66 parts by weight of ethyl alcohol that mass concentration is 80%, stirs to dissolve, and adding appropriate purified water stirring makes its mixing
Uniformly, mixed solution A is obtained.
Comparative example 3
The difference from embodiment 1 is that: the corrigent in the step (2) is glycerol.
Comparative example 4
The difference from embodiment 1 is that: the antioxidant in the step (2) is sodium sulfite.
Comparative example 5
The difference from embodiment 1 is that: the cosolvent in the step (2) is sodium salicylate.
Comparative example 6
The difference from embodiment 1 is that: the buffer acidity mediator agent in the step (3) is citric acid.
Comparative example 7
With embodiment 1 only difference is that: be added without seaweed ester sodium in the step (2).
Comparative example 8
With embodiment 1 only difference is that: be added without vitamin C in the step (2).
Comparative example 9
With embodiment 1 only difference is that: in the step (2) seaweed ester sodium be 10 parts by weight.
Comparative example 10
With embodiment 1 only difference is that: in the step (2) seaweed ester sodium be 40 parts by weight.
Ginkgo leaf extract oral liquid made from the preparation method that above embodiments 1-11 is provided can be applied to the preparation of health care product.
Effect experiment
Ginkgo leaf extract oral liquid made from embodiment 1-11 and comparative example 1-10 is packed as 10mL/ branch respectively in case detection.
Clarity is with the detection of YB-2 type clarity detecting apparatus.
(1) total flavonoids detect: surveying according to high performance liquid chromatography (one annex VI D of Chinese Pharmacopoeia version in 2010)
It is fixed.
Chromatographic condition and system suitability: being filler with octadecylsilane chemically bonded silica；With methanol -0.4%
Phosphoric acid solution (50:50) is mobile phase；Detection wavelength is 360nm.Number of theoretical plate is calculated by Quercetin peak should be not less than 2500,
The separating degree at Kaempferide peak and Isorhamnetin peak should be greater than 1.5.
The preparation of reference substance solution: accurate weigh is dried under reduced pressure 12 hours or more quercitrins through phosphorus pentoxide respectively
Element, Kaempferide, Isorhamnetin reference substance add methanol that solution of every 1ml containing 30 μ g, 30 μ g, 20 μ g is made, molten as reference substance
Liquid.The preparation of test solution: precision measures this product 4mL, adds methanol 10ml, 25% hydrochloric acid solution 5ml, shakes up, set in water-bath
It is heated to reflux 30 minutes, takes out, be rapidly cooled to room temperature, be transferred in 50ml measuring bottle, add methanol dilution to scale, shake up, filter
Cross, take subsequent filtrate to get.It is accurate respectively to draw reference substance solution and each 10 μ l of test solution, liquid chromatograph is injected, is surveyed
It is fixed, the content of Quercetin, Kaempferide and Isorhamnetin is calculated separately, is converted into the content of total flavonoids as the following formula.
Total flavonoids content=(quercetin content+kaempferia galanga cellulose content+Isorhamnetin content) × 2.51
(2) terpene lactone contents detect: measuring according to high performance liquid chromatography (one annex VID of Chinese Pharmacopoeia version in 2010).
Chromatographic condition and system suitability: being filler with octadecylsilane chemically bonded silica；With normal propyl alcohol-tetra-
Hydrogen furans-water (1:15:84) is mobile phase, is detected with evaporative light scattering detector.Number of theoretical plate is calculated by Bilobalide peak
2500 should be not less than.
The preparation of reference substance solution: accurate weigh is dried under reduced pressure 12 hours Bilobalide, silver through phosphorus pentoxide respectively
Ester A processed, ginkolide B and ginkalide C reference substance are appropriate in apricot, add methanol that every 1ml is made and contain 2mg, 1mg, 1mg, 1mg
Mixed solution to get.The preparation of test solution: precision measures this product 16mL, adds 2% hydrochloric acid solution 2 to drip, uses ethyl acetate
4 times (30ml, 15ml, 15ml, 15ml) is extracted in shaking, and combined extract is washed with 5% sodium acetate solution 20m, is divided and is taken sodium acetate
Liquid is washed with ethyl acetate 10ml, is merged ethyl acetate extracting solution and washing lotion, is washed with water 2 times, each 20ml, and washing is merged
Liquid is washed with ethyl acetate 10ml, merges ethyl acetate liquid, to doing, residue acetone makes to dissolve and turn recovery of acetic acid ethyl ester
Move in 5ml measuring bottle, add acetone to scale, shake up to get.It is accurate respectively to draw 5 μ l of reference substance solution, 10 μ l and test sample
20 μ l of solution, injects liquid chromatograph, and measurement calculates separately Bilobalide with external standard two-point method logarithmic equation, ester processed in ginkgo
A, the content of ginkolide B and ginkalide C to get.
