CN106913516B - A kind of Pudilan syrup and its production and use - Google Patents
A kind of Pudilan syrup and its production and use Download PDFInfo
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- CN106913516B CN106913516B CN201710140800.7A CN201710140800A CN106913516B CN 106913516 B CN106913516 B CN 106913516B CN 201710140800 A CN201710140800 A CN 201710140800A CN 106913516 B CN106913516 B CN 106913516B
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- syrup
- pudilan
- extract
- content
- extraction
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- UXYJCYXWJGAKQY-UHFFFAOYSA-N stylopine Chemical compound C1C2=C3OCOC3=CC=C2CC2N1CCC1=C2C=C(OCO2)C2=C1 UXYJCYXWJGAKQY-UHFFFAOYSA-N 0.000 description 1
- 235000019408 sucralose Nutrition 0.000 description 1
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 description 1
- HUTYZQWCTWWXND-NCTFTGAASA-N taraxasterol Natural products C[C@H]1[C@H]2C3=CC[C@@H]4[C@@]5(C)CC[C@H](O)C(C)(C)[C@@H]5CC[C@@]4(C)[C@]3(C)C[C@H](O)[C@@]2(C)CCC1=C HUTYZQWCTWWXND-NCTFTGAASA-N 0.000 description 1
- GGGUGZHBAOMSFJ-GADYQYKKSA-N taraxerol Chemical compound CC([C@@H]1CC2)(C)[C@@H](O)CC[C@]1(C)[C@@H]1[C@]2(C)C2=CC[C@@]3(C)CCC(C)(C)C[C@H]3[C@]2(C)CC1 GGGUGZHBAOMSFJ-GADYQYKKSA-N 0.000 description 1
- HYTFUKZLSYXRDX-UHFFFAOYSA-N taraxerol Natural products CC1CCCC2C3(C)CCC4(C)C5CC(C)(C)CCC5(C)C=CC4(C)C3C(O)CC12C HYTFUKZLSYXRDX-UHFFFAOYSA-N 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- OUYCCCASQSFEME-UHFFFAOYSA-N tyrosine Natural products OC(=O)C(N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-UHFFFAOYSA-N 0.000 description 1
- 239000004474 valine Substances 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 229940045997 vitamin a Drugs 0.000 description 1
- VHBFFQKBGNRLFZ-UHFFFAOYSA-N vitamin p Natural products O1C2=CC=CC=C2C(=O)C=C1C1=CC=CC=C1 VHBFFQKBGNRLFZ-UHFFFAOYSA-N 0.000 description 1
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- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K36/539—Scutellaria (skullcap)
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K2236/30—Extraction of the material
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Abstract
The invention discloses a kind of Pudilan syrup and its production and use, belong to technical field of traditional Chinese medicine preparation.The syrup of the present invention after four kinds of dandelion, Radix Isatidis, corydlis bungeana and radix scutellariae extracted concentrations of Chinese herbal medicine by obtaining extract, it is prepared according to special process, the syrup form for being adapted to take is made, effectively masks adverse drug taste, solves medicine sensory issues.Present invention improves extracting mode, greatly shorten extraction time, the content of principle active component significantly improves, reduce medication dose, with clearing heat and detoxicating, anti-inflammation detumescence and other effects, and active constituent content is high, taking dose is small, for treating the diseases such as parotitis, pharyngitis, tonsillitis or furuncle.Pudilan syrup of the present invention, it is adapted to children taking.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine preparation, more specifically to a kind of Pudilan syrup and preparation method
And purposes.
Background technology
Pudilan is made up of dandelion, Radix Isatidis, Chinese violet, the taste Chinese medicine of radix scutellariae four, and effect is clearing heat and detoxicating, anti-inflammation detumescence.
Dandelion herb contains taraxasterol, choline, synanthrin, caffeic acid, pectin, taraxol, β-amyrin, beans steroid
Alcohol, cupreol, taraxerol, taraxacin, taraxacin and vitamin A, B, C etc..Wherein, dandelion it is effective into
Dividing includes caffeic acid and Cichoric acid.
Radix Isatidis contains indigo, indigo red, Anthraquinones, cupreol, clionasterol and several amino acids：Arginine, paddy
Propylhomoserin, tyrosine, proline, valine, γ-aminobutyric acid.Also contain potassium myronate, indigo, couroupitine A, 1- thiocyanic acid -2- hydroxyls
Base butyl- 3- alkene, table accuse Yichun, gland glucoside, palmitic acid, sucrose and the proteoglycan containing 12% amino acid.
Corydlis bungeana is the herb of bloodroot corydalis bungeana.Herb contains a variety of alkaloids：Racemization and dextrorotation purple Dong
Alcohol spirit alkali, acetylcorynoline, Tetrahydrocoptisine, Biflorine, dextrorotation isocorynoline, tetrahydrocorysamine,
Dihydrosanguinarine, acetylisocorynoline, 11- epicorynolines, corycavine, than the dry spirit of alkali, 12- hydroxyl corydalis alcohol
Clever alkali, scoulerine, broken leaf corydaline, big zizyphine, go the big zizyphine of first, isoboldine, dextrorotation Chinese violet corydaline, dextrorotation
13- epicorynolines.
Radix scutellariae mainly contains flavone compound：Scutelloside be radix scutellariae principle active component, molecular formula C21H18O11, point
Son amount is 446.35, is yellow crystal, 223 DEG C of fusing point or faint yellow needle (methanol).
