CN113952885A - Preparation method of traditional Chinese medicine calculus removing granules - Google Patents

Preparation method of traditional Chinese medicine calculus removing granules Download PDF

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Publication number
CN113952885A
CN113952885A CN202111175775.9A CN202111175775A CN113952885A CN 113952885 A CN113952885 A CN 113952885A CN 202111175775 A CN202111175775 A CN 202111175775A CN 113952885 A CN113952885 A CN 113952885A
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air inlet
chinese medicine
traditional chinese
granules
preparation
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Inventor
罗小荣
陈培武
曾一心
王桂华
周友华
费翼城
邓会云
黄贵平
赵海金
沈震亚
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JIANGXI NANCHANG JISHENG PHARMACEUTICAL Co.,Ltd.
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Jiangxi Jiangzhong Jihai Pharmaceutical Co ltd
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/02—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops
    • B01J2/04—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops in a gaseous medium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/12—Magnesium silicate
    • A—HUMAN NECESSITIES
    • 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
    • A61K36/11—Pteridophyta or Filicophyta (ferns)
    • A61K36/12—Filicopsida or Pteridopsida
    • A—HUMAN NECESSITIES
    • 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)
    • A—HUMAN NECESSITIES
    • 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)
    • A61K36/27—Asclepiadaceae (Milkweed family), e.g. hoya
    • A—HUMAN NECESSITIES
    • 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)
    • A61K36/35—Caprifoliaceae (Honeysuckle family)
    • A61K36/355—Lonicera (honeysuckle)
    • A—HUMAN NECESSITIES
    • 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)
    • A61K36/36—Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
    • A—HUMAN NECESSITIES
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484—Glycyrrhiza (licorice)
    • A—HUMAN NECESSITIES
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A—HUMAN NECESSITIES
    • 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)
    • A61K36/68—Plantaginaceae (Plantain Family)
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/04—Drugs for disorders of the urinary system for urolithiasis
    • 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
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • 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
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Abstract

The invention discloses a preparation method of traditional Chinese medicine calculus removing granules, and relates to the technical field of preparation of traditional Chinese medicine preparations. The preparation method comprises preparing with a granulating device; placing the auxiliary material powder in a material pot for preheating, feeding air into an air inlet pipeline, and controlling the air inlet amount to be 300-plus-one 500g/m3The air inlet temperature is 55-65 ℃; spraying the stone-removing granule extract into a material pot, mixing with adjuvant powder, granulating, and controlling air intake at 700-3The air inlet temperature is 60-70 ℃; after the stone removing granule extract is fed, drying until the moisture of the granules is lower than 3%; the air inlet amount is controlled to be 500-700g/m3The air inlet temperature is 65-75 ℃. Compared with conventional wet granulation, the preparation method has the advantages that the extract with the prescription amount can be completely added, the one-time qualified rate of the particles and the production efficiency of the calculus removing particles are obviously improved, the prepared calculus removing particles are uniform in content, good in dissolubility and fluidity and stable in process.

Description

Preparation method of traditional Chinese medicine calculus removing granules
Technical Field
The invention relates to the technical field of preparation of traditional Chinese medicine granules, and particularly relates to a preparation method of traditional Chinese medicine calculus removing granules.
Background
Stone expelling granules are collected in the first part (2020 edition) of pharmacopoeia of the people's republic of China, and have the main functions of clearing heat, promoting diuresis, treating stranguria and expelling stones. Can be used for treating stranguria caused by damp-heat in lower-jiao with symptoms of lumbago, abdominal pain, urination disorder or hematuria; urinary calculus with the above symptoms.
