CN109106689A - Cefaclor dry suspensoid and preparation method thereof - Google Patents
Cefaclor dry suspensoid and preparation method thereof Download PDFInfo
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- CN109106689A CN109106689A CN201811207084.0A CN201811207084A CN109106689A CN 109106689 A CN109106689 A CN 109106689A CN 201811207084 A CN201811207084 A CN 201811207084A CN 109106689 A CN109106689 A CN 109106689A
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- cefaclor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
- A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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Abstract
The present invention relates to a kind of cefaclor dry suspensoids and preparation method thereof, belong to technical field of medicine.The cefaclor dry suspensoid, by the material composition of following mass fraction: 7-12 parts of Cefaclor；90-110 parts of sucrose；1-3 parts of methylcellulose；0.5-2 parts of xanthan gum；0.5-2 parts of strawberry essence；0.05-0.2 parts of lauryl sodium sulfate；0.05-0.2 parts of citric acid；7-10 parts of wetting agent.The advantages of dry suspensoid agent obtained has acidity uniform, and stability is good, good product quality.Preparation method provided by the invention, it is scientific and reasonable, it is simple and easy.
Description
Technical field
The present invention relates to a kind of cefaclor dry suspensoids and preparation method thereof, belong to technical field of medicine.
Background technique
Cefaclor (cefaclor) also known as ceclor, are second generation cephalosporins, have has a broad antifungal spectrum, drug resistance
Property it is weak, renal toxicity is low, and to gram-positive cocci and gram-Negative bacillus preferable antibacterial activity for oral anti-
Rhzomorph.
At present the country have the compound dry suspensoid agent listing, including compound cefaclor suspension, Crow oneself newly do
Suspension etc., but pass through comprising processes, products such as traditional mixing, softwood processed, granulation, mixed dry, mixing in its preparation process
Wet, the thermal process of long period, complicated for operation, the production cycle is long, large labor intensity.Cefaclor is to wet, thermally labile, through upper
The product for stating process production after 6~9 months, just will appear content or related substance not although quality complies with standard when filling
The case where complying with standard.Existing chemical synthesis includes kinds of processes path, but generally existing conversion ratio is low, product quality
Difference, reaction condition are complicated, complex for operation step, organic solvent residual is serious, purifying crystal handles complexity, production cost height etc. and asks
Topic.Existing similar product customizes the lower auxiliary material of certain acidity by the way of customizing auxiliary material, from auxiliary material manufacturer, reaches production
The satisfactory purpose of product acidity.Which program is cumbersome, excessively high to auxiliary material manufacturer's dependence, as auxiliary material manufacturer stops
Supply, then the production continuity will be on the hazard.
Summary of the invention
In view of the deficiencies of the prior art, the object of the present invention is to provide a kind of cefaclor dry suspensoids, have acidity equal
It is even, the advantages of stability is good, good product quality.
Meanwhile the present invention also provides preparation methods, and it is scientific and reasonable, it is simple and easy.
Cefaclor dry suspensoid of the present invention, by the material composition of following mass fraction:
The Cefaclor, sucrose, methylcellulose, xanthan gum, strawberry essence, pigment and lauryl sodium sulfate
PH value is respectively 3.6-3.7,6.0-6.2,6.4-6.5,6.4-6.5,5.9-6.0,4.8-5.0,8.0-8.5,6.4-6.5.
The wetting agent is water.
The Cefaclor is Cefaclor monohydrate.
The preparation method of cefaclor dry suspensoid of the present invention, comprising the following steps:
1) Cefaclor, sucrose, methylcellulose and the xanthan gum of mass ratio are weighed, it is equal that mixing in mixer is added
It is even, mixture A is made；
2) lauryl sodium sulfate of mass ratio and citric acid are dissolved in wetting agent, are added after dissolution into mixture A,
Mixture B is made；
3) mixture B pelletize using oscillating granulator or fast granulating machine；
4) particle obtained is dried；
5) after particle is dry, the outer auxiliary material strawberry essence of mass ratio is added, is uniformly mixed, it is canned, obtain product.
In the step 4, drying temperature is 30-70 DEG C, and particle drying to moisture is lower than 2.0%.
Compared with prior art, the invention has the following beneficial effects:
The advantages of 1. cefaclor dry suspensoid made from has acidity uniform, and stability is good, good product quality；
Preparation method described in 2., it is scientific and reasonable, it is simple and easy, it is with short production cycle, and production cost is low.
Detailed description of the invention
Fig. 1 is dissolution curve of the embodiment 1-2 product in dissolution medium water；
Fig. 2 is dissolution curve of the embodiment 1-2 product in dissolution medium pH1.2 buffer；
Fig. 3 is dissolution curve of the embodiment 1-2 product in dissolution medium pH4.5 acetate buffer；
Fig. 4 is dissolution curve of the embodiment 1-2 product in dissolution medium pH6.8 phosphate buffer.
