CN112220754A - Method for improving compression formability of traditional Chinese medicine extract powder - Google Patents

Method for improving compression formability of traditional Chinese medicine extract powder Download PDF

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CN112220754A
CN112220754A CN202011291412.7A CN202011291412A CN112220754A CN 112220754 A CN112220754 A CN 112220754A CN 202011291412 A CN202011291412 A CN 202011291412A CN 112220754 A CN112220754 A CN 112220754A
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chinese medicine
traditional chinese
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medicine extract
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林晓
张越
洪燕龙
吴飞
沈岚
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Shanghai University of Traditional Chinese Medicine
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

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Abstract

The invention discloses a method for improving the compression formability of traditional Chinese medicine extract powder, which comprises the steps of drying the traditional Chinese medicine extract and a modifier together, crushing and sieving to prepare composite powder; the modifier is selected from more than one of hydrophilic micropowder silica gel, hydrophobic micropowder silica gel and mesoporous micropowder silica gel, co-drying is co-atmospheric drying, co-reduced pressure drying or spray drying, and the mass of the modifier is 0.99-33.3% of the total mass of the composite powder. According to the method for improving the compression formability of the traditional Chinese medicine extract powder, the micropowder silica gel is relatively uniformly dispersed in the traditional Chinese medicine extract powder particles and on the surfaces of the traditional Chinese medicine extract powder particles in a co-drying mode, so that the compression formability of the traditional Chinese medicine extract powder is remarkably improved, and meanwhile, the problem that the traditional Chinese medicine extract powder is easy to absorb moisture and the flowability of the traditional Chinese medicine extract powder is improved to a certain extent; the method is simple, has good effect and has wide application prospect.

Description

Method for improving compression formability of traditional Chinese medicine extract powder
Technical Field
The invention belongs to the technical field of medicinal preparations, relates to a preparation method of modified traditional Chinese medicine powder, and particularly relates to a method which can solve the problem of poor compression molding property of traditional Chinese medicine extract powder in actual production, and can improve the problem of easy moisture absorption of the traditional Chinese medicine extract powder and increase the fluidity of the traditional Chinese medicine extract powder to a certain extent.
Background
The traditional Chinese medicine extract powder is an aggregate of various components in an amorphous form, and contains various micromolecular sugars and organic acid substances, so that the problems of strong hygroscopicity, poor fluidity, poor compressibility and the like exist, and the production process, transmission, storage, product quality and the like of the solid preparation are seriously influenced. In addition, the traditional Chinese medicine tablet needs higher drug loading, which makes the solution of the problem more difficult.
At present, the main approaches for solving the problems of the traditional Chinese medicine tablets are as follows: (1) further purifying the raw materials of the Chinese medicinal preparation to reduce the dosage and improve the performance; (2) selecting novel high-performance auxiliary materials. Further purifying the raw materials of the traditional Chinese medicine preparation requires a great deal of research on the effectiveness, safety and the like of the medicine, not only has high cost, but also has long time consumption and large risk, and can weaken or lose the characteristics and advantages of multi-component and multi-target comprehensive effects of the traditional Chinese medicine. Although the application of the high-performance auxiliary materials is economical, the period is short, but the performance change is limited due to the fact that the number of the selected auxiliary materials is small, and a scholars think that the physical and chemical properties of the traditional Chinese medicine tablet are complex, the using amount and the effect space of the auxiliary materials are limited, and the research mode of the chemical medicine tablet for increasing the using amount of the auxiliary materials cannot completely adapt to the requirement of developing the traditional Chinese medicine tablet by screening the types of the auxiliary materials, so that the degree and the range for solving the problem of the traditional Chinese medicine tablet by selecting the novel high-performance auxiliary materials.
Therefore, the development of a method for improving the compression formability of the traditional Chinese medicine extract powder, which has lower cost and does not influence the performance of the tablet, has practical significance.
Disclosure of Invention
The invention aims to overcome the defects of high cost and easy influence on the performance of tablets in the prior art, and provides a method for improving the compression formability of traditional Chinese medicine extract powder, which has low cost and does not influence the performance of tablets. The method provided by the invention is simple to operate, not only can effectively solve the problem of poor compression moldability of the traditional Chinese medicine extract powder, but also can improve the problem of easy moisture absorption of the traditional Chinese medicine extract powder and increase the fluidity of the traditional Chinese medicine extract powder to a certain extent.
