CN104055813B - A kind of Radix Notoginseng broken wall preparation - Google Patents
A kind of Radix Notoginseng broken wall preparation Download PDFInfo
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- CN104055813B CN104055813B CN201310089870.6A CN201310089870A CN104055813B CN 104055813 B CN104055813 B CN 104055813B CN 201310089870 A CN201310089870 A CN 201310089870A CN 104055813 B CN104055813 B CN 104055813B
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- Medicinal Preparation (AREA)
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Abstract
The present invention relates to a kind of Chinese medicine preparations, it particularly relates to a kind of Radix Notoginseng broken wall preparation.Invention by Radix Notoginseng by being crushed into superfine powder, further by ethanol water wet granulation, and the extrusion forming under certain rotating speed, dry, thus obtained Radix Notoginseng broken wall preparation has higher bioavailability, and preparation stability is strong, disintegration is good.
Description
Technical field
The present invention relates to tcm fields, more particularly, to a kind of Radix Notoginseng broken wall preparation.
Background technology
Superfine communication technique is the new technology rapidly developed in recent years.Active ingredient in Chinese medicine is distributed in mostly
Into the cell, part active ingredient can only be made to release when conventional medicine materical crude slice decocts, utilization rate of active components 10-30%；And it uses broken
The prepared slices of Chinese crude drugs are such as crushed to 300 mesh or so by wall crushing technology, and cell-wall breaking ratio is up to 86.7%, are improved in medicinal material effectively
The dissolution of ingredient greatly enhances its drug effect, and utilization rate of active components reaches 90% or more and reduces medicinal material usage amount and protection medicine
Aptitude source, while the quality that drug also can be improved increases drug effect.But current main ultrastructurepower technology is remained in Chinese medicine
Material is crushed to the stage of superfine formulation.Since superfine formulation cell-wall breaking ratio increases, there are broken wall dosage surface products to increase, shape
Irregularly, mobility, bad dispersibility are easy to moisture absorption, and the inherent characteristics such as stability difference are pelletized, improve the stability of product,
Preparation prepared by the present invention is solved the problems, such as well present on, reaches the utilization of medicinal material and using maximization.
Currently, for there are technical barriers below in broken wall preparation and its pelletization：（1）Current broken wall preparation is most
The utilization rate of pipe traditional Chinese medicine ingredients is high, but broken wall powder is easily oxidised, and stability is not high, and drug effect is easy to lose；（2）In existing
The product that drug kind is obtained by soft material granulation, it is difficult to ensure yield, disintegration and stability simultaneously；（3）Some herbal species
It is not suitable for that preparation is made using broken wall powder-soft material granulation method, such as matrimony vine, radix achyranthis bidentatae etc；And the present invention pass through it is a large amount of
It is experimental to grope, it will be screened suitable for the herbal species of broken wall powder-soft material granulation method, and find out the item of each step
Part.
Radix Notoginseng is the dry root and rhizome of panax araliaceae plant Panax notoginseng (Burk.) F. H.Chen.
Its active ingredient is tetracyclic triterpene constituents：Ginsenoside Rb1、Rd、Re、Rg1、Rg2、Rh1, Panax Notoginseng saponin R1、R2、R3、R5、R6、
R7, seven leaf courage glycosides, notoginsenoside A, B, C, D etc.；Also contain dencichine, Quercetin and polysaccharide etc. are held using traditional decocting method
Its heat-sensitive ingredients of destructible, another aspect active ingredient decoct not exclusively, cause the loss of active ingredient.Radix Notoginseng is prepared into
Radix Notoginseng superfine powder, is conducive to the utilization rate for improving active ingredient, but simultaneously because powder specific-surface area detection increase, generation is easy to
The disadvantage of the moisture absorption, oxidation, rotten etc..Therefore, on the basis of being prepared into superfine powder, it is also necessary to further be added to it
Work is transformed, effectively to overcome these unfavorable factors, the maximized therapeutic effect for playing drug.
Invention content
The technical problem to be solved by the present invention is to, in order to overcome the above-mentioned deficiency of Radix Notoginseng broken wall powder in the prior art,
A kind of Radix Notoginseng broken wall preparation is provided.
