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Semen armeniacae amarae formula granules as well as preparation and quality control methods thereof

A quality control method and formula granule technology, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, measuring devices, etc., to achieve the effects of strong specificity, scientific detection methods, and strong operability

Inactive Publication Date: 2017-10-20
安徽九洲方圆制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Aiming at the problem that the isomers D-amygdalin and L-amygdalin cannot be distinguished in the infrared spectrum, the present invention provides a bitter almond formula granule and its preparation and quality control method for controlling the production quality of amygdalin , to determine the ratio of L-amygdalin to D-amygdalin in Sangxing Decoction, Sangju Decoction, and Maxing Shigan Decoction to be 0.6-1.0, and to control the content of bitter almond formula granules by adjusting the preparation method of bitter almond formula granules. The content ratio of L-amygdalin to D-amygdalin is 0.6~1.0

Method used

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  • Semen armeniacae amarae formula granules as well as preparation and quality control methods thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Preparation method of amygdalin formula granules: Take bitter almond decoction pieces, add 8 times the amount of water, soak at 60°C for 0.5 hours, decoct for 2 hours, add 6 times the amount of water for the second time and decoct for 1 hour, combine the two decoctions liquid filtration; the filtrate is vacuum-concentrated to a concentrated solution with a relative density of 1.02 to 1.06; the above-mentioned concentrated solution is spray-dried to obtain a dry powder; the dry powder is obtained by adding dextrin to dry granulation.

Embodiment 2

[0035] The preparation method of amygdalin formula granules: take bitter almond decoction pieces, add 10 times the amount of water, soak at 60°C for 1 hour, decoct for 1.5 hours, add 8 times the amount of water for the second time and decoct for 1 hour, combine the two decoctions liquid filtration; the filtrate is vacuum-concentrated to a concentrated solution with a relative density of 1.02 to 1.06; the above-mentioned concentrated solution is spray-dried to obtain a dry powder; the dry powder is obtained by adding dextrin to dry granulation.

Embodiment 3

[0037] Preparation method of amygdalin formula granules: take bitter almond decoction pieces, add 12 times the amount of water, soak at 60°C for 0.5 hours, decoct for 2 hours, add 10 times the amount of water for the second time and decoct for 1.5 hours, combine twice The decoction is filtered; the filtrate is vacuum-concentrated to a concentrated solution with a relative density of 1.02 to 1.06; the above-mentioned concentrated solution is spray-dried to obtain a dry powder; the dry powder is added to dextrin and dry-granulated to obtain the product. Determination of the ratio of L-amygdalin content to D-amygdalin content in bitter almond formula granules:

[0038] Get each 0.25g of 10 batches of bitter almond formula granules prepared according to the preparation method of Example 1, with reference to "Chinese Pharmacopoeia" 2015 edition one bitter almond content assay method and the quality control method among the present invention to bitter almond Glycoside content was de...

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Abstract

The invention belongs to the technical field of traditional Chinese medicine formula granules and particularly relates to semen armeniacae amarae formula granules as well as preparation and quality control methods thereof. The L-amygdalin and D-amygdalin ratio range considering both the curative effect and safety (low toxicity) is determined through study on the ratio of L-amygdalin to D-amygdalin in classical prescription decoction containing semen armeniacae amarae, semen armeniacae amarae formula granule extraction process parameters capable of guaranteeing the L-amygdalin and D-amygdalin ratio range are determined through process purification, high performance liquid chromatography is used for quantitative analysis in the quality control method, the amygdalin isomerization course is controlled by regulating process parameters such as decoction water amount and decoction time for semen armeniacae amarae decoction pieces during preparation, the semen armeniacae amarae formula granules meeting the quality requirement are prepared and has the same effect with classical prescriptions, and quality control of the semen armeniacae amarae formula granules is realized.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine formula granules, in particular to a bitter almond formula granule and a preparation and quality control method thereof. Background technique [0002] Bitter almond is the dried and mature seeds of Rosaceae plants Apricot apricot, Siberian apricot, Northeast apricot and apricot. The ripe fruit is harvested in summer, the pulp and core shell are removed, the seeds are taken out, and dried in the sun. Domestic bitter almonds are mainly produced in Inner Mongolia, Jilin, Liaoning, Hebei, Shanxi, and Shaanxi. The main functions of bitter almond are lowering Qi, relieving cough and asthma, moistening intestines and laxative, used for cough and asthma, chest full of phlegm, intestinal dryness and constipation. The amygdalin contained in bitter almonds plays a major role in reducing qi, relieving cough and asthma, anti-inflammation, analgesia and even cancer treatment and prevention...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74G01N30/86A61K9/16A61K33/06A61K36/17A61K36/23A61K36/287A61K36/34A61K36/342A61K36/346A61K36/48A61K36/484A61K36/534A61K36/605A61K36/634A61K36/73A61K36/736A61K36/744A61K36/8966A61K36/899
CPCG01N30/06A61K9/1652A61K33/06A61K36/17A61K36/23A61K36/287A61K36/34A61K36/342A61K36/346A61K36/48A61K36/484A61K36/534A61K36/605A61K36/634A61K36/73A61K36/736A61K36/744A61K36/8966A61K36/899A61K2236/331G01N30/74G01N30/8634A61K2300/00
Inventor 杜新刚王晓彬王雯韩庆飞
Owner 安徽九洲方圆制药有限公司
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