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Neostigmine methylsulfate composition and preparation method thereof

A technology of neostigmine methosulfate and its composition, which is applied in the direction of drug combination, sanitary equipment for toilets, medical preparations of non-active ingredients, etc., can solve the problems of high production cost and microbial contamination risk, and achieve reduction Effect of pyrogen risk, improvement of medication safety, and reduction of prescription cost

Pending Publication Date: 2021-08-10
CHENGDU XINJIE HIGH TECH DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the patent application number CN201910957301.6, an aseptic production process of freeze-dried powder injection was invented, which can prevent the product from undergoing a high-temperature terminal sterilization process and thereby control the production of impurity A, but whether the aseptic production process can achieve The set sterility assurance level is closely related to the control of the entire production process, which requires strict control of the production environment and production process, which has higher production costs and risks of microbial contamination

Method used

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  • Neostigmine methylsulfate composition and preparation method thereof
  • Neostigmine methylsulfate composition and preparation method thereof
  • Neostigmine methylsulfate composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0041] In this embodiment, the related material composition formulations are shown in Table 1 below.

[0042] Table 1

[0043]

[0044] Take 85% (v / v) of water for injection, add calcium sodium edetate and neostigmine methosulfate to dissolve it; add dilute sulfuric acid to adjust the pH, and finally add water for injection to 100% (v / v) to make the pH of the solution was 3.0, and the filtrate was obtained by filtration; the filtrate was potted and sterilized by moist heat at 121° C. for 12 minutes to obtain a neostigmine methosulfate preparation composition.

Embodiment 2

[0046] In this embodiment, the related material composition formulations are shown in Table 2 below.

[0047] Table 2

[0048]

[0049] Take 85% (v / v) of water for injection, add disodium edetate and neostigmine methosulfate to dissolve it; add dilute sulfuric acid to adjust the pH, and finally add water for injection to 100% (v / v) to make the pH of the solution was 3.0, and the filtrate was obtained by filtration; the filtrate was potted and sterilized by moist heat at 121° C. for 12 minutes to obtain a neostigmine methosulfate preparation composition.

Embodiment 3

[0051] In this embodiment, the related material composition formulations are shown in Table 3 below.

[0052] table 3

[0053]

[0054] Take 85% (v / v) of water for injection, add edetic acid and neostigmine methosulfate to dissolve it; add dilute sulfuric acid to adjust the pH, and finally add water for injection to 100% (v / v), so that the pH of the solution is 3.0 , and filtered to obtain a filtrate; the filtrate was potted and sterilized by moist heat at 121°C for 12 minutes to obtain a neostigmine methosulfate preparation composition.

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Abstract

The invention discloses a neostigmine methylsulfate composition and a preparation method thereof. The neostigmine methylsulfate composition comprises an effective amount of neostigmine methylsulfate; a chelating agent; a pH adjusting agent; and water. The composition is simple and small in dosage, the production cost is reduced, the production risk of microorganism and bacterial endotoxin pollution is reduced, the high-temperature resistance of the neostigmine methylsulfate composition is remarkably improved, and the amount of impurity A can be reduced by half after the composition is subjected to high-temperature sterilization.

Description

technical field [0001] The application relates to the field of medicinal chemistry, in particular to a neostigmine methosulfate composition and a preparation method thereof. Background technique [0002] The chemical name of neostigmine methosulfate is N,N,N-trimethyl-3-[(dimethylamino)formyloxy]anilinium methyl sulfate, which is a commonly used heteroreverse anticholine ester Enzyme drugs are commonly used in various flaccid paralysis, muscle and neurosis in internal medicine, gynecology and ENT. The main dosage form is tablet or injection, and it is available in the Netherlands, Belgium, the United States, Japan, the United Kingdom, Austria, Germany, France, Portugal and other countries. Among them, sodium acetate / acetic acid buffer pair and citric acid / sodium citrate buffer pair are used as excipients to balance the pH in the injection prescriptions listed in the United States and Japan, and the pH control range is 5.0 to 6.5. Antibacterial agents such as phenol. In Eu...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/27A61K47/04A61K47/18A61L2/00A61P21/00A61P25/00
CPCA61K31/27A61K9/08A61K47/183A61K47/18A61K47/02A61L2/0023A61P25/00A61P21/00A61L2202/21
Inventor 王旭蒲洪黄汉伟刘晓琳
Owner CHENGDU XINJIE HIGH TECH DEV CO LTD
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