CN104897789B - A kind of method of quality control of the preparation of relieving sore throat and acesodyne - Google Patents
A kind of method of quality control of the preparation of relieving sore throat and acesodyne Download PDFInfo
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- CN104897789B CN104897789B CN201510117097.9A CN201510117097A CN104897789B CN 104897789 B CN104897789 B CN 104897789B CN 201510117097 A CN201510117097 A CN 201510117097A CN 104897789 B CN104897789 B CN 104897789B
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Abstract
The present invention provides a kind of method of quality control of the preparation of relieving sore throat and acesodyne, by the way that by the preparation of relieving sore throat and acesodyne, through ethyl acetate, treated is evaporated object and is mixed into test solution with ethyl alcohol, carrying out the experiment of first time thin-layered chromatography with reference substance solution is identified；Then, after by being distilled the preparation of relieving sore throat and acesodyne with ethyl acetate, volatilization liquid and aqueous solution are obtained, the acetic acid ethyl fluid that liquid liquid separation obtains that will volatilize is test solution, and carrying out second of thin-layered chromatography experiment with reference substance solution is identified；Finally, by the aqueous solution obtained after distillation, through ethyl acetate, treated is evaporated object and methanol and is mixed into test solution, and carrying out the experiment of third time thin-layered chromatography with control medicinal material solution and reference substance solution is identified.The present invention can targetedly identify the preparation of relieving sore throat and acesodyne, effectively ensure the quality of production of said preparation.
Description
Technical field
The invention belongs to effective ingredient identification technology field more particularly to a kind of quality controls of the preparation of relieving sore throat and acesodyne
Method processed.
Background technology
Application number 200410012697.7, entitled " a kind of preparation of relieving sore throat and acesodyne " patent of invention disclosed in one kind
The preparation of relieving sore throat and acesodyne, using Glabrous Sarcandra Herb as main ingredient, formula is：30~40 parts of (parts by weight) Glabrous Sarcandra Herb, 10~30 parts of honeysuckle,
0~2 part of menthol, the preparation process of the preparation of the relieving sore throat and acesodyne specifically includes：By the way that Glabrous Sarcandra Herb, honeysuckle are added water to cook 1
More than secondary, collecting decoction after being concentrated into regulation density, adds auxiliary material that particle is made, dry；Menthol is ground into fine powder and particle is added
In, or dissolved with ethyl alcohol, sprayed into particle, it is closed overnight, tabletting obtains.Alternatively, the preparation process of the preparation of the relieving sore throat and acesodyne
It specifically includes：Glabrous Sarcandra Herb, honeysuckle are added water to cook 1 time or more, filtered, concentration；Menthol is dissolved with ethyl alcohol, and above-mentioned liquid is added
In, total amount is adjusted with distilled water, is stood, spray or aerosol is made in filtration, sterilizing.
The effect of preparation of the relieving sore throat and acesodyne is to anemopyretic laryngalgia and anemopyretic acute hoarseness is notable, with compound caoshanhu tablets one
It causes.But also lack corresponding technological means in terms of the detection and quality control for this preparation, it would be highly desirable to develop.
Invention content
The purpose of the present invention is to provide a kind of method of quality control of the preparation of relieving sore throat and acesodyne, it is intended to solve current relieving sore-throat
The problem of preparation of analgesic is currently without targetedly Quality Identification and control method.
