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Method for determining content of active compounds in Chinese medicinal freeze-dried injection

A technology of freeze-dried injection and determination method, applied in the field of pharmaceutical preparation analysis, can solve the problems of cumbersome, low content, time-consuming and the like, and achieve the effect of reliable quality control

Active Publication Date: 2011-07-20
SHIJIAZHUANG YILING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the high polarity and low content of saponins, it is cumbersome and time-consuming to separate and identify their active components using traditional ultraviolet or evaporative light detectors. Therefore, a sensitive and selective method was established to analyze simultaneously Saponins and flavonoids, very necessary

Method used

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  • Method for determining content of active compounds in Chinese medicinal freeze-dried injection
  • Method for determining content of active compounds in Chinese medicinal freeze-dried injection
  • Method for determining content of active compounds in Chinese medicinal freeze-dried injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] Raw material weight ratio:

[0096] Total ginseng saponins extract 50g Epimedium total flavonoids extract 40g

[0097] Preparation:

[0098] a. Dissolve 800 grams of hydroxypropyl-β-cyclodextrin with 4000ml of water to make a 20% solution, add 750ml (5.33%) of total flavonoids extract of Epimedium and heat to dissolve, slowly add hydroxypropyl-β-cyclodextrin in stages - In the cyclodextrin 800 solution, keep warm at 80°C±1°C, dynamically stir for inclusion, and the inclusion time is 3 hours. Add 100ml (50%) of the total ginseng saponins extract to water and heat to dissolve, add it to the inclusion solution, and continue the inclusion 1 hour;

[0099] b. Add water to adjust the total amount of the solution to 6000ml, adjust the pH to 7.5 with 10% sodium hydroxide solution, add 24 grams of activated carbon (that is, contain 0.4% activated carbon), boil for 10 minutes, filter with a clarified plate while it is hot, and filter out the activated carbon , and then filter ...

Embodiment 2

[0115] Raw material weight ratio:

[0116] Total Ginseng Saponin Extract 35g Epimedium Total Flavonoid Extract 55g

[0117] Preparation:

[0118] a. Dissolve 900 grams of hydroxypropyl-β-cyclodextrin in 3000ml of water to make a 30% solution, add 1800ml (3.11%) of the total flavonoids extract of Epimedium to dissolve, and slowly add hydroxypropyl-β- In the cyclodextrin solution, keep warm at 50±1°C, dynamically stir for inclusion, and the inclusion time is 8 hours. Add 105ml (33.3%) of the total ginseng saponins extract to water and heat to dissolve, add it to the inclusion solution, and continue inclusion for 2 hours;

[0119] b, add water to adjust the total amount of the solution to 6000ml, adjust the pH to 6.2 with 20% sodium hydroxide solution, add 6 grams of gac (containing 0.1% gac), boil for 10 minutes, filter while hot with a sand filter stick, filter gac, Then filter with 0.22μm microporous membrane, and dilute to 6000ml with water;

[0120] c. Autoclave at 105°C ...

Embodiment 3

[0135] Raw material weight ratio:

[0136] Total Ginseng Saponin Extract 65g Epimedium Total Flavonoid Extract 25g

[0137] Preparation:

[0138] a. Dissolve 650 grams of hydroxypropyl-β-cyclodextrin with 4000 g of water to make a 16.3% solution, add 250 ml (10%) of the total flavonoids extract of Epimedium and heat to dissolve, slowly add hydroxypropyl-β-cyclodextrin in stages - In the cyclodextrin solution, keep warm at 90°C ± 1°C, stir dynamically for inclusion, and the inclusion time is 3 hours. Add 130ml (50%) of the total ginseng saponin extract to water and heat to dissolve, add it to the inclusion solution, and continue inclusion for 1 Hour;

[0139] b. Add water to adjust the total amount of the solution to 6000ml, adjust the pH to 8.5 with 5% sodium hydroxide solution, add 30 grams of activated carbon (containing 0.5% activated carbon), boil for 6 minutes, suction filter while it is hot, filter out the activated carbon, and then use 0.22 Filter with μm microporous...

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Abstract

The invention provides a method for determining content of various components in a Chinese medicinal composition freeze-dried injection. The Chinese medicinal freeze-dried injection comprises ginseng and epimedium herb which serve as raw materials and is clinically used for treating amyotrophy and myasthenia gravis which are caused by diseases such as motoneuron diseases (amyotrophic lateral sclerosis, progressive spinal muscular atrophy, progressive bulbar palsy and primary lateral sclerosis), progressive muscular dystrophy, congenital myopathy and the like. In the method, 15 active compounds in the Chinese medicinal freeze-dried injection are qualitatively and quantitatively analyzed simultaneously by a tandem mass spectrometry of a high performance liquid chromatography, and the method can be used for quality control of a product.

Description

technical field [0001] The invention relates to a method for determining the content of active compounds in traditional Chinese medicine freeze-dried injections, belonging to the technical field of pharmaceutical preparation analysis. Background technique [0002] In terms of quality standards for freeze-dried injections of traditional Chinese medicine, there are many items that require control. Among them, the content control of effective compounds is very important for the quality control of freeze-dried injections of traditional Chinese medicine. [0003] CN1785223A discloses a medicine for treating muscular atrophy and myasthenia gravis and its preparation method. The patent discloses the prescription, preparation, capsule, tablet and other preparation methods of the medicine; the patent also discloses the pharmacodynamics of the medicine Experiments have confirmed that the drug can enhance the vitality of normal motor neurons, promote the growth of neurites, protect mot...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/296G01N30/36G01N30/72A61P21/04
Inventor 宋剑刘敏彦赵韶华贾继明王贵金刘兴国郑亚杰蔡艳裴彩云
Owner SHIJIAZHUANG YILING PHARMA
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