CN109939075A - A kind of Chinese medicine effervescent tablet and preparation method thereof - Google Patents

A kind of Chinese medicine effervescent tablet and preparation method thereof Download PDF

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Publication number
CN109939075A
CN109939075A CN201910170512.5A CN201910170512A CN109939075A CN 109939075 A CN109939075 A CN 109939075A CN 201910170512 A CN201910170512 A CN 201910170512A CN 109939075 A CN109939075 A CN 109939075A
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China
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radix
chinese medicine
cyclodextrin
rhizoma
semen
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王一涛
余华
李鹏
黎畅明
王胜鹏
章津铭
钟章锋
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MACAO UNIV
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MACAO UNIV
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Abstract

The invention discloses a kind of Chinese medicine effervescent tablets and preparation method thereof, are related to Chinese medicine processing technique field.The preparation method of Chinese medicine effervescent tablet disclosed by the invention is the following steps are included: inclusion step: being included with cyclodextrin to the fat-soluble ingredient for extracting from Chinese medicine, obtains cyclodextrin inclusion compound;Flaking step: the cyclodextrin inclusion compound is mixed with the water-soluble component, gas-producing disintegrant and pharmaceutically acceptable auxiliary material for extracting from the Chinese medicine, Chinese medicine effervescent tablet is made through tabletting.The preparation method includes raw material by using cyclodextrin, the defects of improving the volatility, unstability and irritation of difficult active ingredient of Chinese herbs, it can make medicament solubilization and improve outside stability, the toxic side effect of drug can also be reduced, promote the release of drug in vivo, increase drug absorption, improves bioavilability.

Description

A kind of Chinese medicine effervescent tablet and preparation method thereof
Technical field
The present invention relates to Chinese medicine processing technique fields, in particular to a kind of Chinese medicine effervescent tablet and preparation method thereof.
Background technique
Many effective components such as volatile oil, saponin(e, flavones, alkaloid etc. in Chinese medicine, solubility in water, which is far below, to be controlled Concentration required for treatment acts on.Drug solubility is small, and dispersibility, stability are poor in vitro, is difficult to be absorbed by organisms in vivo, from And cause drug bioavailability low.The solubility for how increasing insoluble drug improves its preparation stability and dissolution rate, promotees Into drug in the intracorporal absorption of people, the clinical efficacy of drug is improved, it has also become the research of contemporary pharmaceutical preparation and health care product exploitation One of emphasis.In addition, bitter taste is consumer one of the main reason for Chinese materia medica preparation and health care product are resisted, above-mentioned volatile oil, The effective component of chinese medicine such as saponin(e, flavones all have certain bitter taste, and very big limit is received on formulation development and clinical use System.The Chinese materia medica preparation overwhelming majority all has bitter taste, effectively cover bitter taste of drug, improves product quality and Its Productive Technological Desion The another major issue of urgent need to resolve.Therefore, solubilized taste masking technology is a kind of key technology of Its Productive Technological Desion.
In consideration of it, the present invention is specifically proposed.
Summary of the invention
The purpose of the present invention is to provide a kind of preparation method of Chinese medicine effervescent tablet, preparation method provided by the invention passes through Active ingredient of Chinese herbs, that is, fat-soluble ingredient is included using cyclodextrin, improves the volatility, no of difficult active ingredient of Chinese herbs The defects of stability and irritation, can make medicament solubilization and improve outside stability, can also reduce the toxic side effect of drug, promote medicine The release of object in vivo increases drug absorption, improves bioavilability.
Another object of the present invention is to provide a kind of Chinese medicine effervescent tablets, and the Chinese medicine effervescent tablet is by using cyclodextrin to original Material the defects of being included, improving the volatility, unstability and irritation of difficult active ingredient of Chinese herbs, can make medicament solubilization and It improves outside stability, can also reduce the toxic side effect of drug, promote the release of drug in vivo, increase drug absorption, improve life Object availability.
The present invention is implemented as follows:
On the one hand, the present invention provides a kind of preparation methods of Chinese medicine effervescent tablet comprising following steps:
Inclusion step: the fat-soluble ingredient for extracting from Chinese medicine is included with cyclodextrin, obtains cyclodextrin inclusion compound;
Flaking step: by the cyclodextrin inclusion compound and the water-soluble component, the gas-producing disintegrant that extract from the Chinese medicine And pharmaceutically acceptable auxiliary material mixing, Chinese medicine effervescent tablet is made through tabletting.
Effervescent tablet is a kind of tablet containing gas-producing disintegrant, into the water the rear soda acids effervesce such as organic acid and sodium bicarbonate Acid-base reaction occurs for disintegrating agent, generates great amount of carbon dioxide, so that tablet is disintegrated and is melted rapidly, the carbon dioxide part of generation is molten Yu Shuizhong, drinking solution in entrance has feeling as carbonated drink, is remarkably improved drug mouthfeel.Chinese medicine effervescent tablet is mainly with Chinese medicine at present Medicinal extract, volatile oil, monomer etc. are raw material.According to pharmaceutical properties difference, oral traditional Chinese medicine effervescent tablet can appropriate adjustment effervescent tablet Different taste increases the palatability of drug, covers bad smell, gives full play to effervescent tablet advantage, can be in improving to a certain degree Medicine mouthfeel increases user's compliance, is a kind of tcm product dosage form relatively to get consumer reception.However oral effervescent tablet requires Effervesce, dissolution form clarification, transparent solution in short time, also to have preferable stability, therefore increase the dissolubility of drug It is also the important means for preparing qualified effervescent tablet.
