CN102068478A - Safflower injection and preparation method thereof - Google Patents

Safflower injection and preparation method thereof Download PDF

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CN102068478A
CN102068478A CN 201010588890 CN201010588890A CN102068478A CN 102068478 A CN102068478 A CN 102068478A CN 201010588890 CN201010588890 CN 201010588890 CN 201010588890 A CN201010588890 A CN 201010588890A CN 102068478 A CN102068478 A CN 102068478A
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injection
flos carthami
safflower
water
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CN102068478B (en
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周国龙
叶莽莽
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WUHAN FUXING BIOTECHNOLOGY PHARMACEUTICAL CO Ltd
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Abstract

The invention relates to a safflower injection for preventing and treating diseases such as occlusive cerebrovascular disease, coronary heart disease, angiitis and the like, and a preparation method thereof. With the preparation method of the safflower injection, the problem of thermal stability of major pharmaceutical ingredients (taking hydroxy safflower yellow A as representative) of safflower can be solved; a safflower medicinal material is soaked in alcohol and then soaked in warm water, so that active ingredients of the safflower are extracted to the maximum extent and a heating process is shortened; and a normal extraction process is performed, so that major pharmaceutical ingredients are protected. A preparation process used in the preparation method makes industrial production convenient, safflower extracting efficiency can be improved effectively, an injection with high hydroxy safflower yellow A (a major active ingredient of safflower injection) content is obtained, and the quality of a safflower injection product is enhanced remarkably; a specific safflower injection fingerprint detection method indicates that the obtained safflower injection has a characteristic fingerprint; and macromolecular impurities in the injection are reduced remarkably by membrane filtration technology, product safety is enhanced and adverse reaction is reduced.

Description

A kind of Flos Carthami injection and preparation method thereof
Technical field
Belong to the Chinese medicine field, particularly a kind of prevention and treatment obliterated cerebral vascular disease, coronary heart disease, the Chinese medicine preparation of diseases such as vasculitis and its preparation method of being used for.
Technical background
Cerebrovascular disease (Cerebrovascular disease, CVD) be meant the hemorrhage or thrombosis of rupture of blood vessel in brain, what cause is one group of disease of main clinical manifestation with brain hemorrhagic or ischemia injury symptom, claims cerebrovascular accident or apoplexy again, is commonly called as to be apoplexy.This disease is common in crowd's above middle age acute attack, and disturbance of consciousness and quadriplegia can take place severe patient, be to cause human dead and disabled principal disease, and also be hyperpietic's the main cause of death.CVD is neural commonly encountered diseases and frequently-occurring disease, and along with the quickening of China's aged tendency of population process, its sickness rate, prevalence are all in rising trend.Show that according to Chinese acute ischemic cerebral apoplexy diagnosis and treatment guide in 2010 resident now suffers from cerebrovascular 7,000,000 people, annual kainogenesis cerebrovascular 2,000,000 people ranked first the position in the three big causes of death of present disease.
Flos Carthami is the tubular corolla of feverfew Flos Carthami Carthamus tinctorius L..Be one of Chinese medicine commonly used as China, Flos Carthami has promoting blood circulation to restore menstrual flow, blood stasis removing analgesic effect.Modern study proves that Flos Carthami all has significant pharmacological action for cardiovascular system, nervous system and blood, smooth muscle etc.The chemical constituent of Flos Carthami, Chinese scholars have been carried out comparatively deep research.Up to now, discover that Flos Carthami mainly contains flavonol and glycoside thereof, chalcone, diene alcohols, fatty acid, carbene class, steroidal class, its main component S-A Hydroxysafflor yellow A can suppress hematoblastic gathering, arrhythmia, can obviously improve anoxybiotic tolerance, stronger and persistent analgesic activity is arranged, and there are effects such as tangible antiinflammatory, calmness, blood pressure lowering, chemical property to have characteristics such as thermally labile, easy oxidation.
