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Somatostatin freeze-dried powder injection

A technology for freeze-dried powder injection and somatostatin, which is applied in the field of medical technology and can solve problems such as insufficient stability

Active Publication Date: 2013-07-31
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] However, the existing commercially available somatostatin, especially its powder injection, is usually valid for 24 months, but it is stipulated to be stored in a cold place (2-10°C). and powder injections, also require storage in a cold place
It can be seen that the stability of this preparation is insufficient

Method used

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  • Somatostatin freeze-dried powder injection
  • Somatostatin freeze-dried powder injection
  • Somatostatin freeze-dried powder injection

Examples

Experimental program
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Effect test

preparation example 1

[0094] Preparation Example 1, Preparation of Powder Injection Containing Somatostatin

[0095] formula:

[0096] Somatostatin

0.75mg,

Mannitol

50mg,

Maltitol

5 mg,

pH regulator

to pH5.5,

Water for Injection

Appropriate amount, add to 1ml.

[0097] Preparation:

[0098] (1) Weigh the main drug and excipients (except pH adjuster) of the prescribed amount, place them in a stainless steel bucket, add about 80% of the prescribed amount of water for injection, dissolve each component, and then add 0.1% (w / v) of activated carbon, stirred for 30 minutes, filtered and decarbonized, and added water for injection to close to the full amount of the prescription.

[0099] (2) The filtrate is sampled, and the pH value is measured, and if necessary, it is adjusted to a specified value with a pH regulator (the specified value is the value of the measured pH value of the freeze-dried dry powder diluted with water for injecti...

preparation example 2

[0104]Supplementary Preparation Example 2: Referring to the method of Preparation Example 1 above, the difference is that the amount of mannitol in it is adjusted to 0mg, 5mg, 10mg, 25mg, 75mg, 100mg, 150mg, and 200mg, and the numbers of the obtained powder injections are respectively Ex120, Ex121, Ex122, Ex123, Ex124, Ex125, Ex126, Ex127. For the case where the solid content is greater than 10%, add an appropriate amount of water to make the solid content 10%.

preparation example 3

[0105] Supplementary Preparation Example 3: Referring to the method of Preparation Example 1 above, the difference is that the mannitol in it is replaced by 25 mg of lactose, 75 mg of lactose, 250 mg of dextran, 75 mg of dextran, 25 mg of glycine, 75 mg of glycine, 25 mg of sodium chloride, Sodium chloride 75mg, the powder injection number that obtains is respectively Ex131, Ex132, Ex133, Ex134, Ex135, Ex136, Ex137, Ex138.

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Abstract

The invention relates to somatostatin freeze-dried powder injection and particularly relates to freeze-dried powder injection comprising somatostatin and mannitol. Based on 0.75 weight part of somatostatin, the amount of the mannitol is 5 to 20 parts. The invention also relates to a preparation method of the freeze-dried powder injection. The freeze-dried powder injection has good characteristics.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a freeze-dried powder injection, in particular to a freeze-dried powder injection containing somatostatin, and its preparation for the prevention and treatment of severe acute esophageal variceal bleeding, severe acute gastric or Duodenal ulcer bleeding, acute erosive gastritis or hemorrhagic gastritis, complications after pancreatic surgery, biliary or intestinal fistula, diabetic ketoacidosis and other diseases. The freeze-dried powder injection of the present invention has expected good properties. Background technique [0002] Somatostatin (somatostatin) is a peptide hormone present in the gastric mucosa, pancreatic islets, gastrointestinal nerves, posterior pituitary gland, and central nervous system, which inhibits gastric secretion and peristalsis, and inhibits growth-promoting in the hypothalamus / pituitary hormone release. [0003] Somatostatin is a fourteen peptide, its...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/10A61K47/26A61P1/00A61P7/04A61P1/04A61P1/16A61P1/18A61P3/10A61P3/12
Inventor 赵东明贾红军谷娟丁伟邓洪董国明
Owner CHENGDU TIANTAISHAN PHARMA
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