Sodium bialginate for injection and its preparation method

A technology for sodium alginate diester and injection, which is applied in the field of freeze-dried sodium alginate diester for injection, can solve the problems of instability in the shelf life, degradation of active ingredients, low bioavailability, etc., and achieves improvement of microcirculation. , stable performance, the effect of reducing blood viscosity

Inactive Publication Date: 2004-03-17
吉林市卓怡康纳制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to clinical observation, although diester sodium alginate tablets are more convenient to take, their bioavailability is low due to factors such as disintegration and first-pass effect; diester sodium alginate injection, although bioavailability is relatively low High,

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0158] The proportioning ratio of each raw material is:

[0159] Sodium alginate 200g

[0160] Sodium chloride 25 grams

[0161] 2000ml water for injection to make 1000 bottles

[0162] The preparation method is as follows: take 1600 ml of water for injection, adjust the pH value to 4.5 with 10% hydrochloric acid solution or 4% sodium hydroxide solution, add 25 grams of sodium chloride, and stir until completely dissolved; take sodium alginate diester 200 grams and 2 grams of activated carbon for needles were added to the above solution, stirred until completely dissolved, then added water for injection to 2000 milliliters, and the pH value was adjusted to 4.5 with a concentration of 10% hydrochloric acid solution or a concentration of 4% sodium hydroxide solution. After decarbonization, filter with a 0.45 μm microporous membrane and then filter with a 0.22 μm microporous membrane; bottle the obtained fine filtrate, half-stopper, and freeze-dry for 36 hours, of which: freezi...

Embodiment 2

[0165] The proportioning ratio of each raw material is:

[0166] Sodium alginate 100g

[0167] Mannitol 50g

[0168] 2000ml water for injection to make 1000 bottles

[0169] The preparation method is basically the same as in Example 1, freeze-drying for 37 hours, wherein: freezing temperature -40°C, freezing for 7 hours; first sublimation temperature from -40°C to 30°C, 20 hours; second sublimation temperature by 30°C -38°C, 10 hours.

Embodiment 3

[0171] The proportioning ratio of each raw material is:

[0172] Sodium alginate 25g

[0173] Dextran 40 200g

[0174] 2000ml water for injection to make 1000 bottles

[0175] The preparation method is basically the same as in Example 1, freeze-drying for 36 hours, wherein: freezing temperature -40°C, freezing for 6 hours; first sublimation temperature from -40°C to 30°C, 20 hours; second sublimation temperature from 30°C -38°C, 10 hours.

[0176] The sources and quality standards of the raw and auxiliary materials used in each embodiment are as follows:

[0177] Quality Standards for Sources of Raw and Excipient Materials Sodium Alginate Diester Sodium Alginate Dalian Aosen Pharmaceutical Factory Haibin Branch Standard issued by the Ministry of Health of China Part II Part IV Volume 1995 Sodium Chloride Weihai Asia Pacific Pharmaceutical Co., Ltd. Chinese Pharmacopoeia 2000 Edition Mannitol Jilin City Cornell Pharmaceutical Co., Ltd. Chinese Pharmacopoeia 2000 Edition Dex...

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Abstract

The present invention is one kind of freeze dried polysaccharide sulphate for injection, and each 1000 ampules of the injection contains polysaccharide sulphate 25-200 g and excipient 25-200 g. The injection preparation is prepared through advanced low temperature freeze drying process, and is stable in the preserving period and ever suitable for clinical application. The present invention has the functions of lowering blood viscosity, resisting blood coagulation, lowering blood fat, improving micro circulation, etc. and is used in preventing and treating ischemic cardiac and cerebral vascular diseases and hyperlipemia.

Description

technical field [0001] The invention relates to a freeze-dried sodium alginate diester for injection, which belongs to a pharmaceutical preparation. Background technique [0002] Sodium alginate diester is synthesized with alginic acid as the basic raw material and introduced effective groups by chemical methods. It is an acidic polysaccharide drug. Sodium alginate diester has strong dispersing and emulsifying properties, and is not easily affected by external factors. Because of its anionic polyelectrolyte fiber structure, the charges along the chain are concentrated, and under the action of its electric repulsion, it can make cells rich in negative charges The surface increases mutual repulsion, so it can resist the adhesion between red blood cells and between red blood cells and blood vessel walls, and has the effect of improving the viscoelasticity of blood rheology. In addition, sodium alginate diester can inactivate thrombin, and has prostagl...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/19A61K31/734A61P3/06A61P9/10
Inventor 赵国华李建英
Owner 吉林市卓怡康纳制药有限公司
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