CN100502912C - Medicine for treating deficiency syndrome, its preparing process and usage - Google Patents
Medicine for treating deficiency syndrome, its preparing process and usage Download PDFInfo
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Abstract
The invention relates to a medicine for treating deficiency syndrome, its preparing process and usage, wherein the medicine is prepared from fleece-flower root, root of red rooted saliva, Ligusticum wallichii, wolferry fruit, pipe-fish, long-nosed pit viper through the conventional process.
Description
Technical field
The present invention relates to a kind of medicine and method of quality control thereof and purposes, relating in particular to a kind of is the Chinese patent medicine that is used for the treatment of deficient syndrome of primary raw material preparation with the Chinese crude drug.
Background technology
Theory of Chinese medical science thinks, QI and blood is the base substance that constitutes human body, is the material base that histoorgan such as internal organs carries out physiological activity, and liver, kidney two are dirty particularly close with relation QI and blood.Vigour in people's bromhidrosis is the driving source of life, and its composition is based on kidney institute store essential substances gas; Blood mainly is made up of ying-qi and body fluid, and blood is hidden in liver, and it fills Sheng and depends on the vital essence of kidney full again, i.e. so-called " essence and blood sharing the same origin ".As seen QI and blood and liver, kidney two are dirty is close ties, interactional.Theory of Chinese medical science thinks that also QI and blood interacts, changes mutually and give birth to.QI belonging to YANG, sun are given birth to then cloudy long, so qi promoting blood production, the deficiency of vital energy then blood is difficult the living hyperamization void of satisfying; Blood being the mother of qi, and gas relies blood to go with appendix, blood deficiency and gas is difficult the attached deficiency of vital energy that causes then.Also rely the promotion of gas in the capable arteries and veins of blood, but the weak then hyperamization stream of deficiency of vital energy fate is stagnated, the obstructed blood stasis symptom that forms of venation.
QI and blood deficiency, deficiency of the liver and kindey and blood stasis symptom are the common clinical card, are found in the multiple lysis.Its cause of disease or by the natural endowment deficiency, or support, or hinder by the prolonged illness consumption by losing the day after tomorrow, or by overstrain etc.Suffer from a deficiency of the kidney and to cause immunologic hypofunction and body void; Tumor patient radiotherapy, chemotherapy consumption is hindered healthy energy and must be caused deficiency of vital QI, and blood is difficult to give birth to and QI and blood deficiency shows as leukocyte or granulocytopenia; Deficiency of kidney-essence, yang deficiency heat in blood, Tianjin consumption liquid that burns can cause diabetes, the venation of holding concurrently is obstructed, blood stasis for suffer from can concurrent peripheral neuritis many clinical manifestations; Insufficiency of vital energy and blood can cause visceral dysfunction again, spleen fortune is impaired, and refining is the turbid turbid stasis of blood fat of disease that forms, and is detained in the body and then sees hyperlipidemia.So cards such as QI and blood deficiency, deficiency of the liver and kindey, venation are obstructed are common in the process of multiple diseases such as leukocyte after old body void, immunologic hypofunction, tumor patient radiotherapy or the chemotherapy or granulocytopenia, diabetes complicated peripheral neuritis, hyperlipemia.
At present the medicine of the various diseases due to state's internal therapy deficiency syndrome and the deficiency syndrome is few, and determined curative effect, preparation that specific aim is stronger are more rare.Introduced a kind of Chinese medicine for the treatment of the deficiency of vital energy as Chinese patent 94119239.3, adding decocting system by the Radix Astragali, Radix Codonopsis, Fructus Jujubae, Radix Glycyrrhizae forms, be used for the treatment of the symptom of the deficiency of vital energy, blood deficiency or QI and blood deficiency, but do not have the function and the effects such as treatment hyperlipidemia, diabetes complicated peripheral neuritis of blood circulation promoting and blood stasis dispelling; The 10th 7 pages big complements that record of the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation are fried in shallow oil ball and are made by flavour of a drug such as Radix Angelicae Sinensis, Radix Codonopsis, the Cortex Eucommiae, Radix Glycyrrhizae, Fructus Lycii, Rhizoma Dioscoreae, Fructus Corni, Radix Rehmanniae Preparata, function with benefiting QI and nourishing blood, nourishing the liver and kidney, diseases such as being used for deficiency of the liver and kindey, deficiency of both QI and blood, neurolysis, palpitation and amnesia, having a dizzy spell, extremity are aching and limp, but do not have the effect of diseases such as the function of blood circulation promoting and blood stasis dispelling and treatment hyperlipidemia, diabetes complicated peripheral neuritis, old body void; The 14th 76 pages Ganoderma life prolonging capsules that record of the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation are by Radix Salviae Miltiorrhizae, the Radix Astragali, Ganoderma, Radix Ginseng, Radix Notoginseng, Herba Taxilli, Fructus Schisandrae Chinensis, Herba Epimedii, flavour of a drug such as Radix Polygoni Multiflori Preparata are made, having QI invigorating consolidates, nourishing the liver and kidney, the function of blood circulation promoting and blood stasis dispelling, be used for tired, spontaneous perspiration is breathed hard, insomnia and dreamful sleep, chest pain is uncomfortable in chest, have a dizzy spell, soreness of the waist and knees, thready pulse without strength and the auxiliary treatment of tying diseases such as generation, but benefiting QI and nourishing blood insufficiency of function, to hyperlipemia, the unsatisfactory curative effect of disease such as leukocyte or granulocytopenia behind the chemicotherapy, and contain Radix Ginseng in the side, the medical material that Ganoderma etc. are more valuable, cost is higher.
