CN102846831B - Chinese medicine composition as well as preparation method and application thereof - Google Patents
Chinese medicine composition as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a Chinese medicine composition as well as a preparation method and application thereof. The Chinese medicine composition is a medicament which is prepared from the following raw materials in parts by weight: 35-45 parts of astragalus mongholicus, 6-9 parts of Chinese angelica, 35-45 parts of prepared rehmannia roots, 5-10 parts of Chinese herbaceous peony, 2-8 parts of ligusticum, and 5-10 parts of lithospermum. The preparation method of the Chinese medicine composition comprises the following steps: weighing the raw materials to be smashed, and extracting percolate with ethanol solutions of different concentrations; collecting the percolate, reducing the pressure, concentrating the percolate into extract after the ethanol solutions are recovered, carrying out the chromatography, the separation and the purification with macroreticular resin PHD 100, collecting and compounding eluant, filtering the eluant, adding cyclodextrin, Opadry and colloidal silicon dioxide into the filtrate to be sufficiently and uniformly mixed, carrying out spray drying to obtain dry paste powder, adding glyceryl behenate into the dry paste powder to be uniformly mixed, carrying out filling and polishing, and packaging the resultant with aluminium-plastic to obtain capsules. The Chinese medicine composition provided by the invention is used for treating qi and blood deficiency syndromes as well as alopecia caused by qi and blood deficiency syndromes or chemotherapies.
Description
Technical field
The present invention relates to field of traditional Chinese, specifically, relate to a kind of Chinese medicine composition and its preparation method and application.
Background technology
Along with the quickening of pace of life, the increase of life stress and the aggravation of environmental pollution, in society, the sickness rate of deficiency of both QI and blood increases year by year, it is reported, wherein male's sickness rate is 20%, women's sickness rate is 47%, and the potential sickness rate of under-18s teenager and child is up to 69%; In above-mentioned colony, women's sickness rate is far above the male, and wherein the Female Children sickness rate exceeds 2.7% than the male, and the women's sickness rate of growing up has exceeded 10.2% than the male.The common symptom of deficiency of both QI and blood is that the complexion lip is pale or simple and unadorned, dizziness and blurred vision, inappetence, fatigue and asthenia, nausea and vomiting, lip and nail color are light, thready and weak pulse and female irregular menstruation etc., follows physical signs to descend as erythrocyte, granulocyte, platelet or pancytopenia and function of immune system.Enrich blood at present and mainly take the Colla Corii Asini series products as main, as LVJIAO BUXUE KELI, Donky-hide blood-supplementing tonic etc., but donkey glue source resource is limited on the one hand, price is excessively expensive, cost is too high, and granule, oral liquid etc. need to add sweeting agent on the other hand, and this makes the Colla Corii Asini series products to common income crowd and inapplicable to the crowd who takes the photograph the sugar taboo.In addition, existing treatment deficiency of both QI and blood medicine, SIWU TANG for example, therapeutic effect is not ideal enough.Chemotherapy is one of method for the treatment of at present cancer, and chemotherapeutics has powerful lethality to cancerous cell, but up to the present, any medicine all can not optionally only kill and wound cancerous cell, also can insulting normal cell when killing and wounding cancerous cell.And the normal hematopoiesis cell of active proliferation, gastrointestinal mucosal cell and hair follicle cell more easily sustain damage in human body, will cause the general alopecia after these cells are impaired, health and psychology to the patient cause very large infringement, at present the medicine for the treatment of deficiency of both QI and blood can only solely be used for the treatment of qi-blood deficiency syndrome, does not see after the prescription compatibility report that can be used for treating the alopecia that qi-blood deficiency syndrome or chemotherapy cause.
Summary of the invention
The first purpose of the embodiment of the present invention is to provide a kind of Chinese medicine composition, is intended to solve the curative effect that has the traditional Chinese medicine composition for treating deficiency of both QI and blood now bad, the problem that curative effect is more single.
The second purpose of the embodiment of the present invention is to provide a kind of preparation method of Chinese medicine composition, and the curative effect that is intended to solve the product treatment deficiency of both QI and blood that existing Chinese medicine composition preparation method makes is bad, the problem that curative effect is more single.
Application in the medicine of the alopecia that the 3rd purpose of the embodiment of the present invention is to provide described Chinese medicine composition to cause in preparation treatment qi-blood deficiency syndrome or chemotherapy.
The 4th purpose of the embodiment of the present invention is to provide the application of described Chinese medicine composition in the medicine of preparation treatment qi-blood deficiency syndrome.
The Chinese medicine composition that the embodiment of the present invention provides, it is the medicament of being made by the raw material by following weight proportion: 35～45 parts of the Radixs Astragali, 6～9 parts of Radix Angelicae Sinensis, 35～45 parts of Radix Rehmanniae Preparata, 5～10 parts of Radix Paeoniaes, 2～8 parts of Rhizoma Ligusticis, 5～10 parts of Radix Arnebiae (Radix Lithospermi)s.
