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Combretastain diphosphate tetrasodium composition for injection and preparation method thereof

A technology of compretin diphosphate tetrasodium and retin diphosphate tetrasodium, which is applied in the field of injection compretin tetrasodium diphosphate composition and its preparation, and can solve the problems of poor stability, light and heat instability, It is prone to degradation and other problems, and achieves the effect of uniform quality, good quality and low impurity content

Active Publication Date: 2013-04-17
NANJING CHENGONG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] The technical purpose of the present invention is to provide injection compretine tetrasodium diphosphate composition and preparation method thereof for the above deficiencies, to solve the problem that the compretine tetrasodium diphosphate in the solution state is unstable to light and heat, Easily degraded, resulting in poor stability during production and transportation and storage of finished products

Method used

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  • Combretastain diphosphate tetrasodium composition for injection and preparation method thereof
  • Combretastain diphosphate tetrasodium composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0142] prescription:

[0143] Compretin Tetrasodium Diphosphate 100g

[0144] Lactose 200g

[0145] Add water for injection to 20Kg

[0146] Get the water for injection and put it in the preparation tank, and turn on the magnetic stirrer;

[0147] Weigh compretidine tetrasodium diphosphate and lactose, add lactose into the preparation tank, stir to dissolve and mix evenly, add 0.2g of activated carbon, keep warm at 70°C for 20 minutes, decarbonize and cool to 20°C;

[0148] Add compretidine tetrasodium diphosphate, stir to dissolve and mix evenly, adjust the pH value to 10.5 with sodium hydroxide;

[0149] Add water for injection cooled to 20°C to 20Kg, stir to mix evenly;

[0150] The liquid medicine is filtered through two 0.22μm microporous membranes connected in series to the sterile room, filled in brown vials, half stoppered, put into a plate, and sent to a freeze dryer;

[0151] Close the box door, open the circulation pump, compressor and front box she...

Embodiment 2

[0158] prescription:

[0159] Compretin Tetrasodium Diphosphate 100g

[0160] Lactose 200g

[0161] Add water for injection to 20Kg

[0162] Get the water for injection and put it in the preparation tank, and turn on the magnetic stirrer;

[0163] Weigh compretidine tetrasodium diphosphate and lactose, add lactose into the preparation tank, stir to dissolve and mix evenly, add 0.4g of activated carbon, keep warm at 75°C for 20 minutes, decarbonize and cool to 20°C;

[0164] Add compretidine tetrasodium diphosphate, stir to dissolve and mix evenly, adjust the pH value to 10.5 with sodium hydroxide;

[0165] Add water for injection cooled to 20°C to 20Kg, stir to mix evenly;

[0166] The liquid medicine is filtered through two 0.22μm microporous membranes connected in series to the sterile room, filled in brown vials, half stoppered, put into a plate, and sent to a freeze dryer;

[0167] Close the box door, open the circulation pump, compressor and front box she...

Embodiment 3

[0174] prescription:

[0175] Compretin Tetrasodium Diphosphate 100g

[0176] Lactose 200g

[0177] Add water for injection to 30Kg

[0178] Get the water for injection and put it in the preparation tank, and turn on the magnetic stirrer;

[0179] Weigh compretidine tetrasodium diphosphate and lactose, add lactose into the preparation tank, stir to dissolve and mix evenly, add 0.4g of activated carbon, keep warm at 65°C for 20 minutes, decarbonize and cool to 20°C;

[0180] Add compretidine tetrasodium diphosphate, stir to dissolve and mix evenly, adjust the pH value to 10.3 with sodium hydroxide;

[0181] Add water for injection cooled to 20°C to 30Kg, stir to mix evenly;

[0182] The liquid medicine is filtered through two 0.22μm microporous membranes connected in series to the sterile room, filled in brown vials, half stoppered, put into a plate, and sent to a freeze dryer;

[0183] Close the box door, open the circulation pump, compressor and front box she...

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Abstract

The invention relates to a combretastain diphosphate tetrasodium composition for injection. The composition contains combretastain diphosphate tetrasodium and lactose in the weight ratio of 1:(2-5). The invention also provides a preparation method for the combretastain diphosphate tetrasodium composition for injection. The defects about a preparation process for the combretastain diphosphate tetrasodium composition for injection and the stability of a finished product are overcome, the combretastain diphosphate tetrasodium composition for injection is uniform in quality and low in impurity content which is less than the limit of 0.1 percent, can be stably stored for a long time at the same time, and is better in quality and safety guarantee in clinical medication compared with the same products.

Description

technical field [0001] The invention relates to a comppretine tetrasodium diphosphate composition for injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The comppretidine tetrasodium diphosphate composition for injection prepared by the method is clinically used for the treatment of tumor patients, especially tumor patients resistant to cytotoxic antitumor drugs. Background technique [0002] The chemical name of compretidine tetrasodium diphosphate is 3-methoxy-6-[(Z)-2-(3,4,5-trimethoxyphenyl)vinyl]-1,2-benzenediol Diphosphate tetrasodium salt, CAS No. 288847-34-7. , its molecular formula: C 18 h 18 Na 4 o 12 P 2 ;Molecular weight: 580.2362. [0003] Its structural formula is: [0004] [0005] Combretastatins is an active ingredient isolated from the tropical tree Combretum Caffrum in South Africa. It has a similar chemical structure to the anti-mitotic drug colchicine and has a higher affinity to the c...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/6615A61K47/26A61P35/00
Inventor 郭昭
Owner NANJING CHENGONG PHARM CO LTD