CN109010584A - A kind of preparation method of tonifying spleen granule for infants - Google Patents
A kind of preparation method of tonifying spleen granule for infants Download PDFInfo
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Abstract
The present invention relates to a kind of preparation methods of tonifying spleen granule for infants, the method, steps are as follows: by Semen Lablab Album (stir-fry), Chinese yam (stir-fry), endothelium corneum gigeriae galli (stir-fry), Rhizoma Atractylodis Macrocephalae (stir-fry), bulbus fritillariae cirrhosae, radix aucklandiae Six-element medicinal material is extracted with supercritical liquid extraction technique, extracting solution concentration is spare, sodium bicarbonate is dissolved in saturated sodium chloride solution, by PEG6000 heating melting at liquid, two parts mixed melting, it is rapidly cooled to -20 DEG C, through ultra low temperature vacuum band drier, the abundant curing and drying at 30 DEG C, it is ground into 80 mesh fine powders, by spare concentrated extracting solution, fine powder, calculus bovis factitius, sweetener mixing, particle is made.
Description
Technical field
The present invention relates to a kind of preparation methods of tonifying spleen granule for infants.The invention further relates to a kind of carbonic acid simultaneously
The technique for packing of hydrogen sodium.Belong to pharmaceutical technology field.
Technical background
Tonifying spleen granule for infants is by Semen Lablab Album (stir-fry), Chinese yam (stir-fry), endothelium corneum gigeriae galli (stir-fry), Rhizoma Atractylodis Macrocephalae (stir-fry), bulbus fritillariae cirrhosae, radix aucklandiae, carbon
This 8 taste medicinal material of sour hydrogen sodium, calculus bovis factitius is prepared through modern crafts.Function and cure mainly it is as follows: invigorating the spleen helps digestion, antidiarrheal.With
Stagnant patient is held under the arm in baby's noninfectious diarrhea category spleen deficiency, and card is shown in: times of defecation increases, and excrement matter is dilute, and gas is smelly, containing not changing it
Object, lustreless complexion, newborn deficiency of food is into, abdominal distension abdominal pain, insomnia etc..
Tonifying spleen granule for infants is by Semen Lablab Album (stir-fry) 50-200 parts by weight, Chinese yam (stir-fry) 30-50 parts by weight, endothelium corneum gigeriae galli (stir-fry)
10-50 parts by weight, Rhizoma Atractylodis Macrocephalae (stir-fry) 10-50 parts by weight, bulbus fritillariae cirrhosae 10-50 parts by weight, radix aucklandiae 10-50 parts by weight, sodium bicarbonate
10-50 parts by weight, calculus bovis factitius 1-5 parts by weight are prepared.
Preparation method is as follows: above eight taste, takes Rhizoma Atractylodis Macrocephalae, radix aucklandiae to extract volatile oil, another device is collected after aqueous solution filtration；The dregs of a decoction
Added water to cook with Semen Lablab Album, Chinese yam, endothelium corneum gigeriae galli, bulbus fritillariae cirrhosae it is secondary, 1.5 hours every time, collecting decoction, filtration, filtrate with it is above-mentioned
Aqueous solution merges, and is concentrated into the clear cream that relative density is 1.20~1.25 (60~70 DEG C), and calculus bovis factitius is finely ground, with carbonic acid
Hydrogen sodium and cane sugar powder (950g) facing-up are mixed, are added in above-mentioned clear cream, mix, particle is made.It is dry, above-mentioned volatilization is added
Oil, mix, be made 1000g to get.
Supercritical liquid extraction technique brief introduction:
Traditional decocting process is easy to keep medicinal material local temperature excessively high, cannot complete desorption, dissolution, diffusion very well.It is super to face
Boundary's fluid extraction is state-of-the-art physical extraction technology in the world, abbreviation SFE (supercritical fluid
extraction).At a lower temperature, when being continuously increased the pressure of gas, gas can be converted to liquid, when pressure increases,
The volume of liquid increases, and there is always a critical-temperature (Tc) and critical pressures (Pc) for a certain specific substance, high
In critical-temperature and critical pressure, substance will not become liquid or gas, and this point is exactly critical point.More than critical point
In range, state of matter is between gas and liquid, and the fluid within the scope of this becomes supercritical fluid (SF).It is super to face
The relatively strong penetrating power and greater density and solubility similar to liquid that boundary's fluid has similar gas, have good solvent
Characteristic, can be used as solvent extracted, separating monomer.
