Irinotecan hydrochloride pharmaceutical composition and preparation method thereof

A technology for irinotecan hydrochloride and composition, which is applied in the field of irinotecan hydrochloride composition and its preparation, can solve the problems of insoluble particles and unqualified clarity, see foreign bodies, cannot be completely dissolved, etc., and achieve considerable economic and social benefits , The content is uniform and accurate, and the effect of improving the reconstitution performance

Inactive Publication Date: 2014-03-26
BEIJING KEYUAN CHUANGXIN TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Using the traditional freeze-drying process, because part of the HCl in irinotecan hydrochloride is pumped away under high vacuum conditions, the salt formation of irinotecan hydrochloride is not complete, and part of irinotecan hydrochloride exists in the form of bases, which cannot be completely dissolved in clinical use. Visible foreign matter, insoluble particles and unqualified clarity appear, all of which indicate that there may be more tiny particles in irinotecan hy

Method used

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  • Irinotecan hydrochloride pharmaceutical composition and preparation method thereof
  • Irinotecan hydrochloride pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] The irinotecan hydrochloride pharmaceutical composition described in every 1000 bottles, its formula consists of:

[0059] Irinotecan Hydrochloride 40g

[0060] Lactose 400g

[0061] Add purified water to 50kg

[0062] Preparation Process:

[0063] (1) Preparation: put irinotecan hydrochloride and lactose in a liquid preparation tank in a weight ratio of 1:1 to 20, add water for injection, stir to dissolve completely and mix evenly;

[0064] (2) Sterile filtration and subpackaging: filter the irinotecan hydrochloride solution obtained above through a microporous membrane into a sterile room, subpackage in vials, and half stopper;

[0065] (3) Vacuum freeze drying:

[0066] a. Pre-freezing: Put the above-mentioned irinotecan hydrochloride liquid in a lyophilizer, and reduce the product temperature at a rate of 10-15°C / hour. When the product temperature is lower than –40°C, keep it warm for 60 minutes to freeze the The irinotecan solution is completely frozen;

[00...

Embodiment 2

[0078] The irinotecan hydrochloride pharmaceutical composition described in every 1000 bottles, its formula consists of:

[0079] Irinotecan Hydrochloride 20g

[0080] Lactose 300g

[0081] Add purified water to 50kg

[0082] Preparation process: with embodiment 1.

Embodiment 3

[0084] The irinotecan hydrochloride pharmaceutical composition described in every 1000 bottles, its formula consists of:

[0085] Irinotecan Hydrochloride 40g

[0086] Lactose 200g

[0087] Add purified water to 50kg

[0088] Preparation process: with embodiment 1.

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Abstract

The invention discloses irinotecan hydrochloride pharmaceutical composition and a preparation method thereof. The composition contains irinotecan hydrochloride and mannitol. The preparation method comprises the following steps: 1), preparation is performed: ambroxol hydrochloride and mannitol are placed into a preparation tank in a weight ratio of 1:(1-20), water for injection is added, and the mixture is stirred until complete dissolution and uniform mixing are achieved; 2), sterile filtration, subpackaging and half stoppering are performed; and 3), vacuum freeze drying is performed to obtain a product. The composition and the preparation method have the advantages that the formula is simple, the technology is advanced, the quality is uniform and stable, moisture drying is thorough, and the redissolution performance is better.

Description

technical field [0001] The invention belongs to the field of medical technology preparation, and in particular relates to an irinotecan hydrochloride composition for injection and a preparation method thereof. Background technique [0002] Irinotecan hydrochloride Irinotecan is a semi-synthetic derivative of camptothecin. Camptothecin can specifically bind totoisomerase I, which induces reversible single-strand breaks, thereby unwinding the DNA double-strand structure; irinotecan and its active metabolite SN-38 can bind totoisomerase The I-DNA complex binds, thereby preventing the rejoining of the broken single strands. Existing studies suggest that the cytotoxic effect of irinotecan is due to the interaction between replicase and topoisomerase I-DNA-irinotecan (or SN-38) triple complex during DNA synthesis, thereby causing DNA double Chain break. Mammalian cells cannot efficiently repair such DNA double-strand breaks. It is suitable for the treatment of metastatic color...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4745A61P35/04
Inventor 李晓红
Owner BEIJING KEYUAN CHUANGXIN TECH
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