CN115487154A - Preparation method of doxycycline hydrochloride granules - Google Patents
Preparation method of doxycycline hydrochloride granules Download PDFInfo
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- CN115487154A CN115487154A CN202211438708.6A CN202211438708A CN115487154A CN 115487154 A CN115487154 A CN 115487154A CN 202211438708 A CN202211438708 A CN 202211438708A CN 115487154 A CN115487154 A CN 115487154A
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- doxycycline hydrochloride
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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
- A61K31/65—Tetracyclines
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- 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
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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
- A61K9/14—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
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/14—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
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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
- A61K9/14—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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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Abstract
The invention relates to the technical field of veterinary drugs, and in particular relates to a preparation method of doxycycline hydrochloride granules, which comprises the following steps: (1) Taking sodium carboxymethyl starch, adopting purified water as a solvent, and preparing a sodium carboxymethyl starch solution with the mass concentration of 5-15% as an adhesive; (2) Taking doxycycline hydrochloride raw powder, anhydrous glucose and cationic polyacrylamide with the molecular weight of 1200 ten thousand, respectively sieving, and collecting for later use; (3) Taking the adhesive in the step (1) and the raw materials sieved in the step (2), sequentially putting into a fluidized bed for granulation, wherein the addition amounts of the cationic polyacrylamide and the anhydrous glucose are respectively added according to the mass ratio of the cationic polyacrylamide to the doxycycline hydrochloride raw powder of 1.5-3 and the mass ratio of the anhydrous glucose to the doxycycline hydrochloride raw powder of 2-4; and in the granulation process, controlling the air inlet temperature to be 55-65 ℃, the air inlet amount to be 30-70 m/h, the peristaltic pump to be 10rpm and the atomization pressure to be 0.05MPa, and drying for 5-10min after the pulp spraying is finished to obtain the doxycycline hydrochloride granules. The method avoids the oxidation of the medicine, facilitates the storage, and increases the dissolution rate of the medicine.
Description
Technical Field
The invention relates to the technical field of veterinary drugs, and in particular relates to a preparation method of doxycycline hydrochloride granules.
Background
Doxycycline hydrochloride (also known as doxycycline) is yellow or light yellow powder, has no odor and bitter taste, is easily soluble in water and methanol, is a spectrum antibacterial agent, and is mainly used for respiratory tract infection and tonsil infection caused by gram-positive bacteria and gram-negative bacteria. The doxycycline hydrochloride is mainly soluble powder in dosage forms of veterinary drugs on the market at present, the preparation process of the soluble powder is simple, and the doxycycline hydrochloride is suitable for large-scale production, but dust of the soluble powder easily stimulates respiratory tracts to cause discomfort, certain damage can be caused to human bodies in production and animal administration processes, and the taste of doxycycline hydrochloride is bitter to influence the palatability.
CN111467311A relates to doxycycline hydrochloride soluble powder, anhydrous citric acid, anhydrous glucose and disodium edetate are used, aiming at increasing the solubility and stability of the medicament to ensure that the medicament effect is more durable, but the anhydrous citric acid mentioned in the patent has stronger hygroscopicity, and the medicament is easier to deliquesce in the storage process, thereby influencing the curative effect. Therefore, in order to solve the problems in the prior art, it is necessary to develop a preparation method of doxycycline hydrochloride granules.
Disclosure of Invention
The invention aims to: aiming at the defects in the prior art, the preparation method of the doxycycline hydrochloride granules is provided, the method avoids the oxidation of the medicine, is convenient to store and increases the dissolution rate of the medicine.
In order to achieve the purpose, the technical scheme of the invention is as follows:
a method of preparing doxycycline hydrochloride granules, comprising the steps of:
(1) Taking sodium carboxymethyl starch, adopting purified water as a solvent, and preparing a sodium carboxymethyl starch solution with the mass concentration of 5% -15% as an adhesive;
(2) Taking doxycycline hydrochloride raw powder, anhydrous glucose and medical-grade cationic polyacrylamide with the molecular weight of 1200 ten thousand, respectively sieving with a sieve of 80-100 meshes, and collecting for later use;
(3) Taking the adhesive in the step (1), the doxycycline hydrochloride raw powder sieved in the step (2), anhydrous glucose and cationic polyacrylamide, and sequentially feeding into a fluidized bed for granulation, wherein the addition amount of the cationic polyacrylamide is in a mass ratio of 1.5-3; the addition amount of the anhydrous glucose is added according to the mass ratio of the anhydrous glucose to the doxycycline hydrochloride raw powder of 2-4; and in the granulation process, controlling the air inlet temperature to be 55-65 ℃, the air inlet quantity to be 30-70 m/h, the peristaltic pump to be 10rpm and the atomization pressure to be 0.05MPa, and drying for 5-10min after the guniting is finished to obtain the doxycycline hydrochloride granules.
