A kind of Dan e Fukang granule
Technical field:
The present invention relates to the extraction and the formulation art of Chinese medicine, be specifically related to particulate extraction of a kind of Chinese medicine Dan e Fukang and technology of preparing.
Background technology:
Soft extract is that a kind of medical material decocts with water, and decoction liquor concentrates, and adds the semifluid preparation that refined honey or sugar are made.Existing commercially available DANER FUKANG JIANGAO finished product standard is recorded in " national standard for traditional Chinese medicines compilation " gynecological's fascicle, form by Radix Salviae Miltiorrhizae, Rhizoma Curcumae, HERBA BUPLEURI, Radix Notoginseng, Radix Paeoniae Rubra, Radix Angelicae Sinensis, rhizoma sparganic, Rhizoma Cyperi, Rhizoma Corydalis, Radix Glycyrrhizae etc., according to Yi nationality, distributed over Yunnan, Sichuan and Guizhou's folk remedy prescription, be used for the treatment of menoxenia due to women's stagnation of blood stasis, dysmenorrhea, menstrual period discomfort, lump in the abdomen, endometriosis of pelvis etc., have blood circulation promoting and blood stasis dispelling, depressed liver-energy dispersing and QI regulating, menstruction regulating and pain relieving, the effect of softening the hard mass eliminate indigestion.But because soft extract contains a large amount of sugar or Mel, be not suitable for the use of sugar avoiding patient, product is easily by microbial contamination simultaneously, and storage period is shorter.Divided dose is inaccurate when having use, and onset is slower, takes shortcomings such as volume is bigger.
Granule is easy to use, has avoided soft extract easily to pollute, passive shortcoming of taking a large amount of glucides.
Summary of the invention:
The purpose of this invention is to provide a kind of extraction and preparation method of Dan e Fukang granule, thereby improve the quality of products, enlarge the application of Dan e Fukang preparation, make things convenient for the patient to use.
The present invention is intended to realize a kind of Dan e Fukang granule, it is characterized in that being made by the medical material of following weight proportion:
Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g, Radix Glycyrrhizae 100g use and extract, and cooperate with suitable adjuvant and make.
Preferably, the present invention can realize like this:
More than ten the flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation (2005 editions appendix of Chinese Pharmacopoeia) under fluid extract and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect percolate, decompression recycling ethanol also is concentrated into thick paste, medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, the five tastes such as Radix Glycyrrhizae decoct with water twice, each 2 hours, collecting decoction filtered, filtrate is concentrated into thick paste, merge above-mentioned two kinds of thick pastes, drying is ground into fine powder, add filler, correctives is an amount of, granulate, drying is made granule.
Preferably, the present invention can realize like this:
More than ten the flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation under 2005 editions appendix fluid extracts of Chinese Pharmacopoeia and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect percolate, decompression recycling ethanol also is concentrated into thick paste, medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, the five tastes such as Radix Glycyrrhizae decoct with water twice, add 10 times of amounts of water successively, 10 times of amounts, each 2 hours, collecting decoction, filter, filtrate is concentrated into thick paste, merges above-mentioned two kinds of thick pastes, dry, be ground into fine powder, add filler, correctives is an amount of, granulates, drying is made granule.
Preferably, the present invention can realize like this:
More than ten the flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation under 2005 editions appendix fluid extracts of Chinese Pharmacopoeia and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect percolate, decompression recycling ethanol also is concentrated into thick paste, medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, the five tastes such as Radix Glycyrrhizae decoct with water twice, each 2 hours, collecting decoction filtered, filtrate is concentrated into thick paste, merge above-mentioned two kinds of thick pastes, drying under reduced pressure becomes dried cream, is ground into fine powder, add filler, correctives is an amount of, granulate, drying is made granule.
Preferably, drying under reduced pressure temperature of the present invention is: 60~90 ℃ of temperature, vacuum is 0.07~0.09Mpa.
