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Ambroxol hydrochloride injection composition filled in plastic ampoule and preparation method of same

A technology for ambroxol hydrochloride and injection, which is applied in the directions of drug combination, packaging item types, special packaging items, etc., can solve the problems of different chemical components, different high temperature sterilization tolerance, different melting points, etc. Easy-to-open, reliable results

Inactive Publication Date: 2017-12-22
HAINAN XIANTONG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the different chemical composition and melting point of the two, the resistance to high temperature sterilization is very different

Method used

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  • Ambroxol hydrochloride injection composition filled in plastic ampoule and preparation method of same
  • Ambroxol hydrochloride injection composition filled in plastic ampoule and preparation method of same
  • Ambroxol hydrochloride injection composition filled in plastic ampoule and preparation method of same

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0019] Experimental Example 1: Formula Technology Research

[0020] Antioxidant screening was divided into blank control group, adding anhydrous sodium sulfite group and sodium metabisulfite for testing. Operate according to the determination method of related substances under the item of ambroxol injection in the 2015 edition of "Chinese Pharmacopoeia (Part Two)", and the test results are shown in the table below. It can be seen that the impurities produced are related to the types of antioxidants added, and the impurities produced by different antioxidants are different. The related substances in the two kinds of test solution added with antioxidant all increased, but the related substances in the test solution without antioxidant did not change. Therefore, this formula should not add antioxidants.

[0021] Table 1: Antioxidant test results

[0022]

[0023] Investigation on the amount of activated carbon: Activated carbon is often used in the preparation of injection ...

experiment example 2

[0030] Experimental Example 2: Comparative Experimental Research

[0031] Carry out comparative research with embodiment 1-3 and comparative example 1-3 to determine preparation process

Embodiment 1

[0076] 1. Formula

[0077] Raw materials

Dosage

effect

Ambroxol hydrochloride

1.5g

active ingredient

Propylene Glycol

3g

solvent

glycerin

2g

stabilizer

citric acid

1.6g

pH regulator

Water for Injection

Add to 200ml

solvent

production

100 sticks

-

[0078] 2. Preparation process:

[0079] (1) Weigh citric acid, propylene glycol and glycerin and add and dissolve in an appropriate amount of water for injection;

[0080] (2) Add ambroxol hydrochloride, then add nearly full amount of water for injection, stir to dissolve;

[0081] (3) Use 0.1mol / mL sodium hydroxide to adjust the pH to 3.5, and add water for injection to the full amount;

[0082] (4) Add 0.05% activated carbon and stir well, let it stand for 30 minutes, coarsely filter and decarbonize, and then finely filter with a filter with a suitable pore size of 0.22um. The intermediate is sampled to detect the propertie...

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Abstract

The invention discloses an ambroxol hydrochloride injection composition filled in a plastic ampoule and a preparation method of same. The injection composition is prepared from, by weight, 1-2 parts of citric acid, 1-4 parts of propylene glycol, 1-4 parts of glycerol and 1-2 parts of ambroxol hydrochloride, water for injection added to 150-250 parts by volume. The ambroxol hydrochloride injection composition has reliable quality, satisfies quality standard demand of ambroxol hydrochloride injection and is suitable for industrial production.

Description

technical field [0001] The invention relates to an injection composition and a preparation method thereof, in particular to an ambroxol hydrochloride injection composition and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride is trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol, also known as bromcyclohexyl hydrochloride, is a new generation of mucolytic agent, the earliest in It was launched in Germany in the early 1980s. It has definite curative effect and less toxic and side effects. It is mainly used clinically for the expectorant treatment of acute and chronic respiratory diseases accompanied by abnormal sputum secretion and poor expectoration function, such as acute and chronic bronchitis. , bronchial asthma, bronchiectasis, emphysema, tuberculosis, pneumoconiosis, difficulty expectoration after surgery, etc. [0003] [0004] Low-borosilicate glass ampoules have been widely used in my country for a long time, and the quality l...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/10A61K47/12A61P11/10A61J1/06
CPCA61J1/06A61K9/0019A61K9/08A61K31/137A61K47/10A61K47/12
Inventor 齐慧
Owner HAINAN XIANTONG PHARMA CO LTD
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