CN1872150A - Composition of Chinese traditional medicine for replenishing qi and the blood - Google Patents
Composition of Chinese traditional medicine for replenishing qi and the blood Download PDFInfo
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- CN1872150A CN1872150A CNA2006100118634A CN200610011863A CN1872150A CN 1872150 A CN1872150 A CN 1872150A CN A2006100118634 A CNA2006100118634 A CN A2006100118634A CN 200610011863 A CN200610011863 A CN 200610011863A CN 1872150 A CN1872150 A CN 1872150A
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Abstract
A Chinese medicine for nourishing qi and blood and puerperal abdominolgia of woman is prepared from Chinese angelica root, astragalus root, donkey-hide gelatin, motherwort and tangerine peel.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, specifically, relate to a kind of can benefiting vital QI and blood, the Chinese medicine composition of promoting tissue regeneration by removing blood stasis.
Background technology
The disease of QI and blood deficiency is clinically seen more.Gas and blood relation are very close, and gas is for blood: qi promoting blood production, QI can promote blood circulation, QI can control blood; Blood is for gas: gas is the carrier of blood, and blood constantly is the functional activity of gas provide material base (essence of water and grain).So-called " qi being the governor of blood, blood being the material foundation of QI ", gas and blood are mutually promoted on generating, and rely on mutually in operation.Wound, hemorrhage, the deficiency of vital energy, the stagnation of QI, cold in blood heat in blood all can cause QI-blood circulation to be obstructed and form blood stasis, in case blood stasis forms, have more hindered mechanism of qi, influence the generation and the operation of blood.So " promoting tissue regeneration by removing blood stasis " helped with blood circulation promoting and blood stasis dispelling in vigorate qi and replenish the blood hemorrhage, all diseases of losing blood, taked QI invigorating, enrich blood, blood stasis dispelling is also with weeding out the old and bring forth the new.
The treatment QI and blood deficiency, adopt the famous ancient prescription of qi and blood tonifying very wide in clinical practice as " Radix Angelicae Sinensis decoction for tonifying blood ", " BAZHEN TANG ", " bolus of ten powerful tonics ", " Radix Ginseng is supported and held ball ", " GUIPI TANG " etc., curative effect is reliable, well known deeply, make Chinese patent medicine preparation by a plurality of producers already and be used for clinical.In addition, " Gui Lu enrich blood extract oral liquid " in Jilin is made up of Radix Angelicae Sinensis, the Radix Astragali, Cornu Cervi, Colla Corii Asini, sucrose, is used for the treatment of various anemias, the hemorrhage of QI failing to control blood; " blood speed rises electuary " in Hebei is made up of the Radix Astragali, Radix Angelicae Sinensis, Herba Epimedii, Colla Corii Asini, is used for the chlorosis of deficiency of both QI and blood, diseases such as menoxenia; " the XUEBAO capsule " in Guangdong is made up of Melanteritum, the Radix Astragali, Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae, iron deficiency anemia 253 examples due to the how tame hospitalize a variety of causes such as Guangzhou No.2 People's Hospital, Guangdong People's Hospital, and total effective rate reaches 93.7%.Also have the production of Zhejiang Hangzhou Hu Qingyu Pharmaceutical Workshop pharmaceutical factory " when Chinese herbaceous peony LIUJUNZI WAN " or the like in addition.Add up the composition of above-mentioned multiple prescription, the frequency of occurrences of medicines such as the Radix Astragali, Radix Angelicae Sinensis, Colla Corii Asini, Pericarpium Citri Reticulatae is very high, yet that recipe is prescribed after the establishment of the principle of treatment is determined is rare in the kind of " promoting tissue regeneration by removing blood stasis ".
Herba Leonuri is gynecological's key medicine, and it contains leonurine first, leonurine second, stachydrine, potassium chloride, lauric acid, oleic acid etc. modern study.Have promoting blood flow to regulate menstruation, promoting the circulation of blood dissipating blood stasis, be uterine stimulant, promote uterine contraction, hemorrhage or diseases such as lochia, abdominal part distending pain after managing property, dysmenorrhea to stagnation of QI-blood also has therapeutical effect preferably, because these product have blood vessel dilating, the effect of diuresis blood stasis removing also to be used for diseases such as hypertension, acute and chronic nephritis.
Summary of the invention
(1) technical problem that will solve
Purpose of the present invention aim to provide a kind of can benefiting vital QI and blood, the Chinese medicine composition of promoting tissue regeneration by removing blood stasis.
(2) technical scheme
Chinese medicine composition provided by the invention is to be made by effective ingredient and/or acceptable accessories, and wherein said effective ingredient is to be made by following raw materials according by weight ratio: Radix Angelicae Sinensis 20-500, Radix Astragali 20-500, Colla Corii Asini 10-300, Herba Leonuri 20-500, Pericarpium Citri Reticulatae 1-100.
Preferred weight proportion: Radix Angelicae Sinensis 80-120, Radix Astragali 80-120, Colla Corii Asini 24-36, Herba Leonuri 120-180, Pericarpium Citri Reticulatae 2.4-3.6.
Preferred dosage form is tablet, capsule, soft capsule, granule, syrup, oral liquid, pill, drop pill or dispersible tablet.
The preparation method of Chinese medicine composition of the present invention comprises that step is as follows:
(1) Radix Astragali, Herba Leonuri are added 3-10 times of water gaging and decoct 1-5 time, each 1-3 hour, collecting decoction filtered, and filtrate is concentrated into the clear paste that relative density is 1.10-1.25 (50-90 a ℃), and is standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, doubly measure the ethanol of 40-95% with 3-8 and make solvent, and percolation behind the dipping 8-90h is collected percolate, and percolate reclaims ethanol and is concentrated into the clear paste that relative density is 1.10-1.25 (50-90 a ℃), and is standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, adds Radix Angelicae Sinensis, Pericarpium Citri Reticulatae clear paste again, mix getting final product.
Preferred step (1) be with the Radix Astragali, Herba Leonuri add for the first time 4.8-6 times of water gaging decoct leached decocting liquid in 2 hours after, add 3.2-4.8 times of water gaging for the second time and decocted 1.5 hours, leach decocting liquid, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.10-1.15 (60-70 a ℃), and is standby.
Preferred step (2) is that Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, doubly measures the ethanol of 60-80% with 4-5 and makes solvent, and percolation behind the dipping 40-60h is collected percolate, and percolate is evaporated to the clear paste that relative density is 1.10-1.15 (60-70 a ℃), and is standby.
