Duloxetine hydrochloride enteric capsules and preparation method thereof

A duloxetine hydrochloride and loxetine enteric technology, which is applied in the field of enteric-coated capsules containing duloxetine hydrochloride and its preparation, can solve the problems of difficult control of industrial production, long preparation time, cumbersome process, etc., and achieve The effects of good release and bioavailability, uniform drug content, and simplified process

Inactive Publication Date: 2013-02-06
ZHEJIANG JIUZHOU PHARM SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method can be used, it will cause uneven drug application, different pellet sizes, low recovery rate and poor reproducibility
[0010] The common point of the above patents is to prepare the blank pellets first and then apply the drug, so that although it can be released rapidly in the small intestine, the process parameters of the blank pellets are strict, and the process is cumbersome, the preparation time is long, and industrial production is not easy to control

Method used

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  • Duloxetine hydrochloride enteric capsules and preparation method thereof
  • Duloxetine hydrochloride enteric capsules and preparation method thereof
  • Duloxetine hydrochloride enteric capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Duloxetine hydrochloride is air-pulverized, and the particle size distribution range is: 99% of the diameter is not greater than 50 μm, 90% of the diameter is not greater than 35 μm, 50% of the diameter is not greater than 20 μm, and 5% of the diameter is not greater than 10 μm. The prescription quantity of duloxetine hydrochloride, sucrose, microcrystalline cellulose, cross-linked PVP, and sodium lauryl sulfate is mixed evenly, and 5% hypromellose aqueous solution is used as a binder to prepare a soft material, which is extruded and spheronized Prepare drug-loaded pellet cores with a diameter of 0.425 mm to 1.4 mm for later use. Preparation of the coating solution for the isolation layer: add the prescribed amount of hypromellose to the prescribed amount of water, then add polyethylene glycol and stir to dissolve for later use. Add talcum powder and titanium dioxide, stir evenly, stir at a slow speed for half an hour, and coat with a fluidized bed under continuous stir...

Embodiment 2

[0061] Airflow crush duloxetine hydrochloride, the particle size distribution range is: 99% diameter is not greater than 40 μm, 90% diameter is not greater than 25 μm, 50% diameter is not greater than 10 μm, 5% diameter is not greater than 5 μm, spare, weighed according to prescription 2 Prescription amount of duloxetine hydrochloride, sodium carboxymethyl starch, sucrose, starch, sodium lauryl sulfate mixed evenly, 5% hypromellose as binder, preparation of soft material, prepared by extrusion spheronizer Drug-loaded pill cores with a diameter of 0.425 mm to 1.4 mm are used for later use. Preparation of the coating solution for the isolation layer: add the prescribed amount of pyrrolidone (PVP) to the prescribed amount of water, stir to dissolve and set aside, then add talcum powder and titanium dioxide, stir evenly, stir at a slow speed for half an hour, continue to stir, and use a flow Chemical bed for coating. Enteric-coated layer preparation: Weigh the prescription quanti...

Embodiment 3

[0065] Duloxetine hydrochloride is air-pulverized, and the particle size distribution range is: 99% of the diameter is not greater than 40 μm, 90% of the diameter is not greater than 25 μm, 50% of the diameter is not greater than 10 μm, and 5% of the diameter is not greater than 5 μm. For standby, take according to prescription 3 Prescription amount of duloxetine hydrochloride, sucrose, sodium carboxymethyl starch, and starch are mixed evenly, and 5% hypromellose aqueous solution is used as a binder to prepare a soft material, which is prepared by an extrusion spheronizer into a diameter of 0.425 mm to 1.4 mm drug-loaded pill core, spare. Preparation of the coating solution for the isolation layer: add the prescribed amount of pyrrolidone to the prescribed amount of 50% ethanol aqueous solution (mass ratio), then add polyethylene glycol and stir to dissolve it for later use, then add talcum powder and titanium dioxide, stir evenly, and stir at a slow speed For half an hour, un...

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Abstract

The invention relates to the technical field of medicinal preparations, in particular to duloxetine hydrochloride-containing enteric capsules and a preparation method thereof. The enteric capsules consist of capsule shells and coated pellets, wherein the coated pellets also comprise duloxetine hydrochloride-containing medicine carrying pellet cores and coating layers; and the medicine carrying pellet cores contain a disintegrating agent. In preparation of the medicine carrying pellet cores, the duloxetine hydrochloride raw material is subjected to super micronization, so that the particle size distribution that the diameter of 99 percent is not greater than 50 mum, the diameter of 90 percent is not greater than 35 mum, the diameter of 50 percent is not greater than 20 mum and the diameter of 5 percent is not greater than 10 mum is achieved; and after the disintegrating agent is added into the medicine carrying pellet cores, the release speed of the medicine in intestines is increased. According to the duloxetine hydrochloride-containing enteric capsules and the preparation method thereof, a method of directly preparing the medicine carrying pellet cores is adopted, so that the complexity for loading a medicine on blank pellets of the existing domestic and foreign similar products is reduced, the technological process is simplified, and the duloxetine hydrochloride raw material is firstly crushed to a certain particle size range and then prepared into the medicine carrying pellet cores; and the prepared capsules have uniform medicine content and high reproducibility and are suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an enteric-coated capsule containing duloxetine hydrochloride and a preparation method thereof. Background technique [0002] As people's living standards are getting higher and higher, work pressure is also increasing, and people's psychological endurance is also suffering from huge challenges. According to literature reports, about 12% of people suffer from depression, but the existing clinical The effective rate of antidepressants is less than 70%, and the onset time is generally more than 15 days, and there are some intolerable side effects (sexual dysfunction, severe gastrointestinal reactions), which make many patients lose confidence in treatment . Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor (SNRI). In clinical research, as a safe and effective antidepressant among antidepressant drugs, it can effectively treat severe depressi...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/381A61P25/24
Inventor 阮建山丁仲杰车大庆
Owner ZHEJIANG JIUZHOU PHARM SCI & TECH CO LTD
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