Process for preparing compound antituberculous preparation

A preparation process and anti-tuberculosis technology, applied in the field of medicine, can solve the problems of decreased bioavailability of active ingredients, increased impurities, adverse effects of preparation quality and drug bioavailability, etc.

Inactive Publication Date: 2013-02-13
SHENYANG PHARMA UNIVERSITY
View PDF1 Cites 7 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The study found that the active ingredients rifampicin and isoniazid in the compound preparation have serious incompatibility, and the two are prone to polymerization reaction to form impurity hydrazone. This reaction will undoubtedly have a negative impact ...

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Process for preparing compound antituberculous preparation
  • Process for preparing compound antituberculous preparation
  • Process for preparing compound antituberculous preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] plain tablet prescription

[0032] Rifampicin 75g

[0033] Isoniazid 37.5g

[0034] Microcrystalline Cellulose 11g

[0035] Dextrin 6g

[0036] Croscarmellose Sodium 5g

[0037] Magnesium stearate 0.3g

[0038] Coating Solution Prescription

[0039] Opadry II 12.5g

[0040] Water 62.5g

[0041] Make 500 pieces

[0042] Preparation of plain tablets: Rifampin and isoniazid are passed through a 60-mesh sieve; first, rifampicin, 1 / 2 prescription amount of microcrystalline cellulose, 1 / 2 prescription amount of dextrin, 1 / 3 prescription amount of cross-linked carboxymethyl Base cellulose sodium and 1 / 3 prescription amount of magnesium stearate (passed through a 60 mesh sieve) are mixed and dry granulated; then isoniazid, 1 / 2 prescription amount of microcrystalline cellulose, 1 / 2 prescription amount of dextrin, 1 / 3 of the prescription amount of croscarmellose sodium and 1 / 3 of the prescription amount of magnesium stearate (passed...

Embodiment 2

[0046] plain tablet prescription

[0047] plain tablet prescription

[0048] Rifampicin 75g

[0049] Isoniazid 37.5g

[0050] Pyrazinamide 200g

[0051] Microcrystalline Cellulose 34g

[0052] Dextrin 28g

[0053] Croscarmellose Sodium 9g

[0054] Magnesium Stearate 3.2g

[0055] Coating Solution Prescription

[0056] Opadry II 12.5g

[0057] Water 62.5g

[0058] Make 500 pieces

[0059] Preparation of plain tablets: Preparation of tablet cores: pass rifampicin, pyrazinamide and isoniazid through a 60-mesh sieve. Firstly, rifampicin, 1 / 3 of the prescribed amount of microcrystalline cellulose, 1 / 3 of the prescribed amount of dextrin, 1 / 4 of the prescribed amount of CC-Na and 1 / 6 of the prescribed amount of magnesium stearate (passed through a 60-mesh sieve) Mix well, dry granulate, whole grain; or mix rifampicin, pyrazinamide, 2 / 3 prescription amount of microcrystalline cellulose, 2 / 3 prescription amount of dextrin, 1 / 2 prescrip...

Embodiment 3

[0063] plain tablet prescription

[0064] Rifampicin 75g

[0065] Isoniazid 37.5g

[0066] Pyrazinamide 200g

[0067] Gatifloxacin 137.5g

[0068] Microcrystalline Cellulose 41.5g

[0069] Dextrin 43g

[0070] Croscarmellose Sodium 11g

[0071] Magnesium Stearate 4.5g

[0072] Coating Solution Prescription

[0073] Opadry II 12.5g

[0074] Water 62.5g

[0075] Make 500 pieces

[0076] Preparation of plain tablets: Rifampicin, pyrazinamide, isoniazid and gatifloxacin were passed through a 60-mesh sieve. First, rifampicin, 1 / 4 prescription amount of microcrystalline cellulose, 1 / 4 prescription amount of dextrin, 1 / 6 prescription amount of CC-Na and 1 / 12 prescription amount of magnesium stearate (passed through a 60-mesh sieve) Mix well, dry granulate, granulate; then add isoniazid, pyrazinamide, gatifloxacin, 3 / 4 prescription amount of microcrystalline cellulose, 3 / 4 prescription amount of dextrin, 1 / 2 prescription amount of CC ...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

Abstract

The invention provides a process for preparing a compound antituberculous preparation. Active ingredients are rifampicin and isoniazide and one of mixtures of isoniazide + pyrazinamide and isoniazide + pyrazinamide + gatifloxacin. The process includes that the rifampicin and a part of pharmaceutic adjuvant are sieved and mixed to be subjected to dry granulating, or rifampicin and any other active ingredients except for isoniazide are mixed with corresponding amount of pharmaceutic adjuvant to be subjected to the dry granulating, then the isoniazide, residual active ingredients and corresponding quantity of pharmaceutic adjuvant are sieved and mixed to be subjected to dry granulating or wet granulating, and finally the residual pharmaceutic adjuvant and two types of granules are mixed for a secondary tabletting to obtain the preparation. The process for preparing the compound antituberculous preparation has the advantages that by means of granulation step by step, the contact between the rifampicin and isoniazide is reduced, the amount of impurity hydrazone generated through reaction between the isoniazide and the rifampicin can be effectively reduced, the bioavailability of the isoniazide and the rifampicin is greatly improved, and the medication effectiveness and safety for mass patients with tuberculosis are guaranteed.

Description

technical field [0001] The present invention relates to the field of medical technology, in particular to a compound antibiotic containing one of rifampin and isoniazid, a mixture of isoniazid+pyrazinamide, and a mixture of isoniazid+pyrazinamide+gatifloxacin. Preparation process of tuberculosis preparations. Background technique [0002] Tuberculosis is an ancient infectious disease, and its harm to human beings in history is shocking. Before liberation, the folks called tuberculosis tuberculosis, and there was a saying that "ten tuberculosis and nine deaths". Since the 1990s, tuberculosis has "resurrected" around the world. Many countries, including countries with better tuberculosis epidemic control, have experienced slow decline or severe rebound of the epidemic to varying degrees. The incidence rate has increased by 1.1% per year. Tuberculosis has once again It has become a major infectious disease that threatens human health, a serious public health problem and a maj...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
IPC IPC(8): A61K31/4965A61K31/496A61K31/4409A61K9/20A61K9/28A61P31/06
Inventor 张天虹万新焕
Owner SHENYANG PHARMA UNIVERSITY
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products