CN102038902A - Quality control method of traditional Chinese medicine preparation xiaoerbaishou pill - Google Patents
Quality control method of traditional Chinese medicine preparation xiaoerbaishou pill Download PDFInfo
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- CN102038902A CN102038902A CN2009100709587A CN200910070958A CN102038902A CN 102038902 A CN102038902 A CN 102038902A CN 2009100709587 A CN2009100709587 A CN 2009100709587A CN 200910070958 A CN200910070958 A CN 200910070958A CN 102038902 A CN102038902 A CN 102038902A
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Abstract
The invention relates to a quality control method of a traditional Chinese medicine preparation xiaoerbaishou pill, which comprises the following steps: firstly, carrying out microscopic identification; secondly, identifying whether costus root and hawthorn are contained in the prescription of a xiaoerbaishou pill by thin-layer chromatography; and finally, by using costunolide and dehydrocostus lactone as reference substances, determining the costus root content in the prescription of the xiaoerbaishou pill by high efficiency liquid chromatography. Based on the original standard of the xiaoerbaishou pill, traditional Chinese medicine components of which the relevant descriptions are inexact are removed; the thin-layer identification methods for costus root and hawthorn in the prescription are added; and the method for determining the costus root content is established by using costunolide and dehydrocostus lactone as reference substances. Thus, the revised quality standard improves the medicine quality control, thereby enabling the detection of traditional Chinese medicine to be more accurate.
Description
Technical field
The invention belongs to technical field of Chinese medicines, relate to the detection method of Chinese medicine, especially a kind of method of quality control of Chinese medicine preparation children's hundred longevity ball.
Background technology
The composition of children's's hundred longevity ball is a Ramulus Uncariae Cum Uncis; Bombyx Batryticatus (parched with bran); Arisaema Cum Bile (wine is processed); Concretio Silicea Bambusae; Radix Platycodonis; the Radix Aucklandiae; Fructus Amomi; Pericarpium Citri Reticulatae; Poria; Massa Medicata Fermentata (parched with bran); Cinnabaris; 18 flavor Chinese medicines such as In vitro cultured Calculus Bovis, except that Calculus Bovis, Cinnabaris water flies into impalpable powder with above 18 flavors; ten Six-elements such as all the other Ramulus Uncariae Cum Uncis are ground into fine powder; with the Calculus Bovis porphyrize,, sieve with above-mentioned powder facing-up; mixing; every 100g powder adds refined honey 100～120g and makes big honeyed pills, that is, function with cure mainly: clearing away heat to dispel wind; relieving dyspepsia; relieving convulsion relieving dizziness, high fever, infantile convulsions, epilepsy, etc., preventing phlegm from forming and stopping coughing is used for treating cold due to wind-heat; fever and headache; dyspepsia, the breast of stopping eating, anorexia belch; cough with copious phlegm, the interior-heat infantile convulsion.
Though still there is not the international standard of plant medicine at present in the world, the trend of Chinese medicine standard but the south east asia of the U.S., European Union, China and tradition outlet Chinese medicine is improved, in the case, need to propose to be fit to the standard of China's product quality to adapt to international standard, it is historical that China has the Chinese medicine in thousands of years to use, countries in the world are many Chinese medicine standards with reference to China in working out corresponding plant amedica target level of product quality, so quality standard perfect, that improve Chinese medicine is more extremely urgent.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art part, a kind of method of quality control of Chinese medicine preparation children's hundred longevity ball that can the qualitative and quantitative analysis ingredient is provided.
The objective of the invention is to be achieved through the following technical solutions:
A kind of method of quality control of Chinese medicine preparation children's hundred longevity ball, step is:
(1) microscopical identification;
(2) with the Radix Aucklandiae be control medicinal material, thin layer chromatography differentiates in children's's hundred longevity ball prescription whether contain Radix Aucklandiae composition;
(3) with the ursolic acid be reference substance, thin layer chromatography differentiates in children's's hundred longevity ball prescription whether contain the Fructus Crataegi composition;
(4) be reference substance with costunolide and dehydrocostuslactone, high-efficient liquid phase technique is measured the Radix Aucklandiae content in children's's hundred longevity ball prescription.
