CN114522207B - Industrial production method of children's yellow dragon particles - Google Patents
Industrial production method of children's yellow dragon particles Download PDFInfo
- Publication number
- CN114522207B CN114522207B CN202210189710.8A CN202210189710A CN114522207B CN 114522207 B CN114522207 B CN 114522207B CN 202210189710 A CN202210189710 A CN 202210189710A CN 114522207 B CN114522207 B CN 114522207B
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- China
- Prior art keywords
- ointment
- granule
- schisandra chinensis
- pediatric
- yellow dragon
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Abstract
The application relates to the technical field of Chinese patent medicine production, in particular to an industrialized production method of children's yellow dragon granules, which comprises a raw material treatment step and a granulation step. In the raw material treatment step, the dregs after the volatile oil extraction of the schisandra chinensis are subjected to the extraction of the independent schisandra chinensis effective components, and the schisandra chinensis and other medicinal materials are not mixed and extracted, so that the transfer rate of the effective components of the schisandra chinensis is greatly increased; in the granulating step, the decocting medicinal paste is added into wet granulating equipment step by step, so that the technical problem that wet granulating is difficult to realize due to large amount of medicinal paste is solved, the process time is greatly reduced, and the production efficiency is increased. The technical scheme solves the problems of limited medicinal material utilization rate, long production period and the like in the prior art production process, and has good application prospect in the industrialized production process of the children's yellow dragon particles.
Description
Technical Field
The application relates to the technical field of Chinese patent medicine production, in particular to an industrialized production method of children's yellow dragon granules.
Background
The children's Huanglong granule is a prescription drug, and is mainly used for treating symptoms of restlessness, distraction, urgent irritability, multiple language, night sweat, dry mouth and throat, feverish palms and soles and the like caused by children's hyperactivity in clinic. Chinese patent CN1686237a (an intelligence-promoting and nerve-calming granule for treating children's hyperkinetic syndrome and its preparation method) discloses a formulation of children's yellow dragon granule and its preparation method. The formula of the pediatric Huanglong granule comprises the following components: 40-60 parts of prepared rehmannia root, 40-60 parts of white peony root, 40-60 parts of dwarf lilyturf tuber, 10-30 parts of rhizoma anemarrhenae, 10-30 parts of schisandra chinensis, 60-90 parts of calcined dragon bone, 60-90 parts of calcined oyster shell, 40-60 parts of radix codonopsis pilosulae, 30-50 parts of grassleaf sweelflag rhizome, 10-30 parts of polygala tenuifolia and 5-15 parts of platycodon root. The process comprises the following steps: pulverizing half of rhizoma Acori Graminei and half of radix Codonopsis to obtain crude powder; extracting volatile oil from the schisandra chinensis in a proportioning amount, and coating the volatile oil with beta-cyclodextrin to obtain beta-cyclodextrin coating; decocting the residue of fructus Schisandrae chinensis with the rest materials, collecting extract, and drying to obtain dry extract; and finally, sieving the crude drug powder through a 100-mesh sieve, uniformly mixing the crude drug powder with the beta cyclodextrin inclusion complex and the dry extract powder, crushing, sieving, granulating by a wet method, drying and finishing to obtain the pediatric yellow dragon granules. However, the existing preparation process of the children's yellow dragon granule has the following problems: in the prior art, the scheme of combining and decocting the dregs after extracting volatile oil from the schisandra chinensis and the rest medicinal materials is adopted, and in the batch production process, the combined decoction is unfavorable for extracting key components in the schisandra chinensis, particularly, the transfer rate of schizandrin B and schizandrin A is relatively low, and the identification in the finished product is not obvious. In the prior art, dry paste powder is adopted for granulation, in actual work, as the ingredients of the extract contain more substances such as starch, saponin and sugar, the difficulty in preparing the dry paste powder is very high, the reduced pressure drying time of a batch of ointment is usually 5-7 days, the production efficiency is very low, the energy consumption is very high, the ointment drying mode is not beneficial to industrial production, and the color of the prepared particles is brown, and does not accord with the description of the characteristic of the product of brown according to quality standards. There is a need to develop a new process for producing children's yellow dragon granule to improve the transfer rate of key components in schisandra chinensis and the content of baicalin in finished products, solve the problem of properties, and improve the production efficiency of medicines.
Disclosure of Invention
The application aims to provide an industrialized production method of pediatric Huanglong particles, which aims to solve the technical problems of unsatisfactory content of functional components of schisandra chinensis in finished products, unqualified properties and low production efficiency in the pediatric Huanglong particle production process in the prior art.
In order to achieve the above purpose, the application adopts the following technical scheme:
an industrialized production method of infantile Huanglong granule comprises a raw material treatment step and a granulating step; the raw material treatment step comprises the steps of extracting shizandra berry and extracting other medicinal materials;
in the extraction step of the schisandra chinensis, taking coarse schisandra chinensis powder, using water as a solvent, and obtaining schisandra chinensis volatile oil, first five-flavor extract and schisandra chinensis dregs through distillation extraction; taking the shizandra berry dregs, using water as a solvent, and obtaining a second shizandra berry extract by decoction and extraction; filtering and combining the first five-flavor extract and the second schisandra extract to obtain combined filtrate, and concentrating the combined filtrate into the pediatric yellow dragon granule schisandra ointment;
in the extraction step of other medicinal materials, radix paeoniae alba, radix rehmanniae preparata, radix ophiopogonis, rhizoma anemarrhenae, polygala tenuifolia, calcined dragon bone, calcined oyster shell, platycodon grandiflorum, grassleaf sweelflag rhizome A part and dangshen A part are taken to obtain a decoction piece mixture, water is used as a solvent, and the mixture is decocted and extracted to obtain a mixed extract; filtering and concentrating the mixed extract to obtain the infantile yellow dragon granule combined decoction ointment.