Summary of the invention
Purpose of the present invention promptly is a kind of medicine for the treatment of deficiency syndrome of making at the treatment rule of the benefiting QI and nourishing blood of the cause of disease of QI and blood deficiency, deficiency of the liver and kindey and blood stasis syndrome and pathogenic characteristic establishment, nourishing liver and kidney, blood circulation promoting and blood stasis dispelling.Contain raw material of Chinese medicine such as Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Fructus Lycii, Solenognathus, Agkistrodon in the medicine of the present invention, wherein Radix Polygoni Multiflori Preparata invigorating the liver and kidney, benefiting essence-blood, black beard and hair, bone and muscle strengthening, Radix Salviae Miltiorrhizae promoting blood circulation by removing blood stasis, benefiting QI and nourishing blood, the Rhizoma Chuanxiong blood-activating and qi-promoting can help Radix Salviae Miltiorrhizae to enrich blood and transfer the merit of blood, Fructus Lycii nourishing liver and kidney benefit is smart, can help the power of Radix Polygoni Multiflori invigorating the liver and kidney, beneficial vital essence, Solenognathus, Agkistrodon are the in love product of flesh and blood, but both nourishing blood and replenishing essences, have the power of collateral dredging again, can reach disease institute by messenger drug.So these medicines make up can be so that effect separately produces synergism, thereby produces the effect of unexpected treatment deficiency syndrome.
Can also contain one or more the raw material of Chinese medicine in Radix Codonopsis, the Radix Astragali, the Cortex Eucommiae, Gecko, the Radix Angelicae Sinensis in the medicine of the present invention.This is because the Radix Codonopsis replenishing QI to invigorate the spleen nourishes blood, Radix Astragali QI invigorating and blood producing, can help the merit of Radix Codonopsis benefiting qi and nourishing blood, Cortex Eucommiae invigorating the liver and kidney, bone and muscle strengthening, Gecko invigorating the lung and the kidney, supporing yang benefit are smart, can help the power of Radix Polygoni Multiflori invigorating the liver and kidney, beneficial vital essence, the Radix Angelicae Sinensis inrigorating qi and promoting blood circulation, can help Radix Salviae Miltiorrhizae to enrich blood and transfer the merit of blood, thereby make medicine of the present invention produce more good curative effect.
The raw material of Chinese medicine consumption of drug component of the present invention also through the inventor grope in a large number sum up, research checking draws repeatedly, the consumption of each component all has curative effect preferably in the scope of following weight part ratio example: 50～250 parts of Radix Polygoni Multiflori Preparatas, 120～600 parts of Radix Salviae Miltiorrhizaes, 30～150 parts of Rhizoma Chuanxiongs, 50～250 parts of Fructus Lycii, 12～60 parts of Solenognathus, 60～300 parts of Agkistrodons.
The consumption of the raw material of Chinese medicine of drug component of the present invention can also be: 50～250 parts of Radix Polygoni Multiflori Preparatas, 120～600 parts of Radix Salviae Miltiorrhizaes, 30～150 parts of Rhizoma Chuanxiongs, 50～250 parts of Fructus Lycii, 12～60 parts of Solenognathus, 60～300 parts of Agkistrodons add 30～150 parts of Radix Codonopsis, 25～120 parts of the Radixs Astragali, 12～60 parts of the Cortexs Eucommiae, 5～25 parts of Geckos more in addition, a kind of raw material of Chinese medicine in 60～300 parts of the Radix Angelicae Sinensis or the combination of more than one raw material of Chinese medicine.
The part by weight of each tcm components raw material that medicine of the present invention can adopt especially is: 120～130 parts of Radix Polygoni Multiflori Preparatas, 300～320 parts of Radix Salviae Miltiorrhizaes, 75～80 parts of Rhizoma Chuanxiongs, 120～130 parts of Fructus Lycii, 35～40 parts of Solenognathus, 160～170 parts of Agkistrodons can also add 70～80 parts of Radix Codonopsis, 60～65 parts of the Radixs Astragali, 30～35 parts of the Cortexs Eucommiae, 12～14 parts of Geckos more in addition, a kind of raw material of Chinese medicine in 150～160 parts of the Radix Angelicae Sinensis or the combination of more than one raw material of Chinese medicine.
Medicine of the present invention can add preparation required various conventional adjuvant during different dosage form, as disintegrating agent, lubricant, binding agent, cosolvent etc., and is prepared into any common formulations with the method for Chinese medicinal of routine.Make powder after for example each tcm components raw material directly can being pulverized; Also can or use ethanol extraction with these crude drug waters, remerge extracting solution, concentrate after filtration,, add the required different auxiliary material of different solid preparations in addition, and after handling accordingly, promptly can be made into multi-form solid preparations such as granule, capsule, tablet, pill, powder, drop pill; Also can or use ethanol extraction with all these crude drug waters, concentrate after filtration,, add the required different auxiliary material of preparation different liquids preparation again, and after handling accordingly, promptly can be made into multi-form liquid preparations such as mixture, syrup, injection, Emulsion; Also these crude drug can be extracted with the Spirit of variable concentrations and make medicated wine.