Specific embodiment
The present invention will be further explained with reference to the examples below.
Embodiment 1
A kind of cefaclor dry suspensoid, by the material composition of following mass fraction:
The Cefaclor, sucrose, methylcellulose, xanthan gum, strawberry essence, pigment and lauryl sodium sulfate
PH value is respectively 3.69,6.1,6.42,6.41,5.96,4.9,8.08,6.48.
It is prepared as follows:
It is uniformly mixed 1. weighing the Cefaclor of mass ratio, sucrose, methylcellulose and xanthan gum and being added in mixer,
Mixture A is made；
2. the lauryl sodium sulfate of mass ratio and citric acid are dissolved in the water of mass ratio, it is added after dissolution to mixing
In object A, mixture B is made；
3. mixture B is pelletized through oscillating granulator；
4. particle made from enters boiling drier, and 70 DEG C of dryings to moisture are 1.0%；
5. the outer auxiliary material strawberry essence of mass ratio is added after particle is dry, it is uniformly mixed, it is filling, obtain product.
Embodiment 2
A kind of cefaclor dry suspensoid, by the material composition of following mass fraction:
The Cefaclor, sucrose, methylcellulose, xanthan gum, strawberry essence, pigment and lauryl sodium sulfate
PH value is respectively 3.6,6.0,6.42,6.4,5.92,4.8,8.0,6.4.
It is prepared as follows:
It is uniformly mixed 1. weighing the Cefaclor of mass ratio, sucrose, methylcellulose and xanthan gum and being added in mixer,
Mixture A is made；
2. the lauryl sodium sulfate of mass ratio and citric acid are dissolved in the water of mass ratio, it is added after dissolution to mixing
In object A, mixture B is made；
3. mixture B is pelletized through oscillating granulator；
4. particle made from enters boiling drier, and 30 DEG C of dryings to moisture are 1.5%；
5. the outer auxiliary material strawberry essence of mass ratio is added after particle is dry, it is uniformly mixed, it is filling, obtain product.
Acidity, impurity content and the performance test of dissolution rate in different media are carried out to embodiment 1-2 product, acidity is surveyed
Test result is as shown in table 1, and impurity content test result is as shown in table 2, is water, pH1.2 buffer, pH4.5 and pH6.8 in medium
Dissolution rate test result in buffer respectively as shown in table 3, table 4, table 5 and table 6, Dissolution profiles figure be respectively Fig. 1, Fig. 2,
Shown in Fig. 3 and Fig. 4, dissolution rate test condition is paddle method 50rpm.
1 embodiment 1-2 product acidity test result of table
| Project | Embodiment 1 | Embodiment 2 | Conclusion |
| Acidity (pH) | 3.68 | 3.74 | Meet national standard |
Impurity content is tested in 2 embodiment 1-2 product of table
| Project | Embodiment 1 | Embodiment 2 |
| Impurity A | 0.024% | 0.025% |
| Impurity B | 0.028% | 0.027% |
| Impurity C | ND | ND |
| Impurity G | 0.075% | 0.052% |
| Impurity D | 0.163% | 0.161% |
| Impurity E | 0.080% | 0.071% |
| Impurity H | ND | ND |
| Impurity F | ND | ND |
| Other largest single impurities | 0.081% | 0.095% |
| Other impurities summation | It ignores | It ignores |
| It is total miscellaneous | 0.163% | 0.161% |
Dissolution results of the 3 embodiment 1-2 product of table in dissolution medium water
| Time min | Embodiment 1 | Embodiment 2 |
| 0 | 0.0% | 0.0% |
| 5 | 89.6% | 87.3% |
| 10 | 95.7% | 95.5% |
| 15 | 97.0% | 98.2% |
| 30 | 97.4% | 98.6% |
| 45 | 97.3% | 98.2% |
Dissolution results of the 4 embodiment 1-2 product of table in dissolution medium pH1.2 buffer
| Time min | Embodiment 1 | Embodiment 2 |
| 0 | 0.0% | 0.0% |
| 5 | 86.4% | 85.4% |
| 10 | 95.5% | 94.6% |
| 15 | 97.6% | 96.6% |
| 30 | 97.9% | 97.2% |
| 45 | 97.7% | 97.3% |
Dissolution results of the 5 embodiment 1-2 product of table in dissolution medium pH4.5 acetate buffer
| Time min | Embodiment 1 | Embodiment 2 |
| 0 | 0.0% | 0.0% |
| 5 | 87.1% | 85.3% |
| 10 | 94.5% | 93.4% |
| 15 | 96.9% | 96.4% |
| 30 | 96.8% | 96.8% |
| 45 | 96.6% | 96.5% |
Dissolution results of the 6 embodiment 1-2 product of table in dissolution medium pH6.8 phosphate buffer
| Time min | Embodiment 1 | Embodiment 2 |
| 0 | 0.0% | 0.0% |
| 5 | 82.5% | 83.1% |
| 10 | 87.1% | 86.4% |
| 15 | 85.5% | 86.5% |
| 30 | 79.4% | 78.2% |
| 45 | 72.9% | 71.7% |
Embodiment 1-2 product is in four kinds of different mediums, and in 15min, dissolution rate is greater than 85%, sufficiently shows this hair
Dissolved corrosion is consistent in different media for bright product, Dissolution profiles shape having the same, favorable reproducibility, and process is steady
It is fixed.