The discrimination method of Chinese medicine composition of the present invention is as follows:
Method 1: it is a small amount of to get this product, porphyrize, and the dipping 30min that adds diethyl ether, jolting constantly filters, and filtrate volatilizes, and residue adds dehydrated alcohol makes dissolving, as need testing solution.Other gets Radix Angelicae Sinensis control medicinal material 1g, adds ethanol supersound process 20min, filters, and filtrate is medical material solution in contrast.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) experiment.Drawing above-mentioned two kinds of solution 5ul, put respectively on same silica gel g thin-layer plate, is developing solvent with normal hexane-ethyl acetate (9-1), launches, and takes out, and dries, and puts under the ultra-violet lamp (365nm) and inspects.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical light blue white fluorescent speckle.
Method 2: it is a small amount of to get this product, and porphyrize adds methanol reflux 30min, filter, the filtrate evaporate to dryness, residue is dissolved in water, extract 3 times with water saturated n-butyl alcohol jolting, merge n-butyl alcohol liquid, wash with water 3 times, discard water lotion, n-butyl alcohol liquid is put evaporate to dryness, and residue adds methanol makes dissolving, on the neutral alumina post of having handled well (100-200 order), use 40% methanol-eluted fractions, collect eluent, evaporate to dryness, residue add methanol makes dissolving, as need testing solution.Other gets the astragaloside reference substance, adds methanol and makes the solution that contains 1mg among every 1ml, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) experiment, draw above-mentioned need testing solution 5ul, reference substance solution 3ul, putting respectively on same silica gel g thin-layer plate, is developing solvent with lower floor's solution of chloroform-methanol-water (13-7-2), launches, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃.Put respectively under daylight and the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle and the fluorescence speckle of same color.
The assay photograph N2 method of Chinese medicine composition of the present invention (" appendix Ix.L first method of Chinese pharmacopoeia version in 2000) measure.Wherein nitrogen content must not be less than 12%.
(" an appendix VI of Chinese Pharmacopoeia version in 92000 D " measures the content of Radix Angelicae Sinensis according to high performance liquid chromatography in the Chinese medicine composition of the present invention.
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Methanol-1% glacial acetic acid solution (27-73) is a mobile phase; The detection wavelength is 313nm.Number of theoretical plate calculates by the ferulic acid peak should be not less than 1000.
The preparation of reference substance solution: precision takes by weighing the ferulic acid that is dried to constant weight through phosphorus pentoxide, is formulated as the reference substance solution that every 1ml contains ferulic acid 10ug with methanol.
The preparation of need testing solution: get this product porphyrize, mixing is got 1g, accurate claims surely, puts in the 50ml measuring bottle, adds 60% methanol solution 40ml of 1% glacial acetic acid, and supersound process 40min is put coldly, adds mobile phase and is diluted to scale, shakes up, and filters, and gets subsequent filtrate, promptly.
Algoscopy: accurate respectively reference substance solution and each 10ul of need testing solution of drawing, inject hplc determination.
Wherein contain Radix Angelicae Sinensis with ferulic acid (C
10H
10O
4) meter, must not be less than 1.2mg.
Chinese medicine composition of the present invention has the effect of benefiting vital QI and blood, promoting tissue regeneration by removing blood stasis, is particularly useful for the QI and blood deficiency syndrome of blood stasis puerperal abdonimal pain of holding concurrently.
(3) beneficial effect
Chinese medicine composition of the present invention is to add the Chinese medicine preparation that Herba Leonuri, Pericarpium Citri Reticulatae, Colla Corii Asini are processed into through extraction by the Chinese medicine angelica with blood yiqi, the Radix Astragali, and prescription is terse.This product really has the effect of benefiting vital QI and blood, promoting tissue regeneration by removing blood stasis, to after all kinds of operations of women, puerperal QI and blood deficiency syndrome of blood stasis person truly have curative effect, total effective rate is 93.94%, the improvement effect optimum of deficiency of vital energy blood deficiency symptoms such as especially weak to cardiopalmus, dizziness and blurred vision, the lazy language of few speech.And do not have any toxicity, prompting this product really is therapeutic pharmaceuticals safely and effectively.
The specific embodiment
Can further be expressly understood the present invention by specific embodiments of the invention given below, but following embodiment not a limitation of the invention.
The preparation method of the Chinese medicine composition tablet of embodiment 1 benefiting vital QI and blood of the present invention
Take by weighing the raw material of following weight:
Radix Angelicae Sinensis 500g, Radix Astragali 500g, Colla Corii Asini 10g, Herba Leonuri 500g, Pericarpium Citri Reticulatae 1g, dextrin 150g;
(1) Radix Astragali, Herba Leonuri being added for the first time the 10kg decocting boils after 1 hour and leaches decocting liquid, adding for the second time the 7kg decocting boils after 1 hour and leaches decocting liquid, adding the 4kg decocting for the third time boils after 1 hour and leaches decocting liquid, adding the 3kg decocting for the 4th time boils after 1 hour and leaches decocting liquid, add the 3kg decocting for the 5th time and boil after 1 hour and leach decocting liquid, merge five times decocting liquid, filter, it is 1.10 clear paste in the time of 90 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 4kg 95% is made solvent, flood percolation after 8 hours, collect percolate, it is 1.10 clear paste in the time of 90 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, adds Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste of about 1/2nd amounts, mix, be dried to dried cream powder, adding dextrin 150g, is binding agent with Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste of remainder, and mixing is granulated, drying, tabletting, coating, promptly.
The preparation method of the Chinese medicinal composition granules of embodiment 2 benefiting vital QI and blood of the present invention
Take by weighing the raw material of following weight:
Radix Angelicae Sinensis 208.35g, Radix Astragali 208.35g, Colla Corii Asini 62.5g, Herba Leonuri 312.5g, Pericarpium Citri Reticulatae 6.25g, sucrose 140g, dextrin 105g;
(1) Radix Astragali, Herba Leonuri are added the 3.12kg decocting and boiled 3 hours, leach decocting liquid, it is 1.25 clear paste in the time of 50 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 0.64kg 40% is made solvent, flood after 90 hours slowly percolation, collect percolate, it is 1.25 clear paste in the time of 50 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the Radix Astragali, Herba Leonuri clear paste, add Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste of about 1/2nd amounts, mix, drying adds cane sugar powder, dextrin, is binding agent with Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste of remainder, and mixing is made granule, drying, promptly.
