CN110448594A - A kind of preparation process and compound red sage root preparation of compound red sage root preparation - Google Patents
A kind of preparation process and compound red sage root preparation of compound red sage root preparation Download PDFInfo
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Abstract
The invention discloses a kind of preparation process of compound red sage root preparation and compound red sage root preparations, preparation process includes carrying out pre-treatment to Radix Salviae Miltiorrhizae, in pre-treatment step, red rooted salvia is classified according to the diameter on main root top, sorts, match, cutting, obtains Radix Salviae Miltiorrhizae slice.It is one kind that the diameter on red rooted salvia main root top, which is less than 0.5cm, and it is two classes that the diameter on main root top, which is greater than or equal to 0.5cm, and the total amount of feeding of every batch of red rooted salvia is identical, according to tanshinone, Tanshinone IIAA kind of and two class red rooted salvias are configured in proportion with the content of tanshin polyphenolic acid B.Preparation process of the invention classifies to red rooted salvia, sorts, and has carried out reasonable proportion, also improves preparation process, and the content and yield of effective component can be improved, while reducing the difference between batch, improves production efficiency.
Description
Technical field
The invention belongs to field of medicaments, specifically, being related to the preparation process and compound Danshen Root of a kind of compound red sage root preparation
Preparation.
Background technique
Cardiovascular and cerebrovascular disease is the first disease for leading to human death, raising and population with social standard of living
Aging, the research of cardiovascular and cerebrovascular diseases medicament become the hot spot of drug development.Coronary atherosclerotic heart disease, referred to as
Coronary heart disease, the cause of disease are deposited on dynamic due to some blood lipid substances such as cholesterol, triglycerides etc. that cannot infilter arterial wall
It is formed after " atheromatous plaque " on arteries and veins inner membrance because of calmness calcareous in liquid, so that original flexible artery is hardened.With artery
Atheromatous plaque range on inner membrance increases, and causes lumen of vessels to narrow even and blocks, causes myocardial ischemia, anoxic or necrosis.Ischemic
Property headstroke (cerebral infarction), acute attack stage and apoplexy early period and convalescence be its prevent and treat it is important when
Machine.
Traditional Chinese medicine plays an important role in the prevention and treatment of above-mentioned disease, especially using Radix Salviae Miltiorrhizae as primary raw material
Folk prescription or compound preparation have exact curative effect, such as Fufang Danshen Pian, compound Danshen Root particle, compound injection of red sage root.
Since the effective component in Radix Salviae Miltiorrhizae such as tanshinone IIA, the tanshin polyphenolic acid B content difference in different medicinal materials are larger,
In the preparation process of compound red sage root preparation, if only the total amount of feeding of the raw material of control different batches preparation is identical, it is easy
Effective component and yield between different batches is caused to differ greatly.The preparation process of existing compound red sage root preparation exist effectively at
Point content it is lower, yield is lower, the problem of differing greatly between batch.
In view of this present invention is specifically proposed.
Summary of the invention
The technical problem to be solved in the present invention is that overcoming the deficiencies of the prior art and provide a kind of system of compound red sage root preparation
Standby technique and compound red sage root preparation, preparation process of the invention carries out sorting to red rooted salvia, and improves preparation process,
The content and yield of effective component are improved, while reducing the difference between batch, improves production efficiency.
In order to solve the above technical problems, the present invention is using the basic conception of technical solution:
The first object of the present invention is to provide a kind of preparation process of compound red sage root preparation, preparation process include to Radix Salviae Miltiorrhizae into
Red rooted salvia is classified according to the diameter on main root top in pre-treatment step, sorts, matches, cutting by row pre-treatment,
Obtain Radix Salviae Miltiorrhizae slice.
Red rooted salvia is the dry root of Lamiaceae Salvia platymiscium Radix Salviae Miltiorrhizae, is a kind of conventional Chinese medicine, is loaded in " legendary god of farming's book on Chinese herbal medicine
Through ", it is classified as top grade.Its cold nature, bitter have blood circulation and promoting silt, swelling and pain relieving, the function of nourishing blood and tranquilization, to angina pectoris and the heart
Flesh infarct has certain curative effect.Effective component is two major classes in Radix Salviae Miltiorrhizae, i.e., fat-soluble luxuriant and rich with fragrance quinones, such as: salvia miltiorrhiza bge I, pellet
Join ketone IIA, Tanshinone IIBWith Cryptotanshinone etc. and water soluble ingredient, such as: danshensu, protocatechualdehyde, salviandic acid A, tanshin polyphenolic acid B
With salvianolic acid C etc..Ester soluble components such as tanshinone is mainly distributed on the (portion other than forming layer, skin zone of its root in red rooted salvia
Point)；And water soluble ingredient such as danshinolic acid etc. is mainly distributed on the marrow of its root.Because thinner Radix Salviae Miltiorrhizae possesses relatively large surface
Product, the thinner red rooted salvia Tanshinone II of rhizomeAContent is higher instead.
