CN106109520A - The preparation method of Radix Panacis Quinquefolii breaking cellular wall decoction pieces - Google Patents
The preparation method of Radix Panacis Quinquefolii breaking cellular wall decoction pieces Download PDFInfo
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- CN106109520A CN106109520A CN201610643756.7A CN201610643756A CN106109520A CN 106109520 A CN106109520 A CN 106109520A CN 201610643756 A CN201610643756 A CN 201610643756A CN 106109520 A CN106109520 A CN 106109520A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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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
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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
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/17—Preparation or pretreatment of starting material involving drying, e.g. sun-drying or wilting
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Abstract
The present invention provides the preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces, by using medical material through picking cleaning/process of preparing Chinese medicine, it is dried, broken, the pulverizer of 100 mesh sieves is pulverized, batch (-type) sterilizes, breaking cellular wall, pelletize, it is dried and prepares Radix Panacis Quinquefolii breaking cellular wall decoction pieces, the particle type of the decoction pieces of preparation is preferable, elasticity is moderate, and the granule prepared is easier to be dried, granule leaches comparatively fast, it is easily dispersed when user is taken, the decoction pieces that batch (-type) sterilization is meets the requirement of microbial limit, solve Radix Panacis Quinquefolii breaking cellular wall decoction pieces in the market and leach the difficult and difficult problem up to standard of microbial limit.
Description
Technical field
The present invention relates to Chinese medicine processing technology field, particularly belong to the preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces.
Background technology
Superfine communication technique is the new technique developed rapidly in recent years.Effective ingredient in Chinese crude drug is distributed in mostly
Intracellular, conventional decoction pieces can only make part effective ingredient discharge when decocting, utilization rate of active components 10-30%;And use
Wall breaking pulverization technology, as being crushed to about 300 mesh by the prepared slices of Chinese crude drugs, cell-wall breaking ratio is up to 86.7%, improves in medical material
The dissolution of effective ingredient, is greatly enhanced its drug effect, and utilization rate of active components, more than 90%, reaches to reduce medical material usage amount and guarantor
Protecting herb resource, the quality that the most also can improve medicine increases drug effect.Radix Panacis Quinquefolii (Panax quinquefolius) is Radix Ginseng
One, for the dry root of Araliaceae Radix Panacis Quinquefolii Panax quinquefolium L..It is to originate in the U.S. Canadian one
Plant high-end tonic herb, have resisting fatigue, antioxidation, anti-stress, suppression platelet aggregation, the effect of reduction blood coagulability, right
Diabetics also has the effect regulating blood glucose.Its market using value is high.At present, Radix Panacis Quinquefolii develops substantial amounts of health product,
As by Radix Panacis Quinquefolii buccal tablets, it is all to need be used in mixed way with other medical materials or add substantial amounts of adjuvant.Radix Panacis Quinquefolii instructions of taking is divided into
Boil, stew, steamed wheaten foods, section containing changing, be ground into fine powder and take after mixing it with water, but these use and there is Radix Panacis Quinquefolii ingredient and be difficult to leach, biological
Availability is low, with after have the shortcomings such as residue.
CN201310387183.2 discloses the preparation method of a kind of Radix Panacis Quinquefolii ultra micro blunt powder oral medicinal slice, including following step
Rapid: step 1, by Radix Panacis Quinquefolii raw material dedusting clean;Step 2, Radix Panacis Quinquefolii raw material is dried;Step 3, step 2 is handled well
Radix Panacis Quinquefolii raw material put in liquid nitrogen, at-196 DEG C pulverize;Step 4, will pulverize after Radix Panacis Quinquefolii raw material be put in low pressure dry
Dry, by moisture Control less than 20%;Step 5, ultra-micro powder step 4 formed carry out Co 60 irradiation, and tabletting prepares.
CN200610122171.7 discloses the processing method of a kind of traditional Chinese herbs broken wall powder, and the step of its processing is: (1) medical material
Concoct: it includes selection, section, dried clean medical material;(2) pulverize: with above-mentioned clean medical material, with the omnipotent powder of 100 mesh sieves
Broken machine is pulverized, and wall breaking pulverization obtains the 60 above coarse powder of mesh;(3) wall breaking pulverization: by coarse powder flour obtained as above, through wall cell disruption powder powder
It is broken to more than 300 mesh, obtains superfine powder;(4) pelletize: take superfine powder obtained as above, put in flute profile mixing and blending machine, use water
Or ethanol makes soft material, pelletizing through the oscillating granulator of 30 mesh sieves, the wet granular prepared is put in heated-air circulation oven and is dried;
(5) granulate, screening: with upper strata 40 mesh, above-mentioned granulation granulate is sieved 1-3 time, makes 40 by the vibration pelletizing machine of lower floor 80 mesh sieve
Granule between mesh-80 mesh;(6) subpackage and packaging: take qualified sub-micron-powder, subpackage and outer package and obtain finished product.
