CN111467316A - Cefadroxil dispersible tablet and preparation method thereof - Google Patents
Cefadroxil dispersible tablet and preparation method thereof Download PDFInfo
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- CN111467316A CN111467316A CN202010403696.8A CN202010403696A CN111467316A CN 111467316 A CN111467316 A CN 111467316A CN 202010403696 A CN202010403696 A CN 202010403696A CN 111467316 A CN111467316 A CN 111467316A
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- cefadroxil
- dispersible tablet
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- dispersible
- magnesium stearate
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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 invention belongs to the technical field of pharmaceutical preparations, and particularly relates to cefadroxil dispersible tablets and a preparation method thereof. The cefadroxil dispersible tablet comprises the following components in the formula of each 10000 tablets: 5000g of cefadroxil, 1300g of a filling agent 1000, 800g of a disintegrating agent 500 and 20-100g of magnesium stearate. Weighing cefadroxil, a filler and a disintegrating agent according to the prescription amount, uniformly mixing, adding a lubricant magnesium stearate, uniformly mixing, and tabletting by a tabletting machine to obtain the cefadroxil dispersible tablet. The cefadroxil dispersible tablet preparation prepared by the invention has uniform drug release among units, easily obtained raw materials and controllable quality. The preparation method adopts a mixed powder direct-pressing process to produce the cefadroxil dispersible tablet, has simple process, stable quality, easy operation and suitability for large-scale production, and avoids the risk of degradation of cefadroxil.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to cefadroxil dispersible tablets and a preparation method thereof.
Background
The cefadroxil dispersible tablet has the characteristics of convenience in carrying, good storage and stability of common tablets, and has the advantages of convenience in taking granules and syrup, good absorption and high bioavailability. The cefadroxil can enhance the use effect and expand the use population. Cefadroxil is a broad-spectrum semisynthetic antibiotic of cephalosporins, and the cefadroxil has the characteristics of good oral absorption, small influence by food, high blood concentration, long effective concentration time, low adverse reaction incidence rate and the like. The product has good effect on penicillin-producing and penicillin-non-producing Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, group A hemolytic streptococcus, Escherichia coli, and Proteus mirabilis.
At present, the preparation process of cefadroxil dispersible tablets in the prior art is wet granulation, and has the defects of long production period, high energy consumption, degradation risk of cefadroxil and the like.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: overcomes the defects of the prior art, provides the cefadroxil dispersible tablet which is effective for treating common gram-positive bacteria and gram-negative bacteria and the preparation method thereof, has simple process, stable quality and easy operation, and is suitable for large-scale production.
The cefadroxil dispersible tablet provided by the invention comprises the following components in the formula of each 10000 tablets: 5000g of cefadroxil, 1300g of a filling agent 1000, 800g of a disintegrating agent 500 and 20-100g of magnesium stearate.
Wherein:
the filler is one or more of microcrystalline cellulose, lactose and mannitol.
The microcrystalline cellulose is one or more of common microcrystalline cellulose, microcrystalline cellulose PH101 or microcrystalline cellulose PH 102.
The disintegrant is one or more of starch, carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose.
The cefadroxil, the filler, the disintegrant and the magnesium stearate are sieved by a 30-mesh sieve, the cefadroxil, the filler and the disintegrant are weighed according to the prescription amount, the mixture is uniformly mixed, the magnesium stearate is added, the mixture is uniformly mixed to obtain a mixed material, and the mixed material is tabletted by a tabletting machine to obtain the cefadroxil dispersible tablet.
The bulk density of the mixed material is 0.5-0.7g/cm3Tap density of 0.7-0.9g/cm3。
The hardness of the cefadroxil dispersible tablet is 90-130N.
The invention adopts the powder mixing and direct pressing process to produce cefadroxil dispersible tablets, can better solve the defects in the wet granulation process in the prior art, and shows the comparison condition of the two production processes as shown in the following table.
Comparison table of wet granulation process and mixed powder direct-pressing process of cefadroxil dispersible tablets
Compared with the prior art, the invention has the following beneficial effects:
1. the cefadroxil dispersible tablet preparation prepared by the invention has uniform drug release among units, easily obtained raw materials and controllable quality.