In preparation process of the invention, in the case where the total amount of feeding of each batch preparation is constant, every time in Radix Salviae Miltiorrhizae
In pre-treatment step, red rooted salvia is classified according to the diameter on red rooted salvia main root top, is sorted, collocation is thrown in proportion
Material provides the controllability and stabilization of technique so as to greatly reduce the difference of active constituent content and yield between different batches
Property.
Further embodiment, it is one kind that the diameter on red rooted salvia main root top, which is less than 0.5cm, and the diameter on main root top is greater than
Or being equal to 0.5cm is two classes, the total amount of feeding of every batch of red rooted salvia is identical, according to tanshinone in a kind of and two class red rooted salvias
ⅡAA kind of and two class red rooted salvias will be configured in proportion with the content of tanshin polyphenolic acid B.
Tanshinone II in a kind of red rooted salviaAContent be higher than two class medicinal materials, if every batch of only total amount of feeding it is identical without
Collocation feeds intake, the Tanshinone II of product between different batchesA, the content difference of the effective components such as tanshin polyphenolic acid B it is larger, part batch produces
Product content is relatively low.In the case where total medicinal material inventory of every batch of is fixed, in the pre-treatment step of Radix Salviae Miltiorrhizae, first according to main root
The diameter on top is classified, moisture, tanshinone, Tanshinone II in detection one kind and two class medicinal materialsAAnd tanshin polyphenolic acid B etc. has
The content of ingredient is imitated, then respectively content conversion ratio carries out collocation and feeds intake according to a kind of and two class medicinal materials, wants to meet finished product
It asks, while batch wise differences can be greatly reduced.
Further embodiment after the completion of Radix Salviae Miltiorrhizae pre-treatment, extracts concentration, and extracting concentration step includes: that Radix Salviae Miltiorrhizae adds second
Alcohol impregnates, and is heated to reflux, and extracting solution filtration recycling ethyl alcohol is simultaneously concentrated spare；The dregs of a decoction add 50% ethyl alcohol, are heated to reflux, extracting solution filter
It crosses recycling ethyl alcohol and is concentrated spare；The dregs of a decoction add water to cook, and extracting solution is filtered and is concentrated spare.
Further embodiment, extracting concentration step includes: to extract for the first time: 3-7 times of medicinal material throwing amount being added in Radix Salviae Miltiorrhizae
95% ethyl alcohol impregnates 1h, is heated to reflux 1.5h；
Second of extraction: 50% ethyl alcohol of 2-5 times of medicinal material throwing amount is added in the dregs of a decoction, is heated to reflux 1.5h；
Third time is extracted: the water of 2-5 times of medicinal material throwing amount being added in the dregs of a decoction, decocts 2h；
Further embodiment, the extracting solution that 95% ethyl alcohol obtains after extracting are concentrated into relative density at a temperature of 30-60 DEG C
For 0.80-0.90g/ml, temperature is controlled when measuring relative density at 30-40 DEG C；The extracting solution that 50% ethyl alcohol obtains after extracting exists
It is 1.00-1.10g/ml that relative density is concentrated at a temperature of 30-60 DEG C, and temperature is controlled when measuring relative density at 30-40 DEG C；Water
It is 1.00-1.10g/ml that the extracting solution obtained after extraction is concentrated into relative density at a temperature of 40-60 DEG C, when measuring relative density
Temperature is controlled at 50-60 DEG C.
In the preparation process of original compound red sage root preparation, temperature control is no more than 80 DEG C in extracting solution concentration process, temperature
Degree is higher, and amount of activated substance is easy inactivation and degradation, causes yield lower.In the improved technique of the present invention, by extracting solution
The temperature control that whole process is concentrated is no more than 60 DEG C, and temperature is lower, it is ensured that the activity of substance is conducive to improve yield.
During extracting concentration, different solvents is adapted to using different temperature, i.e. ethanol extract concentration is using 30-60 DEG C
Temperature, aqueous extract concentration use 40-60 DEG C of temperature, to can obtain higher receipts after guaranteeing all extracting solution concentrations
Rate.Control when measurement relative density is also specified since concentrated solution density will be different with temperature Different Results, in this programme
Temperature processed, it is ensured that the consistency in batch production process reduces batch wise differences, is conducive to quality control.
Further embodiment after Radix Salviae Miltiorrhizae extracts concentration, each concentrate is mixed, is spray-dried, and is obtained
Radix Salviae Miltiorrhizae extractum powder, wherein the moisture that the Radix Salviae Miltiorrhizae extractum powder contains is not more than 5%；
Preferably, it is 170-190 DEG C that the parameter of spray drying, which includes: inlet air temperature, the speed of spray drying infusion motor
For 10-30HZ.
When preparing Radix Salviae Miltiorrhizae extractum powder, the moisture control that extract powder is contained is being not more than 5% degree, guarantees that compound is red
The drying time that the later period prepares compound Danshen Root particle can be greatly shortened while joining formulation products moisture, improve production effect
Rate.
