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Pharmaceutical composition for improving pharmaceutical stability

A composition and stability technology, applied in the field of medicine, can solve problems such as poor quality stability of pharmaceutical compositions, unsuitable acceptance by patients, and any research on pH of pharmaceutical compositions, etc., to achieve good water solubility and stability, water solubility and stability The effect of excellent performance and good quality stability

Inactive Publication Date: 2013-06-12
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The technical solution of this document is to solve the problems of high cost and unacceptable patients in the prior art
[0010] Chinese patent document CN101648016A discloses a pharmaceutical composition of a β-lactamase inhibitor and a β-lactamase antibiotic, wherein the β-lactamase inhibitor comprises compound 2, the β-lactamase antibiotic comprises compound 1, compound The weight ratio of 2 and its salt to compound 1 and its salt is 1:2. In the experiment, the pharmaceutical composition was placed in different pH solutions and placed at 60°C for 36 hours to examine the content of polymer impurities. However, No research has been done on the pH of the pharmaceutical composition itself; in addition, it investigated the results of polymer impurities after the pharmaceutical compositions with different water contents were placed in airtight containers at a high temperature of 60°C for three months. Because moisture evaporates quickly and accumulates on the top of the closed container under high temperature conditions of 60°C, it cannot explain the actual impact of moisture on the stability of the pharmaceutical composition
[0011] The pharmaceutical compositions of compound 1 and compound 2 disclosed in the prior art are all obtained by mixing the raw materials compound 1 and compound 2, and the quality stability of the obtained pharmaceutical composition is poor, which seriously affects the safety of the preparation product
[0012] Although the prior art discloses a pharmaceutical composition composed of compound 1 and compound 2 and its preparation method, it has been found in practice that after being prepared by the prior art method, the content of the active ingredient in the pharmaceutical composition gradually decreases during storage , the impurities increase, and its water solubility also changes, which affects the effectiveness and safety of the clinical application of the pharmaceutical composition

Method used

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  • Pharmaceutical composition for improving pharmaceutical stability
  • Pharmaceutical composition for improving pharmaceutical stability
  • Pharmaceutical composition for improving pharmaceutical stability

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Example 1 The pharmaceutical composition composed of compound 1 and compound 2

[0059] Four batches of compound 1 raw materials and three batches of compound 2 raw materials purchased from different manufacturers were tested according to the standards for compound 1 and compound 2 in the second part of the 2010 edition of "Chinese Pharmacopoeia". Moisture, pH The value, content and related substances all meet the relevant requirements of the standard.

[0060] Get 4 batches of compound 1, each batch respectively gets three groups (the weight of each group is 1500g by the free acid weight of compound 1) and respectively with 3 batches of compound 2 (by the free acid weight of compound 2 weight is 750g) and mixed, using a powder injection aseptic filling machine (a total of 12 batches of pharmaceutical compositions composed of Compound 1 and Compound 2 with a weight of 2250g were obtained), and each batch of Compound 1 and Compound 2 The pharmaceutical composition forme...

Embodiment 2

[0061] Example 2 The pharmaceutical composition composed of compound 1 and compound 2

[0062] With the raw material that embodiment 1 moisture, pH value, content and related substance detection all meet standard relevant requirement, get the compound 1 of 4 batches, each get three groups (each group is by the free acid weight of compound 1) Weight is 1500g), is mixed with 3 batches of compound 2 (the weight by the free acid weight of compound 2 is 500g) respectively, adopts powder injection aseptic dispensing machine (the weight that obtains 12 batches altogether is the compound of 2000g 1 and compound 2) to be subpackaged, each batch of compound 1 and compound 2 is divided into 1000 vials, and the amount of compound 1 in each bottle is calculated as the free acid of compound 1 The weight ratio of compound 2 in terms of the free acid of compound 2 is 3:1, the total weight of the free acid of compound 1 and the free acid of compound 2 is 2.0g, that is, each bottle contains 1.5...

Embodiment 3

[0063] Example 3 The pharmaceutical composition composed of compound 1 and compound 2

[0064] With the raw material that embodiment 1 moisture, pH value, content and related substance detection all meet standard relevant requirement, get the compound 1 of 4 batches, each get three groups (each group is by the free acid weight of compound 1) Weight is 2000g), respectively mixed with 3 batches of compound 2 (the weight by the free acid weight of compound 2 is 500g), adopts powder injection aseptic filling machine (obtaining 12 batches in total is the compound that the weight of 2500g 1 and compound 2) to be subpackaged, each batch of compound 1 and compound 2 is divided into 1000 vials, and the amount of compound 1 in each bottle is calculated as the free acid of compound 1 The weight ratio of compound 2 in terms of the free acid of compound 2 is 4:1, the total weight of the free acid of compound 1 and the free acid of compound 2 is 2.5g, that is, each bottle contains 2.0g of f...

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Abstract

The invention provides a pharmaceutical composition for improving pharmaceutical stability containing a compound 1 and a compound 2. Due to the specific power of hydrogen and water content, the pharmaceutical composition has an excellent water solubility, is bright in color and good in clarity after being prepared into a solution and is found to have an excellent stability through a long-term storage process, the product quality is effectively guaranteed, and the pharmaceutical composition has a significant meaning to administration safety and effectiveness.

Description

technical field [0001] The present invention relates to a pharmaceutical composition in the technical field of medicine, in particular to a pharmaceutical composition composed of compound 1 and compound 2. Background technique [0002] Compound 1 (structure shown in formula I) is a second-generation semi-synthetic antibiotic used as a broad-spectrum bactericidal antibiotic. [0003] [0004] Compound 2 (structure shown in formula II) is a β-lactamase inhibitor, which can increase the antibacterial activity of antibiotics when used in combination. [0005] [0006] The research team of the present invention has developed an antibiotic pharmaceutical composition composed of compound 1 and compound 2 in the previous research on compound activity. For example, in the Chinese patent document CN1513457A, the weight ratio of compound 1 and its salt and compound 2 and its salt is disclosed An antibiotic pharmaceutical composition ranging from 2:1 to 8:1, which is effective ag...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K31/43A61P31/04
Inventor 植建琼许长青郭玉倩
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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