A kind of glycopyrrolate injection and preparation method thereof

A technology of glycopyrronium bromide and injection, which is applied in the field of preparation of glycopyrronium bromide injection, can solve the problems of toxic reaction, side effect of benzyl alcohol, large adsorption of main drug content, etc., achieves improved stability, wide application range, The effect of reducing the amount of heat source

Active Publication Date: 2016-01-20
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 cause fatal accidents, especially for pediatric patients. When newborns are given >99mg / kg / day or "Wheezing syndrome" occurs when light-weight newborns are given benzyl alcohol, which is characterized by central nervous system depression, metabolic acidosis, wheezing breathing, etc., and progressive neurasthenia, seizures , intracranial hemorrhage, hematological abnormalities, skin damage, liver and kidney damage, hypotension, bradycardia or cardiovascular collapse and other symptoms, premature babies, low birth weight newborns and patients receiving high doses of benzyl alcohol are more prone to toxicity 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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  • A kind of glycopyrrolate injection and preparation method thereof
  • A kind of glycopyrrolate injection and preparation method thereof
  • A kind of glycopyrrolate injection and preparation method thereof

Examples

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preparation example Construction

[0023] A preparation method of glycopyrrolate injection includes the following steps:

[0024] 1) Add sodium chloride and 50~90% of the formula amount of water for injection into the preparation tank. After dissolving, add the remaining amount of water for injection and pH regulator to adjust the pH to 1.0~4.0 to obtain solution A;

[0025] 2) At a constant temperature of 30~40℃, put glycopyrrolate into solution A, stir until it is completely dissolved, and then coarsely filter through a 0.45μm microporous membrane in the filtrate tank, and then pass through 0.22μm The microporous membrane is used for terminal filtration to obtain intermediate products;

[0026] 3) Fill the filtrate can in a container made of neutral borosilicate material, seal it, and then steam sterilize it at 115-121℃ for 8-30 minutes to obtain glycopyrrolate injection.

[0027] The invention controls the endotoxin of the auxiliary materials and performs fine filtration of the material liquid, thereby reducing the ...

Embodiment 1

[0030] A preparation method of glycopyrrolate injection includes the following steps:

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

[0032] 2) Under the constant temperature condition of 35℃, throw 0.1g glycopyrronium bromide into solution A, stir until it is completely dissolved, and then coarsely filter through 0.45μm microporous membrane in the filtrate tank, and then pass through 0.22μm The microporous membrane is used for terminal filtration to obtain intermediate products;

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

[0034] In this example, the glycopyrrolate injection was made into 1000 injections, and the pH o...

Embodiment 2

[0036] A preparation method of glycopyrrolate injection includes the following steps:

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

[0038] 2) Under the constant temperature condition of 30℃, throw 0.2g glycopyrronium bromide into solution A, stir to completely dissolve, in the filtrate tank through a 0.45μm microporous membrane for coarse filtration, and then through 0.22μm The microporous membrane is used for terminal filtration to obtain intermediate products;

[0039] 3) The filtrate can be filled in a neutral borosilicate container, sealed, and then steam sterilized at 115°C for 30 minutes to obtain glycopyrrolate injection.

[0040] In this example, the glycopyrrolate injection was made into 1000 injections, and the pH of the glycopyrrolate injection was 3.

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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. The invention also relates to a method for preparing a safe and stable glycopyrrolate injection. Background technique [0002] Glycopyrronium Bromide (Glycopyrronium Bromide) is a quaternary ammonium anticholinergic drug, similar to other anticholinergic drugs (such as antimuscarinic agents), it can inhibit the response of cholinergic nerves and smooth muscles to acetylcholine after ganglion. These peripheral choline receptors are located in smooth muscles. Autonomic cells, myocardium, sinoatrial nodes, atrioventricular nodes and exocrine glands, a few are located in the 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. Before using anesthetics, glycopyrrolate is usually used as a preoperative medication, ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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