Radix Notoginseng is ground into fine powder by further embodiment, the Radix Salviae Miltiorrhizae extractum powder and Radix Notoginseng powder of acquisition and dextrin is added mixed
It closes in granulator, is uniformly mixed, wetting agent is added, carry out wet granulation；Wherein, 70% ethyl alcohol of wetting agent, dosage are
Ten thousand bags of 1.5-2.5kg/
Preferably, incorporation time 10min.
Further embodiment, wet granulation is dry by wet granular after the completion, sieves, and obtains compound Danshen Root intermediate particle；It is dry
The moisture of particle is not more than 5% after dry；
Preferably, it is dried using boiling drier, dry temperature is≤85 DEG C.
Further embodiment, borneol is finely ground, is dissolved with dehydrated alcohol, is equably sprayed in compound Danshen Root intermediate particle, spray
Film-coating, coated granule drying screening, total mix, dispense, are packaged into compound Danshen Root finished granule；Contain after coated granule is dry
Moisture less than 4%.
The second object of the present invention is to provide a kind of compound red sage root preparation, the compound red sage root preparation as described in scheme as above
Preparation process is prepared；
Preferably, the compound red sage root preparation is compound Danshen Root particle.
After adopting the above technical scheme, compared with the prior art, the invention has the following beneficial effects:
1, due to the main component Tanshinone II in Radix Salviae MiltiorrhizaeA, tanshin polyphenolic acid B two kinds of content component differences in inhomogeneity medicinal material
It is larger.In preparation process of the invention, in the case where the total amount of feeding of each batch preparation is constant, every time at the preceding place of Radix Salviae Miltiorrhizae
Manage step in, Radix Salviae Miltiorrhizae is classified according to the diameter on red rooted salvia main root top, is sorted, in proportion collocation feed intake, so as to
To greatly reduce the difference of active constituent content and yield between different batches, the controllability and stability of technique are provided.
2, it in preparation process of the invention, during extracting concentration, adapts to different solvents and uses different temperature,
I.e. ethanol extract concentration uses 30-60 DEG C of temperature, and aqueous extract concentration uses 40-60 DEG C of temperature, to guarantee all
Higher yield can be obtained after extracting solution concentration.The temperature control of extracting solution concentration whole process is no more than 60 by the present invention
DEG C, temperature is lower, can be conducive to the yield for improving effective component to avoid active principle high temperature deactivation or degradation.It is also bright simultaneously
Really control temperature when measurement relative density, it is ensured that consistency in batch production process reduces batch wise differences, is conducive to matter
Amount control.
3, in preparation process of the invention, when preparing Radix Salviae Miltiorrhizae extractum powder, the moisture that extract powder is contained is controlled little
In 5% degree, the later period can be greatly shortened by guaranteeing while compound red sage root preparation product moisture prepares compound Danshen Root particle
Drying time, improve production efficiency.
4, in preparation process of the invention, the temperature that concentration is controlled in concentration process is in lower range；Wet granular is dry
It is dried during dry using boiling drier, and controls pellet moisture, in this way, multiple control parameters and step are optimized,
The controllability of technique is improved, the yield of particle significantly improves.
Specific embodiment
In order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below in conjunction with the embodiment of the present invention
Technical solution is clearly and completely described, the following examples are intended to illustrate the invention, but is not limited to model of the invention
It encloses.
Embodiment 1
For preparing 100,000 bags of compound Danshen Root particles, every bag of compound Danshen Root particle 1g.
(1) Radix Salviae Miltiorrhizae extractum powder extracts
1. Radix Salviae Miltiorrhizae pre-treatment: Radix Salviae Miltiorrhizae being classified according to the diameter on red rooted salvia main root top, is sorted；Red rooted salvia master
It is one kind that the diameter on root top, which is less than 0.5cm, and it is two classes that the diameter on main root top, which is greater than or equal to 0.5cm,.
A kind of content with each effective component in two class red rooted salvias of detection；With reference to Chinese Pharmacopoeia version 76-77 in 2015
Detection method in page detects tanshinone, Tanshinone IIAWith the content of tanshin polyphenolic acid B.