The preparation method of the Chinese medicine composition dispersible tablet of embodiment 3 benefiting vital QI and blood of the present invention
Take by weighing the raw material of following weight:
Radix Angelicae Sinensis 20g, Radix Astragali 500g, Colla Corii Asini 300g, Herba Leonuri 20g, Pericarpium Citri Reticulatae 100g, pregelatinized Starch 65g, lactose 50g, carboxymethyl starch sodium 15g, magnesium stearate 2.5g, xylitol 1g;
(1) Radix Astragali, Herba Leonuri are added for the first time the 2.5kg decocting and boil after 2 hours and leach decocting liquid, filtering residue adds the 1.67kg decocting for the second time and boils after 1.5 hours and leach decocting liquid, and it is 1.10 clear paste in the time of 70 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 0.48kg 80% is made solvent, flood percolation after 40 hours, collect percolate, it is 1.10 clear paste in the time of 70 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, adds Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste of about 1/3rd amounts, mix, being concentrated into relative density is the clear paste of 1.25 (70 ℃), is dried to dried cream powder.With dried cream powder, pregelatinized Starch 65g, lactose 50g, carboxymethyl starch sodium 5g mix homogeneously, granulate with Radix Angelicae Sinensis, the moistening of Pericarpium Citri Reticulatae clear paste of remainder, drying, granulate adds carboxymethyl starch sodium 10g, magnesium stearate 2.5g, xylitol 1g mixing, tabletting, promptly.
The preparation method of the Chinese medicinal composition capsules agent of embodiment 4 benefiting vital QI and blood of the present invention
Radix Angelicae Sinensis 500g, Radix Astragali 20g, Colla Corii Asini 20g, Herba Leonuri 500g, Pericarpium Citri Reticulatae 100g, dextrin 70g;
(1) Radix Astragali, Herba Leonuri being added for the first time the 3.12kg decocting boils after 2 hours and leaches decocting liquid, for the second time adding the 2.5kg decocting boiled 1.5 hours, adding the 1.67kg decocting for the third time boils after 1 hour and leaches decocting liquid, adding the 1.56kg decocting for the 4th time boils after 1 hour and leaches decocting liquid, merge four times decocting liquid, filter, it is 1.15 clear paste in the time of 60 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 3kg 60% is made solvent, flood percolation after 60 hours, collect percolate, it is 1.15 clear paste in the time of 60 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, the Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste that add about 2/3rds amounts mix, and being concentrated into relative density is the clear paste of 1.21 (70 ℃), drying is made dried cream powder, add dextrin, with Radix Angelicae Sinensis, the moistening of Pericarpium Citri Reticulatae clear paste of remainder, mixing, granulate, drying, encapsulated, the Chinese medicinal composition capsules agent that promptly gets benefiting vital QI and blood of the present invention.
The preparation method of the Chinese medicine composition pill of embodiment 5 benefiting vital QI and blood of the present invention
Take by weighing the raw material of following weight:
Radix Angelicae Sinensis 208.35g, Radix Astragali 208.35g, Colla Corii Asini 62.5g, Herba Leonuri 312.5g, Pericarpium Citri Reticulatae 6.25g, lactose 170g, microcrystalline Cellulose 45g, carboxymethyl starch sodium 30g
(1) Radix Astragali, Herba Leonuri are added for the first time 3.12kg water logging bubble and decocted 2 hours after 1 hour, leach decocting liquid, add the 2.6kg decocting for the second time and boiled 1.5 hours, leach decocting liquid, merge twice decocting liquid, filter, it is 1.15 clear paste in the time of 60 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 0.70kg70% is made solvent, flood percolation after 48 hours, collect percolate, it is 1.15 clear paste in the time of 60 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, adds Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste of about 1/2nd amounts, mix, being concentrated into relative density is the clear paste of 1.20 (80 ℃), and drying is ground into fine powder, add lactose, microcrystalline Cellulose, carboxymethyl starch sodium, mixing is a binding agent system soft material with Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste of remainder, the refining ball, pill, drying is 14 hours under 60 ℃ of conditions, and polishing, drying get product.
The preparation method of the Chinese medicine composition syrup of embodiment 6 benefiting vital QI and blood of the present invention
Take by weighing the raw material of following weight:
Radix Angelicae Sinensis 200g, Radix Astragali 200g, Colla Corii Asini 60g, Herba Leonuri 300g, Pericarpium Citri Reticulatae 6g, sucrose 450g, 0.3% sodium benzoate sucrose 3g
(1) Radix Astragali, Herba Leonuri are added for the first time 3kg water logging bubble 1 hour, decoct and leach decocting liquid after 2 hours, add the 2.5kg decocting for the second time and boiled 1.5 hours, leach decocting liquid, merge twice decocting liquid, filter, it is 1.12 clear paste in the time of 70 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 1.03kg70% is made solvent, flood percolation after 48 hours, collect percolate, it is 1.14 clear paste in the time of 70 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, add Radix Angelicae Sinensis, Pericarpium Citri Reticulatae clear paste, mix, being concentrated into relative density is the clear paste of 1.22 (70 ℃), adds sucrose, heating for dissolving, filter, filtrate adds 0.3% sodium benzoate and stirs evenly, and filters, add an amount of distilled water and stir to 1000ml, promptly get the Chinese medicine composition syrup of benefiting vital QI and blood of the present invention.
The preparation method of the soft capsule of the Chinese medicine composition of embodiment 7 benefiting vital QI and blood of the present invention
Radix Angelicae Sinensis 120g, Radix Astragali 120g, Colla Corii Asini 24g, Herba Leonuri 120g, Pericarpium Citri Reticulatae 2.4g, Cera Flava 1.5g, olive oil 30g, propylene glycol 25g, soybean lecithin 10g
(1) Radix Astragali, Herba Leonuri are added 1.44kg water for the first time, decoct and leach decocting liquid after 2 hours, for the second time add the 1.15kg decocting to boil 1.5 hours, leach decocting liquid, merges twice decocting liquid, filtration, it is 1.15 clear paste in the time of 60 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 0.98kg 70% is made solvent, flood percolation after 60 hours, collect percolate, it is 1.15 clear paste in the time of 70 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, add Radix Angelicae Sinensis, Pericarpium Citri Reticulatae clear paste, mix, being concentrated into relative density is the clear paste of 1.22 (70 ℃), dry, be ground into 100 purpose fine powders, get Cera Flava be dissolved in be preheated among 60 ℃ of disperse medium olive oil 25g standby, get in the olive oil of soybean lecithin, propylene glycol adding remainder, stir, and be fully mixed to 37 ℃ with above-mentioned disperse medium, add above-mentioned medicinal substances extract fine powder, stir, grind homogenizing, make the Chinese medicine composition soft capsule of benefiting vital QI and blood of the present invention.
