CN114617855A - Preparation method of cefalexin capsule - Google Patents
Preparation method of cefalexin capsule Download PDFInfo
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- CN114617855A CN114617855A CN202011469608.0A CN202011469608A CN114617855A CN 114617855 A CN114617855 A CN 114617855A CN 202011469608 A CN202011469608 A CN 202011469608A CN 114617855 A CN114617855 A CN 114617855A
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- cefalexin
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- ZAIPMKNFIOOWCQ-UEKVPHQBSA-N cephalexin Chemical compound C1([C@@H](N)C(=O)N[C@H]2[C@@H]3N(C2=O)C(=C(CS3)C)C(O)=O)=CC=CC=C1 ZAIPMKNFIOOWCQ-UEKVPHQBSA-N 0.000 title claims abstract description 69
- 229940106164 cephalexin Drugs 0.000 title claims abstract description 68
- 239000002775 capsule Substances 0.000 title claims abstract description 38
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- 238000002156 mixing Methods 0.000 claims abstract description 40
- 239000000203 mixture Substances 0.000 claims abstract description 29
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 28
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 14
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims abstract description 13
- 239000001768 carboxy methyl cellulose Substances 0.000 claims abstract description 13
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims abstract description 13
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims abstract description 13
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 12
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 12
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 12
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 12
- 239000008187 granular material Substances 0.000 claims abstract description 10
- 238000011049 filling Methods 0.000 claims abstract description 8
- 238000004519 manufacturing process Methods 0.000 claims abstract description 7
- 238000007908 dry granulation Methods 0.000 claims abstract description 6
- 238000012216 screening Methods 0.000 claims abstract description 6
- 238000000034 method Methods 0.000 claims description 6
- 239000000463 material Substances 0.000 abstract description 10
- 238000004090 dissolution Methods 0.000 description 11
- 239000002994 raw material Substances 0.000 description 4
- 238000005550 wet granulation Methods 0.000 description 3
- 229930186147 Cephalosporin Natural products 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 229940124587 cephalosporin Drugs 0.000 description 2
- 150000001780 cephalosporins Chemical class 0.000 description 2
- 239000007903 gelatin capsule Substances 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 108090000204 Dipeptidase 1 Proteins 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 229920003081 Povidone K 30 Polymers 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- JBDGDEWWOUBZPM-XYPYZODXSA-N ambroxol Chemical compound NC1=C(Br)C=C(Br)C=C1CN[C@@H]1CC[C@@H](O)CC1 JBDGDEWWOUBZPM-XYPYZODXSA-N 0.000 description 1
- 229960005174 ambroxol Drugs 0.000 description 1
- 102000006635 beta-lactamase Human genes 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 210000002421 cell wall Anatomy 0.000 description 1
- RQFQJYYMBWVMQG-IXDPLRRUSA-N chitotriose Chemical compound O[C@@H]1[C@@H](N)[C@H](O)O[C@H](CO)[C@H]1O[C@H]1[C@H](N)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)N)[C@@H](CO)O1 RQFQJYYMBWVMQG-IXDPLRRUSA-N 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- 229940090589 keflex Drugs 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 239000005022 packaging material Substances 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229960000540 polacrilin potassium Drugs 0.000 description 1
- WVWZXTJUCNEUAE-UHFFFAOYSA-M potassium;1,2-bis(ethenyl)benzene;2-methylprop-2-enoate Chemical compound [K+].CC(=C)C([O-])=O.C=CC1=CC=CC=C1C=C WVWZXTJUCNEUAE-UHFFFAOYSA-M 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
- A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- 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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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a preparation method of cefalexin capsules, which comprises the following steps: placing the first weight part of cefalexin, the second weight part of microcrystalline cellulose and the third weight part of sodium carboxymethyl cellulose in a mixer for mixing for a first preset time to obtain a first mixture; adding a fourth weight part of cefalexin to the mixer, and mixing the cefalexin with the first mixture for a second preset time to obtain a second mixture; the second mixture was added to a dry granulator and granulated according to the following parameters: granulating and screening: 18-24 meshes, roller pressure: 10-20 MPa; mixing the granules prepared by the dry granulation machine with a fifth weight part of magnesium stearate for a third preset time to obtain a cefalexin finished product; and filling the cefalexin finished product into capsules. The invention reduces the use of auxiliary materials in the production process of the cefalexin capsule and reduces the production cost.
