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Doxycycline hyclate enteric-coated tablet and preparation method thereof

A technology of doxycycline hydrochloride and enteric-coated tablets, which is applied in the field of medicine, can solve the problems of difficult drying of pellets, long time consumption, and many releases, and achieves good fluidity and compressibility, good content uniformity, and good preparation. simple craftsmanship

Active Publication Date: 2016-07-27
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

Due to the poor drying efficiency of the centrifugal granulator, it is difficult to dry the pellets in time after spraying purified water, and part of the remaining water will dissolve the enteric coating of the enteric pellets, which eventually leads to excessive release of the preparation in the stomach , easy to cause strong gastric irritation and even make the drug ineffective
In addition, the production process of the invention is cumbersome, time-consuming and inefficient, and is not suitable for commercial mass production.

Method used

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  • Doxycycline hyclate enteric-coated tablet and preparation method thereof
  • Doxycycline hyclate enteric-coated tablet and preparation method thereof
  • Doxycycline hyclate enteric-coated tablet and preparation method thereof

Examples

Experimental program
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Effect test

preparation example Construction

[0053] Preparation of the reference substance: Accurately weigh about 23.1mg of the reference substance of doxycycline monohydrochloride hemiethanol hemihydrate, put it in a 20ml measuring bottle, add 2ml of methanol, shake for 5 minutes to dissolve, add 10ml of purified water and mix well , after standing to room temperature, dilute to the mark with purified water, shake well, that is.

[0054] Sample preparation: Take 1 piece of this product, grind it into pieces, place it in a suitable measuring bottle (see the table below), add methanol with 10% volume of the measuring bottle, shake for 10 minutes, add purified water with 50% volume of the measuring bottle, Shake again for 10 minutes, after standing to room temperature, dilute to the mark with purified water and shake well. Take an appropriate amount of this solution and centrifuge at 8000rpm for 5 minutes, and take the supernatant to obtain the product.

[0055] Detection method: ultraviolet-visible spectrophotometry (Ch...

Embodiment 1

[0060] Preparation of doxycycline hydrochloride medicated pellets:

[0061] name

Weight (g)

Doxycycline Hydrochloride

700

Sugar pill (0.20~0.38mm)

260

Polyvinylpyrrolidone K30

40

purified water

404

gross weight

1000

[0062] Use jet mill JGM-H50 equipment to micronize doxycycline hydrochloride into a particle size of D 90 It is 15μm powder, for later use;

[0063] Dissolving polyvinylpyrrolidone K30 in purified water to form a binder solution with a concentration of 9% by weight;

[0064] 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 t...

Embodiment 2

[0075] The preparation of doxycycline hydrochloride enteric-coated pellets is the same as in Example 1.

[0076] Preparation of doxycycline hydrochloride enteric-coated tablets:

[0077]

[0078] Doxycycline hydrochloride enteric-coated pellets, anhydrous lactose (45 μm to 150 μm), corn starch and crospovidone were mixed for 10 minutes at a speed of 10 rpm, and then passed through a 20-mesh sieve to obtain the mixture. Then the mixture was mixed with anhydrous lactose (250 μm-400 μm), the mixing time was 15 minutes, and the mixing speed was 10 rpm. Finally, it is mixed with the magnesium stearate after passing through a 20-mesh sieve to obtain the material. The mixing time is 5 minutes, and the mixing speed is 10 rpm.

[0079] Add the mixture into a tablet press, adjust the tablet compression parameters, and press the tablet. The hardness of the tablet is 180-220N.

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Abstract

The invention belongs to the technical field of medicine and particularly relates to a doxycycline hyclate enteric-coated tablet and a preparation method thereof. The enteric-coated tablet is prepared from, by weight, 28-32% of doxycycline hyclate enteric-coated pellets, 55-65% of lactose anhydrous, 4-8% of corn starch, 0.1-5% of cross-linking povidone and 0.1-1% of magnesium stearate. The diameter of the doxycycline hyclate enteric-coated pellets ranges from 0.35 mm to 1.00 mm, lactose anhydrous includes lactose anhydrous bodies with two different particle sizes, the particle size of the small-particle-size lactose anhydrous ranges from 45 microns to 150 microns, and the particle size of the large-particle-size lactose anhydrous ranges from 250 microns to 400 microns. The doxycycline hyclate enteric-coated tablet has the advantages that the preparation technology is simple, hardness is moderate, disintegration is quick, content uniformity is good and the release degree accords to quality standards, the treatment effect is good, and adverse effects are small.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a doxycycline hydrochloride enteric-coated tablet and a preparation method thereof. Background technique [0002] 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 hemihydrate, the chemical structure is shown below. [0003] [0004] Doxycycline belongs to a kind of antibiotics, and its absorption site is in the upper part of the gastrointestinal tract, but it has strong gastric irritation and acid instability. Therefore its optimal dosage form should be a kind of enteric-coated preparation, and this preparation has partial release in the stomach, usually 10%~50%, the optimum range is 10%~30%, both can avoid the stimulation of medicine to stomach like this, Can reach the optimal antibacterial concentration again and p...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/65A61K47/26A61P31/04
CPCA61K9/2018A61K31/65
Inventor 诸弘刚叶海平邹小超李惠惠谭海松
Owner 华益泰康药业股份有限公司
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