CN106377555A - Herba sarcandrae injection solution, preparation method thereof and intravenous administration herba sarcandrae injection thereof - Google Patents
Herba sarcandrae injection solution, preparation method thereof and intravenous administration herba sarcandrae injection thereof Download PDFInfo
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- CN106377555A CN106377555A CN201611053461.0A CN201611053461A CN106377555A CN 106377555 A CN106377555 A CN 106377555A CN 201611053461 A CN201611053461 A CN 201611053461A CN 106377555 A CN106377555 A CN 106377555A
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- herba sarcandrae
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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)
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- 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
- A61K9/00—Medicinal preparations characterised by special physical form
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- 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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- 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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- 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
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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Abstract
The invention relates to a herba sarcandrae injection solution, a preparation method thereof and an intravenous administration herba sarcandrae injection thereof, and belongs to the field of traditional Chinese medicine preparations. The herba sarcandrae injection solution is prepared through the following steps: taking 1 to 1000 parts by weight of crude drugs; carrying out decocting, concentrating, addition of a clarifying agent, alcohol precipitation, water precipitation and ultrafiltration, thus obtaining active components of herba sarcandrae; subpackaging and sterilizing, thus obtaining the herba sarcandrae injection solution, wherein each ml of the herba sarcandrae injection solution contains a fumaric acid which is not less than 30 mu g. The herba sarcandrae injection solution disclosed by the invention has the functions of resisting bacteria, diminishing inflammation, dispelling wind, dredging collaterals, activating blood and eliminating stagnation, is used for treating diseases of pneumonia, appendicitis, phlegmon, rheumatic arthralgia, traumatic injury and the like, and can be used for adjuvant therapy of cancer. The herba sarcandrae injection solution can be administrated through an intravenous way, the bioavailability is high, the use is simple and convenient, adverse effects are few, and the adverse effects that blood stasis or even muscle necrosis and the like which are easily caused by inconvenience in clinical use and pain of a medicine administration position of a patient can be avoided.
Description
Technical field
The present invention relates to a kind of ZHONGJIEFENG ZHUSHEYE, its preparation method and its intravenously administrable Herba Sarcandrae injection, belong to Chinese medicine system
Agent field.
Background technology
Herba Sarcandrae, another name Herba Pileae Scriptae, Herba Pileae Scriptae, synthetism lotuses, for the Herb of golden chestnut orchid Herba Pileae Scriptae, perennial evergreen
Draft or undershrub, Herb is used as medicine；Slightly warm in nature, bitter in the mouth, pungent；Main component is volatile oil (having linalyl acetate etc. in oil) succinum
Acid, Fumaric acid, coumarone, flavonoid glycoside, lactone, tannic acid etc..Wherein volatile oil, succinic acid, Fumaric acid, flavonoid glycoside etc. are anti-
Tumor effective ingredient, Herb has anti-inflammation, dispelling wind and removing obstruction in the collateral, and the function of blood circulation promoting and dispersing pathogen accumulation, to Diplococcus pneumoniae, Gold production Fructus Vitis viniferae
Coccus, dysentery bacterium, Boydii dysentery bacterium, Bacillus typhi, escherichia coli, bacillus pyocyaneus have stronger inhibitory action,
For treating the diseases such as pneumonia, appendicitis, cellulitis, rheumatic arthralgia, injury from falling down, and can be used for assistant treating cancer.
Existing ZHONGJIEFENG ZHUSHEYE production technology is shown in the 14th WS3 B 2729 of ministry standard Traditional Chinese medicine historical preparation
97【Preparation method】Described in content；It prepares for Herba Sarcandrae extract, is dark-brown supernatant liquid, being capable of heat clearing away solution
Poison, dispersing swelling and dissipating binds, for treating pneumonia, appendicitis, cellulitis, bacillary dysentery, abscess caused by hyperactivity of toxic heat, with ZHONGJIEFENG PIAN connection
Close and use, the tumors such as digestive tract cancer, cancer of pancreas, hepatocarcinoma can be treated.For intramuscular injection.Because being pure Chinese medicinal preparation, in preservation easily
Medicinal liquid muddiness, precipitation, metachromatism occur, affects product quality, effect duration is only 2 years.
