CN108272756A - A kind of amoxicillin soluble powder and preparation method thereof - Google Patents
A kind of amoxicillin soluble powder and preparation method thereof Download PDFInfo
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
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- A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
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Abstract
The present invention relates to a kind of amoxicillin soluble powders and preparation method thereof, the soluble powder contain Amoxicillin, average molecular weight 1500Da 3000Da gelatin hydrolysied matter, diluent, be preferably made of 30 wt% of Amoxicillin 10wt%, 20 wt% of gelatin hydrolysied matter, 50 wt% of average molecular weight 1500Da 2000Da, 20 wt% of sorbierite, 60 wt%.The soluble powder can form uniform liquid in water, and the stability of solution is high, it is most important that be capable of providing prolonged effective efficacy of a drug, therapeutic effect is persistently reliable.
Description
Technical field
The present invention relates to technical field of veterinary, and in particular, to a kind of amoxicillin soluble powder and its preparation side
Method.
Background technology
Amoxicillin also known as amoxicillin or Amoxicillin are most common semi-synthetic penicillins wide spectrum beta-lactams
Class antibiotic has bactericidal effect strong, the strong feature of penetration cell film ability, can be used for treating blue to the leather that Amoxicillin is sensitive
Family name's positive bacteria and gram positive bacterial infection, such as staphylococcus aureus disease, colibacillosis, white diarrhea, infective rhinitis, calf
Pneumonia, bovine pasteurellosis, mastitis, porcine contagious pleuropneumonia, avian typhoid etc..And applied for the ease of animal, usually will
It is prepared into soluble powder, and when use is dissolved in the water, and is taken by drinking water for animals process.
But amoxicillin soluble powder has following defect in use：
(1) Amoxicillin is metabolized very fast, half-life short, therefore medicine effect is not lasting, needs constantly to be administered repeatedly.
(2) amoxicillin soluble powder, which is added to the water, is commonly formed inhomogenous turbid solution, and may extend at any time and sink
It forms sediment, leads to not ensure that animal takes dose therapeutically effective.
(3) Amoxicillin stability is very poor, easily degrades, and especially under the environment such as high temperature, high humidity, effective content is significantly
It reduces, especially its aqueous solution fails faster, therefore is often difficult to ensure curative effect.
The method that the prior art solves drawbacks described above includes that Amoxicillin and slow-release material are prepared into sustained release preparation to prolong
Long drug effect, but slow-release material is usually not readily dissolved in water, and itself is water-soluble poor, such as ethyl cellulose, crospovidone etc., system
Preparation be finally still difficult to be dissolved in water and form uniform solution, and such sustained release preparation prepares difficult, some were discharged
In slow, drug effect is influenced instead.
The prior art by Amoxicillin there is also being prepared into solid dispersions, or utilizes superfine communication technique, Huo Zhejia
Enter suspending agent such as glycerine, Arabic gum, stabilizer such as calgon, citric acid etc. is either added or is prepared with beta cyclodextrin
At inclusion compound etc. to solve drawbacks described above, but the problems such as these method generally existings preparation process is complicated, and toxic side effect is big.
Therefore, this field still it is expected that a kind of drug effect of acquisition is effectively lasting, and can form uniform solution in water while make
Agent is more resistant to high temperature and humidity, the especially stronger amoxicillin soluble powder of aqueous stability.
Invention content
The purpose of the present invention is to provide a kind of efficacy of a drug persistently, good water solubility, Ah not of stability height (especially aqueous solution)
XiLin soluble powder.The soluble powder high-temp resisting high-humidity resisting, uniform solution can be formed by being added to the water under room temperature, and for 24 hours
The interior drug in solution stable content, degradation rate is low, and is most importantly capable of providing prolonged effective efficacy of a drug, using very
It is convenient.
The present invention provides a kind of amoxicillin soluble powder, the soluble powder contains Amoxicillin, average molecular weight
Gelatin hydrolysied matter, the diluent of 1500Da-3000Da.
