CN106918670B - A kind of quality determining method of pharmaceutical composition - Google Patents
A kind of quality determining method of pharmaceutical composition Download PDFInfo
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- CN106918670B CN106918670B CN201510992366.6A CN201510992366A CN106918670B CN 106918670 B CN106918670 B CN 106918670B CN 201510992366 A CN201510992366 A CN 201510992366A CN 106918670 B CN106918670 B CN 106918670B
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- G—PHYSICS
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- 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
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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
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Abstract
The present invention provides a kind of quality determining methods of pharmaceutical composition, it is accurately qualitative and quantitative that the pharmaceutical composition quality determining method of the present invention only needs about 30min that can be carried out to 8 kinds of index ingredients in test solution, 8 kinds of ingredients contain the three classes main active in two taste medicinal material of wilsonii and Herba Hyperici Monogyni simultaneously, the inherent quality feature that can more comprehensively and truly reflect pharmaceutical composition is suitble to be commercially used for the quality control of pharmaceutical composition.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of quality determining method of pharmaceutical composition.
Background technology
Herba Hyperici Monogyni (Hypericum perfouatum L.) also known as hypericum perforatum, St. john's wort (St.John ' s
Wort), it is Guttiferae hypericum, research in recent years is found, Herba Hyperici Monogyni has an antidepressant effect, and significant in efficacy,
Small side effects, thus paid close attention to by more and more people.Chemical composition is sufficiently complex in extract of hypericum perforatum, main point
For naphthalene a pair of horses going side by side dianthrone class such as hypericin, pseudohypericin etc., phloroglucinol derivatives such as hyperforine, adhyperforin
Deng flavonoids is such as：[Herba Hyperici Monogyni active constituent and its separation such as Hyperoside, rutin, Quercetin, quercitin, isoquercitrin
The progress of purifying and detection method, pharmacy progress, 2007,32 (1)], wherein flavonoids chemicals are considered as passing through Ye Jin
The antidepressant main active of silk peach [verify, and Central China science and technology is big by the virtual screening machine pharmacology of hypericum perforatum moderate resistance depressive component
Learn Master's thesis, Yin Rui, 2009].
Wilsonii is the dry root and rhizome or stem of Araliaceae wilsonii, have replenish qi to invigorate the spleen, tonify the kidney to relieve mental strain, strengthening the essence
The effect of zhuanggu.Modern research shows that the main component of Radix Acanthopanacis Senticosi root and rhizome be glucoside compound, as eleutheroside A, B,
C, D, E [progress of wilsonii, territory are studied with natural resources, Li Lihui etc., 2008].Version in 2010《Chinese Pharmacopoeia》In
Provide that the content of Syringin (Syringin) in wilsonii medicinal material must not be less than 0.050%, European Pharmacopoeia (European
Pharmacopoeia 7.0) in regulation wilsonii medicinal material in the total amount of Syringin and E must not be less than 0.08%, it is seen that thorn five
It is highly important index ingredient to add glycosides B and E.
It is raw material that capsule for reliving liver and reliving upset, which is by Herba Hyperici Monogyni and wilsonii, in being prepared using modern pharmaceutical technique
Patent medicine has effects that soothing liver-qi stagnation, spleen-benefiting mind-tranquilizing, clinic are usually used in light, moderate depressive patients category syndrome of stagnation of liver qi and spleen deficiency person symptoms include feelings
Thread is low, sluggishness, difficulty falling asleep, early awakening, dreaminess, nervous, being irritable and getting angry easily, indigestion and loss of appetite, uncomfortable in chest, the tired nothing of deficiency of food under interest
Power, hidrosis, pain, tongue fur are white or greasy, veins string or thin.Since capsule for reliving liver and reliving upset contains Herba Hyperici Monogyni and wilsonii simultaneously
A variety of chemical compositions of two kinds of medicinal materials, including：Hyperoside, rutin, Quercetin, quercitin, isoquercitrin, eleutheroside E, purple
Syringin and isofraxidin etc., these chemical compositions relate separately to three kinds of flavonoids, glucosides and Coumarins class different chemistry
Structure, physicochemical property are had nothing in common with each other, and are usually interfered with each other in qualitative and quantitative detection, are brought to the quality control of prescribed preparation
Great difficulty.
