Octreotide acetate sterile injection powder preparation and preparation method thereof

A technology for octreotide acetate and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations, can solve the problems of influence, lack of protective measures, microbial contamination and the like, and achieves the effects of simple preparation method, extended shelf life and increased stability

Inactive Publication Date: 2015-06-10
陈卓杰
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN101647773B discloses a kind of octreotide acetate injection, inactive ingredient has mannitol, Tween 80 and citric acid, adds Tween-80 and citric acid to improve solution stability in prescription, but the injection described in this invention It has not been terminally sterilized. Although there is a sterilizing and filtering process, there are hidden dangers of microbial contamination during liquid storage, and the product has not taken effective protective measures against oxidation.
CN101647773B discloses a kind of octreotide acetate injection, inactive ingredient has mannitol, Tween 80 and citric acid, adds Tween-80 and citric acid to improve solution stability in prescription, but the injection described in this invention It has not been terminally sterilized. Although there is a sterilizing and filtering process, there are hidden dangers of microbial contamination during liquid storage, and the product has not taken effective protective measures against oxidation.
However, since the freeze-dried powder needs to be reconstituted before use, the excipients and preparation methods used in it have a great influence on the state after reconstitution.

Method used

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  • Octreotide acetate sterile injection powder preparation and preparation method thereof
  • Octreotide acetate sterile injection powder preparation and preparation method thereof
  • Octreotide acetate sterile injection powder preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1 The preparation of octreotide acetate freeze-dried powder injection of the present invention

[0032] prescription:

[0033]

[0034] Specific steps are as follows:

[0035] 1) Weigh each component according to the formula, add vitamin C, mannitol, dextran, tert-butanol and octreotide acetate into purified water in sequence under nitrogen protection, and stir to dissolve completely;

[0036] 2) filling the prepared medicinal solution into ampoules and freeze-drying.

[0037] 3) Freeze-drying curve: pre-freeze at -35°C for 5 hours; under vacuum conditions -35°C for 5 hours -20°C for 3 hours and then end.

Embodiment 2

[0038] Embodiment 2 The preparation of octreotide acetate freeze-dried powder injection of the present invention

[0039] prescription:

[0040]

[0041] Specific steps are as follows:

[0042] 1) Weigh each component according to the formula, add vitamin C, mannitol, dextran, tert-butanol and octreotide acetate into purified water in sequence under nitrogen protection, and stir to dissolve completely;

[0043] 2) filling the prepared medicinal solution into ampoules and freeze-drying.

[0044] 3) Freeze-drying curve: Pre-freeze at -40°C for 5 hours; under vacuum condition, -40°C for 2 hours, -35°C for 2 hours, and -20°C for 3 hours, then end.

Embodiment 3

[0045] Embodiment 3 The preparation of octreotide acetate freeze-dried powder injection of the present invention

[0046] prescription:

[0047]

[0048] Specific steps are as follows:

[0049] 1) Weigh each component according to the formula, add vitamin C, mannitol, dextran, tert-butanol and octreotide acetate into purified water in sequence under nitrogen protection, and stir to dissolve completely;

[0050] 2) filling the prepared medicinal solution into ampoules and freeze-drying.

[0051] 3) Freeze-drying curve: Pre-freeze at -40°C for 5 hours; under vacuum condition, it lasts at -40°C for 2 hours, at -30°C for 2 hours, and at -20°C for 3 hours before ending.

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PUM

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Abstract

The invention relates to an octreotide acetate sterile injection powder preparation and a preparation method thereof. The octreotide acetate sterile injection powder preparation is prepared by octreotide acetate, TBA (Tert Butyl Alcohol), mannitol, dextran and a vitamin C. The preparation method comprises the following steps: 1) adding the vitamin C, the mannitol, the dextran, the TBA and the octreotide acetate into purified water sequentially, and stirring to completely dissolve; 2) filling a prepared liquid medicine in an ampoule bottle for freeze-drying. According to the octreotide acetate sterile injection powder preparation provided by the invention, the guarantee period can be greatly improved, the stability can be improved, and the preparation method is simple.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a freeze-dried powder preparation of octreotide acetate. Background technique [0002] Octreotide acetate is a synthetic octapeptide compound, which is an analogue of fourteen-peptide human somatostatin. The pharmacological effects of octreotide are similar to natural hormones, but its inhibitory effect on growth hormone, glucagon and insulin is stronger. Similar to somatostatin, octreotide can also inhibit the response of LH to GnRH, reduce splanchnic blood flow, and inhibit the secretion of 5-HT, gastrin, vasoactive intestinal peptide, chymotrypsin, motilin, and glucagon. [0003] Because octreotide acetate is a polypeptide preparation, the drug is poorly absorbed orally and has a strong first-pass effect, but it can be rapidly and completely absorbed by subcutaneous and intravenous administration. Octreotide acetate injection, clinical use can be intravenous inject...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/08A61K9/19A61K47/26A61K47/10A61P5/00A61P5/48
Inventor 陈卓杰
Owner 陈卓杰
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