The preparation method of the Chinese medicine composition that the embodiment of the present invention provides, carry out as follows:
(1) take by weight 35～45 parts of the Radixs Astragali, 6～9 parts of Radix Angelicae Sinensis, 35～45 parts of Radix Rehmanniae Preparata, 5～10 parts of Radix Paeoniaes, 2～8 parts of Rhizoma Ligusticis, 5～10 parts of Radix Arnebiae (Radix Lithospermi)s;
(2) step (1) Raw is ground into to coarse powder, floods 6～24 hours, with 5～10 times of amount 70%～90% ethanol percolate extraction, collect percolate, be concentrated into the extractum of 30 ℃～60 ℃ of relative densities 1.23～1.39 after decompression recycling ethanol;
(3) by 10% sodium bicarbonate adjust pH 5～8 for gained extractum in step (2), take respectively again 2 times of water gagings, 2 times the amount ethyl acetates, 3 times the amount 90% ethanol be eluent, through the separation and purification of PHD100 macroporous adsorbent resin column chromatography, applied sample amount is extractum weight: PHD100 macroporous adsorbent resin=1.0:1.5, collect and merge three kinds of eluents, filter, the cyclodextrin, 0.5%～1.5% Opadry and 0.5%～2.5% the colloidal silica that add raw material gross weight 1.0%～5.0% in filtrate, stir rear spray drying, powder gets dry extract;
(4) add the Glyceryl Behenate of raw material gross weight 0.01%～0.8% in step (3) gained dried cream powder, mix, fill, polishing, aluminum-plastic packaged, make capsule.
Compared with prior art, Chinese medicine composition provided by the invention is that the reasonable assembly by the Radix Astragali, Radix Angelicae Sinensis, Radix Paeoniae, Rhizoma Ligustici, Radix Rehmanniae Preparata and Radix Arnebiae (Radix Lithospermi) realizes, said composition not only has curative effect preferably on the treatment deficiency of both QI and blood, and alopecia is had to good therapeutic effect, the alopecia that particularly deficiency of both QI and blood or chemotherapy cause has good therapeutic effect.
The preparation method of Chinese medicine composition provided by the invention, reasonable assembly by the Radix Astragali, Radix Angelicae Sinensis, Radix Paeoniae, Rhizoma Ligustici, Radix Rehmanniae Preparata and Radix Arnebiae (Radix Lithospermi), adopt the alcoholic solution percolation of variable concentrations to extract, extract adopts the separation and purification of PHD100 macroporous adsorbent resin column chromatography, removes the impurity such as resin, tannin of the easy moisture absorption.Simultaneously, pass through cyclodextrin, after mixing with medicinal liquid, Opadry forms uniform solution, reduce the stickiness of mixed liquor by colloidal silica, make mixed liquor can realize spray drying, and make make particle studded in cyclodextrin and coated outside Opadry, the size uniformity, good fluidity, be applicable to direct filled capsules, Chinese medicine fluid extract or dry cream and auxiliary materials and mixing have been changed, add binding agent (aqueous solution or alcoholic solution etc.) to make wet granular, recharge the technique of capsule after drying, shortened technological process, reduced energy consumption, avoided effective ingredient to be influenced by heat, moreover also by Opadry and liquid medicine mixing spray-drying process, changed the traditional method that traditional dry granule wraps Opadry again, reduced labor intensity, improved the production yield, the Capsule content surface made has good damp-proof layer, avoided content to absorb capsule shells moisture and mouldy, solidify, also avoided the capsule shells rear embrittlement that absorbed water, improved the quality stability of preparation.In addition, the Chinese medicine composition of the embodiment of the present invention is not sugary, and applicable crowd is wider.
The specific embodiment
In order to make purpose of the present invention, technical scheme and advantage clearer, below in conjunction with embodiment, the present invention is further elaborated.Should be appreciated that specific embodiment described herein, only in order to explain the present invention, is not intended to limit the present invention.
The embodiment of the present invention is for solving existing treatment by Chinese herbs qi-blood deficiency syndrome weak curative effect, the problem that curative effect is more single, a kind of Chinese medicine composition is provided, and it is the medicament of being made by the raw material by following weight proportion: 35～45 parts of the Radixs Astragali, 6～9 parts of Radix Angelicae Sinensis, 35～45 parts of Radix Rehmanniae Preparata, 5～10 parts of Radix Paeoniaes, 2～8 parts of Rhizoma Ligusticis, 5～10 parts of Radix Arnebiae (Radix Lithospermi)s.The Chinese medicine composition of the embodiment of the present invention has curative effect preferably for qi-blood deficiency syndrome, and the alopecia caused for qi-blood deficiency syndrome, and the alopecia that even chemotherapy causes all has curative effect preferably.
The embodiment of the present invention also provides the preparation method of described Chinese medicine composition, carries out as follows:
(1) take by weight 35～45 parts of the Radixs Astragali, 6～9 parts of Radix Angelicae Sinensis, 35～45 parts of Radix Rehmanniae Preparata, 5～10 parts of Radix Paeoniaes, 2～8 parts of Rhizoma Ligusticis, 5～10 parts of Radix Arnebiae (Radix Lithospermi)s;
(2) step (1) Raw is ground into to coarse powder, floods 6～24 hours, with 5～10 times of amount 70%～90% ethanol percolate extraction, collect percolate, be concentrated into the extractum of 30 ℃～60 ℃ of relative densities 1.23～1.39 after decompression recycling ethanol;
(3) by 10% sodium bicarbonate adjust pH 5～8 for gained extractum in step (2), take respectively again 2 times of water gagings, 2 times the amount ethyl acetates, 3 times the amount 90% ethanol be eluent, through the separation and purification of PHD100 macroporous adsorbent resin column chromatography, applied sample amount is extractum weight: PHD100 macroporous adsorbent resin=1.0:1.5, collect and merge three kinds of eluents, filter, the cyclodextrin, 0.5%～1.5% Opadry and 0.5%～2.5% the colloidal silica that add raw material gross weight 1.0%～5.0% in filtrate, stir rear spray drying, powder gets dry extract;
(4) add the Glyceryl Behenate of raw material gross weight 0.01%～0.8% in step (3) gained dried cream powder, mix, fill, polishing, aluminum-plastic packaged, make capsule.