The traditional Chinese medicine calculus removing granule granulating process is a wet granulating system, and the granulating method comprises the steps of mixing the Chinese medicine extract and auxiliary materials by a mixer to form a soft material, granulating the soft material by a granulator, and drying granules by a dryer to obtain the traditional Chinese medicine calculus removing granule. The granulation apparatus generally comprises a mixer, a granulator and a dryer. The traditional mixer mainly comprises a trough mixer and a high-speed shearing mixer, wherein stirring paddles in different shapes are used for mixing powdery materials, and traditional Chinese medicine extract can be added for wetting so as to uniformly mix heterogeneous materials. If the addition amount of the traditional Chinese medicine extract is too much, the powdery material is excessively wetted and becomes massive and solid; if the amount of the traditional Chinese medicine extract is too small, the materials are not uniformly mixed. Traditional granulators are mainly swing granulators, and moderately wetted materials are extruded by a crushing mechanism to pass through screens with different meshes to be made into particles with different sizes. Excessively wet, agglomerated and solid materials are easy to be adhered to a screen or a crushing knife when passing through a swing granulator and cannot be made into particles. The traditional dryer is mainly a horizontal boiling dryer, air is heated by a heat exchanger to form hot air to enter a main machine, wet particles enter the dryer, and materials form a boiling state in the dryer under the action of the air pressure and are in wide contact with the hot air to finish material drying. The traditional drier has high heating temperature, is not suitable for drying the thermosensitive and viscous traditional Chinese medicine wet granules, consumes more steam and has higher production cost. The material passes through the conveyer belt and moves in the host computer, and easy scale deposit in host computer cavity dead angle. The traditional Chinese medicine granule granulating system has the existing problems of low disposable qualified rate of granules, easy breakage of the granules, low production efficiency, high safety risk and the like.
When the calculus removing granules are granulated by a wet method, according to the amount of the auxiliary materials in the prescription, the extract is added into 17% of the prescription amount at most, and the extract in the rest prescription amount can only be added through secondary granulation, tertiary granulation and the like, even can not be added, so that the production efficiency is obviously reduced, and the production energy consumption is increased.
In view of this, the invention is particularly proposed.
Disclosure of Invention
The invention aims to provide a preparation method of traditional Chinese medicine calculus removing granules.
The invention is realized by the following steps:
in a first aspect, the present invention provides a method for preparing a traditional Chinese medicine calculus removing granule, which comprises: preparing by adopting a granulating device; the granulating device comprises a diffusion section, a material pot and an air inlet section which are sequentially communicated from top to bottom, wherein the diffusion section is provided with a spray gun, and the air inlet section is provided with an air inlet pipeline and a waste water pipeline;
the preparation method comprises the following steps:
placing the auxiliary material powder in the material pot for preheating, feeding air into the air inlet pipeline, and controlling the air inlet amount to be 300-fold air and 500g/m3The air inlet temperature is 55-65 ℃;
to remove stoneSpraying the granular extract into the material pot and mixing with the adjuvant powder for granulation, and controlling air inlet amount to be 700-3The air inlet temperature is 60-70 ℃;
after the stone removing granule extract is fed, drying until the moisture of the granules is lower than 3%; the air inlet amount is controlled to be 500-700g/m3The air inlet temperature is 65-75 ℃.
In an optional embodiment, when the auxiliary material powder is preheated, the air inlet amount is controlled to be 350-450g/m3The temperature of the inlet air is 58-62 ℃;
when the stone-removing particle extract is sprayed, the air inlet amount is controlled to be 750-850g/m3The air inlet temperature is 63-67 ℃;
when the drying is carried out, the air inlet amount is controlled to be 550-650g/m3The air inlet temperature is 68-72 ℃.
In an optional embodiment, after drying, cooling to a temperature of the material not exceeding 40 ℃, discharging, and sieving to obtain traditional Chinese medicine calculus removing granules, wherein the particle size of the traditional Chinese medicine calculus removing granules is 10-60 meshes.
In an optional embodiment, the stone-removing particle extract is fed by a peristaltic pump and sprayed by a spray gun.
In an alternative embodiment, the atomization pressure of the spray gun is 2-3bar, and the liquid inlet speed of the peristaltic pump is 130-140 rpm.
In an alternative embodiment, the method of making the adjuvant powder comprises: pulverizing sucrose into sugar powder, and mixing dextrin with the sugar powder.
In an optional embodiment, the granulation apparatus further comprises a filtering section, the filtering section is connected to the upper part of the diffusion section, the filtering section is connected with the air outlet pipeline, and a dust capture bag is arranged in the filtering section.