The traditional distillation of supercritical fluid extraction and organic solvent extraction integrally combine, and utilize excellent molten of supercritical CO 2
Matrix is efficiently separated, extracted and purified with extract, extracted using supercritical CO 2 to material by agent power.CO2 is peace
Entirely, nontoxic, cheap liquid, supercritical CO 2 have the dissolving power of the diffusion coefficient of similar gas, liquid, and surface tension is
Zero, can penetrate among solid matter rapidly, mention and selecting the essence, have it is efficient, not oxidizable, pure natural, without chemical contamination etc.
Feature.To make the research application of traditional Chinese medicine extraction enter new developing stage, a new way is opened for extraction process.
Modern granule, it is desirable that dissolution is fast, and solution clarification, in good taste, curative effect is rapid, and but the prior art is difficult to obtain
Such particle, the grain dissolution speed that the prior art obtains is slow, to find out its cause, being to contain costunolide in drug and go
The refractory components that hydrogen constuslactone and part and sodium bicarbonate generate after combining make so.The present invention is to overcome the prior art
The shortcomings that, the present invention uses the extracting method of supercritical fluid extraction, not only remains ingredient to greatest extent, more makes particle
Enhanced dissolution rate.
Summary of the invention
The purpose of the present invention is to provide a kind of preparation methods of tonifying spleen granule for infants
It is another object of the present invention to provide a kind of technique for packing of sodium bicarbonate.
The object of the present invention is achieved like this: continued to optimize by the technique to prescription, by the medicinal material in prescription press than
Example extracts, and makes to extract more abundant by optimizing extracting parameter using adverse current extractive technique.Mixed with auxiliary material and clear cream
It closes, using suitable granulation technique, obtains particle appropriate.
For this purpose, the present invention provides a kind of preparation method of tonifying spleen granule for infants, the method, steps are as follows: by Semen Lablab Album
(stir-fry), Chinese yam (stir-fry), endothelium corneum gigeriae galli (stir-fry), Rhizoma Atractylodis Macrocephalae (stir-fry), bulbus fritillariae cirrhosae, radix aucklandiae Six-element medicinal material are mentioned with supercritical liquid extraction technique
It taking, extracting solution concentration is spare, sodium bicarbonate is dissolved in saturated sodium chloride solution, by PEG6000 heating melting at liquid,
Two parts mixed melting, is rapidly cooled to -20 DEG C, through ultra low temperature vacuum band drier, the abundant curing and drying at 30 DEG C,
80 mesh fine powders are ground into, by spare concentrated extracting solution, fine powder, particle is made in calculus bovis factitius, sweetener mixing.
Tonifying spleen granule for infants of the present invention is prepared by the Chinese medicine material medicine of following weight proportion: Semen Lablab Album (stir-fry)
50-200 parts by weight, Chinese yam (stir-fry) 30-50 parts by weight, endothelium corneum gigeriae galli (stir-fry) 10-50 parts by weight, Rhizoma Atractylodis Macrocephalae (stir-fry) 10-50 parts by weight,
Bulbus fritillariae cirrhosae 10-50 parts by weight, radix aucklandiae 10-50 parts by weight, sodium bicarbonate 10-50 parts by weight, calculus bovis factitius 1-5 parts by weight,
Currently preferred preparation method, steps are as follows:
1), Semen Lablab Album (stir-fry), Chinese yam (stir-fry), endothelium corneum gigeriae galli (stir-fry), Rhizoma Atractylodis Macrocephalae (stir-fry), bulbus fritillariae cirrhosae, radix aucklandiae Six-element medicinal material are used
Supercritical liquid extraction technique extracts, and obtains extracting solution, wherein extracting pressure 25-30Mpa, extraction temperature 35-45 degree, when extraction
Between 1-3 hours, 25-45 kgs/hour of the flow of CO2；
2) sodium bicarbonate is wrapped up using PEG6000, and fine powder is dried, crushed into after package, wherein sodium bicarbonate and
The weight ratio of PEG6000 is 1:0.5-1:5,
3) by extracting solution, fine powder, particle is made in calculus bovis factitius, sweetener mixing.
