CN100361672C - Red sage root ligustrazine freeze dried injecta and preparation method thereof - Google Patents
Red sage root ligustrazine freeze dried injecta and preparation method thereof Download PDFInfo
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- CN100361672C CN100361672C CNB2004100861030A CN200410086103A CN100361672C CN 100361672 C CN100361672 C CN 100361672C CN B2004100861030 A CNB2004100861030 A CN B2004100861030A CN 200410086103 A CN200410086103 A CN 200410086103A CN 100361672 C CN100361672 C CN 100361672C
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Abstract
The present invention relates to an injection solution with red sage root and ligustrazine freezing dry powder and a preparation method of the injection solution, and the present invention belongs to the technical field of medicine. The present invention is used for solving the problems of unstable quality and inconvenient transportation, carrying and storage of the injection solution. The present invention has the technical scheme that the injection solution is in a powdery shape and is composed of red sage root extract, ligustrazine hydrochloride and an appropriate filling agent; the present invention has the components of red sage root raw medicinal material to the ligustrazine hydrochloride to the filling agent of 400 to 1100: 50 to 150: 0 to 200. The preparation method comprises the processes of red sage root liquid extraction, physic liquor configuration, freeze drying, package, etc. The injection solution of the present invention has the advantages of reliable therapeutic effect, stable quality, convenient application and long effective period. The finished product of the injection solution is honeycombed formless powder with loose texture; the powder has a porous structure, so the powder is easily dissolved in water; the powder is rapidly dissolved after water is added and restores the primary characteristics of physic liquor. The preparation method of the present invention can well remove impurities, reduce anaphylactic reaction and farthest reserve effective constituents to increase the therapeutic effect of the product and reduce the secondary reaction.
Description
Technical field
The present invention relates to a kind of injectable drug and preparation method, particularly treat the lyophilized injectable powder and the preparation method of cardiovascular and cerebrovascular disease, belong to medical technical field.
Background technology
Radix Salviae Miltiorrhizae is a kind of medicine of widely used blood circulation promoting and blood stasis dispelling clinically, and it has the effect of coronary blood flow increasing, blood fat reducing, inhibition thrombosis or antithrombotic, microcirculation improvement.Ligustrazine is a kind of typical calcium ion channel blockor, have the generation that suppresses free radical, improve endogenous SOD activity, remove oxygen-derived free radicals, improve hemorheology, pharmacology characteristics such as anticoagulant, inhibition fibrosis, and the effect of blood vessel dilating, coronary blood flow increasing, microcirculation improvement and cerebral blood flow increasing amount is arranged.Radix Salviae Miltiorrhizae, ligustrazine are drug for invigorating blood circulation and eliminating stasis, and use in conjunction has synergy clinically, are used for the treatment of diseases such as ischemic encephalopathy, coronary heart disease, angina pectoris, myocardial infarction, obtain satisfactory effect.Liquid, red-rooted-salvia-root chuanxiong-rhizome azine glucose injection as antiplatelet aggregation, coronary artery expansion medicine, were widely used in clinical when at present existing red-rooted-salvia-root chuanxiong-rhizome azine was annotated.From the clinical practice situation, injection in treatment curative effect significantly better than oral formulations.But because liquid stabilising is poor, easily generation impurity is decomposed in prolongation in time, thereby influences drug quality and therapeutic effect, gives medicine manufacturing enterprise, medical institutions, causes certain hidden danger on all too many levels such as production, storage, use.In addition, the transportation of liquid infusion agent, keeping, carry all inconvenient.In view of the above problems, demand developing more advanced dosage form urgently.
Summary of the invention
Technical problem to be solved by this invention is: overcome the defective of prior art and provide a kind of steady quality, effect duration longer, conveniently transport, carry, the red sage root ligustrazine freeze dried injecta and the preparation method of keeping.
The alleged problem of the present invention is solved by following technical scheme:
A kind of red-rooted-salvia-root chuanxiong-rhizome azine freezes in injectable powder, and its special feature is: the Radix Salviae Miltiorrhizae extract that obtains through extraction by the principal agent Radix Salviae Miltiorrhizae, and ligustrazine hydrochloride and suitable filler form, each component unit is by weight counted:
Radix Salviae Miltiorrhizae raw medicinal herbs: ligustrazine hydrochloride: filler is 400-1100: 50-150: 0-200,
Radix Salviae Miltiorrhizae in the above-mentioned component is made extracting solution,, be mixed after lyophilization and powdered injection again with ligustrazine hydrochloride and filler water dissolution.
