CN106377499A - Ampicillin oil suspension and preparation method thereof - Google Patents
Ampicillin oil suspension and preparation method thereof Download PDFInfo
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Abstract
The invention discloses an ampicillin oil suspension. The oil suspension comprises the following raw and auxiliary materials per 100mL: 2g to 30g of ampicillin, 0.9 to 1.0g of surfactant, 1.0g to 5.1g of colloid protectant, 2.0g to 15.0g of suspending agent, 0g to 0.1g of antioxidant, and the balance of oil phase. According to the ampicillin oil suspension disclosed by the invention, by screening of various process parameters, the ampicillin oil suspension which is slight in color, good in liquidity, good in dispersity and stable in oil suspension state is obtained, and has a wide market prospect.
Description
Technical field
The invention belongs to field of medicaments is and in particular to a kind of ampicillin oil suspension and preparation method thereof.
Background technology
Ampicillin is semisynthetic penbritin, and its free acid contains 3 molecular crystalline water, pro ore；Its sodium salt supplies
Injection.Effect to gram positive bacteria is approximate with benzyl penicillin, more excellent to viridans streptococci and enterococcal effect, to other
The effect of bacterium is then poor.Invalid to the staphylococcus aureus of penicillin resistant G.Be mainly used in urinary system caused by sensitive bacteria,
Respiratory system, biliary tract, enteric infection and meningitis, endocarditis etc..
Insoluble drug is scattered in the heterogeneous liquid preparation formed in oil phase by oil suspension system, and its maximum feature is to make
Drug treating time extend, reduce times for spraying, it is possible to decrease labour intensity and reduce to body stress.However, oil suspension
The preparation of especially oil for injection supensoid agent is more difficult, and physical stability to be obtained, syringeability and weight dispersiveness are preferably produced
Product, determine that suitable supplementary product kind and consumption are very crucial, and, oil suspension is higher to storage environment requirement, improves its storage
Depositing stability is also the factor needing in preparation process to consider.
Patent CN 105769762 A discloses a kind of ampicillin suspension injection and preparation method thereof, and main employing is gathered
, as main suspending auxiliary material, its technique is first polyvinylpyrrolidone and aluminum stearate to exist for vinylpyrrolidone and aluminum stearate
Dissolve in finish, after cooling with colloid mill grind, in process of lapping add main ingredient ampicillin, last homogeneous, constant volume, point
Dress.However, test in inventor finding, the dispersion effect again after the centrifugation of this parenteral solution is not good, easily condenses.
Therefore, it is necessary to improve to the formula of ampicillin oil suspension, thus finding effect more preferable ammonia benzyl west
Woods oil suspension.
Content of the invention
For solving the above problems, the invention provides a kind of ampicillin oil suspension, the every 100mL of described supensoid agent contains
Following supplementary material：Ampicillin 2g～30g, surfactant 0.9g～1.0g, colloid protective agent 1.0g～5.1g, suspending agent
2.0g～15.0g, antioxidant 0g～0.1g, balance of oil phase.
Further, described surfactant is Span-80, Tween-80, one or more is mixed in soybean lecithin
Compound.
Further, described surfactant is grouped into by following groups：Tween-80 0.3g, Span-80 0.3g, big
Fabaceous Lecithin 0.3g.
Further, described colloid protective agent is magnesium stearate, Magnesiumaluminumsilicate or Magnesiumaluminumsilicate and magnesium stearate quality
Ratio 1：1 mixture.
Further, described colloid protective agent is grouped into by following groups：Magnesiumaluminumsilicate 0.5g, magnesium stearate 0.5g.
Further, the every 100mL of described supensoid agent contains 8.5g～15.0g suspending agent；Described suspending agent is preferably by following
Group is grouped into：Poloxamer 1.0g～5.0g, Macrogol 6000 1.0g～5.0g, sodium carboxymethylcellulose 1.0g～5.0g.
Further, described suspending agent is grouped into by following groups：Poloxamer 5.0g, Macrogol 6000 2.5g, carboxylic
Sodium carboxymethylcellulose pyce 1.0g.