The invention is realized in this way a kind of method of quality control of the preparation of relieving sore throat and acesodyne, the system of the relieving sore throat and acesodyne
Agent is a kind of relieving sore-throat disclosed in the patent of invention of application number 200410012697.7, entitled " a kind of preparation of relieving sore throat and acesodyne "
The preparation of analgesic, the method for quality control include the discriminating to the preparation of the relieving sore throat and acesodyne, and the mirror method for distinguishing includes
Following steps：
(1) test solution will be obtained after the preparation of the relieving sore throat and acesodyne of ethyl acetate extraction process is dissolved in ethyl alcohol, it will
The ethanol solution of chlorogenic acid is reference substance solution, is tested according to thin-layered chromatography, it is molten to draw this step test solution, reference substance
Each 1ul of liquid puts respectively on same polyamide film, is unfolded by solvent, takes out, dries, set and examined under 365nm ultraviolet lamps
Depending on；In test sample chromatography, on position corresponding with reference substance chromatography, the fluorescence spot of same color is shown；
(2) preparation of relieving sore throat and acesodyne is distilled with ethyl acetate, volatilised liq progress liquid separation is obtained into ethyl acetate
Liquid, it is spare for volatilization aqueous solution as test solution；Using the ethyl acetate solution of menthol as reference substance solution；According to thin layer
Chromatography experiment draws the test solution, each 5ul of reference substance solution of this step, is put respectively on same silica gel g thin-layer plate,
It is unfolded by solvent, takes out, dry, spray is heated to spot at 110 DEG C and shows clearly, for examination with 5% vanillin-sulfuric acid solution
In product chromatography, on position corresponding with reference substance chromatography, the spot of same color is shown；
(3) aqueous solution spare in step (2) is filtered, filtrate shakes extraction 2 times, each 25ml with ethyl acetate, closes
And acetic acid ethyl fluid, it is evaporated, residue adds methanol 1ml to make dissolving, as test solution；Glabrous Sarcandra Herb control medicinal material 2g separately is taken, is added
Water 50ml is ultrasonically treated 30 minutes, and filtration, filtrate is shaken with ethyl acetate and extracted 3 times, each 25ml, combined ethyl acetate liquid,
It is evaporated, residue adds methanol 1ml to make dissolving, as control medicinal material solution；Isofraxidin reference substance is taken again, adds methanol that every 1ml is made
Solution containing 0.5mg, as reference substance solution；It is tested according to thin-layered chromatography, draws the test solution, control medicinal material of this step
Solution and each 1ul of reference substance solution, put respectively on the silica gel g thin-layer plate in same using sodium carboxymethylcellulose as adhesive,
It is unfolded by solvent, takes out, dry, set and inspected under 365nm ultraviolet lamps；In test sample chromatography, with control medicinal material chromatography
On the corresponding position of reference substance chromatography, the fluorescence spot of same color is shown；It sets in ammonia steam and smokes after ten minutes, examined under daylight
Depending on spot becomes yellow green.
Preferably, the method for quality control of the preparation of the relieving sore throat and acesodyne further includes the survey to the formulation content of relieving sore throat and acesodyne
Fixed, the measurement of the content includes the following steps：
(4) precision weighs that isofraxidin reference substance is appropriate, adds methanol that solution of every 1ml containing 4ug is made, it is molten to obtain reference substance
Liquid；The preparation 2g for taking relieving sore throat and acesodyne adds methanol 20ml, 250w, frequency 40kHz to be ultrasonically treated 1.5h, lets cool, extremely with methanol dilution
Scale 25ml, shakes up, and filtration obtains test solution；
(5) according to liquid chromatograph method, reference substance solution and each 20ul of test solution is taken to carry out assay.
Preferably, in step (1)~(3), the thin-layered chromatography is Chinese Pharmacopoeia one annex VI B note of version in 2010
Support method.
Preferably, in step (1), the preparation of the test solution specifically includes：The preparation 5g for taking relieving sore throat and acesodyne, grinds
Carefully, add 0.2mol/L hydrochloric acid 15ml to make dissolving, filter, filtrate shakes extraction 2 times, each 15ml with ethyl acetate, merges acetic acid
Ethyl ester extracting solution, is evaporated, and residue adds absolute ethyl alcohol 1ml to make dissolving, obtains test solution；
In step (1), the preparation of the reference substance solution specifically includes：0.5mg chlorogenic acids are taken to be dissolved in the anhydrous second of 1ml
Alcohol obtains reference substance solution.
Preferably, the solvent is by being 1 by volume by toluene, ethyl acetate, formic acid, glacial acetic acid and water:
15:1:1:2 are mixed to get.
