CN108888669A - A kind of preparation method of heat-clearing cough-relieving oral liquid for children - Google Patents
A kind of preparation method of heat-clearing cough-relieving oral liquid for children Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
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- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
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- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention belongs to technical field of traditional Chinese medicine pharmacy, and in particular to a kind of preparation method of heat-clearing cough-relieving oral liquid for children.The preparation method of heat-clearing cough-relieving oral liquid for children provided by the invention be by Chinese ephedra, gypsum, fry semen armeniacae amarae, rhizoma menispermi, Radix Isatidis, radix scutellariae, Radix Glycyrrhizae seven flavor medicine material carry out water mention, extract medical fluid, concentration, in concentrate be added flocculant precipitated impurities to get.The preparation method of heat-clearing cough-relieving oral liquid for children provided by the invention has good impurity removing effect, can be very good to retain the effective component in oral solution, makes the advantage that product stability is more preferable；It also has the advantages that operating procedure is simple, with short production cycle, production cost is low simultaneously, is suitble to large-scale industrial production.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, and in particular to a kind of preparation method of heat-clearing cough-relieving oral liquid for children.
Background technique
Heat-clearing cough-relieving oral liquid for children, prescription are originated from the recipe handed down from ancient times of Eastern Han Dynasty's holy doctor Zhang Zhongjing《Ma Xing Shi Gan Tang》, 2,000
Year Curative effect by Chinese ephedra, gypsum, is fried the Chinese materia medica preparation that semen armeniacae amarae, rhizoma menispermi, Radix Isatidis, radix scutellariae, Radix Glycyrrhizae form, is had
Clearing heat and freeing lung, relieving asthma, relieving sore-throat the effect of.The yellow, gas for flu caused by treating cold due to wind-heat symptoms include fever with chilliness, cough phlegm
Rush wheeze, dry hoarse voice, abscess of throat.
In heat-clearing cough-relieving oral liquid for children herbal extract, ingredient is complicated, wherein including tannin, protein, tree
Rouge, wax isocolloid ingredient have a large amount of protein easily to go mouldy in the presence of the clarity of oral solution can be made bad in syrup.For gram
This problem is taken, in the production process of Chinese materia medica preparation, needs to purify the extracting solution of drug to remove impurity, retains medicine
Effective component in material.The main method that traditional Chinese medicine isolates and purifies has water extraction and alcohol precipitation method, ultrafiltration, supercentrifugal process etc..
Water extraction and alcohol precipitation method easily causes the loss of effective component, to influence the curative effect of drug.In addition, water extraction and alcohol precipitation method need to make
With a large amount of alcohol, special equipment is purchased, considerably increases fixed investment, consumption energy consumption object, the production cycle is long, large labor intensity.It is super
The features such as filter method has separative efficiency high, changes without phase-change in separation process, and low energy consumption, is especially suitable for the separation of heat-sensitive substance,
But due on ultrafiltration membrane sieve pore it is minimum, the substance for being deposited on film surface easily forms the gel layer of one layer of high concentration, makes film throughput
It is greatly affected with cutoff performance, needs to take corresponding measure, and pre-processed before ultrafiltration.General refining methd is difficult
When carrying out or be affected to effective component, the method for being centrifuged at a high speed can be used.This method can solve separation of solid and liquid
Problem, but there is also certain limitations for this method, and supercentrifuge energy consumption is high, and cost is caused to increase.Some Chinese medicine impurity simultaneously
It can not be separated by centrifugation complete.Therefore, when preparing heat-clearing cough-relieving oral liquid for children, need to seek during one kind effectively reduces
The method of medicine oral solution contamination precipitation.
Patent document CN108175788A discloses a kind of heat-clearing cough-relieving oral liquid for children and preparation method thereof, the preparation side
Chinese ephedra, semen armeniacae amarae, gypsum, radix scutellariae, Radix Isatidis, rhizoma menispermi and Radix Glycyrrhizae are repeatedly boiled and are mentioned by method, and using heat treatment, resin adsorption,
The techniques such as centrifugation, refrigeration, filter and remove impurity, ensure that medical fluid clarity.Preparation method absorption, centrifugation removal of impurities are more thorough
Bottom is more accurately removed the impurity in medical fluid using equipment such as centrifuge, resin columns, keeps medical fluid purity more preferable.But using big
There is resin stain and regeneration in macroporous adsorbent resin method, at high cost, and when compound or single medicinal material need to retain wherein
The macromolecular substances such as polysaccharide, protein when, need in addition handle.
