CN104096153A - Pharmaceutical composition containing multiple plant active ingredients and preparation method and application thereof - Google Patents
Pharmaceutical composition containing multiple plant active ingredients and preparation method and application thereof Download PDFInfo
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- CN104096153A CN104096153A CN201410380587.3A CN201410380587A CN104096153A CN 104096153 A CN104096153 A CN 104096153A CN 201410380587 A CN201410380587 A CN 201410380587A CN 104096153 A CN104096153 A CN 104096153A
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Abstract
The invention relates to a pharmaceutical composition containing multiple plant active ingredients and a preparation method and application thereof. The pharmaceutical composition comprises, by weight, cistanche extractive 3-9 parts, rehmannia glutinosa extractive 10-20 parts, epimedium extract 5-14 parts, fructus alpiniae oxyphyllae 7-11 parts, poria cocos extractive 11-19 parts and rhizoma anemarrhenae 7-13 parts. By adopting an appropriate extraction method, the pharmaceutical composition containing multiple plant active ingredients has good treatment and/or myopia preventing effects and has good application prospect and industrial potential in the pharmaceutical clinic treatment field.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that comprises active ingredient of Chinese herbs extract of preventing and treating myopia, relate more particularly to a kind of pharmaceutical composition and its production and use that various plants is the extract separately of Herba Cistanches, Radix Rehmanniae Preparata, Herba Epimedii, Fructus Alpiniae Oxyphyllae, Poria, the Rhizoma Anemarrhenae that comprises, the active component that belongs to natural plants extracts and application.
Background technology
Myopia refers to that eye is under naturalness, focuses on, and then cause a kind of ametropia of blurred vision because the prolongation of axis oculi or the reason of cornea curvature of lens cause parallel rays in retina the place ahead.
Along with the development in epoch and scientific and technological progress, being widely used of the computer thereupon bringing, smart mobile phone, student's schoolwork burden the factors such as increase the weight of, cause China's myopia number to rank first in the world, especially with teenager, be the colony occurred frequently of myopia, how preventing and slowing down adolescent myopia has become great medical science and social problem.
The pathogeny of juvenile era myopia is not clear at present, traditional medicine think " YANG deficiency; the moon is had a surplus; sick in the few person of fire also; therefore brilliance can not send out far, and restrain nearly ear ... " (< < Precious Book of Ophthalmology > >.
And modern medicine thinks that this period is in adolescence, health is in the Rapid development stage, under depending on factor combineds effect such as nearly overloads, may promote axis oculi excessively rapid growth that near-sighted degree is increased, have clinical practice in early stage to show to adopt the smart method of the kidney warming benefit can delay the development of adolescent myopia, but mechanism is not yet clear and definite.
At present, myopia adopts the methods such as frame eyeglasses, corneal contact lens, operative treatment and acupuncture, Chinese medicine conventionally.It is generally acknowledged, after medical science optometry, take into full account visual performance and give suitable myoporthosis and can slow down myopia progression, get the nod clinically.
Frame eyeglasses is being most widely used aspect the rectification of vision, but owing to existing mirror eye distance from, the defect such as marginal aberration is large and the visual field is limited, frame eyeglasses is not that best myoporthosis is selected.
Hard air-permeable cornea contact mirror has inhibitory action to the development of adolescent myopia, but stops wearing the trend that rear near-sighted diopter has accelerated development.
Operative treatment has strict indication and complication in various degree, does not have universality and broad applicability.
Motherland's medicine clinical research confirms that acupuncture treatment myopia has good curative effect, but some patients were is low to Therapeutic Method acceptance, also has certain risk.
Up to now, not yet have with natural plant active component and prevent and treat myopia and obtain the report of remarkable treatment curative effect.Therefore, how from natural plants, to extract active component, and be used for control myopia, just important development direction in this field and focus at present.
Summary of the invention
In view of this, in order to obtain a kind of pharmaceutical composition that comprises natural plant active component extract that can effectively prevent and treat myopia, and how research carries out all many-sides such as extraction of active component, the inventor conducts in-depth research this, after having paid a large amount of creative works, thereby completed the present invention.
The basis that the present invention completes is: by consulting ancient literature, and in conjunction with clinical experience for many years, think deficiency of kidney-QI, menses is not extremely, The liver and the kidney have a common source, QI and blood homology, deficiency of the liver and kindey is also prone to deficiency of qi and blood, can not on moisten with order, loss of nutrient of eyes, it is short-sighted that cloudy essence can not restrain appearance, therefore adolescent myopia pathogenesis mostly is insufficiency of kidney-YANG, due to blood and essence asthenia, as innate deficiency, sun declined cloudy so that brilliance can not be far and, and it is depending on closely not looking far away, as < < Precious Book of Ophthalmology > >, say: " YANG deficiency, the moon is had a surplus, disease in the few person of fire also, therefore brilliance can not be sent out far, and restrain nearly ear ... ".
And the inventor finds, when adopting specific extracting method, can from multiple natural plants, extract and obtain active component, when using these active component to be used for preventing and treating myopia, obtained excellent clinical treatment and/or prevention effect, this is beat all.
Particularly, the present invention relates generally to following several aspect.
First aspect, the present invention relates to a kind of near-sighted pharmaceutical composition that is used for preventing and treating, and described pharmaceutical composition, in weight portion, comprises following component:
In described pharmaceutical composition of the present invention, the weight portion of described Herba Cistanches extract is 3-9 part, for example, can be 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts or 9 parts.
In described pharmaceutical composition of the present invention, the weight portion of described Radix Rehmanniae Preparata extract is 10-20 part, for example, can be 10 parts, 12 parts, 14 parts, 16 parts, 18 parts or 20 parts.
In described pharmaceutical composition of the present invention, the weight portion of described Herba Epimedii extract is 5-14 part, for example, can be 5 parts, 7 parts, 9 parts, 11 parts, 13 parts or 14 parts.
In described pharmaceutical composition of the present invention, the weight portion of described Fructus Alpinae Oxyphyllae extract is 7-11 part, for example, can be 7 parts, 8 parts, 9 parts, 10 parts or 11 parts.
In described pharmaceutical composition of the present invention, the weight portion of described Poria extract is 11-19 part, for example, can be 11 parts, 13 parts, 15 parts, 17 parts or 19 parts.
In described pharmaceutical composition of the present invention, the weight portion of described Rhizoma Anemarrhenae extract is 7-13 part, for example, can be 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts or 13 parts.