Further, described oil phase is soybean oil, the mixture of Ergol or soybean oil, isopropyl myristate
Mixture；Wherein, percent by volume in described mixture for the Ergol is 30%～50%；Isopropyl myristate
Percent by volume in described mixture is 20%.
Further, percent by volume in described mixture for the Ergol is 30%.
Further, described ampicillin is 2g～15g.
Further, the every 100mL of described supensoid agent contains following supplementary material：Ampicillin 10g, Tween-80 0.3g, department
Class -80 0.3g, soybean lecithin 0.3g, Magnesiumaluminumsilicate 0.5g, magnesium stearate 0.5g, poloxamer 5.0g, Macrogol 6000
2.5g, sodium carboxymethylcellulose 1.0g, surplus is percent by volume is 70%：30% soybean oil and the mixing of Ergol
Thing.
Present invention also offers a kind of method preparing aforementioned ampicillin oil suspension, oil phase is heated to 60 DEG C～70
DEG C, add colloid protective agent, a part of suspending agent and surfactant, after cooling, add remainder suspending agent and ammonia benzyl west
Woods, stirs, and homogeneous obtains final product；
Or, oil phase is heated to 60 DEG C～70 DEG C, add colloid protective agent and surfactant, after cooling, add suspending agent
And ampicillin, stir, homogeneous, obtain final product.
The present invention passes through the screening of kinds of processes parameter, has obtained of light color, good fluidity, good dispersion, suspension
Stable ampicillin oil suspension, has wide market prospects.
Obviously, the above according to the present invention, according to ordinary technical knowledge and the customary means of this area, without departing from
Under the premise of the present invention above-mentioned basic fundamental thought, modification, replacement or the change of other various ways can also be made.
The specific embodiment of form by the following examples, remakes further specifically to the above of the present invention
Bright.But this scope being interpreted as the above-mentioned theme of the present invention should not be only limitted to Examples below.All based on the above of the present invention
The technology realized belongs to the scope of the present invention.
Specific embodiment
Used in the specific embodiment of the invention, raw material, equipment are known product, are obtained by buying commercially available prod.
In following embodiments, refer to volume ratio except being related to % during oil phase/solvent, remaining is bulking value percentage
Than.
The material being related to and method are as follows：
1st, material：
Ampicillin, North China pharmacy group；Ergol, Shanghai bright moon daily use chemicals Co., Ltd；PEG-4000,
Aladdin reagent Co., Ltd；Poloxamer-188, Beijing Feng Li International Trading Company Ltd；Aluminum stearate, magnesium stearate, tell
Temperature -80, the chemical reagent such as Span-80, methyl alcohol, sodium dihydrogen phosphate, Xi Long Chemical Co., Ltd.；Methyl alcohol, match is silent fly generation you (in
State) Co., Ltd, homogenizer, Shanghai Heng Chuan plant equipment Co., Ltd.
2nd, the investigation method of supensoid agent：
Reference《Chinese veterinary pharmacopoeia》Requirement to suspension, intends checking the ampicillin suspension of preparation using the following method.
(1) sedimentation volume ratio
Apparatus plug graduated cylinder measures test sample 50mL, close plug, firmly shakes 1min, writes down the beginning height H0 of suspended matter, quiet
Put 3 hours, write down the final height H of suspended matter, be calculated as follows：
Sedimentation volume ratio=H/H0
Sedimentation volume ratio is not less than 0.90.
(2) syringeability
Take test sample, with No. 12 needle aspirate, volume aspirated is no less than 2mL in 1 minute after shaking.
(3) with reference to the centrifugation standard of emulsion, test sample is shaken with after the rotating speed centrifugation 15min of 4000r/min, Ying Yifen
Dissipate.
