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A kind of caspofungin acetate pharmaceutical composition for injection and preparation method thereof

A technology of caspofungin acetate and its composition, which is applied in the field of medicine, can solve the problems of insignificant adsorption of activated carbon, instability of caspofungin acetate, and no pharmacological effect, etc., to avoid poor adsorption effect and polymer impurity content Low, quality-controllable effects

Inactive Publication Date: 2016-01-13
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, caspofungin acetate is extremely unstable. For example, during the preparation and storage of caspofungin, some polymer impurities will inevitably be formed, which are difficult to remove in the preparation process, especially its dimer, polymer Impurities basically have no pharmacological effect, and are used as impurity control in product control, such as the impurity of CAF-dimer pointed out in the patent application CN101516387A
[0013] In order to reduce the degradation of caspofungin, the best preparation environment is to operate and store in a low temperature environment, but in a low temperature environment, the adsorption effect of activated carbon on the heat source is not obvious

Method used

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  • A kind of caspofungin acetate pharmaceutical composition for injection and preparation method thereof
  • A kind of caspofungin acetate pharmaceutical composition for injection and preparation method thereof
  • A kind of caspofungin acetate pharmaceutical composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] prescription:

[0073] Caspofungin Acetate 5.55g

[0074] Sucrose 3.75g

[0075] Mannitol 2.5g

[0076] Disodium hydrogen phosphate 0.136g

[0077] Sodium dihydrogen phosphate 44mg

[0078] Add water for injection to 125ml

[0079] Take 80% of the prepared water for injection (125ml×80%), add the prescribed amount of sodium dihydrogen phosphate, disodium hydrogen phosphate, sucrose and mannitol, stir and dissolve; cool to a certain temperature, add the prescribed amount of raw material carboacetate Fenjing, stir until completely dissolved, pH 5.6; under certain temperature conditions, ultrafilter the solution through an ultrafiltration system (1.5kd ultrafiltration membrane, control inlet and outlet pressure) into the batching tank, and add water for injection to the full amount; Semi-finished product inspection, fine filtration through 0.22μm microporous membrane, filling, and half-plugging; put the sample in a freeze dryer, cool down to -40~-45°C for 2 hours, and...

Embodiment 2

[0085] prescription:

[0086] Caspofungin Acetate 5.55g

[0087] Sucrose 3.75g

[0088] Mannitol 2.5g

[0089] Disodium hydrogen phosphate 0.136g

[0090] Sodium dihydrogen phosphate 44mg

[0091] Add water for injection to 125ml

[0092] Take 80% of the prepared water for injection (125ml × 80%), add the prescribed amount of sodium dihydrogen phosphate, disodium hydrogen phosphate, sucrose and mannitol, stir and dissolve; cool to about 10°C, add the prescribed amount of raw material carboxy acetate Pofungin, stir until it is completely dissolved, and the pH is 5.6; at a temperature of about 10°C, pass the solution through an ultrafiltration system (1.5kd ultrafiltration membrane, the inlet pressure is controlled at 0.15Mpa, and the outlet pressure is controlled at 0.1Mpa). Fill the batching tank with water for injection to the full amount; test the semi-finished product, filter it through a 0.22μm microporous membrane after passing the test, fill it, and press half the s...

Embodiment 3

[0094] prescription:

[0095] Caspofungin Acetate 5.55g

[0096] Sucrose 3.75g

[0097] Mannitol 2.5g

[0098] Disodium hydrogen phosphate 0.136g

[0099] Sodium dihydrogen phosphate 44mg

[0100] Add water for injection to 125ml

[0101] Take 80% of the prepared water for injection (125ml×80%), add the prescribed amount of sodium dihydrogen phosphate, disodium hydrogen phosphate, sucrose and mannitol, stir to dissolve; cool to about 8°C, add the prescribed amount of raw materials, and stir Until it is completely dissolved, the pH value is 5.8; at a temperature of about 8°C, pass the solution through an ultrafiltration system (2.0kd ultrafiltration membrane, the inlet pressure is controlled at 0.15Mpa, and the outlet pressure is controlled at 0.1Mpa) into the batching tank. Replenish the water for injection to the full amount; test the semi-finished product, filter it through a 0.22 μm microporous membrane after passing the test, fill it, and press half the stopper; put t...

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PUM

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Abstract

The invention relates to a caspofungin acetate pharmaceutical composition for injection, which uses mannitol and sucrose as excipients, uses a certain amount of phosphate buffer to maintain the pH range, and uses a 1.5-3.0kd ultrafiltration membrane to remove the caspofungin acetate at the same time The pyrogen in the raw material is made into a stable preparation after freeze-drying. In the invention, the limits of pyrogens and microorganisms are effectively controlled, the loss of the main drug is small, the product impurities, especially polymer impurities, are low, stable, easy to industrialized large-scale production, and suitable for clinical application.

Description

Technical field [0001] The invention involves the field of pharmaceutical technology and specifically involves an injection of a acetic acid carbonic drugs and their preparation methods. Background technique [0002] Cepenfen is a semi-synthetic large-ring fat peptide. It is a new type of spiny-white bacterial antifungal. Its antibacterial mechanism is the synthesis of inhibitory (1,3) -D-polysaccharides.Estrocycin has a fast sterilization effect on most Candida, including some strains that are resistant to azol, and have no inhibitory effects on most asemite, and have no inhibitory effects on Sydroma, Joint bacteria, and neonatal bacteria.In 2001, the United States approved the clinical application of the first rowinin, which was Cardorin. [0003] Clinical studies have shown that Cepenfen has obvious effects on fever patients suspected of fungal infection; it is suitable for treatment of invasive mold disease that is invalid or tolerated by other treatments;And non -neutral gra...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K38/12A61P31/10
Inventor 赵小伟宗在伟杜有国杨奇珍陈飞强
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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