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A kind of cefotiam hydrochloride compound, its preparation method and its pharmaceutical composition

A technology of cefotiam hydrochloride and cephalosporin hydrochloride, which is applied in the field of medicine, can solve the problems of poor mixing uniformity, poor fluidity of cefotiam hydrochloride, instability of cefotiam hydrochloride for injection, etc., and achieve good fluidity and good stability Effect

Active Publication Date: 2017-10-03
SHANDONG LUOXIN PHARMA GRP CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] 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, Chinese Journal of Pharmaceutical Sciences of the 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
[0013] 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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  • A kind of cefotiam hydrochloride compound, its preparation method and its pharmaceutical composition
  • A kind of cefotiam hydrochloride compound, its preparation method and its pharmaceutical composition
  • A kind of cefotiam hydrochloride compound, its preparation method and its pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1, the preparation of cefotiam hydrochloride compound

[0047] [Example 1] Preparation of Cefotiam Hydrochloride Compound

[0048] 1) 12kg cefotiam hydrochloride crude product is dissolved in 10L water, obtains the cefotiam hydrochloride aqueous solution of 1.2kg / L;

[0049] 2) Add activated carbon (the amount of activated carbon is 0.3% g / ml of the volume of the cefotiam hydrochloride aqueous solution) to the cefotiam hydrochloride aqueous solution in step 1), stir, suction filter, and get the filtrate;

[0050] 3) Add 50L of organic solvent A (the flow rate of organic solvent A is 13L / min) to the filtrate of step 2) under the condition that the stirring speed is 50r / min to form a turbid solution, wherein said organic solvent A is ethanol A mixed solvent composed of dioxane and dioxane at a volume ratio of 2:1;

[0051] 4) After adjusting the stirring speed to 15r / min, add 300L of organic solvent B to the turbid solution of step 3) (the flow rate of organi...

Embodiment 2

[0057] [embodiment 2] the preparation of cefotiam hydrochloride compound

[0058] 1) 22kg cefotiam hydrochloride crude product is dissolved in 10L water, obtains the cefotiam hydrochloride aqueous solution of 2.2kg / L;

[0059] 2) Add activated carbon (the amount of activated carbon is 0.3% g / ml of the volume of the cefotiam hydrochloride aqueous solution) to the cefotiam hydrochloride aqueous solution in step 1), stir, suction filter, and get the filtrate;

[0060] 3) Add 100L organic solvent A (the flow rate of organic solvent A is 20L / min) to the filtrate of step 2) under the condition that the stirring speed is 60r / min to form a turbid solution, wherein the organic solvent A is ethanol A mixed solvent composed of dioxane and dioxane at a volume ratio of 3:1;

[0061] 4) After adjusting the stirring speed to 25r / min, add 200L of organic solvent B to the turbid solution of step 3) (the flow rate of organic solvent B is 6L / min). It is a mixed solvent composed of acetone and ...

Embodiment 3

[0066] [embodiment 3] the preparation of cefotiam hydrochloride compound

[0067] 1) 20kg cefotiam hydrochloride crude product is dissolved in 10L water, obtains the cefotiam hydrochloride aqueous solution of 2.0kg / L;

[0068] 2) Add activated carbon (the amount of activated carbon is 0.3% g / ml of the volume of the cefotiam hydrochloride aqueous solution) to the cefotiam hydrochloride aqueous solution in step 1), stir, suction filter, and get the filtrate;

[0069] 3) Add 80L of organic solvent A (the flow rate of organic solvent A is 15L / min) to the filtrate of step 2) under the condition that the stirring speed is 55r / min to form a turbid solution, wherein the organic solvent A is ethanol A mixed solvent composed of dioxane and dioxane at a volume ratio of 2.5:1;

[0070] 4) After adjusting the stirring speed to 20r / min, add 100L of organic solvent B to the turbid solution of step 3) (the flow rate of organic solvent B is 8L / min), after adding, crystals are precipitated, an...

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a cefotiam hydrochloride compound, a method for preparing the same and a pharmaceutical composition with the cefotiam hydrochloride compound. The cefotiam hydrochloride compound is cefotiam hydrochloride trihydrate, and a structural formula of the cefotiam hydrochloride compound is shown. The cefotiam hydrochloride compound, the method and the pharmaceutical composition have the advantages that crystals of the cefotiam hydrochloride trihydrate are good in flowability, injection cefotiam hydrochloride made of the crystals of the cefotiam hydrochloride trihydrate, 0.9% sodium chloride injection, 5% glucose injection and 5% glucose and sodium chloride injection can be compatible with one another to obtain liquor, and the liquor is excellent in stability after being placed at the room temperature for 4h.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a cefotiam hydrochloride compound, a preparation method thereof and a pharmaceutical composition thereof. Background technique [0002] Cefotiam hydrochloride, cefotiam dihydrochloride, chemical name is (6R-trans)-7-[[(2-amino-4-thiazolyl)acetyl]amino]-3-[[[1 -[(2-(Dimethylamino)ethyl]-1H-tetrazol-5-yl]thiomethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]octane -2-ene-2-carboxylic acid dihydrochloride is a widely used cephalosporin clinically, and its structural formula is: [0003] [0004] Because cefotiam hydrochloride tends to degrade and polymerize during storage, especially under high temperature (>50°C), which leads to a decrease in the content of the active ingredient in the drug, a stronger color, and an increase in the content of polymer impurities. In addition, cefotiam hydrochloride that has expired, due to long storage time, often reduces the content of ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D501/36C07D501/12A61K31/546A61P31/04
CPCC07D501/12C07D501/36
Inventor 刘新泉朱正传朱全明郑苏苏
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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