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Vecuronium bromide freeze-dried powder injection for injection and preparation method thereof

A technology of freeze-dried powder injection and vecuronium bromide, applied in the field of vecuronium bromide freeze-dried powder injection for injection and its preparation

Active Publication Date: 2014-01-22
HAINAN STAR PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, although there are also some reports about vecuronium bromide freeze-dried powder injections and related products on the market, these freeze-dried preparations still have problems in one way or another in terms of product reconstitution stability, clarity, and the appearance of freeze-dried products. Defects

Method used

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  • Vecuronium bromide freeze-dried powder injection for injection and preparation method thereof
  • Vecuronium bromide freeze-dried powder injection for injection and preparation method thereof
  • Vecuronium bromide freeze-dried powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1, the preparation of vecuronium bromide freeze-dried powder injection for injection

[0028] prescription:

[0029]

[0030]

[0031] The method for preparing the above-mentioned vecuronium bromide freeze-dried powder for injection comprises the following steps:

[0032] Add water for injection at 60°C and 50% of the prescribed amount into the liquid preparation tank, then weigh the prescribed amount of mannitol, lactose, and trehalose into the liquid preparation tank and stir until dissolved, then weigh the prescribed amount of citric acid and phosphoric acid Add disodium hydrogen into the liquid mixing tank and stir until dissolved; then add 40% of the prescribed amount of water for injection, control the temperature at 25-30°C, and weigh the prescribed amount of vecuronium bromide in the dark, add it to the liquid mixing tank and stir to dissolve. After completely dissolving, add water for injection to the full amount, stir evenly, use citric acid ...

Embodiment 2

[0066] Embodiment 2, investigating the influence of different freeze-drying processes on the vecuronium bromide freeze-dried powder injection for injection Prescription: same as embodiment 1.

[0067] Preparation process: Only the freeze-drying process is different from Example 1, and the rest are the same as Example 1.

[0068] 1) Investigate the influence of different pre-freezing time on product properties

[0069]

[0070] 2) Investigate the influence of different pre-freezing methods on product properties

[0071]

[0072]

[0073] 3) Investigate the influence of different sublimation temperature and time on product properties

[0074]

[0075] 4) Investigate the effect of re-drying temperature on product moisture and related substances

[0076] Freeze-dried products generally need to increase the temperature to further remove moisture after the first sublimation drying, but for products with poor stability, increasing the temperature will increase the numbe...

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Abstract

The invention discloses a vecuronium bromide freeze-dried powder injection for injection and a preparation method thereof. The vecuronium bromide freeze-dried powder injection for injection, provided by the invention, is prepared from the following raw materials: 4 g of vecuronium bromide, 5 to 7.5 g of mannitol, 5 to 7.5 g of lactose, 2.5 to 5 g of mycose, 3 to 3.5 g of citric acid, 6.5 to 7 g of disodium hydrogen phosphate and water for injection which is added until the volume is 1000 ml. The freeze-dried formula adopts combination of vecuronium bromide, mannitol, lactose, mycose, citric acid and disodium hydrogen phosphate and is combined with accurate freeze-drying process parameter control, so the appearance is full and not withered, the texture is loose and porous, the stability is high, the rehydration speed is high, and the requirement of the freeze-dried injection powder injection is met.

Description

technical field [0001] The invention relates to a vecuronium bromide freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Vecuronium bromide, chemical name is 1-[3α,17β-diacetoxy-2-β(1-piperidinyl)-5α-androstane-16β-yl]-1-methylpiperidine bromide , molecular weight 637.73, CAS number: 50700-72-6, structural formula as follows: [0003] [0004] Physical and chemical properties: It is a white or off-white loose substance, slightly soluble in water, easily soluble in dichloromethane, almost insoluble in absolute ethanol. [0005] Vecuronium bromide (Vecuronium) was first listed in the Netherlands in 1982, and it is a muscle relaxant commonly used at home and abroad in recent years. It is mainly used as an auxiliary drug for general anesthesia, used for endotracheal intubation during general anesthesia and muscle relaxation during surgery. The dosage forms of the currently listed vecuronium bromide preparations are mainly injec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/58A61K47/36A61K47/26A61P21/02
Inventor 钟昌茂孟琛纪新明
Owner HAINAN STAR PHARM CO LTD
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