As a result as follows:
| Classification | Moisture | Tanshinone | Tanshinone IIA | Tanshin polyphenolic acid B |
| It is a kind of | 11.4% | 0.59% | 0.35% | 5.3% |
| Two classes | 12.1% | 0.48% | 0.26% | 6.5% |
Total amount of feeding 135kg, wherein taking a kind of red rooted salvia 90kg, two class red rooted salvia 45kg arrange in pairs or groups, cutting,
Then cutting obtains red rooted salvia slice；
2. Radix Salviae Miltiorrhizae extracts: red rooted salvia medicine materical crude slice is extracted three times, individually placed after each extracting solution filtering, to be concentrated；
It extracts (95% alcohol extracting) for the first time: 95% ethyl alcohol of 3 times of medicinal material throwing amounts being added in Radix Salviae Miltiorrhizae, impregnate 1h, be heated to reflux
1.5h；
Second of extraction (50% alcohol extracting): 50% ethyl alcohol of 5 times of medicinal material throwing amounts is added in the dregs of a decoction, is heated to reflux 1.5h；
Third time extracts (water mentions): the water of 5 times of medicinal material throwing amounts being added in the dregs of a decoction, decocts 2h；
3. concentration: using single-effect concentrator, each extracting solution is individually concentrated；
The concentration of 95% alcohol extract: it is 0.82g/ that the extracting solution obtained after 95% alcohol extracting is concentrated into relative density at 40 DEG C
Ml controls temperature at 40 DEG C when measuring relative density；
The concentration of 50% alcohol extract: it is 1.05g/ that the extracting solution obtained after 50% alcohol extracting is concentrated into relative density at 40 DEG C
Ml controls temperature at 40 DEG C when measuring relative density；
Aqueous extracts concentration: it is 1.08g/ml, control that the extracting solution that water obtains after extracting is concentrated into relative density at 50 DEG C
Temperature is at 50 DEG C；
4. spray drying: the contracting of 95% alcohol extracting concentrate, 50% alcohol extracting concentrate and water concentrate successively being poured into tank, is stirred
Start to be spray-dried after mixing 10min, 180 DEG C of inlet air temperature, spray drying infusion motor speed is 30HZ；Obtain extract powder；
Moisture≤5.0% that control extract powder contains；
5. total mix: by extract powder sieving, the mixing after spray drying.
(2) compound Danshen Root granular preparation technique
The preparation process operating procedure of compound Danshen Root particle includes: premix, wet granulation, wet granular drying, intermediate particle
Screening, spray borneol, spray film-coating, coated granule drying, screening, total mix, particle packing, outer packing；
1. premix, wet granulation
The whole Radix Salviae Miltiorrhizae extractum powder 46.82kg prepared in (1), Radix Notoginseng powder 42.3kg, dextrin 8.48kg are added
In mixer-granulator, it is stirred 10min, after mixing, stirs and cut lower addition wetting agent, wetting agent is 70% second
Alcohol, dosage 25kg；There is uniform wet granular in granulator, discharges, wet granular sieving (12 mesh) wet whole grain.
2. wet granular is dry, intermediate particle screening
Wet granular is transferred in boiling drier, is dried, temperature≤85 DEG C, pellet moisture < 5.0% are controlled.Out
Material, screening, removes unqualified particle and fine powder to get compound Danshen Root intermediate particle.
3. spraying borneol
It is spare after borneol is dissolved with the dehydrated alcohol that mass ratio is 1:1.Above-mentioned dry particl is added in seed-coating machine, control
Good device parameter, sprays into the ethanol solution of borneol.
4. spraying film-coating
Appropriate 85% ethyl alcohol is added in zein, after being completely dissolved, diethyl phthalate is added, is uniformly mixed,
It is spare.
Control device parameter, by above-mentioned coating solution spray into step 3. in material on.
5. coated granule is dry, screening
Wet granular after coating is transferred in boiling drier to dry, control temperature≤85 DEG C, coated granule moisture <
4.0%, discharging.Screening, removes unqualified particle and fine powder.
6. total mix
The particle of partial size qualification by screening is obtained into compound Danshen Root in carrying out total mix, incorporation time 10min in mixing machine
Coated granule.
7. particle dispenses
By above-mentioned by examining qualified particle, dispensed using composite membrane, specification is per packed 1g.
8. outer packing, warehousing finished products
It examines qualified inner packing product to carry out outer packing, is put in storage after the assay was approved.
Embodiment 2
For preparing 100,000 bags of compound Danshen Root particles, every bag of compound Danshen Root particle 1g.
(1) Radix Salviae Miltiorrhizae extractum powder extracts
1. Radix Salviae Miltiorrhizae pre-treatment: Radix Salviae Miltiorrhizae being classified according to the diameter on red rooted salvia main root top, is sorted；Red rooted salvia master
It is one kind that the diameter on root top, which is less than 0.5cm, and it is two classes that the diameter on main root top, which is greater than or equal to 0.5cm,.
A kind of content with each effective component in two class red rooted salvias of detection；With reference to Chinese Pharmacopoeia version 76-77 in 2015
Detection method in page detects tanshinone, Tanshinone IIAWith the content of tanshin polyphenolic acid B.
