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Isoniazid injection and preparation method thereof

An isoniazid and injection technology, which can be applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as poor stability of isoniazid injection, and improve the Sterility assurance level, improving quality, avoiding the effect of oxidation

Pending Publication Date: 2020-06-12
天津金耀药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because isoniazid is easy to release genotoxic impurity free hydrazine in water, the stability of the isoniazid injection prepared by the existing preparation method is not good.

Method used

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  • Isoniazid injection and preparation method thereof
  • Isoniazid injection and preparation method thereof
  • Isoniazid injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Isoniazid injection was prepared according to the reference preparation prescription of isoniazid injection in Table 1. The preparation method is:

[0054] (a) Preparation: Add 70% water for injection into the dilute preparation tank, cool down to 24°C, fill with nitrogen, the pressure of nitrogen is 0.20Mpa, the dissolved oxygen is 4.6mg / L, add sodium chloride and isoniazid, and stir Until dissolved, adjust the pH value to 6.0 with 3.0mol / L hydrochloric acid, dilute to volume with the remaining water for injection, and stir.

[0055] (b) Filtration: filter with a 0.45 μm polyethersulfone filter element and a 0.22 μm polyethersulfone filter element.

[0056] (c) Filling and sealing: fill with nitrogen, fill and seal in 2mL borosilicate glass ampoules, control the filling volume at 2.1-2.2mL / bottle, fill with nitrogen protection before and after filling, and the pressure of nitrogen is 0.20Mpa.

[0057] (d) Sterilization and leak detection: Transfer the filled ampoules t...

Embodiment 2

[0076] Isoniazid injection was prepared according to the reference preparation prescription of isoniazid injection in Table 1. The preparation method is:

[0077] (a) Dosing: Add 50% water for injection into the dilute tank, cool down to 20°C, fill with nitrogen, the pressure of nitrogen is 0.30Mpa, the dissolved oxygen is 5.0mg / L, add sodium chloride and isoniazid, Stir until dissolved, adjust the pH value to 6.2 with 5.0mol / L hydrochloric acid, dilute to volume with the remaining water for injection, and stir.

[0078] (b) Filtration: filter with a 0.45 μm polyethersulfone filter element and a 0.22 μm polyethersulfone filter element.

[0079] (c) Filling and sealing: fill with nitrogen, fill and seal in 2mL borosilicate glass ampoules, control the filling volume at 2.1-2.2mL / bottle, fill with nitrogen protection before and after filling, and the pressure of nitrogen is 0.25Mpa.

[0080] (d) Sterilization and leak detection: Transfer the filled ampoules to the sterilization...

Embodiment 3

[0091] Isoniazid injection was prepared according to the reference preparation prescription of isoniazid injection in Table 1. The preparation method is:

[0092] (a) Dosing: Add 95% water for injection into the dilute tank, cool down to 50°C, fill with nitrogen, the pressure of nitrogen is 0.03Mpa, the dissolved oxygen is 4.5mg / L, add sodium chloride and isoniazid, Stir until dissolved, adjust the pH value to 5.2 with 0.1mol / L hydrochloric acid, dilute to volume with the remaining water for injection, and stir.

[0093] (b) Filtration: filter with a 0.45 μm polyethersulfone filter element and a 0.22 μm polyethersulfone filter element.

[0094] (c) Filling: fill with nitrogen, fill in 2mL medium borosilicate glass ampoules, control the filling volume at 2.1-2.2mL / bottle, fill with nitrogen protection before and after filling, and the pressure of nitrogen is 0.10Mpa.

[0095] (d) Sterilization and leak detection: Transfer the filled ampoules to the sterilization process. Ster...

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Abstract

The invention provides an isoniazide injection preparation method and an isoniazide injection, and relates to the field of pharmaceutical preparations, the isoniazide injection preparation method comprises a preparation step, the preparation step comprises: introducing nitrogen into water for injection at a temperature of 20-50 DEG C, adding isoniazide, and after dissolving, adjusting the pH valueto 5.2-6.2 for later use. According to the preparation method of the isoniazid injection, conditions are accurately controlled; the reference preparation prescription of the isoniazid injection doesnot need to be changed; the sterility assurance level of the isoniazid injection can be improved; the contents of related substances and genotoxic impurity free hydrazine can be effectively controlled; the content of genotoxic impurity free hydrazine can be controlled below 1000ppm after 6 months, so that the genotoxic impurity free hydrazine is obviously lower than that of a reference preparation, the control level of other key indexes is not lower than that of the reference preparation, and meanwhile, the color of the product is not deeper than that of the reference preparation within the validity period.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of isoniazid injection and the isoniazid injection. Background technique [0002] Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis infection. Mycobacterium tuberculosis can invade various organs of the human body, and tuberculosis is more common. It is one of the major infectious diseases that seriously endanger the health of the people. At present, my country is still one of the 30 countries with a high burden of tuberculosis in the world, with about 900,000 new cases of tuberculosis each year, ranking third in the world. At present, the number of tuberculosis cases in my country is still relatively large, and the situation of tuberculosis prevention and control in central and western regions and rural areas is severe. At the same time, the country proposes that the successful treatment rate of tuberculosis patients...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4409A61K47/02A61K47/04A61P31/06
CPCA61K9/08A61K9/0019A61K31/4409A61K47/02A61P31/06
Inventor 刘欣刘凯张瑜刘明志何光杰张荣张成飞薛化庆韩瑞成赵蒙
Owner 天津金耀药业有限公司
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