Detection method disclosed in the prior art is normally only to certain a kind of chemical composition in Herba Hyperici Monogyni or wilsonii
Quality control is carried out, and cannot be used for the separation detection of a variety of constituents.Such as：[HPLC measures Herba Hyperici Monogyni to Li Ping et al.
The content of middle flavones, Li Ping etc., Acta Pharmaceutica Sinica, 2002] use acetonitrile-phosphate aqueous solution for mobile phase, gradient elution, flow velocity
1.0ml/min, Detection wavelength 254nm, for flavones ingredient in detecting 4 in Herba Hyperici Monogyni, (rutin, Hyperoside, pivots store
Glycosides, Quercetin) detection, applicant by this method for Hyperoside, rutin, Quercetin, quercitin, isoquercitrin, thorn five
It is found under above-mentioned chromatographic condition when being measured while adding glycosides E, Syringin and isofraxidin, Syringin and isoquercitrin
Separating degree is respectively 0.8 and 1.47, undesirable, and Quercetin baseline big rise and fall nearby, can not carry out accurate quantitative analysis；
[HPLC methods measure eleutheroside E content in Radix Et Caulis Acanthopanacis Senticosi total glucosides general flavone soft capsule, Wei Shumei etc., Heilungkiang doctor to refined plum of Wei et al.
Medicine, 2011] it establishes with -0.1% glacial acetic acid (14 of acetonitrile:86) it is mobile phase, flow velocity 1.0ml/min, Detection wavelength 210nm's
HPLC methods, for the assay of eleutheroside E in Radix Et Caulis Acanthopanacis Senticosi total glucosides general flavone soft capsule, but this method is used for above-mentioned 8 kinds
When being measured while chemical composition, Syringin separating degree only 1.2, and baseline fluctuation nearby is larger, flavones ingredient responds too
It is low, and Quercetin appearance is had no in 75min.As it can be seen that the detection method of single kind chemical composition can not disclosed in the prior art
Meet qualitative while multiple types chemical composition in capsule for reliving liver and reliving upset and quantitative.In order to more comprehensively, more effectively relax
The quality control of the strongly fragrant capsule of liver solution, it is necessary to quick, simplicity, accurately and reliably an analysis method are established, for liver solution of relaxing
Qualitative and quantitative analysis while many indexes ingredient in strongly fragrant capsule.
Invention content
The purpose of the present invention is to provide a kind of quick, simplicity, accurately and reliably analysis methods, are carried for Herba Hyperici Monogyni
Qualitative and quantitative analysis while taking many indexes ingredient in the mixed extract of object, siberian Ginseng P.E or the two.
The present invention provides a kind of quality determining method of pharmaceutical composition, is filling with octadecylsilane chemically bonded silica
Agent, mobile phase A are acetonitrile, and Mobile phase B is 0.002% acetic acid aqueous solution, carries out gradient elution；Wherein in described pharmaceutical composition
Active constituent be extract of hypericum perforatum, siberian Ginseng P.E or the two mixture.
In the detection method, Detection wavelength 207nm, 255nm, 265nm and 340nm；
The condition of gradient elution is：
0-30min, mobile phase A 10%-35%, Mobile phase B 90%-65%
30-50min, mobile phase A 35%-60%, Mobile phase B 65%-40%
50-51min, mobile phase A 60%-10%, Mobile phase B 40%-90%；
In detection method, column temperature be 30-40 DEG C can be achieved preferable separation detection effect, preferably 40 DEG C；
Flow velocity is 1ml/min；Sampling volume is 5 μ l；
The preparation method of test solution is in detection method：Take pharmaceutical composition appropriate, it is accurately weighed, with one
First alcohol is Extraction solvent, is heated to reflux or ultrasonic extraction, lets cool, shakes up, and is filtered, take subsequent filtrate to get；The wherein described monohydric alcohol
Selected from methanol or ethyl alcohol, preferably methanol；
The present invention provides a kind of quality determining method of pharmaceutical composition, includes the following steps and condition：
The preparation of test solution：Accurately weighed pharmaceutical composition 0.3g, is placed in 50ml measuring bottles, and 40ml methanol is added,
Be ultrasonically treated 30 minutes, let cool, with methanol dilution and be settled to scale, shake up, filter, take subsequent filtrate to get；
Chromatographic condition：Chromatographic column is Agilent Eclipse Plus C18 chromatographic columns, and mobile phase A is acetonitrile, Mobile phase B
For 0.002% acetic acid aqueous solution, 40 DEG C, Detection wavelength 207nm, 255nm, 265nm and 340nm of column temperature, condition of gradient elution
For：
0-30min, mobile phase A 10%-35%, Mobile phase B 90%-65%
30-50min, mobile phase A 35%-60%, Mobile phase B 65%-40%
50-51min, mobile phase A 60%-10%, Mobile phase B 40%-90%；
It measures：Take 5 μ l of solution to be measured, inject liquid chromatograph, by above-mentioned chromatographic condition measurement to get.
