CN101698032B - Method for preparing tablets for treating hyperlipemia and prepared product - Google Patents
Method for preparing tablets for treating hyperlipemia and prepared product Download PDFInfo
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Abstract
The invention discloses a method for preparing tablets for treating hyperlipemia and a prepared product. The method comprises the following steps: using Alisma orientale, cassia seed, hawthorn fruit and prepared fleece flower root as raw materials, and pulverizing 20% of the prepared fleece flower root into fine powder; carrying out the reflux extraction on the rest prepared fleece flower root and the Alisma orientale twice by heating with 90% ethanol, and carrying out the reflux extraction on the cassia seed and the hawthorn fruit twice by heating with 70% ethanol; respectively recycling ethanol from the reflux extracting solutions, concentrating to a proper amount, decocting the drug residues after the reflux extraction for three times, taking the supernatant, concentrating to a proper amount, mixing with the ethanol-extraction concentrated liquid of cassia seed and hawthorn fruit, drying under reduced pressure, pulverizing into fine powder, adding proper amounts of the fine prepared fleece flower root powder and starch, and evenly mixing; and making the ethanol-extraction concentrated liquid of prepared fleece flower root and Alisma orientale, and mixed powder into particles, drying, adding a proper amount of lubricant, pressing into 1000 tablets, and coating films. The invention improves the prior preparation method; the product has the advantages of stable quality, high retention rate of effective components, obvious curative effect and high efficiency; and the preparation technology is mature, reasonable and feasible.
Description
Technical field
What the present invention relates to is a kind of Chinese patent medicine new preparation process of the turbid accumulation type hyperlipemia of expectorant and product that makes of treating; Referring in particular to a kind of is raw material with Rhizoma Alismatis, Semen Cassiae, Fructus Crataegi, Radix Polygoni Multiflori Preparata; Improve curative effect for remaining with effective constituent; The tablet of adopting new technology and processing belongs to technical field of traditional Chinese medicine pharmacy.
Background technology
The Chinese medicine Rhizoma Alismatis is the dry tuber of Alismataceae plant Alisma orientalis (Sam.) Juzep.; Semen Cassiae is the dry mature seed of leguminous plant Semen Cassiae Cassia obtusifolia L. or little Semen Cassiae Cassia tora L.; Fructus Crataegi is the dry mature fruit of rosaceous plant Fructus Pyri Pashiae Crataegus pinnatifida Bge.var.majorN.E.Br. or Fructus Crataegi Crataegus pinnatifida Bge.; Radix Polygoni Multiflori Preparata is the processing processed product of the dried root of polygonum multiflorum thunb Polygonum muLtiflorum Thunb..By the XUEZHILING PIAN that above-mentioned four flavor compatibilities are formed, the turbid blood fat reducing of having, the function of loosening bowel to relieve constipation cures mainly Chinese medical discrimination and belongs to the turbid accumulation type hyperlipemia of expectorant, and disease is seen that giddy is uncomfortable in chest, is hard and dry.
XUEZHILING PIAN is the new drug of my the company's research and development eighties; Come from distinguished veteran doctors of TCM Wu scholar unit clinical proved recipe for many years; Because prevailing condition limit, its preparation technology falls behind (adopt that normal pressure is concentrated, wet granulation, thermal cycle oven drying), production cycle length, the active ingredient loss is big, quality control index is low.
My company changes former coated tablet into Film coated tablets in 1999, but its preparation technology's reasonability is furtherd investigate.Along with the raising of pharmaceutical technology and quality control level, find that former preparation technology comes with some shortcomings.
In order to overcome above-mentioned shortcoming, the method for preparing of XUEZHILING PIAN has been carried out further research again, a kind of new method for preparing XUEZHILING PIAN has been proposed, not only active ingredient is lost less, curative effect improves obviously, and production efficiency is high.
Summary of the invention
The object of the invention is to provide a kind of Chinese crude drug Rhizoma Alismatis, Semen Cassiae, Fructus Crataegi, Radix Polygoni Multiflori Preparata of using to be raw material; Study and innovate the technical scheme that product quality, clinical efficacy and production efficiency are improved significantly to the technology of preparing of former XUEZHILING PIAN.
The present invention implements through following scheme.