Patent document CN102319308A discloses a kind of preparation method of heat-clearing cough-relieving oral liquid for children, and this method uses
Diaphragm filters pressing circulation extracts the effective component that the existing decocting method of isolation integral technical substitution extracts prescription medicine, not only can be with
Simplification of flowsheet substantially shortens the production cycle, energy saving, is conducive to environmental protection and waste residue utilization, and can be greatly
Improve the rate of recovery of effective component；Substitution is directly filtered using ultrafiltration membrane in formulation process and stands 24 hours sides refiltered
Method can also thoroughly solve the quality problems that finished product is also easy to produce the not scattered precipitating shaken and does not meet relevant regulations under mixture item,
And further shorten the production cycle.But due on ultrafiltration membrane sieve pore it is minimum, be deposited on film surface substance easily formed one layer it is highly concentrated
The gel layer of degree makes film throughput and cutoff performance receive very big influence, needs to take corresponding measure, and carry out before ultrafiltration
Pretreatment, is unfavorable for generating on a large scale.
Summary of the invention
In order to overcome defect existing for heat-clearing cough-relieving oral liquid for children impurity removal process in the prior art.The purpose of the present invention exists
In providing a kind of preparation method of heat-clearing cough-relieving oral liquid for children, to solve drawbacks described above.
The present invention provides a kind of preparation method of heat-clearing cough-relieving oral liquid for children, the heat-clearing cough-relieving oral liquid for children by
Following component and its parts by weight composition：45 parts of Chinese ephedra fries 60 parts of semen armeniacae amarae, 135 parts of gypsum, 45 parts of Radix Glycyrrhizae, 90 parts of radix scutellariae, plate
90 parts of blue root, 45 parts of rhizoma menispermi, 100 parts of honey and 1.5 parts of sodium benzoate；
The preparation method of the heat-clearing cough-relieving oral liquid for children includes the following steps：
S1, which takes in Chinese ephedra and gypsum addition purified water, boils 25~35min of extraction, and the additive amount of the purified water is Chinese ephedra
With 6~10 times of gypsum total weight, be subsequently added into rhizoma menispermi, Radix Isatidis, radix scutellariae, Radix Glycyrrhizae, fry semen armeniacae amarae boil extraction 100~
150min, filtering, takes filtrate, obtains filtrate I, filter residue is spare；
The filtered filter residue of step S1 is added purified water and boils 50~80min of extraction, the additive amount of the purified water by S2
It is 6~10 times of filter residue total weight, filtering takes filtrate, obtains filtrate II, the filtrate I that step S1 is obtained is merged with filtrate II, dense
Contracting, obtains concentrate；
The concentrate that S3 obtains step S2 stirs, and the speed of agitator is 45~55r/min, and flocculant is added, and stirs,
It stands for 24 hours, filtering obtains filtrate II I；
Honey, sodium benzoate are added into the filtrate II I that step S3 is obtained by S4, and stirring and dissolving, constant volume is filling, sterilizing, i.e.,
?.
Further, the step S1 is that Chinese ephedra and gypsum are put into the purified water that temperature is 65~70 DEG C, pressure 0.8
25~35min is extracted under conditions of~1.0MPa, the additive amount of the purified water is 6~10 times of Chinese ephedra and gypsum total weight,
It is subsequently added into that rhizoma menispermi, Radix Isatidis, radix scutellariae, Radix Glycyrrhizae, to fry semen armeniacae amarae in temperature be 65~70 DEG C of purified water, pressure is 0.8~
100~150min is extracted under conditions of 1.0MPa, filtering takes filtrate, obtains filtrate I.
Further, the step S2 is that the filtered filter residue of step S1 is put into the purified water that temperature is 65~70 DEG C,
Pressure extracts 50~80min under conditions of being 0.8~1.0MPa, the additive amount of the purified water is the 6~10 of filter residue total weight
Times, filtering takes filtrate, obtains filtrate II, the filtrate I that step S1 is obtained is merged with filtrate II, is concentrated, obtains concentrate.
Further, the additive amount of flocculant is the 5~15% of the volume of the concentrated liquid in the step S3, and the processing time is 10
~30min.
Further, the flocculant in the step S3 is 1% acetum of chitosan, 101 fruit juice clarifiers and ZTC1+
The combination of one or more of 1 natural clarifying agent；1% acetum of chitosan is with the acetic acid of 1% (W/W) by shell
Glycan is configured to the homogeneous colloids solution of 2% (W/W)；101 fruit juice clarifier is to be configured to 5% (W/W) with deionized water
Aqueous solution；Component A is configured to the gel solution of 1% (W/W), B component with deionized water in the ZTC1+1 natural clarifying agent
The gel solution of 1% (W/W) is configured to 1% (W/W) acetic acid.Component A and B component adds in the ZTC1+1 natural clarifying agent
Dosage adds in a conventional manner, and the volume of the addition of B component is 2 times of component A additive amount.
Further, the flocculant in the step S3 is 1% acetum of chitosan.
Further, the flocculant in the step S3 is that 1% acetum of chitosan and ZTC1+1 natural clarifying agent are pressed
Volume ratio (4~6):(3~5) it forms.
Further, the flocculant in the step S3 is that 1% acetum of chitosan and ZTC1+1 natural clarifying agent are pressed
Volume ratio 5:4 compositions.