The present invention using plus clarifier, ultrafiltration means by the macromole of protein, tannin, polysaccharide etc. in injection extract
Material retains, and effectively removes invalid components, retains active substance it is ensured that the curative effect of product, increased the stability of product.
Due to ZHONGJIEFENG ZHUSHEYE existing route of administration be intramuscular injection, clinically in-convenience in use, patient's
Medicine-feeding part pain, easily causes congestion, the even untoward reaction such as muscular death.
The ZHONGJIEFENG ZHUSHEYE being produced by present invention process can intravenously administrable, bioavailability is high, easy to use, bad
Reaction is few.Including direct intravenous injection, infusion medium includes Glucose Injection, sodium chloride injection etc..
Content of the invention
It is an object of the invention to provide a kind of ZHONGJIEFENG ZHUSHEYE.
Another object of the present invention is to providing the preparation method of above-mentioned injection.
It is still another object of the present invention to provide a kind of intravenously administrable Herba Sarcandrae injection of ZHONGJIEFENG ZHUSHEYE.
The present invention relates to a kind of ZHONGJIEFENG ZHUSHEYE, its preparation method and its intravenously administrable Herba Sarcandrae injection, belong to Chinese medicine system
Agent field.The present invention obtains Herba Sarcandrae active component by decocting in water, concentration, addition clarifier, precipitate with ethanol, water precipitating, ultrafiltration, through dividing
The preparation that dress, sterilizing are obtained.Injection of the present invention has anti-inflammation, dispelling wind and removing obstruction in the collateral, and the function of blood circulation promoting and dispersing pathogen accumulation, for treating lung
The diseases such as inflammation, appendicitis, cellulitis, rheumatic arthralgia, injury from falling down, and can be used for assistant treating cancer.Due to using first
Enter art process technologies preparation, obtain stable injection, efficiently avoid the medicinal liquid occurring during pure Chinese medicinal preparation preserves and mix
Turbid, precipitation, metachromatism, make preparation stabilization, and keeping life extends.Injection of the present invention can be administered by intravenous route, raw
Thing availability is high, and easy to use, untoward reaction is few, it is to avoid clinically in-convenience in use, the medicine-feeding part pain of patient, easily make
Become congestion, the even untoward reaction such as muscular death.
The goal of the invention of the present invention can be achieved in the following manner：
A kind of ZHONGJIEFENG ZHUSHEYE, is by Herba Sarcandrae decocting in water, concentration, adds clarifier clarification, precipitate with ethanol and post-treated swollen
Section wind active ingredient formulation.
The medicinal liquid that wherein said post processing includes precipitate with ethanol and concentrates is dissolved in water, filter after cold preservation, adjust PH, super
Filter, subpackage and sterilizing.
Every milliliter of described ZHONGJIEFENG ZHUSHEYE contains fumaric acid and is no less than 30 μ g.
The invention still further relates to a kind of preparation method of ZHONGJIEFENG ZHUSHEYE is it is characterised in that by Herba Sarcandrae decocting in water, concentration, add
Enter clarifier clarification, precipitate with ethanol and post-treated obtain.
The medicinal liquid that described post processing includes precipitate with ethanol and concentrates adds water, filter after cold preservation, adjust PH, ultrafiltration, subpackage and
Sterilizing.
Specifically, the preparation method of the ZHONGJIEFENG ZHUSHEYE of the present invention is：
(1) decocting in water, concentration：Take Herba Sarcandrae 1-1000 weight portion, add the boiling water of 3-8 times of weight to decoct 2 times, each 2-3 is little
When, filter, merge filtrate twice, concentrate；
(2) add clarifier clarification：The 0.03%～0.06% of concentrated solution weight clarifier, heating is added in concentrated solution
To 70～90 DEG C, standing, add the 0.015%～0.03% of concentrated solution weight clarifier, be centrifuged after standing, take supernatant
Concentrate；
(3) precipitate with ethanol：It is slowly stirred lower addition ethanol and carries out precipitate with ethanol, filter after 4-8 DEG C of cold preservation, filtrate recycling ethanol, and be concentrated into
Every milliliter of medicinal liquid 3～4g containing crude drug amount, adds ethanol, makes alcohol content be 80-85%, filters after 4-8 DEG C of cold preservation, and filtrate reclaims second
Alcohol, concentration filtrate to every milliliter of medicinal liquid 6～8g containing crude drug amount；
(4) post processing：Plus the water for injection of 1-3 times of weight of concentrated solution, filter after cold preservation 24 hours, filtrate uses 10-20% hydrogen-oxygen
Change sodium solution and adjust PH to 5.0-6.0, add 1% activated carbon, boil, filter, being centrifuged, ultrafiltration, addition water for injection, mistake
Filter, then use filtering with microporous membrane, fill sterilizes prepared in ampoule.
