Delayed release preparation containing safe and reliable plasticizer and preparation method thereof

A technology of delayed release and plasticizer, which can be used in medical preparations containing active ingredients, medical preparations without active ingredients, pharmaceutical formulas, etc., and can solve problems such as potential safety hazards.

Active Publication Date: 2012-10-31
华益泰康药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Plasticizers are used in many medicines now, and most plasticizers are phthalates or citrates, but there are certain safety hazards

Method used

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  • Delayed release preparation containing safe and reliable plasticizer and preparation method thereof
  • Delayed release preparation containing safe and reliable plasticizer and preparation method thereof
  • Delayed release preparation containing safe and reliable plasticizer and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] In Example 1, the extrusion spheronization method was used to prepare the drug-loaded pellet core. The preparation method was as follows: firstly, HPMC E5 was dissolved in an appropriate amount of hot water, and placed at room temperature to make a solvent for use. Then weigh the prescribed amount of loxetine hydrochloride, lactose or sucrose powder, and microcrystalline cellulose and place them in a wet granulator. After dry mixing, gradually add the prepared solvent to make a soft material, and then make the soft material Transfer to an extruder for extrusion, then transfer to a spheronizer for spheronization, and finally dry in an oven to obtain the drug-loaded pellet core. The experimental parameters are: wet granulator: paddle speed 3r / s, cutter speed 35r / s; extrusion spheronizer: extrusion net 0.6mm, extrusion speed 35-45 rpm, spheronization speed 1600rpm, spheronization time for 40-60s.

[0031] Examples 2 to 8 are drug-loaded pellet cores prepared by coating dr...

specific Embodiment

[0034] The specific examples are as follows, and the dosage of the formula is calculated by the weight of each material contained in each capsule.

[0035] Example 1: Duloxetine Delayed Release Formulation

[0036] Table 1: Example 1 formulation

[0037]

Embodiment 2

[0038] Example 2: Duloxetine Delayed Release Formulation

[0039] Table 2: Example 2 formulation

[0040]

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PUM

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Abstract

The invention relates to the technical field of medicines and discloses a delayed release preparation containing a safe and reliable plasticizer and a preparation method thereof. The preparation method comprises the following steps of: firstly preparing a medicine-loading pill core, and then coating an isolating layer and an enteric layer containing the specific plasticizer, wherein the medicine-loading pill core can be prepared by preparing active medicine ingredients and auxiliary materials into soft materials and then adopting an extrusion rounding method and also can be prepared by dissolving the active medicine ingredients and the auxiliary materials and directly coating on a hollow pill core by a fluidized bed. The delayed release preparation selects the specific plastic material, and does not contain phthalic acid ester and citrate plastic materials, so that the safety is better.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a delayed-release preparation containing a safe and reliable plasticizer and a preparation method thereof. Background technique [0002] Depression has become a common mental disorder, and the proportion of patients with depression has risen sharply. According to the statistics of relevant departments, the number of depression patients in the world has reached 120 to 200 million, becoming the fifth largest disease affecting human health, and may soon rise to the second place. [0003] Duloxetine hydrochloride is mainly used to treat depression. It is a dual serotonin and norepinephrine reuptake inhibitors (SNRIs). [0004] At present, plasticizers are added to most formulations of duloxetine, and most plasticizers choose phthalates or citrates. However, a new study published in the journal Environmental Health Perspectives finds that many common medicines an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/52A61K47/38A61K47/34A61K47/32A61K31/381A61P25/24
Inventor 徐国杰诸弘刚谭海松赵兰敏黎继清王创生徐艳
Owner 华益泰康药业股份有限公司
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