Preferably, in step (2), the preparation of the test solution specifically includes：The preparation for taking 5g relieving sore throat and acesodynes, grinds
Carefully, it sets in 250ml round-bottomed flasks, adds water 50ml, connect volatile oil determination apparatus, Jia Shui makes to be full of scale portion from analyzer upper end
Point, and when overflow enters flask until, then add ethyl acetate 5ml, connect reflux condenser, be heated to boiling, and slightly boiling 30 is kept to divide
Clock, aqueous solution is spare in flask, and the liquid in volatile oil determination apparatus is moved in separatory funnel, point takes acetic acid ethyl fluid, as
Test solution；
In step (2), the preparation of the reference substance solution specifically includes：2mg menthols are dissolved in 1ml ethyl acetate
Obtain reference substance solution；
In step (2), the solvent is by by hexamethylene and ethyl acetate by volume 17:3 are mixed to get.
Preferably, in step (3), the solvent is by by toluene, ethyl acetate, formic acid by volume 9:9:2 is mixed
Conjunction obtains.
Preferably, in step (5), the liquid chromatograph method is that one VI D of annex of Chinese Pharmacopoeia version in 2010 is recorded
Method, wherein using octadecylsilane chemically bonded silica as filler；With volume ratio for 17:83 acetonitrile, mass fraction 0.1%
Phosphoric acid solution be mobile phase, Detection wavelength 344nm, number of theoretical plate by isofraxidin peak calculate be not less than 4000.
Compared with the prior art the shortcomings that and deficiency, the invention has the advantages that：The present invention can be targetedly right
The preparation of relieving sore throat and acesodyne is differentiated that the preparation of the current relieving sore throat and acesodyne of effective solution is without effectively differentiating and quality control side
The problem of method.
Specific implementation mode
In order to make the purpose , technical scheme and advantage of the present invention be clearer, with reference to embodiments, to the present invention
It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to
Limit the present invention.
Embodiment 1
A kind of preparation of relieving sore throat and acesodyne, using Glabrous Sarcandra Herb as main ingredient, formula is：30~40 parts of (parts by weight) Glabrous Sarcandra Herb, gold
10~30 parts of honeysuckle flower, 0~2 part of menthol.
The preparation process of the preparation of the relieving sore throat and acesodyne specifically includes：By by Glabrous Sarcandra Herb, honeysuckle add water to cook 1 time with
On, collecting decoction after being concentrated into regulation density, adds auxiliary material that particle is made, dry；Menthol is ground into fine powder and is added in particle,
Or dissolved with ethyl alcohol, it sprays into particle, closed overnight, tabletting obtains.
Alternatively, the preparation process of the preparation of the relieving sore throat and acesodyne specifically includes：By Glabrous Sarcandra Herb, honeysuckle add water to cook 1 time with
On, it filters, concentration；Menthol is dissolved with ethyl alcohol, is added in above-mentioned liquid, is adjusted total amount with distilled water, is stood, filtration, sterilizing system
At spray or aerosol.
The identification method of the preparation of 2 relieving sore throat and acesodyne of embodiment, includes the following steps：
(1) the preparation 5g of relieving sore throat and acesodyne is taken, it is finely ground, add 0.2mol/L hydrochloric acid 15ml to make dissolving, filters, filtrate acetic acid second
Ester shaking extraction 2 times, each 15ml, combined ethyl acetate extracting solution is evaporated, and residue adds absolute ethyl alcohol 1ml to make dissolving, as confession
Test sample solution；Chlorogenic acid reference substance separately is taken, adds absolute ethyl alcohol that solution of every 1ml containing 0.5mg is made, as reference substance solution；According to
Thin-layered chromatography (one VI B of annex of Chinese Pharmacopoeia version in 2010) is tested, and it is each to draw this step test solution, reference substance solution
1ul is put respectively on same polyamide film, with toluene-ethyl acetate-formic acid-glacial acetic acid-water (1:15:1:1:2) upper layer