According to current technique, the Radix Panacis Quinquefolii breaking cellular wall decoction pieces of preparation, its granule not only fastens, and granule is less, in reality
Border is difficult to leach during using, and is unfavorable for the Fast Stripping of active ingredient;Medical material only selection, section, big gun special to needs
The medical material of system is inapplicable;For entering whether the coarse powder of clean area meets microbial limit and do not provide processing method.
Summary of the invention
For the deficiencies in the prior art, the present invention provides the preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces, prepared by the method
Radix Panacis Quinquefolii breaking cellular wall decoction pieces particle type preferable, degree of tightness appropriateness, be easier to be dried, and granule leach soon, active ingredient dissolution soon,
The microbial limit of products obtained therefrom meets the requirements, and can guarantee that drug safety, with effectively, uses Radix Panacis Quinquefolii breaking cellular wall prepared by the method
The time of decoction pieces is short, and process costs is low.
For solving above-mentioned technical problem, the present invention provides following technical scheme: the preparation side of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces
Method, described medical material through picking clean/concoct, be dried, broken, the pulverizer pulverizing of 100 mesh sieves, batch (-type) sterilization, breaking cellular wall, system
Grain, dry prepared Radix Panacis Quinquefolii breaking cellular wall decoction pieces.
The preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces, has following steps:
(1) medical material processes: medical material Radix Panacis Quinquefolii is through picking cleaning/process of preparing Chinese medicine, medicinal material drying, broken, the pulverizer of 100 mesh sieves
The medicinal material coarse powder of 80~120 mesh is prepared after pulverizing;
(2) batch (-type) sterilization: the medicinal material coarse powder after step (1) being processed carries out sterilizing-and hypopus grow-sterilizes again
Process, until obtaining meeting the medicinal material coarse powder directly taking decoction pieces microbial limit;
(3) breaking cellular wall: the medicinal material coarse powder after sterilization is ground into superfine powder;
(4) soft material processed: the superfine powder that breaking cellular wall prepares is placed in blender, makes soft with the ethanol of water or variable concentrations
Material;
(5) pelletize: soft material is made granule;
(6) Radix Panacis Quinquefolii breaking cellular wall decoction pieces will be prepared after particle drying.
Described step (1) Chinese crude drug is dried and refers to that medical material Radix Panacis Quinquefolii is dried to water content below 10%;Described step (1)
In broken refer to the medical material Radix Panacis Quinquefolii mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh.
What in described step (2), batch (-type) sterilized concretely comprises the following steps: (A) sterilizes: the Radix Panacis Quinquefolii medicine after step (1) being processed
Material coarse powder is placed in climatic chamber and keeps drying sterilizing a period of time under uniform temperature;(B) hypopus growth: medical material is thick
Powder temperature in climatic chamber is 20~30 DEG C, relative humidity 70~80% environment in maintain 8~24 hours, then by perseverance
The temperature of constant temperature and humidity case be adjusted to 33~40 DEG C, relative humidity be adjusted to 83~92% maintain 8~24 hours;(C) sterilization again:
Further medicinal material coarse powder is placed in climatic chamber drying sterilizing a period of time at a certain temperature;Conventional sense medical material
Microorganism situation in coarse powder, prepares and meets the medicinal material coarse powder directly taking decoction pieces microbial limit;Described uniform temperature is 50
~80 DEG C;Described a period of time is 0.5~8 hour;The thickness that described medicinal material coarse powder is placed in climatic chamber be 5mm~
30mm。
Further, the concretely comprising the following steps of batch (-type) sterilization in described step (2): (A) sterilizes: in climatic chamber 60
~at 70 DEG C, keep drying sterilizing 0.5~4h;(B) hypopus growth: medicinal material coarse powder temperature in climatic chamber is 20~30
DEG C, relative humidity 70~80% environment in maintain 12~15 hours;Then the temperature of climatic chamber is adjusted to 33~40
DEG C, relative humidity 83~92% environment in maintain 12~15 hours;(C) sterilization again: at climatic chamber 60~70 DEG C
Keep drying sterilizing 0.5~4h.