embodiment 1
Take by weight 35 parts of the Radixs Astragali, 6 parts of Radix Angelicae Sinensis, 45 parts of Radix Rehmanniae Preparata, 5 parts of Radix Paeoniaes, 3 parts of Rhizoma Ligusticis, 6 parts of Radix Arnebiae (Radix Lithospermi)s, be total to 300g, be ground into coarse powder, flood 8 hours, with 10 times of amount 75% ethanol percolate extraction, collect percolate, be concentrated into the extractum of 35 ℃ of relative densities 1.23 after decompression recycling ethanol, 10% sodium bicarbonate adjust pH 5.5 for extractum, again respectively with 2 times of water gagings, 2 times of amount ethyl acetates, 3 times of amount 90% ethanol are eluent, through the nonpolar copolymer of PHD100(styrene type) the macroporous adsorbent resin column chromatography separation and purification, applied sample amount is extractum weight: PHD100 macroporous adsorbent resin=1.0:1.5, collect and merge three kinds of eluents, filter, the cyclodextrin that adds raw material gross weight 1.8% in filtrate, 1.5% Opadry and 1.4% colloidal silica, stir rear spray drying, powder gets dry extract.Add the Glyceryl Behenate of raw material gross weight 0.5% in the gained dried cream powder, mix, fill, polishing, aluminum-plastic packaged, make capsule.
embodiment 2
Take by weight 41 parts of the Radixs Astragali, 8 parts of Radix Angelicae Sinensis, 35 parts of Radix Rehmanniae Preparata, 6 parts of Radix Paeoniaes, 4 parts of Rhizoma Ligusticis, 6 parts of Radix Arnebiae (Radix Lithospermi)s, be total to 300g, be ground into coarse powder, flood 20 hours, with 8 times of amount 90% ethanol percolate extraction, collect percolate, be concentrated into the extractum of 50 ℃ of relative densities 1.29 after decompression recycling ethanol, 10% sodium bicarbonate adjust pH 8 for extractum, again respectively with 2 times of water gagings, 2 times of amount ethyl acetates, 3 times of amount 90% ethanol are eluent, through the separation and purification of PHD100 macroporous adsorbent resin column chromatography, applied sample amount is extractum weight: PHD100 macroporous adsorbent resin=1.0:1.5, collect and merge three kinds of eluents, filter, the cyclodextrin that adds raw material gross weight 4.0% in filtrate, 0.5% Opadry and 0.9% colloidal silica, stir rear spray drying, powder gets dry extract.Add the Glyceryl Behenate of raw material gross weight 0.7% in the gained dried cream powder, mix, fill, polishing, aluminum-plastic packaged, make capsule.
embodiment 3
Take by weight 37 parts of the Radixs Astragali, 7 parts of Radix Angelicae Sinensis, 37 parts of Radix Rehmanniae Preparata, 7 parts of Radix Paeoniaes, 5 parts of Rhizoma Ligusticis, 7 parts of Radix Arnebiae (Radix Lithospermi)s, be total to 300g, be ground into coarse powder, flood 15 hours, with 6 times of amount 85% ethanol percolate extraction, collect percolate, be concentrated into the extractum of 55 ℃ of relative densities 1.36 after decompression recycling ethanol, 10% sodium bicarbonate adjust pH 6.5 for extractum, again respectively with 2 times of water gagings, 2 times of amount ethyl acetates, 3 times of amount 90% ethanol are eluent, through the separation and purification of PHD100 macroporous adsorbent resin column chromatography, applied sample amount is extractum weight: PHD100 macroporous adsorbent resin=1.0:1.5, collect and merge three kinds of eluents, filter, the cyclodextrin that adds raw material gross weight 2.8% in filtrate, 1.1% Opadry and 2.3% colloidal silica, stir rear spray drying, powder gets dry extract.Add the Glyceryl Behenate of raw material gross weight 0.1% in the gained dried cream powder, mix, fill, polishing, aluminum-plastic packaged, make capsule.
the extracting method contrast experiment
1, instrument and reagent
Shimadzu LC-10A type high performance liquid chromatograph, the Shimadzu chromatographic work station; Mettler AE240 type 100,000/electronic balance (prunus mume (sieb.) sieb.et zucc. Teller-Tuo benefit Shanghai Instrument Ltd.); Peoniflorin reference substance (Nat'l Pharmaceutical & Biological Products Control Institute), acetonitrile (chromatographically pure), methanol (chromatographically pure), ultra-pure water, phosphoric acid (analytical pure).
2, chromatographic condition and system suitability
Take octadecylsilane chemically bonded silica as filler: acetonitrile-0.2% phosphoric acid solution (15:85) of take is mobile phase; Detecting wavelength is 232.Number of theoretical plate is pressed the calculating of peoniflorin peak should be lower than 2000.
3, extracting method:
Ultrasonic extraction: take 37 parts of the Radixs Astragali, 7 parts of Radix Angelicae Sinensis, 37 parts of Radix Rehmanniae Preparata, 7 parts of Radix Paeoniaes, 5 parts of Rhizoma Ligusticis, 7 parts of Radix Arnebiae (Radix Lithospermi)s, be total to 300g, be ground into coarse powder, be divided into three parts, be placed in respectively triangular flask, add 70% ethanol 400 mL, put supersound extraction 30 min in ultrasonic cleaner, sucking filtration, collect filtrate, is drying to obtain dry cream 67.4g.