One aspect of the present invention proposes a kind of new preparation process of XUEZHILING PIAN, comprises the following steps:
(1) gets raw material: Rhizoma Alismatis 500g, Semen Cassiae 500g, Fructus Crataegi 500g, Radix Polygoni Multiflori Preparata 500g;
(2) get Radix Polygoni Multiflori Preparata 400g, Rhizoma Alismatis 500g, add 90% alcohol heating reflux and extract secondary, each 3 hours, merge extractive liquid,, subsequent use;
(3) get Fructus Crataegi 500g, Semen Cassiae 500g, add 70% alcohol heating reflux and extract secondary, 3 hours for the first time, 2 hours for the second time, merge extractive liquid,, subsequent use;
(4) with the medicinal residues after step (2), (3) extraction, decocte with water is three times respectively, and 2 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrated and left standstill 12 hours, got supernatant, and was subsequent use;
(5) get Radix Polygoni Multiflori, the Rhizoma Alismatis extracting solution that step (2) prepares, reclaim ethanol and also be concentrated into an amount of, subsequent use;
(6) get Fructus Crataegi, the Semen Cassiae extracting solution that step (3) prepares, reclaim ethanol and also be concentrated into an amount of, subsequent use;
(7) water of step (4) preparation being put on clear liquid is concentrated in right amount;
(8) combining step (6) concentrated solution and step (7) concentrated solution, drying under reduced pressure is ground into fine powder, and is subsequent use;
(9) get Radix Polygoni Multiflori Preparata 100g, be ground into fine powder, subsequent use;
(10),, the concentrated solution and the above-mentioned mixed-powder of step (5) preparation are processed granule with the method for spray granulation with step (8) and the fine powder of step (9) preparation and an amount of starch mixing; Drying adds proper amount of lubricating agent, is pressed into 1000; The bag film-coat promptly gets.
Wherein preferably, in the step (2) with after the Radix Polygoni Multiflori Preparata coarse crushing with Rhizoma Alismatis with 90% alcohol reflux, 90% amount of alcohol added is 2～4 times (being preferably 3 times of amounts) by weight.
Wherein preferably, in the step (3) with Semen Cassiae and Fructus Crataegi with 70% alcohol reflux, 70% amount of alcohol added is 2～4 times (being preferably 3 times of amounts) by weight.
Wherein preferably; Amount of water when decocting in the step (4): adding by weight for the first time, the decocting of 1～4 times of amount boils (being preferably 3 times of amounts); For the second time add by weight that the decocting of 1～3 times of amount boils (being preferably 2 times of amounts), adding by weight for the third time, the decocting of 1～3 times of amount boils (being preferably 2 times of amounts).
Wherein preferably, extract with normal pressure when decocting in the step (4), steam pressure is that 0.02Mpa～0.15Mpa (is preferably 0.03Mpa～0.06Mpa).
Wherein preferably, decocting water yield in the step (4) is 4～6 times (by weight), and concentrating the back relative density is 1.10～1.40 (being preferably 1.15～1.25).
Wherein preferably, the drying means of the concentrated solution after the merging is a drying under reduced pressure in the step (8).
Wherein preferably; The middle method of step (10) with spray granulation; Alcohol extraction concentrated solution and the mixed-powder of Radix Polygoni Multiflori Preparata and Rhizoma Alismatis are processed granule, wherein 45～60 ℃ of temperature of charge, internal layer atomisation pressure 1.0～2.0bar, binding agent flow 15～25Hz during spray granulation.
The present invention has proposed the XUEZHILING PIAN that makes according to above-mentioned method for preparing on the other hand.
The present invention has extracted the purposes of XUEZHILING PIAN in the medicine of preparation treatment hyperlipemia that makes like above-mentioned method for preparing on the other hand.
XUEZHILING PIAN novel preparation method of the present invention has improved former preparation technology's deficiency, and not only the active ingredient loss is few, and production efficiency is high.Through experimentation, confirm that the optimal parameter of each step is selected, specifically discuss hereinafter.
XUEZHILING PIAN is 2005 editions standards of pharmacopoeia at present, and its preparation method is called former technology, simultaneously method for preparing of the present invention is called new technology.New technology is that parameter and the method for preparing to each step studied on the basis of former technology; Our effort and constantly trial have been passed through; Improve some specific parameter and special process in each step; Make whole preparation method more optimize, be more suitable for commercial production, the product effective component content that makes simultaneously is higher, has better therapeutic.