The preparation method of the drop pill of the Chinese medicine composition of embodiment 8 benefiting vital QI and blood of the present invention
Radix Angelicae Sinensis 80g, Radix Astragali 80g, Colla Corii Asini 36g, Herba Leonuri 180g, Pericarpium Citri Reticulatae 3.6g, Macrogol 4000 200g, polyethylene glycol 6000 20g
(1) Radix Astragali, Herba Leonuri are added the 1.56kg decocting and boil after 2 hours and leach decocting liquid, filter, it is 1.15 clear paste in the time of 70 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 420g 70% is made solvent, flood percolation after 48 hours, collect percolate, it is 1.15 clear paste in the time of 70 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, add Radix Angelicae Sinensis, Pericarpium Citri Reticulatae clear paste, mix, being concentrated into relative density is the thick paste of 1.22 (70 ℃), 60 ℃ of heating and melting of taking polyethylene glycol 4000 and polyethylene glycol 6000 water-bath, the thick paste that adds medicinal substances extract, mix homogeneously splashes in the dimethicone liquid coolant while hot, drips to make drop pill, remove liquid coolant, promptly get the Chinese medicine composition drop pill of benefiting vital QI and blood of the present invention.
The preparation method of the Chinese medicine composition oral solutions of embodiment 9 benefiting vital QI and blood of the present invention
Radix Angelicae Sinensis 120g, Radix Astragali 120g, Colla Corii Asini 36g, Herba Leonuri 120g, Pericarpium Citri Reticulatae 2.4g, simple syrup 100ml, chitosan 10g
(1) Radix Astragali, Herba Leonuri are added for the first time the 1.44kg decocting and boil after 2 hours and leach decocting liquid, add the 1.20kg decocting for the second time and boiled 1.5 hours, leach decocting liquid, merges twice decocting liquid, filtration, it is 1.15 clear paste in the time of 60 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 610g 70% is made solvent, flood percolation after 48 hours, collect percolate, it is 1.15 clear paste in the time of 60 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri extracting solution, add Radix Angelicae Sinensis, Pericarpium Citri Reticulatae extracting solution, mix, being concentrated into relative density is the clear paste of 1.10 (70 ℃), adds simple syrup, be concentrated into 1000ml, leave standstill 12h, get supernatant, add antiseptic, packing promptly gets the Chinese medicine composition oral solutions of benefiting vital QI and blood of the present invention.
The preparation method of the Chinese medicinal composition granules of embodiment 10 benefiting vital QI and blood of the present invention
Take by weighing the raw material of following weight:
Radix Angelicae Sinensis 208.35g, Radix Astragali 208.35g, Colla Corii Asini 62.5g, Herba Leonuri 312.5g, Pericarpium Citri Reticulatae 6.25g, sucrose 140g, dextrin 105g;
(1) Radix Astragali, Herba Leonuri are added for the first time the 3.12kg decocting and boiled 2 hours, leach decocting liquid, for the second time add the 2.5kg decocting to boil 1.5 hours, leach decocting liquid, merges twice decocting liquid, filtration, it is 1.15 clear paste in the time of 60 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 0.86kg 70% is made solvent, flood after 48 hours slowly percolation, collect percolate, it is 1.15 clear paste in the time of 60 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the Radix Astragali, Herba Leonuri clear paste, add Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste of about 1/2nd amounts, mix, drying adds cane sugar powder, dextrin, is binding agent with Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste of remainder, and mixing is made granule, drying, promptly.
The preparation method of the Chinese medicine composition tablet of embodiment 11 benefiting vital QI and blood of the present invention
Take by weighing the raw material of following weight:
Radix Angelicae Sinensis 208.35g, Radix Astragali 208.35g, Colla Corii Asini 62.5g, Herba Leonuri 312.5g, Pericarpium Citri Reticulatae 6.25g, dextrin 80g
(1) Radix Astragali, Herba Leonuri are added for the first time the 2.5kg decocting and boil after 2 hours and leach decocting liquid, add the 1.67kg decocting for the second time and boiled 1.5 hours, leach decocting liquid, merges twice decocting liquid, filtration, it is 1.15 clear paste in the time of 60 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 0.86kg 70% is made solvent, flood percolation after 48 hours, collect percolate, it is 1.15 clear paste in the time of 60 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, adds Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste of about 1/2nd amounts, mix, be dried to dried cream powder, add dextrin,, granulate with Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste moistening mixing of remainder, drying, tabletting, coating, promptly.
The preparation method of the Chinese medicine composition dispersible tablet of embodiment 12 benefiting vital QI and blood of the present invention
Take by weighing the raw material of following weight:
Radix Angelicae Sinensis 208.35g, Radix Astragali 208.35g, Colla Corii Asini 62.5g, Herba Leonuri 312.5g, Pericarpium Citri Reticulatae 6.25g, pregelatinized Starch 52g, lactose 40g, carboxymethyl starch sodium 12g, magnesium stearate 2g, xylitol 1g;
(1) Radix Astragali, Herba Leonuri are added for the first time the 2.6kg decocting and boil after 2 hours and leach decocting liquid, add the 1.67kg decocting for the second time and boiled 1.5 hours, leach decocting liquid, merges twice decocting liquid, filtration, it is 1.15 clear paste in the time of 60 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 0.86kg 70% is made solvent, flood percolation after 48 hours, collect percolate, it is 1.15 clear paste in the time of 60 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, adds Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste of 1/2nd amounts, mix, being concentrated into relative density is the clear paste of 1.25 (70 ℃), is dried to dried cream powder.With dried cream powder, pregelatinized Starch, lactose, carboxymethyl starch sodium 4g mix homogeneously, granulate with Radix Angelicae Sinensis, the moistening of Pericarpium Citri Reticulatae clear paste of remainder, drying, granulate adds carboxymethyl starch sodium 8g, magnesium stearate 2g, xylitol 1g mixing, tabletting, promptly.
The preparation method of the Chinese medicinal composition capsules agent of embodiment 13 benefiting vital QI and blood of the present invention
Radix Angelicae Sinensis 208.35g, Radix Astragali 208.35g, Colla Corii Asini 62.5g, Herba Leonuri 312.5g, Pericarpium Citri Reticulatae 6.25g, dextrin 60g;
(1) Radix Astragali, Herba Leonuri are added for the first time the 2.6kg decocting and boil after 2 hours and leach decocting liquid, add the 1.67kg decocting for the second time and boiled 1.5 hours, leach decocting liquid, merges twice decocting liquid, filtration, it is 1.15 clear paste in the time of 60 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 0.86kg 70% is made solvent, flood percolation after 48 hours, collect percolate, it is 1.15 clear paste in the time of 60 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, the Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste that add about 1/2nd amounts, mix, being concentrated into relative density is the clear paste of 1.21 (70 ℃), and drying is made dried cream powder, add dextrin, with Radix Angelicae Sinensis, the Pericarpium Citri Reticulatae clear paste moistening mixing of remainder, granulate drying, encapsulated, as promptly to get benefiting vital QI and blood of the present invention Chinese medicinal composition capsules agent.