The invention has the following beneficial effects:
compared with conventional wet granulation, the preparation method provided by the application has the advantages that granulation and drying are carried out simultaneously, the extract with the prescription amount can be completely added, and the risk that the content of the calculus removing particles does not meet the quality standard is avoided. The one-time qualification rate (10-60 meshes) of the granules is about 94% on average, the amount of materials needing to be granulated again is greatly reduced, and the one-time qualification rate of the granules is improved; the preparation method provided by the application can realize that mixing, granulating and drying are all completed in one step in the same device, and the production efficiency of the calculus removing particles is obviously improved. Simultaneously, the drying temperature is low in this application, and the pelletization is fast, and extract and auxiliary material misce bene, the granule is durable difficult broken, and mobility is good. The production process of one-step granulation has the advantages of less dust generation, easily controlled process, convenient operation by personnel, high automation and industrialization level, and remarkably reduced re-granulation process of unqualified granules. Meanwhile, in the one-step granulation process, the extract and the auxiliary materials are mixed more uniformly, the prepared calculus removing particles are uniform in content, good in dissolubility and fluidity, less in dust generated in the production process, and stable in process.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.
Fig. 1 is a schematic structural diagram of a granulating apparatus used in a method for preparing traditional Chinese medicine calculus removing granules provided by the present application at a first viewing angle;
fig. 2 is a schematic structural diagram of a granulating apparatus used in the preparation method of traditional Chinese medicine calculus removing granules provided by the present application at a second viewing angle;
fig. 3 is a mean value visual chart of the comprehensive grading of particles by the atomizing pressure (a), the intake air amount (B) and the liquid inlet speed (C) in the preparation method of the traditional Chinese medicine calculus removing particles provided by the application.
Icon: 100-a granulating device; 110-a filtration section; 111-an air outlet pipeline; 120-a diffuser section; 121-a spray gun; 122-a peristaltic pump; 130-material pot; 131-a thermometer; 140-an air inlet section; 141-an air inlet pipeline; 142-waste water line.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
The application provides a preparation method of traditional Chinese medicine calculus-removing granules, which is characterized in that a granulating device 100 is adopted for preparation, and in order to facilitate description of a subsequent preparation method, a specific structure of the granulating device 100 is described firstly in the application.
Referring to fig. 1 and 2, a granulation apparatus 100 provided by the present application includes a filtering section 110, a diffusing section 120, a material pan 130, and an air intake section 140, the filtering section 110, the diffusing section 120, the material pan 130, and the air intake section 140 are sequentially communicated from top to bottom, wherein the filtering section 110 is connected to an air outlet pipe 111, and a dust capture bag is disposed in the filtering section 110. The diffusion section 120 is provided with a spray gun 121, the outside of the spray gun 121 is communicated with the stone particle removing extract barrel through a hose, and a peristaltic pump 122 is arranged on the hose for feeding. The material pot 130 is provided with a material thermometer 131 for detecting the temperature of the material in the material pot 130. The intake section 140 is provided with an intake duct 141 and a waste water duct 142. When adopting the pelletization device 100 that this application provided to pelletize, place the material in material pot 130, open the fan afterwards, intake pipe 141 air, make the material in the material pot 130 heat up under the boiling motion, the spray gun 121 that sets up on the diffuser section 120 is used for spouting the stone discharge granule extract as the adhesive, last air inlet and heating in whole process, realize mixing pelletization while dry on one side, hot-blast air that gets into in the material pot 130 is discharged from air-out pipeline 111 on the filter segment 110 after the heat transfer, catch the dust that carries in the wind through the dust catching bag before the discharge, the realization is filtered the air-out.
Specifically, in the present application, the preparation method comprises the following steps:
s1, preparing the auxiliary material powder.
Pulverizing sucrose into sugar powder, and mixing dextrin with sugar powder.
S2, preparing the stone-removing particle extract.
Extracting calculus removing granule extract according to ' prescription ' and ' preparation method ' under item of calculus removing granule in pharmacopoeia of people's republic of China (2020 edition): the prescription of the urinary calculus removing granule extract comprises 1038 parts of desmodium, 156 parts of salted plantain seed, 156 parts of paniculate swallowwort root, 260 parts of honeysuckle stem, 156 parts of akebia stem, 156 parts of pyrrosia lingua, 260 parts of talc, 156 parts of fringed pink, 156 parts of crowndaisy hemp seed and 260 parts of liquorice in parts by weight.
The preparation method of calculus removing granule extract comprises decocting part of Glechomae herba in water twice (3 hr for the first time and 2 hr for the second time), filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.20(50 deg.C); decocting the rest nine materials including Glechomae herba and the rest salt semen plantaginis with water twice, 3 hr for the first time and 2 hr for the second time, mixing decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.24(50 deg.C), cooling, adding appropriate amount of ethanol, standing, collecting supernatant, recovering ethanol, concentrating to obtain fluid extract with relative density of 1.20(50 deg.C), mixing with the above fluid extract, and mixing to obtain extract.