The preparation of embodiment 1 ampicillin of the present invention oil suspension
Take soybean oil 40mL, add Ergol 30mL (or isopropyl myristate 30mL), heat (60 DEG C -70 DEG C)
After mixing, add colloid protective agent (Magnesiumaluminumsilicate magnesium stearate 1：1 mixture 1.0%) dissolving, add suspending agent (pool
Luo Shamu 188 5.0g, Macrogol 6000 2.5g) fusing after stir, add surfactant (soybean lecithin 0.3g,
Tween-80 0.3g and Span-80 0.3g), add suspending agent sodium carboxymethylcellulose 1.0g after 25 DEG C about of cooling, stirring is all
Even, add ampicillin 10g, after stirring, be settled to 100mL, homogeneous with soybean oil, the ampicillin oil obtaining final product 10% mixes
Suspension (weight/volume).
The screening of embodiment 2 oil phase species
Respectively using the mixture of each oil phase or each oil phase different volumes proportioning composition as solvent, matching surface activating agent department
Disk -80 (5%), antioxidant BHA (BHA) (0.02%), thickener aluminum stearate (1%) and main ingredient
Different supensoid agents are prepared in ampicillin (10%), and investigate its sedimentation volume ratio, syringeability, the deployment conditions after centrifugation, knot
Fruit is shown in Table 1.
The screening of table 1 oil phase species
| Solvent | Sedimentation volume ratio | Syringeability (mL) | Redisperse after centrifugation |
| Soybean oil | 0.95 | 2.3 | Do not disperse |
| Rapeseed oil | 0.96 | 2.4 | Do not disperse |
| Peanut oil | 0.3 | 2.5 | Do not disperse |
| Corn oil | 0.92 | 2.6 | Do not disperse |
| White oil | 0.92 | 2.4 | Do not disperse |
| Ethyl oleate | 0.65 | 3.2 | Can dispersion |
| Ergol | 0.59 | 3.5 | Can dispersion |
| Isopropyl myristate | 0.42 | 4.5 | Can dispersion |
| Soybean oil 50%+ ethyl oleate 50% | 0.95 | 3.5 | Do not disperse |
| Soybean oil 50%+ Ergol 50% | 0.96 | 2.8 | Can dispersion |
| Soybean oil 50%+ isopropyl myristate 50% | 0.87 | 3.8 | Can dispersion |
| Soybean oil 90%+ Ergol 10% | 0.97 | 2.5 | Do not disperse |
| Soybean oil 80%+ Ergol 20% | 0.95 | 2.7 | Do not disperse |
| Soybean oil 70%+ Ergol 30% | 0.94 | 3.2 | Can dispersion |
| Soybean oil 90%+ isopropyl myristate 10% | 0.96 | 2.5 | Do not disperse |
| Soybean oil 80%+ isopropyl myristate 20% | 0.93 | 3.1 | Can dispersion |
| Soybean oil 70%+ isopropyl myristate 30% | 0.89 | 3.6 | Can dispersion |
| Soybean oil 40%+ Ergol 40%+ isopropyl myristate 20% | 0.88 | 3.1 | Can dispersion |
| Soybean oil 25%+ Ergol 40%+ isopropyl myristate 35% | 0.77 | 3.6 | Can dispersion |
| Soybean oil 10%+ Ergol 40%+ isopropyl myristate 50% | 0.56 | 4.4 | Can dispersion |
| Soybean oil 30%+ Ergol 30%+ isopropyl myristate 40% | 0.83 | 3.1 | Can dispersion |
| Soybean oil 20%+ Ergol 40%+ isopropyl myristate 40% | 0.65 | 3.7 | Can dispersion |
| Soybean oil 10%+ Ergol 50%+ isopropyl myristate 40% | 0.58 | 4.2 | Can dispersion |
As can be seen from Table 1, soybean oil 70%+ Ergol 30%, soybean oil 50%+ Ergol 50%
And during soybean oil 80%+ isopropyl myristate 20%, the quality standard of supensoid agent can be met.In general, soybean oil
70%+ Ergol 30% is preferable.
And be used alone oils or lipid or be applied in combination using soybean oil and other lipids, then cannot take into account simultaneously
Sedimentation volume ratio, syringeability and dispersiveness.
