CN113171349A - Film-coated tablet containing animal medicine and preparation process thereof - Google Patents
Film-coated tablet containing animal medicine and preparation process thereof Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2063—Proteins, e.g. gelatin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/58—Reptiles
- A61K35/583—Snakes; Lizards, e.g. chameleons
-
- 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
- A61K36/126—Drynaria
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- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
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- 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
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—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 film coated tablet containing animal medicine and a preparation process thereof, wherein the film coated tablet comprises the following components, by mass, 140 parts of lizard 150 parts, 95-100 parts of fried rhizoma drynariae, 50-55 parts of yam rhizome, 40-45 parts of microcrystalline cellulose, 3-4 parts of silicon dioxide, 6-7 parts of gelatin for capsules, 9-10 parts of anhydrous calcium hydrophosphate and 7-8 parts of film coating premix. The patent adjusts the prescription and specification of a tablet containing animal drugs, solves the problem of crushing and sieving crude drug powder containing grease animals, and increases the mechanical property of the tablet. Compared with the original sugar-coated tablet, the prepared film-coated tablet has the advantages of simple preparation process, easy operation and easy mastering; the prepared medicine has stable property, ensures the curative effect of the medicine, is suitable for diabetics and has wider application.
Description
Technical Field
The invention relates to a medicine processing technology, in particular to a film-coated tablet containing animal medicine and a preparation process thereof.
Background
The drug core is coated with a thin polymer coating to form a film, which is called a film coating.
For a long time, the traditional lagging syrup coating process is mostly used in tablet coating technology in the production of common medicines in China, and a plurality of auxiliary materials which are mainly talcum powder, cane sugar and gelatin and have no relation with the treatment of medicines are added on the surface layer of a medicine tablet core, so that the extra weight gain of the effective medicine tablet core of the sugar-coated tablet reaches 50-100 percent, and therefore, the sugar-coated tablet can cause great harm to human bodies, especially for diabetics, after long-term use. Meanwhile, the syrup coating production process is difficult to avoid dust flying and environmental pollution, and the sugar melting, glue melting, pigment adding, sheet airing and material storage all occupy larger space of a workshop. The production process is complex, and the operation process mostly depends on the experience of operators and hand feeling to control the coating quality, which is different from the medicine production quality management practice (GMP). Because of more uncontrollable factors in the syrup coating process, many sugar-coated tablet production enterprises are frequently easy to have the defects of cracking, blossoming, mildew, overtime disintegration, content reduction, strong hygroscopicity, difficult storage, long production time, long tablet airing time and the like in the sugar-coated tablet production and storage processes.
The sugar-coated tablets are inconvenient for some patients to take because of containing sugar, and a large amount of auxiliary materials such as talcum powder and cane sugar are used in the production process of the sugar-coated tablets, so the production period is long, and the products are easy to mildew, split and the like. In recent years, film-coated tablets have become the direction of development of tablet medicines and are widely accepted by patients.
Disclosure of Invention
The invention aims to provide a film-coated tablet containing animal medicine, which aims to solve the problems that the sugar-coated tablet is inconvenient for some patients to take due to the sugar content, and the sugar-coated tablet uses a large amount of auxiliary materials such as talcum powder and cane sugar in the production process, so that the production period is long, and the product is easy to mildew and crack.
The invention provides a film-coated tablet containing animal drugs, which comprises the following components, by mass, 140-150 parts of lizard, 95-100 parts of fried rhizoma drynariae, 50-55 parts of Ningpo Yam rhizome, 40-45 parts of microcrystalline cellulose, 3-4 parts of silicon dioxide, 6-7 parts of gelatin for capsules, 9-10 parts of anhydrous calcium hydrophosphate and 7-8 parts of film coating premix.
