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Sodium rabeprazole freeze-dried powder injection for injection, preparation method thereof and detection method thereof

A technology of rabeprazole sodium and freeze-dried powder injection, which is applied in the field of medicine, can solve problems such as acute clinical consequences, and achieve the effects of strong specificity, high precision, and high efficiency and energy saving in the preparation process

Active Publication Date: 2011-06-29
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] For parenterals administered by injection, the degradation of the active ingredient into undesired products that produce side effects can have serious, acute clinical consequences

Method used

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  • Sodium rabeprazole freeze-dried powder injection for injection, preparation method thereof and detection method thereof
  • Sodium rabeprazole freeze-dried powder injection for injection, preparation method thereof and detection method thereof
  • Sodium rabeprazole freeze-dried powder injection for injection, preparation method thereof and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0163] Prescription: Rabeprazole Sodium 5.0g

[0164] Mannitol 45.0g

[0165] Sodium sulfite 1.0g

[0166] Disodium edetate 0.5g

[0167] Add water for injection to 1000ml / 1000 sticks

[0168] Preparation method: Dissolve the prescribed amount of sodium sulfite, mannitol, and disodium edetate in about 60% of water for injection at 60±5°C, add 0.1% (g / ml) activated carbon, absorb for 10 minutes, decarbonize and filter Filtrate is cooled to room temperature, adjusts pH to 12.0 with the NaOH solution of 1mol / L, adds the rabeprazole sodium of recipe quantity, stirs to dissolving, adds water for injection to full amount; Measure intermediate solution pH value, content; Use 0.22 Fine filtration with μm microporous membrane, filling, semi-stoppering, freeze-drying, stoppering, capping, inspection, and packaging.

[0169] Detection method:

[0170] Related substances are measured according to high performance liquid chromatography (two appendix V D of Chinese Pharmacopoeia versio...

Embodiment 2

[0176] Prescription: Rabeprazole Sodium 5.0g

[0177] Mannitol 7.5g

[0178] Sodium sulfite 1.0g

[0179] Disodium edetate 0.5g

[0180] Add water for injection to 1000ml / 1000 sticks

[0181] Preparation method: Dissolve the prescribed amount of sodium sulfite, mannitol, and disodium edetate in about 60% of water for injection at 60±5°C, add 0.1% (g / ml) activated carbon, absorb for 10 minutes, decarbonize and filter Filtrate is cooled to room temperature, adjusts pH to 12.5 with the NaOH solution of 1mol / L, adds the rabeprazole sodium of recipe quantity, stirs to dissolving, adds water for injection to full amount; Measure intermediate solution pH value, content; Use 0.22 Fine filtration with μm microporous membrane, filling, semi-stoppering, freeze-drying, stoppering, capping, inspection, and packaging.

[0182] The relevant substances and contents were detected to be 0.33% and 99.8% respectively.

Embodiment 3

[0184] Prescription: Rabeprazole Sodium 1.0g

[0185] Mannitol 10.0g

[0186] Sodium sulfite 1.0g

[0187] Disodium edetate 0.5g

[0188] Add water for injection to 1000ml / 1000 sticks

[0189] Preparation method: Dissolve the prescribed amount of sodium sulfite, mannitol, and disodium edetate in about 60% of water for injection at 60±5°C, add 0.1% (g / ml) activated carbon, absorb for 10 minutes, decarbonize and filter Filtrate is cooled to room temperature, adjusts pH to 12.3 with the NaOH solution of 1mol / L, adds the rabeprazole sodium of recipe quantity, stirs to dissolve, adds water for injection to full amount; Measure intermediate solution pH value, content; Use 0.22 Fine filtration with μm microporous membrane, filling, semi-stoppering, freeze-drying, stoppering, capping, inspection, and packaging.

[0190] Detection method:

[0191] Related substances are measured according to high performance liquid chromatography (two appendix V D of Chinese Pharmacopoeia version ...

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Abstract

The invention relates to a sodium rabeprazole freeze-dried powder injection for injection, a preparation method thereof and a detection method thereof, and belongs to the technical field of medicines. In the sodium rabeprazole freeze-dried powder injection for the injection, medicinal content and the stability of relevant substances are improved by screening an additament in a prescription and the pH value of a preparation process and controlling the pH value of a finished product. The sodium rabeprazole freeze-dried powder injection for the injection has the advantages of low relevant substances, fewer side effects, high stability and safety, low production cost and the like, and is convenient to store and apply. In addition, by studying the detection method of the freeze-dried powder injection, the detection method has high accuracy, repeatability, sensitivity and specificity, and the quality of the injection can be better controlled.

Description

technical field [0001] The invention relates to a freeze-dried powder injection for treating peptic ulcer, a preparation method and a detection method, more specifically, the invention relates to a rabeprazole sodium freeze-dried powder injection, a preparation method and a detection method, and belongs to the technical field of medicine. Background technique [0002] Peptic ulcer is a kind of common disease, frequently-occurring disease, is a kind of chronic and recurrent disease. Its mortality rate is very small, but it brings great suffering to patients and increases the economic burden on the country and the people. Peptic ulcer is a well-defined mucosal disorder that penetrates the muscularis mucosa and occurs in areas of the gastrointestinal tract that come into contact with gastric juices. The vast majority are located in the stomach and duodenum, so it is called gastric and duodenal ulcer disease. [0003] Rabeprazole sodium is an alkaline acid-suppressing drug, un...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/26G01N21/33G01N30/02A61P1/04
Inventor 张建立曹相林蔡刚李海冰董世杰
Owner BEIJING SIHUAN KEBAO PHARM CO LTD
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