S3, mixing the adjuvant powder and the urinary calculus removing granule extract according to the pharmacopeia proportion.
S4, placing the auxiliary material powder in the material pot 130 for preheating.
The fan is started, the air inlet pipe 141 enters air, and the air inlet amount is controlled to be 300 plus 500g/m3The air inlet temperature is 55-65 ℃; preferably, the air inlet amount is controlled to be 350-3The air inlet temperature is 58-62 ℃, so that the temperature of the auxiliary material powder is raised to 30 ℃ under the boiling motion.
S5, spraying all the stone-removing granular extract into the material pot 130 to be mixed with the auxiliary material powder for granulation.
In the application, the peristaltic pump 122 is used for feeding the stone-removing particle extract, and the spray gun 121 is used for spraying the stone-removing particle extract. The atomization pressure of the spray gun 121 is 2-3bar, the liquid inlet speed of the peristaltic pump 122 is 130-140rpm, and the air inlet amount is controlled to be 700-900g/m3The air inlet temperature is 60-70 ℃; preferably, the air inlet amount is controlled to be 750-3The air inlet temperature is 63-67 ℃.
And S6, after finishing feeding the stone removing granule extract, drying until the moisture of the granule is lower than 3%.
The air inlet amount is controlled to be 500-700g/m3The temperature of the inlet air is 65 DEG-75 ℃. Preferably, the air inlet amount is controlled to be 550-650g/m3The air inlet temperature is 68-72 ℃. Cooling to material temperature not higher than 40 deg.C after drying, discharging, and sieving to obtain traditional Chinese medicine calculus removing granule with particle size of 10-60 mesh.
The features and properties of the present invention are described in further detail below with reference to examples.
Example 1
The embodiment provides a preparation method of traditional Chinese medicine calculus removing granules, which comprises the following steps:
s1, preparing auxiliary material powder: pulverizing sucrose into sugar powder, and mixing dextrin with sugar powder.
S2, preparing a stone removing granule extract: prepared according to the prescription and the preparation method under the item of the calculus removing granules in pharmacopoeia of the people's republic of China (2020 edition).
S3, preheating auxiliary material powder: placing 820g of the adjuvant powder in the material pot 130, starting the fan, feeding air through the air inlet pipeline 141, and controlling the air inlet amount to be 400g/m3The air inlet temperature is 60 ℃, so that the temperature of the auxiliary material powder is raised to 30 ℃ under the boiling motion.
S4, mixing and granulating: starting the peristaltic pump 122 and a spray button, and spraying the stone-removing particle extract; the atomization pressure of the spray gun 121 is 2.6bar, the liquid inlet speed of the peristaltic pump 122 is 135rpm, and the air inlet amount is controlled to be 800g/m3The air inlet temperature is 65 ℃.
S5, drying: after the stone-removing granular extract is fed, controlling the air inlet amount to be 600g/m3The air inlet temperature is 70 ℃, and the drying is carried out until the moisture of the particles is less than 3 percent.
S6, sieving: and (3) cooling the dried material to a temperature of not more than 40 ℃, discharging, sieving, and collecting granules which can pass through a 10-mesh sieve and granules which can not pass through a 60-mesh sieve, wherein the granules are qualified granules.
Example 2
The embodiment provides a preparation method of traditional Chinese medicine calculus removing granules, which comprises the following steps:
s1, preparing auxiliary material powder: pulverizing sucrose into sugar powder, and mixing dextrin with sugar powder.
S2, preparing a stone removing granule extract: prepared according to the prescription and the preparation method under the item of the calculus removing granules in pharmacopoeia of the people's republic of China (2020 edition).
S3, preheating auxiliary material powder: placing 820g of the adjuvant powder in the material pot 130, starting the fan, feeding air through the air inlet pipeline 141, and controlling the air inlet amount to be 400g/m3The air inlet temperature is 60 ℃, so that the temperature of the auxiliary material powder is raised to 30 ℃ under the boiling motion.
S4, mixing and granulating: starting the peristaltic pump 122 and a spray button, and spraying the stone-removing particle extract; the atomization pressure of the spray gun 121 is 3bar, the liquid inlet speed of the peristaltic pump 122 is 130rpm, and the air inlet amount is controlled to be 800g/m3The air inlet temperature is 65 ℃.