2. The invention adopts the powder mixing direct-pressing process to produce the cefadroxil dispersible tablet, has simple process, stable quality, easy operation and suitability for large-scale production, and avoids the risk of degradation of cefadroxil.
Drawings
Fig. 1 shows the dissolution profile of an accelerated investigation of cefadroxil dispersible tablet prepared in example 1 according to the invention.
Detailed Description
The present invention will be further described with reference to the following examples.
Example 1
The prescription composition of each 10000 tablets of preparation is as follows: 5000g of cefadroxil, 1000g of ordinary microcrystalline cellulose, 220g of lactose, 550g of starch and 80g of magnesium stearate.
The preparation method comprises the following steps:
sieving the raw materials with 30 mesh sieve, weighing cefadroxil, common microcrystalline cellulose and milk according to the prescriptionMixing sugar and starch, adding magnesium stearate, and mixing to obtain mixture with apparent density of 0.5g/cm3Tap density of 0.8g/cm3And after the detection is qualified, tabletting the mixed material by a tabletting machine to obtain the cefadroxil dispersible tablet, wherein the hardness of the tablet is 110N.
Example 2
The prescription composition of each 10000 tablets of preparation is as follows: 5000g of cefadroxil, 1110g of microcrystalline cellulose (PH101), 190g of mannitol, 500g of carboxymethyl starch sodium and 60g of magnesium stearate.
The preparation method comprises the following steps:
sieving the raw materials with a 30-mesh sieve, weighing cefadroxil, microcrystalline cellulose PH101, mannitol and carboxymethyl starch sodium according to the prescription amount, uniformly mixing, adding magnesium stearate, and uniformly mixing to obtain a mixed material, wherein the apparent density of the mixed material is 0.5g/cm3Tap density of 0.9g/cm3And after the detection is qualified, tabletting the mixed material by a tabletting machine to obtain the cefadroxil dispersible tablet, wherein the hardness of the tablet is 120N.
Example 3
The prescription composition of each 10000 tablets of preparation is as follows: 5000g of cefadroxil, 1100g of microcrystalline cellulose (PH102), 220g of starch, 500g of carboxymethyl starch sodium and 30g of magnesium stearate.
The preparation method comprises the following steps:
sieving the raw materials with a 30-mesh sieve, weighing cefadroxil, microcrystalline cellulose PH102, starch and sodium carboxymethyl starch according to the prescription, uniformly mixing, adding magnesium stearate, and uniformly mixing to obtain a mixed material, wherein the apparent density of the mixed material is 0.6g/cm3Tap density of 0.9g/cm3And after the detection is qualified, tabletting the mixed material by a tabletting machine to obtain the cefadroxil dispersible tablet, wherein the hardness of the tablet is 110N.
Example 4
The prescription composition of each 10000 tablets of preparation is as follows: 5000g of cefadroxil, 1200g of common microcrystalline cellulose, 220g of mannitol, 600g of low-substituted hydroxypropyl cellulose and 30g of magnesium stearate.
The preparation method comprises the following steps:
sieving the raw materials with 30 mesh sieve, weighing cefadroxil and common microcrystalline according to the prescriptionMixing cellulose, mannitol and low-substituted hydroxypropyl cellulose, adding magnesium stearate, and mixing to obtain a mixture with a bulk density of 0.6g/cm3Tap density of 0.8g/cm3And after the detection is qualified, tabletting the mixed material by a tabletting machine to obtain the cefadroxil dispersible tablet, wherein the hardness of the tablet is 90N.
Example 5
The prescription composition of each 10000 tablets of preparation is as follows: 5000g of cefadroxil, 1100g of microcrystalline cellulose (PH101), 180g of starch, 500g of low-substituted hydroxypropyl cellulose and 70g of magnesium stearate.
The preparation method comprises the following steps:
sieving the raw materials with a 30-mesh sieve, weighing cefadroxil, microcrystalline cellulose PH101, starch and low-substituted hydroxypropyl cellulose according to the prescription amount, uniformly mixing, adding magnesium stearate, and uniformly mixing to obtain a mixed material, wherein the bulk density of the mixed material is 0.7g/cm3Tap density of 0.8g/cm3And after the detection is qualified, tabletting the mixed material by a tabletting machine to obtain the cefadroxil dispersible tablet, wherein the hardness of the tablet is 100N.