In described pharmaceutical composition of the present invention, described Herba Cistanches extract extracts and obtains as follows, and its extracting method is as follows in other words:
(A1) will be dried Herba Cistanches and be added to the water, decoct at a certain temperature, and then filter and obtain decocting liquid I and residue;
(A2) described residue is added to the water, in uniform temperature, decocts, filter and obtain decocting liquid II;
(A3) decocting liquid I and decocting liquid II are merged, then concentrating under reduced pressure, obtains clear paste;
(A4) in described clear paste, add ethanol, obtain clear paste alcoholic solution, then stratification, gets supernatant, and after concentration and recovery ethanol, gained paste is described Herba Cistanches extract.
Wherein, the dry Herba Cistanches in described step (A1) and the weight ratio of water are 1:4-10, for example, can be 1:4,1:6,1:8 or 1:10.
Described decoction temperature is 90-100 ℃, for example, can be 90 ℃, 95 ℃ or 100 ℃.
Decocting time is 0.5-2 hour, for example, can be 0.5 hour, 1 hour, 1.5 hours or 2 hours.
Wherein, the residue in described step (A2) and the weight ratio of water are 1:4-8, for example, can be 1:4,1:6 or 1:8.
Described decoction temperature is 90-100 ℃, for example, can be 90 ℃, 95 ℃ or 100 ℃.
Decocting time is 0.5-1.5 hour, for example, can be 0.5 hour, 1 hour or 1.5 hours.
Wherein, the degree of the concentrating under reduced pressure in described step (A3), should make gained clear paste is 1-1.3 with respect to the density of water, for example, can be 1,1.1,1.2 or 1.3.
Wherein, in described step (A4), to add the mass concentration of ethanol be 92-98%, for example can be 92%, 94%, 96% or 98%.
Add the amount of ethanol should make the alcohol content of gained clear paste alcoholic solution count 58-62% according to percentage by weight, for example can be 58%, 60% or 62%.
The time of stratification is 20-24 hour, for example, can be 20 hours, 22 hours or 24 hours.
In described pharmaceutical composition of the present invention, described Radix Rehmanniae Preparata extract extracts and obtains as follows, and its extracting method is as follows in other words:
(B1) Radix Rehmanniae Preparata is fully dried to constant weight, then grinds, cross 50 mesh sieves, obtain Radix Rehmanniae Preparata powder;
(B2), to the mixed organic solvents that adds dehydrated alcohol and acetone in Radix Rehmanniae Preparata powder, under uniform temperature and certain power, supersound extraction 4-6 hour, filters and obtains filtrate, and filtrate decompression is concentrated, obtains condensed cream;
(B3) in condensed cream, add ethyl acetate, dissolve fully, then join in silicagel column, wherein the silica gel in silicagel column is 300-400 order silica gel, and in sealed container, with ether, fully soaks 20-30 hour before dress post, and silica gel is fully expanded;
(B4) first use the aqueous solution eluting silica gel post of alcohol, then organic solvent gradient elution silicagel column, collects eluent, concentrating under reduced pressure, and gained paste is described Radix Rehmanniae Preparata extract.
Wherein, the dehydrated alcohol in described step (B2) and the volume ratio of acetone are 1:3-7, for example, can be 1:3,1:4,1:5,1:6 or 1:7.
The mass volume ratio of described Radix Rehmanniae Preparata powder and described mixed organic solvents (being the mixed organic solvents of dehydrated alcohol and acetone) is 1:3-5g/ml, be that every 1g Radix Rehmanniae Preparata powder is used mixed organic solvents described in 3-5ml, for example, can be 1:3g/ml, 1:4g/ml or 1:5g/ml.
Described extraction temperature (i.e. " uniform temperature ") is 40-60 ℃, for example, can be 40 ℃, 45 ℃, 50 ℃, 55 ℃ or 60 ℃.
Described extraction power is 100-140W, for example, can be 100W, 120W or 140W.
Wherein, the ethyl acetate consumption in described step (B3) there is no special restriction, as long as condensed cream fully can be dissolved, for subsequent treatment is convenient, considers, its amount is exactly preferably described condensed cream is just dissolved as suitable.
Wherein, the aqueous solution of the alcohol in described step (B4) is the aqueous solution of C1-4 alcohol, and its mass percentage concentration is 20-40%, for example, can be 20%, 30% or 40%; Be preferably mass percentage concentration and be 30% normal propyl alcohol aqueous solution; The use amount of described alcohol-water solution is 3-5 times of silicagel column bed volume, for example, can be 3 times, 4 times or 5 times.
Organic solvent in described step (B4) is the mixed liquor of the different volumes ratio of normal hexane and acetone.
Gradient elution in described step (B4) is specially: use the volume ratio of isopyknic normal hexane and acetone to be respectively the mixed liquor eluting silica gel post of 10:1,7:1,5:1,3:1,1:1, collect the eluent of 5:1,3:1, concentrating under reduced pressure, gained paste is described Radix Rehmanniae Preparata extract.
The use amount of the normal hexane of each different volumes ratio and the mixed liquor of acetone is 2-4 times of silicagel column bed volume, is preferably 3 times.
In described pharmaceutical composition of the present invention, described Herba Epimedii extract extracts and obtains as follows, and its extracting method is as follows in other words:
(C1) Herba Epimedii is dry, pulverizing, crosses 100 mesh sieves, obtains Epimedium Herb;
(C2) Epimedium Herb is added in acetone, then add carbon dioxide, airtight pressurization, forms intumescent system, carry out at a certain temperature expanded solvents extraction, extract after 1-2 hour, rush down and be depressed into normal pressure and naturally cool to room temperature, filtration is extracted liquid, and concentrating under reduced pressure extract obtains thickness cream;
(C3) thickness cream is dissolved in dehydrated alcohol, cross chromatographic column, wherein said chromatographic column is 300-400 order neutral silica gel, the 200-300 order neutral alumina of column volume 25% and the AB-8 adsorbent resin of column volume 20% of packed column volume 35% from top to bottom, use the acetone and ethyl acetate that volume ratio is 1:2 to carry out eluting, collect eluent, concentrating under reduced pressure, gained paste is described Herba Epimedii extract.
Wherein, in described step (C2) in the acetone of milliliter (ml) with take the ratio of gram carbon dioxide of (g) as 1:5-8, for example can be 1:5,1:6,1:7 or 1:8.
In the described Epimedium Herb of gram (g) with take the ratio of acetone of milliliter (ml) as 1:12-16, for example can be 1:12,1:14 or 1:16.
The temperature of carrying out expanded solvents extraction is 75-85 ℃, for example, can be 75 ℃, 80 ℃ or 85 ℃.
Wherein, the consumption of the dehydrated alcohol in described step (C3) there is no special restriction, as long as thickness cream fully can be dissolved, for subsequent treatment is convenient, considers, its amount is exactly preferably described thickness cream is just dissolved as suitable.