Solution is solvent, is unfolded, and takes out, dries, set and inspected under 365nm ultraviolet lamps；In test sample chromatography, with reference substance chromatography
On corresponding position, the fluorescence spot of same color is shown；
(2) the preparation 5g of relieving sore throat and acesodyne is taken, it is finely ground, it sets in 250ml round-bottomed flasks, adds water 50ml, connect determination of volatile oil
Device, from analyzer upper end, Jia Shui makes to be full of scale part, and when overflow enters flask until, then add ethyl acetate 5ml, connection reflux
Condenser is heated to boiling, and keeps slightly boiling 30 minutes, the liquid in volatile oil determination apparatus is moved in separatory funnel, in flask
Aqueous solution is spare, divides and takes acetic acid ethyl fluid, as test solution；Menthol reference substance separately is taken, adds ethyl acetate that every 1ml is made
Solution containing 2mg, as reference substance solution；It tests, draws according to thin-layered chromatography (one VI B of annex of Chinese Pharmacopoeia version in 2010)
Each 5ul of the test solution of this step, reference substance solution is put respectively on same silica gel g thin-layer plate, with hexamethylene-acetic acid second
Ester (17:3) it is solvent, is unfolded, take out, dry, sprays with 5% vanillin-sulfuric acid solution, be heated to spot at 110 DEG C and show clearly
It is clear, in test sample chromatography, on position corresponding with reference substance chromatography, show the spot of same color；
(3) aqueous solution spare in flask in step (2) being filtered with cotton, filtrate shakes extraction 2 times with ethyl acetate,
Each 25ml, combined ethyl acetate liquid, is evaporated, and residue adds methanol 1ml to make dissolving, as test solution；Separately take Glabrous Sarcandra Herb pair
According to medicinal material 2g, add water 50ml, be ultrasonically treated 30 minutes, filtration, filtrate shakes extraction 3 times, each 25ml with ethyl acetate, merges
Acetic acid ethyl fluid is evaporated, and residue adds methanol 1ml to make dissolving, as control medicinal material solution；Isofraxidin reference substance is taken again, adds first
Solution of every 1ml containing 0.5mg is made in alcohol, as reference substance solution；According to thin-layered chromatography (Chinese Pharmacopoeia one annex of version in 2010
VI B) experiment, the test solution, control medicinal material solution and each 1ul of reference substance solution of this step are drawn, is put respectively in same
Using sodium carboxymethylcellulose as on the silica gel g thin-layer plate of adhesive, with toluene-ethyl acetate-formic acid (9:9:2) it is solvent,
Expansion takes out, dries, set and inspected under 365nm ultraviolet lamps.In test sample chromatography, with control medicinal material chromatography and reference substance color
It composes on corresponding position, shows the fluorescence spot of same color；It sets in ammonia steam and smokes after ten minutes, inspected under daylight, spot becomes
Yellow green.
The content assaying method of the preparation of 3 relieving sore throat and acesodyne of embodiment, includes the following steps：
(1) precision weighs that isofraxidin reference substance is appropriate, adds methanol that solution of every 1ml containing 4ug is made, it is molten to obtain reference substance
Liquid；The preparation 2g for taking relieving sore throat and acesodyne adds methanol 20ml, 250w, frequency 40kHz to be ultrasonically treated 1.5h, lets cool, extremely with methanol dilution
Scale 25ml, shakes up, and filtration obtains test solution；
(2) according to liquid chromatograph method, reference substance solution and each 20ul of test solution is taken to carry out assay.The liquid
Chromatography method is one annex of Chinese Pharmacopoeia version in 2010, VI D record methods, wherein is with octadecylsilane chemically bonded silica
Filler；With volume ratio for 17:83 acetonitrile, the phosphoric acid solution of mass fraction 0.1% be mobile phase, Detection wavelength 344nm,
Number of theoretical plate is calculated by isofraxidin peak is not less than 4000.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention
All any modification, equivalent and improvement etc., should all be included in the protection scope of the present invention made by within refreshing and principle.