Further, the addition manner of the flocculant is：1% acetum of chitosan is first added, stands 4~8min,
The component A being subsequently added into ZTC1+1 natural clarifying agent stands 2~4min, the B group being eventually adding in ZTC1+1 natural clarifying agent
Point, stand 4~8min.
Further, the addition manner of the flocculant is：1% acetum of chitosan is first added, stands 6min, then
The component A in ZTC1+1 natural clarifying agent is added, stands 3min, the B component being eventually adding in ZTC1+1 natural clarifying agent is stood
6min。
It is based on the colloid in flocculant and Chinese medicine extract, albumen that the present invention, which reduces contamination precipitation using flocculation technique,
Intermolecular adsorption bridging and charge neutrality effect occur for the particles such as matter, tannin, form floc sedimentation and are allowed to settle, then reach through being separated by solid-liquid separation
To the principle for removing contamination precipitation.Compared with traditional water extraction and alcohol precipitation method, the flocculation technique that the present invention uses reduces children clearing heat
The contamination precipitation of cough stopping oral liquor is with operating procedure is simple, with short production cycle, production cost is low, good impurity removing effect, does not influence
The advantages such as effective component.
Further, the present inventor through largely groped test obtain, 1% acetum of chitosan, 101 fruit juice clarifiers and
ZTC1+1 natural clarifying agent, which is applied to heat-clearing cough-relieving oral liquid for children impurity-removing precipitating, has preferable effect, can retain oral solution
In effective component, keep the stability of oral solution.But the clarity of the oral solution after above-mentioned flocculant process still reaches not
To clarifying bright effect, inventor's continuously research and probe changes the additive amount of flocculant, processing time and compound makes
Mode, but general effect variation is little.
Once groping what 1% acetum of chitosan and ZTC1+1 natural clarifying agent were used in mixed way in test, is inventing
People is first added to 1% acetum of chitosan, is then accidentally added the component A of ZTC1+1 natural clarifying agent as B component,
The B component for finally adding ZTC1+1 natural clarifying agent, it is found that its clarifying effect is more preferable.Being groped to speculate its principle is：First add
1% acetum of chitosan colloid, protein, the tannin in Chinese medicine extract are adsorbed, and add and ZTC1+1
The component A of the B component oppositely charged of natural clarifying agent can promote 1% acetum of chitosan to colloid, protein, tannin
Adsorption effect, meanwhile, when ZTC1+1 natural clarifying agent B component be added when, can be further improved in Chinese medicine extract
The removal effect of impurity, the component A first added can preferably assist the suction-operated of B component, to play better absorption
Effect improves the clarity of oral solution, can preferably keep the stability of oral solution.
In addition, the processing time of three kinds of ingredients is larger to impurity elimination influential effect, it is provided by the invention that chitosan is first added
1% acetum, stand 4~8min, the component A being subsequently added into ZTC1+1 natural clarifying agent, stand 2~4min, finally plus
Enter the B component in ZTC1+1 natural clarifying agent, stands 4~8min, impurity-eliminating effect is best, and the too long or too short processing time is right
Impurity-eliminating effect has large effect.
Rich content of the starch in vegetable drug, and temperature is too high is easy to make starch gelatinization, influences the impurity elimination of flocculant
Effect, the present inventor further grope to find, medicinal material is put into the purified water that temperature is 65~70 DEG C, pressure is 0.8~
The gelatinization that can effectively prevent starch is extracted under conditions of 1.0MPa, can also improve hydrochloric acid in heat-clearing cough-relieving oral liquid for children
The content of ephedrine effective component, to improve the drug effect of oral solution.
Compared with prior art, the preparation method of heat-clearing cough-relieving oral liquid for children provided by the invention has the advantage that：
(1) preparation method of heat-clearing cough-relieving oral liquid for children provided by the invention has good impurity removing effect, and can be very
The good effective component retained in oral solution, makes the advantage that product stability is more preferable；
(2) preparation method of heat-clearing cough-relieving oral liquid for children provided by the invention has that operating procedure is simple, the production cycle
Advantage short, production cost is low is suitble to large-scale industrial production.
Specific embodiment：
The following describes the present invention further through the description of specific embodiments, but it is to limit of the invention that this, which is not,
System, those skilled in the art's basic thought according to the present invention can make various modifications or improvements, but without departing from this
The basic thought of invention, is all within the scope of the present invention.
