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Antibacterial cefotiam hydrochloride drug composition

A technology of cefotiam hydrochloride and antibacterial drugs, applied in the field of medicine, can solve the problems of loss of antibacterial activity, poor mixing uniformity, unstable β-lactam ring, etc.

Inactive Publication Date: 2015-12-09
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the structure of cefotiam hydrochloride contains an unstable β-lactam ring, which is prone to hydrolysis and rearrangement reactions, resulting in the destruction of the structure and the loss of antibacterial activity. Some degradation products may cause allergic reactions. The stability in the
[0005] However, the literature "Study on the Compatibility Stability of Cefotiam Hydrochloride for Injection and Three Kinds of Infusions" [Luo Xiaoru, Wei Liping, et al. Study on the Compatibility Stability of Cefotiam Hydrochloride for Injection and Three Kinds of Infusions, Journal of Pharmaceutical Sciences of PLA [J], 2013, 29 (4): 354-356] After investigating the compatibility stability of cefotiam hydrochloride for injection with 0.9% sodium chloride injection, 5% glucose injection and 5% glucose sodium chloride injection, Its result shows that under room temperature condition, cefotiam hydrochloride for injection is all unstable in above-mentioned 3 kinds of solutions
However, none of the new crystal compounds of the prior art solves the problem
[0006] And, the fluidity of cefotiam hydrochloride is also relatively poor, makes when preparing cefotiam hydrochloride for injection and the mixing homogeneity of auxiliary material is poor

Method used

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  • Antibacterial cefotiam hydrochloride drug composition
  • Antibacterial cefotiam hydrochloride drug composition
  • Antibacterial cefotiam hydrochloride drug composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Preparation of Cefotiam Hydrochloride Crystals

[0024] Prepare a saturated ethanol solution of cefotiam hydrochloride crude product at 30°C, and then add a mixed solvent of isobutanol and petroleum ether whose volume is 8 times the volume of the saturated ethanol solution, and the volume ratio of the isobutanol and petroleum ether is 2:1.5 , after stirring evenly, stir while cooling down, the cooling rate is 10°C / hour, the stirring speed is 105 rpm, and at the same time, add ether twice the volume of the mixed solvent of isobutanol and petroleum ether, and stop after cooling down to 0°C Stirring, standing still for crystal growth for 3 hours, filtering, and drying under reduced pressure to obtain cefotiam hydrochloride crystalline compound.

[0025] The prepared cefotiam hydrochloride crystal uses Cu-Kα ray to measure the X-ray powder diffraction pattern that obtains as follows figure 1 Shown, its purity as determined by high performance liquid chromatogr...

Embodiment 2

[0026] Example 2: Preparation of cefotiam hydrochloride composition

[0027] The composition comprises: 1 part by weight of cefotiam hydrochloride crystal prepared by the present invention, and 0.01 part by weight of arginine.

[0028] The preparation method is:

[0029] (1) Weigh cefotiam hydrochloride crystals and arginine in proportion and mix them thoroughly;

[0030] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0031] Example 3: Preparation of cefotiam hydrochloride composition

[0032] The composition comprises: 1 part by weight of cefotiam hydrochloride crystal prepared by the present invention, and 0.02 part by weight of arginine.

[0033] The preparation method is:

[0034] (1) Weigh cefotiam hydrochloride crystals and arginine in proportion and mix them thoroughly;

[0035] (2) Dispense into sterilized vials and stopper them.

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PUM

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Abstract

The invention discloses an antibacterial cefotiam hydrochloride drug composition, belongs to the technical field of medicines. The drug composition comprises cefotiam hydrochloride and arginine, wherein cefotiam hydrochloride is crystalline, and the X-ray powder diffraction pattern measured by Cu-K-alpha rays is shown in the figure 1 (in the description). The new crystalline form of cefotiam hydrochloride provided by the invention is different from the crystal structure in the prior art, by experimental verification, the purity of the crystalline compound is high, the fluidity is good, the stability is good, the polymer content is low, hygroscopicity is avoided, and the stability of solution is good after being left to stand for 4 h at room temperature, wherein the solution is obtained by compounding the prepared powder injection with 0.9% sodium chloride injection, 5% glucose injection, and 5% sodium chloride and dextrose injection.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an antibacterial drug cefotiam hydrochloride composition. Background technique [0002] Cefotiam hydrochloride is a widely used cephalosporin in clinical practice. During storage, especially at high temperature (>50°C), it often undergoes degradation and polymerization reactions, resulting in a decrease in the content of active ingredients in the drug. The color is enhanced and the content of polymer impurities is increased. In addition, cefotiam hydrochloride that has expired, due to long storage time, often reduces the content of active ingredients of the drug, darkens the color, and has a particularly high polymer content. When the polymer content is high, it is easy to cause allergic reactions in the human body. [0003] Although the prior art has solved its purity problem to a certain extent, it has been found through further research that degradation and polymerization o...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K47/18A61P31/04C07D501/36C07D501/12
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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