In order to achieve the purpose, the invention provides the following technical scheme:
a method for improving compression formability of Chinese medicinal extract powder comprises drying Chinese medicinal extract (fluid extract or soft extract) and modifier, pulverizing, and sieving to obtain composite powder; the modifier is selected from more than one of hydrophilic micropowder silica gel, hydrophobic micropowder silica gel and mesoporous micropowder silica gel. Those skilled in the art can select other materials (i.e. other modifiers such as microcrystalline cellulose, compressible starch and dextrin with larger particle size) to be dispersed in and on the surface of the Chinese medicinal extract powder according to actual needs.
Compared with the prior common process for further purifying the raw materials of the traditional Chinese medicine preparation/selecting novel high-performance auxiliary materials, the processing process of the invention, namely the co-processing with the modifier, can realize the aggregation of the initial particles of the medicine and the modifier, improve the fluidity, simultaneously uniformly distribute one or more modifiers, ensure that the performance of the secondary particles can be obviously improved under the condition of only adding a small amount of the modifier, and has the advantages of simple preparation process, short development period, low cost and the like. Meanwhile, because the co-processing is only the physical combination of a plurality of materials in special forms and no chemical reaction or component change occurs, the potential hazard of reducing the effectiveness and the safety of the medicine is avoided, and the method can be used as an excellent way for solving the problem of medicine tabletting.
The method is simple to operate, and the micropowder silica gel is relatively uniformly dispersed in and on the surface of the traditional Chinese medicine extract powder in a co-drying mode, so that the texture and surface characteristics of the traditional Chinese medicine extract powder particles are changed, and the compression molding performance of the traditional Chinese medicine extract powder is improved. In addition, the superfine silica gel powder can promote the dispersion of the Chinese medicinal extract powder, so that the hygroscopicity and the flowability of the Chinese medicinal extract powder are improved to a certain extent.
As a preferred technical scheme:
the method for improving the compression formability of the traditional Chinese medicine extract powder is characterized in that the co-drying is co-atmospheric drying, co-reduced pressure drying or spray drying.
According to the method for improving the compression formability of the traditional Chinese medicine extract powder, the mass of the modifier is 0.99-33.3% of the total mass of the composite powder. The scope of the present invention is not limited thereto, and the amount of the modifier may be adjusted by those skilled in the art according to actual needs.
According to the method for preparing the traditional Chinese medicine composite powder with improved compression formability, the viscosity of the traditional Chinese medicine extract is controlled to be 12-1000 centipoises, the viscosity is not too high or too low, and the too low viscosity means that the extract is too thin, so that the drying time is prolonged, and the possibility of uneven longitudinal distribution of the extract and the modifier is increased; too high a viscosity means that the extract is too concentrated, which can be detrimental to the uniform dispersion of the modifier in the extract.
Compared with the dry powder prepared by directly drying the traditional Chinese medicine extract, the hygroscopicity and the repose angle of the composite powder are respectively reduced by 10.2-84.0% and 3.3-36.2%.
According to the method for improving the compression formability of the traditional Chinese medicine extract powder, the tensile strength of the tablet prepared by tabletting the composite powder is improved by 9.4-304.6% compared with the tablet prepared by directly drying the traditional Chinese medicine extract and prepared by dry powder, or the tensile strength of the tablet prepared by tabletting the composite powder is improved from the soft tablet prepared by directly drying the traditional Chinese medicine extract and prepared by raw powder and incapable of measuring the tensile strength.
The invention mechanism is as follows:
at present, dry coating (dry coating) is generally adopted as a co-processing method, and MCC (microcrystalline cellulose) and other excellent auxiliary materials are taken as modifiers to further improve the flowability, the disintegration and the hygroscopicity of Chinese medicinal extract powder and improve the flowability and the compression moldability of chemical medicaments, and the dry coating has the following characteristics: 1) the dry-method wrapping operation is simple, and the feasibility is good; 2) MCC is a currently recognized excellent multifunctional tablet auxiliary material, has the functions of adhesion, flow aid, disintegration and the like besides being used as a filler with excellent compressibility, and is a gold standard auxiliary material for researching the compressibility problem of tablet raw materials. The dry wrapping method is adopted to treat the traditional Chinese medicine extract, which can achieve certain effect, but has limited improvement effect.
