Teniposide injection and preparation method thereof

A technology of niposide injection and teniposide, which is applied in the field of medicine, can solve problems such as drug leakage, thermodynamic instability, and particle size increase, achieve good stability and water solubility, reduce work burden, and improve compliance sexual effect

Inactive Publication Date: 2009-05-27
SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these two preparations are thermodynamically unstable systems, and there are problems such as aggregation, delamination, drug leakage, and particle size increase. Some preparations still contain Cremophor EL, and the production process of these two preparations is complicated and the drug loading is low.
Therefore, there is currently no new formulation that is stable, safe, highly compliant, and has a simple production process that can replace the above-mentioned teniposide injection containing Cremophor EL currently used clinically.

Method used

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  • Teniposide injection and preparation method thereof
  • Teniposide injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Example 1 Preparation of Teniposide Injection

[0019] Take 1 g of teniposide, add 3 ml of benzyl alcohol, 6 ml of N,N dimethylacetamide, stir and dissolve at 60°C as solution 1; take 15 ml of absolute ethanol, add 45 g of Tween-80, inject Use 15 grams of soybean lecithin and 1 gram of cholesterol, stir and dissolve at 60°C as solution 2; mix solution 1 and solution 2 evenly, add absolute ethanol to 100 ml, adjust the pH to 5.0 with fumaric acid, and then add 0.3 grams of Use activated carbon for needles, absorb at 30°C for 30 minutes, filter through a 0.45 μm microporous membrane, and then filter and sterilize with a 0.22 μm microporous membrane, then dispense it.

Embodiment 2

[0020] Example 2 Preparation of Teniposide Injection

[0021] Take 0.1 g of teniposide, add 1 ml of benzyl alcohol and 5 ml of absolute ethanol, stir and dissolve at 40°C as solution 1; take 35 ml of absolute ethanol, 10 ml of glycerin, and 15 ml of polyethylene glycol 200 and mix well. Add 3 grams of Tween-80, 25 grams of soybean lecithin for injection, and 0.5 grams of glycerol monooleate, stir and dissolve at 40°C as solution 2; mix solution 1 and solution 2 evenly, add absolute ethanol to 100 ml, and use Adjust the pH to 4.0 with acetic acid, then add 0.05 g of activated carbon for needles, absorb at 60°C for 100 minutes, filter with a sand filter stick, sub-package, and sterilize by high-pressure steam at 105°C for 45 minutes.

Embodiment 3

[0022] Example 3 Preparation of Teniposide Injection

[0023] Take 0.01 g of teniposide, add 5 ml of propylene glycol, and dissolve it with conventional ultrasound as solution 1; take 70 ml of propylene glycol, 10 ml of polyethylene glycol 300 and mix well, add 1 g of Tween-80, and 0.1 g of egg yolk phospholipid for injection 1. Poloxamer 188 (F68) 5 grams, according to conventional ultrasonic dissolution as solution 2; Mix solution 1 and solution 2 evenly, add propylene glycol to 100 ml, adjust pH to 6.5 with citric acid and sodium hydroxide, then add 0.01 gram of needles with activated carbon, adsorbed at 80°C for 25 minutes, filtered with a vertical melting funnel, packed separately, and sterilized by high-pressure steam at 121°C for 20 minutes.

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Abstract

The invention relates to the field of medical technology, in particular to a new injection for teniposide mainline and a preparation method of the new injection. Components of the injection include teniposide, Tween 80, phospholipid, a stabilizer and an injection solvent. As no Cremophor EL is contained, compared with existing clinical preparations, not only the teniposide injection has few side effects and good stability and improves the medicine-taking compliance of patients, but also the preparation method of the teniposide injection is simple and easy to operate and the teniposide injection is suitable for large-scale preparation and industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a teniposide injection for intravenous injection and a preparation method thereof. Background technique [0002] Teniposide (Teniposide, Vumon, VM-26) aliases: Teniposide, Wittner, Vierm 26, Podophylloside, Podophylloside, Podophyllothiophene Glycoside, podophylloside. Teniposide is a biological ester base with anti-cancer effect proposed from the plant of the genus Cephalia, which can inhibit the synthesis of eukaryotic protein, depolymerize polyribosomes, and interfere with the function of ribosome sugar. Teniposide is a cycle-specific cytotoxic drug that acts on the cell cycle S 2 Late and G 2 It works by preventing the mitosis of cells. It can also cause single-strand and double-strand breaks of DNA bonds, and its mechanism of action may be caused by the inhibition of type II topoisomerase. Because teniposide has a broad-spectrum anti-tumor activity, it is mainly used c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048A61K47/24A61K47/34A61P35/00A61K47/10A61K47/14A61K47/26A61K47/28
Inventor 陈建明邓莉吴忠斌高保安张扬郭丹张悦孙靖杨秋霞李莹
Owner SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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