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Duloxetine hydrochloride enteric capsule drug combination

A technology of duloxetine hydrochloride and enteric-coated capsules, which is applied in the field of pharmaceutical preparations, can solve problems such as difficulty in ensuring the uniformity of drug components, unfavorable rehabilitation of patients with depression, and difficulty in unifying drug effects, so as to achieve treatment and drug benefits that are beneficial to the disease. Good safety performance and the effect of reducing the frequency of taking medicine

Inactive Publication Date: 2016-11-30
HAINAN HERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, most of the clinically available antidepressants have an effective rate of less than 70%, and the treatment cycle is long, often accompanied by some intolerable side effects, such as severe gastrointestinal reactions, which are not conducive to the recovery of patients with depression.
In this patent, two pellets with different release times are mixed 1:1 to achieve the purpose of sustained drug effect, but it is difficult to ensure that the quantity strictly reaches 1:1 during the filling process, so it is difficult to ensure the uniformity of the drug components. It is difficult to unify the efficacy of each batch

Method used

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  • Duloxetine hydrochloride enteric capsule drug combination
  • Duloxetine hydrochloride enteric capsule drug combination
  • Duloxetine hydrochloride enteric capsule drug combination

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Prescription 1,

[0063]

[0064]

[0065] Preparation:

[0066] (1) Preparation of B vitamins layer

[0067] Under the condition of stirring, add hydroxypropyl cellulose sodium into purified water, after completely dissolving, add B vitamins and sucrose in the formula amount, stir evenly, and grind in a colloid mill to obtain a B vitamin layer coating solution;

[0068] Place the blank pellet core in a pellet coating machine, and coat it with the B vitamin layer coating solution;

[0069] (2) Preparation of drug-loaded layer

[0070] Under the condition of stirring, add hydroxypropylmethylcellulose into purified water, after completely dissolving, add duloxetine hydrochloride, sucrose, talcum powder, and β-cyclodextrin according to the formula amount, and stir evenly to obtain the drug-loaded layer coating clothing liquid;

[0071] The pellets obtained in step (1) are placed in a pellet coating machine, and coated with the coating liquid of the drug-loaded la...

Embodiment 2

[0081] Prescription 2,

[0082]

[0083] Preparation:

[0084] (1) Preparation of B vitamins layer

[0085] Under the condition of stirring, add hydroxypropyl cellulose sodium into purified water, after completely dissolving, add B vitamins and sucrose in the formula amount, stir evenly, and grind in a colloid mill to obtain a B vitamin layer coating solution;

[0086] Place the blank pellet core in a pellet coating machine, coat it with the B vitamin layer coating solution, and increase the weight by 15%;

[0087] (2) Preparation of drug-loaded layer

[0088] Under the condition of stirring, add hydroxypropylmethylcellulose into purified water, after completely dissolving, add duloxetine hydrochloride, sucrose, talcum powder, and β-cyclodextrin according to the formula amount, and stir evenly to obtain the drug-loaded layer coating clothing liquid;

[0089] The pellets obtained in step (1) are placed in a pellet coating machine, coated with the coating liquid of the dr...

Embodiment 3

[0099] Prescription 3,

[0100]

[0101]

[0102] Preparation:

[0103] (1) Preparation of B vitamins layer

[0104] Under the condition of stirring, add hydroxypropyl cellulose sodium into purified water, after completely dissolving, add B vitamins and sucrose in the formula amount, stir evenly, and grind in a colloid mill to obtain a B vitamin layer coating solution;

[0105] Place the blank pellet core in a pellet coating machine, coat it with the B vitamin layer coating solution, and increase the weight by 20%;

[0106] (2) Preparation of drug-loaded layer

[0107] Under the condition of stirring, add hydroxypropylmethylcellulose into purified water, after completely dissolving, add duloxetine hydrochloride, sucrose, talcum powder, and β-cyclodextrin according to the formula amount, and stir evenly to obtain the drug-loaded layer coating clothing liquid;

[0108] The pellets obtained in step (1) are placed in a pellet coating machine, coated with the coating liqu...

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Abstract

The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition of duloxetine hydrochloride enteric-coated capsules, comprising duloxetine hydrochloride enteric-coated pellets and hollow capsules; the duloxetine hydrochloride enteric-coated pellets include blank The ball core, the drug-loaded layer, the isolation layer and the enteric layer also include a B vitamin layer between the blank core and the drug-loaded layer, and the composition and mass ratio of the B vitamin layer are: 5-15 parts of vitamins, 1-10 parts of hydroxypropyl cellulose sodium, 45-80 parts of sucrose. The invention also provides a method for preparing the duloxetine hydrochloride enteric-coated capsule pharmaceutical composition.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition of duloxetine hydrochloride enteric-coated capsules. Background technique [0002] With the improvement of living standards, work pressure is also increasing, and people's psychological endurance is also suffering from huge challenges. It is reported that about 12% of people currently suffer from depression. This situation is quite serious and has caused widespread concern in society. However, most of the clinically available antidepressants have an effective rate of less than 70%, and the treatment cycle is long, often accompanied by some intolerable side effects, such as severe gastrointestinal reactions, which are not conducive to the recovery of patients with depression. . [0003] Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor (SNRI). Clinical studies have shown that it can effectively treat severe depression, w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/50A61K31/381A61K31/51A61K31/455A61K31/519A61K31/714A61K31/525A61K31/197A61P25/24
CPCA61K9/5078A61K9/501A61K9/5015A61K9/5047A61K31/197A61K31/381A61K31/455A61K31/51A61K31/519A61K31/525A61K31/714A61K2300/00
Inventor 钟正明
Owner HAINAN HERUI PHARMA
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