The application that cyclodextrin inclusion technique is used in Chinese medicine effervescent tablet preparation at present is also less.First passage benefit of the present invention Chinese medicine material composition is included with cyclodextrin or derivatives thereof inclusion technique, then is prepared with the cyclodextrin inclusion compound after inclusion At Chinese medicine effervescent tablet, the method for effectively increasing drug solubility and covering adverse drug smell is conducive to improve insoluble drug And the defects of volatility of numerous active ingredient of Chinese herbs, unstability and irritation, it is in addition to that can make medicament solubilization and improve steady It is qualitative outer, the toxic side effect of drug can be also reduced, promotes the release of drug in vivo, increases drug absorption, improve biological utilisation Degree.
Further, in some embodiments of the present invention, the cyclodextrin encapsulated step includes: that will contain the rouge The organic solution of soluble component is mixed with the cyclodextrin aqueous solution containing cyclodextrin, agitated, after removing solvent, is dried to obtain institute State cyclodextrin inclusion compound;
Preferably, the organic solution is methanol or ethanol solution;
Preferably, the pH of the cyclodextrin aqueous solution is 4~10;
The cyclodextrin is selected from alpha-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin or derivatives thereof.
Further, in some embodiments of the present invention, the gas-producing disintegrant includes sour agent and alkaline agent;
The acid agent is selected from one of citric acid, tartaric acid, fumaric acid and malic acid etc.;
The alkaline agent is selected from one of sodium carbonate, sodium bicarbonate and saleratus etc..
Further, in some embodiments of the present invention, the Chinese medicine is selected from one of following medicinal material: fourth Perfume, illiciumverum, fennel, sword bean, fennel seeds, field thistle, Chinese yam, hawthorn, purslane, zaocys dhumnade, dark plum, pawpaw, fructus cannabis, from generation to generation Flower, radix polygonati officinalis, Radix Glycyrrhizae, the root of Dahurain angelica, gingko, Semen Lablab Album, Flos Semen Lablab Album, arillus longan (also known as longan), cassia seed, lily, nutmeg, meat Osmanthus, emblic, fingered citron, almond, sea-buckthorn, Gorgon fruit, Chinese prickly ash, red bean, donkey-hide gelatin, endothelium corneum gigeriae galli, malt, thallus laminariae (also known as kelp), jujube (such as jujube, dateplum persimmon or wild jujube), Siraitia grosvenorii, brush-cherry seed, honeysuckle, Chinese olive, cordate houttuynia, ginger (such as ginger, rhizoma zingiberis), trifoliate orange Son, fructus lycii, cape jasmine, fructus amomi, the sterculia seed, Poria cocos, citron, elscholtiza, peach kernel, mulberry leaf, mulberries, orange, campanulaceae, fructus alpiniae oxyphyllae, lotus It is leaf, radish seed, lotus seeds, galangal, lophatherum gracile, Fermented Soybean, chrysanthemum, witloof, SEMEN SINAPIS ALBAE, rhizoma polygonati, purple perilla, purple perilla seed, pueraria lobata, black Sesame, black pepper, the sophora bud, sophora flower, dandelion, honey, Chinese torreyanut, semen ziziphi spinosae, fresh Rhizoma Imperatae, fresh Rhizoma Phragmitis, pallas pit viper, orange peel, peppermint, The medicinal and edible Chinese medicines such as semen coicis, Longstamen Onion Bulb, raspberry and wrinkled giant hyssop;
Alternatively, the Chinese medicine can also be selected from one of following medicinal material: ginseng, folium panacis japonici cum caule, panax ginseng fruit, Radix Notoginseng, soil Poria cocos, setose thistle, the fruit of glossy privet, Fructus Corni, radix cyathulae, bulbus fritillariae cirrhosae, Rhizoma Chuanxiong, red deer tire, cervus elaphus linnaeus, red deer bone, Radix Salviae Miltiorrhizae, cortex acanthopanacis, Schisandra chinensis, cimicifugae foetidae, lucid asparagus, Rhizoma Gastrodiae, radix pseudostellariae, Morinda officinalis, radix aucklandiae, scouring rush, great burdock achene, radix bardanae, semen plantaginis, Asiatic plantain, Radix Glehniae, fritillary bulb, radix scrophulariae, radix rehmanniae recen, Radix Polygoni Multiflori, bletilla, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Alba, Amomum cardamomum, the shell of seaear, dendrobium nobile, the root bark of Chinese wolf-berry, It is Radix Angelicae Sinensis, caulis bambusae in taenian, safflower, root of kirilow rhodiola, American Ginseng, evodia rutaecarpa, radix achyranthis bidentatae, Cortex Eucommiae, folium cortex eucommiae, semen astragali complanati, cortex moutan, aloe, grey Art, psoralea corylifolia, Terminalia chebula, radix paeoniae rubra, Radix Polygalae, Radix Ophiopogonis, tortoise plastron, eupatorium, cacumen biotae, rhubarb, prepared fleece flower root, wilsonii, rose hip, Herba Lycopi, rhizoma alismatis, rose, roselle, rhizoma anemarrhenae, bluish dogbane, Ilex Latifolia Thunb, cymose buckwheat rhizome, Cherokee rose, green peel, Flos Magnoliae Officinalis, turmeric, trifoliate orange Shell, the dried immature fruit of citron orange, the seed of Oriental arborvitae, pearl, gynostemma pentaphylla, faenum graecum, madder, Long Pepper, semen allii tuberosi, the vine of multiflower knotweed, rhizoma cyperi, the rhizome of davallia, Radix Codonopsis, mulberry White skin, ramulus mori, fritillaria thunbergii, motherwort, centella, Herba Epimedii, Semen Cuscutae, wild chrysanthemum, ginkgo leaf, Radix Astragali, Hupeh Fritillary Bulb, cassia angustifolia Leaf, gekko, cowberry, Chinese scholartree reality, cattail pollen, puncture vine, propolis, tamarind, eclipta, prepared RADIX ET RHIZOMA RHEI, Rehmannia glutinosa and turtle shell Deng Wei planning commission are public The Chinese medicine that can be used for health food of cloth;
Preferably, the fat-soluble ingredient is selected from least one of following components: flavonoids, triterpenes, is waved saponins Hair oil class, fatty oils and alkaloids.