In described pharmaceutical composition of the present invention, described Fructus Alpinae Oxyphyllae extract extracts and obtains as follows, and its extracting method is as follows in other words:
(D1) Fructus Alpiniae Oxyphyllae is dry, pulverize, adding mass percent concentration is in 50% ethanol water, and usings acetic acid as extracting auxiliary agent, carries out Soxhlet extracting 1-2 hour; Then filter, obtain filtrate and solid insoluble;
(D2) solid insoluble is packed in ultrasonic extraction instrument, using the mixed solvent of ethyl acetate and normal hexane as extractant, ultrasonic extraction 20-30 minute, then adding mass percent concentration is the aqueous sodium carbonate of 5-10%, fully vibration, centrifugalize, obtains the supernatant;
(D3) supernatant of the filtrate of step (D1) and step (D2) is merged, concentrating under reduced pressure obtains just carrying cream, by this first cream of carrying with after anhydrous alcohol solution, cross D101 macroporous adsorptive resins, mixed solvent eluting with petroleum ether and hexanol, collect eluent, concentrating under reduced pressure, gained paste is described Fructus Alpinae Oxyphyllae extract.
Wherein, in described step (D1), the mass ratio of the ethanol water that Fructus Alpiniae Oxyphyllae and mass percent concentration are 50% is 1:10-15, for example, can be 1:10,1:12,1:14 or 1:15.
The mass ratio of Fructus Alpiniae Oxyphyllae and acetic acid is 1:0.1-0.5, for example, can be 1:0.1,1:0.2,1:0.3,1:0.4 or 1:0.5.
Wherein, in described step (D2), the volume ratio of ethyl acetate and normal hexane is 1:1-3, for example, can be 1:1,1:2 or 1:3.
The mixed solvent of ethyl acetate and normal hexane and the volume ratio of aqueous sodium carbonate are 1:0.4-0.8, for example, can be 1:0.4,1:0.6 or 1:0.8.
Described ultrasonic extraction instrument is the known extraction equipment in this area, does not repeat them here.
Wherein, in described step (D3), the consumption of ethanol there is no special restriction, as long as can fully dissolve just carrying cream, for subsequent treatment convenience is considered, its amount is exactly preferably and is just dissolved as suitable by carrying cream at the beginning of described.
In the mixed solvent of petroleum ether and hexanol, the volume ratio of petroleum ether and hexanol is 1:0.4-0.6, is preferably 1:0.5.
In described pharmaceutical composition of the present invention, described Poria extract extracts and obtains as follows, and its extracting method is as follows in other words:
(E1) Poria is dry, pulverizing, crosses 100 mesh sieves, obtains Indian Bread;
(E2) ethanol water that is 70-80% by Indian Bread by mass percentage concentration is reflux, extract, 1-2 hour under reflux temperature, then filters, and obtains filtrate;
(E3) filtrate is stirred in 80-90 ℃ of baking oven to volatilization, until without obvious ethanol taste, the treatment fluid after being concentrated;
(E4) in treatment fluid, add water, stir, obtain water I, then add acetone extract, obtain acetone phase and water II; By water II n-hexane extraction, obtain normal hexane phase and water III; Water III is extracted with isopropyl alcohol, obtain isopropyl alcohol phase and water VI;
(E5) by isopropyl alcohol phase concentrating under reduced pressure, gained paste is described Poria extract.
Wherein, the consumption of the ethanol water in described step (E2) there is no special restriction, can carry out according to specific needs suitable selection, and for example the mass ratio of itself and Indian Bread can be 20-50:1.
Wherein, in described step (E4), the quality that adds the water in treatment fluid is 4-10 times for the treatment of fluid quality, for example, can be 4 times, 6 times, 8 times or 10 times.
The volume ratio of the volume ratio of the volume ratio of acetone and water I, normal hexane and water II, isopropyl alcohol and water III is 1:0.5-1.5, for example, can be 1:0.5,1:1 or 1:1.5.
In described pharmaceutical composition of the present invention, described Rhizoma Anemarrhenae extract extracts and obtains as follows, and its extracting method is as follows in other words:
(F1) Rhizoma Anemarrhenae is dry, pulverizing, crosses 50 mesh sieves, obtains Common Anemarrhena Rhizome;
(F2) Common Anemarrhena Rhizome is joined in ethyl acetate, reflux, extract, 0.5-1 hour, then naturally cools to room temperature, and adding mass percentage concentration is the NaHCO of 1-2%
3aqueous solution, stirs, and layering, obtains water and ethyl acetate phase;
(F3) wash ethyl acetate phase 1-3 time with water, then ethyl acetate is continued again to wash 1-3 time with the ethanol water that mass percentage concentration is 50% mutually, standing water and the organic facies of obtaining, by organic facies anhydrous magnesium sulfate drying, then concentrating under reduced pressure, gained paste is described Rhizoma Anemarrhenae extract.
Wherein, in step (F2), the mass ratio of Common Anemarrhena Rhizome and ethyl acetate is 1:40-60, for example, can be 1:40,1:50 or 1:60.
Ethyl acetate and NaHCO
3the volume ratio of aqueous solution is 1:1-3, for example, can be 1:1,1:2 or 1:3.
Wherein, in step (F3), water is 1:1-2 with the volume ratio of volume ratio, ethanol water and the ethyl acetate phase of ethyl acetate phase.
Pharmaceutical composition of the present invention is except comprising above-mentioned Herba Cistanches extract, Radix Rehmanniae Preparata extract, Herba Epimedii extract, Fructus Alpinae Oxyphyllae extract, Poria extract and Rhizoma Anemarrhenae extract, can also be as required, as the difference of dosage form, comprise a kind of or several arbitrarily in diluent, absorbent, wetting agent, binding agent, disintegrating agent, lubricant, suspending agent, flocculating agent, deflocculant, sweeting agent, aromatic, flavoring agent, stabilizing agent, excipient or antiseptic.
Pharmaceutical composition of the present invention can be made into several formulations form, for example, can be granule, oral liquid, concentrated pill, drop pill, capsule, tablet, powder, capsule, watered pill, honey pill agent, suspensoid, Emulsion, drop, medicated wine or tincture.
Second aspect, the present invention relates to for preventing and treating the preparation method of near-sighted aforementioned pharmaceutical compositions, and described method comprises the steps:
(1) take respectively Herba Cistanches extract, Radix Rehmanniae Preparata extract, Herba Epimedii extract, Fructus Alpinae Oxyphyllae extract, Poria extract and the Rhizoma Anemarrhenae extract of above-mentioned weight portion, then mix, obtain mixture;
(2) in gained mixture, be incorporated as the deionized water of 2-5 times of weight of mixture weight, and to regulate pH value be 7.1-7.3, stir, then standing, filter, obtain filtrate;
And obtain after described filtrate, subpackage obtains oral liquid, or is concentrated into thick paste, then granulate, be dried, incapsulate and obtain capsule, pack obtains granule, also described thick paste can be made to various pills, tablet, suspensoid, Emulsion, drop, medicated wine or tincture etc.