Description
Technical Field
The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of cefalexin capsules.
Background
Cephalexin, also known as cephalosporin IV and cephalosporin IV, is a semi-synthetic beta-lactamase antibiotic. Cephalexin has broad-spectrum antibacterial effect, and can effectively inhibit the synthesis of gram-positive bacteria and gram-negative bacteria cell walls, so that cell contents can swell, crack and dissolve to achieve the bactericidal effect. The traditional production process of cefalexin comprises wet granulation, dry granulation and the like. The wet granulation process is complex, more water can be introduced, and cefalexin is easy to degrade, so that the product quality is influenced. Compared with wet granulation, dry granulation can directly prepare materials into granular products meeting customer requirements without consuming intermediate additives, and the granulated products have uniform density and remarkably increased bulk density.
However, in the prior art, in order to achieve a high dissolution rate of the cefalexin capsule, many auxiliary materials are often required to be added, for example, chinese patent application No. CN201510067701.1 discloses a compound cefalexin capsule and a preparation method thereof, wherein the following contents are specifically disclosed: the cefalexin capsule provided by the invention comprises the following raw material components: 270 parts of cefalexin, 2-20 parts of ambroxol, 25-125 parts of polacrilin potassium, 50-100 parts of chitosan oligosaccharide, 5-50 parts of talcum powder and 10-75 parts of starch. Such a large amount of auxiliary materials greatly increases the production cost of cefalexin capsules.
Disclosure of Invention
The invention mainly aims to provide a preparation method of cefalexin capsules, and aims to solve the problem that in the prior art, a lot of auxiliary materials are used in the production process of cefalexin capsules, so that the production cost is high.
In order to achieve the purpose, the invention provides a preparation method of cefalexin capsules, which comprises the following steps:
placing the first weight part of cefalexin, the second weight part of microcrystalline cellulose and the third weight part of sodium carboxymethyl cellulose in a mixer for mixing for a first preset time to obtain a first mixture;
adding a fourth weight part of cefalexin to the mixer, and mixing the cefalexin with the first mixture for a second preset time to obtain a second mixture;
the second mixture was added to a dry granulator and granulated according to the following parameters:
granulating and screening: the mesh size of the sieve is 18-24 meshes,
roller pressure: 10-20 MPa;
mixing the granules prepared by the dry granulation machine with a fifth weight part of magnesium stearate for a third preset time to obtain a cefalexin finished product;
and filling the cefalexin finished product into capsules.
Preferably, the first weight part is 120 to 130 weight parts, the second weight part is 40 to 50 weight parts, the third weight part is 1.5 to 4.5 weight parts, the fourth weight part is 120 to 130 weight parts, and the fifth weight part is 1.5 to 4.5 weight parts.
Preferably, the first weight part is 125 weight parts, the second weight part is 44 weight parts, the third weight part is 3 weight parts, the fourth weight part is 125 weight parts, and the fifth weight part is 3 weight parts.
Preferably, the mixer is a three-dimensional motion mixer.
Preferably, the first preset time is 10-20 min, and the second preset time is 10-20 min.
Preferably, the third preset time is 4-6 min.
According to the technical scheme, cefalexin is divided into two times to be mixed with microcrystalline cellulose and sodium carboxymethylcellulose, then the mixture is added into a dry-process granulator to be granulated according to corresponding roller pressure and the mesh number of a granulating screen, then the mixture is mixed with magnesium stearate for corresponding time, and finally the obtained cefalexin finished product is filled into capsules, so that a cefalexin capsule product with high dissolution rate is obtained.
Drawings
Fig. 1 is a flow chart of the steps of an embodiment of the preparation method of cefalexin capsules of the present invention.