Existing Pudilan sulfathiazole record in《People's Republic of China's drug standards Traditional Chinese medicine historical preparation the 3rd》, Pu Di
Blue oral liquid record in《Pharmacopoeia of People's Republic of China》2015 editions one.Particular advantages based on these four Chinese medicines, at present city
It is on face to have the formulations such as Pu bring down a fever piece, sulfathiazole, antiphlogistic capsule more, it is safe using rear Small side effects.Such as China is specially
The patent application document of sharp Application No. 2006100837064 discloses a kind of anti-inflammation drugs and preparation method thereof, with being related to Pu
Blue oral liquid and preparation method thereof；The patent application document that Chinese Patent Application No. is 2005101080080 discloses Pudilan
Pudilan antiphlogistic granules prepared by the preparation method and this method of antiphlogistic granules；Chinese Patent Application No. is 2015104294371
Patent application document disclose the preparation method of Pudilan sulfathiazole.
Commercially available Pudilan clinically uses, although curative for effect, curative effect plays slowly, with being primarily due to commercially available Pu
Active ingredient concentration in basket is low, and drug effect need further to improve.Although it can be improved by concentration in Pu bring down a fever piece
Active constituent content, but can equally increase impurity content therein, bring certain side effect.
《Chinese Pharmacopoeia》2015 editions the 4th regulations：Syrup means the dense aqueous sucrose solution containing material medicine.Syrup
Agent is in producing and storing：Amount containing sucrose should be not less than 45% (g/mL).
The content of the invention
1. to solve the problems, such as
The problem of low active ingredient, poor taste be present for existing Pudilan Chinese medicine, the present invention provides a kind of Pudilan
Syrup and its production and use, adverse drug smell is effectively covered, syrup form is made.Present invention improves extraction side
Formula, greatly shorten extraction time, the content of principle active component significantly improves, and reduces medication dose.By using rational work
Process extracts four traditional Chinese medicine thing, keeps and purify active constituents of medicine to greatest extent, is this so as to the stronger medicine of development efficacy
One of inventive concept.The present invention is in terms of active constituent content and curative effect of medication, more commercially available Pu bring down a fever piece, has excellent
Different effect.
2. technical scheme
In order to solve the above problems, the technical solution adopted in the present invention is as follows：
A kind of Pudilan syrup, including corydlis bungeana, Radix Isatidis, the extract of dandelion and radix scutellariae, in addition to sucrose, institute
The extract stated is by the parts by weight of corydlis bungeana 1~3, the parts by weight of Radix Isatidis 2~4, the parts by weight of dandelion 6~9 and the weight of radix scutellariae 2~4
Part is extracted to be concentrated to give；Then sucrose is added into extract, it is 45%~65% (g/mL) to make cane sugar content in syrup,
Active ingredient includes scutelloside in extract, and the content of scutelloside is more than 10mg/mL in syrup；Impurity content is no more than 7%.
Further, active ingredient also includes Cichoric acid and caffeic acid in extract, the content of Cichoric acid in syrup
More than 1mg/mL, caffeinic content is more than 0.1mg/mL.
Further, described impurity includes protein, tannin, pigment, protocatechuic acid, Quercetin, cyanidenon etc..
Further, in addition to aromatic and preservative, the mass content of aromatic is 0.2%~1%, preservative
Mass content is 0.01%~0.5%, and wherein aromatic includes almond flavour, strawberry essence, orange flavor, lychee flavor, apple
Fruity essence, milk flavour, mango essence, lemon extract, chocolate essence, the one or more in flavoring orange essence, preservative bag
Include the one or more in sorbic acid, potassium sorbate, dehydroactic acid sodium, sodium lactate, ethyl, sodium citrate.
Further, in addition to sweetener, mass content are 0.2%~25%, and sweetener adds for conventional edible
Add agent, including high sweetener and low power sweetener, high sweetener be Aspartame, steviol glycoside, acesulfame potassium, honey element,
One or more in Sucralose；Low power sweetener is sorbierite, xylitol, honey, fructose, maltose, starch sugar, breast
One or more in sugar, sucrose.
Salt, dextrin, maltodextrin, glycerine, one kind in CMC-Na or several can also be included in the syrup preparation of the present invention
Kind, content is 3%~10%.
A kind of preparation method of above-mentioned Pudilan syrup, comprises the following steps：
<1>Corydlis bungeana, Radix Isatidis and the extract of dandelion are prepared, is comprised the following steps：
<a>15~20 times of water boiling and extractions of dandelion and Radix Isatidis, extraction twice, each 1-2h, add gelatin 1-
5%, stand, filter to take supernatant；
<b>Corydlis bungeana is boiled twice with 15~20 times of decoctings, each 1-2h；
<c>By step<a>And step<b>Extract solution mixing, concentration, add chitosan to 0.1-2%, adjust PH to 1-
2, stand, filtering；
<2>The extract of scutellaria is prepared, is comprised the following steps：
<d>Radix scutellariae is extracted to obtain alcohol extracting thing with ethanol；
<e>Resulting alcohol extracting thing adds gelatin to 1-5%, filtering, filtrate and adds chitosan 0.1-2%, adjusts pH extremely
1-2, precipitate are Baical Skullcap root P.E, and described Baical Skullcap root P.E is scutelloside；
<3>Corydlis bungeana, Radix Isatidis and the extract of dandelion are mixed with the extract of scutellaria, are concentrated into proportion as 0.8
~1.3 (g/mL), adding sucrose makes cane sugar content in preparation be 45%~65% (g/mL).
Further, the step<d>It is middle with 8~10 times 50%~70% of ethanol water in 40-60 DEG C of condition
Lower ultrasonic wave extraction obtains alcohol extracting thing.
