CN1785230B - Delayed-release compounding Radix astragali gel skeleton tablets and its preparation method - Google Patents
Delayed-release compounding Radix astragali gel skeleton tablets and its preparation method Download PDFInfo
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- CN1785230B CN1785230B CN 200410093886 CN200410093886A CN1785230B CN 1785230 B CN1785230 B CN 1785230B CN 200410093886 CN200410093886 CN 200410093886 CN 200410093886 A CN200410093886 A CN 200410093886A CN 1785230 B CN1785230 B CN 1785230B
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- Medicines Containing Plant Substances (AREA)
Abstract
A slow-release gel skeleton tablet is prepared from astragalus root, red sage root, notoginseng, dalbergia wood and hydroxypropyl methylcellulose. Its preparing process is also disclosed.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of compound slow-releasing Radix Astragali gel matrix tablet and preparation method thereof.
Background technology
The Radix Astragali be leguminous plant Radix Astagali Astragalus membranaceus (Fisch) Bge, var, monghlicus (Bge.) Hsiao or Radix Astragali Astragalus membranaceus (Fisch.) Bge, dry root.Its Main Ingredients and Appearance is glycoside, polysaccharide, aminoacid and trace element.Have enhancing human body immunity power, diuresis, defying age, protect the liver, effect such as blood pressure lowering, heart tonifying, expansion coronary vasodilator and whole body peripheral vessel, anti-mattress, be one of clinical Chinese medicine commonly used.
Motherland's medical science thinks that the Radix Astragali both can be used as medicine separately, also can unite use with other medical material, to reach clinical required curative effect.Through exploration for many years, the inventor finds that drug combinations such as the Radix Astragali and Radix Salviae Miltiorrhizae, Radix Notoginseng are had benefiting QI for activating blood circulation, and angina pectoris has better curative effect and (sees Chinese patent, application number: 02100879.5) for coronary heart disease with qi deficiency and blood stasis clinically.
Wherein, this patent disclosure by the drop pill of said composition preparation and conventional tablet etc., but owing to the intravital half-life of water-soluble active ingredient in the Radix Astragali or the Radix Salviae Miltiorrhizae is shorter, make common oral formulations be faced with a series of problem, frequent as the clinical administration number of times, use inconvenience, patient's compliance (compliance) difference etc.
The inventor finds can reach non-lentamente constant release with making the sustained-release gel matrix tablet with suitable adjuvant after the medicinal material extract such as the Radix Astragali through years of researches, reduces and takes number of times, improves the purpose of patient's compliance.
Summary of the invention
The object of the invention has been to provide a kind of brand-new compound astragalus membranaceus gel matrix tablet with slow release function.
Another object of the present invention is to provide the preparation method of this compound astragalus membranaceus gel matrix tablet.
Compound Salviae Miltiorrhizae prescription of the present invention is (in a weight percentage):
The Radix Astragali 22.2%～66.8%,
Radix Salviae Miltiorrhizae 11.6%～33.4%,
Radix Notoginseng 2.5%～13.5%,
Lignum Dalbergiae Odoriferae 14.5%～44.3%
The optimizing prescriptions proportioning is (in a weight percentage):
The Radix Astragali 30.8%～57.2%,
Radix Salviae Miltiorrhizae 15.4%～28.6%,
Radix Notoginseng 3.5%～6.5%,
Lignum Dalbergiae Odoriferae 20.6%～38.2%
The best prescription proportioning is (in a weight percentage):
The Radix Astragali 44.7%, Radix Salviae Miltiorrhizae 26.7%, Radix Notoginseng 6.3%, Lignum Dalbergiae Odoriferae 22.3%;
Perhaps be: the Radix Astragali 42.2%, Radix Salviae Miltiorrhizae 23.8%, Radix Notoginseng 4.5%, Lignum Dalbergiae Odoriferae 0.5%.
Said medicine prescription proportioning is the weight proportion of institute's uses crude drug, if it is need be to the described Radix Astragali, Radix Salviae Miltiorrhizae, Radix Notoginseng, Lignum Dalbergiae Odoriferae etc. further independent or mixed extraction is processed into extract and suitable adjuvant is made gel matrix tablet to be made into preparation.Extracting method wherein is selected from (but being not limited to this): water extraction method, decoction and alcohol sedimentation technique, percolation, column chromatography method or the way of distillation etc.
For the ease of understanding, the existing extracting method in present technique field is described below for example, but is not limited to this.