The principle and the advantages of the scheme are as follows:
according to the technical scheme, after the volatile oil is extracted from the schisandra chinensis, the schisandra chinensis is extracted for three times, and is concentrated independently, so that the transfer rate of the marking components schisandra chinensis alcohol A and schisandra chinensis B in the schisandra chinensis is effectively improved, the identification and content measurement of the two components in a finished product are obviously improved, the problem of the transfer rate of the schisandra chinensis is solved, the product quality is improved, and the curative effect is further ensured.
In the prior art, the functional components of the schisandra chinensis in the finished product obtained by decocting the schisandra chinensis dregs extracted with volatile oil and the rest medicinal materials in the proportion, collecting the ointment and drying the ointment to obtain dry extract are often not ideal. The inventors studied the causes of the above phenomena in various ways, including extraction temperature, study of sources of medicinal materials, study of extraction solvents, and the like. Finally, the problem of low transfer rate of the functional components caused by simultaneous extraction of the shizandra berry dregs and other medicinal material decoction pieces is found. If the shizandra berry dregs are separately decocted and extracted, the content of schizandrin A and schizandrin B in the finished product can be greatly improved. The analysis of the inventor is that the components in other raw medicinal materials influence the dissolution efficiency of the functional components in the schisandra chinensis dregs and have negative effect on the stability of schisandrin A, schisandrin B and the like. Meanwhile, the combined decoction process of the schisandra chinensis and other medicinal materials has great influence on the extraction of paeoniflorin. Therefore, the independent extraction of the schisandra chinensis can solve the problem of the transfer rate of the effective components of the schisandra chinensis, and simultaneously solve the problem of the transfer rate of paeoniflorin which is a marked component.
Further, the raw material treatment step further comprises a crushing step of other medicinal materials: pulverizing rhizoma Acori Graminei part B and radix Codonopsis part B respectively, and mixing to obtain rhizoma Acori Graminei and radix Codonopsis mixed powder; sterilizing and pulverizing to obtain rhizoma Acori Graminei and radix Codonopsis sterilized pulverized powder; the mass ratio of the grassleaf sweelflag rhizome A part to the grassleaf sweelflag rhizome B part is 1:1; the mass ratio of the radix codonopsis A part to the radix codonopsis B part is 1:1. The powder is sterilized to ensure that the final product meets the relevant hygienic standard.
Further, the raw material treatment step also comprises an inclusion step of the schisandra volatile oil: preparing an ethanol solution of the beta-cyclodextrin dispersion liquid and the schisandra volatile oil; adding ethanol solution of volatile oil of fructus Schisandrae into beta-cyclodextrin dispersion, stirring and drying to obtain beta-cyclodextrin clathrate. Clathrating volatile oil of fructus Schisandrae to prevent volatilization loss of effective components in subsequent processing steps.
Further, the granulating step comprises an ointment treatment step, a pre-granulating step and a boiling granulating step;
in the ointment treatment step, 2/3 weight of the infant yellow dragon granule decocting ointment is taken and heated to 50-60 ℃, and then the ointment is sieved by a 80-mesh sieve, so as to obtain a preheated ointment;
in the pre-granulating step, sterilizing and crushing rhizoma Acori Graminei and radix Codonopsis, mixing the powder, dextrin, beta-cyclodextrin clathrate and stevioside, adding the child's yellow dragon granule shizandra berry ointment, 1/3 weight child's yellow dragon granule mixed decoction ointment and ethanol, mixing to obtain soft material, and preparing the soft material into wet granules;
in the boiling granulation step, feeding wet granules into a boiling drying granulator, and setting the control temperature to be 100+/-10 ℃; keeping the particles in boiling state, and spraying the preheated ointment; then keeping the temperature of the materials at 60-80 ℃ until the moisture is qualified; and cooling and discharging to obtain mixed particles.
According to the technical scheme, through all schisandra chinensis ointment, one third of the residual medicinal material extract ointment is added with the mixed codonopsis pilosula powder, the grassleaf sweetflag rhizome powder, the volatile oil inclusion compound and the dextrin mixture, then wet granulation is carried out, substrate particles are prepared after boiling and drying, finally the residual ointment is sprayed on the substrate particles in the same boiling dryer, and the pediatric yellow dragon particles meeting the character requirements are prepared after drying and granulating (1 day of production time). The method solves the problems of excessive amount of traditional Chinese medicine ointment and difficult wet granulation. More importantly, the problems of long time (5-7 days) and complicated crushing in the process of preparing dry extract powder by the existing process are solved. The technical scheme reduces pollution links, reduces decompression drying time, prevents degradation of unstable components, improves the quality of products, and more importantly, solves the problems that the product is brown and black in shape and difficult to determine whether the product is qualified for a long time, further improves the yield of the finished product in the production process, and greatly improves the production efficiency.
