CN112156082A - Amoxicillin capsule preparation method and amoxicillin capsule - Google Patents
Amoxicillin capsule preparation method and amoxicillin capsule Download PDFInfo
- Publication number
- CN112156082A CN112156082A CN202011276505.2A CN202011276505A CN112156082A CN 112156082 A CN112156082 A CN 112156082A CN 202011276505 A CN202011276505 A CN 202011276505A CN 112156082 A CN112156082 A CN 112156082A
- Authority
- CN
- China
- Prior art keywords
- amoxicillin
- capsule
- granules
- magnesium stearate
- silicon dioxide
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Classifications
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/429—Thiazoles condensed with heterocyclic ring systems
- A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
-
- 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
- A61J3/074—Filling capsules; Related operations
-
- 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
- A61K9/4833—Encapsulating processes; Filling of 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
- A61K9/485—Inorganic compounds
-
- 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
- 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
- A61K9/4866—Organic macromolecular 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
-
- 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
- A61K9/1611—Inorganic compounds
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (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)
Abstract
The application discloses amoxicillin capsule preparation method and amoxicillin capsule, through improving amoxicillin capsule prescription, select the raw materials amoxicillin heavy powder granule that the particle size is less than 20 meshes, and limited the content of the amoxicillin heavy powder granule that the particle size range is between 20 ~ 60 meshes respectively, be convenient for dissolve in the human body, thereby guaranteed that the capsule is long-lived stable dissolving out in the human body, increase supplementary product silicon dioxide, magnesium stearate and carboxymethyl starch sodium that pass 40 mesh sieve, add the raw and auxiliary materials according to amoxicillin granule, carboxymethyl starch sodium, silicon dioxide, magnesium stearate, the order of amoxicillin granule in the mixer, mix, be favorable to accelerating amoxicillin and dissolve, guaranteed the higher degree of dissolving out of amoxicillin. Therefore, the dissolution rate of the amoxicillin capsule can be improved by selecting proper auxiliary materials and adjusting the placing sequence and mixing time of the medicinal materials, the amoxicillin capsule with high dissolution rate is prepared, and the technical problem of low dissolution rate of the existing amoxicillin capsule is solved.
Description
Technical Field
The application relates to the technical field of amoxicillin, in particular to an amoxicillin capsule preparation method and an amoxicillin capsule.
Background
Amoxicillin, also known as amoxicillin or amoxicillin, is one of the most commonly used penicillins, broad-spectrum beta-lactam
The amine antibiotic, a white powder, had a half-life of about 61.3 minutes. Is stable under acidic condition, and the gastrointestinal absorption rate is up to 90%. The amoxicillin has strong bactericidal effect and strong ability of penetrating cell walls. Is one of the oral penicillins which are widely applied at present, and the preparations of the oral penicillins comprise capsules, tablets, granules and the like. Patients with penicillin allergy and penicillin skin test positive are forbidden. The amoxicillin is suitable for the infection of the upper respiratory tract caused by sensitive bacteria (not producing beta-lactamase bacterial strain), such as otitis, sinusitis, pharyngitis, tonsillitis, etc., the infection of genitourinary tract, skin and soft tissue, and the infection of the lower respiratory tract caused by acute bronchitis, pneumonia, etc.
Amoxicillin is used as a broad-spectrum antibiotic and becomes a basic anti-infective medicament which is most widely applied clinically. The preparation can be capsules, tablets, granules and the like. Wherein the amoxicillin capsules belong to a category A in a national basic medical insurance drug category. However, in recent years, due to adverse reactions, market competition, drug resistance and the like, the market explosion and red-going will become the past. Therefore, the method conforms to the market, focuses on developing new products, new formulations and new applications, researches on the preparation and development of the amoxicillin capsules, and aims to realize a set of economic and reasonable preparation process of the amoxicillin capsules with stable product quality.
At present, the amoxicillin capsule sold in the market is often added with the disintegrating agents such as crospovidone, sodium carboxymethyl starch and the like for granulation so as to achieve the purposes of quick disintegration and quick dissolution, but the problems of high polymer impurities and large individual dissolution difference exist, and the auxiliary material magnesium stearate is used as a lubricant and can reduce the dissolution rate of the amoxicillin capsule due to the hydrophobic property of the magnesium stearate.
Disclosure of Invention
The application provides an amoxicillin capsule preparation method and an amoxicillin capsule, which are used for solving the technical problem of low dissolution rate of the existing amoxicillin capsule.
