Somatostatin powder injection composition and preparation process thereof

A technology of somatostatin and preparation process, which is applied in the field of medicine, can solve the problems of polluting liquid medicine, easily producing glass shavings, and the existence of safety and quality risks, and achieve the effects of energy saving, good moldability of finished products, and accelerated water sublimation

Inactive Publication Date: 2018-04-17
SHANDONG SHUNTONG ENVIRONMENT PROTECTION MATERIALCO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Somatostatin for injection (trade name: ) uses ampoule as the inner packaging material. When the ampoule is broken during use, it is easy to produce glass shavings, contaminate the liquid medicine, and there is a risk of safety and quality.

Method used

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  • Somatostatin powder injection composition and preparation process thereof
  • Somatostatin powder injection composition and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A somatostatin powder injection composition, prescription:

[0029] Somatostatin 0.25g

[0030] Glycine 10g

[0031] Add water for injection to 1000ml to make 1000 sticks.

[0032] A preparation process of somatostatin powder injection composition:

[0033] (1) Weigh the prescribed amount of somatostatin and glycine into a liquid preparation tank, add 80% water for injection and stir to dissolve, measure the pH value, adjust the pH to 3.5-5.5 with 1mol / L acetic acid solution.

[0034] (2) Add 0.05% (w / v) activated carbon and stir for 30 minutes, filter and decarbonize.

[0035] (3) Add water for injection to the full amount, stir evenly, and take the intermediate for testing.

[0036] (4) After passing the inspection of the intermediate, it is filtered through a 0.22 μm polyethersulfone filter element, packed in 2ml neutral borosilicate glass control injection bottles, and partially covered with polytetrafluoroethylene membrane brominated butyl rubber stopper for fr...

Embodiment 2

[0039] A somatostatin powder injection composition, prescription:

[0040] Somatostatin 0.75g

[0041] Glycine 10g

[0042] Add water for injection to 1000ml to make 1000 sticks.

[0043] A preparation process of somatostatin powder injection composition:

[0044] (1) Weigh the prescribed amount of somatostatin and glycine into a liquid preparation tank, add 80% water for injection and stir to dissolve, measure the pH value, adjust the pH to 3.5-5.5 with 1mol / L acetic acid solution.

[0045] (2) Add 0.05% (w / v) activated carbon and stir for 30 minutes, filter and decarbonize.

[0046] (3) Add water for injection to the full amount, stir evenly, and take the intermediate for detection.

[0047] (4) After passing the inspection of the intermediate, it is filtered through a 0.22 μm polyethersulfone filter element, packed in 2ml neutral borosilicate glass control injection bottles, and partially covered with polytetrafluoroethylene membrane brominated butyl rubber stopper for ...

Embodiment 3

[0050] A somatostatin powder injection composition, prescription:

[0051] Somatostatin 3.0g

[0052] Glycine 10g

[0053] Add water for injection to 1000ml to make 1000 sticks.

[0054] A preparation process of somatostatin powder injection composition:

[0055] (1) Weigh the prescribed amount of somatostatin and glycine into a liquid preparation tank, add 80% water for injection and stir to dissolve, measure the pH value, adjust the pH to 3.5-5.5 with 1mol / L acetic acid solution.

[0056] (2) Add 0.05% (w / v) activated carbon and stir for 30 minutes, filter and decarbonize.

[0057] (3) Add water for injection to the full amount, stir evenly, and take the intermediate for detection.

[0058] (4) After passing the inspection of the intermediate, it is filtered through a 0.22 μm polyethersulfone filter element, packed in 2ml neutral borosilicate glass control injection bottles, and partially covered with polytetrafluoroethylene membrane brominated butyl rubber stopper for f...

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Abstract

The invention discloses somatostatin powder injection composition and a preparation process thereof. The somatostatin powder injection composition is prepared from somatostatin, a freeze-dried carrieror an excipient and a local laminating brominated butyl rubber plug for freeze-drying injection. Somatostatin and the freeze-dried carrier or the excipient are mixed, and a proper amount of water forinjection is added for dissolution; activated carbon is added for filtration, an acid or alkaline regulator is added to regulate the pH value, the water for injection is added to the prescribed volume, and subpackaging is performed; sub-packaged products are half tamponed and put in a freeze-drying machine to be freeze-dried; nitrogen charging, tamponing and discharging are performed. The pH change of somatostatin in preparation of freeze-dried powder injection and long-time storage of a finished product is remarkably inhibited, the stability of the freeze-dried powder injection is effectively improved, long-time storage at the normal temperature of 25 DEG C is realized, the freeze-drying time is shortened, a large amount of energy consumption is saved, the production cost is substantially reduced, the formability of the finished product is good, and the composition has no withering property and is tidy and attractive in appearance.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a somatostatin powder injection composition and a preparation process thereof. Background technique [0002] Somatostatin (somatostatin, growth hormone release-inlease-inhibitinghormone GHRIH, or somatostatin is a fourteen peptide cleaved from a macromolecular peptide of 116 amino acids, and its molecular structure is cyclic. [0003] Somatostatin is an endogenous regulatory hormone that exists in the human body. It mainly has a wide range of inhibitory effects on various physiological functions, such as inhibiting exocrine, gastrointestinal motility, and visceral bleeding. At the end of the 1970s, the Swiss Serono company used biosynthesis to obtain fourteen peptide somatostatin with the same chemical structure and biological activity as natural somatostatin, and developed it into a commodity (trade name: / Stilamin). [0004] Somatostatin is a synthetic tetradecapeptide, and...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/12A61K47/18F26B5/06
CPCA61K9/0019A61K9/19A61K38/12A61K47/183F26B5/06
Inventor 姜丽
Owner SHANDONG SHUNTONG ENVIRONMENT PROTECTION MATERIALCO LTD
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