Wherein, in step (2), for pH value, regulate and can regulate with the edible acid in field of food or edible base, these materials are all known conventional edible material from soybeans, do not repeat them here.
The 3rd aspect, the present invention relates to the oral liquid that above-mentioned preparation method obtains.
The 4th aspect, the present invention relates to aforementioned pharmaceutical compositions in control the purposes aspect near-sighted, also in preparation, be used for preventing and treating the purposes in near-sighted medicine.
By research, the inventor finds, pharmaceutical composition of the present invention has good control and/or therapeutical effect for adolescent myopia patient, thereby compliance is good, easy to carry simultaneously, plant extract safety non-toxic, has good therapeutic value and application potential.
The specific embodiment
Below by specific embodiment, the present invention is described in detail; but the purposes of these exemplary embodiments and object are only used for exemplifying the present invention; not real protection scope of the present invention is formed to any type of any restriction, more non-protection scope of the present invention is confined to this.
Wherein, in all embodiment and comparative example, the various extracts that use are the corresponding extract extracting in preparation example.
Preparation example 1: the preparation of Herba Cistanches extract
(A1) the dry Herba Cistanches of 1 weight portion is joined in the water of 7 weight portions, at 95 ℃ of temperature, decoct 1 hour, then filter and obtain decocting liquid I and residue;
(A2) described residue is added to the water, wherein the weight of residue and water is 1:6, at 100 ℃, decocts 1 hour, filters and obtains decocting liquid II;
(A3) decocting liquid I and decocting liquid II are merged, concentrating under reduced pressure then, obtains the clear paste that the density with respect to water is 1.2;
(A4) to adding mass percentage concentration in described clear paste, be 95% ethanol, obtain the clear paste alcoholic solution that wherein weight percentage of alcohol is 60%, then stratification is 24 hours, get supernatant, and after concentration and recovery ethanol, gained paste is Herba Cistanches extract, called after RCR.
Preparation example 2: the preparation of Radix Rehmanniae Preparata extract
(B1) Radix Rehmanniae Preparata is fully dried to constant weight, then grinds, cross 50 mesh sieves, obtain Radix Rehmanniae Preparata powder;
(B2) to the mixed organic solvents that adds dehydrated alcohol and acetone in Radix Rehmanniae Preparata powder, (volume ratio of dehydrated alcohol and acetone is 1:5, the mass volume ratio of Radix Rehmanniae Preparata powder and mixed organic solvents is 1:4g/ml), under the power of 50 ℃ and 120W, supersound extraction 5 hours, filtration obtains filtrate, filtrate decompression is concentrated, obtain condensed cream;
(B3) in condensed cream, add ethyl acetate, till making condensed cream exactly dissolve fully, then join in silicagel column, wherein the silica gel in silicagel column is 300-400 order silica gel, and before dress post, in sealed container, with ether, fully soak 25 hours, silica gel is fully expanded;
(B4) the normal propyl alcohol aqueous solution eluting silica gel post that first service property (quality) percentage concentration is 30%, the volume of this normal propyl alcohol aqueous solution is 4 times of silicagel column bed volume; Then by the volume ratio of isopyknic normal hexane and acetone, be respectively the mixture eluting silica gel post (normal hexane of each different volumes ratio and the use amount of acetone mixed liquor are 3 times of silicagel column bed volume) of 10:1,7:1,5:1,3:1,1:1, collect the eluent of 5:1,3:1, concentrating under reduced pressure, gained paste is described Radix Rehmanniae Preparata extract, called after SD.
Preparation example 3: the preparation of Herba Epimedii extract
(C1) Herba Epimedii is dry, pulverizing, crosses 100 mesh sieves, obtains Epimedium Herb;
(C2) Epimedium Herb is added in acetone (in the described Epimedium Herb of gram (g) with take the ratio of acetone of milliliter (ml) as 1:14), add again carbon dioxide (in the acetone of milliliter (ml) with take the ratio of gram carbon dioxide of (g) as 1:7), airtight pressurization, form intumescent system, at 80 ℃, carry out expanded solvents extraction, extract after 2 hours, rush down and be depressed into normal pressure and naturally cool to room temperature, filtration is extracted liquid, concentrating under reduced pressure extract, obtains thickness cream;
(C3) thickness cream is dissolved in and can makes it exactly dissolve completely in dehydrated alcohol, cross chromatographic column, wherein said chromatographic column is 300-400 order neutral silica gel, the 200-300 order neutral alumina of column volume 25% and the AB-8 adsorbent resin of column volume 20% of packed column volume 35% from top to bottom, use the acetone and ethyl acetate that volume ratio is 1:2 to carry out eluting, collect eluent, concentrating under reduced pressure, gained paste is described Herba Epimedii extract, called after YYH.
Preparation example 4: the preparation of Fructus Alpinae Oxyphyllae extract
(D1) Fructus Alpiniae Oxyphyllae of 1 weight portion is dry, pulverize, in the ethanol water that the mass percent concentration that then joins 13 weight portions is 50%, and using the acetic acid of 0.2 weight portion as extracting auxiliary agent, carry out Soxhlet extracting 2 hours; Then filter, obtain filtrate and solid insoluble;
(D2) solid insoluble is packed in ultrasonic extraction instrument, using the mixed solvent (both volume ratios are 1:2) of ethyl acetate and normal hexane as extractant, ultrasonic extraction 25 minutes, then adding mass percent concentration is 8% aqueous sodium carbonate (mixed solvent of ethyl acetate and normal hexane and the volume ratio of aqueous sodium carbonate are 1:0.6), fully vibration, centrifugalize, obtains the supernatant;
(D3) supernatant of the filtrate of step (D1) and step (D2) is merged, concentrating under reduced pressure obtains just carrying cream, by this first cream of carrying with just being dissolved completely after anhydrous alcohol solution, cross D101 macroporous adsorptive resins, the petroleum ether that the volume ratio of take is 1:0.5 and the mixed solvent eluting of hexanol, collect eluent, concentrating under reduced pressure, gained paste is described Fructus Alpinae Oxyphyllae extract, called after YZR.
