CN100335076C - Art for extracting red sage root water soluble ingredient and removing impurities - Google Patents
Art for extracting red sage root water soluble ingredient and removing impurities Download PDFInfo
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- CN100335076C CN100335076C CNB031164706A CN03116470A CN100335076C CN 100335076 C CN100335076 C CN 100335076C CN B031164706 A CNB031164706 A CN B031164706A CN 03116470 A CN03116470 A CN 03116470A CN 100335076 C CN100335076 C CN 100335076C
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- salviae miltiorrhizae
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Abstract
The present invention provides a technology for extracting and removing impurities from a red sage root water soluble component, which adopts a water extracting alcohol sedimentation method to configure an acid sedimentation method and an alcohol-performance solution pH value regulating method according to the physical-chemical properties of the impurities in red sage root extracting liquid. The present invention has the advantages of easy operation, economical and practical performance, short extraction time and good impurity removing effect. The red sage root water soluble extracting liquid prepared by the present invention can be used for preparing red sage root preparations, such as red sage root injections, compound red sage root injections (fragrant red sage root injections and red and Danxiang Guanxin injections), red sage root infusion solutions, compound red sage root infusion solutions, etc.
Description
Technical field
The present invention relates to pharmaceutical field, in particular to the impurity removal processes of red sage root water soluble ingredient leaching process.
Background technology
Salviamiltiorrhizabung has the effect of blood circulation promoting and blood stasis dispelling, nourishing blood to tranquillize the mind and removing heat from blood eliminating carbuncle.Red sage formulations such as the Radix Salviae Miltiorrhizae Injection that is made by the red sage root water soluble ingredient extracting solution, FUFANG DANSHEN ZHUSHEYE (XIANGDAN ZHUSHEYE, DANXIANG GUANXIN ZHUSHEYE), Radix Salviae Miltiorrhizae infusion solutions, compound Salviae Miltiorrhizae infusion solutions have blood vessel dilating, increase the effect of coronary artery amount, be widely used in the treatment of diseases such as uncomfortable in chest, angina pectoris, myocardial infarction and cerebral infarction of coronary heart disease, become treatment cardiovascular disease medicine commonly used clinically.
Red sage root water soluble ingredient extracts and adopts water extracting alcohol precipitation method at present, and its technology may further comprise the steps:
(a) obtain the Radix Salviae Miltiorrhizae decocting liquid.Radix Salviae Miltiorrhizae crude drug water is decocted three times, and collecting decoction filters, and concentrates.
(b) ethanol precipitation for the first time: add ethanol and be about 75% to containing the alcohol amount, left standstill tens of hours at cold place, and leaching alcohol liquid reclaims ethanol.
(c) ethanol precipitation for the second time: concentrated solution adds ethanol again and is about 85% to containing the alcohol amount, and left standstill tens of hours at cold place, and leaching alcohol liquid reclaims ethanol.
(d) alkaline matter is regulated pH and the charcoal treatment first time.Concentrated solution adds in the water for injection of several times amount, and cold preservation is filtered, and filtrate concentrates, and cold preservation is regulated pH value with 10% sodium hydroxide solution, adds proper amount of active carbon and boils, and filters, and obtains filtrate.
(e) the pickling material is regulated pH and the charcoal treatment second time.It is 4 that filtrate is acidified to pH value with dilute hydrochloric acid, adds proper amount of active carbon and boils, and cold preservation is filtered, and obtains filtrate.
(f) regulate pH, make finished product.Regulate pH value with 10% sodium hydroxide solution, can prepare various injection of danshen, transfusion preparation after the filtration.
Yet there is following major defect in present technology.(1) removal of impurity not to the utmost, clarity algesiogenic situation of bad and when injection takes place in product easily.(2) adopt the ethanol precipitation twice step, the ethanol large usage quantity, price is more expensive, and is uneconomical.(3) filtration behind the water precipitating is difficult.(4) step is loaded down with trivial details, and the time is longer.
Therefore, this area presses for the extracting method of new quick, the easy and red sage root water soluble ingredient that impurity removal efficacy is high of exploitation.
Summary of the invention
The object of the present invention is to provide a kind of red sage root water soluble ingredient extracting method, compare with existing processes, that this method has is easy and simple to handle, economical and practical, extraction time short and/or remove advantages such as impurity is effective.
