Processing method for improving stability of terbutaline sulfate injection and terbutaline sulfate injection

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...

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.

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