In one embodiment, the gelatin hydrolysied matter is to obtain gelatin hydrolysied matter by sour water solution.It replaces at another
For in embodiment, the gelatin hydrolysied matter is to obtain gelatin hydrolysied matter by basic hydrolysis.
In a preferred embodiment, the gelatin hydrolysied matter is obtained by protease hydrolytic.
In one embodiment, the average molecular weight 1500Da-3000Da of gelatin hydrolysied matter.
In a preferred embodiment, the average molecular weight 1500Da-2000Da of gelatin hydrolysied matter.
In one embodiment, the one kind of diluent in mannitol, sorb alcohol and glucose.
In a preferred embodiment, diluent is sorbierite.
In one embodiment, the gelatin hydrolysied matter can be commercially available.
In another embodiment, the gelatin hydrolysied matter can be made by oneself to obtain, such as using common a kind of to three
Kind of protease, such as serine protease, cysteine proteinase, aspartic protease, metalloproteinases, aminopeptidase etc. according to
Secondary hydrolysis obtains, as long as the object of the invention can be realized in the average molecular weight 1500Da-3000Da of its gelatin hydrolysied matter.
In a preferred embodiment, the gelatin hydrolysied matter can be prepared via a method which：
Raw material gelatin is configured to aqueous solution, aqueous gelatin solution pH value is adjusted to 5- with citric acid and phosphate buffer
7,40 DEG C -60 DEG C are heated to, trypsase is added in aqueous gelatin solution and is stirred, after reacting 2-3 hours, is added into solution
Solution is heated to 90 DEG C and kills enzyme by bacillus licheniformis after reacting 2-3 hours, is filtered, and is concentrated, dry, obtains gelatin hydrolysis
Object.
In one embodiment, raw material gelatin is type A gelatin or type B gelatin.In another alternate embodiment,
Raw material gelatin is the mixture of type A gelatin and type B gelatin.
In another preferred embodiment, the gelatin hydrolysied matter can be prepared via a method which：
Raw material gelatin is configured to aqueous solution, aqueous gelatin solution pH value is adjusted to 5- with citric acid and phosphate buffer
7,40 DEG C -60 DEG C are heated to, trypsase is added in aqueous gelatin solution and is stirred, after reacting 2-3 hours, is added into solution
After reacting 2-3 hours, the protease obtained from fermentation of Aspergillus niger is added into solution, is reacted 1-2 hours for bacillus licheniformis
Afterwards, solution is heated to 90 DEG C and kills enzyme, filtered, concentrated, it is dry, obtain gelatin hydrolysied matter.
In a preferred embodiment, the group of the amoxicillin soluble powder becomes：
The gelatin hydrolysied matter 20wt%- of Amoxicillin 10wt%-30wt%, average molecular weight 1500Da-2000Da
50wt%, sorbierite 20wt%-60wt%.
In another preferred embodiment, the group of the amoxicillin soluble powder becomes：
Gelatin hydrolysied matter 30wt%, the sorbierite of Amoxicillin 30wt%, average molecular weight 1500Da-2000Da
40wt%.
The present invention also provides the preparation methods of amoxicillin soluble powder, in one embodiment, the solubility
The preparation method of powder is as follows：Amoxicillin, diluent, gelatin hydrolysied matter are crossed to 80 mesh sieve respectively, are uniformly mixed, is dispensed, packaging.
In a preferred embodiment, the preparation method of the soluble powder is as follows：
(1) Amoxicillin, gelatin hydrolysied matter, diluent are dissolved in the water, are stirred evenly；
(2) by the spraying drying of the mixed solution of step (1), obtained powder packing, packaging.
In another highly preferred embodiment, the preparation method of the soluble powder is as follows：
(1) Amoxicillin and diluent are crossed to 80 mesh sieve respectively, are uniformly mixed；
(2) gelatin hydrolysied matter is added to the water and is configured to aqueous solution, be added in the mixed powder of step (1), stirred, granulation,
Dry, whole grain dispenses, packaging.
