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Biapenem crystalline solid and preparation method thereof

A technology of crystals and crystal forms, applied in the field of biapenem crystals and its preparation, can solve the problems of drug safety, effectiveness, stability of physical properties, etc., and achieve solid-liquid separation, low cost, and high purity Effect

Active Publication Date: 2013-06-19
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Due to the difference in the type and purity of the crystal form of the same drug, there may be significant differences in the physical properties (solubility, melting point, dissolution rate, etc.) and stability (crystal form and chemical stability) of the drug, thus affecting the safety and effectiveness of the drug. sex makes a difference

Method used

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  • Biapenem crystalline solid and preparation method thereof
  • Biapenem crystalline solid and preparation method thereof
  • Biapenem crystalline solid and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0053] Experimental example 1 Experiment of influencing factors of biapenem crystals

[0054] Put 10g of crude biapenem into 500ml of water for injection (control the temperature at 5°C to 15°C), stir and dissolve completely, add 2g of activated carbon, stir for 40 minutes to decolorize and filter, filter the solution, then add ethanol under stirring 3000ml, stirred and controlled temperature (5°C-15°C) for 3 hours to crystallize, dried to obtain 8.2g white crystals, decomposition temperature 230°C-232°C, HPLC purity 99.8%, powder X-ray was carried out on the obtained biapenem crystals Diffraction analysis, the results are attached figure 1 ,Table 1.

[0055] Table 1 Powder X-ray Diffraction Data of Biapenem Crystals

[0056] 2θ value

[0057] The obtained white crystals of biapenem were placed under conditions of high temperature, light, and high humidity (92.5%) for 10 days. Compared with 0 days, the total impurities under each condition were as follows, and the ...

experiment example 2

[0061] Experimental Example 2 Stability Investigation

[0062] The crystalline finished product prepared in Example 1 and the self-made amorphous finished product were placed under light (4500lx) for 10 days, high temperature 60°C for 10 days, and high humidity (92.5%) for 10 days, respectively. 1. Comparing the influence of the amorphous powder of apenem and the crystalline product of biapenem prepared in Example 1 under high humidity and strong light conditions. The specific experimental data are shown in Table 3 below.

[0063] Table 3 Experimental results of influencing factors of amorphous fraction and crystalline biapenem

[0064]

[0065]

[0066] It can be seen from Table 3 that the main quality indicators of the biapenem crystals obtained in the present invention: traits, related substances and contents are all stable to biapenem amorphous products under strong light, high temperature and high humidity conditions; Under the conditions, the amorphous product ha...

Embodiment 1

[0068] Example 1 Preparation method of biapenem crystals of the present invention

[0069] Put 10 g of crude biapenem into 500 ml of water for injection (control the temperature at 5°C to 15°C), stir and dissolve completely, add 2 g of activated carbon, stir for decolorization and filter for 40 minutes, filter the solution, and add acetic acid under stirring Ethyl ester was 3000ml, stirred and temperature-controlled (5°C-15°C) for 3 hours to crystallize, and dried to obtain 8.5g of white crystals with a decomposition temperature of 230°C-231°C and a HPLC purity of 99.8%. The obtained biapenem crystals were subjected to powder X - Ray Diffraction Analysis, the results are attached figure 1 ,Table 1.

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Abstract

The invention discloses a biapenem crystalline solid and a preparation method thereof. X ray diffraction spectrogram of the biapenem crystalline powder has a peak at the position where an angle of 2theta is 16.228+ / -0.2. The biapenem crystalline solid is prepared by means of crystallization, three kinds of reagents are used, operation is simple, cost is low, crystalline particles are uniform, solid-liquid separation and dying are convenient and the preparation method is suitable for industrial production. The biapenem crystalline solid prepared with the preparation method has the advantages that purity of crystalline solid is high, and the crystalline solid has good stability in bright, hot and humid environments.

Description

technical field [0001] The invention relates to the field of chemical and pharmaceutical technology, in particular to a biapenem crystal and a preparation method thereof. Background technique [0002] The phenomenon that the same element or compound forms crystals with completely different structures, shapes, and physical properties under different conditions is called polymorphism. Polymorphism exists widely in organic medicines. The crystallization of polymorphic medicines mostly belongs to molecular lattice, and different crystal forms are produced with different process conditions. Due to the difference in the type and purity of the crystal form of the same drug, there may be significant differences in the physical properties (solubility, melting point, dissolution rate, etc.) and stability (crystal form and chemical stability) of the drug, thus affecting the safety and effectiveness of the drug. Sex can make a difference. [0003] For APIs with polymorphic forms, the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D519/06
Inventor 曹晓红彭捷陈媛媛卢福冯冠榕姚志昂邓璐霞
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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