CN101084953A - Method for preparing acanthopanax senticousus extracting liquid/extraction - Google Patents
Method for preparing acanthopanax senticousus extracting liquid/extraction Download PDFInfo
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Abstract
The invention discloses a process for preparing acanthopanax root extract / substance, which comprises steps of: (1) preparing acanthopanax root medicinal extract by employing water extraction and ethanol deposition method, (2) diluting the extract with right amount of water, adjusting the pH to 10.00-12.00 with lime cream, stirring homogeneously and adjusting the pH to 4.5-6.5 with sulfuric acid, stewing, extracting the supernatant fluid and filtering, concentrating, alcohol depositing, (3) freezing, stewing and removing impurities, obtaining acanthopanax root extract, or carrying out concentrating, decompressing and drying to obtain acanthopanax root extract.
Description
Technical field
The present invention relates to field of medicaments, relate in particular to the preparation method of acanthopanax senticosus extract/thing.
Background technology
Radix Et Caulis Acanthopanacis Senticosi (Radix Acanthopanacis Senticosi) is the Araliaceae machaka, high 1-6m.The downward spinelet of Chang Misheng needle-like on the branch.Palmately compound leaf, lobule 5, ellipticity obovate or Long Circle, there is heavy sawtooth at the edge.Petal yellow-white or purple are given birth to or 2-6 consor in the single top of umbel.Fruit is spherical, black when ripe.Be distributed in the Northeast and Hebei, Shanxi, be born in the theropencedrymion that height above sea level 800m following (northeast) locates to 1500-2000m (North China).Also there are distribution in the Korea peninsula, the former Soviet Union, Japan.Medical value is similar to Radix Ginseng.Country's three-level protective vulnerable species.
Radix Et Caulis Acanthopanacis Senticosi injection is the sterile solution for injection that Radix Et Caulis Acanthopanacis Senticosi makes through extraction, is recorded in one one of Chinese Pharmacopoeia, has flat invigorating the liver and kidney, the function of beneficial able-bodied bone.Be used for the transient ischemic attack due to the deficiency of the liver and kindey, cerebral arteriosclerosis, cerebral thrombosis, cerebral embolism etc.
The conventional preparation method of Radix Et Caulis Acanthopanacis Senticosi preparation is a water extract-alcohol precipitation, but generally only extracts 2 times, precipitate with ethanol 1 time.Can not fully its effective ingredient be proposed, remove impurity significantly.What patent documentation 94107718.7 adopted is that the water extract-alcohol precipitation extraction method is extracted after ethyl acetate extraction is used in the macroporous resin column decolouring, obtains Radix Et Caulis Acanthopanacis Senticosi extract.But extraction process can reduce the recovery of effective ingredient, and ethyl acetate toxicity is big, belongs to combustibles again, can cause great injury to human body.
Summary of the invention
The objective of the invention is to provide the preparation method of acanthopanax senticosus extract/thing at above-mentioned deficiency.
Preparation method of the present invention comprises the steps: to adopt decoction and alcohol sedimentation technique to prepare the Radix Et Caulis Acanthopanacis Senticosi drug extract; With the extractum thin up, with lime cream adjusting pH to 10.00～12.00, pH to 4.5～6.5 are regulated with sulphuric acid in the back that stirs, and leave standstill, and extract supernatant liquid filtering, concentrate, and precipitate with ethanol, remove impurity is left standstill in cold preservation, gets acanthopanax senticosus extract; Or concentrated drying under reduced pressure gets Radix Et Caulis Acanthopanacis Senticosi extract.
The present invention utilizes lime cream to transfer alkali, makes total flavonoid form the sequestration thing with it, adds the sulphuric acid acid adjustment again, and the total flavonoid composition is dissolved in the solution, and the impurity component precipitation, this method has increased the stripping of total flavones, and can more effectively remove impurity.