And described microscopical identification is: children's's hundred longevity ball sample is put microscopically observe: the irregular block sheet is colourless, has to peel off vestige layer by layer; Contain prism of calcium oxalate in the parenchyma cell around the fibre bundle, form crystalline cellulose; Connect latex dust diameter 14～25 μ m, contain faint yellow granular substance; Needle-like calcium oxalate crystal bunchy or be dispersed in, length can reach 90 μ m; Calcium oxalate sand crystal is present in the parenchyma cell, and crystal cell connection is sometimes embarked on journey; The body wall fragment is colourless, and there is superfine mycelium on the surface; The dendritic agglomerate of irregular branch is colourless, meets chloral hydrate liquid and gradually dissolves; Hyphae colorless or light brown, diameter 4～6 μ m; Prism of calcium oxalate is present in the parenchyma cell in flakes; The epidermis cell file is by 1 long cell and 2 alternate connections of short cell, long cell wall thickness, wavy bending, lignify; Endotesta prothenchyma (of wood) yellowish-brown or brownish red, the class polygon is seen on the surface, and wall thickness, cell include siliceous; Peel stone cell lilac red, redness or yellowish-brown, similar round or polygon, the about 125 μ m of diameter; The dark brownish red of irregular fine particle, glossy, the edge furvous.
And described thin layer chromatography differentiates that the method for the Radix Aucklandiae in children's's hundred longevity ball prescription is:
Get children's's hundred longevity ball sample 9g, shred, add kieselguhr 3g, grind well, the 30ml that adds diethyl ether, supersound process 10 minutes filters, and filtrate waving is dissipated to about 1ml, as need testing solution; Other gets Radix Aucklandiae control medicinal material 0.5g, and the 10ml that adds diethyl ether shines medical material solution in pairs with legal system; The thin layer chromatography test, draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with toluene: methanol=27: 1 is developing solvent, launches, take out, dry, spray is with 1% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing, detect the test sample chromatograph with the corresponding position of control medicinal material chromatograph on whether show the speckle of same color, determine whether contain Radix Aucklandiae composition for test agent.
And described thin layer chromatography differentiates that the method for Fructus Crataegi in children's's hundred longevity ball prescription is:
Get the ursolic acid reference substance, add methanol and make the solution that every 1ml contains 1mg, in contrast product solution; The thin layer chromatography test, draw Radix Aucklandiae need testing solution and each 2 μ l of above-mentioned reference substance solution in differentiating, put respectively on same silica gel g thin-layer plate, with chloroform: acetone=12: 1 is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, heated several minutes, put under the ultra-violet lamp 365nm and inspect, detect the test sample chromatograph with the corresponding position of reference substance chromatograph on whether show the speckle of same color, determine whether contain the Fructus Crataegi composition for test agent.
And described is reference substance with costunolide and dehydrocostuslactone, and the method that high-efficient liquid phase technique is measured the Radix Aucklandiae content in children's's hundred longevity ball prescription is:
1. chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; With methanol: 0.1% phosphoric acid=63: 37 is mobile phase, and the detection wavelength is 225nm, and number of theoretical plate calculates by the dehydrocostuslactone peak should be not less than 12000;
2. the preparation of reference substance solution: get the costunolide reference substance, the dehydrocostuslactone reference substance is an amount of, accurately claim surely, add methanol and make every 1ml and contain the mixed solution that costunolide 0.22mg contains dehydrocostuslactone 0.028mg, Liquid Detection then;
3. the preparation of need testing solution: it is an amount of to get children's's hundred longevity ball sample, shreds, and gets about 3g, and accurate the title decides, the accurate methanol 50ml that adds, close plug claims decide weight, and supersound process 45 minutes is put coldly, and weight decided in title again, supply the weight that subtracts mistake with methanol, shake up, filter, get subsequent filtrate, then Liquid Detection;
4. detect and result's mensuration: the accurate respectively above-mentioned solution 10 μ l of absorption, inject hplc determination, " the regulation Radix Aucklandiae contains costunolide C under a Radix Aucklandiae medical material of Chinese pharmacopoeia version in 2005 item
15H
20O
2With dehydrocostuslactone C
15H
18O
2Total amount must not be less than 1.8%, children's's hundred longevity ball medicated powder of making a living is used as medicine, the Radix Aucklandiae accounts for 7.11% of prescription total amount, accounts for 3.39% of patent medicine total amount, press 90% calculating of content, per 1 ball of children's's hundred longevity ball contains the Radix Aucklandiae with costunolide C
15H
20O
2With dehydrocostuslactone C
15H
18O
2The total amount meter, should be lower than 1.6mg.