In order to guarantee that the medicine of the present invention that adopts different preparation means to make can have better quality, the present invention has adopted several different methods unlike the prior art to the preparation control of testing in preparation process, and through groping repeatedly and screen, determined the every testing conditions and the parameters such as preparation method, content limit of the extracting method of identification check, the chromatographic column filler that extracts solvent, lamellae, developing solvent, developer and assay, mobile phase, detection wavelength, need testing solution.These methods comprise:
1. Radix Polygoni Multiflori Preparata contained in the medicine of the present invention, Fructus Lycii, Radix Codonopsis, the Radix Astragali are carried out identification check
(1) discriminating of Radix Polygoni Multiflori Preparata:
The preparation of getting this medicine (is equivalent to contain Radix Polygoni Multiflori Preparata 0.5～3g in right amount approximately, wherein solid preparation needs porphyrize), add 1～5mol/L sulphuric acid or hydrochloric acid solution 20～100ml, add chloroform 20～100ml, reflux 0.5～2 hour is put cold, divide and get chloroform layer, evaporate to dryness, residue add chloroform 1～4ml makes dissolving, as need testing solution; Get Radix Polygoni Multiflori control medicinal material 0.2～1.5g, add above-mentioned acid solution and chloroform, shine medical material solution in pairs with legal system; Other gets the emodin reference substance, and chlorination is copied into the reference substance solution that every 1ml contains 0.5～2mg; Employing is the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, upper solution with toluene-ethyl acetate-formic acid (15:2:1) or petroleum ether (30～60 ℃)-Ethyl formate-formic acid (15:5:1) is developing solvent, developer is an ammonia steam, inspects under the daylight.
(2) discriminating of Fructus Lycii:
The preparation of getting this medicine an amount of (be equivalent to contain Fructus Lycii 0.5～4g approximately, wherein solid preparation needs add water 20～100ml) behind the porphyrize, with ethyl acetate extraction 1～3 time, each 10～60ml, extracting solution merges, and is concentrated into 1～3ml in the water-bath, as need testing solution; Other gets Fructus Lycii control medicinal material 0.3～1.5g, adds water 20～100ml, boils the back and keeps little boiling 10～60 minutes, filters, and filtrate is shone medical material solution in pairs with legal system; Adopting silica gel g thin-layer plate, is developing solvent with ethyl acetate-chloroform-formic acid (3:2:1) or chloroform-ethyl acetate-benzene-formic acid (5:6:3:1), uviol lamp (365nm) colour developing down.
(3) discriminating of Radix Codonopsis:
The preparation of getting this medicine (is equivalent to contain Radix Codonopsis 0.5～3g in right amount approximately, wherein solid preparation needs porphyrize, liquid preparation needs water-bath to doing), add dehydrated alcohol 20～100ml supersound extraction 10～60 minutes, filter the filtrate evaporate to dryness, residue adds water 10～80ml makes dissolving, filter, filtrate is extracted with ethyl acetate 20～100ml, and the water intaking layer adds hydrochloric acid 1～4ml, reflux 10～60 minutes, put coldly, extract 1～3 time each 15～60ml with the chloroform jolting, combined chloroform liquid, evaporate to dryness, residue add methanol 0.5～3ml makes dissolving, as need testing solution; Other gets Radix Codonopsis control medicinal material 0.5～3g, adds water 20～100ml and boils and keep little and boiled 10～60 minutes, filters, and filtrate adds hydrochloric acid 1～4ml, shines medical material solution in pairs with legal system; Adopting silica gel g thin-layer plate, be developing solvent with benzene-ethyl acetate-formic acid (12:4:0.6) or toluene-ethyl acetate-formic acid (15:5:2), is developer with 10% ethanol solution of sulfuric acid, 105 ℃ dry by the fire develop the color to speckle clear.
(4) discriminating of the Radix Astragali:
Get the preparation an amount of (be equivalent to contain the Radix Astragali 0.3～2g approximately, wherein solid preparation needs to add 20～100ml methanol supersound extraction 10～60 minutes behind the porphyrize, filters, and filtrate evaporate to dryness, residue add water 20～100ml makes dissolving) of this medicine, by the D that has handled well
101The type macroporous resin column, successively with water, 10%～30% ethanol, 20～80ml eluting of sodium hydroxide solution 20～100ml of 0.2%～1.0%, capacity and discard eluent, use ethanol 20～100ml eluting of 50%～85% at last, the eluent evaporate to dryness, residue adds ethanol 0.5～3ml makes dissolving, as need testing solution; Other gets the astragaloside reference substance, adds methanol and makes the contrast solution that every 1ml contains 0.5～3mg; Adopt silica gel g thin-layer plate, lower floor's solution of placing below 10 ℃ with chloroform-methanol (4:1) or chloroform-methanol-water (13:7:2) is developing solvent, and developer is 10% ethanol solution of sulfuric acid, 105 ℃ dry by the fire develop the color to speckle clear.
2. danshensu in the medicine of the present invention or danshensu sodium content are measured
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Methanol-0.5% acetic acid (5:95) or acetonitrile-water-acetic acid (5:160:1) are mobile phase; The detection wavelength is 270～290nm; Number of theoretical plate calculates by danshensu or danshensu sodium peak should be not less than 3000;
The preparation of reference substance solution: precision takes by weighing danshensu or danshensu sodium reference substance 10mg, puts in the 100ml measuring bottle, adds dissolve with methanol and is diluted to scale, shakes up, and promptly gets (containing danshensu or danshensu sodium 0.1mg among every 1ml);
The preparation of need testing solution: getting the preparation of this medicine, an amount of (be equivalent to contain Radix Salviae Miltiorrhizae 0.1～0.6g approximately, wherein the solid preparation porphyrize is put in the tool plug conical flask; Liquid preparation puts that water-bath evaporates into dried in the tool plug conical flask), the accurate methanol 10～50ml that adds claims decide weight, and supersound process 10～60 minutes is put coldly, supplies the weight that subtracts mistake with methanol, filtration, filtrate is centrifugal, promptly;
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly;
The content that records contained danshensu sodium in the preparation must not be less than 0.60% of contained Radix Salviae Miltiorrhizae amount.
In the prior art, the preparation that much contains Radix Salviae Miltiorrhizae all is to adopt the method for measuring protocatechualdehyde when measuring content.But protocatechualdehyde is not the specificity composition of Radix Salviae Miltiorrhizae, thereby medicine of the present invention adopts the danshensu that contained in the Radix Salviae Miltiorrhizae or the method for danshensu sodium measured in preparation process, can control the quality of preparation better like this, thereby make medicine of the present invention that better therapeutic can be arranged.
