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Freeze-drying technology for commercialized production of s-ornidazole disodium phosphate for injection

A technology for levornidazole phosphate and injection, which is applied in the field of freeze-drying technology, can solve the problems of increased primary drying time, large energy consumption in the production process, and large difference in water content, and achieves the effects of improving solute migration and increasing drying rate.

Active Publication Date: 2018-08-31
YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] (2) The crystallization process of the product during cooling is relatively random, and the initial freezing temperature and time of products at different positions on the same layer have large differences, which will lead to large differences in the internal structure of the product after freezing, thus affecting Final moisture and homogeneity of the product;
[0012] (3) After pre-freezing using the existing technology, the collapse temperature of the product is about -29°C (as shown in the accompanying drawings figure 1 As shown), the product is prone to collapse during the drying process, blocking the channel of water sublimation, causing local melting of the product, affecting the final moisture and shape of the product
[0013] These phenomena such as solute migration, a substantial increase in primary drying time, high residual moisture in the product, and large moisture differences lead to high energy consumption and poor controllability in the production process, and have varying degrees of impact on the appearance and stability of the product.

Method used

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  • Freeze-drying technology for commercialized production of s-ornidazole disodium phosphate for injection
  • Freeze-drying technology for commercialized production of s-ornidazole disodium phosphate for injection
  • Freeze-drying technology for commercialized production of s-ornidazole disodium phosphate for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] The freeze-drying process for the commercial production of levonidazole phosphate disodium for injection in this embodiment is carried out according to the following steps:

[0056](1) Prepare 20 L of levonidazole phosphate disodium liquid, and adjust the pH value to pH5.2-pH5.5;

[0057] (2) Adjust the layer temperature of the lyophilizer to -10°C;

[0058] (3) After filtering the medicinal liquid through a 0.22 μm filter element, pour it into a vial, and put it into a lyophilizer after half stoppering;

[0059] (4) After the sample is kept at -10°C for 1h, adjust the temperature of the plate layer and cool it down to -50°C, with a cooling rate of 40-50°C / hour, and keep it for 1h;

[0060] (5) Adjust the temperature of the plate layer, raise the temperature to -30°C in 0.5h, and keep it for 3h;

[0061] (6) Adjust the temperature of the plate layer, lower the temperature to -50°C, and the cooling rate is 40-50°C / hour, and keep it for 3h;

[0062] (7) Adjust the temp...

Embodiment 2

[0067] The freeze-drying process for the commercial production of levonidazole phosphate disodium for injection in this embodiment is carried out according to the following steps:

[0068] (1) Prepare 20L of medicinal solution, and adjust the pH value to pH5.0~pH5.1;

[0069] (2) Adjust the layer temperature of the lyophilizer to 0°C;

[0070] (3) After filtering the medicinal liquid through a 0.22 μm filter element, pour it into a vial, and put it into a lyophilizer after half stoppering;

[0071] (4) After the sample is kept at 0°C for 0.5h, adjust the temperature of the plate layer and cool it down to -45°C, the cooling rate is 40-50°C / hour, and keep it for 2h;

[0072] (5) Adjust the temperature of the plate layer, raise the temperature to -25°C in 0.5h, and keep it for 2h;

[0073] (6) Adjust the temperature of the plate layer, lower the temperature to -45°C, and the cooling rate is 40-50°C / hour, and keep it for 3h;

[0074] (7) Adjust the temperature of the plate laye...

Embodiment 3

[0079] The freeze-drying process for the commercial production of levonidazole phosphate disodium for injection in this embodiment is carried out according to the following steps:

[0080] (1) Prepare 200L of liquid medicine and adjust the pH value to pH5.2~pH5.5;

[0081] (2) Adjust the layer temperature of the lyophilizer to 0°C;

[0082] (3) After filtering the medicinal liquid through a 0.22 μm filter element, pour it into a vial, and put it into a lyophilizer after half stoppering;

[0083] (4) After the sample is kept at 0°C for 1h, adjust the temperature of the plate layer and cool it down to -45°C, the cooling rate is 40-50°C / hour, and keep it for 2h;

[0084] (5) Adjust the temperature of the plate layer, raise the temperature to -25°C in 0.5h, and keep it for 2h;

[0085] (6) Adjust the temperature of the plate layer, lower the temperature to -45°C, and the cooling rate is 40-50°C / hour, and keep it for 3h;

[0086] (7) Adjust the temperature of the plate layer, ra...

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PUM

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Abstract

The invention belongs to the technical field of chemical preparations, and particularly relates to a freeze-drying technology for commercialized production of s-ornidazole disodium phosphate for injection. According to the technical scheme of the freeze-drying technology, an annealing technology is adopted in the liquid medicine pre-freezing process, so that solute migration occurring in the freeze-drying process of products can be obviously improved, and the primary drying rate can be obviously increased; samples prepared through the freeze-drying technology are complete in appearance, loose,not atrophic and small in moisture difference; and in addition, after the annealing technology is adopted, the production time is not prolonged compared with the prior art, and the production energyconsumption is not increased.

Description

technical field [0001] The invention belongs to the technical field of chemical preparations, in particular to a freeze-drying process for the commercial production of levonidazole phosphate disodium for injection. technical background [0002] Ornidazole is currently a commonly used anti-anaerobic bacteria drug. As the third-generation anti-anaerobic infection drug after metronidazole and tinidazole, it has achieved good clinical results and is widely recognized due to its positive curative effect and small side effects. Recent studies have shown that L-ornidazole, as the L-isomer of ornidazole, is superior to ornidazole in terms of efficacy and adverse reactions. [0003] But whether it is ornidazole or L-ornidazole, its solubility is low, and its solution is only stable in acidic environment. Therefore, when it is necessary to make ornidazole / left-ornidazole into an injection preparation, the pH value will be adjusted to at least 4 or less to meet the preparation require...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): F26B5/06F26B25/00C07F9/6506
CPCF26B5/06F26B25/00Y02A50/30
Inventor 梁衡张亮王嬿钧赵富录丁菲贾树田
Owner YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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