New crystal form composition of cefminox sodium and preparation method thereof

A technology of cefminox sodium and its composition, which is applied in the field of medicine and medicine preparation, can solve problems such as poor stability and slow dissolution speed, and achieve the effects of reasonable specification design, large entropy value and good dissolution stability

Active Publication Date: 2013-02-27
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Adopt the recrystallization method of prior art, although the cefminox sodium crystal obtained can be dissolved in water, yet its dissolving speed is slow, and stability is poor, and long-term placement has solid to separate out

Method used

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  • New crystal form composition of cefminox sodium and preparation method thereof
  • New crystal form composition of cefminox sodium and preparation method thereof
  • New crystal form composition of cefminox sodium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 1. Prescription:

[0043] Cefminox Acid (95%) 1140g

[0044] Sodium isooctanoate for injection (98%) 332g

[0045] Water for injection 3249ml

[0046] 2. Production process:

[0047]Dissolve 332g of sodium isooctanoate in 2000ml of water and 1140g of cefminox acid in 1249ml of water to form sodium isooctanoate solution and cefminox acid solution according to aseptic operation requirements, slowly add sodium isooctanoate solution into cefminox acid solution (The water temperature of the above two solutions is controlled at 5-8°C), and continuously stirred for 30 minutes. After the reaction is complete, add 0.1% activated carbon and stir to adjust the pH to 4.5-6.0. Freeze-dry the large plate (the liquid level height is 3-4cm), and immediately send it to the vacuum freeze-drying box to freeze-dry. Keep warm for 2 hours, keep the vacuum in the box at 10-20Pa, then start to heat up, and the product temperature will rise to 0°C within 20 hours, then increase the temperat...

Embodiment 2

[0052] 1. Prescription

[0053] Cefminox Acid (95%) 1140g

[0054] Sodium isooctanoate for injection (98%) 332g

[0055] Water for injection 3249ml

[0056] 2. Production process:

[0057] Dissolve 332g of sodium isooctanoate in 2000ml of water and 1140g of cefminox acid in 1249ml of water to form sodium isooctanoate solution and cefminox acid solution according to aseptic operation requirements, slowly add sodium isooctanoate solution into cefminox acid solution (The water temperature of the above two solutions is controlled at 5-8°C), and continuously stirred for 30 minutes. After the reaction is complete, add 0.1% activated carbon and stir to adjust the pH to 4.5-6.0. Freeze-dry the large plate (the liquid level is 3-4cm), and immediately send it to the vacuum freeze-drying box for freeze-drying. First, the temperature of the plate layer is lowered to below -45°C, and then the product is sent into the product. The temperature of the product reaches -50°C within 2 hours. ...

Embodiment 3

[0060] Preparation of cefminox sodium new crystal form composition composition powder injection: take by weighing 500 g of cefminox sodium new crystal form composition prepared in Example 1, 15 g of mannitol, sterilize by ultraviolet light, mix, and then aseptic raw materials Put it into the filling machine, adjust the filling amount according to the specification of 0.5g / bottle (calculated as cefminol (C16H21N7O7S3)), fill it into bottles after passing the inspection, buckle the butyl rubber stopper, roll the cap, and pack the finished product into the warehouse and send it check.

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Abstract

The invention provides a new crystal form composition of cefminox sodium and a preparation method thereof, relating to the technical field of medicines and preparation method of medicines. The new crystal form composition of cefminox sodium is measured by powder X-ray diffraction, and the powder X-ray diffraction spectrum represented by a diffraction angle of 2 theta + / - 0.2 degrees has no specific diffractive peaks. The new crystal form is amorphous, and is fused at 171-173 DEG C. According to the invention, the medicine of the crystal form has the advantages of high entropy, good dissolvability, high bioavailability, and good dissolving stability; by using novel freeze drying technology, the operation is simple, the method is suitable for industrial production; and the disadvantages of slow dissolving speed, bad stability, and solid precipitates after long time storage of cefminox sodium crystals prepared by the prior art can be solved.

Description

Technical field: [0001] The invention relates to the technical field of medicines and preparation methods of medicines, in particular to a new crystal form composition of cefminox sodium and a preparation method thereof. Background technique: [0002] The chemical name of cefminox sodium is: (6R,7S)-7β-[(S)-2-[(2-amino-2-carboxyethyl)sulfur]acetamido]-7α-methoxy-3- [1-Methyl-1H-tetrazol-5-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. Molecular formula: C16H20N7NaO7S3, molecular weight: 541.56. Its chemical structural formula is: [0003] [0004] Cefminox sodium not only plays a bactericidal effect on the bacterial proliferation stage, but also on the initial stage of the stable stage. Cefminox sodium is a cefamycin preparation that also shows bactericidal effect under the condition of inactivation of proliferation. It shows antibacterial effect on both the bacterial proliferation stage and the stable stage. Antimicrobial spectrum...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/57C07D501/04A61K31/546A61K9/19A61P31/04
Inventor 汪六一汪金灿吴函峰李彪
Owner HAINAN WEI KANG PHARMA QIANSHAN
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