Further, the granulating step is followed by a sieving mixing step: the mixed particles are sieved to obtain coarse particles and fine particles; and (3) feeding the coarse particles and the fine particles into a one-dimensional motion mixer to obtain finished product particles. The coarse particles and the fine particles are mixed and formed into finished particles by a one-dimensional motion mixer.
Further, in the step of extracting the schisandra chinensis, adding water which is 10 times of the weight of the schisandra chinensis coarse powder into the schisandra chinensis coarse powder, soaking for 45 minutes, and extracting by distillation for 5 hours to obtain schisandra chinensis volatile oil, a first five-flavor extracting solution and schisandra chinensis dregs; taking the shizandra berry dregs, using water as a solvent, and obtaining a second shizandra berry extract by three times of decoction and combination of the extracts; filtering the first five-flavor extract and the second schisandra extract through a 100-mesh sieve, combining to obtain combined filtrate, and concentrating the combined filtrate into the pediatric Huanglong granule schisandra ointment; the relative density of the pediatric yellow dragon granule shizandra berry ointment at 60 ℃ is 1.20-1.25. The condition of distillation extraction can ensure that volatile oil in the schisandra chinensis is fully extracted. Filtering the extractive solution to remove impurities and ensure uniformity of the infantile yellow dragon granule fructus Schisandrae ointment. The children's yellow dragon granule shizandra berry ointment with the relative density of 1.20-1.25 can be evenly mixed with the children's yellow dragon granule decocting ointment in the process of pre-granulating to form wet granules.
Further, in the extraction step of other medicinal materials, white peony root, prepared rehmannia root, dwarf lilyturf tuber, common anemarrhena rhizome, thinleaf milkwort root-bark, calcined dragon bone, calcined oyster shell, platycodon root, grassleaf sweelflag rhizome A part and pilose asiabell root A part are taken to obtain decoction piece mixture, and mixed extract is obtained through three times of decoction and extraction; filtering and concentrating the mixed extract through a 100-mesh sieve to obtain the infantile yellow dragon granule combined decoction ointment; the relative density of the composite decoction ointment of the pediatric yellow dragon particles is 1.25-1.30 at 60 ℃. The density of the pediatric Huanglong granule combined decoction ointment has obvious influence on the quality of finished products. The density of the combined decoction ointment is too large, the spraying state is poor, the granule molding is uneven, the finished product property is unqualified, and the granule dissolution performance is poor. The density of the composite decoction ointment is too small, so that the bonding capability of the composite decoction ointment to substrate particles in the preparation process is reduced, and the finished fine powder is more.
Further, in the pulverizing step of the other medicinal materials: pulverizing rhizoma Acori Graminei part B and radix Codonopsis part B respectively, sieving with 100 mesh sieve, and mixing to obtain rhizoma Acori Graminei and radix Codonopsis mixed powder; sterilizing at 115deg.C for 30 min, drying for 30 min, and pulverizing to obtain powder.
Further, in the pre-granulating step, sterilizing and crushing grassleaf sweelflag rhizome and pilose asiabell root, mixing the powder, dextrin, a beta-cyclodextrin inclusion compound dry product and stevioside for 10 minutes, adding the pediatric yellow dragon granule shizandra berry ointment, 1/3 weight of pediatric yellow dragon granule combined decoction ointment and ethanol, mixing for 1-5 minutes to obtain a soft material, and preparing the soft material into wet granules by using a swinging granulator with a 16-mesh screen. The dosage of the children's yellow dragon granule combined decoction ointment in the pre-granulating process is critical, and excessive dosage can lead to very hard finished granules obtained by preparation and poor solubility; too little can result in the finished product being prepared, the granule character can become brownish black, and the brownish yellow standard is not met. In addition, the pediatric yellow dragon granule shizandra berry ointment needs to be added in a pre-granulating step, and if the pediatric yellow dragon granule shizandra berry ointment is added in a subsequent step, the prepared finished product can be caused to become brownish red in granule character and does not accord with the brownish yellow standard.
Further, the children's yellow dragon granule comprises the following functional components in parts by weight: 40-60 parts of prepared rehmannia root, 40-60 parts of white peony root, 40-60 parts of dwarf lilyturf tuber, 10-30 parts of rhizoma anemarrhenae, 10-30 parts of schisandra chinensis, 60-90 parts of calcined dragon bone, 60-90 parts of calcined oyster shell, 40-60 parts of radix codonopsis pilosulae, 30-50 parts of grassleaf sweelflag rhizome, 10-30 parts of polygala tenuifolia and 5-15 parts of platycodon root.
The children's yellow dragon granule takes prepared rehmannia root, white paeony root and dwarf lilyturf tuber as raw materials for nourishing liver and kidney, rhizoma anemarrhenae for nourishing yin and clearing heat, dragon bone and oyster for calming liver and suppressing yang, grassleaf sweelflag rhizome as aromatic for inducing resuscitation, and radix schisandrae chinensis and polygala tenuifolia for soothing the nerves and improving intelligence, and platycodon grandiflorum as the lifting and guiding drug to achieve the effects of brain, and the whole formula has the effects of nourishing liver and kidney, calming liver and suppressing yang, soothing the nerves and improving intelligence. The children's Huanglong granule has the functions of nourishing liver and kidney, suppressing hyperactive liver and subsiding yang, tranquilizing mind and calming mind, and can be used for treating children's hyperactivity, which is manifested by yin deficiency and yang hyperactivity, restless children's overactivity, concentration, unstable emotion, and decline of learning score.