The pharmaceutical composition quality determining method of the present invention only needs about 30min can be to 8 kinds of indexs in test solution
Property ingredient carry out accurately qualitative and quantitative, which contains simultaneously in two taste medicinal material of wilsonii and Herba Hyperici Monogyni
Three classes main active (flavonoids, glycoside, Coumarins), can more comprehensively and truly reflect the inherence of pharmaceutical composition
Qualitative character.The pharmaceutical composition quality determining method good separating effect of the present invention, baseline is steady, has reproducible, stabilization
Property good, quick, accurate, high sensitivity the advantages that, be suitble to industrial application.
Description of the drawings
Fig. 1 contrast solutions chromatogram (207nm)
Fig. 2 contrast solutions chromatogram (265nm)
Fig. 3 contrast solutions chromatogram (255nm)
Fig. 4 contrast solutions chromatogram (340nm)
Fig. 5 mixed extracts chromatogram (207nm)
Fig. 6 mixed extracts chromatogram (255nm)
Fig. 7 mixed extracts chromatogram (265nm)
Fig. 8 mixed extracts chromatogram (340nm)
1 chromatogram of Fig. 9 embodiments
3 chromatogram of Figure 10 embodiments
Wherein a is eleutheroside E, and b is Syringin, and c is rutin, and d is Hyperoside, and e is isoquercitrin, and f is quercitrin
Glycosides, g are Quercetin, and h is isofraxidin, and i is Interference Peaks.
Specific implementation mode
1, laboratory apparatus and material
Syringin reference substance (Nat'l Pharmaceutical ＆ Biological Products Control Institute's batch：111574-200603), eleutheroside E pair
According to product (Nat'l Pharmaceutical ＆ Biological Products Control Institute's batch：111713-200502), control substance of Rutin (Chinese pharmaceutical biological product inspection
Determine institute's batch：10080-200707), Hyperoside reference substance (Nat'l Pharmaceutical ＆ Biological Products Control Institute's batch：111521-
201004), isofraxidin reference substance (Nat'l Pharmaceutical ＆ Biological Products Control Institute's batch：110837-201005), quercitin reference substance
(Nat'l Pharmaceutical ＆ Biological Products Control Institute's batch：111538-200504), Quercetin reference substance (Chinese pharmaceutical biological product calibrating
Institute's batch：100081-200907), isoquercitrin reference substance (Nat'l Pharmaceutical ＆ Biological Products Control Institute's batch：111809-
201102), acetonitrile (chromatographically pure, Honeywell, batch：DK364), other reagents are that analysis is pure；High performance liquid chromatograph (island
Tianjin LC-210c)；Chromatographic column：Agilent Eclipse Plus C18,5 μm of 4.6*250mm.
Extract of hypericum perforatum：Herba Hyperici Monogyni (is provided) by Chengdu Kanghong Pharmaceutical Co., Ltd, and 70% ethyl alcohol is added to return
Stream extraction is secondary, 1 hour every time, merges extracting solution, filtration, and filtrate decompression is concentrated into the leaching that relative density is about 1.10 (70 DEG C)
Cream, spray drying to get.
Siberian Ginseng P.E：Wilsonii (is provided) by Chengdu Kanghong Pharmaceutical Co., Ltd, is added water to cook three times, and 2 is small every time
When, collecting decoction, filtration, filtrate be concentrated into relative density be 1.18 (70 DEG C) medicinal extract, spray drying to get.
Mixed extract：Extract of hypericum perforatum and siberian Ginseng P.E and appropriate amount of auxiliary materials are taken, ratio on demand is mixed
Close uniformly to get.
2, the preparation of test solution
Accurately weighed pharmaceutical composition 0.3g, sets in 50ml measuring bottles, and 40ml methanol is added, and is ultrasonically treated 30 minutes, lets cool,
With methanol dilution and be settled to scale, shake up, filter, take subsequent filtrate to get.