What in described step (2), batch (-type) sterilized concretely comprises the following steps: (A) sterilizes: the Radix Panacis Quinquefolii after step (1) being processed is thick
Powder is placed and is kept drying sterilizing a period of time under uniform temperature in an oven;(B) hypopus growth: by after sterilization processing
Radix Panacis Quinquefolii coarse powder takes out from baking oven, pack, when temperature is 20~30 DEG C, be filled with in bag sealing after water vapour maintain 8~
24 hours;(C) sterilization again: the Radix Panacis Quinquefolii coarse powder after hypopus grows is placed and is dried the most at a certain temperature
Sterilization a period of time;Microorganism situation in conventional sense Radix Panacis Quinquefolii coarse powder, prepares to meet and directly takes decoction pieces microbial limit
Radix Panacis Quinquefolii coarse powder;Described uniform temperature is 50~80 DEG C;Described a period of time is 0.5~8 hour;Described Radix Panacis Quinquefolii coarse powder is put
Putting the thickness in climatic chamber is 5mm~30mm.
Further, in described step (2) in the concrete steps of batch (-type) sterilization: described a period of time is 0.5~4 little
Time;Described (B) hypopus grows: maintaining growth time is 12~15 hours.
Further, after in described step (2), batch (-type) has sterilized, the microorganism in conventional sense medicinal material coarse powder is not
Meet when directly taking decoction pieces microbial limit, repeat the growth of (B) hypopus and (C) sterilization process 1~4 times;Prepare and meet directly
Connect the medicinal material coarse powder taking decoction pieces microbial limit.
Further, in described step (2), the bag in batch (-type) sterilization is plastic bag or Fibre Bag etc..
Further, described step (2) is filled with water vapour to bag in batch (-type) sterilization, refers to be charged to by sack completely, bag
Son is supported in shape.
Described step (5) is pelletized method particularly includes: the granulator of Radix Panacis Quinquefolii soft material 14~24 mesh sieves that will make
Pelletizing, while adding soft material in granulator, add superfine powder, completing until preparing granule;Described granulator be 14~
The oscillating granulator of 24 mesh sieves or squash type granulator.
In the concrete grammar pelletized in described step (5), the ratio of soft material and superfine powder is 3~6:0.5~1.
In described step (6), particle drying is carried out in heated-air circulation oven, design temperature 50~80 DEG C, be dried to
Moisture is less than or equal to 7%.
In described step (6), granule completes after drying, with upper strata 10 mesh, the concussion pelletizing machine granulate screening of bottom 24 mesh sieve
1~3 time, make granule between 10~24 mesh.
Breaking cellular wall in described step (3) method particularly includes: at room temperature and relative humidity in the environment of 30~70%, passes through
The American ginseng medicine coarse powder of batch (-type) sterilization obtains superfine powder through wall breaking pulverization, and control operating pressure, 0.5~0.8MPa, is divided
Level machine rotating speed is 20~40r/s, more than wall breaking pulverization to 300 mesh;Described room temperature refers to 18~26 DEG C.
In described step (4), blender is trough type mixing machine or wet mixing pelletizer, and the ethanol of described variable concentrations is
The concentration of finger ethanol is 30%~99%.
Further, in the concrete grammar pelletized in described step (5), by step 4) the superfine powder soft material that makes puts into
Oscillating granulator forward direction screen cloth spills a small amount of superfine powder, to reduce the situation of mesh screen blocking.
The screening that the present invention uses the screen cloth clearly pelletized to carry out mesh number makes granularity moderate;Limit is used in pelletization
Adding soft material limit and add the method granulation of breaking cellular wall dry powder, the particle type of gained is preferable, and elasticity is moderate, and the granule prepared is easier to
Being dried, granule leaches comparatively fast.
The sterilization process repeatable operation of medicinal material coarse powder can strengthen sterilization effect, and cycle-index is the first shadow of sterilization process
The factor of sound, circulates the level that substantially can reach to meet the microbial limit directly taking decoction pieces 2 times.Traditional is xeothermic and damp and hot
The high temperature that sterilizing is both needed to more than 80 degrees Celsius processes, and material component exists certain destruction, especially to containing heat
The medical material of quick property composition is inapplicable.The present invention uses the method for batch (-type) sterilizing, the temperature of sterilization process at 50~80 degrees Celsius,
In the environment of keeping being dried, several without destroying to the composition of medical material Radix Panacis Quinquefolii, and grow-go out numerous through the brood body-hypopus that goes out
Grow the process of body, in the environment being grown in high humidity of hypopus, after hypopus grows into brood body, kill, kill work
With substantially, the preparation of follow-up Radix Panacis Quinquefolii breaking cellular wall decoction pieces, meet the requirement of the microbial limit directly taking decoction pieces.