The coating material further comprises the following components, by mass, 140 parts of lizard, 95 parts of fried rhizoma drynariae, 50 parts of Ningpo yam rhizome, 40 parts of microcrystalline cellulose, 3 parts of silicon dioxide, 6 parts of gelatin for capsules, 9-10 parts of anhydrous calcium hydrophosphate and 7 parts of a film coating premix.
The film coating premix comprises 145 parts of lizard, 98 parts of fried rhizoma drynariae, 54 parts of Ningpo Yam rhizome, 42 parts of microcrystalline cellulose, 3 parts of silicon dioxide, 63 parts of gelatin for capsules, 9.5 parts of anhydrous calcium hydrophosphate and 7.5 parts of a film coating premix.
Further, the coating premix comprises, by mass, 150 parts of lizard, 100 parts of fried rhizoma drynariae, 55 parts of Ningpo Yam rhizome, 40-45 parts of microcrystalline cellulose, -4 parts of silicon dioxide, 7 parts of gelatin for capsules, 10 parts of anhydrous calcium hydrogen phosphate and 8 parts of a film coating premix.
A preparation process of a film-coated tablet containing animal medicine comprises the following steps:
the method comprises the following steps:
firstly, pre-treating medicinal materials, including impurity removal, burdening, sterilization and crushing;
step two, extraction, namely extracting and concentrating the medicinal materials processed in the step one;
step three, preparing the preparation, which comprises the following steps,
firstly, material picking, namely picking up raw materials and auxiliary materials which are qualified in inspection;
secondly, pulping, preparing gelatin cement, uniformly mixing 6.36 kg of gelatin with a proper amount of purified water, heating, continuously stirring until the gelatin is completely dissolved, filtering by using a 60-mesh screen, and preserving at constant temperature for later use;
thirdly, burdening, namely taking 1/2 lizard fine powder, extractum and the like with specified amount;
fourthly, adding 1/2 lizard powder, anhydrous calcium hydrophosphate and microcrystalline cellulose into the mixer, stirring for 5 minutes, wet-mixing the gelatin syrup and the extract for 5 minutes, and wet-mixing the two mixtures for 5 minutes to prepare a soft material;
fifthly, granulating, namely putting the mixed soft material into a granulator for granulation, wherein a 20-mesh nylon screen is arranged in the granulator;
sixthly, drying, namely putting the wet granules into a boiling granulator, setting the temperature to be 80 ℃, starting drying for 20 minutes,
seventhly, finishing the particles, namely mounting a stainless steel screen with the mesh number of 20 on a granulator for finishing the particles;
eighthly, total mixing, namely adding the particles and the silicon dioxide into a three-dimensional motion mixer for mixing, discharging and barreling after mixing for 20 minutes;
step nine, tabletting, namely putting the granules into a feeding hopper, starting to tablet, and screening fine powder out of the pressed tablets;
step four, manufacturing the film coating, comprising the following steps,
step one, taking a film coating premix as a film coating material, wherein the concentration is 14%;
secondly, during preparation, starting a stirrer to stir for 2 hours to uniformly disperse the pre-mixed coating material in water;
thirdly, adjusting the pressure of the spraying gas to be 0.4 MPa and the pressure of the thimble gas to be 0.2 MPa;
fourthly, weighing plain tablets, placing the plain tablets in a coating pot, preheating to 40 ℃, and then starting spraying liquid;
in the coating process, the coating liquid is continuously stirred to prevent the coating liquid from layering, and the rotating speed of a coating pan is adjusted to 6 revolutions per minute, the air inlet temperature is 70 ℃, and the air outlet temperature is 40 ℃;
fifthly, drying for 60 minutes after the coating liquid is sprayed, cooling, and controlling the drying temperature below 60 ℃.