The invention adopts co-drying as a co-processing method and uses micro silica gel powder as a modifier. At present, no related research report that the traditional Chinese medicine extract is taken as a research object and the powder compression moldability of the traditional Chinese medicine extract is obviously improved exists.
The invention selects co-drying (common co-drying modes comprise normal pressure drying, reduced pressure drying and spray drying) as a co-processing method, because: the obvious difference from the chemical tablet is that in the production process of the traditional Chinese medicine extract tablet, the effective preparation of the extract powder which is the first operation unit is an important basis and key point for obtaining the tablet with higher drug-loading rate. The reason for selecting the micro silica gel powder as the modifier is as follows: 1) the micro-powder silica gel is commonly used as a flow aid, the flow aid can improve the flowability of sticky powder and particles, the action mechanism of the flow aid is mainly to reduce the cohesion and adhesion of the particles, and the micro-powder silica gel is used as a spacing agent after being added, so that the distance between particles is increased, and further the van der Waals force is reduced; 2) the initial particle size of the micropowder silica gel is about several to tens of nanometers, the bulk density is about 1/10 of that of the conventional auxiliary materials, and the micropowder silica gel has large specific surface area (about 200 m)2The oral administration safety is high, the oral administration safety can be dispersed on the rough surface of particles, the inter-particle interlocking is further prevented, the friction is reduced (when the particle diameter ratio of large particles to small particles is close to 10, the small particles are easily and automatically gathered on the surface of large particles, and fully-coated composite particles, namely the gathering of aerosil on the surface and the new section of the traditional Chinese medicine dry extract powder are formed, the moisture can be prevented from entering the powder, the inter-particle friction is reduced, the particle fluidity is enhanced, the cohesion and the adhesion of the particles are reduced, the adsorbed moisture of the particles is reduced, and the fluidity and the moisture absorption of the particles are; 3) the micro silica gel powder is hard, and when the micro silica gel powder is dispersed in soft traditional Chinese medicine extract powder, the hardness of particles and the connection strength among the particles can be improved, so that the compression formability of the composite particles is improved. The invention directly adds the superfine silica gel powder (modifier) in the conventional preparation method of the traditional Chinese medicine extract powder and then co-processes the superfine silica gel powder, and the conventional preparation method of the traditional Chinese medicine extract powder (adding the superfine silica gel powder) is organically combined with the co-processing mode, thereby greatly saving the processing procedure and shortening the processThe time is long, and compared with dry method co-processing, the compression molding performance of the traditional Chinese medicine extract powder is greatly improved.
Has the advantages that:
(1) according to the method for improving the compression formability of the traditional Chinese medicine extract powder, the micropowder silica gel is relatively uniformly dispersed in the traditional Chinese medicine extract powder particles and on the surfaces of the traditional Chinese medicine extract powder particles in a co-drying mode, so that the compression formability of the traditional Chinese medicine extract powder is remarkably improved, and meanwhile, the problem that the traditional Chinese medicine extract powder is easy to absorb moisture and the flowability of the traditional Chinese medicine extract powder is improved to a certain extent;
(2) the method for improving the compression formability of the traditional Chinese medicine extract powder is simple, has good effect and has wide application prospect.
Drawings
FIGS. 1 and 2 are scanning electron micrographs 800X and 2500X, respectively, of the product of example 2;
FIGS. 3 and 4 are scanning electron micrographs of 800 and 2500, respectively, of the product of comparative example 2;
FIGS. 5 and 6 are scanning electron micrographs of 800 and 2500, respectively, of the product of comparative example 12;
FIGS. 7 and 8 are scanning electron micrographs of 800X and 2500X, respectively, of the product of comparative example 23;
FIGS. 9 and 10 are scanning electron micrographs of 800 and 2500, respectively, of the product of comparative example 30;
FIG. 11 is a schematic diagram showing the change of Chinese medicinal extract powder before and after treatment by the method of the present invention.
Detailed Description
The following further describes the embodiments of the present invention with reference to the attached drawings.