As a result as follows:
| Classification | Moisture | Tanshinone | Tanshinone IIA | Tanshin polyphenolic acid B |
| It is a kind of | 11.9% | 0.70% | 0.36% | 6.0% |
| Two classes | 12.1% | 0.40% | 0.20% | 6.2% |
Total amount of feeding 135kg, wherein taking a kind of red rooted salvia 90kg, two class red rooted salvia 45kg arrange in pairs or groups, cutting,
Then cutting obtains red rooted salvia slice；
2. Radix Salviae Miltiorrhizae extracts: red rooted salvia medicine materical crude slice is extracted three times, individually placed after each extracting solution filtering, to be concentrated；
It extracts (95% alcohol extracting) for the first time: 95% ethyl alcohol of 7 times of medicinal material throwing amounts being added in all red rooted salvias, impregnate 1h,
It is heated to reflux 1.5h；
Second of extraction (50% alcohol extracting): 50% ethyl alcohol of 2 times of medicinal material throwing amounts is added in the dregs of a decoction, is heated to reflux 1.5h；
Third time extracts (water mentions): the water of 2 times of medicinal material throwing amounts being added in the dregs of a decoction, decocts 2h；
3. concentration: using single-effect concentrator, each extracting solution is individually concentrated；
The concentration of 95% alcohol extract: it is 0.80g/ that the extracting solution obtained after 95% alcohol extracting is concentrated into relative density at 30 DEG C
Ml controls temperature at 30 DEG C when measuring relative density；
The concentration of 50% alcohol extract: it is 1.00g/ that the extracting solution obtained after 50% alcohol extracting is concentrated into relative density at 30 DEG C
Ml controls temperature at 30 DEG C when measuring relative density；
Aqueous extracts concentration: it is 1.00g/ml, measurement that the extracting solution that water obtains after extracting is concentrated into relative density at 40 DEG C
Temperature is controlled when relative density at 50 DEG C；
4. spray drying: the contracting of 95% alcohol extracting concentrate, 50% alcohol extracting concentrate and water concentrate successively being poured into tank, is stirred
Start to be spray-dried after mixing 10min, 190 DEG C of inlet air temperature, spray drying infusion motor speed is 10HZ；Obtain extract powder；
Moisture≤5.0% that control extract powder contains；
5. total mix: by extract powder sieving, the mixing after spray drying.
(2) compound Danshen Root granular preparation technique
The preparation process operating procedure of compound Danshen Root particle includes: premix, wet granulation, wet granular drying, intermediate particle
Screening, spray borneol, spray film-coating, coated granule drying, screening, total mix, particle packing, outer packing；
1. premix, wet granulation
The whole Radix Salviae Miltiorrhizae extractum powder 47.12kg prepared in (1), Radix Notoginseng powder 42.3kg, dextrin 8.18kg are added
In mixer-granulator, it is stirred 10min, after mixing, stirs and cut lower addition wetting agent, wetting agent is 70% second
Alcohol, dosage 15kg；There is uniform wet granular in granulator, discharges, wet granular sieving (12 mesh) wet whole grain.
2. wet granular is dry, intermediate particle screening
Wet granular is transferred in boiling drier, is dried, temperature≤85 DEG C, pellet moisture < 5.0% are controlled.Out
Material, screening, removes unqualified particle and fine powder to get compound Danshen Root intermediate particle.
3. spraying borneol
It is spare after borneol is dissolved with the dehydrated alcohol that mass ratio is 1:1.Above-mentioned dry particl is added in seed-coating machine, control
Good device parameter, sprays into the ethanol solution of borneol.
4. spraying film-coating
Appropriate 85% ethyl alcohol is added in zein, after being completely dissolved, diethyl phthalate is added, is uniformly mixed,
It is spare.
Control device parameter, by above-mentioned coating solution spray into step 3. in material on.
5. coated granule is dry, screening
Wet granular after coating is transferred in boiling drier to dry, control temperature≤85 DEG C, coated granule moisture <
4.0%, discharging.Screening, removes unqualified particle and fine powder.
6. total mix
The particle of partial size qualification by screening is obtained into compound Danshen Root in carrying out total mix, incorporation time 10min in mixing machine
Coated granule.
7. particle dispenses
By above-mentioned by examining qualified particle, dispensed using composite membrane, specification is per packed 1g.
8. outer packing, warehousing finished products
It examines qualified inner packing product to carry out outer packing, is put in storage after the assay was approved.
Embodiment 3
For preparing 100,000 bags of compound Danshen Root particles, every bag of compound Danshen Root particle 1g.
(1) Radix Salviae Miltiorrhizae extractum powder extracts
1. Radix Salviae Miltiorrhizae pre-treatment: Radix Salviae Miltiorrhizae being classified according to the diameter on red rooted salvia main root top, is sorted；Red rooted salvia master
It is one kind that the diameter on root top, which is less than 0.5cm, and it is two classes that the diameter on main root top, which is greater than or equal to 0.5cm,.
A kind of content with each effective component in two class red rooted salvias of detection；With reference to Chinese Pharmacopoeia version 76-77 in 2015
Detection method in page detects tanshinone, Tanshinone IIAWith the content of tanshin polyphenolic acid B.