Further, the first step is specifically that, the pretreatment of medicinal materials:
lizard: removing impurities, drying at below 60 deg.C for 8 hr;
1, Ningpo Yam rhizome: removing impurities, cleaning, moistening, slicing into thick slices, drying for 8 hours at the temperature of 60-80 ℃;
rhizoma drynariae (parched): removing impurities, cleaning, moistening, slicing, drying for 8 hours at the temperature of 60-80 ℃; parching in a parching machine;
step two, batching: the method comprises the following steps that a batching operator firstly checks whether a metering device is clean or not, checks whether a zero point is correct or not, and then weighs the Chinese medicinal clean medicinal materials according to the amount of a production prescription after checking that the zero point is correct, and in the weighing process, the weighing and rechecking are carried out;
step three, coarse crushing: pulverizing 1/2 lizards into fine powder;
fourthly, sterilizing and mixing: placing the coarse pulverized crude drug powder in a humid heat sterilization cabinet, sterilizing at 121 deg.C for 30 min, drying for 30 min, and mixing in a mixing tank for 10 min;
step five, crushing and sieving: mixing sterilized Eremiatis Argi coarse powder with anhydrous calcium hydrogen phosphate 12% of Eremiatis Argi coarse powder, pulverizing with liquid nitrogen low temperature pulverizer, sieving with 100 mesh sieve, packaging into clean plastic bag, and transferring into medicinal powder storage room for storage.
Further, the second step is specifically that, firstly, materials are collected, 1/2 lizards, rhizoma drynariae (stir-fried) and rhizoma dioscoreae nipponicae which need to be extracted are collected according to the traditional Chinese medicine extraction production instruction;
and secondly, extracting and concentrating, namely adding the approved materials into a multifunctional extraction tank for extraction for 3 times, adding 8 times of water for decocting for 2 hours each time, combining the three decoctions, introducing the three decoctions into a double-effect concentrator for concentration, setting the temperature of the double-effect concentrator to be 70-80 ℃, the steam pressure to be 0.01-0.1 MPa and the vacuum degree to be-0.04-0.06 MPa, concentrating the filtrate into thick paste with the relative density of 1.32-1.35 g/ml, filling the thick paste into a sealed clean container, transferring the thick paste into an extract storage room, and transferring the thick paste into a freezer for storage.
Further, weighing the tablets once in 15 minutes in the tabletting process of the third step, and measuring the weight difference once every 2 hours, wherein the weight difference is controlled within +/-4.5%.
The invention has the advantages that:
the traditional Chinese medicine is prepared by adopting a medicine for promoting blood circulation and removing blood stasis and a medicine for tonifying the kidney, and mainly comprises lizard, rhizoma drynariae (fried) and Ningpo yam rhizome. The auxiliary materials are microcrystalline cellulose, silicon dioxide, gelatin and anhydrous calcium hydrophosphate.
In the formula, Lizard (Lizard) is the whole body of Lizard belonging to the family scorpiodae. Catching in summer and autumn, kneading, threading with iron wire, and sun drying or oven drying. The snake is also called snake Jiujimu, which is also called snake seed and hop seed. Inhabit near wheat fields in dry sand, hillsides and plain areas. Is distributed in northeast, Gansu, West inner Mongolia, Hebei, Shandong, Shanxi, Shaanxi, Qinghai and other places of China. Soften hardness and dissipate nodulation, resolve phlegm and eliminate scrofula. Can be used for treating scrofula, subcutaneous nodule, and cough and asthma.
Drynaria rhizome (fried), tonifying kidney and strengthening bone, healing wound and relieving pain. Can be used for treating lumbago due to kidney deficiency, tinnitus, deafness, odontoseisis, traumatic injury, contusion, and fracture of bones and muscles; it is used externally to treat alopecia areata and vitiligo. It can be used for preventing and treating streptomycin toxicity and anaphylaxis, clavus, senile lumbago due to kidney deficiency, asthenia, tinnitus, deafness, traumatic injury, and toothache.