In view of the above, the present application provides a method for preparing amoxicillin capsules, comprising the following steps:
s1: preparing raw materials and auxiliary materials, wherein the raw materials comprise: amoxicillin, the auxiliary materials include: silicon dioxide, magnesium stearate and sodium starch glycolate;
s2: sieving, namely respectively sieving the silicon dioxide, the carboxymethyl starch sodium and the magnesium stearate by a 40-mesh sieve;
s3: weighing ingredients, namely weighing the amoxicillin, the silicon dioxide, the sodium carboxymethyl starch and the magnesium stearate according to the prescription amount, and marking;
s4: granulating, namely adding the raw material amoxicillin into a dry-process granulator and granulating through a 0.8mm screen to obtain amoxicillin granules, sucking the prepared amoxicillin granules into a ternary rotary vibration sieve through a vacuum feeding machine, removing coarse granules by using a 20-mesh screen, removing fine granules by using a 60-mesh screen, repeatedly granulating the coarse granules, and collecting heavy powder granules;
s5: mixing, namely adding the raw and auxiliary materials into a mixing machine according to the sequence of the amoxicillin granules, the carboxymethyl starch sodium, the silicon dioxide, the magnesium stearate and the amoxicillin granules, closing a feeding port, setting the mixing time to be 10-30 minutes, and mixing at a constant speed to obtain an intermediate product;
s6: inspecting the intermediate product, taking the intermediate product to detect properties, identify, moisture and content, and calculating the filling amount according to the content;
s7: filling, and generating a production instruction according to the filling amount to control a full-automatic capsule filling machine to prepare the amoxicillin capsule.
Optionally, the temperature of said sieving, said weighing, said compounding, said granulating, said mixing and said filling is between 18 ℃ and 26 ℃.
Optionally, the moisture of said sieving, said weighing, said granulating, said mixing and said filling is between 45% and 65%.
Optionally, in step S4, the pressure of the dry granulator is 8 to 10MPa, and the gap between the rollers is 0.6 to 0.9 mm; the rotating speed of the press roll is 15-20 r/min; the rotating speed of the ternary rotary vibration sieve is 100-120 r/min.
Optionally, in step S5, adding the raw and auxiliary materials into the mixer in the order of amoxicillin granules, carboxymethyl starch sodium, silicon dioxide, magnesium stearate, amoxicillin granules, and setting the mixing time to 10-25 minutes.
Optionally, in step S5, adding the raw and auxiliary materials into the mixer in the order of amoxicillin granules, carboxymethyl starch sodium, silicon dioxide, magnesium stearate, amoxicillin granules, and setting the mixing time to 10-20 minutes.
Optionally, the filling speed of the full-automatic capsule filling machine in the step S7 is 2000-2500 granules/minute.
In a second aspect, the present application provides an amoxicillin capsule prepared according to the amoxicillin capsule preparation method of any one of claims 1-7.
Optionally, the amoxicillin capsule comprises the following raw materials: 250-255 parts of amoxicillin, 1.25-1.3 parts of silicon dioxide, 1-1.1 parts of magnesium stearate and 5-5.5 parts of carboxymethyl starch sodium.
Optionally, the single particle weight of the amoxicillin capsules is 0.25 g.
According to the technical scheme, the embodiment of the application has the following advantages:
the application provides a preparation method of an amoxicillin capsule, which comprises the following steps: s1: preparing raw materials and auxiliary materials, wherein the raw materials comprise: amoxicillin, the auxiliary materials include: silicon dioxide, magnesium stearate and sodium starch glycolate; s2: sieving, namely respectively sieving the silicon dioxide, the carboxymethyl starch sodium and the magnesium stearate by a 40-mesh sieve; s3: weighing ingredients, namely weighing amoxicillin, silicon dioxide, sodium carboxymethyl starch and magnesium stearate according to the formula amount, and marking; s4: granulating, namely adding the raw material amoxicillin into a dry-process granulator and granulating through a 0.8mm screen to obtain amoxicillin granules, sucking the prepared amoxicillin granules into a ternary rotary vibration sieve through a vacuum feeder, removing coarse granules by using a 20-mesh screen, removing fine granules by using a 60-mesh screen, repeatedly granulating the coarse granules, and collecting heavy powder granules; s5: mixing, namely adding the raw and auxiliary materials into a mixing machine according to the sequence of amoxicillin granules, sodium carboxymethyl starch, silicon dioxide, magnesium stearate and amoxicillin granules, closing a feeding port, setting the mixing time to be 10-30 minutes, and mixing at a constant speed to obtain an intermediate product; s6: inspecting the intermediate product, taking the intermediate product to detect properties, identify, moisture and content, and calculating the filling amount according to the content; s7: filling, and generating a production instruction according to the filling amount to control a full-automatic capsule filling machine to prepare the amoxicillin capsule.
The application provides a preparation method of amoxicillin capsules, which comprises the steps of preparing raw materials of amoxicillin and auxiliary materials of silicon dioxide, magnesium stearate and sodium carboxymethyl starch, sieving the silicon dioxide, the sodium carboxymethyl starch and the magnesium stearate with a 40-mesh sieve respectively, weighing the amoxicillin, the silicon dioxide, the sodium carboxymethyl starch and the magnesium stearate according to the prescription amount, marking, adding the raw materials of amoxicillin into a dry granulator, granulating through a 0.8mm sieve to obtain amoxicillin particles, sucking the finished amoxicillin particles into a three-dimensional rotary vibration sieve through a vacuum feeding machine, removing coarse particles by using a 20-mesh sieve, removing fine particles by using a 60-mesh sieve, repeatedly granulating the coarse particles, collecting heavy powder particles, selecting the raw materials of amoxicillin heavy powder particles with the particle size of less than 20 meshes, limiting the content of the amoxicillin heavy powder particles with the particle size range of 20-60 meshes respectively, and facilitating dissolution in a human body, therefore, the long-acting stable dissolution of the capsule in a human body is ensured, the raw and auxiliary materials are added into the mixing machine according to the sequence of the amoxicillin granules, the carboxymethyl starch sodium, the silicon dioxide, the magnesium stearate and the amoxicillin granules, the feeding port is closed, the mixing time is set to be 10-30 minutes, the mixing is carried out at a constant speed, the accelerated dissolution of the amoxicillin is facilitated, and the higher dissolution rate of the amoxicillin is ensured. And obtaining an intermediate product, detecting the characters, identifying, moisture and content of the intermediate product, calculating the filling amount according to the content, and generating a production instruction according to the filling amount to control a full-automatic capsule filling machine to prepare the amoxicillin capsule. Therefore, the dissolution rate of the amoxicillin capsule can be improved by selecting proper auxiliary materials and adjusting the placing sequence and mixing time of the medicinal materials, the amoxicillin capsule with high dissolution rate is prepared, and the technical problem of low dissolution rate of the existing amoxicillin capsule is solved.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments described in the present application, and other drawings can be obtained by those skilled in the art according to the drawings.
