CN108434186A - A kind of ginseng glycopeptide injection pharmaceutical composition and its preparation method and application - Google Patents
A kind of ginseng glycopeptide injection pharmaceutical composition and its preparation method and application Download PDFInfo
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Abstract
The invention particularly discloses a kind of ginseng glycopeptide injection pharmaceutical compositions and its preparation method and application.The present invention is using ginseng as raw material, according to the similar easily compatible principle of substance polarity, the ginseng by the pretreatment procedures such as cleaning, cleaning, drying and crushing repeatedly is extracted by using the ethyl alcohol of same concentrations, pass through concentration and alcohol precipitation process again, obtain ginseng glycopeptide crude product, again by refrigeration, filtering, vacuum-concentrcted and freeze-drying process, it is further purified and cleans to obtain refined ginseng glycopeptide.The ginseng glycopeptide produces ginseng glycopeptide injection by processes such as wash bottle, weighing, preparation, filling, sterilizing, lamp inspection and packagings.
Description
Technical field
The present invention relates to pharmaceutical technology fields, and in particular, to a kind of ginseng glycopeptide injection pharmaceutical composition and its system
Preparation Method and application.
Background technology
Ginseng (scientific name：Panax ginseng, also known as Asia join, at Northeast China popular name " wooden club ") it is with meat
Root, it is pharmaceutically acceptable.Ginseng belongs to Araliaceae, and the common medicinal material in Asia, northern Central America also generally uses American ginseng, after being mainly used for more
Restore, enhancing muscle power, adjust hormone, reduce blood glucose and control blood pressure, control liver index and liver function.
Modern medicine study and assay show that it is exchanged containing a kind of chemical substance for being panaxoside in ginseng
Central nervous system, cardiac stimulant, antifatigue, the Auto-regulator metabolism etc. for saving people have apparent effect, so to treating the nervous system hearts
A variety of diseases of vascular system, internal system and reproductive system have good therapeutic effect；Correlative study is from red ginseng, sun-dried ginseng
Or isolate more than 30 in white ginseng and plant panaxoside, panaxoside is the importance of present ginseng research, present constituent of ginseng
It further includes organic acid and esters, vitamin and its sterol and its glucoside of ginseng etc. to study more aspect.
The World Hygiene Day in this year, WHO issue one group of surprising data, claim China existing 1.1 hundred million diabetic's
On the basis of, there are 500,000,000 or more the adults for being in prediabetes, that is to say, that China has the population of nearly half to be in diabetes
Shade under！Due to our life, the change of eating habit and work, the increase of life stress, lead to the sugar in China
Urine disease has the tendency that rejuvenation, the elderly's number of patients are also increasing year by year, our diabetes control situation is more and more severeer.
In treatment, blood glucose is excessively high and the upper medication of diabetes is still with based on Western medicine hypoglycemic medicine and insulin injection now, in use
Medicine hypoglycemic it is less, Western medicine mainly has sulfonylureas and non-sulfonylureas, melbine class, α-glucosidase inhibitors, thiazolidine two
The oral hypoglycemic medicine such as ketone derivatives, DPP-4 enzyme inhibitors also needs injection hypoglycemic medicine assistant hypoglycemic when diabetes are serious,
The hypoglycemic medicine of injection mainly has insulin and similar medicine, GLP-1 receptor stimulating agents etc.；However, above-mentioned hypoglycemic medicine is all
With some side effects, more universal side effect be hypoglycemia, after taking so that patient it is possible that strongly feeling of empty stomache, go out
Cold sweat, general weakness, palpitaition, tremble hands and feet, blurred vision, headache, it is stupefied phenomena such as, the uncomfortable diseases such as stupor can occur when serious
Shape.
It is relevant that research shows that some Chinese medicines also have blood sugar reducing function, and side effect is less, and the scope of application is wider, for
Human body is hypoglycemic to be of great significance and helps, and correlation has shown that ginseng also has the function of that hypoglycemic, ginseng contained therein are more
Sugar and ginseng polypeptide are hypoglycemic active constituents, are played an important roll for blood sugar for human body adjusting, and in panaxan and people
The medicinal application research aspect for joining polypeptide is also more slow, and special ginseng glycopeptide hypoglycemic medicine is also poorer, quantity, type
Also less.
Invention content
In view of the above problems, the present invention provides a kind of ginseng glycopeptide injection pharmaceutical composition and its preparation sides
Method and application.