Special reticular structure possessed by gelatin hydrolysied matter of the present invention using specified molecular weight, it is embedded in by Amoxicillin
In, the dissolubility of Amoxicillin is on the one hand improved, and improve its physics and chemical stability, the resistance to height of soluble powder moisture-proof
Temperature, especially its aqueous solution stable homogeneous, do not generate precipitation, degradation rate is low；On the other hand prolonged drug effect can be then maintained, provided
More lasting therapeutic effect.
Specific implementation mode
Specific embodiment is named out, further explanation is made to the present invention.In practice, each group of the present composition
The quantity and ratio divided should be limited to ingredient above-mentioned and constitute in range, including but not limited to interior listed by following embodiment
Hold.
Soluble powder prepared by 1 micronization technology of comparative example
| Component | Weight |
| Amoxicillin | 30g |
| Natrium carbonicum calcinatum | 5g |
| Lauryl sodium sulfate | 10g |
| Calgon | 5g |
| Sucrose | 50g |
Amoxicillin is subjected to ultramicro grinding (grain size 50um or less), other flow of feed gas are crushed and crosses 300 mesh sieve；So
Calgon, natrium carbonicum calcinatum and the lauryl sodium sulfate after crushing are mixed afterwards, then by mixed powder and after crushing
Amoxicillin be uniformly mixed, finally by mixed powder with crush after sucrose be uniformly mixed, and cross 150 mesh sieve, dispense to get.
Soluble powder prepared by 2 solid dispersions technique of comparative example
Amoxicillin and Macrogol 6000 are uniformly mixed, heating stirring in pallet is put into and melts, after complete melting
Take out, rapid cooling, obtained coagulum ultralow temperature crushes, and crosses 80 mesh sieve, obtains solid dispersion, then with 80 mesh sieve is already expired
PVPk30 mixing, instill Tween 80 in mixed process, stir evenly to get.
Comparative example 3 prepares soluble powder with gelatin, Arabic gum
| Component | Weight |
| Amoxicillin | 30g |
| Gelatin | 20g |
| Arabic gum | 20g |
| Disodium hydrogen phosphate | 15g |
| Trehalose | 10g |
| Glycerine | 5g |
Gelatin, Arabic gum is soluble in water, Amoxicillin, glycerine, trehalose and disodium hydrogen phosphate is added, mixing is equal
It is even；Mixed solution is sprayed drying, mixed powder is obtained；Obtained mixed powder is heated into 5h at 90 DEG C, it is cooling, it dispenses to obtain the final product.
Comparative example 4 prepares soluble powder with the gelatin hydrolysied matter that average molecular weight is 6000-9000Da
Amoxicillin and sorbierite are crossed to 80 mesh sieve respectively, is uniformly mixed and obtains mixed powder；Gelatin hydrolysied matter is added to the water
Be configured to aqueous solution, be then added in mixed powder, stir, pelletize, dry, whole grain, packing to get.
Comparative example 5 prepares soluble powder with the gelatin hydrolysied matter that average molecular weight is 3000-6000Da
It is prepared by 4 method of comparative example.
Comparative example 6 prepares soluble powder with the gelatin hydrolysied matter that average molecular weight is 1000-1500Da
It is prepared by 4 method of comparative example.
The gelatin hydrolysied matter of embodiment 1 and average molecular weight 1500Da-3000Da prepares soluble powder
Amoxicillin and sorbierite are crossed to 80 mesh sieve respectively, is uniformly mixed and obtains mixed powder；Gelatin hydrolysied matter is added to the water
Be configured to aqueous solution, be then added in mixed powder, stir, pelletize, dry, whole grain, packing to get.
One, soluble test and aqueous solution stability test
Take comparative example 1-6, embodiment 1 soluble powder 1g in terms of Amoxicillin, be placed in 150ml, 25 DEG C ± 2 DEG C of temperature
It in water, shakes 2 minutes, observes solution conditions after standing 30 minutes, while content (being recorded as 0h contents) is measured by sampling；Then will
Each solution is placed in 40 DEG C and places 4h, 12h and for 24 hours, solution conditions is observed and recorded, and content is measured by sampling, with comparision contents when 0
Counting loss rate, as a result see the table below.
