CN106770719A - The fingerprint atlas detection method of low-sugar type intensified loquet distillate - Google Patents
The fingerprint atlas detection method of low-sugar type intensified loquet distillate Download PDFInfo
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- CN106770719A CN106770719A CN201611063288.2A CN201611063288A CN106770719A CN 106770719 A CN106770719 A CN 106770719A CN 201611063288 A CN201611063288 A CN 201611063288A CN 106770719 A CN106770719 A CN 106770719A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
Abstract
The present invention provides a kind of fingerprint atlas detection method of low-sugar type intensified loquet distillate, is related to medicine detection technique field, comprises the following steps：The first step, sets up ingredient standard characteristic spectrum in low-sugar type intensified loquet distillate；Second step, low-sugar type intensified loquet distillate sample characteristic collection of illustrative plates to be measured is determined in above-mentioned identical method；3rd step, low-sugar type intensified loquet distillate sample characteristic collection of illustrative plates to be measured is compared with the low-sugar type intensified loquet distillate characteristic spectrum of standard, judges the quality and the true and false of low-sugar type intensified loquet distillate to be measured.The beneficial effects of the invention are as follows：Globality, broad perspectives and ambiguity, are difficult to reflection product and truly feed intake situation instant invention overcomes single component assay.The present invention provides new ways and means for the quality of complete, accurate evaluation low-sugar type intensified loquet distillate.The similarities and differences of collection of illustrative plates are intuitively recognized with vision；Quantify the true and false, the quality of sample with semiquantitative index.
Description
Technical field
A kind of finger-print the present invention relates to medicine detection technique field, more particularly to low-sugar type intensified loquet distillate is detected
Method.
Background technology
Low-sugar type intensified loquet distillate is the medicinal materials such as loguat leaf, pappy shell, the tuber of stemona, Cynanchum glaucescens, the root bark of white mulberry, balloonflower root, menthol warp
Certain technique is processed.Astringed the lung with yin-nourishing, effect of kobadrin.For chronic cough due to asthenia of viscera, bronchitis etc..
It is well known that the drug effect of Chinese patent drug is not from any single active component, but various effective part groups are common
The result of same-action, at present, the chemical reaction for only having composition of alkaloids in low-sugar type intensified loquet distillate quality standard differentiates, but
This cannot characterize the quality of low-sugar type intensified loquet distillate, there is great risk.And finger-print can be than more comprehensively characterizing low sugar
Type intensified loquet distillate composition, the stricter quality for controlling low-sugar type intensified loquet distillate.
The content of the invention
It is above-mentioned to solve it is an object of the invention to provide a kind of fingerprint atlas detection method of low-sugar type intensified loquet distillate
Technical problem.
The technical problems to be solved by the invention are realized using following technical scheme：
A kind of fingerprint atlas detection method of low-sugar type intensified loquet distillate, it is characterised in that comprise the following steps：
The first step, sets up ingredient standard characteristic spectrum in low-sugar type intensified loquet distillate, and method is as follows：
(1) preparation of need testing solution：Precision pipettes this product 5ml, in putting 25ml measuring bottles, plus 20% first containing 5% acetic acid
Alcohol is diluted to scale, shakes up, filtration, subsequent filtrate is taken, as need testing solution；
(2) preparation of reference solution：Take morphine reference substance appropriate, it is accurately weighed, in putting brown measuring bottle, plus containing 5% vinegar
20% methyl alcohol of acid is made solution of every 1ml containing 20 μ g, used as reference solution；
(3) chromatographic condition：It is filler with octadecylsilane chemically bonded silica, with acetonitrile -0.01mol/L sodium heptanesulfonates
The equivalent mixed liquor of solution and 0.02mol/L potassium dihydrogen phosphates is mobile phase, and with 10% phosphoric acid solution regulation pH value to
2.8；Detection wavelength 300nm, number of theoretical plate is calculated by morphine and is not less than 2000；
(4) determine：It is accurate respectively to draw reference solution and the μ l of need testing solution 20, liquid chromatograph is injected, use liquid phase
Chromatography determination, formulates low-sugar type intensified loquet distillate characteristic spectrum；
In the low-sugar type intensified loquet distillate characteristic spectrum, it is defined as 6 characteristic peaks, with the chromatographic peak of object of reference morphine
(S) relative retention time is 1, first determines the relative retention time of its Characteristic chromatographic peak, and above-mentioned 6 characteristic peaks are respectively：No. 1
The average relative retention time RRT at peak is 1.24, No. 2 average relative retention time RRT at peak for 1.60, No. 3 peaks are averagely relative
Retention time RRT is 1.77, No. 4 average relative retention time RRT in peak for 1.95, No. 5 average relative retention time RRT in peak are
2.14, No. 6 average relative retention time RRT in peak are 2.50, No. 1 peak, No. 2 peaks, No. 3 peaks, No. 4 peaks, No. 5 peaks, No. 6 peaks
The difference of relative retention time is respectively less than 10%；
It is 1 with No. 5 peak-to-peak areas, determines 6 relative peak areas of Characteristic chromatographic peak：No. 1 average relative peak area at peak
0.34, No. 2 average relative peak area at peak is that 0.19, No. 3 average relative peak areas in peak are the average relative peak face in 0.22, No. 4 peaks
Product is that 1, No. 6 average relative peak areas in peak are 0.30 for 0.72, No. 5 average relative peak areas in peak, No. 1 peak, No. 2 peaks, No. 3
Peak, No. 4 peaks, No. 5 peaks, the difference of the relative peak area at No. 6 peaks are respectively less than 10%；
Second step, low-sugar type intensified loquet distillate sample characteristic collection of illustrative plates to be measured is determined in above-mentioned identical method；
3rd step, by low-sugar type intensified loquet distillate sample characteristic collection of illustrative plates to be measured and the low-sugar type intensified loquet distillate feature of standard
Collection of illustrative plates is compared, and judges the quality and the true and false of low-sugar type intensified loquet distillate to be measured.
