CN106236820A - A kind of Radix Astragali injection and preparation method thereof and pharmaceutical composition - Google Patents
A kind of Radix Astragali injection and preparation method thereof and pharmaceutical composition Download PDFInfo
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Abstract
The present invention relates to field of traditional Chinese, it is specifically related to a kind of Radix Astragali injection and preparation method thereof and pharmaceutical composition, the preparation method of described Radix Astragali injection includes making Astragalus membranaceus condensed cream after 75% precipitate with ethanol filtrate with the sodium hydroxide solution regulation pH value that mass concentration is 40% ± 10% to 10.0 ± 1, then cold preservation converts the step of 24～48 hours.The present invention, by studying the long-term system of Radix Astragali injection technique, has been surprisingly found that after 75% precipitate with ethanol filtrate the step that after introducing utilization regulation alcohol deposit fluid pH value, cold preservation converts, and contributes to decreasing up to remove association peak.The Radix Astragali injection prepared according to the method for the invention has and described Radix Astragali injection has beneficially intermediate and the content control of finished product, improves finished product and criticizes the advantage of a stability, and can significantly improve astragaloside quantitative precision.
Description
Technical field
The present invention relates to field of traditional Chinese, be specifically related to a kind of Radix Astragali injection and preparation method thereof, and containing Huang
Stilbene first glycosides and the pharmaceutical composition of calycosin glucoside.
Background technology
Radix Astragali injection is formed by Milkvetch Root Hydrolysis kinetics, have Yiqiyangyuan, strengthening vital QI to eliminate pathogenic factors, nourish heart promote blood circulation, spleen invigorating
The effects such as dampness removing, are one of important Chinese medicine kinds.
In Radix Astragali injection production process, there is astragaloside association Double-peak Phenomenon in intermediate astragaloside inspection collection of illustrative plates.
The flowing of Radix Astragali injection intermediate astragaloside item inspection institute is methanol-water (75:25) mutually, and detector is ELSD.Inspection has
During the Radix Astragali injection semi-finished product batch of bimodal association, at this, under the conditions of flowing mutually, astragaloside peak and association peak thereof cannot be complete
Separate, and this association peak disappears after Radix Astragali terminal sterilization, causes difficult quantitation.And present stage has no that systematic study is as what is the need
Except the document at association peak is reported, inventor finds through test: after adjustment mobile phase ratio is methanol-water (70:30), bimodal divides
From (see Fig. 1,2), the beneficially content of intermediate and finished product controls, and affects finished product and criticizes a stability, and can significantly improve the Radix Astragali
First glycosides quantitative precision.
In view of this, in the urgent need to proposing a kind of stay-in-grade Radix Astragali injection.
Summary of the invention
The first object of the present invention is to provide a kind of method preparing Radix Astragali injection, decreases up to can aid in
Eliminate association peak, improve Astragaloside content simultaneously.
For achieving the above object, the present invention adopts the following technical scheme that
A kind of method preparing Radix Astragali injection, described method includes making Astragalus membranaceus condensed cream 75% precipitate with ethanol mistake
With the sodium hydroxide solution regulation pH value that mass concentration is 40% ± 10% to 10.0 ± 1 after filtrate, then cold preservation converts 24～48
Hour step.
The present invention, by studying the long-term system of Radix Astragali injection technique, has been surprisingly found that after 75% precipitate with ethanol filtrate and draws
The step that after entering to utilize regulation alcohol deposit fluid pH value, cold preservation converts, contributes to decreasing up to remove association peak, and can significantly improve Huang
Stilbene first glycosides quantitative precision.
Preferably, the pH value of 75% precipitate with ethanol filtrate is regulated with the sodium hydroxide solution that mass concentration is 40%.Use
The sodium hydroxide solution of 40% can regulate the pH value of filtrate effectively and rapidly, removes acid impurities further.
And/or；Preferably, the pH value of 75% precipitate with ethanol filtrate being adjusted to 10.0, this pH value is particularly advantageous in removing acidity
Impurity, also ensures that in the Radix Astragali that effective ingredient obtains simultaneously and retains to the limit.
Preferably, the time that described cold preservation converts is 30～42 hours.