Aqueous solution physical stability result
| Comparative example | Aqueous solution (0h) | Aqueous solution (4h) | Aqueous solution (12h) | Aqueous solution (for 24 hours) |
| Comparative example 1 | There is a small amount of precipitation | There is a small amount of precipitation | There is a small amount of precipitation | There is a small amount of precipitation |
| Comparative example 2 | Without precipitation | Without precipitation | Without precipitation | Without precipitation |
| Comparative example 3 | Without precipitation | Without precipitation | Without precipitation | Without precipitation |
| Comparative example 4 | There is a small amount of precipitation | There is a small amount of precipitation | There is a small amount of precipitation | There is obvious sediment |
| Comparative example 5 | Without precipitation | There is a small amount of precipitation | There is a small amount of precipitation | There is obvious sediment |
| Comparative example 6 | There is obvious sediment | There is obvious sediment | There is obvious sediment | There is obvious sediment |
| Embodiment 1 | Without precipitation | Without precipitation | Without precipitation | Without precipitation |
Amoxicillin solubility itself is very low, and 1mg drugs are about dissolved in 1ml water, as can be seen from the above table, in 0h, comparison
Superfine communication technique, solid dispersions technique has been respectively adopted in example 1 and 2, the solubility of Amoxicillin all greatly improved, but right
Ratio 1 still has a small amount of undissolved drug to occur with precipitation form；Comparative example 3 divides Bales Off to cover medicine with gelatin, Arabic gum etc.
Object, what is formed in water is the uniform suspension of no precipitation；Comparative example 4-6 and embodiment 1 then use different molecular weight
Amoxicillin is embedded by gelatin hydrolysied matter using its special construction, but finds only have average molecular weight 1500Da-3000Da
Gelatin hydrolysied matter the uniform liquid without precipitation could be formed with Amoxicillin, and the solution is placed in high temperature and remains good for 24 hours
Physical stability.During animal free water is administered, if the solution formed is inhomogenous, there is precipitation, then can influence
The dosage of animal leads to not timely and effectively play drug effect, specific animal administration experimental result will be given below with
It refers to.
Chemistry of aqueous solution stability result
From the point of view of the chemical stability of aqueous solution, the amoxicillin soluble powder of comparative example 1-6 is high after being configured to solution
Temperature places 12h, on the one hand content loss 7%-13% is solution system in placement process to 12-22% is then increased to for 24 hours
Stability is poor, and Amoxicillin is precipitated, and is on the other hand then that degradation reaction occurs for high warm purgative object, and embodiment 1 is using specific
Then there is water soluble powder prepared by the gelatin hydrolysied matter of molecular weight higher physics and chemical stability, medicament contg to lose pole
It is small.
Two, accelerated test
Comparative example 1-6 and the soluble powder of embodiment 1 are accelerated 6 months under 40 DEG C and 75% environment of humidity, then seen
It examines character and measures content, compared with 0h, calculate content loss rate, as a result see the table below.
Accelerated stability test (June) result
| Comparative example | Character | Content loss rate |
| Comparative example 1 | Yellow is lumpd | 14.1% |
| Comparative example 2 | Buff lumps | 16.3% |
| Comparative example 3 | Yellow is lumpd | 17.9% |
| Comparative example 4 | Buff lumps | 20.4% |
| Comparative example 5 | Yellowish toner | 10.5% |
| Comparative example 6 | Buff lumps | 25.7% |
| Embodiment 1 | Off-white color powder | 4.1% |
As seen from the above table, the soluble powder that comparative example 1 is prepared using superfine communication technique is inhaled since diameter of aspirin particle is minimum
Moist big, large specific surface area is easy moisture absorption and degrades；Solid dispersions prepared by comparative example 2, at high temperature stable system
Property is poor, due to the aging phenomenon that solid dispersions are susceptible to, causes powder bonding serious；Comparative example 3 is due to bright in prescription
Glue is easy aging denaturation, changes colour；Comparative example 4-6 and embodiment 1 then show prepared by the gelatin hydrolysied matter of 1500Da-3000Da
Soluble powder, the resistance to high humidity of high temperature resistant, drug loss is few, and stability is more preferable, storage during it is less perishable.