S5, drying: after the stone-removing granular extract is fed, controlling the air inlet amount to be 600g/m3The air inlet temperature is 70 ℃, and the drying is carried out until the moisture of the particles is less than 3 percent.
S6, sieving: and (3) cooling the dried material to a temperature of not more than 40 ℃, discharging, sieving, and collecting granules which can pass through a 10-mesh sieve and granules which can not pass through a 60-mesh sieve, wherein the granules are qualified granules.
Examples 3 to 5
This example is substantially the same as example 1, except that: the air inlet volume and the air inlet temperature in each step are controlled differently:
in example 3, the intake air amount is controlled to 300g/m in step S33The air inlet temperature is 55 ℃; step S4 is to control the air inlet quantity to be 700g/m3The air inlet temperature is 60 ℃; step S5 is to control the air inlet amount to be 500g/m3The air inlet temperature is 65 ℃.
In example 4, the intake air amount was controlled to 500g/m in step S33The air inlet temperature is 65 ℃; step S4 is to control the air inlet quantity to be 900g/m3The air inlet temperature is 70 ℃; step S5 is to control the air inlet quantity to be 700g/m3The air inlet temperature is 75 ℃.
In the embodiment 5, the step S3, the step S4 and the step S5 control the air inlet amount to be 800g/m3The air inlet temperature is 65 ℃.
Example 6
This example is substantially the same as example 1 except that in this example, the atomization pressure of the spray gun 121 is 2.4bar and the feed rate of the peristaltic pump 122 is 100 rpm.
When the traditional Chinese medicine calculus removing granules obtained in examples 1 to 6 were examined, the disposable yield of the granules was equal to the weight of the qualified granules × 100%/theoretical weight, and the theoretical weight was equal to 1 kg. See table 1 for the results of the tests:
TABLE 1 statistical table of the qualification rate test results of the traditional Chinese medicine calculus removing granules obtained in examples 1 to 6
Figure BDA0003295486270000081
First, parameter orthogonal experiment
The one-time pass percent, the angle of repose and the degree of compression of the granules are taken as evaluation indexes, and L is adopted9(34) Orthogonal design experiment table (see table 2) and multi-index comprehensive scoring method (see table 3) are adopted to design one-step granulation scheme. The experiments were performed as per table 2. Starting the peristaltic pump 122 and the spraying button, spraying the stone-removing particle extract, and keeping the air inlet temperature at 65 ℃ until the extract is completely sprayed. After the liquid inlet is finished, the air inlet temperature is set to be 70 ℃, and the air inlet volume is 600g/m3The moisture of the dried particles is not more than 3 percent, and the material is discharged when the temperature of the material is reduced to be not more than 40 ℃. Sieving the granules, and collecting the granules which can pass through a sieve of 10 meshes and can not pass through a sieve of 60 meshes to obtain qualified granules. The experimental results are shown in table 4, and the comprehensive scoring results are shown in table 5:
TABLE 2 orthogonal experimental table for one-step granulation
Figure BDA0003295486270000082
TABLE 3 comprehensive scoring method
Figure BDA0003295486270000083
TABLE 4 results of orthogonal experiments
Figure BDA0003295486270000084
Figure BDA0003295486270000091
TABLE 5 comprehensive scoring results
Experiment number Percent of one-time qualification rate% Angle of repose ° Degree of compression% Total up to
1 4.47 2.42 1.12 8.01
2 5.29 2.45 1.20 8.93
3 4.99 2.97 1.40 9.36
4 6.11 2.92 1.21 10.24
5 7.00 2.52 1.09 10.61
6 6.85 2.75 1.12 10.72
7 5.66 3.36 1.01 10.03
8 6.26 3.27 1.51 11.03
9 5.88 3.12 0.90 9.90
TABLE 6 visual analysis results
Level of A B C
K1 8.767 9.426 9.92
K2 10.526 10.192 9.692
K3 10.319 9.995 10
R 1.759 0.766 0.308
TABLE 7 ANOVA results
Source Sum of squares of type III df F Sig.