Fig. 1 is a schematic flow chart of a preparation method of amoxicillin capsules provided in the embodiments of the present application.
Detailed Description
In order to make the technical solutions of the present application better understood, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, 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 application.
Example 1
For easy understanding, please refer to fig. 1, a method for preparing amoxicillin capsules comprises the following steps:
s1: preparing raw materials and auxiliary materials, wherein the raw materials comprise 250 parts by weight of amoxicillin, and the auxiliary materials comprise 1.25 parts by weight of silicon dioxide, 1 part by weight of magnesium stearate and 5 parts by weight of carboxymethyl starch sodium;
s2: sieving, namely respectively sieving silicon dioxide, sodium carboxymethyl starch and magnesium stearate by a 40-mesh sieve at the temperature of 18-26 ℃ and the humidity of 45-65%;
s3: weighing ingredients, namely weighing amoxicillin, silicon dioxide, sodium carboxymethyl starch and magnesium stearate according to the formula, and marking at the temperature of 18-26 ℃ and the humidity of 45-65%;
s4: granulating, namely adding the raw material amoxicillin into a dry granulating machine, and granulating through a 0.8mm screen to obtain amoxicillin granules, wherein the pressure of a compression roller of the dry granulating machine is 8-10 MPa, and the gap between the compression rollers is 0.6-0.9 mm; the rotating speed of the press roll is 15-20 r/min; sucking the finished amoxicillin particles into a ternary rotary vibration sieve by a vacuum feeding machine at the rotating speed of 100-120 r/min, removing coarse particles by using a 20-mesh screen, removing fine particles by using a 60-mesh screen, and finishing the coarse particles repeatedly to obtain heavy powder particles, wherein the temperature is 18-26 ℃, and the humidity is 45-65%;
s5: mixing, namely adding the raw and auxiliary materials into a mixing machine according to the sequence of amoxicillin granules, sodium carboxymethyl starch, silicon dioxide, magnesium stearate and amoxicillin granules, closing a feeding port, setting the mixing time to be 10 minutes, and mixing at a constant speed to obtain an intermediate product, wherein the temperature is 18-26 ℃, and the humidity is 45-65%; preferably, the amoxicillin granules added firstly are half of the prescription amount, and the amoxicillin granules added later are the other half of the prescription amount;
s6: inspecting the intermediate product, taking the intermediate product to detect properties, identify, moisture and content, and calculating the filling amount according to the content;
s7: filling, namely controlling a full-automatic capsule filling machine according to a filling production instruction to obtain the amoxicillin capsule, wherein the filling speed of the full-automatic capsule filling machine is 2000-2500 granules/minute, the temperature is 18-26 ℃, and the humidity is 45-65%, so that the amoxicillin capsule is prepared.
Example 2
A preparation method of amoxicillin capsules comprises the following steps:
s1: preparing raw materials and auxiliary materials, wherein the raw materials comprise 250 parts by weight of amoxicillin, and the auxiliary materials comprise 1.25 parts by weight of silicon dioxide, 1 part by weight of magnesium stearate and 5 parts by weight of carboxymethyl starch sodium;
s2: sieving, namely respectively sieving silicon dioxide, sodium carboxymethyl starch and magnesium stearate by a 40-mesh sieve at the temperature of 18-26 ℃ and the humidity of 45-65%;
s3: weighing ingredients, namely weighing amoxicillin, silicon dioxide, sodium carboxymethyl starch and magnesium stearate according to the formula, and marking at the temperature of 18-26 ℃ and the humidity of 45-65%;
s4: granulating, namely adding the raw material amoxicillin into a dry granulating machine, and granulating through a 0.8mm screen to obtain amoxicillin granules, wherein the pressure of a compression roller of the dry granulating machine is 8-10 MPa, and the gap between the compression rollers is 0.6-0.9 mm; the rotating speed of the press roll is 15-20 r/min; sucking the finished amoxicillin particles into a ternary rotary vibration sieve by a vacuum feeding machine at the rotating speed of 100-120 r/min, removing coarse particles by using a 20-mesh screen, removing fine particles by using a 60-mesh screen, and finishing the coarse particles repeatedly to obtain heavy powder particles, wherein the temperature is 18-26 ℃, and the humidity is 45-65%;
s5: mixing, namely adding the raw and auxiliary materials into a mixing machine according to the sequence of amoxicillin granules, sodium carboxymethyl starch, silicon dioxide, magnesium stearate and amoxicillin granules, closing a feeding port, setting the mixing time to be 20 minutes, and mixing at a constant speed to obtain an intermediate product, wherein the temperature is 18-26 ℃, and the humidity is 45-65%; preferably, the amoxicillin granules added firstly are half of the prescription amount, and the amoxicillin granules added later are the other half of the prescription amount;
s6: inspecting the intermediate product, taking the intermediate product to detect properties, identify, moisture and content, and calculating the filling amount according to the content;
s7: filling, namely controlling a full-automatic capsule filling machine according to a filling production instruction to obtain the amoxicillin capsule, wherein the filling speed of the full-automatic capsule filling machine is 2000-2500 granules/minute, the temperature is 18-26 ℃, and the humidity is 45-65%, so that the amoxicillin capsule is prepared.