Flos Carthami injection is the sterile water solution of being made by the Chinese medicine safflower extract.Have promoting blood circulation to restore menstrual flow, blood stasis removing analgesic effect.Use symptom and the ischemic ECG change that obviously to improve angina pectoris clinically; Be used for the treatment of satisfactory effects such as diabetic peripheral neuropathy, retinopathy, pulmonary heart disease, chronic kidney hypofunction; Be used for acupoint injection therapy, surgical diseasess such as treatment dermatosis such as erythema multiforme and scapulohumeral periarthritis, and the satisfaction of producing effects; Flos Carthami injection also has many new purposes to remain further to be developed and research.Mostly be 5~20ml during application and add 100~500ml liquid iv drip.
Similar technique
Flos Carthami injection is that the flos carthami extraction prepares, and prior art comprises:
Chinese patent .-CN 1091016. discloses a kind of manufacture method of Flos Carthami injection, and Flos Carthami is added soak with ethanol, squeezing, filtration, removes alcohol again, adjust pH, and adding distil water is to required solution concentration again, and fine straining and fill are sterilized then.This method is bright have been related to flos carthami process ethanol warm macerating, but does not see the integrated artistic that its Flos Carthami extracts.
Chinese patent CN1327846C discloses a kind of Flos Carthami injection and preparation method thereof, the Flos Carthami injection of this invention is a raw material with fresh flos carthami, fresh flos carthami is concentrated with percolate again behind the Flos Carthami usefulness alcohol reflux percolation with cold preservation after the nitrogen cold preservation, at room temperature handle with petroleum ether, remove petroleum ether, again concentrated solution is made injection with well-established law.This method is bright to require height to medical material, uses fresh flos carthami among the preparation technology and needs nitrogen cold preservation, uses the organic solvent petroleum ether in the process, so requirement is high, and the cost height, and be not suitable for suitability for industrialized production.
Chinese patent application numbers 200710164082 discloses a kind of Flos Carthami injection and preparation method thereof, the Flos Carthami injection of this invention is major ingredient with the Flos Carthami, adopt that water is carried, precipitate with ethanol, cold preservation, supercritical extraction, the method of ultrafiltration improves content of medicines, impurity reduces, and is equipped with other adjuvants such as a certain proportion of disodiumedetate, sodium metabisulfite, sodium hydroxide, and proportioning is made injection by weight.The thermal stability problems of the bright unresolved Flos Carthami main component of this method, the main effective ingredient of Flos Carthami (S-A Hydroxysafflor yellow A) content is uncertain.
Chinese patent .-CN 1895317. (application number 200610012864.0) discloses a kind of Flos Carthami injection and preparation method thereof, it is characterized in that comprising the steps: (1) extraction: with the Flos Carthami is raw material, add the water of 8~20 times of the Flos Carthami weight of throwing, under the condition of 40~90 ℃ of feeding inert gas shieldings, extracted 30~90 minutes, extracting liquid filtering, filtering residue add again the water of 8~20 times of the Flos Carthami weight of throwing, the control temperature is extracted twice at 80~100 ℃, extraction time is 30~90min, filters, and merges three times filtrate, it is 1.0~1.3 that filtrate decompression is concentrated into relative density, time Flos Carthami concentrated solution of winning; (2) precipitate with ethanol: the Flos Carthami concentrated solution is under constantly stirring for the first time, add 70wt%~95wt% medicinal alcohol, make pure content reach 10wt%~30wt%, left standstill 10~30 minutes, adding 80wt%~95wt% ethanol again makes pure content reach 50wt%~70wt%, cold preservation was left standstill 24~48 hours, filter and remove precipitation, filtrate recycling ethanol, and to be concentrated into relative density be 1.0~1.2, adds ethanol again and make pure content reach 60wt%~85wt%, 24~48h is left standstill in cold preservation, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.10~1.3 obtains Flos Carthami concentrated solution for the second time; (3) water precipitating: the Flos Carthami concentrated solution adds 5~20 times of amount deionized waters by volume for the second time, cold preservation was left standstill 12~48 hours, filtered and removed precipitation, and the control temperature is below 60 ℃, concentrating under reduced pressure filtrate to relative density is 1.0~1.05, obtains Flos Carthami concentrated solution for the third time; (4) dosing: the Flos Carthami concentrated solution is transferred pH to 7.0~8.0 with 20wt%~50wt% sodium hydroxide solution for the third time, adding the injection water, to make the final volume of Flos Carthami solution and the Flos Carthami part by weight of throwing be 2 liters: 1 kilogram, and filtration, embedding, sterilization promptly gets the Flos Carthami injection finished product.The thermal stability problems of the bright same unresolved Flos Carthami main component of this method, the main effective ingredient of Flos Carthami (S-A Hydroxysafflor yellow A) content is also uncertain.