Preparation example 5: the preparation of Poria extract
(E1) Poria is dry, pulverizing, crosses 100 mesh sieves, obtains Indian Bread;
(E2) ethanol water that is 70% by the Indian Bread of 1 weight portion by the mass percentage concentration of 8 weight portions reflux, extract, 2 hours under reflux temperature, then filters, and obtains filtrate;
(E3) filtrate is stirred in the baking oven of 90 ℃ to volatilization, until without obvious ethanol taste, the treatment fluid after being concentrated;
(E4) in treatment fluid, add isopyknic water, stir, obtain water I, then add isopyknic acetone extract with water I, obtain acetone phase and water II; By the isopyknic n-hexane extraction of water II, obtain normal hexane phase and water III; Water III is extracted with isopyknic isopropyl alcohol, obtain isopropyl alcohol phase and water VI;
(E5) by isopropyl alcohol phase concentrating under reduced pressure, gained paste is described Poria extract, called after FL.
Preparation example 6: the preparation of Rhizoma Anemarrhenae extract
(F1) Rhizoma Anemarrhenae is dry, pulverizing, crosses 50 mesh sieves, obtains Common Anemarrhena Rhizome;
(F2) Common Anemarrhena Rhizome of 1 weight portion is joined in the ethyl acetate of 50 weight portions, reflux, extract, 1 hour, then naturally cools to room temperature, and adding mass percentage concentration is 1.5% NaHCO
3aqueous solution (ethyl acetate and NaHCO
3the volume ratio of aqueous solution is 1:2), to stir, layering, obtains water and ethyl acetate phase;
(F3) wash ethyl acetate phase 1-3 time (water is 1:1.5 with the volume ratio of ethyl acetate phase) with water, then the ethanol water that ethyl acetate to be continued by mass percentage concentration be mutually 50% washs (ethanol water is 1:2 with the volume ratio of ethyl acetate phase) again 1-3 time, standing water and the organic facies of obtaining, by organic facies anhydrous magnesium sulfate drying, then concentrating under reduced pressure, gained paste is described Rhizoma Anemarrhenae extract, called after ZM.
Contrast preparation example 1: the preparation of contrast Herba Cistanches extract
Except not carrying out step (A4), the clear paste that is about to obtain in step (A3) directly carries out concentrating under reduced pressure, with the same way with preparation example 1, has carried out contrast preparation example 1, obtains comparative example Herba Cistanches extract, called after DRCR.
Contrast preparation example 2-3: the preparation of contrast Radix Rehmanniae Preparata extract
Contrast preparation example 2: the silica gel in step (B3) does not fully soak 25 hours with fully expanding before dress post in sealed container with ether, with the same way with preparation example 2, carried out contrast preparation example 2, obtain comparative example Radix Rehmanniae Preparata extract, called after DSD1.
Contrast preparation example 3: always use normal hexane and the acetone mixture that volume ratio is 5:1 to carry out (not carrying out gradient elution) eluting in step (B4), with the same way with preparation example 2, carried out contrast preparation example 3, obtain comparative example Radix Rehmanniae Preparata extract, called after DSD2.
Contrast preparation example 4-6: the preparation of contrast Herba Epimedii extract
Contrast preparation example 4: is only (soon neutral alumina and AB-8 adsorbent resin all replace with neutral silica gel) 300-400 order neutral silica gel except chromatographic column filling in step (C3), with the same way with preparation example 3, carried out contrast preparation example 4, obtain comparative example Herba Epimedii extract, called after DYYH1.
Contrast preparation example 5: is only (soon neutral silica gel and AB-8 adsorbent resin all replace with neutral alumina) 200-300 order neutral alumina except chromatographic column filling in step (C3), with the same way with preparation example 3, carried out contrast preparation example 5, obtain comparative example Herba Epimedii extract, called after DYYH2.
Contrast preparation example 6: is only (soon neutral silica gel and neutral alumina all replace with AB-8 adsorbent resin) AB-8 adsorbent resin except chromatographic column filling in step (C3), with the same way with preparation example 3, carried out contrast preparation example 6, obtain comparative example Herba Epimedii extract, called after DYYH3.
Contrast preparation example 7: the preparation of contrast Fructus Alpinae Oxyphyllae extract
In step (D1), do not add the acetic acid as extracting auxiliary agent, in the mode identical with preparation example 4, carried out contrast preparation example 7, obtain comparative example Fructus Alpinae Oxyphyllae extract, called after DYZR.
Contrast preparation example 8: the preparation of contrast Poria extract
In step (E4), do not carry out (treatment fluid that is about to step (E3) directly extracts with isopropyl alcohol) acetone extract and n-hexane extraction, in the mode identical with preparation example 5, carried out contrast preparation example 7, obtain comparative example Poria extract, called after DFL.
Contrast preparation example 9: the preparation of contrast Rhizoma Anemarrhenae extract
Except not adding mass percentage concentration in step (F2), be 1.5% NaHCO
3aqueous solution is outer (after soon in step (F2), ethyl acetate backflow extracted, directly carry out the water washing of step (F3)), in the mode identical with preparation example 6, carried out contrast preparation example 8, obtained comparative example Rhizoma Anemarrhenae extract, called after DZM.
Embodiment 1
(1) take respectively Herba Cistanches extract 6 weight portions of preparation example 1, Herba Epimedii extract 9 weight portions of Radix Rehmanniae Preparata extract 15 weight portions of preparation example 2, preparation example 3, Poria extract 15 weight portions of Fructus Alpinae Oxyphyllae extract 9 weight portions of preparation example 4, preparation example 5, Rhizoma Anemarrhenae extract 10 weight portions of preparation example 6, then mixed, obtained mixture;
(2) in gained mixture, add 195 parts by weight of deionized water, and to regulate pH value be between 7.1-7.3, stir, then standing, filter, obtain filtrate, subpackage, obtains and can prevent and treat/treat near-sighted pharmaceutical composition and can take liquid, called after KF.
Embodiment 2
(1) take respectively Herba Cistanches extract 3 weight portions of preparation example 1, Herba Epimedii extract 12 weight portions of Radix Rehmanniae Preparata extract 10 weight portions of preparation example 2, preparation example 3, Poria extract 12 weight portions of Fructus Alpinae Oxyphyllae extract 10 weight portions of preparation example 4, preparation example 5, Rhizoma Anemarrhenae extract 13 weight portions of preparation example 6, then mixed, obtained mixture;
(2) in gained mixture, add 240 parts by weight of deionized water, and to regulate pH value be between 7.1-7.3, stir, then standing, filtration, obtains filtrate, in filtrate, adds appropriate steviosin and starch, stir, then be concentrated into thick paste, granulation, dry, obtain granule, called after KL
On the basis of above-described embodiment 1-2, according to the suitable mode of embodiment 1-2 (difference is only that the extract using is different), and having made the multi-medicament compositions that is respectively oral liquid and granule form, the naming number of the concrete extract that wherein comprised, prepared oral liquid or granule is (KF and the KL that have comprised embodiment 1-2) as shown in following table 1 and 2.Wherein all take " KF " name be drink form, it carries out according to the mode of embodiment 1; And all take " KL " name be granule form, it carries out according to the mode of embodiment 2.