Embodiment 1, a kind of preparation of heat-clearing cough-relieving oral liquid for children
The heat-clearing cough-relieving oral liquid for children is made of following component and its parts by weight：45 parts of Chinese ephedra fries semen armeniacae amarae 60
Part, 135 parts of gypsum, 45 parts of Radix Glycyrrhizae, 90 parts of radix scutellariae, 90 parts of Radix Isatidis, 45 parts of rhizoma menispermi, 100 parts of honey and sodium benzoate 1.5
Part；
The preparation method of the heat-clearing cough-relieving oral liquid for children includes the following steps：
S1, which takes to boil in Chinese ephedra and gypsum addition purified water, extracts 25min, and the additive amount of the purified water is Chinese ephedra and stone
6 times of cream total weight are subsequently added into rhizoma menispermi, Radix Isatidis, radix scutellariae, Radix Glycyrrhizae, stir-fry semen armeniacae amarae and boil and extract 100min, filter, take
Filtrate, obtains filtrate I, and filter residue is spare；
The filtered filter residue of step S1 is added purified water and boils extraction 50min by S2, and the additive amount of the purified water is filter
6 times of slag total weight, filtering, take filtrate, obtain filtrate II, the filtrate I that step S1 is obtained is merged with filtrate II, are concentrated, obtain dense
Contracting liquid；
The concentrate that S3 obtains step S2 stirs, and the speed of agitator is 45r/min, and ZTC1+1 natural clear is added
Agent, the additive amount of the ZTC1+1 natural clarifying agent are the 10% of the volume of the concentrated liquid, and the processing time is 20min, the ZTC1+1
Component A is configured to the gel solution of 1% (W/W) with deionized water in natural clarifying agent, and B component is configured to 1% (W/W) acetic acid
B component in ZTC1+1 natural clarifying agent is first added in the gel solution of 1% (W/W), when addition, adds ZTC1+1 natural clarifying agent
Middle component A, stirring are stood for 24 hours, and filtering obtains filtrate II I；
Honey, sodium benzoate are added into the filtrate II I that step S3 is obtained by S4, and stirring and dissolving, constant volume is filling, sterilizing, i.e.,
?.
Embodiment 2, a kind of preparation of heat-clearing cough-relieving oral liquid for children
The heat-clearing cough-relieving oral liquid for children is made of following component and its parts by weight：45 parts of Chinese ephedra fries semen armeniacae amarae 60
Part, 135 parts of gypsum, 45 parts of Radix Glycyrrhizae, 90 parts of radix scutellariae, 90 parts of Radix Isatidis, 45 parts of rhizoma menispermi, 100 parts of honey and sodium benzoate 1.5
Part；
The preparation method of the heat-clearing cough-relieving oral liquid for children includes the following steps：
S1, which takes to boil in Chinese ephedra and gypsum addition purified water, extracts 30min, and the additive amount of the purified water is Chinese ephedra and stone
8 times of cream total weight are subsequently added into rhizoma menispermi, Radix Isatidis, radix scutellariae, Radix Glycyrrhizae, stir-fry semen armeniacae amarae and boil and extract 120min, filter, take
Filtrate, obtains filtrate I, and filter residue is spare；
The filtered filter residue of step S1 is added purified water and boils extraction 60min by S2, and the additive amount of the purified water is filter
8 times of slag total weight, filtering, take filtrate, obtain filtrate II, the filtrate I that step S1 is obtained is merged with filtrate II, are concentrated, obtain dense
Contracting liquid；
The concentrate that S3 obtains step S2 stirs, and the speed of agitator is 50r/min, and it is molten that 1% acetic acid of chitosan is added
Liquid, the additive amount of 1% acetum of chitosan are the 10% of the volume of the concentrated liquid, and the processing time is 20min, the chitosan
1% acetum is the homogeneous colloids solution that chitosan is configured to 2% (W/W) with the acetic acid of 1% (W/W)；Stirring is stood
For 24 hours, it filters, obtains filtrate II I；
Honey, sodium benzoate are added into the filtrate II I that step S3 is obtained by S4, and stirring and dissolving, constant volume is filling, sterilizing, i.e.,
?.
Embodiment 3, a kind of preparation of heat-clearing cough-relieving oral liquid for children
The heat-clearing cough-relieving oral liquid for children is made of following component and its parts by weight：45 parts of Chinese ephedra fries semen armeniacae amarae 60
Part, 135 parts of gypsum, 45 parts of Radix Glycyrrhizae, 90 parts of radix scutellariae, 90 parts of Radix Isatidis, 45 parts of rhizoma menispermi, 100 parts of honey and sodium benzoate 1.5
Part；
The preparation method of the heat-clearing cough-relieving oral liquid for children includes the following steps：
S1, which takes to boil in Chinese ephedra and gypsum addition purified water, extracts 35min, and the additive amount of the purified water is Chinese ephedra and stone
10 times of cream total weight are subsequently added into rhizoma menispermi, Radix Isatidis, radix scutellariae, Radix Glycyrrhizae, stir-fry semen armeniacae amarae and boil and extract 150min, filter, take
Filtrate, obtains filtrate I, and filter residue is spare；
The filtered filter residue of step S1 is added purified water and boils extraction 80min by S2, and the additive amount of the purified water is filter
10 times of slag total weight, filtering, take filtrate, obtain filtrate II, the filtrate I that step S1 is obtained is merged with filtrate II, are concentrated, obtain dense
Contracting liquid；
The concentrate that S3 obtains step S2 stirs, and the speed of agitator is 55r/min, and 101 fruit juice clarifiers, institute is added
The additive amount for stating 101 fruit juice clarifiers is the 15% of the volume of the concentrated liquid, and the processing time is 10min, and 101 fruit juice clarifier is used
Deionized water is configured to the aqueous solution of 5% (W/W), stirring, stands for 24 hours, and filtering obtains filtrate II I；
Honey, sodium benzoate are added into the filtrate II I that step S3 is obtained by S4, and stirring and dissolving, constant volume is filling, sterilizing, i.e.,
?.