Medicine of the present invention has benefiting QI and nourishing blood, nourishing the liver and kidney, blood circulation promoting and blood stasis dispelling and raise immunity, physical strength reinforcing, rise white, antiinflammatory, blood fat reducing, improve functions such as reticuloendothelial system phagocytic effect, can improve QI and blood deficiency, deficiency of the liver and kindey, the various symptoms of Chinese medicine deficiency-syndrome due to the blood stasis are to immunologic hypofunction, diabetes complicated peripheral neuritis, hyperlipemia, old age and presenium body void, body void after being ill, leukocyte or granulocytopenia and chronic fatigue syndrome behind the chemicotherapy, tumor, coronary heart disease, struma lymphomatosa, the concurrent bone does not connect of fracturing, chloasma etc. all have treatment and auxiliary treatment effect preferably.
The specific embodiment
Further set forth the beneficial effect of medicine of the present invention below by the specific embodiment, these specific embodiment have comprised the result of toxicity test, pharmacodynamics test and the clinical research of medicine of the present invention.
Toxicity test:
As laboratory sample, gavage for respectively mice and rat medicine of the present invention, record the LD of mice
5050g crude drug/kg, be more than 212 times of a clinical consumption per day, to the LD of rat
5060g crude drug/kg, be more than 254 times of a clinical consumption per day, illustrate that its toxicity is little, the clinical extremely safe of taking.Long term toxicity test shows, rat gavages medicine 0.9,2.8 of the present invention, 20g crude drug/kg (be equivalent to a clinical consumption per day 3.8,11.9,84.7 times) every day, its outward appearance of 9 weeks back inspection, body weight, routine blood test, blood biochemical, postmortem and internal organs counting, histopathology etc. are all no abnormal, compare there was no significant difference (P＜0.01 or P＜0.05) with matched group, illustrate that it also is safe that medicine of the present invention is taken for a long time.
Pharmacodynamic test of active extract:
Pharmacodynamic experiment proves, can obviously improve the situation (P＜0.01) that leukocyte count that cyclophosphamide causes reduces behind the mouse gavaging medicine of the present invention; That can obviously improve mice cleans up index (K) (P＜0.01), phagocytic index (α) (P＜0.01 or P＜0.05) and haemolysis value (P＜0.01); Xylol induced mice ear swelling has obvious suppression effect (P＜0.01 or P＜0.05), the swelling of the caused rat hindleg pad of Fround ' s Freund's complete adjuvant is obviously disappeared, and tangible dose-effect relationship (P＜0.01) is arranged; Hemoglobin and erythrocyte to the mice that loses blood have tangible increase effect (P＜0.01); Can effectively prevent the weight loss due to the mouse subcutaneous injection hydrocortisone and the atrophy (P＜0.01) of thymus, adrenal gland and spleen, obviously increase the swimming time of animal and dose-effect relationship (P＜0.01) is arranged; Can make cholesterol, triglyceride due to the quiet notes alloxan of rat feeding high lipid food and mice obviously descend (P＜0.01 or P＜0.05) that raises.This explanation medicine of the present invention has antagonism to the leukopenia that chemotherapy etc. is caused, and has the effect of raising reticuloendothelial system (RES) phagocytic function, has effects such as antiinflammatory, blood fat reducing, physical strength reinforcing and raise immunity.
The clinical research result:
Clinical research is the result prove, medicine of the present invention is to old age and presenium body void, the effective percentage of body void is 93.33% after being ill, and every tcm symptom is clearly better (P＜0.01), CD
3 +, CD
4 +, CD
8 +, complement C
3Obviously improve (P＜0.01 or P＜0.05) Deng immune indexes; To put, the effective percentage of leukocyte or granulocytopenia is 93.33% (P＜0.01 or P＜0.05) after the chemotherapy, the effective percentage of tcm syndrome curative effect is 90.00% (P＜0.01): the effective percentage to the hyperlipidemia treatment is 92.00%, patient's cholesterol, glycerol
Ester obviously reduces, high density lipoprotein obviously raise (being P＜0.01), tcm symptom is clearly better (P＜0.01 or P＜0.05): the total effective rate to diabetes complicated peripheral neuritis is 90.20% (P＜0.01), every tcm symptom be clearly better (P＜0.01 or P＜0.05), doctor trained in Western medicine sign and cardinal symptom are also obviously improved (P＜0.01 or P＜0.05), fasting glucose obviously descend (P＜0.01); Every symptom behind the treating malignant tumor is obviously improved even disappearance, and total effective rate is 94.44%, and numeration of leukocyte obviously rises.Medicine of the present invention also has therapeutical effect preferably to chronic fatigue syndrome, coronary heart disease, struma lymphomatosa, the concurrent bone does not connect of fracture, chloasma etc. and QI and blood deficiency, deficiency of the liver and kindey, the relevant disease of blood stasis.
Come further to set forth medicine of the present invention and method of quality control thereof by the following examples.
