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Neostigmine methylsulfate injection and preparation method thereof

A technology of neostigmine methosulfate and injection, which is applied in the fields of medical formula, drug delivery, muscular system diseases, etc. It can solve the problems of poor quality of neostigmine methylsulfate injection, achieve the effect of reducing visible foreign matter and ensuring product quality

Inactive Publication Date: 2017-09-01
SHANGHAI XINYI JINZHU PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved by the present invention is to overcome the defective quality of neostigmine methylsulfate injection in the prior art, and a kind of neostigmine methylsulfate injection and preparation method thereof are provided

Method used

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Experimental program
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Effect test

Embodiment 1

[0020] The preparation method of neostigmine methylsulfate injection comprises the following steps:

[0021] (1) Add an appropriate amount of water for injection in the preparation tank, add 225.0 g of neostigmine methosulfate, stir to dissolve, and dilute to the full amount with water for injection, stir for 15 minutes to make it uniform;

[0022] (2) Back-filter with Suzhou sand filter rod, 0.45 μm polyethersulfone and 0.22 μm polyethersulfone (PES) microporous membrane until clear; this step needs to check that the visible foreign matter is qualified;

[0023] (3) Sampling and testing the intermediate content and pH value, if the intermediate content is in the range of 95.0 to 105.0%, and the pH is in the range of 5.2 to 6.8, filter the medicinal liquid into the liquid storage tank;

[0024] (4) The medicinal liquid in the liquid storage tank is filtered through two 0.22 μm polyethersulfone (PES) microporous membranes, and after sampling for visible foreign matter inspectio...

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PUM

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Abstract

The invention discloses a neostigmine methyl sulfate injection and a preparation method thereof. It includes the following steps: ① Add water for injection and mix 225.0g of neostigmine methyl sulfate in the preparation tank, stir to dissolve, dilute to the full amount with water for injection, and stir evenly; ② Use Suzhou sand filter rods, 0.45 μm and 0.22 μm polyethylene sulfate. Filter back through the ethersulfone microporous membrane until it becomes clear; ③ Take samples to test the intermediate content and pH value. If the intermediate content is in the range of 95.0 to 105.0% and the pH is in the range of 5.2 to 6.8, the medicinal solution is qualified. Filter the medicinal solution. into the liquid storage tank; ④ The liquid in the liquid storage tank is filtered through two 0.22 μm polyethersulfone microporous membranes. After sampling for visible foreign matter and passing the inspection, it is input into the filling buffer tank for potting; ⑤ Potting; ⑥ Destroy Bacteria: 100℃, 30 minutes. The preparation method of the present invention adopts secondary sterilization filtration, which reduces visible foreign matter in the medicine, makes the whole process sterile, and ensures product quality.

Description

Technical field [0001] The invention relates to a neostigmine methyl sulfate injection and a preparation method thereof. Background technique [0002] Neostigmine methyl sulfate injection is a muscle relaxant. It is a specific antidote for myasthenia gravis and restoring muscle relaxation after surgical anesthesia. In particular, myasthenia gravis patients almost depend on this drug for survival. However, the quality of the existing neostigmine methyl sulfate injection is poor, and this phenomenon needs to be solved urgently. Contents of the invention [0003] The technical problem to be solved by the present invention is to overcome the defect of poor quality of neostigmine methyl sulfate injection in the prior art, and provide a neostigmine methyl sulfate injection and a preparation method thereof. The preparation method of the present invention adopts secondary sterilization filtration, which reduces visible foreign matter in the medicine, makes the whole process steri...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/27A61P21/04A61P21/00
CPCA61K9/08A61K9/0019A61K31/27
Inventor 徐欣
Owner SHANGHAI XINYI JINZHU PHARMA
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