Embodiment 4, a kind of preparation of heat-clearing cough-relieving oral liquid for children
It is with the difference of embodiment 2：Flocculant in the step S3 is 1% acetum of chitosan and ZTC1+1 days
Right clarifying agent is 1 by volume:1 composition, first adds B component in 1% acetum of chitosan and ZTC1+1 natural clarifying agent, connects
Component A in addition ZTC1+1 natural clarifying agent, remaining step such as embodiment 2.
Embodiment 5, a kind of preparation of heat-clearing cough-relieving oral liquid for children
It is with the difference of embodiment 2：Flocculant in the step S3 is 1% acetum of chitosan and 101 fruit juice
Clarifying agent is 1 by volume:1 composition, remaining step such as embodiment 2.
Embodiment 6, a kind of preparation of heat-clearing cough-relieving oral liquid for children
The heat-clearing cough-relieving oral liquid for children is made of following component and its parts by weight：45 parts of Chinese ephedra fries semen armeniacae amarae 60
Part, 135 parts of gypsum, 45 parts of Radix Glycyrrhizae, 90 parts of radix scutellariae, 90 parts of Radix Isatidis, 45 parts of rhizoma menispermi, 100 parts of honey and sodium benzoate 1.5
Part；
The preparation method of the heat-clearing cough-relieving oral liquid for children includes the following steps：
Chinese ephedra and gypsum are put into the purified water that temperature is 68 DEG C by S1, and pressure extracts 30min under conditions of being 0.9MPa, institute
The additive amount for stating purified water is 8 times of Chinese ephedra and gypsum total weight, is subsequently added into rhizoma menispermi, Radix Isatidis, radix scutellariae, Radix Glycyrrhizae, fries hardship
The purified water that almond is 68 DEG C in temperature, pressure extract 120min under conditions of being 0.9MPa, filter, take filtrate, obtain filtrate I,
Filter residue is spare；
The filtered filter residue of step S1 is put into the purified water that temperature is 68 DEG C by S2, and pressure is extracted under conditions of being 0.9MPa
60min, the additive amount of the purified water are 8 times of filter residue total weight, and filtering takes filtrate, obtains filtrate II, step S1 is obtained
Filtrate I merges with filtrate II, and concentration obtains concentrate；
The concentrate that S3 obtains step S2 stirs, and the speed of agitator is 50r/min, and it is molten that 1% acetic acid of chitosan is added
Liquid, the additive amount of 1% acetum of chitosan are the 10% of the volume of the concentrated liquid, and the processing time is 20min, the chitosan
1% acetum is the homogeneous colloids solution that chitosan is configured to 2% (W/W) with the acetic acid of 1% (W/W)；Stirring is stood
For 24 hours, it filters, obtains filtrate II I；
Honey, sodium benzoate are added into the filtrate II I that step S3 is obtained by S4, and stirring and dissolving, constant volume is filling, sterilizing, i.e.,
?.
Embodiment 7, a kind of preparation of heat-clearing cough-relieving oral liquid for children
It is with the difference of embodiment 6：Flocculant in the step S3 be flocculant be 1% acetum of chitosan and
ZTC1+1 natural clarifying agent by volume 4:5 compositions, are first added 1% acetum of chitosan, stand 4min, are subsequently added into ZTC1
Component A in+1 natural clarifying agent stands 2min, and the B component being eventually adding in ZTC1+1 natural clarifying agent stands 4min,
Remaining step such as embodiment 6.
Embodiment 8, a kind of preparation of heat-clearing cough-relieving oral liquid for children
It is with the difference of embodiment 6：Flocculant in the step S3 be flocculant be 1% acetum of chitosan and
ZTC1+1 natural clarifying agent by volume 5:4 compositions, are first added 1% acetum of chitosan, stand 6min, are subsequently added into ZTC1
Component A in+1 natural clarifying agent stands 3min, and the B component being eventually adding in ZTC1+1 natural clarifying agent stands 6min,
Remaining step such as embodiment 6.
