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Quality control method for medicament composition for treating knubble

A quality control method and composition technology, which is applied in the direction of drug combination, antineoplastic drugs, and pharmaceutical formulations, and can solve problems that do not involve the determination of astragalus content

Active Publication Date: 2008-09-24
CHANGBAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The invention patent with the application number 200510090766.4 discloses the research on the fingerprints of finished products and intermediates in its quality control method, but it does not involve the fingerprints of its raw materials, ginseng and astragalus, the identification of ginseng, and the determination of the content of astragalus. Therefore, it is necessary to further improve The quality control method of this pharmaceutical composition

Method used

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  • Quality control method for medicament composition for treating knubble
  • Quality control method for medicament composition for treating knubble
  • Quality control method for medicament composition for treating knubble

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0190] Embodiment 1: the preparation of injection of the present invention

[0191] Weigh 250g of Astragalus membranaceus, 120g of ginseng, 8g of matrine, ginseng with 75% ethanol, reflux extraction 3 times, 2 hours each time, combine the extracts, concentrate under reduced pressure to a clear paste with a relative density of 1.10-1.20 , the measured temperature is 65°C, and it is set aside; Astragalus is decocted twice with water, each time for 2 hours, filtered, combined with the filtrate, concentrated under reduced pressure to a clear paste with a relative density of 1.10-1.20, the measured temperature is 65°C, mixed with ginseng clear Combine the pastes, add ethanol to make the alcohol content reach 75%, adjust the pH value to 6-7 with sodium hydroxide, let it stand for 12 hours, take the supernatant, recover the ethanol, concentrate under reduced pressure to a clear liquid with a relative density of 1.10-1.15 Paste, measuring temperature is 65°C; add ethanol to make the a...

Embodiment 2

[0192] Embodiment 2: the preparation of the injection intermediate of the present invention

[0193] Take by weighing 350 parts by weight of Astragalus membranaceus, 70 parts by weight of ginseng, 12 parts by weight of matrine, three flavor raw materials, 75% ethanol for ginseng, reflux extraction 3 times, each 2 hours, combine the extracts, concentrate under reduced pressure to a relative density of 1.10-1.20 clear ointment, measuring temperature is 65 ℃, set aside; Astragalus is decocted twice with water, 2 hours each time, filtered, combined filtrate, concentrated under reduced pressure to clear ointment with relative density of 1.10-1.20, measuring temperature is Combine with ginseng clear paste at 65°C, add ethanol to make the alcohol content reach 75%, adjust the pH value to 6-7 with sodium hydroxide, let stand for 12 hours, take the supernatant, recover ethanol, concentrate under reduced pressure to relative density It is a clear ointment of 1.10-1.15, and the measureme...

Embodiment 3

[0194] Embodiment 3: pharmaceutical composition preparation quality control method of the present invention

[0195] Identification:

[0196] Get 20 parts by volume of the pharmaceutical composition preparation of the present invention, evaporate to dryness on a water bath, add 5 parts by volume of methanol to the residue to dissolve, and use it as the test solution; take 1 part by weight of the ginseng reference medicinal material, add 40 parts by volume of chloroform, and heat Reflux for 1 hour, discard the chloroform solution, evaporate the solvent from the dregs, add 0.5 parts by volume of water to stir and moisten, add 10 parts by volume of water-saturated n-butanol, ultrasonicate for 30 minutes, absorb the supernatant and add 3 times the amount of ammonia test solution, Shake well, place to separate layers, take the supernatant and evaporate to dryness, add 1 volume part of methanol to the residue to dissolve, and use it as a reference medicinal solution; then take ginse...

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Abstract

The invention discloses a quality control method of a drug compound pharmaceutical preparation for treating tumors. The drug compound pharmaceutical preparation is prepared by the flowing ingredients according to the weight proportion: 200 to 400 shares of milk veteh, 60 to 130 shares of ginseng and 6 to 13 shares of oxymatrine. The quality control method of the drug compound pharmaceutical preparation consists of a method of authentication and / or content measurement for the preparation and also a fingerprint quality control method of the finished preparation product and the intermediate product. The quality control method of the drug compound pharmaceutical preparation for treating tumors adopts a specific method to treat the provided testing solution or adopts specific filling agents and moving phases to make the final result of data more precise, thereby controlling the quality of the drug compound pharmaceutical preparation effectively.

Description

technical field [0001] The invention relates to a quality control method of a pharmaceutical composition, in particular to a quality control method of a pharmaceutical composition for treating tumors. Background technique [0002] The quality control of traditional Chinese medicine is one of the key problems to be solved urgently in the process of modernization. The invention patent with the application number 02153335.0 discloses a pharmaceutical composition for treating tumors and a preparation method thereof. The pharmaceutical composition is made of the following raw materials: 200-400 parts by weight of astragalus; 60-130 parts by weight of ginseng; 6-13 parts by weight of parameters. The pharmaceutical composition of the present invention has the functions of invigorating qi and strengthening the body, enhancing the immune function of the body, and is suitable for primary liver cancer, lung cancer, rectal cancer, malignant lymphoma, and gynecological malignant tumors;...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/481G01N30/02G01N30/90A61P35/00A61K31/353
Inventor 翁红张子安姜丽萍杨梅李禹西马松梅
Owner CHANGBAISHAN PHARMA
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