Above-mentioned red sage root ligustrazine freeze dried injecta, described each component is the unit meter by weight, and it is preferably than being: Radix Salviae Miltiorrhizae raw medicinal herbs: ligustrazine hydrochloride: filler is for being 500-1000: 90-110: 50-150.
Above-mentioned red sage root ligustrazine freeze dried injecta, described filler are a kind of of sorbitol, mannitol, glucose, sodium lactonic, sodium citrate or any two or two or more combinations.
The preparation method of above-mentioned red sage root ligustrazine freeze dried injecta, it is undertaken by following operation:
A. extract liquid salvia: get said ratio amount Radix Salviae Miltiorrhizae raw medicinal herbs, decoct with water 2～3 times, merge decoction liquor, being concentrated into cocnentration factor is 1: 2, carry out precipitate with ethanol one time, a described precipitate with ethanol is that concentrated solution is regulated pH value to 12, leaching precipitate with 20% lime cream, filtrate adds 95% ethanol and reaches 60% to containing the alcohol amount, cold preservation 24 hours filters filtrate recycling ethanol, be condensed into every 1ml and be equivalent to the clear liquid of 4g medical material, regulating pH value with the hydrochloric acid solution of 0.1M is 3.5-5.5;
B. dispose medicinal liquid: get the above-mentioned Radix Salviae Miltiorrhizae extract that makes, add about 3000ml water for injection, filter; Get said ratio amount ligustrazine hydrochloride and add in about 1000ml water for injection, it is dissolved fully, be heated to 58～63 ℃, add 0.05% needle-use activated carbon, heated about 15 minutes, put cold after-filtration and take off charcoal; Merge Radix Salviae Miltiorrhizae extract and ligustrazine hydrochloride filtrate, add the injection water, use the filtering with microporous membrane degerming of 0.45 μ m and 0.22 μ m respectively to 5000ml;
C. vacuum lyophilization: after the content of danshensu and ligustrazine hydrochloride is measured in customary sampling, be sub-packed in the control lyophilizing vial of 10ml, every bottle of 5ml puts into freeze dryer with the packing sample, earlier with extremely-45 ℃ of sample pre-freezes, be incubated 3-4 hour, slowly be warming up to-20 ℃ and need 18-24 hour, slowly be warming up to 0 ℃ and need 18-24 hour, need 10-14 hour to 25 ℃, 25 ℃ of insulations 3 hours, there is not significant change to vacuum, can go out sample;
D. pack.
For further improving purity, the preparation method of above-mentioned red sage root ligustrazine freeze dried injecta, in described extraction liquid salvia operation, carry out the secondary precipitate with ethanol, with precipitate with ethanol filtrate recycling ethanol a to cocnentration factor is 1: 2, and concentrated solution adds 95% ethanol again and reaches 70% to containing the alcohol amount, and cold preservation made it to precipitate fully in 24 hours, filter filtrate recycling ethanol.
The preparation method of above-mentioned red sage root ligustrazine freeze dried injecta, red rooted salvia decocts with water 3 times in described extraction liquid salvia operation, adds 12 times of water yields at every turn, the 1st decoction 1.5 hours, the 2nd, 3 decoction 1.0 hours.
The preparation method of above-mentioned red sage root ligustrazine freeze dried injecta, in extracting the liquid salvia operation, the precipitate that pH value is transferred to the leaching of 12 o'clock institutes adds 2 times of amount ethanol suspendibles, with 50% sulphuric acid adjust pH to 3.0, stirs, and filters, and gained filtrate is carried out precipitate with ethanol and is handled.
Injection curative effect of the present invention is reliable, steady quality, application are convenient, compare with existing injection and to have following characteristics: 1. Radix Salviae Miltiorrhizae adopts technology of the present invention to extract, can remove materials such as protein common in the general Chinese medicine, tannin, resin preferably, reduce anaphylaxis, kept effective ingredient to greatest extent, the product curative effect is improved, and side reaction reduces; 2. product of the present invention adopts freeze drying process, and the product water content is low, compare with injection to delay the speed that decomposition reaction takes place, and steady quality, effect duration is long; 3. product of the present invention is made through lyophilization, be easy to during lyophilizing be shaped, and formability is good, sticking bottle, spray bottle phenomenon do not occur.Finished product is cellular unformed powder, and quality is loose, and powder tool loose structure, thereby soluble in water can dissolve rapidly after adding water, recovers the medicinal liquid primary characteristic.
The specific embodiment
Lyophilized injectable powder of the present invention is made up of Radix Salviae Miltiorrhizae, ligustrazine hydrochloride and filler.Its major ingredient is Radix Salviae Miltiorrhizae and ligustrazine hydrochloride, and the two is collaborative, has the effect of coronary blood flow increasing, blood fat reducing, inhibition thrombosis or antithrombotic, microcirculation improvement.Be used for the treatment of diseases such as ischemic encephalopathy, coronary heart disease, angina pectoris, myocardial infarction clinically, have better curative effect.Its adjuvant is that filler is a kind of of sorbitol, mannitol, glucose, sodium lactonic or sodium citrate or two or more combination arbitrarily, but can also select the filler of other injection for use, plays effects such as figuration, solubilising.
Product of the present invention is Powdered, and the dry powder quality is loose, adds can dissolve rapidly behind the water to recover the medicinal liquid primary characteristic.Because of adopting freeze drying process, so the product water content is low than conventional formulation, have longer effect duration than injection, quality is more stable, and side effect still less and is conveniently stored, transportation, is taken care of.
Preparation method of the present invention, abstraction process to Radix Salviae Miltiorrhizae, comprise select materials, link such as decoction, precipitate with ethanol is through contrast test repeatedly, repeated screening, find out optimum condition, formulated strict operating procedure one by one, make the content of Danshensu height in the Radix Salviae Miltiorrhizae extract, impurity is few, thereby effectively improves the quality of products.
One, the selection in the Radix Salviae Miltiorrhizae place of production: get each 100g of red rooted salvia in the different places of production, the accurate title, decide, and places round-bottomed flask, add 12 times of distilled water respectively, reflux, extract, 2 hours, filtered while hot, get subsequent filtrate 100ml, regulate pH value to 2.0, reuse ethyl acetate 100ml extraction 1 time with 10% hydrochloric acid.Extract is concentrated into dried, and residue 100ml dissolve with methanol as need testing solution, is used filtering with microporous membrane, gets 1ul and injects chromatograph of liquid.The record chromatogram, relatively the peak area of danshensu draws following result:
Sichuan, Shaanxi, Shandong, Hebei, the place of production
Danshensu peak area 648,829 1,037,013 771,169 689145
As seen, it is higher that the contained content of Danshensu of red rooted salvia is produced in Shandong, and other components contents are also higher.
Its two, Radix Salviae Miltiorrhizae extraction process amount of water, the screening of extraction time: take by weighing Radix Salviae Miltiorrhizae 100g, test according to different experimental conditions respectively, danshensu trap value result is as follows after measured:
| Amount of water | Extraction time | |||
| (multiple) 8 10 12 15 | 0.5 hour 0.345 0.430 0.488 0.447 | 1.0 hour 0.530 0.534 0.598 0.544 | 1.5 hour 0.567 0.632 0.654 0.606 | 2.0 hour 0.470 0.506 0.538 0.520 |
Can find out and adopt 12 times of water yields, decoction 1.5 hours, the content of danshensu is higher than the content of other conditions.
Its three, the screening of precipitate with ethanol impurity removal process: in the prior art, the Radix Salviae Miltiorrhizae impurities removing method is mainly used alcohol deposition method, promptly merges the Radix Salviae Miltiorrhizae aqueous extract, is concentrated into cocnentration factor and is 1: 2 concentrated solution.Adding 95% ethanol precipitates.In this process, the loss of danshensu is bigger.The present invention adopts diverse ways to carry out remove impurity, and is as follows with the conventional method contrast:
A (conventional method): concentrated solution directly adds 95% ethanol and reaches 60% to containing the alcohol amount, and cold preservation made it to precipitate fully in 24 hours, filtered, and filtrate recycling ethanol to cocnentration factor is 1: 2.
