CN101804151A - Method for preparing Yixinshu tablets - Google Patents
Method for preparing Yixinshu tablets Download PDFInfo
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- CN101804151A CN101804151A CN 201010135022 CN201010135022A CN101804151A CN 101804151 A CN101804151 A CN 101804151A CN 201010135022 CN201010135022 CN 201010135022 CN 201010135022 A CN201010135022 A CN 201010135022A CN 101804151 A CN101804151 A CN 101804151A
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Abstract
The invention discloses a method for preparing Yixinshu tablets, comprising the following steps of a. taking materials according to the formulation; b. taking ginseng for grinding, sieving by a 100-mesh sieve, and sterilizing for standby application; c. taking the fruit of Chinese magnoliavine and the root of red-rooted salvia for extracting for twice, blending and filtering, concentrating filtrate to have the relative density of 1.12-1.15 (20 DEG C), and obtaining extractum; d. decocting dwarf lilyturf tuber, radix astragali, Ligusticum wallichii and hawthorn for twice, blending decocted liquid, filtering, concentrating filtrate to be 650ml, adding 85% of ethanol with equal quantity, fully stirring, standing still overnight, filtering, concentrating to be the relative density of 1.30-1.36 (80 DEG C), and obtaining water extracted extractum; and e. blending the two extractums, adding ginseng powder and microcrystalline cellulose into the extractum mixture, evenly mixing, sieving by a 160-mesh sieve by using 80% of ethanol, carrying out wet granulation, drying, sieving by a 20-mesh sieve for completing granules, adding dried granules into magnesium stearate, adding right amount of starch, adjusting the total quantity to be 380g, evenly mixing, tabletting to be 1000 tablets, coating film and obtaining the Yixinshu tablets.
Description
Technical field
The present invention relates to a kind of method for preparing Yixinshu tablet.
Background technology
The YIXINSHU Chinese medicine preparation has Yiqi and vein recovery, blood circulation promoting and blood stasis dispelling, the effect of YIN nourishing and the production of body fluid promoting, be used for deficiency of both QI and YIN, the cardiopalmus irregularly intermittent and regularly intermittent pulse, uncomfortable in chestly do not relax, chest pain and angina pectoris are seen the person that has the above-mentioned symptom, are widely used in treatment angina pectoris, myocardial ischemia, various arrhythmia, artrial premature beat, chest pain and angina pectoris trouble etc. at present clinically.But existing its preparation technology of YIXINSHU Chinese medicine is relatively complicated, and the quality of product can not get guaranteeing.
Summary of the invention
The objective of the invention is provides a kind of technology simple in order to overcome weak point of the prior art, the method for preparing Yixinshu tablet of good product quality.
In order to achieve the above object, the present invention adopts following scheme:
A kind of method for preparing Yixinshu tablet may further comprise the steps:
A, by the prescription in proportioning take by weighing Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Astragali, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Fructus Crataegi, microcrystalline Cellulose, magnesium stearate;
B, get Radix Ginseng and pulverize, cross 100 mesh sieves, use pulsation vacuum sterilizer sterilization back standby;
C, get Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae and add 5～6 times of amount 85% alcohol reflux 2 times, 3 hours for the first time, 1.5 hours for the second time, filter, merging filtrate, decompression recycling ethanol, and filtrate is concentrated into relative density 1.12～1.15 (20 ℃), pure extractum;
D, Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi are added 8～12 times of water gagings decoct 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate is concentrated into about 650ml, adds equivalent 85% ethanol, after fully stirring, standing over night, filter, decompression filtrate recycling ethanol (60～70 ℃ ,-0.08Mpa) and be concentrated into relative density 1.30～1.36 (80 ℃) the water extracted immersing paste;
E, above-mentioned two kinds of extractum are merged after, add above-mentioned Radix Ginseng fine powder, and add microcrystalline Cellulose, mix homogeneously is crossed 16 mesh sieve wet granulations with 80% ethanol, and 40～50 ℃ dry down, cross 20 mesh sieve granulate, dried granule adds magnesium stearate, and it is an amount of to add starch, regulates total amount to 380g, evenly mixed, be pressed into 1000, the bag film-coat promptly gets product Yixinshu tablet of the present invention.