Former technology: above four flavors, get Radix Polygoni Multiflori Preparata 100g, be ground into fine powder; Remaining Radix Polygoni Multiflori Preparata and Rhizoma Alismatis are extracted secondary, each 3 hours, merge extractive liquid, with 90% alcohol heating reflux; Semen Cassiae and Fructus Crataegi are with 70% alcohol reflux secondary, and 3 hours for the first time, 2 hours for the second time, merge extractive liquid, reclaims ethanol, is condensed into thick paste, and was subsequent use; Above-mentioned each medicinal residues decocte with water after alcohol extraction three times, first and second time each 2 hours, 1 hour for the third time, collecting decoction; Filter, filtrating was left standstill 12 hours, got supernatant concentration and became the thick paste shape, added above-mentioned alcohol extraction thick paste and fine powder; Stir, process granule, drying; Be pressed into 1000, the bag film-coat promptly gets.
New technology: above four flavors, get Radix Polygoni Multiflori Preparata 100g, be ground into fine powder; Remaining Radix Polygoni Multiflori Preparata and Rhizoma Alismatis are extracted secondary with 90% alcohol heating reflux, and each 3 hours, merge extractive liquid, reclaimed ethanol and is concentrated into an amount of; Semen Cassiae and Fructus Crataegi are extracted secondary with 70% alcohol heating reflux, and 3 hours for the first time, 2 hours for the second time, merge extractive liquid, reclaimed ethanol and is concentrated into an amount of; Above-mentioned medicinal residues after alcohol extraction, decocte with water is three times respectively, first and second time each 2 hours, 1 hour for the third time; Collecting decoction filters, and filtrating was left standstill 12 hours, got supernatant; Be concentrated in right amount, carry concentrated solution with Semen Cassiae and uvaol and merge drying under reduced pressure; Be ground into fine powder, add Radix Polygoni Multiflori Preparata fine powder and an amount of starch, mixing; With the method for spray granulation, alcohol extraction concentrated solution and the above-mentioned mixed-powder of Radix Polygoni Multiflori Preparata and Rhizoma Alismatis are processed granule, drying adds proper amount of lubricating agent, is pressed into 1000, and the bag film-coat promptly gets.
Through technology and pharmacodynamics comparative study, the granule of the preparation of adopting new technology all is superior to former technology, and concrete innovation shows as follows:
1, with being used for reflux, extract, after the Radix Polygoni Multiflori Preparata coarse crushing, the active ingredient glucoside rate of transform obviously improves (glucoside content mean transferred rate brings up to 78% from 57%).
2, with the alcohol-extracted extract of Radix Polygoni Multiflori Preparata and Rhizoma Alismatis as the binding agent spray granulation, be beneficial to and remain with effective constituent, enhance productivity, and the spray granulation parameter carried out preferably.The granule of adopting new technology and preparing, the glucoside rate of transform exceeds more than 40% than former technology, has significantly improved the content of glucoside in the XUEZHILING PIAN finished product, the corresponding drug effect that improved.
The parameter that occurs in the preparation processes such as the water yield when 3, decocting being boiled, pressure is carried out careful research, finds under specific parameter is selected, can make the effective ingredient rate of transform obtain bigger raising.
For verify granule that the present invention makes have steady quality, evident in efficacy, technology is reasonable, the applicant has carried out series of experimental research, and is specific as follows:
1. when refluxing the Radix Polygoni Multiflori Preparata coarse crushing is studied the influence of glucoside extraction ratio
Get Radix Polygoni Multiflori Preparata decoction pieces 160g, be divided into 2 parts, the portion of getting wherein carries out coarse crushing.Add Rhizoma Alismatis 100g respectively, add 90% alcohol reflux 2 times, each 3 hours, backflow, measure glucoside content, result see the following form (parallel twice relatively):
The result shows: after the Radix Polygoni Multiflori coarse crushing, glucoside content mean transferred rate is 78%, is higher than decoction pieces and feeds intake (glucoside content mean transferred rate is 57%), is beneficial to the extraction of active ingredient glucoside.