Embodiment 9, a kind of preparation of heat-clearing cough-relieving oral liquid for children
It is with the difference of embodiment 6：Flocculant in the step S3 be flocculant be 1% acetum of chitosan and
ZTC1+1 natural clarifying agent by volume 6:3 compositions, are first added 1% acetum of chitosan, stand 8min, are subsequently added into ZTC1
Component A in+1 natural clarifying agent stands 4min, and the B component being eventually adding in ZTC1+1 natural clarifying agent stands 8min,
Remaining step such as embodiment 6.
Comparative example 1, a kind of preparation of heat-clearing cough-relieving oral liquid for children
It is with the difference of embodiment 1：Flocculant in the step S3 is gelatin, remaining step such as embodiment 1.
Comparative example 2, a kind of preparation of heat-clearing cough-relieving oral liquid for children
It is with the difference of embodiment 1：Flocculant ZTC1+1 natural clarifying agent in the step S3, when addition, are first added
Component A in ZTC1+1 natural clarifying agent adds B component in ZTC1+1 natural clarifying agent, stirring, stands for 24 hours, and filtering must filter
Liquid III, remaining step such as embodiment 1.
Comparative example 3, a kind of preparation of heat-clearing cough-relieving oral liquid for children
It is with the difference of embodiment 8：Flocculant in the step S3 be flocculant be 1% acetum of chitosan and
ZTC1+1 natural clarifying agent by volume 1:1 composition, is first added 1% acetum of chitosan, stands 6min, is subsequently added into ZTC1
Component A in+1 natural clarifying agent stands 3min, and the B component being eventually adding in ZTC1+1 natural clarifying agent stands 6min,
Remaining step such as embodiment 8.
Comparative example 4, a kind of preparation of heat-clearing cough-relieving oral liquid for children
It is with the difference of embodiment 8：Flocculant in the step S3 be flocculant be 1% acetum of chitosan and
ZTC1+1 natural clarifying agent by volume 5:4 compositions, are first added 1% acetum of chitosan, stand 6min, are subsequently added into ZTC1
Component A in+1 natural clarifying agent stands 6min, and the B component being eventually adding in ZTC1+1 natural clarifying agent stands 6min,
Remaining step such as embodiment 8.
Comparative example 5, a kind of preparation of heat-clearing cough-relieving oral liquid for children
It is with the difference of embodiment 8：Flocculant in the step S3 be flocculant be 1% acetum of chitosan and
ZTC1+1 natural clarifying agent by volume 5:4 compositions are first added the component A in ZTC1+1 natural clarifying agent, stand 3min, then
The B component in ZTC1+1 natural clarifying agent is added, stands 6min, is eventually adding 1% acetum of chitosan, stands 6min,
Remaining step such as embodiment 8.
Comparative example 6, a kind of preparation of heat-clearing cough-relieving oral liquid for children
It is with the difference of embodiment 8：Flocculant in the step S3 be flocculant be 1% acetum of chitosan and
ZTC1+1 natural clarifying agent by volume 5:4 compositions are first added the B component in ZTC1+1 natural clarifying agent, stand 6min, then
The component A in ZTC1+1 natural clarifying agent is added, stands 3min, is eventually adding 1% acetum of chitosan, stands 6min,
Remaining step such as embodiment 8.
The quality testing test of test example one, heat-clearing cough-relieving oral liquid for children
1, test material：
Embodiment 1, embodiment 3, embodiment 4, embodiment 5, embodiment 6, embodiment 7, embodiment 8, is implemented embodiment 2
Heat-clearing cough-relieving oral liquid for children prepared by example 9, comparative example 1, comparative example 2, comparative example 3, comparative example 4, comparative example 5 and comparative example 6.
2, test method：
To embodiment 1, embodiment 2, embodiment 3, embodiment 4, embodiment 5, embodiment 6, embodiment 7, embodiment 8, reality
It is oral to apply infantile heat-clearing and antitussive prepared by example 9, comparative example 1, comparative example 2, comparative example 3, comparative example 4, comparative example 5 and comparative example 6
Liquid carries out clarity and Determination of ephedrine hydrochloride measurement.Wherein：
2.1, clarity measurement is measured using transmissometer.
2.2, content determination method of ephedrine hydrochloride is：
Precision measure this product 5mL, add water 10mL and concentrated ammonia liquor 0.5mL, with ether shaking extract 5 times (30mL, 30mL,
20mL, 20mL, 20mL), merge ether solution, add ethanol solution hydrochloride (1-20) 2mL, mixes, low temperature recycling design to dry, residue
Dissolved, be transferred in 25mL measuring bottle with ethyl alcohol 5mL, add 0.1mol/L hydrochloric acid solution to scale, shake up to get.Take hydrochloric acid Chinese ephedra
Alkali reference substance is appropriate, accurately weighed, adds the hydrochloric acid solution of 0.1mol/L that the reference substance solution of 45 μ g/ml is made.It is accurate respectively to draw
Reference substance solution and each 10 μ l of test solution inject liquid chromatograph, using octadecylsilane chemically bonded silica as filler；With
Acetonitrile-water-phosphoric acid (4.5:95:0.5) it is measured for mobile phase.
