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Method for preparing medicinal mixture containing amoxicillin sodium and potassium clavulanate

A technology of potassium clavulanate and amoxicillin sodium, applied in the field of pharmaceutical preparation, can solve the problems of poor mixed powder fluidity, drug contamination, difficulty in aseptic sub-packaging, etc., and achieves good product fluidity, uniform particles, and good post-processing. performance effect

Active Publication Date: 2006-10-25
ZHUHAI UNITED LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this approach has several obvious drawbacks
The most prominent defect is: the mechanical equipment used for grinding and mixing is in direct contact with the drug ingredients, making the drug contaminated by pyrogens and other impurities, which is very unfavorable for the aseptic production of parenteral drugs
The obtained mixed powder has the problem of poor fluidity, which brings certain difficulties to aseptic packaging

Method used

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  • Method for preparing medicinal mixture containing amoxicillin sodium and potassium clavulanate
  • Method for preparing medicinal mixture containing amoxicillin sodium and potassium clavulanate
  • Method for preparing medicinal mixture containing amoxicillin sodium and potassium clavulanate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Amoxicillin sodium / potassium clavulanate was weighed in proportion and dissolved in methanol so that the concentrations of sodium amoxicillin and potassium clavulanate were 100 mg / ml and 20 mg / ml, respectively. After the CO2 gas is filtered, it is compressed to a predetermined pressure of 8.0MPa, and after preheating, it is pumped into the precipitator. The drug solution was sprayed into the supercritical fluid at a flow rate of 0.8ml / min, and the temperature of the precipitator was maintained at 30°C. After decompression, the obtained particles were collected at the bottom of the precipitator to obtain sample 1.

Embodiment 2

[0049] Weigh amoxicillin sodium / clavulanate potassium in proportion and dissolve them in distilled water, so that the concentrations of amoxicillin sodium and clavulanate potassium are 50 mg / ml and 5 mg / ml respectively. After the CO2 gas is filtered, it is compressed to a predetermined pressure range of 10MPa, and after preheating, it is pumped into the precipitator. The drug solution was sprayed into the supercritical fluid at a flow rate of 1.0ml / min, and the temperature of the precipitator was maintained at 35°C. After decompression, the obtained particles were collected at the bottom of the precipitator to obtain sample 2.

[0050] The supercritical fluid equipment used in the present invention is a commercially available product, such as the supercritical anti-solvent granulation system of Thar Technologies in the United States.

[0051] Take the same amoxicillin sodium and potassium clavulanate raw materials and mix them according to the conventional production method. ...

Embodiment 3

[0063] Amoxicillin sodium / potassium clavulanate was weighed in proportion and dissolved in a mixture of distilled water and methanol, so that the concentrations of amoxicillin sodium and potassium clavulanate were 100 mg / ml and 1 mg / ml, respectively. After the CO2 gas is filtered, it is compressed to a predetermined pressure range of 15MPa, and after preheating, it is pumped into the precipitator. The drug solution was sprayed into the supercritical fluid at a flow rate of 1.5ml / min, and the temperature of the precipitator was maintained at 40°C. After decompression, the resulting particles were collected at the bottom of the precipitator to obtain a sample.

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Abstract

The present invention relates to a method for preparing medicine mixture containing amoxicillin sodium and potassium clavulunate. Said method includes the following processes: (a), dissolving two medicine active components in solvent according to a certain ratio so as to form a solution; (b), mixing said solution with supercritical fluid; and (c), separating out medicine micropowder from supercritical fluid. Said medicine granules have good fluidity.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a method for preparing a drug mixture containing amoxicillin sodium and clavulanate potassium. Background technique [0002] Most of the pharmaceutical compositions containing two or more antibiotics are mixed products of dry powder. In order to ensure the uniformity of the drug content in the preparation, each component needs to be pulverized, sieved, etc., so that the components in the composition can be mixed evenly . Due to the differences in particle size, density, morphology and surface state and surface energy between the different components, the mixing process is difficult, and the mixed materials can also be separated again during the conveying process. Conventional production methods for uniformly mixing two or more drugs into granules or mixed powder include mechanical grinding, freeze drying, spray drying and the like. However, there are considerable defects in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K9/14A61K31/424A61P31/04
Inventor 肖拥军罗瑜戴永道
Owner ZHUHAI UNITED LAB
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