Preparation method of milnacipran hydrochloride preparation

A technology of milnacipran hydrochloride and preparation, which is applied in the field of drug preparation to achieve the effects of shortening production cycle, ensuring stability and low production efficiency

Pending Publication Date: 2022-06-03
SICHUAN CREDIT PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Aiming at the defects in the production process of existing milnacipran hydrochloride preparations, the present invention provides a preparation method of milnacipran hydrochloride preparations, the purpose of which is to provide a raw material medicine with few steps, low cost, and no need to strictly control the moisture content. A method for preparing a milnacipran hydrochloride preparation with less sieving times, low requirements on particle size and density of excipients, and strong practicability

Method used

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  • Preparation method of milnacipran hydrochloride preparation
  • Preparation method of milnacipran hydrochloride preparation
  • Preparation method of milnacipran hydrochloride preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] In this embodiment, the filler is anhydrous calcium hydrogen phosphate, the disintegrant is calcium carboxymethyl cellulose, the binder is hypromellose, the glidant is colloidal silicon dioxide, and the lubricant is stearic acid magnesium. According to the prescription composition shown in table 1, adopt the powder direct compression technology, respectively obtain the milnacipran hydrochloride specification (content of active ingredient in the unit preparation) that is 12.5mg, 15mg, 25mg, 50mg milnacipran hydrochloride tablets .

[0061] Table 1 Specifications 12.5mg, 15mg, 25mg, 50mg prescription composition

[0062]

[0063]

[0064] The specific preparation method is as follows:

[0065] (1) Pretreatment: The raw material drug (namely, milnacipran hydrochloride, with a particle size of 50-160 μm) is passed through a 0.45 mm sieve with a pulverizing and granulating machine for use.

[0066] (2) Weighing ingredients: Weigh the raw and auxiliary materials acco...

experiment example 1

[0093]Experimental Example 1: Influencing Factors Test of Milnacipran Hydrochloride Tablets

[0094] (1) Test method

[0095] The product stability of the milnacipran hydrochloride tablets of the present invention, the milnacipran hydrochloride tablets obtained by wet granulation, the commercial product and the reference preparation under the condition of high temperature of 60°C for 30 days was investigated.

[0096] sample:

[0097] Sample prepared in Example 1 (Milnacipran hydrochloride tablets obtained by powder direct compression, specifications: 12.5mg, 15mg, 25mg, 50mg);

[0098] The sample prepared by comparative example 1 (milnacipran hydrochloride tablets obtained by wet granulation process, specification: 25mg);

[0099] Commercial product (Milnacipran hydrochloride tablets, specification: 25mg, manufacturer: Shanghai Modern Pharmaceutical Co., Ltd.);

[0100] Reference preparation (Milnacipran hydrochloride tablets, specifications: 25 mg, 50 mg, manufacturer: As...

experiment example 2

[0111] Experimental Example 2: Accelerated Test of Milnacipran Hydrochloride Tablets

[0112] (1) Test method

[0113] Samples prepared in Example (Milnacipran hydrochloride tablets obtained by powder direct compression, specifications: 12.5mg, 15mg, 25mg, 50mg);

[0114] Samples prepared by comparative example (Milnacipran hydrochloride tablets obtained by wet granulation process, specification: 25mg); commercial product (Milnacipran hydrochloride tablets, specification: 25mg, manufacturer: Shanghai Modern Pharmaceutical Co., Ltd.); Specific formulation (Milnacipran hydrochloride tablets, specifications: 25 mg, 50 mg, manufacturer: Asahi Kasei Pharmaceutical Co., Ltd.).

[0115] experiment method:

[0116] The samples were sealed and packaged in polyethylene film plastic bags, placed in a constant temperature and humidity incubator at 40 °C ± 2 °C and a relative humidity of 75 ± 5%, placed for three months, and samples were taken at the end of 1, 2, and 3 months. And compa...

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Abstract

The invention relates to the technical field of medicine preparation, in particular to a preparation method of a milnacipran hydrochloride preparation. Aiming at the defects in the production process of the existing milnacipran hydrochloride preparation, the preparation method of the milnacipran hydrochloride preparation comprises the following steps: crushing milnacipran hydrochloride; the preparation method comprises the following steps: taking milnacipran hydrochloride, adding a flow aid, a part of filler, an adhesive and / or a disintegrating agent, mixing, crushing, dispersing and sieving; the dosage of the filling agent is 0-2 times of the total weight of milnacipran hydrochloride, the flow aid and the adhesive and / or disintegrating agent; taking the residual filling agent, and sieving; if the adhesive or the disintegrating agent is not added in the step, the adhesive or the disintegrating agent is taken and sieved; uniformly mixing the sieved powder; uniformly mixing lubricant powder; and molding to obtain the core material. And coating the core material. The method is low in cost, and the prepared milnacipran hydrochloride preparation is good in stability and high in applicability to raw materials of different batches and manufacturers.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparation, in particular to a preparation method of a milnacipran hydrochloride preparation. Background technique [0002] The chemical name of milnacipran hydrochloride 1 is 2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride, which is a specific product developed by PierreFabre in France. - Serotonin (5-HT) and norepinephrine reuptake inhibitors, with high activity in a series of experiments showing antidepressant activity, significantly better than desipramine and imipramine. As a fourth-generation antidepressant, milnacipran hydrochloride has no anticholinergic effect, and has a relatively short half-life. After stopping treatment, there is no residual effect, so it has good tolerance and safety. In addition, compared with tricyclic antidepressants (TCA) and selective 5-HT reuptake inhibitors, milnacipran hydrochloride has better curative effect and no adverse r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/02A61K47/04A61K31/165A61P25/24
CPCA61K9/2095A61K9/2054A61K9/2009A61K31/165A61P25/24
Inventor 吴三平刘均胜陈功政陈刚
Owner SICHUAN CREDIT PHARMA
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