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Medicinal cefetamet pivoxil hydrochloride dry suspension for treating sensitive bacterial infection diseases

A technology of ceftazidime hydrochloride and dry suspension, applied in the field of medicine, can solve problems such as patient harm and immediate allergic reaction, and achieve the effects of low polymer content, significant antibacterial activity, and low impurity content

Inactive Publication Date: 2015-12-30
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, because its basic structure is the same as that of many semi-synthetic β-lactam lactam antibiotics already on the market, ceftazidime hydrochloride will also form high molecular polymers, which will also cause immediate hypersensitivity reactions in clinical use, which is harmful to patients. great

Method used

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  • Medicinal cefetamet pivoxil hydrochloride dry suspension for treating sensitive bacterial infection diseases
  • Medicinal cefetamet pivoxil hydrochloride dry suspension for treating sensitive bacterial infection diseases
  • Medicinal cefetamet pivoxil hydrochloride dry suspension for treating sensitive bacterial infection diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1: Preparation of ceftazidime pivoxil hydrochloride crystal

[0029] Dissolve ceftamet pivoxil hydrochloride in a mixed solvent of methanol and acetonitrile whose volume is 10 times the weight of ceftamet pivoxil hydrochloride at 35°C, the volume ratio of methanol and acetonitrile is 3:1, after the dissolution is completed, add a volume of hydrochloric acid 6 times the weight of ceftazidime as an ether solvent, the temperature was lowered to room temperature within 1-2 hours, kept at room temperature for 3 hours, and then further cooled to 0-5°C, and then placed at 0-5°C for 2 -3 hours, crystals were precipitated, and ceftazidime hydrochloride crystals were obtained.

[0030] The X-ray powder diffraction pattern obtained by the ceftazidime hydrochloride crystals prepared using Cu-Kα ray measurement is as follows figure 1 Shown, its purity as determined by high performance liquid chromatography is 99.9%.

Embodiment 2

[0031] Example 2: Preparation of Cefetamet Pixil Hydrochloride Dry Suspension

[0032] Prescription: in parts by weight as shown in Table 1

[0033] Table 1 Ceftamet pivoxil hydrochloride dry suspension prescription

[0034]

[0035]

[0036] Preparation:

[0037] 1) Processing of raw and auxiliary materials: use a vibrating sieving machine to pass sucrose through a 60-mesh sieve, and ceftazidime hydrochloride through a 80-mesh sieve;

[0038] 2) Weighing: Weighing according to the prescription;

[0039] 3) Granulation: Add the prescribed amount of ceftazidime hydrochloride, dextrin, sucrose, hypromellose, and xanthan gum into the wet granulator, turn on the stirring motor and dry mix for 5 minutes, add absolute ethanol, Wet mixing and cutting for 90-120 seconds to make soft materials, and 20-mesh nylon mesh is installed in a swinging granulator to granulate;

[0040] 4) Drying: Set the inlet air temperature of the boiling dryer to 55°C, dry until the moisture cont...

Embodiment 3

[0043] Example 3: Preparation of Cefetamet Pixil Hydrochloride Dry Suspension

[0044] Prescription: in parts by weight as shown in Table 2

[0045] Table 2 Ceftamet pivoxil hydrochloride dry suspension prescription

[0046]

[0047] Preparation:

[0048] 1) Processing of raw and auxiliary materials: use a vibrating sieving machine to pass sucrose through a 60-mesh sieve, and ceftazidime hydrochloride through a 80-mesh sieve;

[0049] 2) Weighing: Weighing according to the prescription;

[0050] 3) Granulation: Add the prescribed amount of ceftazidime hydrochloride, dextrin, sucrose, hypromellose, and xanthan gum into the wet granulator, turn on the stirring motor and dry mix for 5 minutes, add absolute ethanol, Wet mixing and cutting for 90-120 seconds to make soft materials, and 20-mesh nylon mesh is installed in a swinging granulator to granulate;

[0051]4) Drying: Set the inlet air temperature of the boiling dryer to 55°C, dry until the moisture content is less t...

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Abstract

The invention discloses a medicinal cefetamet pivoxil hydrochloride dry suspension for treating sensitive bacterial infection diseases and belongs to the technical field of medicine. The dry suspension is prepared from cefetamet pivoxil hydrochloride, dextrin, sucrose, HPMC, xanthan gum and absolute ethyl alcohol. The cefetamet pivoxil hydrochloride is a novel crystal-form compound. As shown in Figure 1 of X-ray powder diffraction diagram obtained by means of Cu-K alpha ray measurement, the cefetamet pivoxil hydrochloride is different from cefetamet pivoxil hydrochloride reported in the prior art. Tests find that the dry suspension prepared from the novel crystal-form compound of the cefetamet pivoxil hydrochloride is low in high-molecular polymer content and good in stability, and the content of high-molecular polymers gradually decreases along with prolonging of storage time; meanwhile, the composition has more remarkable antibacterial activity with respect to pneumococcocci and hemophilus influenza and also has strong antibacterial activity with respect to enterococcocci and staphylococcocci.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a dry suspension of ceftazidime hydrochloride used for treating susceptible bacterial infection diseases. Background technique [0002] Ceftazidime pivoxil hydrochloride is a third-generation broad-spectrum cephalosporin antibiotic. After oral administration, it is rapidly hydrolyzed in the body to cefetamet with antibacterial activity to play a bactericidal effect. Ceftazidime hydrochloride has strong antibacterial activity against Gram-positive bacteria such as Streptococcus (except for Streptococcus faecalis), Pneumococcus, Escherichia coli, Klebsiella, influenza bacilli, and Neisseria gonorrhoeae, especially Serratia spp., indole-positive Proteus spp., Enterobacter spp. and Citrobacter spp. with low sensitivity to cephalosporins had obvious antibacterial activity. Stable to β-lactamases produced by bacteria. Ceftazidime hydrochloride is ineffective against Pseudomonas, Myco...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/546C07D501/22C07D501/12A61P31/04
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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