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Ranitidine hydrochloride capsules and preparation method thereof

A technology of ranitidine hydrochloride and capsules, which is applied in the field of medicine, can solve problems such as damp heat instability, easy moisture absorption and accumulation, and achieve the effect of avoiding drug yellowing, improving stability and drug safety

Active Publication Date: 2020-05-26
SUZHOU KELUN PHARMA RES CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Based on this, it is necessary to provide a kind of preparation method of ranitidine hydrochloride capsules aiming at the problem that the ranitidine bulk drug is unstable to heat and humidity and easy to absorb moisture and accumulate

Method used

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  • Ranitidine hydrochloride capsules and preparation method thereof
  • Ranitidine hydrochloride capsules and preparation method thereof
  • Ranitidine hydrochloride capsules and preparation method thereof

Examples

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preparation example Construction

[0056] The embodiment of the present invention provides a kind of preparation method of ranitidine hydrochloride capsule, comprises the following steps:

[0057] S1. The materials in the prescribed amount are mixed in a fluidized state, and the materials at least include ranitidine hydrochloride;

[0058] S2. Keep the mixed material at a predetermined temperature, atomize and spray the wetting agent or binder solution, and granulate the material to form drug granules;

[0059] S3, drying the drug particles;

[0060] S4, making the dried drug granules into mixed granules; and

[0061] S5. Capsule filling of the mixed granules,

[0062] The steps of mixing, granulating and drying are carried out in the same airtight container.

[0063]In the ranitidine hydrochloride capsules provided in the embodiments of the present invention and the preparation method thereof, the step S1 mixing, the step S2 granulation, and the step S3 drying are all completed in the same airtight containe...

Embodiment 1

[0091] prescription weight Ranitidine hydrochloride 99 copies Crospovidone 0.5 parts Magnesium stearate 0.5 parts Capsule content weight 169mg

[0092] Preparation:

[0093] S1, get the material ranitidine hydrochloride of recipe quantity in fluidized bed, make ranitidine hydrochloride form fluidized state;

[0094] S2. Heat the ranitidine hydrochloride to 35-45°C, atomize and spray water into the fluidized bed, the pressure of the atomized spray is 0.1MPa, and the spray speed of the atomized spray is 35ml / min, The atomized water is sprayed onto the ranitidine hydrochloride in a fluidized state, and the material is granulated so that the ranitidine hydrochloride forms drug granules;

[0095] S3. After the drug granules are in good condition, dry the ranitidine hydrochloride drug granules in a fluidized bed until the moisture content is not higher than 5%;

[0096] S4, take out the dried ranitidine hydrochloride drug granules from th...

Embodiment 2

[0099] prescription weight Ranitidine hydrochloride 83 copies starch 5 copies lactose 7 copies Calcium stearate 5 copies Capsule content weight 202mg

[0100] Preparation:

[0101] S1, get the material ranitidine hydrochloride and lactose of recipe quantity in fluidized bed, make the mixed material of ranitidine hydrochloride and lactose form fluidized state, mix 10 minutes;

[0102] S2. Heat the mixture of ranitidine hydrochloride and lactose to 25-35°C, atomize and spray starch slurry solution with a mass concentration of 5% into the fluidized bed, and spray the pressure of 0.3MPa, atomize The spray speed of injection is 60ml / min, and the material is granulated to form drug granules;

[0103] S3. After the drug granules are in good condition, dry the drug granules in a fluidized bed until the water content is not higher than 5%;

[0104] S4, the dried drug granules are taken out from the fluidized bed, crushed and granulated ...

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Abstract

The invention provides ranitidine hydrochloride capsules and a preparation method thereof. The preparation method comprises the following steps that materials of a prescription amount are taken and mixed in a fluidized state, and the materials at least comprise ranitidine hydrochloride; the mixed materials are enable to be at a preset temperature, a wetting agent or an adhesive solution are subjected to atomizing and spraying, and the materials are granulated to form medicine particles; the medicine particles are dried; and the dried medicine particles are prepared into mixed particles; and the capsule filling is carried out on the mixed particles, wherein the steps of mixing, granulating and drying are carried out in a same closed container.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to ranitidine hydrochloride capsules and a preparation method thereof. Background technique [0002] Ranitidine hydrochloride capsules are powerful H 2 Beta blockers are used to relieve stomach pain, heartburn (heartburn), acid reflux and other diseases caused by hyperacidity. Ranitidine hydrochloride crude drug is off-white to light yellow crystalline powder, very easy to deliquescence, the color becomes dark after absorbing moisture, and is more sensitive to temperature and humidity in the process of technological preparation. [0003] The preparation method of existing ranitidine hydrochloride capsules all has some problems in the process of preparing ranitidine hydrochloride capsules. Powder direct injection method prepares ranitidine hydrochloride capsules, because the density of ranitidine hydrochloride is small, the proportion of ranitidine hydrochloride raw material in th...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/26A61K47/36A61K47/32A61K47/38A61K31/341A61P1/04
CPCA61K9/16A61K9/1623A61K9/1652A61K9/1635A61K31/341A61P1/04
Inventor 张欢丁子莹危军吴灵静王琦王利春王晶翼
Owner SUZHOU KELUN PHARMA RES CO LTD
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