CN106198834A - The quality of production control method of juice mended by the one seed ginseng stilbene Radix Polygoni Multiflori - Google Patents
The quality of production control method of juice mended by the one seed ginseng stilbene Radix Polygoni Multiflori Download PDFInfo
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Abstract
The invention discloses a seed ginseng stilbene Radix Polygoni Multiflori and mend the quality of production control method of juice, the method includes production control method, method of quality control.The active ingredient that the ginseng stilbene Radix Polygoni Multiflori is mended juice by the method differentiates respectively, detects, thus its quality is carried out overall merit, efficiently controls the quality of product, it is ensured that use safely, effectively and stable.
Description
Technical field
The present invention relates to pharmaceutical production, drugs analysis, field of quality control, is specifically related to a seed ginseng stilbene Radix Polygoni Multiflori and mends the production of juice
Method of quality control.
Background technology
The active ingredient astragaloside that the ginseng stilbene Radix Polygoni Multiflori is mended in juice has enhancing human body immunity power, resistance against diseases, antiviral energy
Power and growth promotion, improve the effects such as cardiopulmonary；Rheum emodin has the effect of anti-tumor activity, antimicrobial growth, immunity
Inhibitory action, the effect to cardiovascular system, spasmolytic, antitussive action；2,3,5,4 '-tetrahydroxystilbene-2-O-B-D Fructus Vitis viniferae
Glucosides has the biological activitys such as regulation blood fat, antioxidation, raising memory, protection neurocyte, protection vascular endothelial.
Juice mended by the ginseng stilbene Radix Polygoni Multiflori that the most many enterprises produce, and is mainly used in benefiting qi and nourishing blood, liver and kidney tonifying etc. and acts on, but state so far
Family, place, enterprise there is not yet the corresponding quality of production and control standard, for ensureing that stablizing and using of juice quality mended by the ginseng stilbene Radix Polygoni Multiflori
Safely, effectively, it is necessary to set up a perfect quality of production control method.
Summary of the invention
It is desirable to provide the quality of production control method of juice mended by a seed ginseng stilbene Radix Polygoni Multiflori, to solve to there is no quality control at present
Its active ingredient can be differentiated, detect comprehensively by method processed, it is difficult to control the safe and effective problem of product quality.
The present invention is achieved by the following technical programs:
The quality of production control method of juice mended by the one seed ginseng stilbene Radix Polygoni Multiflori, and the method includes production control method, quality control side
Method；
Production control method:
Take Radix Codonopsis 170g, Radix Astragali 100g, Radix Polygoni Multiflori Preparata 170g, Rhizoma Polygonati 170g, boiling secondary, each 3h, merge and decoct
Liquid, filters, and filtrate is concentrated into about 600ml, lets cool, and adds amount of alcohol and reaches 75%, stand, filters, filtrate be concentrated into 500～
600ml, adds simple syrup 280ml, preservative, adds water to 1000ml, stir evenly, and stands, and filters, to obtain final product；
Method of quality control:
1) discriminating of astragaloside
Prepared by a, need testing solution: take ginseng the stilbene Radix Polygoni Multiflori mend juice 20mL, with water saturated butanol solution extraction 3 times, every time
20mL, merges butanol solution, then washs with sodium hydroxide solution, remove aqueous solution, and butanol solution is evaporated, and residue adds methanol
1mL dissolves；
Prepared by b, reference substance solution: take astragaloside reference substance appropriate, adds methanol and dissolves, and makes every 1mL solution containing 1mg
Astragaloside；
C, point sample: according to thin layer chromatography (one annex VI B of China's coastal port) test, draw above-mentioned test sample
The each 10 μ L of solution, reference substance solution put on same silica gel G plate, with chloroform-acetate-methanol-water at 10 DEG C respectively
Lower floor's solution arranged below is developing solvent, launches, takes out, dries；