More specifically, extractum is diluted with water to 15 times more than the volume, stirs, treat that temperature reduces to below 50 ℃, add the fresh lime cream of 1 0-30%, adjust pH to 10.00～12.00 are after stirring, reuse 10-30% sulphuric acid adjust pH to 4.5～6.5, continue to stir after 5～10 minutes, be cooled to room temperature, left standstill 4～6 hours, extract supernatant liquid filtering, further improve the effect of remove impurity again through precipitate with ethanol.Here the method for precipitate with ethanol is, filtrate decompression is concentrated into relative density 1.08～1.17 (80 ℃ of surveys), when treating that temperature is reduced to below 40 ℃, slowly adds ethanol and makes and contain alcohol amount and reach 82～85%, precipitates 12～36 hours.
The method that above-mentioned decoction and alcohol sedimentation technique prepares drug extract is: the Radix Et Caulis Acanthopanacis Senticosi bar is cut into pieces, add water to few extraction 2 times, add 2～10 times of water gagings at every turn, decocted 30～60 minutes, merging filtrate concentrates, and 2 precipitate with ethanol leave standstill, filter, reclaim ethanol, promptly get drug extract to there not being the alcohol flavor.
More specifically, can prepare extractum by following method: get the Radix Et Caulis Acanthopanacis Senticosi bar, cut into the fragment of 1～3cm, decoct 2～4 times, add 4～8 times of water gagings at every turn, decocted 30～60 minutes, collecting decoction is concentrated into relative density 1.08～1.17 (80 ℃ of surveys), when treating that temperature is reduced to below 40 ℃, adding ethanol makes and contains the alcohol amount and reach 65～75%, left standstill 6-1 after stirring 8 hours, and filtered, residue adds ethanol to be made and contains the alcohol amount and reach 75～85%, left standstill 4～12 hours, filter, filtrate is collected in residue centrifugal filtration, recovery ethanol gets equivalent extract to there not being the alcohol flavor.
The present invention carries out the purpose that cold preservation leaves standstill and is further remove impurity, the cold preservation standing methods is: get the precipitate with ethanol supernatant liquid filtering, residue centrifugal filtration, reclaim ethanol to not having the alcohol flavor and being concentrated into relative density 1.05～1.20 (80 ℃ of surveys), add water for injection and be diluted to 5g (crude drug)/ml, sterilization, freezing, negative catalysis, cold preservation is filtered.
More specifically, can leave standstill remove impurity by following method cold preservation: get supernatant liquid filtering, residue centrifugal filtration, reclaiming ethanol does not extremely have the alcohol flavor and is concentrated into relative density 1.08～1.17 (80 ℃ of surveys), adds water for injection and is diluted to 5g (crude drug)/ml, sterilizes 40 minutes for 115 ℃, freezing more than 12 hours down in-20 ℃～-10 ℃, negative catalysis, cold preservation are more than seven days, and medicinal liquid is through 0.45 μ m membrane filtration.
Preparation technology's advantage of the present invention: the content height of total flavones and syringoside, impurity is few, and technology is simple, and rationally, cost is low, pollutes few.
1) precipitate with ethanol repeatedly repeatedly can effectively be removed impurity such as macro-molecular protein.
2) add lime cream earlier and transfer alkali, make the total flavonoid composition form the sequestration thing with it, add the sulphuric acid acid adjustment again, the total flavonoid composition is dissolved in the solution, and the impurity component precipitation has increased the stripping of total flavones, and can more effective removal impurity.
Acanthopanax senticosus extract/the thing and the pharmaceutic adjuvant that can further method for preparing be obtained are prepared into various dosage forms, comprise injection, lyophilized injectable powder, infusion solution, oral liquid, capsule, granule and tablet etc.Described pharmaceutic adjuvant comprises glucose, ethanol (95%), mannitol, dextran, lactose, sodium chloride, polyoxyethylene sorbitan monoleate etc.When said preparation was injection, it was 1.8-5.5mg that this injection of every 1ml contains total flavones; Contain syringoside and should be 0.20-2.0mg.
The specific embodiment
Further set forth the present invention below in conjunction with specific embodiment.Should be appreciated that these embodiment only are used to illustrate the present invention, and can not limit protection scope of the present invention.