Step<a>And step<b>Operation order, the operation order of step (1) and step (2) is to the syrup system of the present invention
The preparation of agent does not influence, and can first carry out step<b>Step is carried out again<a>；Step (2) can also first be carried out and carry out step again
(1)。
A kind of purposes of above-mentioned Pudilan syrup, there is clearing heat and detoxicating or anti-inflammation detumescence medicine.
Further, for preparing treatment parotitis, pharyngitis, tonsillitis or the medicine of furuncle.
Above-mentioned Pudilan syrup for prepare that child form is clearing heat and detoxicating or the medicine of anti-inflammation detumescence in application.
3. beneficial effect
Compared to prior art, beneficial effects of the present invention are：
(1) Pudilan syrup of the invention is safe for herbal mixture, significant effect；In we, radix scutellariae has clear
The effect of hot eliminating dampness, purging intense heat detoxicating；Dandelion has the effect of clearing heat and detoxicating, to clear liver and improve vision；Corydlis bungeana has clearing heat and detoxicating, work
The effect of blood is subsided a swelling；Radix Isatidis has the effect of clearing heat and detoxicating, cool blood relieving sore-throat, the matching of four medicines, has well clearing heat and detoxicating, anti-
The effect of virus and antibacterial action；
(2) present invention overcomes the shortcomings of Pudilan Chinese medicine poor taste, by the auxiliary material added with flavored action, improves mouth
Taste, adverse drug smell is effectively covered, syrup form is made, it is not difficult matter to make medication；Overcome existing Pudilan tablet and capsule
The water-insoluble formulation absorption difference such as agent, the defects of oral liquid formulation active constituent content is low, there is provided one kind is easy to absorb, effectively into
Divide high formulation；
(3) commercially available Pudilan clinically uses, although curative for effect, curative effect plays slowly, and drug effect need into one
Step improves.The Pudilan syrup antiphlogistic activity of the present invention improves, and the enhancing of inflammation inhibiting rate, with the extracting method of the present invention, makes
Extraction time greatly reduces, and active ingredient significantly improves, and its active ingredient includes scutelloside, Cichoric acid, caffeic acid, and the present invention carries
The content of scutelloside in thing is taken to be more than 10mg/mL, the content of Cichoric acid is more than 1mg/mL, and caffeinic content is more than 0.1mg/
ML, this method radix scutellariae directly select ethanol water extraction, it is time-saving simultaneously, the recovery rate of active ingredient also increases
Add, for Pudilan syrup of the invention compared with commercially available Pu bring down a fever piece, antiphlogistic effects are good, the enhancing of inflammation inhibiting rate；Compare
In improving the content of active principle by concentrating merely, this method, which is not present, causes impurity content to increase, and drug side-effect increases
The shortcomings of adding；
(4) for this method using ethanol water extraction scutelloside, the content of obtained scutelloside is high, then is precipitated by acid adding
Method, can effectively remove impurity component, obtain the higher scutelloside of purity；Extracted jointly using dandelion and Radix Isatidis
Method, the content of active ingredient Cichoric acid can be improved；
(5) active ingredient in Pudilan syrup of the present invention includes scutelloside, baicalein, wogonin, apiolin, witloof
Acid, caffeic acid, chlorogenic acid, forulic acid, corynoline, acetycorynoline, adenosine, epigoitrin etc., these are the master of said preparation
Want active component；In addition to active ingredient, remaining is the impurity of said preparation, including protein, tannin, pigment, protocatechuic acid, quercitrin
Element, cyanidenon etc.；Active constituent content is measured using high performance liquid chromatograph in present invention experiment, using coomassie
Light blue decoration method and ultraviolet specrophotometer etc. are no more than 7% to dirt content test, impurity content；
(6) existing Pudilan extracting method carries out alcohol precipitation this step after the extraction, although the clarification of medicine can be improved
Degree, but active ingredient can be reduced, and the problem of so is then not present in the extracting method provided in the present invention, selection is certain density
Alcoholic solution, it can not only increase recovery rate, moreover it is possible to suppress the dissolution of the macromolecule impurities such as tannin, be easy to Purification by filtration.Medicine is clear
Clear degree is high, and active constituent content is high so that the cost of extraction substantially reduces；
(7) for preparation method, commercially available Pu bring down a fever piece is using water extraction, acid is heavy, filters, the extraction of the method for alkali soluble
Scutelloside, Pudilan sulfathiazole, antiphlogistic capsule, antiphlogistic granules etc. is milled using half, the method extraction radix scutellariae of second half alcohol extracting
Glycosides, these method shortcomings are：If first, it can not only increase extraction from certain density alcoholic solution when scutelloside extracts
Rate, moreover it is possible to suppress the dissolution of the macromolecule impurities such as tannin, be easy to Purification by filtration, so, compare water extraction method, select alcohol extracting to increase
Add recovery rate；Second, the radix scutellariae active compound material of milling is not completely soluble in water, it is only suitable for the solid dosage forms such as tablet, capsule, if
Raw material is crushed and extracted, although the recovery rate of scutelloside can be increased, also easily causes extractor filtering system simultaneously
The appearance of the problems such as blocking of system；
(8) present invention improves extracting mode, greatly shorten extraction time, the content of principle active component significantly carries
Height, reduce medication dose；
(9) Pudilan syrup of the invention, compared to more existing Pudilan preparation, it is especially suitable for children taking.