Oral liquid when table 1. comprises different extract
Granule when table 2. comprises different extract
prevent and treat near-sighted measure of merit
Choose 60 healthy guinea pigs, be divided at random 5 groups, 12 every group.Grouping situation is:
Group I: blank group.
Group II: lens-induced myopia model matched group.
Group III: lens-induced myopia model+low dosage perfusion group.
Group IV: lens-induced myopia model+middle dosage perfusion group.
Group V: lens-induced myopia model+high dose perfusion group.
Group II, group III, group IV, group V are all chosen the modeling of right eye concavees lens hypermetropia out of focus, and left eye is contrast eye.Five treated animals adopt hypermetropia optical defocus legal system to make near-sighted guinea pig model: choose common-6D sphere resin lens, adopt JD-168 type automatic lens trim grinder that eyeglass is milled to diameter 2.5cm, then use hand edge-grinder instead and be processed as the eyeglass that diameter is 1.0cm; Then after being wound around with medical adhesive tape, all-purpose adhesive adheres to Cavia porcellus right eye, notes not adhesion eyelid, avoids glue to flow into ophthalmic; The distance of eyeglass and eyes is controlled at 3mm left and right; Sooner or later make an inspection tour every day 2 times, as found, eyeglass falls down, and again adheres in time; Note keeping eyeglass clean transparent, if any noticeable wear cut, change in time.
It is original half that the oral liquid that the embodiment of the present invention 1 is prepared (being KF) is concentrated into volume, be 200% concentration, as the medicine of high-dose therapy group, be stored in 4 ℃ of refrigerators, during perfusion, by medicinal liquid heating in water bath to 30 ℃, and be finished in Yu Santian.If needed again after being finished, reopen oral liquid and again concentrate, to prevent that long-term placement from causing medicinal liquid curative effect decline or rotten.
Grouping administration: 1. blank group, normal saline 1ml/100g gavage, every day 1 time; 2. lens-induced myopia model matched group (below also referred to as " model control group "): normal saline 1ml/100g gavage, every day 1 time; 3. each treatment group gives above-mentioned concentrated medicament gavage:
Lens-induced myopia model+low dosage perfusion group (below also referred to as " low dose treatment group "): 0.25m1/100g;
Lens-induced myopia model+middle dosage perfusion group (below also referred to as " middle dosage treatment group "): 0.5ml/100g;
Lens-induced myopia model+high dose perfusion group (below also referred to as " high-dose therapy group "): 1ml/100g;
Three groups are every day 1 time.After modeling, continuously the thoughtful experiment of gastric infusion 2 finishes, and finishes each group to be carried out to diopter below detects, measurement and the flash electroretinogram inspection of axiallength afterwards.
Diopter detects: before retinoscopy optometry, give 1% cyclopentolate hydrochloride eye drop (U.S. Alcon Universal Ltd., match flies outstanding person) eye dripping mydriasis; Every 5 minute hour 1 time, continuity point 4 times, observed platycoria after 60 minutes, and light reflex situation, starts to examine shadow; In inspection shadow process, as found, still have obvious adjusting reaction, stop examining shadow, then eye dripping 2 times, wait for optometry again after 10 minutes.In inspection shadow process, keep Cavia porcellus head in horizontal position, keep stablizing motionless, along Head And Face direction of travel, choose level, vertical two principal meridians, apart from cornea 50cm place, examining respectively shadow, in and eyeglass apart from eyeball 5mm place, place, get the dioptric optical value that two meridian diopter algebraic mean values are this guinea pig eye.
This experiment adopts single blind method to carry out, and the work of inspection shadow is completed in the situation that the unknown is divided into groups by the same optometrist, and optometry process should be tried one's best and is controlled at rapidly in 5 minutes, avoids high light to stimulate and causes adjusting reaction.
The measurement of axiallength: before detecting,, with the topical anesthesia of Oxybuprocaine hydrochloride eye drops eye dripping, interval even puts twice in 1 minute, as Cavia porcellus is mismatched; By neck cover, animal head is fixed on to horizontal plane, ajusts head position gently with hands, the super alignment probe pupil of A is also measured perpendicular to corneal vertex; During observation waveform, get compared with standard person and measure, measured value is that corneal vertex front surface is to the distance of posterior pole of eyeball portion retina front surface; With manual mode continuous measurement 10 times, calculating mean value, is accurate to 0.01mm, gets rid of the numerical value obviously departing from, and averages.
Flash electroretinogram checks: Cavia porcellus more than dark adaptation 12h, before experiment, 30min drips cyclopentolate hydrochloride eye drop mydriasis, the chloral hydrate anesthesia Cavia porcellus of lumbar injection 10%, dosage is 2ml/kg, cotton swab test absent corneal reflex, situation of flaccid muscles, by checking that extremity have passivity, judges whether to reach general anesthesia state.By on the solid Phoenix-visual electrophysiology system instrument pallet of Cavia porcellus, ground electrode, reference electrode and recording electrode are laid respectively in afterbody, buccal, left side and cornea of left eye surface, and at anterior corneal surface, drip the methylcellulose of 10g/L.Reference electrode and ground electrode are that stainless pin is made, recording electrode is the annular electrode that 0.2mm silver-silver chloride is made, adopt Phoenix-visual electrophysiology system to carry out F-ERG detection, record respectively maximum hybrid reaction (Max-ERG) the ERG a in each period of dark adapted eye, b wave-wave width, a are to b incubation period, peak swing.Above process is all carried out under the red signal light of darkroom.Stimulate and record condition: adopt the full visual field to stimulate ball white flash to stimulate, flash intensity 2.0cd/s
-1/ m
-2single stimulates, and interval 5s, stimulates 8 times altogether, single channel recording, passband is 100-300Hz, each sampling time 250ms, and each is measured eye and at least measures 3 times, each interval time 20s, detect completely, anterior corneal surface drips ofloxacin eye drops, and a ripple of F-ERG and b wave-amplitude, a are carried out to statistical analysis to b incubation period, peak swing.
Before experiment, respectively organize Cavia porcellus diopter (in Table 3,4), between each group, Cavia porcellus diopter adopts one factor analysis of variance respectively to organize comparing difference not statistically significant (P > 0.05).
