Arginine hydrochloride injection and preparation method thereof

A technology for arginine hydrochloride and injection, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., can solve the problems of raw materials contained in arginine hydrochloride, and achieve the effect of stable and reliable 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 defect that arginine hydrochloride contains more impurities such as raw materials in the prior art, and provide a kind of arginine hydrochloride injection and its preparation method

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The preparation method of arginine hydrochloride injection comprises the following steps:

[0023] (1) Add about 50% water for injection into the concentrated preparation tank, add arginine hydrochloride, stir to dissolve; add medicinal charcoal, stir evenly, boil for 30 minutes, and place to cool;

[0024] The steps of adding medicinal charcoal and boiling can effectively adsorb impurities in arginine hydrochloride;

[0025] (2) Use a Suzhou sand filter rod to back-filter and decarburize until it is clear, and then filter it into a dilute tank;

[0026] (3) Add water for injection to the full amount, and stir for more than 15 minutes to make it uniform;

[0027] This step needs to be quantified accurately and stirred evenly;

[0028] (4) Filter through Suzhou sand filter stick, 0.45 μm polyethersulfone and 0.22 μm polyethersulfone (PES) fins until clear;

[0029] (5) Sampling and testing the intermediate content and pH value; if the intermediate content and pH value...

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PUM

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Abstract

The invention discloses an arginine hydrochloride injection and a preparation method thereof. It includes the following steps: ①adding 50% water for injection and arginine hydrochloride in the concentrated preparation tank, stirring and dissolving; then adding medicinal charcoal, stirring evenly, boiling for 30 minutes, and standing to cool; ②filtering with Suzhou sand After rod back filtration and decarbonization to clarity, filter into the dilute tank; ③add water for injection to the full amount, and stir evenly; ④filter through Suzhou sand filter rod, 0.45μm polyethersulfone and 0.22μm polyethersulfone fins until clarity; ⑤ Take a sample to test the intermediate content and pH value. If the intermediate content and pH value are qualified, filter the liquid medicine into the liquid storage tank; Filling liquid storage container for filling; ⑦ filling and sealing; ⑧ sterilization: temperature 115 ℃, time 30 minutes. The arginine hydrochloride injection prepared by the invention can effectively remove impurities such as raw materials, and has stable and reliable quality.

Description

technical field [0001] The invention relates to arginine hydrochloride injection and a preparation method thereof. Background technique [0002] Arginine hydrochloride is an intermediate metabolite of the ornithine cycle, which can promote the generation and excretion of urea, correct ammonia poisoning and relieve hepatic coma. Arginine hydrochloride injection is used for hepatic encephalopathy, suitable for patients who avoid sodium, and also suitable for the treatment of mental symptoms caused by increased blood ammonia caused by other reasons. However, arginine hydrochloride contains more impurities such as raw materials, 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 that arginine hydrochloride contains many impurities such as raw materials in the prior art, and provide a kind of arginine hydrochloride injection and its preparation method. The ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/198A61P1/16A61P25/00
CPCA61K9/08A61K9/0019A61K31/198
Inventor 徐欣
Owner SHANGHAI XINYI JINZHU PHARMA
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