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Digestive system medicine freeze-dried powder and preparation process

A technology of digestive system and preparation process, which is applied in the field of freeze-dried powder and preparation of digestive system medicines to achieve the effects of perfect and stable crystal skeleton, improvement of reconstitution performance, and guarantee of effectiveness and safety

Inactive Publication Date: 2021-04-13
SHANDONG LUOXIN PHARMA GRP CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The invention effectively solves the problems of stability of esomeprazole sodium and compatibility and redissolution with 0.9% sodium chloride by improving the preparation process of the prescription and freeze-dried powder injection, and ensures the effectiveness and safety of the product

Method used

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  • Digestive system medicine freeze-dried powder and preparation process
  • Digestive system medicine freeze-dried powder and preparation process
  • Digestive system medicine freeze-dried powder and preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] prescription:

[0040]

[0041] Preparation Process:

[0042] (1) Dosing: first add water for injection, which accounts for about 80% of the total amount of the prescription, cool down to below 20°C, weigh the prescribed amount of esomeprazole sodium, add it to the liquid mixing tank and stir until dissolved, and the complexed Add the agent into the liquid mixing tank, stir to dissolve all the materials, then add an appropriate amount of 1mol / L sodium hydroxide to adjust the pH to 11, and add water for injection to the prescribed amount. Add 0.01% activated carbon and stir for 15 minutes, circulate and filter through 1.0um, 0.45um, 0.22um sterile filters for 15min, and take samples to test the intermediate to make it qualified;

[0043] (2) Filling: the medicinal liquid is filled in a sterile room after sterilization and filtration; the medicinal liquid is divided into vials, half-plugged, and put into a freeze-drying box;

[0044] (3) Pre-freezing: the inlet tempe...

Embodiment 2

[0048] prescription:

[0049]

[0050] Preparation Process:

[0051] (1) Dosing: first add water for injection, which accounts for about 80% of the total amount of the prescription, cool down to below 20°C, weigh the prescribed amount of esomeprazole sodium, add it to the liquid mixing tank and stir until dissolved, and the complexed Add the agent into the liquid mixing tank, stir to dissolve all the materials, then add an appropriate amount of 1mol / L sodium hydroxide to adjust the pH to 11.5, and add water for injection to the prescribed amount. Add 0.01% activated carbon and stir for 15 minutes, circulate and filter through 1.0um, 0.45um, 0.22um sterile filters for 15min, and take samples to test the intermediate to make it qualified;

[0052] (2) Filling: the medicinal liquid is filled in a sterile room after sterilization and filtration; the medicinal liquid is divided into vials, half-plugged, and put into a freeze-drying box;

[0053] (3) Pre-freezing: the inlet tem...

Embodiment 3

[0057] prescription:

[0058]

[0059] Preparation Process:

[0060] (1) Dosing: first add water for injection, which accounts for about 80% of the total amount of the prescription, cool down to below 20°C, weigh the prescribed amount of esomeprazole sodium, add it to the liquid mixing tank and stir until dissolved, and the complexed Add the agent into the liquid mixing tank, stir to dissolve all the materials, then add an appropriate amount of 1mol / L sodium hydroxide to adjust the pH to 11, and add water for injection to the prescribed amount. Add 0.025% activated carbon and stir for 15 minutes, circulate and filter through 1.0um, 0.45um, 0.22um sterile filters for 15min, and take samples to test the intermediate to make it qualified;

[0061] (2) Filling: the medicinal liquid is filled in a sterile room after sterilization and filtration; the medicinal liquid is divided into vials, half-plugged, and put into a freeze-drying box;

[0062] (3) Pre-freezing: the inlet temper...

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Abstract

The invention discloses digestive system medicine freeze-dried powder and a preparation process, and belongs to the field of pharmaceutical preparations. A formula of the medicine freeze-dried powder comprises a main medicine esomeprazole sodium, a complexing agent and a pH regulator, the dosage of the esomeprazole sodium in the formula is 40 mg / ml, and the dosage of the complexing agent in the formula is 1.2 mg / ml-1.7 mg / ml. The prepared product solves the problem of product stability, improves the redissolving property of a freeze-dried powder injection, is more stable in compatibility with infusion during clinical use, and ensures the effectiveness and safety of product application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a digestive system drug freeze-dried powder and a preparation process. Background technique [0002] Proton pump inhibitors (PPIs) are the drug of choice for the treatment of acid-related diseases such as peptic ulcer and gastroesophageal reflux disease. Currently, there are five commonly used PPIs in clinical practice: omeprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole. As the first PPI drug, omeprazole has been unanimously recognized for its efficacy in the treatment of acid-related diseases. Esomeprazole, trade name Nexium, is a single isomer of omeprazole, ie (S)-isomer. Due to its metabolic advantages, esomeprazole has higher bioavailability and more consistent pharmacokinetics than omeprazole, which increases the drug reaching the proton pump, and its acid suppression effect is better than other PPIs. [0003] Although oral esomeprazole ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61P1/04
CPCA61K31/4439A61K9/19A61K9/0019A61K47/183A61P1/04
Inventor 李明华张明法朱绪辉齐媛晶李三鸣
Owner SHANDONG LUOXIN PHARMA GRP CO LTD