Gemcitabine hydrochloride lyophilized powder injection and preparation method thereof

A technology of gemcitabine hydrochloride and freeze-dried powder injection, applied in the field of pharmaceutical preparations, can solve the problems of unsuitable popularization, high production cost, long freeze-drying cycle and the like

Active Publication Date: 2011-08-10
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above-mentioned prescription is simple, and the main drug content is also high, but the freeze-drying cycle is too long, generally greater than 33h, resulting in high production costs in the preparation process, and it is not suitable for popularization and use

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] (1) Prescription:

[0076]

[0077] (2) Preparation process:

[0078] Weigh prescription amounts of gemcitabine hydrochloride, sodium acetate, lactose and mannitol. First add 85% of the total amount of water for injection into the liquid mixing tank, put in the materials, stir to dissolve completely; control the temperature of the solution in the liquid mixing tank at 38°C, adjust the pH to 2.7-3.3, and replenish the water for injection to the full amount , mix evenly, add medicinal activated carbon, stir and absorb, decarbonize, after the intermediate is qualified, the liquid is sterilized and filtered at 0.22 μm, and then the liquid is moved to the 100-level laminar flow hood of the filling machine for a second time at 0.22 μm Terminally sterilized and filtered into the liquid medicine barrel, filled, half-tamped, and freeze-dried.

[0079] Pre-freezing stage: reduce the shelf temperature to -50°C at a constant rate within 3 hours, and keep warm for 5 hours after...

Embodiment 2

[0083] (1) Prescription:

[0084]

[0085] (2) Preparation process:

[0086] Weigh prescription amounts of gemcitabine hydrochloride, sodium acetate, lactose and mannitol. First add 85% of the total amount of water for injection into the liquid mixing tank, put in the materials, stir to dissolve completely; control the temperature of the solution in the liquid mixing tank at 45°C, adjust the pH to 2.7-3.3, and replenish the water for injection to the full amount , mix evenly, add medicinal activated carbon, stir and absorb, decarbonize, after the intermediate is qualified, the liquid is sterilized and filtered at 0.22 μm, and then the liquid is moved to the 100-level laminar flow hood of the filling machine for a second time at 0.22 μm Terminally sterilized and filtered into the liquid medicine barrel, filled, half-tamped, and freeze-dried.

[0087] Pre-freezing stage: reduce the shelf temperature to -48°C within 3 hours, and keep warm for 4 hours after the product temperat...

Embodiment 3

[0091] (1) Prescription:

[0092]

[0093]

[0094] (2) Preparation process:

[0095] Weigh prescription amounts of gemcitabine hydrochloride, sodium acetate, lactose and mannitol. First add 85% of the total amount of water for injection into the liquid mixing tank, put in the materials, stir to dissolve completely; control the temperature of the solution in the liquid mixing tank at 30°C, adjust the pH to 2.7-3.3, and replenish the water for injection to the full amount , mix evenly, add medicinal activated carbon, stir and absorb, decarbonize, after the intermediate is qualified, the liquid is sterilized and filtered at 0.22 μm, and then the liquid is moved to the 100-level laminar flow hood of the filling machine for a second time at 0.22 μm Terminally sterilized and filtered into the liquid medicine barrel, filled, half-tamped, and freeze-dried.

[0096] Pre-freezing stage: reduce the shelf temperature to -50°C within 3 hours, and keep warm for 3 hours after the pr...

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PUM

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Abstract

The invention relates to a gemcitabine hydrochloride lyophilized powder injection and a preparation method thereof. The lyophilized powder injection comprises the following components in parts by weight: 20-30 parts of gemcitabine hydrochloride, 5-9 parts of mannitol, and 3-10 parts of sodium acetate. The freeze-drying step includes the following three stages: a pre-freezing stage, a primary drying stage and a secondary drying stage, and the entire freeze-drying time is lower than 20 hours. The gemcitabine hydrochloride lyophilized powder injection provided by the invention has the advantages of less types and amounts of adjuvants, easily-controlled technological parameters, simple process route, short freeze-drying time, convenience in operation, good repeatability, low contents of related substances, and controllable quality; and the redissolved lyophilized powder injection has good clarity and forming performance. The lyophilized powder injection has stable and controllable quality, is easy to realize industrial production, and can generate considerable economic and social benefits.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, and more specifically, the invention provides a gemcitabine hydrochloride freeze-dried powder injection and a preparation method thereof. Background technique [0002] Gemcitabine hydrochloride, English name: Gemcitabine Hydrochloride, its chemical name is: (+) 2'-deoxy-2', 2'-difluorocytosine hydrochloride, its structural formula is: [0003] [0004] Molecular formula: C 9 h 11 f 2 N 3 o 4 • HCl, molecular weight: 299.66. [0005] Lung cancer is currently the most common malignant tumor that causes the death of cancer patients in the world, and its death toll is equivalent to the sum of the deaths from breast cancer, prostate cancer and colon cancer, among which non-small cell lung cancer (NSCLC) patients account for a considerable proportion. According to the statistics of the United States in 1999, the number of new cases of NSCLC in the United States reached as many as 180...

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 马鹰军钟正明
Owner HAINAN JINRUI PHARMA CO LTD
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