As a result as follows:
| Classification | Moisture | Tanshinone | Tanshinone IIA | Tanshin polyphenolic acid B |
| It is a kind of | 12.3% | 0.57% | 0.32% | 5.8% |
| Two classes | 12.3% | 0.43% | 0.23% | 5.7% |
Total amount of feeding 135kg, wherein taking a kind of red rooted salvia 90kg, two class red rooted salvia 45kg arrange in pairs or groups, cutting,
Then cutting obtains red rooted salvia slice；
2. Radix Salviae Miltiorrhizae extracts: red rooted salvia medicine materical crude slice is extracted three times, individually placed after each extracting solution filtering, to be concentrated；
It extracts (95% alcohol extracting) for the first time: 95% ethyl alcohol of 6 times of medicinal material throwing amounts being added in Radix Salviae Miltiorrhizae, impregnate 1h, be heated to reflux
1.5h；
Second of extraction (50% alcohol extracting): 50% ethyl alcohol of 4 times of medicinal material throwing amounts is added in the dregs of a decoction, is heated to reflux 1.5h；
Third time extracts (water mentions): the water of 3 times of medicinal material throwing amounts being added in the dregs of a decoction, decocts 2h；
3. concentration: using single-effect concentrator, each extracting solution is individually concentrated；
The concentration of 95% alcohol extract: it is 0.90g/ that the extracting solution obtained after 95% alcohol extracting is concentrated into relative density at 60 DEG C
Ml controls temperature at 40 DEG C when measuring relative density；
The concentration of 50% alcohol extract: it is 1.10g/ that the extracting solution obtained after 50% alcohol extracting is concentrated into relative density at 60 DEG C
Ml controls temperature at 40 DEG C when measuring relative density；
Aqueous extracts concentration: it is 1.10g/ml, measurement that the extracting solution that water obtains after extracting is concentrated into relative density at 60 DEG C
Temperature is controlled when relative density at 60 DEG C；
4. spray drying: the contracting of 95% alcohol extracting concentrate, 50% alcohol extracting concentrate and water concentrate successively being poured into tank, is stirred
Start to be spray-dried after mixing 10min, 170 DEG C of inlet air temperature, spray drying infusion motor speed is 30HZ；Obtain extract powder；
Moisture≤5.0% that control extract powder contains；
5. total mix: by extract powder sieving, the mixing after spray drying.
(2) compound Danshen Root granular preparation technique
The preparation process operating procedure of compound Danshen Root particle includes: premix, wet granulation, wet granular drying, intermediate particle
Screening, spray borneol, spray film-coating, coated granule drying, screening, total mix, particle packing, outer packing；
1. premix, wet granulation
The whole Radix Salviae Miltiorrhizae extractum powder 46.96kg prepared in (1), Radix Notoginseng powder 42.3kg, dextrin 8.34kg are added
In mixer-granulator, it is stirred 10min, after mixing, stirs and cut lower addition wetting agent, wetting agent is 70% second
Alcohol, dosage 25kg；There is uniform wet granular in granulator, discharges, wet granular sieving (12 mesh) wet whole grain.
2. wet granular is dry, intermediate particle screening
Wet granular is transferred in boiling drier, is dried, temperature≤85 DEG C, pellet moisture < 5.0% are controlled.Out
Material, screening, removes unqualified particle and fine powder to get compound Danshen Root intermediate particle.
3. spraying borneol
It is spare after borneol is dissolved with the dehydrated alcohol that mass ratio is 1:1.Above-mentioned dry particl is added in seed-coating machine, control
Good device parameter, sprays into the ethanol solution of borneol.
4. spraying film-coating
Appropriate 85% ethyl alcohol is added in zein, after being completely dissolved, diethyl phthalate is added, is uniformly mixed,
It is spare.
Control device parameter, by above-mentioned coating solution spray into step 3. in material on.
5. coated granule is dry, screening
Wet granular after coating is transferred in boiling drier to dry, control temperature≤85 DEG C, coated granule moisture <
4.0%, discharging.Screening, removes unqualified particle and fine powder.
6. total mix
The particle of partial size qualification by screening is obtained into compound Danshen Root in carrying out total mix, incorporation time 10min in mixing machine
Coated granule.
7. particle dispenses
By above-mentioned by examining qualified particle, dispensed using composite membrane, specification is per packed 1g.
8. outer packing, warehousing finished products
It examines qualified inner packing product to carry out outer packing, is put in storage after the assay was approved.
Comparative example one
During Radix Salviae Miltiorrhizae extractum powder extracts, the method for use before improving are as follows: do not classify, directly sort fixation and always feed intake
The red rooted salvia of weight, cutting obtain salvia piece；Extraction process is by the way of being heated to reflux, the temperature control of extracting solution concentration
No more than 80 DEG C；It is specific:
The concentration of 95% alcohol extract: it is 0.81- that the extracting solution after 95% alcohol extracting is concentrated into relative density at 50-80 DEG C
0.85g/ml；
The concentration of 50% alcohol extract: it is 1.03- that the extracting solution after 50% alcohol extracting is concentrated into relative density at 50-80 DEG C
1.08g/ml；
Aqueous extracts concentration: the extracting solution after water extracts is concentrated into relative density at 60-80 DEG C as 1.05-1.10g/ml；
Other steps are identical as 1 step of embodiment；The extraction of Radix Salviae Miltiorrhizae extractum powder is carried out using the method for embodiment 1 after improvement.
By analysis Radix Salviae Miltiorrhizae inventory and the numerical relation for obtaining extract powder amount, yield numerical value is obtained.Before improving and after improving
The result of the yield of acquisition is as shown in table 1.The results show that improved yield greatly improves, and yield is more stable, batch
Between difference greatly reduce.
