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Cefbuperazone sodium medicinal composite for injection and preparation method thereof

A technology of cefrazone sodium and cefrazone, applied in the field of medicine, can solve the problems of local circulation disorder, blockage of blood supply, large degradation range and the like

Inactive Publication Date: 2013-03-27
北京世仁堂医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] 1. Low temperature preservation is required, which increases the cost of production, transportation and storage;
[0005] 2. Even under low temperature storage, the degradation rate is still relatively large
Insoluble particles in intravenous infusion can cause harm to the human body. For example, larger insoluble particles can cause local circulation disorders and cause vascular embolism; too many particles can cause local blockage and insufficient blood supply, and further lead to tissue hypoxia and edema. And phlebitis, can also cause granuloma, allergic reaction, pyrogen-like reaction, etc., all of which can cause harm to the human body
The present inventor has carried out insoluble particle determination to commercially available cefbuperazone sodium for injection and the above-mentioned cefbuperazone composition in the research process of cefbuperazone sodium medicine for injection, regrettably finds that the insoluble particle of above-mentioned two kinds of medicines Although it can meet the requirements of "Chinese Pharmacopoeia" 2010 edition at the initial stage of compatibility, as the storage time prolongs, the insoluble particles change greatly, and they do not meet the requirements of "Chinese Pharmacopoeia" 2010 edition after storage for 1 hour

Method used

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  • Cefbuperazone sodium medicinal composite for injection and preparation method thereof
  • Cefbuperazone sodium medicinal composite for injection and preparation method thereof
  • Cefbuperazone sodium medicinal composite for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] [embodiment 1] the preparation of cefbuperazone crystal

[0087] 1) Take the cefbuperazone crude product at room temperature, add a mixed solvent of tetrahydrofuran and acetone, stir and dissolve, and obtain cefbuperazone tetrahydrofuran / acetone solution;

[0088] 2) Add active carbon to the cefbuperazone tetrahydrofuran / acetone solution obtained in step 1) to stir and adsorb, filter, collect the filtrate, and set aside;

[0089] 3) Add deionized water at 0-5°C dropwise to the filtrate under an ultrasonic field until crystals are precipitated;

[0090] 4) Turn off the ultrasonic field, filter, wash with dichloromethane and acetone, and dry to obtain the cefbuperazone hydrate crystal.

[0091] Gained cefbuperazone hydrate crystals use Cu-K α rays to measure characteristic peaks in the X-ray powder diffraction pattern obtained at 2θ of 5.4°, 6.1°, 7.5°, 11.6°, 14.6°, 15.8°, 17.7°, 18.9°, 20.4°, 21.6°, 24.9°, 26.1°, 26.9°, 29.4°, 31.4°, 34.1°, 36.5° and 42.2° displays, s...

Embodiment 1

[0099] [Preparation Example 1] Cefbuperazone Sodium for Injection

[0100] Prescription: per 1000 prescriptions

[0101]

[0102] Preparation Process:

[0103] 1) take the cefbuperazone of described consumption and join in the cooling water for injection of 80% of total volume, stir, make it become suspension, wherein cefbuperazone is the commercially available cefbuperazone bulk drug;

[0104] 2) Take the sodium bicarbonate of described consumption, slowly join in above-mentioned suspension, fully stir, make solution clarification, then add the potassium sorbate of described consumption, stir, make solution clarified;

[0105] 3) measure the pH value of the solution, if the pH value is not in the acidic range, adjust the pH value to the acidic range with a pH regulator;

[0106] 4) Add cooling water for injection to 100%;

[0107] 5) Add activated carbon, stir, stand still, filter for decarbonization, and filter with a 0.22 μm filter membrane;

[0108] 6) Intermediate ...

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Abstract

The invention relates to a cefbuperazone sodium medicinal composite for injection and a preparation method thereof. The cefbuperazone sodium medicinal composite for injection is the royal jelly powder injection solution which is prepared from cefbuperazone, sodium bicarbonate, potassium sorbate, pH regulator and water for injection, wherein the dosage of the potassium sorbate is 7.2-7.6 % of that of the cefbuperazone in weight percentage; and the dosage of the sodium bicarbonate is 11.0-12.0% of that of the cefbuperazone. The medicinal composite provided by the invention has better stability, fewer insoluble particles after being prepared with a plurality of injecta, and can completely accord with the rules of Chinese Pharmacopoeia of 2010 version, and the insoluble particles of the medicinal composite are still in accordance with the rules of Chinese Pharmacopoeia of 2010 version after being carried out standing for 4h.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition of cefbuperazone sodium for injection and a preparation method thereof. Background technique [0002] Cefbuprazone Sodium (Cefbuprazone Sodium) is a cephamycin antibiotic, and the listed Cefbuprazone Sodium is a freeze-dried powder for injection. Cefbuperazone sodium has a broad antibacterial spectrum, especially for β-lactamase-resistant bacteria, showing good antibacterial effect, so it has broad prospects for clinical anti-infection use. [0003] But cefbuperazone sodium has the following disadvantages due to poor stability: [0004] 1. Low temperature preservation is required, which increases the cost of production, transportation and storage; [0005] 2. Even under low temperature storage, the degradation rate is still relatively large. According to the standard of this product included in "The Fifteenth Edition of Japanese Pharm...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/546A61P31/04
Inventor 朱正兵石均平
Owner 北京世仁堂医药有限公司
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