CN107789318A - A kind of preparation method for improving danshen injections bioactivity - Google Patents
A kind of preparation method for improving danshen injections bioactivity Download PDFInfo
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- CN107789318A CN107789318A CN201711040056.XA CN201711040056A CN107789318A CN 107789318 A CN107789318 A CN 107789318A CN 201711040056 A CN201711040056 A CN 201711040056A CN 107789318 A CN107789318 A CN 107789318A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention belongs to parenteral solution technical field, especially a kind of preparation method for improving danshen injections bioactivity, specific method is as follows：（1）The preparation of red sage root Ultramicro-powder；（2）The preparation of red sage root extract；（3）The preparation of secondary red sage root extract；（4）The preparation of danshen injections；（5）It is filling, sterilizing, obtain finished product；Present invention process flow is simple to operation, the precipitation of effective component in red sage can be effectively facilitated, improve its recovery rate, so that not only property is stable for the danshen injections prepared, pharmacological action is efficient, efficient promoting blood circulation and removing blood stasis, freeing vessels and nourishing heart, effectively suppress the abnormal generation of platelet aggregation, there is good prevention effect to thromboembolia type cardiovascular and cerebrovascular disease, so that the body of people is preferably adjusted, and without using harmful chemical reagent and organic solvent, have no toxic side effect, be noresidue, safe and reliable, avoid polluting environment.
Description
Technical field
The invention belongs to parenteral solution technical field, especially a kind of preparation method for improving danshen injections bioactivity.
Background technology
Danshen injections is the extracting in water using the red sage root as raw material, and by alcohol precipitation, water is heavy etc., folk prescription Chinese medicine made of step is noted
Agent is penetrated, its effect is promoting blood circulation and removing blood stasis, freeing vessels and nourishing heart, is mainly used in the diseases such as uncomfortable in chest, angina pectoris caused by treating coronary heart disease, to other hearts
The diseases such as cranial vascular disease, hepatopathy, nephrosis, ALI, pancreatitis, clinically also there is good auxiliary therapeutic action.
Pharmacological research shows, water-soluble phenolic acrylic component is the main component that danshen injections plays blood circulation invigorating efficacies, injection of danshen
The chemical composition of liquid is mainly water miscible phenol acid compound, including:Salvianic acidA, B, C, salviol acid A, B, C, D, E, G,
Rosmarinic acid, methyl rosmarinate, alkannic acid mono methyl ester, alkannic acid dimethyl ester, alkannic acid ethyl ester, alkannic acid B, protocatechualdehyde,
Caffeic acid, isoferulic acid etc., wherein content it is higher have Sodium Danshensu, protocatechualdehyde, Rosmarinic acid, tanshin polyphenolic acid B etc., its four kinds
The content height of composition represents the height of danshen injections bioactivity；But danshen injections prepared by currently available technology
Bioactivity it is unsatisfactory, its pharmacological action is not played greatly, therefore, invention one kind can effectively improve the red sage root
The preparation method of parenteral solution bioactivity is current urgent problem to be solved.
The content of the invention
A kind of in view of the above-mentioned problems, the present invention is intended to provide preparation method for improving danshen injections bioactivity.
The present invention is achieved through the following technical solutions：
A kind of preparation method for improving danshen injections bioactivity, specific method are as follows：
（1）The red sage root is crushed to 40 ~ 50 mesh, temperature be 188 ~ 190 DEG C under conditions of constant temperature steam handle 16 ~ 18min, with
3.7 ~ 4.1 DEG C/min rate of temperature fall be cooled to 127 ~ 129 DEG C continue constant temperature steams handle 11 ~ 13min, input temperature be 88 ~
13 ~ 15min of constant temperature frying in 90 DEG C of frying pan, ultramicro grinding to 360 ~ 370 mesh, obtains red sage root Ultramicro-powder；
（2）It is to be incubated in 5 ~ 6 times of amounts of red sage root Ultramicro-powder weight, the water that temperature is 70 ~ 72 DEG C that red sage root Ultramicro-powder is put into weight
Mix 12 ~ 14min, continue 66 ~ 68min of heat-insulation soaking and be simultaneously ultrasonically treated, continue after being boiled by slow fire slow fire infusion 46 ~
48min, 0.2 μm of membrane filtration is crossed, obtains a filter residue and a red sage root extract；
（3）Filter residue is inserted in the vacuum freezing drying oven that temperature is -13 ~ -12 DEG C and dried to no moisture, is taken out, input
Be to weight 4 ~ 5 times of red sage root Ultramicro-powder weight amount ethanol solutions in, be first heated to 66 ~ 68 DEG C of insulation backflow extractions 80 ~
90min, 99 ~ 101 DEG C of insulation backflow 120 ~ 130min of extraction are then heated to, 0.2 μm of membrane filtration is crossed, obtains secondary filter residue and two
Secondary red sage root extract；
（4）Red sage root extract and secondary red sage root extract are merged, are heated to seething with excitement, being concentrated under reduced pressure into relative density is
1.2 ~ 1.3, add the agitator that water for injection rotating speed is 100 ~ 120r/min and stir 44 ~ 46min, obtain danshen injections；
（5）It is filling, sterilizing, obtain finished product.
