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Quality control method and uses of antirheumatic medicament

A detection method and anti-rheumatic technology, applied in the direction of drug combinations, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve the problems of inability to judge the quality of drugs scientifically and accurately, and achieve simple, reproducible, and exclusive methods strong effect

Active Publication Date: 2011-09-21
RONGCHANG PHARM ZIBO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The quality of medicines cannot be judged scientifically and accurately, which has been questioned in the international market. In order to comprehensively and accurately control the quality of medicines and ensure the reputation of traditional Chinese medicines in the international market, it is necessary to study their quality control methods

Method used

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  • Quality control method and uses of antirheumatic medicament
  • Quality control method and uses of antirheumatic medicament
  • Quality control method and uses of antirheumatic medicament

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] Embodiment 1 application method provided by the present invention to the detection example of Xiaoluotong tablet

[0098] 1. The identification and determination steps are as follows:

[0099] Preparation of the test solution: cancel 6 tablets of Luotong tablets, grind finely, take about 0.1-0.6g of the sample, add 5-15ml of ethanol to dissolve, extract by ultrasonic (power 100W, frequency 25kHz) for 30min, filter, and concentrate the filtrate to 1ml , as the test solution.

[0100] Preparation of the reference medicinal material solution: take 0.5 g of the reference medicinal material Daphne genkwa Tiao, and prepare the reference medicinal material solution in the same way.

[0101] Determination by thin-layer chromatography: according to the thin-layer chromatography of appendix VIB of the Chinese Pharmacopoeia 2005 edition, draw 5 μl of each of the above two solutions, and spot them on the same silica gel G thin-layer board with sodium carboxymethylcellulose as a bi...

Embodiment 2

[0111] Embodiment 2 Application of the method provided by the present invention to the detection example of Xiaoluotong capsules

[0112] During differential determination, 3 capsules were sampled; all the other were the same as in Example 1;

[0113] When checking and measuring, it should comply with the relevant regulations under the capsules of the Chinese Pharmacopoeia;

[0114] When the extract is measured, 10 capsules are sampled; the alcohol-soluble extract content of the capsule must not be less than 18.0%; the rest are the same as in Example 1;

[0115] When determining the content, the capsule is sampled at about 0.5-1g, and each gram of the capsule contains Daphne genkwatiao and siparinin (C 19 h 12 o 7 ) meter, must not be less than 0.50mg; All the other are with embodiment 1.

Embodiment 3

[0116] Embodiment 3 Application of the method provided by the present invention to the detection example of Xiaoluotong Granules

[0117] During identification and determination, 1 to 2 bags of granules are sampled; all the other are the same as in Example 1;

[0118] When checking and measuring, it should comply with the relevant regulations under the Chinese Pharmacopoeia granules;

[0119] When the extract was measured, 10 bags of granule were sampled; the alcohol-soluble extract content of the granule should not be less than 4.0%; the rest were the same as in Example 1;

[0120] During content determination, about 2-6g of the granules are sampled, and each gram of the granules contains genkwatiao and siparinin (C 19 h 12 o 7 ) meter, must not be less than 0.10mg; All the other are with embodiment 1.

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Abstract

The invention provides a quality control method for an antirheumatic medicine. Besides the characters and inspection, the method also comprises the steps of identification, extract determination and assaying, wherein the identification step is to dissolve the content of the antirheumatic medicine--a rheumatalgia-relieving preparation in alcohol, carry out ultrasonic extraction to prepare a solution to be tested, prepare a comparison solution with the comparison crude drug of lilac daphne strips, and then carry out thin layer chromatographic comparison. The extract determination step is to carry out the alcohol backflow and leaching of the content of the antirheumatic medicine--the rheumatalgia-relieving preparation and determine the dry substance amount of the methanol extract. The assaying step is to carry out methanol backflow and leaching of the content of the antirheumatic medicine--the rheumatalgia-relieving preparation to prepare the solution to be tested, carry out the high pressure liquid chromatography detection together with the reference substance of daphnetin, and determine the content of the daphnetin in the content of the antirheumatic medicine--the rheumatalgia-relieving preparation. The method is suitable for the quality control of the antirheumatic medicine -the Rheumatalgia-relieving preparation including tablets, capsules, granules, pills, and the like.

Description

technical field [0001] The invention discloses a quality control method for antirheumatic drug Xiaoluotong, which belongs to the analysis method of traditional Chinese medicine preparations, and in particular relates to a quality control method for antirheumatic drug. It is suitable for the quality control of tablets, capsules, granules or pills of the commercially available antirheumatic drug "Xiaoluotong". Background technique [0002] A Chinese patent medicine for treating rheumatism, Xiaoluotong, has been on the market for many years. Because of its high safety and good curative effect, it was once exported to Southeast Asia and is well received by rheumatism patients. [0003] The anti-rheumatic drug "Xiaoluotong" is mainly made of Daphne genkwatiao extract. The quality control method of the prior art only has two items of traits and inspection, and the content of the control preparation is brown; the smell is slight, the taste is bitter, and numb; And meet the relevan...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/83G01N30/02G01N30/90A61K9/20A61K9/48A61K9/16A61P29/00A61K135/00
Inventor 郭桂秋翟勇王立庆李雪梅
Owner RONGCHANG PHARM ZIBO CO LTD
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