Brief description of the drawings
Fig. 1 is the standard curve schematic diagram of scutelloside of the present invention；
Fig. 2 is the standard curve schematic diagram of Cichoric acid of the present invention；
Fig. 3 is the caffeinic standard curve schematic diagram of the present invention；
Fig. 4 is the result of variations figure of mouse ear swelling degree in the present invention；
Fig. 5 is the chromatograms of Pudilan syrup of the present invention, and in figure, 1 represents adenosine；2 represent epigoitrin；3 represent coffee
Coffee acid；4 represent Cichoric acid；5 represent scutelloside；
Fig. 6 is the chromatograms of commercially available Pu bring down a fever piece, and in figure, 1 represents adenosine；2 represent epigoitrin；3 represent coffee
Coffee acid；4 represent Cichoric acid；5 represent scutelloside.
Embodiment
With reference to embodiment, the present invention is described further, as described below, is only the preferable implementation to the present invention
Example, is not limited the present invention, any person skilled in the art is possibly also with the disclosure above
Technology contents be changed to the equivalent embodiment changed on an equal basis.It is every of the invention without departing from the present invention program content, foundation
Technical spirit any simple modification that following examples are done or equivalent variations, all fall within protection scope of the present invention.
Embodiment 1
The research of Extraction Process of Scuytellaria Baicalenksis
Tested by table 1-1,1-2,1-3 experiment table, compared using the peak height of HPLC scutelloside and peak area as index
More optimal extraction process.
One, experimental methods
Tested by table 1-1,1-2,1-3,1-4 experiment table, every group is to weigh radix scutellariae 10g, adds alcohol reflux to extract,
Merge extract solution, reclaim ethanol, concentration, HPLC is detected, respectively to concentration of alcohol, extraction alcohol used in Extracting temperature, extraction
The conditions such as amount, extraction time, pH, addition gelatin amount, addition chitosan amount carry out contrast optimization.
Two, experimentations
1. instrument and reagent：High performance liquid chromatograph (Agilent company)；Methanol is chromatographically pure, and water is up water, Qi Tashi
Medicine is that analysis is pure.
2. chromatographic condition：It is filler with octadecylsilane chemically bonded silica；Mobile phase is methanol-water-phosphoric acid (44:56:
0.2)；Detection wavelength is 280nm, flow velocity 0.8mL/min.
3. the preparation of medicinal material solution：Precision measures this product 1mL, is placed in 50mL measuring bottles, adds methanol to be shaken up to scale.Essence
It is close to measure 5mL, it is placed in 10mL measuring bottles, adds methanol to shake up, produce to scale.
4. determination method：It is accurate respectively to draw reference substance solution and each 20 μ L of each group need testing solution, liquid chromatograph is injected,
It is measured, produces under above-mentioned chromatographic condition.
Three, experimental results
1. concentration of alcohol experiment used in Extracting temperature and extraction
Concentration of alcohol experiment used in table 1-1 Extracting temperatures and extraction
Analyzed more than it can be seen from experiment for peak area and peak height：Extracting temperature P>0.05, it is poor without conspicuousness
It is different；Extracting mode P>0.05, without significant difference.Due to Extracting temperature and extraction concentration of alcohol there are no significant difference, institute
So that with 50%~70% ethanol water, ultrasonic wave extraction obtains alcohol extracting thing under the conditions of 40-60 DEG C.
2. extract alcohol amount and extraction time experiment
Table 1-2 extracts alcohol amount and extraction time experiment
Analyzed more than it can be seen from experiment for peak area and peak height：Extract alcohol amount P>0.05, it is poor without conspicuousness
It is different；Extraction time P<0.05, there is significant difference.Extraction alcohol amount used selects 8~10 times of ethanol, extraction time 2h.
3.pH, gelatin amount is added, add the experiment of chitosan amount
Table 1-3 pH, gelatin is added, add chitosan experiment
Contrasted by form：PH is little in the influence of 1~2 pair of peak area, without significant difference；Gelatin is added in 1-
Peak area is influenceed less, without significant difference in the range of 5%；Add chitosan influences in 0.1-2% scopes on peak area
Less, without significant difference.So alternative condition is：Add gelatin to 1-5%, filtering, filtrate and add chitosan 0.1-
2%, pH to 1-2 is adjusted, precipitate is Baical Skullcap root P.E.
Four, radix scutellariaes techniques determine
2~4 parts of radix scutellariae, with 8~10 times 50%~70% of ethanol water, ultrasonic wave extraction obtains under the conditions of 40-60 DEG C
Alcohol extracting thing, 2 hours every time, merging filtrate, filter, concentration, add gelatin to 1-5%, filtering, filtrate and add chitosan 0.1-
2%, pH to 1-2 is adjusted, precipitate is Baical Skullcap root P.E.
Dandelion, the research of Chinese violet, Extraction Technology of Radix Isatidis
Tested by table 2-1,2-2 experiment table, compared most using the peak height of HPLC Cichoric acid and peak area as index
Excellent extraction process.
One, experimental methods
Tested by table 2-1,2-2 experiment table, every group is to weigh dandelion 12.5g, Radix Isatidis 4.7g, corydlis bungeana
3.125g, add water refluxing extraction, merge extract solution, concentration, HPLC is detected.
Two, experimentations
1. instrument and reagent：High performance liquid chromatograph (Agilent company)；Acetonitrile is chromatographically pure, and water is up water, Qi Tashi
Medicine is that analysis is pure.
2. chromatographic condition：It is filler with octadecylsilane chemically bonded silica；Mobile phase is acetonitrile-water-phosphoric acid (15:85:
0.2)；Detection wavelength is 326nm, flow velocity 0.8mL/min.
3. the preparation of medicinal material solution：Precision measures this product 1mL, puts in 20mL measuring bottles, adds 70% ethanol to shake up to scale,
Produce.
4. determination method：It is accurate respectively to draw reference substance solution and each 20 μ L of each group need testing solution, liquid chromatograph is injected,
It is measured, produces under above-mentioned chromatographic condition.
