Terbutaline sulfate injection and preparation method thereof

A technology of terbutaline sulfate and injection, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as poor stability, improve stability and avoid disadvantages Influence and reduce the effect of impurity content

Pending Publication Date: 2021-05-25
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the problems that the existing terbutaline sulfate injection has poor stability and contains m

Method used

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  • Terbutaline sulfate injection and preparation method thereof
  • Terbutaline sulfate injection and preparation method thereof
  • Terbutaline sulfate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The present embodiment provides a kind of terbutaline sulfate injection, and prescription consumption is as shown in the table below:

[0039] Terbutaline Sulfate 50g

[0040] Sodium chloride 89g

[0041] 0.1mol / L hydrochloric acid solution appropriate amount

[0042] Water for injection to 100L.

[0043] The preparation method of above-mentioned terbutaline sulfate injection is as follows:

[0044] Step a, add water for injection of more than 1 / 3 of its volume into the preparation tank, start stirring, add sodium edetate, mix well, obtain a solution of sodium edetate with a concentration of 0.1mol / L, start kneading Pump, so that the sodium edetate solution is circulated and sprayed into the preparation tank through the circulation pipeline and the spray device on the top of the preparation tank, and the spray is circulated for 40 minutes, and the sodium edetate solution is discharged for 30 minutes. After the discharge is completed, rinse with water for injection unt...

Embodiment 2

[0048] The present embodiment provides a kind of terbutaline sulfate injection, and prescription consumption is as shown in the table below:

[0049] Terbutaline Sulfate 25g

[0050] Sodium chloride 80g

[0051] 0.1mol / L hydrochloric acid solution appropriate amount

[0052] Water for injection to 100L.

[0053] The preparation method of above-mentioned terbutaline sulfate injection is as follows:

[0054] Step a, add water for injection of more than 1 / 3 of its volume into the preparation tank, start stirring, add sodium edetate, mix well, obtain a solution of sodium edetate with a concentration of 0.05mol / L, start kneading Pump, so that the sodium edetate solution is circulated and sprayed into the preparation tank through the circulation pipeline and the spray device on the top of the preparation tank, and the spray is circulated for 30 minutes, and the sodium edetate solution is discharged, and the discharge time is 50 minutes. After the discharge is completed, rinse wi...

Embodiment 3

[0058] The present embodiment provides a kind of terbutaline sulfate injection, and prescription consumption is as shown in the table below:

[0059] Terbutaline Sulfate 100g

[0060] Sodium chloride 90g

[0061] 0.1mol / L hydrochloric acid solution appropriate amount

[0062] Water for injection to 100L.

[0063] The preparation method of above-mentioned terbutaline sulfate injection is as follows:

[0064] Step a, add more than 1 / 3 of the volume of water for injection into the preparation tank, start stirring, add sodium edetate, mix well, obtain a solution of sodium edetate with a concentration of 0.15mol / L, start kneading Pump, so that the sodium edetate solution is circulated and sprayed into the preparation tank through the circulation pipeline and the spray device on the top of the preparation tank, and the spray is circulated for 60 minutes, and the sodium edetate solution is discharged, and the discharge time is 40 minutes. After the discharge is completed, rinse w...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses a terbutaline sulfate injection and a preparation method thereof. The preparation tank is subjected to complexing treatment by using a sodium ethylene diamine tetracetate solution, and after complexing is completed, the preparation tank is flushed by using water for injection until the pH value is 5.0-7.0 and the electrical resistivity is less than 0.5, so that the preparation tank can be used for preparing the injection; and in the preparation process, the water for injection is filled with nitrogen, the terbutaline sulfate is added after dissolved oxygen in the water is controlled to be lower than 100 ppb, and the headspace residual oxygen content in an ampoule bottle is controlled to be smaller than 2% in cooperation with nitrogen introduction in the filling process, so that the influence of oxygen and metal ions on the terbutaline sulfate is effectively avoided. The terbutaline sulfate injection provided by the invention is simple in prescription, and the stability of terbutaline sulfate is remarkably improved on the premise of not introducing other auxiliary materials such as an antioxidant or a complexing agent, a stabilizer and the like, so that the clinical application safety is improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a terbutaline sulfate injection and a preparation method thereof. Background technique [0002] Terbutaline sulfate, the English name is Terbutaline Sulfate, the chemical name is (±)α-[(tert-butylamino)methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1), the structural formula is as follows, which is An adrenergic agonist that selectively excites β2 receptors, relaxes bronchial smooth muscle, inhibits the release of endogenous spasm-causing substances and edema caused by endogenous media, improves bronchial mucosal ciliated epithelial clearance, and relaxes the uterus Smooth muscle, mainly for short-term treatment of bronchiectasis and preterm labor. [0003] [0004] Terbutaline sulfate contains resorcinol groups, and under the influence of light, oxygen, metal ions and temperature, resorcinol will not only make the content and color of the product unstable...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/02A61K47/04A61P11/08A61P15/06
CPCA61K31/137A61K9/0019A61K9/08A61K47/02A61P11/08A61P15/06A61J3/00
Inventor 崔雪妹闫永娜仝巧林徐建伟王素珍杨学杰刘晓娟张金葆
Owner SHIJIAZHUANG NO 4 PHARMA
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