CN111000816A - Hoof nail polypeptide tablet and preparation process thereof - Google Patents
Hoof nail polypeptide tablet and preparation process thereof Download PDFInfo
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- CN111000816A CN111000816A CN201911398377.6A CN201911398377A CN111000816A CN 111000816 A CN111000816 A CN 111000816A CN 201911398377 A CN201911398377 A CN 201911398377A CN 111000816 A CN111000816 A CN 111000816A
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 36
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 9
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Images
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K38/02—Peptides of undefined number of amino acids; Derivatives thereof
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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
- A61K9/2009—Inorganic compounds
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- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
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- 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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A—HUMAN NECESSITIES
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Abstract
The invention discloses hoof nail polypeptide tablets and a preparation process thereof, the hoof nail polypeptide tablets are prepared from 35-40 parts of hoof nail polypeptide, 5-10 parts of corn starch, 15-20 parts of cane sugar, 5-10 parts of sodium carboxymethyl starch, 0.2-0.4 part of magnesium stearate, 0.5-0.8 part of silicon dioxide, 8-12 parts of ethanol (60%) and 20-25 parts of ethanol (80%), and the preparation process comprises the following steps of firstly, removing external packages from the hoof nail polypeptide raw materials; step two, material preparation, step three, crushing, step four, and material preparation; step five, granulating, step six, drying and the like, so that the problems that the effect of hoof nail polypeptide is influenced to a certain extent by uneven medicine mixing, high loss rate, inaccurate purification and the like in the existing pill or decoction preparation method are solved.
Description
Technical Field
The invention relates to the field of medicine processing, in particular to hoof nail polypeptide tablets and a preparation process thereof.
Background
The hoof nail of pig (Susscrofolistica Brisson) is called pig hoof nail for short, also called pig hoof suspension, pig zygote, etc. The pig nail is a traditional Chinese medicinal material, has mild salty and non-toxic taste, enters Yangming channel and has certain medicinal value. The record of hoof nail as medicine is recorded in Shennong Ben Cao Jing (Shennong's herbal Jing), the record of hoof nail suspension in Ben Cao gang mu (Ben Cao gang mu), the indication of five hemorrhoids with heat in abdomen and intestinal abscess with no toxicity, salty taste and no toxicity. The record of burning and smoking the rosewood to develop all malignant sore qi is provided.
Modern traditional Chinese medicine pharmacological research shows that the ungula Sus Domestica mainly contains chemical components such as keratin, peptides, amino acids, esters, saccharides, steroid compounds and inorganic salts, wherein the polypeptide components have obvious hemostatic pharmacological activity. Research shows that the extracts of the pig nail and the pangolin have similar components and similar content, which provides a basis for the pig nail to replace the pangolin for medical use, so the pig nail has wide application in the field of traditional Chinese medicine.
At present, hoof nail polypeptides are mostly used in other medicines, or are directly used to be matched with other medicines for treating diseases, a precedent that hoof nail polypeptides are used for preparing tablets is not provided, the existing method for treating diseases by using hoof nail polypeptides cannot play a better role of hoof nail polypeptides, and the existing method for preparing pills or decoction has the defects of uneven medicine mixing, high loss rate, inaccurate purification and the like, which influence the role of hoof nail polypeptides to a certain extent.
Disclosure of Invention
The invention aims to provide hoof nail polypeptide tablets and a preparation process thereof, so as to solve the problems.
The invention provides hoof nail polypeptide tablets, which are prepared from 35-40 parts of hoof nail polypeptide, 5-10 parts of corn starch, 15-20 parts of cane sugar, 5-10 parts of sodium carboxymethyl starch, 0.2-0.4 part of magnesium stearate, 0.5-0.8 part of silicon dioxide, 8-12 parts of ethanol (60%) and 20-25 parts of ethanol (80%), wherein 2.5-4.5 parts of medicinal film coating premix is added during coating preparation.