Flavonoids is selected from rutin, Quercetin, Puerarin, isoflavones genistein, daidzein, silymarin and different Radix Glycyrrhizae One of elements etc. are a variety of.
Saponins are selected from ginsenoside Rb1, astragaloside, notoginsenoside, oleanolic acid, diosgenin and rhizoma anemarrhenae soap One of glycosides etc. is a variety of.
Triterpenes is selected from pachymic acid, asiaticosid, (20R)-protopanaxatriol, 11-O- momordica grosvenori glycoside V, glycyrrhizic acid, Radix Glycyrrhizae One of hypo acid and 20 (R)-ginsenoside Rg2s etc. are a variety of.
Volatile oil is in menthones, menthofuran, D- limonene, α-curcumene, hundred hay-scented phenol and cinnaldehydrum etc. It is one or more.
Fatty oils are in methyl hexadecanoate, methyl oleate, methyl stearate and 11- eicosenoic acid methyl esters etc. It is one or more.
Alkaloids is selected from one of lotus leaf alkaloid and radish seed alkaloid etc. or a variety of.
The water-soluble component is selected from least one of following components: polysaccharide, phenolic acid and glucosides.
Wherein, polysaccharide in panaxan, astragalus polyose, aloe polysaccharide, Chinese yam polysaccharide and dendrobium polysaccharide at least It is a kind of.
Phenolic acid is root of red-rooted salvia phenolic acid.
Further, in some embodiments of the present invention, the Chinese medicine is Milkvetch Root;The fat-soluble ingredient For astragaloside;The water-soluble component is astragalus polyose.
Radix Astragali is clinical conventional Chinese medicine, first recorded in Shennong's Herbal, has invigorating qi for strengthening superficies, diuretic and maintain drug, apocenosis, sore The effect of myogenic.It is usually used in deficiency of vital energy and acking in strength, anorexia and loose stool, the sinking of qi of middle-jiao, rush down prolapse of the anus for a long time, uterine bleeding of having blood in stool, table on traditional treatment Empty spontaneous perspiration, deficiency of vital energy and edema, ulcer is difficult to burst, burst for a long time and does not holds back, blood deficiency chlorosis, Heat Diabetes, chronic rephrilis protinuria and diabetes etc. Disease, principle active component are astragalus polyose, saponins, flavones, amino acid etc., and wherein polysaccharide and saponin component are that Radix Astragali is anti- Oxidation, immune, anti-inflammatory, anti-aging the main active component of enhancing.But astragaloside water-soluble, oral bio in liquid preparation Availability is poor, while its mouthfeel is poor, it is difficult to meet the requirement of liquid preparation.
Further, in some embodiments of the present invention, preparation method further include: astragaloside preparation step: Milkvetch Root is added 8~20 times of 60%~80% ethanol solution, 55~75 DEG C heating extraction 1~3 time, 1~3h, is closed every time And alcohol extract, dry astragaloside extract after reduced pressure.
Further, in some embodiments of the present invention, preparation method further include: astragalus polyose preparation step: Solvent is flung to through treated the Milkvetch Root drying of astragaloside preparation step by above-mentioned, is added 8~20 times of water, 70~100 DEG C Heating extraction 1~3 time, 1~3h, merges decocting liquid, filtering every time, and filtrate is concentrated into the medicinal extract of relative density 0.8~1.3, adds Enter 95% ethanol precipitation, filtering and concentrating, low temperature drying obtains astragalus polyose.
Further, in some embodiments of the present invention, the pharmaceutically acceptable auxiliary material include lubricant and The combination of one or more of sweetener;
Preferably, the lubricant is selected from Macrogol 4000 or 6000, lauryl sodium sulfate, dodecyl sulphate One of magnesium, magnesium stearate, talcum powder and superfine silica gel powder.
Preferably, the sweetener is selected from one of aspartame, Steviosin and sucrose.
On the other hand, the present invention provides a kind of Chinese medicine effervescent tablets comprising cyclodextrin inclusion compound extracts from Chinese medicine Water-soluble component, gas-producing disintegrant and pharmaceutically acceptable auxiliary material;
Wherein, cyclodextrin inclusion compound includes the fat-soluble ingredient and the inclusion fat-soluble ingredient for extracting from the Chinese medicine Cyclodextrin.