Table 1
In addition, the extract powder obtained before improving with improved method took 50mg respectively, with reference to Chinese Pharmacopoeia 2015
Tanshinone II in the 1217-1219 pages of versionADetection method, detect extract powder in Tanshinone IIAContent.Before improving and change
The extract powder that method after obtains takes 60mg respectively, with reference to tanshin polyphenolic acid B in the 1217-1219 pages of version of Chinese Pharmacopoeia 2015
Detection method detects the content of tanshin polyphenolic acid B in extract powder.
Then according to detected in above-mentioned 50mg 60mg extract powder content results, red rooted salvia always throwing amount 135kg with
And the extract powder total amount obtained is extracted, it calculates every 1350g red rooted salvia and extracts gained extract powder containing Tanshinone IIAAnd tanshin polyphenolic acid B
Amount.It is computed, every 1350g red rooted salvia extracts gained extract powder and contains Tanshinone IIAWith the result such as table 2 of the amount of tanshin polyphenolic acid B
Shown in.
Table 2
It is provided in standard, every 1350g red rooted salvia extracts gained extract powder and contains Tanshinone IIAAmount must not be lower than 1.5g,
Every 1350g red rooted salvia, which extracts gained amount of the extract powder containing tanshin polyphenolic acid B, must not be lower than 16g.
The improved principle active component Tanshinone II it can be seen from the above resultsAIt is improved with the content of tanshin polyphenolic acid B,
Difference greatly reduces between batch, and content is more stable.
Comparative example two
Method after improvement using embodiment one prepares compound Danshen Root particle, and the method difference used before improving exists
In: red rooted salvia is not classified, and directly sorts the red rooted salvia of charged material weight, cutting obtains salvia piece；Extraction process is using heating
The mode of reflux, the temperature control of extracting solution concentration are no more than 80 DEG C, and specific temperature control is the same as comparative example one；Control extract powder
The moisture contained reaches≤10.0%；Moisture when wet granular is dry is controlled in < 4.0%；Other steps and 1 step of embodiment
It is identical；
The result of the drying time of the final products moisture and needs that obtain before improving and after improving is as shown in table 3.Knot
Fruit shows that the moisture that control extract powder contains in the present invention reaches≤5.0%, and moisture when wet granular is dry is controlled in <
4.0%, it can substantially shorten drying time, the moisture content of final products is essentially identical.
Table 3
Comparative example three
Compound Danshen Root particle is prepared using the method for embodiment one after improvement, material utilization amount is adjusted according to production bag number
Improve before use method the difference is that: red rooted salvia is not classified, directly sorting charged material weight Radix Salviae Miltiorrhizae
Medicinal material, cutting obtain salvia piece；For extraction process by the way of being heated to reflux, the temperature control of extracting solution concentration is no more than 80
DEG C, specific: the concentration of 95% alcohol extract: it is 0.81- that the extracting solution after 95% alcohol extracting is concentrated into relative density at 50-80 DEG C
0.85g/ml；
The concentration of 50% alcohol extract: it is 1.03- that the extracting solution after 50% alcohol extracting is concentrated into relative density at 50-80 DEG C
1.08g/ml；
Aqueous extracts concentration: the extracting solution after water extracts is concentrated into relative density at 60-80 DEG C as 1.05-1.10g/ml；
The moisture that control extract powder contains reaches≤10.0%；Moisture when wet granular is dry is controlled in < 4.0%；Other
Step is identical as 1 step of embodiment.
Include: before improving and in place of improved difference
Table 4
The result of the ultimate yield obtained before improving and after improving is as shown in table 5.The results show that the present invention is using improvement
Method afterwards, improved output and yield greatly improve, and yield is more stable, and difference greatly reduces between batch.
Table 5
In addition, the compound Danshen Root finished granule obtained before improving with improved method takes 0.2g respectively, with reference to China
Detection method in the 1217-1219 pages of version of pharmacopeia 2015, detection wherein principle active component Tanshinone IIAAnd tanshin polyphenolic acid B
Content, then calculate 1g compound Danshen Root particle in Tanshinone IIAWith the content of tanshin polyphenolic acid B, as a result as shown in table 6.
Table 6
It is provided in Chinese Pharmacopoeia, is no less than 1.3mg containing tanshinone IIA in every bag of (1g) compound Danshen Root particle, tanshin polyphenolic acid B is not
Less than 15mg.The improved principle active component Tanshinone II it can be seen from the above resultsAIt is improved with the content of tanshin polyphenolic acid B,
And it is much higher than standard value, while difference greatly reduces between batch, content is more stable.
In summary comparative example can be seen that in preparation process of the invention, each batch preparation total amount of feeding not
In the case where change, every time in the pre-treatment step of Radix Salviae Miltiorrhizae, Radix Salviae Miltiorrhizae is classified according to the diameter on red rooted salvia main root top,
Sort, collocation feeds intake in proportion, so as to greatly reduce the difference of active constituent content and yield between different batches, provide work
The controllability and stability of skill.The moisture content of each intermediate product is controlled in preparation process, it can be in the moisture for guaranteeing final products
In the case where complying with standard, substantially shorten drying time, improves production efficiency, reduce cost.
