CN113332441A - Cefixime composition and application thereof - Google Patents
Cefixime composition and application thereof Download PDFInfo
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- CN113332441A CN113332441A CN202110561532.2A CN202110561532A CN113332441A CN 113332441 A CN113332441 A CN 113332441A CN 202110561532 A CN202110561532 A CN 202110561532A CN 113332441 A CN113332441 A CN 113332441A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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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
- A61K31/546—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 containing further heterocyclic rings, e.g. cephalothin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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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 discloses a cefixime composition which comprises the following raw materials in parts by weight: the composite material comprises the following raw materials in parts by weight: 35-45 parts of cefixime, 22-30 parts of microcrystalline cellulose, 15-20 parts of calcium hydrogen phosphate dihydrate, 3-8 parts of pregelatinized starch, 3-8 parts of mannitol and 0.5-1 part of silicon dioxide. The composition can improve the stability of cefixime, and ensure that the cefixime has better dissolution rate, thereby improving the bioavailability of the cefixime.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to a cefixime composition and application thereof.
Background
Cefixime (Cefixime) is an oral third-generation cephalosporin antibiotic commonly used to treat gonorrhea, tonsillitis, and pharyngitis; it is unstable to moist heat, so that degradation of cefixime is easily caused in the preparation and storage processes, thereby increasing the impurity content and influencing the effectiveness and safety of medication. In addition, because cefixime is almost insoluble in water, the dissolution rate is poor, and the in vivo bioavailability is low.
Therefore, how to improve the stability of cefixime and ensure the dissolution rate thereof is a technical problem to be solved urgently by the technical personnel in the field.
Disclosure of Invention
In view of the above, the invention provides a cefixime composition, which is applied to the preparation of a cefixime pharmaceutical preparation, and can improve the stability of the product and ensure the dissolution rate of the product.
In order to achieve the purpose, the invention adopts the following technical scheme:
the cefixime composition comprises the following raw materials in parts by weight:
35-45 parts of cefixime, namely,
22-30 parts of microcrystalline cellulose,
15-20 parts of calcium hydrogen phosphate dihydrate,
3-8 parts of pregelatinized starch,
3-8 parts of mannitol,
0.5-1 part of silicon dioxide.
The microcrystalline cellulose, the calcium hydrophosphate dihydrate, the pregelatinized starch, the mannitol and the silicon dioxide are arranged to ensure that the cefixime has good dispersibility in the composition, particles can be uniformly formed, the drug dissolution rate of the cefixime can be improved, and the stability of the cefixime can be ensured.
Preferably, cefixime is 200-300 mesh;
sieving microcrystalline cellulose with 400 mesh sieve;
the calcium hydrogen phosphate dihydrate is 200 meshes and 300 meshes;
the pregelatinized starch is 100-300 meshes;
the mannitol is 100-300 meshes;
the silicon dioxide is 200-300 meshes.
The particle size selection of each raw material ensures that the raw materials can be quickly and uniformly mixed.
A preparation method of cefixime composition comprises the following steps:
uniformly mixing microcrystalline cellulose, calcium hydrophosphate dihydrate and pregelatinized starch to obtain a mixture A;
uniformly mixing mannitol, silicon dioxide and cefixime to obtain a mixture B;
mixing mixture A and mixture B.
All the raw materials are mixed step by step, so that the mixing uniformity can be improved.
Mixing microcrystalline cellulose, calcium hydrogen phosphate dihydrate and pregelatinized starch at 10-15rpm for 10-15min to obtain a mixture A;
mixing mannitol, silicon dioxide and cefixime at 10-15rpm for 5-10min to obtain a mixture B;
mixing mixture A and mixture B10-15rpm for 3-5 min.
The cefixime composition can be used for preparing a cefixime medicinal preparation, and pharmaceutically acceptable auxiliary materials can be added into the cefixime composition to prepare the medicinal preparation.
Preferably, the pharmaceutical formulation comprises granules.