The Radix Astragali water extraction alcohol sedimentation method: get the Radix Astragali, pulverize, extracting in water filters, suitably concentrate the back and adopt ethanol to precipitate, precipitate with ethanol again after supernatant suitably concentrates, supernatant reclaims ethanol, concentrate Radix Astragali extract.
The (+)-Astragenol extraction method: get Milkvetch Root, pulverize, add alcohol reflux, collect backflow, reclaim alcohol, concentrate Radix Astragali extract.
Radix Astragali microwave extraction method: after getting Radix Astragali pulverizing, put into flask, and this flask is put in people's microwave reactor, alcohol reflux is adjusted microwave power and is extracted, and collects extracting solution, gets Radix Astragali extract.
The Radix Salviae Miltiorrhizae water extraction: get red rooted salvia, 20 mesh sieves are pulverized, extracting in water 2 times, the water logging bubble that adds for the first time 9～10 times of amounts, heating extraction 1.5 hours adds 5～7 times of water gagings, heating extraction 1 hour for the second time, merge extractive liquid,, suitably concentrate, add 95% ethanol, make to contain alcohol amount arrival 50%～70%, concentrate and reclaim ethanol, get Radix Salviae Miltiorrhizae extract.
The tanshinol extraction method: get red rooted salvia, 20 mesh sieves are pulverized, and 7～9 times of amount 70% alcohol heating reflux extract 2 times, each 1 hour, merge extractive liquid,, concentrate Radix Salviae Miltiorrhizae extract.
The extraction of active component of red sage root: get red rooted salvia, 20 mesh sieves are pulverized, water or ethanol extraction concentrate, and add ethanol precipitation, be dissolved in water after reclaiming ethanol, last macroporous resin chromatography separates, after water elution is removed impurity, ethanol elution to effective ingredient fully till, reclaim ethanol, get exsiccant Radix Salviae Miltiorrhizae extract.
The ethanol extraction of Radix Notoginseng: add the ethanol extraction 3 times of 10 times of amount 10%～30% concentration, reflux 8 hours, merge extractive liquid, concentrates and reclaims ethanol, Radix Notoginseng extract.
Radix Notoginseng column chromatography method: get Radix Notoginseng, suitably pulverize, add ethanol and divide 2 extractions, filter, merge filtering, decompression recycling ethanol is to a certain amount of, add suitable quantity of water, continuing to be recycled to does not have the alcohol flavor, and it is past that medicinal liquid is crossed pretreated macroporous adsorbent resin, and it is colourless to be washed to filter liquor, continue to use 50% ethanol elution, collect eluent, concentrate, get Radix Notoginseng extract.
Except that the independent extraction of above-mentioned medical material, described Radix Salviae Miltiorrhizae, all right mixed extraction of Radix Notoginseng are mainly: Radix Salviae Miltiorrhizae, the pseudo-ginseng of learning from else's experience and pulverizing, and boiling water boils to be carried, filter, merging filtrate, and filtrate is suitably concentrated; Add ethanol and carry out precipitate with ethanol in concentrated solution, leave standstill, supernatant reclaims ethanol, is condensed into extractum, gets medicinal substances extract.
The Lignum Dalbergiae Odoriferae reflux extraction: get the Lignum Dalbergiae Odoriferae medical material, add water, reflux, extract, is collected volatile oil.
The compound slow-releasing Radix Astragali of the present invention gel matrix tablet, except that above-mentioned Chinese crude drug extract as the active component, also must be aided with the effect that certain adjuvant just can reach slow release.
Adjuvant of the present invention is selected from: hydroxypropyl emthylcellulose (HPMC), lactose, magnesium stearate; The quality summation of described red rooted salvia extract and pseudo-ginseng extract and Borneolum Syntheticum: hydroxypropyl emthylcellulose: lactose is 1: 0.8～1.2: 0.8～1.2, and preferred proportion is 1: 1: 1; Magnesium stearate has played lubricated effect in the tabletting process, its consumption be whole heavy by 1%, also need 70% an amount of ethanol as binding agent in addition.