This product every containing terpene lactone with Bilobalide (C15H18O8), ginkalide A (C20H24O9), ginkolide B
(C20H24O10) and the total amount meter of ginkalide C (C20H24O11).
(3) determination of total flavonoids: 120 DEG C are taken to be dried under reduced pressure to the control substance of Rutin 20.0mg of constant weight, until 100mL amount
In bottle, add the dilution of 70% ethanol solution and constant volume, shakes up to get (every 1mL contains anhydrous rutin 0.2mg), precision measures rutin pair
According to product 0.2mL, 0.4mL, 0.6mL, 0.8mL, 1.0mL, 1.2mL, it is respectively placed in 10mL measuring bottle, respectively adds water to 3mL, add vinegar
Acid-sodium-acetate buffer (pH4.5) 2mL is mixed, is added 70% ethyl alcohol to scale, shake up.Using corresponding solution as blank.According to purple
Outside-visible spectrophotometry (two IV A of annex of Chinese Pharmacopoeia version in 2010), measures extinction at the wavelength of 273nm respectively
Degree, using absorbance as ordinate, concentration is abscissa, draws standard curve.
Test solution preparation, precision measure this product 2mL, set in 50mL measuring bottle, add purified water dilution and constant volume, shake up,
Precision measures 1mL, sets in 10mL measuring bottle, and " respectively adding water to 3mL " rises and measure absorbance in accordance with the law under sighting target directrix curve preparation.From
The general flavone content for being equivalent to rutin in test sample is read on standard curve, is calculated in every oral solution and is equivalent to rutin
General flavone content.
PH value is with the detection of DELTA320 type pH meter.
Total flavonoids content and terpene lactone contents meet 2010 editions Chinese Pharmacopoeia requirements in every oral solution, and steady
Qualitative investigation is qualified.
Measurement result is as follows:
(1) ginkgo leaf extract oral liquid made from the preparation method that embodiment 1-5 and comparative example 1-2 and comparative example 7-10 are provided
Measurement result is as follows:
As upper table it is recognised that general flavone in ginkgo leaf extract oral liquid made from the preparation method that 1-5 of the embodiment of the present invention is provided
The content of glycol, terpene lactone and general flavone is high, and is over time not in degradation, and stability is good.In strong light
It is still substantially non-degradable under the environment such as irradiation, high temperature, low temperature, there is good stability.
(2) measurement of ginkgo leaf extract oral liquid made from the preparation method that embodiment 1, embodiment 6-7 and comparative example 3 provide
The result is as follows:
As upper table it is recognised that ginkgo leaf extract oral liquid made from the preparation method that the embodiment of the present invention 1, embodiment 6-7 are provided
The content of middle general flavone glycol, terpene lactone and general flavone is high, and is over time not in degradation, stability
It is good.It is still substantially non-degradable under the environment such as strong illumination, high temperature, low temperature, there is good stability.
(3) the measurement knot of ginkgo leaf extract oral liquid made from the preparation method that embodiment 1, embodiment 8 and comparative example 4 provide
Fruit is as follows:
As upper table it is recognised that in ginkgo leaf extract oral liquid made from the preparation method that the embodiment of the present invention 1, embodiment 8 provide
The content of general flavone is high, and is over time not in degradation, and stability is good.In strong illumination, high temperature, low temperature etc.
It is still substantially non-degradable under environment, there is good stability.
(4) survey of ginkgo leaf extract oral liquid made from the preparation method that embodiment 1, embodiment 9-10 and comparative example 5 provide
Amount the result is as follows:
As upper table it is recognised that ginkgo leaf extract oral liquid made from the preparation method that the embodiment of the present invention 1, embodiment 9-10 are provided
The content of middle general flavone glycol is high, and is over time not in degradation, and stability is good.Strong illumination, high temperature,
It is still substantially non-degradable under the environment such as low temperature, there is good stability.
(5) measurement of ginkgo leaf extract oral liquid made from the preparation method that embodiment 1, embodiment 11 and comparative example 6 provide
The result is as follows:
As upper table it is recognised that in ginkgo leaf extract oral liquid made from the preparation method that the embodiment of the present invention 1, embodiment 11 provide
The content of terpene lactone is high, and is over time not in degradation, and stability is good.In strong illumination, high temperature, low temperature
It is still substantially non-degradable under equal environment, there is good stability.
Ginkgo leaf extract oral liquid made from embodiment 1-11 can be used for the preparation of health care product.
Only as described above, is only a preferred embodiment of the present invention, when the model that cannot limit implementation of the invention with this
It encloses, i.e., generally according to simple equivalent changes and modifications made by content documented by the claims in the present invention and description of the invention,
All it is still covered by the claims of the invention.It is searched in addition, abstract part and title are intended merely to auxiliary patent document
It seeks and being used, the interest field being not intended to limit the invention.