Three, experimental results
1. extract water and extraction time experiment
Table 2-1 extracts water and extraction time experiment
Analyzed more than it can be seen from experiment for peak area and peak height：Extract water P>0.05, there was no significant difference；
Extraction time P>0.05, there was no significant difference.Due to extraction water and there are no significant extraction time difference, so dandelion 6
~9 parts mix with 2~4 parts of Radix Isatidis with 15~20 times of water boiling and extractions, extraction twice, each 1-2h, 1~3 part of use 15 of Chinese violet
~20 times of decoctings are boiled twice, each 1-2h, and both mix, and are filtered, concentration.
2. adding gelatin, chitosan is added, the pH experiments adjusted
Table 2-2 adds gelatin, adds chitosan, the pH experiments adjusted
Contrasted by form：Add gelatin influences less, without significant difference in 0.1-2% scopes on peak area；pH
It is little in the influence of 1~2 pair of peak area, without significant difference；Add chitosan influences not in 0.1-2% scopes on peak area
Greatly, without significant difference.So alternative condition is：Gelatin 1-5% is added after dandelion and Radix Isatidis extraction, is stood, filtering
Take supernatant；Concentrated after two kinds of extract solution mixing, add chitosan 0.1-2%, adjust pH to 1-2, stand, filtering.
Four, dandelions, Chinese violet, Extraction Technology of Radix Isatidis determine
2~4 parts of 6~9 parts of dandelion and Radix Isatidis is mixed with 15~20 times of water boiling and extractions, extraction twice, each 1-2h,
Gelatin 1-5% is added, stands, filters to take supernatant；1~3 part of Chinese violet is boiled twice with 15~20 times of decoctings, each 1-2h, and both are mixed
Close, filter, concentration, add chitosan to 0.1-2%, regulation PH to 1-2, stand, filtering.
Active ingredient scutelloside, Cichoric acid, caffeinic content in HPLC measure Pudilans
One, experimentations
1. instrument and reagent：High performance liquid chromatograph (Agilent company)；Acetonitrile, methanol are chromatographically pure, and water is up water, its
Its reagent is that analysis is pure.
2. chromatographic condition：It is filler with octadecylsilane chemically bonded silica；
The testing conditions of scutelloside are：Mobile phase methanol-water-trifluoroacetic acid (44:56:0.2)；Detection wavelength is 280nm,
Flow velocity is 0.8mL/min, and column temperature is 30 DEG C, the μ L of sample size 20.
The testing conditions of Cichoric acid are：Mobile phase acetonitrile-water-trifluoroacetic acid (22:78:0.2)；Detection wavelength is 326nm,
Flow velocity is 0.8mL/min, and column temperature is 30 DEG C, the μ L of sample size 20.
Caffeinic testing conditions are：Mobile phase acetonitrile-water-trifluoroacetic acid (9:91:0.2)；Detection wavelength is 323nm,
Flow velocity is 0.8mL/min, and column temperature is 30 DEG C, the μ L of sample size 20.
3. the preparation of reference substance solution：
Precision weighs that scutelloside standard items are appropriate, adds methanol that the reference substance storing solution that mass concentration is 0.32mg/mL is made,
Gradient dilution.Scutelloside standard liquid concentration to be matched somebody with somebody：0mg/mL、0.01mg/mL、0.02mg/mL、0.04mg/mL、0.08mg/
mL、0.16mg/mL、0.32mg/mL。
Precision weighs that Cichoric acid standard items are appropriate, adds methanol that the reference substance storing solution that mass concentration is 0.32mg/mL is made,
Gradient dilution.Cichoric acid standard liquid concentration to be matched somebody with somebody：0mg/mL、0.0025mg/mL、0.005mg/mL、0.01mg/mL、
0.02mg/mL、0.04mg/mL、0.08mg/mL、0.16mg/mL、0.32mg/mL。
Precision weighs that caffeic acid standard items are appropriate, adds methanol that the reference substance storing solution that mass concentration is 0.1mg/mL is made,
Gradient dilution.Caffeic acid standard liquid concentration to be matched somebody with somebody：0mg/mL、0.0015625mg/mL、0.003125mg/mL、
0.00625mg/mL、0.0125mg/mL、0.025mg/mL、0.05mg/mL、0.1mg/mL。
4. the preparation of medicinal material solution：Compare this method extraction Pudilan and commercially available Pu bring down a fever piece and they effectively into
The assay divided.
Determine the preparation of scutelloside medicinal material solution：Precision measures 1mL, is placed in 50mL measuring bottles, adds methanol to be shaken to scale
It is even.Precision measures 5mL, is placed in 10mL measuring bottles, adds methanol to shake up, produce to scale.
Determine the preparation of Cichoric acid medicinal material solution：Precision measures 1mL, puts in 20mL measuring bottles, adds 70% ethanol to be shaken to scale
It is even, produce.
Determine the preparation of caffeic acid medicinal material solution：Precision measures 1mL, puts in 20mL measuring bottles, adds 70% ethanol to be shaken to scale
It is even, produce.
5. determination method：It is accurate respectively to draw each standard solution and each 20 μ L of each group need testing solution, inject liquid chromatogram
Instrument, it is measured, produces under above-mentioned chromatographic condition.Using sample introduction concentration as abscissa, peak area is ordinate, and it is bent to draw standard
Line, obtain regression equation.