Example 3
A preparation method of amoxicillin capsules comprises the following steps:
s1: preparing raw materials and auxiliary materials, wherein the raw materials comprise 250 parts by weight of amoxicillin, and the auxiliary materials comprise 1.25 parts by weight of silicon dioxide, 1 part by weight of magnesium stearate and 5 parts by weight of carboxymethyl starch sodium;
s2: sieving, namely respectively sieving silicon dioxide, sodium carboxymethyl starch and magnesium stearate by a 40-mesh sieve at the temperature of 18-26 ℃ and the humidity of 45-65%;
s3: weighing ingredients, namely weighing amoxicillin, silicon dioxide, sodium carboxymethyl starch and magnesium stearate according to the formula, and marking at the temperature of 18-26 ℃ and the humidity of 45-65%;
s4: granulating, namely adding the raw material amoxicillin into a dry granulating machine, and granulating through a 0.8mm screen to obtain amoxicillin granules, wherein the pressure of a compression roller of the dry granulating machine is 8-10 MPa, and the gap between the compression rollers is 0.6-0.9 mm; the rotating speed of the press roll is 15-20 r/min; sucking the finished amoxicillin particles into a ternary rotary vibration sieve by a vacuum feeding machine at the rotating speed of 100-120 r/min, removing coarse particles by using a 20-mesh screen, removing fine particles by using a 60-mesh screen, and finishing the coarse particles repeatedly to obtain heavy powder particles, wherein the temperature is 18-26 ℃, and the humidity is 45-65%;
s5: mixing, namely adding the raw and auxiliary materials into a mixing machine according to the sequence of amoxicillin granules, sodium carboxymethyl starch, silicon dioxide, magnesium stearate and amoxicillin granules, closing a feeding port, setting the mixing time to be 25 minutes, and mixing at a constant speed to obtain an intermediate product, wherein the temperature is 18-26 ℃, and the humidity is 45-65%; preferably, the amoxicillin granules added firstly are half of the prescription amount, and the amoxicillin granules added later are the other half of the prescription amount;
s6: inspecting the intermediate product, taking the intermediate product to detect properties, identify, moisture and content, and calculating the filling amount according to the content;
s7: filling, namely controlling a full-automatic capsule filling machine according to a filling production instruction to obtain the amoxicillin capsule, wherein the filling speed of the full-automatic capsule filling machine is 2000-2500 granules/minute, the temperature is 18-26 ℃, and the humidity is 45-65%, so that the amoxicillin capsule is prepared.
Example 4
A preparation method of amoxicillin capsules comprises the following steps:
s1: preparing raw materials and auxiliary materials, wherein the raw materials comprise 255 parts by weight of amoxicillin, and the auxiliary materials comprise 1.3 parts by weight of silicon dioxide, 1.1 parts by weight of magnesium stearate and 5.5 parts by weight of carboxymethyl starch sodium;
s2: sieving, namely respectively sieving silicon dioxide, sodium carboxymethyl starch and magnesium stearate by a 40-mesh sieve at the temperature of 18-26 ℃ and the humidity of 45-65%;
s3: weighing ingredients, namely weighing amoxicillin, silicon dioxide, sodium carboxymethyl starch and magnesium stearate according to the formula, and marking at the temperature of 18-26 ℃ and the humidity of 45-65%;
s4: granulating, namely adding the raw material amoxicillin into a dry granulating machine, and granulating through a 0.8mm screen to obtain amoxicillin granules, wherein the pressure of a compression roller of the dry granulating machine is 8-10 MPa, and the gap between the compression rollers is 0.6-0.9 mm; the rotating speed of the press roll is 15-20 r/min; sucking the finished amoxicillin particles into a ternary rotary vibration sieve by a vacuum feeding machine at the rotating speed of 100-120 r/min, removing coarse particles by using a 20-mesh screen, removing fine particles by using a 60-mesh screen, and finishing the coarse particles repeatedly to obtain heavy powder particles, wherein the temperature is 18-26 ℃, and the humidity is 45-65%;
s5: mixing, namely adding the raw and auxiliary materials of amoxicillin granules, sodium carboxymethyl starch, silicon dioxide and magnesium stearate into a mixer, closing a feeding port, setting the mixing time to be 10 minutes, and mixing at a constant speed to obtain an intermediate product, wherein the temperature is 18-26 ℃, and the humidity is 45-65%; preferably, the amoxicillin granules added firstly are half of the prescription amount, and the amoxicillin granules added later are the other half of the prescription amount;
s6: inspecting the intermediate product, taking the intermediate product to detect properties, identify, moisture and content, and calculating the filling amount according to the content;
s7: filling, namely controlling a full-automatic capsule filling machine according to a filling production instruction to obtain the amoxicillin capsule, wherein the filling speed of the full-automatic capsule filling machine is 2000-2500 granules/minute, the temperature is 18-26 ℃, and the humidity is 45-65%, so that the amoxicillin capsule is prepared.
