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Medicine composition and preparing method and application thereof

A technology of composition and medicine, which is applied in the field of pharmaceutical composition and its preparation, can solve the problems of not finding the stability of cycloserine preparations, poor variety stability, discoloration of contents, etc., and achieve good fluidity, lubricity, and stability Improvement of sex and stability

Active Publication Date: 2016-04-13
LAKERSPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In addition, in the stability test of this prescription, it was found that there was a problem of discoloration of the content. The reason may be related to the fact that the metal particles in the mold wear were brought into the content, thereby accelerating the degradation of the active ingredients. The patent did not solve the problem of poor stability of this type of product. problem, and no patent has been found that discloses improving the stability of cycloserine preparations

Method used

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  • Medicine composition and preparing method and application thereof
  • Medicine composition and preparing method and application thereof
  • Medicine composition and preparing method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 5

[0076] Cycloserine accounts for 64.1% of the total, the content of cycloserine is 99.713%, and the talc powder is 200 mesh (75μm in diameter).

[0077] prescription:

[0078]

[0079] Preparation:

[0080] Take the prescription amount of cycloserine through a 200-mesh sieve, then mix it with the prescription amount of talc, and fill the No. 1 hollow gelatin capsule with 250 mg of cycloserine per capsule.

[0081] The capsule prepared by the above method has a loss on drying of 0.496%, a disintegration time in water of 5 minutes, and a 15-minute dissolution rate of greater than 90% at pH 1.2, pH 4.0, pH 6.8 and water.

[0082] The stability data is shown in Table 2.

Embodiment 6

[0084] Cycloserine accounts for 64.1% of the total, the content of cycloserine is 99.713%, and the talc powder is 200 mesh.

[0085] prescription:

[0086]

[0087] Preparation:

[0088] Take the prescription amount of cycloserine through a 100-mesh sieve, then mix it with the prescription amount of talc, and fill the No. 1 hollow gelatin capsule with 250 mg of cycloserine per capsule.

[0089] The capsule prepared by the above method has a loss on drying of 0.583%, a disintegration time in water of 5 minutes, and a dissolution rate of more than 90% at pH 1.2, pH 4.0, pH 6.8 and 15 minutes in water.

[0090] The stability data is shown in Table 2.

Embodiment 7

[0092] Cycloserine accounts for 64.1% of the total, the content of cycloserine is 99.713%, and the talc powder is 100 mesh (particle size 150μm).

[0093] prescription:

[0094]

[0095] Preparation:

[0096] Take the prescription amount of cycloserine through a 100-mesh sieve, then mix it with the prescription amount of talc, and fill the No. 1 hollow gelatin capsule with 250 mg of cycloserine per capsule.

[0097] The capsule prepared by the above method has a loss on drying of 0.578%, a disintegration time in water of 4 minutes, and a dissolution rate of more than 90% at pH 1.2, pH 4.0, pH 6.8 and 15 minutes in water.

[0098] The stability data is shown in Table 2.

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Abstract

The invention discloses a medicine composition and a preparing method and application thereof. The medicine composition is prepared from cycloserine and auxiliaries. A D90 particle size of the medicine composition is 75-380mum, and the dosage of the auxiliaries is 9-45% of the total mass of the medicine composition. The stability of the medicine composition is greatly improved compared with the prior art, in an optimal example, the medicine composition is hermetically stored for 180d in a normal temperature condition (temperature is 25 DEG C and humidity is 60%), a degrading content of a percentage content of a labeled amount of the preparation is smaller than 0.5%, and the medicine composition is hermetically stored for 180d in an acceleration condition (temperature is 40 DEG C and humidity is 75%), a degrading content of a percentage content of a labeled amount of the preparation is smaller than 4.0%.

Description

Technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition and a preparation method and application thereof. Background technique [0002] Tuberculosis is a disease of tuberculosis that affects people's health. With the emergence of anti-tuberculosis drugs such as streptomycin and isoniazid, tuberculosis has become a treatable disease. However, due to the lack of relevant knowledge and non-standard treatment, the drug resistance of tuberculosis is becoming more and more serious. [0003] Pulmonary tuberculosis is a highly infectious disease caused by Mycobacterium tuberculosis. Among the three diseases to be controlled by the World Health Organization, tuberculosis is second only to AIDS. China is a country where tuberculosis is severely endemic. In addition, with the drug resistance of Mycobacterium tuberculosis, the number of drug-resistant patients in China is also increasing. Therefore, it...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/42A61P31/06A61P11/00A61P25/18A61P25/24A61P25/28A61P29/00
CPCA61K31/42A61K9/485A61K9/4858A61K9/4866
Inventor 陈日星陈建豪罗盛莲范红银陈万英郝小妹
Owner LAKERSPHARMA CO LTD
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