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Terlipressin acetate preparation and preparation method thereof

A technology of terlipressin and acetic acid, used in lighting and heating equipment, pharmaceutical formulations, drying solid materials without heating, etc., can solve problems such as poor stability, achieve low impurity content, good stability, meet transportation and Effects of storage requests

Active Publication Date: 2022-04-12
苏州天马医药集团天吉生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to overcome the shortcomings and deficiencies in the prior art, the present invention provides a preparation method of terlipressin acetate preparation, which improves the problem of poor stability in the prior art

Method used

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  • Terlipressin acetate preparation and preparation method thereof

Examples

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Effect test

Embodiment 1

[0044] A preparation method of terlipressin acetate preparation, comprising the following steps:

[0045] (a) Preparation of mixed solution: Measure 40L of water for injection in the liquid preparation tank, weigh 470g of mannitol and add it to the water for injection, stir to make it completely dissolve; weigh 43g of terlipressin acetate raw material until adding the mannitol solution , stir to dissolve it; weigh 105g of dextran and add it to the liquid medicine, stir to dissolve it; use 1mol / L hydrochloric acid solution to adjust the pH to 3.8, and use water for injection to set the volume to 50L;

[0046] (b) Intermediate detection: take an appropriate amount of intermediate medicinal liquid, and measure the content of intermediates and other indicators;

[0047] (c) Filtration: use a 0.22 μm polyvinylidene fluoride filter membrane to filter and sterilize;

[0048] (d) Filling: according to the test results of the intermediate liquid medicine, fill the liquid medicine into...

Embodiment 2

[0063] A preparation method of terlipressin acetate preparation, comprising the following steps:

[0064] (a) Preparation of mixed solution: Measure 40L of water for injection in the liquid preparation tank, weigh 431g of mannitol and add it to the water for injection, stir to make it completely dissolve; weigh 42g of terlipressin acetate raw material until adding the mannitol solution , stir to dissolve it; weigh 107g of dextran and add it to the liquid medicine, stir to dissolve it; use 1mol / L hydrochloric acid solution to adjust the pH to 4.0, and use water for injection to set the volume to 50L;

[0065] (b) Intermediate detection: take an appropriate amount of intermediate medicinal liquid, and measure the content of intermediates and other indicators;

[0066] (c) Filtration: use a 0.22 μm polyvinylidene fluoride filter membrane to filter and sterilize;

[0067] (d) Filling: according to the test results of the intermediate liquid medicine, fill the liquid medicine into...

Embodiment 3

[0082] A preparation method of terlipressin acetate preparation, comprising the following steps:

[0083] (a) Preparation of mixed solution: Measure 40L of water for injection in a liquid preparation tank, weigh 950g of mannitol and add it to the water for injection, stir to make it completely dissolve; weigh 88g of terlipressin acetate raw material until adding the mannitol solution , stir to dissolve it; weigh 223g of dextran and add it to the liquid medicine, stir to dissolve it; use 1mol / L hydrochloric acid solution to adjust the pH to 3.0, and dilute the volume to 100L with water for injection;

[0084] (b) Intermediate detection: take an appropriate amount of intermediate medicinal liquid, and measure the content of intermediates and other indicators;

[0085] (c) Filtration: use a 0.22 μm polyvinyl chloride filter membrane to filter and sterilize;

[0086] (d) Filling: according to the test results of the intermediate liquid medicine, fill the liquid medicine into a 7m...

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Abstract

The invention discloses a terlipressin acetate preparation and a preparation method thereof, and the preparation method comprises the following steps: (1) dissolving terlipressin acetate, an excipient and dextran in water to obtain a mixed solution, and adding an acid into the mixed solution to adjust the pH value to 2.5-4.0; and (2) filtering the mixed solution, filling, freezing and drying to obtain the blocky terlipressin acetate freeze-dried powder. The dextran is introduced to prevent the structure of the active pharmaceutical ingredient from being irreversibly influenced in the dehydration process to reduce the pharmaceutical activity, and in addition, by controlling the heating and cooling rates and the vacuum degree of each step of freezing and desorption drying, the terlipressin acetate preparation which is low in moisture content, low in impurity content and fast in redissolution is prepared. Compared with a terlipressin acetate preparation prepared in the prior art, the terlipressin acetate preparation has the advantages that the stability under the conditions of high temperature, high humidity and illumination is improved, the drug effect is ensured, the drug administration safety is improved, and the drug effect period under the same storage condition is prolonged.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a terlipressin acetate preparation and a preparation method thereof. Background technique [0002] The chemical name of terlipressin is N-α-triglycyl-8-lysine-vasopressin, which is a synthetic long-acting vasopressin preparation. As a prodrug, terlipressin itself has no activity. After injection, it will be released slowly by the action of aminopeptidase in vivo after removing the 3 glycyl residues at its N-terminus. Active lysine vasopressin, terlipressin is therefore equivalent to a sustained release formulation of lysine vasopressin. Vasopressin has two main effects: on the one hand, it has obvious vasoconstriction effect, which can reduce the venous blood flow to the hepatic portal system, so as to reduce portal blood pressure, and has hemostatic effect; secondly, it can act on some kidneys. Receptor, prevents excessive loss of water in urine, has anti-enuresis function. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/095A61K47/26A61P7/04F26B5/06
Inventor 杨振亚金成杰孔晴晴张易
Owner 苏州天马医药集团天吉生物制药有限公司
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