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Stable terbutaline sulfate injection and preparation process thereof

A technology of terbutaline and injection, which is applied in the fields of drug delivery, respiratory system diseases, inorganic non-active ingredients, etc., can solve the problems of hidden safety hazards, excessive time, toxic and side effects of clinical application of injection, and reduce metal ions. Complexing agents, reducing the use of antioxidants, and ensuring the effect of clinically safe medication

Inactive Publication Date: 2015-04-22
CHENGDU SINO STRONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, sodium metabisulfite has strong toxic and side effects, including causing bronchospasm and allergic reactions, and severe cases can cause death; in addition, EDTA-2Na may cause hypocalcemia if the time is too fast or the dose is too long
Therefore there is certain hidden danger in the safety of the clinical application of the disclosed injection of CN201310511264.9

Method used

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  • Stable terbutaline sulfate injection and preparation process thereof
  • Stable terbutaline sulfate injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Prescription: Terbutaline Sulfate 0.25g

[0027] Sodium chloride 8.9g

[0028] Add water for injection to 1000ml.

[0029] Preparation process: brief description: water for injection with prescription quantity 98, temperature 40°C, add sodium chloride and terbutaline sulfate at one time, stir to dissolve, add activated carbon with 0.3% sodium chloride, stir for 15 minutes, decarburize, filter , the filtrate was adjusted to pH 4.0. It was filtered through a 0.22um pore-size terminal filter, filled in neutral borosilicate glass ampoules, each filled with 1ml, and sterilized by moist heat at 115°C for 35 minutes to obtain the product.

Embodiment 2

[0031] Prescription: Terbutaline Sulfate 0.20g

[0032] Sodium chloride 8.5g

[0033] Add water for injection to 1000ml.

[0034] The preparation process is the same as in Example 1.

Embodiment 1-2

[0036] Example 1-2 Stability investigation setting comparative example 1-2:

[0037] Prescription: Terbutaline Sulfate 0.25g

[0038] Sodium metabisulfite 0.25g

[0039] EDTA-2Na 0.1g

[0040] Sodium chloride 8.5g

[0041] Add water for injection to 1000ml.

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Abstract

The invention discloses a stable terbutaline sulfate injection, wherein 1 ml of the stable terbutaline sulfate injection comprises 0.1-0.4mg of terbutaline sulfate, 8.0-10mg of sodium chloride and the balance of water for injection. In the preparation process of the stable terbutaline sulfate injection, nitrogen is used for protection so that the using of antioxidant can be decreased; low-temperature preparation is adopted to control the stability of the product so that the impurity stability after steam sterilization is ensured and the metal ion complexing agent can be decreased. According to the stable terbutaline sulfate injection and the preparation process thereof, the problem of adding other auxiliary materials to maintain the stability of the preparation in a clinic intravenous fluid is solved and the clinic safe medication is ensured.

Description

technical field [0001] The invention relates to a stable terbutaline sulfate injection and a preparation process, belonging to the field of pharmaceutical preparations. Background technique [0002] Terbutaline sulfate chemical name (±)α-[(tert-butylamino)methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1), also known as m-hydroxyalbuterol, terbutaline, It is a selective β2-receptor agonist, its bronchodilator effect is weaker than albuterol, clinically used for the treatment of bronchial asthma, asthmatic bronchitis, emphysema, etc. [0003] Terbutaline sulfate is sensitive to light, oxygen, alkali and high temperature and is easily hydrolyzed, so it has poor stability after being made into injection. At present, Terbutaline Sulfate Injection listed in the domestic market mainly solves the stability of the drug by adding antioxidant sodium metabisulfite and metal ion complexing agent EDTA-2Na in the drug prescription. As described in CN201310511264.9. However, sodium metab...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/02A61P11/06A61P11/00
Inventor 黄汉伟许娟蒲洪陈小宁
Owner CHENGDU SINO STRONG PHARMA
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