Content of the present invention
The present invention relates to a kind of Flos Carthami injection and preparation method thereof, belong to field of traditional Chinese, Chinese number of patent application 200610012864.0 disclosed Flos Carthami injections and preparation method thereof are improved, be a kind of by the active Chinese medicine that makes that divides of Flos Carthami, the present invention by flos carthami carried out extract after alcohol leaching, the water logging behind the main effective ingredient of Flos Carthami again through decocting in water earlier, concentrate, secondary precipitate with ethanol, water precipitating obtain the Flos Carthami active component, macromole impurity is removed in ultrafiltration, makes Flos Carthami injection through preparation again, packing, sterilization.
Injection of the present invention has the effect of blood circulation promoting and blood stasis dispelling, is used for the treatment of obliterated cerebral vascular disease, coronary heart disease, vasculitis.Preparation of safflower injection of the present invention has solved the thermal stability problems of Flos Carthami main pharmacodynamics composition (is representative with the S-A Hydroxysafflor yellow A); soak through alcohol, water temperature respectively earlier by flos carthami; extract safflower effective ingredients to greatest extent and reduce it and be subjected to thermal process, carry out again by normal extraction process with protection main pharmacodynamics composition.The preparation technology used with the present invention makes things convenient for suitability for industrialized production, can effectively improve the Flos Carthami extraction efficiency, obtains the injection of high-load S-A Hydroxysafflor yellow A (the main effective ingredient of Flos Carthami injection), and the Flos Carthami injection product quality is significantly improved; Flos Carthami injection fingerprint atlas detection method with feature shows that prepared safflower injection has characteristic fingerprint pattern; The present invention makes by membrane filtration technique that macromole impurity obviously reduces in the injection, and Product Safety improves, and untoward reaction is few.
The present invention is achieved in the following manner:
Get 1 part of flos carthami, add water and run through, add 5~20 parts of 40~60 ℃ of warm macerating of ethanol 0.5~3 hour, filter, it is standby to preserve pure immersion; Medicinal residues add 5~20 parts of purified water, and 40~70 ℃ of warm macerating 1~2 hour filter, and it is standby to preserve infusion; Medicinal residues add purified water again and decoct 2 times, adding for the first time 5~20 parts decocted 0.5~1 hour, adding for the second time 5~10 parts decocted 0.5~1 hour, collecting decoction and infusion, being evaporated to relative density is 1.10~1.28 (50~60 ℃), constantly stir and add ethanol down and make and contain alcohol and measure and reach 60~80%, cold preservation (below 10 ℃) was left standstill more than 48 hours, filtered, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.10~1.14 (50~60 ℃), add ethanol again and make and contain alcohol amount and reach 70~80%, cold preservation (below 10 ℃) was left standstill more than 48 hours, filter, filtrate is with above-mentioned pure immersion decompression recycling ethanol and to be concentrated into relative density be 1.10~1.25 (50~60 ℃), adds 10 times of amount waters for injection, cold preservation (below 10 ℃), left standstill 16~36 hours, filter, it is 1.02~1.05 (50~60 ℃) that filtrate decompression is concentrated into relative density, and the sodium hydroxide solution with 10~30% slowly adds in the above-mentioned solution, the limit edged stirs, and regulates pH value 7.5~8.0; After hot-pressing processing, cold preservation, leave standstill more than 48 hours, add active carbon, filtering decarbonization and ultrafiltration filter (molecular cut off 10000), add the 1.5 times amounts of injection water (through the ultrafiltration eluting) to medical material, sodium hydroxide solution with 10~30% slowly adds in the above-mentioned solution, and the limit edged stirs, and regulates pH value 7.5~8.0; Add 0.05~0.1% sodium calcium edetate, add the 2 times amounts of injection water to flos carthami, mixing, through membrane filtration, inflated with nitrogen embedding, 115 ℃, sterilization in 30 minutes.The preparation method of finger printing of the present invention:
It is an amount of to get the S-A Hydroxysafflor yellow A reference substance, and accurate the title decides, and adds water and makes the solution that contains 0.1mg among every 1ml, in contrast product solution.Measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2010 D).
