Production technology of miconazole nitrate vaginal tablets

A miconazole nitrate, production process technology, applied in the direction of pill delivery, organic active ingredients, diseases, etc., can solve the problems of low efficiency of the pharmaceutical process, reduce the content of defective products, improve manufacturing efficiency, and ensure product quality Effect

Inactive Publication Date: 2019-09-17
JINAN LIMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the deficiencies of the prior art, the invention provides a miconazole nitrate vaginal ta

Method used

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  • Production technology of miconazole nitrate vaginal tablets

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Effect test

Embodiment 1

[0034] Such as figure 1 Shown, the embodiment of the present invention provides miconazole nitrate vaginal tablet production process, comprises the steps:

[0035] Sp1 weighing ingredients: pass miconazole nitrate and microcrystalline cellulose through a 100-mesh sieve for later use, and weigh miconazole nitrate, microcrystalline cellulose, starch, and crospovidone according to the confidential process prescription;

[0036] Sp2 dry mixing: Mix the weighed microcrystalline cellulose and miconazole nitrate for 6 minutes to make them uniform, add an appropriate amount of 8% starch slurry, and mix for 3 minutes to make a soft material;

[0037] Sp3 wet granules: pass the soft material through a 2-mesh sieve to make wet granules;

[0038] Sp4 drying: Vacuumize the wet granules into fluidized bed drying, and dry at 60°C;

[0039] Sp5 granulation: pass the dried granules through an 18-mesh regulating sieve drum;

[0040] Sp6 blending: add the sized granules to the prescribed amou...

Embodiment 2

[0045] Such as figure 1 As shown, the embodiment of the present invention provides miconazole nitrate vaginal tablet production process, the operation process of weighing: miconazole nitrate, microcrystalline cellulose are crossed 100 mesh sieves for subsequent use, accurately weigh respectively corn starch, The processes of microcrystalline cellulose, crospovidone, miconazole nitrate, dry mixing and wet granulation are connected together. The dry mixing process first prepares the binder: dissolve the prescribed amount of corn starch in purified water to prepare After slurring 8% cornstarch the dry powder is blended:

[0046] Adding order: microcrystalline cellulose, miconazole nitrate, mixed to obtain dry powder;

[0047]Process steps: use a vacuum pump to suck the weighed raw and auxiliary materials into the wet mixing granulator in sequence, set the stirring knife speed: 120rpm, the granulating knife speed: 500rpm; dry mixing time: 360 seconds, add binder: use The fast-lo...

Embodiment 3

[0049] Such as figure 1 As shown, the embodiment of the present invention provides the miconazole nitrate vaginal tablet production process, the weighing process adopts two people to weigh, one person weighs, and one person checks, the moisture that is finally dried by the drying process is no more than 3%, and the granulation process needs to be screened. Damaged, confirm the mesh number of the sieve cylinder, the quality inspection of the total blend includes product shape, moisture, particle content and theoretical tablet weight, the weight difference of the tableting process is ±4%, the packaging process checks the airtightness of the package, the batch number printing, and the appearance of damage And weight parameters, wet mixing granulator with signal GM500 is used for dry mixing and wet granulation, fluidized bed model FBD400 is used for drying, lifting transfer machine model LHM-500 is used for granulation, and model The hopper mixer is BDV-1800, the tablet is pressed...

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Abstract

The invention provides a production technology of miconazole nitrate vaginal tablets, and relates to the technical field of a medicine making technology. The production technology of miconazole nitrate vaginal tablets comprises the following steps of performing weighing and blending, performing dry mixing to obtain wet granules, performing drying, performing granule trimming, performing total mixing, performing tabletting, performing packaging, and performing warehousing: performing packaging, performing total inspection, and performing warehousing. The miconazole nitrate vaginal tablets are produced through an assembly line of whole automated equipment, so that the making efficiency of the whole products can be improved, the yield of unit time can be increased, enterprise profits are increased, quality control is performed for products produced through multiple working procedures, the quality of products produced through a single working procedure can be guaranteed, control on the quality of finished products is realized, the content of defectives in the pharmacy process is reduced, and the whole rate of finished products in the whole pharmacy technological process is increased.

Description

technical field [0001] The invention relates to the technical field of medicine manufacturing technology, in particular to the production technology of miconazole nitrate vaginal tablets. Background technique [0002] Vaginitis is the most common infectious disease in women. Its common symptoms are increased vaginal discharge, genital itching and burning pain, which may be accompanied by frequent urination, dysuria and dyspareunia. Gynecological examination shows increased vaginal discharge, vaginal mucosa hyperemia or scattered Bleeding spots, a large amount of leucorrhea in the posterior fornix of the vagina, gray-yellow or yellow-green purulent discharge, sometimes foamy or white thick curd or bean dregs-like, edema, scratches, geographic erythema can be seen in the vulva, vaginal mucosa administration It has a history of nearly 100 years. Compared with traditional oral administration, it has many advantages. It can be used not only locally, but also systemically. The dru...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4174A61P15/00A61P31/10
CPCA61K9/0034A61K9/2027A61K9/2054A61K9/2059A61K9/2095A61K31/4174A61P15/00A61P31/10
Inventor 赵先亮冯俊平刘新宁
Owner JINAN LIMIN PHARMA
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