The compound slow-releasing Radix Astragali of the present invention gel matrix tablet prepares by following method:
1. by the following weight proportion material of getting it filled,
The Radix Astragali 22.2%～66.8%,
Radix Salviae Miltiorrhizae 11.6%～33.4%,
Radix Notoginseng 2.5%～13.5%,
Lignum Dalbergiae Odoriferae 14.5%～44.3%
The Radix Astragali wherein, Radix Salviae Miltiorrhizae and Radix Notoginseng are processed into extract, and Lignum Dalbergiae Odoriferae extracts volatile oil, and other gets hydroxypropyl emthylcellulose, lactose and magnesium stearate, and is standby;
2. with above-mentioned medicinal substances extract and Borneolum Syntheticum and lactose mix homogeneously, adopt an amount of 70% ethanol moistening, granulate drying, granulate;
3. the granule and the hydroxypropyl emthylcellulose mix homogeneously that obtain of above-mentioned steps 2;
4. use the mixture in the lubricated step 3 of magnesium stearate, tabletting.
Wherein, constant in order to guarantee compound astragalus membranaceus gel matrix tablet of the present invention curative effect when slowly discharging, the sheet of the gel matrix tablet of method for preparing heavily is 0.50g～0.70g/ sheet, preferred 0.56g/ sheet.
In motherland's medical science to record that pill has " the ball person is slow also, releives and controls it ... " (Li Gao, 1180-1251).As seen Ancient Times in China medicine man early has recognized that and has used practice of pharmacy, reaches the purpose of steadily lasting curative effect.
Conventional dosage forms, most drug release process is all undertaken by first order kinetics, and the blood drug level of its medicine might be lower than minimum effective blood drug concentration and hold time short shortcoming in treatment concentration.For reaching therapeutic purposes and reducing side effect and often take repeatedly medicining mode, the compliance that makes the patient take medicine like this descends.Slow releasing preparation has overcome the deficiency of conventional formulation just, and steady, persistent blood drug level is provided.
Compound astragalus membranaceus gel matrix tablet of the present invention has adopted the design principle of Western medicine slow releasing preparation to obtain achievement at aspects such as adjuvant selection, quality evaluations, for the research of Chinese medicine slow releasing preparation is used for reference.
The following beneficial effect by the gel matrix tablet of the present invention of external release description of test
The external release experiment of compound astragalus membranaceus gel matrix tablet
By changeing the basket method, adopt the content of astragaloside in the high effective liquid chromatography for measuring Radix Astragali, come the difference of comparison compound astragalus membranaceus gel matrix tablet of the present invention and the external release of conventional tablet.
Instrument and reagent:
Day island proper Tianjin LC-10A high performance liquid chromatograph, R1-6A detector, CLASS-10A chromatographic work station, CQ-250 type ultrasonic cleaner.Methanol is chromatographically pure, and water is distilled water, and other reagent are analytical pure.Astragaloside (Nat'l Pharmaceutical ﹠ Biological Products Control Institute), compound astragalus membranaceus gel matrix tablet of the present invention is provided by Tianjin Tianlishi Group Co.,Ltd's modern Chinese medicine institute, prepares according to embodiment 2 methods.The compound astragalus membranaceus conventional tablet is provided by Tianjin Tianlishi Group Co.,Ltd's modern Chinese medicine institute, prepares according to embodiment 1 method.
Experimental technique:
Chromatographic condition, chromatographic column are HypersilODS2 (200mm * 4.6mm, 5 μ m), and mobile phase is methanol-water (67: 33), and flow velocity is 1mL/min, and column temperature is 35 ℃.
The preparation of standard curve takes by weighing the astragaloside reference substance 1.0022mg of drying to constant weight, with dissolve with methanol and standardize solution in the 2mL volumetric flask, the astragaloside reference substance solution.Accurate this solution 2,6,10,14,18,20 μ L that draw, sample introduction is each 3 times respectively, with concentration C honeybee area average A is obtained equation of linear regression: A=2.868 * 10
4C 10, r=0.9996, and the range of linearity is 1-10 μ g.
Chinese Pharmacopoeia version appendix in 2000 the XD drug release determination method first method pertinent regulations, measure fresh degassing distilled water 900ml and inject each container, regulating and controlling temperature is (37 ± 0.1) ℃, rotating speed is 50r/min, respectively at dropping into 1 of compound Salviae Miltiorrhizae gel matrix tablet in each container, totally 6, and respectively 0.5,1,2,3,4,5,6,7,8,10, the 12h sampling, ask its cumulative release amount, get the release curve; With the conventional tablet dissolution behind the method mensuration desaccharide clothing, every interval 15min sampling gets the release curve with method, sees Fig. 1.
The result shows that the compound astragalus membranaceus gel matrix tablet of adopting HPMC to prepare has good external release effect.