Claims (10)
1. a kind of preparation method of ginkgo leaf extract oral liquid, characterized by the following steps:
(1) 100 parts by weight of ginkgo leaf are weighed, the ethyl alcohol Soakage extraction three times for being 45-60% with mass concentration takes extracting solution to be concentrated
Ethyl alcohol is recycled, concentrate dilutes after being diluted with purified water through being centrifuged crude separation, then with purified water, and cooling natural subsidence is subtracted
Press dry it is dry after, it is spare；
(2) take step (1) to spare ginkgo leaf 20-60 parts by weight and corrigent 11-18 parts by weight, antioxidant 5-15 weight
Part, seaweed ester sodium 15-35 parts by weight, 20-40 parts of vitamin C and cosolvent 3-10 parts by weight, being added into mass concentration is
It in 80% ethyl alcohol 30-60 parts by weight, stirs to dissolve, adding appropriate purified water stirring is uniformly mixed it, is mixed
Solution A；
(3) pH value of step (2) resulting mixed solution A is adjusted to 4.5-6.5 with buffer acidity mediator agent, then with pure
Change water constant volume, crosses 0.25um filtering with microporous membrane and sterilize and dispense, ginkgo leaf extract oral liquid can be obtained.
2. the preparation method of ginkgo leaf extract oral liquid according to claim 1, it is characterised in that: the step (2) is such as
Under: take step (1) to spare ginkgo leaf 30-40 parts by weight and corrigent 13-15 parts by weight, antioxidant 10-12 parts by weight,
Seaweed ester sodium 25-30 parts by weight, vitamin C 28-32 parts by weight and cosolvent 5-7 parts by weight, being added into mass concentration is
It in 80% ethyl alcohol 45-50 parts by weight, stirs to dissolve, adding appropriate purified water stirring is uniformly mixed it, is mixed
Solution A.
3. the preparation method of ginkgo leaf extract oral liquid according to claim 1 or 2, it is characterised in that: the step (2)
In corrigent be selected from one or more of sorbierite, mannitol, stevioside or lemon extract.
4. the preparation method of ginkgo leaf extract oral liquid according to claim 1 or 2, it is characterised in that: the step (2)
In antioxidant be selected from one or more of sodium pyrosulfite or thiocarbamide.
5. the preparation method of ginkgo leaf extract oral liquid according to claim 1 or 2, it is characterised in that: the step (2)
In cosolvent be selected from one or more of calcium lactate, sodium benzoate, p-aminobenzoic acid, urea, nicotinic acid amide or acetamide.
6. the preparation method of ginkgo leaf extract oral liquid according to claim 1, it is characterised in that: in the step (3)
Buffer acidity mediator agent be selected from one or more of potassium citrate, lactic acid or tartaric acid.
7. the preparation method of ginkgo leaf extract oral liquid according to claim 1, it is characterised in that: in the step (3)
Buffer acidity mediator agent be selected from one or more of lactic acid or tartaric acid.
8. the preparation method of ginkgo leaf extract oral liquid according to claim 1, it is characterised in that: in the step (3)
The pH value of step (2) resulting mixed solution A is adjusted to 5-6 with buffer acidity mediator agent.
9. the preparation method of ginkgo leaf extract oral liquid according to claim 1, it is characterised in that: in the step (3)
Sterilising temp is 100 DEG C, sterilization time 45min.
10. a kind of ginkgo leaf extract oral liquid as made from claim 1-9 any preparation method is in the application prepared in health care product.
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| JPS5353801A (en) * | 1976-10-25 | 1978-05-16 | Bridgestone Corp | Zero pressure rubber tire wheel for agricultural machines |
| CN1283503A (en) * | 1999-08-04 | 2001-02-14 | 蔡文芳 | Oral liquid of gingko |
| CN103251659A (en) * | 2013-06-03 | 2013-08-21 | 青岛三九九洲生物技术有限公司 | Preparation method of ginkgo leaf essence |
| CN103393730A (en) * | 2013-08-21 | 2013-11-20 | 上海信谊百路达药业有限公司 | Oral ginkgo biloba extract liquid and preparation method thereof |
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2018
- 2018-11-07 CN CN201811320767.7A patent/CN109223838A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5353801A (en) * | 1976-10-25 | 1978-05-16 | Bridgestone Corp | Zero pressure rubber tire wheel for agricultural machines |
| CN1283503A (en) * | 1999-08-04 | 2001-02-14 | 蔡文芳 | Oral liquid of gingko |
| CN103251659A (en) * | 2013-06-03 | 2013-08-21 | 青岛三九九洲生物技术有限公司 | Preparation method of ginkgo leaf essence |
| CN103393730A (en) * | 2013-08-21 | 2013-11-20 | 上海信谊百路达药业有限公司 | Oral ginkgo biloba extract liquid and preparation method thereof |
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Application publication date: 20190118 |