D, develop the color and inspect: to the ethanol solution of sulfuric acid of above-mentioned silica gel G plate spray 10%, being heated to, at 105 DEG C, the speckle that develops the color
Clearly；
E, discriminating: in test sample chromatograph, on position corresponding with reference substance chromatograph, aobvious identical punctation, then supply
Test product contains astragaloside；
2) discriminating of rheum emodin:
Prepared by a, need testing solution: take the ginseng stilbene Radix Polygoni Multiflori and mend juice 20mL, with chloroform extraction 3 times, each 20mL, merge three
Chloromethanes solution, is evaporated, and residue adds chloroform 1mL and dissolves；
Prepared by b, reference substance solution: take rheum emodin reference substance appropriate, adds chloroform and dissolves, makes every 1mL solution and contain
1mg rheum emodin；
C, point sample: according to thin layer chromatography (one annex VI B of China's coastal port) test, draw above-mentioned test sample
Solution, reference substance solution are put respectively on same silica gel G plate, with toluene-ethyl acetate-formic acid as developing solvent, launch, take out,
Dry；
D, develop the color and inspect: above-mentioned glue G plate is first placed under the uviol lamp of wavelength 365nm and inspects, Show Color speckle, then uses
Ammonia steam is smoked, and inspects Show Color speckle under daylight；
E, discriminating: in test sample chromatograph, on position corresponding with reference substance chromatograph, aobvious identical punctation, then supply
Test product contains rheum emodin；
3), 2,3,5, the detection of 4 '-tetrahydroxystilbene-2-O-B-D glucoside:
A, testing conditions: measure according to high performance liquid chromatography (one annex VI D of China's coastal port), with 18
Alkyl silane bonded silica gel be filler, volume ratio be the nitrile water of 25: 75 be 320nm for flowing phase, detection wavelength；
Prepared by b, need testing solution: precision measures the ginseng stilbene Radix Polygoni Multiflori and mends juice 5mL, is placed in 25mL measuring bottle, adds Diluted Alcohol to carving
Degree, shakes up；
Prepared by c, reference substance solution: accurately weighed 2, and 3,5,4 '-tetrahydroxystilbene-2-O-B-D glucoside compares
Product are appropriate, add Diluted Alcohol and shake up, and make every 1mL solution 2,3,5 containing 20ug, 4 '-tetrahydroxystilbene-2-O-B-D Fructus Vitis viniferae
Glucosides；
D, mensuration: accurate absorption reference substance solution, each 10 μ L of need testing solution, be injected separately into chromatograph of liquid and survey
Fixed.
Described step 1) concentration of sodium hydroxide solution is 1% in a, wash 3 times, each 20mL.
Described step 1) in a after sodium hydroxide solution washing again with the saturated solution washing of n-butyl alcohol to neutral.
Described step 1) butanol solution is evaporated in a temperature is 55-68 DEG C.
Described step 1) volume ratio of developing solvent chloroform-acetate-methanol-water is 10: 20: 15: 5 in c.
Described step 2) chloroform soln is evaporated in a temperature is 40-70 DEG C.
Described step 2) c draws need testing solution be 10 μ L, reference substance solution be 3 μ L.
Described step 2) volume ratio of developing solvent toluene-ethyl acetate-formic acid is 15: 2: 1 in c.
Described step 3) number of theoretical plate is by 2,3,5 in a, and 4 '-tetrahydroxystilbene-2-O-B-D glucoside peak calculates
≥2000。
The described ginseng stilbene Radix Polygoni Multiflori mends the every 1mL of juice containing Radix Polygoni Multiflori Preparata with 2, and 3,5,4 '-tetrahydroxystilbene-2-O-B-D Fructus Vitis viniferae
Glucosides (C20H22O9) meter >=80 μ g.
The beneficial effects of the present invention is: use the present invention first the ginseng stilbene Radix Polygoni Multiflori is mended the active ingredient astragaloside in juice,
Rheum emodin differentiates respectively, then to 2,3,5, the content of 4 '-tetrahydroxystilbene-2-O-B-D glucoside detects,
The quality of product can be efficiently controlled efficiently against deficiency of the prior art.And use thin layer chromatography operation letter
Just, fast, using high-efficient liquid chromatograph to detect, the result drawn is good in accuracy, repeatability, precision, the response rate,
Can effectively control to join the stilbene Radix Polygoni Multiflori and mend the quality of juice, it is ensured that the effect of product.