Preferably, filler of the present invention is selected from one or more in dextrin, sucrose, starch, pregelatinized Starch, microcrystalline Cellulose, the lactose etc.
Preferably, correctives of the present invention is selected from sucrose, citric acid, one or more in aspartame, stevioside, fructose, vitamin C, protein sugar, rose essence, flavoring pineapple essence, almond essence, the xylitol.
8, power 1 or 2 or 3 or 4 described a kind of Dan e Fukang granules is characterized in that
Preferably, the present invention can realize like this:
More than ten the flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation under 2005 editions appendix fluid extracts of Chinese Pharmacopoeia and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect 8 times of amounts of medical material percolate, decompression recycling ethanol also is concentrated under 50 ℃ of conditions 1.30 thick paste, medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, the five tastes such as Radix Glycyrrhizae decoct with water twice, and each 2 hours, collecting decoction, filter, filtrate is concentrated into the thick paste of relative density 1.30 under 50 ℃ of conditions, merges above-mentioned two kinds of thick pastes, and drying under reduced pressure becomes dried cream, be ground into fine powder, it is an amount of to add dextrin, makes granule, drying, make 1000g, promptly.
Preferably, the present invention can realize like this:
More than ten the flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation under 2005 editions appendix fluid extracts of Chinese Pharmacopoeia and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect 8 times of amounts of medical material percolate, decompression recycling ethanol also is concentrated under 50 ℃ of conditions 1.30 thick paste, medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, the five tastes such as Radix Glycyrrhizae decoct with water twice, and each 2 hours, collecting decoction, filter, filtrate is concentrated into the thick paste of relative density 1.30 under 50 ℃ of conditions, merges above-mentioned two kinds of thick pastes, and drying under reduced pressure becomes dried cream, be ground into 80~120 purpose fine powders, the dextrin that adds 2 times of amounts of dried cream powder weight is with 80~85% alcohol granulations, drying, make 1000g, promptly.
The particulate preparation of embodiment 1 Dan e Fukang
Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g, Radix Glycyrrhizae 100g;
(1) above ten flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation (2005 editions appendix of Chinese Pharmacopoeia) under fluid extract and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect percolate, decompression recycling ethanol also is concentrated into thick paste, and the five tastes such as medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, Radix Glycyrrhizae decoct with water twice, add 10 times of amounts of water, 10 times of amounts successively; Each 2 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, merges above-mentioned two kinds of thick pastes, and drying is crushed to more than 80 orders, promptly gets medicinal substances extract, and is standby;
(2) the material extract of getting it filled, even in right amount with the filler dextrin, granulate with the wetting agent moistening, drying, granulate, packing, promptly.
The particulate preparation of embodiment 2 Dan e Fukangs
By Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g,
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g,
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g, Radix Glycyrrhizae 100g,
Filler: dextrin 400g
Pregelatinized Starch 240g
(1) above ten flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation (2005 editions appendix of Chinese Pharmacopoeia) under fluid extract and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect percolate, decompression recycling ethanol also is concentrated into thick paste, and the five tastes such as medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, Radix Glycyrrhizae decoct with water twice, each 2 hours, collecting decoction, filter, filtrate is concentrated into thick paste, merges above-mentioned two kinds of thick pastes, dry, be crushed to more than 80 orders, promptly get medicinal substances extract, standby;
(2) the material extract of getting it filled with the filler mix homogeneously, is granulated with the wetting agent moistening, drying, and packing, promptly.
The particulate preparation of embodiment 3 Dan e Fukangs
By Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
Specific embodiment:
Filler: dextrin 410g
Sucrose 100g
Correctives: citric acid 20g
Wetting agent: the aqueous solution 50ml of 5.0% polyvinylpyrrolidone.
