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In-vitro in-vivo drug release characteristics of various drug pills in compound anti-tuberculosis preparation and application thereof

A drug release and preparation technology, which is applied to the in vivo and in vitro drug release characteristics and application fields of each drug pellet in the compound anti-tuberculosis preparation, and can solve the problems of inability to obtain in vivo absorption pellets and different drug release characteristics.

Inactive Publication Date: 2006-11-22
高华
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because, even if the prescription is exactly the same, without a large number of experimental explorations and perfect operation skills and strict process checks obtained on this basis, it is impossible to obtain pellets with in vivo and external drug release characteristics that are conducive to in vivo absorption. Different characteristics will be closely related to the quality of drug absorption in the body. Therefore, it is necessary to publish the drug release characteristics of the pellets obtained in successive experimental measurements in the 03101211.6 invention patent, and hope to obtain corresponding knowledge property rights protection

Method used

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  • In-vitro in-vivo drug release characteristics of various drug pills in compound anti-tuberculosis preparation and application thereof
  • In-vitro in-vivo drug release characteristics of various drug pills in compound anti-tuberculosis preparation and application thereof
  • In-vitro in-vivo drug release characteristics of various drug pills in compound anti-tuberculosis preparation and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 The in vitro release characteristics of rifampicin enteric-coated pellets:

[0028] 1. Experimental purpose: To determine the dissolution curve of enteric-coated rifampicin pellets in hydrochloric acid solution (9→1000), water, pH5.0, pH5.6, pH6.8 phosphate buffer.

[0029] 2. Experimental basis: method 2 of the second method under the second appendix of the 2005 edition of the Chinese Pharmacopoeia "Determination of release rate". Get this product (equivalent to rifampicin 50mg) respectively according to the first method device of dissolution assay, respectively with water, hydrochloric acid solution (9 → 1000), pH5.0 phosphate buffer saline, pH5.0 phosphate buffer saline, pH 6.8 phosphate buffer 900ml as the solvent, rotate at 50 rpm, operate according to the law, take 10ml of the solution at 5 minutes, 10 minutes, 20 minutes, 30 minutes, 45 minutes, and 60 minutes, filter, and replenish the same volume For the solvent, take 4ml of the continued filtrate an...

Embodiment 2

[0032] Example 2 In vitro release characteristics of isoniazid enteric-coated pellets:

[0033] 1. Experimental purpose: To determine the dissolution curve of enteric-coated isoniazid pellets in hydrochloric acid solution (9→1000), water, pH6.8 phosphate buffer, and pH5.0 phosphate buffer.

[0034] 2. Experimental basis: method 2 of the second method under the second appendix of the 2005 edition of the Chinese Pharmacopoeia "Determination of release rate". Take this product (equivalent to isoniazid 150mg) according to the first method of dissolution assay, respectively, with hydrochloric acid solution (9 → 1000), water, pH5.0 phosphate buffer, pH6.8 phosphate buffer 900ml As a solvent, the rotation speed is 50 rpm, operate according to the law, take 5ml of the solution at 10 minutes, 20 minutes, 30 minutes, 45 minutes, and 60 minutes, filter, and replenish the same volume of solvent at the same time, take 1ml of the filtrate and put it in a 10ml volume Dilute to the mark with...

Embodiment 3

[0037] Example 3 The in vitro drug release characteristics of rifampicin stomach-dissolved pellets

[0038] 1. Experimental purpose: To determine the dissolution curve of rifampicin Weirong pellets in hydrochloric acid solution (9→1000).

[0039] 2. Experimental basis: the second appendix of the Chinese Pharmacopoeia 2005 edition "dissolution assay", take this product (equivalent to rifampicin 75mg) according to the first method of dissolution assay, using 900ml of hydrochloric acid solution (9→1000) as solvent , using a speed of 50 rpm, operate according to the law; take 10ml of the solution at 5, 10, 15, 20, 30, and 45 minutes, filter, and replenish the same volume of solvent at the same time. Accurately measure 3ml of continued filtrate, put in a 10ml measuring bottle, dilute to the mark with hydrochloric acid solution (9→1000), and use it as the test solution; take rifampicin reference substance in addition, and dilute it with hydrochloric acid solution (9→1000) to form T...

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Abstract

The present invention is that on the basis of rifampicin and isoniazide micro pill preparation of patent No. 03101211.6, the release status of the micro pill inside solution in specific conditions and the human body's pharmacokinetic characteristic of the micro pill in human body as the tested object are measured according to the method of Chinese pharmacopoeia.

Description

technical field [0001] This application is actually a continuation application that has obtained patent authorization. The inventor has obtained the authorization of the invention patent title "a drug delivery system for compound rifampicin preparations". Its patent application number is 03101211.6, and its authorized patent certificate number It is 208518, and this application is to further disclose to the public the content not disclosed in the content of the invention involved in the patent and the in vivo and in vitro drug release characteristics of the drug pellets obtained from further experiments. technical background [0002] The invention patent "a drug delivery system for a compound rifampin preparation" is actually an invention of a compound rifampicin preparation, which can be interpreted as a drug delivery system for a compound rifampicin preparation. Because this preparation involves the preparation of four drug pellets from four first-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4965A61K9/20A61K9/36A61K9/48A61K31/133A61K31/4409A61P31/06
Inventor 李思思杨勇王伟和琳琳高艺歌
Owner 高华
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