Two, results
1. content of baicalin calculates
If Fig. 1 is scutelloside standard curve：Y=63447x+96.002 (R2=0.9994), standard curve is substituted into obtain, this
Amount of the Pudilan containing scutelloside of method extraction be 0.15mg/mL, i.e., the Pudilan that often 1mL this method is extracted and after syrup is made
13.8mg/mL containing scutelloside, the content of scutelloside is more than 10mg/mL in syrup.Record in《Pharmacopoeia of People's Republic of China》
The Pu bring down a fever piece requirement of 2015 editions one：It is not less than 6.0mg containing scutelloside per 1mL.Compare therewith, active ingredient scutelloside
Content greatly increase.
2. Cichoric acid cubage
If Fig. 2 is Cichoric acid standard curve：Y=106854x-520.11 (R2=0.9927), substitute into standard curve and obtain city
The content for selling Cichoric acid in Pu bring down a fever piece is 0.01mg/mL, and amount of the Pudilan syrup containing Cichoric acid of this method extraction is
0.08mg/mL, i.e., per the commercially available Pu bring down a fever piece 0.32mg/mL containing Cichoric acid of 1mL, the Pudilan sugar per the extraction of 1mL this method
Starch 1.64mg/mL containing Cichoric acid.
3. caffeic acid cubage
If Fig. 3 is caffeic acid standard curve：Y=111154x+57.693 (R2=0.9998), substitute into standard curve and obtain city
It is 0.002mg/mL to sell caffeinic content in Pu bring down a fever piece, and the Pudilan syrup of this method extraction is containing caffeinic amount
0.011mg/mL, i.e., per the commercially available Pu bring down a fever piece 0.038mg/mL containing caffeic acid of 1mL, per the Pudilan of 1mL this method extraction
Syrup 0.212mg/mL containing caffeic acid.
Embodiment 2
Anti- small white mouse acute inflammation pharmacological experiment study
One, test materials
Animal：24 icr mouse, male, body weight is in 25g or so
Medicine：Made syrup
Two, test methods
Healthy mice 24, random point 3 groups, every group 8：Blank control, the commercially available Pu bring down a fever piece of purchase, this laboratory
Made Pudilan syrup.
6h and 1h is administered once respectively before causing acute inflammation model, each blank control group and administration group small white mouse difference
Gavage 0.21mL/10g body weight physiological saline and corresponding decoction.
Laboratory mouse 1h after administration, the wide thickness of mouse right ear is first determined, then in the wide instillation of auris dextra
0.07mL dimethylbenzene, mouse ear swelling degree is determined with slide measure every 15min, to instill the thickness of ear after dimethylbenzene
The difference of the thickness of ear before instilling is subtracted as inflammatory swelling degree index, and on the basis of blank control group inflammation swelling,
Calculate each administration group inflammation inhibiting rate.
Three, result of the tests
Fig. 4 is the change that mouse ear swelling degree is determined with slide measure；Table 5-1 causes for syrup paraxylene of the present invention
The inflammation inhibiting rate of the inflammatory swelling degree index of small white mouse ear acute inflammation and each administration group 15min and 30min.By Fig. 4 and
Table 5-1 understands that small white mouse ear acute inflammation caused by paraxylene, syrup of the present invention has obvious antiphlogistic effects, with blank pair
Compared according to group, there is significant difference, and compared with commercially available Pu bring down a fever piece, the enhancing of inflammation inhibiting rate.
Table 5-1 syrup paraxylene of the present invention causes the inflammatory swelling degree index of small white mouse ear acute inflammation and each administration group
Inflammation inhibiting rate
Note：Compared with blank control group, t is examined, * p<0.05, * * p<0.01, n=8
Embodiment 3
Pudilan syrup
Dandelion 100g, Chinese violet 25g, Radix Isatidis 37.6g, radix scutellariae 37.6g, sucrose 130g.
<1>Dandelion 100g, Radix Isatidis 37.6g mixing plus 15 times of decoctings are boiled twice, add gelatin 1%, 1h are stirred, to it
It is completely dissolved, stands, take supernatant.
<2>Chinese violet 25g adds 15 times of decoctings to boil twice, is cooled to room temperature, filtering.
Step<1>And step<2>Order on extraction do not influence.
<3>Extract solution<1>With<2>Both mixing, filtering, it is 1.1 to be concentrated into density, addition chitosan to 0.1%, regulation
PH to 2, stand, filtering, remove precipitation.
<4>8 times of 50% ethanol of amount of radix scutellariae 37.6g, in 40 DEG C of ultrasonic wave extraction alcohol extractings twice, each 2h, extract solution mistake
Filter out miscellaneous, gelatin 1% is added in filtrate, 1h is stirred, is completely dissolved to it, stands, filters to take supernatant, filtrate adds chitosan
2%, hydrochloric acid adjusts pH to 2, stands 12h, precipitate is Baical Skullcap root P.E.
<5>Baical Skullcap root P.E is added<3>In gained concentrate, it is well mixed, is settled to 200mL, obtains traditional Chinese medicine extraction
Thing concentrate.
<6>130g sucrose will be added in the concentrated liquid of tradition Chinese medicine, heating makes its dissolving, stirred and evenly mixed, and sterilize 30min, produces.
Embodiment 4
Pudilan syrup
Dandelion 75g, Chinese violet 12.5g, Radix Isatidis 25g, radix scutellariae 25g, sucrose 110g.
<1>Dandelion 75g, Radix Isatidis 25g mixing plus 20 times of decoctings are boiled twice, add gelatin 5%, stir 1h, complete to its
Fully dissolved, stand, take supernatant.
<2>Chinese violet 12.5g adds 20 times of decoctings to boil twice, is cooled to room temperature, filtering.
<3>Extract solution<1>With<2>Both mixing, filtering, it is 0.9 to be concentrated into density, addition chitosan to 0.1%, regulation
PH to 2, stand, filtering, remove precipitation.