Detailed Description
The present application will be described in further detail with reference to the following examples, but the embodiments of the present application are not limited thereto. The technical means used for the following implementation are, unless otherwise indicated, conventional means well known to those skilled in the art: the materials, reagents, and the like used are all commercially available.
Example 1:
1. formula of children's Huanglong granule
The formula of the pediatric Huanglong granule comprises the following components (the functional components are calculated according to the parts by weight): 40-60 parts of prepared rehmannia root, 40-60 parts of white peony root, 40-60 parts of dwarf lilyturf tuber, 10-30 parts of rhizoma anemarrhenae, 10-30 parts of schisandra chinensis, 60-90 parts of calcined dragon bone, 60-90 parts of calcined oyster shell, 40-60 parts of radix codonopsis pilosulae, 30-50 parts of grassleaf sweelflag rhizome, 10-30 parts of polygala tenuifolia and 5-15 parts of platycodon root. The preparation process can realize the industrialized production of the children's yellow dragon granule with the formula, and has the effects of shortening the production time and ensuring the transfer rate of the functional components. To further illustrate the effect, the present example is specifically described with the formulation shown in table 1.
Table 1: the raw materials and auxiliary materials of the pediatric Huanglong granule of the embodiment are composed of
2. Extraction and concentration of Schisandra chinensis
(1) Distilling and extracting shizandra decoction pieces:
36.05kg of shizandra decoction pieces are crushed into coarse powder with 40-60 meshes, 35.00kg of shizandra coarse powder (the material loss exists in the crushing process) is weighed and added into a 3000L straight barrel extraction tank (alcohol extraction), and distillation extraction is carried out. Adding 10 times of drinking water, soaking for 45 min, boiling with steam valve, distilling to extract volatile oil for 5 hr, transferring the collecting tank into the paste collecting chamber, separating and collecting volatile oil, packaging with clean container, sealing, weighing, labeling with material label, marking name, lot number, quantity, production time, etc., and storing in warehouse; filtering the distilled extraction solution with a square filter with 100 meshes, and placing the filtrate in a 8000L percolate storage tank or a 8000L alcohol extract storage tank; extracting the distilled fructus Schisandrae chinensis residue for three times (decoction extraction), adding 10 times of drinking water, heating to boiling, maintaining boiling state for 2 hr, discharging medicinal liquid, filtering with square filter of 100 mesh, and placing into 8000L ethanol extractive solution storage tank; adding drinking water with the weight 8 times of that of the coarse powder of the schisandra chinensis for the second time, opening a steam valve to heat to boiling, keeping the boiling state for 1 hour, discharging the liquid medicine, filtering by a square filter with 100 meshes, and placing the liquid medicine in a 8000L alcohol extract storage tank; adding 6 times of drinking water, heating to boiling, maintaining boiling state for 1 hr, discharging medicinal liquid, filtering with square filter of 100 mesh, and placing the filtrate into 8000L ethanol extractive solution storage tank. The filtrates obtained by four extractions were combined to obtain a combined filtrate.
(2) Concentrating the schisandra chinensis extract
Starting a single-effect concentrator, sucking the schisandra chinensis filtrate (combined filtrate) into the single-effect concentrator, concentrating to a proper relative density, and closing the single-effect concentrator; and transferring the extract to a spherical concentrator for concentrating until the relative density is 1.20-1.25 (60 ℃), closing the concentrator, wherein the specific condition adopted in the embodiment is that the relative density is 1.20 when the temperature is 60 ℃, and the process takes about 3-4 hours. The traditional process uses a vacuum drying oven for drying under reduced pressure, and the drying time under reduced pressure is 72-96 hours. Discharging infantile yellow dragon granule fructus Schisandrae ointment in the ointment collecting room, packaging with clean barrel, sealing, weighing, labeling with material label, and storing (time consuming 3-4 hr) with name, lot number, production time, etc.
3. Extracting and concentrating other decoction pieces
(1) Extracting other decoction pieces: the 10-flavor decoction pieces for extraction, namely 87.50kg of white peony root, 87.50kg of prepared rehmannia root, 87.50kg of dwarf lilyturf tuber, 35.00kg of common anemarrhena rhizome, 35.00kg of polygala tenuifolia, 131.25kg of calcined dragon bone, 131.25kg of calcined oyster shell, 17.50kg of platycodon grandiflorum, 48.125kg of grassleaf sweelflag rhizome (half amount) and 53.375kg of pilose asiabell root (half amount), are divided into two tanks for feeding. Respectively putting into 6000L straight barrel extraction tanks. Decocting with water for 3 times in each pot to obtain decoction. Adding 10 times of drinking water into the decoction pieces for the first time, heating to boiling by opening a steam valve, keeping boiling state for 2 hours, discharging the liquid medicine, filtering by a square filter with 100 meshes, and placing the filtrate into a 8000L alcohol extract storage tank; adding 8 times of drinking water into the decoction pieces for the second time, opening a steam valve to heat to boiling, keeping the boiling state for 1 hour, discharging the liquid medicine, filtering by a square filter with 100 meshes, and placing the filtrate into a 8000L alcohol extract storage tank; adding 6 times of drinking water, heating to boiling, maintaining boiling state for 1 hr, discharging medicinal liquid, filtering with square filter of 100 mesh, and placing the filtrate into 8000L ethanol extractive solution tank.