3, the preparation of reference substance solution
Accurately weighed Syringin, eleutheroside E, isofraxidin, Hyperoside, rutin, isoquercitrin, quercitin, Mongolian oak
Skin element reference substance is appropriate, adds methanol that every lml is made containing 8 μ g of Syringin, 6 μ g of eleutheroside E, 2 μ g of isofraxidin, 65 μ of rutin
G, 50 μ g of Hyperoside, 40 μ g of isoquercitrin, 15 μ g of quercitin, 40 μ g of Quercetin mixed solution to get.
4, measuring method
Precision draws mixing contrast solution and each 5 μ l of test solution inject liquid chromatograph, peak area is recorded, with external standard
Method calculates the content of each index components.
Influence of 1 Detection wavelength of embodiment to testing result
Using octadecylsilane chemically bonded silica as filler (Agilent Eclipse Plus C18,5 μm of 4.6*
250mm)；Using acetonitrile as mobile phase A, 0.002% acetic acid solution is Mobile phase B, is eluted by following condition of gradient elution：
0-30min, mobile phase A 10%-35%, Mobile phase B 90%-65%
30-50min, mobile phase A 35%-60%, Mobile phase B 65%-40%
50-51min, mobile phase A 60%-10%, mobile phase 40%-90%；
Flow velocity 1.0ml/min；Column temperature:40℃；
Reference substance solution and each 5 μ l injections liquid chromatograph of mixed extract test solution are taken, to each index components color
Spectral peak carries out spectrum analysis, the results showed that：The a length of 207nm of eleutheroside E maximum absorption wave, Syringin maximum absorption wave are a length of
220nm, flavones ingredient (rutin, Hyperoside, isoquercitrin, quercitin, Quercetin) maximum absorption wave a length of 203nm, it is different
The a length of 205nm of piperazine skin pyridine maximum absorption wave；However, under the conditions of these maximum wavelengths, the testing result of pharmaceutical composition is but simultaneously
It is undesirable, such as：Under 220nm or 203nm wavelength, sample baseline is unstable, and fluctuation is larger, under 205nm wavelength, different piperazine skin
There is apparent impurity interference (attached drawing 9) at pyridine chromatographic peak.Inventor pass through a large amount of experimental study, finally found that 207nm,
Under 255nm, 265nm and 340nm wavelength condition, 8 index components separation in pharmaceutical composition is good, and baseline is steady, nothing
It significantly interferes with, can be used for the qualitative and quantitative analysis of 8 ingredients.
Influence of 2 elution requirement of embodiment to testing result
Using octadecylsilane chemically bonded silica as filler (Agilent Eclipse Plus C18,5 μm of 4.6*
250mm)；Using acetonitrile as mobile phase A, water is Mobile phase B, flow velocity 1ml/min, Detection wavelength 270nm and 340nm, 50 DEG C of column temperature,
Mixed extract test solution sample detection is taken, different condition of gradient elution are investigated, the results are shown in Table 1：
Influence of 1 condition of gradient elution of table to testing result
Influence of 3 acetic acid concentration of embodiment to testing result
Using octadecylsilane chemically bonded silica as filler (Agilent Eclipse Plus C185 μm 4.6*250mm)；
Using acetonitrile as mobile phase A, various concentration acetic acid aqueous solution be Mobile phase B, flow velocity 1ml/min, Detection wavelength 207nm, 255nm,
265nm and 340nm takes 5 μ l of mixed extract test solution sample introduction, gradient as follows：
0-30min, mobile phase A 10%-35%, Mobile phase B 90%-65%
30-50min, mobile phase A 35%-60%, Mobile phase B 65%-40%
50-51min, mobile phase A 60%-10%, Mobile phase B 40%-90%；
As a result such as the following table 2：
Influence of 2 acetic acid concentration of table to testing result
According to 2 result of table it is found that when Mobile phase B is pure water solution, 8 index components can meet preferable separating effect,
But Quercetin will produce apparent trailing phenomenon after sample introduction is repeated several times, and so that its rate of recovery is exceeded critical field, can not carry out standard
True quantifies；Inventor has found that 0.002% acetic acid aqueous solution can be preferable after having investigated the acetic acid aqueous solution of various concentration
It solves the above problems, therefore selects 0.002% acetic acid aqueous solution for Mobile phase B.