Preferably (but being not limited thereto), described Astragalus membranaceus condensed cream prepares by the following method: take the Radix Astragali,
Add and be equivalent to its quality 8～the soak by water 2 of 10 times～3 times, each 1～2 hour, collecting decoction, filter, filtrate is concentrated into often
1ml is equivalent to crude drug 1～2g, to obtain final product.
Use above-mentioned preparation method, be conducive to fully being enriched with the active component in the Radix Astragali.
Preferably, described 75% precipitate with ethanol filtrate uses and takes Astragalus membranaceus condensed cream, is slowly added under stirring
More than 93% ethanol precipitation process obtains.
The present invention is by utilizing more than 93% ethanol precipitation process Astragalus membranaceus condensed cream, it is possible to effectively remove fat-soluble
Impurity, also ensure that in the Radix Astragali simultaneously effective ingredient also retain to the limit.
Additionally, the method for the invention also comprise the steps: by cold preservation convert after precipitate with ethanol filtrate further with
It is 85% that more than 93% ethanol is precipitated to alcohol content, reclaims ethanol and is concentrated into every 1ml and is equivalent to crude drug 10g, and cold preservation is placed,
Filter, add purified water and carry out water precipitating, water precipitating filtrate is concentrated into every 1ml and is equivalent to crude drug 5～6g, be 20% by mass concentration
± 10% sodium hydroxide solution regulation pH value, to 7.5, boils, adds the activated carbon of 0.125%, boil 4～8 minutes, filter while hot
Cross, add to the full amount of water for injection, filter, embedding, sterilizing, to obtain final product.
Preferably:
It is 85% that precipitate with ethanol filtrate after cold preservation being converted is precipitated to alcohol content further with ethanol, and recovery ethanol is the denseest
Being reduced to every 1ml and be equivalent to crude drug 10g, cold preservation is placed, and filters, adds purified water and carry out water precipitating, water precipitating filtrate is concentrated into every 1ml
Be equivalent to crude drug 5～6g, with 20% sodium hydroxide solution regulation pH value to 7.5, boil, add the activated carbon of 0.125%, boil
Boil 5 minutes, filter while hot, add to the full amount of water for injection, filter, embedding, sterilizing, to obtain final product.
Using above-mentioned steps, the present invention can quickly prepare the content control of Radix Astragali injection, beneficially intermediate and finished product
System, it is ensured that the quality of the pharmaceutical preparations.
Preferably, injecting with after water, before filtration again with 20% sodium hydroxide solution regulation pH value to 7.5, with
Further ensure that described Radix Astragali injection has stable pH value.
The present invention protects the Radix Astragali injection that said method prepares, the more existing astragalus injection of described injection simultaneously
Liquid has finished product and criticizes the advantage that a stability is high, and can significantly improve astragaloside quantitative precision.
Concrete, containing astragaloside 0.08-0.25 (mg/mL) in Radix Astragali injection of the present invention, calycosin
Glucoside 0.04-0.12 (mg/mL).In above-mentioned content range, described Radix Astragali injection has the most prominent QI invigorating and supports
Unit, strengthening vital QI to eliminate pathogenic factors, nourish heart promote blood circulation, the effect such as invigorating spleen to remove dampness.
In addition, invention also provides a kind of pharmaceutical composition, containing astragaloside in described pharmaceutical composition
1-5 part, calycosin glucoside 1-2 part.Aforementioned pharmaceutical compositions includes but not limited to that injection (is only used as preferred side
Case), in addition to this it is possible to be tablet etc., when described pharmaceutical composition is injection, it can use of the present invention
" preparation method of Radix Astragali injection " prepares, it is also possible to directly take astragaloside and the calycosin glucose of recipe quantity
Glycosides is the most formulated.
Pharmaceutical composition of the present invention utilizes the astragaloside of specific amount ratio and calycosin glucoside to make
For active component, it is possible to well play Yiqiyangyuan, strengthening vital QI to eliminate pathogenic factors, nourish heart promote blood circulation, effect of invigorating spleen to remove dampness.
Accompanying drawing explanation
Fig. 1: adjust the astragaloside reference substance chromatographic peak after flowing mutually；
Fig. 2: adjust the astragaloside chromatographic peak after flowing mutually and association chromatographic peak；
Fig. 3: under different pH value, astragaloside high performance liquid chromatograph detects collection of illustrative plates in the Radix Astragali alcohol deposit fluid converted；
Fig. 4: under different pH value in 75% alcohol deposit fluid calycosin glucoside (being denoted as calycosin G in figure) and
Astragaloside content schematic diagram；
Fig. 5: after adjusting pH value, 75% alcohol deposit fluid converts each Substances variation schematic diagram of different time.