Reflux extraction: take 37 parts of the Radixs Astragali, 7 parts of Radix Angelicae Sinensis, 37 parts of Radix Rehmanniae Preparata, 7 parts of Radix Paeoniaes, 5 parts of Rhizoma Ligusticis, 7 parts of Radix Arnebiae (Radix Lithospermi)s, be total to 300g, be ground into coarse powder, be divided into three parts, be placed in the 1000mL round-bottomed flask, add 70% ethanol 800 mL, reflux, extract, 2 h, sucking filtration, collect filtrate, drying, 69.3g gets dry extract.
The microwave extraction method: take 37 parts of the Radixs Astragali, 7 parts of Radix Angelicae Sinensis, 37 parts of Radix Rehmanniae Preparata, 7 parts of Radix Paeoniaes, 5 parts of Rhizoma Ligusticis, 7 parts of Radix Arnebiae (Radix Lithospermi)s, 300g, be ground into coarse powder altogether, be divided into three parts, put in extractor, add 5 times of weight water, be heated to boiling, supplement the quantity of solvent of volatilization, the little fire heating of microwave, keep boiling 5min, sucking filtration, collect filtrate, drying, 70.9g gets dry extract.
Supercritical CO
2extraction method: take 37 parts of the Radixs Astragali, 7 parts of Radix Angelicae Sinensis, 37 parts of Radix Rehmanniae Preparata, 7 parts of Radix Paeoniaes, 5 parts of Rhizoma Ligusticis, 7 parts of Radix Arnebiae (Radix Lithospermi)s, be total to 300g, be ground into coarse powder, be divided into three parts, be placed in respectively extractor, respectively with not containing entrainer, take 95% ethanol as entrainer, take 70% ethanol as entrainer, extract 3 hours, each 3 parts.Extraction pressure is 10MPa, extracts temperature 50 C, CO
2flow is 2.50 L/min, entrainer consumption 500 mL, and separator pressure is normal temperature and pressure.Collect extract, concentrated, drying, 68.7g gets dry extract.
Decoct extracting method: take 37 parts of the Radixs Astragali, 7 parts of Radix Angelicae Sinensis, 37 parts of Radix Rehmanniae Preparata, 7 parts of Radix Paeoniaes, 5 parts of Rhizoma Ligusticis, 7 parts of Radix Arnebiae (Radix Lithospermi)s, 300g, be ground into coarse powder altogether, be divided into three parts, be placed in respectively extraction pot, add the water of its 5 times of weight, heated and boiled 2 hours, leach medicinal liquid standby, medicinal residues add the water of 4 times of weight of former medicine weight, and heated and boiled 1 hour is concentrated by boiling for twice after carrying medicinal liquid and merging, drying, 67.5g gets dry extract.
Extracting method in the embodiment of the present invention 3: take 37 parts of the Radixs Astragali, 7 parts of Radix Angelicae Sinensis, 37 parts of Radix Rehmanniae Preparata, 7 parts of Radix Paeoniaes, 5 parts of Rhizoma Ligusticis, 7 parts of Radix Arnebiae (Radix Lithospermi)s, be total to 300g, be ground into coarse powder, add 2 times of amount 80% alcohol dipping 12 hours, with 7 times of amount 80% ethanol percolate extraction, collect percolate, be concentrated into the extractum of 40 ℃ of relative densities 1.27 after decompression recycling ethanol, 10% sodium bicarbonate adjust pH 6.5 for extractum, again respectively with 2 times of water gagings, 2 times of amount ethyl acetates, 3 times of amount 90% ethanol are eluent, through the separation and purification of PHD100 macroporous resin column chromatography, applied sample amount is extractum weight: PHD100 macroporous adsorbent resin=1.0:1.5, collect and merge three kinds of eluents, filter, filtrate recycling ethanol, concentrating under reduced pressure is dried to dry extract, 71.5g gets dry extract.
4, need testing solution preparation:
Get the about 0.2g of gained sample under described each extracting method, accurately weighed, put in tool plug conical flask, precision adds 50% methanol 25mL, weighed quality, supersound process (power 250 W, frequency 33 kHz) 30 min, take out, and puts to room temperature, again weighed, supply the quality of less loss with 50% methanol, shake up, filter, get subsequent filtrate, obtain need testing solution.
5, the preparation of contrast solution:
Get the peoniflorin reference substance appropriate, accurately weighed, add the solution that methanol is made concentration 0.1mg/ml, obtain.
6, algoscopy
Precision is drawn reference substance solution and each 20 μ l of need testing solution respectively, and the injection liquid chromatography, measure, and obtains paeoniflorin content.