The screening of embodiment 3 surfactant
From oiliness surface active agent tween -80, Span-80 and lecithin as surfactant, with solvent (soybean oil
70%+ Ergol 30%) preparation 10% ampicillin suspension, and investigate its sedimentation volume ratio, syringeability, after centrifugation
Deployment conditions, the results are shown in Table 2.
The screening of table 2 surfactant
As can be seen from Table 2, each group surfactant preparation supensoid agent quality all meet the requirements, show Span-
80th, Tween-80, soybean lecithin all suitably use in supensoid agent of the present invention as surfactant.In general, 0.3% tell
Temperature -80+0.3% Span-80+0.3% soybean lecithin can also keep when consumption is less preferably imitating as surfactant
Really, therefore preferably 0.3% Tween-80+0.3% Span-80+0.3% soybean lecithin is as surfactant.
The screening of embodiment 4 colloid protective agent
From different colloid protective agents, with solvent (soybean oil 70%+ Ergol 30%) and surfactant
The ampicillin suspension of (0.3% Tween-80+0.3% Span-80+0.3% soybean lecithin) preparation 10%, and it is heavy to investigate it
Fall volume ratio, syringeability, the deployment conditions after centrifugation, the results are shown in Table 3.
The screening of table 3 colloid protective agent
Can be drawn by the result of table 3, using aluminum stearate group preparation ampicillin suspension color be light yellow extremely
Flaxen suspension liquid, Magnesiumaluminumsilicate and magnesium stearate press 1:1 ratio mixing, and one of them suspension of obtaining alone
Liquid color is more preferable.
The screening of embodiment 5 colloid protective agent consumption
From different colloid protective agent consumptions, with solvent (soybean oil 70%+ Ergol 30%) and surface-active
The ampicillin suspension of agent (0.3% Tween-80+0.3% Span-80+0.3% soybean lecithin) preparation 10%, and investigate it
Sedimentation volume ratio, syringeability, the deployment conditions after centrifugation, the results are shown in Table 4.Wherein, Magnesiumaluminumsilicate magnesium stearate mixture is silicon
Sour magnalium and magnesium stearate press 1:1 ratio mixing.
The screening of table 4 colloid protective agent consumption
| Addition | Sedimentation volume ratio | Syringeability (mL) | Redisperse after centrifugation | Proterties |
| Magnesium stearate 1.0% | 1.00 | 3.8 | Can dispersion | Milky suspension liquid |
| Magnesium stearate 2.0% | 1.00 | 3.5 | Can dispersion | Milky suspension liquid |
| Magnesiumaluminumsilicate 3.0% | 1.00 | 3.1 | Can dispersion | Milky suspension liquid |
| Magnesium stearate 4.0% | 1.00 | 2.9 | Can dispersion | Milky suspension liquid |
| Magnesiumaluminumsilicate magnesium stearate mixture 1.0% | 1.00 | 4.2 | Can dispersion | Milky suspension liquid |
| Magnesiumaluminumsilicate magnesium stearate mixture 2.0% | 1.00 | 3.9 | Can dispersion | Milky suspension liquid |
| Magnesiumaluminumsilicate magnesium stearate mixture 3.0% | 1.00 | 3.5 | Can dispersion | Milky suspension liquid |
| Magnesiumaluminumsilicate magnesium stearate mixture 4.0% | 1.00 | 2.8 | Can dispersion | Milky suspension liquid |
The result of table 4 shows, when the addition of Magnesiumaluminumsilicate magnesium stearate mixture is 1.0%-2.0%, effect is significant
Better than other groups.
The screening of embodiment 6 suspending agent
Individually by PLURONICS F87, Macrogol 4000, Macrogol 6000, sodium carboxymethylcellulose, polyethylene
Pyrrolidones K30 disperses in soybean oil, and result shows PLURONICS F87, Macrogol 6000, sodium carboxymethylcellulose, gathers
Tetra- kinds of materials of vinylpyrrolidone K30 dispersiveness in soybean oil preferably, illustrates that above-mentioned four kinds of materials suitably make as suspending agent
With.