It is right now studies have shown that the several kinds of Chinese medicinal materials such as Radix Astragali, ginseng, the coptis, Chinese yam and glutinous rehmannia all have blood sugar reducing function
In adjusting blood sugar for human body, treatment diabetes are of great significance, and it is more friendly to human body to use Chinese medicine hypoglycemic medicine to have, no
The advantages that good reaction is less, target user is wider；Wherein, correlative study shows that the active constituent ginseng glycopeptide of ginseng not only has drop
The effect of low blood sugar for human body, also adjusting blood glucose to insulin has facilitation, and blood sugar for human body, which is adjusted, has valuable help, people
The relevant drug of ginseng glycopeptide has a vast market foreground and commercial value.
In order to realize that above-mentioned target, the present invention are achieved by the following technical programs：
A kind of preparation method of ginseng glycopeptide injection pharmaceutical composition, the ginseng glycopeptide include following preparation work
Sequence：
S1. ginseng is obtained into ginseng coarse powder by pretreatment process；Pretreatment process includes：It cleans, clean, drying, powder
It is broken, pack and process of weighing；
S2. ginseng coarse powder is obtained into ginseng glycopeptide crude product by crude process；Crude process includes：It is refluxing extraction, dense
Contracting and alcohol precipitation process；
S3. ginseng glycopeptide crude product is obtained into refined ginseng glycopeptide by refining step and freeze-drying；Refining step
Including：Refrigeration, filtering and vacuum-concentrcted process.
Preferably, the refined ginseng glycopeptide is to have the function of tonifying Qi, promote the production of body fluid, quench the thirst and do not dissolve in ethyl alcohol, solvable
Drying, loose micro-yellow powder in water.
Preferably, the ginseng is that treated by the pretreatment procedures such as cleaning, clean, dry and crush ginseng is thick
Powder.
Preferably, the ginseng glycopeptide crude product precipitates for brown color.
Preferably, it is described clean process be ginseng crude drug is placed in clean removed on workbench impurity, go mouldy, damage by worms,
The non-medicinal effects such as adulterant；It is characterized in that the clean process is to be put into the ginseng after cleaning on the web plate of wash slot
Ginseng is cleaned with circulating water in face；It is characterized in that, the drying process is to divide the ginseng cleaned in basin,
It is put into heated-air circulation oven, it is 2~4 hours dry in the case where obtaining temperature condition not higher than 60 DEG C, until ginseng contained humidity is not higher than
12%；It is characterized in that the pulverizing process is that ginseng is ground into coarse powder with efficient Roughpulverizer.
Preferably, the abstraction process is right under the conditions of 70 DEG C~90 DEG C with the ethyl alcohol of 6~8 times of amounts 45%~65%
Ginseng coarse powder carries out refluxing extraction, extracts 2~4 times, and each extraction time is 2~4 hours, merges liquid after the completion of extraction.
It is highly preferred that the abstraction process be with 6~8 times amount 50% ethyl alcohol under the conditions of 75 DEG C~85 DEG C to ginseng
Coarse powder carries out refluxing extraction, extracts 3 times, and each extraction time is 2~3 hours, merges liquid after the completion of extraction.
It is highly preferred that the abstraction process is thick to ginseng under the conditions of 75 DEG C~85 DEG C with the ethyl alcohol of 7 times of amounts 50%
Powder carries out refluxing extraction, extracts 3 times, and each extraction time is 2~3 hours, merges liquid after the completion of extraction.
Preferably, the enrichment process of the ginseng glycopeptide crude product is that ethanol extract is concentrated under reduced pressure into relative density
For 1.05~1.25 (50 DEG C), steam pressure when concentration：0.05~0.25MPa, vacuum degree are -0.01~0.10MPa, concentration temperature
It spends temperature and is less than 85 DEG C.
It is highly preferred that the enrichment process of the ginseng glycopeptide crude product is relatively close for ethanol extract to be concentrated under reduced pressure into
Degree is 1.10~1.20 (50 DEG C), steam pressure when concentration：0.1~0.15MPa, vacuum degree are -0.02~0.08MPa, concentration
Temperature is less than 80 DEG C.
Preferably, the alcohol precipitation process is that the ethyl alcohol that the alcohol precipitation process is gained liquid after adjusting enrichment process contains
Amount reaches 80%, and makes liquid in the environment of not higher than 35 DEG C, stand 12 hours or more.
