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Composition for preparing triple compound preparation for treatment of pulmonary tuberculosis and preparation method and application of composition

A technology of compound preparations and compositions, applied in the field of pharmaceutical preparations, which can solve problems such as difficult for patients to swallow, no longer suitable for the treatment process, large tablet size, etc., and achieve the effect of small size, simple preparation process, and easy intake

Inactive Publication Date: 2019-09-06
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, this FDC also has the following disadvantages in the process of preparation and use: (1) the size of the tablet is very large, and it is difficult for the patient to swallow, and the weight of a single tablet of the quadruple compound preparation is basically more than 1000 mg; (2) pyrazinamide It is one of the drugs in short-course chemotherapy for tuberculosis. It is only used for the first two months in the standard tuberculosis chemotherapy regimen. Therefore, the most commonly used quadruple compound preparation is no longer suitable for the treatment process after two months, and the later treatment time is as long as 2 months. 4 months or more, accounting for more than 2 / 3 of the entire treatment cycle, especially in the recommended chemotherapy regimens for retreatment of smear-positive pulmonary tuberculosis and tuberculous pleurisy ( figure 1 shown)

Method used

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  • Composition for preparing triple compound preparation for treatment of pulmonary tuberculosis and preparation method and application of composition
  • Composition for preparing triple compound preparation for treatment of pulmonary tuberculosis and preparation method and application of composition
  • Composition for preparing triple compound preparation for treatment of pulmonary tuberculosis and preparation method and application of composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1 The triple compound preparation for the treatment of pulmonary tuberculosis

[0058] 1. Preparation prescription (made into 1000 tablets)

[0059]

[0060] 2. Preparation process

[0061] 1) Mix isoniazid, ethambutol hydrochloride, microcrystalline cellulose and croscarmellose sodium first, and set aside;

[0062] 2) passing the mixed material through a 60-mesh standard sieve, and dissolving povidone in water to make a solution;

[0063] 3) The granulation parameters are: the rotation speed of the stirring blade is 2 rpm, the rotation speed of the cutter is 25 rpm, and the granulation time is 45 seconds;

[0064] 4) Place the obtained particles in a fluidized bed for drying after passing through a 24-mesh standard sieve;

[0065] 5) The drying parameters are: material temperature: 30-65°C; air inlet temperature: 40-100°C; air volume: 5-40m 3 / h, when the temperature of the material reaches 60-65°C, the material is discharged;

[0066] 4) After the dryi...

Embodiment 2

[0068] Example 2 The triple compound preparation for the treatment of pulmonary tuberculosis

[0069] 1. Preparation prescription (made into 1000 tablets)

[0070]

[0071] 2. Preparation process

[0072] 1) mixing isoniazid, ethambutol hydrochloride, microcrystalline cellulose and croscarmellose sodium, and set aside;

[0073] 2) passing the mixed material through a 60-mesh standard sieve, and dissolving povidone in water to make a solution;

[0074] 3) The granulation parameters are: the rotation speed of the stirring blade is 5 rpm, the rotation speed of the cutter is 40 rpm, and the granulation time is 90 seconds;

[0075] 4) Place the obtained particles in a fluidized bed for drying after passing through a 24-mesh standard sieve;

[0076] 5) The drying parameters are: material temperature: 30-65°C; air inlet temperature: 40-100°C; air volume: 10-40m 3 / h, when the temperature of the material reaches 60-65°C, the material is discharged;

[0077] 4) After the drying...

Embodiment 3

[0090] Comparative analysis of quadruple compound preparation and triple compound preparation described in embodiment 3

[0091] The fluidity of the granules, the weight, hardness, friability, and disintegration time of the tablet composition were used as indicators to conduct a comparative study on the formulations of Examples 1-2 and Comparative Example 1.

[0092] 1. Fluidity and compressibility

[0093] Since the Carr index can reflect the fluidity and compressibility of particles, a comparative study was carried out on the above examples. Take an appropriate amount of blended particles, measure them with a powder density meter, and calculate the Carr index.

[0094] Table 1: Carr Index Values ​​of Blend Granules

[0095] Example 1 Example 2 Comparative Example 1 Carr Index (%) 18.4 19.0 27.8

[0096] Note: The calculation method of the Carr index is real density / bulk density*100; the smaller the Carr index, the better the fluidity.

[0097]...

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Abstract

The invention belongs to the technical field of pharmaceutical preparation and particularly relates to a composition for preparing a triple compound preparation for treatment of pulmonary tuberculosis, a preparation method and application of the composition and a prepared medicine. The composition comprises rifampicin, isoniazide, ethambutol or pharmaceutically acceptable ethambutol salt and an analogue thereof. Compared with a quadruple compound preparation, the triple compound preparation which is a triple compound tablet is small in size, easy to swallow, low in cracking risk and convenientfor patients to take and is applicable to the whole treatment period of recurrent smear-positive pulmonary tuberculosis and tuberculous pleuritis. By adoption of the preparation, tablet intake and pharmaceutical adjuvant amount can be sharply reduced, and accordingly compliance of the patients can be improved while drug resistance is reduced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a composition for preparing a triple compound preparation for treating pulmonary tuberculosis, a preparation method and application thereof, and the prepared medicine. Background technique [0002] Tuberculosis is a chronic infectious disease that seriously endangers health. There are about 8 to 10 million new tuberculosis patients every year. Developing countries in Africa and Asia account for the majority of infected people. my country is one of the 22 countries with severe tuberculosis epidemics in the world. It is also one of the 27 countries in the world where MDR-TB is prevalent. The annual incidence of tuberculosis in my country is about 1.3 million, and the annual tuberculosis death toll reaches 130,000. Tuberculosis is mainly caused by Mycobacterium tuberculosis, which can invade many organs of the human body, and pulmonary tuberculosis is...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/496A61K31/4409A61K31/133A61P11/00A61P31/06
CPCA61K9/2054A61K31/133A61K31/4409A61K31/496A61P11/00A61P31/06A61K2300/00
Inventor 胡敏陈博程刚徐宏杨
Owner CHONGQING HUAPONT PHARMA
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