It is respectively adopted the suspending agent shown in table 5～7, and lived with oil phase (soybean oil 70%+ Ergol 30%), surface
Property agent (0.3% Tween-80+0.3% Span-80+0.3% soybean lecithin) and colloid protective agent (Magnesiumaluminumsilicate magnesium stearate 1：1
Mixture 1.0%) preparation 10% ampicillin suspension, and investigate its sedimentation volume ratio, syringeability, the dispersion feelings after centrifugation
Condition, the results are shown in Table 5.
The single suspending agent of table 5 and the screening of consumption
| Addition w/v | Sedimentation volume ratio | Syringeability (mL) | Redisperse after centrifugation |
| PLURONICS F87 2.0% | 1.00 | 3.8 | It is difficult to disperse |
| PLURONICS F87 5.0% | 1.00 | 3.3 | It is difficult to disperse |
| PLURONICS F87 8.0% | 1.00 | 2.9 | It is difficult to disperse |
| Macrogol 6000 2.0% | 1.00 | 3.8 | It is difficult to disperse |
| Macrogol 6000 5.0% | 1.00 | 3.6 | It is difficult to disperse |
| Macrogol 6000 8.0% | 1.00 | 2.6 | It is difficult to disperse |
| Sodium carboxymethylcellulose 2.0% | 1.00 | 3.6 | It is difficult to disperse |
| Sodium carboxymethylcellulose 5.0% | 1.00 | 3.0 | It is difficult to disperse |
| Sodium carboxymethylcellulose 8.0% | 1.00 | 2.2 | It is difficult to disperse |
| PVP K30 2.0% | 1.00 | 3.9 | It is difficult to disperse |
| PVP K30 5.0% | 1.00 | 2.8 | It is difficult to disperse |
| PVP K30 8.0% | 1.00 | 2.5 | It is difficult to disperse |
Experimental result according to table 5 can obtain, with PLURONICS F87, Macrogol 6000, sodium carboxymethylcellulose or poly- second
Alkene pyrrolidone K30 all can prepare sedimentation volume ratio, the satisfactory supensoid agent of syringeability as suspending agent.But supensoid agent
It is difficult after centrifugation to disperse, show only to be difficult to obtain the preferable supensoid agent of quality using the suspending agent of single kind.In addition, in suspending
In the case of the increase of agent consumption, syringeability reduces, and after being centrifuged, dispersion effect difference is little.
Table 6 mixes the screening of suspending agent
Can be obtained by the result of the test of table 6, Macrogol 6000, PLURONICS F87 and carboxymethyl cellulose sodium cellulosate pair
The oil suspension of 10% ampicillin has suspending to act on, and PVP K30 acts on weaker to the suspending of this product.
Table 7 mixes the screening of suspending agent proportioning
Can be obtained by the result of the test of table 7, the addition of Lip river on the berth Pehanorm is 1.0%-5.0%, the adding of Macrogol 6000
Dosage is 1.0%-5.0%, under conditions of the addition of sodium carboxymethylcellulose is 1.0%-5.0%, all can prepare matter
Measure preferable supensoid agent, wherein PLURONICS F87 5.0%+ Macrogol 6000 2.5%+ sodium carboxymethylcellulose 1.0%
When, the supensoid agent quality preparing is optimal.
Whether embodiment 7 adds antioxidant to screen
With vitamin C palm ester (0.01%-0.02%), butylated hydroxyarisol (0.005%-0.02%), do not have
Propyl galate (0.05%-0.1%), vitamin E (0.05%-0.075%), oil phase (soybean oil 70%+ Ergol
30%), surfactant (0.3% Tween-80+0.3% Span-80+0.3% soybean lecithin), colloid protective agent (Magnesiumaluminumsilicate
Magnesium stearate 1：1 mixture 1.0%) and suspending agent (PLURONICS F87 5.0%+ Macrogol 6000 2.5%+ carboxymethyl fibre
The plain sodium 1.0% of dimension) preparation 10% ampicillin suspension, and use blank, place 12 hours in 60 DEG C of water-baths, result
The suspension adding antioxidant all meets quality standard regulation, and blank color change less, therefore can be not added with anti-oxidant
Agent.