The preparation method of the soft capsule of the Chinese medicine composition of embodiment 14 benefiting vital QI and blood of the present invention
Radix Angelicae Sinensis 208.35g, Radix Astragali 208.35g, Colla Corii Asini 62.5g, Herba Leonuri 312.5g, Pericarpium Citri Reticulatae 6.25g, Cera Flava 3g, olive oil 60g, propylene glycol 50g, soybean lecithin 20g
(1) Radix Astragali, Herba Leonuri are added for the first time the 2.6kg decocting and boil after 2 hours and leach decocting liquid, add the 1.67kg decocting for the second time and boiled 1.5 hours, leach decocting liquid, merges twice decocting liquid, filtration, it is 1.15 clear paste in the time of 60 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 0.86kg 70% is made solvent, flood percolation after 48 hours, collect percolate, it is 1.15 clear paste in the time of 60 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, add Radix Angelicae Sinensis, Pericarpium Citri Reticulatae clear paste, mix, being concentrated into relative density is the clear paste of 1.22 (70 ℃), dry, be ground into 100 purpose fine powders, get Cera Flava be dissolved in be preheated among 60 ℃ of disperse medium olive oil 50g standby, get in the olive oil of soybean lecithin, propylene glycol adding remainder, stir, and be fully mixed to 37 ℃ with above-mentioned disperse medium, add above-mentioned medicinal substances extract fine powder, stir, grind homogenizing, make the Chinese medicine composition soft capsule of benefiting vital QI and blood of the present invention.
The preparation method of the drop pill of the Chinese medicine composition of embodiment 15 benefiting vital QI and blood of the present invention
Radix Angelicae Sinensis 208.35g, Radix Astragali 208.35g, Colla Corii Asini 62.5g, Herba Leonuri 312.5g, Pericarpium Citri Reticulatae 6.25g, Macrogol 4000 400g, polyethylene glycol 6000 40g
(1) Radix Astragali, Herba Leonuri are added for the first time the 3kg decocting and boil after 2 hours and leach decocting liquid, add the 2kg decocting for the second time and boiled 1.5 hours, leach decocting liquid, merges twice decocting liquid, filtration, it is 1.15 clear paste in the time of 60 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 0.86kg 70% is made solvent, flood percolation after 48 hours, collect percolate, it is 1.15 clear paste in the time of 60 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, add Radix Angelicae Sinensis, Pericarpium Citri Reticulatae clear paste, mix, being concentrated into relative density is the thick paste of 1.22 (70 ℃), 60 ℃ of heating and melting of taking polyethylene glycol 4000 and polyethylene glycol 6000 water-bath, the thick paste that adds medicinal substances extract, mix homogeneously splashes in the dimethicone liquid coolant while hot, drips to make drop pill, remove liquid coolant, promptly get the Chinese medicine composition drop pill of benefiting vital QI and blood of the present invention.
The preparation method of the Chinese medicine composition oral solutions of embodiment 16 benefiting vital QI and blood of the present invention
Radix Angelicae Sinensis 208.35g, Radix Astragali 208.35g, Colla Corii Asini 62.5g, Herba Leonuri 312.5g, Pericarpium Citri Reticulatae 6.25g, simple syrup 200ml, chitosan 20g
(1) Radix Astragali, Herba Leonuri are added for the first time the 3kg decocting and boil after 2 hours and leach decocting liquid, add the 2kg decocting for the second time and boiled 1.5 hours, leach decocting liquid, merges twice decocting liquid, filtration, it is 1.15 clear paste in the time of 60 ℃ that filtrate is concentrated into relative density, standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (" an appendix I of Chinese pharmacopoeia version in 2005 O), ethanol with 0.86kg 70% is made solvent, flood percolation after 48 hours, collect percolate, it is 1.15 clear paste in the time of 60 ℃ that percolate is evaporated to relative density, standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri extracting solution, add Radix Angelicae Sinensis, Pericarpium Citri Reticulatae extracting solution, mix, being concentrated into relative density is the clear paste of 1.10 (70 ℃), adds simple syrup, be concentrated into 1000ml, leave standstill 12h, get supernatant, add antiseptic, packing promptly gets the Chinese medicine composition oral solutions of benefiting vital QI and blood of the present invention.
We compare with similar medicine with reference to " new Chinese medicine pharmacodynamics guideline ", have observed the hemostasis of said preparation, the pharmacological action of blood yiqi aspect, and the result is reported as follows:
Experimental example 1
1 experiment material
1.1 medicine
No. 1 Hospital Affiliated to Hunan Traditional Chinese Medical College, Annex II institute of Hunan College of Traditional Chinese Medicine, three tame hospitals of Changsha second hospital adopt the new Chinese medicine " the Herba Leonuri granule of enriching blood " of Zhuzhou Qianjin Pharmacy Co., Ltd's development, it is the granule that embodiment 10 makes, carried out clinical verification according to the clinical verification scheme, systematically investigate all kinds of operations of Herba Leonuri granule therapy gynecological of enriching blood, puerperal and belonged to traditional Chinese medical science asthenia of qi and blood the hold concurrently curative effect and the safety thereof of syndrome of blood stasis, observe 255 examples (containing matched group 90 examples) altogether, now the result be reported as follows:
1 clinical data
1.1 physical data
1.1.1 the case source sees Table 1
Table 1, the Herba Leonuri granule clinical verification case of enriching blood source situation
| Group | The example number | Be in hospital | Outpatient service | Be in hospital/outpatient service |
| The test group matched group | 165 90 | 93 50 | 72 40 | 1.29/1 1.25/1 |
1.1.2 two groups of case ages, symptom integral and hematochrome (Hb) inspection situation relatively sees Table 2
Table 2, two groups of ages, symptom integral and hematochrome (Hb) inspection situation be (X ± s) relatively
| Group | The example number | Age | Symptom integral | Hb(g/l) |
| The test group matched group | 165 90 | 34.18±5.82 33.73±6.89 | 8.56±3.24 8.86±6.41 | 93.86±16.93 101.10±17.10 |
Above-mentioned data is checked through T, and there was no significant difference (p＞0.05) illustrates two groups of ages between age, symptom integral and Hb group, and the state of an illness is basic identical, and comparability is arranged.