Preferably, the cefixime composition is prepared by mixing the raw materials and then performing dry granulation, wherein the particle size of the particles is 20-40 meshes;
transferring the granules meeting the particle size requirement into a fluidized bed, controlling the air inlet temperature to be 80 +/-5 ℃ and the material temperature to be less than or equal to 65 ℃, and performing fluidized bed coating; the weight of the coating is increased by 20-25%.
Preferably, the coating agent used in the fluidized bed coating process comprises the following components in parts by weight:
40-50 parts of hydroxypropyl methyl cellulose,
20-30 parts of beta-cyclodextrin,
10-15 parts of chitosan, namely,
10-15 parts of titanium dioxide, namely,
100010-15 parts of polyethylene glycol.
Preferably, the coating agent is prepared into 50-100g/L coating solution for fluidized bed coating.
In conclusion, the composition can improve the stability of cefixime, and ensure that the cefixime has better dissolution rate, thereby improving the bioavailability of the cefixime.
Detailed Description
Example 1
The cefixime composition comprises the following raw materials in parts by weight:
40 parts of cefixime, namely 40 parts of cefixime,
25 parts of microcrystalline cellulose, namely 25 parts of,
18 parts of calcium hydrogen phosphate dihydrate,
5 parts of pregelatinized starch, namely 5 parts of starch,
5 parts of mannitol, namely adding 5 parts of mannitol,
0.8 part of silicon dioxide.
The cefixime is 200-300 meshes;
sieving microcrystalline cellulose with 400 mesh sieve;
the calcium hydrogen phosphate dihydrate is 200 meshes and 300 meshes;
the pregelatinized starch is 100-300 meshes;
the mannitol is 100-300 meshes;
the silicon dioxide is 200-300 meshes.
The preparation method of the cefixime composition comprises the following steps:
mixing microcrystalline cellulose, calcium hydrogen phosphate dihydrate and pregelatinized starch at 15rpm for 10min to obtain a mixture A; mixing mannitol, silicon dioxide and cefixime at 15rpm for 5min to obtain a mixture B;
mix mixture A with mixture B for 3min at 15 rpm.
Example 2
The cefixime composition comprises the following raw materials in parts by weight:
35 parts of cefixime, namely 35 parts of cefixime,
22 parts of microcrystalline cellulose, namely 22 parts of,
15 parts of calcium hydrogen phosphate dihydrate,
3 parts of pregelatinized starch, namely 3 parts of starch,
3 parts of mannitol, namely adding 3 parts of mannitol,
0.5 part of silicon dioxide.
The cefixime is 200-300 meshes;
sieving microcrystalline cellulose with 400 mesh sieve;
the calcium hydrogen phosphate dihydrate is 200 meshes and 300 meshes;
the pregelatinized starch is 100-300 meshes;
the mannitol is 100-300 meshes;
the silicon dioxide is 200-300 meshes.
The preparation method of the cefixime composition comprises the following steps:
mixing microcrystalline cellulose, calcium hydrogen phosphate dihydrate and pregelatinized starch at 10rpm for 12min to obtain a mixture A;
mixing mannitol, silicon dioxide and cefixime at 10rpm for 8min to obtain a mixture B;
mix mixture A with mixture B for 3min at 10 rpm.
Example 3
The cefixime composition comprises the following raw materials in parts by weight:
45 parts of cefixime, namely 45 parts of cefixime,
30 parts of microcrystalline cellulose, namely 30 parts of,
20 parts of calcium hydrogen phosphate dihydrate,
8 parts of pregelatinized starch, namely 8 parts of starch,
8 parts of mannitol, namely 8 parts of mannitol,
and 1 part of silicon dioxide.
The cefixime is 200-300 meshes;
sieving microcrystalline cellulose with 400 mesh sieve;
the calcium hydrogen phosphate dihydrate is 200 meshes and 300 meshes;
the pregelatinized starch is 100-300 meshes;
the mannitol is 100-300 meshes;
the silicon dioxide is 200-300 meshes.