Detailed description of the invention
Technical scheme is further described by following example, but claimed scope is not limited to institute
State.
The quality of production control method of juice mended by the one seed ginseng stilbene Radix Polygoni Multiflori, and the method includes production control method, quality control side
Method；
Production control method:
Take Radix Codonopsis 170g, Radix Astragali 100g, Radix Polygoni Multiflori Preparata 170g, Rhizoma Polygonati 170g, boiling secondary, each 3h, merge and decoct
Liquid, filters, and filtrate is concentrated into about 600ml, lets cool, and adds amount of alcohol and reaches 75%, stand, filters, filtrate be concentrated into 500～
600ml, adds simple syrup 280ml, preservative, adds water to 1000ml, stir evenly, and stands, and filters, to obtain final product；
Method of quality control:
1) discriminating of astragaloside
Take the ginseng stilbene Radix Polygoni Multiflori and mend juice 20mL, extract 3 times with water saturated butanol solution, each 20mL, merge n-butyl alcohol molten
Liquid, washs 3 times with sodium hydroxide solution that concentration is 1%, each 20mL, then with the saturated solution washing of n-butyl alcohol extremely in
Property, removing aqueous solution, butanol solution is 61 DEG C in temperature and is evaporated, and residue adds methanol 1mL and dissolves, as need testing solution；Take
Astragaloside reference substance is appropriate, adds methanol and dissolves, makes every 1mL solution astragaloside Han 1mg as reference substance solution；Foundation
Thin layer chromatography (one annex VI B of China's coastal port) is tested, and draws above-mentioned need testing solution, reference substance solution each 10
μ L puts respectively on same silica gel G plate, is 10: 20: 15: 5 at 10 DEG C with the volume ratio of chloroform-acetate-methanol-water
Lower floor's solution arranged below is developing solvent, launches, takes out, dries；To the ethanol solution of sulfuric acid of above-mentioned silica gel G plate spray 10%,
It is heated to the clear spot that develops the color at 105 DEG C；In test sample chromatograph, position corresponding with reference substance chromatograph show identical red
Mottle point, test sample contains astragaloside；
2) discriminating of rheum emodin:
Take the ginseng stilbene Radix Polygoni Multiflori and mend juice 20mL, with chloroform extraction 3 times, each 20mL, merge chloroform soln, in temperature
Being 55 DEG C to be evaporated, residue adds chloroform 1mL and dissolves as need testing solution；Take rheum emodin reference substance appropriate, add three chloromethanes
Alkane dissolves, and makes every 1mL solution rheum emodin Han 1mg as reference substance solution；According to thin layer chromatography (China's coastal port
One annex VI B) test, absorption need testing solution is 10 μ L, reference substance solution is that 3 μ L put respectively on same silica gel G plate, with
The volume ratio of toluene-ethyl acetate-formic acid is to make developing solvent at 15: 2: 1, launches, takes out, dries；Above-mentioned glue G plate is first placed in wavelength
Inspect under the uviol lamp of 365nm, Show Color speckle, then smoke with ammonia steam, under daylight, inspect Show Color speckle；Test sample color
In spectrum, showing identical punctation on position corresponding with reference substance chromatograph, test sample contains rheum emodin；
3), 2,3,5, the detection of 4 '-tetrahydroxystilbene-2-O-B-D glucoside:
Measure according to high performance liquid chromatography (one annex VI D of China's coastal port), with octadecylsilane key
Conjunction silica gel be filler, volume ratio be the nitrile water of 25: 75 be 320nm for flowing phase, detection wavelength, number of theoretical plate by 2,3,5,
4 '-tetrahydroxystilbene-2-O-B-D glucoside peak is calculated as 2000；Precision measures the ginseng stilbene Radix Polygoni Multiflori and mends juice 5mL, is placed in
In 25mL measuring bottle, add Diluted Alcohol to scale, shake up as need testing solution；Accurately weighed 2,3,5,4 '-tetrahydroxystilbene-
2-O-B-D glucoside reference substance is appropriate, adds Diluted Alcohol and shakes up, and makes every 1mL solution 2,3,5 containing 20ug, 4 '-tetrahydroxy two
Styrene-2-O-B-D glucoside is as reference substance solution；Accurate reference substance solution, each 10 μ L of need testing solution of drawing, difference
Injection chromatograph of liquid is measured.