As the further scheme of invention：Step（2）Described supersound process is：It is first 101 ~ 103W, frequency with power
Handle 17 ~ 18min, pause 7min for 182 ~ 184kHz ultrasonic echography, be then 144 ~ 146W with power, frequency be 222 ~
224kHz ultrasonic echography handles 32 ~ 33min.
As the further scheme of invention：Step（3）The mass fraction of described ethanol solution is 77% ~ 79%.
As the further scheme of invention：The described red sage root and the weight ratio of water for injection are 1:1.9~2.1.
Beneficial effects of the present invention：A kind of preparation method for improving danshen injections bioactivity provided by the invention, work
Skill flow is simple to operation, can effectively facilitate the precipitation of effective component in red sage, improves its recovery rate so that the red sage root prepared
Not only property is stable for parenteral solution, and pharmacological action is efficient, efficient promoting blood circulation and removing blood stasis, freeing vessels and nourishing heart, effectively suppresses the different of platelet aggregation
Often occurring, there is good prevention effect to thromboembolia type cardiovascular and cerebrovascular disease so that the body of people is preferably adjusted,
And without using harmful chemical reagent and organic solvent, have no toxic side effect, be noresidue, safe and reliable, avoid causing environment
Pollution.
Embodiment
Illustrate the present invention with specific embodiment below, but be not limitation of the present invention.
Embodiment 1
In the embodiment of the present invention, a kind of preparation method for improving danshen injections bioactivity, specific method is as follows：
（1）The red sage root is crushed to 40 mesh, constant temperature steam handles 16min, with 3.7 DEG C/min's under conditions of being 188 DEG C in temperature
Rate of temperature fall is cooled to 127 DEG C and continues constant temperature steam processing 11min, and input temperature is constant temperature frying 13min in 88 DEG C of frying pan,
Ultramicro grinding obtains red sage root Ultramicro-powder to 360 mesh；
（2）It is that insulation mixing is stirred in red sage root Ultramicro-powder weight 5 times of amounts, water that temperature is 70 DEG C that red sage root Ultramicro-powder is put into weight
12min is mixed, continues heat-insulation soaking 66min and is ultrasonically treated, continue slow fire infusion 46min after being boiled by slow fire, crosses 0.2 μm of filter
Membrane filtration, obtain a filter residue and a red sage root extract；
（3）Filter residue is inserted in the vacuum freezing drying oven that temperature is -13 DEG C and dried to no moisture, is taken out, puts into weight
Measure in the ethanol solution for 4 times of amounts of red sage root Ultramicro-powder weight, be first heated to 66 DEG C of insulation backflow extraction 80min, be then heated to
99 DEG C of insulation backflow extraction 120min, cross 0.2 μm of membrane filtration, obtain secondary filter residue and secondary red sage root extract；
（4）Red sage root extract and secondary red sage root extract are merged, are heated to seething with excitement, being concentrated under reduced pressure into relative density is
1.2, add the agitator that water for injection is 100r/min with rotating speed and stir 44min, obtain danshen injections；
（5）It is filling, sterilizing, obtain finished product.
As the further scheme of invention：Step（2）Described supersound process is：Be first 101W with power, frequency be
182kHz ultrasonic echography processing 17min, pause 7min, is then surpassed with the ultrasonic wave that power is 144 ~ W, frequency is 222kHz
Sonication 32min.
As the further scheme of invention：Step（3）The mass fraction of described ethanol solution is 77%.
As the further scheme of invention：The described red sage root and the weight ratio of water for injection are 1:1.9.