Beneficial effects of the present invention:
The present invention provides the preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces, by use medical material through picking cleaning/process of preparing Chinese medicine,
Be dried, broken, pulverizer pulverizings of 100 mesh sieves, batch (-type) sterilization, breaking cellular wall, limit add soft material limit add breaking cellular wall dry powder method granulation,
Being dried and prepare Radix Panacis Quinquefolii breaking cellular wall decoction pieces, the particle type of the decoction pieces of preparation is preferable, and elasticity is moderate, and the granule prepared is easier to
Being dried, granule leaches comparatively fast, is easily dispersed when user is taken, and batch (-type) sterilization completes within one device so that decoction pieces
Meet the requirement of microbial limit, solve Radix Panacis Quinquefolii breaking cellular wall decoction pieces in the market and leach difficult and difficult up to standard the asking of microbial limit
Topic.
By killing the brood body of antibacterial in medicinal material coarse powder at a certain temperature, then under conditions of room temperature high humidity, allow not
Dormancy body grows up to bacterial propagule, then through killing the brood body of the antibacterial in medicinal material coarse powder at a certain temperature, the most repeatedly 0~
4 times, thus the purpose that reaches to sterilize the most thoroughly;Method for disinfection, can not only ensure with the west being prepared by the method for the present invention
Radix Panacis Quinquefolii breaking cellular wall decoction pieces meets the microbial limit requirement directly taking decoction pieces, and is able to ensure that the medication of Radix Panacis Quinquefolii breaking cellular wall decoction pieces
Safety and drug effect.The sterilising temp of the medicinal material coarse powder of preparation is 50~80 degrees Celsius, several without impact on the content of medical material Radix Panacis Quinquefolii,
So that it is guaranteed that drug effect and sterilizing;Do not have the situation of the oxidized degeneration of effective ingredient of medical material Radix Panacis Quinquefolii;The time of method is short,
Consume energy low.It addition, the present invention uses climatic chamber, it is effectively guaranteed the growing environment of hypopus in medicinal material coarse powder, simultaneously
Can effectively prevent that the situation that foreign body, dust enter medicinal material coarse powder occurs owing to medicinal material coarse powder moves when batch (-type) sterilizing,
Effectively prevent secondary pollution, it can be ensured that the drug safety of Radix Panacis Quinquefolii breaking cellular wall decoction pieces and drug effect.It addition, the present invention uses to bag
In be filled with water vapour, be effectively guaranteed the humidity of the growing environment of hypopus in medicinal material coarse powder, pack can be the most anti-simultaneously
Only in hypopus growth course, occur that foreign body, dust enter the situation of medicinal material coarse powder due to medicinal material coarse powder, effectively prevent two
Secondary pollution, it can be ensured that the drug safety of breaking cellular wall decoction pieces and drug effect.By using limit to add the method system that soft material limit adds breaking cellular wall dry powder
Grain, the particle type of gained is preferable, and elasticity is moderate, and the granule prepared is easier to be dried, and granule leaches comparatively fast.The present invention carries
The method of confession adds Radix Panacis Quinquefolii breaking cellular wall decoction pieces dry powder in pelletization, and prepared granule elasticity is moderate, the later stage is dried,
Granulate is strong, is easily dispersed when user is taken, and solves Radix Panacis Quinquefolii breaking cellular wall decoction pieces in the market and leaches difficult and microorganism limit
The difficult problem up to standard of degree.
The preparation method that the present invention provides is simple, easily operates, low cost, is suitable for commercial Application.
Detailed description of the invention
With specific embodiment, the present invention is further illustrated below, but the present invention is not limited by following embodiment.
Embodiment 1
Radix Panacis Quinquefolii breaking cellular wall decoction pieces
1) medical material process: by American ginseng medicine through pick cleaning/process of preparing Chinese medicine, medicinal material drying to medical material water content 10% with
Under, the medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh;Coarse pulverization medical material reaches further
About 100 mesh;
2) batch (-type) sterilization: Radix Panacis Quinquefolii coarse powder is put in climatic chamber, places thickness and is about 10mm, and arranging temperature is 65
DEG C (actual temperature is 60~70 DEG C), keeps drying sterilizing 8h;Medicinal material coarse powder after process is 25 DEG C, relative humidity in temperature
75% maintains 12 hours;Then the temperature of climatic chamber is adjusted to 35 DEG C, relative humidity 88% maintain 24 hours;Change sets
Putting temperature is 75 DEG C (actual temperature is 70~80 DEG C), keeps drying sterilizing 4h;Microorganism feelings in conventional sense medicinal material coarse powder
Condition, must meet the Radix Panacis Quinquefolii coarse powder directly taking decoction pieces microbial limit requirement;
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100~120 mesh at room temperature and relative humidity in the environment of 30%, warp
Wall breaking pulverization, controls operating pressure and more than 20r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.6MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns);
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 50~60% ethanol, makes
Soft material;
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 16 mesh, and during granulation, limit adds step 4) the wall cell disruption powder soft material that makes time limit add step 3) prepare
Radix Panacis Quinquefolii superfine powder, soft material is 3:1 with the ratio of superfine powder;
6) it is placed in 70 DEG C~80 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 2 times, and subpackage i.e. obtains Radix Panacis Quinquefolii breaking cellular wall decoction pieces.
