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Drying method of rocuronium raw material medicine for injection

A drying method and technology for APIs, applied in steroids, organic chemistry, etc., can solve problems such as inability to guarantee sterility and microorganisms exceeding the standard, and achieve the effects of improving production efficiency, ensuring clarity, and reducing production costs.

Active Publication Date: 2017-06-13
SHANDONG VOCATIONAL COLLEGE OF LIGHT IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] (3) The existing drying tower environment cannot guarantee sterility, making the microorganisms exceed the standard

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Gained rocuronium bromide crude product 1000g is dissolved in the 8L dichloromethane, then adds the neutral aluminum oxide of 1000g in the crude product solution, stirs 1 h, then through the rough filter that filter membrane aperture is 1.0 μ m, filter membrane aperture is The filtrate after two passes of 0.22μm fine filter enters the temperature control tank, the temperature in the temperature control tank is kept at 25°C, the residence time is 8min, and then the filtrate is atomized into mist by the atomizer and then blown into the drying room at 65°C Evaporation of solvent in the tower forms a fine powder, which is collected from the bottom discharge port after being collected by a cyclone separator to obtain 925g of Rocuronium bromide finished product. The drying tower is pre-filled with hot air at 65°C. The hot air is drawn in by the fan, processed by an air filter and an air dehumidification device, and then heated by a gas heater; the hot air at 65°C is evenly dis...

Embodiment 2

[0025] Gained rocuronium bromide crude product 1200g is dissolved in 8L acetone, and the neutral alumina of 1320g in the crude product solution, stirs 1.5h, then through the rough filter that filter membrane aperture is 1.0 μ m, the filter membrane aperture is 0.22 μ m The filtrate after the two passes of the fine filter enters the temperature control tank, the temperature in the temperature control tank is kept at 20°C, and the residence time is 12min. Solvent forms fine powder, collects and obtains rocuronium bromide finished product 1111g from bottom outlet after being collected by cyclone separator. The drying tower is pre-filled with hot air at 70°C. The hot air is drawn in by the fan, processed by an air filter and an air dehumidification device, and then heated by a gas heater; the hot air at 70°C is evenly distributed in the hot air distributor. After distribution, it enters the drying tower. The air dehumidification device is a rotary dehumidifier, which makes the ai...

Embodiment 3

[0027] The gained rocuronium bromide crude product 1400g is dissolved in the 8L dichloromethane, then in the crude product solution, add the neutral alumina of 1400g, stir 2h, be the rough filter of 1.2 μ m through filter membrane aperture then, filter membrane aperture is 0.20 The filtrate after two passes of the μm fine filter enters the temperature control tank, the temperature in the temperature control tank is kept at 25°C, the residence time is 10min, and then the filtrate is atomized into mist by the atomizer and then blown into the drying tower at 75°C Internal evaporation solvent forms fine powder, collects and obtains rocuronium bromide finished product 1294g from the discharge port at the bottom after being collected by a cyclone separator. The drying tower is pre-filled with hot air at 75°C. The hot air is drawn in by the fan, passed through the air filter and air dehumidification device, and then enters the gas heater for heating; the hot air at 75°C is evenly dist...

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Abstract

The invention discloses a drying method of a rocuronium raw material medicine for injection, and belongs to the technical field of raw material medicine preparation. The drying method of the rocuronium raw material medicine for the injection is characterized in that a rocuronium crude product is dissolved in an organic solvent with the boiling point lower than 60 DEG C to form a crude product solution, neutral alumina with the weight being 0.9 to 1.2 times of that of the rocuronium crude product is added into the crude product solution and stirred for 1h to 2h, then a filtrate filtered through a coarse filter and a fine filter for two times enters a temperature control tank, the temperature in the temperature control tank is kept at 10 to 35 DEG C, the residence time of the temperature control tank is 5min to 15min, then the filtrate is atomized into droplets through an atomizer and blown into a drying tower at the temperature of 50 to 80 DEG C to evaporate the solvent and form fine powder, and the fine powder is collected from a bottom discharge port after being separated through a cyclone separator to obtain the rocuronium raw material medicine for the injection. The drying method of the rocuronium raw material medicine for the injection successfully uses a spray drying process to replace the traditional vacuum oven drying and vacuum freeze-drying production process.

Description

technical field [0001] The invention discloses a drying method of a rocuronium bromide bulk medicine for injection, which belongs to the technical field of raw medicine preparation. Background technique [0002] As a raw material drug for injection, the quality requirements of the finished product of rocuronium bromide are very high, and many literatures and patented methods only improve one or two indicators of the quality of rocuronium bromide, which cannot be fully considered. [0003] In the impurity of the finished product of rocuronium bromide, impurity A will be produced under long-term light and high temperature conditions, and impurity C will be easily produced in the case of high ambient humidity. Conventional vacuum drying method cannot be applied to the drying of rocuronium bromide bulk drug, because rocuronium bromide is easy to bond with solvent to form a solvate in the preparation process, and it takes a long time for decompression drying to reduce the residua...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07J43/00
CPCC07J43/003
Inventor 申万意王莹莹张莉莉于子建
Owner SHANDONG VOCATIONAL COLLEGE OF LIGHT IND
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