Detailed Description
In the following, the embodiments of the present invention will be described in detail with reference to the accompanying drawings, and it is apparent that the embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The invention provides a preparation method of cefalexin capsules, and the preparation method comprises the following steps of:
and S100, placing the first weight part of cefalexin, the second weight part of microcrystalline cellulose and the third weight part of sodium carboxymethyl cellulose in a mixer, and mixing for a first preset time to obtain a first mixture. In the step, cefalexin is used as a raw material drug, microcrystalline cellulose and sodium carboxymethyl cellulose are used as auxiliary materials, wherein the microcrystalline cellulose plays a role of a filler, and the sodium carboxymethyl cellulose plays a role of an adhesive. Sodium carboxymethylcellulose can also be replaced here by povidone K30. Weighing cefalexin, microcrystalline cellulose and sodium carboxymethylcellulose in corresponding parts by weight respectively, and putting the cefalexin, the microcrystalline cellulose and the sodium carboxymethylcellulose into a mixer, wherein the mixer can be a square cone mixer. When a two-dimensional motion mixer such as a square cone mixer is selected, the mixing time can be properly prolonged, for example, the first preset time is 20-30 min, but the specific mixing time needs to be different in equipment and different in processing technological parameters, the judgment of the mixing end point is based on the content uniformity, and when the content uniformity is less than 5%, the mixing can be stopped.
And step S200, adding a fourth weight part of cefalexin into the mixer, and mixing the cefalexin with the first mixture for a second preset time to obtain a second mixture. In this step, cephalexin in the corresponding weight portion is continuously added into the mixer to be mixed with the first mixture. The cefalexin raw material and the auxiliary materials of microcrystalline cellulose and sodium carboxymethylcellulose are mixed in two steps, so that the mixing uniformity of the auxiliary materials can be greatly improved. The second preset time may be the same as the first preset time, for example, when the mixing is performed by using a square cone mixer, the mixing time may be 20 to 30 min.
Step S300, adding the second mixture into a dry granulator, and granulating according to the following parameters:
granulating and screening: the mesh size of the sieve is 18-24 meshes,
roller pressure: 10 to 20 MPa. In this step, the dry granulator is started by adding the second mixture into the dry granulator, and corresponding parameters are adjusted to granulate, for example, the mesh number of the granulating screen can be 18 meshes, 24 meshes, etc.; the rolling pressure can be 10MPa, 15MPa, 20MPa and the like.
And step S400, mixing the granules prepared by the dry granulator and a fifth part by weight of magnesium stearate for a third preset time to obtain a cefalexin finished product. In this step, magnesium stearate is a lubricant. And adding the cefalexin granules prepared by the dry granulator and the corresponding weight parts of magnesium stearate into the mixer, wherein the mixing time is adjusted according to the equipment parameters of the mixer, for example, when a square cone mixer is adopted, the mixing time can be 6-8 min.
And step S500, filling the cefalexin finished product into capsules. In the step, the cefalexin finished product is also required to be filled into a gelatin capsule to be prepared into a cefalexin capsule product. The filling is usually carried out by means of a capsule filling machine, the type of capsule used being generally # 2 gelatin capsules.
In a preferred embodiment, the first weight portion is 120 to 130 weight portions, the second weight portion is 40 to 50 weight portions, the third weight portion is 1.5 to 4.5 weight portions, the fourth weight portion is 120 to 130 weight portions, and the fifth weight portion is 1.5 to 4.5 weight portions.
In this embodiment, the preparation method of cefalexin capsules comprises the following steps: placing 120-130 parts by weight of cefalexin, 40-50 parts by weight of microcrystalline cellulose and 1.5-4.5 parts by weight of sodium carboxymethylcellulose into a mixer, and mixing for a first preset time to obtain a first mixture; adding 120-130 parts by weight of cefalexin into a mixer, and mixing with the first mixture for a second preset time to obtain a second mixture; the second mixture was added to a dry granulator and granulated according to the following parameters: granulating and screening: 18-24 meshes, roller pressure: 10-20 MPa; mixing the granules prepared by the dry granulator with 1.5-4.5 parts by weight of magnesium stearate for a third preset time to obtain a cefalexin finished product; and filling the cefalexin finished product into capsules.