(1) above ten flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation (2005 editions appendix of Chinese Pharmacopoeia) under fluid extract and the extractum item, make solvent with 70% alcohol, flood and carry out percolation after 24 hours, collect percolate, decompression recycling ethanol also is concentrated into thick paste, and the five tastes such as medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, Radix Glycyrrhizae decoct with water twice, each 2 hours, collecting decoction, filter, filtrate is concentrated into thick paste, merges above-mentioned two kinds of thick pastes, dry, be crushed to more than 80 orders, promptly get medicinal substances extract, standby;
(2) the material extract of getting it filled with filler, correctives mix homogeneously, is granulated with the wetting agent moistening, drying, and granulate, packing is promptly.
The particulate preparation of embodiment 4 Dan e Fukangs
By Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
Filler: dextrin 350g
Correctives: sucralose 20g
Fructose 25g
Wetting agent: 60% ethanol 50ml
(1) above ten flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation (2005 editions appendix of Chinese Pharmacopoeia) under fluid extract and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect percolate, decompression recycling ethanol also is concentrated into thick paste, and the five tastes such as medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, Radix Glycyrrhizae decoct with water twice, each 2 hours, collecting decoction, filter, filtrate is concentrated into thick paste, merges above-mentioned two kinds of thick pastes, dry, be crushed to more than 80 orders, promptly get medicinal substances extract, standby;
(2) the material extract of getting it filled with the filler mix homogeneously, is granulated with the wetting agent moistening, drying, and granulate, packing is promptly.
The particulate preparation of embodiment 5 Dan e Fukangs
Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
(1) above ten flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation (2005 editions appendix of Chinese Pharmacopoeia) under fluid extract and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect percolate, decompression recycling ethanol also is concentrated into thick paste, the five tastes such as medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, Rhizoma Corydalis, Radix Glycyrrhizae decoct with water twice, each 2 hours, collecting decoction filtered, filtrate is concentrated into thick paste, merge above-mentioned two kinds of thick pastes, be dried to dried cream powder, be crushed to more than 80 orders;
(2) the material extract fine powder of getting it filled,
The particulate preparation of embodiment 6 Dan e Fukangs
Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
Dextrin 650g
More than ten the flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation under 2005 editions appendix fluid extracts of Chinese Pharmacopoeia and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect 8 times of amounts of medical material percolate, decompression recycling ethanol also is concentrated under 50 ℃ of conditions 1.30 thick paste, medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, the five tastes such as Radix Glycyrrhizae decoct with water twice, and each 2 hours, collecting decoction, filter, filtrate is concentrated into the thick paste of relative density 1.30 under 50 ℃ of conditions, merges above-mentioned two kinds of thick pastes, and drying under reduced pressure becomes dried cream, be ground into 80~120 purpose fine powders, the dextrin that adds 2 times of amounts of dried cream powder weight is with 80~85% alcohol granulations, drying, make 1000g, promptly.
Result of use of the present invention:
The clinical observation of Dan e Fukang preparation treatment seriousness dysmenorrhea
Dan e Fukang preparation function blood circulation promoting and blood stasis dispelling, depressed liver-energy dispersing and QI regulating, menstruction regulating and pain relieving, softening the hard mass eliminate indigestion.Treatment dysmenorrhea curative effect is better.
Diagnostic criteria
All patients all meet " disease of tcm diagnosis criterion of therapeutical effect " middle dysmenorrhea diagnostic criteria that State Administration of Traditional Chinese Medicine issued in 1994.Clinical primary symptom is:
1. through preceding or cold-type pain in the lower abdomen during menstruation;
2. tenderness or like warm pain relieved by pressing, pain alleviated while getting warmth:
3. delayed menstrual period, amount is few, and color secretly has piece, blockage of menstruation.Cold blood stasis has the cold general pain of fear concurrently, the history of catching cold, or aversion to cold usually, extremity are not warm, purplish tongue or ecchymosis is arranged, thin lingual fur from or greasy certainly, deep and tense pulse or heavy etc.
All possess primary symptom more than one, holds concurrently disease more than two, and two above persons of tongue arteries and veins all can be used as the observation case.