The invention provides a process for preparing hoof nail polypeptide tablets, which comprises the following steps,
removing an outer package of a hoof nail polypeptide raw material;
step two, preparing materials, namely preparing 35-40 parts of hoof nail polypeptide, 5-10 parts of corn starch, 15-20 parts of cane sugar, 5-10 parts of sodium carboxymethyl starch, 0.2-0.4 part of magnesium stearate, 0.5-0.8 part of silicon dioxide, 8-12 parts of ethanol (60%) and 20-25 parts of ethanol (80%), and adding three quarters of water into 95% ethanol (60%) and ethanol (80%) for dilution;
crushing, namely crushing the prepared sucrose and hoof nail polypeptide raw materials by using a crusher, wherein the crushing amount and the crushing time of the crusher are 168-800 kg/h;
step four, batching, namely weighing the materials by using an electronic platform scale, performing different preparations on the materials required during granulation and the materials required during total mixing, using corn starch, sucrose powder, carboxymethyl starch sodium, hoof nail polypeptide powder and ethanol for the preparation of granulation, and using the carboxymethyl starch sodium, magnesium stearate and silicon dioxide for the preparation of total mixing;
step five, granulating, namely putting corn starch, sucrose powder, sodium carboxymethyl starch and hoof nail polypeptide powder into a mixer, mixing for 10 minutes, adding diluted ethanol (60%), mixing for 10 minutes, making into a soft material which is held by a hand to be agglomerated and dispersed by light pressure, transferring the prepared soft material to a granulator by using a clean stainless steel barrel, making wet granules by using a screen with 16 meshes, and containing the prepared wet granules by using a clean stainless steel tank car;
drying, namely feeding the prepared wet particles into a dryer through a feeder, wherein the drying temperature is 70-80 ℃, the drying time is 60-80 minutes, and after drying is finished, collecting the particles by using a clean stainless steel barrel;
step seven, finishing, namely properly finishing the dried granules by using a granulator to disperse the agglomerated and adhered granules, and finishing the granules by using a sieve with 14 meshes to obtain granules with uniform size;
step eight, total mixing, namely putting the granules prepared in the step seven and the prepared carboxymethyl starch sodium, magnesium stearate and silicon dioxide in the step four into a mixer, mixing for 40 minutes, and filling the total mixed hoof nail polypeptide tablet granules into a medical low-density polyethylene bag after mixing;
step nine, transferring the particles, and transferring the particles to an intermediate station for storage;
step ten, tabletting, namely adding hoof nail polypeptide tablet particles into a tabletting machine, tabletting by using the tabletting machine, and sampling 10 tablets every 30 minutes for inspection;
step eleven, coating, namely mixing diluted ethanol (80%) and medicinal film coating premix powder to prepare a coating solution, putting the coating solution into a film coating spray gun, putting the pressed hoof nail polypeptide tablets into a coating machine, setting machine parameters, coating the hoof nail polypeptide tablets, drying after the treatment is finished, wherein the drying time is 8-15 hours, and putting the dried hoof nail polypeptide tablets into a medicine barrel sleeved with a medicinal low-density polyethylene bag;
and step twelve, packaging, namely packaging the hoof nail polypeptide tablets after coating.
Preferably, the composition is prepared from 35 parts of hoof nail polypeptide, 5 parts of corn starch, 15 parts of sucrose, 5 parts of sodium starch glycolate, 0.2 part of magnesium stearate, 0.5 part of silicon dioxide, 8 parts of ethanol (60%) and 20 parts of ethanol (80%), wherein 2.5 parts of medicinal film coating premix is added during coating preparation.
Preferably, the composition is prepared from 40 parts of hoof nail polypeptide, 10 parts of corn starch, 20 parts of sucrose, 10 parts of sodium starch glycolate, 0.4 part of magnesium stearate, 0.8 part of silicon dioxide, 12 parts of ethanol (60%) and 25 parts of ethanol (80%), wherein 4.5 parts of medicinal film coating premix is added during coating preparation.
Preferably, the pulverizer is a universal pulverizer with the model of WF-40B; the mixer for granulating is a groove mixer with the model of CH-200; the granulator is a swing granulator with the model of YK-160A; the dryer is a boiling dryer with the model number of FG-300; the tablet press is a rotary tablet press, and the model is ZPW-21B; the mixer used for the total mixing is a double cone mixer with the model number of SH 1500; the model of the coating machine is BG-150D.
Preferably, in the step twelve, the packaging comprises inner packaging and outer packaging, wherein the inner packaging is carried out by using aluminum plastic, and the inner packaging is carried out by using a multifunctional automatic aluminum plastic packaging machine with the model of DPB-250F; the extranal packing is packed with the packing carton to use the shrink film to seal the membrane to a plurality of packing carton, the extranal packing uses far infrared heat shrink packagine machine when packing.
Preferably, in the fourth step of batching, when the weighed material is less than 5.0kg, weighing by using an electronic platform scale with the specification of 5.0 kg; when the material to be weighed is greater than or equal to 5.0kg, the material is weighed by using an electronic platform scale with the specification of 50.0 kg.
Preferably, the screens in step five and step seven are stainless steel screens.
Preferably, the coating solution is prepared in the first step, and diluted ethanol (80%) is poured into a solution preparation container; secondly, stretching the stirrer into 2/3 below the liquid level, starting the stirrer, wherein the stirring speed is required to ensure that the liquid in the container is completely stirred, and the liquid level is just formed into a vortex; thirdly, continuously scattering the medicinal film coating premix powder on the liquid level of the vortex at a stable speed, wherein the adding speed is that the powder is rapidly stirred into the vortex, and the feeding process is finished within 5-10 minutes; and fourthly, after the feeding is finished, slowing down the stirring speed to enable the vortex of the liquid level to just disappear, and continuously stirring for 45 minutes until the medicinal film coating premix powder is completely dissolved.
Preferably, in the eleventh step, the parameters of the coating machine are set as follows, wherein the temperature of the slice bed is as follows: 40 +/-2 ℃; air inlet temperature: 75-80 ℃; rotating speed of the pot body: 2-7 revolutions per minute; atomization pressure: 3.5kg/cm 2; air intake: 3000m 2/h; flow rate of coating liquid: 180-260 ml/min.