Claims (6)
1. a kind of cefaclor dry suspensoid, it is characterised in that: by the material composition of following mass fraction:
2. cefaclor dry suspensoid according to claim 1, it is characterised in that: Cefaclor, sucrose, Methyl cellulose
Element, xanthan gum, strawberry essence, pigment and lauryl sodium sulfate pH value be respectively 3.6-3.7,6.0-6.2,6.4-6.5,
6.4-6.5,5.9-6.0,4.8-5.0,8.0-8.5,6.4-6.5.
3. cefaclor dry suspensoid according to claim 1, it is characterised in that: wetting agent is water.
4. cefaclor dry suspensoid according to claim 1, it is characterised in that: Cefaclor is the hydration of Cefaclor one
Object.
5. a kind of preparation method of cefaclor dry suspensoid described in claim 1, it is characterised in that: the following steps are included:
1) Cefaclor, sucrose, methylcellulose and the xanthan gum of mass ratio are weighed, is added in mixer and is uniformly mixed, system
Resulting mixture A；
2) lauryl sodium sulfate of mass ratio and citric acid are dissolved in wetting agent, are added after dissolution into mixture A, are made
Mixture B；
3) mixture B pelletize using oscillating granulator or fast granulating machine；
4) particle obtained is dried；
5) after particle is dry, the outer auxiliary material strawberry essence of mass ratio is added, is uniformly mixed, it is canned, obtain product.
6. the preparation method of cefaclor dry suspensoid according to claim 5, it is characterised in that: in step 4, dry temperature
Degree is 30-70 DEG C, and particle drying to moisture is lower than 2.0%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811207084.0A CN109106689A (en) | 2018-10-17 | 2018-10-17 | Cefaclor dry suspensoid and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811207084.0A CN109106689A (en) | 2018-10-17 | 2018-10-17 | Cefaclor dry suspensoid and preparation method thereof |
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| Publication Number | Publication Date |
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| CN109106689A true CN109106689A (en) | 2019-01-01 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201811207084.0A Pending CN109106689A (en) | 2018-10-17 | 2018-10-17 | Cefaclor dry suspensoid and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115876900A (en) * | 2021-09-28 | 2023-03-31 | 江苏正大清江制药有限公司 | Method for measuring dissolution amount of bromhexine hydrochloride in clohexine dry suspension |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101011360A (en) * | 2007-02-05 | 2007-08-08 | 深圳致君制药有限公司 | Recipe composition of dry turbid agent and its preparation process |
| EP2727591A2 (en) * | 2012-10-31 | 2014-05-07 | Kücükgüzel, Sükriye Güniz | Stable pharmaceutical compositions containing cefaclor and clavulanic acid |
| CN107550857A (en) * | 2017-09-27 | 2018-01-09 | 江西省子轩科技有限公司 | A kind of good cefaclor dry suspensoid of stability |
-
2018
- 2018-10-17 CN CN201811207084.0A patent/CN109106689A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101011360A (en) * | 2007-02-05 | 2007-08-08 | 深圳致君制药有限公司 | Recipe composition of dry turbid agent and its preparation process |
| EP2727591A2 (en) * | 2012-10-31 | 2014-05-07 | Kücükgüzel, Sükriye Güniz | Stable pharmaceutical compositions containing cefaclor and clavulanic acid |
| CN107550857A (en) * | 2017-09-27 | 2018-01-09 | 江西省子轩科技有限公司 | A kind of good cefaclor dry suspensoid of stability |
Non-Patent Citations (2)
| Title |
|---|
| 刘文: "《药用高分子材料学》", 30 June 2017, 中国中医药出版社 * |
| 常丽梅等: "头孢克洛干混悬剂的工艺优化及稳定性研究", 《海南医学》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115876900A (en) * | 2021-09-28 | 2023-03-31 | 江苏正大清江制药有限公司 | Method for measuring dissolution amount of bromhexine hydrochloride in clohexine dry suspension |
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Application publication date: 20190101 |