Further, in some embodiments of the present invention, the cyclodextrin is alpha-cyclodextrin, beta-cyclodextrin, γ-ring Dextrin or derivatives thereof.
Further, in some embodiments of the present invention, the gas-producing disintegrant includes sour agent and alkaline agent;
The acid agent is selected from one of citric acid, tartaric acid, fumaric acid and malic acid.
The alkaline agent is selected from one of sodium carbonate, sodium bicarbonate and saleratus.
Further, in some embodiments of the present invention, the Chinese medicine is selected from one of following medicinal material:
Cloves, illiciumverum, fennel, sword bean, fennel seeds, field thistle, Chinese yam, hawthorn, purslane, zaocys dhumnade, dark plum, pawpaw, fire Edestan, bitter orange flower, radix polygonati officinalis, Radix Glycyrrhizae, the root of Dahurain angelica, gingko, Semen Lablab Album, Flos Semen Lablab Album, arillus longan, cassia seed, lily, nutmeg, meat It is osmanthus, emblic, fingered citron, almond, sea-buckthorn, Gorgon fruit, Chinese prickly ash, red bean, donkey-hide gelatin, endothelium corneum gigeriae galli, malt, thallus laminariae, jujube, Siraitia grosvenorii, strongly fragrant Li Ren, honeysuckle, Chinese olive, cordate houttuynia, ginger, trifoliate orange, fructus lycii, cape jasmine, fructus amomi, the sterculia seed, Poria cocos, citron, elscholtiza, peach kernel, Mulberry leaf, mulberries, orange, campanulaceae, fructus alpiniae oxyphyllae, lotus leaf, radish seed, lotus seeds, galangal, lophatherum gracile, Fermented Soybean, chrysanthemum, witloof, Huang It is mustard seed, rhizoma polygonati, purple perilla, purple perilla seed, pueraria lobata, Semen sesami nigrum, black pepper, the sophora bud, sophora flower, dandelion, honey, Chinese torreyanut, semen ziziphi spinosae, fresh The medicinal and edible Chinese medicines such as rhizoma imperatae, fresh Rhizoma Phragmitis, pallas pit viper, orange peel, peppermint, semen coicis, Longstamen Onion Bulb, raspberry and wrinkled giant hyssop;
Alternatively, the Chinese medicine can also be selected from one of following medicinal material: ginseng, folium panacis japonici cum caule, panax ginseng fruit, Radix Notoginseng, soil Poria cocos, setose thistle, the fruit of glossy privet, Fructus Corni, radix cyathulae, bulbus fritillariae cirrhosae, Rhizoma Chuanxiong, red deer tire, cervus elaphus linnaeus, red deer bone, Radix Salviae Miltiorrhizae, cortex acanthopanacis, Schisandra chinensis, cimicifugae foetidae, lucid asparagus, Rhizoma Gastrodiae, radix pseudostellariae, Morinda officinalis, radix aucklandiae, scouring rush, great burdock achene, radix bardanae, semen plantaginis, Asiatic plantain, Radix Glehniae, fritillary bulb, radix scrophulariae, radix rehmanniae recen, Radix Polygoni Multiflori, bletilla, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Alba, Amomum cardamomum, the shell of seaear, dendrobium nobile, the root bark of Chinese wolf-berry, It is Radix Angelicae Sinensis, caulis bambusae in taenian, safflower, root of kirilow rhodiola, American Ginseng, evodia rutaecarpa, radix achyranthis bidentatae, Cortex Eucommiae, folium cortex eucommiae, semen astragali complanati, cortex moutan, aloe, grey Art, psoralea corylifolia, Terminalia chebula, radix paeoniae rubra, Radix Polygalae, Radix Ophiopogonis, tortoise plastron, eupatorium, cacumen biotae, rhubarb, prepared fleece flower root, wilsonii, rose hip, Herba Lycopi, rhizoma alismatis, rose, roselle, rhizoma anemarrhenae, bluish dogbane, Ilex Latifolia Thunb, cymose buckwheat rhizome, Cherokee rose, green peel, Flos Magnoliae Officinalis, turmeric, trifoliate orange Shell, the dried immature fruit of citron orange, the seed of Oriental arborvitae, pearl, gynostemma pentaphylla, faenum graecum, madder, Long Pepper, semen allii tuberosi, the vine of multiflower knotweed, rhizoma cyperi, the rhizome of davallia, Radix Codonopsis, mulberry White skin, ramulus mori, fritillaria thunbergii, motherwort, centella, Herba Epimedii, Semen Cuscutae, wild chrysanthemum, ginkgo leaf, Radix Astragali, Hupeh Fritillary Bulb, cassia angustifolia Leaf, gekko, cowberry, Chinese scholartree reality, cattail pollen, puncture vine, propolis, tamarind, eclipta, prepared RADIX ET RHIZOMA RHEI, Rehmannia glutinosa and turtle shell Deng Wei planning commission are public The Chinese medicine that can be used for health food of cloth;
Preferably, the fat-soluble ingredient is selected from least one of following components: flavonoids, triterpenes, is waved saponins Hair oil class, fatty oils and alkaloids;
The water-soluble component is selected from least one of following components: polysaccharide, phenolic acid and glucosides.
Further, in some embodiments of the present invention, the Chinese medicine is Milkvetch Root;The fat-soluble ingredient For astragaloside;The water-soluble component is astragalus polyose.