3, test result：
Test result is as shown in table 1.
The quality testing test result of 1 heat-clearing cough-relieving oral liquid for children of table
| Clarity (NTU) | Determination of ephedrine hydrochloride (mg/ml) | |
| Embodiment 1 | 30.8 | 0.22 |
| Embodiment 2 | 20.2 | 0.27 |
| Embodiment 3 | 25.5 | 0.26 |
| Embodiment 4 | 19.4 | 0.28 |
| Embodiment 5 | 17.5 | 0.30 |
| Embodiment 6 | 18.2 | 0.29 |
| Embodiment 7 | 5.0 | 0.32 |
| Embodiment 8 | 3.4 | 0.36 |
| Embodiment 9 | 5.4 | 0.30 |
| Comparative example 1 | > 100 | 0.10 |
| Comparative example 2 | 40.3 | 0.20 |
| Comparative example 3 | 9.8 | 0.29 |
| Comparative example 4 | 8.6 | 0.31 |
| Comparative example 5 | 16.4 | 0.30 |
| Comparative example 6 | 10.7 | 0.31 |
As shown in Table 1, the children clearing heat that the preparation method of heat-clearing cough-relieving oral liquid for children provided by the invention is prepared
Cough stopping oral liquor has clarity high, can achieve bright degree of clarifying, and clarity is less than 30.8NTU, and ephedrine hydrochloride contains
Amount is high, illustrates that the heat-clearing cough-relieving oral liquid for children for the flocculant process that the present invention uses can preferably retain infantile heat-clearing and antitussive mouth
The effective component in liquid is taken, keeps the stability of heat-clearing cough-relieving oral liquid for children more preferable, but also production technology can be shortened, is reduced
Production cost is a kind of preparation method of ideal heat-clearing cough-relieving oral liquid for children.
The stability test of test example two, heat-clearing cough-relieving oral liquid for children
1, test material：
Heat-clearing cough-relieving oral liquid for children prepared by embodiment 1, embodiment 2, embodiment 4 and embodiment 8.
2, test method：
With reference to《Two annex XIXC of Chinese Pharmacopoeia version in 2015》Test method, to embodiment 1, embodiment 2, embodiment
4 and the heat-clearing cough-relieving oral liquid for children for preparing of embodiment 8 in 25 DEG C ± 2 DEG C of temperature, relative humidity 60% ± 10%, carry out long-term
Test, measures the clarity and Determination of ephedrine hydrochloride of oral solution.
Wherein：
2.1, clarity measurement is measured using transmissometer.
2.2, content determination method of ephedrine hydrochloride is：
Precision measure this product 5mL, add water 10mL and concentrated ammonia liquor 0.5mL, with ether shaking extract 5 times (30mL, 30mL,
20mL, 20mL, 20mL), merge ether solution, add ethanol solution hydrochloride (1-20) 2mL, mixes, low temperature recycling design to dry, residue
Dissolved, be transferred in 25mL measuring bottle with ethyl alcohol 5mL, add 0.1mol/L hydrochloric acid solution to scale, shake up to get.Take hydrochloric acid Chinese ephedra
Alkali reference substance is appropriate, accurately weighed, adds the hydrochloric acid solution of 0.1mol/L that the reference substance solution of 45 μ g/ml is made.It is accurate respectively to draw
Reference substance solution and each 10 μ l of test solution inject liquid chromatograph, using octadecylsilane chemically bonded silica as filler；With
Acetonitrile-water-phosphoric acid (4.5:95:0.5) it is measured for mobile phase.
3, test result：
Test result is as shown in table 2.
The stability test of 2 heat-clearing cough-relieving oral liquid for children of table
As shown in Table 2, the children clearing heat that the preparation method of heat-clearing cough-relieving oral liquid for children provided by the invention is prepared
Cough stopping oral liquor is under conditions of 25 DEG C ± 2 DEG C of temperature, relative humidity 60% ± 10%, the clarification of heat-clearing cough-relieving oral liquid for children
Less, the heat-clearing cough-relieving oral liquid for children for illustrating that the present invention is prepared has in 12 months for degree and Determination of ephedrine hydrochloride variation
There is higher stability, and heat-clearing cough-relieving oral liquid for children made from most preferred embodiment 8 can keep oral solution in 18 months
Clarity and Determination of ephedrine hydrochloride be basically unchanged, can effectively extend the shelf-life of oral solution.