Ningpo Yam rhizome, rhizoma Dioscoreae Discoreae Nipponicae, Lumbricus, Os Draconis, Os gallus Domesticus, and rhizoma Dioscoreae Septemlobae. Liaoning, Jilin, Heilongjiang, Hebei, inner Mongolia, Shanxi, Shaanxi, staple productions. The medicine has the functions of dispelling wind and eliminating dampness, relaxing muscles and tendons, dredging meridian, promoting blood circulation to arrest pain, relieving cough and asthma. Can be used for treating rheumatism, paralysis, arthroncus, pain, numbness, traumatic injury, lumbar sprain, chest pain, cough, and asthma. The medicines are combined to play the effects of promoting qi and activating blood circulation, relieving swelling and pain and reuniting bones and muscles.
Compared with the traditional sugar-coated tablet, the traditional Chinese medicine film-coated tablet is beneficial to maintaining the quality and stability of the preparation. In the coating process, the coating pan is always in a negative pressure state, the environment is not polluted, dust is not easy to generate, and the production process is completely in a controllable state and meets the GMP (good manufacturing practice) requirement; the film-coated tablets have less ineffective components, relatively smaller volume and less tablet weight increase (the weight of the film-coated tablets is increased by only 2-4 percent, while the weight of the sugar-coated tablets can be increased by 50-100 percent), and the tablets are smooth; the patients who are not suitable for sugar and the patients who have diabetes are not restricted in taking the sugar-free health care wine, so that the application range of the patients is expanded; in addition, the film coating material is composed of high molecular compounds, is nontoxic and tasteless, and has no obvious adverse reaction case display after being taken by patients for a long time; meanwhile, compared with sugar coating, the film coating has the characteristics of short production period, no sugar, no talcum powder, material saving, light shielding, moisture prevention, wear resistance, taste masking, difficulty in generating mildew, spots and cracks, easiness in disintegration and the like, thereby greatly enhancing the bioavailability and dissolution of the medicine and the validity period of medicine preservation.
The patent adjusts the prescription and specification of a tablet containing animal drugs, solves the problem of crushing and sieving crude drug powder containing grease animals, and increases the mechanical property of the tablet. Compared with the original sugar-coated tablet, the prepared film-coated tablet has the advantages of simple preparation process, easy operation and easy mastering; the prepared medicine has stable property, ensures the curative effect of the medicine, is suitable for diabetics and has wider application.
Detailed Description
The following is further detailed by the specific embodiments:
the first embodiment is as follows:
the invention provides a film coated tablet containing animal medicine, which comprises 140kg of lizard, 95kg of fried rhizoma drynariae, 50kg of yam, 40kg of microcrystalline cellulose, 3kg of silicon dioxide, 6kg of gelatin for capsules, 9kg of anhydrous calcium hydrophosphate and 7kg of film coating premix.
The method comprises the following steps:
the first step, pretreatment, comprises the following steps,
firstly, pretreatment of medicinal materials:
lizard: removing impurities, drying at below 60 deg.C for 8 hr;
1, Ningpo Yam rhizome: removing impurities, cleaning, moistening, slicing into thick slices, drying for 8 hours at the temperature of 60-80 ℃;
rhizoma drynariae (parched): removing impurities, cleaning, moistening, slicing, drying at 60-80 deg.C for 8 hr. Parching in a parching machine;
step two, batching: the ingredient operator firstly checks whether the measuring instrument is clean or not, checks whether the zero point is correct or not, and after checking that the zero point is correct, the Chinese medicinal materials are weighed according to the amount of the production prescription. In the weighing process, carrying out weighing and rechecking;
step three, coarse crushing: pulverizing 1/2 lizards into fine powder;
fourthly, sterilizing and mixing: placing the coarse pulverized crude drug powder in a humid heat sterilization cabinet, sterilizing at 121 deg.C for 30 min, drying for 30 min, and mixing in a mixing tank for 10 min;
step five, crushing and sieving: uniformly mixing sterilized lizard coarse powder with anhydrous calcium hydrogen phosphate accounting for 12% of the lizard coarse powder, pulverizing with a liquid nitrogen low-temperature pulverizer, sieving with a 100-mesh sieve, packaging into a clean plastic bag, accurately weighing, tightening the bag opening, filling into a barrel card, transferring into a medicine powder storage room, and storing for one year;
step two, the extraction comprises the following steps,
firstly, collecting 1/2 lizards, rhizoma drynariae (stir-fried) and Ningpo yam rhizome to be extracted according to a traditional Chinese medicine extraction production instruction, and checking the name, batch number and quantity of the lizards and rhizoma drynariae to be extracted according to the instruction.