The ginseng stilbene Radix Polygoni Multiflori mends the every 1mL of juice containing Radix Polygoni Multiflori Preparata with 2, and 3,5,4 '-tetrahydroxystilbene-2-O-B-D glucoside
(C20H22O9) it is calculated as 84 μ g.
Claims (10)
1. the quality of production control method of juice mended by a seed ginseng stilbene Radix Polygoni Multiflori, it is characterised in that the method includes production control method, matter
Amount control method；
Production control method:
Take Radix Codonopsis 170g, Radix Astragali 100g, Radix Polygoni Multiflori Preparata 170g, Rhizoma Polygonati 170g, boiling secondary, each 3h, collecting decoction, filter
Crossing, filtrate is concentrated into about 600ml, lets cool, and adds amount of alcohol and reaches 75%, stand, filters, and filtrate is concentrated into 500～600ml, adds
Enter simple syrup 280ml, preservative, add water to 1000ml, stir evenly, stand, filter, to obtain final product；
Method of quality control:
1) discriminating of astragaloside:
Prepared by a, need testing solution: take the ginseng stilbene Radix Polygoni Multiflori and mend juice 20mL, extract 3 times with water saturated butanol solution, each 20mL,
Merging butanol solution, then wash with sodium hydroxide solution, remove aqueous solution, butanol solution is evaporated, and it is molten that residue adds methanol 1mL
Solve；
Prepared by b, reference substance solution: take astragaloside reference substance appropriate, adds methanol and dissolves, makes every 1mL solution Radix Astragali Han 1mg
First glycosides；
C, point sample: according to thin layer chromatography test, draw above-mentioned need testing solution, each 10 μ L of reference substance solution put respectively in same
On silica gel G plate, with chloroform-acetate-methanol-water at 10 DEG C of lower floor's solution arranged below as developing solvent, launch, take
Go out, dry；
D, develop the color and inspect: on above-mentioned silica gel G plate, spraying the ethanol solution of sulfuric acid of 10%, clear at 105 DEG C of speckles that are heated to developing the color
Clear；
E, discriminating: in test sample chromatograph, on position corresponding with reference substance chromatograph, the speckle of display same color, then for examination
Product contain astragaloside；
2) discriminating of rheum emodin:
Prepared by a, need testing solution: take the ginseng stilbene Radix Polygoni Multiflori and mend juice 20mL, with chloroform extraction 3 times, each 20mL, merge three chloromethanes
Alkane solution, is evaporated, and residue adds chloroform 1mL and dissolves；
Prepared by b, reference substance solution: take rheum emodin reference substance appropriate, adds chloroform and dissolves, makes every 1mL solution big containing 1mg
Flavin；
C, point sample: test according to thin layer chromatography, draw above-mentioned need testing solution, reference substance solution and put respectively in same silica gel G
On plate, with toluene-ethyl acetate-formic acid as developing solvent, launch, take out, dry；
D, develop the color and inspect: above-mentioned silica gel G plate is first placed under the uviol lamp of wavelength 365nm and inspects, Show Color speckle, then uses ammonia
Steam is smoked, and inspects Show Color speckle under daylight；
E, discriminating: in test sample chromatograph, on position corresponding with reference substance chromatograph, the speckle of display same color, then for examination
Product contain rheum emodin；
3), 2,3,5, the detection of 4 '-tetrahydroxystilbene-2-O-B-D glucoside:
A, testing conditions: according to high effective liquid chromatography for measuring, with octadecylsilane chemically bonded silica as filler, volume ratio be
The nitrile water of 25: 75 is 320nm for flowing phase, detection wavelength；
Prepared by b, need testing solution: precision measures the ginseng stilbene Radix Polygoni Multiflori and mends juice 5mL, is placed in 25mL measuring bottle, adds Diluted Alcohol to scale, shakes
Even；
Prepared by c, reference substance solution: accurately weighed 2, and 3,5,4 '-tetrahydroxystilbene-2-O-B-D glucoside reference substance is fitted
Amount, adds Diluted Alcohol and shakes up, and makes every 1mL solution 2,3,5 containing 20ug, 4 '-tetrahydroxystilbene-2-O-B-D glucoside；
D, mensuration: accurate absorption reference substance solution, each 10 μ L of need testing solution, be injected separately into high performance liquid chromatograph and survey
Fixed.
