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Drying process for lansoprazole bulk drug

A technology of lansoprazole and drying process, applied in the direction of drying solid materials, drying solid materials without heating, drying, etc., can solve problems affecting drug safety, effectiveness, internal quality, and unqualified clarity, and achieve The effect of eliminating adverse reactions, good clarity, and reduced impurity content

Active Publication Date: 2015-05-27
江苏金丝利药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When this product enters the preparation process and dissolves in sodium hydroxide aqueous solution, it often leads to unqualified clarity, which in turn affects the internal quality of the drug such as safety and effectiveness.

Method used

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  • Drying process for lansoprazole bulk drug
  • Drying process for lansoprazole bulk drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] A kind of drying process of lansoprazole crude drug, concrete steps are:

[0020] (1) Disperse 1.2 kg of wet crystals of lansoprazole monohydrate and monoethanolate in 12 kg of ice water, maintain the temperature at 2 to 4 °C, and stir in the dark for 1 hour at a stirring speed of 270 rpm Centrifuged to remove water, the crystals obtained by centrifugation were rinsed with 2.4 kg of 4 ° C ice water and dried to obtain pretreated lansoprazole white crystalline solid with a wet weight of 1.16 kg.

[0021] (2) Turn on the freeze-drying machine, adjust the temperature in the freeze-drying chamber to -35°C, spread the white crystalline solid of lansoprazole after the pretreatment in the freeze-drying tray and put it into the freeze-drying machine, the thickness of the laying is 8 mm, control the temperature of the lansoprazole crystals to drop to -20°C, and then keep it for 1 hour under the condition that the temperature in the freeze-drying chamber is -35°C.

[0022] (3) A...

Embodiment 2

[0027] (1) Disperse 6.0 kg of wet crystals of lansoprazole monohydrate and monoethanolate in 60 kg of ice water, maintain the temperature at 2-4°C, and stir in the dark for 1 hour at a stirring speed of 270 rpm The water was removed by centrifugation, and the crystals obtained by centrifugation were washed with 6.0 kg of ice water at 4°C and dried to obtain the pretreated lansoprazole white crystalline solid with a wet weight of 5.92 kg.

[0028] (2) Turn on the freeze-drying machine, adjust the temperature in the freeze-drying chamber to-35°C, spread the white crystalline solid of lansoprazole after the pretreatment in the freeze-drying tray and put it into the freeze-drying machine, the thickness of the flat laying is Control the temperature of the lansoprazole crystals to drop to -20°C, and then keep it under the condition of -35°C in the freeze-drying chamber for 1 hour.

[0029] (3) Adjust the temperature of the freeze-drying chamber to -40°C, and pre-freeze the product f...

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Abstract

The invention provides a drying process for a lansoprazole bulk drug. The drying process is characterized by comprising the following steps that lansoprazole crystals to be freeze-dried are pretreated; the lansoprazole crystals are placed into a freeze drier and pre-frozen for 1-2 hours; the temperature of a condenser is adjusted to below -45 DEG C, a vacuum system is started up, and when the vacuum degree in a freeze-drying chamber is reduced to 15.0 Pa, the temperature starts to be raised for drying; the temperature of the freeze-drying chamber is gradually raised to 0 DEG C, temperature rise per hour is not more than 2 DEG C, the vacuum degree in the freeze-drying chamber is maintained to be 10 Pa-20 Pa during the temperature rise, and then the lansoprazole crystals are kept for 1-2 hours at the temperature of 0 DEG C with the vacuum degree being 10 Pa-20 Pa in the freeze-drying chamber; the temperature of the freeze-drying chamber continues to be adjusted to 15 DEG C, the temperature rise per hour is not more than 5 DEG C, the vacuum degree in the freeze-drying chamber is maintained to be 10 Pa-20 Pa during the temperature rise, and then the lansoprazole crystals are kept for 2-3 hours at the temperature of 15 DEG C with the vacuum degree being 10 Pa-20 Pa in the freeze-drying chamber; the freeze dryer is shut down. Compared with a conventional process, the impurity content in the lansoprazole bulk drug manufactured through the drying process is remarkably reduced.

Description

technical field [0001] The present invention relates to the field of pharmaceutical manufacturing, in particular to a lansoprazole bulk drug, more specifically to a lansoprazole freeze-dried product and a freeze-drying (freeze-drying) process thereof. Background technique [0002] Lansoprazole chemical name: 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]- 1H-benzimidazole, which belongs to the substituted benzimidazole gastric acid inhibitors, was developed and marketed by Takeda Corporation of Japan in 1991. This product acts on the H of gastric parietal cells + -K + -ATPase can reduce gastric acid secretion, thereby effectively treating various types of peptic ulcer and diseases caused by hypersecretion of gastric acid, with remarkable therapeutic effect and good acceptance. Clinical indications mainly include duodenal ulcer, gastric ulcer, reflux esophagitis, Zollinger-Ellison syndrome, etc. It also has a good inhibitory effect on Helicobacter pylor...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): F26B5/06C07D401/12
Inventor 金幸汤磊王琰许洁杨应娜
Owner 江苏金丝利药业股份有限公司
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