1.1.3 disease and operation distribution situation see Table 3
Table 3, test group and matched group disease surgery distribution situation
| Disease, operation names | Test group | Matched group |
| The artificial abortion drug induced abortion | 37 30 | 17 16 |
| Pregnant miscarriage vesicular mole miscarriage dilatation and curettage is produced the palace of the Qing Dynasty product ectopic pregnancy operation fibroid curettage of showing no increases in output and is examined the multiple huge myomectomy of broad ligament chronic endometritis essential uterine bleeding dysmenorrhoea of erasion uterectomy postoperative colporrhagia in the missed abortion | 6 11 2 5 23 10 5 6 2 16 7 4 | 3 5 5 10 3 3 2 4 4 1 5 9 3 |
Above case all belongs to the QI and blood deficiency syndrome of blood stasis of holding concurrently through Chinese medical discrimination
2 case choice criteria
Employing is demonstrate,proved the disease combination and is selected the object of observation based on card.
Dialectical standard of syndrome of blood stasis and foundation thereof 2.1 QI and blood deficiency is held concurrently
Work out with reference to " the clinical research guideline of new Chinese medicine treatment syndrome of deficiency of QI ", " the clinical research guideline of new Chinese medicine treatment syndrome of deficiency of blood ", " the clinical research guideline of new Chinese medicine treatment syndrome of blood stasis ".
2.1.1 deficiency of vital energy main symptom:
(1) short breath; (2) spiritlessness and weakness; (3) deficiency of QI with disinclination to talk; (4) light red tongue is fat or tooth seal, thready pulse without strength arranged.
2.1.2 blood deficiency main symptom:
(1) dizziness and blurred vision; (2) pale complexion; (3) pale tongue, thready pulse; (4) cardiopalmus.
2.1.3 blood stasis main symptom:
(1) pain, twinge, localized pain, tenderness; Purplish tongue or ecchymosis, petechia are arranged; (2) hesitant pulse.
2.1.4 it is dialectical: the QI and blood deficiency syndrome of blood stasis of holding concurrently
Primary symptom: (1) dizziness and blurred vision; (2) stomachache (twinge, localized pain, tenderness); (3) spiritlessness and weakness; (4) pale tongue or petechia is arranged.
Inferior disease: (1) cardiopalmus is out of breath; (2) deficiency of QI with disinclination to talk; (3) pale complexion; (4) deficient pulse unable (carefully slow and puckery or thin and delicate and puckery).
All possess two of three of primary symptoms, inferior disease and can be dialectical be the QI and blood deficiency syndrome of blood stasis of holding concurrently.
2.2 test case standard
2.2.1 include the case standard in
The women in various obstetrics and gynecology operation (behind caesarean operation, the artificial abortion postoperative is got ring and gone up ring postoperative, uterus and ovary postoperative etc.) and puerperal is all to meet the QI and blood deficiency syndrome of blood stasis person that holds concurrently, and all can include the test case in.
2.2.2 get rid of the case standard
(1) has and obviously hold concurrently folder or merge other patients.
(2) age is at under-18s or over-65s, gestation or women breast-feeding their children, allergic constitution and to this medicine allergy sufferers.
(3) merge to have the inclination, cerebrovascular, serious primary disease such as liver, kidney and hemopoietic system, psychotic.
(4) do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safe judgement person.
3 verification methods
The grouping of employing completely random, double blind control is observed design.
3.1 case source and routine number
3.1.1 case source
Being in hospital or clinic case of clinical verification participant.Inpatient is no less than total example several 1/3.
Clinic case is noted strict control variable factor, and the assurance study subject is taken the checking medication merely.
3.1.2 observe routine number
According to the regulation of new Chinese medicine clinical verification example number and the requirement of the relevant sample content of statistics, observe 225 examples altogether.
3.2 group technology and blind method are selected
3.2.1 group technology
At first by intending checking case load numbering 001～255, will number then to be divided into test group, matched group by 2: 1 usefulness table of random number methods, and making random assortment card.
3.2.2 blind method is selected and is implemented
Because parameters for observation on effect based on patient's subjective symptom, for avoiding the deviation in the observation process as far as possible, is observed case to two groups in the checking and is adopted double-blind method to observe, and take following measure to guarantee the enforcement of double-blind method:
(1) is subjected to reagent consistent, publishes identical with each random assortment card respectively random number with the outer package of contrast medicine.Then random assortment is snapped fits into the envelope sealing, envelope is by 001～255 serial number.
By going to a doctor and including sequencing numbering observing time in, take the identical envelope of sequence number apart when (2) verifying, provide the identical medicine of random number according to random assortment card in the envelope.
(3) double blinding is encoded and is not specifically participated in director's grasp of clinical verification by responsible department, and an envelope and a medicine are designated a special person to take charge by the pharmacy.
3.3 therapeutic scheme
3.3.1 checking medicine
(1) is subjected to reagent: the Herba Leonuri granule (providing) of enriching blood by Zhuzhou Qianjin Pharmacy Co., Ltd.Specification 12g/ bag.
(2) contrast medicine: LVJIAO BUXUE CHONGJI (producing) by Changsha Jiu Zhitang Pharmaceutical limited company.Specification 20g/ bag.
3.3.2 usage and dosage
(1) test group: the oral Herba Leonuri granule of enriching blood, one time 1 bag, one day twice, boiled water was taken after mixing it with water;
(2) matched group: oral LVJIAO BUXUE CHONGJI, one time 1 bag, one day twice, boiled water was taken after mixing it with water.
3.3.3 the course of treatment:
(1) test group: 10 days is a course of treatment, observes two courses of treatment (20 days) altogether.
(2) matched group: 10 days is a course of treatment, observes two courses of treatment (20 days) altogether.
Check accordingly after finishing each course of treatment.
3.3.4 take medicine taboo and and control with therapy:
Viewing duration, it is the Chinese and western drugs of principal indication that the experimenter must not take with observed disease, and adopts the other treatment method at above-mentioned disease.
3.4 main observation index
3.4.1 curative effect observation index
(1) disease symptom: by serious, heavy, in, light, no Pyatyi classification 4,3,2,1,0 minutes.See attached list.
(2) gynecologial examination: pudendum, vagina, cervix uteri, palace body, left and right sides adnexa etc., unmarried woman's row anus is looked into.
(3) all carry out the super inspection of uterus and accessories B before and after the treatment, judge blood stasis situation in the uterine cavity.
(4) all carry out blood routine examination before and after the treatment, observe the Hb situation of change.
3.4.2 safety detects index
(1) general physical examination: Bp, R, P etc.
(2) three big routine examinations: blood, urine, just conventional.
(3) liver function, renal function, Electrocardioscopy.