Table 3. patients before and after intervention right eye is respectively organized Cavia porcellus diopter (dioPter, D)
Table 4. patients before and after intervention left eye is respectively organized Cavia porcellus diopter (dioPter, D)
Before and after experiment, respectively organize Cavia porcellus anterior chamber depth, lens thickness, glass cavity length, axiallength value respectively in Table 5,6,7 and 8.
Table 5. eyes patients before and after intervention anterior chamber depth (ACD) measurement numerical value (millimeter, mm)
Table 6. eyes patients before and after intervention lens thickness (LENS) measurement numerical value (millimeter, mm)
Table 7. eyes patients before and after intervention Length of the vitreous (Vitreous) measurement numerical value (millimeter, mm)
Table 8. eyes patients before and after intervention axiallength (Axiallength) measurement numerical value (millimeter, mm)
The comparison of table 9. Cavia porcellus F-ERG a, b wave-amplitude value (x+s μ V)
From table 9, F-ERG a ripple, b involve net amplitude after two weeks, respectively organize difference that Cavia porcellus lens-induced eyes retina electrograph a ripple, b involve net amplitude all have statistical significance (F=3.24,2.53,2.87, P<0.05); Each organizes difference relatively SNK check group I, group V and group II, group III, group IV between two, and difference has statistical significance (P<0.05), and a ripple, the b of group I, group V involves net amplitude higher than group II.
Table 10. Cavia porcellus F-ERG compares (x+s) s incubation period often
From table 10, after two weeks, respectively organize the equal not statistically significant of difference (F=0.71,1.32, P > 0.05) that Cavia porcellus is induced eyes retina electrograph total incubation period (ImPlicit Time) and arrives a ripple time (Time to A) net amplitude.
From upper table 3-10, pharmaceutical composition of the present invention can be prevented and treated myopia effectively, and ball wall sclera has been reinvented to certain inhibitory action, thereby can be for myope's control and/or treatment.
contrast test
1, except using respectively KFD1, KFD5, KFD9, KFD11, KFD15, KFD25, KFD29, KFD36, outside KFD38, to detect with above-mentioned diopter, the same procedure of the measurement of axiallength and flash electroretinogram inspection is shown each index measurement of 3-table 10, find: the measurement index that it is effect improved while being all significantly smaller than the KF of corresponding dosage is improved (the best person of effect also measures low 5-10% than KF improvement), wherein, (KFD1, KFD5, KFD9) > (KFD11, KFD15, KFD25) (KFD38 effect height is close to blank group for >KFD29>KFD36>K FD38, without actual effect), the meaning that " > " expression wherein " is better than ".
2, use the variable grain agent form in table 2, be mixed with respectively the contrast medicinal liquid that uses medicinal liquid same concentrations with upper table 3-table 10, wherein except using respectively KLD2, KLD7, KLD8, KLD12, KLD18, KLD24, KLD30, KLD35, outside KLD38, to detect with above-mentioned diopter, the same procedure of the measurement of axiallength and flash electroretinogram inspection is shown each index measurement of 3-table 10, find: the measurement index that it is effect improved while being all weaker than the KF of corresponding dosage is improved (the best person of effect also measures low 5-10% than KF improvement), wherein, (KLD2, KLD7, KLD8) > (KLD12, KLD18, KLD24) (KLD38 effect height is close to blank group for >KLD30>KLD35>K LD38, without actual effect), the meaning that " > " expression wherein " is better than ".
As can be seen here, when changing certain extraction step of any extract of said extracted thing, all by causing control and/or treating near-sighted effect, decrease, this has proved to only have the extracting method of the present invention of employing, by the synergism of various active composition, can obtain the best effect that treats and/or prevents.
myope's therapeutic effect
Selecting for 80 example ages is the simple myopia patient in 8-14 year, is divided at random experimental group and matched group, experimental group 40 examples wherein, and matched group 40 examples, 2 groups of patients comparing difference not statistically significant aspect sex, age, diopter, has comparability.
Experiment gives the granule of the embodiment of the present invention 2, every day dosage 6g, administration 3 months.
Matched group is suffered from eyespot 1% atropine eye ointment 1 time before sleeping every night, 1 time 1.Within 10 days, be 1 course for the treatment of, 9 courses for the treatment of of Continuous Observation, 3 months by a definite date.
Observe far visual acuity, diopter and eye local symptoms before and after 2 groups of treatments, take vision, diopter is observation index.
After finish all courses for the treatment of, carry out efficacy determination.The < < traditional Chinese medical science disease Standardization of diagnosis and curative effect > > that standard is promulgated with reference to State Administration of Traditional Chinese Medicine drafts:
Cure: far away, near vision is normal, near-sighted diopter disappears.
Take a turn for the better: more than distant vision improves 2 row, near-sighted diopter reduces 1D.
Do not heal: distant vision raising is less than 2 row.
Invalid: dioptric as before.
Allly the results are shown in Table 11.
Table 11. experimental group and the comparison of matched group curative effect
From upper table 11, granule of the present invention has significant clinical therapeutic efficacy for myopia, thereby can be used for preventing and/or treating of myope.
As mentioned above, the invention provides a kind of pharmaceutical composition that comprises various plants active component, it can be used to treat and/or prevent myopia, thereby has good clinical treatment application prospect and industrialization potentiality.
The purposes that should be appreciated that these embodiment only limits the scope of the invention for the present invention being described but not being intended to.In addition; also should understand; after having read technology contents of the present invention, those skilled in the art can make various changes, modification and/or modification to the present invention, within these all equivalent form of values fall within the protection domain that the application's appended claims limits equally.
Claims (10)
1. be used for preventing and treating a near-sighted pharmaceutical composition, described pharmaceutical composition, in weight portion, comprises following component:
2. pharmaceutical composition as claimed in claim 1, is characterized in that: the extracting method of described Herba Cistanches extract is as follows:
(A1) will be dried Herba Cistanches and be added to the water, decoct at a certain temperature, and then filter and obtain decocting liquid I and residue;
(A2) described residue is added to the water, in uniform temperature, decocts, filter and obtain decocting liquid II;
(A3) decocting liquid I and decocting liquid II are merged, then concentrating under reduced pressure, obtains clear paste;
(A4) in described clear paste, add ethanol, obtain clear paste alcoholic solution, then stratification, gets supernatant, and after concentration and recovery ethanol, gained paste is described Herba Cistanches extract.
