Concentrated solution for temsirolimus injection and preparation method thereof

A technology for injection and concentrated solution, which is applied in the field of medicine, can solve the problems of not being able to reduce the tendency of substances to increase, and the safety of injections is not enough, so as to overcome the increase of temsirolimus isomers and related substances, and related substances. Substance small effect

Active Publication Date: 2016-06-22
LUNAN BETTER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Chinese patent CN103989676A discloses an injectable temsirolimus composition, which consists of a concentrated solution and a diluent, wherein the concentrated solution contains the main drug temsirolimus, absolute ethanol, organic acid and propylene glycol, and the diluent Contains polysorbate 80, ethanol, polyethylene glycol 400, which effectively reduces the problem that the isomers of temsirolimus become larger in the injection due to the introduction of water during lon

Method used

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  • Concentrated solution for temsirolimus injection and preparation method thereof
  • Concentrated solution for temsirolimus injection and preparation method thereof
  • Concentrated solution for temsirolimus injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] 1. Preparation of Temsirolimus Concentrated Solution for Injection

[0025] prescription

[0026]

[0027] Preparation

[0028] (1) Preparation of dilute sodium hydroxide solution: take 0.1g of sodium hydroxide and add it to 100ml of absolute ethanol, stir to dissolve;

[0029] (2) Take by weighing temsirolimus, benzyl alcohol, and butylparaben of prescription quantity, add in the dehydrated alcohol of 300.0ml, stir and dissolve;

[0030] (3) take the anhydrous citric acid of recipe quantity, add in the dehydrated alcohol of 100.0ml, stir and dissolve;

[0031] (4) Slowly add the medicinal solution in (2) to the solution (3) under stirring, adjust the pH with dilute sodium hydroxide solution, adjust the volume to the total amount with absolute ethanol, stir and mix evenly; filter, fill, and Inspection, packaging to get the finished product.

[0032] 2. Preparation of solvent for injection

[0033] Weigh 720.0g of Polysorbate 80 and 770.4g of Polyethylene Glycol ...

Embodiment 2

[0035] 1. Preparation of Temsirolimus Concentrated Solution for Injection

[0036] prescription

[0037]

[0038]

[0039] Preparation method: with embodiment 1.

[0040] 2. The preparation of solvent for injection: with embodiment 1.

Embodiment 3

[0042] 1. Preparation of Temsirolimus Concentrated Solution for Injection

[0043] prescription

[0044]

[0045] Preparation method: with embodiment 1.

[0046] 2. The preparation of solvent for injection: with embodiment 1.

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Abstract

The invention provides a preparation method of a concentrated solution for temsirolimus injection. The concentrated solution is mainly prepared from active component, benzyl alcohol, butyl hydroxybenzoate, organic acid or inorganic acid, pH regulator and absolute ethyl alcohol. The prepared preparation has few related substances, is stable in long-term storage process, and meanwhile solves the problem that due to the introduction of water, temsirolimus isomers and related substances are increased.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a concentrated solution of temsirolimus for injection and a preparation method thereof. Background technique [0002] Tesirolimus, also known as Temsirolimus, trade name: Torisel (temsirolimus, CCI-779) is a derivative of rapamycin C42 propionate, developed by Wyeth, and approved by the US FDA in May 2007. , temsirolimus injection for the treatment of advanced renal cell carcinoma, and designated as an orphan drug, is the first anti-tumor mTOR inhibitor. [0003] Temsirolimus is the 42-bis-hydroxymethyl propionate of rapamycin, which exhibits cell growth and proliferation inhibition in vivo, and can delay the time of tumor cell development or tumor recurrence. Temsirolimus binds to the cellular protein FKBP and forms a complex that inhibits the enzyme mTOR (mammalian target of rapamycin). Inhibition of mTOR's kinase activity inhibits various signal transduction path...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/14A61K47/10A61K31/436A61P35/00
CPCA61K9/0019A61K9/08A61K31/436A61K47/10A61K47/14
Inventor 张贵民董其松
Owner LUNAN BETTER PHARMA
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