Description of drawings
The external release curve of gel matrix tablet of Fig. 1 compound astragalus membranaceus and conventional tablet
The specific embodiment
The present invention is further illustrated below in conjunction with Comparative Examples and embodiment, and following this embodiment only is used to the present invention is described and to the present invention without limits.
The preparation of embodiment 1 compound astragalus membranaceus conventional tablet
Get Radix Astragali 86.5g, Radix Salviae Miltiorrhizae 21.3g, Radix Notoginseng 3.5g, Lignum Dalbergiae Odoriferae 20.6g; Will be through Radix Salviae Miltiorrhizae, the Radix Notoginseng of pulverizing, decocting boils 2 times, adds 7 times of water gagings at every turn, each 2 hours, merges decoction liquor, filter, filtrate is concentrated into 900ml, adds 95% ethanol, makes determining alcohol reach 70%, left standstill 12～24 hours, and filtered, reclaim ethanol, continue to be condensed into the Salvia miltiorrhiza and Panax notoginseng extract;
To decoct with water 2 times through the Radix Astragali of pulverizing, add 6 times of water gagings at every turn, extracted successively 2 hours, 1 hour, merging filtrate is when being concentrated into the 1500ml left and right sides, adding 95% ethanol, to make determining alcohol be 60%, left standstill 12～24 hours, filters, filtrate recycling ethanol, when being concentrated into the 400ml left and right sides, adding 95% ethanol, to make determining alcohol be 80%, left standstill 12～24 hours, filter, filtrate recycling ethanol, and continue to be condensed into Radix Astragali extract; Get Lignum Dalbergiae Odoriferae, add 5 times of water gagings, reflux, extract, 5 hours is collected volatile oil; Get above-mentioned Salvia miltiorrhiza and Panax notoginseng extract, Radix Astragali extract, volatile oil of Lignum Dalbergiae Odoriferae and lactose, adopt 70% ethanol to granulate as binding agent, oven dry, granulate adds the magnesium stearate tabletting.
Embodiment 2
Get Radix Astragali 40.6g (30.0%), Radix Salviae Miltiorrhizae 44.8g (33.1%), Radix Notoginseng 11.2g (8.3%), Lignum Dalbergiae Odoriferae 38.6g (28.6%); Will be through Radix Salviae Miltiorrhizae, the Radix Notoginseng of pulverizing, decocting boils 2 times, adds 7 times of water gagings at every turn, each 2 hours, merges decoction liquor, filter, filtrate is concentrated into 900ml, adds 95% ethanol, makes determining alcohol reach 70%, left standstill 12～24 hours, and filtered, reclaim ethanol, continue to be condensed into the Salvia miltiorrhiza and Panax notoginseng extract;
To decoct with water 2 times through the Radix Astragali of pulverizing, add 6 times of water gagings at every turn, extracted successively 2 hours, 1 hour, merging filtrate is when being concentrated into the 1500ml left and right sides, adding 95% ethanol, to make determining alcohol be 60%, left standstill 12～24 hours, filters, filtrate recycling ethanol, when being concentrated into the 400ml left and right sides, adding 95% ethanol, to make determining alcohol be 80%, left standstill 12～24 hours, filter, filtrate recycling ethanol continues to be condensed into Radix Astragali extract; Get Lignum Dalbergiae Odoriferae, add 5 times of water gagings, reflux, extract, 5 hours is collected volatile oil;
Get above-mentioned Salvia miltiorrhiza and Panax notoginseng extract 2.5g, Radix Astragali extract 2.5g and volatile oil of Lignum Dalbergiae Odoriferae 0.46g; Other gets the lactose of 5.46g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 5.46g, add 0.16g magnesium stearate tabletting, every heavily is 0.57g.