The preparation method of the cefixime composition comprises the following steps:
mixing microcrystalline cellulose, calcium hydrogen phosphate dihydrate and pregelatinized starch at 10rpm for 15min to obtain a mixture A;
mixing mannitol, silicon dioxide and cefixime at 10rpm for 10min to obtain a mixture B;
mix mixture A with mixture B for 5min at 10 rpm.
Example 4
Cefixime granules were prepared using the cefixime compositions of examples 1-3, comprising the steps of:
1. preparing coating agent
The coating agent comprises the following components in parts by weight:
45 parts of hydroxypropyl methyl cellulose, namely 45 parts of hydroxypropyl methyl cellulose,
25 parts of beta-cyclodextrin, namely beta-cyclodextrin,
10 parts of chitosan, namely 10 parts of chitosan,
10 parts of titanium dioxide, namely titanium dioxide,
100010 parts of polyethylene glycol.
The components are weighed according to the proportion, and are mixed to prepare 65g/L coating solution by using water.
2. Granulating
And (3) performing dry granulation on the mixed cefixime composition, wherein the particle size of the particles is 20-40 meshes, further crushing oversize particles, and re-granulating undersize particles.
3. Coating film
Transferring the particles meeting the particle size requirement into a fluidized bed, controlling the air inlet temperature to be 80 +/-5 ℃, controlling the material temperature to be less than or equal to 65 ℃, spraying a coating solution on the particles, increasing the coating weight by 20-25%, obtaining the cefixime granules, and subpackaging.
The dissolution rate and impurity content of cefixime granules prepared from the compositions of examples 1-3 were measured, and the results are shown in table 1.
TABLE 1
Example 5
Cefixime granules prepared according to the method of example 4 were placed at 40 ± 2 ℃ and humidity of 75 ± 5% for 6 months, and the initial dissolution rate, impurity content, and dissolution rate and impurity content after 6 months of placement were measured, respectively, and set as follows:
control group 1
40 parts of cefixime, 25 parts of microcrystalline cellulose, 18 parts of calcium hydrophosphate dihydrate, 5 parts of pregelatinized starch, 5 parts of mannitol and 0.8 part of silicon dioxide; sieving all the raw materials with a 60-mesh sieve, mixing, and performing dry granulation to obtain granules with the particle size of 10-20 meshes; the granules are transferred into a fluidized bed, the air inlet temperature is controlled to be 80 +/-5 ℃, the material temperature is less than or equal to 65 ℃, and coating liquid is sprayed on the granules (the same as the example 4), the coating weight is increased by 20-25%, and the cefixime granules are obtained and subpackaged.
Control group 2
40 parts of cefixime, 45 parts of pregelatinized starch, 10 parts of magnesium stearate and 0.8 part of silicon dioxide. Sieving all the raw materials with a 60-mesh sieve, mixing, and performing dry granulation to obtain granules with the particle size of 10-20 meshes; the granules are transferred into a fluidized bed, the air inlet temperature is controlled to be 80 +/-5 ℃, the material temperature is less than or equal to 65 ℃, and coating liquid is sprayed on the granules (the same as the example 4), the coating weight is increased by 20-25%, and the cefixime granules are obtained and subpackaged.
The results are shown in Table 2.
TABLE 2
Example 6
Dry granulating the cefixime composition of example 1, wherein the particle size of the granules is 20-40 meshes; the obtained granules were made into cefixime granules according to the following method.
Group 1. same as example 4;
group 2. coating solution concentration was 50g/L, the rest of example 4;
group 3. coating solution concentration was 20g/L, the rest of example 4;
group 4. coating weight gain 10-15%, the rest as in example 4;
group 5. coating was performed using a commercially available gastric-soluble type coating agent, as in example 4.
The cefixime granules prepared in each group were placed at 40 ± 2 ℃ and humidity of 75 ± 5% for 6 months, and the initial dissolution rate, impurity content, and dissolution rate and impurity content after 6 months of placement were measured, respectively, and the results are shown in table 3.
TABLE 3
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to the above-described embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (9)
1. The cefixime composition is characterized by comprising the following raw materials in parts by weight:
35-45 parts of cefixime, namely,
22-30 parts of microcrystalline cellulose,
15-20 parts of calcium hydrogen phosphate dihydrate,
3-8 parts of pregelatinized starch,
3-8 parts of mannitol,
0.5-1 part of silicon dioxide.