Three, animal metabolism is tested
Health pig 30, weight 20-30kg is selected to weigh and record, control water 2 hours, forbid feeding during experiment before testing,
It is divided into 6 groups, every group 5, by the soluble powder water dissolution of comparative example 1-5 and embodiment 1, according to every 1kg weight with 10mg Ahs
The dosage of Amdinocillin is gavaged to test pig, and perfusion vena cava anterior is taken a blood sample as a contrast, 15min, 30min after perfusion, 45min,
1h, 2h, 3h, 4h, 6h, 8h, 12h venous blood collection 3ml measure the Determination of amoxicillin in blood plasma, each comparative example of different time
Blood concentration average value such as following table.
As can be seen from the above table, comparative example 1-2 reaches highest blood concentration in 45min-1h, and decline rapidly in 4h, 4h
Drug effect reduces rapidly afterwards, and needing to be administered again could maintain；Comparative example 3 is slower in preceding 3h drug releasing rates, blood concentration dimension
It holds in reduced levels, until 12h just reaches higher blood concentration, but its blood concentration is in reduced levels for a long time, will influence
Drug effect time and pharmaceutical efficacy；Comparative example 4 and 5 reaches highest blood concentration in medication 1h, and declines rapidly in 4h,
Drug effect reduces after 4h, and drug effect is integrally held time shorter；And embodiment 1 reaches higher blood concentration in medication 30min, and
Higher blood concentration is maintained in 30min-8h, until blood concentration continuously decreases after 12h, and highest blood concentration is compared with it
His comparative example is high, it is seen that 30min can play drug effect to the soluble powder of embodiment 1 after the tablet has been ingested, and the drug effect can be tieed up
As long as holding 8h, the residence time is longer in blood for drug, medication ultrahigh in efficiency, can need not be weighed in even 16h in 8h-12h
New administration.
Four, to the therapeutic effect of manual-induced colibacillosis
30 age in days healthy chick 180 is taken, is randomly divided into 6 groups, every group 30.The oral artificial challenge's avian Escherichia coli of every chicken
The mixed liquor 0.3ml (containing Escherichia coli 500,000,000, haemophilus paragallinarum 700,000,000) of bacteria culture fluid and haemophilus paragallinarum bacillus culture solution,
There are apparent clinical symptoms in most of chicken after 48h.It is configured at this point, comparative example 1-5 and 1 soluble powder of embodiment are added to the water
50mg/L drinks water (in terms of soluble powder weight), takes free water administering mode, drinking-water is primary per new preparation for 24 hours, is used in conjunction 5
It.
It after continuous dispensing 5 days, then observes 7-14 days, as a result the morbidity of record each group and Cure see the table below.
| Comparative example | Test number of elements | Morbidity number of elements | Dead number of elements | Effective number of elements | Cure number of elements | Cure rate | It is efficient |
| Comparative example 1 | 30 | 28 | 10 | 14 | 10 | 35% | 50% |
| Comparative example 2 | 30 | 27 | 9 | 12 | 7 | 26% | 44% |
| Comparative example 3 | 30 | 28 | 14 | 10 | 7 | 25% | 36% |
| Comparative example 4 | 30 | 30 | 12 | 15 | 8 | 27% | 50% |
| Comparative example 5 | 30 | 26 | 10 | 14 | 10 | 38% | 54% |
| Embodiment 1 | 30 | 28 | 0 | 26 | 23 | 82% | 93% |
Upper table can see, and embodiment 1 is far above due to the provision of the persistently longer efficacy of a drug, cure rate and effective percentage
Other comparative example groups.The gelatin hydrolysied matter for the specified molecular weight range that the present invention selects, since its special construction can be by Ah not
XiLin is embedded, and the soluble powder that stable homogeneous solution is formed with water can not only be prepared, and the aqueous solution can be grown
Phase keeps physics and chemical stability, and the soluble powder moisture-proof high temperature resistant, while can maintain the prolonged efficacy of a drug, greatly
The therapeutic effect of drug is played.