Wherein, after decocting in water filtrate, filtrate is concentrated into every ml medicinal liquid 1～2g containing crude drug amount.Plus by concentration of liquid medicine before ethanol
To every ml medicinal liquid 3～4g containing crude drug amount.Before water precipitating, filtrate is concentrated into every ml medicinal liquid 6～8g containing crude drug amount.After ultrafiltration, add note
Penetrate with water to every ml μ g containing fumaric acid 30～300；Centrifuge RPMs are 4000 revs/min；Ultrafiltration from molecular cut off is
100000 ultrafiltration post.
The water for injection boiling adding 3-8 times of weight of Herba Sarcandrae in decocting in water, concentration decocts 2 times, and each 2-3 hour filters,
Merge filtrate twice, and be concentrated into every ml medicinal liquid 1～2g containing crude drug amount.
After adding clarifier for the first time and heating, after 2 hours, standing is after 4 hours for the first time for standing.
After being slowly stirred lower addition ethanol, 4-8 DEG C of cold preservation 48 hours, filter, filtrate recycling ethanol, and concentrate, add
Ethanol, 4-8 DEG C of cold preservation 48 hours, filter, filtrate flow back in extractor, recovery ethanol；Plus the injection of 1-3 times of weight of concentrated solution
Use water.
The invention still further relates to intravenously administrable Herba Sarcandrae injection agent and preparation method thereof.
Clarifier in above-mentioned preparation method is only to remove in Aqueous extracts granularity the greater and have precipitation trend
Particle, can retain effective polymer substance, thus improving the clarifier of the stability of medicinal liquid, including but not limited to existing
Have the various clarifiers that can be used in Chinese medicine in technology, such as commercially available 101 fruit juice clarifiers, chitin kind absorptive clarificant, ZTC days
So clarifier clarification and clarifier B, clarifier A etc..
More specifically, the ZHONGJIEFENG ZHUSHEYE of the present invention or intravenously administrable Herba Sarcandrae injection and preparation method thereof are：Take
Herba Sarcandrae 1-1000 weight portion, described weight portion can for mg, g, kg, jin, two, the conventional unit such as money；Add Herba Sarcandrae 3-8
The water for injection boiling of times weight decocts 2 times, each 2-3 hour, and filter paper filtering merges filtrate twice, and is concentrated into every ml medicine
Liquid 1～2g containing crude drug amount；The 0.03%～0.06% of concentrated solution weight clarifier B is added in concentrated solution, it is heated to 70～
90 DEG C, standing, after 2 hours, adds the 0.015%～0.03% of concentrated solution weight clarifier A, and standing, after 4 hours, is centrifuged,
Supernatant pours out, and is concentrated into every ml medicinal liquid 3～4g containing crude drug amount；It is slowly stirred lower addition ethanol, plus ethanol makes the alcohol content be
70-75%, 4-8 DEG C of cold preservation 48 hours, filter paper filtering, filtrate recycling ethanol, and it is concentrated into every ml medicinal liquid 3～4g containing crude drug amount,
Add ethanol, make alcohol content be 80-85%, 4-8 DEG C of cold preservation 48 hours, filter paper filtering, filtrate flow back in extractor, recovery second
Alcohol, concentrates filtrate, and is concentrated into every ml medicinal liquid 6～8g containing crude drug amount；Plus the water for injection of 1-3 times of weight of concentrated solution, 4-8 DEG C is cold
Hide 24 hours, filter paper filtering, filtrate adjusts PH to 5.0-6.0 with 10-20% sodium hydroxide solution, add 1% activated carbon, boil
Boiling 30 minutes, filter paper filtering, centrifugation, ultrafiltration, add water for injection, make every ml μ g containing fumaric acid 30～300, filter, use
0.22 μm of filtering with microporous membrane, in ampoule, 100 DEG C of sterilizings in 30 minutes are obtained for fill.