A 5.540 2 35.650 0.027
B 0.942 2 6.065 0.142
C 0.744 2 4.791 0.173
Error of the measurement 0.155 2
F0.05(2,2)＝19.00，F0.01(2,2)＝99.00
Results of orthogonal experimentsVisual analysis (see Table 6) shows that the range is ordered as A > B > C. Analysis of variance was performed using SPSS (21.0) and the results are shown in Table 7, where P < 0.05, this factor had a significant effect on the results. According to the visual analysis result and the ANOVA result, the air intake of the factor A has obvious influence on the particles, and the influence sequence on the calculus removing particles is A > B > C. From the visual chart (fig. 3), the optimal one-step granulation process conditions are A2B2C 3. Namely the atomization pressure of the inlet air is 2.6bar, 800g/m3And the liquid inlet speed is 135 rpm.
Second, verification experiment
According to the preparation method of the traditional Chinese medicine calculus removing granules provided in example 1, the prescription amount of 20 times of 1 batch is adopted, 3 verification experiments are carried out, and the experimental results refer to table 8:
TABLE 8 one-step granulation Process verification Experimental results
Figure BDA0003295486270000102
The one-time pass percent of the granules is the weight of the qualified granules multiplied by 100 percent/theoretical weight, and the theoretical weight is 20 kg.
The production cycle is as follows: the materials enter a one-step granulator to start timing until the materials are discharged from the boiler to be a junction.
The mass of the lithagogue granules prepared by the 3 batches of the verified one-step granulation process in the example 1 was compared with that prepared by the wet granulation process of the original granulation process, and the test was performed according to the lithagogue granules item in the ministry of pharmacopoeia of the people's republic of china (2020 edition). As can be seen from Table 9, the granules obtained by the one-step granulation process all meet the legal standards and are slightly superior to the original wet granulation process in some test items.
TABLE 9 comparison of granulation Process before and after optimization of calculus removing granule
Figure BDA0003295486270000101
Figure BDA0003295486270000111
The stone-removing particle original granulating system is a traditional Chinese medicine granule granulating system, namely a wet granulating system. Compared with the prior art, the invention has the following advantages:
(1) solves the problem that the extractum is excessive and can not be granulated by a wet method. When the calculus removing granules are granulated by a wet method, according to the amount of the auxiliary materials in the prescription, the extract is added into 17% of the prescription amount at most, and the extract in the rest prescription amount can only be added through secondary granulation, tertiary granulation and the like, even can not be added, so that the production efficiency is obviously reduced, and the production energy consumption is increased. The preparation method provided by the application is to granulate and dry, and extract with the prescription amount can be completely added, so that the risk that the content of the calculus removing particles does not meet the quality standard is avoided.
(2) The one-time qualification rate of the particles is improved. When the stone-removing granules are produced by adopting the original granulating system, the one-time qualification rate (10 meshes-60 meshes) of the granules is about 55 percent on average. About 40% or more of the granules are crushed, mixed and re-granulated. By adopting the preparation method provided by the application, the one-time qualified rate (10-60 meshes) of the granules is about 94% on average, and the amount of materials needing to be re-granulated is greatly reduced.
(3) The production efficiency is improved. When the wet granulation process is adopted for the stone-removing granules, secondary granulation, tertiary granulation, even quartic granulation and the like are required due to the low one-time qualification rate of the granules, so that the production period is greatly prolonged, and the labor burden of operators is increased. By adopting the preparation method provided by the application, mixing, granulating and drying can be completed in one step in the same device, and the production efficiency of the calculus removing granules is obviously improved. Simultaneously, the drying temperature is low in this application, and the pelletization is fast, and extract and auxiliary material misce bene, the granule is durable difficult broken, and mobility is good. The production process of one-step granulation has less dust generation, the process is easy to control, the operation is convenient for personnel, and the automation and industrialization level is high.