Claims (10)
1. a kind of preparation method of heat-clearing cough-relieving oral liquid for children, which is characterized in that the heat-clearing cough-relieving oral liquid for children by with
Lower ingredient and its parts by weight composition：45 parts of Chinese ephedra fries 60 parts of semen armeniacae amarae, 135 parts of gypsum, 45 parts of Radix Glycyrrhizae, 90 parts of radix scutellariae, plate indigo plant
90 parts of root, 45 parts of rhizoma menispermi, 100 parts of honey and 1.5 parts of sodium benzoate；
The preparation method of the heat-clearing cough-relieving oral liquid for children includes the following steps：
S1, which takes in Chinese ephedra and gypsum addition purified water, boils 25~35min of extraction, and the additive amount of the purified water is Chinese ephedra and stone
6~10 times of cream total weight, be subsequently added into rhizoma menispermi, Radix Isatidis, radix scutellariae, Radix Glycyrrhizae, fry semen armeniacae amarae boil extraction 100~
150min, filtering, takes filtrate, obtains filtrate I, filter residue is spare；
The filtered filter residue of step S1 is added purified water and boils 50~80min of extraction by S2, and the additive amount of the purified water is filter
6~10 times of slag total weight, filtering, take filtrate, obtain filtrate II, the filtrate I that step S1 is obtained is merged with filtrate II, are concentrated,
Obtain concentrate；
The concentrate that S3 obtains step S2 stirs, and the speed of agitator is 45~55r/min, and flocculant is added, and is stirred, and stands
For 24 hours, it filters, obtains filtrate II I；
Honey, sodium benzoate are added into the filtrate II I that step S3 is obtained by S4, and stirring and dissolving, constant volume is filling, sterilizing to get.
2. the preparation method of heat-clearing cough-relieving oral liquid for children as described in claim 1, which is characterized in that the step S1 is will
Chinese ephedra and gypsum are put into the purified water that temperature is 65~70 DEG C, and pressure extracts 25~35min under conditions of being 0.8~1.0MPa,
The additive amount of the purified water is 6~10 times of Chinese ephedra and gypsum total weight, is subsequently added into rhizoma menispermi, Radix Isatidis, radix scutellariae, sweet
Grass fries the purified water that semen armeniacae amarae is 65~70 DEG C in temperature, and pressure extracts 100~150min under conditions of being 0.8~1.0MPa,
Filtering, takes filtrate, obtains filtrate I.
3. the preparation method of heat-clearing cough-relieving oral liquid for children as described in claim 1, which is characterized in that the step S2 is will
The filtered filter residue of step S1 is put into the purified water that temperature is 65~70 DEG C, and pressure extracts 50 under conditions of being 0.8~1.0MPa
~80min, the additive amount of the purified water are 6~10 times of filter residue total weight, and filtering takes filtrate, obtains filtrate II, by step S1
Obtained filtrate I merges with filtrate II, and concentration obtains concentrate.
4. the preparation method of heat-clearing cough-relieving oral liquid for children as described in claim 1, which is characterized in that wad a quilt with cotton in the step S3
The additive amount of solidifying agent is the 5~15% of the volume of the concentrated liquid, and the processing time is 10~30min.
5. the preparation method of heat-clearing cough-relieving oral liquid for children as described in claim 1, which is characterized in that in the step S3
Flocculant is one or more of 1% acetum of chitosan, 101 fruit juice clarifiers and ZTC1+1 natural clarifying agent group
It closes；1% acetum of chitosan is molten for the homogeneous colloids that chitosan is configured to 2% (W/W) with the acetic acid of 1% (W/W)
Liquid；101 fruit juice clarifier is the aqueous solution that 5% (W/W) is configured to deionized water；In the ZTC1+1 natural clarifying agent
Component A is configured to the gel solution of 1% (W/W) with deionized water, and B component is configured to the solidifying of 1% (W/W) with 1% (W/W) acetic acid
Sol solution.
6. the preparation method of heat-clearing cough-relieving oral liquid for children as claimed in claim 5, which is characterized in that in the step S3
Flocculant is 1% acetum of chitosan.
7. the preparation method of heat-clearing cough-relieving oral liquid for children as claimed in claim 5, which is characterized in that in the step S3
Flocculant be 1% acetum of chitosan and ZTC1+1 natural clarifying agent by volume (4~6):(3~5) it forms.
8. the preparation method of heat-clearing cough-relieving oral liquid for children as claimed in claim 7, which is characterized in that in the step S3
Flocculant is 1% acetum of chitosan and ZTC1+1 natural clarifying agent by volume 5:4 compositions.
9. the preparation method of heat-clearing cough-relieving oral liquid for children as claimed in claim 7, which is characterized in that the flocculant adds
Add mode is：1% acetum of chitosan is first added, stands 4~8min, the A group being subsequently added into ZTC1+1 natural clarifying agent
Point, 2~4min is stood, the B component being eventually adding in ZTC1+1 natural clarifying agent stands 4~8min.
10. the preparation method of heat-clearing cough-relieving oral liquid for children as claimed in claim 9, which is characterized in that the flocculant
Addition manner is：1% acetum of chitosan is first added, stands 6min, the A group being subsequently added into ZTC1+1 natural clarifying agent
Point, 3min is stood, the B component being eventually adding in ZTC1+1 natural clarifying agent stands 6min.
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