Above-mentioned technical problem to be solved by this invention is achieved by the following technical programs：
A kind of Radix Notoginseng broken wall preparation provided by the invention, adopts the following technical scheme that：Radix Notoginseng is carried out broken wall crushing to obtain
Superfine powder is obtained, ethanol-water solution is added and is sufficiently mixed, softwood is made, further squeezes and obtains wet grain, drying obtains Radix Notoginseng
The sporoderm-broken rate of broken wall preparation, the superfine powder is 80 ~ 95%；90% or more grain diameter is less than in the superfine powder
Equal to 35 μm.
Preferably, the sporoderm-broken rate of the superfine powder can be 80 ~ 95%.
Radix Notoginseng broken wall preparation prepared by the present invention can make consumer when taking without decoction, by being rushed with warm water
Clothes may make utilizing for active ingredient to maximize.
Radix Notoginseng can be first crushed to 100 mesh, be further carried out ultramicro grinding so that 90% or more in superfine powder
（For example can be 90%, 91%, 92%, 93%, 94% or 95%）Grain diameter be less than or equal to 35 μm.It is used in the present invention program
Superfine powder, 90% grain diameter are nearly 35 μm of powder, preferably 28 ~ 35 μm（Such as can be 28,29,30,31,
32,33,34 or 35 μm）.But those skilled in the art can understand the limitation for being appreciated that these embodiments cannot function as the present invention, only
It wants grain size to be less than or equal to 35 μm and the present invention can be achieved.
The present invention carries out wet granulation using ethanol-water solution, and the advantage protruded is not needing any other addition
Agent, you can so that the superfine powder of the present invention becomes notoginseng preparations particle by subsequent granulation, drying.But in this process,
The proportioning between the ethanol-water solution and the solution and superfine powder of which kind of concentration should be used, is all to need stringent control
Parameter so that the humidity of softwood, solid content, viscosity etc. are applicable to the characteristic of Radix Notoginseng superfine powder, make superfine powder it
Between can effectively bond；Further by the setting of specific squeezing parameter, softwood is squeezed as density, sizeable Radix Notoginseng
Granular preparation keeps its density/fluffy degree appropriate, thus after drying becomes finished product, even if can if being positioned in air at room temperature
To prevent the oxidation of air.Also, the finished product obtained, when taking with warm water, superfine formulation can be more rapid
It scatters on ground so that active ingredient is rapid and fully dissolves and spreads, and improves utilization rate of active components.
The present invention finally has chosen following scheme by repeatedly groping：
When wet granulation, the mass fraction of ethyl alcohol is 30% ~ 90% in used ethanol-water solution；Preferably, ethyl alcohol
Mass fraction be the ﹪ of 40 ﹪~80, the more preferably ﹪ of 50 ﹪~75.When ethyl alcohol mass fraction is 30% ~ 39%, superfine powder
Body is with ethanol-water solution than 1 ︰ 0.4 ~ 0.45 by weight, preferably 1 ︰ 0.4；When ethyl alcohol mass fraction is 40% ~ 49%,
Superfine powder is with ethanol-water solution than 1 ︰ 0.4 ~ 0.45 by weight, preferably 1 ︰ 0.45；When ethyl alcohol mass fraction be 50% ~
When 59%, superfine powder is with ethanol-water solution than 1 ︰ 0.4 ~ 0.6 by weight, preferably 1 ︰ 0.4 ~ 0.5；When ethyl alcohol quality point
When number is 60% ~ 69%, superfine powder is with ethanol-water solution than 1 ︰ 0.4 ~ 0.7 by weight, preferably 1 ︰ 0.5 ~ 0.7；Work as second
When alcohol mass fraction is 70% ~ 79%, superfine powder and ethanol-water solution than 1 ︰ 0.4 ~ 0.8 by weight, preferably 1 ︰ 0.6 ~
0.8；When ethyl alcohol mass fraction is 80% ~ 90%, superfine powder and ethanol-water solution are than 1 ︰ 0.4 ~ 1.0 by weight, preferably
For 1 ︰ 0.6 ~ 0.9.
When squeezing softwood as wet grain, it is preferably controlled in the following conditions：Using the prepackage mesh screen of 10 mesh~30, squeeze
Surging 0.05Mpa~1Mpa, rotating speed 50r/min~100r/min；Preferably, dynamics 0.75Mpa~0.85Mpa is squeezed, is turned
Fast 65r/min~75r/min.
