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Cefaclor compound, medicine composition of cefaclor compound and bromhexine hydrochloride, and preparation of cefaclor compound

A technology of bromhexine hydrochloride and cefaclor, applied in the field of medicine, can solve problems such as research on bioavailability of preparations, and achieve the effects of good clinical treatment effect, good stability and improved synergistic drug effect

Active Publication Date: 2015-11-25
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, the above patents did not conduct in-depth research on the bioavailability of the preparation

Method used

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  • Cefaclor compound, medicine composition of cefaclor compound and bromhexine hydrochloride, and preparation of cefaclor compound
  • Cefaclor compound, medicine composition of cefaclor compound and bromhexine hydrochloride, and preparation of cefaclor compound
  • Cefaclor compound, medicine composition of cefaclor compound and bromhexine hydrochloride, and preparation of cefaclor compound

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] The preparation of embodiment 1 cefaclor trihydrate

[0040] 1. Dissolve the cefaclor crude product in water with a pH of 3.0 and a temperature of 40°C;

[0041] 2. While stirring, add a mixed solvent of diethyl ether and n-hexane with a volume ratio of 2:1; the stirring speed is 1200 rpm; the weight of the mixed solvent is 4 times the weight of the cefaclor aqueous solution, and the adding speed is 30 ml / min;

[0042] 3. After adding the mixed solvent, cool down to -1°C with a cooling rate of 4°C / hour; adjust the pH value to 4.5, obtain crystals and then stand for crystallization; filter, wash, and vacuum dry for 2 hours to obtain cefaclor tris Hydrate.

[0043] The compound crystal is detected by high-performance liquid chromatography, and the purity is 99.96%, and the yield is 94.0%; the X-ray powder diffraction pattern obtained by using Cu-Kα ray measurement is as follows: figure 1 As shown, the thermogravimetric analysis diagram is shown as figure 2 Shown; Elem...

Embodiment 2

[0045] The preparation of embodiment 2 cefaclor trihydrate

[0046] 1. The cefaclor crude product is dissolved in water with a pH of 2.5 and a temperature of 35°C;

[0047] 2. While stirring, add a mixed solvent of diethyl ether and n-hexane with a volume ratio of 2:0.8; the stirring speed is 1000 rpm; the weight of the mixed solvent is 3 times the weight of the cefaclor aqueous solution, and the adding speed is 20 ml / min;

[0048] 3. After adding the mixed solvent, cool down to 0°C with a cooling rate of 5°C / hour; adjust the pH value to 5.0, obtain crystals and then stand for crystallization; filter, wash, and vacuum dry for 4 hours to obtain cefaclor trihydrate thing.

[0049]The compound crystal is detected by high-performance liquid chromatography, and the purity is 99.95%, and the yield is 93.5%; the X-ray powder diffraction pattern obtained by using Cu-Kα ray measurement is as follows: figure 1 As shown, the thermogravimetric analysis diagram is shown as figure 2 Sho...

Embodiment 3

[0050] The preparation of embodiment 3 cefaclor trihydrate

[0051] 1. The cefaclor crude product is dissolved in water with a pH of 3.0 and a temperature of 38°C;

[0052] 2. While stirring, add a mixed solvent of diethyl ether and n-hexane with a volume ratio of 4:1; the stirring speed is 900 rpm; the weight of the mixed solvent is 3 times the weight of the cefaclor aqueous solution, and the adding speed is 20 ml / min;

[0053] 3. After adding the mixed solvent, lower the temperature to -1°C, and the cooling rate is 4°C / hour; adjust the pH value to 4.5, obtain crystals and then stand for crystallization; filter, wash, and vacuum dry for 3 hours to obtain cefaclor tris Hydrate.

[0054] The compound crystal is detected by high-performance liquid chromatography, and the purity is 99.96%, and the yield is 94.2%; the X-ray powder diffraction pattern obtained by using Cu-Kα ray measurement is as follows: figure 1 As shown, the thermogravimetric analysis diagram is shown as fig...

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Abstract

The invention relates to the field of medicines, in particular to a cefaclor trihydrate and a preparation thereof. The cefaclor trihydrate has a structural formula shown in formula (I). The invention further relates to a medicine composition prepared from the cefaclor trihydrate and bromhexine hydrochloride. The form of the medicine composition is selected from tablets, capsules and granules. Stability tests prove that the prepared cefaclor trihydrate is high in stability and bioavailability, and suitable for clinical application.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a cefaclor compound, a pharmaceutical composition of the compound and bromhexine hydrochloride and a preparation thereof. Background technique [0002] Cefaclor is a second-generation oral cephalosporin, which has a strong killing effect on a variety of Gram-positive and Gram-negative bacteria. Cefaclor is a broad-spectrum semi-synthetic cephalosporin antibiotic. The activity against penicillinase-producing Staphylococcus aureus, group A hemolytic streptococcus, viridans streptococcus and staphylococcus epidermidis is the same as that of cefadroxil, and the antibacterial effect against non-enzyme-producing staphylococcus aureus and pneumococcus is higher than that of cefadroxil 2 to 4 times stronger. The activity against Gram-negative bacilli, including Escherichia coli and Klebsiella pneumoniae, is stronger than cephalexin, similar to cefadroxil, and the activity against Proteus mirabi...

Claims

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Application Information

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IPC IPC(8): C07D501/59A61K31/546A61P31/04A61K31/137
CPCA61K31/137A61K31/546C07B2200/13C07D501/59A61K2300/00
Inventor 刘桂军田松张峰
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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