Preparation method of tigecycline composition

A technology of tigecycline and its composition, which is applied in the field of pharmaceutical preparations, can solve the problems of easily causing allergic reactions, etc., and achieve the effects of easy industrial operation, stable sample quality, low protein content and bacterial endotoxin content

Inactive Publication Date: 2012-08-22
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Although the addition of lactose solves the instability of this product, the lactose used comes from whey

Method used

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  • Preparation method of tigecycline composition
  • Preparation method of tigecycline composition
  • Preparation method of tigecycline composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Tigecycline 50g

[0022] Lactose 100g

[0023] Add water for injection to 2000ml

[0024] Freeze-dried to make 1000 vials

[0025] Weigh lactose and put it in a sterile container, add 80% water for injection to dissolve it, and carry out ultrafiltration treatment on the lactose solution, collect the ultrafiltrate, after the solution drops to 4°C, add tigecycline, dissolve and stir Evenly, adjust the pH to 5.0 with 1mol / L hydrochloric acid or 1mol / L sodium hydroxide solution, add water for injection to the full amount, then add 0.1% activated carbon for needles, stir and adsorb for 20 minutes, and remove carbon by suction filtration; after the intermediate inspection is qualified, The solution is filtered through two 0.22m microporous membranes and then sent to the sterile room, filled in vials, half-plugged with butyl rubber stoppers, placed in a plate, placed in a freeze-drying box, closed the box door, and turned on for refrigeration , using heat...

Embodiment 2

[0027] Tigecycline 50g

[0028] Lactose 200g

[0029] Add water for injection to 2000ml

[0030] Freeze-dried to make 1000 vials

[0031] Weigh lactose and put it in a sterile container, add 80% water for injection to dissolve it, and carry out ultrafiltration treatment on the lactose solution, collect the ultrafiltrate, after the solution drops to 6°C, add tigecycline, dissolve and stir Evenly, adjust the pH to 5.5 with 1mol / L hydrochloric acid or 1mol / L sodium hydroxide solution, add water for injection to the full amount, then add 0.1% activated carbon for needles, stir and adsorb for 20 minutes, and remove carbon by suction filtration; after the intermediate inspection is qualified, The solution is filtered through two 0.22m microporous membranes and then sent to the sterile room, filled in vials, half-plugged with butyl rubber stoppers, placed in a plate, placed in a freeze-drying box, closed the box door, and turned on for refrigeration , using heat...

Embodiment 3

[0033] Tigecycline 50g

[0034] Lactose 150g

[0035] Add water for injection to 2000ml

[0036] Freeze-dried to make 1000 vials

[0037] Weigh lactose and put it in a sterile container, add 80% water for injection to dissolve it, and carry out ultrafiltration treatment on the lactose solution, collect the ultrafiltrate, after the solution drops to 4°C, add tigecycline, dissolve and stir Evenly, adjust the pH to 4.5 with 1mol / L hydrochloric acid or 1mol / L sodium hydroxide solution, add water for injection to the full amount, then add 0.1% activated carbon for needles, stir and absorb for 20 minutes, and remove carbon by suction filtration; after the intermediate inspection is qualified, The solution is filtered through two 0.22m microporous membranes and then sent to the sterile room, filled in vials, half-plugged with butyl rubber stoppers, placed in a plate, placed in a freeze-drying box, closed the box door, and turned on for refrigeration , using heat...

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Abstract

The invention relates to a preparation method of tigecycline composition, which comprises enabling lactose to be dissolved by using 80% water for injection, conducting ultrafiltration treatment on lactose solution, collecting ultrafiltrate, adding tigecycline after the solution is cooled, evenly mixing, adjusting the potential of hydrogen (pH) value to 4.0-6.0, adding activated carbon for a needle for stirring, adsorption and decarburization, and conducting constant volume; enabling the solution to be filled in a penicillin bottle after filtration, conducting semi-plugging, disc loading, freeze-drying, nitrogen communicating, plug pressing, outbox and cover rolling, packaging after quality testing is qualified, and then obtaining the tigecycline composition. The protein concentration of the composition obtaining through the preparation method is smaller than 0.005g/L, untoward effects caused by the fact that lactose is added in the products are greatly reduced, the preparation method is simple and convenient in operation and low in cost, and prepared products are good in quality and easy in industrial production.

Description

technical field [0001] The invention relates to a method for preparing a pharmaceutical composition, belonging to the field of pharmaceutical preparations, in particular to a method for preparing a tigecycline composition for injection. Background technique [0002] Tigecycline is a tetracycline antibiotic, an analogue of minocycline, its English name is tigecycline, and its chemical name is (4S, 4aS, 5aR, 12aS)-4,7-bis(dimethylamino)-9 -[(tert-butylamino)acetamido]-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydro Naphthacene-2-carboxamide. [0003] The chemical structural formula is: [0004] [0005] Tigecycline is the first glycylcycline antibiotic approved for clinical intravenous administration. It was developed and marketed by Wyeth. Methicillin-resistant Staphylococcus aureus, penicillin-resistant Streptococcus pneumoniae, and vancomycin-resistant Enterococcus are still active. [0006] The study also showed that tigecycline can overcome two...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/65A61K47/26A61P31/04
Inventor 张建义宗在伟杨奇珍赵霞
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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