7, the comparison of extract obtained kind of paeoniflorin content of Different Extraction Method.Result is as shown in table 1:
Table 1
| Method | Paeoniflorin content (%) |
| Ultrasonic extraction | 1.573 |
| Reflux extraction | 1.587 |
| The microwave extraction method | 1.591 |
| Supercritical CO 2Extraction method | 1.490 |
| Decoct extracting method | 1.321 |
| Extracting method in the embodiment of the present invention 3 | 1.756 |
From table 1, embodiment of the present invention extracting method and existing ultrasonic extraction, reflux extraction, microwave extraction method, supercritical CO
2extraction method is compared with the decoction extracting method, adopts embodiment of the present invention extracting method, and the paeoniflorin content of acquisition is the highest.
hygroscopicity contrast experiment
1, sample and instrument
Comparative Examples 1: get by weight percentage Radix Angelicae Sinensis 18%, Radix Rehmanniae Preparata 18%, the Radix Paeoniae Alba 18%, Rhizoma Chuanxiong 10%, the Radix Astragali 18%, Radix Arnebiae (Radix Lithospermi) 18%, put in extraction pot, add the water of 5 times of weight of its gross weight, heated and boiled 2 hours, leach medicinal liquid standby, medicinal residues are put in extraction pot the water that adds 4 times of weight of former medicine weight again, and heated and boiled 1 hour is boiled after the medicinal liquid of carrying gained mixes and crossed 100 mesh sieves twice, be concentrated into the clear paste that relative density is 1.15 (60-70 ℃), put in spray dryer that to be dried to dried cream powder standby; Working as in component, put in order in extraction pot, the ethanol that the content that adds its 5 times of weight is 70%, reflux 2 hours, leach medicinal liquid standby, and medicinal residues are put in extraction pot again, the ethanol that the content that adds 3 times of weight of former medicine is 70%, reflux 1.5 hours, leach medicinal liquid, and twice proposition liquid is mixed in rearmounted ethanol recovery device and reclaims ethanol, cooling rear mistake 100 mesh sieves, the clear paste that to be concentrated into relative density be 1.18 (60-70 ℃) is standby; The above-mentioned dried cream powder made and clear paste are mixed, add the dextrin of former medicine gross weight 6.8% and the Icing Sugar of former medicine weight 20%, the packing of granulating.
Comparative Examples 2: Ajiaobuxue Granula, purchased from Dong-E donkey-hide Gelatin Co., Ltd., Shandong Prov., specification: 4g * 30 bag, lot number: 110102.
2, test method
Getting Comparative Examples 1,2 samples and embodiment of the present invention 1-3 sample contents puts in clean culture dish in right amount, accurately weighed weight, the thin layer that spread out into≤5mm is thick, be placed on again in the hermetic container of constant humidity, 25 ℃ of temperature, under the condition of relative humidity 75%, place, respectively at the 12nd hour, 18 hours and 36 hours accurately weighed its weight.
3, hygroscopicity comparing result (it hour is unit that humidity exposure time be take, and sample be take gram as unit of weight) as shown in table 2.
Table 2
As shown in Table 2, the product moisture effect of the embodiment of the present invention all obviously is better than prior art.
the QI invigorating and blood producing test of pesticide effectiveness
Experimental principle: this experiment adopts mouse subcutaneous injection APH(acetylphenylhydrazine) and lumbar injection CY(cyclophosphamide) allow mice produce various types of anemias and bone marrow hematogenesis obstacle, erythrocyte, granulocyte, platelet or pancytopenia occur, then observe the impact of tested medicine on various blood constituents and hemopoietic function of bone marrow.
The preparation of tested medicine:
Comparative sample: in hygroscopicity contrast experiment, Comparative Examples 1 below legal system is standby, makes the solution (in raw medicinal herbs) of 60g/100ml, standby.
The SIWU TANG agent: get Radix Rehmanniae Preparata 120g, Radix Angelicae Sinensis 90g, Radix Paeoniae Alba 90g, Rhizoma Chuanxiong 60g, add 10 times of water gagings and decoct 2 hours, filters, and filtering residue adds 8 times of water gagings and decocts 2 hours, filters, and merging filtrate, be concentrated into the solution (in raw medicinal herbs) of 60g/100ml, standby.
Normal saline: 500ml.
Experimental design: 60 of laboratory animal white mice, in age 6-8 week, male and female half and half, be divided into 5 groups at random, 12 every group.Wherein the 1st group is the comparative sample group, and the 2nd group is SIWU TANG agent formulation group, and the 3rd group is Chinese medicinal composition capsules agent group of the present invention (press embodiment 3 preparation), and the 4th group is that model group, the 5th group are the blank group.1st, 2,3 each administration groups all use gastric infusion 0.6ml/ only.Blank and model group give the tap water of isometric(al) scalding.Model group and each administration group mice were respectively at the 2nd day and the 5th day subcutaneous injection APH(acetylphenylhydrazine) 20mg/kg, 40mg/kg, since the 5th day continuous 4 days lumbar injection CY(cyclophosphamide) 40mg/kg, blank group mice such as injects at the normal saline of capacity simultaneously.Each group is weighed before administration in the 1st, 4,7 days, and after the last administration, routine blood test is surveyed in the blood sampling of 1.5h eyeground vein clump.Result is as shown in table 3:
Table 3 is respectively organized blood routine examination result (x+s)
| Group | HGB/g·L -1 | RBC/10 12·L -1 | HCT |
| The blank group | 131.8±7.4 | 8.16±0.59 | 0.45±0.03 |
| Model group (normal saline) | 101.2±8.7△△ | 4.41±0.75△△ | 0.25±0.04△△ |
| The comparative sample group | 112.8±6.8** | 5.38±0.23** | 0.23±0.03** |
| SIWU TANG agent group | 123.4±5.7** | 5.22±0.54* | 0.30±0.02* |
| 3 groups of the embodiment of the present invention | 129.6±7.2** | 6.49±0.47** | 0.42±0.01** |
△ △ P<0.01vs blank group, * p<0.01, * * P<0.05Vs model group
Animal, after modeling, starts to occur that lazyness in various degree is moving, hair color is withered, few food.Tail, ear, eye are pale, and body weight gain is slow.Model group is the most obvious.Administration decoction, granule, capsule group mice physical agility, hair color is normal, eye, ear, tail pinkiness, with normal group without significant difference.Result shows, comprehensive each index, embodiment of the present invention Chinese medicine composition is at the RBC(erythrocyte), the HCT(packed cell volume) all be significantly higher than comparative sample and SIWU TANG agent, and embodiment of the present invention Chinese medicine composition HGB(hemoglobin)/gL
-1with blank group indifference, illustrate that embodiment of the present invention Chinese medicine composition pharmacological effect is the most obvious.
the hair growth promoting test of pesticide effectiveness
Experimental principle: this experiment adopts medicine to investigate its hair growth promoting effect to the impact of guinea pig back skin histology.