Embodiment 2
In the embodiment of the present invention, a kind of preparation method for improving danshen injections bioactivity, specific method is as follows：
（1）The red sage root is crushed to 45 mesh, constant temperature steam handles 17min, with 3.9 DEG C/min's under conditions of being 189 DEG C in temperature
Rate of temperature fall is cooled to 128 DEG C and continues constant temperature steam processing 12min, and input temperature is constant temperature frying 14min in 89 DEG C of frying pan,
Ultramicro grinding obtains red sage root Ultramicro-powder to 365 mesh；
（2）It is to be incubated mixing in red sage root Ultramicro-powder weight 5.5 times of amounts, water that temperature is 71 DEG C that red sage root Ultramicro-powder is put into weight
13min is stirred, continues heat-insulation soaking 67min and is ultrasonically treated, continue slow fire infusion 47min after being boiled by slow fire, cross 0.2 μm
Membrane filtration, obtain a filter residue and a red sage root extract；
（3）Filter residue is inserted in the vacuum freezing drying oven that temperature is -12.5 DEG C and dried to no moisture, takes out, puts into
Weight is in the ethanol solution of 4.5 times of amounts of red sage root Ultramicro-powder weight, is first heated to 67 DEG C of insulation backflow extractions 85min, Ran Houjia
Heat crosses 0.2 μm of membrane filtration, obtains secondary filter residue and secondary red sage root extract to 100 DEG C of insulation backflow extraction 125min；
（4）Red sage root extract and secondary red sage root extract are merged, are heated to seething with excitement, being concentrated under reduced pressure into relative density is
1.25, add the agitator that water for injection is 110r/min with rotating speed and stir 45min, obtain danshen injections；
（5）It is filling, sterilizing, obtain finished product.
As the further scheme of invention：Step（2）Described supersound process is：Be first 102W with power, frequency be
183kHz ultrasonic echography processing 17.5min, pause 7min, then with the ultrasonic wave that power is 145W, frequency is 223kHz
It is ultrasonically treated 32.5min.
As the further scheme of invention：Step（3）The mass fraction of described ethanol solution is 78%.
As the further scheme of invention：The described red sage root and the weight ratio of water for injection are 1:2.
Embodiment 3
In the embodiment of the present invention, a kind of preparation method for improving danshen injections bioactivity, specific method is as follows：
（1）The red sage root is crushed to 50 mesh, constant temperature steam handles 18min, with 4.1 DEG C/min's under conditions of being 190 DEG C in temperature
Rate of temperature fall is cooled to 129 DEG C and continues constant temperature steam processing 13min, and input temperature is constant temperature frying 15min in 90 DEG C of frying pan,
Ultramicro grinding obtains red sage root Ultramicro-powder to 370 mesh；
（2）It is that insulation mixing is stirred in red sage root Ultramicro-powder weight 6 times of amounts, water that temperature is 72 DEG C that red sage root Ultramicro-powder is put into weight
14min is mixed, continues heat-insulation soaking 68min and is ultrasonically treated, continue slow fire infusion 48min after being boiled by slow fire, crosses 0.2 μm of filter
Membrane filtration, obtain a filter residue and a red sage root extract；
（3）Filter residue is inserted in the vacuum freezing drying oven that temperature is -12 DEG C and dried to no moisture, is taken out, puts into weight
Measure in the ethanol solution for 5 times of amounts of red sage root Ultramicro-powder weight, be first heated to 66 ~ 68 DEG C of insulation backflow extraction 90min, then heat
To 101 DEG C of insulation backflow extraction 130min, 0.2 μm of membrane filtration is crossed, obtains secondary filter residue and secondary red sage root extract；
（4）Red sage root extract and secondary red sage root extract are merged, are heated to seething with excitement, being concentrated under reduced pressure into relative density is
1.3, add the agitator that water for injection is 120r/min with rotating speed and stir 46min, obtain danshen injections；
（5）It is filling, sterilizing, obtain finished product.
As the further scheme of invention：Step（2）Described supersound process is：Be first 103W with power, frequency be
184kHz ultrasonic echography processing 18min, pause 7min, is then surpassed with the ultrasonic wave that power is 146W, frequency is 224kHz
Sonication 33min.
As the further scheme of invention：Step（3）The mass fraction of described ethanol solution is 79%.
As the further scheme of invention：The described red sage root and the weight ratio of water for injection are 1:2.1.
The commercially available common danshen injections of danshen injections and comparative example prepared to the preparation method of embodiment carries out biology
The measure of activity, its measurement result such as table 1：
The measurement result of the embodiment of table 1 and comparative example bioactivity
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example | |
| Sodium Danshensu（mg/mL） | 7.923 | 7.979 | 7.898 | 2.235 |
| Protocatechualdehyde（mg/mL） | 0.989 | 0.933 | 0.897 | 0.414 |
| Rosmarinic acid（mg/mL） | 0.681 | 0.699 | 0.678 | 0.287 |
| Tanshin polyphenolic acid B（mg/mL） | 0.998 | 0.931 | 0.959 | 0.388 |
| Platelet Aggregation in Rabbits inhibiting rate (%) | 66.82 | 66.85 | 66.78 | 43.56 |
As known from Table 1, the bioactivity of danshen injections prepared by embodiment preparation method has efficient apparently higher than comparative example
Pharmacological action.