It is highly preferred that the alcohol precipitation process is by gained liquid after enrichment process, 40 DEG C are cooled to hereinafter, being added appropriate
The ethyl alcohol of 85% concentrations above, and keep stirring, ethanol content 80% is adjusted, keeps fluid temperature at 35 DEG C hereinafter, quiet simultaneously
It sets 12 hours or more.
Preferably, the refining step is that the water for injection for measuring ginseng glycopeptide crude product with 0.7~1.2 times dissolves,
And refrigeration is placed 18~36 hours under cryogenic；Then, refrigeration liquid centrifugation is removed into impurity and goes to precipitate, add 0.02 inward
~0.05 times of amount Powdered Activated Carbon, stirring are stood, and make its adsorption equilibrium；Filtrate is filtered to take, then carries out ultrafiltration；And by filtrate into
Row vacuum-concentrcted, vacuum degree is -0.01~0.10MPa when concentration, and thickening temperature is less than 85 DEG C, and concentrate relative density is
1.05~1.25 (50 DEG C).
It is highly preferred that it is the note for measuring ginseng glycopeptide crude product with 0.8~1.1 times that the refining step, which is refining step,
It penetrates and uses water dissolution, and refrigeration is placed 20~28 hours under cryogenic；Then, refrigeration liquid centrifugation is removed into impurity and goes to sink
It forms sediment, inward plus 0.02~0.05 times of amount Powdered Activated Carbon, stirring 15~30 minutes stand 12~25 minutes, make its adsorption equilibrium,
Filtrate is filtered to take, hollow fiber membrane ultrafiltration device filtrate is used in combination to carry out ultrafiltration；And filtrate is subjected to vacuum-concentrcted, vacuum when concentration
Degree is -0.02~0.08MPa, and thickening temperature is less than 80 DEG C, and concentrate relative density is 1.10~1.20 (50 DEG C).
It is highly preferred that the preparation section of the ginseng glycopeptide includes the following process：
S1. ginseng first removed into impurity, go mouldy, damage by worms, the non-medicinal effects such as adulterant；Secondly, ginseng is washed with circulating water
Only；It puts it into heated-air circulation oven again, it is 2~4 hours dry in the case where obtaining temperature condition not higher than 60 DEG C, until contained by ginseng
Moisture is not higher than 12%；Ginseng is finally ground into coarse powder with efficient Roughpulverizer；
S2. by the ginseng coarse powder Jing Guo pre-treatment, 50% ethyl alcohol that 6~8 times of amounts are added carries out refluxing extraction, extraction time
It 2.5~3.5 hours, takes filtrate, then 50% ethyl alcohol measured with 5.5~7.5 times to extract filter residue 2 hours, takes filtrate, then use
5.5~7.5 times of 50% ethyl alcohol extracts filter residue 2 hours, goes filtrate, and merge filtrate three times；
S3. will three times ethanol extract by be concentrated under reduced pressure into relative density be 1.05~1.25.
S4. about 4~5 times of 95% ethyl alcohol of amount are added under stirring condition, it is 80% to make ethanol content, keeps 30 DEG C of temperature in tank
Hereinafter, stand 12 hours or more, precipitation is filtered to take, ginseng glycopeptide crude product is obtained.
S5. the water for injection of 0.5~2 times of amount, stirring and dissolving are added into ginseng crude product, and 0~3 DEG C is placed 18~36
Hour；
S6. refrigeration liquid centrifugation cleaned, go to precipitate, gone filtrate that activated carbon is added inward and stir 0.02~0.05 times of amount, stir
It mixes standing 30~50 minutes, filters off filtrate, then ultrafiltration is carried out to filtrate with the hollow fiber membrane ultrafiltration device of 10,000 dalton, to filter
Liquid is concentrated in vacuo, and it is 1.00~1.30 (50 DEG C) to be concentrated into concentrate relative density.
Preferably, the application of the ginseng glycopeptide is to prepare a kind of ginseng glycopeptide injection.
Preferably, the ginseng glycopeptide injection is in terms of parts by weight, including following raw material：Ginseng glycopeptide 3~10
Part, 7~15 parts of sodium chloride, 2~6 parts of Tween 80 and 950~1050 parts of water for injection.