(2) Concentrating the extract of other decoction pieces: starting a single-effect concentrator, filtering the above filtrates by a bag filter with 250 mesh, sucking into the single-effect concentrator, concentrating to a relative density of 1.25-1.30 (60deg.C), closing the single-effect concentrator, and discharging the infantile yellow dragon granule mixed decoction ointment in the ointment collecting chamber. The conditions specifically employed in this example were 60℃concentration to a relative density of 1.25, which took 6-7 hours. The concentration process of the composite decoction ointment of the infantile yellow dragon particles in the prior art generally needs to adopt a vacuum drying oven for drying under reduced pressure, and the concentration time is 120-168 hours until the relative density is 1.26-1.28, so that the subsequent granulation process can be carried out.
4. Crushing other decoction pieces
And (3) respectively crushing the prepared rhizoma acori graminei decoction pieces with half formula amount and the codonopsis pilosula decoction pieces with half formula amount into fine powder, and sieving the fine powder with a 100-mesh sieve. During and after sieving, the granularity of the powder should be checked. Subsequently, the grassleaf sweelflag rhizome and the dangshen medicinal powder are collected, weighed and mixed according to a proportion, and then are split into 10 bags on average. Collecting mixed powder of rhizoma Acori Graminei and radix Codonopsis, packaging with clean container or bag, sealing, weighing, labeling with material label, marking name, lot number, production time, etc., and storing in warehouse.
Sterilizing and drying: spreading rhizoma Acori Graminei and radix Codonopsis mixed powder on a tray, marking, placing the amount of each tray slightly lower than the upper level of the sterilizing tray, sterilizing in a Chinese medicinal sterilizing cabinet for 30 min at 115deg.C, drying at 115deg.C for 30 min, discharging, collecting sterilized powder, and pulverizing or sieving.
Crushing: starting a pulverizer, pulverizing sterilized rhizoma Acori Graminei and radix Codonopsis powder, and sieving with 80 mesh sieve to obtain sterilized pulverized powder of rhizoma Acori Graminei and radix Codonopsis. The clean container is used for containing, sealing, weighing, labeling material labels, and marking name, batch number, production time, etc.
5. Clathrating volatile oil, and drying at low temperature
Clathrating volatile oil, and drying at low temperature: dissolving beta-cyclodextrin (3 times of the volatile oil) in heated purified water (the purified water is about 14 times of the volatile oil), dissolving the volatile oil of fructus Schisandrae chinensis with 5 times of ethanol, slowly adding the volatile oil into the aqueous solution of the beta-cyclodextrin at a constant temperature of about 50 ℃, stirring at constant temperature for 5 hours to complete inclusion, refrigerating and standing for 48 hours, filtering, collecting precipitate, drying at low temperature (50+/-2 ℃ for 2-3 hours) in an oven to obtain a beta-cyclodextrin clathrate, loading into a clean container, weighing, marking the name, specification, batch number, quantity, production time and the like on a container material label, and delivering to the next process or storing in an intermediate station.
5. Granulating and drying
I, ointment treatment: heating the rest weight of the mixed decoction ointment of the infantile yellow dragon particles (2/3 weight of the mixed decoction ointment of the infantile yellow dragon particles) to 50-60 ℃ in a jacketed kettle, and maintaining for 10-20 minutes until the extract is in a state of flowable filtration (when the ointment is thicker and difficult to heat, a proper amount of purified water can be added for stirring and then heating, the embodiment adopts heating to 55 ℃), discharging, sieving with a 80-mesh sieve, and obtaining the preheated ointment for boiling granulation.
II, pre-granulating: sterilizing rhizoma Acori Graminei and radix Codonopsis, pulverizing into powder, dextrin (115.21 kg), clathrate of beta-cyclodextrin, and stevioside (steviosin, 4.20 kg), mixing with stirring at 20 rpm for 10 min, adding 1/3 weight of the mixture, ethanol (50.00 kg), and stirring for 1-5 min (stirring for 3 min in this example), and making into soft mass. The soft material is transferred into a swinging granulation machine with a 16-mesh screen to prepare wet granules with uniform thickness.
III, boiling granulation: after the boiling drying granulator is started to heat to about 80 ℃, a feeding valve is started, wet particles are continuously transferred into the boiling drying granulator, the boiling condition of materials is observed at any time in the feeding process, and the phenomenon of hardening of the materials possibly occurs when the materials are fed too fast. Setting the control temperature to be 100+/-10 ℃, and boiling and granulating when the temperature of the material is raised to 60 ℃. Keeping the particles in a boiling state, spraying preheated ointment (preheated ointment) until the temperature of the material is kept at 60-80 ℃ (dynamic range), continuously drying until the moisture is qualified (the qualification standard is that the moisture content is not more than 4.0%), regulating the temperature to lower the temperature of the material to below 40 ℃, and opening a discharging baffle plate to discharge.
6. Sieving and mixing
And I, sieving: opening a discharging baffle, transferring the particles into a high-efficiency powder screening machine, screening by using a 10-mesh and 60-mesh stainless steel screen, and collecting qualified particles until the qualified particles are mixed. Collecting coarse particles and fine particles, and adding the coarse particles and the fine particles into the material to be granulated in the next pot together for granulating. And finally, destroying the coarse particles and the fine particles in the pot. After sieving, the screen is inspected and should be intact.