The wet grain grain size for squeezing gained is the mesh of 20 mesh ~ 40, and drying temperature is 45 DEG C ~ 85 DEG C when dry, and drying time is
0.5h~2.5h。
The density of the Radix Notoginseng broken wall preparation obtained is 0.35g/ml~0.75g/ml.
Compared with prior art, the invention has the advantages that：
（1）The notoginseng preparations that method through the invention obtains, utilization rate of active components greatly improve, and utilization rate is close
In 100%；Being tested through bioequivalence confirms, the drug effect of 1 part of traditional Radix Notoginseng can be equivalent to using 1/4 part of Radix Notoginseng broken wall preparation；
（2）The present invention obtains suitable wet granulation technology by groping so that addition of the pelletization in addition to alcohol-water
Except, do not introduce other any additives, you can obtain solid content, modest viscosity softwood, to be successfully squeezed into
Grain technique, it is strong to be formed by Chinese medicinal granule stability, is not easy to collapse in storage and transportational process rotten；
（3）The present invention extruding condition groped suitable rotating speed and extruding force, be thus made stickiness, medium density three
Seven granular preparations during taking and make its easy disintegration disperse, are rushed convenient for warm water while acquisition finished product stability is strong
Clothes；
（4）Radix Notoginseng broken wall system of the present invention leaches uniformly in water, overcomes superfine powder system in the prior art
At after preparation with the water-soluble dense problem of the dilute lower part solution of existing top solution that sheds, and active ingredient dissolved out substantially it is referred to as molten
Liquid, is not present in dregs of a decoction powder, simply takes after mixing it with water and can be obtained good drug effect.
Specific implementation mode
In order to be more clearly understood that the technology contents of the present invention, spy are lifted following embodiment and are described in detail, but the present invention
Embodiment it is without being limited thereto.
Embodiment 1
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding in superfine powder 90%
Grain grain size is less than or equal to 35 μm of powder, and ethanol-water solution is added（Ethyl alcohol mass fraction is 30%）Wet method softwood, solution with
Superfine powder addition is than 0.4 ︰ 1（By weight）, after mixing, through pre-installing 10 mesh sieve, select and squeeze rotating speed 50r/min, squeeze
Dynamics 1MPa wet granulars in wet granular transposition heated-air circulation oven, set 85 DEG C of drying temperature, dry 2.5h to dry, whole grain
Up to Radix Notoginseng broken wall preparation after screening.
Remarks：Full marks are in terms of 10.
Embodiment 2
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding in superfine powder 90%
Grain grain size is less than or equal to 35 μm of powder, and ethanol-water solution is added（Ethyl alcohol mass fraction is 50%）Wet method softwood, solution with
Superfine powder addition is than 0.5 ︰ 1（By weight）, after mixing, through pre-installing 10 mesh sieve, select and squeeze rotating speed 60r/min, squeeze
Dynamics 0.8MPa wet granulars in wet granular transposition vacuum microwave drying case, set 45 DEG C of drying temperature, dry 0.75h to dry,
Up to Radix Notoginseng broken wall preparation after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 3
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding in superfine powder 90%
Grain grain size is less than or equal to 35 μm of powder, and ethanol-water solution is added（Ethyl alcohol mass fraction is 90%）Wet method softwood, solution with
Superfine powder addition is than 0.8 ︰ 1（By weight）, after mixing, through pre-installing 30 mesh sieve, select and squeeze rotating speed 80r/min, squeeze
Dynamics 0.3MPa wet granulars in wet granular transposition heated-air circulation oven, set 85 DEG C of drying temperature, and dry 2.5h is whole to dry
Up to Radix Notoginseng broken wall preparation after grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 4
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding in superfine powder 90%
Grain grain size is less than or equal to 35 μm of powder, and ethanol-water solution is added（Ethyl alcohol mass fraction is 80%）Wet method softwood, solution with
Superfine powder addition is than 0.8 ︰ 1（By weight）, after mixing, through pre-installing 30 mesh sieve, select and squeeze rotating speed 60r/min, squeeze
Dynamics 0.5MPa wet granulars in wet granular transposition vacuum microwave drying case, set 50 DEG C of drying temperature, dry 0.5h to dry,
Up to Radix Notoginseng broken wall preparation after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 5
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, be ground into 90% in superfine powder through ultramicro grinding
Grain diameter be less than or equal to 35 μm of powder, ethanol-water solution is added（Second mass fraction is 75%）Wet method softwood, solution