2. amount of ethanol is to the influence research of paste-forming rate when refluxing.The result shows, adds 3 times of amount ethanol by weight and is used for refluxing, and paste-forming rate is higher, economical rationality.
The research of table 2-1:90% amount of ethanol
| Project | Appearance 1 | Appearance 2 | Appearance 3 |
| Medical material amount (g) | 900 | 900 | 900 |
| Concentration of alcohol | 90％ | 90％ | 90％ |
| Amount of ethanol (g) | 1350 | 2700 | 4500 |
| Paste-forming rate (%) | 8.6 | 15.2 | 16.4 |
Annotate: paste-forming rate obviously reduced when alcohol adding amount was very few, and paste-forming rate did not have obvious raising when alcohol adding amount was excessive.
The research of table 2-2:70% amount of ethanol
| Project | Appearance 1 | Appearance 2 | Appearance 3 |
| Medical material amount (g) | 1000 | 1000 | 1000 |
| Concentration of alcohol | 70％ | 70％ | 70％ |
| Amount of ethanol (g) | 1350 | 3000 | 4500 |
| Paste-forming rate (%) | 9.4 | 16.5 | 17.1 |
Annotate: paste-forming rate obviously reduced when alcohol adding amount was very few, and paste-forming rate did not have obvious raising when alcohol adding amount was excessive.
3. decoct the influence research of amount of water to paste-forming rate, the result shows, first fries in shallow oil and add 3 times of water gagings, and second fries in shallow oil the 2 times of amounts that add, and the 3rd to fry in shallow oil the paste-forming rate that adds 2 times of water gagings reasonable.
| Project | Appearance 1 | Appearance 2 | Appearance 3 |
| Medical material amount (g) | 1900 | 1900 | 1900 |
| One fries in shallow oil amount of water (g) | 3800 | 5700 | 9500 |
| Two fry in shallow oil amount of water (g) | 1900 | 3800 | 5700 |
| Three fry in shallow oil amount of water (g) | 1900 | 3800 | 5700 |
| Paste-forming rate (%) | 8.7 | 12.4 | 13.9 |
Annotate: paste-forming rate obviously reduced when amount of water was very few, and paste-forming rate did not have obvious raising when amount of water was excessive.
4. new technology and former prepared granule compare the influence of glucoside content
Above-mentioned data show: XUEZHILING PIAN is adopted new technology obviously excellent than former technology, and the new technology glucoside rate of transform obviously improves than former technology, the corresponding drug effect that improved.
5. to spray-dired technological parameter research
Atomisation pressure helps the flow-like drop is refined into vaporific droplet, increases the area coverage of drop, prevented from caking.But atomisation pressure is excessive, and size droplet diameter is too little, and most of droplet is not striking the surperficial dry powder that just become of powder particle; Atomisation pressure is too small, forms bigger drop easily, and granule is grown up too fast, and inside has little time drying, and moisture is higher.
Material flow is directly proportional with the particle diameter of drop, and flow velocity increases, and particle diameter increases.Make granule have little time drying but flow velocity is crossed conference, be prone to form white heart granule; And the too small prolongation spray time of flow velocity, and droplet is prone to by band to the filter chamber.
Fluidized-bed temperature is too high, and droplet drying is too fast, and owing to the expansion of self, density reduces, and forms hollow particle easily, and is big and unreal in the process that descends; Temperature is crossed to hang down and can be caused particle, sticking wall.So select atomisation pressure, material flow, fluidized-bed temperature as the investigation factor, select L for use
9(3
4) orthogonal table makes an experiment, the particulate qualification rate of once going is investigated.
Table 5.1 factor level table
Annotate: (1) particle grain size requires between 20 ~ 65 orders, greater than 20 orders or classify as defective less than 65 purpose granules; (2) moisture 2.0～6.0% is certified products.
Orthogonal test table and result:
Can be found out that by analysis of variance table A, B, three factors of C are to particulate qualification rate influence degree difference, the influence degree of each factor is followed successively by B＞C＞A, and wherein, B has remarkable influence to the qualification rate of granulating.
Table 5.2 L
9(3
4) orthogonal test table
The result shows: the factor that has the greatest impact is B, i.e. temperature of charge.The result shows A
2B
2C
2Make up excellent, so the optimum combination process conditions are: the extractum flow velocity (15～25Hz), thing temperature (45～60), internal layer atomisation pressure (1.0～2.0bar).
