A processing method for improving the stability of terbutaline sulfate injection

A technology of terbutaline sulfate and a treatment method, which is applied in the field of medicine, can solve the problems of ineffective removal of metal ions, limited complexation ability, and decreased blood calcium, so as to reduce the content of metal ions, improve stability, and coordinate The effect of high ability

Active Publication Date: 2020-01-21
石药银湖制药有限公司
View PDF7 Cites 2 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, disodium edetate can combine with calcium ions to form a soluble complex, causing a decrease in calcium. The use of disodium edetate in intravenous preparations can lead to a decrease in blood calcium, which may cause severe voluntary muscle and smooth muscle damage. Spasms, leading to convulsions, seizures, severe asthma, spasm of the laryngeal muscles leading to asphyxia in severe cases, cardiac insufficiency, cardiac arrest
Therefore, the amount of excipients used in injections is very strictly controlled, and the usual content is generally controlled at a few ten-thousandths. Such a low-concentration metal ion complexing agent has very limited complexing ability to metal ions, and cannot effectively remove metal ions in the product.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • A processing method for improving the stability of terbutaline sulfate injection
  • A processing method for improving the stability of terbutaline sulfate injection
  • A processing method for improving the stability of terbutaline sulfate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Prescription: Terbutaline sulfate 0.25g, sodium chloride 0.9kg, add water for injection treated with nitrogen to 100000mL, make 1000 bottles.

[0051] A processing method for improving the stability of terbutaline sulfate injection, comprising the steps of:

[0052] S1: First use 1wt% sodium hydroxide solution to conduct closed cycle treatment on stainless steel preparation tanks and pipelines. The cycle treatment temperature is 70°C and the cycle treatment time is 30 minutes. Then rinse with water for injection until the pH is 5.7-7.0; then use 8wt % nitric acid to passivate the stainless steel preparation tank and pipeline, the passivation treatment temperature is 50°C, the passivation treatment time is 1h, and then rinse with water for injection until the pH is 5.0-7.0;

[0053] S2: Take 14% of the prepared water for injection and place it in a passivated stainless steel preparation tank, add the prescribed amount of sodium chloride, and stir until it is completely d...

Embodiment 2

[0058] Prescription: terbutaline sulfate 0.25g, sodium chloride 0.9kg, sodium bisulfite 0.8g, cysteine ​​hydrochloride 0.6g, add nitrogen-filled water for injection to 100000mL, make 1000 bottles.

[0059] A processing method for improving the stability of terbutaline sulfate injection, comprising the steps of:

[0060] S1: First use 1wt% sodium hydroxide solution to conduct closed cycle treatment on the stainless steel preparation tank and pipeline. The cycle treatment temperature is 75°C, and the cycle treatment time is 40min. Then rinse with water for injection until the pH is 5.0-7.0; then use 8wt % nitric acid to passivate the stainless steel preparation tank and pipeline, the passivation treatment temperature is 50°C, the passivation treatment time is 0.5h, and then rinse with water for injection until the pH is 5.0-7.0;

[0061] S2: Take 14% of the prepared water for injection and place it in a passivated stainless steel preparation tank, add the prescribed amount of so...

Embodiment 3

[0066] Prescription: terbutaline sulfate 0.25g, sodium chloride 0.9kg, sodium bisulfite 0.8g, cysteine ​​hydrochloride 0.6g, add nitrogen-filled water for injection to 100000mL, make 1000 bottles.

[0067] A processing method for improving the stability of terbutaline sulfate injection, comprising the steps of:

[0068] S1: First use 1wt% sodium hydroxide solution to conduct closed cycle treatment on stainless steel preparation tanks and pipelines, the cycle treatment temperature is 80 ° C, and the cycle treatment time is 45 minutes, then rinse with water for injection until the pH is 5.0-7.0; then use 8wt % nitric acid to passivate the stainless steel preparation tank and pipeline, the passivation treatment temperature is 50°C, the passivation treatment time is 1h, and then rinse with water for injection until the pH is 5.0-7.0;

[0069] S2: Take 14% of the prepared water for injection and place it in a passivated stainless steel preparation tank, add the prescribed amount of...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

Abstract

The invention relates to a processing method for improving the stability of a terbutaline sulfate injection. The processing method comprises the following steps: S1, passivating a stainless steel preparation tank and a pipeline by using nitric acid of 8 wt% before preparing the terbutaline sulfate injection, wherein the passivating temperature is 49 DEG C to 52 DEG C, the passivating time is 0.5-2hours; washing with water for injection until the pH is 5.0-7.0; S2, putting the pipeline passivated by the terbutaline sulfate injection prepared through the passivated stainless steel preparation tank in a glass bottle under the protection of nitrogen, and sterilizing, wherein the inner surface of the glass bottle is modified by an active group, and the active group is one or more of amino, sulfydryl, carboxyl and anhydride. The stability of the terbutaline sulfate injection is greatly improved through passivating and silanization, so that the content of the terbutaline sulfate is kept stable before and after filling and in the long-term storage process.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a treatment method for improving the stability of terbutaline sulfate injection and terbutaline sulfate injection obtained by the treatment method. Background technique [0002] Terbutaline sulfate is an adrenergic agonist. It can selectively stimulate β2-receptors, relax bronchial smooth muscle, inhibit the release of endogenous spasm-causing substances and edema caused by endogenous media, improve the clearance ability of bronchial mucous ciliated epithelium, and relax uterine smooth muscle. It is mainly used for the treatment of bronchospasm in bronchial asthma, asthmatic bronchitis and chronic obstructive pulmonary disease. [0003] The chemical name of terbutaline sulfate is (±)α-[(tert-butylamino)methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1), and its structural formula is [0004] Terbutaline sulfate contains resorcinol groups, and resorcinol turns pink...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/137A61K47/02A61K47/18A61P11/06A61P11/00
CPCA61K9/0019A61K9/08A61K31/137A61K47/02A61K47/183
Inventor 狄彩霞王振国康月菊郭良张俊燕高凯丽董晓花邵梦超
Owner 石药银湖制药有限公司
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap