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Preparation method of terlipressin for injection and prepared terlipressin for injection

A technology for terlipressin and injection, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., can solve problems such as lack of freeze-drying process, and achieve complete appearance and moisture content The content and pH value remain stable and the effect of small increase

Active Publication Date: 2022-03-15
FUJIAN MINDONG REJUVENATION PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Terlipressin for injection is usually obtained by freeze-drying terlipressin acetate solution, and currently there is no freeze-drying process with excellent effect

Method used

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  • Preparation method of terlipressin for injection and prepared terlipressin for injection
  • Preparation method of terlipressin for injection and prepared terlipressin for injection
  • Preparation method of terlipressin for injection and prepared terlipressin for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The sucrose 200g is added to the injection of water (≤30 ° C), stirring to completely dissolve; referred to acetic acid, electropperipilloxil 40 g, adding to the sucrose solution, stirring to dissolve. The pH of the drug solution was then adjusted using 0.1 mol / L of hydrochloric acid solution such that the pH of the drug solution was 3.6 to 3.9, and water was supplied to 40L using injection; and after filtering with 0.22 μm PVDF, the liquid was filled with 1mL In the 5ml Willow Bottle, half of the brominated butyl rubber plug is used for half-pressure, spare.

[0036] The glass bottle placed in the separator was placed in a vacuum freeze dryer, and the sample separator temperature was room temperature, and then the temperature of the product was reduced from room temperature to -45 ° C (first temperature), heat insulation for 6 h at room temperature.

[0037] The vacuum pump is opened, and the vacuum is 10 Pa below, and the sublimation process is entered, and the product ...

Embodiment 2

[0049] The sucrose 200g is added to the injection of water (≤30 ° C), stirring to completely dissolve; referred to acetic acid, electropperipilloxil 40 g, adding to the sucrose solution, stirring to dissolve. The pH of the drug solution was then adjusted using 0.1 mol / L of hydrochloric acid solution such that the pH of the drug solution was 3.6 to 3.9, and water was supplied to 40L using injection; and after filtering with 0.22 μm PVDF, the liquid was filled with 1mL In the 5ml Willow Bottle, half of the brominated butyl rubber plug is used for half-pressure, spare.

[0050] The glass bottle placed in the separator was placed in a vacuum freeze dryer, and the sample separator temperature was room temperature, and then the temperature of the product was reduced from room temperature to -45 ° C (first temperature), heat insulation for 6 h at room temperature.

[0051]The vacuum pump until a vacuum degree in the following 10pa into the sublimation process, when the temperature was ...

Embodiment 3

[0062] Sample 1: Weigh 5g of sucrose was added water for injection (≤30 ℃), stirred and completely dissolved; Terry said take vasopressin acetate 1g sucrose added to the above solution and stirred to dissolve. Then 0.1mol L hydrochloric acid solution using the pH / adjusted drug solution, a drug solution so that the pH value of 3.6 to 3.9, water for injection to 1000ml volume; then filtered using 0.22μmPVDF water film, the liquid filling 1ml to 5ml resistant bottle, using semi-bromobutyl rubber stopper tamponade standby;

[0063] The glass bottles filled with a liquid is placed on the spacer is pushed into the vacuum freeze drier, and the separator sample temperatures are room temperature during 4h with the article from room temperature down to a temperature of -45 deg.] C, heat 6H;

[0064] The vacuum pump until a vacuum degree in the following 10pa into the sublimation process, when the article with 4h -5 ℃ temperature was raised from -45 deg.] C, held 23 h, the degree of vacuum...

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Abstract

The invention provides a preparation method of terlipressin for injection, which comprises the following steps: 1) in a vacuum freeze dryer, cooling an aqueous solution containing terlipressin acetate and cane sugar to a first temperature, and pre-freezing at the temperature for 2-10 hours, the first temperature being-30 to-50 DEG C; (2) a vacuum pump is started, after the vacuum degree is smaller than or equal to 10 pa, the product obtained in the step (1) is heated to the second temperature, the temperature is kept for 15 h to 40 h, the second temperature ranges from 0 DEG C to-20 DEG C, and the vacuum degree is kept to range from 15 pa to 20 pa during heating and keeping; and (3) heating the product obtained in the step (2) to a third temperature of 20-45 DEG C, keeping the temperature for 15-30 hours, and keeping vacuumizing and prohibiting aeration during heating and keeping. The method is simple and easy to operate and suitable for large-scale industrialization; the prepared terlipressin for injection has good resolubility and stability, and has no atrophy phenomenon and honeycomb appearance.

Description

Technical field [0001] The present invention relates to the field of medicinal technology, and in particular, the present invention relates to the preparation method of thermally charged pressure suppressors. Background technique [0002] Tere Pressure is a new type of labor-synthetic long-acting blood vessel preparation, the chemical name "tritlaxyonyl lysine plus pressure" belongs to a precursor drug, itself is inactive, in vivo The amino peptidase acts, after the three glycyl residues of the N-terminus, slowly "release" active lysine plug. It is this "slow release" mechanism to maintain a smooth muscle contract for 10 h after administration, while the same dose of vascular pressure is only 20-40 minutes. On the other hand, since the enzymatic hydrolysis is slow, the lysine chargedin in the cycle is less than the poisonous level, so the use of Trink Pressure is relatively safe. [0003] The pharmacological effect of Special Plippump is to shrink internal vascular smooth muscle,...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/095A61K47/26A61P1/16A61P7/04A61P9/02A61P9/14A61P13/12
CPCA61K38/095A61K9/19A61K9/0019A61K47/26A61P9/14A61P7/04A61P1/16A61P13/12A61P9/02
Inventor 宋涵孟书舫张亚珊江良红王小明林立志
Owner FUJIAN MINDONG REJUVENATION PHARMA
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