6. the particulate stability and the granular mass comparative study that make of the granule that makes of new technology and former technology
6.1 adopt the accelerated stability test method, the steadiness of granule under experiment condition that granule that the investigation new technology makes and former technology make.Under the accelerated test condition, preserve (40 ℃ ± 2 ℃ of temperature, 75% ± 5%RH), examine its character, glucoside and emodin content January, February, March, June.
The result shows: granule glucoside and emodin content that new technology makes are higher, and steady quality.
6.2 XUEZHILING PIAN " former technology " compares with " new technology " granule hygroscopicity
Get XUEZHILING PIAN (new technology) granule 5g, get XUEZHILING PIAN (former technology) granule 5g, the accurate title, decide, and puts in numbering, the known surface plate of weight, shakeouts.Put in the climatic chamber of 25 ± 2 ℃ of humidity 75 ± 5%, temperature, claim to decide particle weight respectively at 1h, 2h, 4h, 8h, 12h, 24h, 48h are accurate, the ratio of granule gain in weight and starting weight is the moisture absorption percentage rate, and the result sees the following form:
Hydroscopicity=(weight-sampling is heavy after the moisture absorption)/sampling heavy * 100%
The result shows: new technology granule and former technology granular pattern hygroscopicity do not have obvious difference.
6.3 investigating of XUEZHILING PIAN mobility of particle
Measure with fixed funnel method for investigating the parameter of mobility of particle angle of repose.Two conical hoppers are fixed on above the horizontal glass plate central point up and down; Get about 200g sample by falling into gradually on first funnel limit on second funnel limit; Fall into again on the following glass plate, on glass plate, be piled into chevron, survey form height degree and circular radius; Press tg α=h/r, calculate α angle of repose.The result shows average angle of repose all less than 35 degree, and mobility of particle is good.
7. XUEZHILING PIAN new technology and former technology effect for reducing fat are relatively
Get 40 of rats, body weight 50～70g is divided into 4 groups at random by sex, 10 every group.The normal control group gives normal diet and feeds, and model group gives high lipid food and feeds, and test group gives high lipid food and adds the preceding granule nursing of blood fat spirit tabletting.Formal experiment beginning, except that the normal control group, each group was fed 7 days with high lipid food earlier, got tail blood, measured blood fat to determine whether to form hyperlipidemia.Carry out random packet according to the TC level again, former technology and new technology granule per os are irritated stomach, once a day, and continuous 28 days.Model group is given consubstantiality accumulation of pathogenic cold boiled water, continues to give high lipid food.In experiment beginning second and the around the time, get tail blood respectively, mensuration blood fat each item index.
The result shows, but the equal blood fat reducing of granule of former technology and new technology preparation, and new technology is more obvious.
Former technology of table 7.1 XUEZHILING PIAN and new technology are to the influence (n=7, the mmol/L of unit) of blood fat reducing
Annotate: with the model group ratio,
*P＜0.01
*P＜0.05
Former technology of table 7.2 XUEZHILING PIAN and new technology are to the influence (n=7, the mmol/L of unit) of blood fat reducing
Annotate: with the model group ratio,
*P＜0.01
*P＜0.05
The specific embodiment
Below in conjunction with embodiment the present invention is further described, following each embodiment only is used to explain the present invention, to not restriction of the present invention.