Advantage of the present invention and good effect are:
The present invention removes the inapt Chinese medicine ingredients of associated description on children's's hundred longevity ball primary standard basis, has increased the Radix Aucklandiae and hawthorn thin-layer discrimination method in the prescription; With costunolide and dehydrocostuslactone is reference substance, has formulated the content assaying method of the Radix Aucklandiae, and revised quality standard has improved the quality control of medicine, makes the detection of Chinese medicine more accurate.
Description of drawings
Fig. 1 detects thin-layer chromatogram for the present invention for the Radix Aucklandiae in the test agent, wherein band is followed successively by from left to right: 1: Radix Aucklandiae control medicinal material, 2: Chengde JingFuKang pharmacy Group Co.,Ltd (lot number: 071032), 3～5 are respectively: in new Pharmaceutical reach Ren Tang pharmaceutical factory (lot number: 200801,200802,200803);
Fig. 2 detects chromatogram for the present invention for Fructus Crataegi in the test agent, wherein be followed successively by from left to right: 1: the ursolic acid reference substance, 2: Chengde JingFuKang pharmacy Group Co.,Ltd (lot number: 071032), 3～5 are respectively: in new Pharmaceutical reach Ren Tang pharmaceutical factory (lot number: 200801,200802,200803);
Fig. 3 is costunolide of the present invention and dehydrocostuslactone reference substance liquid chromatogram;
Fig. 4 is children's's hundred longevity ball sample liquid chromatogram of the present invention;
Fig. 5 is a negative sample liquid chromatogram of the present invention.
The specific embodiment
Below in conjunction with embodiment, the present invention is further described, and following embodiment is illustrative, is not determinate, can not limit protection scope of the present invention with following embodiment.
The method of quality control of Chinese medicine preparation children's hundred longevity ball, the step of its method is:
(1) microscopical identification: put microscopically and observe: the irregular block sheet is colourless, has to peel off vestige (Talcum) layer by layer.Contain prism of calcium oxalate in the parenchyma cell around the fibre bundle, form crystalline cellulose (Radix Glycyrrhizae).Connect latex dust diameter 14～25 μ m, contain faint yellow granular substance (Radix Platycodonis).Needle-like calcium oxalate crystal bunchy or be dispersed in, length can reach 90 μ m (Arisaema Cum Bile).Calcium oxalate sand crystal is present in the parenchyma cell, and crystal cell connects embark on journey (Ramulus Uncariae Cum Uncis) sometimes.The body wall fragment is colourless, and there is superfine mycelium (Bombyx Batryticatus) on the surface.The dendritic agglomerate of irregular branch is colourless, meets chloral hydrate liquid and gradually dissolves; Hyphae colorless or light brown, diameter 4～6 μ m (Poria).Prism of calcium oxalate is present in (Pericarpium Citri Reticulatae) in the parenchyma cell in flakes.The epidermis cell file is by 1 long cell and 2 alternate connections of short cell, long cell wall thickness, wavy bending, lignify (Fructus Hordei Germinatus).Endotesta prothenchyma (of wood) yellowish-brown or brownish red, the class polygon is seen on the surface, and wall thickness, cell include siliceous (Fructus Amomi).Peel stone cell lilac red, redness or yellowish-brown, similar round or polygon, the about 125 μ m (Fructus Crataegi) of diameter.The dark brownish red of irregular fine particle, glossy, edge furvous (Cinnabaris).
