Sodium dichlorophenolate sustained-release tablet and method for controlling sustained-release of sodium dichlorophenolate sustained-release tablet

A technology of diclofenac sodium and sustained-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as retention and no release of diclofenac sodium sustained-release preparations, Achieve the effect of reducing rework, reducing energy consumption, and saving production costs

Active Publication Date: 2009-11-11
GUANGDONG HUANAN PHARMACEUTICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the patents on diclofenac sodium sustained-release preparations only stay on the formulation and preparation process, and there are no patents on how to control the release of diclofenac sodium sustained-release preparations

Method used

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  • Sodium dichlorophenolate sustained-release tablet and method for controlling sustained-release of sodium dichlorophenolate sustained-release tablet
  • Sodium dichlorophenolate sustained-release tablet and method for controlling sustained-release of sodium dichlorophenolate sustained-release tablet
  • Sodium dichlorophenolate sustained-release tablet and method for controlling sustained-release of sodium dichlorophenolate sustained-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Take by weighing diclofenac sodium slow-release tablet powder 25g (wherein HPMC K4M CR accounts for 20% of powder gross weight), add 50g hot distilled water, glass rod stirs and makes it disperse, add distilled water 425g, high-shear mixing emulsifier fully stirs 40 minutes, Prepare an aqueous solution containing 1% HPMC, and use a Brookfield LVDV-C digital display viscometer to select the #2 rotor at a speed of 10 rpm to measure the viscosity to be 441 centipoise. The release rate of diclofenac sodium sustained-release tablets prepared at this time is shown in Table 1, and compared with the release rate of commercially available preparations, the dissolution curve similarity f2 factor method evaluation is shown in Table 1. figure 1 .

[0035] The release degree of table 1 embodiment 1

[0036]

[0037] Conclusion: Example 1 is evaluated according to the dissolution curve similarity f2 factor, f2=55>50, it is judged that its release is similar to the commerci...

Embodiment 2

[0039] Take by weighing diclofenac sodium slow-release tablet powder 25g (wherein HPMC K15M CR accounts for 20% of powder gross weight), add 50g hot distilled water, glass rod stirs and make it disperse, add distilled water 425g, high-shear mixing emulsifier fully stirs 40 minutes, Prepare an aqueous solution containing 1% HPMC, and use a Brookfield LVDV-C digital display viscometer to select the #2 rotor at a speed of 10 rpm to measure the viscosity to be 846 centipoise. The release rate of diclofenac sodium sustained-release tablets prepared at this time is shown in Table 2, and compared with the release rate of commercially available preparations, the dissolution curve similarity f2 factor method evaluation is shown in Table 2. figure 2 .

[0040] The release degree of table 2 embodiment 2

[0041]

[0042] Conclusion: Example 2 is evaluated according to the dissolution curve similarity f2 factor, f2=54>50, it is judged that its release is similar to the commerc...

Embodiment 3

[0044] Take by weighing 20g of diclofenac sodium sustained-release tablet granules (wherein the total amount of HPMC K4M CR and HPMC K15M CR accounts for 25% of the total weight of the granules; HPMC K4M CR: HPMC K15M CR=1: 1.5), add 50g of hot distilled water, and stir with a glass rod Make it dispersed, add distilled water 430g, high-shear mixing emulsifier fully stir for 40 minutes, prepare an aqueous solution containing 1% HPMC, use Brookfield LVDV-C digital display viscometer, select #2 rotor, and measure the viscosity under the condition of rotating speed 10rpm to be 898 centimeters moor. The release rate of diclofenac sodium sustained-release tablets prepared at this time is shown in Table 3, and compared with the release rate of commercially available preparations, the dissolution curve similarity f2 factor method evaluation is shown in Table 3. image 3 .

[0045] The release degree of table 3 embodiment 3

[0046]

[0047] Conclusion: Example 3 is evaluated...

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Abstract

The invention discloses a sodium dichlorophenolate sustained-release tablet, and a method for controlling sustained-release of sodium dichlorophenolate sustained-release tablet. The sodium dichlorophenolate sustained-release tablet comprises sodium dichlorophenolate and HPMC high polymer material, the sodium dichlorophenolate accounts for 58.6-71.6% of the sum of the granules or the powder, wherein, the viscosity range of the granules or the powder of the prepared sodium dichlorophenolate sustained-release tablet is respectively 411-471centipoise and 955-1015centipoise. The sodium dichlorophenolate sustained-release tablet has quality conforming to the standard and similar release property with the preparation of the same type sold in markets, and the quality control is carried out before production, thus reducing re-doing, saving production cost, reducing energy consumption and improving productivity.

Description

technical field [0001] The invention relates to a diclofenac sodium sustained-release tablet and a method for controlling the release of the diclofenac sodium sustained-release tablet. Background technique [0002] Sustained-release preparations containing pharmacologically active agents are very beneficial for treatment due to their slow release characteristics in vivo. [0003] Diclofenac sodium is a non-steroidal anti-inflammatory drug. This product can reduce the synthesis of prostaglandins by inhibiting the COX (cyclooxygenase) produced by the tissue due to the inflammatory response, relieve pain and play an analgesic effect. This product can also inhibit lipoxygenase to a certain extent and reduce the effects of leukotrienes, bradykinase and other products. Clinical studies on animals and humans have proved that this product also has an antipyretic effect by inhibiting the synthesis of prostaglandins in the hypothalamus thermoregulation center. This product is mainly...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/196A61K47/38A61P29/00
Inventor 谢称石张兰王金超廖广华
Owner GUANGDONG HUANAN PHARMACEUTICAL GROUP CO LTD
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