Technological method of producing ibuprofen tablets through two times of granulation

A technology of ibuprofen tablet and process method, which is applied in the direction of anti-inflammatory agent, pill delivery, pharmaceutical formulation, etc., can solve the problems such as improvement of tabletting performance, achieve the effects of improving fluidity, good stability, and improving tabletting efficiency

A technology of ibuprofen tablet and process method, which is applied in the direction of anti-inflammatory agent, pill delivery, pharmaceutical formulation, etc., can solve the problems such as improvement of tabletting performance, achieve the effects of improving fluidity, good stability, and improving tabletting efficiency

CN109512792AInactive Publication Date: 2019-03-26安徽东盛友邦制药有限公司
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Experimental program
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specific Embodiment approach

[0031] The specific embodiment: a kind of processing method of twice granulation production ibuprofen tablet, concrete steps are as follows:

[0032] (1) Preparation of ibuprofen micropowder:

[0033] In an ice-water bath at 0-5°C, under the condition of ultrasound or stirring, add dropwise at a constant rate of 1ml / min-5ml / min, and add a certain amount dropwise to the aqueous solution containing 2% stabilizer povidone K30 Amount of 0.05g / ml-0.10g / ml ibuprofen ethanol solution until the solution system becomes turbid, let it stand for 5-10h, and centrifuge at a high speed until the separation is complete, the obtained solid sample is washed and centrifuged, and the supernatant is removed. Dried in a vacuum drying oven at -50°C, ground and sieved to obtain ibuprofen micropowder;

[0034] (2) preparation of ibuprofen dispersion:

[0035] According to the mass ratio of silicon dioxide and acrylic resin drug carrier 1: (2-4) mixed as carrier;

[0036] According to the ratio of ...

Embodiment 1

[0046] The preparation of every 1000 ibuprofen tablets, concrete steps are as follows:

[0047] (1) Preparation of ibuprofen micropowder:

[0048] Get 400g ibuprofen and dissolve in absolute ethanol solution to prepare 0.10g / ml ibuprofen ethanol solution;

[0049] In an ice-water bath at 0°C, under ultrasonic conditions, add ibuprofen ethanol solution dropwise at a constant rate of 2ml / min to the aqueous solution containing 2% stabilizer povidone K30 until the solution system becomes cloudy , stand still for 10 hours, centrifuge at high speed until the separation is complete, wash and centrifuge the obtained solid sample, remove the supernatant, dry the obtained product in a vacuum oven at 50°C, grind and sieve to obtain ibuprofen micropowder;

[0050] (2) preparation of ibuprofen dispersion:

[0051]Weigh 25g of silicon dioxide and 70g of acrylic resin drug carrier as the carrier, mix evenly with the ibuprofen micropowder obtained above, add to the hopper of the hot-melt ex...

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Abstract

The invention discloses a technological method of producing ibuprofen tablets through two times of granulation. Silicon dioxide is used for assisting an acrylic resin drug carrier in coating ibuprofenmicro-powder, then one-time granulation is conducted, in the one-time granulation process, colloidal silicon dioxide is taken as an auxiliary material, it is ensured that ibuprofen original drugs isevenly distributed in the granulation process, the flowability of ibuprofen dispersions is improved, and the tabletting efficiency of ibuprofen granules is improved; and the ibuprofen granules obtained through a two-time granulation treatment technology are subjected to tabletting treatment, compared with a technological method in the prior art, the ibuprofen tablets prepared through the technological method is good in flowability, the content of the ibuprofen original medicine in the ibuprofen tablets is maintained, and the obtained tablets have the higher active ingredient dose and have theadvantages of being good in stability, high in bioavailability, not liable to absorb moisture and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a process for producing ibuprofen tablets through double granulation. Background technique [0002] Ibuprofen is a commonly used non-steroidal anti-inflammatory and analgesic drug in clinic, and its analgesic effect is remarkable. Ibuprofen is almost insoluble in water, and the pharmacokinetic parameter Tmax value (time to reach maximum blood drug concentration) of its tablet is 1.5-2 hour, and onset of action is relatively slow. [0003] The ibuprofen content in ibuprofen tablets is usually very high. The high ibuprofen content in ibuprofen formulations is such that, for example, the properties of the tableting mixture are determined almost exclusively by the properties of the ibuprofen. The low melting point of ibuprofen is only 75°C and thus causes serious difficulties in the processing of formulations, problems arise due to its tendency to st...

Claims

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Application Information

Patent Timeline
26 Mar 2019
Publication
CN109512792A
IPC
A61K9/20; A61K47/32; A61K47/04; A61K31/192; A61P29/00
CPC
A61K9/2009; A61K9/2027; A61K9/2081; A61K9/2095; A61K31/192; A61P29/00
Inventors
傅兆瑞; 朱永香