The preparation of tested medicine:
Capsule of the present invention: the Capsule content of getting under embodiment 2 is appropriate, is converted to the about 100g of medical material, and adding distil water 100ml, stir evenly, and makes the solution containing medical material 60g/100ml, standby.
Comparative sample: in photograph hygroscopicity contrast test, Comparative Examples 1 below legal system is standby, makes the solution (in raw medicinal herbs) of 60g/ml, standby.
The SIWU TANG agent: get Radix Rehmanniae Preparata 120g, Radix Angelicae Sinensis 90g, Radix Paeoniae Alba 90g, Rhizoma Chuanxiong 60g, add 10 times of water gagings and decoct 2 hours, filters, and filtering residue adds 8 times of water gagings and decocts 2 hours, filters, and merging filtrate, be concentrated into the solution containing medical material 60g/100ml, standby.
Hair-growth ballet: purchased from market; Manufacturer: Jiuzhitang Jinding Pharmaceutical Co., Ltd., Chengdu, specification: 60 grams/bottle/box.Get content appropriate, make the solution (in raw medicinal herbs) of 60g/100ml, standby.
Normal saline: 500ml.
Experimental design: get 50 of Cavia porcelluss, male and female are regardless of, and the sodium sulfate with 8% is sloughed the about 10cm of chaeta at the back of every Cavia porcellus
2, expose glabrous skin.Then Cavia porcellus is divided into to 5 groups at random, 10 every group.Wherein the 1st group is capsule group of the present invention, and the 2nd group is the comparative sample group, and the 3rd group is SIWU TANG agent group, and the 4th group is the hair-growth ballet group, and the 5th group is the blank group.1,2,3,4 each administration groups all use gastric infusion 0.6ml/ only, and every day 2 times, 5 groups by gavage to normal saline 0.6ml/ only, every day 2 times.Get at random 10 new piliations in each Mus depilation district after 30 days, by the length of vernier caliper measurement hair, compare its diversity.Then Cavia porcellus is put to death, takes off the test block skin histology, fix with 10% formaldehyde, get continuously 4 along the vertical tangent plane of hair follicle and organize soon, dehydration, paraffin embedding, HE(hematoxylin-eosin) dyeing, light microscopy checking.(1) high dermis blood vessels caliber (um), measure 5 crosscut capillary tube calibers, calculating mean value at random; (2) high dermis blood vessel number (individual), calculate several 5 visuals field, calculating mean value with 200 times of visuals field.Result is as shown in table 4.
The new piliation of each treated animal of table 4 and skin histology change assay (x+s)
| Group | Newborn hair length (mm) | Times visual field, blood capillary number/200 | Blood capillary caliber (um) |
| 2 groups of the embodiment of the present invention | 13.81±0.617 △△△ | 8.41±1.006 △△ | 9.07±0.983 △△△ |
| The comparative sample group | 10.95±2.176 △△ | 6.63±0.751 | 7.12±1.231 |
| SIWU TANG agent group | 9.04±1.704△ | 8.08±1.046 | 8.21±1.006△△ |
| The hair-growth ballet group | 9.22±1.704 △ | 6.98±0.718 | 8.08±1.046 △ |
| The blank group | 6.33±0.942 | 6.51±0.652 | 6.17±0.805 |
Annotate: with the blank group, compare
△p<0.05;
△ △p<0.01;
△ △ △p<0.001
Result shows, capsule of the present invention has good hair growth promoting effect.
the impact of the alopecia that embodiment of the present invention Chinese medicine composition causes chemotherapy
Cyclophosphamide is a kind of Common Chemotherapy medication, but uses this medicine easily to cause alopecia.Take cyclophosphamide as example, and the alopecia that embodiment of the present invention Chinese medicine composition causes chemotherapy has therapeutic effect preferably.
Experimental principle: this experiment adopts medicine to induce alopecia back part skin follicle survival number to investigate the effect of Chinese medicine composition of the present invention to the rat alopecia to rat injection cyclophosphamide.
The preparation of tested medicine:
Capsule of the present invention: the Capsule content of getting under embodiment 2 is appropriate, is converted to the about 100g of medical material, and adding distil water 100ml, stir evenly, and makes the solution containing medical material 60g/100ml, standby.
Comparative sample: in photograph hygroscopicity contrast test, Comparative Examples 1 below legal system is standby, makes the solution (in raw medicinal herbs) of 60g/ml, standby.
The SIWU TANG agent: get Radix Rehmanniae Preparata 120g, Radix Angelicae Sinensis 90g, Radix Paeoniae Alba 90g, Rhizoma Chuanxiong 60g, add 10 times of water gagings and decoct 2 hours, filters, and filtering residue adds 8 times of water gagings and decocts 2 hours, filters, and merging filtrate, be concentrated into the solution containing medical material 60g/100ml, standby.
