Preparation method of deslanoside injection

A technology of acetyl lanatoin injection and deacetyl lanatoside, which is applied in the preparation of deacetyl lanatoin injection and in the field of drug preparation, which can solve problems such as excess and achieve the effects of reducing risks, simple methods, and improving quality

Inactive Publication Date: 2013-03-13
SHANGHAI ZHAOHUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] With the improvement of requirements for injection, deacetyllanatoside injection has been included in the second part of the "Chinese Pharmacopoeia" 2010 edition, the quality standard is more stringent, and the inspection of related substances has been added. However, it is produced under the above process conditions In the deacetyllanatoside injection, the amount of related substances greatly exceeded the prescribed standard, so the preparation method needs to be improved

Method used

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  • Preparation method of deslanoside injection
  • Preparation method of deslanoside injection
  • Preparation method of deslanoside injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1 prepares lanatoside injection:

[0037]

ingredients

per 10,000 ml

1

deacetyllanatoside

2.00g

2

ethanol (medicinal)

810g

3

Glycerin (for injection)

500g

4

Water for Injection

up to 10,000 ml

[0038] (1) Put 50% of the formula water for injection (38-40°C) into the liquid mixing tank.

[0039] (2) Add ethanol liquid into a stainless steel barrel, add water for injection to make a concentration of 70%, add deacetyllanatoside and stir until completely dissolved.

[0040] (3) Slowly add glycerin into the ethanol solution of lanatoside, and stir evenly.

[0041] (4) Add water for injection to the full amount.

[0042] (5) Turn on the mixer and stir for 20 minutes.

[0043] (6) The solution is circulated and filtered with a titanium filter, 0.45 μm, 0.2 μm microporous membrane cartridge filter.

[0044] (7) Adjust the pH value to the range of 5.5-6.5.

[0045] (8) Determin...

Embodiment 2

[0049] Example 2 Preparation of deacetyllanatoside injection

[0050] The composition and preparation method are the same as in Example 1, but the water temperature of the water for injection in step (1) is 35-37°C.

Embodiment 3

[0051] Example 3 Preparation of deacetyllanatoside injection

[0052] The composition and preparation are the same as in Example 1, but the water temperature of the water for injection is 40-42°C.

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Abstract

The invention provides a preparation method of deslanoside injection. According to the preparation method, the temperature of water for injection of liquor is lowered to 35-42 DEG C, heat treatment is carried out at 100 DEG C for 30 minutes or is not adopted, and ethanol (re-steaming) is changed into ethanol (medicinal) and is directly used without re-steaming, so that the re-steaming time and cost are saved, and the quality can be ensured. According to an experimental study, the related substance indexes of the product prepared by the method are obviously reduced, the product quality is improved, and the product risk is lowered. A complete inspection according to the standard of Chinese Pharmacopoeia 2010 shows that all indexes of the deslanoside injection produced by the new method meet the standard requirements. The preparation method is simple, the product quality is ensured without increasing new cost, and the cost and energy consumption can be lowered. The preparation method is suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a preparation method of the medicine, in particular to a preparation method of deacetyllanatoside injection. Background technique [0002] Deacetyllanatoside Injection is an injection and is an antiarrhythmic drug. Mainly used for heart failure. Because of its rapid action, it is suitable for patients with acute cardiac insufficiency or acute exacerbation of chronic cardiac insufficiency. It can also be used to control the ventricular rate in patients with atrial fibrillation and atrial flutter with rapid ventricular rate. [0003] The composition of the existing deacetyllanatoside injection is as follows: [0004] ingredients per 10,000 ml 1 deacetyllanatoside 2.00g 2 Ethanol (redistilled) 810g 3 Glycerin (for injection) 500g 4 Water for Injection up to 10,000 ml [0005] The preparation met...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7048A61P9/06A61P9/04
Inventor 王燕付林
Owner SHANGHAI ZHAOHUI PHARMA
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