What the objective of the invention is to be achieved through the following technical solutions:
A kind of red sage root water soluble ingredient extracting method comprises step:
(a) usefulness acid to 2.0-3.5, is placed the pH regulator of Radix Salviae Miltiorrhizae decocting liquid 8-24 hour, filters and obtains filtrate;
(b) adding ethanol to final volume concentration in filtrate is 75 ± 10%, places then 36-72 hour, filters and obtains filtrate;
(c) with alkali with the filtrate pH regulator to 7.5-8.5, placed 8-24 hour, filter and to obtain filtrate;
(d) usefulness acid to 5.0-7.0, is reclaimed the filtrate pH regulator ethanol and is also obtained concentrated solution;
(e) with concentrated solution with the active carbon processing of decolouring, filter and obtain filtrate;
(f) regulate filtrate to pH6.8 ± 0.5, obtain the red sage root water soluble ingredient extracting solution.
In another preference, the Radix Salviae Miltiorrhizae decocting liquid described in the step (a) is that Radix Salviae Miltiorrhizae crude drug water is decocted three times, and collecting decoction filters, and concentrates the decocting liquid that the back obtains.
In another preference, the acid described in the step (a) comprises hydrochloric acid, and weight percent concentration is 5-30%.
In another preference, adding ethanol to final volume concentration in the step (b) is 75-85%.
In another preference, the alkali described in the step (c) comprises sodium hydroxide, and its weight percent concentration is 5-40%.
In another preference, the acid described in the step (d) comprises hydrochloric acid, and weight percent concentration is 5-30%.
In another preference, the treatment conditions of active carbon are to add 0.3 ± 0.2% active carbon to boil 30 ± 15 minutes in the step (e).
In another preference, also comprise step (g): the red sage root water soluble ingredient extracting solution is made Radix Salviae Miltiorrhizae Injection, FUFANG DANSHEN ZHUSHEYE (as XIANGDAN ZHUSHEYE, DANXIANG GUANXIN ZHUSHEYE), Radix Salviae Miltiorrhizae infusion solutions or compound Salviae Miltiorrhizae infusion solutions.
In another preference, the number of processes of active carbon is for once in the step (e).
In another preference, the placement described in the step (a) is to place at normal temperatures.
Description of drawings
Fig. 1 has shown the general flow chart of the red sage root water soluble ingredient extracting method in the one embodiment of the invention.
The specific embodiment
The inventor furthers investigate red sage root water soluble ingredient extraction/removal impurity technology, physicochemical property according to impurity in the Radix Salviae Miltiorrhizae extract, in the red sage root water soluble ingredient extraction process, adopt water extracting alcohol precipitation method configuration acidic precipitation method, alcohol solution to transfer technological means such as pH method first, thereby developed new quick, easy and red sage root water soluble ingredient extracting method that impurity removal efficacy is high.
Particularly, the inventive method may further comprise the steps:
(a) usefulness acid to 2.0-3.5, is placed the pH regulator of Radix Salviae Miltiorrhizae decocting liquid 8-24 hour, filters and obtains filtrate;
(b) adding ethanol to final volume concentration in filtrate is 75 ± 10%, places then 36-72 hour, filters and obtains filtrate;
(c) with alkali with the filtrate pH regulator to 7.5-8.5, placed 8-24 hour, filter and to obtain filtrate;
(d) usefulness acid to 5.0-7.0, is reclaimed the filtrate pH regulator ethanol and is also obtained concentrated solution:
(e) with concentrated solution with the active carbon processing of decolouring, filter and obtain filtrate;
(f) regulate filtrate to pH6.8 ± 0.5, obtain the red sage root water soluble ingredient extracting solution.
Referring to Fig. 1.In a concrete preference, the inventive method comprises:
(a) with hydrochloric acid solution (5%-30%) the Radix Salviae Miltiorrhizae decocting liquid is acidified to pH value (2.0-3.5), leaves standstill more than a few hours, filter and obtain filtrate.
(b) filtrate to add ethanol be 75% to 85% to the alcohol amount of containing, left standstill tens of hours at cold place, filters to obtain filtrate.
(c) filtrate is regulated pH value (7.5-8.5) with sodium hydroxide solution (5%-40%), and left standstill more than a few hours at cold place, filters to obtain filtrate.
(d) regulate pH value to 5.0-7.0 with hydrochloric acid solution (5%-30%), reclaim ethanol, obtain concentrated solution.
(e) concentrated solution adds in the water for injection of several times amount, and cold preservation is filtered, and filtrate concentrating obtains concentrated solution.But concentrated solution cold preservation.Add proper amount of active carbon then and boil, cold preservation is filtered and is obtained filtrate.