Detailed description of the invention
With embodiment, the present invention is described further below in conjunction with the accompanying drawings.
The present invention, by studying the long-term system of Radix Astragali injection technique, has been surprisingly found that after 75% precipitate with ethanol filtrate and draws
The step that after entering to utilize regulation alcohol deposit fluid pH value, cold preservation converts, contribute to decreasing up to removing association peak, beneficially intermediate with
The content of finished product controls, and improves finished product and criticizes a stability, and can significantly improve astragaloside quantitative precision.
Meanwhile, for further determining that optimal pH and the time of conversion, the present invention also expands Multitest, length institute
Limit, is only exemplified by experimental data and the result of part of representative.
One, prepared by sample:
Take and be slowly added to more than 93% ethanol to alcohol content under Astragalus membranaceus condensed cream, stirring and reach 75%, Cryoprecipitation
Filter after 12 hours, take filtrate (pH value is about at about 5.8-6.3, relevant with condensed cream pH value) and regulate pH with sodium hydroxide solution
Value converts to alkalescence, cold preservation.According to the situation of change of astragaloside Yu its association peak, determine applicable conversion pH value and time.
Two, experimental result:
1, pH value is converted: by the detection of 75% alcohol deposit fluid Astragaloside content after converting is found, yellow under different pH value
Stilbene first glycosides and association crest state thereof are different, refer to table 1 and Fig. 3,4.
Table 1: content and astragaloside peak and association p-ratio in 75% alcohol deposit fluid under different pH value
Fig. 3 is through the Radix Astragali alcohol deposit fluid high performance liquid chromatograph detection collection of illustrative plates converted under different pH value.As can be seen from Figure 3,
Along with the rising of conversion pH value, astragaloside association peak decreases, and astragaloside peak raises.Alcohol deposit fluid before non-tone pitch
(pH5.87) astragaloside and association peak thereof can substantially be observed.When regulation pH value is 9.50, and astragaloside peak has raised, yellow
Stilbene first glycosides association peak significantly reduces.When regulate pH value to 9.98 and above time, astragaloside association peak disappears.
Fig. 4 is bent through the Radix Astragali alcohol deposit fluid astragaloside converted and calycosin glucoside content under different pH value
Line chart.As can be seen from Figure 4, the content of calycosin glucoside reduces along with the rising converting pH value.Containing of astragaloside
Measure and slightly raise between conversion pH value 5.5～8.5；Converting between pH value 8.5～10, Astragaloside content has by a relatively large margin
Rising；When converting pH value and rising to more than 10, Astragaloside content is without significant change.Astragaloside and Mao Ruiyi from Fig. 4
The Changing Pattern of flavone glucoside content apparently, converts pH value and selects about 10.0 to be advisable.
Result in conjunction with table 1 and Fig. 3,4 understands, 75% alcohol deposit fluid Cryoprecipitation after sodium hydroxide regulation pH value.Along with pH value
Rising, Astragaloside content rise, the peak of institute's association decreases.When pH value rises to about 10.0, association peak disappears,
Astragaloside content tends towards stability.PH value is increased to more than 9, and calycosin glucoside content is declined slightly.For guaranteeing to disappear
Except astragaloside association peak and improve Astragaloside content, convert pH value and be preferably chosen to be about 10.0 (as 9.98-11 more manages
Think).
2, transformation time: for determining the transformation time impact on Astragaloside content, exchanges pH 9.5 and 10.0 sample and enters
Go the research of different transformation time.75% alcohol deposit fluid is divided into two parts, respectively regulation pH value 9.48 and 10.13,4 DEG C of conversions.Point
Not in 0 (tune), sampling in 18,24,48,72 hours, detection astragaloside and calycosin glucoside content, determine tune pH
The sample transformation time impact on content after value, the results are shown in Table 2 and Fig. 5.
Table 2: after tone pitch, 75% alcohol deposit fluid converts the changes of contents of each material of different time
From the data of table 2 and Fig. 5 it can be seen that adjust pH9.48 sample changing effect relatively to adjust pH value 10.13 sample to convert effect
The poorest, Astragaloside content difference is obvious, and having confirmed optimal conversion pH value is about 10.0.