Embodiment 2 prepares the gelatin hydrolysied matter of average molecular weight 1500Da-3000Da
1kgA type gelatin is added in 2kg water, is heated to 55 DEG C of dissolvings, and aqueous gelatin solution pH is adjusted with disodium phosphate soln
It is worth 6.5, is heated to 60 DEG C, 0.1%w/w trypsase is added in aqueous gelatin solution and is stirred, after reacting 2 hours, Xiang Rong
0.1%w/w bacillus licheniformis is added in liquid, after reacting 2 hours, solution is heated to 90 DEG C and kills enzyme, is filtered, and is concentrated, it is dry,
Obtain gelatin hydrolysied matter.It is 2488Da to measure its average molecular weight.
Embodiment 3 prepares the gelatin hydrolysied matter of average molecular weight 1500Da-2000Da
1kgB type gelatin is added in 2kg water, is heated to 55 DEG C of dissolvings, and aqueous gelatin solution pH is adjusted with disodium phosphate soln
It is worth 6.5, is heated to 60 DEG C, 0.1%w/w trypsase is added in aqueous gelatin solution and is stirred, after reacting 3 hours, Xiang Rong
0.1%w/w bacillus licheniformis is added in liquid, and after reacting 3 hours, 0.08%w/w is added into solution from fermentation of Aspergillus niger
Solution is heated to 90 DEG C and kills enzyme by obtained protease after reacting 1.5 hours, is filtered, and is concentrated, dry, obtains gelatin hydrolysis
Object.It is 1623Da to measure its average molecular weight.
Embodiment 4 prepares Amoxicillin water soluble powder
Amoxicillin and glucose are crossed to 80 mesh sieve respectively, is uniformly mixed and obtains mixed powder；Gelatin hydrolysied matter is added to the water
Be configured to aqueous solution, be then added in mixed powder, stir, pelletize, dry, whole grain is added magnesium stearate, packing to get.
Embodiment 5 prepares Amoxicillin water soluble powder
Amoxicillin and mannitol are crossed to 80 mesh sieve respectively, is uniformly mixed and obtains mixed powder；Gelatin hydrolysied matter is added to the water
Be configured to aqueous solution, be then added in mixed powder, stir, pelletize, dry, whole grain is added talcum powder, packing to get.
Embodiment 6 prepares Amoxicillin water soluble powder
Amoxicillin and sorbierite are crossed to 80 mesh sieve respectively, is uniformly mixed and obtains mixed powder；Gelatin hydrolysied matter is added to the water
Be configured to aqueous solution, be then added in mixed powder, stir, pelletize, dry, whole grain, packing to get.
Embodiment 7 prepares Amoxicillin water soluble powder
It is prepared according to 6 the method for embodiment.
Embodiment 8 prepares Amoxicillin water soluble powder
It is prepared according to 6 the method for embodiment.
Embodiment 9 prepares Amoxicillin water soluble powder
It is prepared according to 6 the method for embodiment.
Aqueous solution physical stability and soluble powder high temperature and humidity (40 DEG C, 75%) accelerated test result of embodiment 4-9
It see the table below.