(4) untoward reaction: new sings and symptoms occurs after mainly observing medication, note levying discriminating mutually with the disease of disease itself.The untoward reaction degree is pressed following standard calibration:
Slightly: occur once in a while in the drug administration process, symptom is slight, and the persistent period is no more than half an hour, does not have influence to taking medicine.
Moderate: be interrupted appearance after take medicine back or a period of time, symptom is lighter, and the persistent period is no more than 2 hours; The patient still can tolerate, but proposes to reduce dosage or medicining times.
Severe: promptly occur after taking medicine, severe symptoms and often generation often continue more than 2 hours.The patient can not tolerate, and proposes even drug withdrawal voluntarily.
3.5 observational record
(1) clinical verification is carried out 3 above medical institutions, and participant is necessary for diformazan to go to the hospital.
(2) the clinical verification director should possess the above academic title of associate chief physician's (comprising suitable academic title), and the clinical and scientific research of observed disease is had certain attainments; The observed and recorded person all should have the above professional titles of Chinese physician, and each is observed case and is finished by same observer.
(3) whole cases are all by above scheme observed and recorded.Observation of symptoms is recorded in before the beginning of taking medicine and finishes in back 1 day the course of treatment, and per five days observed and recordeds are 1 time in the drug administration process, conscientiously mark according to the above-mentioned disease symptom standard of keeping the score, and mark is inserted the observation of symptoms table.Untoward reaction clinical grading standard is inserted the untoward reaction summary sheet in detail; When if twice an above untoward reaction of moderate or a severe untoward reaction occurring, corresponding anti symptom treatment is made in drug withdrawal in time.Before curative effect and the safety indexes medication and finish in back 2 days each detection record the course of treatment once.After various laboratory examining report lists should be pasted on the case observation log.
(4) case observation log and appended report thereof must not be changed in principle as protocol.During because of wrong must the change, also protocol must not be changed, the additional description explanation can only be adopted, and by the physician's signature who participates in clinical verification with date.
(5) situation of taking medicine of conscientious record patient, reply is all taken by therapeutic scheme, misses sometimes, has situation such as not clothes over half to carry out itemized record, explanation.
3.6 observation form:
See attached " the Herba Leonuri granule clinical verification observation table of enriching blood "
4 summary methods
4.1 curative effect judging standard and foundation thereof
Formulate with reference to " the clinical research guideline of new Chinese medicine treatment syndrome of deficiency of QI ", " the clinical research guideline of new Chinese medicine treatment syndrome of deficiency of blood ", " the clinical research guideline of new Chinese medicine treatment syndrome of blood stasis ".
(1) recovery from illness: symptom, sign disappear; Treatment back symptom integral reduces more than 91% before the treatment; The physico-chemical examination index is normal substantially.
(2) produce effects: symptom, sign are obviously improved; Treatment back symptom integral reduces 70%～90.9% before the treatment; Physico-chemical examination obviously improves.
(3) effective: symptom, sign all take a favorable turn; Treatment back symptom integral reduces 35%～69.9% before the treatment; Physico-chemical examination has corresponding improvement.
(4) invalid: symptom, sign do not have improvement; Treatment back symptom integral reduces＜35% before the treatment; Physico-chemical examination does not have improvement.
4.2 safety evaluatio standard
(1) I level: safety, without any side effects.Do not find untoward reaction in the i.e. observation process, detect normal before and after every safety indexes medication.
(2) II level: compare safety.Mild adverse effects is promptly arranged, but need not to deal with, can continue administration; Detect normal before and after every safety indexes medication.
(3) III level: safety issue is arranged.The moderate untoward reaction is promptly arranged, can continue administration after treatment; Or safety detects index a mile abnormality arranged, but can recover after the drug withdrawal.
(4) IV level: poor stability.Middle severe untoward reaction is promptly arranged, and the patient can not tolerate, voluntarily drug withdrawal; Or safety detection index has one or multinomial unusual.
4.3 stop and remove the clinical verification standard:
(1) patient of serious adverse reaction appears in the proof procedure.
(2) sb.'s illness took a turn for the worse, must the person of taking urgent measure.
(3) other serious merging disease patients appear in the proof procedure.
(4) can not adhere to therapist because of the non-subjectivity relevant of patient or odjective cause with test drug.
(5) non-curative effect reason, the patient proposes to withdraw from clinical verification person.
(6) do not meet the standard of including in, not medication in accordance with regulations can't judge that curative effect or data are incomplete, affects the treatment and safety judgement person.
Meet above (1) (2) (3) bar, handle by invalid case; Meet above (4) (5) (6) bar, handle by rejecting case.
4.4 data is handled
(1) takes off blind and sum up: after checking finishes, by after participating in the checking constituent parts and presiding over the verifier and the clinical verification data is concentrated respectively and gathered, preside over the unit application to checking and take off blind earlier; Then, write the clinical verification brief summary.Gather by responsible department again and write the clinical verification summary.
(2) significance test of data method: cause data relatively to adopt Ridit to analyze, enumeration data relatively adopts x
2Check; Continuous data relatively adopts the T check.
5 observed results
5.1 test group and matched group curative effect are relatively: see Table 4
Table 4, test group and matched group curative effect be (%) relatively
| Group | The example number | Recovery from illness | Produce effects | Recovery from illness ± produce effects | Effectively | Invalid | Effectively total |
| The test group matched group | 165 90 | 72(43.64) 24(26.27) | 44(26.67) 32(35.56) | 116(70.30) 56(62.22) | 39(23.64) 21(23.33) | 10(6.06) 9(10.0) | 155(93.94) 81(90.00) |
The statistical result of two groups of curative effects shows that the test group curative effect is higher than matched group in the last table, but curative effect difference nonsignificance (comparing (Ridit check) u=1.93p＞0.05 between two groups) between group.
