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A kind of doxycycline hydrochloride drug-containing pellet and preparation method thereof

A technology of doxycycline hydrochloride and pill core, applied in the field of medicine, can solve the problems of difficulty in industrialized production, uneven distribution of drug content, and time-consuming process of pellet adhesion, achieve narrow particle size distribution, and increase patient medication compliance. , The effect of improving storage stability

Active Publication Date: 2017-06-30
华益泰康药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Regardless of whether coating pan or fluidized bed is used for drug application, it is easy to cause pellets to stick and the process takes a long time
Although the inventor of this invention tried to solve the above-mentioned defects by increasing the particle size of the blank pellet core and reducing the drug load, the too low drug content would cause the final product size to be too large, which would bring great inconvenience to patients orally, reducing the drug load. Drug administration compliance; in the capsule filling process, the particle size of the pellet core is too large, which will cause a very large difference in the filling volume, making it difficult to realize industrial production
In addition, in the process of applying the drug in a coating pan or a fluidized bed, part of the drug powder adheres to the blank pellet core through a binder, and the other part of the drug powder itself is also bonded to each other to form pellets through the adhesive, so that The final pellets are not uniform in size, drug content distribution and very poor roundness
Excessive particle size distribution of pellets leads to extremely low yield of useful pellets, and poor roundness of pellets will lead to uneven coating of pellets, so that the dissolution in acid solution will increase with the prolongation of storage time, thus losing the product’s energy. Controlled Release Properties in Acid

Method used

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  • A kind of doxycycline hydrochloride drug-containing pellet and preparation method thereof
  • A kind of doxycycline hydrochloride drug-containing pellet and preparation method thereof
  • A kind of doxycycline hydrochloride drug-containing pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] name Weight (g) Doxycycline Hydrochloride 700 Sugar pill (0.20~0.38mm) 260 Polyvinylpyrrolidone K30 40 purified water 404 gross weight 1000

[0064] Use jet mill JGM-H50 equipment to micronize doxycycline hydrochloride into a particle size of D 90 It is 15μm powder, for later use;

[0065] Dissolving polyvinylpyrrolidone K30 in purified water to form a binder solution with a concentration of 9% by weight;

[0066] Put the sugar pellets into the centrifugal granulator, set the host speed to 150rpm, air supply frequency to 35HZ, heating temperature to 55°C, and spray pressure to 0.3Mpa. Start the centrifugal granulator, spray the above binder solution in, stop spraying the binder solution after the sugar pellets are wet, add an appropriate amount of micronized doxycycline hydrochloride, dry at 50°C for 5 minutes, and continue to Spray the binder solution, stop spraying the binder solution after the pellets are wet, then add ...

Embodiment 2

[0073] name Weight (g) Doxycycline Hydrochloride 700 Sugar pill (0.38~0.55mm) 260 Polyvinylpyrrolidone 40 purified water 404 gross weight 1000

[0074] Use jet mill JGM-H50 equipment to micronize doxycycline hydrochloride into particle size D 90 It is 15μm powder, for later use;

[0075] Dissolving polyvinylpyrrolidone in purified water to form a binder solution with a concentration of 9% by weight;

[0076] Put the sugar pellets into the centrifugal granulator, set the host speed to 150rpm, air supply frequency to 35HZ, heating temperature to 55°C, and spray pressure to 0.3Mpa. Start the centrifugal granulator, spray the above binder solution in, stop spraying the binder solution after the sugar pellets are wet, add an appropriate amount of micronized doxycycline hydrochloride, dry at 50°C for 5 minutes, and continue to Spray the binder solution, stop spraying the binder solution after the pellets are wet, then add an appropriat...

Embodiment 3

[0078] name Weight (g) Doxycycline Hydrochloride 700 Sugar pill (0.20~0.38mm) 260 Hydroxypropyl Methyl Cellulose E5 40 purified water 404 gross weight 1000

[0079] Use jet mill JGM-H50 equipment to micronize doxycycline hydrochloride into a particle size of D 90 It is 15μm powder, for later use;

[0080] Dissolving hydroxypropyl methylcellulose E5 in purified water at 80°C to form a binder solution with a concentration of 9% by weight;

[0081]Put the sugar pellets into the centrifugal granulator, set the host speed to 150rpm, air supply frequency to 35HZ, heating temperature to 55°C, and spray pressure to 0.3Mpa. Start the centrifugal granulator, spray the above binder solution in, stop spraying the binder solution after the sugar pellets are wet, add an appropriate amount of micronized doxycycline hydrochloride, dry at 50°C for 5 minutes, and continue to Spray the binder solution, stop spraying the binder solution after the pe...

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Abstract

The invention belongs to the technical field of medicine, and in particular relates to a doxycycline hydrochloride drug-containing pellet. The drug-containing pellets sequentially include from the inside to the outside: a blank core and a drug layer; the drug layer contains doxycycline hydrochloride and a binder; wherein, the weight percentage of each component of the drug-containing pellets is as follows: 19 -33% blank core, 65-75% doxycycline hydrochloride, and 2-6% binder. The invention also provides a preparation method of the above drug-containing pellets. The drug-containing pellets of the invention have the characteristics of uniform size, narrow particle size distribution, large drug loading capacity, uniform drug distribution and good roundness, thereby significantly improving the storage stability of the doxycycline hydrochloride enteric-coated preparation.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a drug-containing doxycycline hydrochloride pellet and a preparation method thereof. Background technique [0002] Doxycycline hydrochloride is mainly used for the treatment of upper respiratory tract infection, lymphadenitis, tonsillitis, senile chronic bronchitis, biliary tract infection, genitourinary infection and acne. However, since doxycycline hydrochloride is often irritated to the gastrointestinal tract, patients often experience symptoms such as nausea and vomiting after taking it, which greatly reduces the curative effect. Therefore, after doxycycline hydrochloride is made into an enteric-coated preparation, its curative effect can be improved. [0003] The chemical name of doxycycline hydrochloride is 6-methyl-4-(dimethylamino)-3,5,10,12,12a,-pentahydroxy-1,11-dioxo-1,4,4a, 5,5a,6,11,12a-octahydro-2-tetracenecarboxamide hydrochloride hemiethanol hemihyd...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/65A61K47/38A61K47/32A61P31/04A61P11/00A61P1/16A61P13/00A61P15/00A61P17/10
Inventor 诸弘刚谭海松叶海平邹小超洪江生周淑清张梦珍
Owner 华益泰康药业股份有限公司
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