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Duloxetine hydrochloride capsule and preparation method thereof

A technology of duloxetine hydrochloride and capsules, applied in the field of duloxetine hydrochloride capsules and preparation thereof, can solve the problem of hazardous chemicals, the bioavailability of product stability Cymbalta capsules has not been disclosed, and the equivalent cannot be clearly defined. Key quality comparison and other issues

Active Publication Date: 2016-04-27
浙江美华鼎昌医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the complex variety of auxiliary materials, ethanol is needed in this preparation method, and there is a certain risk of dangerous chemicals in industrialization; and the main drug disclosed in it has a weight gain of 2%-10%, while the positive control (reference preparation) purchased from the market The main content of Cymbalta Capsules is 18%, and there is a large difference between the two, and the weight gain ratio of the main drug in Examples 2 and 3 in this patent is not within this range, and the stability of the prepared product has not been disclosed in this patent. Due to the in vivo bioavailability and bioavailability of Cymbalta Capsules, it is impossible to clarify the key quality comparison of the pharmaceutical equivalent of its developed products

Method used

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  • Duloxetine hydrochloride capsule and preparation method thereof
  • Duloxetine hydrochloride capsule and preparation method thereof
  • Duloxetine hydrochloride capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] In this example, duloxetine enteric-coated capsules are composed of a capsule shell, a drug-loaded pill core, a drug, an isolation gown, and an enteric-coated layer. The gel material is dissolved and wrapped on the upper pill to form an isolation coat, and the coating solution is completed in ice water (also known as enteric coating), and the drug-loaded pill core, drug, isolation coat and coating form a coated microcapsule , put the coated microcapsules in the capsule shell to get the finished duloxetine hydrochloride capsules.

[0041] In the present embodiment, the composition of the upper pill is as shown in Table 1.

[0042] Composition of pills on Table 1

[0043]

[0044]

[0045] Among them, blank sugar pill: Hangzhou Gaocheng Bio-Nutrition Technology Co., Ltd. (Model: 20140370), API refers to the main drug duloxetine hydrochloride: Wuhan Dahua Weiye Biomedical Chemical Co., Ltd. (Model: 20140401), HPMCE5: Shanghai Card Lekang Coating Technology Co., Ltd...

Embodiment 2

[0067] The setting and working principle of this embodiment are the same as that of Embodiment 1, the difference is that:

[0068] (1) The composition of the upper pill is shown in Table 4.

[0069] The composition of the pills on Table 4

[0070] Element

weighing (g)

blank sugar pill

350.1

APIs

180.0

HPMC E5 (2%)

36.0

water

1700

[0071] Wherein, because 3% binder HPMCE5 coating is difficult, so need to add the water of 500ml and dilute to its concentration to be 2%.

[0072] (2) The composition of the gown is shown in Table 5.

[0073] Table 5 Composition of gowns

[0074] Element

weighing (g)

on the pill

400.0

HPMC E5

24.0

water

379.0

ethanol

422.5

[0075] Note: 4.75% weight gain.

[0076] (3) The ingredients of the coating (enteric coating) are shown in Table 6.

[0077] Table 6 Composition of the coating

[0078] Element

...

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Abstract

The present invention relates to a duloxetine hydrochloride capsule and a preparation method thereof, and belongs to the technical field of medical products. The duloxetine hydrochloride capsule comprises a drug carrying pill core, a high grade drug, an isolation coating and an enteric coating layer, the high grade drug, the isolation coating and the enteric coating layer from the inside to the outside successively coats the drug carrying pill core, the high grade drug comprises duloxetine and a binder, the isolation coating comprises a water-soluble gel, and the enteric coating layer comprises an enteric coating material, a plasticizer, an antisticking agent and a surfactant. The method is used in preparation of the duloxetine hydrochloride capsule, and the duloxetine hydrochloride capsule has good drug stability, high universality and other advantages.

Description

technical field [0001] The invention relates to a duloxetine hydrochloride capsule and a preparation method thereof, belonging to the technical field of pharmaceutical products. Background technique [0002] With the improvement of people's living standards, work pressure is also increasing, and people's mental strength is also suffering from huge challenges. According to literature reports, about 12% of people suffer from depression, but currently there are antidepressants in clinical practice. The effective rate 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 tract reaction), which make many people lose confidence in treatment. Duloxetine is a 5-hydroxytryptamine and norepinephrine dual reuptake inhibitor (SNRI). In clinical research, it is a safe and effective antidepressant in antidepressant drugs. It can effectively treat severe depression with small side effect...

Claims

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Application Information

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IPC IPC(8): A61K9/62A61K31/381A61P25/24
CPCA61K9/4866A61K9/5042A61K9/5047A61K31/381
Inventor 王传跃孙超德方浩传方庆华刘永莉王震东
Owner 浙江美华鼎昌医药科技有限公司
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