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Preparation method of injection-use oxaliplatin freeze-dried preparation

The technology of oxaliplatin and freeze-dried preparation is applied in the field of preparation of oxaliplatin freeze-dried powder injection, and can solve the problems of large difference between product temperature and partition temperature, high solution concentration, cracked vial of vial, etc. Achieve the effect of high yield, fast redissolving and slowing down the freezing time

Active Publication Date: 2013-08-07
湖北一半天制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Prepare oxaliplatin for injection according to the conventional method, the concentration of the solution is relatively high, the filling volume is relatively large, the temperature of the product and the temperature of the partition are greatly different during pre-freezing, and the cracking and bottoming of the vial are serious.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Taking 50 bottles of oxaliplatin freeze-dried preparation for injection as an example, the specific preparation method is:

[0021] Accurately weigh 22.5g of lactose monohydrate, add 50ml of water for injection, stir at 60-80°C to dissolve. Add 0.1% (w / w) medicinal charcoal to the above solution, heat and stir at 60-80°C for 30 minutes, filter and decarbonize, cool to room temperature, and set aside. Weigh an appropriate amount of water for injection, and inject nitrogen into it to eliminate oxygen in the water. Accurately weigh 2.5g of oxaliplatin, add 425ml of water for injection, stir at 20-30°C to dissolve, and keep nitrogen and light out during the dissolution of the main drug. The obtained oxaliplatin solution is placed for no more than 6 hours under nitrogen-filled and light-shielded conditions, and the above-mentioned lactose solution is added to the oxaliplatin solution, supplemented with water for injection to the full amount, and mixed evenly under light-shi...

Embodiment 2

[0027] Prepare 1.0 g of oxaliplatin solution according to conventional methods, then carry out low-temperature freeze-drying according to the following procedures:

[0028] A. Pre-freezing: adopt the quick-freezing process, first cool down the freeze-drying cabinet to -5~-10°C, and quickly set the temperature of the heat transfer oil to -45°C after the sample enters the cabinet, keep the temperature of the product and the heat transfer oil at the same temperature for 2~3 hours .

[0029] B. Sublimation drying: Raise the temperature of the heat transfer oil to -10°C at a speed of 1°C / 5min. When the temperature of the product and the heat transfer oil are similar, raise the temperature of the heat transfer oil to 0°C at a speed of 2°C / 5min. ℃, the sublimation drying stage ends, and the total time of this process is not less than 15h.

[0030] C. Analytical drying: heat the heat transfer oil at a rate of 2°C / 5min, raise the temperature of the product to 30±2°C, and keep it warm ...

Embodiment 3

[0033] Prepare 1.0 g of oxaliplatin solution according to conventional methods, then carry out low-temperature freeze-drying according to the following procedures:

[0034] A. Pre-freezing: adopt the quick-freezing process, first cool down the freeze-drying cabinet to -5~-10°C, and quickly set the temperature of the heat transfer oil to -45°C after the sample enters the cabinet, keep the temperature of the product and the heat transfer oil at the same temperature for 3-4 hours .

[0035] B. Sublimation drying: Raise the temperature of the heat transfer oil to -10°C at a speed of 1°C / 5min. When the temperature of the product and the heat transfer oil are similar, raise the temperature of the heat transfer oil to 0°C at a speed of 2°C / 5min. ℃, the sublimation drying stage ends, and the total time of this process is not less than 15h.

[0036] C. Analytical drying: heat the heat transfer oil at a rate of 2°C / 5min, raise the temperature of the product to 30±2°C, and keep it warm ...

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PUM

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Abstract

The invention discloses a preparation method of an injection-use oxaliplatin freeze-dried preparation. The method comprises the steps that: A, pre-freezing is carried out, wherein a quick-freezing process is adopted; a freeze-drying cabinet is cooled to -5 DEG C to -10 DEG C; when a sample is delivered into the cabinet, heat-conduction oil temperature is rapidly set as -45 DEG C; and when the temperature of the product is consistent with that of the heat-conduction oil, the temperature is maintained for 3-4h; B, sublimation-drying is carried out, wherein the temperature of the heat-conduction oil is rapidly increased to -10 DEG C with a speed of 1 DEG C / 5min; when the temperature of the product is similar to that of the heat-conduction oil, the temperature of the heat-conduction oil is rapidly increased to 0 DEG C with a speed of 2 DEG C / 5min; when the temperature of the product reaches 0 DEG C, sublimation-drying is finished, wherein a total time of the process is no shorter than 15h; C, vacuum-drying is carried out, wherein the heat-conduction oil is heated with a speed of 2 DEG C / 5min; the temperature of the product is increased to 30+ / -2 DEG C, and the temperature is maintained for 2-4h; and D, a nitrogen filling treatment is carried out, wherein nitrogen is filled under a vacuum state; the preparation is plugged, and is fetched from the cabinet. The freeze-dried preparation provided by the invention has the characteristics such as loose product, stable quality, fast re-dissolving, and good clarification degree.

Description

technical field [0001] The invention relates to a preparation method of oxaliplatin freeze-dried powder injection. Background technique [0002] Oxaliplatin is developed by Debiopharm in Switzerland and produced and sold by Sanofi in France. It is the third-generation platinum-based anticancer drug first launched in France in October 1996. It is mainly used for the treatment of metastatic colorectal cancer. [0003] Prepare oxaliplatin freeze-dried preparations for injection according to conventional methods. The process steps include pre-freezing, sublimation, and drying. ℃, after the sample enters the cabinet, quickly set the temperature of the heat transfer oil to -45°C, and keep the temperature of the product and the heat transfer oil at the same temperature for 3-4h; B, sublimation drying: raise the temperature of the heat transfer oil to -10°C at a speed of 1°C / 5min , when the temperature of the product and the heat transfer oil are similar, the temperature of the hea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P35/00A61J3/00A61K9/19A61K31/282
Inventor 易镇海李方芝
Owner 湖北一半天制药有限公司
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