After the 75% tone pitch alcohol deposit fluid adjusting pH value 10.13 converts different time, Astragaloside content raises, and at 24 hours
Reaching peak and tend towards stability, calycosin glucoside content extends in a slight decrease in time.
As can be seen here, the present invention increases by 75% alcohol deposit fluid tone pitch step of converting in Radix Astragali extract production process can have
The removal astragaloside association peak of effect, promotes Astragaloside content, and calycosin glucoside is content when adjusting below pH10
Reduce the most notable.
Binding experiment data, technical parameter selected in production is for using 40% sodium hydroxide solution by the Radix Astragali 75% alcohol
Heavy filtrate regulation pH value is to about 10.0, and cold preservation converts 24～48 hours.
Embodiment 1: the preparation of Astragalus membranaceus
Present embodiments provide the preparation of Astragalus membranaceus, specific as follows: to take Radix Astragali 2000g, add 10 times amount soak by water 3
Secondary. each 1.5 hours, collecting decoction, filter, filtrate is concentrated into every 1ml and is equivalent to crude drug 1g, to obtain final product.
Embodiment 2: the preparation of Astragalus membranaceus
Present embodiments provide the preparation of Astragalus membranaceus, specific as follows: to take Radix Astragali 2000g, add and be equivalent to its quality 9 times
Soak by water 2 times, each 2 hours, collecting decoction, filter, filtrate is concentrated into every 1ml and is equivalent to crude drug 1.5g, to obtain final product.
Embodiment 3: the preparation of Radix Astragali injection
Example 1 gained Astragalus membranaceus, adds ethanol (concentration is more than 93%) regulation to being 75% (i.e. containing amount of alcohol
Make 75% precipitate with ethanol filtrate), with the sodium hydroxide solution regulation pH value that mass concentration is 40% to 10.0, then cold preservation converts 30
Hour, after according to a conventional method by cold preservation convert after precipitate with ethanol filtrate be prepared as Radix Astragali injection.
Cold preservation obtained by the present embodiment convert after precipitate with ethanol filtrate after testing, without astragaloside association peak, Qi Zhonghuang
Stilbene glucoside content 0.4729mg/mL, calycosin glucoside content 0.142mg/mL.
Embodiment 4: the preparation of Radix Astragali injection
Example 1 gained Astragalus membranaceus, adds ethanol (concentration is more than 93%) regulation to being 75% (i.e. containing amount of alcohol
Make 75% precipitate with ethanol filtrate), with the sodium hydroxide solution regulation pH value that mass concentration is 45% to 10.5, then cold preservation converts 48
Hour, after according to a conventional method by cold preservation convert after precipitate with ethanol filtrate be prepared as Radix Astragali injection.
Cold preservation obtained by the present embodiment convert after precipitate with ethanol filtrate after testing, without astragaloside association peak, Qi Zhonghuang
Stilbene glucoside content 0.4701mg/mL, calycosin glucoside content 0.138mg/mL.
Embodiment 5: the preparation of Radix Astragali injection
Example 1 gained Astragalus membranaceus, adds ethanol (concentration is more than 93%) regulation to being 75% (i.e. containing amount of alcohol
Make 75% precipitate with ethanol filtrate), with sodium hydroxide solution that mass concentration is 50% regulation pH value to 11, then cold preservation to convert 24 little
Time, after according to a conventional method by cold preservation convert after precipitate with ethanol filtrate be prepared as Radix Astragali injection.
Cold preservation obtained by the present embodiment convert after precipitate with ethanol filtrate after testing, without astragaloside association peak, Qi Zhonghuang
Stilbene glucoside content 0.4692mg/mL, calycosin glucoside content 0.121mg/mL.
Embodiment 6: the preparation of Radix Astragali injection
Example 1 gained Astragalus membranaceus, adds ethanol (concentration is more than 93%) regulation to being 75% (i.e. containing amount of alcohol
Make 75% precipitate with ethanol filtrate), with sodium hydroxide solution that mass concentration is 30% regulation pH value to 9, then cold preservation to convert 36 little
Time, after according to a conventional method by cold preservation convert after precipitate with ethanol filtrate be prepared as Radix Astragali injection.
