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Cefotiam hydrochloride compound, method for preparing same and pharmaceutical composition with cefotiam hydrochloride compound

A technology of cefotiam hydrochloride and cefotiam hydrochloride, applied in the field of medicine, can solve the problems of poor mixing uniformity, poor fluidity of cefotiam hydrochloride, unstable cefotiam hydrochloride for injection, etc., and achieves good fluidity and good stability Effect

Active Publication Date: 2015-09-23
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK 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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  • Cefotiam hydrochloride compound, method for preparing same and pharmaceutical composition with cefotiam hydrochloride compound
  • Cefotiam hydrochloride compound, method for preparing same and pharmaceutical composition with cefotiam hydrochloride compound
  • Cefotiam hydrochloride compound, method for preparing same and pharmaceutical composition with cefotiam hydrochloride compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Example 1. Preparation of Cefotiam Hydrochloride Compound

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

[0048] 1) Dissolve 12kg crude cefotiam hydrochloride in 10L water to obtain 1.2kg / L cefotiam hydrochloride aqueous solution;

[0049] 2) Add activated carbon to the cefotiam hydrochloride aqueous solution of step 1) (the amount of activated carbon is 0.3% g / ml of the volume of the cefotiam hydrochloride aqueous solution), stir, filter with suction, and take 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) at a stirring speed of 50r / min to form a turbid solution, wherein the organic solvent A is ethanol A mixed solvent composed of dioxane and dioxane in a volume ratio of 2:1;

[0051] 4) After adjusting the stirring speed to 15r / min, add 300L of organic solvent B (the flow acceleration of organic solvent B is 12L / min) into the turbid solution of step 3). After the addition, ...

Embodiment 2

[0057] [Example 2] Preparation of Cefotiam Hydrochloride Compound

[0058] 1) Dissolve 22kg of crude cefotiam hydrochloride in 10L of water to obtain 2.2kg / L cefotiam hydrochloride aqueous solution;

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

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

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

Embodiment 3

[0066] [Example 3] Preparation of Cefotiam Hydrochloride Compound

[0067] 1) Dissolve 20kg crude cefotiam hydrochloride in 10L water to obtain 2.0kg / L cefotiam hydrochloride aqueous solution;

[0068] 2) Add activated carbon to the cefotiam hydrochloride aqueous solution of step 1) (the amount of activated carbon is 0.3% g / ml of the volume of the cefotiam hydrochloride aqueous solution), stir, filter with suction, and take 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) at a stirring speed of 55r / min to form a turbid solution, wherein the organic solvent A is ethanol A mixed solvent composed of 2.5:1 by volume with dioxane;

[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 the addition, crystals are precipitated, wherein the organic solvent B It is a mixed solvent composed of a...

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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 medicine, and specifically relates to a cefotiam hydrochloride compound, a preparation method and a pharmaceutical composition thereof. Background technique [0002] Cefotiam hydrochloride, namely 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, a cephalosporin widely used in clinical practice, its structural formula is: [0003] [0004] Because cefotiam hydrochloride is in the storage process, especially at high temperature (> Under the condition of 50°C), degradation and polymerization reactions often occur, resulting in a decrease in the content of active ingredients of the drug, an enhanced color and an increase in polymer impurities. In addition, cefotiam hydrochloride over the expiration date, due to long storage ti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12A61K31/546A61P31/04
CPCC07D501/12C07D501/36
Inventor 刘新泉封春香朱全明郑苏苏
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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