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A stable lyophilized preparation of rocuronium bromide and preparation method thereof

A technology of freeze-dried preparations and freeze-dried excipients, applied in the field of rocuronium bromide freeze-dried preparations and its preparation, can solve the problems of increasing production costs, unfavorable storage for hospitals and patients, etc.

Inactive Publication Date: 2006-11-22
CHONGQING PHARMA RES INST +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In practical application, it is found that the aqueous solution of rocuronium bromide is very easy to be hydrolyzed at the 17th position, so it is required to store it at 2-8°C in the manual of the marketed product, and the validity period is three years. Storage under this condition will inevitably increase the production cost, and it is not conducive to Hospital and Patient Storage

Method used

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  • A stable lyophilized preparation of rocuronium bromide and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Accurately weigh 5.6g of glycine, dissolve it in a 50ml volumetric flask with water for injection, add 1mol / l hydrochloric acid to adjust the pH value to 4.0, add precisely weighed 2.5g of rocuronium bromide, and shake to dissolve. Packed in 7ml vials, the volume of each bottle is 1ml.

[0021] Put the prepared cillin bottle filled with rocuronium bromide into a freeze-drying box, and then lower the temperature inside the freeze-drying machine to below -45°C within 2 hours to make it freeze quickly. Vacuumize and make the atmospheric pressure in the box reach 2.66pa within 30 minutes. Dry according to the temperature program from -45°C to 30°C at the beginning of the plate temperature. After drying, stoppering and capping were performed to obtain rocuronium bromide freeze-dried powder injection.

Embodiment 2

[0023] Accurately weigh 4.5g of mannitol and 450mg of sodium citrate dihydrate, and dissolve them in a 50ml volumetric flask with water for injection, add 1mol / l hydrochloric acid to adjust the pH value to 4.0, add 1.25g of precisely weighed rocuronium bromide, Shake to dissolve. Packed in vials of 7ml size, the volume of each bottle is 2ml.

[0024] Put the prepared cillin bottle filled with rocuronium bromide into the freeze-drying box, and obtain the rocuronium bromide freeze-dried powder injection according to the freeze-drying method of implementation 1.

Embodiment 3

[0026] Accurately weigh 2.5g of glycine, dissolve it in a 50ml volumetric flask with water for injection, add 1mol / l hydrochloric acid to adjust the pH value to 4.0, add precisely weighed 2.5g of rocuronium bromide, and shake to dissolve. Packed in 7ml vials, the volume of each bottle is 1ml.

[0027] Put the prepared cillin bottle filled with rocuronium bromide into the freeze-drying box, and obtain the rocuronium bromide freeze-dried powder injection according to the freeze-drying method of implementation 1.

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Abstract

The present invention relates to stable freeze dried rocuronium bromide preparation and its preparation process. The freeze dried rocuronium bromide preparation includes rocuronium bromide and freeze drying excipient in the weight ratio of 0.2-1. The freeze dried rocuronium bromide preparation needs no low temperature preservation and convenient storing, and is used for muscular relaxation of patient in surgical operation.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a stable freeze-dried preparation of rocuronium bromide (rocuronium) and a preparation method thereof. Background technique [0002] Rocuronium bromide is a steroidal non-depolarizing muscle relaxant, and its synthesis method and use are disclosed in European Patent EP 0287150. WO0044334 discloses a compound injection composed of rocuronium bromide and other traditional muscle relaxants. The parenteral administration composition of US5767112 rocuronium bromide contains a muscle relaxant and a zwitterionic substance with a weight ratio of 2-30% and an isoionic point not greater than 7, and the pH value of the composition is 5.2-5.6. DE19903894 discloses a compound preparation containing vecuronium bromide and rocuronium bromide and having a synergistic effect. WO05068487 discloses an intermediate of rocuronium bromide and a preparation method thereof, as well as a meth...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/58A61K47/08A61K47/30A61P21/02
Inventor 林佳亮付云牟才华
Owner CHONGQING PHARMA RES INST
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