Example 5
A preparation method of amoxicillin capsules comprises the following steps:
s1: preparing raw materials and auxiliary materials, wherein the raw materials comprise 255 parts by weight of amoxicillin, and the auxiliary materials comprise 1.3 parts by weight of silicon dioxide, 1.1 parts by weight of magnesium stearate and 5.5 parts by weight of carboxymethyl starch sodium;
s2: sieving, namely respectively sieving silicon dioxide, sodium carboxymethyl starch and magnesium stearate by a 40-mesh sieve at the temperature of 18-26 ℃ and the humidity of 45-65%;
s3: weighing ingredients, namely weighing amoxicillin, silicon dioxide, sodium carboxymethyl starch and magnesium stearate according to the formula, and marking at the temperature of 18-26 ℃ and the humidity of 45-65%;
s4: granulating, namely adding the raw material amoxicillin into a dry granulating machine, and granulating through a 0.8mm screen to obtain amoxicillin granules, wherein the pressure of a compression roller of the dry granulating machine is 8-10 MPa, and the gap between the compression rollers is 0.6-0.9 mm; the rotating speed of the press roll is 15-20 r/min; sucking the finished amoxicillin particles into a ternary rotary vibration sieve by a vacuum feeding machine at the rotating speed of 100-120 r/min, removing coarse particles by using a 20-mesh screen, removing fine particles by using a 60-mesh screen, and finishing the coarse particles repeatedly to obtain heavy powder particles, wherein the temperature is 18-26 ℃, and the humidity is 45-65%;
s5: mixing, namely adding the raw and auxiliary materials into a mixing machine according to the sequence of amoxicillin granules, sodium carboxymethyl starch, silicon dioxide, magnesium stearate and amoxicillin granules, closing a feeding port, setting the mixing time to be 10 minutes, and mixing at a constant speed to obtain an intermediate product, wherein the temperature is 18-26 ℃, and the humidity is 45-65%; preferably, the amoxicillin granules added firstly are half of the prescription amount, and the amoxicillin granules added later are the other half of the prescription amount;
s6: inspecting the intermediate product, taking the intermediate product to detect properties, identify, moisture and content, and calculating the filling amount according to the content;
s7: filling, namely controlling a full-automatic capsule filling machine according to a filling production instruction to obtain the amoxicillin capsule, wherein the filling speed of the full-automatic capsule filling machine is 2000-2500 granules/minute, the temperature is 18-26 ℃, and the humidity is 45-65%, so that the amoxicillin capsule is prepared.
Example 6
The dissolution rate test method comprises the following steps: taking an amoxicillin capsule sample prepared in example 1-6, according to a dissolution determination method (appendix XC first method), using 900mL of water as a solvent, the temperature of the solvent being (37 +/-0.5) DEG C, the rotation speed: 100r/min, operating according to the method for 45min, taking a proper amount of solution, filtering through a 0.45-micron filter membrane, precisely taking a proper amount of subsequent filtrate, diluting the filtrate with a solvent to obtain a solution containing about 130 mug of solution in each 1mlL, and measuring the absorbance at the wavelength of 272nm by an ultraviolet-visible spectrophotometry (appendix IV A); taking the contents with different loading amounts, mixing uniformly, precisely weighing a proper amount (about equal to the average loading amount), adding a dissolution medium according to the marked amount to dissolve and dilute the dissolution medium into a solution containing about 130 mug per 1mL, filtering, taking the subsequent filtrate as a control solution, measuring by the same method, and calculating the dissolution amount of each granule. The limit is 80%, which should be met.
Comparison group: according to the preparation method of the amoxicillin capsule in the prior art, 0.25g of amoxicillin, 0.0075g of magnesium stearate and 0.01g of carboxymethyl starch sodium are taken to prepare the amoxicillin capsule as a comparative example, and the results are as follows: the dissolution rate of the amoxicillin capsule is 80%.
A first group: taking 250 parts by weight of amoxicillin as a raw material, taking 1.25 parts by weight of silicon dioxide, 1 part by weight of magnesium stearate and 5 parts by weight of carboxymethyl starch sodium as auxiliary materials, adding the amoxicillin granules, the carboxymethyl starch sodium, the silicon dioxide, the magnesium stearate and the amoxicillin granules into a mixer in sequence according to the preparation method of amoxicillin in example 1, mixing for 10 minutes to prepare amoxicillin capsules, carrying out dissolution rate determination on the amoxicillin capsules, comparing the determination result with the dissolution rate of the amoxicillin capsules in a comparison group, wherein the dissolution rate of the amoxicillin capsules is higher than that of the amoxicillin capsules in the comparison group.
