Gemcitabine hydrochloride lyophilized powder for injection and preparation method thereof

A technology of gemcitabine hydrochloride and freeze-dried powder, which is applied in the direction of freeze-dried transportation, medical preparations containing no active ingredients, and medical preparations containing active ingredients. It can solve the problems of restricting large-scale production and achieve quality control. Small amount, good stability

Active Publication Date: 2012-10-03
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The production of the freeze-dried powder injection requires gemcitabine hydrochloride prepared according to a specific synthesis and refining process as a raw material, which limits the large-scale production of the preparation

Method used

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  • Gemcitabine hydrochloride lyophilized powder for injection and preparation method thereof
  • Gemcitabine hydrochloride lyophilized powder for injection and preparation method thereof
  • Gemcitabine hydrochloride lyophilized powder for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Prescription amount:

[0023] Gemcitabine Hydrochloride 228g

[0024] Lactose 410g

[0025] Sodium citrate 13.5g

[0026] Preparation Process:

[0027] Weigh the prescribed amount of lactose and sodium citrate, add 3.5L of water for injection to dissolve, then add the prescribed amount of gemcitabine hydrochloride, stir to dissolve, set the volume to 4L, heat to 50±2°C, add 0.05% of the prepared amount (g / ml) Activated carbon for needles, keep warm and adsorb for 30min, decarbonize, let cool, adjust pH=2.5~2.8 with 1mol / L hydrochloric acid solution or / and 1mol / L sodium hydroxide solution, filter and sterilize, fill the liquid medicine 1000 bottles, half-stoppered, samples into boxes, freeze-dried according to the following steps:

[0028] (1) Pre-freezing: adopt the slow freezing method, after the sample temperature drops to -35°C and the samples are all frozen and the color is consistent, continue to pre-freeze for 2 hours to completely freeze the samples;

[0029...

Embodiment 2

[0032] Prescription amount:

[0033] Gemcitabine Hydrochloride 228g

[0034] Lactose 365g

[0035] Sodium citrate 7.2g

[0036] Preparation process: with embodiment 1.

Embodiment 3

[0038] Prescription amount:

[0039] Gemcitabine Hydrochloride 1140g

[0040] Lactose 1930g

[0041] Sodium citrate 45g

[0042] Preparation Process:

[0043]Weigh the prescribed amount of lactose and sodium citrate, add 18L of water for injection to dissolve, then add the prescribed amount of gemcitabine hydrochloride, stir to dissolve, set the volume to 20L, heat to 50±2°C, add the prepared amount of 0.05% ( g / ml) activated carbon for needles, keep warm for 40min, decarbonize, let cool, adjust pH=2.5~3.0 with 1mol / L hydrochloric acid solution or / and 1mol / L sodium hydroxide solution, filter and sterilize, fill the liquid medicine, Half stoppered, the sample is put into the box, and freeze-dried according to the following steps:

[0044] (1) Pre-freezing: Use the slow freezing method. After the sample temperature drops to -35°C and the samples are all frozen and the color is consistent, continue to pre-freeze for 2 hours to completely freeze the samples;

[0045] (2) Subl...

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PUM

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Abstract

The invention discloses gemcitabine hydrochloride lyophilized powder for injection. The gemcitabine hydrochloride lyophilized powder consists of the following components in parts by mass: 100 parts of gemcitabine hydrochloride, 160-180 parts of lactose and 3-6 parts of sodium citrate. As proved by influencing factor testing investigation, each detection index the gemcitabine hydrochloride lyophilized powder for injection prepared by adopting a formula and a process provided by the invention does not change remarkably in a high-temperature, high-humidity and strong-light-irradiation environment, and high stability is achieved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a gemcitabine hydrochloride freeze-dried powder for injection and a preparation method thereof. Background technique [0002] As a prodrug, gemcitabine is a good substrate for deoxythymidine kinase phosphorylation in cells, and is converted into the following metabolites under the action of the enzyme: gemcitabine monophosphate (dFdCMP), gemcitabine diphosphate (dFdCDP) and gemcitabine triphosphate Phosphate (dFdCTP), where dFdCDP and dFdCTP are active products. dFdCDP inhibits ribonucleotide reductase, thereby reducing the amount of deoxynucleotides needed for repair of DNA synthesis (especially dCTP), and low levels of dCTP reverse the normal negative feedback inhibition of deoxyglycoside kinases, resulting in more dFdCTP accumulation. At the same time, dFdCDP inhibits the deamination of dFdCMP by dCTP-induced deoxycytidine, and dFdCTP directly...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/7068A61K47/26A61P35/00
Inventor 巩绪娟吴成飞
Owner NANJING CHIA TAI TIANQING PHARMA
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