4 sample detection of embodiment
Using octadecylsilane chemically bonded silica as filler (Agilent Eclipse Plus C18,5 μm of 4.6*
250mm)；Using acetonitrile as mobile phase A, 0.002% acetic acid solution is Mobile phase B, is eluted by following condition of gradient elution：
0-30min, mobile phase A 10%-35%, Mobile phase B 90%-65%
30-50min, mobile phase A 35%-60%, Mobile phase B 65%-40%
50-51min, mobile phase A 60%-10%, Mobile phase B 40%-90%；
Flow velocity 1.0ml/min；Column temperature:40℃；Detection wavelength is 207nm, 255nm, 265nm, 340nm.
It is accurate respectively to draw reference substance solution and each 5 μ l of pharmaceutical composition test solution, liquid chromatograph is injected, according to
Aforementioned chromatographic condition carries out content detection to many indexes ingredient such as Hyperoside in pharmaceutical composition, the results are shown in Table 3.
Multiple key coastituents testing result in 3 pharmaceutical composition of table
Detection method can in 30min in pharmaceutical composition Syringin, eleutheroside E, isofraxidin,
Hyperoside, rutin, Quercetin, quercitin and different dry measure used in former times skin glycosides isoreactivity ingredient carry out qualitative and quantitative, each target component chromatography
Peak separator well, nothing significantly interfere with (mixed extract detection chromatogram is shown in Fig. 1-8).
5 accuracy of embodiment is tested
Using octadecylsilane chemically bonded silica as filler (Agilent Eclipse Plus C18,5 μm of 4.6*
250mm)；Using acetonitrile as mobile phase A, 0.002% acetic acid solution is Mobile phase B, is eluted by following condition of gradient elution：
0-30min, mobile phase A 10%-35%, Mobile phase B 90%-65%
30-50min, mobile phase A 35%-60%, Mobile phase B 65%-40%
50-51min, mobile phase A 60%-10%, Mobile phase B 40%-90%；
Flow velocity 1.0ml/min；Column temperature:40℃；Detection wavelength is 207nm, 255nm, 265nm, 340nm.
In the mixed extract 0.15g to 50ml measuring bottles for taking known each index components content, accurately weighed 6 parts, add respectively
Enter to mix contrast solution 25ml, it is 40ml to add methanol to liquor capacity, from " supersound process ", is prepared by test sample preparation method
It is loaded test solution, is operated by test sample assay method, measures and calculate the rate of recovery of each index components, test result is shown in Table 4.
Result is investigated in 4 accuracy of table
*：With reference to version in 2015《9101 drug standard analysis method verification guide of the 4th general rule of Chinese Pharmacopoeia is former
Then》
4 result of table illustrates that the rate of recovery of each ingredient and rate of recovery RSD meet in detection method《Chinese Pharmacopoeia》
Related request, illustrate that this method accuracy is good.
6 repeated experiment of embodiment
Using octadecylsilane chemically bonded silica as filler (Agilent Eclipse Plus C18,5 μm of 4.6*
250mm)；Using acetonitrile as mobile phase A, 0.002% acetic acid solution is Mobile phase B, is eluted by following condition of gradient elution：
0-30min, mobile phase A 10%-35%, Mobile phase B 90%-65%
30-50min, mobile phase A 35%-60%, Mobile phase B 65%-40%
50-51min, mobile phase A 60%-10%, mobile phase 40%-90%；
Flow velocity 1.0ml/min；Column temperature:40℃；Detection wavelength is 207nm, 255nm, 265nm, 340nm.
It takes mixed extract appropriate, 6 parts of test liquid is prepared by test solution preparation method is parallel, by aforementioned chromatographic condition
Measure the content of each index components.The content difference for calculating identical component in each part test solution, the results are shown in Table 5.
5 repeatability of table investigates result
*：With reference to version in 2015《9101 drug standard analysis method verification guide of the 4th general rule of Chinese Pharmacopoeia is former
Then》
5 result of table illustrates that the repeatability of each ingredient meets in detection method《Chinese Pharmacopoeia》Related request,
Further illustrate that this method is accurate and reliable, it is reproducible.
7 stability experiment of embodiment
Using octadecylsilane chemically bonded silica as filler (Agilent Eclipse Plus C18,5 μm of 4.6*
250mm)；Using acetonitrile as mobile phase A, 0.002% acetic acid solution is Mobile phase B, is eluted by following condition of gradient elution：
0-30min, mobile phase A 10%-35%, Mobile phase B 90%-65%
30-50min, mobile phase A 35%-60%, Mobile phase B 65%-40%
50-51min, mobile phase A 60%-10%, Mobile phase B 40%-90%；
Flow velocity 1.0ml/min；Column temperature:40℃；Detection wavelength is 207nm, 255nm, 265nm, 340nm.