Wherein step 1) supercritical liquid extraction technique is CO_2 supercritical technology, wherein in step 1), extraction pressure
Power 25Mpa, 45 degree of extraction temperature, extraction time 1 hour, 25 kgs/hour of the flow of CO2.
The wherein step 2) package, steps are as follows: first sodium bicarbonate is first dissolved in saturated sodium chloride solution,
PEG6000 heating melting is rapidly cooled to -20 DEG C using cryogenic freezing technology, through ultra low temperature vacuum at liquid, mixed melting
Band drier, the abundant curing and drying at 30 DEG C, is ground into 80 mesh fine powders.
The present invention is by medicinal material, using supercritical liquid extraction technique, for extracting pressure, extraction temperature, extraction particle,
The flow of CO2 carries out technical study, carries out craft screening by above-mentioned parameter, determines optimum extraction process.
The present invention has carried out package to sodium bicarbonate to improve solution rate: sodium bicarbonate being first first dissolved in saturation chlorine
Change in sodium solution, PEG6000 heating melting is joined at liquid, mixed melting for substrates quantity, cryogenic temperature, drying temperature etc.
Number is screened, and determines best packing technology.
The present invention is by medicine preparation at granule.Wherein filler are as follows: cane sugar powder.Using wet granulation according to molding need
It asks, determines related manufacturing processes, carry out machine point with automatic granule packing machine, finally pack.
In order to improve the dissolution of the active principle in tonifying spleen granule for infants medicinal material, according to experiment parameter, optimization mentions accordingly
Take parameter.
Its preferred process is as follows:
It is Semen Lablab Album (stir-fry) 50-200 parts by weight, Chinese yam (stir-fry) 30-50 parts by weight, endothelium corneum gigeriae galli (stir-fry) 10-50 parts by weight, white
Art (stir-fry) 10-50 parts by weight, bulbus fritillariae cirrhosae 10-50 parts by weight, radix aucklandiae 10-50 parts by weight, using ultrasonic adverse current extractive technique.Root
(become a full member the detection of the 30th WS3-253 (Z-046) -2001Z tonifying spleen granule for infants of standard referring to new drug according to testing result
Method), carry out experiment screening.It is shown in Table 1
The extraction of step 1 carries out process optimization, using ultrasonic wave adverse current extractive technique.It is to examine with the sodium bicarbonate rate of transform
It examines index and carries out orthogonal experiment by 4 factor 3 is horizontal, using clear cream yield as reference index, carry out process optimization experimental result and side
Difference analysis is shown in Table 1, table 2, table 3.
Table 1 influences 4 factor, 3 water-glass that tonifying spleen granule for infants extracts
The orthogonal design table that table 2 is screened about extraction factor
Table 3 influences the variance analysis that content extracts the factor of the rate of transform
(F critical value is greater than 19, there is conspicuousness)
As can be seen from the above table: extracting pressure is most significant factor, followed by extraction temperature.Comprehensive energy consumption is optimal
It is required that therefore use extracting pressure 25Mpa, 45 degree of extraction temperature, extraction time 1 hour, 25 kgs/hour of flow of CO2 were
Optimum extraction process.
In order to improve the finished product stability of tonifying spleen granule for infants, content degradation rate is reduced, according to experiment parameter, optimizes phase
The parameter answered.
Its preferred process is as follows:
Since tonifying spleen granule for infants is wet granulation, paste containing amount is larger, and particle draws moist relatively strong, therefore leads to carbonic acid
The content degradation of hydrogen sodium is fast, for this case, carries out sodium bicarbonate technique for packing, carries out from step 2, first by sodium bicarbonate
It being first dissolved in saturated sodium chloride solution, PEG6000 heating melting is at liquid, mixed melting, fast using cryogenic freezing technology
Speed is cooled to -20 DEG C, and through ultra low temperature vacuum band drier, 30 degree of abundant curing and dryings are ground into the particle of 80 mesh, and make
For at tonifying spleen granule for infants sample, carrying out high temperature and humidity experiment to the tonifying spleen granule for infants sample of preparation, (experimental design is referring in
2015 editions the 4th material medicines of state's pharmacopeia and preparation stability test direction principle), sample is tested in collection in the 10th day of experiment
Product, and test experience data.Process optimization is carried out by reference index of sodium bicarbonate content.It is shown in Table 4.
