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Anti-infective medicinal cefotiam hydrochloride composition

A technology of cefotiam hydrochloride and composition, which is applied in the field of anti-infective drug cefotiam hydrochloride composition, and can solve problems such as loss of antibacterial activity, poor mixing uniformity, unstable β-lactam ring, etc.

Inactive Publication Date: 2015-11-18
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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  • Anti-infective medicinal cefotiam hydrochloride composition
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  • Anti-infective medicinal cefotiam hydrochloride composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1: Preparation of Cefotiam Hydrochloride Crystals

[0025] Take cefotiam hydrochloride raw material, add in the mixed solvent A of water and N-methylacetamide whose volume is 8 times of the weight of cefotiam hydrochloride at 30°C, the volume ratio of water and N-methylacetamide is 4:1 , to obtain the solution; then on the horizontal direction of the liquid surface of the obtained solution, the applied magnetic field intensity is a constant magnetic field of 0.5T, and under the condition of the constant magnetic field, the solution is dripped with a volume that is 5 times of the weight of cefotiam hydrochloride ethanol, iso Mixed solvent B of butanol and diethyl ether, the volume ratio of ethanol, isobutanol and diethyl ether is 2:3:4; after the dropwise addition is completed, cool down to -3°C, let stand for 2 hours, filter, wash, and vacuum dry to obtain Described cefotiam hydrochloride crystal.

[0026] The prepared cefotiam hydrochloride crystal uses Cu-K...

Embodiment 2

[0027] Example 2: Preparation of cefotiam hydrochloride composition

[0028] The composition comprises: 1 part by weight of cefotiam hydrochloride crystal prepared by the invention, and 0.4 part by weight of sodium chloride.

[0029] The preparation method is:

[0030] (1) Weigh cefotiam hydrochloride crystals and sodium chloride in proportion and mix them thoroughly;

[0031] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0032] Example 3: Preparation of cefotiam hydrochloride composition

[0033] The composition comprises: 1 part by weight of cefotiam hydrochloride crystal prepared by the invention, and 0.5 part by weight of sodium chloride.

[0034] The preparation method is:

[0035] (1) Weigh cefotiam hydrochloride crystals and sodium chloride in proportion and mix them thoroughly;

[0036] (2) Dispense into sterilized vials and stopper them.

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PUM

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Abstract

The invention relates to an anti-infective medicinal cefotiam hydrochloride composition, and belongs to the technical field of medicines. The composition consists of cefotiam hydrochloride and sodium chloride; the cefotiam hydrochloride is crystals; an X-ray powder diffraction pattern obtained by measuring the crystals by using Cu-K alpha rays is shown as figure 1. The new crystal form of the cefotiam hydrochloride provided by the invention is different from the crystal form structure in the prior art; through experimental verification, people surprisingly find that the crystal compound is high in purity, high in mobility, high in stability and low in polymer content, and does not have hygroscopicity; after prepared powder-injection is matched with 0.9 percent sodium chloride injection, 5 percent dextrose injection, and 5 percent sodium chloride and dextrose injection and is then placed for 4 hours, the stability of the solution is high.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an anti-infection 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 ...

Claims

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Application Information

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