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Qualitative determination method of traditional Chinese medicine lyophilized injection

A technology of freeze-dried injections and determination methods, which is applied in the field of qualitative determination of freeze-dried injections of traditional Chinese medicine, and can solve problems such as undisclosed determination methods of freeze-dried injections

Active Publication Date: 2013-01-02
HEBEI YILING MEDICINE INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patent does not disclose the assay method for the preparation of freeze-dried injection and its quality control

Method used

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  • Qualitative determination method of traditional Chinese medicine lyophilized injection
  • Qualitative determination method of traditional Chinese medicine lyophilized injection
  • Qualitative determination method of traditional Chinese medicine lyophilized injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Raw material weight ratio:

[0089] Total ginseng saponins extract 50g Epimedium total flavonoids extract 40g

[0090] Preparation:

[0091] 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;

[0092] 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

[0101] Raw material weight ratio:

[0102] Total Ginseng Saponin Extract 35g Epimedium Total Flavonoid Extract 55g

[0103] Preparation:

[0104] 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;

[0105] 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;

[0106] c. Autoclave at 105°C ...

Embodiment 3

[0114] Raw material weight ratio:

[0115] Total ginseng saponin extract 65g Epimedium total flavonoid extract 25g Ratio?

[0116] Preparation:

[0117] 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;

[0118] 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 micr...

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Abstract

The invention provides a method for determining contents of multiple components in a lyophilized injection of a traditional Chinese medicine composition. The raw materials of the traditional Chinese medicine lyophilized injection include ginseng and short-horned epimedium herb. The lyophilized injection is clinically used for treating muscular atrophy and myasthenia gravis caused by motor neuron diseases (amyotrophy lateral sclerosis, progressive spinal myodystrophia, progressive bulbar paralysis and primary lateral sclerosis), progressive muscular dystrophy, congenital myopathy and other diseases. The method provided by the invention adopts a high performance liquid chromatography to conduct fingerprint measurement which is used for qualitative quality control of products.

Description

technical field [0001] The invention relates to a qualitative determination method of a traditional Chinese medicine freeze-dried injection, 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 qualitative fingerprint is a comprehensive and quantifiable means of identification. It is based on the systematic research on the chemical components of traditional Chinese medicine. Evaluate the authenticity, excellence and stability of the quality of traditional Chinese medicinal materials and semi-finished products of traditional Chinese medicine preparations. "Integrity" and "ambiguity" are its salient features. At present, the fingerprint technology of traditional Chinese medicine has involved many methods, including thin layer scanning (TLCS), high performance liquid chromatograph...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/86
Inventor 宋剑刘兴国郑亚杰蔡艳王贵金贾继明裴彩云王胜超
Owner HEBEI YILING MEDICINE INST
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