Further, in some embodiments of the present invention, astragaloside is astragalus root total saponin or Astragaloside IV.
Further, in some embodiments of the present invention, astragaloside is prepared via a method which: by Milkvetch Root Be added 8~20 times of 60%~80% ethanol solution, 55~75 DEG C heating extraction 1~3 time, 1~3h, merges alcohol extract every time, Dry astragaloside extract after reduced pressure.
Further, in some embodiments of the present invention, astragalus polyose is prepared via a method which: by above-mentioned through alcohol Mentioning treated, solvent is flung in Milkvetch Root drying, is added 8~20 times of water, 70~100 DEG C heating extraction 1~3 time, every time 1~ 3h merges decocting liquid, filtering, and filtrate is concentrated into the medicinal extract of relative density 0.8~1.3, and 95% ethanol precipitation is added, and filters dense Contracting, low temperature drying obtain astragalus polyose.
Further, in some embodiments of the present invention, cyclodextrin inclusion compound is prepared via a method which: by Radix Astragali Saponin(e is dissolved in methanol or ethyl alcohol, obtains the organic solution containing astragaloside, separately takes cyclodextrin soluble in water, at 30~70 DEG C It is configured to saturated aqueous solution, adjusts pH4~10, astragaloside solution is added according to the ratio that mass ratio is 1-6:1, and (i.e. ring is pasted Essence: astragaloside=1-6:1), after dissolution, 40~100MHz, 20~60min of ultrasound stirs 1~4h, after taking-up at 60~80 DEG C Solvent evaporated, 95% ethanol washing filter, are drying to obtain astragaloside cyclodextrin inclusion compound.
Further, in some embodiments of the present invention, by weight, the raw material includes: astragaloside ring 20~40 parts of cyclodextrin inclusion compound, 10~20 parts of astragalus polyose, 10~30 parts of gas-producing disintegrant and pharmaceutically acceptable auxiliary material 10~40 parts.
Chinese medicine effervescent tablet of the invention forms cyclodextrin inclusion compound by using cyclodextrin encapsulated fat-soluble ingredient, and it is difficult to increase The water solubility of soluble components such as fat-soluble ingredient covers bad smell;The fat-soluble ingredient and water solubility of Chinese medicine will be extracted from Component is transmitted using effervesce sheet form, is disintegrated quick, convenient to take, action rapidly, is increased drug mouthfeel, is improved consumer and is complied with Property.
Specific embodiment
It in order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below will be in the embodiment of the present invention Technical solution be clearly and completely described.The person that is not specified actual conditions in embodiment, according to normal conditions or manufacturer builds The condition of view carries out.Reagents or instruments used without specified manufacturer is the conventional production that can be obtained by commercially available purchase Product.
Feature and performance of the invention are described in further detail with reference to embodiments.
Embodiment 1
Milkvetch Root is added 8 times of 80% ethanol solution, 75 DEG C heating extraction 2 times, each 2h, merge alcohol extract, decompression Dry astragaloside extract, spare after concentration;
By treated, solvent is flung in medicinal material drying, and 10 times of water are added, refluxing extraction 2 times, each 1h, merge decocting liquid, Filtering, filtrate are concentrated into the medicinal extract of relative density 1.1,95% ethanol precipitation are added, filtering and concentrating, it is more that low temperature drying obtains Radix Astragali Sugar.
Embodiment 2
Milkvetch Root is added 10 times of 70% ethanol solution, 70 DEG C heating extraction 3 times, each 1h, merge alcohol extract, decompression Dry astragaloside extract, spare after concentration;
Solvent is flung into the drying of treated medicinal material, is added 20 times of water, 90 DEG C heating extraction 3 times, each 1h, merge decocting Liquid, filtering, filtrate are concentrated into the medicinal extract of relative density 1.05, and 95% ethanol precipitation, filtering and concentrating is added, and low temperature drying obtains Radix Astragali Polysaccharide;
Embodiment 3
20 times of 60% ethanol solution is added in Milkvetch Root, and 65 DEG C of heating extraction 3h merge alcohol extract, does after reduced pressure Dry astragaloside extract, it is spare;
Solvent is flung into the drying of treated medicinal material, is added 20 times of water, 70 DEG C heating extraction 3 times, each 1h, merge decocting Liquid, filtering, filtrate are concentrated into the medicinal extract of relative density 1.2, and 95% ethanol precipitation, filtering and concentrating is added, and low temperature drying obtains Radix Astragali Polysaccharide;
Embodiment 4
The preparation of astragaloside alpha-cyclodextrin inclusion compound
Using saturated water solution method, accurately weighs 5g α-CD (alpha-cyclodextrin) and be placed in 100mL tool plug conical flask, be added Distilled water, boiling water bath dissolve by heating, and room temperature is cooled to 45 DEG C, adjust pH to 7.0, in stirring 30min on magnetic force thermostatic mixer; 5g total saponins in astragalus (the astragaloside extract provided by any embodiment in embodiment 1-3) is accurately weighed, with 15ml methanol It after dissolution, is added in α-CD saturated solution with dropper, stirring to stipulated time sets refrigerator cold-storage for 24 hours, filters, 60 DEG C of dryings 4h weighs, grinding, crosses No. 5 sieves, obtains astragaloside alpha-cyclodextrin inclusion compound.
