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Preparation method of composite rifampicin micro-tablet capsule

A technology of rifampicin microtablets and microtablets, which is applied in capsule delivery, medical preparations containing active ingredients, pharmaceutical formulas, etc., and can solve problems such as degradation that is difficult to overcome and quality decline of FDC preparations

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

[0005] 3. Since the anti-tuberculosis FDC preparations containing rifampicin have the above-mentioned degradation problems that are difficult to overcome in the manufacture, it is easy to cause the decline in the quality of FDC preparations in the process of manufacturing, storage and transportation of FDC preparations
However, due to improvements in some places, there will also be unavoidable defects

Method used

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  • Preparation method of composite rifampicin micro-tablet capsule
  • Preparation method of composite rifampicin micro-tablet capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Preparation and in vitro drug release characteristics of isoniazid enteric-coated microtablets:

[0033] 1. Preparation of isoniazid enteric-coated microtablets

[0034] Prescription of isoniazid tablets 25g of isoniazid, 5g of starch, appropriate amount of 5% povidone (K30) solution, 0.12g of magnesium stearate, 1000 tablets in total.

[0035] Preparation method Weigh isoniazid and starch respectively according to the prescription quantity, pass through a 100-mesh sieve and mix evenly, granulate with 5% povidone (K30) solution, dry in an oven at 60°C, sieve, granulate, add hard Magnesium fatty acid was mixed and pressed into tablets with a diameter of 4mm.

[0036] Preparation of enteric coating solution: take 5 g of hydroxypropylmethyl phthalate, add 100 ml of acetone / ethanol solution (3 / 7) to dissolve, add 0.5 g of diethyl phthalate, and dissolve evenly.

[0037] Preparation of enteric-coated micro-tablets: Put the prepared plain tablets in the coating pa...

Embodiment 2

[0043] Example 2 Preparation and in vitro drug release characteristics of rifampicin enteric-coated microtablets

[0044] 1. Preparation of rifampicin enteric-coated microtablets

[0045] Rifampicin tablet prescription rifampicin 50g, microcrystalline cellulose 15g, vitamin C 1g, sodium carboxymethyl starch 1g, magnesium stearate 0.25g, a total of 1000 tablets were made.

[0046] Preparation method According to the above prescription, the raw materials and auxiliary materials are weighed, passed through an 80-mesh sieve, mixed evenly, granulated, granulated, compressed into tablets, and the diameter of the tablets is 5.5mm.

[0047] Preparation of film coating solution: take 3 g of hydroxypropyl methylcellulose and 3 g of polyethylene glycol 4000, and dissolve them evenly with 70% ethanol solution.

[0048] Preparation of film coating: Put the prepared plain tablets in the coating pot, roll the coating pot, spray the film coating solution while blowing hot air, wrap until the...

Embodiment 3

[0057] Example 3 Preparation and in vitro drug release characteristics of rifampicin gastric soluble microtablets

[0058] 1. Preparation of rifampicin gastric-soluble microtablets

[0059] Rifampicin tablet prescription rifampicin 50g, microcrystalline cellulose 15g, vitamin C 2g, low-substituted hydroxypropyl cellulose 4g, magnesium stearate 0.3g, a total of 1000 tablets were made.

[0060] Production method Weigh the raw materials and auxiliary materials according to the above prescription, pass through an 80-mesh sieve, mix them evenly, granulate, granulate, and compress into tablets. The diameter of the tablets is 5.5mm.

[0061] Preparation of gastric soluble coating solution: take 9 g of gastric soluble film coating premix, add 100 ml of 50% ethanol solution and dissolve evenly.

[0062] Preparation of stomach-soluble micro-tablets: Put the prepared plain tablets in the coating pan, roll the coating pan, spray the stomach-dissolving solution while blowing hot air, pack...

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Abstract

The preparation process of compound rifampicin micro tablet capsule features that during compounding rifampicin, isoniazide, pyrazinamide and ethambutol hydrochloride, at least one of the medicine components is first formed into micro tablet before encapsulating. During the preparation process, the micro tablet is coated to avoid the excess contact between rifampicin and other medicine components inside the compound capsule and to raised the stability of the compound rifampicin preparation further.

Description

technical field [0001] This application is actually a continuation application that has obtained patent authorization. The invention patent title that the inventor has obtained authorization is "a drug delivery system for compound rifampicin preparation", and its patent application number is 03101211.6, and its authorized patent certificate The No. is 208518. This application is based on further research and a method for preparing a compound rifampicin preparation newly invented on the basis of patent 03101211.6. technical background [0002] In order to prevent the occurrence of drug-resistant tuberculosis, the World Health Organization (WHO) recommended 12 standardized prescription combinations of fixed-dose compound (FDC) preparations to the world in its No. 1 (Volume 79, No. 1) announcement in 2001. While recommending the standard prescription of FDC preparations, WHO emphasizes that when manufacturing FDC preparations, the product quality of FDC...

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 李思思杨勇和琳琳高艺歌
Owner 高华
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