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Pharmaceutical composition for treating pulmonary tuberculosis and preparation method thereof

A composition and a technology for pulmonary tuberculosis, which are applied in the field of medicine, can solve the problems of safety, large reduction in drug content, unstable drug quality, etc., and achieve the effects of convenient use and storage, simple preparation, and improved drug efficacy and safety.

Inactive Publication Date: 2021-03-12
ZHUOHE PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

4. Combined with other anti-leprosy drugs for leprosy treatment may be effective
[0004] However, the biggest shortcoming of the drug at present is its extremely poor stability. During the shelf life of the drug, the drug content decreases greatly, and the impurities increase rapidly, which makes the drug quality unstable and brings curative effect and safety problems to clinical use.

Method used

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  • Pharmaceutical composition for treating pulmonary tuberculosis and preparation method thereof
  • Pharmaceutical composition for treating pulmonary tuberculosis and preparation method thereof
  • Pharmaceutical composition for treating pulmonary tuberculosis and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] This embodiment discloses a new drug technology for pulmonary tuberculosis, including the following components and dosage:

[0047] Element Dosage / tablet Rifapentine 150g Carmine 1.03g ethanol 480g Croscarmellose Sodium 10g starch 25g Hypromellose 10g Sodium dodecyl sulfate 2.6g Calcium stearate 1.6g Polyacrylic resin (Eudragit EPO) 21g polyethylene glycol 4000 5g production 1000 pieces

[0048] Preparation Process:

[0049] Step 1: dissolving carmine in 80g of ethanol; adding polyacrylic acid resin into 400g of ethanol, stirring to dissolve, then adding polyethylene glycol 4000 and stirring to dissolve;

[0050] Step 2: Add the prescribed amount of rifapentine raw materials into the fluidized granulator and set the air intake volume to 12m 3 / h, the inlet air temperature is 45°C, the flow rate is 10rpm, and the atomization pressure is 0.04MPa. Spray the carmine solution into the raw mat...

Embodiment 2

[0055] This embodiment discloses a new drug technology for pulmonary tuberculosis, including the following components and dosage:

[0056] Element Dosage / tablet rifampicin 150g Carmine 1.03g ethanol 480g Croscarmellose Sodium 10g starch 25g Hypromellose 10g Sodium dodecyl sulfate 2.6g Calcium stearate 1.6g Ethyl cellulose 18.8g polyethylene glycol 4000 5g production 1000 pieces

[0057] Preparation Process:

[0058]Step 1: Dissolve carmine in 80g ethanol; add ethyl cellulose into 400g ethanol, stir to dissolve, then add polyethylene glycol 4000 and stir to dissolve;

[0059] Step 2: Add the prescribed amount of rifampin raw material into the fluidized granulator and set the air intake volume to 12m 3 / h, the inlet air temperature is 45°C, the flow rate is 10rpm, and the atomization pressure is 0.04MPa. Spray the carmine solution into the raw material;

[0060] Step 3: Continue to set the air i...

Embodiment 3

[0064] This embodiment discloses a new drug technology for pulmonary tuberculosis, including the following components and dosage:

[0065] Element Dosage / tablet Rifapentine 150g Amaranth 1.2g ethanol 480g Croscarmellose Sodium 10g starch 25g Hypromellose 10g Sodium dodecyl sulfate 2.6g Calcium stearate 1.6g Polyacrylic resin (Eudragit EPO) 21g polyethylene glycol 4000 5g production 1000 pieces

[0066] Preparation Process:

[0067] Step 1: dissolving carmine in 80g of ethanol; adding polyacrylic acid resin into 400g of ethanol, stirring to dissolve, then adding polyethylene glycol 4000 and stirring to dissolve;

[0068] Step 2: Add the prescribed amount of rifapentine raw materials into the fluidized granulator and set the air intake volume to 12m 3 / h, the inlet air temperature is 45°C, the flow rate is 10rpm, and the atomization pressure is 0.04MPa. Spray the carmine solution into the raw mat...

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Abstract

The invention discloses a pharmaceutical composition for treating pulmonary tuberculosis, comprising: a main drug comprising rifapentine or rifampicin; an adjuvant which comprises a stable material, afilling agent, a disintegrating agent, an adhesive and a lubricating agent. The preparation method of the pharmaceutical composition comprises the following specific steps: S1, preparing a first stable material solution; S2, preparing a second stable material solution; S3, preparing a first mixture; S4, preparing a second mixture; S5, mixing a filler, a disintegrating agent, an adhesive and the second mixture, and granulating by using a dry granulator to obtain a third mixture; S6, adding a lubricant into the third mixture, and pressing into tablets or filling into capsules. According to thepharmaceutical composition for treating pulmonary tuberculosis and the preparation method of the pharmaceutical composition, provided by the invention, the preparation is simple, the curative effect and the safety of the pharmaceutical composition are fundamentally improved, and great convenience can be brought to the use and the storage of clinical medicines.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition for treating pulmonary tuberculosis and a preparation method thereof. Background technique [0002] Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis, which is mainly transmitted through the respiratory tract. When a patient coughs, sneezes or speaks loudly, a droplet nucleus with a single tuberculosis bacterium as the core will be formed and suspended in the air, thus infecting a new host to retransmit. The disease once ravaged the world and was regarded as the "white plague". Fever is the most common symptom, mostly long-term hot flashes in the afternoon, that is, it starts to rise in the afternoon or evening, and returns to normal the next morning. Some patients have fatigue, night sweats, loss of appetite and weight loss. Clinically, tuberculosis can be divided into primary pulmonary tuberculosis, hematogenously...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61K47/38A61K47/10A61K47/32A61K47/20A61P31/06
CPCA61K31/496A61K47/10A61K47/20A61K47/32A61K47/38A61P31/06
Inventor 张峰李晓明
Owner ZHUOHE PHARM GRP CO LTD
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