With the octadecylsilane chemically bonded silica is filler, and Phenomenex Gemini-C18 chromatographic column (column length is 250mm, and internal diameter is 4.6mm) is a mobile phase A with the acetonitrile, is Mobile phase B with 0.05% aqueous formic acid, and according to the form below carries out gradient elution; The detection wavelength is 223nm; Column temperature is 30 ℃.Number of theoretical plate calculates by the S-A Hydroxysafflor yellow A peak should be not less than 6000.
Figure BSA00000390419600041
Accurate respectively reference substance solution and each 10 μ l of this product of drawing inject chromatograph of liquid, write down the chromatogram in 70 minutes.
Specific implementation method
Embodiment 1
Get Flos Carthami 1kg, add water and run through, add ethanol 20kg and 40~45 ℃ of warm macerating 3 hours, filter, it is standby to preserve pure immersion; Medicinal residues add purified water 20kg, and 50~60 ℃ of warm macerating 1.5 hours filter, and it is standby to preserve infusion; Medicinal residues add purified water again and decoct 2 times, adding for the first time 8kg decocted 1 hour, adding for the second time 5kg decocted 0.5~1 hour, collecting decoction and infusion, being evaporated to relative density is 1.10~1.28 (50~60 ℃), add ethanol and make and contain alcohol amount and reach 60%, cold preservation (below 10 ℃) was left standstill 48 hours, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.120 (60 ℃) adds ethanol again and makes and contain the alcohol amount and reach 70%, cold preservation (below 10 ℃), leave standstill more than 48 hours, filter, filtrate is with above-mentioned pure immersion decompression recycling ethanol and to be concentrated into relative density be 1.10~1.25 (50~60 ℃), adds 10 times of amount waters for injection, cold preservation (below 10 ℃), left standstill 36 hours, and filtered, remove potassium, it is 1.02~1.05 (50~60 ℃) that filtrate decompression is concentrated into relative density, sodium hydroxide solution with 10% slowly adds in the above-mentioned solution, and the limit edged stirs, and regulates pH value 7.5~8.0; After hot-pressing processing, cold preservation, left standstill 48 hours, add 0.05% active carbon, filtering decarbonization and ultrafiltration filter (molecular cut off 10000), add the 1.5 times amounts of injection water (through the ultrafiltration eluting) to medical material, sodium hydroxide solution with 10% slowly adds in the above-mentioned solution, and the limit edged stirs, and regulates pH value 7.5~8.0; Add 0.1% sodium calcium edetate, add injection water to 2 times amount, mixing, through membrane filtration, the inflated with nitrogen embedding, 30 minutes, gets 36 of 20ml Flos Carthami injections by 115 ℃.It is up to specification that experiment detects gained injection quality index, hydroxyl carthamin yellow A-containing 0.52mg/ml.
