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Stable rocuronium injection preparation and preparation method thereof

A technology of rocuronium bromide and injection, which is applied in directions such as medical preparations without active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas

Inactive Publication Date: 2013-12-25
河北凯盛医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] When CN101653412A solved the problem of the stability of the rocuronium bromide aqueous solution, the method of simultaneously controlling the pH of the solution and adding a metal chelating agent was adopted to improve the stability of the rocuronium bromide aqueous solution

Method used

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  • Stable rocuronium injection preparation and preparation method thereof
  • Stable rocuronium injection preparation and preparation method thereof
  • Stable rocuronium injection preparation and preparation method thereof

Examples

Experimental program
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Embodiment 1

[0139] Implementation 1: Accurately measure the citric acid-sodium dihydrogen phosphate buffer solution with a pH of 3.7, add an appropriate amount of water for injection, and mix well; add sodium chloride, stir or shake to completely dissolve; add rocuronium bromide, and stir Or shake until completely dissolved, adjust the pH to 3.7 with 1mol / L hydrochloric acid or 1mol / L sodium hydroxide; then add 0.1% (w / v) activated carbon for needles, stir at room temperature for 30min, and coarsely filter; quantitatively, after 0.22 Sterilize by microporous membrane filtration; filling, 2.5ml or 5ml per bottle, fully pressed rubber stopper, crimping cap; 121°C autoclaving for 12 minutes; inspection, printing, packaging, and storage in the refrigerator at 2-8°C .

Embodiment 2

[0140] Implementation 2: Accurately measure the citric acid-trisodium citrate buffer solution with a pH of 3.8, add an appropriate amount of water for injection, and mix well; add sodium chloride, stir or shake to completely dissolve; add rocuronium bromide, stir or After shaking until completely dissolved, adjust the pH to 4.0 with 1 mol / L citric acid or 1 mol / L sodium hydroxide; then add 0.05% (w / v) activated carbon for needles, stir at room temperature for 30 min, and coarsely filter; quantitatively, after 0.22 Sterilize by microporous membrane filtration; filling, 2.5ml or 5ml per bottle, fully pressed rubber stopper, rolling cap; 121℃ autoclaving for 20 minutes; inspection, printing, packaging, and storage in the refrigerator at 2-8℃ .

Embodiment 3

[0141]Implementation 3: Accurately measure the phosphoric acid-sodium dihydrogen phosphate buffer solution with a pH of 4.0, add an appropriate amount of water for injection, and mix well; add sodium chloride, stir or shake to dissolve completely; add rocuronium bromide, stir or shake After shaking until completely dissolved, adjust the pH to 4.3 with 1mol / L phosphoric acid or 1mol / L sodium hydroxide; then add 0.15% (w / v) activated carbon for needles, stir at room temperature for 30min, and filter coarsely; quantify to 50ml; Sterilize by microporous membrane filtration; filling, 2.5ml or 5ml per bottle, fully pressed rubber stopper, crimping cap; 121°C autoclaving for 15 minutes; inspection, printing, packaging, and storage in a refrigerator at 2-8°C .

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Abstract

The invention discloses a stable rocuronium injection preparation prescription and a preparation method thereof. The injection contains the active ingredient rocuronium, a stabilizer, an osmotic pressure regulator, a pH (potential of Hydrogen) regulator and injection water, and has two specifications, i.e., 2.5 ml:25 mg and 5ml:50 mg. Rocuronium is added into the proper stabilizer, so that the problem of stability is solved; autoclave sterilization of 121 DEG C is adopted with the help of a filtration sterilization mode to guarantee the sterility. The preparation has the advantages of reasonable prescription, simple process and stable quality and is suitable for industrial production. The injection is used for muscular relaxation of surgical patients.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a stable rocuronium bromide (rocuronium) injection preparation and a preparation method thereof. Background technique [0002] Rocuronium bromide is a deacyloxy derivative of vecuronium bromide, which belongs to steroidal non-depolarizing muscle relaxants, and its chemical name is 1-[(2β, 3α, 5α, 16β, 17β)-17-(acetyl Oxy)-3-hydroxy-2-(4-morpholinyl)androstan-16-yl]-1-(2-propenyl)pyrrolidine bromide, its structural formula is as follows: [0003] [0004] Rocuronium bromide is a short-term and short-acting muscle relaxant, but it acts quickly and recovers quickly. It is a non-depolarizing muscle relaxant with the fastest effect so far. The characteristics of rocuronium bromide are also reflected in the fact that after entering the human body, it is mainly absorbed by the liver, mainly excreted through bile, followed by renal excretion, and has little effect on liver ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/58A61K47/04A61K47/02A61K47/12A61P21/02
Inventor 赵凯李新苑洪忠侯建平
Owner 河北凯盛医药科技有限公司
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