Second group: taking 250 parts by weight of amoxicillin as a raw material, taking 1.25 parts by weight of silicon dioxide, 1 part by weight of magnesium stearate and 5.3 parts by weight of sodium carboxymethyl starch as auxiliary materials, adding the amoxicillin granules, the sodium carboxymethyl starch, the silicon dioxide, the magnesium stearate and the amoxicillin granules into a mixer in sequence according to the preparation method of amoxicillin in example 2, mixing for 20 minutes to prepare the amoxicillin capsule, carrying out dissolution determination on the amoxicillin capsule, comparing the determination result with the dissolution of the amoxicillin capsule in a comparison group, wherein the dissolution of the amoxicillin capsule is higher than that of the amoxicillin capsule in the comparison group.
Third group: taking 250 parts by weight of amoxicillin as a raw material, taking 1.25 parts by weight of silicon dioxide, 1 part by weight of magnesium stearate and 5 parts by weight of carboxymethyl starch sodium as auxiliary materials, adding the amoxicillin granules, the carboxymethyl starch sodium, the silicon dioxide, the magnesium stearate and the amoxicillin granules into a mixer in sequence according to the preparation method of amoxicillin of example 3, mixing for 25 minutes to prepare amoxicillin capsules, carrying out dissolution rate determination on the amoxicillin capsules, comparing the determination result with the dissolution rate of the amoxicillin capsules of a comparison group, wherein the dissolution rate of the amoxicillin capsules is higher than that of the amoxicillin capsules of the comparison group.
And a fourth group: taking 255 parts by weight of amoxicillin as a raw material, taking 1.3 parts by weight of silicon dioxide, 1.1 parts by weight of magnesium stearate and 5.5 parts by weight of carboxymethyl starch sodium as auxiliary materials, adding the amoxicillin granules, the carboxymethyl starch sodium, the silicon dioxide and the magnesium stearate as the raw auxiliary materials into a mixer according to the amoxicillin preparation method of example 4, mixing for 10 minutes to prepare an amoxicillin capsule, carrying out dissolution rate determination on the amoxicillin capsule, comparing the determination result with the dissolution rate of the amoxicillin capsule of a comparison group, wherein the dissolution rate of the amoxicillin capsule is higher than that of the amoxicillin capsule of the comparison group.
And a fifth group: taking 255 parts by weight of amoxicillin as a raw material, taking 1.3 parts by weight of silicon dioxide, 1.1 parts by weight of magnesium stearate and 5.5 parts by weight of carboxymethyl starch sodium as auxiliary materials, adding the amoxicillin granules, the carboxymethyl starch sodium, the silicon dioxide and the magnesium stearate as the raw and auxiliary materials into a mixer according to the amoxicillin preparation method of example 5, mixing for 10 minutes to prepare an amoxicillin capsule, carrying out dissolution rate determination on the amoxicillin capsule, comparing the determination result with the dissolution rate of the amoxicillin capsule of a comparison group, wherein the dissolution rate of the amoxicillin capsule is higher than that of the amoxicillin capsule of the comparison group.
Table of dissolution test of the product:
and (4) conclusion: as can be seen from the table, the first, second and third groups had a mixing time within a certain range, and the smaller the mixing time, the higher the dissolution rate, compared with the comparative example.
And compared with the comparison group, the fourth group can improve the dissolution rate of the amoxicillin by putting the auxiliary materials into the mixer in sequence for mixing in a mixing ratio which is not in sequence.
In the first and fifth groups, compared with the comparative example, the excipients are within a certain amount range, and the larger the amount of the excipients, the higher the dissolution rate of amoxicillin.
Therefore, the amoxicillin preparation method provided by the application can improve the dissolution rate of the amoxicillin capsule, prepare the amoxicillin capsule with high dissolution rate, and solve the technical problem of low dissolution rate of the existing amoxicillin capsule.
The above embodiments are only used for illustrating the technical solutions of the present application, and not for limiting the same; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions in the embodiments of the present application.
Claims (10)
1. The preparation method of the amoxicillin capsule is characterized by comprising the following steps:
s1: preparing raw materials and auxiliary materials, wherein the raw materials comprise: amoxicillin, the auxiliary materials include: silicon dioxide, magnesium stearate and sodium starch glycolate;
s2: sieving, namely respectively sieving the silicon dioxide, the carboxymethyl starch sodium and the magnesium stearate by a 40-mesh sieve;
s3: weighing ingredients, namely weighing the amoxicillin, the silicon dioxide, the sodium carboxymethyl starch and the magnesium stearate according to the prescription amount, and marking;
s4: granulating, namely adding the raw material amoxicillin into a dry-process granulator and granulating through a 0.8mm screen to obtain amoxicillin granules, sucking the prepared amoxicillin granules into a ternary rotary vibration sieve through a vacuum feeding machine, removing coarse granules by using a 20-mesh screen, removing fine granules by using a 60-mesh screen, repeatedly granulating the coarse granules, and collecting heavy powder granules;
s5: mixing, namely adding the raw and auxiliary materials into a mixing machine according to the sequence of the amoxicillin granules, the carboxymethyl starch sodium, the silicon dioxide, the magnesium stearate and the amoxicillin granules, closing a feeding port, setting the mixing time to be 10-30 minutes, and mixing at a constant speed to obtain an intermediate product;
s6: inspecting the intermediate product, taking the intermediate product to detect properties, identify, moisture and content, and calculating the filling amount according to the content;
s7: filling, and generating a production instruction according to the filling amount to control a full-automatic capsule filling machine to prepare the amoxicillin capsule.