And secondly, extracting and concentrating, and operating according to the operating rules of an extraction post, a multifunctional extraction tank and a double-effect concentrator. Adding the approved materials into a multifunctional extraction tank according to instructions to extract for 3 times, adding 8 times of water for decocting for 2 hours each time (timing from boiling), merging decoction of three times, introducing into a double-effect concentrator to concentrate (temperature is 70-80 ℃, steam pressure is 0.01-0.1 MPa, vacuum degree is-0.04-0.06 MPa), concentrating filtrate to thick paste with relative density of 1.32-1.35 (55 ℃), filling into a sealed clean container, filling a containing list, transferring into an extract storage room, transferring into a freezer (2-10 ℃) to store, filling a counter and a goods space card, wherein the storage period of the extract is one year;
step three, preparing the preparation, which comprises the following steps,
firstly, material picking, namely, according to batch production instructions, a workshop material worker correctly fills a material acceptance sheet, the material acceptance sheet is rechecked by a workshop principal and a subordinate, and the signature and the confirmation are carried out, so that qualified raw materials and auxiliary materials are picked up from a material storehouse and delivered to a material matching operator for matching or moved into a workshop raw material and auxiliary material temporary storage room for temporary storage;
secondly, pulping, preparing gelatin cement, uniformly mixing 6.36 kg of gelatin with a proper amount of purified water, placing the mixture in an induction cooker, heating, continuously stirring, filtering by using a 60-mesh screen after the gelatin is completely dissolved, and preserving at constant temperature for later use;
thirdly, batching, namely taking 1/2 lizard fine powder, extractum and the like with specified amount according to a production instruction, and handling handover procedures when checking that the name, the code, the batch number, the quantity and the qualified state of the lizard meet the specifications;
fourthly, checking whether the mixer is clean, adding 1/2 lizard powder, anhydrous calcium hydrophosphate and microcrystalline cellulose after the air conditioner runs normally, stirring for 5 minutes, wet mixing gelatin slurry and the extract for 5 minutes, and wet mixing the two mixtures for 5 minutes to prepare a soft material;
and fifthly, granulating, checking whether the granulator is clean or not, and after the empty machine runs normally. Installing a 20-mesh nylon screen, putting the mixed soft material into a granulator, and starting granulation to collect wet particles in a clean container;
sixthly, drying, namely after checking whether the boiling granulator is clean or not, putting wet granules into the boiling granulator after the starting machine operates normally, setting the temperature to be 80 ℃, and starting drying; observing the boiling state and the blowing condition of the particles at any time to prevent the particles from sticking to the bottom of the pot to cause coking or gelatinization, wherein the drying time is 20 minutes,
seventhly, finishing granules, namely mounting a stainless steel screen with the mesh number of 20 on a granulator, and finishing the granules of the dry granules by the granulator after the start-up machine runs normally;
eighthly, total mixing, namely adding the particles and the silicon dioxide into a three-dimensional motion mixer for mixing, discharging and barreling after mixing for 20 minutes;
and ninthly, tabletting, namely selecting a proper punch die to be correctly installed on the tabletting machine, after the trial operation of the emptying machine is correct, putting the granules into a feeding hopper, starting to press a small amount of tablets according to a set weight difference range, and starting to tabletting after the appearance, hardness, weight difference and disintegration time limit are qualified, wherein the measured tablets are weighed once after 15 minutes in the tabletting process, the weight difference is measured once by QA on site every 2 hours, and the weight difference is controlled within +/-4.5%. Pressing out tablets, screening out fine powder, placing in a special barrel or bag, weighing, binding the bag opening, filling in a filling list, rechecking by a manager of the intermediate station, sending into the intermediate station, and storing properly;
