Duloxetine hydrochloride enteric-coated tablet and preparation method thereof

A technology of enteric and hydrochloric acid degree of loxetine, which is applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as poor dissolution rate and achieve the effect of good dissolution rate.

Pending Publication Date: 2021-07-16
SHANGHAI ZHONGXI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is to provide a kind of duloxetine hydrochloride enteric-coated tablets in order to overcome the defect that the dissolu

Method used

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  • Duloxetine hydrochloride enteric-coated tablet and preparation method thereof
  • Duloxetine hydrochloride enteric-coated tablet and preparation method thereof
  • Duloxetine hydrochloride enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0082] Example 1

[0083] The raw material of the hydrochloride monohydrin form is prepared according to the above table, and the preparation method is as follows:

[0084] (1) Preparation of the core: After the active ingredient, the filler is written by 40 mesh sieve, pour it into the rapid stirring granulator, and the stirring paddle is prepared for 5 minutes. Then open the flying knife at low speed and add purified water, the mass ratio of the purified water and the mass ratio of the core material is 1: 5. After the purification water is finished, the flying knife is high-speed, and the granulation is continued for about 3-8 minutes, stop stirring, out The oven is dried 50 ° C, and drying is stopped when moisture <1.0 wt%. Install 1.2mm to 2.0mm specifications of stainless steel screen for pan, then adding a lubricant for 5 minutes, tablets, control hardness 4-10kg, fragmentation of less than 0.8%, weight difference ratio of ± 5%.

[0085] (2) Isolation layer coating: 1 Prepar...

Example Embodiment

[0087] Example 2-3

[0088] The raw material of the hydrochloride monohydrin form is prepared according to the above table, and the preparation method is as follows:

[0089] (1) Preparation of the core: Prerequisites: Pink the sucrose to 40 mesh sieve, and the remaining raw materials have passed the 40 mesh sieve. Wet granulation: 1 formulation of binder: dissolve the binder in a water solution of 70% (w / w), the mass ratio of the ethanol aqueous solution and the mass ratio of the core material is 1: 18. 2 Among the tank type mixer, mixed 10 minutes, mixed 10 minutes, uniformly poured into the binder, and then stirred for 3 to 5 minutes, forming a soft material, and closed stirring. 3 Mount 20 mesh nylon nets on the rocking machine, add the soft material to the feed bucket, granulation operation, the prepared wet particles are collected into stainless steel basins, and even properly, the tile is clean. The surface of the coated stainless steel baking dish, the surface of the wet...

Example Embodiment

[0092] Example 4-7

[0093] The raw material of the hydrochloride olitatin formula sheet is prepared according to the following table, and the method is prepared in Example 1.

[0094]

[0095]

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Abstract

The invention discloses a duloxetine hydrochloride enteric-coated tablet and a preparation method thereof. The enteric-coated tablet comprises a tablet core, an isolating layer, and an enteric-coated layer; the tablet core comprises duloxetine hydrochloride, lactose, a lubricant and a non-lactose filler, and the mass percentages of the duloxetine hydrochloride, the lactose, the lubricant and the non-lactose filler in the tablet core are 7.7%-22.3%, 31.8%-56.7%, 0.3%-1.5% and supplemented to 100% respectively; the isolating layer comprises an adhesive, cane sugar and an anti-sticking agent, and the mass percentages of the adhesive, the cane sugar and the anti-sticking agent in the isolating layer are 20.0%-50.0%, 20.0%-50.0% and 10.0%-50.0% respectively; the enteric-coated layer comprises an enteric-coated material, an anti-sticking agent and a plasticizer, and the mass percentages of the enteric-coated material, the anti-sticking agent and the plasticizer in the enteric-coated layer are 60.0%-85.7%, 5.4%-30.0% and 5.0%-25% respectively; and the weight of the coating of the isolating layer is increased by 4-12%, and the weight of the coating of the enteric-coated layer is increased by 5.4-12%. The dissolution rate of the enteric-coated tablet in a buffer solution is better.

Description

technical field [0001] The invention relates to a duloxetine hydrochloride enteric-coated tablet and a preparation method thereof. Background technique [0002] Duloxetine Hydrochloride (DuloxetineHydrochloride, API) is an effective dual absorption inhibitor of serotonin and norepinephrine for the treatment of depression. The chemical name is: S-(+)-N-methyl-3 -(1-naphthyloxy)-3-(2-thienyl)-propylamine hydrochloride, its structural formula is: [0003] [0004] Duloxetine hydrochloride is white or off-white crystalline powder, which is soluble in ethanol and has a certain solubility in water. It is unstable under acidic conditions and easy to degrade. Therefore, it is suitable to be made into enteric-coated preparations to resist the damage of gastric juice to the drug. [0005] The original research uses a fluidized bed to prepare enteric-coated pellets and fill gelatin capsule capsules. In the United States, it was first approved for the treatment of major depressive ...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/32A61K31/381A61K47/26A61P25/22A61P25/24
CPCA61K9/2018A61K9/2846A61K9/2866A61K9/2886A61K31/381A61P25/22A61P25/24
Inventor 綦宁姣徐豪石海芹丁祎馨傅麟勇周敏丁云晖王菲李星旺王永
Owner SHANGHAI ZHONGXI PHARMA
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