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, low content of related substances, and safe and reliable quality

Active Publication Date: 2012-11-28
CHONGQING LUMMY PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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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 po

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] Preparation: Weigh 228 g of gemcitabine hydrochloride, add 4.5L of water for injection, stir to dissolve, then add 200 g of mannitol and 12.5 g of sodium acetate, stir to dissolve completely, and add water for injection to 5L. Add 2.5g of activated carbon, stir and let stand for 15min, filter, fill at 5mL / bottle, half stopper, and send it to the freeze drying oven.

[0037] Freeze-drying: reduce the temperature of the freeze-drying box to -40°C and keep it warm for 4 hours. Turn on the vacuum pump. After the vacuum degree in the drying box is 20-30Pa, start heating and drying at a rate of 0.15℃ / min to raise the product temperature to -13℃, control the vacuum degree at 15-30Pa, and dry for 15h. Then the temperature is increased at a rate of 1.0°C / min to increase the temperature of the product to 20°C, and the vacuum is controlled to dry at 15-30Pa for 5h. The freeze-dried products are plugged, out of the box, tied with aluminum lid, and packaged and stored after passing th...

Embodiment 2～8

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

[0040] Table 1 Examples 2-8 freeze-drying process

[0041]

Embodiment 9

[0043] The liquid preparation process is the same as in Example 1. In the freeze-drying process, the pre-freezing method adopts the quick-freezing method, that is, the temperature of the freeze-drying box is lowered to -40° C., and then the sample is pre-frozen for 4 hours. The remaining freeze-drying process is the same as in 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 synthetic new type of difluoronucleoside anti-metabolic antineoplastic agent, which mainly acts on tumor cells in the DNA synthesis phase, namely S phase cells. Under certain conditions, it can prevent the progression from G1 phase to 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 easily decomposes. According to research reports, gemcitabine hydrochloride is placed in a 0.1N hydrochloric acid solution at 40℃ for four weeks, and the content of gemcitabine hydrochloride in the solution is only 86%; it is placed for four weeks at 40℃ ...

Claims

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Application Information

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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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