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Artemether injection and preparation method thereof

A technique for artemether and injection, applied in the field of artemether injection and preparation thereof, can solve the problems of low artemether content, difficulty in satisfying quality control, poor stability of artemether injection and the like

Active Publication Date: 2021-02-05
安徽海洋药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the artemether injection prepared by the above process has the disadvantages of poor stability and low artemether content, which is difficult to meet the needs of quality control

Method used

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  • Artemether injection and preparation method thereof
  • Artemether injection and preparation method thereof
  • Artemether injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] (1) Mix 100g artemether, 10g soybean lecithin, and 100mg vitamin E in a reaction kettle, and use supercritical CO at a temperature of 35°C and 15MPa. 2 After 30 minutes of fluid treatment, depressurize and discharge CO 2 , to obtain mixture A;

[0023] (2) Mixture A and 30g benzyl alcohol were mixed for 30min to obtain component one;

[0024] (3) 150g ethyl oleate was mixed with 650mL soybean oil for injection for 15min to obtain component 2;

[0025] (4) Heat component two to 60°C, then add component one to dissolve for 15 minutes, and then add soybean oil for injection at 60°C to 1000 mL to obtain artemether injection.

Embodiment 2

[0027] (1) Mix 90g of artemether, 9g of soybean lecithin and 90mg of vitamin E in a reaction kettle, and use supercritical CO at a temperature of 32°C and 14MPa. 2 After 25 minutes of fluid treatment, depressurize and discharge CO 2 , to obtain mixture A;

[0028] (2) Mixture A was mixed with 25g benzyl alcohol for 25min to obtain component one;

[0029] (3) 110g ethyl oleate was mixed with 640mL soybean oil for injection for 12min to obtain component 2;

[0030] (4) Heat component two to 55°C, then add component one to dissolve for 12 minutes, and then add soybean oil for injection at 55°C to 1000 mL to obtain artemether injection.

Embodiment 3

[0032] (1) Mix 80g of artemether, 5g of soybean lecithin and 50mg of vitamin E in a reaction kettle, and use supercritical CO at a temperature of 30°C and 10MPa. 2 After 20 minutes of fluid treatment, depressurize and discharge CO 2 , to obtain mixture A;

[0033] (2) Mixture A and 20g benzyl alcohol were mixed for 20min to obtain component one;

[0034] (3) 100g ethyl oleate was mixed with 550mL soybean oil for injection for 10min to obtain component 2;

[0035] (4) Heat component two to 50°C, then add component one to dissolve for 10 minutes, and then add soybean oil for injection at 50°C to 1000 mL to obtain artemether injection.

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Abstract

The invention discloses an artemether injection and a preparation method thereof. Every 1000 mL of the artemether injection contains 80-100 g of artemether, 20-30 g of benzyl alcohol, 100-150 g of ethyl oleate, 5-10 g of phospholipid, 50-100 mg of an antioxidant and the balance of soybean oil for injection. The prepared artemether injection not only has high content of effective components, but also has excellent stability.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an artemether injection and a preparation method thereof. Background technique [0002] Artemether is a derivative of artemisinin, which has a strong and rapid killing effect on the erythrocytic apomict of Plasmodium. To control the clinical onset and symptoms, it is used for the treatment of chloroquine-resistant falciparum malaria and dangerous malaria, and the effect is rapid and the curative effect is good. Animal experiments have shown that its antimalarial effect is 10 to 20 times that of artemisinin. [0003] The existing artemether injection is prepared by heating and miscible with artemether as the active ingredient, benzyl alcohol and soybean oil as the solvent. However, the artemether injection prepared by the above process has the disadvantages of poor stability and low artemether content, and it is difficult to meet the requirements of quality c...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/357A61K47/44A61P33/06
CPCA61K9/0019A61K9/08A61K31/357A61K47/44A61P33/06
Inventor 吴延柱汤彬吴鹏杨怀玉吴楠
Owner 安徽海洋药业有限公司