Embodiment 2
Get Flos Carthami 1kg, add water and run through, add ethanol 5kg and 50~60 ℃ of warm macerating 1 hour, filter, it is standby to preserve pure immersion; Medicinal residues add purified water 5kg, and 50~60 ℃ of warm macerating 1.5 hours filter, and it is standby to preserve infusion; Medicinal residues add purified water again and decoct 2 times, adding for the first time 8kg decocted 1 hour, adding for the second time 5kg decocted 1 hour, collecting decoction and infusion, being evaporated to relative density is 1.10~1.28 (50~60 ℃), add ethanol and make and contain alcohol amount and reach 60%, cold preservation (below 10 ℃) was left standstill 48 hours, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.120 (60 ℃) adds ethanol again and makes and contain the alcohol amount and reach 70%, cold preservation (below 10 ℃), leave standstill more than 48 hours, filter, filtrate is with above-mentioned pure immersion decompression recycling ethanol and to be concentrated into relative density be 1.10~1.25 (50~60 ℃), adds 10 times of amount waters for injection, cold preservation (below 10 ℃), left standstill 36 hours, and filtered, remove potassium, it is 1.02~1.05 (50~60 ℃) that filtrate decompression is concentrated into relative density, sodium hydroxide solution with 30% slowly adds in the above-mentioned solution, and the limit edged stirs, and regulates pH value 7.5~8.0; After hot-pressing processing, cold preservation, left standstill 72 hours, add 0.05% active carbon, filtering decarbonization and ultrafiltration filter (molecular cut off 10000), add the 1.5 times amounts of injection water (through the ultrafiltration eluting) to medical material, sodium hydroxide solution with 30% slowly adds in the above-mentioned solution, and the limit edged stirs, and regulates pH value 7.5~8.0; Add 0.1% sodium calcium edetate, add injection water to 2 times amount, mixing, through membrane filtration, the inflated with nitrogen embedding, 30 minutes, gets 34 of 20ml Flos Carthami injections by 115 ℃.It is up to specification that experiment detects gained injection quality index, hydroxyl carthamin yellow A-containing 0.54mg/ml.
Embodiment 3
Get Flos Carthami 5kg, add water and run through, add ethanol 50kg55~60 ℃ warm macerating 1 hour, filter, it is standby to preserve pure immersion; Medicinal residues add purified water 50kg, and 65~70 ℃ of warm macerating 1 hour filter, and infusion is standby; Medicinal residues add purified water again and decoct 2 times, adding for the first time 50kg decocted 1 hour, adding for the second time 40kg decocted 0.5 hour, collecting decoction and infusion, being evaporated to relative density is 1.10~1.28 (50~60 ℃), adding ethanol makes and contains alcohol amount and reach 60%, cold preservation (below 10 ℃) was left standstill more than 48 hours, filtered, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.10~1.14 (50~60 ℃), add ethanol again and make and contain alcohol amount and reach 70%, cold preservation (below 10 ℃) was left standstill more than 48 hours, filter, filtrate is with above-mentioned pure immersion decompression recycling ethanol and to be concentrated into relative density be 1.10~1.25 (50~60 ℃), adds 10 times of amount waters for injection, cold preservation (below 10 ℃), left standstill 24 hours, filter, it is 1.02~1.05 (50~60 ℃) that filtrate decompression is concentrated into relative density, and the sodium hydroxide solution with 20% slowly adds in the above-mentioned solution, the limit edged stirs, and regulates pH value 7.5~8.0; Left standstill 72 hours, and added 0.05% active carbon, filtering decarbonization and ultrafiltration filter (molecular cut off 10000), add the 7.5kg of injection water (through the ultrafiltration eluting) to medical material, with the molten adjusting pH value 7.5~8.0 of 20% sodium hydroxide; Add 0.05% sodium calcium edetate, add the injection water to 10kg, mixing, through membrane filtration, the inflated with nitrogen embedding, 115 ℃, sterilization in 30 minutes makes 456 of 20ml Flos Carthami injections.It is up to specification that experiment detects gained injection quality index, hydroxyl carthamin yellow A-containing 0.55mg/ml.