Resulting product specification is propped up for 2ml/, 5ml/ props up, 10ml/ props up, 20ml/ props up, and preferably 2ml/ props up, 5ml/ props up, 10ml/
, every 1ml contains fumaric acid and is no less than 30 μ g, the preferably μ g/ml containing fumaric acid 30～300；Intramuscular injection, a 2ml-
4ml, 2 times a day；Intravenous drip, 10ml-15ml on the one, or follow the doctor's advice.
In preparation process, clarifier is commercially available, and for making technique, product quality stable, clarifier B, clarifier A are by fixing life
Business men provides.Above-mentioned clarifier is purchased from Tianjin Zheng Tiancheng clarification technique company limited, and model has two kinds, be denoted as clarifier A,
Clarifier B.
Intravenous mode is adopted, bioavailability is high, easy to use, untoward reaction when injection of the present invention uses
Few.Injection system can be：Anti-inflammation：Intramuscular injection, a 2～4ml, 1～2 time on the one；Intravenous drip：One time 4～
12ml, 1～2 time on the one, is added in 5%～10% Glucose Injection or 0.9% sodium chloride injection and uses.
Antitumor：Intramuscular injection, a 3～4ml, 2 times a day.Intravenous drip：8～24ml, 1～2 time on the one, plus
Enter in 5%～10% Glucose Injection or 0.9% sodium chloride injection use.Or follow the doctor's advice.
Injection of the present invention has following medicinal usage：
Heat-clearing and toxic substances removing, dispersing swelling and dissipating binds；
For treating pneumonia, appendicitis, cellulitis, bacillary dysentery, abscess caused by hyperactivity of toxic heat；
It is used in combination with ZHONGJIEFENG PIAN, the tumors such as digestive tract cancer, cancer of pancreas, hepatocarcinoma can be treated.
Injection of the present invention effectively avoids conventional injection agent on the premise of having good drug effect in long-term storage
The phenomenons such as the degraded of generation, muddiness, precipitation, preparation stabilization, extend the effect duration of ZHONGJIEFENG ZHUSHEYE；Given with intravenous route
Medicine, bioavailability is high, and easy to use, untoward reaction is few, it is to avoid clinically in-convenience in use, the medicine-feeding part pain of patient,
Reduce and cause congestion, the even untoward reaction such as muscular death.
Specific embodiment
Embodiment 1
Take Herba Sarcandrae 1000g, add the water for injection boiling of 6 times of weight of Herba Sarcandrae to decoct 2 times, 2 hours every time, filter paper filtering,
Merge filtrate twice, and concentrate every ml medicinal liquid 1g containing crude drug amount；The 0.05% of concentrated solution weight clarification is added in concentrated solution
Agent B, is heated to 70～90 DEG C, and standing, after 2 hours, adds the 0.025% of concentrated solution weight clarifier A, stands 4 hours
Afterwards, it is centrifuged, supernatant pours out, and is concentrated into every ml medicinal liquid 3g containing crude drug amount；It is slowly stirred lower addition ethanol, plus ethanol makes containing alcohol
Measure as 75%, 4-8 DEG C of cold preservation 48 hours, filter paper filtering, filtrate recycling ethanol, and be concentrated into every ml medicinal liquid 3g containing crude drug amount, plus
Enter ethanol, make alcohol content be 85%, 4-8 DEG C of cold preservation 48 hours, filter paper filtering, filtrate recycling ethanol, concentrate filtrate, and be concentrated into
Every ml medicinal liquid 6g containing crude drug amount；Plus the water for injection of 3 times of weight of concentrated solution, 4-8 DEG C of cold preservation 24 hours, filter paper filtering, filtrate is used
10% sodium hydroxide solution adjusts PH to 5.5, adds 1% activated carbon, boils 30 minutes, filter paper filtering, centrifugation, ultrafiltration, plus
Enter water for injection, make every ml μ g containing fumaric acid 30, filter, with 0.22 μm of filtering with microporous membrane, fill in ampoule,
