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Diprophylline injection and preparation method thereof

A diprophylline and injection technology, which is applied in blood diseases, medical formulas, extracellular fluid diseases, etc., can solve the problems of low product quality and foreign matter, and 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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  • Summary
  • 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 defects of the existing diprophylline injection containing foreign matter and low product quality, and to provide a diprophylline injection and a preparation method thereof

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A preparation method for dihydroxyprophylline injection, comprising the steps of:

[0024] (1) Add about 50% of hot water for injection at a temperature of 70-80°C in the concentrated preparation tank, add diprophylline, stir to dissolve, filter back to clear with a Suzhou sand filter rod, and filter to dilute In the tank;

[0025] (2) Add water for injection to the full amount, stir for 15 minutes, make it uniform, and adjust the pH value with 20wt% sodium hydroxide solution;

[0026] (3) Back-filter with Suzhou sand filter rods, 0.45 μm and 0.22 μm polyethersulfone (PES) fins until clear;

[0027] (4) Sampling is done for inspection of visible foreign matter, and the intermediate content and pH value are measured. After all items are qualified, the medicinal liquid is filtered into the liquid storage tank;

[0028] (5) The medicinal liquid in the liquid storage tank is filtered through multiple 0.22 μm polyethersulfone (PES) fins, and then input to the filling buffe...

Embodiment 2

[0032] A preparation method for dihydroxyprophylline injection, comprising the steps of:

[0033] (1) Add about 50% of hot water for injection at a temperature of 70-80°C in the concentrated preparation tank, add diprophylline, stir to dissolve, filter back to clear with a Suzhou sand filter rod, and filter to dilute In the tank;

[0034] (2) Add water for injection to the full amount, stir for 15 minutes to make it uniform, and adjust the pH value with dilute hydrochloric acid;

[0035] (3) Back-filter with Suzhou sand filter rods, 0.45 μm and 0.22 μm polyethersulfone (PES) fins until clear;

[0036] (4) Sampling is done for inspection of visible foreign matter, and the intermediate content and pH value are measured. After all items are qualified, the medicinal liquid is filtered into the liquid storage tank;

[0037] (5) The medicinal liquid in the liquid storage tank is filtered through multiple 0.22 μm polyethersulfone (PES) fins, and then input to the filling buffer tan...

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PUM

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Abstract

The invention discloses a dihydroxyprophylline injection and a preparation method thereof. The method comprises the following steps: (1) adding 50% hot water for injection and dihydroprophylline into a concentrated preparation tank, stirring and dissolving , use a Suzhou sand filter rod to filter back until it is clear, and filter it into a dilute tank; (2) Add water for injection to the full amount, stir evenly, and adjust the pH value; (3) Use a Suzhou sand filter rod, 0.45 μm and 0.22 μm poly Ethersulfone fin back filtration until clarity; (4) Sampling for visible foreign matter inspection, measuring intermediate content and pH value, after all items are qualified, filter the medicinal liquid into the liquid storage tank; (5) the medicinal liquid in the liquid storage tank The solution is filtered through multiple 0.22 μm polyethersulfone fins, and then input to the filling buffer tank for filling; (6) filling; (7) sterilization, the sterilization temperature is 100 ° C, and the time is 30 minutes. The preparation method of the invention adopts secondary sterilization and filtration, the whole process is aseptic, the visible foreign matter of the medicine is reduced, and the product quality is guaranteed.

Description

technical field [0001] The invention relates to a dihydroxyprophylline injection and a preparation method thereof. Background technique [0002] Diprophylline is a smooth muscle relaxant, which has the effect of dilating bronchi and coronary arteries. The antiasthmatic effect is similar to that of aminophylline, especially suitable for asthmatic patients with tachycardia. Diprophylline injection is suitable for bronchial asthma, wheezing bronchitis, obstructive emphysema, etc. to relieve wheezing symptoms, and is also used for asthma caused by cardiogenic pulmonary edema. However, the existing diprophylline injection contains foreign matter, which affects product quality. Contents of the invention [0003] The technical problem to be solved by the present invention is to overcome the defects of the existing diprophylline injection containing foreign matter and low product quality, and to provide a diprophylline injection and a preparation method thereof. The preparation...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/522A61P11/06A61P11/00A61P7/10A61P9/10
CPCA61K9/08A61K9/0019A61K31/522
Inventor 徐欣
Owner SHANGHAI XINYI JINZHU PHARMA
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