5.2 the comparison of two groups of treatment front and back symptom integral sees Table 5
The comparison of table 5, two groups of treatment front and back symptom integral (X ± s)
| Group | The example number | Before the treatment | After the treatment | P |
| The test group matched group | 165 90 | 8.56±3.24 8.86±6.41 | 1.92±1.43 2.13±1.96 | ＜0.01 ＜0.01 |
Relatively all do not have significant difference (p＞0.05) 5.3 test group with two groups of treatment backs before (T check) treatment between group and compare, see Table 6 with treatment of control group front and back primary symptom integration
Symptom integral comparison before and after table 6, test group and the treatment of control group (X ± s)
| Test group | Matched group | |||||||||||
| Before the treatment | After the treatment | Before the treatment | After the treatment | |||||||||
| n | Integration | X±S | n | Integration | X±S | n | Integration | X±S | n | Integration | X±S | |
| Dizziness and blurred vision stomachache spiritlessness and weakness cardiopalmus deficiency of QI with disinclination to talk pale complexion out of breath | 148 135 157 73 11 134 | 292 278 382 118 131 256 | 1.97±0.31 2.06±0.34 2.43±0.53 1.62±0.27 1.91±0.21 1.97±0.34 | 30 30 34 19 21 25 | 48 37 57 19 36 45 | 1.03±0.27 ** 1.01±0.41 1.00±0.39 ** 1.60±0.30 1.17±0.18 ** 1.07±0.38 * | 85 83 90 49 57 *61 | 173 92 207 83 136 110 | 2.04±0.43 1.11±0.34 2.30±0.61 1.69±0.31 2.39±0.27 1.80±0.32 | 23 20 29 16 18 22 | 25 21 34 23 23 25 | 1.09±0.39 ** 1.05±0.34 1.17±0.34 ** 1.43±0.81 1.28±0.31 ** 1.14±0.36 ** |
*Compare P＜0.05 before and after showing treatment
*Compare P＜0.01 before and after showing treatment
Table 6 data shows that difference has significance (P＜0.01P＜0.05) before and after test group primary symptom (cardiopalmus is out of breath, stomachache the is outer) treatment; Matched group primary symptom (cardiopalmus is out of breath, stomachache is outer), difference has significance (P＜0.01 P＜0.05) before and after the integration treatment.But comparing difference does not have significance (P all＞0.05) between two groups
5.4 the Hb variation relatively sees Table 7 before and after test group and the treatment of control group
Table 7 shows before and after test group and the treatment of control group relatively, comparing difference nonsignificance between two groups of test group and the matched groups (P equal＞0.05).
Hb variation before and after table 7, test group and the treatment of control group (X ± s)
| Group | The example number | Before the treatment (g/l) | Treatment back (g/l) |
| The test group matched group | 165 90 | 93.86±16.93 101.10±17.10 | 106.31±14.18 109.36±15.36 |
5.5 ultrasound diagnosis the results are shown in Table 8 before and after test group and the treatment of control group
Ultrasound diagnosis result before and after table 8, test group and the treatment of control group
| Group | The example number | Blood stasis is arranged before the treatment | The no blood stasis in treatment back | Disappearance rate (%) |
| The test group matched group | 165 90 | 55 45 | 26 18 | 47.27 40.00 |
Table 8 shows that the treatment group is that test group elimination uterus blood stasis is higher than matched group, but difference not statistically significant (P all＞0.05).
5.6 untoward reaction
Test group and matched group there is no untoward reaction when period in a medicine and treatment observation end, the no abnormality seen change is compared in functional check before and after the test group 55 example treatments.
6 discuss
By above-mentioned 255 examples (containing matched group 90 examples) clinical research, we think:
1. the Herba Leonuri granule of enriching blood truly has the effect of benefiting vital QI and blood, promoting tissue regeneration by removing blood stasis, to after all kinds of operations of women, belong to the QI and blood deficiency syndrome of blood stasis person that holds concurrently puerperal that definite curative effect is arranged, its total obvious effective rate, total effective rate are respectively: 70.30%, 93.94%, and suitable with matched group medicine (LVJIAO BUXUE CHONGJI).
2. enrich blood the Herba Leonuri granule to gynecologic surgery and puerperal the asthenia of qi and blood syndrome of blood stasis deficiency of vital energy disease such as spiritlessness and weakness, dizziness and blurred vision, deficiency of QI with disinclination to talk improve significantly.
3. the Herba Leonuri granule of enriching blood is slow to the Hb effect, and influence has certain elimination improvement effect to B ultrasonic uterus blood stasis.
4. the Herba Leonuri granule taking convenience of enriching blood is not found toxic and side effects in the process of the test.
Claims (6)
1, a kind of Chinese medicine composition of benefiting vital QI and blood, it is to be made by effective ingredient and/or acceptable accessories, it is characterized in that described effective ingredient is to be made by following raw material by weight ratio: Radix Angelicae Sinensis 20-500, Radix Astragali 20-500, Colla Corii Asini 10-300, Herba Leonuri 20-500, Pericarpium Citri Reticulatae 1-100.
2, Chinese medicine composition as claimed in claim 1 is characterized in that described effective ingredient is to be made by following raw material by weight ratio: Radix Angelicae Sinensis 80-120, Radix Astragali 80-120, Colla Corii Asini 24-36, Herba Leonuri 120-180, Pericarpium Citri Reticulatae 2.4-3.6.
3, Chinese medicine composition as claimed in claim 1 or 2 is characterized in that it is tablet, capsule, soft capsule, granule, syrup, oral liquid, pill, drop pill or dispersible tablet.
4, the preparation method of Chinese medicine composition as claimed in claim 1 or 2 is characterized in that comprising that step is as follows:
(1) Radix Astragali, Herba Leonuri are added 3-10 times of water gaging and decoct 1-5 time, each 1-3 hour, collecting decoction filtered, and filtrate is concentrated into the clear paste that relative density is 1.10-1.25 (50-90 a ℃), and is standby;
(2) Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, doubly measure the ethanol of 40-95% with 3-8 and make solvent, and percolation behind the dipping 8-90h is collected percolate, and percolate reclaims ethanol and is concentrated into the clear paste that relative density is 1.10-1.25 (50-90 a ℃), and is standby;
(3) Colla Corii Asini is dissolved in the above-mentioned Radix Astragali, the Herba Leonuri clear paste, adds Radix Angelicae Sinensis, Pericarpium Citri Reticulatae clear paste again, mix getting final product.
5, the preparation method of Chinese medicine composition as claimed in claim 4, it is characterized in that step (1) be with the Radix Astragali, Herba Leonuri add for the first time 4.8-6 times of water gaging decoct leached decocting liquid in 2 hours after, adding for the second time 3.2-4.8 times of water gaging decocted 1.5 hours, leach decocting liquid, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.10-1.15 (60-70 a ℃), and is standby.
6, the preparation method of Chinese medicine composition as claimed in claim 4, it is characterized in that step (2) is that Radix Angelicae Sinensis, Pericarpium Citri Reticulatae are ground into coarse powder, doubly measure the ethanol of 60-80% with 4-5 and make solvent, percolation behind the dipping 40-60h, collect percolate, percolate is evaporated to the clear paste that relative density is 1.10-1.15 (60-70 a ℃), and is standby.
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| CN114073729A (en) * | 2020-07-31 | 2022-02-22 | 株洲千金药业股份有限公司 | Traditional Chinese medicine composition for preventing and treating thalassemia |
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