Lansoprazole preparation for injection and preparation method thereof

A technology of lansoprazole and freeze-dried powder for injection is applied in the field of lansoprazole freeze-dried powder for injection and its preparation, and achieves the effect of good clarity

Active Publication Date: 2010-08-18
JUMPCAN PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] In order to overcome the problems existing in the above-mentioned lansoprazole freeze-dried powder prepar...

Method used

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  • Lansoprazole preparation for injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The prescription of lansoprazole freeze-dried powder preparation:

[0039] Lansoprazole 30g

[0040] Sodium Hydroxide 4 g

[0041] Meglumine 10g

[0042] Mannitol 60g

[0043] Preparation Process:

[0044] 1. Wash the vials and stoppers, sterilize, dry and sterilize for later use.

[0045] 2. Dosing: Weigh 10g of meglumine and 4g of sodium hydroxide according to the prescription, dissolve in 80% freshly distilled water for injection, and stir to dissolve. Take by weighing lansoprazole crude drug 30g, stir and dissolve. Weigh 60g of mannitol and add and stir to dissolve. 2 g of activated carbon was stirred at room temperature for 20 minutes, and filtered. Add water for injection to a full volume of 2000ml. First filter with a 0.45μm mixed cellulose ester filter, and then use a double-layer 0.22μm mixed cellulose ester filter to sterilize and filter, and fill in 2ml / bottle.

[0046] 3. Freeze-drying: put the sample into a freeze dryer, place it at -45°C, pre-free...

Embodiment 2

[0048] The prescription of lansoprazole freeze-dried powder preparation:

[0049] Lansoprazole 30g

[0050] Sodium hydroxide 4.1 g

[0051] Meglumine 10g

[0052] Mannitol 60g

[0053] Preparation Process:

[0054] 1. Wash the vials and stoppers, sterilize, dry and sterilize for later use.

[0055] 2. Dosing: Weigh 10 g of meglumine and 4.1 g of sodium hydroxide according to the prescription, dissolve in 80% freshly distilled water for injection, and stir to dissolve. Take by weighing lansoprazole crude drug 30g, stir and dissolve. Weigh 60g of mannitol and add and stir to dissolve. 2 g of activated carbon was stirred at room temperature for 20 minutes, and filtered. Add water for injection to a full volume of 2000ml. First filter with a 0.45μm mixed cellulose ester filter, and then use a double-layer 0.22μm mixed cellulose ester filter to sterilize and filter, and fill in 2ml / bottle.

[0056] 3. Freeze-drying: place the sample in a freeze-drying machine, place it at -4...

Embodiment 3

[0058] Example 3 Freeze-Drying Condition Experiment

[0059] Carry out operation by embodiment 1, except that the freeze-drying process is different, other is the same, take the moisture of freeze-dried product, related substances and resolubility as investigation index, determine the best freeze-drying process, the results are shown in Table 1

[0060] Table 1 Investigation of freeze-drying process conditions

[0061]

[0062] From the above experimental results, from the production cost control and the actual situation, it is determined that the second batch is the best freeze-drying process.

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Abstract

Lansoprazole is a second generation proton pump inhibitor developed by Takeda in Japan, and is clinically and widely applied for treatment of acid related diseases and helicobacter pylori eradiation. The invention provides a preparation method of a Lansoprazole lyophilized powder injection preparation, creatively screens and tests the composition and dosage as well as the technology of the Lansoprazole lyophilized powder injection, obtains the optimal experiment condition, and gains good effect. The weight ratio of all the components of the Lansoprazole lyophilized powder injection satisfies the relation that Lansoprazole: meglumine: mannitol: sodium hydroxide equals to 30:10:60:4-4.1, the optimal weight ratio of all the components meets the relation that Lansoprazole: meglumine: mannitol: sodium hydroxide equals to 30:10:60:4.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an injection preparation of a proton pump inhibitor drug and a preparation method thereof, in particular to a lansoprazole freeze-dried powder preparation for injection and a preparation method thereof. Background technique [0002] Lansoprazole (Lansoprazole), a second-generation proton pump inhibitor developed by Takeda Corporation of Japan, has strong effects on basic gastric acid secretion and gastric acid formation and secretion caused by histamine, pentagastrin, choline and food. The long-lasting inhibitory effect has been widely used clinically in the treatment of acid-related diseases and the eradication of Helicobacter pylori. [0003] [0004] In the double-blind comparative experiment of lansoprazole on patients with gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, and Zhuoyi syndrome, the dose was 30 mg, and the gastric ulcer was admini...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61K47/02A61P1/04
Inventor 曹龙祥董自波王林
Owner JUMPCAN PHARMA GRP
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