(f) regulate pH value with sodium hydroxide solution (5%-40%) or hydrochloric acid solution (5%-30%), can prepare various injection of danshen, transfusion preparation after the filtration.
Inventive point of the present invention can carry out by this area routine techniques as for step (e) with (f) mainly at step (a)-(d).
In addition, can be used for Radix Salviae Miltiorrhizae decocting liquid of the present invention without limits, the Radix Salviae Miltiorrhizae decocting liquid that available various conventional methods make.A kind of preferred Radix Salviae Miltiorrhizae decocting liquid is that Radix Salviae Miltiorrhizae crude drug water is decocted three times, and collecting decoction filters, the concentrated solution that obtains after concentrating.
Can test by the various technical specifications of this area routine according to the prepared Radix Salviae Miltiorrhizae extract of red sage root water soluble ingredient extracting method of the present invention.Index commonly used comprises:
Performance: yellowish-brown or brown clear liquid.
PH value: 5.0-7.0.
Sterility test: qualified.
Pyrogen testing: qualified.
Protein: get the Radix Salviae Miltiorrhizae extract that is equivalent to 1g Radix Salviae Miltiorrhizae crude drug, add tannic acid test solution 1-3 and drip, muddiness must not occur.
Oxalates: get the Radix Salviae Miltiorrhizae extract that is equivalent to 2g Radix Salviae Miltiorrhizae crude drug, add 3% calcium chloride solution 2-3 and drip, placed 10 minutes, muddiness or precipitation must not occur.
Tannin: get the Radix Salviae Miltiorrhizae extract that is equivalent to 1g Radix Salviae Miltiorrhizae crude drug, add the normal saline 5ml that contains 1% Ovum Gallus domesticus album of new preparation, placed 10 minutes, muddiness or precipitation must not occur.
Residue on ignition: precision is measured the Radix Salviae Miltiorrhizae extract of 2g Radix Salviae Miltiorrhizae crude drug, and evaporate to dryness is checked (an appendix IX of Chinese Pharmacopoeia version in 2000 J) in accordance with the law, must not cross 1.5% (g/ml).
Heavy metal: get the residue under the residue on ignition item, check (an appendix IX of Chinese Pharmacopoeia version in 2000 E second method) in accordance with the law, must not cross 5/1000000ths.
Arsenic salt: precision is measured the Radix Salviae Miltiorrhizae extract of 2g Radix Salviae Miltiorrhizae crude drug, puts in the crucible evaporate to dryness in the water-bath, add 2% magnesium nitrate alcoholic solution 5ml, light, after extinguishing, burn to carbonization with little heated, put coldly, add nitric acid 0.5ml, evaporate to dryness, after eliminating to nitrogen oxide steam, blazingly make complete ashing, put cold at 500 ℃-600 ℃, check (an appendix IX of Chinese Pharmacopoeia version in 2000 F first method) in accordance with the law, must not cross 5/10000000ths.
Potassium ion: precision is measured the Radix Salviae Miltiorrhizae extract of 2g Radix Salviae Miltiorrhizae crude drug, checks (an appendix IX of Chinese Pharmacopoeia version in 2000 S) in accordance with the law, should be up to specification.
Total solid: precision is measured the Radix Salviae Miltiorrhizae extract of 10g Radix Salviae Miltiorrhizae crude drug, puts in the evaporating dish of constant weight, and evaporate to dryness 105 ℃ of dryings 3 hours, in the dislocation exsiccator, cooled off 30 minutes, accurately rapidly claims decide weight, calculating.Leave over residue and must not be less than 2.0%.
Trap: get the Radix Salviae Miltiorrhizae extract of 1g Radix Salviae Miltiorrhizae crude drug, thin up becomes 500ml, measures according to spectrophotography (an appendix V of Chinese Pharmacopoeia version in 2000 A), at the wavelength place of 281 ± 3nm absorption maximum is arranged, and trap must not be lower than 0.35.
The various detections that the prepared red sage root water soluble ingredient extracting solution of the inventive method is carried out show that its product quality meets the requirement of various technical specifications fully.
Major advantage of the present invention is:
(1) transfer the PH method to make two step alcohol precipitations in the existing technology become a step alcohol precipitation with acidic precipitation method, alcohol solution, the ethanol consumption obviously reduces, and is economical.