(2) adopting thin layer chromatography, is control medicinal material with the Radix Aucklandiae, differentiates the Radix Aucklandiae in children's's hundred longevity ball prescription.
Get children's's hundred longevity ball sample 9g, shred, add kieselguhr 3g, grind well, the 30ml that adds diethyl ether, supersound process 10 minutes filters, and filtrate waving is dissipated to about 1ml, as need testing solution; Other gets Radix Aucklandiae control medicinal material 0.5g, and the 10ml that adds diethyl ether shines medical material solution in pairs with legal system; According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2005 B) test, draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with toluene: methanol=27: 1 is developing solvent, launch, take out, dry, spray is with 1% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of two same colors, testing result is seen Fig. 1, wherein negative sample is not for containing children's's hundred longevity ball reference substance of the Radix Aucklandiae, processing method is with children's's hundred longevity ball sample.
(3) adopting thin layer chromatography, is reference substance with the ursolic acid, differentiates Fructus Crataegi in children's's hundred longevity ball prescription.
Get the ursolic acid reference substance, add methanol and make the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2005 B) test, draw need testing solution and each 2 μ l of above-mentioned reference substance solution in the step (2), put respectively on same silica gel g thin-layer plate, with chloroform: acetone=12: 1 is developing solvent, launches, and takes out, dry, spray was heated several minutes with 10% ethanol solution of sulfuric acid, put under the ultra-violet lamp (365nm) and inspected.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.Testing result is seen Fig. 2, and wherein negative sample is not for containing children's's hundred longevity ball reference substance of Fructus Crataegi, and processing method is with children's's hundred longevity ball sample.
(4) adopting high-efficient liquid phase technique, is reference substance with costunolide and dehydrocostuslactone, measures the Radix Aucklandiae content in the prescription children's hundred longevity ball.
1. chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; With methanol-0.1% phosphoric acid (63: 37) is mobile phase, and the detection wavelength is 225nm, and number of theoretical plate calculates by the dehydrocostuslactone peak should be not less than 12000.
2. the preparation of reference substance solution: get the costunolide reference substance, the dehydrocostuslactone reference substance is an amount of, the accurate title, decide, add methanol and make every 1ml and contain the mixed solution that costunolide 0.22mg contains dehydrocostuslactone 0.028mg, that is, Liquid Detection the results are shown in Figure 3.
3. the preparation of need testing solution: it is an amount of to get children's's hundred longevity ball sample, shreds, and gets about 3g, the accurate title, decide, accurate methanol 50ml, the close plug of adding, claim to decide weight, supersound process (power 240W, frequency 45kHz) 45 minutes, put coldly, claim again to decide weight, supply the weight that subtracts mistake with methanol, shake up, filter, get subsequent filtrate, that is, Liquid Detection the results are shown in Figure 4.
4. the preparation of negative sample solution: get the medical material of respectively distinguishing the flavor of except that the Radix Aucklandiae by prescription, make sample by children's's hundred longevity ball preparation method, by this 3. need testing solution preparation method in the step not, make negative sample solution again, Liquid Detection the results are shown in Figure 5.
5. detect and result's mensuration: the accurate respectively above-mentioned solution 10 μ l of absorption, inject chromatograph of liquid, mensuration, " the regulation Radix Aucklandiae contains costunolide (C under a Radix Aucklandiae medical material of Chinese pharmacopoeia version in 2005 item
15H
20O
2) and dehydrocostuslactone (C
15H
18O
2) total amount must not be less than 1.8%.This product medicated powder of making a living is used as medicine, and the Radix Aucklandiae accounts for 7.11% of prescription total amount, accounts for 3.39% of patent medicine total amount, press 90% calculating of content, and per 1 ball of this product contains the Radix Aucklandiae with costunolide (C
15H
20O
2) and dehydrocostuslactone (C
15H
18O
2) the total amount meter, should be lower than 1.6mg.