II, mixing: and (5) taking the sieved particles (coarse particles and fine particles) and putting the particles into a one-dimensional motion mixer. Starting a one-dimensional motion mixer to mix for 10 minutes, and discharging. The particles are contained in a clean container, sealed, weighed and labeled with a material label.
And III, subpackaging particles: and starting the automatic particle packing machine, selecting corresponding measuring cups to carry out sub-packing according to the technological parameters, wherein the packing amount of each bag is 5g. Before formal packaging, test run should be performed first, and check that the batch number word nails on the automatic particle packaging machine should be consistent with the batch number of the intermediate product; checking whether the printing position is correct; and checking the filling quantity and the heat sealing quality. In the packaging process, the heat sealing quality should be checked at any time, products with unclear batch numbers and unqualified heat sealing quality are selected, particles are poured out in time, and sub-packaging is carried out again; and the filling quantity inspection (taking an empty bag after heat sealing, weighing, removing the skin, extracting 4 bags of particles each time, respectively weighing each bag, and recording the weight of each bag).
Comparative example 1
The comparative example adopts the preparation method in patent CN1686237A (an intelligence-promoting and mind-tranquilizing granule for treating the attention deficit hyperactivity disorder of children and a preparation method thereof), namely:
according to the formula shown in Table 1, rhizoma Acori Graminei (half amount) and radix Codonopsis (half amount) are crushed and sieved for 100 days; pulverizing fructus Schisandrae into coarse powder, soaking in 4 times of water for 45 min, extracting by steam distillation for 5 hr, collecting volatile oil, clathrating the volatile oil with beta-cyclodextrin (volatile oil: beta-cyclodextrin=1 ml:3 g), and drying at low temperature; decocting fructus Schisandrae residue and distilled water solution with the rest materials in water for three times, decocting with 10 times of water for 2 hr for the first time, decocting with 8 times of water for 1 hr for the second time, decocting with 6 times of water for 1 hr for the third time, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.26-1.28 (80deg.C, vacuum drying with vacuum drying oven for 120-168 hr), drying under reduced pressure to obtain dry extract, adding above medicinal material fine powder and beta cyclodextrin clathrate, mixing, pulverizing into fine powder, and adding stevioside and dextrin. Adding into groove mixer, stirring and mixing for 5 min, adding appropriate amount of ethanol, and making into soft material. The soft material is transferred into a swinging granulation machine with a 16-mesh screen to prepare wet granules with uniform thickness. After the boiling drying granulator is started to heat to about 80 ℃, a feeding valve is started, wet particles are continuously transferred into the boiling drying granulator, the boiling condition of materials is observed at any time in the feeding process, and the phenomenon of hardening of the materials possibly occurs when the materials are fed too fast. Setting the control temperature to be 100+/-10 ℃, and boiling and granulating when the temperature of the material is raised to 60 ℃. Keeping the temperature of the materials at 60-80 ℃ (the comparative example is specifically 70 ℃), continuously drying until the moisture is qualified, regulating the temperature to lower the temperature of the materials to below 40 ℃, and opening a discharging baffle plate to discharge. The remaining preparation was the same as in example 1.
Comparative example 2
This comparative example is basically the same as example 1, except that: the volatile oil of schisandra chinensis is obtained by the method of '2 extraction and concentration' of schisandra chinensis in the embodiment 1, then the schisandra chinensis dregs and other decoction pieces are mixed, and the infantile yellow dragon granule combined decoction ointment is obtained by the method of '3 extraction and concentration of other decoction pieces'. Because the pediatric yellow dragon granule shizandra berry ointment is not prepared separately, the adding process of the materials is omitted in the step of granulating and drying 5. That is, the comparative example did not extract the schisandra chinensis residue and other decoction pieces separately, but the other steps were basically the same as in example 1.
Comparative example 3
This comparative example is basically the same as example 1, except that: in the ' II pre-granulation of ' 5 granulating and drying ', the dosage of the combined decoction ointment of the pediatric yellow dragon granules is 2/3; in the process of 'I ointment treatment' of '5' granulating and drying ', the dosage of the combined decoction ointment of the children's yellow dragon particles is 1/3 of the dosage. The prepared finished product particles are very hard and have poor solubility.
Comparative example 4
This comparative example is basically the same as example 1, except that: in the ' II pre-granulation of ' 5 granulating and drying ', the dosage of the combined decoction ointment of the pediatric yellow dragon granules is 1/4 of the dosage; in the process of ' I ointment treatment ' of ' 5 granulating and drying ', the dosage of the combined decoction ointment of the children's yellow dragon particles is 3/4 of the dosage. The prepared finished product has the particle shape of brownish black and does not accord with the brownish yellow standard.
Comparative example 5
This comparative example is basically the same as example 1, except that: and (5) granulating and drying the ' II prefabricated granules ', and not adding the children's yellow dragon granule shizandra berry ointment. The infant yellow dragon granule shizandra berry ointment is obtained by a method of 'I ointment treatment'. Then in the "III boiling granulation", the preheated ointment is sprayed into the particles in a boiling state together. The prepared finished product has the characteristics of brownish red and does not accord with the brownish yellow standard.
Comparative example 6
This comparative example is basically the same as example 1, except that: in the concentrating of the extracting solution of other decoction pieces (2), the relative density of the composite decoction ointment of the pediatric yellow dragon particles is controlled at 1.32. The density of the combined decoction ointment is too large, the spraying state is poor, the granule molding is uneven, the finished product property is unqualified, and the granule dissolution performance is poor.