Take mixed extract appropriate, by legal system available test sample solution below test sample preparation method item, respectively at 0,2,4,
9,13,19,28h takes 5 μ l injection liquid chromatographs, records each index components peak area, calculates the change of each index components peak area
Change, the results are shown in Table 6.
6 study on the stability result of table
Table 6 the result shows that, each index components peak area RSD is respectively less than 5% in 28h, illustrate in test solution 28h stablize
Property is good.
Claims (9)
1. a kind of quality determining method of pharmaceutical composition, it is characterised in that using octadecylsilane chemically bonded silica as filler,
Mobile phase A is acetonitrile, and Mobile phase B is 0.002% acetic acid aqueous solution, carries out gradient elution, Detection wavelength 207nm, 255nm,
265nm and 340nm；Wherein, active constituent is extract of hypericum perforatum and siberian Ginseng P.E in described pharmaceutical composition
Mixture, the condition of gradient elution are：0-30min, mobile phase A 10%-35%, Mobile phase B 90%-65%；30-
50min, mobile phase A 35%-60%, Mobile phase B 65%-40%；50-51min, mobile phase A 60%-10%, Mobile phase B
40%-90%；The target component detected in the detection method includes：Hyperoside, rutin, Quercetin, quercitin, isoquercitrin
Glycosides, eleutheroside E, Syringin and Isofraxidin.
2. detection method according to claim 1, it is characterised in that column temperature is 30-40 DEG C in the detection method.
3. detection method according to claim 2, it is characterised in that column temperature is 40 DEG C in the detection method.
4. detection method according to claim 1, it is characterised in that flow velocity is 1ml/min in the detection method.
5. detection method according to claim 1, it is characterised in that sampling volume is 5 μ l in the detection method.
6. detection method according to any one of claims 1-5, it is characterised in that test solution in detection method
Preparation method is：Take pharmaceutical composition appropriate, it is accurately weighed, it using monohydric alcohol as Extraction solvent, is heated to reflux or ultrasonic extraction, puts
It is cold, shake up, filter, take subsequent filtrate to get.
7. detection method according to claim 6, it is characterised in that the monohydric alcohol is selected from methanol or ethyl alcohol.
8. detection method according to claim 7, it is characterised in that the monohydric alcohol is selected from methanol.
9. a kind of quality determining method of pharmaceutical composition, including following condition and step：The preparation of test solution：Precision claims
Determine pharmaceutical composition 0.3g, be placed in 50ml measuring bottles, 40ml methanol is added, is ultrasonically treated 30 minutes, lets cool, simultaneously with methanol dilution
It is settled to scale, shakes up, filter, take subsequent filtrate to obtain the final product；Chromatographic condition：Chromatographic column is Agilent Eclipse Plus C18 colors
Column is composed, mobile phase A is acetonitrile, and Mobile phase B is 0.002% acetic acid aqueous solution, 40 DEG C of column temperature, Detection wavelength 207nm, 255nm,
265nm and 340nm, condition of gradient elution are：0-30min, mobile phase A 10%-35%, Mobile phase B 90%-65%；30-
50min, mobile phase A 35%-60%, Mobile phase B 65%-40%；50-51min, mobile phase A 60%-10%, Mobile phase B
40%-90%；It measures：It takes 5 μ l of solution to be measured, injects liquid chromatograph, measure to obtain the final product；
Active constituent is siberian Ginseng P.E and the mixture of extract of hypericum perforatum, institute wherein in described pharmaceutical composition
Stating the target component detected in detection method includes：Hyperoside, rutin, Quercetin, quercitin, isoquercitrin, eleutheroside
E, Syringin and Isofraxidin.
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Effective date of registration: 20201112 Address after: Pengzhou City, Chengdu City, Sichuan province 611930 days Peng Zhen Hua Long Road No. 89 Patentee after: Sichuan Jishengtang Pharmaceutical Co.,Ltd. Address before: 610036 Jinniu District, Sichuan, Sichuan West Road, No. 36, No. Patentee before: CHENGDU KANGHONG PHARMACEUTICAL GROUP Co.,Ltd. |