Search

CN-122005448-A - Isoniazid injection and preparation method thereof

CN122005448ACN 122005448 ACN122005448 ACN 122005448ACN-122005448-A

Abstract

The invention relates to isoniazid injection and a preparation method thereof, wherein each 1000ml of isoniazid injection contains 50g of isoniazid, anhydrous disodium hydrogen phosphate and methionine, and each 1000ml of injection contains 3.5-4.0 g of anhydrous disodium hydrogen phosphate and 10.2-12.6 g of methionine, so that the isoniazid injection has better stability, and the preparation method is simple and does not need complex processes of nitrogen flushing, oxygen content control and the like.

Inventors

  • ZENG YI
  • YANG SANMING
  • YUE HUIJUN
  • HU CHENGZHONG

Assignees

  • 湖北美林药业有限公司

Dates

Publication Date
20260512
Application Date
20260309

Claims (6)

  1. 1. An isoniazid injection, which is characterized in that every 1000ml of injection contains anhydrous disodium hydrogen phosphate and methionine besides 50g of isoniazid.
  2. 2. The isoniazid injection according to claim 1 wherein each 1000ml of injection contains 3.5 g-4.0 g anhydrous disodium hydrogen phosphate and 10.2 g-12.6 g methionine.
  3. 3. Isoniazid injection according to claim 2 containing 3.8g anhydrous disodium hydrogen phosphate and 11.3g methionine per 1000ml injection.
  4. 4. The isoniazid injection according to claim 1, 2 or 3 wherein the isoniazid injection has a specification of 2ml to 100mg.
  5. 5. The preparation method of isoniazid injection is characterized by comprising the following steps: (1) Dissolving a prescribed amount of anhydrous disodium hydrogen phosphate into 700ml of water for injection at 45-50 ℃; (2) Reducing the water temperature to 30-35 ℃, sequentially adding the methionine and isoniazid with the prescribed amount, stirring and dissolving, adding water for injection to 850ml, and adjusting the pH value to 6.0-6.5 by using hydrochloric acid solution or sodium hydroxide solution; (3) Adding water for injection to 1000ml, measuring pH and content of the solution, filtering with 0.22 μm filter membrane, filling into ampoule according to specification, and sterilizing at 121deg.C for 25 min to obtain isoniazid injection.
  6. 6. The method for preparing isoniazid injection according to claim 5 wherein step (2) is performed to adjust pH to 6.1.

Description

Isoniazid injection and preparation method thereof Technical Field The invention belongs to the technical field of medicines, and particularly relates to isoniazid injection and a preparation method thereof. Background Isoniazid is a antitubercular drug with chemical name 4-pyridine formylhydrazine. Tuberculosis is a chronic infectious disease caused by tubercle bacillus infection, and is commonly seen as pulmonary tuberculosis, which is the first infectious disease. Isoniazid is still the first line drug in current tuberculosis treatment. As an alternative to oral treatment, isoniazid injection is of clinical significance for the treatment of patients who cannot be orally administered. Under the oxidation and hydrolysis conditions, the isoniazid can degrade free hydrazine which is a genotoxic impurity, and the existing isoniazid injection preparation process mostly needs to be added with metal chelating agent and antioxidant effect, and the residual oxygen amount needs to be strictly controlled by nitrogen flushing, so that the process is strictly complicated and has high requirements, and the isoniazid injection prepared by the existing preparation method has poor stability and the defects limit the safe use of the isoniazid injection. The isoniazid injection and the preparation method thereof are obtained through a large amount of long-term researches on isoniazid injection by the inventor, the preparation method is simple, nitrogen flushing is not needed, the oxygen content is controlled, and the isoniazid injection prepared by the method has extremely high quality stability, increases the safety of medication and is obviously superior to the prior art. Disclosure of Invention The invention aims to provide isoniazid injection and a preparation method thereof, wherein the isoniazid injection has good stability, and the preparation method is simple, and does not need complex processes of nitrogen flushing, oxygen content control and the like. The technical scheme provided by the invention is that the isoniazid injection contains 50g isoniazid, anhydrous disodium hydrogen phosphate and methionine in addition to every 1000ml of isoniazid. Preferably, each 1000ml of injection contains 3.5-4.0 g of anhydrous disodium hydrogen phosphate and 10.2-12.6 g of methionine. Preferably, each 1000ml of injection contains 3.8g of anhydrous disodium hydrogen phosphate and 11.3g of methionine. Preferably, the isoniazid injection has a specification of 2ml to 100mg. The preparation method comprises the following steps: (1) Dissolving a prescribed amount of anhydrous disodium hydrogen phosphate into 700ml of water for injection at 45-50 ℃; (2) Reducing the water temperature to 30-35 ℃, sequentially adding the methionine and isoniazid with the prescribed amount, stirring and dissolving, adding water for injection to 850ml, and adjusting the pH value to 6.0-6.5 by using hydrochloric acid solution or sodium hydroxide solution; (3) Adding water for injection to 1000ml, measuring pH and content of the solution, filtering with 0.22 μm filter membrane, filling into ampoule according to specification, and sterilizing at 121deg.C for 25 min to obtain isoniazid injection. Preferably, step (2) adjusts the pH to 6.1. According to the invention, anhydrous disodium hydrogen phosphate and methionine are adopted as auxiliary materials of the isoniazid injection, the combined use of the 2 auxiliary materials is beneficial to increasing the stability of the isoniazid injection, the preparation process of the isoniazid injection is simplified, an unexpected effect is achieved, and 3.5-4.0 g of anhydrous disodium hydrogen phosphate and 10.2-12.6 g of methionine are added into 1000 ml. The special proportion has better effect, especially the effect that each 1000ml of injection contains 3.8g of anhydrous disodium hydrogen phosphate and 11.3g of methionine is optimal, and the aim is not to adjust the pH value of the isoniazid injection to 6.1 on the basis, so that insoluble particles of the injection can be obviously reduced, and the safety of the injection is improved. Detailed Description Example 1 preparation of Isoniazid injection (2 ml:100 mg) Prescription: isoniazid 50g Anhydrous disodium hydrogen phosphate 3.5g Methionine 10.2g The water for injection is added to 1000ml Made into 500 pieces The preparation method comprises the following steps: (1) Dissolving a prescribed amount of anhydrous disodium hydrogen phosphate in 700ml of water for injection at 45 ℃; (2) Reducing the water temperature to 30 ℃, sequentially adding methionine and isoniazid with the prescribed amount, stirring and dissolving, adding water for injection to 850ml, and adjusting the pH value to 6.0 by using hydrochloric acid solution or sodium hydroxide solution; (3) Adding water for injection to 1000ml, measuring pH and content of the solution, filtering with 0.22 μm filter membrane, filling into ampoule according to specification, and sterilizing at 121deg.C for 25 mi