Preferably, the preparation method of the ginseng glycopeptide injection includes the following process：
S1. prescription is pressed to prepare and weigh ginseng glycopeptide, sodium chloride supplementary material related to Tween 80 etc.；
S2. the water for injection for matching liquid total amount 50% needed for being first added into Agitation Tank, when water temperature is down to 45 DEG C~75 DEG C,
Ginseng glycopeptide, sodium chloride are added separately in water for injection in proportion, after its dissolving after again by liquid recycle 5 minutes, then
Filtrate is filtered to take, then the required water for injection for matching liquid total amount 37.5% is added inward；It is 50~80 DEG C to keep temperature；
S3. Tween 80 is dissolved with the water for injection with liquid total amount 6.25%, is stirred continuously in adition process, until it is fully molten
Solution, adds it to thereafter in liquid and supplies water, adjust the pH value of solution to 5.6~6.4, and to liquid correlation fingering row
Detection mark ensures it conform to related request.
S4. filling, sterilizing, lamp inspection and packaging are then carried out.
Description of the drawings
Fig. 1 is ginseng pre-treating technology flow chart.
Fig. 2 is ginseng glycopeptide production technological process.
Fig. 3 is ginseng glycopeptide process for preparing injection liquid flow chart.
Specific implementation mode
The present invention is further elaborated with reference to specific embodiment, the embodiment is served only for explaining this hair
It is bright, it is not intended to limit the scope of the present invention.Test method used in following embodiments is routine unless otherwise specified
Method；Used material, reagent etc., unless otherwise specified, for the reagent and material commercially obtained.
Embodiment 1
A kind of preparation method of ginseng glycopeptide injection pharmaceutical composition, includes the following process：
S1. ginseng first removed into impurity, go mouldy, damage by worms, the non-medicinal effects such as adulterant；Secondly, ginseng is washed with circulating water
Only；It puts it into heated-air circulation oven again, it is 2~4 hours dry in the case where obtaining temperature condition not higher than 60 DEG C, until contained by ginseng
Moisture is not higher than 12%；Ginseng is finally ground into coarse powder with efficient Roughpulverizer；
S2. by the ginseng coarse powder Jing Guo pre-treatment, 50% ethyl alcohol that 6 times of amounts are added carries out refluxing extraction, extraction time 2.5
Hour, it takes filtrate, then extracted 2 hours to filter residue with 50% ethyl alcohol of 5.5 times of amounts, takes filtrate, then with 5.5 times of 50% second
Alcohol extracts filter residue 2 hours, goes filtrate, and merge filtrate three times；
S3. will three times ethanol extract by be concentrated under reduced pressure into relative density be 1.05.
S4. about 4 times of 95% ethyl alcohol of amount are added under stirring condition, it is 80% to make ethanol content, keep in tank 30 DEG C of temperature with
Under, stand 12 hours or more, precipitation is filtered to take, ginseng glycopeptide crude product is obtained.
S5. the water for injection of 0.5~2 times of amount, stirring and dissolving are added into ginseng crude product, and 0 DEG C is placed 18 hours；
S6. refrigeration liquid centrifugation cleaned, go to precipitate, gone filtrate that activated carbon is added inward and stir 0.02 times of amount, stirring is stood
30 minutes, filtrate is filtered off, then ultrafiltration is carried out to filtrate with the hollow fiber membrane ultrafiltration device of 10,000 dalton, filtrate is subjected to vacuum
Concentration, it is 1.00 (50 DEG C) to be concentrated into concentrate relative density.
A kind of ginseng glycopeptide injection is in terms of parts by weight, including following raw material：3 parts of ginseng glycopeptide, is spat 7 parts of sodium chloride
950 parts of 80 2 parts of temperature and water for injection.
A kind of preparation method of ginseng glycopeptide injection, including following preparation section：
S1. prescription is pressed to prepare and weigh ginseng glycopeptide, sodium chloride supplementary material related to Tween 80 etc.；
S2. the water for injection for matching liquid total amount 50% needed for being first added into Agitation Tank, when water temperature is down to 45 DEG C DEG C, by people
Ginseng glycopeptide, sodium chloride are added separately in water for injection in proportion, are again recycled liquid 5 minutes after its dissolving, are then filtered
Filtrate is taken, then the required water for injection for matching liquid total amount 37.5% is added inward；It is 50 DEG C to keep temperature；
S3. Tween 80 is dissolved with the water for injection with liquid total amount 6.25%, is stirred continuously in adition process, until it is fully molten
Solution, adds it to thereafter in liquid and supplies water, adjust the pH value of solution to 5.6, and refer to liquid correlation and be detected
Mark ensures it conform to related request.