Embodiment 2
Radix Panacis Quinquefolii breaking cellular wall decoction pieces
1) medical material processes: by American ginseng medicine through picking the water content cleaned/concoct, be dried to medical material below 10%,
The medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh;Coarse pulverization medical material reaches 100 further
About mesh;
2) batch (-type) sterilization: Radix Panacis Quinquefolii coarse powder is put in climatic chamber, places thickness and is about 5mm, and arranging temperature is 70
DEG C (actual temperature is 65~75 DEG C), keeps drying sterilizing 4h;Medicinal material coarse powder after process is 20 DEG C, relative humidity in temperature
70% maintains 15 hours;Then the temperature of climatic chamber is adjusted to 33 DEG C, relative humidity 83% maintain 8 hours;Change sets
Putting temperature is 65 DEG C (actual temperature is 60~70 DEG C), keeps drying sterilizing 6h;Repeat hypopus grow-again to go out bacterial reproduction
Body step 1 time, the microorganism situation in conventional sense medicinal material coarse powder;The west directly taking decoction pieces microbial limit requirement must be met
Radix Panacis Quinquefolii coarse powder;
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100~120 mesh at room temperature and relative humidity in the environment of 50%, warp
Wall breaking pulverization, controls operating pressure and more than 40r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.5MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns);
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 30~40% ethanol, makes
Soft material;
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 20 mesh, and during granulation, limit adds step 4) the superfine powder soft material that makes time limit add step 3) prepare
Radix Panacis Quinquefolii superfine powder, the ratio of soft material and superfine powder is 3:0.5;
6) it is placed in 60 DEG C~70 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 1 time, and subpackage i.e. obtains Radix Panacis Quinquefolii breaking cellular wall decoction pieces.
Embodiment 3
Radix Panacis Quinquefolii breaking cellular wall decoction pieces
1) medical material processes: by American ginseng medicine through picking the water content cleaned/concoct, be dried to medical material below 10%,
The medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh;Coarse pulverization medical material reaches 100 further
About mesh;
2) batch (-type) sterilization: Radix Panacis Quinquefolii coarse powder is put in climatic chamber, places thickness and is about 30mm, and arranging temperature is 75
DEG C (actual temperature is 70~80 DEG C), keeps drying sterilizing 4h;Medicinal material coarse powder after process is 25 DEG C, relative humidity in temperature
75% maintains 24 hours;Then the temperature of climatic chamber is adjusted to 40 DEG C, relative humidity 80% maintain 12 hours;By medical material
Coarse powder is in climatic chamber, and placement thickness is 10mm, and arranging temperature is 80 DEG C (actual temperature is 75~85 DEG C), keeps being dried
Sterilization 0.5h;Repeat step 4 time, the microorganism situation in conventional sense medicinal material coarse powder;Must meet and directly take decoction pieces microorganism
The Radix Panacis Quinquefolii coarse powder of bound requirements;
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100~120 mesh at room temperature and relative humidity in the environment of 70%, warp
Wall breaking pulverization, controls operating pressure and more than 30r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.8MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns);
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 60~70% ethanol, makes
Soft material;
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 20 mesh, and during granulation, limit adds step 4) the superfine powder soft material that makes time limit add step 3) prepare
Radix Panacis Quinquefolii superfine powder, the ratio of soft material and superfine powder is 6:1;
6) it is placed in 50 DEG C~60 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 3 times, and subpackage i.e. obtains Radix Panacis Quinquefolii breaking cellular wall decoction pieces.