100 DEG C of sterilizings in 30 minutes are obtained.Resulting product specification is propped up for 2ml/.
Embodiment 2
Take Herba Sarcandrae 2000g, add the water for injection boiling of 8 times of weight of Herba Sarcandrae to decoct 2 times, 3 hours every time, filter paper filtering,
Merge filtrate twice, and concentrate every ml medicinal liquid 1.5g containing crude drug amount；To in concentrated solution, the 0.04% of addition concentrated solution weight is clear
Clear agent B, is heated to 70～90 DEG C, and standing, after 2 hours, adds the 0.02% of concentrated solution weight clarifier A, stands 4 hours
Afterwards, it is centrifuged, supernatant pours out, and is concentrated into every ml medicinal liquid 4g containing crude drug amount；It is slowly stirred lower addition ethanol, plus ethanol makes containing alcohol
Measure as 70%, 4-8 DEG C of cold preservation 48 hours, filter paper filtering, filtrate recycling ethanol, and be concentrated into every ml medicinal liquid 4g containing crude drug amount, plus
Enter ethanol, make alcohol content be 80%, 4-8 DEG C of cold preservation 48 hours, filter paper filtering, filtrate recycling ethanol, concentrate filtrate, and be concentrated into
Every ml medicinal liquid 8g containing crude drug amount；Plus the water for injection of 1 times of weight of concentrated solution, 4-8 DEG C of cold preservation 24 hours, filter paper filtering, filtrate is used
20% sodium hydroxide solution adjusts PH to 5.0, adds 1% activated carbon, boils 30 minutes, filter paper filtering, centrifugation, ultrafiltration, plus
Enter water for injection, make every ml μ g containing fumaric acid 60, filter, with 0.22 μm of filtering with microporous membrane, fill in ampoule,
100 DEG C of sterilizings in 30 minutes are obtained.Resulting product specification is propped up for 5ml/.
Claims (2)
1. a kind of ZHONGJIEFENG ZHUSHEYE is it is characterised in that prepared by following methods；
(1) decocting in water, concentration：Take Herba Sarcandrae 1-1000 weight portion, add the boiling water of 3-8 times of weight to decoct 2 times, each 2-3 is little
When, filter, merge filtrate twice, concentrate；
(2) add clarifier clarification：Add the 0.03%～0.06% of concentrated solution weight clarifier in concentrated solution, be heated to
70～90 DEG C, standing, add the 0.015%～0.03% of concentrated solution weight clarifier, be centrifuged after standing, take supernatant dense
Contracting；
(3) precipitate with ethanol：It is slowly stirred lower addition ethanol and carries out precipitate with ethanol, filter after 4-8 DEG C of cold preservation, filtrate recycling ethanol, and be concentrated into
Every milliliter of medicinal liquid 3～4g containing crude drug amount, adds ethanol, makes alcohol content be 80-85%, filters after 4-8 DEG C of cold preservation, and filtrate reclaims second
Alcohol, concentration filtrate to every milliliter of medicinal liquid 6～8g containing crude drug amount；
(4) post processing：Plus the water for injection of 1-3 times of weight of concentrated solution, filter after cold preservation 24 hours, filtrate uses 10-20% hydrogen-oxygen
Change sodium solution and adjust PH to 5.0-6.0, add 1% activated carbon, boil, filter, being centrifuged, ultrafiltration, addition water for injection, mistake
Filter, then use filtering with microporous membrane, fill sterilizes prepared in ampoule.
2. injection according to claim 1 is it is characterised in that every milliliter described of ZHONGJIEFENG ZHUSHEYE contains anti-butylene two
Acid is no less than 30 μ g.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113398232A (en) * | 2021-05-31 | 2021-09-17 | 四川升和药业股份有限公司 | Preparation method of pharmaceutical composition for treating gout and gouty arthritis |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113398232A (en) * | 2021-05-31 | 2021-09-17 | 四川升和药业股份有限公司 | Preparation method of pharmaceutical composition for treating gout and gouty arthritis |
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Application publication date: 20170208 |