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Delayed-releasing compound diclofenac sodium prepn

A technology for diclofenac sodium and sustained-release preparations, which is applied in the fields of anti-inflammatory agents, pill delivery, and pharmaceutical formulations. It can solve the problems of inconvenient ingestion for patients and increase the financial burden of patients, and achieve economical cost-effectiveness, reduced side effects, and stable preparations. Effect

Inactive Publication Date: 2003-11-05
GUANGZHOU PUIS PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, Diclofenac Sodium in Neurofenac is an ordinary tablet, which acts quickly and can control acute pain very well and quickly, but the ordinary tablet is also discharged quickly. For chronic pain after acute pain control, it needs to be administered multiple times a day. It brings inconvenience to the patient not to take it, and also increases the financial burden of the patient

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] prescription:

[0032] Diclofenac Sodium 50g

[0033] HPMC K15M 35g

[0034] EC 15g

[0035] Lactose 55g

[0036] Microcrystalline Cellulose 80g

[0037] Vitamin B 1 50g

[0038] Vitamin B 6 50g

[0039] Vitamin B 12 0.25g

[0040] Magnesium stearate 1.8g

[0041] 10% PVP solution appropriate amount

[0042] Preparation Process:

[0043] Mix 50 g of diclofenac sodium, 35 g of HPMC, 15 g of EC, 45 g of microcrystalline cellulose, and 30 g of lactose, granulate with 10% PVP solution, dry, add magnesium stearate, and press into tablets.

[0044] Vitamin B 1 50g, B 6 50g, B 12 0.25g is mixed evenly with microcrystalline cellulose 35g and lactose 20g, and then compressed with the above-mentioned compressed diclofenac sodium sustained-release tablet into a double-layer tablet to obtain the compound sodium clofenac sustained-release tablet.

Embodiment 2

[0046] prescription:

[0047] Diclofenac Sodium 50g

[0048] HPMC K15M 15g

[0049] EC 25g

[0050] Lactose 15g

[0051] Microcrystalline Cellulose 30g

[0052] Vitamin B 1 50g

[0053] Vitamin B 6 50g

[0054] Vitamin B 12 0.25g

[0055] Magnesium stearate 1.8g

[0056] 10% PVP solution appropriate amount

[0057] Preparation Process:

[0058] Mix 50 g of diclofenac sodium, 15 g of HPMC, 25 g of EC, and 15 g of microcrystalline cellulose, granulate with 10% PVP solution, dry, add magnesium stearate, and press into tablets with a 6 mm die.

[0059] Vitamin B 1 50g, B 6 50g, B 12 0.25g is mixed with microcrystalline cellulose 15g and lactose 15g, and then filled with No. 1 hard capsule together with the above-mentioned compressed diclofenac sodium sustained-release small tablets, to obtain the compound sustained-release capsule of the present invention.

Embodiment 3

[0061] prescription:

[0062] Diclofenac Sodium 50g

[0063] Lactose 50g

[0064] Microcrystalline Cellulose 50g

[0065] 10% PVP solution appropriate amount

[0066] Eudragit NE 30D 16.5g

[0067] Talc powder 1.5g

[0068] Pure water 80ml

[0069] Vitamin B 1 50g

[0070] Vitamin B 6 50g

[0071] Vitamin B 12 0.25g

[0072] Magnesium stearate 1.8g

[0073] Preparation Process:

[0074] Using 10% PVP as a binder, diclofenac sodium-containing pill cores were prepared by extrusion / spheronization, the obtained drug-containing pellets were dried, placed in a centrifugal coating granulator, and coated with the prepared Eudragit NE30D coating solution. The diclofenac sodium sustained-release pellets were obtained. Then the obtained diclofenac sodium sustained-release pellets are mixed with properly processed vitamin B 1 B 6 B 12 Mix and fill capsules to obtain the compound sustained-release capsules of the pr...

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PUM

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Abstract

The present invention relates to delayed-releasing compound diclofenac sodium preparation and its preparation process, and is especially the delayed-releasing compound preparation of diclofenac sodium, vitamin B1, vitamin B6 and vitamin B12 and its application in medical treatment.

Description

Technical field: [0001] The invention relates to a compound slow-release preparation and a preparation process thereof, in particular to diclofenac sodium and vitamin B 1 B 6 B 12 The compound slow-release preparation of composition, and the application of this compound slow-release preparation in medical treatment. Background technique: [0002] Diclofenac sodium is a non-steroidal anti-inflammatory drug. This product reduces the synthesis of prostaglandins by inhibiting COX (cyclooxygenase) produced by tissues due to inflammatory reactions. Reduced local prostaglandin synthesis reduces pain sensation and acts as a peripheral analgesic. This product still has the effect of inhibiting lipoxygenase and reducing leukotrienes, bradykinase and other products. In addition, animal experiments and human clinical practice have proved that this product also has antipyretic effects by inhibiting the synthesis of prostaglandins in the hypothalamic thermoregulation center. This p...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K9/52A61K31/196A61K31/714A61P19/02A61P29/00
Inventor 贝庆生
Owner GUANGZHOU PUIS PHARMA FACTORY
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