As a preferable technical scheme, the adding amount of the cationic polyacrylamide in the step (2) is added according to the mass ratio of 2 to 5 of the doxycycline hydrochloride raw powder, and the adding amount of the anhydrous glucose is added according to the mass ratio of 3 to 5 of the doxycycline hydrochloride raw powder.
As a preferable technical scheme, in the step (1), a sodium carboxymethyl starch solution with the mass concentration of 8% is prepared as a binding agent.
As a preferable technical scheme, in the granulating process in the step (3), controlling the air inlet temperature to be 60 ℃, the air inlet air volume to be 50 m/h, the peristaltic pump to be 10rpm and the atomizing pressure to be 0.05MPa, and drying for 10min after the guniting is finished to obtain the doxycycline hydrochloride granules.
By adopting the technical scheme, compared with the prior art, the invention has the following advantages:
according to the preparation method of the doxycycline hydrochloride granules, the water-soluble high polymer material cationic polyacrylamide is used as a chelating agent, metal ions such as calcium, magnesium and the like in water interact with carboxylate anion electrostatic attraction on a polyacrylamide chain, the water solubility is good, and a small amount of cationic polyacrylamide can be added to fully play a role. The sodium hydroxymethyl starch is prepared into a solution which is used as an adhesive for spraying on one hand to enable the materials to be granulated more quickly, and meanwhile, the sodium hydroxymethyl starch can be used as a coating material, so that the prepared granules are high in hardness and round and smooth in particle size; doxycycline hydrochloride and cationic polyacrylamide are coated, so that the medicine is prevented from being oxidized and is convenient to store; on the other hand, the interaction between the sodium carboxymethyl starch and the polyacrylamide increases the chelation of the polyacrylamide, the dissolution rate of the medicine is increased during dissolution, the cationic polyacrylamide can be completely released, the chelation effect is increased, and the ideal state can be reached by a small amount of chelating agent.
Detailed Description
The present invention will be described in further detail in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are merely illustrative of the invention and do not limit the invention.
Example 1
A preparation method of doxycycline hydrochloride granules comprises the following steps:
(1) Taking sodium carboxymethyl starch, adopting purified water as a solvent, and preparing a sodium carboxymethyl starch solution with the mass concentration of 5% as an adhesive;
(2) Taking doxycycline hydrochloride raw powder, anhydrous glucose and cationic polyacrylamide (medical grade, molecular weight of 1200 ten thousand) to respectively pass through a 80-100-mesh sieve, and collecting for later use;
(3) Taking the adhesive in the step (1), the doxycycline hydrochloride raw powder sieved in the step (2), anhydrous glucose and cationic polyacrylamide, and sequentially putting the raw powder, the anhydrous glucose and the cationic polyacrylamide into a fluidized bed for granulation; wherein the adding amount of the cationic polyacrylamide is added according to the mass ratio of the cationic polyacrylamide to doxycycline hydrochloride raw powder (300 g) of 1.5; the addition amount of the anhydrous glucose is added according to the mass ratio of the anhydrous glucose to the doxycycline hydrochloride raw powder of 2; and in the granulation process, controlling the air inlet temperature to be 55 ℃, the air inlet amount to be 30 m/h, the peristaltic pump to be 10rpm and the atomization pressure to be 0.05MPa, and drying for 5min after the guniting is finished to obtain the doxycycline hydrochloride granules.
Example 2
A preparation method of doxycycline hydrochloride granules comprises the following steps:
(1) Taking sodium carboxymethyl starch, adopting purified water as a solvent, and preparing a sodium carboxymethyl starch solution with the mass concentration of 10% as an adhesive;
(2) Taking doxycycline hydrochloride raw powder, anhydrous glucose and cationic polyacrylamide (medical grade, molecular weight of 1200 ten thousand) to respectively pass through a 80-100-mesh sieve, and collecting for later use;
(3) Taking the adhesive in the step (1), the doxycycline hydrochloride raw powder sieved in the step (2), anhydrous glucose and cationic polyacrylamide, and sequentially putting into a fluidized bed for granulation; wherein the adding amount of the cationic polyacrylamide is added according to the mass ratio of the cationic polyacrylamide to doxycycline hydrochloride raw powder (300 g) of 3; the addition amount of the anhydrous glucose is added according to the mass ratio of the anhydrous glucose to the doxycycline hydrochloride raw powder of 4; and in the granulation process, controlling the air inlet temperature to be 65 ℃, the air inlet air volume to be 70 m/h, the peristaltic pump to be 10rpm and the atomization pressure to be 0.05MPa, and drying for 10min after the guniting is finished to obtain the doxycycline hydrochloride granules.