Example 1
A method for improving the compression formability of traditional Chinese medicine extract powder comprises the following steps:
(1) preparing a traditional Chinese medicine thick paste and characterizing physical properties;
taking a proper amount of honeysuckle decoction pieces, performing reflux extraction twice (10 times and 8 times) with a solvent (water or alcohol with a certain concentration) for 1.5 hours each time, filtering the extract, merging the extract, and concentrating into a paste (clear paste or thick paste) with the viscosity of 12-1000 centipoises;
(2) taking the paste (clear paste or thick paste), and mixing the paste with the hydrophilic micro-powder silica gel according to the mass ratio of the solid content of the extract to the hydrophilic micro-powder silica gel of 1: 0.5 adding hydrophilic silica micropowder into the paste (fluid extract or soft extract), mixing, drying under reduced pressure, and pulverizing to obtain composite powder.
Examples 2 to 11
A method for improving the compression formability of Chinese medicinal extract powder comprises the same steps as example 1 except that flos Lonicerae decoction pieces are replaced according to the following table.
Figure BDA0002783965900000051
Figure BDA0002783965900000061
Comparative example 1
A method for preparing modified traditional Chinese medicine powder, which comprises the steps substantially the same as those in example 1, except that MCC is used instead of hydrophilic aerosil.
Comparative examples 2 to 10
A method for preparing modified Chinese medicinal powder comprises the same steps as comparative example 1 except that flos Lonicerae decoction pieces are replaced according to the following table.
Comparative example 2 Dried ginger decoction pieces
Comparative example 3 Silybum marianum decoction pieces
Comparative example 4 White peony root decoction pieces
Comparative example 5 Licorice root decoction pieces
Comparative example 6 Gardenia decoction pieces
Comparative example 7 Haw decoction pieces
Comparative example 8 Wind-dispelling and detoxifying prescription decoction piece
Comparative example 9 Paeonia lactiflora prescription decoction pieces
Comparative example 10 Ningfang decoction pieces for treating cold in children
Comparative example 11
A method for preparing modified Chinese medicinal powder comprises the same steps as example 1, except that hydrophilic micropowder silica gel is not added into the paste in step (2) (i.e. the paste is taken in step (2), dried under reduced pressure, and pulverized).
Comparative examples 12 to 21
A method for preparing modified Chinese medicinal powder comprises the same steps as in comparative example 11 except that flos Lonicerae decoction pieces are replaced according to the following table.
Comparative example 12 Dried ginger decoction pieces
Comparative example 13 Silybum marianum decoction pieces
Comparative example 14 White peony root decoction pieces
Comparative example 15 Licorice root decoction pieces
Comparative example 16 Gardenia decoction pieces
Comparative example 17 Haw decoction pieces
Comparative example 18 Andrographis paniculata decoction pieces
Comparative example 19 Wind-dispelling and detoxifying prescription decoction piece
Comparative example 20 Paeonia lactiflora prescription decoction pieces
Comparative example 21 Ningfang decoction pieces for treating cold in children
Comparative example 22
A method for preparing modified traditional Chinese medicine powder, which has the basically same steps as the embodiment 1, and is different from the step (2) in that: drying the paste to obtain dry powder, and then mixing the dry powder with the hydrophilic micropowder silica gel according to the mass ratio of 1: adding hydrophilic micropowder silica gel at a ratio of 0.06, and mixing to obtain fine powder.
Comparative examples 23 to 27
A method for preparing modified Chinese medicinal powder comprises the same steps as in comparative example 22, except that flos Lonicerae decoction pieces are replaced according to the following table.
Comparative example 23 Dried ginger decoction pieces
Comparative example 24 Licorice root decoction pieces
Comparative example 25 Haw decoction pieces
Comparative example 26 Andrographis paniculata decoction pieces
Comparative example 27 Wind-dispelling and detoxifying prescription decoction piece
Comparative example 28 Ningfang decoction pieces for treating cold in children
Comparative example 29
A method for preparing modified traditional Chinese medicine powder, which has the basically same steps as the embodiment 1, and is different from the step (2) in that: drying the paste to obtain dry powder, and then mixing the dry powder with MCC according to the mass ratio of 1: adding MCC at a ratio of 0.5, and mixing to obtain fine powder.
Comparative examples 30 to 35
A method for preparing modified Chinese medicinal powder comprises the same steps as in comparative example 29, except that flos Lonicerae decoction pieces were replaced as shown in the following table.