step four, manufacturing the film coating, comprising the following steps,
step one, taking a film coating premix as a film coating material, wherein the concentration is 14%;
secondly, during preparation, starting a stirrer to stir for 2 hours to uniformly disperse the pre-mixed coating material in water;
thirdly, adjusting the pressure of the spraying gas to be 0.4 MPa and the pressure of the thimble gas to be 0.2 MPa;
fourthly, weighing plain tablets, placing the plain tablets in a coating pot, preheating to 40 ℃, and then starting spraying liquid;
the coating liquid is continuously stirred in the coating process to prevent the coating liquid from layering. Adjusting parameters such as the rotating speed of a coating pan of 6 revolutions per minute, the air inlet temperature of 70 ℃, the air outlet temperature of 40 ℃, the spraying pressure, the spraying flow and the like. The spraying speed is limited by the adhesion of the tablet surface, and particularly, the coating is not uniform due to the blockage of a nozzle;
and fifthly, after the coating liquid is sprayed, drying for 60 minutes (the drying temperature is controlled below 60 ℃) again, and then cooling.
The difference between the second embodiment and the first embodiment is only that: comprises 145kg of lizard, 98kg of rhizoma drynariae (fried), 54kg of Ningpo Yam rhizome, 42kg of microcrystalline cellulose, 3kg of silicon dioxide, 63kg of gelatin for capsules, 9.5kg of anhydrous calcium hydrophosphate and 7.5kg of film coating premix.
The difference between the third embodiment and the first embodiment is only that:
comprises 145kg of lizard, 98kg of rhizoma drynariae (fried), 54kg of Ningpo Yam rhizome, 42kg of microcrystalline cellulose, 3kg of silicon dioxide, 63kg of gelatin for capsules, 9.5kg of anhydrous calcium hydrophosphate and 7.5kg of film coating premix.
Study of film coating weight gain:
the dosage of the coating premix is determined by observing the appearance of the film-coated tablets with different weights and the hygroscopicity of different weight samples in a constant humidity chamber.
Taking 5 parts of plain tablets, preparing each 1000 tablets into a concentration of 14% by adopting gastric-soluble film premix, and researching coating weight increase, wherein the coating weight increase is 1%, 1.5%, 2%, 2.5% and 3%, respectively, and preparing into film-coated tablets.
And (3) taking 10 film-coated tablets (the appearance and the character meet the requirements), precisely weighing, placing in a constant humidity box with relative humidity RH75 +/-5% for 10 days, respectively taking out the tablets for precise weighing in 5 days and 10 days, and calculating the moisture absorption rate. The amount of film coating premix used in the screening study is shown in Table 5.
TABLE 5 film coating weight gain study test results
The result shows that when the film is coated, the weight is increased by 2.0-3.0%, the appearance of the coated tablet meets the requirement, the larger the weight of the coating is increased, the better the moisture absorption resistance of the film coated tablet is, and comprehensively considering, the weight of the coating is determined to be the weight increased by 3%, and the specification of the film coated tablet after the weight is increased by 3% is as follows: 0.53g (1+ 3%) -0.55 g.
For the film coating liquid, the concentration is too high, the spray gun is easy to block, and the plain piece is easy to stick to the pan; if the concentration of the film coating liquid is too low, the water content is high, the drying is slow, and the coating time is long. Therefore, the coating solution was prepared to a concentration of 14% using a film coating premix.