Example 6
The prescription composition of each 10000 tablets of preparation is as follows: 5000g of cefadroxil, 1200g of microcrystalline cellulose (PH102), 200g of lactose, 500g of low-substituted hydroxypropyl cellulose and 50g of magnesium stearate.
The preparation method comprises the following steps:
sieving the raw materials with a 30-mesh sieve, weighing cefadroxil, microcrystalline cellulose PH102, lactose and low-substituted hydroxypropyl cellulose according to the prescription amount, uniformly mixing, adding magnesium stearate, and uniformly mixing to obtain a mixed material, wherein the bulk density of the mixed material is 0.7g/cm3Tap density of 0.9g/cm3And after the detection is qualified, tabletting the mixed material by a tabletting machine to obtain the cefadroxil dispersible tablet, wherein the hardness of the tablet is 130N.
Of course, the foregoing is only a preferred embodiment of the invention and should not be taken as limiting the scope of the embodiments of the invention. The present invention is not limited to the above examples, and equivalent changes and modifications made by those skilled in the art within the spirit and scope of the present invention should be construed as being included in the scope of the present invention.
Claims (7)
1. A cefadroxil dispersible tablet is characterized in that: the prescription composition of each 10000 tablets of the preparation is as follows: 5000g of cefadroxil, 1300g of a filling agent 1000, 800g of a disintegrating agent 500 and 20-100g of magnesium stearate.
2. Cefadroxil dispersible tablet according to claim 1, characterized in that: the filler is one or more of microcrystalline cellulose, lactose and mannitol.
3. Cefadroxil dispersible tablet according to claim 2, characterized in that: the microcrystalline cellulose is one or more of common microcrystalline cellulose, microcrystalline cellulose PH101 or microcrystalline cellulose PH 102.
4. Cefadroxil dispersible tablet according to claim 1, characterized in that: the disintegrant is one or more of starch, carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose.
5. A process for the preparation of cefadroxil dispersible tablets according to claim 1, characterised in that: sieving cefadroxil, a filling agent, a disintegrating agent and magnesium stearate with a 30-mesh sieve, weighing cefadroxil, the filling agent and the disintegrating agent according to the prescription amount, uniformly mixing, adding magnesium stearate, uniformly mixing to obtain a mixed material, and tabletting the mixed material by a tabletting machine to obtain the cefadroxil dispersible tablet.
6. Process for the preparation of cefadroxil dispersible tablets according to claim 5, characterized in that: the bulk density of the mixed material is 0.5-0.7g/cm3Tap density of 0.7-0.9g/cm3。
7. Process for the preparation of cefadroxil dispersible tablets according to claim 5, characterized in that: the hardness of the cefadroxil dispersible tablet is 90-130N.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010403696.8A CN111467316A (en) | 2020-05-13 | 2020-05-13 | Cefadroxil dispersible tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010403696.8A CN111467316A (en) | 2020-05-13 | 2020-05-13 | Cefadroxil dispersible tablet and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN111467316A true CN111467316A (en) | 2020-07-31 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010403696.8A Withdrawn CN111467316A (en) | 2020-05-13 | 2020-05-13 | Cefadroxil dispersible tablet and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113908134A (en) * | 2021-12-03 | 2022-01-11 | 陕西恒诚制药有限公司 | Preparation method of cefadroxil dispersion coating tablet |
-
2020
- 2020-05-13 CN CN202010403696.8A patent/CN111467316A/en not_active Withdrawn
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113908134A (en) * | 2021-12-03 | 2022-01-11 | 陕西恒诚制药有限公司 | Preparation method of cefadroxil dispersion coating tablet |
| CN113908134B (en) * | 2021-12-03 | 2023-10-27 | 陕西恒诚制药有限公司 | Preparation method of cefadroxil dispersion coated tablet |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20200731 |
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| WW01 | Invention patent application withdrawn after publication |