B:(the inventive method) concentrated solution is transferred pH to 12 with 20% lime cream (calcium oxide), the leaching precipitate, precipitate adds 2 times of amount ethanol suspendibles, regulate pH value to 3.0 with 50% sulphuric acid, stir, filter, filtrate adds 95% ethanol and reaches 60% to containing the alcohol amount, cold preservation 24 hours filters, and filtrate recycling ethanol to cocnentration factor is 1: 2.Measure the total amount of precipitate with ethanol front and back danshensu.The result is as follows:
| Before and after the precipitate with ethanol | The A method | The B method | |
| The danshensu total amount response rate (%) clarity | 65.78 it is obviously muddy | 38.35 58.31 muddinesses | 56.47 85.85 clarifications |
As seen adopt the B method, the response rate of danshensu obviously improves, and liquid is clarification, good impurity removing effect.Infer that this is because danshensu salt is more stable than danshensu, the salt precipitation that generates danshensu behind the adding alkali is separated out, and has both removed impurity, has improved the purity of danshensu, makes danshensu survivable again, has improved the response rate of danshensu.In addition, in order further to remove impurity, can carry out the precipitate with ethanol second time, contain the alcohol amount and reach 70%, cold preservation 24 hours filters filtrate recycling ethanol.
Product of the present invention has carried out influence factor's test, accelerated test and long term test respectively with reference to (two appendix XIX of Chinese Pharmacopoeia version in 2000 C) medicine stability test guideline, and its stability has obtained confirmation by test, referring to subordinate list 1～4.
Table 1 influence factor result of the test
| Experimental condition | Time (my god) | Character | PH | Clarity | Content (mg/ props up) | |
| Danshensu | Ligustrazine hydrochloride | |||||
| 0 | Faint yellow loose block | 2.7 | Clear and bright | 2.01 | 100.2 | |
| High temperature (60 ℃) | 5 10 | The pale brown color of faint yellow loose block is the bead of fusing slightly | 2.7 2.9 | Clear and bright | 2.01 2.02 | 100.3 100.7 |
| High humidity (25 ℃ of RH92.5%) | 5 10 | The faint yellow loose block of faint yellow loose block | 2.8 2.8 | Clear and bright | 2.00 2.02 | 100.1 101.3 |
| Strong illumination (4800Lx) | 5 10 | The faint yellow loose block of faint yellow loose block | 2.7 2.8 | Clear and bright | 2.00 1.98 | 100.1 100.2 |
Table 2 accelerated test result
| Lot number | Time (moon) | Character | PH | Clarity | Content (mg/ props up) | |
| Danshensu | Ligustrazine hydrochloride | |||||
| 030701 | 0 1 2 3 6 | The loose block of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of light brown yellow | 2.7 2.8 2.6 2.9 2.7 | Up to specification up to specification | 2.01 2.00 2.01 1.99 2.02 | 100.2 100.5 99.9 101.2 100.6 |
| 030702 | 0 1 2 3 6 | The loose block of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of light brown yellow | 2.9 2.9 2.8 2.6 2.9 | Up to specification up to specification | 1.99 2.02 1.99 2.01 1.99 | 99.8 100.7 101.2 100.4 101.9 |
| 030703 | 0 1 2 3 6 | The loose block of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of light brown yellow | 2.8 2.8 2.9 2.7 2.7 | Up to specification up to specification | 2.00 2.02 1.99 1.98 2.01 | 100.1 101.8 100.2 99.5 100.6 |
Table 3 long-term test results
| Lot number | Time (moon) | Character | PH | Clarity | Content (mg/ props up) | |
| Danshensu | Ligustrazine hydrochloride | |||||
| 030701 | 0 1 3 6 9 12 18 24 | The loose block of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of light brown yellow | 2.7 2.9 2.7 2.9 2.8 2.7 2.6 2.7 | Up to specification | 2.01 2.00 2.02 1.98 2.02 2.01 1.98 1.98 | 100.2 100.7 100.5 101.2 99.7 100.3 99.8 99.9 |
| 030702 | 0 1 3 6 9 12 18 24 | The loose block of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of light brown yellow | 2.9 2.9 2.6 2.8 2.6 2.9 2.7 2.6 | Up to specification | 2.01 2.02 1.98 2.02 1.99 2.00 2.00 1.98 | 99.8 100.7 99.6 101.2 100.9 100.5 99.5 99.8 |