Claims (4)
1. a kind of detection method of the preparation of relieving sore throat and acesodyne, it is characterised in that：The preparation of the relieving sore throat and acesodyne is with Glabrous Sarcandra Herb
Main ingredient, formula are：Glabrous Sarcandra Herb 30-40 parts by weight, honeysuckle 10-30 parts by weight, menthol 0-2 parts by weight；
The preparation process of the preparation of the relieving sore throat and acesodyne specifically comprises the following steps：By the way that Glabrous Sarcandra Herb, honeysuckle are added decocting
It boils 1 time or more, collecting decoction, after being concentrated into regulation density, adds auxiliary material that particle is made, it is dry；Menthol is ground into fine powder addition
In particle, or dissolved with ethyl alcohol, sprayed into particle, it is closed overnight, tabletting obtains；Alternatively, Glabrous Sarcandra Herb, honeysuckle are added water to cook
It 1 time or more, filters, concentration；Menthol is dissolved with ethyl alcohol, is added in above-mentioned concentrate, is adjusted total amount with distilled water, is stood, filter
It crosses, spray or aerosol is made in sterilizing；
Detection method includes the following steps for the relieving sore throat and acesodyne preparation：
(1) test solution will be obtained after the preparation of the relieving sore throat and acesodyne of ethyl acetate extraction process is dissolved in ethyl alcohol, by green original
The ethanol solution of acid is reference substance solution, is tested according to thin-layered chromatography, it is each to draw this step test solution, reference substance solution
1 μ l put respectively on same polyamide film, are unfolded by solvent I, take out, dry, set and examined under 365nm ultraviolet lamps
Depending on；In test sample chromatography, on position corresponding with reference substance chromatography, the fluorescence spot of same color is shown；
(2) preparation of relieving sore throat and acesodyne is distilled with ethyl acetate, volatilised liq progress liquid separation is obtained into acetic acid ethyl fluid, is made
It is spare for volatilization aqueous solution for test solution；Using the ethyl acetate solution of menthol as reference substance solution；According to thin-layered chromatography
Experiment, draws the test solution, each 5 μ l of reference substance solution of this step, is put respectively on same silica gel g thin-layer plate, pass through exhibition
Agent II expansion is opened, takes out, dries, spray with 5% vanillin-sulfuric acid solution, spot is heated at 110 DEG C and is shown clearly, test sample color
In spectrum, on position corresponding with reference substance chromatography, the spot of same color is shown；
(3) aqueous solution spare in step (2) is filtered, filtrate shakes extraction 2 times, each 25ml with ethyl acetate, merges second
Acetoacetic ester liquid, is evaporated, and residue adds methanol 1ml to make dissolving, as test solution；Glabrous Sarcandra Herb control medicinal material 2g separately is taken, adds water
50ml is ultrasonically treated 30 minutes, filtration, and filtrate shakes extraction 3 times, each 25ml with ethyl acetate, and combined ethyl acetate liquid steams
Dry, residue adds methanol 1ml to make dissolving, as control medicinal material solution；Isofraxidin reference substance is taken again, adds methanol to be made molten according to medicinal material
Liquid and each 1 μ l of reference substance solution, put respectively on the silica gel g thin-layer plate in same using sodium carboxymethylcellulose as adhesive, lead to
Solvent III expansion is crossed, is taken out, is dried, set and inspected under 365nm ultraviolet lamps；In test sample chromatography, with control medicinal material chromatography
On the corresponding position of reference substance chromatography, the fluorescence spot of same color is shown；It sets in ammonia steam and smokes after ten minutes, examined under daylight
Depending on spot becomes yellow green；
The detection method of the preparation of the relieving sore throat and acesodyne further includes the measurement to the formulation content of relieving sore throat and acesodyne, the survey of the content
Surely include the following steps：
(4) precision weighs that isofraxidin reference substance is appropriate, adds methanol that the solution that every 1ml contains 4 μ g is made, obtains reference substance solution；
The preparation 2g for taking relieving sore throat and acesodyne adds methanol 20ml, 250w, frequency 40kHz to be ultrasonically treated 1.5h, lets cool, with methanol dilution to quarter
25ml is spent, is shaken up, filters, obtains test solution；
(5) according to liquid chromatograph method, reference substance solution and each 20 μ l of test solution is taken to carry out assay；
The solvent I of the step (1) is by being 1 by volume by toluene, ethyl acetate, formic acid, glacial acetic acid and water:
15:1:1:2 are mixed to get；
The solvent II of the step (2) is by by hexamethylene and ethyl acetate by volume 17:3 are mixed to get；
The solvent III of the step (3) is by by toluene, ethyl acetate, formic acid by volume 9:9:2 are mixed to get；
When the step (5) is measured using liquid chromatograph method, using octadecylsilane chemically bonded silica as filler；With body
Product is than being 17:83 acetonitrile, the phosphoric acid solution of mass fraction 0.1% are mobile phase, and Detection wavelength 344nm, number of theoretical plate presses
Isofraxidin peak, which calculates, is not less than 4000.