Embodiment 5
The preparation of astragaloside Benexate Hydrochloride
Using saturated water solution method, accurately weighs 10g β-CD and be placed in 100mL tool plug conical flask, distilled water, boiling is added Heating water bath dissolution, room temperature are cooled to 60 DEG C, adjust pH to 6.0, in stirring 30min on magnetic force thermostatic mixer;It accurately weighs 8g total saponins in astragalus is added in β-CD saturated solution after the dissolution of 20ml methanol with dropper, is stirred to the stipulated time, is set ice Case refrigerates for 24 hours, filters, and 60 DEG C are dried overnight, and weighs, grinding, crosses No. 5 sieves, obtains astragaloside Benexate Hydrochloride.
Embodiment 6
The preparation of astragaloside gamma-cyclodextrin inclusion compound
Using saturated water solution method, accurately weighs 5g γ-CD and be placed in 100mL tool plug conical flask, distilled water, boiling is added Heating water bath dissolution, room temperature are cooled to 40 DEG C, adjust pH to 6.0, in stirring 30min on magnetic force thermostatic mixer;It accurately weighs 5g total saponins in astragalus is added in γ-CD saturated solution after the dissolution of 15ml methanol with dropper, is stirred to the stipulated time, is set ice Case refrigerates for 24 hours, filters, and 60 DEG C are dried overnight, and weighs, grinding, crosses No. 5 sieves, obtains astragaloside gamma-cyclodextrin inclusion compound.
Embodiment 7
Radix Astragali effervescent tablet compressing dry granulation
Tartaric acid, sodium bicarbonate be crushed into 80~100 meshes respectively, are sealed spare;Menthol, aspartame powder Broken 100~120 mesh of mistake, lubricant Macrogol 4000 crushed 140~200 meshes, and preparation process controls formulation environment temperature Degree is in 25 DEG C, humidity below 45%;Astragalus polyose is uniformly mixed with tartaric acid, menthol, aspartame by required proportion; Sodium bicarbonate, starch are uniformly mixed with astragaloside inclusion compound, then two parts component is mixed, Macrogol 4000 is added, It mixes well, obtains effervescent tablet through mixed-powder tabletting.
Embodiment 8
Radix Astragali effervescent tablet mixing granulation tabletting
Fumaric acid, sodium bicarbonate be crushed into 80~100 meshes respectively, are sealed spare;Steviosin and essence crush 100~120 meshes are crossed, lubricant Macrogol 4000 crushed 140~200 meshes, and preparation process controls formulation environment temperature In 25 DEG C, humidity below 45%;Astragalus polyose is uniformly mixed with fumaric acid, dextrin, Steviosin and essence by required proportion, Granulation;Sodium bicarbonate is uniformly mixed with astragaloside inclusion compound then, carboxymethyl cellulose aqueous solution granulation is added, by two Divide particle mixing that lubricant Macrogol 4000 is added, mixes well, tabletting, obtain Radix Astragali effervescent tablet.
The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention, for the skill of this field For art personnel, the invention may be variously modified and varied.All within the spirits and principles of the present invention, made any to repair Change, equivalent replacement, improvement etc., should all be included in the protection scope of the present invention.

Claims (10)

1. a kind of preparation method of Chinese medicine effervescent tablet, which is characterized in that itself the following steps are included:
Inclusion step: the fat-soluble ingredient for extracting from Chinese medicine is included with cyclodextrin, obtains cyclodextrin inclusion compound;
Flaking step: by the cyclodextrin inclusion compound with extract from the water-soluble component of the Chinese medicine, gas-producing disintegrant and Pharmaceutically acceptable auxiliary material mixing, is made Chinese medicine effervescent tablet through tabletting.
2. preparation method according to claim 1, which is characterized in that the preparation method includes cyclodextrin encapsulated step;
The cyclodextrin encapsulated step includes: by the organic solution containing the fat-soluble ingredient and containing the cyclodextrin of cyclodextrin Aqueous solution mixing, it is agitated, after removing solvent, it is dried to obtain the cyclodextrin inclusion compound;
Preferably, the organic solution is methanol or ethanol solution;
Preferably, the pH of the cyclodextrin aqueous solution is 4~10;
Preferably, the cyclodextrin is alpha-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin or derivatives thereof.
3. preparation method according to claim 1, which is characterized in that the gas-producing disintegrant includes sour agent and alkaline agent;
The acid agent is selected from one kind of citric acid, tartaric acid, fumaric acid and malic acid;
The alkaline agent is selected from one kind of sodium carbonate, sodium bicarbonate and saleratus.