The preparation of embodiment 1 acanthopanax senticosus extract
Get the Radix Et Caulis Acanthopanacis Senticosi bar, cut into the fragment of 1～3cm.Decoct three times, add 5 times of water gagings for the first time and decocted 30 minutes; Adding for the second time 6 times of water gagings decocted 40 minutes; Adding 10 times of water gagings for the third time decocted 30 minutes.Collecting decoction is concentrated into relative density 1.10 (80 ℃ of surveys), when treating that temperature is reduced to below 40 ℃, adding ethanol makes and contains the alcohol amount and reach 70%, left standstill after stirring 10 hours, and filtered, residue adds ethanol to be made and contains the alcohol amount and reach 80%, left standstill 8 hours, filter, filtrate is collected in residue centrifugal filtration, recovery ethanol gets equivalent extract to there not being the alcohol flavor.Add purified water to 15 times of volumes of equivalent extract, stir, treat that temperature reduces to below 50 ℃, add 20% fresh lime cream, adjust pH to 11.00 is after stirring, reuse 20% sulphuric acid adjust pH to 5.5, continue to stir after 8 minutes, be cooled to room temperature, left standstill 5 hours, extract supernatant liquid filtering, be evaporated to relative density 1.15 (80 ℃ of surveys), when treating that temperature is reduced to below 40 ℃, slowly add ethanol and make and contain alcohol amount and reach 85%, precipitate 24 hours, get supernatant liquid filtering, residue centrifugal filtration is reclaimed ethanol to not having the alcohol flavor and being concentrated into relative density 1.05 (80 ℃ of surveys).Add water for injection and be diluted to 5g (crude drug)/ml, sterilized 40 minutes for 115 ℃.Descended negative catalysis, cold preservation seven days freezing 12 hours in-10 ℃.Medicinal liquid promptly gets acanthopanax senticosus extract through 0.45 μ m membrane filtration.
The preparation of embodiment 2 Radix Et Caulis Acanthopanacis Senticosi extracts
Get the Radix Et Caulis Acanthopanacis Senticosi bar, cut into the fragment of 1～3cm.Decoct 2 times, add 4 times of water gagings for the first time and decocted 40 minutes; Adding for the second time 8 times of water gagings decocted 60 minutes.Collecting decoction is concentrated into relative density 1.08 (80 ℃ of surveys), when treating that temperature is reduced to below 40 ℃, adding ethanol makes and contains the alcohol amount and reach 75%, left standstill after stirring 18 hours, and filtered, residue adds ethanol to be made and contains the alcohol amount and reach 85%, left standstill 12 hours, filter, filtrate is collected in residue centrifugal filtration, recovery ethanol gets equivalent extract to there not being the alcohol flavor.Add purified water to 18 times of volumes of equivalent extract, stir, treat that temperature reduces to below 50 ℃, add 10% fresh lime cream, adjust pH to 12.00 is after stirring, reuse 10% sulphuric acid adjust pH to 6.5, continue to stir after 10 minutes, be cooled to room temperature, left standstill 6 hours, extract supernatant liquid filtering, be evaporated to relative density 1.17 (80 ℃ of surveys), when treating that temperature is reduced to below 40 ℃, slowly add ethanol and make and contain alcohol amount and reach 82%, precipitate 36 hours, get supernatant liquid filtering, residue centrifugal filtration is reclaimed ethanol to not having the alcohol flavor and being concentrated into relative density 1.08 (80 ℃ of surveys).Add water for injection and be diluted to 5g (crude drug)/ml, sterilized 40 minutes for 115 ℃.Descended negative catalysis, cold preservation ten days freezing 16 hours in-15 ℃.Medicinal liquid is through 0.45 μ m membrane filtration, and concentrated drying under reduced pressure promptly gets Radix Et Caulis Acanthopanacis Senticosi extract.