2. A process for the preparation of amoxicillin capsules as claimed in claim 1, wherein the temperature of said sieving, said weighing and batching, said granulating, said mixing and said filling is from 18 ℃ to 26 ℃.
3. A process for the preparation of amoxicillin capsules as claimed in claim 1, wherein the moisture of said sieving, said dosing, said granulating, said mixing and said filling is comprised between 45% and 65%.
4. The method for preparing amoxicillin capsules according to claim 1, wherein in step S4, the pressure of the compression roller of the dry granulator is 8 to 10MPa, and the gap between the compression rollers is 0.6 to 0.9 mm; the rotating speed of the press roll is 15-20 r/min; the rotating speed of the ternary rotary vibration sieve is 100-120 r/min.
5. The method for preparing an amoxicillin capsule according to claim 1, characterized in that in step S5, the raw and auxiliary materials are sequentially added into a mixer according to the sequence of amoxicillin granules, the carboxymethyl starch sodium, the silicon dioxide, the magnesium stearate and the amoxicillin granules, and the mixing time is set to 10-25 minutes.
6. The method for preparing an amoxicillin capsule according to claim 1, characterized in that in step S5, the raw and auxiliary materials are sequentially added into a mixer according to the sequence of amoxicillin granules, the carboxymethyl starch sodium, the silicon dioxide, the magnesium stearate and the amoxicillin granules, and the mixing time is set to 10-20 minutes.
7. The method for producing an amoxicillin capsule according to claim 1, wherein in step S7, the filling speed of the fully automatic capsule filling machine is 2000 to 2500 granules/min.
8. An amoxicillin capsule, characterized in that it is prepared according to the amoxicillin capsule preparation method of any one of claims 1-7.
9. An amoxicillin capsule according to claim 8, characterized in that the excipients comprises: 250-255 parts of amoxicillin, 1.25-1.3 parts of silicon dioxide, 1-1.1 parts of magnesium stearate and 5-5.5 parts of carboxymethyl starch sodium.
10. An amoxicillin capsule according to claim 8 or 9, characterized in that the single particle weight of the amoxicillin capsule is 0.25 g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011276505.2A CN112156082A (en) | 2020-11-16 | 2020-11-16 | Amoxicillin capsule preparation method and amoxicillin capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011276505.2A CN112156082A (en) | 2020-11-16 | 2020-11-16 | Amoxicillin capsule preparation method and amoxicillin capsule |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN112156082A true CN112156082A (en) | 2021-01-01 |
Family
ID=73865865
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202011276505.2A Pending CN112156082A (en) | 2020-11-16 | 2020-11-16 | Amoxicillin capsule preparation method and amoxicillin capsule |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN112156082A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113081996A (en) * | 2021-04-01 | 2021-07-09 | 海南锦瑞制药有限公司 | Simvastatin capsule and preparation method thereof |
| CN113133985A (en) * | 2021-04-16 | 2021-07-20 | 海南通用三洋药业有限公司 | Preparation method of amoxicillin capsule |
Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4925674A (en) * | 1988-08-25 | 1990-05-15 | Himedics, Inc. | Amoxicillin microencapsulated granules |
| CN104706618A (en) * | 2015-02-04 | 2015-06-17 | 上海华源安徽仁济制药有限公司 | Amoxicillin capsules and preparation method thereof |
| CN104887645A (en) * | 2015-06-15 | 2015-09-09 | 吉林万通药业集团梅河药业股份有限公司 | Amoxicillin capsule and preparation method thereof |
| CN107019677A (en) * | 2017-04-26 | 2017-08-08 | 四川制药制剂有限公司 | The preparation method of amoxicillin dispersible tablet |
| CN107095857A (en) * | 2017-04-26 | 2017-08-29 | 四川制药制剂有限公司 | The production technology of Biomox |
| CN107875136A (en) * | 2017-12-27 | 2018-04-06 | 广州白云山医药集团股份有限公司白云山制药总厂 | A kind of Amoxicillin pharmaceutical preparation and preparation method thereof |
| CN108210475A (en) * | 2016-12-13 | 2018-06-29 | 河南后羿实业集团有限公司 | A kind of amoxil capsule and preparation method thereof |
| CN108578383A (en) * | 2018-06-08 | 2018-09-28 | 安徽安科恒益药业有限公司 | A kind of amoxil capsule and its manufacturing method |
| CN108888603A (en) * | 2018-09-07 | 2018-11-27 | 石药集团中诺药业（石家庄）有限公司 | A kind of amoxicillin tablets of reliable in quality |
| CN109953971A (en) * | 2019-05-14 | 2019-07-02 | 吉林市吴太感康药业有限公司 | A kind of preparation method of amoxil capsule |