4 packing technology effect expedition table of table
By upper table data it can be seen that
As material proportion (raw material: matrix) 1:4, the content rate of descent of sodium bicarbonate is 0.19%, when material proportion is (former
Material: matrix) continue to improve to 1:4.5, when 1:5, the content rate of descent of sodium bicarbonate without significant downward trend, because
This thinks from the angle of economy and energy consumption, when sodium bicarbonate carries out package material proportion (raw material: matrix) 1:4 using PEG6000
When be best.
It is therefore preferable that optimised process are as follows:
It is Semen Lablab Album (stir-fry) 50-200 parts by weight, Chinese yam (stir-fry) 30-50 parts by weight, endothelium corneum gigeriae galli (stir-fry) 10-50 parts by weight, white
Art (stir-fry) 10-50 parts by weight, bulbus fritillariae cirrhosae 10-50 parts by weight, radix aucklandiae 10-50 parts by weight, using supercritical liquid extraction technique,
Extracting pressure 25Mpa, 45 degree of extraction temperature, extraction time 1 hour, 25 kgs/hour of the flow of CO2, extracting solution was concentrated into suitable
Amount.First sodium bicarbonate is first dissolved in saturated sodium chloride solution, PEG6000 heating melting is used at liquid, mixed melting
Cryogenic freezing technology is rapidly cooled to -20 DEG C, and through ultra low temperature vacuum band drier, the abundant curing and drying at 30 DEG C is crushed
At 80 mesh fine powders, said extracted liquid and fine powder and calculus bovis factitius 1-5 parts by weight, cane sugar powder are mixed in right amount, are made 1000 grams
Grain.Packaging to get.
Detection method of content
It is measured according to high performance liquid chromatography (VI D of annex).
[assay] ether-soluble extractive takes this product 20g, accurately weighed, sets in Soxhlet extractor, adds diethyl ether appropriate,
It is heated to reflux 3 hours, lets cool, filter, filtrate low temperature is concentrated into 20ml, sets in the evaporating dish of constant weight, continues low temperature and is concentrated into
It is dry, residue set it is 24 hours dry in sulphuric acid desiccator, it is accurately weighed rapidly, calculate to get.
This product should must not be less than 0.01% containing ether-soluble extractive.
Sodium bicarbonate this product 4g, it is accurately weighed, it sets in conical flask, adds water 25ml, shaking makes to dissolve.Precision measures hydrochloric acid
Liquid (0.1mol/L) 25ml, is slowly added into conical flask, when no bubble generates, is heated to boiling, lets cool to room temperature, add phenol
Phthalein indicator solution 3 drips, and it is in orange red for being titrated to solution with caustic lye of soda (0.1mol/L), and is not taken off within half a minute for yellow.
Blank test correction is done simultaneously.Every 1ml hydrochloric acid solution (0.1mol/L) is equivalent to the sodium bicarbonate (NaHCO3) of 8.4mg.
This product should be between 2.7~3.3% containing sodium bicarbonate (NaHCO3).
The sample for choosing optimised process preparation carries out accelerated stability investigation, investigates condition are as follows: 40 DEG C ± 2 DEG C of temperature, phase
It is placed 6 months under conditions of humidity 75% ± 5%.0th month during test, the 1st month, the 2nd month, the 3rd month,
6th month separately sampled primary, is detected.As shown in the table
The accelerated stability data of 5 scheme of table
Solution rate experiment:
Obtain from above-mentioned all data analyses: the sample prepared using optimised process is better than the stability of standard technology, institute
Product is anti-draws that wet ability is strong, stability is strong, curative effect is stablized；Integrated artistic is easily operated, is suitable for popularization and application.