Comparative example 30 Dried ginger decoction pieces
Comparative example 31 Licorice root decoction pieces
Comparative example 32 Haw decoction pieces
Comparative example 33 Andrographis paniculata decoction pieces
Comparative example 34 Wind-dispelling and detoxifying prescription decoction piece
Comparative example 35 Ningfang decoction pieces for treating cold in children
Example 12
The method for improving the compression formability of the traditional Chinese medicine extract powder basically comprises the following steps of 1, wherein the mass ratio of the solid content of the extract to the hydrophilic micropowder silica gel is 1: 0.06.
examples 13 to 15
A method for improving the compression moldability of Chinese medicinal extract powder, which comprises the steps substantially the same as those of example 12, except that honeysuckle decoction pieces were replaced as shown in the following table.
Example 13 Dried ginger decoction pieces
Example 14 Haw decoction pieces
Example 15 Wind-dispelling and detoxifying prescription decoction piece
Comparative example 36
A method for preparing modified traditional Chinese medicine powder, the steps of which are substantially the same as those in example 12, except that MCC is used instead of hydrophilic aerosil.
Comparative examples 37 to 39
A method for preparing modified Chinese medicinal powder comprises the same steps as in comparative example 36 except that flos Lonicerae decoction pieces are replaced according to the following table.
Comparative example 37 Dried ginger decoction pieces
Comparative example 38 Haw decoction pieces
Comparative example 39 Wind-dispelling and detoxifying prescription decoction piece
Example 16
A method for improving the compression formability of Chinese medicinal extract powder comprises the steps of example 1, and is different from the steps of replacing hydrophilic silica micropowder with hydrophobic silica micropowder.
Examples 17 to 19
A method for improving the compression moldability of Chinese medicinal extract powder, which comprises the steps substantially the same as those of example 16, except that the decoction pieces of honeysuckle flower are replaced as shown in the following table.
Example 17 Andrographis paniculata decoction pieces
Example 18 Haw decoction pieces
Example 19 Chinese date decoction pieces
Example 20
A method for improving the compression formability of traditional Chinese medicine extract powder, which has the basically same steps as the embodiment 16, and is different in that the mass ratio of the solid content of the extract to the hydrophobic micropowder silica gel is 1: 0.06.
example 21
A method for improving the compression formability of Chinese medicinal extract powder, which comprises the steps substantially the same as those in example 1, except that honeysuckle decoction pieces are replaced by dried ginger decoction pieces, and hydrophilic silica gel micropowder is replaced by mesoporous silica gel micropowder.
Comparative example 40
A method for preparing modified Chinese medicinal powder, which comprises the following steps in substantially the same manner as in example 21, except that the step (2) is replaced by: drying the paste to obtain dry powder, and then mixing the dry powder with the hydrophilic micropowder silica gel according to the mass ratio of 1: adding hydrophilic silica gel micropowder at a ratio of 0.06, mixing, and pulverizing to obtain fine powder.
Comparative example 41
A method for preparing modified Chinese medicinal powder, which comprises the following steps in substantially the same manner as in example 21, except that the step (2) is replaced by: drying the paste to obtain dry powder, and then mixing the dry powder with MCC according to the mass ratio of 1: adding MCC at a ratio of 0.06, mixing, and pulverizing to obtain fine powder.
Example 22
A method for improving compression formability of traditional Chinese medicine extract powder, which has the basically same steps as example 1, and is different in that honeysuckle decoction pieces are replaced by wind-dispelling and detoxifying decoction pieces, and the mass ratio of the solid content of the extract to hydrophilic micropowder silica gel is 1: 0.06, the reduced pressure drying is changed into spray drying, and the parameter conditions are set as follows: air inlet temperature: 135 ℃, liquid inlet speed: 9.0mL/min, atomization pressure of 0.75bar, air inlet volume: 35m3And h, finally drying the collected powder in an oven at 60 ℃ for 1 h.
Example 23
A method for improving compression moldability of Chinese medicinal extract powder, which comprises the steps substantially the same as those of example 22, except that decoction pieces of wind-dispelling and toxicity-removing formula are replaced by decoction pieces of dried ginger.
Comparative example 42
A method for preparing modified traditional Chinese medicine powder, which comprises the steps basically the same as the embodiment 22, except that no hydrophilic micropowder silica gel is added in the step (2).
Comparative example 43
A method for preparing modified Chinese medicinal powder comprises the same steps as in comparative example 42, except that decoction pieces of formula for dispelling pathogenic wind and removing toxic substance are replaced by decoction pieces of rhizoma Zingiberis.