With superfine powder addition than 0.5 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieve, select and squeeze rotating speed 100r/min, squeeze
Surging 0.05MPa wet granulars in wet granular transposition heated-air circulation air box, set 85 DEG C of drying temperature, dry 2.0h to dry,
Up to Radix Notoginseng broken wall preparation after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 6
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, be ground into 90% in superfine powder through ultramicro grinding
Grain diameter be less than or equal to 35 μm of powder, the solution wet method softwood that the mass fraction of ethanol-water solution is 40% is added,
Solution is with superfine powder addition than 0.45 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieve, select and squeeze rotating speed 50r/
Min squeezes dynamics 0.2MPa wet granulars, using fluidized drying, sets dry 85 DEG C of inlet air temperature, and dry 1.0h is whole to dry
Up to Radix Notoginseng broken wall preparation after grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 7
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, be ground into 90% in superfine powder through ultramicro grinding
Grain diameter be less than or equal to 35 μm of powder, ethanol-water solution is added（Second mass fraction is 65%）Wet method softwood, solution
With superfine powder addition than 0.6 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieve, select and squeeze rotating speed 70r/min, squeeze
Surging 0.75MPa wet granulars in wet granular transposition heated-air circulation air box, set 85 DEG C of drying temperature, dry 2.0h to dry,
Up to Radix Notoginseng broken wall preparation after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 8
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, be ground into 90% in superfine powder through ultramicro grinding
Grain diameter be less than or equal to 35 μm of powder, ethanol-water solution is added（Mass fraction is 40%）Solution wet method softwood, it is molten
Liquid is with superfine powder addition than 0.6 ︰ 1（By weight）, after mixing, through pre-installing 14 mesh sieve, selects and squeezes rotating speed 50r/min,
Extruding dynamics 0.8MPa wet granulars set dry 85 DEG C of inlet air temperature, dry 1.0h to dry, whole grain sieve using fluidized drying
Up to Radix Notoginseng broken wall preparation after point.
Remarks：Full marks are in terms of 10.
Embodiment 9
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, through ultramicro grinding in superfine powder 90%
Grain grain size is less than or equal to 35 μm of powder, and ethanol-water solution is added（Ethyl alcohol mass fraction is 90%）Wet method softwood, solution with
Superfine powder addition is than 1.0 ︰ 1（By weight）, after mixing, through pre-installing 30 mesh sieve, select and squeeze rotating speed 80r/min, squeeze
Dynamics 0.9MPa wet granulars in wet granular transposition heated-air circulation oven, set 85 DEG C of drying temperature, and dry 2.5h is whole to dry
Up to Radix Notoginseng broken wall preparation after grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 10
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, be ground into 90% in superfine powder through ultramicro grinding
Grain diameter be less than or equal to 35 μm of powder, ethanol-water solution is added（Second mass fraction is 70%）Wet method softwood, solution
With superfine powder addition than 0.7 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieve, select and squeeze rotating speed 90r/min, squeeze
Surging 0.6MPa wet granulars in wet granular transposition heated-air circulation air box, set 85 DEG C of drying temperature, dry 2.0h to dry,
Up to Radix Notoginseng broken wall preparation after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 11
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, be ground into 90% in superfine powder through ultramicro grinding
Grain diameter be less than or equal to 35 μm of powder, ethanol-water solution is added（Second mass fraction is 75%）Wet method softwood, solution
With superfine powder addition than 1.0 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieve, select and squeeze rotating speed 70r/min, squeeze
Surging 0.95MPa wet granulars in wet granular transposition heated-air circulation air box, set 85 DEG C of drying temperature, dry 2.0h to dry,
Up to Radix Notoginseng broken wall preparation after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 12
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, be ground into 90% in superfine powder through ultramicro grinding
Grain diameter be less than or equal to 35 μm of powder, ethanol-water solution is added（Second mass fraction is 60%）Wet method softwood, solution
With superfine powder addition than 0.6 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieve, select and squeeze rotating speed 105r/min, squeeze
Surging 1.1MPa wet granulars in wet granular transposition heated-air circulation air box, set 85 DEG C of drying temperature, dry 2.0h to dry,
Up to Radix Notoginseng broken wall preparation after whole grain screening.
Remarks：Full marks are in terms of 10.