Example 3
A preparation method of doxycycline hydrochloride granules comprises the following steps:
(1) Taking sodium carboxymethyl starch, adopting purified water as a solvent, and preparing a sodium carboxymethyl starch solution with the mass concentration of 8% as an adhesive;
(2) Taking doxycycline hydrochloride raw powder, anhydrous glucose and cationic polyacrylamide (medical grade, molecular weight of 1200 ten thousand) to respectively pass through a 80-100-mesh sieve, and collecting for later use;
(3) Taking the adhesive in the step (1), the doxycycline hydrochloride raw powder sieved in the step (2), anhydrous glucose and cationic polyacrylamide, and sequentially putting into a fluidized bed for granulation; wherein the adding amount of the cationic polyacrylamide is added according to the mass ratio of the cationic polyacrylamide to doxycycline hydrochloride raw powder (300 g) of 2; the addition amount of the anhydrous glucose is added according to the mass ratio of the anhydrous glucose to the doxycycline hydrochloride raw powder of 3; and in the granulation process, controlling the air inlet temperature to be 60 ℃, the air inlet amount to be 50 m/h, the peristaltic pump to be 10rpm and the atomization pressure to be 0.05MPa, and drying for 10min after the guniting is finished to obtain the doxycycline hydrochloride granules.
Example 4
A preparation method of doxycycline hydrochloride granules comprises the following steps:
(1) Taking sodium carboxymethyl starch, adopting purified water as a solvent, and preparing a sodium carboxymethyl starch solution with the mass concentration of 12% as an adhesive;
(2) Taking doxycycline hydrochloride raw powder, anhydrous glucose and cationic polyacrylamide (with the molecular weight of 1200 ten thousand) to respectively pass through a sieve of 80-100 meshes, and collecting for later use;
(3) Taking the adhesive in the step (1), the doxycycline hydrochloride raw powder sieved in the step (2), anhydrous glucose and cationic polyacrylamide, and sequentially putting the raw powder, the anhydrous glucose and the cationic polyacrylamide into a fluidized bed for granulation; wherein the adding amount of the cationic polyacrylamide is added according to the mass ratio of the cationic polyacrylamide to doxycycline hydrochloride raw powder (300 g) of 3; the addition amount of the anhydrous glucose is added according to the mass ratio of the anhydrous glucose to the doxycycline hydrochloride raw powder of 4; and in the granulation process, controlling the air inlet temperature to be 65 ℃, the air inlet air volume to be 70 m/h, the peristaltic pump to be 10rpm and the atomization pressure to be 0.05MPa, and drying for 10min after the guniting is finished to obtain the doxycycline hydrochloride granules.
Example 5
A preparation method of doxycycline hydrochloride granules comprises the following steps:
(1) Taking sodium carboxymethyl starch, adopting purified water as a solvent, and preparing a sodium carboxymethyl starch solution with the mass concentration of 15% as an adhesive;
(2) Taking doxycycline hydrochloride raw powder, anhydrous glucose and cationic polyacrylamide (medical grade, molecular weight of 1200 ten thousand) to respectively pass through a 80-100-mesh sieve, and collecting for later use;
(3) Taking the adhesive in the step (1), the doxycycline hydrochloride raw powder sieved in the step (2), anhydrous glucose and cationic polyacrylamide, and sequentially putting the raw powder, the anhydrous glucose and the cationic polyacrylamide into a fluidized bed for granulation; wherein the adding amount of the cationic polyacrylamide is added according to the mass ratio of the cationic polyacrylamide to doxycycline hydrochloride raw powder (300 g) of 2; the addition amount of the anhydrous glucose is added according to the mass ratio of the anhydrous glucose to the doxycycline hydrochloride raw powder of 3; and in the granulation process, controlling the air inlet temperature to be 60 ℃, the air inlet air volume to be 50 m/h, the peristaltic pump to be 10rpm and the atomization pressure to be 0.05MPa, and drying for 10min after the guniting is finished to obtain the doxycycline hydrochloride granules.
In order to better prove that the granule preparation obtained by the preparation method of the invention has better solubility and stability, 3 comparative examples are given by taking example 3 as a reference, and the solubility and stability of the granule preparation are detailed in tables 1 and 2.