Embodiment 3
Get Radix Astragali 86.5g (65.6%), Radix Salviae Miltiorrhizae 21.3g (16.1%), Radix Notoginseng 3.5g (2.7%), Lignum Dalbergiae Odoriferae 20.6g (15.6%); Will be through Radix Salviae Miltiorrhizae, the Radix Notoginseng of pulverizing, decocting boils 2 times, adds 7 times of water gagings at every turn, each 2 hours, merges decoction liquor, filter, filtrate is concentrated into 900ml, adds 95% ethanol, makes determining alcohol reach 70%, left standstill 12～24 hours, and filtered, reclaim ethanol, continue to be condensed into the Salvia miltiorrhiza and Panax notoginseng extract;
To decoct with water 2 times through the Radix Astragali of pulverizing, add 6 times of water gagings at every turn, extracted successively 2 hours, 1 hour, merging filtrate is when being concentrated into the 1500ml left and right sides, adding 95% ethanol, to make determining alcohol be 60%, left standstill 12～24 hours, filters, filtrate recycling ethanol, when being concentrated into the 400ml left and right sides, adding 95% ethanol, to make determining alcohol be 80%, left standstill 12～24 hours, filter, filtrate recycling ethanol continues to be condensed into Radix Astragali extract; Get Lignum Dalbergiae Odoriferae, add 5 times of water gagings, reflux, extract, 5 hours is collected volatile oil;
Get above-mentioned Salvia miltiorrhiza and Panax notoginseng extract 2.5g, Radix Astragali extract 2.5g and volatile oil of Lignum Dalbergiae Odoriferae 0.46g; Other gets the lactose of 5.46g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 5.46g, add 0.16g magnesium stearate tabletting, every heavily is 0.57g.
Embodiment 4
Get Radix Astragali 77.3g (57.1%), Radix Salviae Miltiorrhizae 22.8g (16.8%), Radix Notoginseng 4.8g (3.6%), Lignum Dalbergiae Odoriferae 30.5g (22.5%); Will be through Radix Salviae Miltiorrhizae, the Radix Notoginseng of pulverizing, decocting boils 2 times, adds 7 times of water gagings at every turn, each 2 hours, merges decoction liquor, filter, filtrate is concentrated into 900ml, adds 95% ethanol, makes determining alcohol reach 70%, left standstill 12～24 hours, and filtered, reclaim ethanol, continue to be condensed into the Salvia miltiorrhiza and Panax notoginseng extract;
To decoct with water 2 times through the Radix Astragali of pulverizing, add 6 times of water gagings at every turn, extracted successively 2 hours, 1 hour, merging filtrate is when being concentrated into the 1500ml left and right sides, adding 95% ethanol, to make determining alcohol be 60%, left standstill 12～24 hours, filters, filtrate recycling ethanol, when being concentrated into the 400ml left and right sides, adding 95% ethanol, to make determining alcohol be 80%, left standstill 12～24 hours, filter, filtrate recycling ethanol continues to be condensed into Radix Astragali extract; Get Lignum Dalbergiae Odoriferae, add 5 times of water gagings, reflux, extract, 5 hours is collected volatile oil;
Get above-mentioned Salvia miltiorrhiza and Panax notoginseng extract 2.5g, Radix Astragali extract 2.5g and volatile oil of Lignum Dalbergiae Odoriferae 0.46g; Other gets the lactose of 5.46g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 5.46g, add 0.16g magnesium stearate tabletting, every heavily is 0.57g.
Embodiment 5
Get Radix Astragali 42.3g (31.0%), Radix Salviae Miltiorrhizae 39.2g (28.7%), Radix Notoginseng 8.2g (6.0%), Lignum Dalbergiae Odoriferae 46.8g (34.3%); Will be through Radix Salviae Miltiorrhizae, the Radix Notoginseng of pulverizing, decocting boils 2 times, adds 7 times of water gagings at every turn, each 2 hours, merges decoction liquor, filter, filtrate is concentrated into 900ml, adds 95% ethanol, makes determining alcohol reach 70%, left standstill 12～24 hours, and filtered, reclaim ethanol, continue to be condensed into the Salvia miltiorrhiza and Panax notoginseng extract;
To decoct with water 2 times through the Radix Astragali of pulverizing, add 6 times of water gagings at every turn, extracted successively 2 hours, 1 hour, merging filtrate is when being concentrated into the 1500ml left and right sides, adding 95% ethanol, to make determining alcohol be 60%, left standstill 12～24 hours, filters, filtrate recycling ethanol, when being concentrated into the 400ml left and right sides, adding 95% ethanol, to make determining alcohol be 80%, left standstill 12～24 hours, filter, filtrate recycling ethanol continues to be condensed into Radix Astragali extract; Get Lignum Dalbergiae Odoriferae, add 5 times of water gagings, reflux, extract, 5 hours is collected volatile oil;
Get above-mentioned Salvia miltiorrhiza and Panax notoginseng extract 2.5g, Radix Astragali extract 2.5g and volatile oil of Lignum Dalbergiae Odoriferae 0.46g; Other gets the lactose of 4.37g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 4.37g, add 0.14g magnesium stearate tabletting, every heavily is 0.57g.
