Cefotiam hydrochloride pharmaceutical composition for injection and preparation method thereof

A technology for cefotiam hydrochloride and a composition, which is applied in the field of drug synthesis and preparation, can solve problems such as poisoning, poor pH stability, and excessively low partial pressure, and achieves the effects of good stability, enhanced pH stability, and small variation range

Inactive Publication Date: 2013-12-18
HANGZHOU TONGSHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] For this reason, the technical problem to be solved by the present invention is that the cefotiam hydrochloride medicine for injection in the prior art causes CO in the blood 2 The partial pressure is too low, the pH stability is poor, and the long-term use of human beings is easy to cause poisoning, thus providing a CO2 in the blood after injection. 2 The pharmaceutical composition of cefotiam hydrochloride for injection with stable partial pressure, good pH stability, safety and stability

Method used

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  • Cefotiam hydrochloride pharmaceutical composition for injection and preparation method thereof
  • Cefotiam hydrochloride pharmaceutical composition for injection and preparation method thereof
  • Cefotiam hydrochloride pharmaceutical composition for injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0076] The pharmaceutical composition of cefotiam hydrochloride for injection described in the present embodiment, its formula is as follows:

[0077] Cefotiam hydrochloride 500g, sodium carbonate 120g, sodium bicarbonate 2g;

[0078] The pharmaceutical composition is prepared by the following steps:

[0079] (1) Filling. After mixing cefotiam hydrochloride with sodium carbonate / sodium bicarbonate, the filling is filled into sterilized vials using an automatic filling machine, and the vials are sterilized using a tunnel sterilizer. The sterilization temperature is 320 degrees;

[0080] (2) Capping and adding a sterilized rubber stopper, the rubber stopper is autoclaved at 121 degrees for 20 minutes, and then dried at 50 degrees for 2 hours;

[0081] (3) Sealing, cover the aluminum cover on the rubber plug;

[0082] (4) Visual inspection.

Embodiment 2

[0084] The pharmaceutical composition of cefotiam hydrochloride for injection described in the present embodiment, its formula is as follows:

[0085] Cefotiam hydrochloride 500g, sodium carbonate 118g, sodium bicarbonate 6g;

[0086] The pharmaceutical composition is prepared by the following steps:

[0087] (1) Filling. After mixing cefotiam hydrochloride with sodium carbonate / sodium bicarbonate, the filling is filled into sterilized vials using an automatic filling machine, and the vials are sterilized using a tunnel sterilizer. The sterilization temperature is 320 degrees;

[0088] (2) Capping and adding a sterilized rubber stopper, the rubber stopper is autoclaved at 121 degrees for 20 minutes, and then dried at 50 degrees for 2 hours;

[0089] (3) Sealing, cover the aluminum cover on the rubber plug;

[0090] (4) Visual inspection.

Embodiment 3

[0092] The pharmaceutical composition of cefotiam hydrochloride for injection described in the present embodiment, its formula is as follows:

[0093] Cefotiam hydrochloride 500g, sodium carbonate 116g, sodium bicarbonate 10g;

[0094] The pharmaceutical composition is prepared by the following steps:

[0095] (1) Filling. After mixing cefotiam hydrochloride with sodium carbonate / sodium bicarbonate, the filling is filled into sterilized vials using an automatic filling machine, and the vials are sterilized using a tunnel sterilizer. The sterilization temperature is 320 degrees;

[0096] (2) Capping and adding a sterilized rubber stopper, the rubber stopper is autoclaved at 121 degrees for 20 minutes, and then dried at 50 degrees for 2 hours;

[0097] (3) Sealing, cover the aluminum cover on the rubber plug;

[0098] (4) Visual inspection.

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Abstract

The invention discloses a cefotiam hydrochloride pharmaceutical composition for injection and a preparation method thereof. The cefotiam hydrochloride pharmaceutical composition for injection comprises the following components in parts by weight: 500 parts of cefotiam hydrochloride, (121-x) parts of anhydrous sodium bicarbonate and 2x parts of anhydrous sodium carbonate, wherein x is not less than 1 and not more than 120. The cefotiam hydrochloride pharmaceutical composition for injection disclosed by the invention can be used for solving the problems in the prior art that CO2 partial pressure in blood is extremely low and pH stability is low after cefotiam hydrochloride injection is injected to a human body and the problem that intoxication is easily caused after long-term use of the cefotiam hydrochloride injection.

Description

technical field [0001] The invention relates to the field of medicine synthesis and preparation. Specifically relates to a cefotiam hydrochloride pharmaceutical composition for injection. Background technique [0002] Cefotiam hydrochloride, the English name is Cefotiam Hydrochloride, the chemical name is (6R,7R)-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]oct-2-ene-2 -Carboxylate hydrochloride. Its structural formula is as follows: [0003] [0004] Cefotiam hydrochloride is commonly used in the treatment of sepsis, postoperative infection, burn infection, subcutaneous abscess, bloat, boil, boil, osteomyelitis, suppurative arthritis, tonsillitis (peritonsillar inflammation, peritonsillar abscess), bronchitis, Bronchial tension infection, pneumonia, pulmonary suppuration, empyema, cholangitis, cholecystitis, peritonitis, pyelonephritis, cystitis, urinary tract inflammation, prostat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/546A61K47/02A61P31/04A61P31/00
Inventor 黄宇樑
Owner HANGZHOU TONGSHENG PHARMA
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