S4. filling, sterilizing, lamp inspection and packaging are then carried out.
Embodiment 2
A kind of preparation method of ginseng glycopeptide, includes the following process：
S1. ginseng first removed into impurity, go mouldy, damage by worms, the non-medicinal effects such as adulterant；Secondly, ginseng is washed with circulating water
Only；It puts it into heated-air circulation oven again, it is 2~4 hours dry in the case where obtaining temperature condition not higher than 60 DEG C, until contained by ginseng
Moisture is not higher than 12%；Ginseng is finally ground into coarse powder with efficient Roughpulverizer；
S2. by the ginseng coarse powder Jing Guo pre-treatment, 50% ethyl alcohol that 8 times of amounts are added carries out refluxing extraction, extraction time 3.5
Hour, it takes filtrate, then extracted 2 hours to filter residue with 50% ethyl alcohol of 7.5 times of amounts, takes filtrate, then with 7.5 times of 50% second
Alcohol extracts filter residue 2 hours, goes filtrate, and merge filtrate three times；
S3. will three times ethanol extract by be concentrated under reduced pressure into relative density be 1.25.
S4. about 5 times of 95% ethyl alcohol of amount are added under stirring condition, it is 80% to make ethanol content, keep in tank 30 DEG C of temperature with
Under, stand 12 hours or more, precipitation is filtered to take, ginseng glycopeptide crude product is obtained.
S5. the water for injection of 2 times of amounts, stirring and dissolving are added into ginseng crude product, and 3 DEG C are placed 36 hours；
S6. refrigeration liquid centrifugation cleaned, go to precipitate, gone filtrate that activated carbon is added inward and stir 0.05 times of amount, stirring is stood
30~50 minutes, filter off filtrate, then ultrafiltration carried out to filtrate with the hollow fiber membrane ultrafiltration device of 10,000 dalton, then by filtrate into
Row is concentrated in vacuo, and it is 1.30 (50 DEG C) to be concentrated into concentrate relative density.
A kind of ginseng glycopeptide injection is in terms of parts by weight, including following raw material：10 parts of ginseng glycopeptide, 15 parts of sodium chloride,
1050 parts of 6 parts of Tween 80 and water for injection.
A kind of preparation method of ginseng glycopeptide injection, includes the following process：
S1. prescription is pressed to prepare and weigh ginseng glycopeptide, sodium chloride supplementary material related to Tween 80 etc.；
S2. the water for injection for matching liquid total amount 50% needed for being first added into Agitation Tank, when water temperature is down to 75 DEG C, by ginseng
Glycopeptide, sodium chloride are added separately in water for injection in proportion, are again recycled liquid 5 minutes after its dissolving, are then filtered to take
Filtrate, then the required water for injection for matching liquid total amount 37.5% is added inward；It is 80 DEG C to keep temperature；
S3. Tween 80 is dissolved with the water for injection with liquid total amount 6.25%, is stirred continuously in adition process, until it is fully molten
Solution, adds it to thereafter in liquid and supplies water, adjust the pH value of solution to 6.4, and refer to liquid correlation and be detected
Mark ensures it conform to related request.
S4. filling, sterilizing, lamp inspection and packaging are then carried out.
Embodiment 3
A kind of ginseng glycopeptide preparation method, includes the following process：
S1. ginseng first removed into impurity, go mouldy, damage by worms, the non-medicinal effects such as adulterant；Secondly, ginseng is washed with circulating water
Only；It puts it into heated-air circulation oven again, it is 2~4 hours dry in the case where obtaining temperature condition not higher than 60 DEG C, until contained by ginseng
Moisture is not higher than 12%；Ginseng is finally ground into coarse powder with efficient Roughpulverizer；
S2. by the ginseng coarse powder Jing Guo pre-treatment, 50% ethyl alcohol that 7 times of amounts are added carries out refluxing extraction, and extraction time 3 is small
When, it takes filtrate, then 50% ethyl alcohol measured with 6.5 times extracts filter residue 2 hours, takes filtrate, then with 6.5 times of 50% ethyl alcohol
Filter residue is extracted 2 hours, goes filtrate, and merge filtrate three times；
S3. will three times ethanol extract by be concentrated under reduced pressure into relative density be 1.15.
