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Freeze dried perhexiline powder for injection and its prepn process

A technology of freeze-dried powder injection and Guanxinning, which is applied in freeze-dried delivery, powder delivery, pharmaceutical formulation and other directions, can solve the problems of thermal instability of ferulic acid, decreased biological activity of the product, and short storage period of water injection. Achieve the effect of reducing the scope of myocardial ischemia, fast onset, and avoiding decomposition and deterioration

Inactive Publication Date: 2006-08-02
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] (1) The phenolic acids contained in Salvia miltiorrhiza are prone to physical and chemical changes such as hydrolysis, oxidation, and polymerization in aqueous solution, resulting in a decrease in the biological activity of the product or an increase in toxicity
[0007] (2) Ligustrazine contained in Ligusticum chuanxiong is very easy to sublimate, and ferulic acid is unstable to heat
[0009] (4) The storage period of aqueous injection is short, and the storage and transportation are inconvenient, which is not conducive to long-term storage

Method used

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  • Freeze dried perhexiline powder for injection and its prepn process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Weigh 2000g of Salvia miltiorrhiza, add water and decoct three times, 1.0h each time, combine the decoction, filter, and concentrate the filtrate to about 2000ml (0.1MP, 70°C). The concentrated solution was purified by HPD-100 type macroporous adsorption resin column, first eluted with 4BV distilled water, then 30% ethanol 6BV, collected the 30% ethanol eluate, and concentrated to 100mL under reduced pressure to obtain the salvia miltiorrhiza extract.

[0045] Weigh 2000g of Ligusticum chuanxiong, add 10 times the amount of 95% ethanol to reflux and extract 3 times, each time for 1.5h, filter the extract, combine the extract, recover ethanol (0.1MP, 60°C) under reduced pressure, and add appropriate amount of distilled water to heat and dissolve. Suction. The filtrate was passed through a macroporous adsorption resin column, washed with water, and then eluted with 30% ethanol. The 30% ethanol eluate was collected and concentrated under reduced pressure (0.1MP, 60° C.) to...

Embodiment 2

[0048] Weigh 1000g of Salvia miltiorrhiza, add 8 times the amount of 30% ethanol to reflux and extract 3 times, each time for 1h, combine the decoction, filter, and concentrate the filtrate to about 1000ml (0.1MP, 70°C). The concentrated solution was purified by D101 macroporous adsorption resin column, first eluted with 4BV distilled water, then 40% ethanol 6BV, collected 40% ethanol eluate, and concentrated under reduced pressure to 50mL to obtain the Danshen extract.

[0049]Weigh 1000g of Ligusticum chuanxiong, add 10 times the amount of 80% ethanol to reflux and extract 3 times, each time for 1h, filter the extract, combine the extract, recover ethanol (0.1MP, 60°C) under reduced pressure, add appropriate amount of distilled water to dissolve, and extract filter. The filtrate was passed through a D101 macroporous adsorption resin column, washed with water, and then eluted with 30% ethanol. The 30% ethanol eluate was collected and concentrated under reduced pressure (0.1MP...

Embodiment 3

[0052] Weigh 2000g of Danshen medicinal material, 2000g of Chuanxiong medicinal material, and the above two flavors, add water and decoct three times, 1.0h each time, combine the decoction, filter, and concentrate the filtrate to about 2000ml (0.1MP, 70°C). The concentrated solution was purified by HPD-100 macroporous adsorption resin column, first eluted with 4BV distilled water, then 30% ethanol 6BV, collected 30% ethanol eluate, and concentrated to 100mL under reduced pressure to obtain the extracts of Salvia miltiorrhiza and Rhizoma Chuanxiong thing. Dilute the extracts of Danshen and Chuanxiong with water for injection to 500mL, add 25g of glucose and 10g of sorbitol to dissolve, add water for injection to make 1000mL, sterilize by ultrafiltration membrane filtration (6000 molecular weight), and fill in 5mL under aseptic operation Put it in a sterilized vial (2mL per bottle), freeze-dry it in a freeze dryer, and seal it to get the powder injection.

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Abstract

The present invention provides one kind of freeze- dried powder, named as Guanxinning, for injection and its preparation process. It consists of red sage and Chuanxiong rhizome extract 50-100 weight portions and excipient 0-50 weight portions. The Guanxinning injection has the features of quick acting, high effect, high solubility and high stability, and is suitable for treatment of cardiac cerebral vascular diseases.

Description

technical field [0001] The invention relates to a traditional Chinese medicine preparation and a preparation method thereof. More specifically, it is a freeze-dried powder injection containing salvia miltiorrhiza extract and chuanxiong extract and a preparation method thereof. Background technique [0002] The injection containing Salvia miltiorrhiza and Chuanxiong (referred to as Guanxinning injection) is a standard prescription issued by the Ministry ("Ministry issued standard" 17 volumes 174 pages), which is composed of two Chinese medicinal materials, Danshen and Chuanxiong. , Tongmai Yangxin effect, as a drug for the treatment of coronary heart disease, angina pectoris, etc., has a wide range of clinical applications, welcomed by the majority of medical staff and patients. [0003] Salvia miltiorrhiza is a commonly used traditional Chinese medicine for promoting blood circulation and removing blood stasis. It is widely used in cardiovascular and other traditional Chine...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/53A61K9/19A61P9/10
Inventor 张铁军许浚胡静龚苏晓
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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