(2) acidic precipitation method, alcohol solution are transferred in the operation of the diminishbb relatively alcohol precipitation of PH method step easier.
(3) the acidic precipitation method does not need freezing processing, can improve the utilization rate of freezer, reduces the consumption of the energy.
(4) after the crude drug decocting and concentrating, adopt the acidic precipitation method to destroy pyrogen effectively immediately, improve the quality of products.
(5) water extracting alcohol precipitation method configuration acidic precipitation method, alcohol solution are transferred the PH method, can remove impurity wherein effectively, and as tannin, resin, it is convenient to filter, and the product clarity is good, can reduce clinically because of the pain due to the tannin.
(6) extraction step is few, and the time is shorter.
Further set forth the present invention below in conjunction with embodiment.Should be understood that these embodiment do not play the qualification effect to the present invention.
Embodiment 1
1000g Radix Salviae Miltiorrhizae crude drug water is decocted three times, and each 2 hours, collecting decoction filtered, and filtrate is concentrated into 480ml.With 5% hydrochloric acid solution acidify pH value to 3.5, left standstill 16 hours, filter, it is 75% to containing the alcohol amount that filtrate adds ethanol, and left standstill 48 hours at cold place, filters, filtrate is regulated pH value to 7.5 with 5% sodium hydroxide solution, left standstill 24 hours at cold place, filters, and regulates pH value to 7.0 with 5% hydrochloric acid solution, reclaim ethanol, be concentrated into 120ml, concentrated solution adds in the water for injection of 880ml, cold preservation 16 hours, filter, filtrate is concentrated into 250ml, and cold preservation 72 hours adds 0.4% active carbon and boiled 30 minutes, cold preservation 24 hours, filter, with 5% sodium hydroxide solution adjusting pH value to 6.8, after the filtration promptly.
(281 ± 3nm) is 0.730 to the trap of the Radix Salviae Miltiorrhizae extract that makes, and every indexs such as pH value, sterility test, pyrogen testing, protein, oxalates, tannin, residue on ignition, heavy metal, arsenic salt, potassium ion, total solid, trap all meet the requirements.
Embodiment 2
1000g Radix Salviae Miltiorrhizae crude drug water is decocted three times, each 2 hours, collecting decoction, filter, filtrate is concentrated into 480ml, with 20% hydrochloric acid solution acidify pH value to 2.8, left standstill 12 hours, and filtered, it is 80% to containing the alcohol amount that filtrate adds ethanol, left standstill 48 hours at cold place, filter, filtrate is regulated pH value to 8.0 with 20% sodium hydroxide solution, and left standstill 12 hours at cold place, filter, regulate pH value to 6.0 with 20% hydrochloric acid solution, reclaim ethanol, be concentrated into 120ml, concentrated solution adds in the water for injection of 880ml, cold preservation 16 hours is filtered, and filtrate is concentrated into 250ml, cold preservation 72 hours, add 0.3% active carbon and boiled 30 minutes, cold preservation 24 hours is filtered, regulate pH value to 6.8 with 20% sodium hydroxide solution, after the filtration promptly.
(281 ± 3nm) is 0.554 to the trap of the Radix Salviae Miltiorrhizae extract that makes, and every indexs such as pH value, sterility test, pyrogen testing, protein, oxalates, tannin, residue on ignition, heavy metal, arsenic salt, potassium ion, total solid, trap all meet the requirements.
Embodiment 3
1000g Radix Salviae Miltiorrhizae crude drug water is decocted three times, each 2 hours, collecting decoction, filter, filtrate is concentrated into 500ml, with 30% hydrochloric acid solution acidify pH value to 2.0, left standstill 8 hours, and filtered, it is 85% to containing the alcohol amount that filtrate adds ethanol, left standstill 48 hours at cold place, filter, filtrate is regulated pH value to 8.5 with 40% sodium hydroxide solution, and left standstill 8 hours at cold place, filter, regulate pH value to 5.0 with 30% hydrochloric acid solution, reclaim ethanol, be concentrated into 120ml, concentrated solution adds in the water for injection of 880ml, cold preservation 16 hours is filtered, and filtrate is concentrated into 250ml, cold preservation 72 hours, add 0.1% active carbon and boiled 30 minutes, cold preservation 24 hours is filtered, regulate pH value to 6.8 with 40% sodium hydroxide solution, after the filtration promptly.
