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A method for the determination of organic solvent residues in traditional Chinese medicine freeze-dried injections

A technology for freeze-dried injection and determination method, which is applied in the field of determination of organic solvent residues in freeze-dried injections of traditional Chinese medicine, can solve problems such as undisclosed content determination methods of freeze-dried injections, and achieve the effect of ensuring safe, effective and reliable quality control.

Inactive Publication Date: 2011-12-21
HEBEI YILING MEDICINE INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The patent does not disclose the preparation of freeze-dried injection and its content determination method

Method used

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  • A method for the determination of organic solvent residues in traditional Chinese medicine freeze-dried injections
  • A method for the determination of organic solvent residues in traditional Chinese medicine freeze-dried injections

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Raw material weight ratio:

[0067] Total ginseng saponins extract 50g Epimedium total flavonoids extract 40g

[0068] Preparation:

[0069] 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;

[0070] 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

[0084] Raw material weight ratio:

[0085] Total Ginseng Saponin Extract 35g Epimedium Total Flavonoid Extract 55g

[0086] Preparation:

[0087] 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;

[0088] 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;

[0089]c. Autoclave at 105°C f...

Embodiment 3

[0102] Raw material weight ratio:

[0103] Total Ginseng Saponin Extract 65g Epimedium Total Flavonoid Extract 25g

[0104] Preparation:

[0105] 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;

[0106] 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 residual organic solvents in the freeze-dried injection of a traditional Chinese medicine composition. The raw materials of the freeze-dried injection of the Chinese medicine include ginseng and epimedium, which are clinically used for motor neuron diseases (amyotrophic lateral sclerosis, amyotrophic lateral sclerosis, spinal muscular atrophy, progressive bulbar palsy, primary lateral sclerosis), progressive muscular dystrophy, congenital myopathy and other diseases caused by muscular atrophy and myasthenia gravis, the method of the present invention uses the top The residual amount of organic solvent can be determined by air chromatography, which can be used for the quality control of the product.

Description

technical field [0001] The invention relates to a method for determining residual organic solvents 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 traditional Chinese medicine freeze-dried injections, there are many items that require control. Among them, for the use of macroporous adsorption resins in the drug separation process, according to the requirements of the drug research and development guidelines, it is necessary to detect and control the organic solvent residues of the drug. Drug safety is of paramount importance. [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...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/26G01N30/06A61K36/296A61P21/04
Inventor 宋剑郑亚杰贾继明刘兴国王贵金蔡燕裴彩云
Owner HEBEI YILING MEDICINE INST
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