Comparative example 7
This comparative example is basically the same as example 1, except that: in the concentrating of the extracting solution of other decoction pieces (2), the relative density of the composite decoction ointment of the pediatric yellow dragon particles is controlled at 1.15. The density of the mixed decoction ointment is too small, so that the adhesion capability of the mixed decoction ointment to substrate particles in the preparation process is reduced, the finished fine powder is more, and the content of effective components such as the yield and paeoniflorin after screening is lower, so that the curative effect is affected.
Experimental example 1: example 1 and comparative examples 1 to 7 mass statistics
The detection method comprises the following steps: the national drug quality standard (standard number YBZ 00892011) of the pediatric Huanglong granule and the experimental results are shown in Table 2.
Table 2: results of finished product detection of examples and comparative examples
The research results show that the particles prepared by the application are brown-yellow, conform to the description of the product by the quality standard (YBZ 00892011) of the children's yellow dragon particles, and the particles prepared by comparative examples 1, 2, 3, 5, 6 and 7 are brown-black, brown-red or brown-yellow to brown-brown and other particles with uneven colors, and the properties of the particles do not conform to the standard requirements. It is important to control the type and amount of ointment used for substrate granulation and the amount of secondary granulation spray granulation in production. The ointment amount (the infantile yellow dragon granule composite decoction ointment) used for preparing the substrate for granulating for the first time is excessive, the prepared granules are relatively moist, the prepared materials are in a strip shape, and are subjected to boiling drying and spray granulating again, so that the dried and granulated granules are very hard and have poor solubility; the ointment amount used for preparing the substrate for granulation (the pre-granulation step) for the first time is reduced, the prepared granules are relatively dry, the prepared granules are very loose, and the fine powder in the granules after boiling and drying, spraying the ointment again for granulation, drying and granulating affects the uniformity. The fructus Schisandrae ointment is preferably used as wetting agent in the first wet granulation, and if the fructus Schisandrae ointment is sprayed into substrate granule at last, the final product will be brownish red, and the properties of the final product do not meet quality requirements. In addition, the combined decoction of the schisandra chinensis and other medicinal materials can greatly influence the extraction transfer rate of schisandra chinensis alcohol A and the identification of schisandra chinensis B, so that the identification of schisandra chinensis B is unqualified, and meanwhile, the combined decoction process of the schisandra chinensis and other medicinal materials also has great influence on the extraction of paeoniflorin, so that the problem of the transfer rate of the effective components of the schisandra chinensis can be solved by independently extracting the schisandra chinensis, and the problem of the transfer rate of the paeoniflorin serving as a marker component is also solved.
The foregoing is merely exemplary of the present application, and specific technical solutions and/or features that are well known in the art have not been described in detail herein. It should be noted that, for those skilled in the art, several variations and modifications can be made without departing from the technical solution of the present application, and these should also be regarded as the protection scope of the present application, which does not affect the effect of the implementation of the present application and the practical applicability of the patent. The protection scope of the present application is subject to the content of the claims, and the description of the specific embodiments and the like in the specification can be used for explaining the content of the claims.
Claims (7)
1. An industrialized production method of children's yellow dragon granule is characterized by comprising a raw material treatment step and a granulating step; the raw material treatment step comprises the steps of extracting schisandra chinensis, extracting other medicinal materials, crushing other medicinal materials and clathrating schisandra chinensis volatile oil;
in the extraction step of the schisandra chinensis, taking coarse schisandra chinensis powder, using water as a solvent, and obtaining schisandra chinensis volatile oil, first five-flavor extract and schisandra chinensis dregs through distillation extraction; taking the shizandra berry dregs, using water as a solvent, and obtaining a second shizandra berry extract by decoction and extraction; filtering and combining the first five-flavor extract and the second schisandra extract to obtain combined filtrate, and concentrating the combined filtrate into the pediatric yellow dragon granule schisandra ointment; the relative density of the pediatric yellow dragon granule shizandra berry ointment at 60 ℃ is 1.20;
in the extraction step of other medicinal materials, radix paeoniae alba, radix rehmanniae preparata, radix ophiopogonis, rhizoma anemarrhenae, polygala tenuifolia, calcined dragon bone, calcined oyster shell, platycodon grandiflorum, grassleaf sweelflag rhizome A part and dangshen A part are taken to obtain a decoction piece mixture, water is used as a solvent, and the mixture is decocted and extracted to obtain a mixed extract; filtering and concentrating the mixed extract to obtain the pediatric yellow dragon granule combined decoction ointment; the relative density of the pediatric yellow dragon granule combined decoction ointment at 60 ℃ is 1.25;
in the pulverizing step of other medicinal materials, pulverizing rhizoma Acori Graminei part B and radix Codonopsis part B respectively, and mixing to obtain rhizoma Acori Graminei and radix Codonopsis mixed powder; sterilizing and pulverizing to obtain rhizoma Acori Graminei and radix Codonopsis sterilized pulverized powder; the mass ratio of the grassleaf sweelflag rhizome A part to the grassleaf sweelflag rhizome B part is 1:1; the mass ratio of the radix codonopsis part A to the radix codonopsis part B is 1:1;
in the step of clathrating the volatile schisandra chinensis oil, preparing a beta cyclodextrin dispersion liquid and an ethanol solution of the volatile schisandra chinensis oil; adding ethanol solution of volatile oil of fructus Schisandrae into beta-cyclodextrin dispersion, stirring and drying to obtain beta-cyclodextrin clathrate;
the granulating step comprises an ointment treatment step, a pre-granulating step and a boiling granulating step;
in the ointment treatment step, 2/3 weight of the infant yellow dragon granule decocting ointment is taken and heated to 50-60 ℃, and then the ointment is sieved by a 80-mesh sieve, so as to obtain a preheated ointment;
in the pre-granulating step, sterilizing and crushing rhizoma Acori Graminei and radix Codonopsis, mixing the powder, dextrin, beta-cyclodextrin clathrate and stevioside, adding the child's yellow dragon granule shizandra berry ointment, 1/3 weight child's yellow dragon granule mixed decoction ointment and ethanol, mixing to obtain soft material, and preparing the soft material into wet granules;
in the boiling granulation step, feeding wet granules into a boiling drying granulator, and setting the control temperature to be 100+/-10 ℃; keeping the particles in boiling state, and spraying the preheated ointment; then keeping the temperature of the materials at 60-80 ℃ until the moisture is qualified; and cooling and discharging to obtain mixed particles.