Hair-growth ballet: purchased from market; Manufacturer: Jiuzhitang Jinding Pharmaceutical Co., Ltd., Chengdu, specification: 60 grams/bottle/box.Get content appropriate, make the solution (in raw medicinal herbs) of 60g/100ml, standby.
Normal saline: 500ml.
Experimental design: get 50 of 7 days neonate rats, be divided at random 5 groups, wherein the 1st group is the product of the embodiment of the present invention 3, and the 2nd group is the comparative sample group, and the 3rd group is SIWU TANG agent group, and the 4th group is the hair-growth ballet group, and the 5th group is the blank group.In latter 8 to 25 days of rat birth, 1,2,3,4 each administration groups all used gastric infusion 0.6ml/ only, and every day 2 times, 5 groups by gavage to normal saline 0.6ml/ only, every day 2 times.After the 1st group, 2 groups, 3 groups, 4 groups and the birth of 5 groups of rats, the 15th day disposable celiac injection cyclophosphamide 35mg/kg induces alopecia.The injection cyclophosphamide after the 10th day, get skin of back (perpendicular to paravertebral line), formaldehyde is fixed, the dehydration, embedding, dyeing, light microscopy checking.Calculate hair follicle survival number, calculate several 5 visuals field, calculating mean value with 200 times of visuals field.Result is shown as table 5.
Each treated animal hair follicle survival number assay (x+s) of table 5
| Group | Times visual field, hair follicle number/200 |
| 2 groups of the embodiment of the present invention | 7.89±1.171 △△ |
| The comparative sample group | 6.01±1.592 |
| SIWU TANG agent group | 5.83±1.216 |
| The hair-growth ballet group | 6.29±1.085 |
| The blank group | 3.62±1.357 |
Annotate: with the blank group, compare
△ △p<0.01.Result shows, capsule of the present invention can obviously alleviate the hair follicle cell apoptosis that cyclophosphamide is induced, and stops the hair follicle regression also to extend persistent period anagen phase.
experimental example 6the clinical test of pesticide effectiveness situation of Chinese medicinal composition capsules agent of the present invention
(1) 100 routine anemia patient is all from City Hospitals and outpatient service.Male 22 examples wherein, female's 78 examples; Age is 17
~between 59 years old; The course of disease is the shortest 1 month, the longest 3 years.
(2) diagnostic criteria diagnostic criteria
(1) microcytic hypochromic anemia: male Hb(hemoglobin)<120g/L, women Hb<110g/L, anemia of pregnant woman Hb<100g/L; The MCV(mean corpuscular volume)<80fl, MCH (average hemoglobin content)<26pg, MCHC (mean corpuscular hemoglobin)<0.31; Red cell morphology can have obviously low pigment performance;
(2) have clear and definite Fe deficiency symptoms because of and clinical manifestation;
(3) serum (blood plasma) ferrum<10.7pmol/L(6otc/a1), TIBC (total iron binding capacity) > 64.44 p.mol/L (360pg/d1);
(4) transferrin saturation<0.15;
(5) bone marrow iron stain shows that the bone marrow granule can dye ferrum and disappear, sideroblast<15%;
(6) free erythrocyte protoporphyrin (FEP) > 0.9tml/L(50pg/d1) (whole blood), or blood zinc protoporphyrin (ZPP) 0.96/anol/L(60tc ,/d1) (whole blood), or FEP/Hb 4.5t, g/gHb.
(3) Therapeutic Method
(1) grouping: take 50 examples as test group, take 50 examples as matched group.
(2) usage and dosage: test group takes Chinese medicinal composition capsules of the present invention, according to the embodiment of the present invention 1 preparation method preparation, each 5, every day three times; It is standby according to Comparative Examples 1 below legal system in the hygroscopicity contrast test that matched group is taken sample, each 10g, every day three times.Within 1 month, be 1 course for the treatment of, take medicine and within first 1 week, stop using that all can affect the medicine of result, instruct rational diet.
(4) before and after the observation index medication, clinical primary symptom changes
Symptoms is that the complexion lip is pale or simple and unadorned, inappetence, fatigue and asthenia, nausea and vomiting, absent minded, detects RBC, Hb, MCH, SF(serum ferritin).
(5) treatment standard
Curative effect determinate standard is drafted with reference to related standards in " new Chinese medicine guideline of clinical investigations ".Cure: the man 120g/L, the female > 105g/L, RBC: man > 4.0 * 10/L, the female > 3.5 * 10/L, clinical symptom disappearance, it is normal that the indexs such as RBC, Hb, Fe, TIBC are recovered.Produce effects: clinical symptoms is clearly better, and the anemia Severity gradation is transferred to slightly by severe, or transfers moderate (improving more than 2 grades) to by utmost point severe.Effectively: clinical symptoms take a favorable turn, and severity of anemia improves 1 grade.Invalid: clinical symptoms and anemia classification of severity are without change.
(6) therapeutic outcome
Therapeutic outcome is as shown in following table 6, table 7
The clinical cardinal symptom of table 6 is improved the time (d) (x+s)
| Group the time | Pale complexion | Poor appetite | Lip is light | Onyx is pale | Conjunctiva is pale | Fatigue and asthenia |
| Test group | 18.71±2.75 | 16.53±1.75 | 19.42±1.90 | 15.97±2.13 | 30.05±8.4 | 25.2±7.9 |
| Matched group | 15.41±2.6 | 14.5±1.31 | 17.31±1.84 | 13.97±2.24 | 25.14±6.9 | 21.1±8.7 |
There is significant difference test group and matched group P<0.01, show that therapeutic effect of the present invention is better than prior art.