The screening of embodiment 8 preparation technology
The present embodiment is compared and is mixed after PLURONICS F87 and Macrogol 6000 heating fusing with oil phase, or directly
Add the suspending effect of oil phase.Specific experiment method is as follows：
Preparation technology A：Take soybean oil 40mL, add Ergol 30mL (or isopropyl myristate 30mL), heating
After (60 DEG C -70 DEG C) mix, add colloid protective agent (Magnesiumaluminumsilicate magnesium stearate 1：1 mixture 1.0%) dissolving, then plus
Stir after entering suspending agent (PLURONICS F87 5.0g, Macrogol 6000 2.5g) fusing, add surfactant (big
Fabaceous Lecithin 0.3g, Tween-80 0.3g and Span-80 0.3g), add suspending agent carboxymethylcellulose calcium after being cooled to 25 DEG C about
Sodium 1.0g, stirs, and adds ampicillin 10g, is settled to 100mL, homogeneous with soybean oil, obtains final product 10% after stirring
Ampicillin suspension A.
Preparation technology B：Take soybean oil 40mL, add Ergol 30mL (or isopropyl myristate 30mL), heating
After (60 DEG C -70 DEG C) mix, add colloid protective agent (Magnesiumaluminumsilicate magnesium stearate 1：1 mixture 1.0g), surface-active
Agent (soybean lecithin 0.3g, Tween-80 0.3g and Span-80 0.3g), adds suspending agent (poloxamer after 25 DEG C about of cooling
188 5.0g, Macrogol 6000 2.5g, sodium carboxymethylcellulose 1.0g), stir, add ampicillin 10g, stirring
It is settled to 100mL, homogeneous with soybean oil after uniformly, obtain final product 10% ampicillin suspension B.
It was found that mixing with oil phase again after PLURONICS F87 and the heated fusing of Macrogol 6000, or incite somebody to action the two
It is directly added in oil phase, all can prepare the preferable supensoid agent of quality；Wherein, the former quality more preferably, is shown in Table 8.
The screening of the different preparation process of table 8
| Preparation process | Sedimentation volume ratio | Syringeability (ml) | Redisperse after centrifugation |
| A | 1.00 | 3.9 | Easily disperse |
| B | 0.97 | 3.2 | Easily disperse |
Prove beneficial effects of the present invention below by way of test example.
Test example 1 serviceability test
According to the ampicillin oil suspension of the method preparation 2%, 5%, 10%, 15%, 20%, 30% of embodiment 1, and
Investigate its sedimentation volume ratio, syringeability, the deployment conditions after centrifugation, the results are shown in Table 9.
Table 9 serviceability test
| Addition and proportioning | Sedimentation volume ratio | Syringeability (mL) | Redisperse after centrifugation |
| 2% | 0.98 | 4.8 | Easily disperse |
| 5% | 0.99 | 4.2 | Easily disperse |
| 10% | 0.99 | 3.9 | Easily disperse |
| 15% | 1.00 | 3.3 | Easily disperse |
| 20% | 1.00 | 2.8 | Easily disperse |
| 30% | 1.00 | 2.3 | Easily disperse |
Can be drawn by upper table, this technique can be used for the preparation of 2%-30% ampicillin oil suspension, but content is low
More excellent in 15% suspension effect.
Test example 2 stability test
Example 1 prepare 10% ampicillin oil suspension, be respectively placed in 4 DEG C, 25 DEG C, 40 DEG C and 60 DEG C
Place 3 months in environment, with reference to the quality standard detection level of ampicillin parenteral solution, the results are shown in Table 10.
Table 10 stability is tested
| Addition and proportioning | Sedimentation volume ratio | Syringeability (mL) | Redisperse after centrifugation | Content (%) |
| 4℃ | 0.96 | 3.8 | Easily disperse | 99.8 |
| 25℃ | 0.97 | 3.8 | Easily disperse | 99.5 |
| 40℃ | 0.96 | 3.7 | Easily disperse | 99.6 |
| 60℃ | 0.96 | 3.6 | Easily disperse | 99.6 |
The result of table 10 can draw having good stability of this product, places 3 months under various circumstances, plays content, cleansing pin
Property, when bad dispersibility is different notable for settling volume, illustrates that this product has good stability.
