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Glycopyrronium bromide injection and preparation method thereof

A technology containing glycopyrrolate bromide and glycopyrrolate bromide, which is applied in the field of medicine, can solve safety problems and other problems, and achieve the effects of low cost, stable stability and high product quality

Inactive Publication Date: 2016-03-02
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, sodium chloride is a component that is not included in the original research product. For injections, the introduction of new components may bring unnecessary safety problems

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

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Element

[0040]The preparation method is as follows: weigh about 950mL of water for injection below 40°C, adjust the pH value of the solution to 2.5 with concentrated hydrochloric acid; add the prescribed amount of glycopyrronium bromide to the above solution, stir to dissolve, and add water for injection to 1000mL; After filtering with a 0.22 μm improved PVDF filter membrane, fill it, and sterilize it at 121°C for 15 minutes to obtain a glycopyrronium bromide injection containing 0.2 mg of glycopyrronium bromide per mL, wherein the bacterial endotoxin of the glycopyrronium bromide injection was measured to be ≤111.1 Eu / mL.

Embodiment 2

[0042] Element

[0043] The preparation method is as follows: weigh about 950mL of water for injection below 40°C, adjust the pH value of the solution to 2.0 with concentrated hydrochloric acid; add the prescribed amount of glycopyrronium bromide to the above solution, stir to dissolve, and add water for injection to 1000mL; After filtering with a 0.22 μm improved PVDF filter membrane, fill it, and sterilize it at 121°C for 15 minutes to obtain a glycopyrronium bromide injection containing 0.2 mg of glycopyrronium bromide per 1 mL, wherein the bacterial endotoxin of the glycopyrronium bromide injection was measured to be ≤111.1 Eu / mL.

Embodiment 3

[0046] The preparation method is as follows: weigh about 950 mL of water for injection below 40°C, adjust the pH value of the solution to 3.0 with concentrated hydrochloric acid; add the prescribed amount of glycopyrronium bromide to the above solution, stir to dissolve, and add water for injection to 1000 mL; After filtering with a 0.22 μm improved PVDF filter membrane, fill it, and sterilize it at 121°C for 15 minutes to obtain a glycopyrronium bromide injection containing 0.2 mg of glycopyrronium bromide per mL, wherein the bacterial endotoxin of the glycopyrronium bromide injection was measured to be ≤111.1 Eu / mL.

[0047] The samples of Comparative Example 1 and Example 1 were taken and placed at a high temperature of 60°C (0 days, 10 days, 20 days) to investigate the stability. The results are shown in Table 1.

[0048]

[0049]

[0050] According to the results in Table 1, compared with benzyl alcohol-containing and non-benzyl alcohol-containing prescriptio...

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PUM

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Abstract

The invention discloses glycopyrronium bromide injection and a preparation method thereof. The glycopyrronium bromide injection comprises glycopyrronium bromide, a pH adjusting agent and water for injection, and no benzyl alcohol or sodium chloride is contained. The glycopyrronium bromide injection prepared through the preparation method is controllable in quality, good in stability and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a glycopyrronium bromide injection and a preparation method thereof. Background technique [0002] Glycopyrronium bromide, the chemical name is bromide-3-hydroxy-1,1-dimethylpyrrolidinyl-α-cyclopentylmandelate. [0003] Glycopyrronium bromide is a quaternary ammonium anticholinergic drug that can inhibit gastric acid secretion and regulate gastrointestinal peristalsis. This product also has a stronger anti-saliva secretion effect than atropine, but has no central anticholinergic activity. At present, there are only tablets in China, and injections are available in the United States. [0004] Glycopyrronium Bromide Injection was approved by the FDA for marketing in the United States on February 6, 1975, and then on September 7, 2007 in the UK. As a product of a new route of administration for glycopyrronium bromide, this product is different from the oral preparations. It is mai...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/40A61K47/02A61P1/04
CPCA61K9/0019A61K9/08A61K31/40A61K47/02
Inventor 施祥杰陈浩汪月明王新石
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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