Embodiment 1: the preparation tablets of medicine of the present invention
Get the raw material of Chinese medicine of following weight: Radix Polygoni Multiflori Preparata 85g, Radix Salviae Miltiorrhizae 210g, Rhizoma Chuanxiong 50g, Fructus Lycii 85g, Solenognathus 24g, Agkistrodon 110g, wherein Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Fructus Lycii add 10,8,6 times of water gagings decoctions 3 times respectively, respectively are 1.5,1,0.5 hours, collecting decoction, filter, be concentrated into relative density and be 1.20 clear paste, add ethanol and make and contain the alcohol amount and reach 65%, left standstill 24 hours, filter filtrate for later use; Solenognathus, Agkistrodon were with 60% soak with ethanol 15 days; filter; filtrate and above-mentioned filtrate merge, and is centrifugal behind the decompression recycling ethanol, concentrates; add the adjuvant granulation after adding adjuvant one-step palletizing or spray drying; be pressed into 1000, every 0.5g, coating; following through identification check, assay approval, that is:
(1) discriminating of Radix Polygoni Multiflori Preparata:
Get 10 in this tablet, add 2.5mol/L sulfuric acid solution 50ml behind the porphyrize, add chloroform 40ml again, reflux 1 hour is put coldly, divides and to get chloroform layer, and evaporate to dryness, residue add chloroform 2ml makes dissolving, as need testing solution; Get Radix Polygoni Multiflori control medicinal material 1g, add above-mentioned identical acid solution and chloroform, shine medical material solution in pairs with legal system; Other gets the emodin reference substance, and chlorination is copied into the reference substance solution that every 1ml contains 1mg; Method according to Chinese Pharmacopoeia detects, and adopting with the sodium carboxymethyl cellulose is the silica gel g thin-layer plate of binding agent, is developing solvent with toluene-ethyl acetate-formic acid (15:2:1), and developer is an ammonia steam, inspects under the daylight.
(2) discriminating of Fructus Lycii:
Get 12 in this tablet, add water 40ml behind the porphyrize, use ethyl acetate extraction 2 times, each 40ml, extracting solution merges, and is concentrated into 3ml in the water-bath, as need testing solution; Other gets Fructus Lycii control medicinal material 1g, adds water 60ml, boils the back and keeps little boiling 20 minutes, filters, and filtrate is shone medical material solution in pairs with legal system; Method according to Chinese Pharmacopoeia detects, and adopts silica gel g thin-layer plate, is developing solvent with ethyl acetate-chloroform-formic acid (3:2:1), uviol lamp (365nm) colour developing down.
(3) assay:
High effective liquid chromatography for measuring according to Chinese Pharmacopoeia.
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Methanol-0.5% acetic acid (5:95) is mobile phase; The detection wavelength is 280nm; Number of theoretical plate calculates by danshensu or danshensu sodium peak should be not less than 3000;
The preparation of reference substance solution: precision takes by weighing danshensu or danshensu sodium reference substance 10mg, puts in the 100ml measuring bottle, adds dissolve with methanol and is diluted to scale, shakes up, and promptly gets (containing danshensu or danshensu sodium 0.1mg among every 1ml);
The preparation of need testing solution: get the preparation porphyrize of this medicine, get 0.4g, accurate claim surely, put in the tool plug conical flask, the accurate methanol 30ml that adds claims decide weight, and supersound process 30 minutes is put coldly, supplies the weight that subtracts mistake with methanol, filtration, and filtrate is centrifugal, promptly;
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly;
The content that records contained danshensu sodium in the preparation must not be less than 0.60% of contained Radix Salviae Miltiorrhizae amount.
Embodiment 2: the granule preparation of medicine of the present invention
Get the raw material of Chinese medicine of following weight: Radix Polygoni Multiflori Preparata 130g, Radix Salviae Miltiorrhizae 320g, Rhizoma Chuanxiong 80g, Fructus Lycii 125g, Solenognathus 38g, Agkistrodon 170g, Radix Codonopsis 75g, Radix Astragali 65g, Cortex Eucommiae 32g, Gecko 13g, Radix Angelicae Sinensis 160g, wherein Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Fructus Lycii, the Cortex Eucommiae, Radix Codonopsis, the Radix Astragali, Radix Angelicae Sinensis add 10,8 times of water gagings decoctions 2 times respectively, each 1.5 hours, collecting decoction filters filtrate for later use; Solenognathus, Agkistrodon, Gecko filter with 70% soak with ethanol 10 days, and decompression recycling ethanol merges with above-mentioned filtrate, be concentrated into relative density 1.16, add the adjuvant one-step palletizing, granulate is distributed into 250 bags, every bag of 4g, following through identification check, assay approval, that is:
(1) discriminating of Radix Polygoni Multiflori Preparata:
Get this granule 8g, add 3mol/L hydrochloric acid solution 40ml behind the porphyrize, add chloroform 40ml again, reflux 1 hour is put coldly, divides and to get chloroform layer, and evaporate to dryness, residue add chloroform 2ml makes dissolving, as need testing solution; Get Radix Polygoni Multiflori control medicinal material 1g, add above-mentioned identical acid solution and chloroform, shine medical material solution in pairs with legal system; Other gets the emodin reference substance, and chlorination is copied into the reference substance solution that every 1ml contains 1mg; Detect according to the method for Chinese Pharmacopoeia, adopting with the sodium carboxymethyl cellulose is the silica gel g thin-layer plate of binding agent, is developing solvent with the upper solution of petroleum ether (30～60 ℃)-Ethyl formate-formic acid (15:5:1), and developer is an ammonia steam, inspects under the daylight.
(2) discriminating of Fructus Lycii:
Get this granule 10g, add water 40ml behind the porphyrize, use ethyl acetate extraction 2 times, each 30ml, extracting solution merges, and is concentrated into 2ml in the water-bath, as need testing solution; Other gets Fructus Lycii control medicinal material 0.5g, adds water 50ml, boils the back and keeps little boiling 30 minutes, filters, and filtrate is shone medical material solution in pairs with legal system; Method according to Chinese Pharmacopoeia detects, and adopts silica gel g thin-layer plate, is developing solvent with chloroform-ethyl acetate-benzene-formic acid (5:6:3:1), uviol lamp (365nm) colour developing down.