| 030703 | 0 1 3 6 9 12 18 24 | The loose block of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of the loose block light brown yellow of light brown yellow | 2.8 2.6 2.8 2.7 2.7 2.6 2.6 2.7 | Up to specification | 2.00 2.02 1.98 1.99 2.01 2.01 1.99 2.00 | 100.1 101.8 99.8 101.2 99.5 100.8 100.2 99.9 |
Long-term 24 months result of the tests of table 4 Radix Salviae Miltiorrhizae for injection ligustrazine
| Lot number | 030701 | 030702 | 030703 |
| Character pH value Radix Salviae Miltiorrhizae related substance related substance clarity aseptic pyrogen finger printing content danshensu (mg/ props up) ligustrazine hydrochloride | Faint yellow loose block 2.7 up to specification 0.29 up to specification 1.98 99.9 | Faint yellow loose block 2.6 up to specification 0.30 up to specification 1.98 99.8 | Faint yellow loose block 2.7 up to specification 0.30 up to specification 2.00 99.9 |
Several embodiment are provided below:
Embodiment 1. Radix Salviae Miltiorrhizaes (crude drug) 1000g, ligustrazine hydrochloride 110g, sorbitol 100g
Embodiment 2. Radix Salviae Miltiorrhizaes (crude drug) 500g, ligustrazine hydrochloride 90g, sorbitol 50g, sodium citrate 50g
Embodiment 3. Radix Salviae Miltiorrhizaes (crude drug) 800g, ligustrazine hydrochloride 100g, mannitol 150g,
Embodiment 4. Radix Salviae Miltiorrhizaes (crude drug) 400g, ligustrazine hydrochloride 50g, glucose 100g,
Embodiment 5. Radix Salviae Miltiorrhizaes (crude drug) 1100g, ligustrazine hydrochloride 150g, sorbitol 100g, sodium lactonic 100g
Preparation technology is as follows:
One. extract liquid salvia: get the recipe quantity red rooted salvia, decoct with water 3 times, add 12 times of water yields at every turn, the 1st decoction 1.5 hours, the 2nd, 3 decoction 1.0 hours.Merge decoction liquor, being concentrated into cocnentration factor is 1: 2, concentrated solution is regulated pH value to 12 with 20% lime cream (calcium oxide), and leaching precipitate, precipitate add 2 times of amount ethanol suspendibles, with 50% sulphuric acid adjust pH to 3.0, stir, filter, filtrate adds 95% ethanol and reaches 60% to containing the alcohol amount, cold preservation 24 hours, filter, filtrate recycling ethanol to cocnentration factor is 1: 2, and concentrated solution adds 95% ethanol again and reaches 70% to containing the alcohol amount, cold preservation made it to precipitate fully in 24 hours, filter, filtrate recycling ethanol is condensed into the clear liquid that every 1ml is equivalent to the 4g medical material, hydrochloric acid solution with 0.1M is regulated pH value 3.5-5.5, and is standby as reserve liquid.
Two. the medicinal liquid configuration:
Get the above-mentioned Radix Salviae Miltiorrhizae extract that makes, add about 3000ml water for injection, carry out the ultrafiltration post and filter; Get ligustrazine hydrochloride and add in about 1000ml water for injection, make dissolving fully, be heated to 58～63 ℃, add 0.05% needle-use activated carbon, heated about 15 minutes, put cold after-filtration and take off charcoal; Merge Radix Salviae Miltiorrhizae extract and ligustrazine hydrochloride filtrate, add the injection water, use the filtering with microporous membrane degerming of 0.45 μ m and 0.22 μ m respectively to 5000ml.
Three. lyophilization: measure the content of danshensu and ligustrazine hydrochloride, be sub-packed in the control lyophilizing vial of 10ml every bottle of 5ml, totally 1000 bottles after qualified.The packing sample is put into freeze dryer, with extremely-45 ℃ of sample pre-freezes, be incubated 3-4 hour earlier, slowly be warming up to-20 ℃ and need 18-24 hour, slowly be warming up to 0 ℃ and need 18-24 hour, need 10-14 hour to 25 ℃, 25 ℃ of insulations 3 hours, there is not significant change to vacuum, can go out sample.
Four. packing: after finishing, lyophilization adds butyl rubber plug, outlet, the sealing of jewelling lid gets product.
Finished product system is applied to the clinical vein drop together.Face with preceding and fully dissolve with an amount of water for injection, 0.9% sodium chloride injection or 5% glucose injection earlier, reuse 0.9% sodium chloride injection or 5% glucose injection 250--500ml dilution.One time 1--2 props up, and once-a-day, or follows the doctor's advice.