2. the detection method of the preparation of relieving sore throat and acesodyne according to claim 1, it is characterised in that：Step (1)-(3)
Thin-layered chromatography be one annex of Chinese Pharmacopoeia version in 2010, VI B record methods.
3. the detection method of the preparation of relieving sore throat and acesodyne according to claim 1, which is characterized in that the confession of the step (1)
The preparation method of test sample solution includes the following steps：The preparation 5g of relieving sore throat and acesodyne is taken, it is finely ground, the salt of a concentration of 0.2mol/L is added
Sour 15ml makes formulation dissolution, filtration, and filtrate shakes extraction 2 times with ethyl acetate, and the dosage of each ethyl acetate is 15ml, is merged
Acetic acid ethyl acetate extract is evaporated, and absolute ethyl alcohol 1ml is added in residue makes residue dissolve, and obtains test solution；
The preparation method of the reference substance solution of the step (1) includes the following steps：0.5mg chlorogenic acids are taken to be dissolved in the anhydrous second of 1ml
Alcohol obtains reference substance solution.
4. the detection method of the preparation of relieving sore throat and acesodyne according to claim 1, which is characterized in that the confession of the step (2)
The preparation method of test sample solution includes the following steps：The preparation of 5g relieving sore throat and acesodynes is taken, it is finely ground, it is placed in 250ml round-bottomed flasks, adds
Water 50ml connects volatile oil determination apparatus, and from analyzer upper end, Jia Shui makes to be full of scale part, and when overflow enters flask until, then
Add ethyl acetate 5ml, connects reflux condenser, be heated to boiling, and keep slightly boiling 30 minutes, aqueous solution is spare in flask, will wave
Liquid in hair oil analyzer moves in separatory funnel, divides and takes acetic acid ethyl fluid, as test solution；
The preparation of the reference substance solution of the step (2) includes the following steps：2mg menthols are dissolved in 1ml ethyl acetate and are obtained
To reference substance solution.
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| CN105334286A (en) * | 2015-11-25 | 2016-02-17 | 吉林修正药业新药开发有限公司 | Quality control method for medicine for treating common cold due to wind-cold |
| CN109521137A (en) * | 2018-12-03 | 2019-03-26 | 国药集团新疆制药有限公司 | Menthol thin layer method in a kind of analysis cough-relieving pears soft extracts |
| CN113759031A (en) * | 2021-05-08 | 2021-12-07 | 北京康仁堂药业有限公司 | Thin-layer identification method for sculellaria barbata and sculellaria barbata formula preparation |
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| CN101564514A (en) * | 2009-06-12 | 2009-10-28 | 杨文龙 | Method for analyzing children Fengreqing particle |
| CN101576545A (en) * | 2009-02-02 | 2009-11-11 | 江中药业股份有限公司 | Method for determining content of compound Caoshanhu lozenge |
| CN101612173A (en) * | 2008-06-26 | 2009-12-30 | 暨南大学 | The method of quality control of Herba Sarcandrae extract and preparation thereof and application thereof |
| CN104147077A (en) * | 2014-08-18 | 2014-11-19 | 广西昌弘制药有限公司 | Preparation method of traditional Chinese medicinal preparation for heat clearing, throat disinhibiting and pain relieving |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101612173A (en) * | 2008-06-26 | 2009-12-30 | 暨南大学 | The method of quality control of Herba Sarcandrae extract and preparation thereof and application thereof |
| CN101576545A (en) * | 2009-02-02 | 2009-11-11 | 江中药业股份有限公司 | Method for determining content of compound Caoshanhu lozenge |
| CN101564514A (en) * | 2009-06-12 | 2009-10-28 | 杨文龙 | Method for analyzing children Fengreqing particle |
| CN104147077A (en) * | 2014-08-18 | 2014-11-19 | 广西昌弘制药有限公司 | Preparation method of traditional Chinese medicinal preparation for heat clearing, throat disinhibiting and pain relieving |
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Denomination of invention: Quality control method of a preparation for promoting pharynx and relieving pain Effective date of registration: 20230504 Granted publication date: 20180713 Pledgee: Guangxi SME Financing Guarantee Co.,Ltd. Pledgor: GUANGXI CHANGHONG PHARMACY CO.,LTD. Registration number: Y2023450000069 |