After testing, Astragaloside content rises the precipitate with ethanol filtrate after cold preservation conversion obtained by the present embodiment, Radix Astragali first
Glycosides association peak substantially reduces, wherein Astragaloside content 0.2964mg/mL, calycosin glucoside content 0.155mg/
mL。
Embodiment 7: the preparation of Radix Astragali injection
Example 1 gained Astragalus membranaceus, adds ethanol (concentration is more than 93%) regulation to being 75% (i.e. containing amount of alcohol
Make 75% precipitate with ethanol filtrate), with the sodium hydroxide solution regulation pH value that mass concentration is 40% to 10.0, then cold preservation converts 24
～48 hours, obtain the precipitate with ethanol filtrate after cold preservation converts.
It is 85% that precipitate with ethanol filtrate after above-mentioned cold preservation being converted is precipitated to alcohol content further with more than 93% ethanol,
Reclaiming ethanol and be concentrated into every 1ml and be equivalent to crude drug 10g, cold preservation is placed, and filters, adds purified water and carry out water precipitating, is filtered by water precipitating
Liquid is concentrated into every 1ml and is equivalent to crude drug 5～6g, is that 20% ± 10% sodium hydroxide solution regulates pH value extremely by mass concentration
7.5, boil, add the activated carbon of 0.125%, boil 4～8 minutes, filter while hot, inject with water, filter, embedding, sterilizing,
Obtain.
Precipitate with ethanol filtrate obtained by the present embodiment after testing, without astragaloside association peak, wherein Astragaloside content
0.4726mg/mL, calycosin glucoside content 0.143mg/mL.Refine in gained Radix Astragali injection yellow the most further
Stilbene glucoside content 0.113mg/mL, calycosin glucoside content 0.052mg/mL.
Embodiment 8: the preparation of Radix Astragali injection
Compared with Example 7, distinctive points is only that: the present embodiment is injecting with after water, again with 20% before filtration
Sodium hydroxide solution regulation pH value is to 7.5, to further ensure that described Radix Astragali injection has stable pH value.
Radix Astragali injection obtained by the present embodiment after testing, without astragaloside association peak, wherein Astragaloside content
0.114mg/mL, calycosin glucoside content 0.050mg/mL.
Embodiment 9: pharmaceutical composition
Present embodiments providing a kind of pharmaceutical composition, containing astragaloside 3 parts in described pharmaceutical composition, Mao Ruiyi is yellow
Ketone glucoside 2 parts.
In the present embodiment, using astragaloside and calycosin glucoside as active component, according to conventional method system
Standby one-tenth injection.
Embodiment 10: pharmaceutical composition
Present embodiments providing a kind of pharmaceutical composition, containing astragaloside 1 part in described pharmaceutical composition, Mao Ruiyi is yellow
Ketone glucoside 1 part.
In the present embodiment, using astragaloside and calycosin glucoside as active component, according to conventional method system
Standby piece agent.
Comparative example 1
Compared with Example 7, distinctive points is only that: this comparative example direct Example 1 gained Astragalus membranaceus adds ethanol
(concentration is more than 93%) regulation, to being 75% (i.e. making 75% precipitate with ethanol filtrate) containing amount of alcohol, after filtrate concentrates, is used
It is 85% that more than 93% ethanol is precipitated to alcohol content, reclaims ethanol and is concentrated into every 1ml and is equivalent to crude drug 10g, and cold preservation is placed,
Filter, add purified water and carry out water precipitating, water precipitating filtrate is concentrated into every 1ml and is equivalent to crude drug 5～6g, be 20% by mass concentration
± 10% sodium hydroxide solution regulation pH value, to 7.5, boils, adds the activated carbon of 0.125%, boil 4～8 minutes, filter while hot
Cross, inject with water, filter, embedding, sterilizing, to obtain final product.
It is to say, this comparative example eliminates, embodiment 1 gained becomes 75% precipitate with ethanol filtrate mass concentration is 40%
Sodium hydroxide solution regulation pH value to 10.0, then cold preservation converts the processing procedure of 24～48 hours.
Precipitate with ethanol filtrate obtained by this comparative example after testing, has astragaloside association peak, wherein Astragaloside content
0.157mg/mL, calycosin glucoside content 0.156mg/mL.
As can be seen here, because comparative example alcohol deposit fluid does not carries out pH value regulation, in gained alcohol deposit fluid, Astragaloside content is the lowest
In experimental example.