Embodiment 4
Radix Panacis Quinquefolii breaking cellular wall decoction pieces
1) medical material processes: by American ginseng medicine through picking the water content cleaned/concoct, be dried to medical material below 10%,
The medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh;Coarse pulverization medical material reaches 100 further
About mesh;
2) batch (-type) sterilization: Radix Panacis Quinquefolii coarse powder is put in climatic chamber, often dish placement thickness is about 25mm, arranges temperature
It is 55 DEG C (actual temperature is 50~60 DEG C), keeps drying sterilizing 0.5h;Be adjusted to 30 DEG C, relative humidity 80% maintains
8 hours, be adjusted to 37 DEG C, relative humidity 92% maintain 15 hours;Medicinal material coarse powder is put in climatic chamber, often dish
Placement thickness is 5mm, and arranging temperature is 55 DEG C (actual temperature is 50~60 DEG C), keeps drying sterilizing 8h;Conventional sense medical material
Microorganism situation in coarse powder, is repeated 2 times again, the microorganism situation in conventional sense medicinal material coarse powder;Must meet and directly take
The Radix Panacis Quinquefolii coarse powder that decoction pieces microbial limit requires;
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100~120 mesh at room temperature and relative humidity in the environment of 40%, warp
Wall breaking pulverization, controls operating pressure and more than 30r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.7MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns);
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 80~99% ethanol, makes
Soft material;
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 20 mesh, and during granulation, limit adds step 4) the wall cell disruption powder soft material that makes time limit add step 3) prepare
Radix Panacis Quinquefolii superfine powder, soft material is 6:0.5 with the ratio of superfine powder;
6) it is placed in 50 DEG C~60 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 3 times, and subpackage i.e. obtains Radix Panacis Quinquefolii breaking cellular wall decoction pieces.
Embodiment 5
Radix Panacis Quinquefolii breaking cellular wall decoction pieces
1) medical material process: by American ginseng medicine through pick cleaning/process of preparing Chinese medicine, medicinal material drying to medical material water content 10% with
Under, the medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh;Coarse pulverization medical material reaches further
About 100 mesh;
2) batch (-type) sterilization: go out bacterial propagule: Radix Panacis Quinquefolii coarse powder is put in baking oven, places thickness and is about 5mm, arrange temperature
Degree is 70 DEG C (actual temperature is 65~75 DEG C), keeps drying sterilizing 4h;Hypopus grows: the medicinal material coarse powder after process is from baking oven
Middle taking-up, pack, when temperature is 20 DEG C, after being filled with water vapour in bag, sealing maintains 15 hours;Go out bacterial propagule again:
Medicinal material coarse powder being put in baking oven, placement thickness is 20mm, and arranging temperature is 65 DEG C (actual temperature is 60~70 DEG C), keeps dry
Dry sterilization 6h;Repeat hypopus grow-again to go out bacterial propagule step 1 time, the microorganism feelings in conventional sense medicinal material coarse powder
Condition;The Radix Panacis Quinquefolii coarse powder directly taking decoction pieces microbial limit requirement must be met;
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100~120 mesh at room temperature and relative humidity in the environment of 30%, warp
Wall breaking pulverization, controls operating pressure and more than 20r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.6MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns);
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 50~60% ethanol, makes
Soft material;
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 16 mesh, and during granulation, limit adds step 4) the superfine powder soft material that makes time limit add step 3) prepare
Radix Panacis Quinquefolii superfine powder, the ratio of soft material and superfine powder is 4:0.8;
6) it is placed in 70 DEG C~80 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 2 times, and subpackage i.e. obtains Radix Panacis Quinquefolii breaking cellular wall decoction pieces.
Embodiment 6
Radix Panacis Quinquefolii breaking cellular wall decoction pieces
1) medical material processes: by American ginseng medicine through picking the water content cleaned/concoct, be dried to medical material below 10%,
The medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh;Coarse pulverization medical material reaches 100 further
About mesh;
2) batch (-type) sterilization: go out bacterial propagule: Radix Panacis Quinquefolii coarse powder is placed in an oven, places thickness and is about 10mm, if
Putting temperature is 65 DEG C (actual temperature is 60~70 DEG C), keeps drying sterilizing 8h;Hypopus grow: the medicinal material coarse powder after process from
Taking out in baking oven, pack, when temperature is 25 DEG C, after being filled with water vapour in bag, sealing maintains 12 hours;Go out bacterial propagule:
Medicinal material coarse powder being put in baking oven, placement thickness is 30mm, and arranging temperature is 75 DEG C (actual temperature is 70~80 DEG C), keeps dry
Dry sterilization 4h;Microorganism situation in conventional sense medicinal material coarse powder, must meet the west directly taking decoction pieces microbial limit requirement
Radix Panacis Quinquefolii coarse powder;
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100~120 mesh at room temperature and relative humidity in the environment of 50%, warp
Wall breaking pulverization, controls operating pressure and more than 40r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.5MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns);
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 30~40% ethanol, makes
Soft material;
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 20 mesh, and during granulation, limit adds step 4) the superfine powder soft material that makes time limit add step 3) prepare
Radix Panacis Quinquefolii superfine powder, the ratio of soft material and superfine powder is 5:0.6;
6) it is placed in 60 DEG C~70 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 1 time, and subpackage i.e. obtains Radix Panacis Quinquefolii breaking cellular wall decoction pieces.