The present invention is binding tests research work, establishes the standard feature collection of illustrative plates of low-sugar type intensified loquet distillate, can be preferably
Ground ensures the accuracy and correctness that low-sugar type intensified loquet distillate Chinese medicine feeds intake.Up to the present, there is no on above-mentioned low sugar
The open report of type intensified loquet distillate fingerprint control method.
The beneficial effects of the invention are as follows：
1st, globality, broad perspectives and ambiguity, are difficult to reflection product true instant invention overcomes single component assay
Feed intake situation.The present invention provides new ways and means for the quality of complete, accurate evaluation low-sugar type intensified loquet distillate.
2nd, the similarities and differences of collection of illustrative plates are intuitively recognized with vision；Quantify the true and false, the quality of sample with semiquantitative index.
Brief description of the drawings
Fig. 1 is low-sugar type intensified loquet distillate standard feature collection of illustrative plates.
Specific embodiment
In order that technological means, creation characteristic, reached purpose and effect that the present invention is realized are easy to understand, tie below
Specific embodiment is closed, the present invention, but following embodiments only the preferred embodiments of the present invention are expanded on further, and it is not all.
Based on the embodiment in implementation method, those skilled in the art obtain other realities on the premise of creative work is not made
Example is applied, protection scope of the present invention is belonged to.
Embodiment 1：The foundation of low-sugar type intensified loquet distillate characteristic spectrum
1st, instrument and reagent
1.1 instruments
Shimadzu high performance liquid chromatograph and Shimadzu LCsolution work stations.
1.2 reagents
Morphine reference substance is provided by Nat'l Pharmaceutical ＆ Biological Products Control Institute；Acetonitrile is chromatographically pure, sodium heptanesulfonate, di(2-ethylhexyl)phosphate
Hydrogen potassium is pure for analysis；Low-sugar type intensified loquet distillate by Hefei Jinyue Pharmaceutical Co., Ltd. provide, lot number be 150301,150302,
150303、151201、151202、151203、151204、160101、160102、160103。
2nd, method and result
2.1 chromatographic conditions and system suitability
Be filler with octadecylsilane chemically bonded silica, with acetonitrile -0.01mol/L heptane sulfonic acid sodium salts with
The equivalent mixed liquor (adjusting pH value to 2.8 with 10% phosphoric acid solution) (13: 87) of 0.02mol/L potassium dihydrogen phosphates is flowing
Phase；Detection wavelength 300nm, number of theoretical plate is calculated by morphine and is not less than 2000.
3rd, the measure of characteristic spectrum characteristic peak
The foundation of 3.1 low-sugar type intensified loquet distillate characteristic spectrum characteristic peaks
(1) preparation of need testing solution：Precision pipettes this product 5ml, in putting 25ml measuring bottles, plus 20% first containing 5% acetic acid
Alcohol is diluted to scale, shakes up, filtration, subsequent filtrate is taken, as need testing solution.
(2) preparation of reference solution：Take morphine reference substance appropriate, it is accurately weighed, in putting brown measuring bottle, plus containing 5% vinegar
20% methyl alcohol of acid is made solution of every 1ml containing 20 μ g, used as reference solution.