The case exclusion standard
1. merge hysteromyoma, serious disease persons such as cardiovascular and cerebrovascular vessel, liver, kidney and hemopoietic system; 2. psychotic; 3. to this medicine allergy sufferers; 4. do not meet the standard of including in, not medication in accordance with regulations, can't judge curative effect or data not umbra sound curative effect and safe judgement person.
Therapeutic Method
The Dan e Fukang groups of grains: oral Dan e Fukang granule, each 1~2 bag (5~10g), to take after mixing it with water, two in Rhizoma Zingiberis Recens is for drawing.
Matched group: oral DANER FUKANG JIANGAO, each 10-15g, every day 2 times, 10-15 days begin before menstruation, and serveing on 10-15 days is a course of treatment.
The efficacy assessment standard reference literature.
The standards of grading of dysmenorrhea:, adopt the disease associated methods to keep the score with reference to " new Chinese medicine clinical research guideline " and " tcm clinical practice disease diagnosis criterion of therapeutical effect "; Dysmenorrhea weight grade scale: severe: more than 14 minutes; Moderate: 8~13 minutes; Slightly: below 8 minutes.
Criterion of therapeutical effect: with reference to " new Chinese medicine clinical research guideline〉and<up-to-date domestic and international medical diagnosis on disease standard " formulate.Recovery from illness: clinical symptoms, sign disappear, and integration is 0, and continuous 3 menstrual cycle do not recur; Produce effects: clinical symptoms, sign disappear, and the treatment integration reduces below 2/3 than the preceding integration of treatment; Effectively: clinical symptoms, sign all alleviate, and the treatment integration reduces below 1/3 than the preceding integration of treatment; Invalid: as not have before and after the treatment and improve.
The result: with the total effects evaluation, the granule group is 94.5% (n=52), and matched group is 84.5% (n=40), learns check by statistics, t check analysis: P<0.05, and difference has significance.
The soft extracts sugar content is big, influences the human body normal energy metabolism, especially is not suitable for the occur together patient of dysmenorrhea or hysteromyoma of diabetes; And the character thickness, divided dose is inaccurate.The Dan e Fukang granule is easy to use, faces with taking after mixing it with water temperature drink, is applicable to that all kinds of crowds use, but is blended into other guiding drugs and nourishing flavour of a drug such as Sucus Zingberis, Colla Corii Asini, bone-strengthening powder etc. before the Yu Linyong, uses accurate and flexible, and the drug effect performance is more abundant.
The particulate preparation of embodiment 7 Dan e Fukangs
Radix Salviae Miltiorrhizae 450g, Rhizoma Curcumae 250g, HERBA BUPLEURI 250g
Radix Notoginseng 150g, Radix Paeoniae Rubra 250g, Radix Angelicae Sinensis 250g
Rhizoma sparganic 175g, Rhizoma Cyperi 150g, Rhizoma Corydalis 175g Radix Glycyrrhizae 100g,
Dextrin 650g
Correctives: sucralose 5g
Aspartame 5g
More than ten the flavor medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, Rhizoma Corydalis etc. are according to the percolation under 2005 editions appendix fluid extracts of Chinese Pharmacopoeia and the extractum item, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, collect 8 times of amounts of medical material percolate, decompression recycling ethanol also is concentrated under 50 ℃ of conditions 1.30 thick paste, medicinal residues and all the other HERBA BUPLEURI, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Cyperi, the five tastes such as Radix Glycyrrhizae decoct with water twice, each 2 hours, collecting decoction, filter, filtrate is concentrated into the clear paste of relative density 1.30 under 50 ℃ of conditions, merges above-mentioned two kinds of thick pastes, drying under reduced pressure becomes dried cream, the drying under reduced pressure temperature be: 60~90 ℃ of temperature, vacuum is 0.07~0.09Mpa, is ground into fine powder, it is an amount of to add dextrin, granulate, drying is made 1000g.