Leach time detecting test
Test method: take about 2g prepare dry granule be placed in the transparent cup of 300 milliliters, add 90 degrees Celsius Celsius to 95
100 milliliters of the water (being no longer heat up during shaking) of degree, shakes 1 minute, 2 minutes, 3 points with the clockwise direction of 1 circle per second
Clock, 5 minutes, see granule in cup after 10 minutes leach situation, separately take the American-European gram LS-609 laser grain of liquid 0.5 milliliter in cup
Degree instrument detection shading rate, result of the test see table 1:
Knowable to table 1 data, the superfine powder method of granulating that the present invention provides is more preferable than the effect of conventional method of granulating, molten
Go out diffusion rate than conventional method faster.
Microbial limit detection test
By " Chinese Pharmacopoeia " 2015 editions the 4th the 140-151 page
1105 non-sterile product microbial limit detections: microorganism count method
1106 non-sterile product microbial limit detections: Control bacteria examination method
1107 non-sterile medicine limitation standard in microbes
According to the method for pharmacopeia, the sample of embodiment 1~6 is carried out microbial limit detection to test, concrete outcome such as table 2:
The detection test of table 2 microbial limit
Knowable to table 2 data, batch (-type) sterilizing methods is more preferable than conventional dry heat sterilization effect, more can guarantee that hygiology matter
Amount.
Active constituent content measuring is tested
By " Chinese Pharmacopoeia " 2015 editions first
Page 131 is about Radix Panacis Quinquefolii detection method of content
Medicinal material coarse powder after sterilizing the batch (-type) of embodiment 1~6 according to the regulation of pharmacopeia carries out assay, specifically ties
Fruit is such as table 3:
The active constituent content measuring test of the medicinal material coarse powder after the sterilization of table 3 batch (-type)
As known from Table 3, the batch (-type) sterilizing methods that the present invention uses is several without impact, energy on the medical material content of embodiment 1~6
The effective active constituent content keeping medicinal material coarse powder.
The foregoing is only the preferred embodiments of the present invention, be not limited to the present invention, for the skill of this area
For art personnel, the present invention can have various modifications and variations.All within the spirit and principles in the present invention, that is made any repaiies
Change, equivalent, improvement etc., should be included within the scope of the present invention.
Claims (10)
1. the preparation method of a Radix Panacis Quinquefolii breaking cellular wall decoction pieces, it is characterised in that there are following steps:
(1) medical material processes: Radix Panacis Quinquefolii is system after picking the pulverizer pulverizing of cleanings/processs of preparing Chinese medicine, medicinal material drying, broken, 100 mesh sieves
Obtain the Radix Panacis Quinquefolii coarse powder of 80~120 mesh;
(2) batch (-type) sterilization: the Radix Panacis Quinquefolii coarse powder after step (1) being processed carries out sterilizing-mistake that grow-again sterilizes of hypopus
Journey, until obtaining meeting the Radix Panacis Quinquefolii coarse powder directly taking decoction pieces microbial limit;
(3) breaking cellular wall: the Radix Panacis Quinquefolii coarse powder after sterilization is ground into Radix Panacis Quinquefolii superfine powder;
(4) soft material processed: the Radix Panacis Quinquefolii superfine powder that breaking cellular wall prepares is placed in blender, makes with the ethanol of water or variable concentrations
Soft material;
(5) pelletize: soft material is made american ginseng granules;
(6) Radix Panacis Quinquefolii breaking cellular wall decoction pieces will be prepared after particle drying.
The preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces the most according to claim 1, it is characterised in that described step (2)
Concretely comprising the following steps of middle batch (-type) sterilization: (A) sterilizes: it is permanent that the American ginseng medicine coarse powder after step (1) being processed is placed on constant temperature
Wet tank keeps drying sterilizing a period of time under uniform temperature;(B) hypopus growth: by medicinal material coarse powder in the middle temperature of climatic chamber
Degree is 20~30 DEG C, relative humidity 70~80% environment in maintain 8~24 hours, then the temperature of climatic chamber is adjusted
Be 33~40 DEG C, relative humidity is adjusted to 83~92% and maintains 8~24 hours;(C) sterilization again: further by medicinal material coarse powder
It is placed in climatic chamber drying sterilizing a period of time at a certain temperature;Microorganism feelings in conventional sense medicinal material coarse powder
Condition, prepares and meets the medicinal material coarse powder directly taking decoction pieces microbial limit;Described uniform temperature is 50~80 DEG C;When described one section
Between be 0.5~8 hour;The thickness that described medicinal material coarse powder is placed in climatic chamber is 5mm~30mm.
The preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces the most according to claim 1, it is characterised in that described step (2)
Concretely comprising the following steps of middle batch (-type) sterilization: (A) sterilizes: the Radix Panacis Quinquefolii coarse powder after step (1) being processed is placed the most certain
At a temperature of keep drying sterilizing a period of time;(B) hypopus growth: by the Radix Panacis Quinquefolii coarse powder after sterilization processing from baking oven
Taking out, pack, when temperature is 20~30 DEG C, after being filled with water vapour in bag, sealing maintains 8~24 hours;(C) sterilization again:
Radix Panacis Quinquefolii coarse powder after hypopus grows is placed drying sterilizing a period of time the most at a certain temperature;Conventional inspection
Survey the microorganism situation in Radix Panacis Quinquefolii coarse powder, prepare and meet the Radix Panacis Quinquefolii coarse powder directly taking decoction pieces microbial limit;Described one
Fixed temperature is 50~80 DEG C;Described a period of time is 0.5~8 hour;Described Radix Panacis Quinquefolii coarse powder is placed in climatic chamber
Thickness is 5mm~30mm.
The preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces the most according to claims 2 to 3, it is characterised in that described step
(2), after in, batch (-type) has sterilized, the microorganism in conventional sense medicinal material coarse powder does not meets directly takes decoction pieces microbial limit
Time, repetition (B) hypopus growth and (C) sterilization process 1~4 times;Prepare and meet the medical material directly taking decoction pieces microbial limit
Coarse powder.
The preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces the most according to claims 1 to 3, it is characterised in that described step
(5) pelletize in method particularly includes: the soft material the made granulator of 14~24 mesh sieves is pelletized, is adding in granulator
Adding Radix Panacis Quinquefolii superfine powder while soft material, completing until preparing granule;Described granulator is the swing system of 14~24 mesh sieves
Grain machine or squash type granulator.
The preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces the most according to claim 5, it is characterised in that described step (5)
In the concrete grammar of middle granulation, the ratio of soft material and Radix Panacis Quinquefolii superfine powder is 3~6:0.5~1.
The preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces the most according to claims 1 to 3, it is characterised in that described step
(1) Chinese crude drug is dried and refers to that Radix Panacis Quinquefolii is dried to water content below 10%;In described step (1), Radix Panacis Quinquefolii is used by broken referring to
The mechanical crusher of the screen cloth of 10 mesh is broken into the little granule of the Radix Panacis Quinquefolii about 10 mesh.
The preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces the most according to claims 1 to 3, it is characterised in that described step
(6) in, particle drying is carried out in heated-air circulation oven, design temperature 50~80 DEG C, is dried to moisture less than or equal to 7%;
In described step (6), granule completes after drying, and with upper strata 10 mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 1~3 time,
Make granule between 10~24 mesh.
The preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces the most according to claims 1 to 3, it is characterised in that described broken step
Suddenly breaking cellular wall in (3) method particularly includes: at room temperature and relative humidity in the environment of 30~70%, through step (2) batch (-type)
The Radix Panacis Quinquefolii coarse powder of sterilization obtains Radix Panacis Quinquefolii superfine powder through wall breaking pulverization, controls operating pressure 0.5~0.8MPa, grader
Rotating speed is 20~40r/s, more than wall breaking pulverization to 300 mesh;Described room temperature refers to 18~26 DEG C.
The preparation method of a kind of Radix Panacis Quinquefolii breaking cellular wall decoction pieces the most according to claim 9, it is characterised in that described step (4)
Middle blender is trough type mixing machine or wet mixing pelletizer, the ethanol of described variable concentrations refer to the concentration of ethanol be 30%~
99%.
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CN108014155A (en) * | 2018-01-31 | 2018-05-11 | 湖南康尔佳新型中药创新研究所有限公司 | A kind of preparation method of the directly oral broken wall prepared slices of Chinese crude drugs of American Ginseng |
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CN104055814A (en) * | 2013-03-20 | 2014-09-24 | 中山市中智药业集团有限公司 | Preparation method of American ginseng wall-broken preparation |
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CN104055814A (en) * | 2013-03-20 | 2014-09-24 | 中山市中智药业集团有限公司 | Preparation method of American ginseng wall-broken preparation |
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CN108014155A (en) * | 2018-01-31 | 2018-05-11 | 湖南康尔佳新型中药创新研究所有限公司 | A kind of preparation method of the directly oral broken wall prepared slices of Chinese crude drugs of American Ginseng |
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