Somatostation a aqua prepn and its prepn process and application

A technology of somatostatin and aqueous solution, which is applied in blood diseases, pharmaceutical formulations, aerosol delivery, etc., and can solve problems such as limitations, single dosage forms, and increased drug pollution

Active Publication Date: 2007-09-12
BEIJING SL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Like other polypeptide substances, the preparation of somatostatin is limited by factors such as its stability in aqueous solution. At present, there is only freeze-dried powder injection of somatostatin on the market. This dosage form needs to be dissolved when it is used. While increasing the operation steps, it

Method used

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  • Somatostation a aqua prepn and its prepn process and application
  • Somatostation a aqua prepn and its prepn process and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Example 1. Preparation of the pharmaceutical preparation according to claim 7

[0055] Precisely weighed sodium chloride 7.0g, disodium hydrogen phosphate (containing 12 crystal water) 4.37g, sodium dihydrogen phosphate (containing 2 crystal water) 1.22g, disodium edetate 1.28g, somatostatin 3.0g , Dissolve in water for injection, and finally dissolve to 1000ml, then use 2ml vials to dispense into 1000 pieces. The final specification is 3mg / bottle. According to this prescription, a total of 3 batches of samples were produced, numbered 01, 02, and 03 respectively. The operating procedure is carried out in accordance with the description of the manual.

Embodiment 2

[0056] Example 2. Preparation of the pharmaceutical preparation according to claim 10

[0057] Precisely weighed sodium chloride 7.0g, disodium hydrogen phosphate (containing 12 crystal water) 4.37g, sodium dihydrogen phosphate (containing 2 crystal water) 1.22g, disodium edetate 1.28g, somatostatin 3.0g , Hydroxypropyl β-cyclodextrin 20g, dissolved in water for injection, and finally dissolved to 1000ml, divided into 1000 with 2ml vials. The final specification is 3mg / bottle. A total of 1 batch of samples were produced according to the prescription, number 04. The operating procedure is carried out in accordance with the description of the manual.

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Abstract

The present invention relates to one kind of somatostation aqua preparation and its preparation process and application in preparing medicine for preventing and treating serious acute esophagus varicose hemorrhage, acute gastric and duodenal ulcer hemorrhage, acute erosive gastritis, acute hemorrhagic gastritis, etc. The preparation consists of somatostation in 0.1-1000 mg each 0.1-500 ml, medicinal supplementary material, which may be mannitol, polyglycol, cyclodextrin, etc., and water. The preparation process includes compounding, sterilizing, packing, and other steps. The somatostation aqua preparation has high stability, easy preparation and other features, and has wide application foreground in preparing medicine for preventing and treating serious acute esophagus varicose hemorrhage, acute gastric and duodenal ulcer hemorrhage, acute erosive gastritis, acute hemorrhagic gastritis, etc.

Description

Technical field [0001] The invention relates to the field of medicines and their preparations. The core of the invention is to provide a new preparation of somatostatin, its preparation method and its preparation for the prevention and treatment of severe acute esophageal varices bleeding, severe acute gastric or duodenal ulcer bleeding, acute erosive gastritis or Application in drugs for hemorrhagic gastritis, postoperative complications of pancreatic surgery, biliary or intestinal fistula, diabetic ketoacidosis and other diseases. Background technique [0002] Somatostatin is a fourteen peptide, and its amino acid sequence is as follows: [0003] [0004] Somatostatin molecular formula is C 76 H 104 N 18 O 19 S 2 , The molecular weight is 1638. [0005] Somatostatin is a cyclic polypeptide hormone secreted by D cells, mainly distributed in the gastrointestinal tract and central nervous system, of which the gastrointestinal tract accounts for 70%, and its main function is to i...

Claims

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Application Information

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IPC IPC(8): A61K38/12A61K9/08A61K9/12A61P7/04A61P1/04A61P1/18A61P3/10
Inventor 徐明波吴彦卓王勇波杨仲凡何瑞峰刘成东李振武尚海花邵兵王俊玲邓迪歌蔡祥胜
Owner BEIJING SL PHARMA
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