Aforesaid preparation method, wherein the sterilization of the pulsation vacuum sterilizer described in the step b is at 134 ℃, 0.21Mpa sterilized 1 hour down.
Aforesaid preparation method, wherein the decompression recycling ethanol described in step c and the steps d is at 50～60 ℃, carries out under-the 0.08Mpa.
Among the present invention to the selection of sterilization method:
Directly be used as medicine after this product ginseng crude drug pulverizes, antibacterial is more.For guaranteeing the quality of finished product, select for use the sterilization of 75% ethanol, Co60 irradiation sterilization, ethylene oxide sterilizing to compare experiment.75% ethanol sterilization effect is bad as a result, and the Co60 sterilization is inconvenient, and is influential to the medical material active constituent content simultaneously, therefore adopts simple and easy to do pulsation vacuum sterilizer sterilization (temperature: 134 ℃; Pressure: 0.21MPa time: 1 hour), the medical material fine powder after pulverizing is sterilized.
Among the present invention to the optimization of extraction process:
Respectively the alcohol adding amount of alcohol extraction, the amount of water that water is carried are optimized selection in the inventive method.
(1) the alcohol extraction alcohol adding amount is preferred
1, the selection of evaluation index
The Fructus Schisandrae Chinensis main component is to be the lignanoids of representative with the schisandrin, can be with the content of schisandrin as one of evaluation index of alcohol extraction process.The main component of Radix Salviae Miltiorrhizae is to be the anthrone class of representative with the tanshinone, can be with tanshinone another evaluation index as alcohol extraction process.
2, experimental technique
Take by weighing three parts of Fructus Schisandrae Chinensis 50g, Radix Salviae Miltiorrhizae 100g, first part adds 4 times of amount 85% ethanol, second part adds 5 times of amount 85% ethanol, and the 3rd part adds 6 times of amount 85% ethanol, every part of reflux, extract, 2 times respectively, 3 hours for the first time, 1.5 hours for the second time, filter the record first time and total amount of filtrate, calculate liquid absorption, filtrate for later use.
3, the assay method of evaluation index
3.1 the assay of schisandrin
Chromatographic condition and system suitability condition octadecylsilane chemically bonded silica are filler; Methanol-water (65: 35) is a mobile phase; The detection wavelength is 250nm; Flow velocity 1ml/ minute.
3.11 the preparation of reference substance solution
It is an amount of to get the schisandrin reference substance, and accurate the title decides, and adds methanol and makes the reference substance solution that every 1ml contains 60 μ g.
3.12 the preparation of need testing solution
Pipette 1/100 of every part of alcohol extract, put in the brown volumetric flask of 50ml, add 85% ethanol, shake up, filter with microporous filter membrane (0.45 μ m), promptly to scale.
3.13 accurate respectively reference substance solution and each 20 μ 1 of need testing solution of drawing of assay method inject chromatograph of liquid, measure, promptly.
3.2 the assay of tanshinone
3.21 chromatographic condition and system suitability test
With octadecyl silane is filler; Methanol-water (75: 25) is a mobile phase; The detection wavelength is 270nm; Flow velocity 1ml/ minute.
3.22 the preparation of reference substance solution
It is an amount of to get the tanshinone reference substance, and accurate the title decides, and adds methanol and makes the reference substance solution that every 1ml contains 16 μ g.
3.23 the preparation of need testing solution
Get the solution of measuring schisandrin, as need testing solution.
3.24 assay method
Accurate respectively reference substance solution and each 20 μ l of need testing solution of drawing inject chromatograph of liquid, measure, promptly.
4, result of the test
Alcohol adding amount result of the test table
Above-mentioned result of the test shows, not greatly 0.7 times of the liquid absorption of medicine; From the content of schisandrin and tanshinone, it is suitable substantially with 6 times of amount 85% ethanol to add 5 times of amounts, all apparently higher than 85% ethanol that adds 4 times of amounts.From saving cost, improve on the preparation efficiency and consider, 85% the ethanol of selecting to add 5 times of amounts extracts.