Embodiment in above-described embodiment can be further combined or replace, and embodiment is only to the present invention's
Preferred embodiment is described, and is not defined the spirit and scope of the present invention, without departing from design philosophy of the present invention
Under premise, the various changes and modifications that in this area, technical scheme is made by professional and technical personnel, belong to this
Bright protection domain.
Claims (10)
1. the method preparing Radix Astragali injection, it is characterised in that include Astragalus membranaceus condensed cream is made 75% precipitate with ethanol
With sodium hydroxide solution that mass concentration is 40% ± 10% regulation pH value to 10.0 ± 1 after filtrate, then cold preservation convert 24～
The step of 48 hours.
Method the most according to claim 1, it is characterised in that: with the sodium hydroxide solution regulation that mass concentration is 40%
The pH value of 75% precipitate with ethanol filtrate, and/or, the pH value of 75% precipitate with ethanol filtrate is adjusted to 10.0.
Method the most according to claim 1 and 2, it is characterised in that: the time that described cold preservation converts is 30～42 hours.
4. according to the method described in any one of claim 1-3, it is characterised in that: described Astragalus membranaceus condensed cream is by such as lower section
Method prepares: take the Radix Astragali, adds and is equivalent to its quality 8～the soak by water 2 of 10 times～3 times, each 1～2 hour, collecting decoction,
Filtering, filtrate is concentrated into every 1ml and is equivalent to crude drug 1～2g, to obtain final product.
5. the method described in any one of claim 1-3, it is characterised in that: described 75% precipitate with ethanol filtrate uses and takes Radix Astragali decocting
Liquid condensed cream, is slowly added to more than 93% ethanol precipitation process under stirring and obtains.
6. according to the method described in any one of claim 1-5, it is characterised in that: described method also comprises the steps: cold
Hiding the precipitate with ethanol filtrate after converting and being precipitated to alcohol content further with more than 93% ethanol is 85%, reclaims ethanol and is concentrated into
Every 1ml is equivalent to crude drug 10g, and cold preservation is placed, and filters, adds purified water and carry out water precipitating, water precipitating filtrate is concentrated into every 1ml suitable
In crude drug 5～6g, with mass concentration be 20% ± 10% sodium hydroxide solution regulation pH value to 7.5, boil, add
The activated carbon of 0.125%, boils 4～8 minutes, filters while hot, injects with water, filters, embedding, sterilizing, to obtain final product.
Method the most according to claim 6, it is characterised in that: injecting with after water, before filtration, again using 20% hydrogen
Sodium hydroxide solution regulation pH value is to 7.5.
8. a pharmaceutical composition, it is characterised in that: containing astragaloside 1～5 parts in described pharmaceutical composition, calycosin
Glucoside 1～2 parts；Preferably described pharmaceutical composition is Radix Astragali injection.
9. the Radix Astragali injection that method described in any one of claim 1-7 prepares.
Radix Astragali injection the most according to claim 9, it is characterised in that: containing astragaloside in described Radix Astragali injection
0.08～0.25 (mg/ml), calycosin glucoside 0.04～0.12 (mg/ml).
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1273116A (en) * | 1999-05-05 | 2000-11-15 | 方同华 | Process for refining astragalus injection |
| CN102895294A (en) * | 2012-10-30 | 2013-01-30 | 黑龙江珍宝岛药业股份有限公司 | Astragalus mongholicus injection and preparation method thereof |
| CN104739920A (en) * | 2015-04-13 | 2015-07-01 | 山西大学 | Method for extracting total saponins of astragalus from traditional Chinese medicine astragalus |
-
2016
- 2016-08-26 CN CN201610768271.0A patent/CN106236820A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1273116A (en) * | 1999-05-05 | 2000-11-15 | 方同华 | Process for refining astragalus injection |
| CN102895294A (en) * | 2012-10-30 | 2013-01-30 | 黑龙江珍宝岛药业股份有限公司 | Astragalus mongholicus injection and preparation method thereof |
| CN104739920A (en) * | 2015-04-13 | 2015-07-01 | 山西大学 | Method for extracting total saponins of astragalus from traditional Chinese medicine astragalus |
Non-Patent Citations (1)
| Title |
|---|
| 马雪松等: "正交试验法优选黄芪甲苷的提取工艺", 《河北科技大学学报》 * |
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