The method of quality control of juice mended by a seed ginseng stilbene Radix Polygoni Multiflori the most according to claim 1, it is characterised in that described step 1)
In a, concentration of sodium hydroxide solution is 1%, washs 3 times, each 20mL.
The quality of production control method of juice mended by a seed ginseng stilbene Radix Polygoni Multiflori the most according to claim 1, it is characterised in that described step
Rapid 1) the most neutral with the solution washing that n-butyl alcohol is saturated again after sodium hydroxide solution washing in a.
The quality of production control method of juice mended by a seed ginseng stilbene Radix Polygoni Multiflori the most according to claim 1, it is characterised in that described step
Rapid 1) temperature that in a, butanol solution is evaporated is 55-68 DEG C.
The quality of production control method of juice mended by a seed ginseng stilbene Radix Polygoni Multiflori the most according to claim 1, it is characterised in that described step
Rapid 1) in c, the volume ratio of developing solvent chloroform-acetate-methanol-water is 10: 20: 15: 5.
The quality of production control method of juice mended by a seed ginseng stilbene Radix Polygoni Multiflori the most according to claim 1, it is characterised in that described step
Rapid 2) temperature that in a, chloroform soln is evaporated is 40-70 DEG C.
The quality of production control method of juice mended by a seed ginseng stilbene Radix Polygoni Multiflori the most according to claim 1, it is characterised in that described step
Rapid 2) in c draw need testing solution be 10 μ L, reference substance solution be 3 μ L.
The quality of production control method of juice mended by a seed ginseng stilbene Radix Polygoni Multiflori the most according to claim 1, it is characterised in that described step
Rapid 2) in c, the volume ratio of developing solvent toluene-ethyl acetate-formic acid is 15: 2: 1.
The quality of production control method of juice mended by a seed ginseng stilbene Radix Polygoni Multiflori the most according to claim 1, it is characterised in that described step
Rapid 3) in a, number of theoretical plate is by 2,3,5, and 4 '-tetrahydroxystilbene-2-O-B-D glucoside peak calculates >=2000.
10. mend the quality of production control method of juice according to the seed ginseng stilbene Radix Polygoni Multiflori described in claim 1-9, it is characterised in that institute
State the ginseng stilbene Radix Polygoni Multiflori and mend the every 1mL of juice containing Radix Polygoni Multiflori Preparata with 2,3,5,4 '-tetrahydroxystilbene-2-O-B-D glucoside
(C20H22O9) meter >=80 μ g.
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Citations (2)
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2016
- 2016-06-24 CN CN201610481319.XA patent/CN106198834A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101926889A (en) * | 2010-08-09 | 2010-12-29 | 四川美大康药业股份有限公司 | Method for detecting white paeony root-medlar particles |
| CN102218122A (en) * | 2011-04-13 | 2011-10-19 | 济南宏济堂制药有限责任公司 | Quality control and detection method for sea dragon and gecko oral liquid |
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| Title |
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| 张清波 等: "春常在口服液质量标准研究", 《中成药》 * |
| 蒋玉芳 等: "肝宁胶囊的制备及质量标准", 《时珍国医国药》 * |
| 黄园 等: "HPLC法测定参芪首乌补汁中２,３,５,４′四羟基二苯乙烯-２-Ｏ-β-Ｄ葡萄糖苷的含量", 《广西科学》 * |
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