Claims (5)
1. the method for quality control of Chinese medicine preparation children's hundred a longevity ball, it is characterized in that: the step of its method is:
(1) microscopical identification;
(2) with the Radix Aucklandiae be control medicinal material, thin layer chromatography differentiates in children's's hundred longevity ball prescription whether contain Radix Aucklandiae composition;
(3) with the ursolic acid be reference substance, thin layer chromatography differentiates in children's's hundred longevity ball prescription whether contain the Fructus Crataegi composition;
(4) be reference substance with costunolide and dehydrocostuslactone, high-efficient liquid phase technique is measured the Radix Aucklandiae content in children's's hundred longevity ball prescription.
2. the method for quality control of Chinese medicine preparation children's hundred longevity ball according to claim 1, it is characterized in that: described microscopical identification is: children's's hundred longevity ball sample is put microscopically observe: the irregular block sheet is colourless, has to peel off vestige layer by layer; Contain prism of calcium oxalate in the parenchyma cell around the fibre bundle, form crystalline cellulose; Connect latex dust diameter 14～25 μ m, contain faint yellow granular substance; Needle-like calcium oxalate crystal bunchy or be dispersed in, length can reach 90 μ m; Calcium oxalate sand crystal is present in the parenchyma cell, and crystal cell connection is sometimes embarked on journey; The body wall fragment is colourless, and there is superfine mycelium on the surface; The dendritic agglomerate of irregular branch is colourless, meets chloral hydrate liquid and gradually dissolves; Hyphae colorless or light brown, diameter 4～6 μ m; Prism of calcium oxalate is present in the parenchyma cell in flakes; The epidermis cell file is by 1 long cell and 2 alternate connections of short cell, long cell wall thickness, wavy bending, lignify; Endotesta prothenchyma (of wood) yellowish-brown or brownish red, the class polygon is seen on the surface, and wall thickness, cell include siliceous; Peel stone cell lilac red, redness or yellowish-brown, similar round or polygon, the about 125 μ m of diameter; The dark brownish red of irregular fine particle, glossy, the edge furvous.
3. the method for quality control of Chinese medicine preparation children's hundred longevity ball according to claim 1 is characterized in that: described thin layer chromatography differentiates that the method for the Radix Aucklandiae in children's's hundred longevity ball prescription is:
Get children's's hundred longevity ball sample 9g, shred, add kieselguhr 3g, grind well, the 30ml that adds diethyl ether, supersound process 10 minutes filters, and filtrate waving is dissipated to about 1ml, as need testing solution; Other gets Radix Aucklandiae control medicinal material 0.5g, and the 10ml that adds diethyl ether shines medical material solution in pairs with legal system; The thin layer chromatography test, draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with toluene: methanol=27: 1 is developing solvent, launches, take out, dry, spray is with 1% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing, detect the test sample chromatograph with the corresponding position of control medicinal material chromatograph on whether show the speckle of same color, determine whether contain Radix Aucklandiae composition for test agent.
4. the method for quality control of Chinese medicine preparation children's hundred longevity ball according to claim 1 is characterized in that: described thin layer chromatography differentiates that the method for Fructus Crataegi in children's's hundred longevity ball prescription is:
Get the ursolic acid reference substance, add methanol and make the solution that every 1ml contains 1mg, in contrast product solution; The thin layer chromatography test, draw Radix Aucklandiae need testing solution and each 2 μ l of above-mentioned reference substance solution in differentiating, put respectively on same silica gel g thin-layer plate, with chloroform: acetone=12: 1 is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, heated several minutes, put under the ultra-violet lamp 365nm and inspect, detect the test sample chromatograph with the corresponding position of reference substance chromatograph on whether show the speckle of same color, determine whether contain the Fructus Crataegi composition for test agent.