S4. about 4.5 times of 95% ethyl alcohol of amount are added under stirring condition, it is 80% to make ethanol content, keeps 30 DEG C of temperature in tank
Hereinafter, stand 12 hours or more, precipitation is filtered to take, ginseng glycopeptide crude product is obtained.
S5. the water for injection of 1 times of amount, stirring and dissolving are added into ginseng crude product, and 2 DEG C are placed 24 hours；
S6. refrigeration liquid centrifugation cleaned, go to precipitate, gone filtrate that activated carbon is added inward and stir 0.03 times of amount, stirring is stood
40 minutes, filtrate is filtered off, then ultrafiltration is carried out to filtrate with the hollow fiber membrane ultrafiltration device of 10,000 dalton, vacuum is carried out to filtrate
Concentration, it is 1.15 (50 DEG C) to be concentrated into concentrate relative density.
A kind of ginseng glycopeptide injection, in terms of parts by weight, including following raw material：
1000 parts of 5 parts of ginseng glycopeptide, 10 parts of sodium chloride, 4 parts of Tween 80 and water for injection.
A kind of preparation method of ginseng glycopeptide injection, includes the following process：
S1. prescription is pressed to prepare and weigh ginseng glycopeptide, sodium chloride supplementary material related to Tween 80 etc.；
S2. the water for injection for matching liquid total amount 50% needed for being first added into Agitation Tank, when water temperature is down to 55 DEG C, by ginseng
Glycopeptide, sodium chloride are added separately in water for injection in proportion, are again recycled liquid 5 minutes after its dissolving, are then filtered to take
Filtrate, then the required water for injection for matching liquid total amount 37.5% is added inward；It is 60 DEG C to keep temperature；
S3. Tween 80 is dissolved with the water for injection with liquid total amount 6.25%, is stirred continuously in adition process, until it is fully molten
Solution, adds it to thereafter in liquid and supplies water, adjust the pH value of solution to 6, and refer to liquid correlation and be detected mark
Ensure it conform to related request.
S4. filling, sterilizing, lamp inspection and packaging are then carried out.
The present invention ginseng glycopeptide injection have the function of adjust blood glucose and treat diabetes, be lead to mouse blood sugar,
The variation of liver glycogen is verified.
Ginseng glycopeptide hypoglycemic is tested
1, ginseng glycopeptide causes streptozotocin the hypoglycemic experiment of hyperglycemia
It takes 80 mouse to take 8 to be only used as blank control group at random, remaining 10 hours on an empty stomach, is noted by 160mg/kg dosage abdominal cavity
Penetrate streptozotocin (STZ) solution that the citrate buffer solution of pH4.5 is prepared.After 72, tail vein blood, Johnson ＆ Johnson surveys blood glucose conveniently
Instrument measures the fasting blood sugar after fasting 12h, and it is molding diabetic mice to take mouse of the blood glucose value more than 15.00mmol/L.Sugar
Urine disease model mouse is divided into 7 groups by blood glucose value, and every group 8, model control group gavage is to distilled water, and positive controls gavage is to small
Certain hypoglycemic medicine of mouse, remaining 5 groups are ginseng glycopeptide group.Panaxan's group is divided into 12.5,25,50,100 and 200mg/kg dosage
Group.Daily gastric infusion 1 time, continuous 10d, after the last administration by all each group mouse empty stomach 12h, eye socket takes blood, detaches serum,
Determination of glucose oxidase blood-sugar content (table 1).
1 ginseng glycopeptide of table influences STZ blood glucose in diabetic mice values
As known from Table 1, after filling 10 days, ginseng glycopeptide and certain hypoglycemic medicine can significantly reduce the blood glucose of hyperglycemia mouse
Value, wherein panaxan 50mg/kg groups are capable of the hyperglycemia of pole significant decrease mouse, and can reach normal value, illustrate ginseng
Polysaccharide has the function of hypoglycemic in the case of oral, and in the raising with ginseng glycopeptide concentration, blood glucose reduces numerical value
Declined, this shows 50mg/kg in the more suitable numerical intervals of ginseng glycopeptide.
