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Quality control method of spirit quieting oral liquid preparation

A quality control method and technology of liquid preparations, applied in the direction of testing pharmaceutical preparations, measuring devices, pharmaceutical formulations, etc., can solve problems such as difficult to achieve quality, difficult to control the quality of agents, and incomplete methods

Active Publication Date: 2006-06-14
GUIZHOU YIBAI PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] For a long time, the quality of traditional Chinese medicine preparations has been difficult to effectively control. Effectively controlling the quality of traditional Chinese medicine products is a major issue. The methods used in the prior art are incomplete, and a few are not targeted. It is difficult to achieve the purpose of real quality control by using these methods
Due to the lack of quality control methods for the preparation of the above soothing syrup, it is difficult to control the quality of the preparation; it has brought difficulties to normal production and operation, and it is difficult to provide a good quality control method for the preparation product by using known technologies. The present invention aims at the present There are technical deficiencies, and new methods are used to control the quality of Anshen oral liquid preparations, especially the use of high-performance liquid chromatography to determine the content of glycyrrhizic acid in the drug and the use of thin-layer chromatography to identify the finished Chinese medicinal materials Atractylodes macrocephala, Shou Wuteng and Agrimony solve the problem of quality control of the preparation

Method used

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  • Quality control method of spirit quieting oral liquid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117] The quality control of embodiment 1 tranquilizing syrup

[0118] Take 50g of Chinese herbal medicine Ganoderma lucidum, 100g of Atractylodes macrocephala (stir-fried), 100g of Ligustrum lucidum (made), 150g of Albizia radix, 150g of Shouwu vine, 250g of agrimony, 100g of Eclipta chinensis, and 50g of licorice. , 5 hours for the first time, 3 hours for the second time, combine the decoction, filter, concentrate the filtrate to a relative density of 1.05 (90°C), let it stand for 24 hours, take the supernatant for later use; Boil twice, the first time for 2 hours, the second time for 1.5 hours, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.05 (90°C), let it stand for 24 hours, and take the supernatant for later use. Take another 264g of sucrose, add an appropriate amount of water, boil to dissolve, filter, mix with the above two concentrates, continue to concentrate to a relative density of 1.10 (90°C), let cool, add 3g of sodium be...

Embodiment 2

[0143] The quality control of embodiment 2 Anshen Oral Liquid

[0144] Take 50g of Chinese herbal medicine Ganoderma lucidum, 100g of Atractylodes macrocephala (stir-fried), 100g of Ligustrum lucidum (made), 150g of Albizia radix, 150g of Shouwu vine, 250g of agrimony, 100g of Eclipta chinensis, and 50g of licorice. , 5 hours for the first time, 3 hours for the second time, combine the decoction, filter, concentrate the filtrate to a relative density of 1.05 (90°C), let it stand for 24 hours, take the supernatant for later use; Boil twice, the first time for 2 hours, the second time for 1.5 hours, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.05 (90°C), let it stand for 24 hours, and take the supernatant for later use. Add 264ml of simple syrup, 2.5g of sodium benzoate, mix with the above two concentrates, add water to 1000ml, stir well, filter, potting, each bag has a capacity of 10ml, and you get it.

[0145] 【Properties】This product...

Embodiment 3

[0170] Take 50g of Ganoderma lucidum, 100g of Atractylodes macrocephala (stir-fried), 100g of Ligustrum lucidum (made), 150g of Albizia juniper, 150g of Shouwu vine, 250g of agrimony, 100g of Eclipta, 50g of licorice,

[0171] [preparation method], [properties], [inspection] are all identical with embodiment 1. Its quality control methods are:

[0172] 1, measure the content of glycyrrhizic acid monoammonium salt with high performance liquid chromatography (an appendix VI D of Chinese Pharmacopoeia edition in 2000), can carry out according to the following steps:

[0173] a. Chromatographic conditions: use octadecylsilane bonded silica gel as filler; Mobile phase is acetonitrile-2.5% glacial acetic acid aqueous solution (26:58); Detection wavelength is 247nm; The calculation should be no less than 2000.

[0174] b. Preparation of reference substance solution Take about 10 mg of glycyrrhizinate monoammonium salt reference substance, accurately weighed, put in a 50ml measuring...

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Abstract

A quality control method for the Chinese medicine í‹Calming oral liquidíŒ features that a thin-layer chromatography is used for identification to white atractylodes rhizome, fleece flower stem and hairyvien agrimonia herb, and an efficient liquid-phase chromatography is used to measure the content of glycyrrhizic acid.

Description

Technical field: [0001] The present invention relates to a calming oral medicine made from 50g of Chinese medicinal material Ganoderma lucidum, 100g of Atractylodes macrocephala (stir-fried), 100g of Ligustrum lucidum (produced), 150g of Albizia radiata, 150g of Shouwu vine, 250g of agrimony, 100g of Eclipta chinensis and 50g of licorice. The quality control method of the liquid preparation, especially relates to the quality control method of the oral liquid preparation for tranquilizing the nerves by using high-performance liquid chromatography to determine the content of glycyrrhizic acid in the drug and using thin-layer chromatography to identify Chinese medicinal materials Atractylodes Rhizoma Atractylodes Rhizome, Shouwu Teng and Agrimony. Background technique: [0002] The sixth volume (WS3-B-1130-92) of "Drug Standards of the Ministry of Health of the People's Republic of China" (Chinese patent medicine preparations) announced the soothing syrup for the treatment of an...

Claims

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Application Information

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IPC IPC(8): A61K36/73A61P25/20G01N30/90G01N33/15
Inventor 叶湘武王泽坤
Owner GUIZHOU YIBAI PHARMA CO LTD
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