Embodiment 4
Get Flos Carthami 50kg, add water and run through, add ethanol 500kg50~60 ℃ warm macerating 3 hours, filter, it is standby to preserve pure immersion; Medicinal residues add purified water 500kg, and 70 ℃ of warm macerating 2 hours filter, and it is standby to preserve infusion; Medicinal residues add purification again and decoct 2 times, adding for the first time 500kg decocted 1 hour, adding for the second time 400kg decocted 0.5 hour, collecting decoction and infusion, being evaporated to relative density is 1.10~1.28 (50~60 ℃), adding ethanol makes and contains alcohol amount and reach 70%, cold preservation (below 10 ℃) was left standstill more than 48 hours, filtered, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.10~1.14 (50~60 ℃), add ethanol again and make and contain alcohol amount and reach 70%, cold preservation (below 10 ℃) was left standstill more than 48 hours, filter, filtrate is with above-mentioned pure immersion decompression recycling ethanol and to be concentrated into relative density be 1.10~1.25 (50~60 ℃), adds 10 times of amount waters for injection, cold preservation (below 10 ℃), left standstill 16~36 hours, filter, it is 1.02~1.05 (50~60 ℃) that filtrate decompression is concentrated into relative density, and the sodium hydroxide solution with 20% slowly adds in the above-mentioned solution, the limit edged stirs, and regulates pH value 7.5~8.0; After hot-pressing processing, cold preservation, leave standstill more than 72 hours, add 0.05% active carbon, filtering decarbonization and ultrafiltration filter (molecular cut off 10000), add the injection water to 150kg, and the sodium hydroxide solution with 20% slowly adds in the above-mentioned solution, the limit edged stirs, and regulates pH value 7.5~8.0; Add 0.05% sodium calcium edetate, add the injection water to 100kg, mixing, through membrane filtration, the inflated with nitrogen embedding, 115 ℃, sterilization in 30 minutes makes 4880 of 20ml Flos Carthami injections.It is up to specification that experiment detects gained injection quality index, hydroxyl carthamin yellow A-containing 0.53mg/ml.

Claims (6)

1. Flos Carthami injection, by with decocting in water after flos carthami alcohol leaching, the water logging, concentrate, after secondary precipitate with ethanol, water precipitating, ultrafiltration obtain Flos Carthami and extract active component, the Chinese medicine injection agent formulation that makes through preparation, packing, sterilization.
2. a kind of injection according to claim 1, it is characterized in that its preparation method is earlier through alcohol leaching, water logging with flos carthami, again through decocting in water, concentrate, secondary precipitate with ethanol, water precipitating obtain Flos Carthami and extract active component, Flos Carthami extracts active component and removes macromole impurity after the Chinese medicine preparation that preparation, packing, sterilization make through ultrafiltration.
3. the preparation method of a kind of Flos Carthami injection according to claim 2, it is characterized in that Flos Carthami is got 1 part of flos carthami, adding water runs through, add 5~20 parts of 40~60 ℃ of warm macerating of ethanol 0.5~3 hour, filter, it is standby to preserve pure immersion, medicinal residues add 5~20 parts in water, 40~70 ℃ of warm macerating 1~2 hour, filter, the preservation infusion is standby, decoct with water again 2 times, the purified water that adds for the first time 5~20 parts decocted 0.5~1 hour, the purified water that adds for the second time 5~10 parts decocted 0.5~1 hour, collecting decoction and infusion, being evaporated to relative density is 1.10~1.28 (50~60 ℃), add ethanol and make and contain alcohol amount and reach 60~80%, cold preservation (below 10 ℃) was left standstill more than 48 hours, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.10~1.14 (50~60 ℃) adds ethanol again and makes and contain the alcohol amount and reach 70~80%, cold preservation (below 10 ℃), leave standstill more than 48 hours, filter, filtrate is with above-mentioned pure immersion decompression recycling ethanol and to be concentrated into relative density be 1.10~1.25 (50~60 ℃), adds 10 times of amount waters for injection, cold preservation (below 10 ℃), left standstill 16~36 hours, and filtered, remove potassium, it is 1.02~1.05 (50~60 ℃) that filtrate decompression is concentrated into relative density, sodium hydroxide solution with 10~30% slowly adds in the above-mentioned solution, and the limit edged stirs, and regulates pH value 7.5~8.0; After hot-pressing processing, cold preservation, leave standstill more than 48~600 hours, add 0.05% active carbon, filtering decarbonization and ultrafiltration filter, and add the 1.5 times amounts of injection water to medical material, and the sodium hydroxide solution with 10~30% slowly adds in the above-mentioned solution, the limit edged stirs, and regulates pH value 7.5~8.0; Add 0.05~0.1% sodium calcium edetate, add injection water to 2 times amount, mixing, through membrane filtration, inflated with nitrogen embedding, 115 ℃, sterilization in 30 minutes.
