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Method for preparing antitumor medical preparation

A technology of liquid medicine and lobaplatin, which is used in anti-tumor drugs, drug combinations, active ingredients of heavy metal compounds, etc., can solve the problems of excessive moisture and poor product crystallization, achieve uniform particles, uniform temperature transfer, avoid moisture absorption and The effect of slow oxidation

Active Publication Date: 2011-01-26
海南长安国际制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a preparation method of lobaplatin for injection, so as to solve the problems of excessive moisture in existing products and poor product crystallization

Method used

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  • Method for preparing antitumor medical preparation
  • Method for preparing antitumor medical preparation
  • Method for preparing antitumor medical preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] (1) Take 50g of lobaplatin anhydrate, add 2100ml of water for injection, the water temperature is 40°C, and prepare a solution;

[0056] (2) Add 1.5g of activated carbon for needles, add water for injection to 3000ml, keep warm and stir for 30 minutes, and filter aseptically;

[0057] (3) Take the filtrate and fill it with a semi-tampon, collect it into a freeze-drying tray, put it into the freezer of the freeze dryer, and pre-freeze it. Set the temperature at -10°C, keep it for 30 minutes, and cool it down to -40°C within 10 minutes. , keep for 2.5 hours, vacuum, vacuum degree: 15Pa, heat, adjust the temperature of silicone oil to -20°C, keep for 10 hours, rise to -10°C, keep for 2 hours, raise the temperature to 0°C, keep for 2 hours, and then raise the temperature To 10°C, keep for 1 hour, heat up to 20°C, keep for 1 hour, rise to 30°C, keep warm for 1 hour, rise to 40°C, keep hold for 1 hour, finally rise to 43°C, do pressure rise test after the vacuum is stable, W...

Embodiment 2

[0060] (1) Take 10g of lobaplatin anhydrate, add 1800ml of water for injection, the water temperature is 30°C, and prepare a solution;

[0061] (2) Add 1.6g of activated carbon for needles, add water for injection to 2000ml, keep warm and stir for 40 minutes, and filter aseptically;

[0062] (3) Take the filtrate and fill it with a semi-tampon, collect it into a freeze-drying tray, put it into the freezer of the freeze dryer, and pre-freeze it. Set the temperature at -10°C, keep it for 30 minutes, and cool it down to -50°C within 10 minutes. , kept for 2 hours, vacuumed, the vacuum degree is: 20Pa, heated, the temperature rose to -20°C, kept for 8 hours, raised to -10°C, kept for 3 hours, raised to 0°C, kept for 3 hours, and the temperature was raised to 20°C ℃, keep for 2 hours, rise to 30°C, keep warm for 2 hours, rise to 40°C, keep warm for 1 hour, finally rise to 45°C, after the vacuum is stable, do a pressure rise test, the pressure rises ≤ 3pa per minute, and the freeze-...

Embodiment 3

[0065] (1) Take 10g of lobaplatin anhydrate, add 1400ml of water for injection, the water temperature is 35°C, and prepare a solution;

[0066] (2) Add 0.6g of activated carbon for needles, add water for injection to 2000ml, keep warm and stir for 25 minutes, and filter aseptically;

[0067] (3) Take the filtrate and fill it with a semi-tampon, collect it into a freeze-drying tray, put it into the freezer of the freeze dryer, and pre-freeze it. Set the temperature at -10°C, keep it for 30 minutes, and cool it down to -40°C within 10 minutes. , kept for 4 hours, vacuumed, the vacuum degree is: 25Pa, heated, the temperature rose to -10°C, kept for 10 hours, raised to -10°C and kept for 3 hours, raised to 0°C, kept for 3 hours, and the temperature was raised to 20°C ℃, hold for 2 hours, rise to 30°C, hold for 2 hours, rise to 35°C, hold for 1 hour, finally rise to 40°C, finally rise to 44°C, do a pressure rise test after the vacuum is stable, and the pressure rises every minute ...

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Abstract

The invention belongs to the technical field of chemical pharmacy and in particular relates to a method for preparing an antitumor medical preparation. The method comprises the following steps of: (1) preparing solution by taking Lobaplatin as a raw material and adding a proper amount of cooled water for injection; (2) adding a proper amount of active carbon with needle uses and adding the water for injection until full content, stirring while preserving heat and then performing aseptic filtration; (3) bulking filtrate and half pressing the plug, collecting the filtrate to a free-drying plate; putting into a freeze fryer cooling chamber, prefreezing, vacuumizing and heating, performing sublimation drying and desorbtion drying and performing vacuum breaking and free-drying; (4) introducing dried and degermed high-purity nitrogen, taking the obtained product out of the freezer and rolling the cover to obtain Lobaplatin for injection.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmacy, and in particular relates to a preparation method of an injection preparation of an antitumor drug lobaplatin. Background technique [0002] Lobaplatin, chemical name: 1,2-diaminomethyl-cyclobutane-lactate platinum. Molecular formula is C 9 h 18 N 2 o 3 Pt, with a molecular weight of 397.34, belongs to the alkylating agent anticancer drug, and is the third generation platinum antitumor drug after cisplatin and carboplatin. It has definite cytotoxic effect on various animal and human tumor cell lines, similar and strong antitumor effect to cisplatin, and still has a certain cytotoxic effect on cisplatin-resistant cell lines, and is mainly used for breast cancer, small Cell lung cancer and chronic myelogenous leukemia treatment. [0003] Lobaplatin is characterized by strong anticancer activity, low toxicity, easy solubility in dimethyl sulfoxide, and slightly soluble in water. Com...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/282A61P35/00
Inventor 窦啟玲钟洪生周黎亚彭雯
Owner 海南长安国际制药有限公司
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