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Prescription and preparation method of injection lansoprazole

A lansoprazole prescription and lansoprazole technology, applied in the field of injections, can solve the problems of complex preparation process of solid preparations, increased drug side effects, high production costs, etc., to improve drug bioavailability, reduce production costs, and protect activity The effect of ingredients

Inactive Publication Date: 2012-05-16
双鹤药业(海南)有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, its solid preparation preparation process is complex and the production cost is high
[0006] The lyophilized preparations of lansoprazole currently on the market use organic bases and antioxidants to maintain the stability of lansoprazole. The addition of organic bases may cause the quality of the preparations to be unstable, and adding too much antioxidants may cause side effects of the drug. increase, medication is unsafe

Method used

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  • Prescription and preparation method of injection lansoprazole

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Lansoprazole 30.0g

[0021] Mannitol 90.0g

[0022] Sodium hydroxide 3.4g

[0023]

[0024] Made 1000 pieces

[0025] Take by weighing prescription quantity mannitol, join in the water for injection of preparation full amount 85% (water temperature 30~40 ℃), stir and dissolve, add lansoprazole, adjust to PH11.0 with 1mol / L sodium hydroxide under stirring, supplement Add water for injection to the full amount, add medicinal charcoal, stir and absorb at room temperature, filter to remove charcoal; take the filtrate for filling, put the filled product on the partition of the freeze-drying box, pre-freeze at -33°C for 2.5 hours, and vacuum to a vacuum When the temperature reaches 15pa, raise the temperature at 2°C / h until the product temperature reaches above 5°C, and then set the partition temperature to 35°C for secondary drying. The product temperature reaches above 30°C, equilibrate for 4 hours, and press the plug to obtain Lansol for Injec...

Embodiment 2

[0027] Lansoprazole 30.0g

[0028] Mannitol 150.0g

[0029] Sodium hydroxide 3.4g

[0030]

[0031] Made 1000 pieces

[0032] Take by weighing prescription quantity mannitol, join in the water for injection of preparation full amount 85% (water temperature 30~40 ℃), stir and dissolve, add lansoprazole, adjust to PH12.0 with 1mol / L sodium hydroxide under stirring, supplement Add water for injection to the full amount, add medicinal charcoal, stir and absorb at room temperature, filter to remove charcoal; take the filtrate for filling, put the filled product on the partition of the freeze-drying box, pre-freeze at -33°C for 2.5 hours, and vacuum to a vacuum When the temperature reaches 15pa, raise the temperature at 2°C / h until the product temperature reaches above 5°C, and then set the partition temperature to 35°C for secondary drying. The product temperature reaches above 30°C, equilibrate for 4 hours, and press the plug to obtain Lansol for Inje...

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Abstract

The invention provides a prescription and preparation method of injection lansoprazole used for treating gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome and Stomal ulcer. In the injection lansoprazole, the weight ratio of lansoprazole to mannitol to sodium hydroxide is 1:(3-5):0.11. The injection lansoprazole is prepared by dissolving the raw and auxiliary materials at certain temperature and acidity, and then lyophilizing. The invention aims at overcoming the defect of a medicinal preparation using lansoprazole as an active component, and provides the prescription of the injection lansoprazole and the preparation method thereof. The preparation prepared by the method is stable, the safety of clinical application is improved, and the production cost is reduced.

Description

Technical field: [0001] The invention relates to an injection for treating gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome, and anastomotic ulcer, in particular to a lyophilized injection with lansoprazole as an active ingredient. preparation. Background technique: [0002] The chemical name of lansoprazole is: (+)-2[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] Benzimidazole, molecular formula: C 16 h 14 f 3 N 3 o 2 S, its structural formula is: [0003] [0004] This product is an H / K-ATPase inhibitor developed by Takeda Pharmaceutical Company in Japan in 1992. It is a benzimidazole substitute developed after omeprazole and is a proton pump inhibitor. Its mechanism of action is that after the drug is absorbed, it is transferred to the acid secretion duct of the parietal cells of the gastric mucosa, and under acidic conditions, it is transformed into an active body structure. This active substance interacts with the ...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K47/10A61K47/02A61K9/19A61P1/04
Inventor 魏雪纹李强
Owner 双鹤药业(海南)有限责任公司
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