2. The method for industrially producing the pediatric yellow dragon granule according to claim 1, wherein the granulating step further comprises a sieving and mixing step of: the mixed particles are sieved to obtain coarse particles and fine particles; and (3) feeding the coarse particles and the fine particles into a one-dimensional motion mixer to obtain finished product particles.
3. The industrialized production method of pediatric yellow dragon granules according to claim 2, wherein in the step of extracting schisandra chinensis, the schisandra chinensis coarse powder is taken, water which is 10 times of the weight of the schisandra chinensis coarse powder is added, and after soaking for 45 minutes, the schisandra chinensis volatile oil, the first five-ingredient extracting solution and the schisandra chinensis dregs are obtained through distillation and extraction for 5 hours; taking the shizandra berry dregs, using water as a solvent, and obtaining a second shizandra berry extract by three times of decoction and combination of the extracts; filtering the first five-flavor extractive solution and the second Chinese magnoliavine extractive solution by a 100 mesh sieve, mixing to obtain a mixed filtrate, and concentrating the mixed filtrate into the pediatric Huanglong granule Chinese magnoliavine ointment.
4. The industrialized production method of pediatric yellow dragon granules according to claim 3, wherein in the step of extracting other medicinal materials, white paeony root, prepared rehmannia root, dwarf lilyturf tuber, common anemarrhena rhizome, thinleaf milkwort root-bark, calcined dragon bone, calcined oyster shell, platycodon root and grassleaf sweelflag rhizome A part and pilose asiabell root A part are taken to obtain decoction piece mixture, and mixed extract is obtained through three times of decoction and extraction; filtering and concentrating the mixed extract through a 100-mesh sieve to obtain the infantile yellow dragon granule combined decoction ointment.
5. The method for the industrialized production of pediatric yellow dragon granules according to claim 4, wherein in the step of crushing the other medicinal materials: pulverizing rhizoma Acori Graminei part B and radix Codonopsis part B respectively, sieving with 100 mesh sieve, and mixing to obtain rhizoma Acori Graminei and radix Codonopsis mixed powder; sterilizing at 115deg.C for 30 min, drying for 30 min, and pulverizing to obtain powder.
6. The method for industrialized production of pediatric yellow dragon granule according to claim 5, wherein in the pre-granulating step, the sterilizing and pulverizing powder of grassleaf sweelflag rhizome and pilose asiabell root, dextrin, a dry product of betacyclodextrin inclusion compound and stevioside are mixed for 10 minutes, then the pediatric yellow dragon granule shizandra berry ointment, 1/3 weight pediatric yellow dragon granule combined decoction ointment and ethanol are added, after mixing for 1-5 minutes, a soft material is obtained, and then a swinging granulator with a 16-mesh screen is used for preparing the soft material into wet granules.
7. The industrial production method of the pediatric yellow dragon granule according to any one of claims 1 to 6, wherein the pediatric yellow dragon granule comprises the following functional components in parts by weight: 40-60 parts of prepared rehmannia root, 40-60 parts of white peony root, 40-60 parts of dwarf lilyturf tuber, 10-30 parts of rhizoma anemarrhenae, 10-30 parts of schisandra chinensis, 60-90 parts of calcined dragon bone, 60-90 parts of calcined oyster shell, 40-60 parts of radix codonopsis pilosulae, 30-50 parts of grassleaf sweelflag rhizome, 10-30 parts of polygala tenuifolia and 5-15 parts of platycodon root.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1686237A (en) * | 2005-03-30 | 2005-10-26 | 重庆思科药物研究所 | Intelligent benficial spirit calming granules for treating child profuse action syndrome and its preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1686237A (en) * | 2005-03-30 | 2005-10-26 | 重庆思科药物研究所 | Intelligent benficial spirit calming granules for treating child profuse action syndrome and its preparation method |
Non-Patent Citations (2)
| Title |
|---|
| 小儿黄龙颗粒对记忆障碍模型小鼠学习记忆功能的影响;吕姗珊等;《中国实验方剂学杂志》;20140731;第20卷(第14期);172-177 * |
| 脑蛋白水解物联合小儿黄龙颗粒治疗小儿多动症的临床疗效;苏洁等;《贵州医药》;20201231;第44卷(第10期);1744-1745 * |
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