(3) discriminating of Radix Codonopsis:
Get this granule 12g, add dehydrated alcohol 40ml supersound extraction 30 minutes behind the porphyrize, filter, filtrate evaporate to dryness, residue add water 50ml makes dissolving, filters, filtrate is extracted with ethyl acetate 40ml, and the water intaking layer adds hydrochloric acid 2ml, reflux 40 minutes, put coldly, extract 2 times each 20ml with the chloroform jolting, combined chloroform liquid, evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution; Other gets Radix Codonopsis control medicinal material 1g, adds water 40ml and boils and keep little and boiled 40 minutes, filters, and filtrate adds hydrochloric acid 2ml, shines medical material solution in pairs with legal system; Detecting according to the method for Chinese Pharmacopoeia, adopt silica gel g thin-layer plate, be developing solvent with benzene-ethyl acetate-formic acid (12:4:0.6), is developer with 10% ethanol solution of sulfuric acid, 105 ℃ dry by the fire develop the color to speckle clear.
(4) discriminating of the Radix Astragali:
Get this granule 12g, add 50ml methanol supersound extraction 40 minutes behind the porphyrize, filter, filtrate evaporate to dryness, residue add water 60ml makes dissolving, by the D that has handled well
101The type macroporous resin column successively with water, the 20% ethanol 50ml eluting of 0.5% sodium hydroxide solution 60ml, capacity and discard eluent, is used 70% ethanol 50ml eluting at last, and eluent evaporate to dryness, residue add ethanol 1ml makes dissolving, as need testing solution; Other gets the astragaloside reference substance, adds methanol and makes the contrast solution that every 1ml contains 1mg; Detect according to the method for Chinese Pharmacopoeia, adopt silica gel g thin-layer plate, lower floor's solution of placing below 10 ℃ with chloroform-methanol-water (13:7:2) is developing solvent, and developer is 10% ethanol solution of sulfuric acid, 105 ℃ dry by the fire develop the color to speckle clear.
(5) assay:
High effective liquid chromatography for measuring according to Chinese Pharmacopoeia.
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-water-acetic acid (5:160:1) is mobile phase; The detection wavelength is 285nm; Number of theoretical plate calculates by danshensu or danshensu sodium peak should be not less than 3000;
The preparation of reference substance solution: precision takes by weighing danshensu or danshensu sodium reference substance 10mg, puts in the 100ml measuring bottle, adds dissolve with methanol and is diluted to scale, shakes up, and promptly gets (containing danshensu or danshensu sodium 0.1mg among every 1ml);
The preparation of need testing solution: get the preparation porphyrize of this medicine, get 0.8g, accurate claim surely, put in the tool plug conical flask, the accurate methanol 30ml that adds claims decide weight, and supersound process 20 minutes is put coldly, supplies the weight that subtracts mistake with methanol, filtration, and filtrate is centrifugal, promptly;
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly;
The content that records contained danshensu sodium in the preparation must not be less than 0.60% of contained Radix Salviae Miltiorrhizae amount.
Embodiment 3: the injection preparation of medicine of the present invention
Get the raw material of Chinese medicine of following weight: Radix Polygoni Multiflori Preparata 240g, Radix Salviae Miltiorrhizae 550g, Rhizoma Chuanxiong 75g, Fructus Lycii 120g, Solenognathus 36g, Agkistrodon 100g, Cortex Eucommiae 15g, Radix Angelicae Sinensis 150g, wherein Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Fructus Lycii, the Cortex Eucommiae, the Radix Angelicae Sinensis water for injection that adds 8,6 times of amounts respectively respectively decocted 1.5,1 hours, collecting decoction filters, and filtrate is concentrated into relative density 1.20, adding ethanol makes and contains alcohol amount and reach 60%, left standstill 24 hours, and filtered filtrate for later use; Solenognathus, Agkistrodon filter with 60% soak with ethanol 15 days, merge decompression recycling ethanol with above-mentioned filtrate, reconcentration is to relative density 1.15, adds ethanol and makes and contain the alcohol amount and reach 80%, leaves standstill 48 hours, filter, centrifugal behind the recovery ethanol, get supernatant, add the needed adjuvant of injection, mixing is regulated pH value to 5.0～7.0, add the injection water to 1000ml, filter fill, sterilization, following through identification check, assay approval, that is:
(1) discriminating of Radix Polygoni Multiflori Preparata:
Get said preparation 5ml, add 5mol/L sulfuric acid solution 30ml, add chloroform 40ml, reflux 1.5 hours is put coldly, divides and gets chloroform layer, and evaporate to dryness, residue add chloroform 1.5ml makes dissolving, as need testing solution; Get Radix Polygoni Multiflori control medicinal material 1g, add 3mol/L hydrochloric acid solution 40ml, shine medical material solution in pairs with legal system; Other gets the emodin reference substance, and chlorination is copied into the reference substance solution that every 1ml contains 1mg; Detect according to the method for Chinese Pharmacopoeia, adopting with the sodium carboxymethyl cellulose is the silica gel g thin-layer plate of binding agent, is developing solvent with the upper solution of petroleum ether (30～60 ℃)-Ethyl formate-formic acid (15:5:1), and developer is an ammonia steam, inspects under the daylight.
(2) discriminating of Fructus Lycii:
Get said preparation 10ml, use ethyl acetate extraction 3 times, each 20ml, extracting solution merges, and is concentrated into 2ml in the water-bath, as need testing solution; Other gets Fructus Lycii control medicinal material 0.5g, adds water 40ml, boils the back and keeps little boiling 30 minutes, filters, and filtrate is shone medical material solution in pairs with legal system; Method according to Chinese Pharmacopoeia detects, and adopts silica gel g thin-layer plate, is developing solvent with chloroform-ethyl acetate-benzene-formic acid (5:6:3:1), uviol lamp (365nm) colour developing down.