Comparative example 44
A method for preparing modified traditional Chinese medicine powder, which comprises the steps substantially the same as those in embodiment 22, except that hydrophilic aerosil is changed into MCC.
Comparative example 45
A method for preparing modified Chinese medicinal powder comprises the same steps as in comparative example 44, except that decoction pieces of formula for dispelling pathogenic wind and removing toxic substance are replaced by decoction pieces of rhizoma Zingiberis.
Example 24
A method for improving the compression formability of traditional Chinese medicine extract powder basically has the same steps as the embodiment 2, and is different in that the mass ratio of the solid content of the extract to the hydrophilic micropowder silica gel is 1: 0.01.
example 25
The method for improving the compression formability of the traditional Chinese medicine extract powder basically comprises the following steps of 1, wherein the mass ratio of the solid content of the extract to the hydrophilic micropowder silica gel is 1: 0.01.
comparative example 46
The method for preparing the modified traditional Chinese medicine powder basically comprises the same steps as the comparative example 2, and is different in that the mass ratio of the solid content of the extract to the MCC is 1: 0.01.
comparative example 47
The method for preparing the modified traditional Chinese medicine powder basically comprises the following steps of 1, wherein the mass ratio of the solid content of the extract to the MCC is 1: 0.01.
example 26
A method for improving the compression formability of traditional Chinese medicine extract powder, which has the basically same steps as the embodiment 23, and is different in that the mass ratio of the solid content of the extract to the hydrophilic micropowder silica gel is 1: 0.01.
comparative example 48
The method for preparing the modified traditional Chinese medicine powder basically comprises the following steps of comparing with 45, wherein the mass ratio of the solid content of the extract to MCC is 1: 0.01.
for the products prepared in examples 1-25 and comparative examples 1-48, the following methods are respectively adopted to characterize the basic physical properties of the particles and the related functional properties of the tablets prepared by applying the products.
Method for characterizing particle basic properties
(1) Particle shape, particle size and particle size distribution
The particle size analyzer (Occhi 500Nano, Kangta instruments Co., Ltd.) was used to analyze the particle size and particle size of the powder. Meanwhile, the particle diameter D was measured by dry method using a laser particle size measuring apparatus (model 2000, Markov, England)0.1,D0.5,D0.9(mum) and according to the formula Span ═ D0.9-D0.1)/D0.5And calculating the diameter distance of the particle size distribution.
(2) Fluidity and density
The angle of repose and bulk density ρ of the powder were measured using a powder comprehensive characteristic measuring instrument (BT-1000, Baite instruments Ltd., Denton)bAnd tap density ρtaCalculating the Carl index CI ═ ptab)/ρtaAnd Haosner ratio HR ═ ρtab. The true density was measured by helium substitution.
(3) Water content
About 2g of the sample was weighed, evenly spread in a weighing pan of an infrared rapid moisture meter (Sartorius, germany), the measurement temperature was 105 ℃ until the sample was constant weight, and the moisture content measurement was recorded.
(4) Moisture absorption property
Weighing dry glass bottle with stopper, and accurately weighing1) Then taking a proper amount of the test sample, spreading the test sample in the weighing bottle, placing the test sample with the thickness of about 1mm in a dryer for dehumidifying and balancing for 24h, and precisely weighing the test sample with the weight (m)2). After equilibration, the mixture was placed in a constant temperature and humidity cabinet (25 ℃, 75%) containing saturated NaCl solution and then precisely weighed (m) at 24h3). And calculating the moisture absorption weight gain percentage according to a formula.
Figure BDA0002783965900000131
Method for characterizing relevant functional properties of tablets
(1) Compression work condition
Effective compression work, friction work and elastic work in the material compression forming process are obtained through an Extended Data Analysis system of an induction tablet press (Korsch XP1, Germany), and then the plastic constant (namely the ratio of the effective compression work to the tablet weight, and describing the effective compression energy consumed in the compression process of the powder with single mass under the set tabletting condition) and the elastic coefficient (namely the proportion of the elastic recovery work in the total compression work and reflecting the elastic recovery capacity of the tablet in the decompression process) of the material are calculated.