It is accurate respectively to draw reference solution and each 20 μ l of need testing solution, liquid chromatograph is injected separately into, according to liquid phase color
Spectrometry is determined, and is obtained final product.With the chromatographic peak retention time 1 of object of reference, relative retention time, No. 5 peak areas of chromatographic peak, meter are calculated
Other peak-to-peak area ratios are calculated, low-sugar type intensified loquet distillate standard feature collection of illustrative plates is obtained final product.
3.2 characteristic peaks determine
By 10 batches of measure of low-sugar type intensified loquet distillate characteristic spectrum, compare its collection of illustrative plates, determine characteristic peak for 6, with
The chromatographic peak retention time 1 of object of reference, calculates relative retention time, and No. 5 peak areas of chromatographic peak calculate other peak peak area ratios
Value, 10 batches of samples of statistics total peak relative retention time and relative peak area.Result see the table below 1, table 2.
Table 1：10 batches of sample retention time statisticses
Table 2：10 batches of sample peak area ratio statisticses
The description of 3.3 characteristic peaks
(1) characteristic peak has 6, wherein No. 5 peak-to-peak areas are maximum.
The average value of (2) 1,2,3,4,5, No. 6 relative retention times at peak is respectively：1.24、1.60、1.77、1.95、
2.14、2.50。
The average value of (3) 1,2,3,4,5, No. 6 peak area ratios at peak is respectively：0.34、0.19、0.22、0.72、1、
0.30。
3.4 character collection of illustrative plates precision tests
Operated according to characteristic spectrum precision prescriptive procedure, be for examination with the low-sugar type intensified loquet distillate that lot number is 150301
Product, prepare in accordance with the law, continuous sample introduction 6 times, and common characteristic peak time and peak area ratio are counted respectively, have peak relative
The RSD of retention time is respectively：0.44%th, 0.57%, 0.44%, 0.79%, 0.89%, 0.91%, the RSD of peak area ratio
Respectively：0.71%th, 0.80%, 0.99%, 0.73% ,/, 0.85%.
3.5 characteristic spectrum stability tests
Operated according to characteristic spectrum 4stability determination, the low-sugar type intensified loquet distillate with lot number 150301 is for examination
Product, prepare in accordance with the law, in different time (0,2,4,8,16,24h) detection, feature peak time and peak area ratio are carried out respectively
Statistics, the RSD of characteristic peak relative retention time is respectively：0.52%th, 0.45%, 0.61%, 0.70%, 0.53%, 0.42%,
The RSD of peak area ratio is respectively：0.65%th, 0.49%, 0.52%, 0.52% ,/, 0.42%.
3.6 character collection of illustrative plates replica tests
Operated according to characteristic spectrum repeatability prescriptive procedure, be for examination with the low-sugar type intensified loquet distillate that lot number is 150301
Product, prepare 6 parts of samples in accordance with the law, and sample detection is counted to common characteristic peak time and peak area ratio respectively, have peak
The RSD of relative retention time is respectively：0.87%th, 0.56%, 0.78%, 0.52%, 0.75%, 0.87%, peak area ratio
RSD be respectively：0.59%th, 0.49%, 0.62%, 0.72% ,/, 0.79%.
Above result of the test shows that adopting said method is measured method to low-sugar type intensified loquet distillate standard feature collection of illustrative plates
It is reliable, can be than the chemical information in more comprehensively reflection this product, it is ensured that accuracy and correctness that product feeds intake.
General principle of the invention, principal character and advantages of the present invention has been shown and described above.The technology of the industry
It should be appreciated that the present invention is not limited to the above embodiments, described in above-described embodiment and specification is only the present invention to personnel
Preference, be not intended to limit the present invention, without departing from the spirit and scope of the present invention, the present invention also have it is various
Changes and improvements, these changes and improvements all fall within the protetion scope of the claimed invention.The claimed scope of the invention is by institute
Attached claims and its equivalent thereof.