4. preparation method according to claim 1-3, which is characterized in that the Chinese medicine is in following medicinal material One kind: cloves, illiciumverum, fennel, sword bean, fennel seeds, field thistle, Chinese yam, hawthorn, purslane, zaocys dhumnade, dark plum, pawpaw, fire fiber crops Benevolence, bitter orange flower, radix polygonati officinalis, Radix Glycyrrhizae, the root of Dahurain angelica, gingko, Semen Lablab Album, Flos Semen Lablab Album, arillus longan, cassia seed, lily, nutmeg, cortex cinnamomi, Emblic, fingered citron, almond, sea-buckthorn, Gorgon fruit, Chinese prickly ash, red bean, donkey-hide gelatin, endothelium corneum gigeriae galli, malt, thallus laminariae, jujube, Siraitia grosvenorii, Yu Li Benevolence, honeysuckle, Chinese olive, cordate houttuynia, ginger, trifoliate orange, fructus lycii, cape jasmine, fructus amomi, the sterculia seed, Poria cocos, citron, elscholtiza, peach kernel, mulberry Leaf, mulberries, orange, campanulaceae, fructus alpiniae oxyphyllae, lotus leaf, radish seed, lotus seeds, galangal, lophatherum gracile, Fermented Soybean, chrysanthemum, witloof, yellow mustard It is son, rhizoma polygonati, purple perilla, purple perilla seed, pueraria lobata, Semen sesami nigrum, black pepper, the sophora bud, sophora flower, dandelion, honey, Chinese torreyanut, semen ziziphi spinosae, fresh white Lalang grass rhizome, fresh Rhizoma Phragmitis, pallas pit viper, orange peel, peppermint, semen coicis, Longstamen Onion Bulb, raspberry and wrinkled giant hyssop;
Or the Chinese medicine is selected from one of following medicinal material: ginseng, folium panacis japonici cum caule, panax ginseng fruit, Radix Notoginseng, smilax, setose thistle, glossy privet Son, Fructus Corni, radix cyathulae, bulbus fritillariae cirrhosae, Rhizoma Chuanxiong, red deer tire, cervus elaphus linnaeus, red deer bone, Radix Salviae Miltiorrhizae, cortex acanthopanacis, Schisandra chinensis, cimicifugae foetidae, day Men Dong, Rhizoma Gastrodiae, radix pseudostellariae, Morinda officinalis, radix aucklandiae, scouring rush, great burdock achene, radix bardanae, semen plantaginis, Asiatic plantain, Radix Glehniae, fritillary bulb, Radix scrophulariae, radix rehmanniae recen, Radix Polygoni Multiflori, bletilla, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Alba, Amomum cardamomum, the shell of seaear, dendrobium nobile, the root bark of Chinese wolf-berry, Radix Angelicae Sinensis, caulis bambusae in taenian, safflower, Root of kirilow rhodiola, American Ginseng, evodia rutaecarpa, radix achyranthis bidentatae, Cortex Eucommiae, folium cortex eucommiae, semen astragali complanati, cortex moutan, aloe, rhizoma atractylodis, psoralea corylifolia, Terminalia chebula, Radix paeoniae rubra, Radix Polygalae, Radix Ophiopogonis, tortoise plastron, eupatorium, cacumen biotae, rhubarb, prepared fleece flower root, wilsonii, rose hip, Herba Lycopi, rhizoma alismatis, rose Flower, roselle, rhizoma anemarrhenae, bluish dogbane, Ilex Latifolia Thunb, cymose buckwheat rhizome, Cherokee rose, green peel, Flos Magnoliae Officinalis, turmeric, Fructus Aurantii, the dried immature fruit of citron orange, the seed of Oriental arborvitae, Pearl, gynostemma pentaphylla, faenum graecum, madder, Long Pepper, semen allii tuberosi, the vine of multiflower knotweed, rhizoma cyperi, the rhizome of davallia, Radix Codonopsis, the root bark of white mulberry, ramulus mori, bulb of thunberg fritillary Mother, motherwort, centella, Herba Epimedii, Semen Cuscutae, wild chrysanthemum, ginkgo leaf, Radix Astragali, Hupeh Fritillary Bulb, folium sennae, gekko, cowberry, Chinese scholartree reality, cattail pollen, puncture vine, propolis, tamarind, eclipta, prepared RADIX ET RHIZOMA RHEI, Rehmannia glutinosa and turtle shell;
Preferably, the fat-soluble ingredient is selected from least one of following components: flavonoids, saponins, triterpenes, volatile oil Class, fatty oils and alkaloids;
The water-soluble component is selected from least one of following components: polysaccharide, phenolic acid and glucosides.
5. the preparation method according to claim 4, which is characterized in that the Chinese medicine is Milkvetch Root;It is described fat-soluble Group is divided into astragaloside;The water-soluble component is astragalus polyose.
6. preparation method according to claim 1-3, which is characterized in that the pharmaceutically acceptable accessory package Include the combination of one or more of lubricant and sweetener;
Preferably, the lubricant is selected from Macrogol 4000 or 6000, lauryl sodium sulfate, Stepanol MG, hard One of fatty acid magnesium, talcum powder and superfine silica gel powder;
Preferably, the sweetener is selected from one of aspartame, Steviosin and sucrose.
7. a kind of Chinese medicine effervescent tablet, characterized in that it comprises: cyclodextrin inclusion compound, the water-soluble component for extracting from Chinese medicine, Gas-producing disintegrant and pharmaceutically acceptable auxiliary material;
Wherein, cyclodextrin inclusion compound includes the fat-soluble ingredient for extracting from the Chinese medicine and the ring for including the fat-soluble ingredient Dextrin.
8. Chinese medicine effervescent tablet according to claim 7, which is characterized in that the cyclodextrin be alpha-cyclodextrin, beta-cyclodextrin, Gamma-cyclodextrin or derivatives thereof.
9. Chinese medicine effervescent tablet according to claim 7, which is characterized in that the gas-producing disintegrant includes sour agent and alkaline agent;
The acid agent is selected from one of citric acid, tartaric acid, fumaric acid and malic acid;
The alkaline agent is selected from one of sodium carbonate, sodium bicarbonate and saleratus.