Embodiment 6
Get Radix Astragali 65.2g (44.7%), Radix Salviae Miltiorrhizae 38.9g (26.7%), Radix Notoginseng 9.3g (6.3%), Lignum Dalbergiae Odoriferae 32.5g (22.3%); Will be through Radix Salviae Miltiorrhizae, the Radix Notoginseng of pulverizing, decocting boils 2 times, adds 7 times of water gagings at every turn, each 2 hours, merges decoction liquor, filter, filtrate is concentrated into 900ml, adds 95% ethanol, makes determining alcohol reach 70%, left standstill 12～24 hours, and filtered, reclaim ethanol, continue to be condensed into the Salvia miltiorrhiza and Panax notoginseng extract;
To decoct with water 2 times through the Radix Astragali of pulverizing, add 6 times of water gagings at every turn, extracted successively 2 hours, 1 hour, merging filtrate is when being concentrated into the 1500ml left and right sides, adding 95% ethanol, to make determining alcohol be 60%, left standstill 12～24 hours, filters, filtrate recycling ethanol, when being concentrated into the 400ml left and right sides, adding 95% ethanol, to make determining alcohol be 80%, left standstill 12～24 hours, filter, filtrate recycling ethanol continues to be condensed into Radix Astragali extract; Get Lignum Dalbergiae Odoriferae, add 5 times of water gagings, reflux, extract, 5 hours is collected volatile oil;
Get above-mentioned Salvia miltiorrhiza and Panax notoginseng extract 2.5g, Radix Astragali extract 2.5g and volatile oil of Lignum Dalbergiae Odoriferae 0.46g; Other gets the lactose of 6.07g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 6.07g, add 0.17g magnesium stearate tabletting, every heavily is 0.57g.
Embodiment 7
Get Radix Astragali 56.2g (42.2%), Radix Salviae Miltiorrhizae 32.5g (23.8%), Radix Notoginseng 6.2g (4.5%), Lignum Dalbergiae Odoriferae 41.6g (30.5%); Will be through Radix Salviae Miltiorrhizae, the Radix Notoginseng of pulverizing, decocting boils 2 times, adds 7 times of water gagings at every turn, each 2 hours, merges decoction liquor, filter, filtrate is concentrated into 900ml, adds 95% ethanol, makes determining alcohol reach 70%, left standstill 12～24 hours, and filtered, reclaim ethanol, continue to be condensed into the Salvia miltiorrhiza and Panax notoginseng extract;
To decoct with water 2 times through the Radix Astragali of pulverizing, add 6 times of water gagings at every turn, extracted successively 2 hours, 1 hour, merging filtrate is when being concentrated into the 1500ml left and right sides, adding 95% ethanol, to make determining alcohol be 60%, left standstill 12～24 hours, filters, filtrate recycling ethanol, when being concentrated into the 400ml left and right sides, adding 95% ethanol, to make determining alcohol be 80%, left standstill 12～24 hours, filter, filtrate recycling ethanol continues to be condensed into Radix Astragali extract; Get Lignum Dalbergiae Odoriferae, add 5 times of water gagings, reflux, extract, 5 hours is collected volatile oil;
Get above-mentioned Salvia miltiorrhiza and Panax notoginseng extract 2.5g, Radix Astragali extract 2.5g and volatile oil of Lignum Dalbergiae Odoriferae 0.46g; Other gets the lactose of 6.07g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 6.07g, add 0.17g magnesium stearate tabletting, every heavily is 0.57g.
Embodiment 8
Get Radix Astragali 36.5g (31.3%), Radix Salviae Miltiorrhizae 32.4g (27.7%), Radix Notoginseng 6.2g (5.3%), Lignum Dalbergiae Odoriferae 41.7g (35.7%); Will be through Radix Salviae Miltiorrhizae, the Radix Notoginseng of pulverizing, decocting boils 2 times, adds 7 times of water gagings at every turn, each 2 hours, merges decoction liquor, filter, filtrate is concentrated into 900ml, adds 95% ethanol, makes determining alcohol reach 70%, left standstill 12～24 hours, and filtered, reclaim ethanol, continue to be condensed into the Salvia miltiorrhiza and Panax notoginseng extract;
To decoct with water 2 times through the Radix Astragali of pulverizing, add 6 times of water gagings at every turn, extracted successively 2 hours, 1 hour, merging filtrate is when being concentrated into the 1500ml left and right sides, adding 95% ethanol, to make determining alcohol be 60%, left standstill 12～24 hours, filters, filtrate recycling ethanol, when being concentrated into the 400ml left and right sides, adding 95% ethanol, to make determining alcohol be 80%, left standstill 12～24 hours, filter, filtrate recycling ethanol continues to be condensed into Radix Astragali extract; Get Lignum Dalbergiae Odoriferae, add 5 times of water gagings, reflux, extract, 5 hours is collected volatile oil;
Get above-mentioned Salvia miltiorrhiza and Panax notoginseng extract 2.5g, Radix Astragali extract 2.5g and volatile oil of Lignum Dalbergiae Odoriferae 0.46g; Other gets the lactose of 6.07g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 6.07g, add 0.17g magnesium stearate tabletting, every heavily is 0.57g.