Embodiment 1
Get Radix Polygoni Multiflori Preparata 100g, be ground into fine powder, subsequent use; Get 400g Radix Polygoni Multiflori Preparata (coarse crushing) and Rhizoma Alismatis 500g, extract secondary (adding 3 times of amount 90% ethanol), each 3 hours, merge extractive liquid, with 90% alcohol heating reflux; Depend on pine torch 500g and Fructus Crataegi 500g, extract secondary (adding 3 times of amount 70% ethanol), 3 hours for the first time, 2 hours for the second time, merge extractive liquid, with 70% alcohol heating reflux; Reflux extracting liquid is reclaimed ethanol respectively, and it is 1.18～1.22 that Radix Polygoni Multiflori Preparata and alisol extract are concentrated into relative density, and Semen Cassiae and uvaol extract are concentrated into relative density and are 1.25～1.35, and be subsequent use; The decocte with water three times respectively of above-mentioned each medicinal residues after alcohol extraction (steam pressure 0.03Mpa～0.06Mpa); 2 hours (adding the water of 3 times of amounts by weight) of the first time, each 2 hours (adding the water of 2 times of amounts by weight) of the second time; 1 hour for the third time (adding the water of 2 times of amounts by weight), collecting decoction, 100 orders filter; Filtrating was left standstill 12 hours, and getting supernatant concentration to relative density is 1.15～1.25; Water extracting liquid, Semen Cassiae and uvaol are carried concentrated solution merge, drying under reduced pressure is ground into fine powder; Add Radix Polygoni Multiflori Preparata fine powder and appropriate amount of starch; Alcohol extraction concentrated solution with Radix Polygoni Multiflori Preparata and Rhizoma Alismatis is a binding agent, and granule (45～60 ℃ of temperature of charge, internal layer atomisation pressure 1.0～2.0bar, binding agent flow 15～25Hz), drying are processed in spraying; Add the moderate lubrication agent; Be pressed into 1000, the bag film-coat promptly gets.
Embodiment 2
Get Radix Polygoni Multiflori Preparata 100g, be ground into fine powder, subsequent use; Get 400g Radix Polygoni Multiflori Preparata (coarse crushing) and Rhizoma Alismatis 500g, extract secondary (adding 2 times of amount 90% ethanol), each 3 hours, merge extractive liquid, with 90% alcohol heating reflux; Depend on pine torch 500g and Fructus Crataegi 500g, extract secondary (adding 2 times of amount 70% ethanol), 3 hours for the first time, 2 hours for the second time, merge extractive liquid, with 70% alcohol heating reflux; Reflux extracting liquid is reclaimed ethanol respectively, and it is 1.15～1.18 that Radix Polygoni Multiflori Preparata and alisol extract are concentrated into relative density, and Semen Cassiae and uvaol extract are concentrated into relative density and are 1.20～1.25, and be subsequent use; Above-mentioned each medicinal residues decocte with water after alcohol extraction three times (steam pressure 0.08Mpa～0.15Mpa); 2 hours (adding the water of 3 times of amounts by weight) of the first time, each 2 hours (adding the water of 2 times of amounts by weight) of the second time; 1 hour for the third time (adding the water of 2 times of amounts by weight), collecting decoction, 100 orders filter; Filtrating was left standstill 12 hours, and getting supernatant concentration to relative density is 1.10～1.15; Water extracting liquid, Semen Cassiae and uvaol are carried concentrated solution merge, drying under reduced pressure is ground into fine powder; Add Radix Polygoni Multiflori Preparata fine powder and appropriate amount of starch; Alcohol extraction concentrated solution with Radix Polygoni Multiflori Preparata and Rhizoma Alismatis is a binding agent, and granule (45～60 ℃ of temperature of charge, internal layer atomisation pressure 1.0～2.0bar, binding agent flow 15～25Hz), drying are processed in spraying; Add the moderate lubrication agent; Be pressed into 1000, the bag film-coat promptly gets.
Embodiment 3
Get Radix Polygoni Multiflori Preparata 100g, be ground into fine powder, subsequent use; Get 400g Radix Polygoni Multiflori Preparata (coarse crushing) and Rhizoma Alismatis 500g, extract secondary (at every turn adding 4 times of amount 90% ethanol), each 3 hours, merge extractive liquid, with 90% alcohol heating reflux; Depend on pine torch 500g and Fructus Crataegi 500g, with 70% alcohol reflux secondary (adding 4 times of amount 70% ethanol), 3 hours for the first time, 2 hours for the second time, merge extractive liquid, at every turn; Reflux extracting liquid is reclaimed ethanol respectively, and it is 1.25～1.35 that Radix Polygoni Multiflori Preparata and alisol extract are concentrated into relative density, and Semen Cassiae and uvaol extract are concentrated into relative density and are 1.30～1.40, and be subsequent use; Above-mentioned each medicinal residues decocte with water after alcohol extraction three times (steam pressure 0.02Mpa～0.10Mpa); 2 hours (adding the water of 4 times of amounts by weight) of the first time, each 2 hours (adding the water of 3 times of amounts by weight) of the second time; 1 hour for the third time (adding the water of 3 times of amounts by weight), collecting decoction, 100 orders filter; Filtrating was left standstill 12 hours, and getting supernatant concentration to relative density is 1.30～1.40; Water extracting liquid, Semen Cassiae and uvaol are carried concentrated solution merge, drying under reduced pressure is ground into fine powder; Add Radix Polygoni Multiflori Preparata fine powder and appropriate amount of starch; Alcohol extraction concentrated solution with Radix Polygoni Multiflori Preparata and Rhizoma Alismatis is a binding agent, and granule (45～60 ℃ of temperature of charge, internal layer atomisation pressure 1.0～2.0bar, binding agent flow 15～25Hz), drying are processed in spraying; Add the moderate lubrication agent; Be pressed into 1000, the bag film-coat promptly gets.