10. Chinese medicine effervescent tablet according to claim 7, which is characterized in that the Chinese medicine in following medicinal material one Kind: cloves, illiciumverum, fennel, sword bean, fennel seeds, field thistle, Chinese yam, hawthorn, purslane, zaocys dhumnade, dark plum, pawpaw, fructus cannabis, It is bitter orange flower, radix polygonati officinalis, Radix Glycyrrhizae, the root of Dahurain angelica, gingko, Semen Lablab Album, Flos Semen Lablab Album, arillus longan, cassia seed, lily, nutmeg, cortex cinnamomi, remaining Gan Zi, fingered citron, almond, sea-buckthorn, Gorgon fruit, Chinese prickly ash, red bean, donkey-hide gelatin, endothelium corneum gigeriae galli, malt, thallus laminariae, jujube, Siraitia grosvenorii, brush-cherry seed, Honeysuckle, Chinese olive, cordate houttuynia, ginger, trifoliate orange, fructus lycii, cape jasmine, fructus amomi, the sterculia seed, Poria cocos, citron, elscholtiza, peach kernel, mulberry leaf, Mulberries, orange, campanulaceae, fructus alpiniae oxyphyllae, lotus leaf, radish seed, lotus seeds, galangal, lophatherum gracile, Fermented Soybean, chrysanthemum, witloof, SEMEN SINAPIS ALBAE, Rhizoma polygonati, purple perilla, purple perilla seed, pueraria lobata, Semen sesami nigrum, black pepper, the sophora bud, sophora flower, dandelion, honey, Chinese torreyanut, semen ziziphi spinosae, fresh cogongrass Root, fresh Rhizoma Phragmitis, pallas pit viper, orange peel, peppermint, semen coicis, Longstamen Onion Bulb, raspberry and wrinkled giant hyssop;
Alternatively, the Chinese medicine is selected from one of following medicinal material: ginseng, folium panacis japonici cum caule, panax ginseng fruit, Radix Notoginseng, smilax, setose thistle, The fruit of glossy privet, Fructus Corni, radix cyathulae, bulbus fritillariae cirrhosae, Rhizoma Chuanxiong, red deer tire, cervus elaphus linnaeus, red deer bone, Radix Salviae Miltiorrhizae, cortex acanthopanacis, Schisandra chinensis, liter Fiber crops, Rhizoma Gastrodiae, radix pseudostellariae, Morinda officinalis, radix aucklandiae, scouring rush, great burdock achene, radix bardanae, semen plantaginis, Asiatic plantain, Radix Glehniae, are put down at lucid asparagus Fritillaria, radix scrophulariae, radix rehmanniae recen, Radix Polygoni Multiflori, bletilla, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Alba, Amomum cardamomum, the shell of seaear, dendrobium nobile, the root bark of Chinese wolf-berry, Radix Angelicae Sinensis, caulis bambusae in taenian, Safflower, root of kirilow rhodiola, American Ginseng, evodia rutaecarpa, radix achyranthis bidentatae, Cortex Eucommiae, folium cortex eucommiae, semen astragali complanati, cortex moutan, aloe, rhizoma atractylodis, psoralea corylifolia, Terminalia chebula, radix paeoniae rubra, Radix Polygalae, Radix Ophiopogonis, tortoise plastron, eupatorium, cacumen biotae, rhubarb, prepared fleece flower root, wilsonii, rose hip, Herba Lycopi, rhizoma alismatis, Rose, roselle, rhizoma anemarrhenae, bluish dogbane, Ilex Latifolia Thunb, cymose buckwheat rhizome, Cherokee rose, green peel, Flos Magnoliae Officinalis, turmeric, Fructus Aurantii, the dried immature fruit of citron orange, cypress Sub- benevolence, pearl, gynostemma pentaphylla, faenum graecum, madder, Long Pepper, semen allii tuberosi, the vine of multiflower knotweed, rhizoma cyperi, the rhizome of davallia, Radix Codonopsis, the root bark of white mulberry, ramulus mori, Fritillaria thunbergii, centella, Herba Epimedii, Semen Cuscutae, wild chrysanthemum, ginkgo leaf, Radix Astragali, Hupeh Fritillary Bulb, folium sennae, gekko, is got at motherwort Tangerine, Chinese scholartree reality, cattail pollen, puncture vine, propolis, tamarind, eclipta, prepared RADIX ET RHIZOMA RHEI, Rehmannia glutinosa and turtle shell;
Preferably, the fat-soluble ingredient is selected from least one of following components: flavonoids, saponins, triterpenes, volatile oil Class, fatty oils and alkaloids;
The water-soluble component is selected from least one of following components: polysaccharide, phenolic acid and glucosides.
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CN110403909A (en) * 2019-08-21 2019-11-05 青岛农业大学 A kind of raphanin pulvis and preparation method thereof
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CN113350523A (en) * 2021-06-02 2021-09-07 京津冀联创药物研究(北京)有限公司 Fat oil inclusion compound and preparation method thereof
CN114272354A (en) * 2022-02-21 2022-04-05 澳门大学 Traditional Chinese medicine composition for preventing and improving senile dementia, preparation method and application thereof
CN114377105A (en) * 2022-02-25 2022-04-22 澳门大学 Baoyuan effervescent tablet and preparation method and application thereof

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