2, ginseng glycopeptide tests the hypoglycemic of hyperglycemia caused by glucose
30 mouse are taken, are randomly divided into 3 groups, the 1st group and the 2nd group hypodermic injection physiological saline 5ml/kg, the 3rd group is subcutaneously noted
Penetrate ginseng glycopeptide 85mg/kg, successive administration 6 days, 30min, the 1st group of intravenous injection physiological saline 10ml/ after last time is administered
Kg, the 2nd group and the 3rd group is injected intravenously and gives glucose 2g/kg, after intravenous injection 3min, 30min, 60min and
120min and 240min, test blood glucose value (table 2).
2 ginseng glycopeptide of table causes glucose the effect of hyperglycemia
From table 2 it is known that the mouse of continuous 6 days injection ginseng polypeptides, the adjusting for blood glucose rise and inhibition energy
Power be obviously better than without injection ginseng glycopeptide group mouse, injection ginseng glycopeptide group mouse blood glucose also closer to blank pair
According to the blood glucose value of group mouse, this, which also shows continuous injection ginseng glycopeptide, plays an important roll the blood glucose-control of mouse, to small
The raising of mouse blood glucose also functions to apparent inhibiting effect.
2, ginseng glycopeptide is tested for taking influence of the glucose to hepatic glycogen
30 mouse are taken, are randomly divided into 3 groups, the 1st group and the 2nd group hypodermic injection physiological saline 5ml/kg, the 3rd group is subcutaneously noted
Penetrate ginseng glycopeptide 85mg/kg, successive administration 6 days, 30min, the 1st group of intravenous injection physiological saline 10ml/ after last time is administered
Kg, the 2nd group and the 3rd group is injected intravenously and gives glucose 2g/kg, after intravenous injection 3min, 30min, 60min and
120min and 240min, test hepatic glycogen (table 3)
3 ginseng glycopeptide of table is for taking influence of the glucose to hepatic glycogen
From table 3 it is known that the mouse of continuous 6 days injection ginseng polypeptides, for the raised adjusting of hepatic glycogen and inhibits
Ability is obviously better than the mouse without injection ginseng glycopeptide group, injection ginseng glycopeptide group mouse hepatic glycogen also closer to empty
The hepatic glycogen numerical value of white control group mice, this also shows continuous injection ginseng glycopeptide and the hepatic glycogen of mouse is adjusted with important
Effect, apparent inhibiting effect is also functioned to the raising of mouse hepatic glycogen.
Finally it should be noted that the above embodiments are merely illustrative of the technical solutions of the present invention, rather than the present invention is protected
The limitation of range is protected, although being explained in detail to the present invention with reference to preferred embodiment, those skilled in the art answer
Work as understanding, technical scheme of the present invention can be modified or replaced equivalently, without departing from the reality of technical solution of the present invention
Matter and range.
Claims (10)
1. a kind of ginseng glycopeptide injection pharmaceutical composition, which is characterized in that the ginseng glycopeptide includes following preparation section：
S1. ginseng is obtained into ginseng coarse powder by pretreatment process；Pretreatment process includes：It cleans, clean, dry, crush, wrap
Fill and weigh process；
S2. ginseng coarse powder is obtained into ginseng glycopeptide crude product by crude process；Crude process includes：Refluxing extraction, concentration with
And alcohol precipitation process；
S3. ginseng glycopeptide crude product is obtained into refined ginseng glycopeptide by refining step and freeze-drying；Refining step includes：
Refrigeration, filtering and vacuum-concentrcted process.
2. ginseng glycopeptide injection pharmaceutical composition according to claim 1, which is characterized in that the refined ginseng
Glycopeptide is to have the function of tonifying Qi, promote the production of body fluid, quench the thirst and do not dissolve in ethyl alcohol, water-soluble drying, loose micro-yellow powder；It is described
Ginseng glycopeptide crude product be brown color precipitation.
3. ginseng glycopeptide injection pharmaceutical composition according to claim 1, which is characterized in that the process that cleans is
Ginseng crude drug is placed in and is cleaned on workbench, impurity is removed, goes mouldy, damages by worms, the non-medicinal effects such as adulterant；It is characterized in that described
Clean process be the ginseng after cleaning is put into above the web plate of wash slot, ginseng is cleaned with circulating water；It is characterized in that,
The drying process is to divide the ginseng cleaned in basin, is put into heated-air circulation oven, is being obtained not higher than 60 DEG C
It is 2~4 hours dry under temperature condition, until ginseng contained humidity is not higher than 12%；It is characterized in that the pulverizing process is to use
Ginseng is ground into coarse powder by efficient Roughpulverizer.