The foregoing is merely an example of the present invention, and common general knowledge in the field of known specific structures and characteristics is not described herein in any greater extent than that known in the art at the filing date or prior to the priority date of the application, so that those skilled in the art can now appreciate that all of the above-described techniques in this field and have the ability to apply routine experimentation before this date can be combined with one or more of the present teachings to complete and implement the present invention, and that certain typical known structures or known methods do not pose any impediments to the implementation of the present invention by those skilled in the art. It should be noted that, for those skilled in the art, without departing from the structure of the present invention, several changes and modifications can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicability of the patent. The scope of the claims of the present application shall be determined by the contents of the claims, and the description of the embodiments and the like in the specification shall be used to explain the contents of the claims.
Claims (8)
1. A film-coated tablet containing an animal drug characterized in that: the film coating premix comprises, by mass, 140-150 parts of lizard, 95-100 parts of fried rhizoma drynariae, 50-55 parts of Ningpo yam rhizome, 40-45 parts of microcrystalline cellulose, 3-4 parts of silicon dioxide, 6-7 parts of gelatin for capsules, 9-10 parts of anhydrous calcium hydrophosphate and 7-8 parts of a film coating premix.
2. A film-coated tablet containing an animal drug according to claim 1, wherein: the film coating premix comprises, by mass, 140 parts of lizard, 95 parts of fried rhizoma drynariae, 50 parts of Ningpo yam rhizome, 40 parts of microcrystalline cellulose, 3 parts of silicon dioxide, 6 parts of gelatin for capsules, 90 parts of anhydrous calcium hydrophosphate and 7 parts of a film coating premix.
3. A film-coated tablet containing an animal drug according to claim 1, wherein: the film coating premix comprises, by mass, 145 parts of lizard, 98 parts of fried rhizoma drynariae, 54 parts of Ningpo Yam rhizome, 42 parts of microcrystalline cellulose, 3 parts of silicon dioxide, 63 parts of gelatin for capsules, 9.5 parts of anhydrous calcium hydrophosphate and 7.5 parts of a film coating premix.
4. A film-coated tablet containing an animal drug according to claim 1, wherein: the film coating premix comprises, by mass, 150 parts of lizard, 100 parts of fried rhizoma drynariae, 55 parts of Ningpo Yam rhizome, 40-45 parts of microcrystalline cellulose, -4 parts of silicon dioxide, 7 parts of gelatin for capsules, 10 parts of anhydrous calcium hydrophosphate and 8 parts of a film coating premix.
5. A process for preparing a film-coated tablet containing an animal drug according to any one of claims 1 to 4, characterized in that: the method comprises the following steps:
firstly, pre-treating medicinal materials, including impurity removal, burdening, sterilization and crushing;
step two, extraction, namely extracting and concentrating the medicinal materials processed in the step one;
step three, preparing the preparation, which comprises the following steps,
firstly, material picking, namely picking up raw materials and auxiliary materials which are qualified in inspection;
secondly, pulping, preparing gelatin cement, uniformly mixing 6.36 kg of gelatin with a proper amount of purified water, heating, continuously stirring until the gelatin is completely dissolved, filtering by using a 60-mesh screen, and preserving at constant temperature for later use;
thirdly, burdening, namely taking 1/2 lizard fine powder, extractum and the like with specified amount;
fourthly, adding 1/2 lizard powder, anhydrous calcium hydrophosphate and microcrystalline cellulose into the mixer, stirring for 5 minutes, wet-mixing the gelatin syrup and the extract for 5 minutes, and wet-mixing the two mixtures for 5 minutes to prepare a soft material;
fifthly, granulating, namely putting the mixed soft material into a granulator for granulation, wherein a 20-mesh nylon screen is arranged in the granulator;
sixthly, drying, namely putting the wet granules into a boiling granulator, setting the temperature to be 80 ℃, starting drying for 20 minutes,