(3) assay:
High effective liquid chromatography for measuring according to Chinese Pharmacopoeia.
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-water-acetic acid (5: 160: 1) is mobile phase; The detection wavelength is 275nm; Number of theoretical plate calculates by danshensu or danshensu sodium peak should be not less than 3000;
The preparation of reference substance solution: precision takes by weighing danshensu or danshensu sodium reference substance 10mg, puts in the 100ml measuring bottle, adds dissolve with methanol and is diluted to scale, shakes up, and promptly gets (containing danshensu or danshensu sodium 0.1mg among every 1ml);
The preparation of need testing solution: get the preparation 0.5ml of this medicine, put in the tool plug conical flask, water-bath evaporates into dried, and the accurate methanol 20ml that adds claims decide weight, and supersound process 30 minutes is put coldly, supplies the weight that subtracts mistake with methanol, filtration, and filtrate is centrifugal, promptly;
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly;
The content that records contained danshensu sodium in the preparation must not be less than 0.60% of contained Radix Salviae Miltiorrhizae amount.
Claims (18)
1. medicine for the treatment of deficiency syndrome is characterized in that it is made up of following bulk drugs: 50～250 parts of Radix Polygoni Multiflori Preparatas, 120～600 parts of Radix Salviae Miltiorrhizaes, 30～150 parts of Rhizoma Chuanxiongs, 50～250 parts of Fructus Lycii, 12～60 parts of Solenognathus, 60～300 parts of Agkistrodons.
2. medicine according to claim 1 is characterized in that the weight portion of each crude drug is: 120～130 parts of Radix Polygoni Multiflori Preparatas, 300～320 parts of Radix Salviae Miltiorrhizaes, 75～80 parts of Rhizoma Chuanxiongs, 120～130 parts of Fructus Lycii, 35～40 parts of Solenognathus, 160～170 parts of Agkistrodons.
3. medicine for the treatment of deficiency syndrome, it is characterized in that: it also contains weight portion and is a kind of crude drug among 60～300 parts of 30～150 parts of the Radix Codonopsis, 25～120 parts of the Radixs Astragali, 12～60 parts of the Cortexs Eucommiae, 5～25 parts of Geckos, Radix Angelicae Sinensis or more than one combination raw materials medicine except containing the crude drug that weight portion is 50～250 parts of Radix Polygoni Multiflori Preparatas, 120～600 parts of Radix Salviae Miltiorrhizaes, 30～150 parts of Rhizoma Chuanxiongs, 50～250 parts of Fructus Lycii, 12～60 parts of Solenognathus, 60～300 parts of Agkistrodons.
4. medicine according to claim 3 is characterized in that: described weight portion is 120～130 parts of Radix Polygoni Multiflori Preparatas, 300～320 parts of Radix Salviae Miltiorrhizaes, 75～80 parts of Rhizoma Chuanxiongs, 120～130 parts of Fructus Lycii, 35～40 parts of Solenognathus, 160～170 parts of Agkistrodons, 70～80 parts of Radix Codonopsis, 60～65 parts of the Radixs Astragali, 30～35 parts of the Cortexs Eucommiae, 12～14 parts of Geckos, 150～160 parts of Radix Angelicae Sinensis.
5. as the detection method of claim 1,2,3 or 4 described treatment deficiency syndrome medicines, it is characterized in that: the preparation of (1) need testing solution: the preparation of getting this medicine that is equivalent to contain Radix Polygoni Multiflori Preparata 0.5～3g is an amount of, and wherein solid preparation needs porphyrize; Add 1～5mol/L sulphuric acid or hydrochloric acid solution 20～100ml, add chloroform 20～100ml, reflux 0.5～2 hour is put coldly, divides and gets chloroform layer, and evaporate to dryness, residue add chloroform 1～4ml makes dissolving, as need testing solution;
(2) preparation of control medicinal material solution: get Radix Polygoni Multiflori control medicinal material 0.2～1.5g, add 1～5mol/L sulphuric acid or hydrochloric acid solution 20～100ml, chloroform 20～100ml, reflux 0.5～2 hour, put coldly, divide and to get chloroform layer, evaporate to dryness, residue adds chloroform 1～4ml makes dissolving, makes control medicinal material solution;
(3) reference substance: emodin reference substance;
(4) lamellae: with the sodium carboxymethyl cellulose is the silica gel g thin-layer plate of binding agent;
The upper solution of petroleum ether-Ethyl formate-formic acid of 30～60 ℃ of toluene-ethyl acetate of (5) developing solvent: 15:2:1-formic acid or 15:5:1;
(6) developer: inspect under the ammonia steam, daylight.
6. as the detection method of claim 1,2,3 or 4 described treatment deficiency syndrome medicines, it is characterized in that:
(1) preparation of need testing solution: the preparation of getting this medicine that is equivalent to contain Fructus Lycii 0.5～4g is an amount of, and wherein solid preparation needs add water 20～100ml behind the porphyrize; With ethyl acetate extraction 1～3 time, each 10～60ml, extracting solution merges, and is concentrated into 1～3ml in the water-bath, as need testing solution;
(2) preparation of control medicinal material solution: get Fructus Lycii control medicinal material 0.3～1.5g, add water 20～100ml, boil the back and keep little boiling 10～60 minutes, filter, filtrate is used ethyl acetate extraction 1～3 time, each 10～60ml, extracting solution merges, and is concentrated into 1～3ml in the water-bath, in contrast product solution;
(3) lamellae: silica gel g thin-layer plate;
(4) chloroform-ethyl acetate of ethyl acetate-chloroform of developing solvent: 3:2:1-formic acid or 5:6:3:1-benzene-formic acid;
(5) uviol lamp of developer: 365nm.