(2) Compression set behavior and formability
A change curve of the porosity along with the pressure in the material compression forming process is obtained through a tablet press Data Analysis system, Kawakita and Heckel equations are further adopted to respectively represent material compression deformation behaviors in low-pressure, medium-pressure and high-pressure stages, and physical property parameters such as material yield pressure are calculated. The viscoelastic property of the material is further obtained through the change of the compression deformation behavior of the material along with the tabletting speed. The compression formability of the material is mainly characterized by establishing a relationship between the tabletting force and the tensile strength of the tablet and a relationship between the tabletting force and the plasticity constant, and the concrete operations are as follows: the tablets were compressed under various pressures using a Korsch XP1 induction tablet press, respectively, and the tablet weight W was weighed, and the breaking force F, thickness T and diameter D of the tablets were measured using a tablet hardness tester to calculate the tensile strength TS by the following formula.
Figure BDA0002783965900000132
The test results of the tablets prepared from the products prepared in the examples 1-11 and the comparative examples 1-35 are shown in the following table 1:
TABLE 1
Figure BDA0002783965900000141
Figure BDA0002783965900000151
Figure BDA0002783965900000161
Figure BDA0002783965900000171
Figure BDA0002783965900000181
The basic physical properties of the products prepared in the examples 1 to 11 and the comparative examples 1 to 35 were characterized, and the results of the characterization are shown in table 2 (the unit of angle of repose is °, the unit of bulk density is g/cm, the unit of tap density is g/cm, and the unit of carr index), and the results of the moisture absorption are shown in table 3:
TABLE 2
Figure BDA0002783965900000191
TABLE 3
Figure BDA0002783965900000192
Figure BDA0002783965900000201
Analysis based on the above test results can find that:
from the aspect of compression moldability, in examples 1 to 11, compression moldability was improved substantially in three pressure steps (i.e., about 50N, 100N and 150N) in comparison with comparative examples 1 to 21 except for the soft tablets of the extract specific materials such as licorice, hawthorn and Ningfang for treating infantile common cold. However, compared with comparative examples 1 to 10, examples 1 to 11 have more obvious effects in solving the problem of compression molding of the traditional Chinese medicine extract powder: firstly, for traditional Chinese medicine extract powder with soft-tablet problems of liquorice, hawthorn, Ningfang prescription for treating infantile common cold and the like, the soft-tablet problem can be effectively solved only by a mode of drying together with micro silica gel powder; secondly, the traditional Chinese medicine extract powder with poor compression molding property is obviously improved, and the advantages and the necessity of the hydrophilic micro-powder silica gel co-drying technology can be embodied.
From the analysis of the fluidity test result (table 1), compared with the traditional Chinese medicine extract raw powder and the physical mixture, the fluidity of the co-dried sample is obviously improved (the angle of repose is reduced by 3.3-36.2% compared with the proportion), and the advantages and the necessity of the hydrophilic micropowder silica gel co-drying technology can be embodied. From the analysis of the moisture absorption test result (table 2), compared with the traditional Chinese medicine extract raw powder and the physical mixture, the moisture absorption of the co-dried sample is obviously improved (the moisture absorption is reduced by 10.2 to 84.0 percent compared with the comparative example), and the advantages and the necessity of the co-drying technology with the hydrophilic micropowder silica gel can be reflected.
Generally, the powder is co-dried with hydrophilic micropowder silica gel, so that the hydrophilic micropowder silica gel is uniformly dispersed in the traditional Chinese medicine extract powder, the problem of poor compression molding property of the traditional Chinese medicine extract powder in actual production can be effectively solved, meanwhile, the flowability of the powder is increased, the hygroscopicity of the powder is reduced, and the loss of a tabletting machine in the actual production process is reduced.
As can be seen from fig. 1 and 2, the hydrophilic silica micropowder is uniformly, completely and densely dispersed on the surface of the powder, so that the shape of the powder is more round, the surface of the powder is smoother and the particle size of the powder is larger in the sample prepared by the method (example 2) of the present invention. As can be seen from fig. 3 and 4, the MCC was dispersed as larger particles on the powder surface on the sample of comparative example 2 and did not form a complete coverage layer as in fig. 1 and 2 (i.e., example 2). The products of comparative examples 23 and 30 are shown in fig. 7-10, respectively, and the product of comparative example 12 is shown in fig. 5 and 6, it can be seen that the auxiliary materials and the extract raw powder are randomly distributed in the space, and the hydrophilic micropowder silica gel has a little dispersion on the surface of the powder, but does not form a dense layer. Whereas MCC is simply attached to the powder surface. In addition, it was found that the co-drying treatment with hydrophilic silica gel micropowder can significantly increase the powder flowability (table 1) and reduce the hygroscopicity (table 2). These results indicate that the silica gel micropowder has a multifunctional improving effect on the Chinese medicinal extract powder in the co-drying treatment process.