The above is only presently preferred embodiments of the present invention, is not intended to limit the present invention in any form, though
So the present invention has been disclosed as a preferred embodiment, and however, it is not intended to limit the invention, any technology people for being familiar with this patent
Member without departing from the scope of the present invention, when the technology contents using above-mentioned prompt make it is a little change or be modified to
The equivalent embodiment of equivalent variations, but anything that does not depart from the technical scheme of the invention content, it is right according to the technical essence of the invention
Any simple modification, equivalent change and modification made by above embodiments, in the range of still falling within the present invention program.
Claims (10)
1. a kind of preparation process of compound red sage root preparation, which is characterized in that preparation process includes carrying out pre-treatment to Radix Salviae Miltiorrhizae, preceding
In processing step, Radix Salviae Miltiorrhizae is classified according to the diameter on red rooted salvia main root top, sorted, is matched, cutting, Radix Salviae Miltiorrhizae is obtained and cuts
Piece.
2. a kind of preparation process of compound red sage root preparation according to claim 1, which is characterized in that on red rooted salvia main root
It is one kind that the diameter in portion, which is less than 0.5cm, and it is two classes that the diameter on main root top, which is greater than or equal to 0.5cm, every batch of red rooted salvia
Total amount of feeding is identical, according to Tanshinone II in a kind of and two class red rooted salviasAWith the content of tanshin polyphenolic acid B by a kind of and two class Radix Salviae Miltiorrhizaes
Medicinal material will configure in proportion.
3. a kind of preparation process of compound red sage root preparation according to claim 1 or 2, which is characterized in that Radix Salviae Miltiorrhizae pre-treatment
After the completion, concentration is extracted, extracting concentration step includes: that Radix Salviae Miltiorrhizae adds ethyl alcohol to impregnate, and is heated to reflux, extracting solution filtration recycling second
Alcohol is simultaneously concentrated spare；The dregs of a decoction add 50% ethyl alcohol, are heated to reflux, and extracting solution filtration recycling ethyl alcohol is simultaneously concentrated spare；The dregs of a decoction add decocting
It boils, extracting solution is filtered and is concentrated spare.
4. a kind of preparation process of compound red sage root preparation according to claim 3, which is characterized in that extract concentration step packet
It includes: extracting for the first time: 95% ethyl alcohol of 3-7 times of medicinal material throwing amount being added in Radix Salviae Miltiorrhizae, impregnate 1h, be heated to reflux 1.5h；
Second of extraction: 50% ethyl alcohol of 2-5 times of medicinal material throwing amount is added in the dregs of a decoction, is heated to reflux 1.5h；
Third time is extracted: the water of 2-5 times of medicinal material throwing amount being added in the dregs of a decoction, decocts 2h.
5. a kind of preparation process of compound red sage root preparation according to claim 4, which is characterized in that after 95% ethyl alcohol extracts
It is 0.80-0.90g/ml that obtained extracting solution is concentrated into relative density at a temperature of 30-60 DEG C；What 50% ethyl alcohol obtained after extracting
It is 1.00-1.10g/ml that extracting solution is concentrated into relative density at a temperature of 30-60 DEG C；The extracting solution that water obtains after extracting is in 40-
It is 1.00-1.10g/ml that relative density is concentrated at a temperature of 60 DEG C.
6. a kind of preparation process of compound red sage root preparation according to claim 3-5 any one, which is characterized in that Radix Salviae Miltiorrhizae
After extracting concentration, each concentrate is mixed, is spray-dried, obtain Radix Salviae Miltiorrhizae extractum powder, wherein the Radix Salviae Miltiorrhizae leaching
The moisture that cream powder contains is not more than 5%；
Preferably, it is 170-190 DEG C that the parameter of spray drying, which includes: inlet air temperature, and the speed of spray drying infusion motor is 10-
30HZ。
7. a kind of preparation process of compound red sage root preparation according to claim 6, which is characterized in that Radix Notoginseng to be ground into carefully
The Radix Salviae Miltiorrhizae extractum powder and Radix Notoginseng powder of acquisition and dextrin are added in mixer-granulator, are uniformly mixed by powder, and wetting agent is added,
Carry out wet granulation；Wherein, 70% ethyl alcohol of wetting agent；
Preferably, incorporation time 10min.
8. a kind of preparation process of compound red sage root preparation according to claim 7, which is characterized in that after the completion of wet granulation
Wet granular is dry, screening, obtains compound Danshen Root intermediate particle；The moisture of particle is not more than 5% after drying；
Preferably, it is dried using boiling drier, dry temperature is≤85 DEG C.
9. a kind of preparation process of compound red sage root preparation according to claim 8, which is characterized in that borneol is finely ground, with nothing
Water-ethanol dissolution, be equably sprayed in compound Danshen Root intermediate particle, spray film-coating, coated granule drying, screening, total mix, packing,
It is packaged into compound Danshen Root finished granule；The moisture contained after coated granule is dry is less than 4%.
10. a kind of compound red sage root preparation, by the preparation process system of compound red sage root preparation as described in any one of claims 1-9
It is standby to form；
Preferably, the compound red sage root preparation is compound Danshen Root particle.
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