The preparation of embodiment 3 acanthopanax senticosus extracts
Get the Radix Et Caulis Acanthopanacis Senticosi bar, cut into the fragment of 1～3cm.Decoct 3 times, add 5 times of water gagings for the first time and decocted 30 minutes; Adding for the second time 6 times of water gagings decocted 40 minutes; Adding 4 times of water gagings for the third time decocted 50 minutes.Collecting decoction is concentrated into relative density 1.17 (80 ℃ of surveys), when treating that temperature is reduced to below 40 ℃, adding ethanol makes and contains the alcohol amount and reach 65%, left standstill after stirring 6 hours, and filtered, residue adds ethanol to be made and contains the alcohol amount and reach 75%, left standstill 4 hours, filter, filtrate is collected in residue centrifugal filtration, recovery ethanol gets equivalent extract to there not being the alcohol flavor.Add purified water to 15 times of volumes of equivalent extract, stir, treat that temperature reduces to below 50 ℃, add 30% fresh lime cream, adjust pH to 10.00 is after stirring, reuse 30% sulphuric acid adjust pH to 4.5, continue to stir after 5 minutes, be cooled to room temperature, left standstill 4 hours, extract supernatant liquid filtering, be evaporated to relative density 1.17 (80 ℃ of surveys), when treating that temperature is reduced to below 40 ℃, slowly add ethanol and make and contain alcohol amount and reach 84%, precipitate 12 hours, get supernatant liquid filtering, residue centrifugal filtration is reclaimed ethanol to not having the alcohol flavor and being concentrated into relative density 1.17 (80 ℃ of surveys).Add water for injection and be diluted to 5g (crude drug)/ml, sterilized 40 minutes for 115 ℃.Descended negative catalysis, cold preservation 15 days freezing 20 hours in-20 ℃.Medicinal liquid promptly gets acanthopanax senticosus extract through 0.45 μ m membrane filtration.
The preparation of embodiment 4 injection
Get the extracting solution of embodiment 1, with 40% NaOH solution adjust pH to 5.5, post-heating stirs, the active carbon of adding 0.2%, boil absorption 15 minutes, be cooled to below 50 ℃ NaOH solution adjust pH to 5.5, add fresh water for injection to original volume with 40%.Through 0.45 μ m membrane filtration to clarification, fill, 115 ℃ of autoclavings 40 minutes.Freezing, cold preservation is 15 days after the negative catalysis, and room temperature was placed 3 months.0.65 μ m filter element filtering adds the injection water to original volume, adjust pH to 5.5 adds activated carbon decolorizing, filters, and adjust pH to 5.5 is added water for injection to original volume, through 0.45 μ m, 0.22 μ m filter element fine straining, and embedding, 115 ℃ of sterilizations in 30 minutes, promptly.
Through check, the every 1ml of this injection contains total flavones, with anhydrous rutin (C
27H
30O
16) count 2.0mg, contain syringoside 0.20mg.
The preparation of embodiment 5 injection
Get the extract of embodiment 2, add the injection water and make dissolving, NaOH solution adjust pH to 5.5 with 40%, post-heating stirs, the active carbon of adding 0.2%, boil absorption 15 minutes, be cooled to below 50 ℃ NaOH solution adjust pH to 5.7, add fresh water for injection to containing crude drug 5g/ml with 40%.Through 0.45 μ m membrane filtration to clarification, fill, 115 ℃ of autoclavings 40 minutes.Freezing, cold preservation is 20 days after the negative catalysis, and room temperature was placed 3.5 months.0.65 μ m filter element filtering adds the injection water to containing crude drug 5g/ml, adjust pH to 5.0 adds activated carbon decolorizing, filter, adjust pH to 5.0 is added water for injection to containing crude drug 5g/ml, respectively through 0.45 μ m, 0.22 μ m filter element fine straining, embedding, 115 ℃ of sterilizations in 30 minutes, promptly.
Through check, the every 1ml of this injection contains total flavones, with anhydrous rutin (C
27H
30O
16) count 5.1mg, contain syringoside 2.0mg.
The preparation of embodiment 6 injection
Get the extracting solution of embodiment 3, with 40% NaOH solution adjust pH to 5.5, post-heating stirs, the active carbon of adding 0.2%, boil absorption 15 minutes, be cooled to below 50 ℃ NaOH solution adjust pH to 5.3, add fresh water for injection to original volume with 40%.Through 0.45 μ m membrane filtration to clarification, fill, 115 ℃ of autoclavings 40 minutes.Freezing, cold preservation is 25 days after the negative catalysis, and room temperature was placed 4 months.0.65 μ m filter element filtering adds the injection water to original volume, adjust pH to 6.0 adds activated carbon decolorizing, filters, and adjust pH to 6.0 is added water for injection to original volume, respectively through 0.45 μ m, 0.22 μ m filter element fine straining, and embedding, 115 ℃ of sterilizations in 30 minutes, promptly.