In a preferred embodiment, the first weight part is 125 weight parts, the second weight part is 44 weight parts, the third weight part is 3 weight parts, the fourth weight part is 125 weight parts, and the fifth weight part is 3 weight parts.
In this embodiment, the preparation method of cefalexin capsules comprises the following steps: placing 125 parts by weight of cefalexin, 44 parts by weight of microcrystalline cellulose and 3 parts by weight of sodium carboxymethylcellulose into a mixer to mix for a first preset time to obtain a first mixture; adding 125 parts by weight of cefalexin into a mixer, and mixing with the first mixture for a second preset time to obtain a second mixture; the second mixture was added to a dry granulator and granulated according to the following parameters: granulating and screening: 18-24 meshes, roller pressure: 10-20 MPa; mixing the granules prepared by the dry granulator with 3 parts by weight of magnesium stearate for a third preset time to obtain a cefalexin finished product; and filling the cefalexin finished product into capsules.
In a preferred embodiment, the mixer is a three-dimensional motion mixer.
In this embodiment, compare in two-dimensional motion's square cone mixer, three-dimensional motion mixes the machine and can three-dimensionally rotate, can improve mixing efficiency by a wide margin, increases the content degree of consistency that the raw and auxiliary materials mixed, and mixing time also shortens thereupon.
In a preferred embodiment, the first predetermined time is 10 to 20min, and the second predetermined time is 10 to 20 min.
In this embodiment, the second preset time may be the same as the first preset time. Just by adopting the three-dimensional motion mixer, the mixing time (namely the first preset time and the second preset time) of the raw materials and the auxiliary materials can be shortened to 10-20 min, and generally, the preferred mixing time is 15 min.
The specific mixing time also needs to consider the difference of equipment and the difference of processing technological parameters, the judgment of the mixing end point is based on the content uniformity, and when the content uniformity is less than 5%, the mixing can be stopped.
In a preferred embodiment, the third predetermined time is 4-6 min.
In this embodiment, when the granules obtained by the dry granulation machine and magnesium stearate are mixed by using a three-dimensional motion mixer, the mixing time may be 4 to 6min, and generally, 5min is preferred.
The dissolution rate test of the cefalexin capsule product prepared by the scheme of the invention comprises the following steps:
1. prescription
| Prescription | Roller pressure/Mpa | Mesh/mesh of granulating screen | Mixing time/min of magnesium stearate |
| 1 | 10 | 18 | 5 |
| 2 | 15 | 18 | 5 |
| 3 | 20 | 18 | 5 |
| 4 | 15 | 24 | 5 |
| 5 | 15 | 18 | 10 |
2. Reference formulation information:
| the country on the market | USA |
| Trade name | Keflex |
| Batch number | FP8326A |
| Dosage forms | Capsule preparation |
| Specification of | 250mg |
| Tablet/capsule weight | 0.3480g/0.3595g average 0.3538g |
| Plain tablet/content weight | 0.2899g/0.2963g average 0.2931g |
| Size (length, width, thickness) | No. 1 capsule |
| Sheet/content moisture | 5.46％ |
| Inner packaging material | HDPE bottle |
| Storage conditions | Storing at room temperature in sealed condition |
| Unit packing volume (box/bottle) | 100 granules/bottle |
3. Detection method
4. The dissolution rates of the cefalexin capsules prepared according to the formula 1, the formula 2, the formula 3, the formula 4 and the formula 5 are measured according to a dissolution rate measuring method, and the roller pressure, the number of granulation screens and the mixing time of magnesium stearate are respectively considered:
1.) roller pressure survey
And (4) conclusion: the roller pressure in the dry-method granulator influences the dissolution rate of the product, the dissolution rate of the product is slowed down when the roller pressure is higher, but when the roller pressure is lower, more fine powder exists, the product flowability is poor, and the roller pressure of the formula 2 is finally selected to be 15 MPa.
