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Miriplatin lyophilized preparation and preparation method thereof

A technology of freeze-dried preparations and rice platinum, which is applied in freeze-dried transportation, active ingredients of heavy metal compounds, powder transportation, etc., can solve the problems of unfavorable large-scale production, cumbersome production process, and increased production costs. It is difficult to achieve viscosity, enhance curative effect, Reduce the effect of embolism

Active Publication Date: 2015-04-15
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In the large-scale industrial production of preparations, especially when the water content is extremely low, special treatment needs to be carried out on the raw materials of the preparations, production equipment, solvents used, etc., which makes the production process cumbersome and significantly increases the production cost, which is not conducive to large-scale industrial production

Method used

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  • Miriplatin lyophilized preparation and preparation method thereof
  • Miriplatin lyophilized preparation and preparation method thereof
  • Miriplatin lyophilized preparation and preparation method thereof

Examples

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Comparison scheme
Effect test

reference example 1

[0042] Prescription (per 1000 bottles):

[0043] Mi Platinum

[0044] It can be prepared with reference to Chinese patent ZL02818527.7: take the prescribed amount of tert-butanol, add the prescribed amount of rice platinum, heat to 30-40 degrees, mix until the drug is completely dissolved, and adjust the water content of the solution under the monitoring of a Karl-Hugh moisture analyzer. To 1.5mg / mL, use a 0.22μm filter membrane to perform sterile filtration to obtain the intermediate of miplatin preparation.

reference example 2

[0046] Prescription (per 1000 bottles):

[0047] Mi Platinum

[0048] It can be prepared by referring to Chinese patent ZL201110201119.1: take the prescribed amount of tert-butanol, add the prescribed amount of rice platinum, heat to 30-40 degrees, mix until the drug is completely dissolved, add the prescribed amount of absolute ethanol, mix well, and use a 0.22 μm filter membrane Sterile filtration is carried out to obtain the intermediate of Miplatin preparation.

Embodiment 1

[0050] Prescription (per 1000 bottles):

[0051] Mi Platinum

[0052] Take the prescribed amount of tert-butanol, add the prescribed amount of miplatin, heat to 30-40°C, mix until the drug is completely dissolved, add the prescribed amount of water for injection and absolute ethanol, mix evenly, and use a 0.22 μm filter membrane to perform sterilizing filtration to obtain Miplatin preparation intermediate.

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Abstract

The present invention provides a miriplatin lyophilized preparation and a preparation method thereof, wherein the miriplatin lyophilized preparation adopts a tert butyl alcohol-ethanol-water ternary system during a preparation process, and the vacuum degree is controlled to more than 500 Pa during sublimation drying. According to the miriplatin lyophilized preparation of the present invention, the particle size distribution is uniform, and the number of the particles with the extreme small particle size is almost minimal while the number of the particles with the large particle size is less; with the preparation method of the miriplatin lyophilized preparation, the strictly limited waste content in the prior art is avoided, such that the preparation production is convenient, and the production cost is significantly reduced; and with the control of the vacuum degree during the freeze drying process, the eruption phenomenon is effectively eliminated, and it is ensured that the product with the good appearance quality is obtained.

Description

technical field [0001] The invention relates to a freeze-dried preparation of miplatin and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Miriplatin, the chemical name is (SP-4-2)-[(1R,2R)-1,2-cyclohexanediamine-N,N']bis(tetradecanoic acid-O)platinum, It is a new fat-soluble platinum anti-tumor drug developed by Sumitomo Corporation of Japan. Its monohydrate was approved for marketing in Japan in 2009. It is mainly used for the treatment of liver cancer clinically. Its structural formula is shown in formula Ⅰ: [0003] [0004] Metaplatin is soluble in chloroform and dichloromethane, slightly soluble in ethanol, and almost insoluble in water. Due to the extremely poor solubility of miplatin in water, it is technically difficult to develop lyophilized formulations. [0005] Studies have shown that suspending miplatin in iodized oil, a peripheral embolic agent, the formed miplatin-iodol can not only embol...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/282A61P35/00
Inventor 张勇沈静
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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