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Glycopyrronium bromide injection and preparation method thereof

A technology for glycopyrronium bromide and injection, which is applied in the field of preparation of glycopyrronium bromide injection, can solve the problems of side effects of benzyl alcohol, large adsorption of main drug content, and toxic reactions, so as to improve safety, reduce heat source, The effect of improving stability

Active Publication Date: 2014-04-02
GUANGDONG JIABO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Currently commonly used glycopyrronium bromide injections usually first add activated carbon to the feed solution for decolorization, and then filter through a filter to remove the activated carbon, but for small-scale injections, this method is not suitable for use. The adsorption of the drug content is large, which will affect the storage stability of the injection
Now there is also the addition of benzyl alcohol to improve the storage stability of injections. However, the addition of benzyl alcohol can cause side effects and even death, especially for pediatric patients. When newborns are given >99 mg / kg / day or birth When light-weight newborns were given benzyl alcohol, "wheeze syndrome" would appear, in which the central nervous system depression, metabolic acidosis, wheezing breathing and other symptoms were the main manifestations, and at the same time, progressive neurasthenia, epilepsy, etc. Seizures, intracranial hemorrhage, hematological abnormalities, skin lesions, liver and kidney damage, hypotension, bradycardia, or cardiovascular collapse are more likely to occur in premature infants, low birth weight neonates, and patients receiving high doses of benzyl alcohol toxic reaction
Therefore, the existing glycopyrronium bromide injection has unstable performance and high drug risk, and is not suitable for long-term use

Method used

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  • Glycopyrronium bromide injection and preparation method thereof
  • Glycopyrronium bromide injection and preparation method thereof
  • Glycopyrronium bromide injection and preparation method thereof

Examples

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preparation example Construction

[0023] A preparation method for glycopyrronium bromide injection, comprising the following steps:

[0024] 1) Add sodium chloride and 50-90% of the formula water for injection into the preparation tank, and after dissolving, add the rest of the water for injection and a pH regulator to adjust the pH value to 1.0-4.0 to obtain solution A;

[0025] 2) Under the constant temperature condition of 30~40℃, put glycopyrronium bromide into solution A, stir until it is completely dissolved, carry out coarse filtration through a 0.45μm microporous membrane in the filtrate tank, and then pass through a 0.22μm The microporous filter membrane carries out terminal filtration, obtains intermediate product;

[0026] 3) Pack the filtrate in a container made of neutral borosilicate material, seal it, and then steam sterilize it at 115-121°C for 8-30 minutes to obtain glycopyrronium bromide injection.

[0027] The invention controls the endotoxin of the excipients and finely filters the feed li...

Embodiment 1

[0030] A preparation method for glycopyrronium bromide injection, comprising the following steps:

[0031] 1) Add 50% volume of water for injection and 7.0g of sodium chloride into the preparation tank, add the remaining amount of water for injection after dissolving, add 0.1ml of hydrochloric acid and then add 0.01g of sodium hydroxide, adjust the pH value to 2.5 to obtain a solution A;

[0032] 2) Under the constant temperature condition of 35℃, put 0.1g of glycopyrronium bromide into the solution A, stir until completely dissolved, carry out coarse filtration through a 0.45μm microporous filter membrane in the filtrate tank, and then filter through a 0.22μm The microporous filter membrane carries out terminal filtration, obtains intermediate product;

[0033] 3) Pack the filtrate in a container made of neutral borosilicate material, seal it, and then steam sterilize it at 121°C for 15 minutes to obtain glycopyrronium bromide injection.

[0034] In this example, the glycop...

Embodiment 2

[0036] A preparation method for glycopyrronium bromide injection, comprising the following steps:

[0037] 1) Add 80% volume of water for injection and 9.0 g of sodium chloride into the preparation tank, add the remaining amount of water for injection after dissolving, then add 0.1 ml of hydrochloric acid, adjust the pH value to 3.0, and obtain solution A;

[0038] 2) At a constant temperature of 30°C, put 0.2 g of glycopyrronium bromide into solution A, stir until it is completely dissolved, carry out coarse filtration through a 0.45 μm microporous membrane in the filtrate tank, and then pass through a 0.22 μm The microporous filter membrane carries out terminal filtration, obtains intermediate product;

[0039] 3) Pack the filtrate in a container made of neutral borosilicate material, seal it, and then steam sterilize it at 115°C for 30 minutes to obtain glycopyrronium bromide injection.

[0040] The glycopyrronium bromide injection in this example was made into 1000 inject...

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Abstract

The invention discloses glycopyrronium bromide injection and a preparation method thereof. The preparation method disclosed by the invention comprises the following steps of: (1), adding 50-90% of injection water into a preparation tank, adding sodium chloride, adding a pH adjusting agent after dissolving to adjust the pH value to 1.0-4.0, and then, diluting to total weight by adding injection water to obtain solution A; (2), adding glycopyrronium bromide into the solution A at the constant temperature of 30-40 DEG C, stirring till dissolving completely, crudely filtering in a filtrate tank through a milliporous filtration membrane which is 0.45 mu m, and finally filtering through a milliporous filtration membrane which is 0.22 mu m to obtain an intermediate product; (3), filling the filtrate tank into a neutral boron-silicon container, sealing, and sterilizing through steam at 115-121 DEG C for 8-30 min to obtain the glycopyrronium bromide injection. The glycopyrronium bromide injection disclosed by the invention has the characteristics of being good in stability, high in safety and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a safe and stable glycopyrrolate injection, and also relates to a method for preparing the safe and stable glycopyrronium bromide injection. Background technique [0002] Glycopyrronium Bromide is a quaternary ammonium anticholinergic drug that, like other anticholinergics (such as antimuscarinic agents), inhibits the response to acetylcholine in postganglionic cholinergic nerves and smooth muscles whose peripheral choline receptors are located in Smooth muscle autonomic cells, myocardium, sinoatrial node, atrioventricular node and exocrine glands, a few are located in autonomic ganglia, so they can reduce the free acid and volume secreted by gastric juice, and control the excessive secretion of throat, trachea and bronchial glands. Glycopyrronium bromide is usually used as a premedication before anesthesia, which reduces cardiac depression caused by the vagal...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/40A61K47/02A61P9/00A61P1/02
Inventor 曾少群吴艳华岳峰黄健鹏
Owner GUANGDONG JIABO PHARM CO LTD
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