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Lyophilized powder injection containing red sage root and dalbergia wood volatile oil and preparation method thereof

A technology for freeze-dried powder injection and volatile oil, which is applied in the field of freeze-dried powder injection of hydroxypropyl-β-cyclodextrin inclusion complex and its preparation, and can solve problems such as easy oxidation, decreased active substance content, unstable properties, etc. To achieve the effect of reducing plasma lactic acid content, improving metabolic disorders, and improving microcirculation disorders

Inactive Publication Date: 2007-05-16
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] As we all know, because the volatile oil of balsamic is a fat-soluble component, its solubility in water is small, it is almost insoluble in water, and its stability is poor; while the current existing preparation technology is to plan the balsamic into thin slices, add water to infiltrate, and steam Distill, collect the distillate, refrigerate, and separate the oil layer
Only the water-saturated solution of balsamic volatile oil is used, and the oil layer is partially discarded, resulting in a great waste of medicinal resources
[0009] Salvia miltiorrhiza contains various water-soluble phenolic compounds such as danshensu and protocatechuic aldehyde, which are unstable in nature and easily oxidized in aqueous solution. It is easy to change, which leads to the deepening of the color of the finished product; some also contain fat-soluble ingredients such as tanshinone, which are prone to physical and chemical changes such as hydrolysis, oxidation, and polymerization in aqueous solution, resulting in a decrease in the content of active substances and an increase in toxicity
Therefore, there are certain disadvantages in making water needles from this formula.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0118] Take an appropriate amount of Danshen medicinal material, crush it, and pass through a 10-mesh sieve. Weigh 100g, mix and add 60% ethanol to soak for 24 hours, move to the percolation cylinder, percolate at a speed of 0.6mL / min, collect 900ml percolation liquid, concentrate under reduced pressure until no alcohol smell (0.1MP, 60°C ). Adjust the pH to 2.0 with 2M hydrochloric acid, let it stand, filter, and the filtrate is purified by HPD-100 macroporous adsorption resin column (400ml), first eluted with 4BV distilled water, then 60% ethanol 6BV, and collected 60% ethanol The eluate was concentrated under reduced pressure (0.1MP, 60°C) to 100ml, (salvianolic acid B45mg / ml), and the assay content was 85%. Then add 8g of hydroxypropyl-β-cyclodextrin to the concentrated solution. After the hydroxypropyl-β-cyclodextrin is dissolved, put it in a water bath at 40°C, and slowly add 0.17ml of balsamic essential oil dropwise into the above solution , with vigorous magnetic sti...

Embodiment 2

[0120] Take an appropriate amount of Salvia miltiorrhiza medicinal material, crush it, weigh 1000g of coarse powder, percolate with 30L of 30% ethanol, concentrate the percolation liquid to 0.5g / ml (according to the amount of medicinal material) under reduced pressure, adjust the pH to 2.5 with 2M hydrochloric acid, let stand, filter After the filtrate was passed through HPD400 resin, the washed part was discarded, and the 40% ethanol eluted part was collected, concentrated under reduced pressure to no alcohol smell, added water for injection to 450ml, (salvianolic acid B90mg / ml), and the measured content was 90%. Separately weigh 75g of hydroxypropyl-β-cyclodextrin, dissolve it in about 450ml of water for injection, and slowly add 1.7ml of balsamic volatile oil drop by drop under the condition of vigorous electric stirring in a water bath at 30°C, seal the container, and continue stirring 2 hours, overnight at room temperature. To obtain the aqueous solution of hydroxypropyl-...

Embodiment 3

[0122] Take an appropriate amount of Salvia miltiorrhiza, crush it, pass through a 10-mesh sieve, weigh 800g of coarse powder, add 50% ethanol and heat it under reflux for 1 hour, filter out the medicinal liquid, extract the medicinal residue as above again, combine the medicinal liquid, and concentrate under reduced pressure until alcohol-free Odor (0.1MP, 60°C). Adjust the pH to 2.8 with 2M hydrochloric acid, let it stand, filter, and purify the filtrate through a D101 macroporous adsorption resin column (200ml), elute with 4BV distilled water first, then elute with 30% ethanol 6BV, and collect 30% ethanol to elute Liquid, and concentrated under reduced pressure (0.1MP, 60 ℃) to 800ml (salvianolic acid B31mg / ml), the assay content is 55%. Dissolve 150g of hydroxypropyl-β-cyclodextrin in 1200ml of water for injection, put it in a water bath at 50°C, and under vigorous electric stirring, slowly add 3.5ml of balsamic volatile oil dropwise, continue stirring for 180 minutes, and...

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PUM

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Abstract

The invention provides a freeze dried powder injection and its preparing process, wherein the injection comprises 2-6 parts of water-soluble constituent extract of red sage root, and 4-8 parts of hydroxypropyl-beta-cyclodextrin inclusion compound of dalbergia wood volatile oil, wherein the ratio of hydroxypropyl-beta-cyclodextrin and dalbergia wood volatile oil is 10-45:1. The main effective constituents of the injection include root of red rooted saliva extract, salvanic acid B and cis-nerolidol, and can be used for treating cardiovascular system diseases such as acute myocardial ischemia.

Description

technical field [0001] The invention relates to a traditional Chinese medicine preparation and a preparation method thereof. Specifically, it is a freeze-dried powder injection containing hydroxypropyl-beta-cyclodextrin inclusion compound of salvia miltiorrhiza water-soluble component extract and balsamic volatile oil and a preparation method thereof. Background technique [0002] Danxiang Guanxin Injection, Xiangdan Injection, and Compound Danshen Injection are injections for treating angina pectoris and myocardial infarction. They have the functions of promoting blood circulation and removing stasis, regulating qi and resuscitation, dilating blood vessels, increasing coronary blood flow, and reducing myocardial oxygen consumption. . Its prescriptions are composed of Jiangxiang and Danshen in different proportions. [0003] Salvia miltiorrhiza is the dry root and rhizome of Salvia miltiorrhiza Bge, a plant in the Labiatae family. Salvia miltiorrhiza has the functions of d...

Claims

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Application Information

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IPC IPC(8): A61K36/53A61K9/19A61P9/10
Inventor 张铁军侯文彬王靖吴疆
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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