Embodiment 4
Get Radix Polygoni Multiflori Preparata 100g, be ground into fine powder, subsequent use; Get 400g Radix Polygoni Multiflori Preparata (coarse crushing) and Rhizoma Alismatis 500g, extract secondary (at every turn adding 4 times of amount 90% ethanol), each 3 hours, merge extractive liquid, with 90% alcohol heating reflux; Depend on pine torch 500g and Fructus Crataegi 500g, with 70% alcohol reflux secondary (adding 4 times of amount 70% ethanol), 3 hours for the first time, 2 hours for the second time, merge extractive liquid, at every turn; Reflux extracting liquid is reclaimed ethanol respectively, and it is 1.18～1.22 that Radix Polygoni Multiflori Preparata and alisol extract are concentrated into relative density, and Semen Cassiae and uvaol extract are concentrated into relative density and are 1.30～1.35, and be subsequent use; Above-mentioned each medicinal residues decocte with water after alcohol extraction three times (steam pressure 0.03Mpa～0.06Mpa); 2 hours (adding the water of 3 times of amounts by weight) of the first time, each 2 hours (adding the water of 2 times of amounts by weight) of the second time; 1 hour for the third time (adding the water of 2 times of amounts by weight), collecting decoction, 100 orders filter; Filtrating was left standstill 12 hours, and getting supernatant concentration to relative density is 1.15～1.20; Water extracting liquid, Semen Cassiae and uvaol are carried concentrated solution merge, drying under reduced pressure is ground into fine powder; Add Radix Polygoni Multiflori Preparata fine powder and appropriate amount of starch; Alcohol extraction concentrated solution with Radix Polygoni Multiflori Preparata and Rhizoma Alismatis is a binding agent, and granule (45～60 ℃ of temperature of charge, internal layer atomisation pressure 1.0～2.0bar, binding agent flow 15～25Hz), drying are processed in spraying; Add the moderate lubrication agent; Be pressed into 1000, the bag film-coat promptly gets.
Claims (10)
1. the method for preparing of an XUEZHILING PIAN, this method comprises the following steps:
(1) gets raw material: Rhizoma Alismatis 500g, Semen Cassiae 500g, Fructus Crataegi 500g, Radix Polygoni Multiflori Preparata 500g;
(2) get Radix Polygoni Multiflori Preparata 400g, Rhizoma Alismatis 500g, add 90% alcohol heating reflux and extract secondary, each 3 hours, merge extractive liquid,, subsequent use;
(3) get Fructus Crataegi 500g, Semen Cassiae 500g, add 70% alcohol heating reflux and extract secondary, 3 hours for the first time, 2 hours for the second time, merge extractive liquid,, subsequent use;
(4) with the medicinal residues after step (2), (3) extraction, decocte with water is three times respectively, and 2 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrated and left standstill 12 hours, got supernatant, and was subsequent use;
(5) get Radix Polygoni Multiflori Preparata, the Rhizoma Alismatis extracting solution that step (2) prepares, reclaim ethanol and also be concentrated into an amount of, subsequent use;
(6) get Fructus Crataegi, the Semen Cassiae extracting solution that step (3) prepares, reclaim ethanol and also be concentrated into an amount of, subsequent use;
(7) supernatant concentration of step (4) preparation is extremely an amount of;
(8) combining step (6) concentrated solution and step (7) concentrated solution, drying under reduced pressure is ground into fine powder, and is subsequent use;
(9) get Radix Polygoni Multiflori Preparata 100g, be ground into fine powder, subsequent use;
(10),, the concentrated solution and the above-mentioned mixed-powder of step (5) preparation are processed granule with the method for spray granulation with step (8) and the fine powder of step (9) preparation and an amount of starch mixing; Drying adds proper amount of lubricating agent, is pressed into 1000; The bag film-coat promptly gets.