(2) water is carried the preferred of amount of water
1, the selection of evaluation index
Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi four Chinese medicine decoct with water, and Radix Astragali main component is to be the saponins of representative with the astragaloside, can be with the content of astragaloside as one of evaluation index of extraction process by water.50% ethanol soluble extraction can reflect the extraction effect of aqueous soluble active constituent, so with its another evaluation index as extraction process by water.
2, experimental technique
Take by weighing three parts of 30g Radix Ophiopogonis, Radix Astragali 30g, Rhizoma Chuanxiong 20g, Fructus Crataegi 30g, first part adds 8 times of water gagings, second part adds 10 times of water gagings, and the 3rd part adds 12 times of water gagings, and every part decocts 2 times, 2.5 hours for the first time, 1.5 hours for the second time, filter the record first time and total amount of filtrate, calculate liquid absorption, filtrate for later use.
3, the assay method of evaluation index
3.1, the assay of astragaloside
3.11, use evaporative light scattering detector, sample size and absworption peak area are the double-log linear relationship, are a straight line without initial point.With the external standard two-point method, promptly with point (LOG
10C1, LOG
10A1) and point (LOG
10C2, LOG
10A2) determine linear relationship.
3.12, the test of chromatographic condition and system suitability
With octadecylsilane chemically bonded silica is filler; Acetonitrile-water (40: 60) is a mobile phase, and flow velocity is 1.0ml/min.Evaporative light scattering detector (ELSD800) parameter: 40 ℃ of drift tube temperatures, nebulizer gas pressure 3.0bar (being equivalent to flow rate of carrier gas 2.6L/min).
3.13, the preparation of reference substance solution
It is an amount of to take by weighing the astragaloside reference substance, accurate claims surely, uses dissolve with methanol, and make every 1ml and contain the solution of 0.1mg and the solution that every 1ml contains 0.4mg, product solution in contrast respectively, promptly.
3.14, the preparation of need testing solution
Accurate 1/10 of the every part of water extract of drawing, water-bath is concentrated into about 10ml, adds diethyl ether to extract twice, each 10ml discards ether solution, and medicinal residues are flung to residual ether, precision adds methanol 50ml, claims to decide weight, supersound process 30 minutes, put coldly, claim to decide weight, supply the weight that subtracts mistake with methanol, filter, precision is measured subsequent filtrate 40ml, water bath method, residue adds water 15ml, and slight fever makes dissolving, with water saturated n-butanol extraction three times, each 20ml merges n-butyl alcohol liquid, washes secondary with strong ammonia solution, each 30ml, discard ammoniacal liquor, n-butyl alcohol liquid is extremely neutral with the saturated water washing of n-butyl alcohol again, discards water liquid, n-butyl alcohol liquid water bath method, residue add methanol make the dissolving and be transferred in the 5ml measuring bottle, add methanol and be diluted to scale, shake up, filter with microporous filter membrane (0.45um), promptly.
3.15, assay method
Accurate respectively reference substance solution and each 20 μ l of need testing solution of drawing inject chromatograph of liquid, measure, promptly.
3.2,50% ethanol soluble extraction
Precision is measured every part of water and is carried 1/10 of pre-test solution, concentrates, and drying, dry thing porphyrize adds 10 times of amount 50% dissolve with ethanols, left standstill 24 hours, and filtered, reclaim ethanol, water liquid water bath method, put and be dried to constant weight in the baking oven, claim that fixed dry thing is heavy, be 50% ethanol soluble extraction and weigh.
4, result of the test
Amount of water result of the test table
Above-mentioned result of the test shows, not greatly 1.6 times of the liquid absorptions of medicine decoct that to add 8,10,12 times of water little to Astragaloside content and the influence of 50% ethanol soluble extraction amount, can extract with 8 times of water gagings, extracts to reduce, the spissated time, improves preparation efficiency.
In sum, beneficial effect of the present invention:
The extraction process cost is low in the preparation method of the present invention, the preparation efficiency height; Technology is simple, and the mass effect of product is good.