Claims (1)
1. a kind of fingerprint atlas detection method of low-sugar type intensified loquet distillate, it is characterised in that comprise the following steps：
The first step, sets up ingredient standard characteristic spectrum in low-sugar type intensified loquet distillate, and method is as follows：
(1) preparation of need testing solution：Precision pipettes this product 5ml, and in putting 25ml measuring bottles, plus 20% methyl alcohol containing 5% acetic acid is dilute
Release to scale, shake up, filter, subsequent filtrate is taken, as need testing solution；
(2) preparation of reference solution：Take morphine reference substance appropriate, it is accurately weighed, in putting brown measuring bottle, plus containing 5% acetic acid
20% methyl alcohol is made solution of every 1ml containing 20 μ g, used as reference solution；
(3) chromatographic condition：It is filler with octadecylsilane chemically bonded silica, with acetonitrile -0.01mol/L heptane sulfonic acid sodium salts
It is mobile phase with the equivalent mixed liquor of 0.02mol/L potassium dihydrogen phosphates, and pH value to 2.8 is adjusted with 10% phosphoric acid solution；
Detection wavelength 300nm, number of theoretical plate is calculated by morphine and is not less than 2000；
(4) determine：It is accurate respectively to draw reference solution and the μ l of need testing solution 20, liquid chromatograph is injected, use liquid chromatogram
Method is determined, and formulates low-sugar type intensified loquet distillate characteristic spectrum；
In the low-sugar type intensified loquet distillate characteristic spectrum, it is defined as 6 characteristic peaks, with the chromatographic peak (S) of object of reference morphine
Relative retention time is 1, first determines the relative retention time of its Characteristic chromatographic peak, and above-mentioned 6 characteristic peaks are respectively：No. 1 peak
Average relative retention time RRT is that 1.24, No. 2 average relative retention time RRT at peak retain for 1.60, No. 3 peaks are averagely relative
Time RRT is that 1.77, No. 4 average relative retention time RRT in peak are that 1.95, No. 5 average relative retention time RRT in peak are 2.14,6
Number average relative retention time RRT in peak is 2.50, No. 1 peak, No. 2 peaks, No. 3 peaks, No. 4 peaks, No. 5 peaks, the relative guarantor at No. 6 peaks
The difference of time is stayed to be respectively less than 10%；
It is 1 with No. 5 peak-to-peak areas, determines 6 relative peak areas of Characteristic chromatographic peak：No. 1 average relative peak area 0.34 at peak,
No. 2 average relative peak areas at peak are for 0.19, No. 3 average relative peak areas in peak for 0.22, No. 4 average relative peak areas in peak are
0.72, No. 5 average relative peak area in peak is that 1, No. 6 average relative peak areas in peak are 0.30, No. 1 peak, No. 2 peaks, No. 3 peaks, 4
Number peak, No. 5 peaks, the difference of the relative peak area at No. 6 peaks are respectively less than 10%；
Second step, low-sugar type intensified loquet distillate sample characteristic collection of illustrative plates to be measured is determined in above-mentioned identical method；
3rd step, by low-sugar type intensified loquet distillate sample characteristic collection of illustrative plates to be measured and the low-sugar type intensified loquet distillate characteristic spectrum of standard
Compare, judge the quality and the true and false of low-sugar type intensified loquet distillate to be measured.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110361459A (en) * | 2019-05-20 | 2019-10-22 | 国药集团德众（佛山）药业有限公司 | The method for building up of loguat leaf standard decoction finger-print |
| CN111007169A (en) * | 2019-12-12 | 2020-04-14 | 哈尔滨市康隆药业有限责任公司 | Construction method and quality evaluation method of fingerprint of strong loquat syrup |
| CN111505191A (en) * | 2020-05-26 | 2020-08-07 | 哈尔滨市康隆药业有限责任公司 | Fingerprint detection method of low-sugar strong loquat syrup based on high performance liquid chromatography |
| CN113009040A (en) * | 2021-03-15 | 2021-06-22 | 玉林市食品药品检验检测中心 | Detection method of fingerprint of strong loquat syrup and fingerprint thereof |
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| CN102854281A (en) * | 2012-08-29 | 2013-01-02 | 哈尔滨市康隆药业有限责任公司 | Detection method of sugar-free strong loquat syrup |
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| CN105372350A (en) * | 2015-12-07 | 2016-03-02 | 合肥今越制药有限公司 | Fingerprint spectrum control method of low-sugar strong loquat syrup |
| CN105606752A (en) * | 2016-01-22 | 2016-05-25 | 哈尔滨市康隆药业有限责任公司 | Detection method of fingerprint spectrums of sugar-free strong pipa syrup |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110361459A (en) * | 2019-05-20 | 2019-10-22 | 国药集团德众（佛山）药业有限公司 | The method for building up of loguat leaf standard decoction finger-print |
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| CN111505191A (en) * | 2020-05-26 | 2020-08-07 | 哈尔滨市康隆药业有限责任公司 | Fingerprint detection method of low-sugar strong loquat syrup based on high performance liquid chromatography |
| CN113009040A (en) * | 2021-03-15 | 2021-06-22 | 玉林市食品药品检验检测中心 | Detection method of fingerprint of strong loquat syrup and fingerprint thereof |
| CN113009040B (en) * | 2021-03-15 | 2022-10-04 | 玉林市食品药品检验检测中心 | Detection method of fingerprint of strong loquat syrup and fingerprint thereof |
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Application publication date: 20170531 |