CN111544408A - Preparation process of sodium valproate tablets - Google Patents
Preparation process of sodium valproate tablets Download PDFInfo
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- CN111544408A CN111544408A CN202010376504.9A CN202010376504A CN111544408A CN 111544408 A CN111544408 A CN 111544408A CN 202010376504 A CN202010376504 A CN 202010376504A CN 111544408 A CN111544408 A CN 111544408A
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- granules
- soft material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
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- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
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- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
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- Epidemiology (AREA)
- Medicinal Preparation (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- General Chemical & Material Sciences (AREA)
Abstract
The invention provides a preparation process of a sodium valproate tablet, which comprises the following steps: the preparation method comprises the steps of feeding proportioning, preparation technology, raw and auxiliary material treatment, batching, soft material preparation, wet granule preparation, drying, granule finishing, total mixing, tabletting, coating and packaging. The method has the advantages of simple process, easy operation and low cost, and greatly reduces the production cost of enterprises.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a preparation process of a sodium valproate tablet.
Background
Sodium valproate is a nitrogen-free broad-spectrum antiepileptic drug, and has different degrees of antagonistic action on convulsion caused by various methods. It is effective on various epilepsy such as small seizures, myoclonic epilepsy, local seizures, grand mal epilepsy and mixed epilepsy. Oral administration is rapid and complete, and is mainly distributed in extracellular fluid, where most of the blood binds to plasma proteins. It is mainly used for various epileptics with ineffective antiepileptic drugs, especially for small seizures.
The sodium valproate preparation process in the prior art is complex, the production cost is high, and the development of enterprises is restricted.
Disclosure of Invention
The invention aims to solve the technical problem of complex preparation process in the prior art, and provides a preparation process of a sodium valproate tablet to overcome the defects in the prior art.
The invention is realized by the following technical scheme:
the invention relates to a preparation process of a sodium valproate tablet, which comprises the following steps:
(1) feeding and proportioning:
300g of sodium valproate, 27g of starch, 45.8 g of talcum powder, 67g of absolute ethyl alcohol and 39g of magnesium stearate;
(2) the preparation process comprises the following steps:
1) treating raw materials and auxiliary materials: removing the outer package of the raw and auxiliary materials, crushing and sieving;
2) preparing materials: weighing the processed raw and auxiliary materials according to the prescription requirement;
3) preparing a soft material: pre-mixing the prepared raw and auxiliary materials in a trough mixer for 30 minutes, adding a wetting agent (absolute ethyl alcohol) with the formula amount, continuously stirring for 40 minutes to form a qualified soft material, and inspecting the quality of the soft material;
4) preparing wet granules: feeding the prepared soft material into a swing type granulator to prepare wet granules, and sieving with a 20-mesh iron sieve;
5) and (3) drying: uniformly feeding the wet granules into a hot air circulation oven, and drying by blowing at 58 ℃ for 13 hours to ensure that the water content of the dry granules is below 1%;
6) straightening: putting the dried granules into a swing type granulator, and granulating through a 20-mesh iron screen to obtain granules with uniform sizes;
7) total mixing: placing the whole granules in a three-dimensional motion mixer, adding magnesium stearate with prescription amount, and setting the rotation speed to
8 r/min, starting up and mixing for 30 minutes to uniformly mix;
8) tabletting: putting a stamping die, cleaning and disinfecting, adjusting the filling amount, and then adjusting the pressure to ensure that the weight, hardness, friability, appearance and the like of the pressed tablets meet the quality requirements; weighing the tablet weight once every 10 minutes in the tabletting process, ensuring that the tablet weight difference is within an allowable range, and observing the appearance of the tablet at any time;
9) coating: the procedure comprises an isolation layer, a powder coating layer, a sugar coating layer and a polishing layer in sequence;
10) packaging: the packaging bottle and the bottle cap enter the inner package chamber after the outer package is removed, the operation is carried out according to the operation rules of the inner package of the bottle, the label is pasted in the outer package chamber, the middle box is arranged, the code is assigned, the box is arranged, the code is scanned, the packing list and the code are arranged in the paper box, and the packing and the bundling are carried out.
The method has the advantages of simple process, easy operation and low cost, and greatly reduces the production cost of enterprises.
Detailed Description
The present invention is described in detail below with reference to various embodiments, but it should be understood that these embodiments are not intended to limit the present invention, and those skilled in the art should be able to make modifications and substitutions on the functions, methods, or structures of these embodiments without departing from the scope of the present invention.