seventhly, finishing the particles, namely mounting a stainless steel screen with the mesh number of 20 on a granulator for finishing the particles;
eighthly, total mixing, namely adding the particles and the silicon dioxide into a three-dimensional motion mixer for mixing, discharging and barreling after mixing for 20 minutes;
step nine, tabletting, namely putting the granules into a feeding hopper, starting to tablet, and screening fine powder out of the pressed tablets;
step four, manufacturing the film coating, comprising the following steps,
step one, taking a film coating premix as a film coating material, wherein the concentration is 14%;
secondly, during preparation, starting a stirrer to stir for 2 hours to uniformly disperse the pre-mixed coating material in water;
thirdly, adjusting the pressure of the spraying gas to be 0.4 MPa and the pressure of the thimble gas to be 0.2 MPa;
fourthly, weighing plain tablets, placing the plain tablets in a coating pot, preheating to 40 ℃, and then starting spraying liquid;
in the coating process, the coating liquid is continuously stirred to prevent the coating liquid from layering, and the rotating speed of a coating pan is adjusted to 6 revolutions per minute, the air inlet temperature is 70 ℃, and the air outlet temperature is 40 ℃;
fifthly, drying for 60 minutes after the coating liquid is sprayed, cooling, and controlling the drying temperature below 60 ℃.
6. A process for preparing a film-coated tablet containing an animal drug according to claim 5, wherein:
the first step is specifically that the pretreatment of medicinal materials:
lizard: removing impurities, drying at below 60 deg.C for 8 hr;
1, Ningpo Yam rhizome: removing impurities, cleaning, moistening, slicing into thick slices, drying for 8 hours at the temperature of 60-80 ℃;
rhizoma drynariae (parched): removing impurities, cleaning, moistening, slicing, drying for 8 hours at the temperature of 60-80 ℃; parching in a parching machine;
step two, batching: the method comprises the following steps that a batching operator firstly checks whether a metering device is clean or not, checks whether a zero point is correct or not, and then weighs the Chinese medicinal clean medicinal materials according to the amount of a production prescription after checking that the zero point is correct, and in the weighing process, the weighing and rechecking are carried out;
step three, coarse crushing: pulverizing 1/2 lizards into fine powder;
fourthly, sterilizing and mixing: placing the coarse pulverized crude drug powder in a humid heat sterilization cabinet, sterilizing at 121 deg.C for 30 min, drying for 30 min, and mixing in a mixing tank for 10 min;
step five, crushing and sieving: mixing sterilized Eremiatis Argi coarse powder with anhydrous calcium hydrogen phosphate 12% of Eremiatis Argi coarse powder, pulverizing with liquid nitrogen low temperature pulverizer, sieving with 100 mesh sieve, packaging into clean plastic bag, and transferring into medicinal powder storage room for storage.
7. A process for preparing a film-coated tablet containing an animal drug according to claim 6, wherein:
the second step is specifically that, in the first step, materials are collected, 1/2 lizards, rhizoma drynariae (fried) and yam are collected according to the traditional Chinese medicine extraction production instruction;
and secondly, extracting and concentrating, namely adding the approved materials into a multifunctional extraction tank for extraction for 3 times, adding 8 times of water for decocting for 2 hours each time, combining the three decoctions, introducing the three decoctions into a double-effect concentrator for concentration, setting the temperature of the double-effect concentrator to be 70-80 ℃, the steam pressure to be 0.01-0.1 MPa and the vacuum degree to be-0.04-0.06 MPa, concentrating the filtrate into thick paste with the relative density of 1.32-1.35 g/ml, filling the thick paste into a sealed clean container, transferring the thick paste into an extract storage room, and transferring the thick paste into a freezer for storage.
8. A process for preparing a film-coated tablet containing an animal drug according to claim 7, wherein: weighing the tablets once in 15 minutes in the tabletting process of the third step, and measuring the weight difference once every 2 hours, wherein the weight difference is controlled within +/-4.5 percent.
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