Through check, the every 1ml of this injection contains total flavones, with anhydrous rutin (C
27H
30O
16) count 3.3mg, contain syringoside 0.85mg.
Claims (9)
1, a kind of method for preparing acanthopanax senticosus extract/thing, it comprises step: 1) adopt decoction and alcohol sedimentation technique to prepare the Radix Et Caulis Acanthopanacis Senticosi drug extract; 2) with the extractum thin up, regulate pH to 10.00～12.00 with lime cream, pH to 4.5～6.5 are regulated with sulphuric acid in the back that stirs, and leave standstill, and extract supernatant liquid filtering, concentrate precipitate with ethanol; 3) cold preservation is left standstill remove impurity and is got acanthopanax senticosus extract; Or concentrated drying under reduced pressure gets Radix Et Caulis Acanthopanacis Senticosi extract.
2, the method for claim 1, wherein step 1) adds water to few extraction 2 times for the Radix Et Caulis Acanthopanacis Senticosi bar is cut into pieces, and adds 2～10 times of water gagings at every turn, decocted 30～60 minutes, merging filtrate concentrates, and 2 precipitate with ethanol leave standstill, filter, recovery ethanol gets drug extract to there not being the alcohol flavor.
3, the method for claim 1, wherein step 1) is: get the Radix Et Caulis Acanthopanacis Senticosi bar, cut into the fragment of 1～3cm, decoct 2～4 times, add 4～8 times of water gagings at every turn, decocted 30-60 minute, collecting decoction is concentrated into relative density 1.08～1.17 for 80 ℃ by detected temperatures, when treating that temperature is reduced to below 40 ℃, adding ethanol makes and contains the alcohol amount and reach 65～75%, left standstill after stirring 6-18 hour, and filtered, residue adds ethanol to be made and contains the alcohol amount and reach 75～85%, left standstill 4-12 hour, filter, filtrate is collected in residue centrifugal filtration, recovery ethanol gets drug extract to there not being the alcohol flavor.
4, the method for claim 1, step 2 wherein) method of precipitate with ethanol is that filtrate decompression is concentrated into relative density 1.08～1.17 for 80 ℃ by detected temperatures in, when treating that temperature is reduced to below 40 ℃, slowly add ethanol and make and contain alcohol amount and reach 82～85%, precipitate 12～36 hours.
5, the be weight percentage sulphuric acid of 10-30% of the be weight percentage fresh lime cream of 10-30% of the method for claim 1, wherein said lime cream, described sulphuric acid.
6, the method for claim 1, wherein the method that remove impurity is left standstill in cold preservation in the step 3) is: get supernatant liquid filtering, residue centrifugal filtration, reclaim ethanol to not having the alcohol flavor and being concentrated into relative density 1.05～1.20 for 80 ℃, add water for injection and be diluted to 5g crude drug/ml, sterilization by detected temperatures, freezing more than 12 hours down in-20 ℃～-10 ℃, negative catalysis, cold preservation were filtered more than seven days.
7, a kind of preparation that contains acanthopanax senticosus extract/thing is characterized in that, described acanthopanax senticosus extract/thing makes by each preparation method of claim 1-6.
8, preparation according to claim 7 is characterized in that, said preparation is injection, lyophilized injectable powder, infusion solution, oral liquid, capsule, granule or tablet.
9, preparation according to claim 7 is characterized in that, said preparation is an injection, and it is 1.8-5.5mg that this injection of every 1ml contains total flavones; Containing syringoside is 0.20-2.0mg.