7. as the detection method of claim 2 or 4 described treatment deficiency syndrome medicines, it is characterized in that:
(1) preparation of need testing solution: the preparation of getting this medicine that is equivalent to contain Radix Codonopsis 0.5～3g is an amount of, and wherein solid preparation needs porphyrize, and liquid preparation needs water-bath to doing; Add dehydrated alcohol 20～100ml supersound extraction 10～60 minutes, filter the filtrate evaporate to dryness, residue adds water 10～80ml makes dissolving, filters, and filtrate is extracted with ethyl acetate 20～100ml, the water intaking layer adds hydrochloric acid 1～4ml, and reflux 10～60 minutes is put cold, extract 1～3 time with the chloroform jolting, each 15～60ml, combined chloroform liquid, evaporate to dryness, residue adds methanol 0.5～3ml makes dissolving, as need testing solution;
(2) preparation of control medicinal material solution: get Radix Codonopsis control medicinal material 0.5～3g, add water 20～100ml and boil and keep little and boiled 10～60 minutes, filter, filtrate adds hydrochloric acid 1～4ml, reflux 10～60 minutes, put coldly, extract 1～3 time each 15～60ml with the chloroform jolting, combined chloroform liquid, evaporate to dryness, residue add methanol 0.5～3ml makes dissolving, in contrast medical material solution;
(3) lamellae: silica gel g thin-layer plate;
(4) toluene-ethyl acetate of benzene-ethyl acetate of developing solvent: 12:4:0.6-formic acid or 15:5:2-formic acid;
(5) developer: 10% ethanol solution of sulfuric acid, 105 ℃ dry by the fire to speckle colour developing clear.
8. as the detection method of claim 2 or 4 described treatment deficiency syndrome medicines, it is characterized in that:
(1) preparation of need testing solution: the preparation of getting this medicine that is equivalent to contain the Radix Astragali 0.3～2g is an amount of, and wherein solid preparation needs add 20～100ml methanol supersound extraction 10～60 minutes behind the porphyrize, filters, and filtrate evaporate to dryness, residue add water 20～100ml makes dissolving; By the D that has handled well
101The type macroporous resin column, successively with water, 10%～30% ethanol, 20～80ml eluting of sodium hydroxide solution 20～100ml of 0.2%～1.0%, capacity and discard eluent, use ethanol 20～100ml eluting of 50%～85% at last, the eluent evaporate to dryness, residue adds ethanol 0.5～3ml makes dissolving, as need testing solution;
(2) reference substance: astragaloside reference substance;
(3) lamellae: silica gel g thin-layer plate;
(4) lower floor's solution that chloroform-methanol of developing solvent: 4:1 or chloroform-methanol of 13:7:2-water is placed below 10 ℃;
(5) developer: 10% ethanol solution of sulfuric acid, 105 ℃ dry by the fire to speckle colour developing clear.
9. as claim 1,2,3 or 4 described treatment deficiency syndrome content of medicines assay methods, it is characterized in that:
(1) filler: octadecylsilane chemically bonded silica; Acetonitrile-water of the methanol of mobile phase: 5:95-0.5% acetic acid or 5:160:1-acetic acid; Detect wavelength: 270～290nm;
(2) reference substance: danshensu or danshensu sodium;
(3) preparation of need testing solution: the preparation of getting this medicine that is equivalent to contain Radix Salviae Miltiorrhizae 0.1～0.6g is an amount of, and wherein the solid preparation porphyrize is put in the tool plug conical flask, and liquid preparation puts that water-bath evaporates into dried in the tool plug conical flask; The accurate methanol 10～50ml that adds claims decide weight, and supersound process 10～60 minutes is put coldly, supplies the weight that subtracts mistake with methanol, filtration, and filtrate is centrifugal, promptly;
(4) content that records contained danshensu sodium in the preparation must not be less than 0.60% of contained Radix Salviae Miltiorrhizae weight.
10. has application in the preparation of benefiting QI and nourishing blood, nourishing the liver and kidney or blood circulation promoting and blood stasis dispelling function as claims 1,2,3 or 4 described medicines in preparation.
11. have the physical strength reinforcing function or improve application in the preparation of symptom of Chinese medicine deficiency-syndrome in preparation as claims 1,2,3 or 4 described medicines.
12. application according to claim 11 is characterized in that: described physical strength reinforcing is for increasing hemoglobin and erythrocyte, prevent weight loss or preventing the atrophy of thymus, adrenal gland or spleen.
13. application according to claim 11 is characterized in that: described Chinese medicine deficiency-syndrome is the empty or body void after being ill of old age and presenium body.
14. have application in the preparation of raise immunity in preparation as claims 1,2,3 or 4 described medicines.
15. application according to claim 14 is characterized in that: described raise immunity is for improving immune indexes CD
3 +, CD
4 +, CD
8 +Or complement C
3Or improve and clean up index, phagocytic index or haemolysis value.
16. as the application of claims 1,2,3 or 4 described medicines in the preparation of preparation diabetes complicated peripheral neuritis of treatment or hyperlipemia.
17. as the application in the preparation of claims 1,2,3 or 4 described medicines leukocyte or granulocytopenia behind preparation treatment tumor or chemicotherapy.
18. have application in the preparation of antiinflammatory action in preparation as claims 1,2,3 or 4 described medicines.
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Non-Patent Citations (4)
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| 中华人民共和国药典（第一部）. 药典委员会，140，化学工业出版社. 2000 |
| 中华人民共和国药典(第一部). 药典委员会，140，化学工业出版社. 2000 * |
| 常见中药药名错误分析. 李占永.中国民间疗法，第11卷第4期. 2003 |
| 常见中药药名错误分析. 李占永.中国民间疗法，第11卷第4期. 2003 * |
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