Cefmetazole sodium powder for injection and preparation method thereof

A technology for ceftazole sodium and azole sodium powder, which is applied in the field of medicine, can solve problems such as dysplasia, nutritional anemia, central nervous system obstruction, etc., and achieves the effects of reasonable composition, simple preparation process and good stability

Active Publication Date: 2012-12-19
YOUCARE PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If lack of lysine, it will cause insufficient secretion of gastric juice and cause anorexia and nutritional anemia, resulting in central nervous system obstruction and dysplasia.

Method used

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  • Cefmetazole sodium powder for injection and preparation method thereof
  • Cefmetazole sodium powder for injection and preparation method thereof
  • Cefmetazole sodium powder for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] prescription:

[0037] Ceftezole Sodium 1000g

[0038] L-Lysine 10g

[0039] Preparation process (see attached figure 1 ):

[0040] (1) After the original and auxiliary materials are removed from the outer packaging, they are dust-cleaned, wiped and sterilized, and put into a sterile room for standby;

[0041] (2) In the 100-level clean area, ceftezole sodium and L-lysine are respectively crushed and passed through an 80-mesh sieve;

[0042] (3) Take ceftezole sodium and L-lysine in a 100-level clean area, mix them evenly according to the prescription ratio, subpackage them in control bottles after the measured content is qualified, press the stopper, roll the cap, light inspection, and pass the inspection, Label and pack.

Embodiment 2

[0044] prescription:

[0045] Ceftezole Sodium 1000g

[0046] L-Lysine 15g

[0047] Preparation Process:

[0048] (3) After the original and auxiliary materials are removed from the outer packaging, they are dust-cleaned, wiped and sterilized, and put into a sterile room for standby;

[0049] (4) In the 100-level clean area, ceftezole sodium and L-lysine are respectively crushed and passed through an 80-mesh sieve;

[0050] (3) Take ceftezole sodium and L-lysine in a 100-level clean area, mix them evenly according to the prescription ratio, subpackage them in control bottles after the measured content is qualified, press the stopper, roll the cap, light inspection, and pass the inspection, Label and pack.

Embodiment 3

[0052] prescription:

[0053] Ceftezole Sodium 1000g

[0054] L-Lysine 20g

[0055] Preparation Process:

[0056] (5) After the original and auxiliary materials are removed from the outer packaging, they are dust-cleaned, wiped and sterilized, and put into a sterile room for standby;

[0057] (6) In the 100-level clean area, ceftezole sodium and L-lysine were respectively crushed and passed through an 80-mesh sieve;

[0058] (3) Take ceftezole sodium and L-lysine in a 100-level clean area, mix them evenly according to the prescription ratio, subpackage them in control bottles after the measured content is qualified, press the stopper, roll the cap, light inspection, and pass the inspection, Label and pack.

[0059] The beneficial effects of the present invention are described through the following experimental examples and comparative examples.

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PUM

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Abstract

The invention discloses a cefmetazole sodium powder for injection. The cefmetazole sodium powder for injection comprises: by weight, 1000 parts of cefmetazole sodium used as a raw material and 10-20 parts of L-lysine used as an auxiliary material. The power injection is prepared according to the following preparation method: firstly removing dust from the raw material and the auxiliary material, cleaning, wiping and sterilizing; respectively crushing cefmetazole sodium and L-lysine in a clean area of 100 level, and sieving through a sieve of 80 meshes; weighing and mixing according to a prescription, subpackaging into tube-type bottles after testing content qualified, pressing plugs, capping, carrying out lamp inspection, examining qualified, labeling and packaging. The cefmetazole sodiumpowder for injection in the prescription has stable performance to temperature and light. After 6 months of accelerated testing and 12 months of long-term sample storage for observation, contents of related substances are all less than 1%, and color, clarity, bacterial endotoxin and the like of the powder injection all accord with the pharmacopeial standard. The preparation method of the prescription has advantages of simple technology and stable and reliable quality.

Description

[technical field] [0001] The invention belongs to the technical field of medicine, and relates to a cephalosporin drug and a preparation method thereof, in particular to a ceftezole sodium powder for injection and a preparation method thereof. [Background technique] [0002] Ceftezole Sodium is a sterile powder, its English name: Ceftezole Sodium for Injection. This product is easily soluble in water, slightly soluble in methanol, almost insoluble in ethanol and ether. The molecular weight is 462.47, the molecular formula is C13H11N8NaO4S3, and the chemical name is: (6R,7R)-3[[(1,3,4-thiadiazol-2-yl)sulfur]methyl]-7-[(1H-tetrazole- 1 group) Acetylamino] 8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. The properties are white to light yellow crystalline powder, odorless and hygroscopic. Its chemical structural formula is as follows: [0003] [0004] Ceftezole sodium is the first generation of cephalosporin antibiotics for injection. It is a se...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/546A61K47/16A61P31/04
Inventor 杨磊
Owner YOUCARE PHARMA GROUP
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