Embodiment 9
Get Radix Astragali 35.5g (22.9%), Radix Salviae Miltiorrhizae 50.8g (32.8%), Radix Notoginseng 16.3g (10.5%), Lignum Dalbergiae Odoriferae 52.3g (33.8%); Will be through Radix Salviae Miltiorrhizae, the Radix Notoginseng of pulverizing, decocting boils 2 times, adds 7 times of water gagings at every turn, each 2 hours, merges decoction liquor, filter, filtrate is concentrated into 900ml, adds 95% ethanol, makes determining alcohol reach 70%, left standstill 12～24 hours, and filtered, reclaim ethanol, continue to be condensed into the Salvia miltiorrhiza and Panax notoginseng extract;
To decoct with water 2 times through the Radix Astragali of pulverizing, add 6 times of water gagings at every turn, extracted successively 2 hours, 1 hour, merging filtrate is when being concentrated into the 1500ml left and right sides, adding 95% ethanol, to make determining alcohol be 60%, left standstill 12～24 hours, filters, filtrate recycling ethanol, when being concentrated into the 400ml left and right sides, adding 95% ethanol, to make determining alcohol be 80%, left standstill 12～24 hours, filter, filtrate recycling ethanol continues to be condensed into Radix Astragali extract; Get Lignum Dalbergiae Odoriferae, add 5 times of water gagings, reflux, extract, 5 hours is collected volatile oil;
Get above-mentioned Salvia miltiorrhiza and Panax notoginseng extract 2.5g, Radix Astragali extract 2.5g and volatile oil of Lignum Dalbergiae Odoriferae 0.46g; Other gets the lactose of 6.07g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 6.07g, add 0.17g magnesium stearate tabletting, every heavily is 0.57g.
Embodiment 10
Get Radix Astragali 40.6g (30.0%), Radix Salviae Miltiorrhizae 44.8g (33.1%), Radix Notoginseng 11.2g (8.3%), Lignum Dalbergiae Odoriferae 38.6g (28.6%); Wherein the Radix Astragali is pulverized, adopted ethanol to carry out reflux, extract, 2 times, adopting 95% ethanol, consumption for the first time is 10 times of medical material amounts, backflow 90min is 70% ethanol for the second time, and consumption is 8 times of raw medicinal herbs, backflow 60min, merge extractive liquid, concentrates and reclaims ethanol, obtains Radix Astragali extract; Get above-mentioned Radix Salviae Miltiorrhizae, 20 mesh sieves are pulverized, extracting in water 2 times, the water logging bubble that adds for the first time 9～10 times of amounts, heating extraction 1.5 hours adds 5～7 times of water gagings, heating extraction 1 hour for the second time, merge extractive liquid,, suitably concentrate, add 95% ethanol, make to contain alcohol amount arrival 60%, concentrate and reclaim ethanol, get Radix Salviae Miltiorrhizae extract; Get above-mentioned pseudo-ginseng, add 10 times of amount ethanol extractions of 20% 3 times, reflux 8 hours, merge extractive liquid, concentrates and reclaims ethanol, Radix Notoginseng extract; Get Lignum Dalbergiae Odoriferae, add 5 times of water gagings, reflux, extract, 5 hours is collected volatile oil;
Get above-mentioned Radix Salviae Miltiorrhizae 1.25g, Radix Notoginseng extract 1.25g, Radix Astragali extract 2.5g and volatile oil of Lignum Dalbergiae Odoriferae 0.46g; Other gets the lactose of 6.07g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 6.07g, add 0.17g magnesium stearate tabletting, every heavily is 0.57g.
