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Method for preparing gemcitabine hydrochloride lyophilized powder

A technology for gemcitabine hydrochloride and freeze-dried powder injection, which is applied in the field of preparing gemcitabine hydrochloride freeze-dried powder for injection, can solve problems such as poor clarity, and achieve the effects of low drying temperature, simple operation and low content of related substances

Active Publication Date: 2013-08-07
CHONGQING LUMMY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In view of this, the object of the present invention is to provide a method for preparing gemcitabine hydrochloride freeze-dried powder to overcome the problem of poor clarity after reconstitution of gemcitabine hydrochloride freeze-dried powder prepared by the freeze-drying process in the prior art. There are technical defects, and the preparation of gemcitabine hydrochloride freeze-dried powder injection products with good resolubility, high clarity and meeting the drug requirements

Method used

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  • Method for preparing gemcitabine hydrochloride lyophilized powder
  • Method for preparing gemcitabine hydrochloride lyophilized powder
  • Method for preparing gemcitabine hydrochloride lyophilized powder

Examples

Experimental program
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Effect test

Embodiment 1

[0036] Dosing: Weigh 228g of gemcitabine hydrochloride, add 4.5L of water for injection, stir to dissolve, then add 200g of mannitol and 12.5g of sodium acetate, stir to dissolve completely, then add water for injection to 5L. Add 2.5g of activated carbon, stir and let stand for 15 minutes, filter, fill with 5mL / bottle, stopper halfway, and send it to a freeze-drying box.

[0037] Freeze-drying: lower the temperature of the freeze-drying box to -40°C and keep it warm for 4 hours. Turn on the vacuum pump, and after the vacuum degree in the drying oven is 20-30Pa, start to heat up and dry at a rate of 0.15°C / min, so that the product temperature rises to -13°C, control the vacuum degree at 15-30Pa, and dry for 15 hours. Then, the temperature was raised at a rate of 1.0°C / min, and after the temperature of the product was raised to 20°C, the vacuum degree was controlled at 15-30Pa for 5 hours. The freeze-dried product is stuffed, out of the box, covered with an aluminum cover, and...

Embodiment 2～8

[0039] The dosing process is the same as in Example 1, and the parameters of the freeze-drying process are shown in Table 1.

[0040] Table 1 embodiment 2~8 lyophilization process

[0041]

Embodiment 9

[0043] The dosing process is the same as in Example 1. In the freeze-drying process, the quick-freezing method is used for pre-freezing, that is, the temperature of the freeze-drying box is lowered to -40° C., and then the samples are put into the freeze-drying process for 4 hours. The rest of the freeze-drying process is the same as that of Example 1.

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Abstract

The invention relates to the field of pharmaceutic preparations and discloses a method for preparing gemcitabine hydrochloride lyophilized powder. According to the method for preparing the gemcitabine hydrochloride lyophilized powder, a primary pre-freezing process and a stage drying process are used for lyophilization; appropriate vacuum degrees and temperature are matched at all drying stages to avoid the problem that hydrochloric acid is removed from gemcitabine hydrochloride under high vacuum degree, and drying efficiency is low due to low vacuum degree; meanwhile, temperature is slowly raised at different speed at different drying stages, and the problem that the gemcitabine hydrochloride is deacidified due to too high heating speed can be solved. Compared with the prior art, the method for preparing the gemcitabine hydrochloride lyophilized powder has the advantages that the method is easy to operate, lyophilization time is short, and drying temperature is low; the prepared gemcitabine hydrochloride lyophilized powder product is high in outer structural quality and redissolution performance; a redissolution solution is clear and transparent, and opalescence is avoided; relative substances are low in content, and the prepared gemcitabine hydrochloride lyophilized powder is safe and reliable in quality; and the method is suitable for preparing the gemcitabine hydrochloridelyophilized powder and can be widely applied to large-scale production of the gemcitabine hydrochloride lyophilized powder.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for preparing gemcitabine hydrochloride freeze-dried powder injection. Background technique [0002] Gemcitabine hydrochloride is a new type of artificially synthesized difluoronucleoside antimetabolite and antineoplastic drug. It mainly acts on tumor cells in the DNA synthesis phase, that is, cells in the S phase. Under certain conditions, it can prevent the progress from the G1 phase to the S phase. It is suitable for locally advanced or metastatic non-small cell lung cancer, pancreatic cancer, bladder cancer, breast cancer and other solid tumors. [0003] Gemcitabine hydrochloride has poor stability, is very unstable in aqueous solution, and is easy to decompose. According to research reports, gemcitabine hydrochloride is placed for four weeks at 40°C in 0.1N hydrochloric acid solution, and the content of gemcitabine hydrochloride in the solution is only 86...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7068A61P35/00
Inventor 吴应纯王浩胡显刚翁益明
Owner CHONGQING LUMMY PHARMA
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