The specific embodiment
Below in conjunction with the specific embodiment the present invention is described further:
Embodiment 1
Preparation prescription is: Radix Ginseng 200g, Radix Ophiopogonis 200g, Fructus Schisandrae Chinensis 133g, Radix Astragali 200g, Radix Salviae Miltiorrhizae 267g, Rhizoma Chuanxiong 133g, Fructus Crataegi 200g, microcrystalline Cellulose 40g, magnesium stearate 2g; The preparation Yixinshu tablet that starch is an amount of may further comprise the steps:
Take by weighing Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Astragali, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Fructus Crataegi, microcrystalline Cellulose, magnesium stearate by the proportioning in the prescription; Get Radix Ginseng and pulverize, cross 100 mesh sieves, use pulsation vacuum sterilizer at 134 ℃, sterilization is standby after 1 hour down for 0.21Mpa; Get Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae and add 5 times of amount 85% alcohol reflux 2 times, 3 hours for the first time, 1.5 hours for the second time, filter, merging filtrate, at 50 ℃, decompression recycling ethanol under the-0.08Mpa, and filtrate is concentrated into relative density 1.12 (20 ℃), pure extractum; Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi are added 8 times of water gagings to be decocted 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate is concentrated into about 650ml, adds equivalent 85% ethanol, after fully stirring, standing over night, filter, filtrate is at 60 ℃, under-the 0.08Mpa decompression recycling ethanol and be concentrated into relative density 1.30 (80 ℃) the water extracted immersing paste; After above-mentioned two kinds of extractum merging, add above-mentioned Radix Ginseng fine powder, and add microcrystalline Cellulose, mix homogeneously is crossed 16 mesh sieve wet granulations with 80% ethanol, and 40 ℃ dry down, cross 20 mesh sieve granulate, dried granule adds magnesium stearate, and it is an amount of to add starch, regulates total amount to 380g, evenly mixed, be pressed into 1000, the bag film-coat promptly gets product Yixinshu tablet of the present invention.
Embodiment 2
Preparation prescription is: Radix Ginseng 180g, Radix Ophiopogonis 230g, Fructus Schisandrae Chinensis 100g, Radix Astragali 220g, Radix Salviae Miltiorrhizae 250g, Rhizoma Chuanxiong 140g, Fructus Crataegi 180g, microcrystalline Cellulose 50g, magnesium stearate 2.5g; The preparation Yixinshu tablet that starch is an amount of may further comprise the steps:
Take by weighing Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Astragali, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Fructus Crataegi, microcrystalline Cellulose, magnesium stearate by the proportioning in the prescription; Get Radix Ginseng and pulverize, cross 100 mesh sieves, use pulsation vacuum sterilizer at 134 ℃, sterilization is standby after 1 hour down for 0.21Mpa; Get Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae and add 6 times of amount 85% alcohol reflux 2 times, 3 hours for the first time, 1.5 hours for the second time, filter, merging filtrate, at 60 ℃, decompression recycling ethanol under the-0.08Mpa, and filtrate is concentrated into relative density 1.15 (20 ℃), pure extractum; Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi are added 12 times of water gagings to be decocted 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate is concentrated into about 650ml, adds equivalent 85% ethanol, after fully stirring, standing over night, filter, filtrate is at 60 ℃, under-the 0.08Mpa decompression recycling ethanol and be concentrated into relative density 1.36 (80 ℃) the water extracted immersing paste; After above-mentioned two kinds of extractum merging, add above-mentioned Radix Ginseng fine powder, and add microcrystalline Cellulose, mix homogeneously is crossed 16 mesh sieve wet granulations with 80% ethanol, and 40 ℃ dry down, cross 20 mesh sieve granulate, dried granule adds magnesium stearate, and it is an amount of to add starch, regulates total amount to 380g, evenly mixed, be pressed into 1000, the bag film-coat promptly gets product Yixinshu tablet of the present invention.