<4>10 times of 60% ethanol of amount of radix scutellariae 25g, in 60 DEG C of ultrasonic wave extraction alcohol extractings twice, each 2h, extract solution filtering
Removal of impurities, gelatin 5% is added, stir 1h, be completely dissolved to it, stood, filter to take supernatant, filtrate adds chitosan 0.1%, hydrochloric acid
PH to 1 is adjusted, stands 12h, precipitate is Baical Skullcap root P.E.
<5>Baical Skullcap root P.E is added<3>In gained concentrate, it is well mixed, is settled to 250mL, obtains traditional Chinese medicine extraction
Thing concentrate.
<6>110g sucrose will be added in the concentrated liquid of tradition Chinese medicine, heating makes its dissolving, stirred and evenly mixed, and sterilize 30min, produces.
Embodiment 5
Pudilan syrup
Dandelion 112.5g, Chinese violet 37.5g, Radix Isatidis 50g, radix scutellariae 50g, sucrose 90g.
<1>Dandelion 112.5g, Radix Isatidis 50g mixing plus 15 times of decoctings are boiled twice, add gelatin 3%, 1h are stirred, to it
It is completely dissolved, stands, take supernatant.
<2>Chinese violet 37.5g adds 15 times of decoctings to boil twice, is cooled to room temperature, filtering.
<3>Extract solution<1>With<2>Both mixing, filtering, it is 1.1 to be concentrated into density, adds chitosan to 1%, adjusts PH
To 1, stand, filtering, remove precipitation.
<4>8 times of 50% ethanol of amount of radix scutellariae 50g, in 60 DEG C of ultrasonic wave extraction alcohol extractings twice, each 2h, extract solution filtering
Removal of impurities, gelatin 5% is added, stir 1h, be completely dissolved to it, stood, filter to take supernatant, filtrate adds chitosan 0.1%, hydrochloric acid
PH to 1 is adjusted, stands 12h, precipitate is Baical Skullcap root P.E.
<5>Carried scutelloside is added<3>In gained concentrate, it is well mixed, is settled to 200mL, obtains traditional Chinese medicine extraction
Thing concentrate.
<6>90g sucrose will be added in the concentrated liquid of tradition Chinese medicine, heating makes its dissolving, stirred and evenly mixed, and sterilize 30min, produces.
Embodiment 6
Pudilan syrup
Dandelion 75g, Chinese violet 12.5g, Radix Isatidis 25g, radix scutellariae 25g, sucrose 120g, flavoring apple essence 1g, sorbierite 1g, lemon
Lemon acid sodium 0.4g.
<1>Dandelion 75g, Radix Isatidis 25g mixing plus 20 times of decoctings are boiled twice, add gelatin 3%, stir 1h, complete to its
Fully dissolved, stand, take supernatant.
<2>Chinese violet 12.5g adds 20 times of decoctings to boil twice, is cooled to room temperature, filtering.
<3>Extract solution<1>With<2>Both mixing, filtering, density are concentrated into as 1.0.
<4>10 times of 70% ethanol of amount of radix scutellariae 25g, in 40 DEG C of ultrasonic wave extraction alcohol extractings twice, each 2h, extract solution filtering
Removal of impurities, gelatin 5% is added, stir 1h, be completely dissolved to it, stood, filter to take supernatant, filtrate adds chitosan 2%, and hydrochloric acid is adjusted
PH to 1,12h is stood, precipitate is Baical Skullcap root P.E.
<5>Baical Skullcap root P.E is added<1>In gained concentrate, it is well mixed, is settled to 200mL, obtains traditional Chinese medicine extraction
Thing concentrate.
<6>120g sucrose being added in the concentrated liquid of tradition Chinese medicine, heating makes its dissolving, adds flavoring apple essence 1g, sorbierite 1g,
Sodium citrate 0.4g, is stirred and evenly mixed, and sterilize 30min, produces.
Flavoring apple essence in the present embodiment can use the conventional aromatic such as almond flavour, strawberry essence, orange flavor to replace,
Mass content scope of the aromatic in syrup is between 0.2%~1%.Sucrose and sorbierite can use it is conventional can
Edible high sweetener or low power sweetener are replaced, and high sweetener can be Aspartame, steviol glycoside etc., low power sweetener
Can be maltose, xylitol, honey etc., when the sweetener in syrup is high sweetener, sweetener is in syrup
Mass content it is low, for example, it may be 0.2%；When the sweetener in syrup is low power sweetener, sweetener is in syrup
In mass content it is high, for example, it may be 25%.Sodium citrate can use conventional sorbic acid, sorbic acid as preservative
Potassium, dehydroactic acid sodium etc. are replaced, and mass content scope is between 0.01%~0.5%.
Embodiment 7
Pudilan impurity is studied
Active ingredient in Pudilan syrup of the present invention has scutelloside, baicalein, wogonin, apiolin, Cichoric acid, coffee
Coffee acid, chlorogenic acid, forulic acid, corynoline, acetycorynoline, adenosine, epigoitrin etc., be said preparation chief active into
Point.In addition to active ingredient, remaining is the impurity of said preparation, including protein, tannin, pigment, protocatechuic acid, Quercetin, sweet-scented osmanthus
Careless element etc..
The present invention experiment in active constituent content is measured using high performance liquid chromatograph, by each peak peak height with
Peak area can be seen that active ingredient and impurity content how much.Step is the same as embodiment 2.
Fig. 5 is the chromatograms of Pudilan syrup of the present invention.Wherein active ingredient, such as：Peak 4 is Cichoric acid, peak area
For 5953.59, peak height 123.85, this peak accounts for the 9.50% of total peak area；Peak 5 is scutelloside, peak area 39159.10, peak
A height of 613.21, this peak accounts for the 62.45% of total peak area.