4. according to claim 2 or 3 described preparation methoies, it is characterized in that using the ultrafiltration membrance filter technology, molecular cut off 10000 daltonian macromole impurity.
5. according to claim 2 or the prepared Chinese medicine of 3 described preparation methoies, it is characterized in that having the feature spectral curve with the Flos Carthami injection finger printing that the special-purpose fingerprint analysis method of Flos Carthami injection obtains.
6. according to claim 2 or the prepared Chinese medicine of 3 described preparation methoies, its feature is equivalent to flos carthami 0.5g at the Flos Carthami injection 1ml that makes, and the content of its main effective ingredient S-A Hydroxysafflor yellow A is no less than 0.5mg/ml.
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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103735592A (en) * 2013-12-19 2014-04-23 湖北武当金鼎制药有限公司 Preparation method of flowers carthami injection
CN103735593A (en) * 2013-12-24 2014-04-23 江西天施康中药股份有限公司 Preparation method for safflower injection liquid
WO2014121666A1 (en) * 2013-02-07 2014-08-14 浙江永宁药业股份有限公司 New hydroxysafflor yellow pharmaceutical salts
CN104230864A (en) * 2013-06-08 2014-12-24 浙江永宁药业股份有限公司 Novel hydroxysafflor yellow A divalent medicinal salts, and preparing method and uses thereof
CN108671004A (en) * 2018-08-01 2018-10-19 青海大学 A kind of extracting method and its extract of improving eyesight preparation active ingredient
CN108904568A (en) * 2018-08-01 2018-11-30 青海大学 A kind of preparation method and eyesight improving liquid of eyesight improving liquid

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1895317A (en) * 2006-06-24 2007-01-17 太原华卫药业有限公司 Preparation of safflower injection

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1895317A (en) * 2006-06-24 2007-01-17 太原华卫药业有限公司 Preparation of safflower injection

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014121666A1 (en) * 2013-02-07 2014-08-14 浙江永宁药业股份有限公司 New hydroxysafflor yellow pharmaceutical salts
CN104230864A (en) * 2013-06-08 2014-12-24 浙江永宁药业股份有限公司 Novel hydroxysafflor yellow A divalent medicinal salts, and preparing method and uses thereof
EP2899186A4 (en) * 2013-06-08 2016-01-06 Zhejiang Yongning Pharmaceutical Co Ltd New hydroxysafflor yellow pharmaceutical salts
CN103735592A (en) * 2013-12-19 2014-04-23 湖北武当金鼎制药有限公司 Preparation method of flowers carthami injection
CN103735592B (en) * 2013-12-19 2015-07-29 湖北武当金鼎制药有限公司 A kind of preparation method of Flos Carthami injection
CN103735593A (en) * 2013-12-24 2014-04-23 江西天施康中药股份有限公司 Preparation method for safflower injection liquid
CN108671004A (en) * 2018-08-01 2018-10-19 青海大学 A kind of extracting method and its extract of improving eyesight preparation active ingredient
CN108904568A (en) * 2018-08-01 2018-11-30 青海大学 A kind of preparation method and eyesight improving liquid of eyesight improving liquid

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