3. the pharmaceutical composition as described in claim 1-2 any one, is characterized in that: the extracting method of described Radix Rehmanniae Preparata extract is as follows:
(B1) Radix Rehmanniae Preparata is fully dried to constant weight, then grinds, cross 50 mesh sieves, obtain Radix Rehmanniae Preparata powder;
(B2), to the mixed organic solvents that adds dehydrated alcohol and acetone in Radix Rehmanniae Preparata powder, under uniform temperature and certain power, supersound extraction 4-6 hour, filters and obtains filtrate, and filtrate decompression is concentrated, obtains condensed cream;
(B3) in condensed cream, add ethyl acetate, dissolve fully, then join in silicagel column, wherein the silica gel in silicagel column is 300-400 order silica gel, and in sealed container, with ether, fully soaks 20-30 hour before dress post, and silica gel is fully expanded;
(B4) first use the aqueous solution eluting silica gel post of alcohol, then organic solvent gradient elution silicagel column, collects eluent, concentrating under reduced pressure, and gained paste is described Radix Rehmanniae Preparata extract.
4. the pharmaceutical composition as described in claim 1-3 any one, is characterized in that: described Herba Epimedii extract extracts and obtains as follows, and its extracting method is as follows in other words:
(C1) Herba Epimedii is dry, pulverizing, crosses 100 mesh sieves, obtains Epimedium Herb;
(C2) Epimedium Herb is added in acetone, then add carbon dioxide, airtight pressurization, forms intumescent system, carry out at a certain temperature expanded solvents extraction, extract after 1-2 hour, rush down and be depressed into normal pressure and naturally cool to room temperature, filtration is extracted liquid, and concentrating under reduced pressure extract obtains thickness cream;
(C3) thickness cream is dissolved in dehydrated alcohol, cross chromatographic column, wherein said chromatographic column is 300-400 order neutral silica gel, the 200-300 order neutral alumina of column volume 25% and the AB-8 adsorbent resin of column volume 20% of packed column volume 35% from top to bottom, use the acetone and ethyl acetate that volume ratio is 1:2 to carry out eluting, collect eluent, concentrating under reduced pressure, gained paste is described Herba Epimedii extract.
5. the pharmaceutical composition as described in claim 1-4 any one, is characterized in that: the extracting method of described Fructus Alpinae Oxyphyllae extract is as follows:
(D1) Fructus Alpiniae Oxyphyllae is dry, pulverize, adding mass percent concentration is in 50% ethanol water, and usings acetic acid as extracting auxiliary agent, carries out Soxhlet extracting 1-2 hour; Then filter, obtain filtrate and solid insoluble;
(D2) solid insoluble is packed in ultrasonic extraction instrument, using the mixed solvent of ethyl acetate and normal hexane as extractant, ultrasonic extraction 20-30 minute, then adding mass percent concentration is the aqueous sodium carbonate of 5-10%, fully vibration, centrifugalize, obtains the supernatant;
(D3) supernatant of the filtrate of step (D1) and step (D2) is merged, concentrating under reduced pressure obtains just carrying cream, by this first cream of carrying with after anhydrous alcohol solution, cross D101 macroporous adsorptive resins, mixed solvent eluting with petroleum ether and hexanol, collect eluent, concentrating under reduced pressure, gained paste is described Fructus Alpinae Oxyphyllae extract.
6. according to the pharmaceutical composition described in claim 1-5 any one, it is characterized in that: the extracting method of described Poria extract is as follows:
(E1) Poria is dry, pulverizing, crosses 100 mesh sieves, obtains Indian Bread;
(E2) ethanol water that is 70-80% by Indian Bread by mass percentage concentration is reflux, extract, 1-2 hour under reflux temperature, then filters, and obtains filtrate;
(E3) filtrate is stirred in 80-90 ℃ of baking oven to volatilization, until without obvious ethanol taste, the treatment fluid after being concentrated;
(E4) in treatment fluid, add water, stir, obtain water I, then add acetone extract, obtain acetone phase and water II; By water II n-hexane extraction, obtain normal hexane phase and water III; Water III is extracted with isopropyl alcohol, obtain isopropyl alcohol phase and water VI;
(E5) by isopropyl alcohol phase concentrating under reduced pressure, gained paste is described Poria extract.
7. according to the pharmaceutical composition described in claim 1-6 any one, it is characterized in that: the extracting method of described Rhizoma Anemarrhenae extract is as follows:
(F1) Rhizoma Anemarrhenae is dry, pulverizing, crosses 50 mesh sieves, obtains Common Anemarrhena Rhizome;
(F2) Common Anemarrhena Rhizome is joined in ethyl acetate, reflux, extract, 0.5-1 hour, then naturally cools to room temperature, and adding mass percentage concentration is the NaHCO of 1-2%
3aqueous solution, stirs, and layering, obtains water and ethyl acetate phase;
(F3) wash ethyl acetate phase 1-3 time with water, then ethyl acetate is continued again to wash 1-3 time with the ethanol water that mass percentage concentration is 50% mutually, standing water and the organic facies of obtaining, by organic facies anhydrous magnesium sulfate drying, then concentrating under reduced pressure, gained paste is described Rhizoma Anemarrhenae extract.
8. according to the pharmaceutical composition described in claim 1-7 any one, it is characterized in that: also comprise a kind of or several arbitrarily in diluent, absorbent, wetting agent, binding agent, disintegrating agent, lubricant, suspending agent, flocculating agent, deflocculant, sweeting agent, aromatic, flavoring agent, stabilizing agent, excipient or antiseptic.
9. the preparation method of the pharmaceutical composition as described in claim 1-8 any one, described method comprises the steps:
(1) take respectively Herba Cistanches extract, Radix Rehmanniae Preparata extract, Herba Epimedii extract, Fructus Alpinae Oxyphyllae extract, Poria extract and the Rhizoma Anemarrhenae extract of above-mentioned weight portion, then mix, obtain mixture;
(2) in gained mixture, be incorporated as the deionized water of 2-5 times of weight of mixture weight, and to regulate pH value be 7.1-7.3, stir, then standing, filter, obtain filtrate;
Obtain after described filtrate, subpackage obtains oral liquid, or is concentrated into thick paste, then granulate, be dried, incapsulate and obtain capsule, or pack obtains granule, or described thick paste is made various pills, tablet, suspensoid, Emulsion, drop, medicated wine or tincture etc.
10. the pharmaceutical composition described in claim 1-8 any one is used for preventing and treating the purposes in near-sighted medicine in preparation.
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| CN111514177A (en) * | 2020-03-24 | 2020-08-11 | 金科涛 | Oral liquid or oral preparation |
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| CN1634272A (en) * | 2004-10-27 | 2005-07-06 | 丁玉波 | Eye disease treating medicine and its preparing process |
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| CN108938814A (en) * | 2018-10-08 | 2018-12-07 | 赵翔 | A kind of Chinese materia medica preparation for treating kidney deficiency and liver type myopia |
| CN111514177A (en) * | 2020-03-24 | 2020-08-11 | 金科涛 | Oral liquid or oral preparation |
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