In conclusion, compared with the conventional wet granulation process, the one-step granulation process provided by the invention has the advantages that the one-time qualified rate (10-60 meshes) of the granules is increased from about 65% on average to 95.83% on average, and the increase range is 47.4%. The production period is increased from about 60min to 38.7min, and the reduction range is 55%. The one-step granulation process synchronously finishes granulation and drying, obviously improves the production efficiency and the one-time qualification rate of the calculus removing granules, and obviously reduces the re-granulation process of unqualified granules. Meanwhile, in the one-step granulation process, the extract and the auxiliary materials are mixed more uniformly, the prepared calculus removing particles are uniform in content, good in dissolubility and fluidity, less in dust generated in the production process, and stable in process.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (7)

1. A preparation method of traditional Chinese medicine calculus removing granules is characterized by comprising the following steps: preparing by adopting a granulating device; the granulating device comprises a diffusion section, a material pot and an air inlet section which are sequentially communicated from top to bottom, wherein the diffusion section is provided with a spray gun, and the air inlet section is provided with an air inlet pipeline and a waste water pipeline;
the preparation method comprises the following steps:
placing the auxiliary material powder in the material pot for preheating, feeding air into the air inlet pipeline, and controlling the air inlet amount to be 300-fold air and 500g/m3The air inlet temperature is 55-65 ℃;
spraying the stone-removing granular extract into the material pot to be mixed with the auxiliary material powder for granulation, and controlling the air inlet amount to be 700-one-step 900g/m3The air inlet temperature is 60-70 ℃;
after the stone removing granule extract is fed, drying until the moisture of the granules is lower than 3%; the air inlet amount is controlled to be 500-700g/m3The air inlet temperature is 65-75 ℃.
2. The method for preparing traditional Chinese medicine calculus removing granules as claimed in claim 1, wherein the air intake is controlled to be 350-450g/m when the auxiliary material powder is preheated3The temperature of the inlet air is 58-62 ℃;
when the stone-removing particle extract is sprayed, the air inlet amount is controlled to be 750-850g/m3The air inlet temperature is 63-67 ℃;
when the drying is carried out, the air inlet amount is controlled to be 550-650g/m3The air inlet temperature is 68-72 ℃.
3. The preparation method of the traditional Chinese medicine calculus removing granules according to claim 1, wherein the traditional Chinese medicine calculus removing granules are obtained by drying, cooling to a temperature of less than 40 ℃, discharging, and sieving, wherein the particle size of the traditional Chinese medicine calculus removing granules is 10-60 meshes.
4. The method for preparing traditional Chinese medicine calculus removing granules according to claim 1, wherein the calculus removing granule extract is fed by a peristaltic pump and sprayed by a spray gun.
5. The method as claimed in claim 4, wherein the atomization pressure of the spray gun is 2-3bar, and the liquid inlet speed of the peristaltic pump is 130-140 rpm.
6. The method for preparing the traditional Chinese medicine calculus-removing granules according to claim 1, wherein the method for preparing the auxiliary material powder comprises the following steps: pulverizing sucrose into sugar powder, and mixing dextrin with the sugar powder.
7. The method for preparing traditional Chinese medicine calculus removing granules according to claim 1, wherein the granulating device further comprises a filtering section, the filtering section is connected to the upper part of the diffusion section, the filtering section is connected with an air outlet pipeline, and a dust capturing bag is arranged in the filtering section.
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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2103367U (en) * 1991-09-22 1992-05-06 袁汝淳 One-step device for granulating materials
CN102179204A (en) * 2011-04-26 2011-09-14 安徽安科恒益药业有限公司 Pelletizing and drying device
US8821942B1 (en) * 2011-04-06 2014-09-02 Access Business Group International Llc Highly compressible, low density ground calcium carbonate granulation and a related method of preparation
CN106692316A (en) * 2016-12-22 2017-05-24 江西济民可信药业有限公司 Preparation method of frankincense and elecampane urinary calculus-removing granules
CN111495273A (en) * 2020-05-29 2020-08-07 江中药业股份有限公司 Method and equipment for granulating, drying, finishing and total mixing integrated production
CN112191191A (en) * 2020-09-27 2021-01-08 毛学明 Quick granulation method of traditional Chinese medicine extract

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2103367U (en) * 1991-09-22 1992-05-06 袁汝淳 One-step device for granulating materials
US8821942B1 (en) * 2011-04-06 2014-09-02 Access Business Group International Llc Highly compressible, low density ground calcium carbonate granulation and a related method of preparation
CN102179204A (en) * 2011-04-26 2011-09-14 安徽安科恒益药业有限公司 Pelletizing and drying device
CN106692316A (en) * 2016-12-22 2017-05-24 江西济民可信药业有限公司 Preparation method of frankincense and elecampane urinary calculus-removing granules
CN111495273A (en) * 2020-05-29 2020-08-07 江中药业股份有限公司 Method and equipment for granulating, drying, finishing and total mixing integrated production
CN112191191A (en) * 2020-09-27 2021-01-08 毛学明 Quick granulation method of traditional Chinese medicine extract

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