Specific embodiment
Present invention is further described in detail with reference to embodiments.
A kind of embodiment 1: preparation method of tonifying spleen granule for infants
50 parts by weight of Semen Lablab Album (stir-fry), 30 parts by weight of Chinese yam (stir-fry), 10 parts by weight of endothelium corneum gigeriae galli (stir-fry), 10 weight of Rhizoma Atractylodis Macrocephalae (stir-fry)
Part, 10 parts by weight of bulbus fritillariae cirrhosae, 10 parts by weight of radix aucklandiae are measured, using supercritical liquid extraction technique, extracting pressure 25Mpa, extraction temperature
45 degree of degree, extraction time 1 hour, 25 kgs/hour of the flow of CO2, extracting solution was concentrated into right amount.It is first that sodium bicarbonate is first molten
In saturated sodium chloride solution, PEG6000 heating melting is cooled down rapidly at liquid, mixed melting using cryogenic freezing technology solution
To -20 DEG C, through ultra low temperature vacuum band drier, the abundant curing and drying at 30 DEG C is ground into 80 mesh fine powders, mentions above-mentioned
It takes liquid and fine powder and 1 parts by weight of calculus bovis factitius, cane sugar powder to mix in right amount, 1000 grams of particles is made.Packaging to get.
A kind of embodiment 2: preparation method of tonifying spleen granule for infants
100 parts by weight of Semen Lablab Album (stir-fry), 40 parts by weight of Chinese yam (stir-fry), 30 parts by weight of endothelium corneum gigeriae galli (stir-fry), 30 weight of Rhizoma Atractylodis Macrocephalae (stir-fry)
Part, 30 parts by weight of bulbus fritillariae cirrhosae, 30 parts by weight of radix aucklandiae are measured, using supercritical liquid extraction technique, extracting pressure 25Mpa, extraction temperature
45 degree of degree, extraction time 1 hour, 25 kgs/hour of the flow of CO2, extracting solution was concentrated into right amount.It is first that sodium bicarbonate is first molten
In saturated sodium chloride solution, PEG6000 heating melting is cooled down rapidly at liquid, mixed melting using cryogenic freezing technology solution
To -20 DEG C, through ultra low temperature vacuum band drier, the abundant curing and drying at 30 DEG C is ground into 80 mesh fine powders, mentions above-mentioned
It takes liquid and fine powder and 3 parts by weight of calculus bovis factitius, cane sugar powder to mix in right amount, 1000 grams of particles is made.Packaging to get.
Comparative example 1
50 parts by weight of Semen Lablab Album (stir-fry), 30 parts by weight of Chinese yam (stir-fry), 10 parts by weight of endothelium corneum gigeriae galli (stir-fry), 10 weight of Rhizoma Atractylodis Macrocephalae (stir-fry)
Measure part, 10 parts by weight of bulbus fritillariae cirrhosae, 10 parts by weight of radix aucklandiae, preparation method is as follows: above eight taste takes Rhizoma Atractylodis Macrocephalae, radix aucklandiae to extract volatile oil,
Another device is collected after aqueous solution filtration；The dregs of a decoction add water to cook secondary with Semen Lablab Album, Chinese yam, endothelium corneum gigeriae galli, bulbus fritillariae cirrhosae, and 1.5 is small every time
When, collecting decoction filters, and filtrate merges with above-mentioned aqueous solution, and being concentrated into relative density is 1.20~1.25 (60~70 DEG C)
Clear cream, calculus bovis factitius is finely ground, it with sodium bicarbonate and cane sugar powder (950g) facing-up, mixes, is added in above-mentioned clear cream, mix, system
At particle.It is dry, above-mentioned volatile oil is added, mixes, be made 1000g to get.