2. method for preparing as claimed in claim 1, it is characterized in that in the step (2) with after the Radix Polygoni Multiflori Preparata coarse crushing with Rhizoma Alismatis with 90% alcohol reflux, 90% amount of alcohol added is 2～4 times by weight.
3. method for preparing as claimed in claim 1 is characterized in that in the step (3) that with Semen Cassiae and Fructus Crataegi with 70% alcohol reflux, 70% amount of alcohol added is 2～4 times by weight.
4. method for preparing as claimed in claim 1; Amount of water when it is characterized in that decocting in the step (4): adding by weight for the first time, the decocting of 1～4 times of amount boils; For the second time add by weight that the decocting of 1～3 times of amount boils, adding by weight for the third time, the decocting of 1～3 times of amount boils.
5. method for preparing as claimed in claim 4 is extracted with normal pressure when it is characterized in that decocting in the step (4), and steam pressure is 0.02Mpa～0.15Mpa.
6. method for preparing as claimed in claim 1 is characterized in that concentrating the back relative density in the step (7) is 1.10～1.40.
7. method for preparing as claimed in claim 1, the drying means of the concentrated solution after it is characterized in that merging in the step (8) is a drying under reduced pressure.
8. method for preparing as claimed in claim 1; It is characterized in that the middle method of step (10) with spray granulation; Alcohol extraction concentrated solution and the mixed-powder of Radix Polygoni Multiflori Preparata and Rhizoma Alismatis are processed granule, wherein 45～60 ℃ of temperature of charge, internal layer atomisation pressure 1.0～2.0bar, binding agent flow 15～25Hz during spray granulation.
9. as the XUEZHILING PIAN that makes of the method for preparing of above-mentioned each claim.
10. the purposes of XUEZHILING PIAN as claimed in claim 9 in the medicine of preparation treatment hyperlipemia.
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| CN102462787B (en) * | 2010-11-12 | 2013-07-17 | 关森林 | Chinese medicine composition for treating hypertension and improving hyperlipidemia and preparation method of Chinese medicine composition |
| CN103006835B (en) * | 2012-12-14 | 2015-01-28 | 四川省通江山霸王野生食品有限公司 | Pharmaceutical composition with effects of reducing blood fat and relaxing bowels and preparation method thereof |
| CN103083429B (en) * | 2013-01-04 | 2014-10-08 | 山西师范大学 | Blood fat-reducing traditional Chinese medicine formula |
| CN103598557B (en) * | 2013-10-31 | 2016-04-27 | 安徽强旺调味食品有限公司 | A kind of flavouring with effect for reducing blood fat |
| CN107260685B (en) * | 2017-06-02 | 2020-11-24 | 神威药业集团有限公司 | Preparation method of solanum nigrum fruit formula granules |
| CN112843140B (en) * | 2021-02-22 | 2023-01-10 | 内蒙古蒙奇药业有限公司 | Medicine for treating thirst and conjunctival congestion caused by diabetes, preparation method and application |
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| CN1600359A (en) * | 2004-07-06 | 2005-03-30 | 谢子龙 | Capsule for curing high blood fat and preparation method |
| CN1911334A (en) * | 2006-07-28 | 2007-02-14 | 湖南恒伟药业有限公司 | Traditional Chinese medicine composition for lowering blood fat, and prepn. method therefor |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1600359A (en) * | 2004-07-06 | 2005-03-30 | 谢子龙 | Capsule for curing high blood fat and preparation method |
| CN1911334A (en) * | 2006-07-28 | 2007-02-14 | 湖南恒伟药业有限公司 | Traditional Chinese medicine composition for lowering blood fat, and prepn. method therefor |
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Effective date of registration: 20160620 Address after: 321100 No. 1, Tianyi Road, Zhejiang, Lanxi Patentee after: Zhejiang Tianyi Pharmaceutical Co., Ltd. Address before: 321100 No. 6, Yongjin Road, Lanxi, Zhejiang Patentee before: Tianyitang Group Co., Ltd., Zhejiang |