Embodiment 10
Get Radix Astragali 40.6g (30.0%), Radix Salviae Miltiorrhizae 44.8g (33.1%), Radix Notoginseng 11.2g (8.3%), Lignum Dalbergiae Odoriferae 38.6g (28.6%); After wherein the above-mentioned Radix Astragali being pulverized, put in the 50mL flask, this flask is put in the people MCL-3 type continuous microwave reactor, adopt 80% alcohol reflux, adjustment power is 400W, reacted 20 minutes, and be evaporated to half of original volume, add 0.1% active carbon, decolouring, filter, filtrate concentrates, and gets Radix Astragali extract; Learn from else's experience the Radix Salviae Miltiorrhizae, pseudo-ginseng of coarse pulverization to extraction pot, add 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 1, slowly adds 95% ethanol, makes medicinal liquid contain determining alcohol 69～71%, leaves standstill 12 hours.Get the supernatant of medicinal liquid behind the precipitate with ethanol, filter, filtrate recycling ethanol is condensed into extract; Get Lignum Dalbergiae Odoriferae, add 5 times of water gagings, reflux, extract, 5 hours is collected volatile oil;
Get above-mentioned Salvia miltiorrhiza and Panax notoginseng extract 2.5g, Radix Astragali extract 2.5g and volatile oil of Lignum Dalbergiae Odoriferae 0.46g; Other gets the lactose of 6.07g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 6.07g, add 0.17g magnesium stearate tabletting, every heavily is 0.57g.
Claims (7)
1. compound astragalus membranaceus gel matrix tablet is an active component by the extract of the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Notoginseng and Lignum Dalbergiae Odoriferae, and lactose and hydroxypropyl methylcellulose are that adjuvant is formed, and the weight ratio of active component wherein and lactose and hydroxypropyl methylcellulose is 1: 1: 1; The weight percentage of the active component Radix Astragali wherein, Radix Salviae Miltiorrhizae, Radix Notoginseng and Lignum Dalbergiae Odoriferae crude drug is the Radix Astragali 22.2%～66.8%, Radix Salviae Miltiorrhizae 11.6%～33.4%, Radix Notoginseng 2.5%～13.5%, Lignum Dalbergiae Odoriferae 14.5%～44.3%; Described active component extract is that the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Notoginseng, Lignum Dalbergiae Odoriferae medical material extract separately and get, and wherein the Milkvetch Root extract adopts alcohol extraction to follow the example of or the microwave extraction method prepares; The red rooted salvia extract adopts water extraction method or alcohol extraction is followed the example of or the chromatography preparation; The extract of pseudo-ginseng adopts alcohol extraction to follow the example of or the chromatography preparation; Lignum Dalbergiae Odoriferae extract adopts the reflux extraction preparation.
2. the described gel matrix tablet of claim 1, the weight percentage of active component crude drug wherein is the Radix Astragali 30.8%～57.2%, Radix Salviae Miltiorrhizae 15.4%～28.6%, Radix Notoginseng 3.5%～6.5%, Lignum Dalbergiae Odoriferae 20.6%～38.2%.
3. the described gel matrix tablet of claim 1, the weight percentage of active component crude drug wherein are the Radix Astragali 44.7%, Radix Salviae Miltiorrhizae 26.7%, Radix Notoginseng 6.3%, Lignum Dalbergiae Odoriferae 22.3%.
4. the described gel matrix tablet of claim 1, the weight percentage of active component crude drug wherein are the Radix Astragali 42.2%, Radix Salviae Miltiorrhizae 23.8%, Radix Notoginseng 4.5%, Lignum Dalbergiae Odoriferae 0.5%.
5. the preparation method of the described a kind of compound astragalus membranaceus gel matrix tablet of claim 1 comprises the following steps:
A. by the following weight proportion material of getting it filled: the Radix Astragali 22.2%～66.8%, Radix Salviae Miltiorrhizae 11.6%～33.4%, Radix Notoginseng 2.5%～13.5%, Lignum Dalbergiae Odoriferae 14.5%～44.3%, and it is processed into extract, other gets hydroxypropyl emthylcellulose, lactose and magnesium stearate, and is standby;
B. with medicinal substances extract among the step a and lactose mix homogeneously, adopt an amount of 70% ethanol moistening, granulate drying, granulate;
C. the granule and the hydroxypropyl emthylcellulose mix homogeneously that obtain of above-mentioned steps b;
D. use the mixture among the lubricated step c of magnesium stearate, tabletting.
6. the described method of claim 5, wherein the sheet of Zhi Bei gel matrix tablet heavily is 0.50g～0.70g/ sheet.
7. the described method of claim 5, wherein the sheet of Zhi Bei gel matrix tablet heavily is the 0.56g/ sheet.
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