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Freeze-dried preparation containing dexrazolone and preparation method of freeze-dried preparation

A technology for dexrazoxane and freeze-dried preparations, which is applied to medical preparations containing active ingredients, medical preparations without active ingredients, freeze-dried transportation, etc. Long drying time and other issues

Active Publication Date: 2022-04-12
LEPU PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The color of the product prepared by US patent US4963551 is light red and can be stored at room temperature, but the water content is as high as 6%.
And although the product provided by WO93 / 07873 patent is white, moisture is below 2%, to guarantee that medicine does not degrade, but the freeze-drying time of this freeze-drying method is longer
[0011] It can be seen from the above two patents that dexrazoxane is unstable to light, and the moisture content of the freeze-dried product exceeds 2%, and the freeze-dried product will form crystals, which will affect the stability

Method used

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  • Freeze-dried preparation containing dexrazolone and preparation method of freeze-dried preparation
  • Freeze-dried preparation containing dexrazolone and preparation method of freeze-dried preparation
  • Freeze-dried preparation containing dexrazolone and preparation method of freeze-dried preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] prescription:

[0031] Raw materials batch prescription concentration Right Lei Zuosheng 700g 35mg / mL hydrochloric acid 注

180g 0.09mol / L Water for Injection Add water to 20L /

[0032] Note: The concentration of hydrochloric acid is 37wt%, the same below.

[0033] Preparation:

[0034] Lower the temperature of the water for injection to 5°C-10°C, add 18L of water for injection into the liquid mixing tank, add 180g (about 1.8mol) of concentrated hydrochloric acid, stir for 10min, then add the raw material of dexrazoxane, stir for 120min to dissolve it completely Afterwards, take a sample to measure the pH value of 1.8-1.9, then add water for injection (temperature 5-10°C) to the total amount, and stir for 10 minutes. Sterilize and filter through 0.45 μm and 0.22 μm filter elements in turn to the filling room. The filtrate is evenly distributed into 1000 25mL vials, and the liquid level of the lyophilized liquid is 32-35mm. ...

Embodiment 2

[0053] prescription:

[0054] Raw materials batch prescription concentration Right Lei Zuosheng 700g 35mg / mL hydrochloric acid 160g 0.08mol / L Water for Injection Add water to 20L /

[0055] Preparation:

[0056]Lower the temperature of the water for injection to 5°C-10°C, add 18L of water for injection into the liquid mixing tank, add 160g of concentrated hydrochloric acid (about 1.6mol), stir for 10min, then add the raw material of dexrazoxane, stir for 120min to dissolve it completely After that, take a sample to measure the pH value of 1.9-2.0, then add water for injection (temperature 5-10°C) to the total amount, and stir for 10 minutes. Sterilize and filter through 0.45μm and 0.22μm filter elements to the filling room. The filtrate is evenly distributed into 1000 25mL vials, and the liquid level of the lyophilized liquid is 32-35mm.

[0057] The freeze-drying process is the same as in Example 1.

Embodiment 3

[0059] prescription:

[0060] Raw materials batch prescription concentration Right Lei Zuosheng 700g 35mg / mL hydrochloric acid 220g 0.11mol / L Water for Injection Add water to 20L /

[0061] Preparation:

[0062] Lower the temperature of the water for injection to 5°C-10°C, add 18L of water for injection into the liquid mixing tank, add 220g of concentrated hydrochloric acid (about 2.2mol), stir for 10min, then add the raw material of dexrazoxane, stir for 120min to make it completely dissolved After that, take a sample to measure the pH value of 1.6-1.8, then add water for injection (temperature 5-10°C) to the total amount, and stir for 10 minutes. Sterilize and filter through 0.45μm and 0.22μm filter elements to the filling room. The filtrate is evenly distributed into 1000 25mL vials, and the liquid level of the lyophilized liquid is 32-35mm.

[0063] The freeze-drying process is the same as in Example 1.

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Abstract

The invention discloses a lyophilized preparation containing dexrazodone and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. A solution for preparing the dexrazoxane freeze-dried preparation is composed of dexrazoxane, hydrochloric acid and water according to a certain proportion, the concentration of dexrazoxane is 30-40 mg / mL, and the pH value of the solution is 1.6-2.0. The invention further provides a method for preparing the dexrazoxane freeze-dried preparation, the dexrazoxane freeze-dried preparation is kept at the temperature of-55 DEG C to-60 DEG C for 4-5 hours, then a vacuum pump is started, the vacuum degree is reduced to be below 0.2 mbar, primary drying is carried out at the temperature of-25 DEG C to 15 DEG C, the primary drying time is 60-70 hours, finally, desorption drying is continued at the temperature of 0.15 mbar and the temperature of 25-35 DEG C, and the drying time is 5-10 hours. The prepared freeze-dried product has water content of less than 1%, has good stability and can be stored at room temperature.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a freeze-dried preparation containing dexrazoxane and a preparation method thereof. Background technique: [0002] Malignant tumor is one of the common chronic diseases in clinical practice, and the incidence rate of Chinese residents is still on the rise. Most antineoplastic drugs are often accompanied by extensive acute and cumulative toxicity during treatment, which brings pain to patients and significantly reduces the quality of life. If continued use may even cause serious consequences. Anthracycline chemotherapeutic drugs include antitumor antibiotics such as doxorubicin (DOX), daunorubicin (DAU), epirubicin (EPI), etc. These drugs have good therapeutic effects on various tumors, and DOX is considered It is a standard drug for the treatment of advanced breast cancer. However, even with a lower dose, it can induce short-term and long-term cardiotoxicity, especial...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/496A61K47/10A61P35/00A61P9/00
Inventor 于力强乔慧洁郭旭光张明
Owner LEPU PHARMACEUTICAL CO LTD
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