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Quality control method for Ditong rhinitis drop and mist

A quality inspection method and spray technology, which are used in aerosol delivery, biochemical equipment and methods, and microbial determination/inspection to achieve the effect of ensuring clinical efficacy.

Inactive Publication Date: 2012-02-29
广西厚德药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The quality standard of the original drops only carried out qualitative identification of volatile oil and alkaloids in test tubes and TLC identification of Angelica dahurica, which is difficult to ensure the efficacy of drugs

Method used

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  • Quality control method for Ditong rhinitis drop and mist
  • Quality control method for Ditong rhinitis drop and mist
  • Quality control method for Ditong rhinitis drop and mist

Examples

Experimental program
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Effect test

preparation example Construction

[0043] Comparison of the preparation methods of Magnolia magnolia test solution:

[0044] Method 1 Take 50ml of this product, put it in a separatory funnel, extract 2 times with ethyl acetate, 15ml each time, combine the ethyl acetate solution, evaporate to dryness, add 1ml of ethyl acetate to the residue to dissolve, and use it as the test solution. Prepare magnolia-deficient negative control solution in the same way.

[0045] Method 2 Take 50ml of this product, put it in a separatory funnel, extract 2 times with chloroform, 15ml each time, combine the chloroform solution, evaporate to dryness, add 1ml of methanol to the residue to dissolve, and use it as the test solution. Prepare magnolia-deficient negative control solution in the same way.

[0046] Method 3 Take 20ml of this product, put it in a separatory funnel, extract 2 times with ether, 15ml each time, combine the ether solution, evaporate to dryness, add 1ml of ethanol to the residue to dissolve, and use it as the t...

Embodiment 1

[0124] Quality control steps of Ditong rhinitis water spray:

[0125] 1. Carry out qualitative identification of Magnolia Magnolia in medicine with thin-layer chromatography:

[0126] Take 50ml of Ditong rhinitis water spray, put it in a separatory funnel, extract twice with ethyl acetate, 15ml each time, combine the extracts, evaporate to dryness, add 1ml of ethyl acetate to the residue to dissolve, and add it to a neutral tube with an inner diameter of 9mm. On the alumina column (2-4g), elute with 15ml of methanol, collect the eluate, concentrate to about 1ml, and use it as the test solution. Take another 1 g of magnolia as reference drug, add 15 ml of ethyl acetate, sonicate for 30 minutes, filter, concentrate the filtrate to about 1 ml, add it to a neutral alumina column (2-4 g) with an inner diameter of 9 mm, and elute with 15 ml of methanol. Collect the eluent, concentrate to about 1ml, and use it as the test solution. Then take the magnolanin reference substance, add ...

Embodiment 2

[0143] Embodiment 2: the quality control method of Ditong rhinitis water drops comprises the following steps:

[0144] 1. Carry out qualitative identification of Magnolia Magnolia in medicine with thin-layer chromatography:

[0145] Take 50 ml of Ditong rhinitis water drops, put it in a separatory funnel, extract 2 times with ether, 30 ml each time, combine the extracts, evaporate to dryness, add 1 ml of methanol to the residue to dissolve, add to a neutral alumina column with an inner diameter of 12 mm (2 ~4g), elute with 30ml of ethanol, collect the eluate, concentrate to about 1ml, and use it as the test solution. Take another 1 g of magnolia reference medicinal material, add 30 ml of ether, heat and reflux for 40 minutes, filter, concentrate the filtrate to about 1 ml, add it to a neutral alumina column (2-4 g) with an inner diameter of 12 mm, elute with 30 ml of ethanol, collect and wash Deliquid, concentrated to about 1ml, as the test solution. Then take the magnolin r...

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Abstract

The invention discloses a method for controlling the quality of rhinitis-treating drop medicine and spray. The method carries out TLC identification to biond magnolia flower and / or grassleaf sweelflag rhizome, and / or carries out content determination to ephedrine hydrochloride which is a main active constituent of ephedra, and establishes a microbial limit examination method at the same time. Themethod for controlling the quality of rhinitis-treating drop medicine and spray can be favorable for effectively ensuring the internal quality of products in industrial production and further guarantee the efficacy of medicine.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a quality detection method of Ditong rhinitis water drops and sprays. Background technique [0002] The prescription and preparation method of Ditong rhinitis water are recorded on page 199 of the fifth volume of traditional Chinese medicine preparations in the Ministry of Health's drug standard. The standard code is WS3-B-1061-91. 50g, Magnolia 25g, Angelica dahurica 25g, Asarum 5g, Shichangpu 60g, the above raw materials are made into 1000ml in total. Sprays and drops have the same prescription, preparation method and function, and are the same medicinal substance, but the packaging materials are different. Ditong rhinitis water has the effect of expelling wind and clearing heat, clearing the lungs and clearing the orifices. It is used to treat cold and stuffy nose, nasal congestion (chronic rhinitis), rhinorrhea (allergic rhinitis), nasal si...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/888A61K9/08A61K9/12A61P11/02G01N30/02G01N30/90C12Q1/04
CPCY02A50/30
Inventor 唐弟光莫少红陈晓军梁山丹吴伟廖厚知梁霞蒙华英
Owner 广西厚德药业有限公司