2.) examination of the mesh size of the granulation Screen
And (4) conclusion: in the dry granulator, the mesh number of the granulating screen has an influence on the dissolution rate of the product, when the mesh number of the granulating screen is larger, the dissolution rate of the product is slowed down, and finally the 18-mesh granulating screen of the formula 2 is selected.
3.) magnesium stearate mixing time study
And (4) conclusion: the magnesium stearate mixing time has influence on the dissolution rate of the product, the dissolution rate of the product is slowed down when the mixing time is longer, and the mixing time of the prescription 2 is finally selected for 5 min.
The above description is only a part of or preferred embodiments of the present invention, and neither the text nor the drawings should be construed as limiting the scope of the present invention, and all equivalent structural changes, which are made by using the contents of the present specification and the drawings, or any other related technical fields, are included in the scope of the present invention.
Claims (6)
1. A preparation method of cefalexin capsules is characterized by comprising the following steps:
placing the first weight part of cefalexin, the second weight part of microcrystalline cellulose and the third weight part of sodium carboxymethyl cellulose in a mixer for mixing for a first preset time to obtain a first mixture;
adding a fourth weight part of cefalexin to the mixer, and mixing the cefalexin with the first mixture for a second preset time to obtain a second mixture;
the second mixture was added to a dry granulator and granulated according to the following parameters:
granulating and screening: the mesh size of the sieve is 18-24 meshes,
roller pressure: 10-20 MPa;
mixing the granules prepared by the dry granulation machine with a fifth weight part of magnesium stearate for a third preset time to obtain a cefalexin finished product;
and filling the cefalexin finished product into capsules.
2. The process for preparing cefalexin capsules according to claim 1, wherein the first weight part is 120 to 130 parts, the second weight part is 40 to 50 parts, the third weight part is 1.5 to 4.5 parts, the fourth weight part is 120 to 130 parts, and the fifth weight part is 1.5 to 4.5 parts.
3. A process for the preparation of cefalexin capsules according to claim 2, wherein the first part by weight is 125 parts by weight, the second part by weight is 44 parts by weight, the third part by weight is 3 parts by weight, the fourth part by weight is 125 parts by weight, and the fifth part by weight is 3 parts by weight.
4. Process for the preparation of cephalexin capsules according to claim 1, characterised in that the mixer is a three-dimensional motion mixer.
5. The process for the preparation of cefalexin capsules according to claim 4, wherein the first predetermined time is 10-20 min and the second predetermined time is 10-20 min.
6. The process for the preparation of cefalexin capsules according to claim 4, wherein the third predetermined time is 4-6 min.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1543543A (en) * | 1976-05-13 | 1979-04-04 | Shionogi & Co | Long acting preparation of cefalexin |
| CN110613697A (en) * | 2019-10-30 | 2019-12-27 | 长春迪瑞制药有限公司 | Cefalexin capsule and preparation method thereof |
| CN110917160A (en) * | 2019-12-04 | 2020-03-27 | 北京悦康科创医药科技股份有限公司 | Cefalexin tablet and preparation method thereof |
| CN112022830A (en) * | 2020-08-04 | 2020-12-04 | 华北制药河北华民药业有限责任公司 | Preparation method of cefalexin capsules |
-
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- 2020-12-14 CN CN202011469608.0A patent/CN114617855A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1543543A (en) * | 1976-05-13 | 1979-04-04 | Shionogi & Co | Long acting preparation of cefalexin |
| CN110613697A (en) * | 2019-10-30 | 2019-12-27 | 长春迪瑞制药有限公司 | Cefalexin capsule and preparation method thereof |
| CN110917160A (en) * | 2019-12-04 | 2020-03-27 | 北京悦康科创医药科技股份有限公司 | Cefalexin tablet and preparation method thereof |
| CN112022830A (en) * | 2020-08-04 | 2020-12-04 | 华北制药河北华民药业有限责任公司 | Preparation method of cefalexin capsules |
Non-Patent Citations (1)
| Title |
|---|
| 刘雅敏等: "《药物制剂常用辅料》", 31 January 1994, 天津科技翻译出版公司, pages: 243 - 244 * |
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