-
2020
- 2020-11-16 CN CN202011276505.2A patent/CN112156082A/en active Pending
Patent Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4925674A (en) * | 1988-08-25 | 1990-05-15 | Himedics, Inc. | Amoxicillin microencapsulated granules |
| CN104706618A (en) * | 2015-02-04 | 2015-06-17 | 上海华源安徽仁济制药有限公司 | Amoxicillin capsules and preparation method thereof |
| CN104887645A (en) * | 2015-06-15 | 2015-09-09 | 吉林万通药业集团梅河药业股份有限公司 | Amoxicillin capsule and preparation method thereof |
| CN108210475A (en) * | 2016-12-13 | 2018-06-29 | 河南后羿实业集团有限公司 | A kind of amoxil capsule and preparation method thereof |
| CN107019677A (en) * | 2017-04-26 | 2017-08-08 | 四川制药制剂有限公司 | The preparation method of amoxicillin dispersible tablet |
| CN107095857A (en) * | 2017-04-26 | 2017-08-29 | 四川制药制剂有限公司 | The production technology of Biomox |
| CN107875136A (en) * | 2017-12-27 | 2018-04-06 | 广州白云山医药集团股份有限公司白云山制药总厂 | A kind of Amoxicillin pharmaceutical preparation and preparation method thereof |
| CN108578383A (en) * | 2018-06-08 | 2018-09-28 | 安徽安科恒益药业有限公司 | A kind of amoxil capsule and its manufacturing method |
| CN108888603A (en) * | 2018-09-07 | 2018-11-27 | 石药集团中诺药业（石家庄）有限公司 | A kind of amoxicillin tablets of reliable in quality |
| CN109953971A (en) * | 2019-05-14 | 2019-07-02 | 吉林市吴太感康药业有限公司 | A kind of preparation method of amoxil capsule |
Non-Patent Citations (4)
| Title |
|---|
| YOKO UEMATSU等: "Determination ofMagnesium Stearate in Capsule- or Tablet-Type Supplements", 《JOURNAL OF AOAC INTERNATIONAL》 * |
| 奚念朱等: "《高等医药院校教材 药剂学 第2版》", 31 May 1980, 人民卫生出版社 * |
| 李德公等: "阿莫西林胶囊溶出度的主要因素探讨", 《黑龙江科技信息》 * |
| 高峰: "《药用高分子材料学》", 31 October 2014, 华东理工大学出版社 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113081996A (en) * | 2021-04-01 | 2021-07-09 | 海南锦瑞制药有限公司 | Simvastatin capsule and preparation method thereof |
| CN113133985A (en) * | 2021-04-16 | 2021-07-20 | 海南通用三洋药业有限公司 | Preparation method of amoxicillin capsule |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN112156082A (en) | Amoxicillin capsule preparation method and amoxicillin capsule | |
| JP3718341B2 (en) | Low substituted hydroxypropylcellulose and process for producing the same | |
| CN105193763B (en) | A kind of hydrobromic acid Vortioxetine piece and preparation method thereof | |
| CN107095857A (en) | The production technology of Biomox | |
| CN110613697A (en) | Cefalexin capsule and preparation method thereof | |
| CN103110595B (en) | Cefdinir dispersible tablet and preparation method thereof | |
| CN105412026B (en) | Acotiamide hydrochloride hydrate piece and preparation method thereof | |
| CN107115312A (en) | A kind of Noroxin and preparation method thereof | |
| CN107320456B (en) | N-acetyl-D-glucosamine capsule preparation and preparation method thereof | |
| CN110123770A (en) | A kind of Eliquis pharmaceutical composition and preparation method thereof | |
| CN109481412A (en) | A kind of II crystal linezolid piece and its preparation process | |
| CN104800177B (en) | A kind of Cefadroxil tablets and preparation method thereof | |
| CN106511288A (en) | Preparation method of febuxostat tablets | |
| CN103145733A (en) | Amoxicillin compound and pharmaceutical composition of amoxicillin compound and potassium clavulanate | |
| CN101862307A (en) | Bisulfate Cefdinir sodium capsule and preparation method thereof | |
| AU2019268481A1 (en) | HC-1119 formulation, preparation method and use thereof | |
| CN104173310A (en) | Stable amoxicillin tablet composition, as well as preparation method and application thereof | |
| CN107519144A (en) | A kind of preparation method of telmisartan amlodipine tablets | |
| CN111557897B (en) | Pharmaceutical composition containing nifuratel and preparation method thereof | |
| CN115105483A (en) | Opopinacone capsule and preparation method thereof | |
| CN112546018A (en) | Cefaclor capsule and preparation method thereof | |
| CN112986289A (en) | Consistency evaluation and detection method of amoxicillin capsules | |
| CN108143723B (en) | A kind of Cefteram Pivoxil Tablets and preparation method thereof and purposes | |
| CN112190556A (en) | Compound sulfamethoxazole trimethoprim tablet and preparation method thereof | |
| CN103239411B (en) | Cefdinir, citric acid and sodium citrate dry suspension composition |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20210101 |
|
| RJ01 | Rejection of invention patent application after publication |