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Milplatin freeze-dried powder injection and preparation method thereof

A technology of freeze-dried powder injection and miplatin, which is applied in the field of medicine, can solve the problems of increased cost and difficult work, and achieve the effects of reduced production cost, reduced production cost and stable quality

Active Publication Date: 2011-12-07
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the prepared product is suspended in the iodine adduct (iodolized oil injection) of fatty acid ethyl ester of poppy seed oil, it is relatively stable and easy to operate clinically, but when this product is produced, in order to prevent the During the filtration and filling process, due to the low ambient temperature, the solution solidifies or partially solidifies (the melting point of tert-butanol is 25.5°C). During the entire filtration and filling process, a special heat preservation device is required to ensure that the tert-butanol does not condense and the production proceeds normally. This method of production not only increases the cost, but also makes it difficult for operators to work in a sterile environment

Method used

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  • Milplatin freeze-dried powder injection and preparation method thereof
  • Milplatin freeze-dried powder injection and preparation method thereof

Examples

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Effect test

reference example 1

[0019] It can be prepared with reference to Chinese patent CN02818527.7:

[0020] prescription:

[0021] The preparation steps are as follows: measure tert-butanol, add it to the batching tank, and add the prescribed amount of rice platinum, stir the mixture at 30-40 ° C for 30 minutes, and use a Karl-Fischer hygrometer to measure the water content. The amount of water is 1.5mg / ml. Under sterile conditions, filter it with a 0.22μm organic microporous membrane until it is clear. Fill it into a vial with the amount calculated according to the intermediate, half-plug it with a butyl rubber stopper, and pack it into a plate. , into the freeze dryer, close the door, open the freeze dryer for freeze-drying, use heat transfer oil to cool the plate layer, make the product temperature reach -40 degrees, continue to freeze for 4 hours, and open the condenser until the temperature reaches -45 degrees Below, turn on the vacuum system again to make the vacuum of the front box below 133P...

Embodiment 1

[0023] prescription:

[0024] The preparation steps are as follows: measure tert-butanol, add it to the batching tank, control the solution temperature at 30-35°C, then weigh the prescribed amount of miplatin, stir or ultrasonically dissolve it evenly at the temperature, and then measure the prescribed amount Add dehydrated ethanol into the batching tank, stir evenly and maintain the solution temperature at 20-25°C. After the intermediate inspection is qualified, filter it with a 0.22μm organic microporous membrane under sterile conditions until it is clear, press The calculated amount of the intermediate is filled in a vial, half-plugged with a butyl rubber stopper, loaded into a plate, sent to a freeze dryer, closed the door, opened the freeze dryer for freeze-drying, and refrigerated the plates with heat transfer oil. Make the temperature of the product reach -40°C, continue to freeze for 4 hours, and at the same time turn on the condenser until the temperature reaches be...

Embodiment 2

[0026] prescription:

[0027] The preparation steps are as follows: measure tert-butanol, add it to the batching tank, control the solution temperature at 30-35°C, then weigh the prescribed amount of miplatin, stir or ultrasonically dissolve it evenly at the temperature, and then measure the prescribed amount Add dehydrated ethanol into the batching tank, stir evenly and maintain the solution temperature at 20-25°C. After the intermediate inspection is qualified, filter it with a 0.22μm organic microporous membrane under sterile conditions until it is clear, press The calculated amount of the intermediate is filled in a vial, half-plugged with a butyl rubber stopper, loaded into a plate, sent to a freeze dryer, closed the door, opened the freeze dryer for freeze-drying, and refrigerated the plates with heat transfer oil. Make the temperature of the product reach -40°C, continue to freeze for 4 hours, and at the same time turn on the condenser until the temperature reaches be...

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Abstract

The invention provides a miriplatin freeze-dried powder injection and a preparation method thereof; the miriplatin freeze-dried powder injection contains miriplatin, and a mixed solvent of tert-butyl alcohol and anhydrous alcohol is used during the preparation of the miriplatin freeze-dried powder injection. Anhydrous alcohol is used during the preparation of the freeze-dried powder injection of the invention, which can reduce the temperature requirement of production environment for miriplatin powder injection, and can ensure that the miriplatin solution does not coagulate or locally coagulate in room temperature environment during production; the freeze-dried finished product has a central particle size distribution of 10-25 microns; when the freeze-dried finished product is suspended in an iodinate oil injection for 24 hours, the sedimentation coefficient and viscosity do not change significantly, that is, the produced sample is stable during clinical application; the preparation method of the miriplatin freeze-dried powder injection of the invention can effectively prevent the solution from coagulating or locally coagulating during production, and can reduce production cost, and the obtained miriplatin freeze-dried powder injection has low contents of relevant substances and stable quality.

Description

technical field [0001] The invention relates to a miplatin freeze-dried powder injection and a preparation method thereof, belonging to the technical field of medicines. Background technique [0002] Lipid-soluble platinum metal complex Miplatinum, the chemical name is cis[((1R,2R)-1,2-cyclohexanediamine-N,N)bis(tetradecanoyloxy)]platinum(II ) and hydrates thereof, the structural formula is as follows: [0003] [0004] Molecular formula: C 34 h 68 N 2 o 4 Pt H 2 o [0005] Molecular weight: 782.01 [0006] Miplatin is white to light yellow crystalline powder, fat-soluble platinum metal complex; this product is soluble in chloroform and dichloromethane, slightly soluble in ethanol, very slightly soluble in methanol, almost soluble in water and acetonitrile insoluble. [0007] Miplatin is a platinum-based anticancer drug developed by Sumitomo Pharmaceutical Co., Ltd. of Japan. The specification of freeze-dried powder injection is 70mg / bottle. It is effective in th...

Claims

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Application Information

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IPC IPC(8): A61P35/00A61K9/19A61K31/282
Inventor 赵俊杨奇珍宗在伟
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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