Fig. 6 is the chromatograms of commercially available Pu bring down a fever piece.Wherein active ingredient, such as：Peak 4 is Cichoric acid, peak area
For 1527.84, peak height 31.93, this peak accounts for the 4.28% of total peak area；Peak 5 is scutelloside, peak area 2.6358.00, peak
A height of 406.33, this peak accounts for the 53.97% of total peak area.
Two figures of contrast are as can be seen that active constituent content of the present invention is high.
Also, the result of dirt content test is obtained by dying method with coomassie brilliant blue and ultraviolet specrophotometer etc., this
Invention protein impurities content is 220ug/mL or so, and commercially available Pudilan protein impurities content is 300ug/mL or so.
The result of dirt content test is drawn with reference to chromatograms and ultraviolet specrophotometer etc., what the present invention determined
Impurity content is no more than 7%.
The present invention is described according to preferred embodiment.It should be understood that description above and embodiment are only
In order to demonstrate the invention.On the premise of without departing from the spirit and scope of the present invention, those skilled in the art can be with
The a variety of alternatives and improvement project of the present invention are designed, it all should be understood to be within protection scope of the present invention.
Claims (11)
- A kind of 1. preparation method of Pudilan syrup, it is characterised in that：Comprise the following steps：<1>Corydlis bungeana, Radix Isatidis and the extract of dandelion are prepared, described extract is blue by the parts by weight of corydlis bungeana 1~3, plate The parts by weight of root 2~4, the parts by weight of dandelion 6~9 are extracted to be concentrated to give, and is comprised the following steps：<a>Dandelion and Radix Isatidis water boiling and extraction, gelatin 1-5% is added in extract solution, stand, filter to take supernatant；<b>Corydlis bungeana water boiling and extraction；<c>By step<a>And step<b>Extract solution mixing, concentration, add chitosan to 0.1-2%, adjust pH to 1-2, it is quiet Put, filter；<2>The extract of scutellaria is prepared, described extract is concentrated to give by the parts by weight of radix scutellariae 2~4 are extracted, including following step Suddenly：<d>Radix scutellariae is extracted to obtain alcohol extracting thing with ethanol；<e>Resulting alcohol extracting thing adds gelatin to 1-5%, filters, chitosan is added in filtrate to 0.1-2%, adjusts pH extremely 1-2, precipitate are Baical Skullcap root P.E, and described Baical Skullcap root P.E is scutelloside；<3>Corydlis bungeana, Radix Isatidis and the extract of dandelion are mixed with the extract of scutellaria, are concentrated into proportion as 0.8~1.3 (g/mL), adding sucrose makes cane sugar content in preparation be 45%~65% (g/mL).
- 2. the preparation method of Pudilan syrup according to claim 1, it is characterised in that：The step<d>It is middle with 8~ 10 times 50%~70% of ethanol water ultrasonic wave extraction under the conditions of 40-60 DEG C obtains alcohol extracting thing.
- 3. the preparation method of Pudilan syrup according to claim 1, it is characterised in that：In step (a) and step (b) Each extraction time is 1~2h.
- 4. the preparation method of the Pudilan syrup according to claim 1 or 3, it is characterised in that：In step (a) with 15~ 20 times of water decoct extraction twice to dandelion and Radix Isatidis；Extraction is decocted twice to corydlis bungeana with 15~20 times of water in step (b).
- A kind of 5. Pudilan syrup, it is characterised in that：Include the extract of corydlis bungeana, Radix Isatidis, dandelion and radix scutellariae, also wrap Sucrose is included, described extract uses any one method in claim 1-4 to be prepared；Wherein cane sugar content in syrup For 45%~65% (g/mL), active ingredient includes scutelloside in extract, and the content of scutelloside is more than 10mg/ in syrup mL；Impurity content is no more than 7%.
- 6. Pudilan syrup according to claim 5, it is characterised in that：Active ingredient also includes Cichoric acid in extract And caffeic acid, the content of Cichoric acid is more than 1mg/mL in syrup, and caffeinic content is more than 0.1mg/mL.
- 7. the Pudilan syrup according to claim 5 or 6, it is characterised in that：Also include aromatic and preservative, fragrance The mass content of agent is 0.2%~1%, and the mass content of preservative is 0.01%~0.5%.
- 8. the Pudilan syrup according to claim 5 or 6, it is characterised in that：Also include sweetener, mass content is 0.2%~25%.
- 9. the purposes of the Pudilan syrup described in claim 5, it is characterised in that：There is clearing heat and detoxicating or anti-inflammatory for preparing The medicine of detumescence.
- 10. the purposes of Pudilan syrup according to claim 9, it is characterised in that：For preparing treatment parotitis, pharynx The medicine of scorching, tonsillitis or furuncle.
- 11. Pudilan syrup in claim 5-8 described in any one is for preparing, child form is clearing heat and detoxicating or anti-inflammatory Application in the medicine of detumescence.
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Effective date of registration: 20190627 Address after: 211100 No. 105, 34 Building, Wenboyuan, Longmian Avenue, Jiangning District, Nanjing City, Jiangsu Province Co-patentee after: Qi Weiyan Patentee after: Xu Hanmei Address before: 211100 No. 105, 34 Building, Wenboyuan, Longmian Avenue, Jiangning District, Nanjing City, Jiangsu Province Patentee before: Xu Hanmei |
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Decision date of declaring invalidation: 20190730 Decision number of declaring invalidation: 41099 Granted publication date: 20180330 |
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