4. ginseng glycopeptide injection pharmaceutical composition according to claim 1, which is characterized in that the ginseng glycopeptide is thick
The enrichment process of product is that ethanol extract is concentrated under reduced pressure into relative density is 1.05~1.25 (50 DEG C), vapour pressure when concentration
Power：0.05~0.25MPa, vacuum degree are -0.01~0.10MPa, and thickening temperature is less than 85 DEG C.
5. ginseng glycopeptide according to claim 1, which is characterized in that the refluxing extraction process is with ginseng glycopeptide 6
45%~65% ethyl alcohol of~8 times of dosages under 70 DEG C~90 DEG C conditions and 0.1~0.2MPa steam pressures to ginseng coarse powder into
Row refluxing extraction is extracted 2~4 times, and each extraction time is 2~4 hours, merges liquid after the completion of extraction.
6. ginseng glycopeptide injection pharmaceutical composition according to claim 1, which is characterized in that the alcohol precipitation process is
The ethanol content of gained liquid reaches 80% after adjusting enrichment process, and makes liquid in the environment of not higher than 35 DEG C, quiet
It sets 12 hours or more.
7. ginseng glycopeptide injection pharmaceutical composition according to claim 1, which is characterized in that the refining step is
The water for injection that ginseng glycopeptide crude product is measured with 0.7~1.2 times dissolves, and refrigeration placement 18~36 is small under cryogenic
When；Then, liquid centrifugation removal impurity will be refrigerated and go to precipitate, inward plus 0.02~0.05 times is measured Powdered Activated Carbon, stirs, is quiet
It sets, makes its adsorption equilibrium；Filtrate is filtered to take, then carries out ultrafiltration；And filtrate is subjected to vacuum-concentrcted, vacuum degree when concentration
For -0.02~0.08MPa, thickening temperature is less than 80 DEG C, and concentrate relative density is 1.10~1.20 (50 DEG C).
8. application of the ginseng glycopeptide injection pharmaceutical composition in preparing ginseng candies peptide medicament described in claim 1.
9. ginseng glycopeptide injection according to claim 8, which is characterized in that the ginseng glycopeptide injection, with weight
Number meter is measured, including following raw material：3~10 parts of ginseng glycopeptide, 7~15 parts of sodium chloride, 2~6 parts of Tween 80 and water for injection
950~1050 parts.
10. ginseng glycopeptide injection according to claim 8, which is characterized in that the ginseng glycopeptide infusion pump contains
Following preparation section：
S1. prescription is pressed to prepare and weigh ginseng glycopeptide, sodium chloride supplementary material related to Tween 80 etc.；
S2. the water for injection for matching liquid total amount 50% needed for being first added into Agitation Tank, when water temperature is down to 45 DEG C~75 DEG C, by people
Ginseng glycopeptide, sodium chloride are added separately in water for injection in proportion, are again recycled liquid 5 minutes after its dissolving, are then filtered
Filtrate is taken, then the required water for injection for matching liquid total amount 37.5% is added inward；It is 50~80 DEG C to keep temperature；
S3. Tween 80 is dissolved with the water for injection with liquid total amount 6.25%, is stirred continuously in adition process, until it is fully dissolved,
Thereafter water is added it in liquid and supplied, adjusts the pH value of solution to 5.6~6.4, and liquid correlation fingering row is examined
Mark ensures it conform to related request.
S4. filling, sterilizing, lamp inspection and packaging are then carried out.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1931874A (en) * | 2006-10-11 | 2007-03-21 | 吉林省中医中药研究院 | Prepn process, medicine prepn and medicinal use of ginseng glycopeptide |
| JP2015168614A (en) * | 2014-03-04 | 2015-09-28 | 長瀬産業株式会社 | Glp-1 secretion enhancer |
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2018
- 2018-06-19 CN CN201810631110.6A patent/CN108434186A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1931874A (en) * | 2006-10-11 | 2007-03-21 | 吉林省中医中药研究院 | Prepn process, medicine prepn and medicinal use of ginseng glycopeptide |
| JP2015168614A (en) * | 2014-03-04 | 2015-09-28 | 長瀬産業株式会社 | Glp-1 secretion enhancer |
Non-Patent Citations (1)
| Title |
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| 张秋梅等: "人参糖肽治疗2型糖尿病的临床观察 ", 《中国现代医学杂志》 * |
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