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Method for evaluating in-vivo and in-vitro correlation of diclofenac sodium sustained release tablets

A technology of diclofenac sodium and sustained-release tablets, which is applied in the field of medicine and can solve problems such as high costs

Inactive Publication Date: 2022-02-25
HQ PHARMA (SHANGHAI) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, clinical trials have high cost constraints, so in the testing process of new drug development or generic drug consistency evaluation, it is generally necessary to first evaluate through in vitro testing

Method used

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  • Method for evaluating in-vivo and in-vitro correlation of diclofenac sodium sustained release tablets
  • Method for evaluating in-vivo and in-vitro correlation of diclofenac sodium sustained release tablets
  • Method for evaluating in-vivo and in-vitro correlation of diclofenac sodium sustained release tablets

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0018] HQ-0096-21052001 batch prescription composition:

[0019]

Embodiment 2

[0021] 21032107-01 Batch prescription composition:

[0022]

Embodiment 3

[0024] 21032107-02 Batch prescription composition:

[0025]

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Abstract

The invention discloses a method for evaluating in vivo and in vitro correlation (In Vivoin Vitro Correlation) of a diclofenac sodium sustained release tablet, and a novel diclofenac sodium sustained release tablet. According to the method for evaluating the in-vivo and in-vitro correlation of the diclofenac sodium sustained release tablet, the in-vivo pharmacokinetic characteristics can be well evaluated. The formula of the diclofenac sodium sustained release tablet comprises the following components: 100 mg / tablet of diclofenac sodium, 119 mg / tablet of cane sugar, 59 mg / tablet of hexadecanol, 4 mg / tablet of povidone K30, 3 mg / tablet of colloidal silicon dioxide, 3 mg / tablet of magnesium stearate and 10 mg / tablet of film coating premix. According to the diclofenac sodium sustained-release tablet disclosed by the invention, the release speed of the medicine is controlled, the irritation of the traditional diclofenac sodium sustained-release tablet to the stomach is reduced, and meanwhile, the administration mode of keeping a relatively high effective blood concentration for a long time is achieved. The medicine effect is ensured, the side effect is reduced, and the clinical use is greatly facilitated.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for evaluating the in vivo and in vitro correlation of diclofenac sodium sustained-release tablets, and provides a novel prescription for diclofenac sodium sustained-release tablets. Background technique [0002] Diclofenac sodium, also known as diclofenac, has a structural formula such as figure 1 , with a molecular weight of 318.13, is a non-Yong body anti-inflammatory drug. Its properties are white, odorless, hygroscopic crystalline powder. Diclofenac sodium is used to relieve the acute attack or persistent joint swelling and pain symptoms of various chronic arthritis such as rheumatoid arthritis, osteoarthritis, spondyloarthropathy, gouty arthritis, and rheumatoid arthritis. Diclofenac sodium will have a stronger irritating effect on the gastrointestinal tract during use, so pharmaceutical preparations are generally used as sustained-release preparations now. How...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15G01N21/84A61K9/28A61K31/196A61K47/32A61K47/26A61K47/04A61P19/02A61P19/06A61P29/00
CPCG01N33/15G01N21/84A61K31/196A61K9/2806A61K9/2027A61K9/2018A61K9/2009A61P29/00A61P19/02A61P19/06
Inventor 贺敦伟秦杰子张艳
Owner HQ PHARMA (SHANGHAI) CO LTD
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