Claims (4)
1. the preparation method of a red sage root ligustrazine freeze dried injecta is characterized in that: it is made up of through the Radix Salviae Miltiorrhizae extract, ligustrazine hydrochloride and the filler that extract gained the principal agent Radix Salviae Miltiorrhizae, and each component unit is by weight counted:
Radix Salviae Miltiorrhizae raw medicinal herbs: ligustrazine hydrochloride: filler is 400-1100: 50-150: 0-200, and is undertaken by following operation:
A. extract liquid salvia: get said ratio amount Radix Salviae Miltiorrhizae raw medicinal herbs, decoct with water 2～3 times, merge decoction liquor, being concentrated into cocnentration factor is 1: 2, carry out precipitate with ethanol one time, a described precipitate with ethanol is that concentrated solution is regulated pH value to 12, leaching precipitate with 20% lime cream, filtrate adds 95% ethanol and reaches 60% to containing the alcohol amount, cold preservation 24 hours filters filtrate recycling ethanol, be condensed into every 1ml and be equivalent to the clear and bright fluid of 4g medical material, regulating pH value with the hydrochloric acid solution of 0.1M is 3.5-5.5;
B. dispose medicinal liquid: get the above-mentioned Radix Salviae Miltiorrhizae extract that makes, add 3000ml water for injection, filter; Get said ratio amount ligustrazine hydrochloride, add in the 1000ml water for injection, it is dissolved fully, be heated to 58～63 ℃, add 0.05% needle-use activated carbon, heated 15 minutes, put cold after-filtration and take off charcoal; Merge Radix Salviae Miltiorrhizae extract and ligustrazine hydrochloride filtrate, add the injection water, use the filtering with microporous membrane degerming of 0.45 μ m and 0.22 μ m respectively to 5000ml;
C. vacuum lyophilization: behind the content of customary mensuration danshensu and ligustrazine hydrochloride, be sub-packed in the control lyophilizing vial of 10ml, every bottle of 5ml puts into freeze dryer with the packing sample, earlier with extremely-45 ℃ of sample pre-freezes, be incubated 3-4 hour, slowly be warming up to-20 ℃ and need 18-24 hour, slowly be warming up to 0 ℃ and need 18-24 hour, need 10-14 hour to 25 ℃, 25 ℃ of insulations 3 hours, there is not significant change to vacuum, can go out sample;
D. pack.
2. the preparation method of red sage root ligustrazine freeze dried injecta according to claim 1, it is characterized in that: in the described extraction liquid salvia operation, carry out the secondary precipitate with ethanol, with precipitate with ethanol filtrate recycling ethanol a to cocnentration factor is 1: 2, concentrated solution adds 95% ethanol again and reaches 70% to containing the alcohol amount, cold preservation made it to precipitate fully in 24 hours, filtered filtrate recycling ethanol.
3. the preparation method of red sage root ligustrazine freeze dried injecta according to claim 2, it is characterized in that: red rooted salvia decocts with water 3 times in the described extraction liquid salvia operation, adds 12 times of water yields at every turn, decocts 1.5 hours for the 1st time, decocts 1.0 hours for the 2nd, 3 time.
4. according to the preparation method of claim 2 or 3 described red sage root ligustrazine freeze dried injectas, it is characterized in that: in extracting the liquid salvia operation, the precipitate that pH value is transferred to the leaching of 12 o'clock institutes adds 2 times of amount ethanol suspendibles, with 50% sulphuric acid adjust pH to 3.0, stir, filter, gained filtrate is carried out precipitate with ethanol and is handled.
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| CN102357083A (en) * | 2011-11-08 | 2012-02-22 | 贵州拜特制药有限公司 | Preparation method of salvia tetramethylpyrazine freeze-dried powder injection preparation for injection |
| CN103405500A (en) * | 2013-07-31 | 2013-11-27 | 哈药集团中药二厂 | Preparation method of radix salviae miltiorrhizae freeze-dried powder for intravenous injection |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1226439A (en) * | 1998-11-20 | 1999-08-25 | 李国荣 | Composite medicinal injection for hemiparalysis |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1226439A (en) * | 1998-11-20 | 1999-08-25 | 李国荣 | Composite medicinal injection for hemiparalysis |
Non-Patent Citations (1)
| Title |
|---|
| 国家药品监督管理局国家药品 标准化学药品地方标准上升为国家标准第12册. 国家药典委员会主编，12-125 12-126页，化学工业出版社. 2002 * |
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