Claims (3)
1. method for preparing Yixinshu tablet is characterized in that may further comprise the steps:
A, by the prescription in proportioning take by weighing Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Astragali, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Fructus Crataegi, microcrystalline Cellulose, magnesium stearate;
B, get Radix Ginseng and pulverize, cross 100 mesh sieves, use pulsation vacuum sterilizer sterilization back standby;
C, get Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae and add 5～6 times of amount 85% alcohol reflux 2 times, 3 hours for the first time, 1.5 hours for the second time, filter, merging filtrate, decompression recycling ethanol, and filtrate is concentrated into relative density 1.12～1.15 (20 ℃), pure extractum;
D, Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi are added 8～12 times of water gagings decoct 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, filtrate is concentrated into about 650ml, add equivalent 85% ethanol, after fully stirring, standing over night, filter, decompression filtrate recycling ethanol and be concentrated into relative density 1.30～1.36 (80 ℃) the water extracted immersing paste;
E, above-mentioned two kinds of extractum are merged after, add above-mentioned Radix Ginseng fine powder, and add microcrystalline Cellulose, mix homogeneously is crossed 16 mesh sieve wet granulations with 80% ethanol, and 40～50 ℃ dry down, cross 20 mesh sieve granulate, dried granule adds magnesium stearate, and it is an amount of to add starch, regulates total amount to 380g, evenly mixed, be pressed into 1000, the bag film-coat promptly gets product Yixinshu tablet of the present invention.
2. preparation method according to claim 1 is characterized in that the pulsation vacuum sterilizer sterilization described in the step b is at 134 ℃, and 0.21Mpa sterilized 1 hour down.
3. preparation method according to claim 1 is characterized in that the decompression recycling ethanol described in step c and the steps d is at 50～60 ℃, carries out under-the 0.08Mpa.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103784726A (en) * | 2014-01-27 | 2014-05-14 | 海南葫芦娃制药有限公司 | Heart relaxing tablet and preparation method thereof |
| CN104547506A (en) * | 2013-10-14 | 2015-04-29 | 山东中泰药业有限公司 | Traditional Chinese medicine preparation containing ginseng ultrafine powder and preparation method of traditional Chinese medicine preparation |
| CN106226435A (en) * | 2016-08-29 | 2016-12-14 | 江苏康缘药业股份有限公司 | A kind of fingerprint atlas detection method of Yixinshu tablet saponin component |
| CN109432293A (en) * | 2019-01-09 | 2019-03-08 | 山东中泰药业有限公司 | A kind of Chinese medicinal granule and preparation method thereof for treating cardiovascular and cerebrovascular disease |
| CN112263623A (en) * | 2020-11-09 | 2021-01-26 | 海南葫芦娃科技开发有限公司 | Preparation process of Yixinshu tablet alcohol extract |
| CN112741809A (en) * | 2021-02-08 | 2021-05-04 | 海南海力制药有限公司 | Preparation method of Yixinshu granules |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104547506A (en) * | 2013-10-14 | 2015-04-29 | 山东中泰药业有限公司 | Traditional Chinese medicine preparation containing ginseng ultrafine powder and preparation method of traditional Chinese medicine preparation |
| CN103784726A (en) * | 2014-01-27 | 2014-05-14 | 海南葫芦娃制药有限公司 | Heart relaxing tablet and preparation method thereof |
| CN103784726B (en) * | 2014-01-27 | 2017-06-13 | 海南葫芦娃药业集团股份有限公司 | Yixinshu tablet and preparation method thereof |
| CN106226435A (en) * | 2016-08-29 | 2016-12-14 | 江苏康缘药业股份有限公司 | A kind of fingerprint atlas detection method of Yixinshu tablet saponin component |
| CN109432293A (en) * | 2019-01-09 | 2019-03-08 | 山东中泰药业有限公司 | A kind of Chinese medicinal granule and preparation method thereof for treating cardiovascular and cerebrovascular disease |
| CN112263623A (en) * | 2020-11-09 | 2021-01-26 | 海南葫芦娃科技开发有限公司 | Preparation process of Yixinshu tablet alcohol extract |
| CN112741809A (en) * | 2021-02-08 | 2021-05-04 | 海南海力制药有限公司 | Preparation method of Yixinshu granules |
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Application publication date: 20100818 |