5. the method for quality control of Chinese medicine preparation children's hundred longevity ball according to claim 1 is characterized in that: described is reference substance with costunolide and dehydrocostuslactone, and the method that high-efficient liquid phase technique is measured the Radix Aucklandiae content in children's's hundred longevity ball prescription is:
1. chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; With methanol: 0.1% phosphoric acid=63: 37 is mobile phase, and the detection wavelength is 225nm, and number of theoretical plate calculates by the dehydrocostuslactone peak should be not less than 12000;
2. the preparation of reference substance solution: get the costunolide reference substance, the dehydrocostuslactone reference substance is an amount of, accurately claim surely, add methanol and make every 1ml and contain the mixed solution that costunolide 0.22mg contains dehydrocostuslactone 0.028mg, Liquid Detection then;
3. the preparation of need testing solution: it is an amount of to get children's's hundred longevity ball sample, shreds, and gets about 3g, and accurate the title decides, the accurate methanol 50ml that adds, close plug claims decide weight, and supersound process 45 minutes is put coldly, and weight decided in title again, supply the weight that subtracts mistake with methanol, shake up, filter, get subsequent filtrate, then Liquid Detection;
4. detect and result's mensuration: the accurate respectively above-mentioned solution 10 μ l of absorption, inject hplc determination, " the regulation Radix Aucklandiae contains costunolide C under a Radix Aucklandiae medical material of Chinese pharmacopoeia version in 2005 item
15H
20O
2With dehydrocostuslactone C
15H
18O
2Total amount must not be less than 1.8%, children's's hundred longevity ball medicated powder of making a living is used as medicine, the Radix Aucklandiae accounts for 7.11% of prescription total amount, accounts for 3.39% of patent medicine total amount, press 90% calculating of content, per 1 ball of children's's hundred longevity ball contains the Radix Aucklandiae with costunolide C
15H
20O
2With dehydrocostuslactone C
15H
18O
2The total amount meter, should be lower than 1.6mg.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102426213A (en) * | 2011-11-08 | 2012-04-25 | 山东阿如拉药物研究开发有限公司 | Method for controlling quality of Xueshan Weibao wan |
| CN103018396A (en) * | 2013-01-01 | 2013-04-03 | 吉林紫鑫药业股份有限公司 | Test method of cynomorium songaricum kidney-tonifying capsule |
| CN103163272A (en) * | 2013-04-01 | 2013-06-19 | 山西振东开元制药有限公司 | Quality control method of infant spleen tonifying medicament |
| CN104007223A (en) * | 2014-06-10 | 2014-08-27 | 山西振东开元制药有限公司 | Quality control method of hawthorn middle burner adjusting preparation |
| CN105548454A (en) * | 2016-02-29 | 2016-05-04 | 广州市香雪制药股份有限公司 | Quality detecting method of traditional Chinese medicine preparation for helping digestion of children |
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2009
- 2009-10-26 CN CN2009100709587A patent/CN102038902A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102426213A (en) * | 2011-11-08 | 2012-04-25 | 山东阿如拉药物研究开发有限公司 | Method for controlling quality of Xueshan Weibao wan |
| CN102426213B (en) * | 2011-11-08 | 2014-01-08 | 山东阿如拉药物研究开发有限公司 | Method for controlling quality of Xueshan Weibao wan |
| CN103018396A (en) * | 2013-01-01 | 2013-04-03 | 吉林紫鑫药业股份有限公司 | Test method of cynomorium songaricum kidney-tonifying capsule |
| CN103163272A (en) * | 2013-04-01 | 2013-06-19 | 山西振东开元制药有限公司 | Quality control method of infant spleen tonifying medicament |
| CN104007223A (en) * | 2014-06-10 | 2014-08-27 | 山西振东开元制药有限公司 | Quality control method of hawthorn middle burner adjusting preparation |
| CN105548454A (en) * | 2016-02-29 | 2016-05-04 | 广州市香雪制药股份有限公司 | Quality detecting method of traditional Chinese medicine preparation for helping digestion of children |
| CN105548454B (en) * | 2016-02-29 | 2017-12-26 | 广州市香雪制药股份有限公司 | The quality determining method of children's helping digestion Chinese medicine preparation |
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Application publication date: 20110504 |