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A kind of sulfasalazine tablet and preparation method thereof

A sulfasalazine and tablet-dissolving technology, which is applied in the field of medicine, can solve the problems of rapid drug absorption and achieve the effects of convenient taking, definite curative effect and high stability

Active Publication Date: 2022-05-10
NANJING GRITPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In an alkaline intestinal environment, sulfasalazine will be dissolved and released quickly, and the drug will be absorbed into the body too quickly

Method used

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  • A kind of sulfasalazine tablet and preparation method thereof
  • A kind of sulfasalazine tablet and preparation method thereof
  • A kind of sulfasalazine tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Extrusion spheronization granulation (prescription 1-5)

[0054] The composition of the prescription is as follows:

[0055]

[0056]

[0057] 1. Preparation of binding solution: 8% HPMCP-55 was prepared as a binding solution with 70% ethanol as a solvent.

[0058] 2. Pretreatment: Colloidal silica passed through 80 mesh sieve;

[0059] 3. Mixing: Add the above-mentioned internally added excipients and raw materials into the wet granulator, stir for 5r / s, shear for 15r / s, and mix for 10min.

[0060] 4. Making soft materials: stirring 8r / s, shearing 23r / s, adding adhesive solution at a constant speed for 1-1.5min, stopping midway to scrape the material, and continuing to stir for 1min

[0061] 5. Extrusion and spheronization: the plate thickness is 2mm, the hole diameter is 1mm, extruded and granulated to form granules; the granules are extruded and granulated again.

[0062] 6. Drying: Dry at 50°C, control the moisture content to less than 2%;

[0063] 7. Grai...

Embodiment 2

[0077] High Shear Granulation (Recipe 6)

[0078] Prescription composition:

[0079] API:

[0080] Sulfasalazine 500.00g

[0081] Adding accessories:

[0082]

[0083] Additional accessories:

[0084]

[0085] Coating accessories:

[0086] Triethyl citrate 2.2g

[0087] HPMCP-55 22.00g

[0088] Makes 1000 pieces

[0089] Preparation process:

[0090] 1. Pretreatment: Colloidal silica passed through 80 mesh sieve;

[0091] 2. Add sulfasalazine into the wet granulator, atomize and add 1-10% K90 binding solution (purified water as solvent) 15-25ml to granulate (atomization and liquid addition time 30-40s), not enough Use 30-40ml of pure water as a wetting agent to stir 8r / s, shear 35r / s, and granulate for 3min.

[0092] 3. Granulate with a 30-mesh oscillating granulator; dry at 60°C for 1 hour (moisture content <1%). Weigh and add additional auxiliary materials and mix for 3min (5,15r / s).

[0093] 4. Granulate with 40-46ml of 10% K30 (purified water as solvent) ...

Embodiment 3

[0103] Trough mixer + grinder combined with granulation (recipe 7)

[0104] The composition of the prescription is as follows:

[0105] API:

[0106] Sulfasalazine 500.00g

[0107] Adding accessories:

[0108]

[0109]

[0110] Additional accessories:

[0111]

[0112] Coating accessories:

[0113] Triethyl citrate 2.2g

[0114] HPMCP-55 22.00g

[0115] Makes 1000 pieces

[0116] Preparation process:

[0117] 1. Pretreatment: Colloidal silica passed through 80 mesh sieve;

[0118] 2. Add sulfasalazine into the tank mixer, add 15-25ml of K90 binding solution with 1-10% to granulate, if not enough, stir with 30-40ml of pure water as wetting agent, stirring frequency 15-30HZ , and granulated for 3 minutes to obtain a relatively wet and sticky agglomerate material.

[0119] 3. Dry at 60°C for 0.5 hours.

[0120] 3. After grinding at a low speed (5-50HZ) with a planetary grinder or a screw grinder, pass through a 0.7mm-1.4mm high-speed centrifugal sizing machine f...

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Abstract

The invention provides a sulfasalazine tablet and a preparation method thereof, belonging to the field of pharmaceutical preparation research. The sulfasalazine tablet contains bulk drug: sulfasalazine, excipients: filler, binder lubricant, disintegrant, enteric-coated material, and is made into tablets through multiple granulation and tabletting steps. The particle size distribution range of the particles obtained in the granulation step is 30-40 mesh, 40-50 mesh, and the ratio of particles below 50 mesh is 0.2:1:(2.0-1.5). The sulfasalazine tablet has uniform color, strong physical resistance against external stress and friction, good stability, controllable quality, excellent enteric-coating characteristics and sustained-release curve. The preparation method is convenient to operate, easy to master and adjust, and has good controllability in production scale-up.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical preparation and a preparation method thereof, in particular to a sulfasalazine tablet and a preparation method thereof. Background technique [0002] Sulfasalazine is a sulfonamide antibacterial drug that is not easily absorbed when taken orally. It came out in the 1950s. As shown in Table 1, there are companies such as Pfizer and Teva in Japan that are selling this product; in the U.S. market, there are two companies, VINTAGE and PHARMACIA AND UPJOHN, that have approval for this product; in Europe, this product is only listed in Denmark. Taste. In 1996, Beijing Shuanghe Pharmaceutical Co., Ltd. was the first to market this product in China. At present, the domestic approval specification of this product is 0.25g. In 1983, the United States approved the marketing of 500mg enteric-coated tablets of Pfizer's subsidiary Pharmacia Upjohn. [0003] Sulfasalazine is ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/36A61K47/38A61K47/36A61K47/32A61K31/655A61P1/00A61P1/04
CPCA61P1/00A61P1/04A61K9/2027A61K9/2054A61K9/2059A61K9/2077A61K9/2866A61K31/655
Inventor 赵海峰何攀陆滢炎侯改芳匡小录熊汝菊吴小涛赵卿霍立茹李战
Owner NANJING GRITPHARMA CO LTD
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