In sum, the present invention is by the screening of kinds of processes parameter, obtained of light color, good fluidity, good dispersion,
The stable ampicillin oil suspension of suspension, has wide market prospects.
Claims (12)
1. a kind of ampicillin oil suspension it is characterised in that：The every 100mL of described supensoid agent contains following supplementary material：Ammonia benzyl west
Woods 2g～30g, surfactant 0.9g～1.0g, colloid protective agent 1.0g～5.1g, suspending agent 2.0g～15.0g, anti-oxidant
Agent 0g～0.1g, balance of oil phase.
2. ampicillin according to claim 1 oil suspension it is characterised in that：Described surfactant be Span-80,
One or more mixture in Tween-80, soybean lecithin.
3. ampicillin according to claim 2 oil suspension it is characterised in that：Described surfactant is by following groups
It is grouped into：Tween-80 0.3g, Span-80 0.3g, soybean lecithin 0.3g.
4. ampicillin according to claim 1 oil suspension it is characterised in that：Described colloid protective agent is stearic acid
Magnesium, Magnesiumaluminumsilicate or Magnesiumaluminumsilicate and magnesium stearate mass ratio 1：1 mixture.
5. ampicillin according to claim 4 oil suspension it is characterised in that：Described colloid protective agent is by following components
Composition：Magnesiumaluminumsilicate 0.5g, magnesium stearate 0.5g.
6. ampicillin according to claim 1 oil suspension it is characterised in that：The every 100mL of described supensoid agent contains
8.5g～15.0g suspending agent；Described suspending agent is preferably grouped into by following groups：Poloxamer 1.0g～5.0g, polyethylene glycol
6000 1.0g～5.0g, sodium carboxymethylcellulose 1.0g～5.0g.
7. ampicillin according to claim 6 oil suspension it is characterised in that：Described suspending agent is grouped by following groups
Become：Poloxamer 5.0g, Macrogol 6000 2.5g, sodium carboxymethylcellulose 1.0g.
8. the ampicillin oil suspension according to any one of claim 1～7 it is characterised in that：Described oil phase is big
The mixture of soya-bean oil, the mixture of Ergol or soybean oil, isopropyl myristate；Wherein, Ergol is described
Percent by volume in mixture is 30%～50%；Percent by volume in described mixture for the isopropyl myristate is
20%.
9. ampicillin according to claim 8 oil suspension it is characterised in that：Ergol is in described mixture
Percent by volume be 30%.
10. the ampicillin oil suspension according to any one of claim 1～9 it is characterised in that：Described ampicillin is
2g～15g.
11. ampicillin according to claim 1 oil suspensions it is characterised in that：The every 100mL of described supensoid agent contain as
Lower supplementary material：Ampicillin 10g, Tween-80 0.3g, Span-80 0.3g, soybean lecithin 0.3g, Magnesiumaluminumsilicate 0.5g, tristearin
Sour magnesium 0.5g, poloxamer 5.0g, Macrogol 6000 2.5g, sodium carboxymethylcellulose 1.0g, surplus is that percent by volume is
70%：30% soybean oil and the mixture of Ergol.
A kind of 12. methods of the ampicillin oil suspension prepared described in any one of claim 1～11 it is characterised in that：Will
Oil phase is heated to 60 DEG C～70 DEG C, adds colloid protective agent, a part of suspending agent and surfactant, adds remainder after cooling
Divide suspending agent and ampicillin, stir, homogeneous, obtain final product；
Or, oil phase is heated to 60 DEG C～70 DEG C, add colloid protective agent and surfactant, after cooling, add suspending agent and ammonia
Benzyl XiLin, stirs, and homogeneous obtains final product.
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Cited By (1)
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| CN108403630A (en) * | 2018-05-31 | 2018-08-17 | 佛山市南海东方澳龙制药有限公司 | Suspension and preparation method thereof |
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