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Preparation method of sodium morrhuate injection

A technology of sodium morrhuate and its manufacturing method, which is applied in the field of manufacturing sodium morrhuate injection, can solve problems such as low production quality, achieve the effect of reducing visible foreign matter and ensuring production quality

Inactive Publication Date: 2014-12-24
SHANGHAI XINYI JINZHU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Visible foreign matter exists in the existing sodium morrhuate injection, and the production quality is low

Method used

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Comparison scheme
Effect test

Embodiment Construction

[0013] The manufacture method of sodium morrhuate injection of the present invention comprises the following steps:

[0014] Step 1, prepare 0.5mol / l sodium hydroxide solution, stand-by after calibration;

[0015] Step 2, taking the cod liver oil fatty acid of prescription quantity and adding to the preparation barrel;

[0016] Step 3, adding the sodium hydroxide solution into the preparation barrel at one time; heating the preparation barrel in a water bath, and stirring the liquid medicine until it becomes clear;

[0017] Step 4, after cooling the clarified liquid medicine to room temperature, pour it into the preparation barrel, add water for injection to 2 / 3 of the preparation amount, and stir evenly;

[0018] Step 5, add benzyl alcohol and water for injection to the full amount, stir evenly; take a sample to detect the content and pH of the intermediate;

[0019] Step 6: After all items are qualified, the medicinal liquid is filtered through a 10um polypropylene micropo...

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Abstract

The invention discloses a preparation method of a sodium morrhuate injection. The method comprises the following steps: 1 preparing 0.5mol / l of sodium hydroxide solution, and calibrating for later use; 2 weighing prescription amount of oleum morrhuae fatty acid and adding to a preparation barrel; 3 adding the sodium hydroxide solution to the preparation barrel one time, putting the preparation barrel into a water bath kettle to heat, and stirring a liquid medicine until the liquid is clear; 4 cooling the clear liquid medicine to room temperature, pouring into the preparation barrel, adding injection water to be 2 / 3 of the preparation amount, and stirring evenly; 5 adding benzyl alcohol and injection water to full dose, and stirring evenly; 6 after all indicators are qualified, filtering the liquid medicine by a polypropylene micropore filter membrane of 10 microns until the liquid is clear, and filtering into a preparation barrel after inspection of visible particles is qualified; and 7 inputting liquid storage base bottles to encapsulate. Secondary aseptic filtration is adopted, so that the visible particles of the medicine are reduced, and the production quality is ensured.

Description

technical field [0001] The invention relates to a sodium morrhuate injection, in particular to a method for preparing the sodium morrhuate injection. Background technique [0002] After local sodium morrhuate injection is injected, it stimulates the intima of the blood vessel, promotes its proliferation, gradually occludes the blood vessel, and makes it harden. Those), also used in gynecology, surgery and other wound oozing and bleeding. Visible foreign matter exists in the existing sodium morrhuate injection, and the production quality is low. Contents of the invention [0003] The technical problem to be solved by the present invention is to provide a manufacturing method of sodium morrhuate injection, which adopts secondary sterilization and filtration, which reduces the visible foreign matter of the medicine and ensures the production quality. [0004] The present invention solves the problems of the technologies described above through the following technical soluti...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/20A61P35/00A61P9/14A61P19/02A61P7/04
Inventor 周圣慧
Owner SHANGHAI XINYI JINZHU PHARMA
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