Embodiment 13
Take the net medicinal material of Radix Notoginseng, after coarse powder is broken to 100 mesh or so coarse powder, be ground into 90% in superfine powder through ultramicro grinding
Grain diameter be less than or equal to 35 μm of powder, ethanol-water solution is added（Second mass fraction is 65%）Wet method softwood, solution
With superfine powder addition than 0.6 ︰ 1（By weight）, after mixing, through pre-installing 20 mesh sieve, select and squeeze rotating speed 45r/min, squeeze
Surging 0.04MPa wet granulars in wet granular transposition heated-air circulation air box, set 85 DEG C of drying temperature, dry 2.0h to dry,
Up to Radix Notoginseng broken wall preparation after whole grain screening.
Remarks：Full marks are in terms of 10.
1~7 lower finished product of Example presses final product quality standard test, as a result meets under Chinese Pharmacopoeia correlation dosage form item
Prescribed requirement, the results are shown in Table 1.
Further by 1 ~ 7 lower Radix Notoginseng broken wall preparation of embodiment and Radix Notoginseng superfine powder, Radix Notoginseng routine medicine materical crude slice, with character,
Moisture and ginsenoside Rg1、Rb1、R1For total amount as evaluation index, three is placed on temperature after being all made of sealed plastic bag encapsulation
40 DEG C ± 2 DEG C, each preparation stability is evaluated after being placed 3 months under conditions of relative humidity 75% ± 5%.As a result such as following table：
Another step is by acute toxicity, the advance of the drug effect contrasts description of test present invention below, made from Example 7
Radix Notoginseng broken wall preparation is compared with traditional medicine materical crude slice.
One, acute toxicity test
Kunming small white mouse 40,18~22 grams of weight, half male and half female is randomly divided into according to group（Distilled water 0.4ml/10g mouse）,
Sanqi tablets group, Radix Notoginseng clip group, Radix Notoginseng broken wall preparation group give the original liquid of 1g/ml concentration（For maximum concentration）0.4ml/10g
Mouse.
Table 2 is the result shows that sanqi tablets, Radix Notoginseng clip medicine materical crude slice, Radix Notoginseng broken wall preparation are to intragastric administration on mice maximum dosage-feeding on the one
120g/kg is generated without apparent acute toxicity.
Two, pharmacodynamics compares
Kunming small white mouse 56, half male and half female are randomly divided into 7 groups, every group 8.It is divided into normal group（Physiological saline）, Radix Notoginseng
Medicine materical crude slice group（62.5mg/kg）, Radix Notoginseng clip medicine materical crude slice group（62.5mg/kg）, the dosage groups such as Radix Notoginseng broken wall preparation（62.5mg/kg）、
Radix Notoginseng broken wall preparation low dose group（7.8mg/kg）, Radix Notoginseng broken wall preparation middle dose group（15.6mg/kg）, Radix Notoginseng broken wall preparation it is high
Dosage group（31.25mg/kg）.Broken wall preparation group is after placing preparation made from embodiment 7 90 days, with 60 ° or so of temperature
Boiling water reconstitutes, and takes supernatant gastric infusion.
Table 3 is the result shows that the drug action of Radix Notoginseng broken wall preparation is equivalent to 1/4 better than Radix Notoginseng routine medicine materical crude slice, clip medicine materical crude slice
Amount.
Claims (1)
1. a kind of Radix Notoginseng broken wall preparation, which is characterized in that be prepared by following steps：The net medicinal material of Radix Notoginseng is taken, is broken to through coarse powder
After 100 mesh coarse powder, it is ground into superfine powder 90% powder of the grain diameter less than or equal to 35 μm through ultramicro grinding, matter is added
Measure the ethanol-water solution wet method softwood that score is 65%, solution and superfine powder are added 0.6 ︰ 1 of weight ratio, after mixing, through pre-
20 mesh sieve is filled, selects and squeezes rotating speed 70r/min, squeezes dynamics 0.75MPa wet granulars, wet granular transposition heated-air circulation air box
In, 85 DEG C of drying temperature is set, dry 2.0h is to doing, up to Radix Notoginseng broken wall preparation after whole grain screening.
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| CN106265802A (en) * | 2016-08-08 | 2017-01-04 | 湖南盟合投资管理有限公司 | The preparation method of Radix Notoginseng breaking cellular wall decoction pieces |
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