Aqueous solution physical stability result
| Embodiment | Aqueous solution (0h) | Aqueous solution (4h) | Aqueous solution (12h) | Aqueous solution (for 24 hours) |
| Embodiment 4 | Without precipitation | Without precipitation | Without precipitation | Without precipitation |
| Embodiment 5 | Without precipitation | Without precipitation | Without precipitation | Without precipitation |
| Embodiment 6 | Without precipitation | Without precipitation | Without precipitation | Without precipitation |
| Embodiment 7 | Without precipitation | Without precipitation | Without precipitation | Without precipitation |
| Embodiment 8 | Without precipitation | Without precipitation | Without precipitation | Without precipitation |
| Embodiment 9 | Without precipitation | Without precipitation | Without precipitation | Without precipitation |
Accelerated stability test (June) result
| Embodiment | Character | Content loss rate |
| Embodiment 4 | Off-white color powder | 5.7% |
| Embodiment 5 | Off-white color powder | 4.5% |
| Embodiment 6 | Off-white color powder | 3.8% |
| Embodiment 7 | Off-white color powder | 3.6% |
| Embodiment 8 | Off-white color powder | 3.5% |
| Embodiment 9 | Off-white color powder | 3.2% |
Claims (9)
1. a kind of amoxicillin soluble powder, it is characterised in that the soluble powder contains Amoxicillin, average molecular weight
Gelatin hydrolysied matter, the diluent of 1500Da-3000Da.
2. amoxicillin soluble powder according to claim 1, it is characterised in that the gelatin hydrolysied matter passes through protease
Hydrolysis obtains.
3. amoxicillin soluble powder according to claim 1, it is characterised in that the diluent is selected from mannitol, sorb
One kind in alcohol and glucose.
4. amoxicillin soluble powder according to claim 1, it is characterised in that the mean molecule of the gelatin hydrolysied matter
Measure 1500Da-2000Da.
5. amoxicillin soluble powder according to claim 1, it is characterised in that the preparation of the gelatin hydrolysied matter contains
Following steps：
Raw material gelatin is configured to aqueous solution, aqueous gelatin solution pH value is adjusted to 5-7 with citric acid and phosphate buffer, adds
Trypsase is added in aqueous gelatin solution and stirs to 40 DEG C -60 DEG C by heat, and after reacting 2-3 hours, lichens is added into solution
Solution is heated to 90 DEG C and kills enzyme by bacillus after reacting 2-3 hours, is filtered, and is concentrated, dry, obtains gelatin hydrolysied matter.
6. amoxicillin soluble powder according to claim 4, it is characterised in that the preparation of the gelatin hydrolysied matter contains
Following steps：
Raw material gelatin is configured to aqueous solution, aqueous gelatin solution pH value is adjusted to 5-7 with citric acid and phosphate buffer, adds
Trypsase is added in aqueous gelatin solution and stirs to 40 DEG C -60 DEG C by heat, and after reacting 2-3 hours, lichens is added into solution
After reacting 2-3 hours, the protease obtained from fermentation of Aspergillus niger is added into solution for bacillus, after reacting 1-2 hours,
Solution is heated to 90 DEG C and kills enzyme, is filtered, is concentrated, it is dry, obtain gelatin hydrolysied matter.
7. amoxicillin soluble powder according to claim 4, it is characterised in that the group of the amoxicillin soluble powder
Become：Amoxicillin 10wt%-30 wt %, average molecular weight 1500Da-2000Da 20 wt%-50 wt % of gelatin hydrolysied matter,
20 wt%-60 wt % of sorbierite.
8. amoxicillin soluble powder according to claim 4, it is characterised in that the group of the amoxicillin soluble powder
Become：30 wt % of Amoxicillin, 30 wt % of gelatin hydrolysied matter of average molecular weight 1500Da-2000Da, 40 wt of sorbierite
%。
9. according to the amoxicillin soluble powder described in any one of claim 1-8, it is characterised in that the soluble powder
Preparation method it is as follows：
（1）Amoxicillin and diluent are crossed to 80 mesh sieve respectively, are uniformly mixed；
（2）Gelatin hydrolysied matter is added to the water and is configured to aqueous solution, is added to step（1）Mixed powder in, stir, pelletize, it is dry,
Whole grain dispenses, packaging.
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| CN201810309559.0A Active CN108272756B (en) | 2018-04-09 | 2018-04-09 | Amoxicillin soluble powder and preparation method thereof |
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| CN112089693A (en) * | 2020-09-28 | 2020-12-18 | 成都倍特药业股份有限公司 | Penicillin composition for injection and preparation method thereof |
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