Claims (4)
1. a kind of preparation method of tonifying spleen granule for infants, the tonifying spleen granule for infants by following weight proportion Chinese medicine material medicine system
It is standby to form: Semen Lablab Album (stir-fry) 50-200 parts by weight, Chinese yam (stir-fry) 30-50 parts by weight, endothelium corneum gigeriae galli (stir-fry) 10-50 parts by weight, Rhizoma Atractylodis Macrocephalae
(stir-fry) 10-50 parts by weight, bulbus fritillariae cirrhosae 10-50 parts by weight, radix aucklandiae 10-50 parts by weight, sodium bicarbonate 10-50 parts by weight, artificial ox
Yellow 1-5 parts by weight, the preparation method, steps are as follows:
1), Semen Lablab Album (stir-fry), Chinese yam (stir-fry), endothelium corneum gigeriae galli (stir-fry), Rhizoma Atractylodis Macrocephalae (stir-fry), bulbus fritillariae cirrhosae, radix aucklandiae Six-element medicinal material are faced using super
Boundary's fluid extraction technology extracts, and obtains extracting solution, wherein extracting pressure 25-30Mpa, extraction temperature 35-45 degree, extraction time 1-3
Hour, 25-45 kgs/hour of the flow of CO2；
2) sodium bicarbonate is wrapped up using PEG6000, fine powder is dried, crushed into after package, wherein sodium bicarbonate and PEG6000
Weight ratio be 1:0.5-1:5,
3) by extracting solution, fine powder, particle is made in calculus bovis factitius, sweetener mixing.
2. preparation method according to claim 1, which is characterized in that wherein step 1) supercritical liquid extraction technique is super
Critical CO2 abstraction technique.
3. preparation method according to claim 1, which is characterized in that wherein in step 1), extracting pressure 25Mpa, extraction
45 degree of temperature, extraction time 1 hour, 25 kgs/hour of the flow of CO2.
4. preparation method according to claim 1, which is characterized in that the wherein step 2) package, steps are as follows: first will
Sodium bicarbonate is first dissolved in saturated sodium chloride solution, and PEG6000 heating melting is at liquid, mixed melting, using cryogenic freezing
Technology is rapidly cooled to -20 DEG C, and through ultra low temperature vacuum band drier, at 30 DEG C, abundant curing and drying, it is thin to be ground into 80 mesh
Powder.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112316103A (en) * | 2020-10-28 | 2021-02-05 | 健民药业集团股份有限公司 | Preparation method of infant spleen-tonifying powder |
| CN115400151A (en) * | 2022-06-08 | 2022-11-29 | 成都中医药大学 | Processed chicken's gizzard-membrane product and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1227748A (en) * | 1998-03-03 | 1999-09-08 | 四川梓橦宫制药有限公司 | Novel method for preparing ultramicro infant essence |
| CN1544065A (en) * | 2003-11-20 | 2004-11-10 | 张晴龙 | Effervescence tablet for treating cold and fever and its preparation |
| CN102579784A (en) * | 2011-12-21 | 2012-07-18 | 江西济民可信药业有限公司 | Preparation method of tonifying spleen granule for infants |
-
2018
- 2018-08-24 CN CN201810970892.6A patent/CN109010584A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1227748A (en) * | 1998-03-03 | 1999-09-08 | 四川梓橦宫制药有限公司 | Novel method for preparing ultramicro infant essence |
| CN1544065A (en) * | 2003-11-20 | 2004-11-10 | 张晴龙 | Effervescence tablet for treating cold and fever and its preparation |
| CN102579784A (en) * | 2011-12-21 | 2012-07-18 | 江西济民可信药业有限公司 | Preparation method of tonifying spleen granule for infants |
Non-Patent Citations (3)
| Title |
|---|
| 李广洲等: "《学科教学详解 初中化学》", 31 July 2015, 湖南教育出版社 * |
| 申奕等: "《化工典型设备操作技术》", 31 January 2014, 天津大学出版社 * |
| 谢秀琼: "《现代中药制剂新技术》", 30 June 2004, 化学工业出版社 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112316103A (en) * | 2020-10-28 | 2021-02-05 | 健民药业集团股份有限公司 | Preparation method of infant spleen-tonifying powder |
| CN115400151A (en) * | 2022-06-08 | 2022-11-29 | 成都中医药大学 | Processed chicken's gizzard-membrane product and preparation method thereof |
| CN115400151B (en) * | 2022-06-08 | 2024-09-20 | 成都中医药大学 | Chicken's gizzard-membrane processed product and preparation method thereof |
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