The test results of the tablets prepared from the products prepared in examples 12-15 and comparative examples 36-39 are shown in the following table 3:
TABLE 3
Figure BDA0002783965900000211
Figure BDA0002783965900000221
The data analysis shows that the co-drying treatment with a small amount (about 5.6%) of hydrophilic micropowder silica gel can obviously improve the compression formability of the original powder and solve the problem of soft tablets of materials with special physical properties, such as hawthorn, and the co-drying treatment with 33.3% MCC can not achieve similar effect.
The test results of the tablets prepared from the products prepared in examples 16 to 21 are shown in the following table 4:
TABLE 4
Figure BDA0002783965900000222
Figure BDA0002783965900000231
Analysis combining the above test results can find that: the hydrophobic micro silica gel and the mesoporous micro silica gel can more effectively solve the problem of poor compression molding property of the traditional Chinese medicine extract raw powder than MCC.
The test results of the tablets made from the products obtained in comparative examples 40 and 41 are shown in table 5 below:
TABLE 5
Figure BDA0002783965900000232
Figure BDA0002783965900000241
Analysis combining the above test results can find that: the dry coating method can not improve the compression formability of the original powder, so that the TS of the tablet is more than or equal to 2, the production requirement is further met, and the advantage of co-drying treatment is further embodied.
The test results of the tablets prepared from the products prepared in examples 22-23 and comparative examples 42-45 are shown in the following table 6:
TABLE 6
Figure BDA0002783965900000242
Figure BDA0002783965900000251
Analysis combining the above test results can find that: the compression moldability of the raw powder can be improved by co-spray drying with aerosil, but MCC has no such effect.
The test results of the tablets prepared from the products prepared in examples 24 to 26 and comparative examples 46 to 48 are shown in the following table 7:
TABLE 7
Figure BDA0002783965900000252
Figure BDA0002783965900000261
Analysis combining the above test results can find that: adopting a mode of co-spray drying or co-decompression drying with micropowder silica gel in the ratio of 1: 0.01 (i.e., 0.99% Gum silica gel content) also improved the compression moldability of the raw powder, whereas MCC did not.
Although specific embodiments of the present invention have been described above, it will be appreciated by those skilled in the art that these embodiments are merely illustrative and various changes or modifications may be made without departing from the principles and spirit of the invention.

Claims (6)

1. A method for improving the compression formability of Chinese medicinal extract powder is characterized in that the Chinese medicinal extract powder and a modifier are co-dried, crushed and sieved to prepare composite powder; the modifier is selected from more than one of hydrophilic micropowder silica gel, hydrophobic micropowder silica gel and mesoporous micropowder silica gel.
2. The method for improving the compression formability of the traditional Chinese medicine extract powder according to claim 1, wherein the viscosity of the traditional Chinese medicine extract is 12-1000 centipoises.
3. The method for improving the compression moldability of Chinese medicinal extract powder according to claim 1, wherein the co-drying is co-atmospheric drying, co-reduced pressure drying or spray drying.
4. The method for improving the compression formability of the traditional Chinese medicine extract powder according to claim 1, wherein the mass of the modifier is 0.99-33.3% of the total mass of the composite powder.
5. The method for improving the compression formability of the traditional Chinese medicine extract powder according to claim 1, wherein the hygroscopicity and the repose angle of the composite powder are respectively reduced by 10.2-84.0% and 3.3-36.2% compared with dry powder prepared by directly drying the traditional Chinese medicine extract.
6. The method as claimed in claim 1, wherein the tensile strength of the tablet prepared by compressing the composite powder is improved by 9.4-304.6% compared with the tablet prepared by directly drying the Chinese medicinal extract, or the tensile strength of the tablet prepared by compressing the composite powder is improved from the soft tablet prepared by directly drying the Chinese medicinal extract and unable to test the tensile strength to the tablet prepared by compressing the composite powder.
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Citations (2)

* Cited by examiner, † Cited by third party
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