Comparative example 1
Different from the embodiment 3, the cationic polyacrylamide is not added in the step 2, and the rest operations are the same;
comparative example 2
Different from the embodiment 3, the operation is the same as the rest operation except that the solution with the mass concentration of 8 percent and prepared by the pvc and the purified water is used as the adhesive in the step (1);
comparative example 3
The difference from the example 3 is that the molecular weight of the cationic polyacrylamide used in the step (2) is 800 ten thousand, and the rest operations are the same;
comparative example 4
Different from the embodiment 3, the adding amount of the cationic polyacrylamide in the step 2 is added according to the mass ratio of the cationic polyacrylamide to doxycycline hydrochloride raw powder (300 g) of 1; the rest of the operation is the same.
The feed amount was 600g, and examples 1 to 5 and comparative examples 1 to 3 were fluid bed granulated according to the set parameters. Taking the granules obtained in the examples 1-5 and the comparative examples 1-3, respectively preparing 10000ppm of solution by using tap water at 4 ℃ and 25 ℃ according to the operation specification of the solution stability experiment, sampling after 0h, 2h, 4h, 6h, 8h and 24h, diluting to 100ppm, carrying out sample detection, and preparing 100ppm of doxycycline hydrochloride raw powder as a reference substance;
the data in table 1 show that doxycycline hydrochloride granular formulations obtained by the preparation methods of examples 1 to 5 of the present invention have better solubility than the product obtained by the preparation method of comparative example 1; from the experimental results of comparative examples 2 and 3, it was found that the solubility of the granular product prepared by the preparation method of example 3 of the present invention was higher than that of comparative examples 2 to 4. Since example 1 was observed to have a slight amount of suspension in the lamp light at 24 hours, example 3 was the most preferable process in view of the amount of cationic polyacrylamide, although the products obtained in examples 2, 4 and 5 had better solubility.
The granular formulations obtained in examples 1 to 5 and the granular formulations obtained in comparative examples 1 to 4 were placed in a stability laboratory (temperature 40 ℃. + -. 2 ℃ C., humidity 75%. + -. 5%), respectively, and sampled at 1 month, 2 months, 3 months and 6 months, observed and weighed, and the weight gain was calculated. The specific experimental results are detailed in table 2.
As can be seen from the data in table 2, the doxycycline hydrochloride granules obtained in examples 1 to 5 by the preparation method of the present invention have better stability than those of comparative examples 1 to 4.
The present invention is not limited to the above-described embodiments, and various modifications made by those skilled in the art without inventive skill from the above-described conception fall within the scope of the present invention.
Claims (4)
1. A preparation method of doxycycline hydrochloride granules is characterized by comprising the following steps:
(1) Taking sodium carboxymethyl starch, adopting purified water as a solvent, and preparing a sodium carboxymethyl starch solution with the mass concentration of 5-15% as an adhesive;
(2) Taking doxycycline hydrochloride raw powder, anhydrous glucose and medical-grade cationic polyacrylamide with molecular weight of 1200 ten thousand, respectively sieving with a 80-100 mesh sieve, and collecting for later use;
(3) Taking the adhesive in the step (1), the doxycycline hydrochloride raw powder sieved in the step (2), anhydrous glucose and cationic polyacrylamide, and sequentially feeding into a fluidized bed for granulation, wherein the addition amount of the cationic polyacrylamide is in a mass ratio of 1.5-3; the addition amount of the anhydrous glucose is added according to the mass ratio of the anhydrous glucose to the doxycycline hydrochloride raw powder of 2-4; and in the granulation process, controlling the air inlet temperature to be 55-65 ℃, the air inlet amount to be 30-70 m/h, the peristaltic pump to be 10rpm and the atomization pressure to be 0.05MPa, and drying for 5-10min after the pulp spraying is finished to obtain the doxycycline hydrochloride granules.
2. The preparation method of doxycycline hydrochloride granules according to claim 1, wherein in the step (2), the cationic polyacrylamide is added in a ratio of 2 to 5 in terms of mass of doxycycline hydrochloride raw powder, and the anhydrous glucose is added in a ratio of 3 to 5 in terms of mass of doxycycline hydrochloride raw powder.
3. The preparation method of doxycycline hydrochloride granules according to claim 1, wherein in the step (1), a sodium carboxymethyl starch solution with a mass concentration of 8% is prepared as a binder.
4. The preparation method of doxycycline hydrochloride granules according to claim 1, wherein during the granulation in step (3), the air inlet temperature is controlled to be 60 ℃, the air inlet amount is controlled to be 50 m/h, the peristaltic pump is 10rpm, the atomization pressure is 0.05MPa, and the granules are dried for 10min after the guniting is finished, so that doxycycline hydrochloride granules are obtained.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116531334A (en) * | 2023-01-13 | 2023-08-04 | 山东国邦药业有限公司 | Doxycycline hydrochloride granule and preparation method thereof |
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Cited By (2)
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