The embodiment discloses a preparation process of a sodium valproate tablet, which comprises the following steps:
(1) feeding and proportioning:
300g of sodium valproate, 27g of starch, 45.8 g of talcum powder, 67g of absolute ethyl alcohol and 39g of magnesium stearate;
(2) the preparation process comprises the following steps:
1) treating raw materials and auxiliary materials: removing the outer package of the raw and auxiliary materials, crushing and sieving;
2) preparing materials: weighing the processed raw and auxiliary materials according to the prescription requirement;
3) preparing a soft material: pre-mixing the prepared raw and auxiliary materials in a trough mixer for 30 minutes, adding a wetting agent (absolute ethyl alcohol) with the formula amount, continuously stirring for 40 minutes to form a qualified soft material, and inspecting the quality of the soft material;
4) preparing wet granules: feeding the prepared soft material into a swing type granulator to prepare wet granules, and sieving with a 20-mesh iron sieve;
5) and (3) drying: uniformly feeding the wet granules into a hot air circulation oven, and drying by blowing at 58 ℃ for 13 hours to ensure that the water content of the dry granules is below 1%;
6) straightening: putting the dried granules into a swing type granulator, and granulating through a 20-mesh iron screen to obtain granules with uniform sizes;
7) total mixing: placing the whole granules in a three-dimensional motion mixer, adding magnesium stearate with prescription amount, and setting the rotation speed to
8 r/min, starting up and mixing for 30 minutes to uniformly mix;
8) tabletting: putting a stamping die, cleaning and disinfecting, adjusting the filling amount, and then adjusting the pressure to ensure that the weight, hardness, friability, appearance and the like of the pressed tablets meet the quality requirements; weighing the tablet weight once every 10 minutes in the tabletting process, ensuring that the tablet weight difference is within an allowable range, and observing the appearance of the tablet at any time;
9) coating: the procedure comprises an isolation layer, a powder coating layer, a sugar coating layer and a polishing layer in sequence;
10) packaging: the packaging bottle and the bottle cap enter the inner package chamber after the outer package is removed, the operation is carried out according to the operation rules of the inner package of the bottle, the label is pasted in the outer package chamber, the middle box is arranged, the code is assigned, the box is arranged, the code is scanned, the packing list and the code are arranged in the paper box, and the packing and the bundling are carried out.
The method has the advantages of simple process, easy operation and low cost, and greatly reduces the production cost of enterprises.
The above-listed detailed description is only a specific description of a possible embodiment of the present invention, and they are not intended to limit the scope of the present invention, and equivalent embodiments or modifications made without departing from the technical spirit of the present invention should be included in the scope of the present invention.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Claims (1)
1. A preparation process of a sodium valproate tablet is characterized by comprising the following steps:
(1) feeding and proportioning:
300g of sodium valproate, 27g of starch, 45.8 g of talcum powder, 67g of absolute ethyl alcohol and 39g of magnesium stearate;
(2) the preparation process comprises the following steps:
1) treating raw materials and auxiliary materials: removing the outer package of the raw and auxiliary materials, crushing and sieving;
2) preparing materials: weighing the processed raw and auxiliary materials according to the prescription requirement;
3) preparing a soft material: pre-mixing the prepared raw and auxiliary materials in a trough mixer for 30 minutes, adding a wetting agent (absolute ethyl alcohol) with the formula amount, continuously stirring for 40 minutes to form a qualified soft material, and inspecting the quality of the soft material;
4) preparing wet granules: feeding the prepared soft material into a swing type granulator to prepare wet granules, and sieving with a 20-mesh iron sieve;
5) and (3) drying: uniformly feeding the wet granules into a hot air circulation oven, and drying by blowing at 58 ℃ for 13 hours to ensure that the water content of the dry granules is below 1%;
6) straightening: putting the dried granules into a swing type granulator, and granulating through a 20-mesh iron screen to obtain granules with uniform sizes;
7) total mixing: placing the whole granules in a three-dimensional motion mixer, adding magnesium stearate with prescription amount, and setting the rotation speed to
8 r/min, starting up and mixing for 30 minutes to uniformly mix;
8) tabletting: putting a stamping die, cleaning and disinfecting, adjusting the filling amount, and then adjusting the pressure to ensure that the weight, hardness, friability, appearance and the like of the pressed tablets meet the quality requirements; weighing the tablet weight once every 10 minutes in the tabletting process, ensuring that the tablet weight difference is within an allowable range, and observing the appearance of the tablet at any time;
9) coating: the procedure comprises an isolation layer, a powder coating layer, a sugar coating layer and a polishing layer in sequence;
10) packaging: the packaging bottle and the bottle cap enter the inner package chamber after the outer package is removed, the operation is carried out according to the operation rules of the inner package of the bottle, the label is pasted in the outer package chamber, the middle box is arranged, the code is assigned, the box is arranged, the code is scanned, the packing list and the code are arranged in the paper box, and the packing and the bundling are carried out.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010376504.9A CN111544408A (en) | 2020-05-07 | 2020-05-07 | Preparation process of sodium valproate tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010376504.9A CN111544408A (en) | 2020-05-07 | 2020-05-07 | Preparation process of sodium valproate tablets |
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| Publication Number | Publication Date |
|---|---|
| CN111544408A true CN111544408A (en) | 2020-08-18 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010376504.9A Pending CN111544408A (en) | 2020-05-07 | 2020-05-07 | Preparation process of sodium valproate tablets |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110448536A (en) * | 2019-08-23 | 2019-11-15 | 仁和堂药业有限公司 | Sodium valproate tablets and its processing technology |
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2020
- 2020-05-07 CN CN202010376504.9A patent/CN111544408A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110448536A (en) * | 2019-08-23 | 2019-11-15 | 仁和堂药业有限公司 | Sodium valproate tablets and its processing technology |
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| PB01 | Publication | ||
| PB01 | Publication | ||
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Application publication date: 20200818 |