Table 7 clinical curative effect analysis (example/rate)
| Group | Number of cases | Produce effects | Effectively | Invalid | Aggregate efficiency (%) |
| Test group | 49 | 36 | 8 | 5 | 90 |
| Matched group | 47 | 34 | 5 | 8 | 84 |
Test group with compare, produce effects, effectively, total effective rate is all good than matched group, shows that therapeutic effect of the present invention is better than prior art products.
The foregoing is only preferred embodiment of the present invention, not in order to limit the present invention, all any modifications of doing within the spirit and principles in the present invention, be equal to and replace and improvement etc., within all should being included in protection scope of the present invention.
Claims (9)
1. a Chinese medicine composition, is characterized in that, it is the medicament of being made by the raw material by following weight proportion: 35～45 parts of the Radixs Astragali, 6～9 parts of Radix Angelicae Sinensis, 35～45 parts of Radix Rehmanniae Preparata, 5～10 parts of Radix Paeoniaes, 2～8 parts of Rhizoma Ligusticis, 5～10 parts of Radix Arnebiae (Radix Lithospermi)s.
2. Chinese medicine composition according to claim 1, is characterized in that, it is the medicament of being made by the raw material by following weight proportion: 35 parts of the Radixs Astragali, 6 parts of Radix Angelicae Sinensis, 45 parts of Radix Rehmanniae Preparata, 5 parts of Radix Paeoniaes, 3 parts of Rhizoma Ligusticis, 6 parts of Radix Arnebiae (Radix Lithospermi)s.
3. Chinese medicine composition according to claim 1, is characterized in that, it is the medicament of being made by the raw material by following weight proportion: 41 parts of the Radixs Astragali, 8 parts of Radix Angelicae Sinensis, 35 parts of Radix Rehmanniae Preparata, 6 parts of Radix Paeoniaes, 4 parts of Rhizoma Ligusticis, 6 parts of Radix Arnebiae (Radix Lithospermi)s.
4. Chinese medicine composition according to claim 1, is characterized in that, it is the medicament of being made by the raw material by following weight proportion: 37 parts of the Radixs Astragali, 7 parts of Radix Angelicae Sinensis, 37 parts of Radix Rehmanniae Preparata, 7 parts of Radix Paeoniaes, 5 parts of Rhizoma Ligusticis, 7 parts of Radix Arnebiae (Radix Lithospermi)s.
5. the preparation method of Chinese medicine composition according to claim 1, is characterized in that, carries out as follows:
(1) take by weight 35～45 parts of the Radixs Astragali, 6～9 parts of Radix Angelicae Sinensis, 35～45 parts of Radix Rehmanniae Preparata, 5～10 parts of Radix Paeoniaes, 2～8 parts of Rhizoma Ligusticis, 5～10 parts of Radix Arnebiae (Radix Lithospermi)s;
(2) step (1) Raw is ground into to coarse powder, floods 6～24 hours, with 5～10 times of amount 70%～90% ethanol percolate extraction, collect percolate, be concentrated into the extractum of 30 ℃～60 ℃ of relative densities 1.23～1.39 after decompression recycling ethanol;
(3) by 10% sodium bicarbonate adjust pH 5～8 for gained extractum in step (2), take respectively again 2 times of water gagings, 2 times the amount ethyl acetates, 3 times the amount 90% ethanol be eluent, through the separation and purification of PHD100 macroporous adsorbent resin column chromatography, applied sample amount is extractum weight: PHD100 macroporous adsorbent resin=1.0:1.5, collect and merge three kinds of eluents, filter, the cyclodextrin, 0.5%～1.5% Opadry and 0.5%～2.5% the colloidal silica that add raw material gross weight 1.0%～5.0% in filtrate, stir rear spray drying, powder gets dry extract;
(4) add the Glyceryl Behenate of raw material gross weight 0.01%～0.8% in step (3) gained dried cream powder, mix, fill, polishing, aluminum-plastic packaged, make capsule.
6. the preparation method of Chinese medicine composition according to claim 5, is characterized in that, the parts by weight of raw materials that described step (1) takes is 35 parts of the Radixs Astragali, 6 parts of Radix Angelicae Sinensis, 45 parts of Radix Rehmanniae Preparata, 5 parts of Radix Paeoniaes, 3 parts of Rhizoma Ligusticis, 6 parts of Radix Arnebiae (Radix Lithospermi)s.
7. the preparation method of Chinese medicine composition according to claim 5, is characterized in that, the parts by weight of raw materials that described step (1) takes is 41 parts of the Radixs Astragali, 8 parts of Radix Angelicae Sinensis, 35 parts of Radix Rehmanniae Preparata, 6 parts of Radix Paeoniaes, 4 parts of Rhizoma Ligusticis, 6 parts of Radix Arnebiae (Radix Lithospermi)s.
8. the preparation method of Chinese medicine composition according to claim 5, is characterized in that, the parts by weight of raw materials that described step (1) takes is 37 parts of the Radixs Astragali, 7 parts of Radix Angelicae Sinensis, 37 parts of Radix Rehmanniae Preparata, 7 parts of Radix Paeoniaes, 5 parts of Rhizoma Ligusticis, 7 parts of Radix Arnebiae (Radix Lithospermi)s.
9. the application in the medicine of the alopecia that the described Chinese medicine composition of claim 1-4 causes in preparation treatment qi-blood deficiency syndrome or chemotherapy.
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