Claims (4)
1. a kind of preparation method for improving danshen injections bioactivity, it is characterised in that specific method is as follows：
（1）The red sage root is crushed to 40 ~ 50 mesh, temperature be 188 ~ 190 DEG C under conditions of constant temperature steam handle 16 ~ 18min, with
3.7 ~ 4.1 DEG C/min rate of temperature fall be cooled to 127 ~ 129 DEG C continue constant temperature steams handle 11 ~ 13min, input temperature be 88 ~
13 ~ 15min of constant temperature frying in 90 DEG C of frying pan, ultramicro grinding to 360 ~ 370 mesh, obtains red sage root Ultramicro-powder；
（2）It is to be incubated in 5 ~ 6 times of amounts of red sage root Ultramicro-powder weight, the water that temperature is 70 ~ 72 DEG C that red sage root Ultramicro-powder is put into weight
Mix 12 ~ 14min, continue 66 ~ 68min of heat-insulation soaking and be simultaneously ultrasonically treated, continue after being boiled by slow fire slow fire infusion 46 ~
48min, 0.2 μm of membrane filtration is crossed, obtains a filter residue and a red sage root extract；
（3）Filter residue is inserted in the vacuum freezing drying oven that temperature is -13 ~ -12 DEG C and dried to no moisture, is taken out, input
Be to weight 4 ~ 5 times of red sage root Ultramicro-powder weight amount ethanol solutions in, be first heated to 66 ~ 68 DEG C of insulation backflow extractions 80 ~
90min, 99 ~ 101 DEG C of insulation backflow 120 ~ 130min of extraction are then heated to, 0.2 μm of membrane filtration is crossed, obtains secondary filter residue and two
Secondary red sage root extract；
（4）Red sage root extract and secondary red sage root extract are merged, are heated to seething with excitement, being concentrated under reduced pressure into relative density is
1.2 ~ 1.3, add the agitator that water for injection rotating speed is 100 ~ 120r/min and stir 44 ~ 46min, obtain danshen injections；
（5）It is filling, sterilizing, obtain finished product.
2. the preparation method according to claim 1 for improving danshen injections bioactivity, it is characterised in that step（2）
Described supersound process is：17 ~ 18min first is handled with the ultrasonic echography that power is 101 ~ 103W, frequency is 182 ~ 184kHz,
Pause 7min, then handle 32 ~ 33min with the ultrasonic echography that power is 144 ~ 146W, frequency is 222 ~ 224kHz.
3. the preparation method according to claim 1 for improving danshen injections bioactivity, it is characterised in that step（3）
The mass fraction of described ethanol solution is 77% ~ 79%.
4. the preparation method according to claim 1 for improving danshen injections bioactivity, it is characterised in that described pellet
The weight ratio for participating in water for injection is 1:1.9~2.1.
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| CN201711040056.XA CN107789318A (en) | 2017-10-31 | 2017-10-31 | A kind of preparation method for improving danshen injections bioactivity |
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| CN201711040056.XA CN107789318A (en) | 2017-10-31 | 2017-10-31 | A kind of preparation method for improving danshen injections bioactivity |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104224911A (en) * | 2013-06-17 | 2014-12-24 | 天士力制药集团股份有限公司 | New radix salviae milliorrhizae extract and preparation thereof |
| CN106860513A (en) * | 2016-12-31 | 2017-06-20 | 上海华源安徽锦辉制药有限公司 | A kind of red sage roo drip liquid and its production process method of quality control |
| CN107260803A (en) * | 2017-06-19 | 2017-10-20 | 上海华源安徽锦辉制药有限公司 | The preparation method of Sodium Danshensu content in a kind of raising red sage roo drip liquid |
-
2017
- 2017-10-31 CN CN201711040056.XA patent/CN107789318A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104224911A (en) * | 2013-06-17 | 2014-12-24 | 天士力制药集团股份有限公司 | New radix salviae milliorrhizae extract and preparation thereof |
| CN106860513A (en) * | 2016-12-31 | 2017-06-20 | 上海华源安徽锦辉制药有限公司 | A kind of red sage roo drip liquid and its production process method of quality control |
| CN107260803A (en) * | 2017-06-19 | 2017-10-20 | 上海华源安徽锦辉制药有限公司 | The preparation method of Sodium Danshensu content in a kind of raising red sage roo drip liquid |
Non-Patent Citations (1)
| Title |
|---|
| 蔡萍等: "微粉化对丹参质量影响的研究", 《中药材》 * |
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Application publication date: 20180313 |