2. A cefixime composition according to claim 1,
the cefixime is 200-300 meshes;
sieving the microcrystalline cellulose with a 400-mesh sieve;
the calcium hydrophosphate dihydrate is 200-300 meshes;
the pregelatinized starch is 100-300 meshes;
the mannitol is 100-300 meshes;
the silicon dioxide is 200-300 meshes.
3. A process for preparing a cefixime composition according to claim 1 or 2, which comprises the steps of:
uniformly mixing microcrystalline cellulose, calcium hydrophosphate dihydrate and pregelatinized starch to obtain a mixture A;
uniformly mixing mannitol, silicon dioxide and cefixime to obtain a mixture B;
mixing mixture A and mixture B.
4. A process for preparing a cefixime composition according to claim 3, wherein,
mixing microcrystalline cellulose, calcium hydrogen phosphate dihydrate and pregelatinized starch at 10-15rpm for 10-15min to obtain a mixture A;
mixing mannitol, silicon dioxide and cefixime at 10-15rpm for 5-10min to obtain a mixture B;
mixing mixture A and mixture B10-15rpm for 3-5 min.
5. Use of a cefixime composition according to claim 1 or 2 in the preparation of a pharmaceutical formulation of cefixime,
the cefixime composition is added with pharmaceutically acceptable auxiliary materials to prepare a medicinal preparation.
6. The use according to claim 5,
the pharmaceutical preparation comprises granules.
7. The use according to claim 6,
mixing the raw materials of the cefixime composition, and performing dry granulation, wherein the particle size of the particles is 20-40 meshes;
transferring the granules meeting the particle size requirement into a fluidized bed, controlling the air inlet temperature to be 80 +/-5 ℃ and the material temperature to be less than or equal to 65 ℃, and performing fluidized bed coating; the weight of the coating is increased by 20-25%.
8. The use according to claim 7,
the coating agent used in the fluidized bed coating process comprises the following components in parts by weight:
40-50 parts of hydroxypropyl methyl cellulose,
20-30 parts of beta-cyclodextrin,
10-15 parts of chitosan, namely,
10-15 parts of titanium dioxide, namely,
100010-15 parts of polyethylene glycol.
9. The use according to claim 8,
preparing the coating agent into 50-100g/L coating solution for fluidized bed coating.
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Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080069879A1 (en) * | 2006-05-02 | 2008-03-20 | Ravishekhar Bhiwgade | Stable solid dosage form containing amorphous cefditoren pivoxil and process for preparation thereof |
US20090252787A1 (en) * | 2006-07-28 | 2009-10-08 | Dr. Reddy's Laboratories Ltd. | Granular pharmaceutical compositions |
CN103494821A (en) * | 2013-10-01 | 2014-01-08 | 迪沙药业集团有限公司 | Cefixime compound |
CN103655486A (en) * | 2013-12-12 | 2014-03-26 | 人福医药集团股份公司 | Sirolimus micro-emulsion particles and preparation method and application thereof |
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2021
- 2021-05-22 CN CN202110561532.2A patent/CN113332441B/en active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080069879A1 (en) * | 2006-05-02 | 2008-03-20 | Ravishekhar Bhiwgade | Stable solid dosage form containing amorphous cefditoren pivoxil and process for preparation thereof |
US20090252787A1 (en) * | 2006-07-28 | 2009-10-08 | Dr. Reddy's Laboratories Ltd. | Granular pharmaceutical compositions |
CN103494821A (en) * | 2013-10-01 | 2014-01-08 | 迪沙药业集团有限公司 | Cefixime compound |
CN103655486A (en) * | 2013-12-12 | 2014-03-26 | 人福医药集团股份公司 | Sirolimus micro-emulsion particles and preparation method and application thereof |
Non-Patent Citations (1)
Title |
---|
李宁等: "逆向工程研究方法在头孢克肟片研究中应用", 《黑龙江科技信息》 * |
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