(281 ± 3nm) is 0.447 to the trap of the Radix Salviae Miltiorrhizae extract that makes, and every indexs such as pH value, sterility test, pyrogen testing, protein, oxalates, tannin, residue on ignition, heavy metal, arsenic salt, potassium ion, total solid, trap all meet the requirements.
Extracting method parameter and the properties of product of table embodiment 1-3
| The acidify salt acid concentration | Be acidified to pH value | Alcohol precipitation concentration | Alcohol liquid is regulated the naoh concentration of pH value | Alcohol liquid is regulated pH value extremely | Trap (281 ± 3nm) | Other | |
| Embodiment 1 | 5％ | 3.5 | 75％ | 5％ | 7.5 | 0.730 | Meet index request |
| Embodiment 2 | 20％ | 2.8 | 80％ | 20％ | 8.0 | 0.554 | Meet index request |
| Embodiment 3 | 30％ | 2.0 | 85％ | 40％ | 8.5 | 0.447 | Meet index request |
Should be understood that those skilled in the art can make various changes or modifications the present invention after having read above-mentioned teachings of the present invention, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Claims (10)
1. a red sage root water soluble ingredient extracting method is characterized in that, comprises step:
(a) usefulness acid to 2.0-3.5, is placed the pH regulator of Radix Salviae Miltiorrhizae decocting liquid 8-24 hour, filters and obtains filtrate;
(b) adding ethanol to final volume concentration in filtrate is 75 ± 10%, places then 36-72 hour, filters and obtains filtrate;
(c) with alkali with the filtrate pH regulator to 7.5-8.5, placed 8-24 hour, filter and to obtain filtrate;
(d) usefulness acid to 5.0-7.0, is reclaimed the filtrate pH regulator ethanol and is also obtained concentrated solution;
(e) with concentrated solution with the active carbon processing of decolouring, filter and obtain filtrate;
(f) regulate filtrate to pH6.8 ± 0.5, obtain the red sage root water soluble ingredient extracting solution.
2. the method for claim 1 is characterized in that, the Radix Salviae Miltiorrhizae decocting liquid described in the step (a) is that Radix Salviae Miltiorrhizae crude drug water is decocted three times, and collecting decoction filters, and concentrates the decocting liquid that the back obtains.
3. the method for claim 1 is characterized in that, the acid described in the step (a) comprises hydrochloric acid, and weight percent concentration is 5-30%.
4. the method for claim 1 is characterized in that, adding ethanol to final volume concentration in the step (b) is 75-85%.
5. the method for claim 1 is characterized in that, the alkali described in the step (c) comprises sodium hydroxide, and its weight percent concentration is 5-40%.
6. the method for claim 1 is characterized in that, the acid described in the step (d) comprises hydrochloric acid, and weight percent concentration is 5-30%.
7. the method for claim 1 is characterized in that, the treatment conditions of active carbon are to add 0.3 ± 0.2% active carbon to boil 30 ± 15 minutes in the step (e).
8. the method for claim 1 is characterized in that, also comprises step (g): the red sage root water soluble ingredient extracting solution is made Radix Salviae Miltiorrhizae Injection, FUFANG DANSHEN ZHUSHEYE, Radix Salviae Miltiorrhizae infusion solutions or compound Salviae Miltiorrhizae infusion solutions.
9. the method for claim 1 is characterized in that, the number of processes of active carbon is for once in the step (e).
10. the method for claim 1 is characterized in that, the placement described in the step (a) is to place at normal temperatures.
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| CN100335076C true CN100335076C (en) | 2007-09-05 |
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| CN104758352A (en) * | 2014-01-02 | 2015-07-08 | 成都百草和济科技有限公司 | Red sage root injection and preparation method thereof |
| CN115429752B (en) * | 2022-09-21 | 2023-07-18 | 常熟雷允上制药有限公司 | Red sage root injection and its preparation method and application |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1247855A (en) * | 1998-09-11 | 2000-03-22 | 中国科学院上海药物研究所 | Preparation and application of tanshinpolyphenolic salt |
| CN1384090A (en) * | 2001-09-26 | 2002-12-11 | 中国医学科学院药物研究所 | Extraction process of tanshin general phenolic acid and its prepn and use |
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2003
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1247855A (en) * | 1998-09-11 | 2000-03-22 | 中国科学院上海药物研究所 | Preparation and application of tanshinpolyphenolic salt |
| CN1384090A (en) * | 2001-09-26 | 2002-12-11 | 中国医学科学院药物研究所 | Extraction process of tanshin general phenolic acid and its prepn and use |
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