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| CN101810656A (en) * | 2010-04-27 | 2010-08-25 | 哈尔滨珍宝制药有限公司 | Siberian ginseng extract and medicine combination thereof |
| CN101554370B (en) * | 2008-04-08 | 2011-11-23 | 苑立超 | Syringin for injection, preparation method and application thereof |
| CN102579532A (en) * | 2011-10-17 | 2012-07-18 | 哈尔滨珍宝制药有限公司 | Radix acanthopanacis senticosl composition, preparation containing composition and detection method of preparation |
| CN104306417A (en) * | 2014-09-28 | 2015-01-28 | 哈尔滨珍宝制药有限公司 | Low-toxicity acanthopanax injection and preparation method thereof |
| CN105412187A (en) * | 2015-11-25 | 2016-03-23 | 哈尔滨珍宝制药有限公司 | Preparation method for low-potassium acanthopanax senticosus extract |
| CN106038580A (en) * | 2016-08-09 | 2016-10-26 | 哈尔滨珍宝制药有限公司 | Acanthopanax composition and related application |
| CN109010398A (en) * | 2018-09-28 | 2018-12-18 | 黑龙江省格润药业有限责任公司 | A kind of Radix Et Caulis Acanthopanacis Senticosi injection and its preparation process |
| CN109042877A (en) * | 2018-07-23 | 2018-12-21 | 哈尔滨学院 | A kind of wilsonii water extract and preparation method thereof, health care yoghourt, control method |
| CN114209059A (en) * | 2021-12-20 | 2022-03-22 | 黑龙江乌苏里江制药有限公司 | Acanthopanax senticosus polysaccharide calcium and preparation method and application thereof |
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| CN1053817C (en) * | 1994-07-04 | 2000-06-28 | 宋士岳 | Acanthopanax root injection freeze-dried powder injection and producing technology for acanthopanax root extract |
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| CN1813834A (en) * | 2006-03-03 | 2006-08-09 | 中国科学院长春应用化学研究所 | Method for preparing total flavone extract of many prickle acanthopanax |
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| CN101810656A (en) * | 2010-04-27 | 2010-08-25 | 哈尔滨珍宝制药有限公司 | Siberian ginseng extract and medicine combination thereof |
| CN102579532A (en) * | 2011-10-17 | 2012-07-18 | 哈尔滨珍宝制药有限公司 | Radix acanthopanacis senticosl composition, preparation containing composition and detection method of preparation |
| CN104306417A (en) * | 2014-09-28 | 2015-01-28 | 哈尔滨珍宝制药有限公司 | Low-toxicity acanthopanax injection and preparation method thereof |
| CN104306417B (en) * | 2014-09-28 | 2017-09-19 | 哈尔滨珍宝制药有限公司 | A kind of Radix Et Caulis Acanthopanacis Senticosi injection of low toxicity and preparation method thereof |
| CN105412187A (en) * | 2015-11-25 | 2016-03-23 | 哈尔滨珍宝制药有限公司 | Preparation method for low-potassium acanthopanax senticosus extract |
| CN106038580A (en) * | 2016-08-09 | 2016-10-26 | 哈尔滨珍宝制药有限公司 | Acanthopanax composition and related application |
| CN109042877A (en) * | 2018-07-23 | 2018-12-21 | 哈尔滨学院 | A kind of wilsonii water extract and preparation method thereof, health care yoghourt, control method |
| CN109010398A (en) * | 2018-09-28 | 2018-12-18 | 黑龙江省格润药业有限责任公司 | A kind of Radix Et Caulis Acanthopanacis Senticosi injection and its preparation process |
| CN114209059A (en) * | 2021-12-20 | 2022-03-22 | 黑龙江乌苏里江制药有限公司 | Acanthopanax senticosus polysaccharide calcium and preparation method and application thereof |
| CN114209059B (en) * | 2021-12-20 | 2024-01-19 | 黑龙江乌苏里江制药有限公司 | Acanthopanax polysaccharide calcium and preparation method and application thereof |
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Free format text: CORRECT: ADDRESS; FROM: 158400 NO.72, HONGXING STREET, HULIN CITY, HEILONGJIANG PROVINCE TO: 150060NO.8, YANTAIYI ROAD, JIZHONG DISTRICT, HAPIN ROAD, HARBIN CITY DEVELOPMENT AREA, HEILONGJIANG PROVINCE |
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Effective date of registration: 20100520 Address after: Haping Road Development Zone in Harbin City, Heilongjiang province 150060 Central Road District No. 8 Yantai Patentee after: Haerbin Zhenbao Pharmaceutical Co., Ltd. Address before: 158400 Hulin Red Star Street, Heilongjiang, No. 72 Patentee before: Helongjiang Zhenbaodao Pharmaceutical Co., Ltd. |