The invention has the following effects:
1. the dosage is accurate, and the content difference of the medicine in the tablet is small. Because the tablet is a medicinal preparation obtained by uniformly mixing the raw material medicaments and the auxiliary materials, compared with the traditional pill, the medicine is more uniformly mixed. Therefore, the blood concentration of the patient is relatively more stable, and various adverse reactions caused by unstable blood concentration are avoided.
2. The quality is stable, the tablets are dry solids, and certain hoof nail polypeptide tablets which are easy to oxidize and deteriorate and easy to deliquesce can be protected by coatings, and the influence of light, air, moisture and the like on the hoof nail polypeptide tablets is small. And the influence on the curative effect of the medicine caused by the pollution of the medicine due to the contact with other external substances like pills or decoction is avoided.
3. The hoof nail polypeptide tablet can excite uterus, increase frequency and amplitude of uterine contraction, excite uterine muscle rhythmically to affect intimal blood vessel, make blood vessel show biphasic change of expansion and contraction, thereby improving endometrial blood flow disorder of 'functional blood', and can regulate endocrine, promote glucocorticoid secretion of adrenal fascial band, inhibit fibrinolysis, reduce vascular permeability, stabilize lysosome membrane, etc., thereby improving or inhibiting bleeding during 'functional blood'.
4. Compared with the prior art, the invention solves the problems that the effect of hoof nail polypeptide is influenced to a certain extent by the existing pill or decoction preparation, uneven medicine mixing, high loss rate, inaccurate purification and the like.
Drawings
Fig. 1 is a flow chart of a hoof nail polypeptide tablet preparation process according to an embodiment of the invention.
Detailed Description
The following is further detailed by the specific embodiments:
the technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The first embodiment is as follows:
the invention provides hoof nail polypeptide tablets and a preparation process thereof, the hoof nail polypeptide tablets are prepared from 35 parts of hoof nail polypeptide, 5 parts of corn starch, 15 parts of cane sugar, 5 parts of sodium carboxymethyl starch, 0.2 part of magnesium stearate, 0.5 part of silicon dioxide, 8 parts of ethanol (60%) and 20 parts of ethanol (80%), wherein 2.5 parts of medicinal film coating premix is added during coating preparation.
The preparation process of hoof nail polypeptide tablets is shown in figure 1:
removing an outer package of a hoof nail polypeptide raw material;
step two, preparing materials, namely preparing 35-40 parts of hoof nail polypeptide, 5-10 parts of corn starch, 15-20 parts of cane sugar, 5-10 parts of sodium carboxymethyl starch, 0.2-0.4 part of magnesium stearate, 0.5-0.8 part of silicon dioxide, 8-12 parts of ethanol (60%) and 20-25 parts of ethanol (80%), and adding three quarters of water into 95% ethanol (60%) and ethanol (80%) for dilution;
crushing, namely crushing the prepared sucrose and hoof nail polypeptide raw materials by using a crusher, wherein the crushing amount and the crushing time of the crusher are 168-800 kg/h;
step four, batching, namely weighing the materials by using an electronic platform scale, performing different preparations on the materials required during granulation and the materials required during total mixing, using corn starch, sucrose powder, carboxymethyl starch sodium, hoof nail polypeptide powder and ethanol for the preparation of granulation, and using the carboxymethyl starch sodium, magnesium stearate and silicon dioxide for the preparation of total mixing; when the weighed material is less than 5.0kg, weighing by using an electronic platform scale with the specification of 5.0 kg; when the material to be weighed is greater than or equal to 5.0kg, the material is weighed by using an electronic platform scale with the specification of 50.0 kg.
Step five, granulating, namely putting corn starch, sucrose powder, sodium carboxymethyl starch and hoof nail polypeptide powder into a mixer, mixing for 10 minutes, adding diluted ethanol (60%), mixing for 10 minutes, making into a soft material which is held by a hand to be agglomerated and dispersed by light pressure, transferring the prepared soft material to a granulator by using a clean stainless steel barrel, making wet granules by using a stainless steel screen with 16 meshes, and filling the prepared wet granules by using a clean stainless steel tank car;
drying, namely feeding the prepared wet particles into a dryer through a feeder, wherein the drying temperature is 70-80 ℃, the drying time is 60-80 minutes, and after drying is finished, collecting the particles by using a clean stainless steel barrel;
step seven, finishing, namely properly finishing the dried granules by using a granulator to disperse the agglomerated and adhered granules, and finishing the granules by using a stainless steel screen with the mesh number of 14 to obtain granules with uniform size;
step eight, total mixing, namely putting the granules prepared in the step seven and the prepared carboxymethyl starch sodium, magnesium stearate and silicon dioxide in the step four into a mixer, mixing for 40 minutes, and filling the total mixed hoof nail polypeptide tablet granules into a medical low-density polyethylene bag after mixing;
step nine, transferring the particles, and transferring the particles to an intermediate station for storage;
step ten, tabletting, wherein the weight of the tablets is calculated according to the percentage content of hoof nail polypeptide tablets, and the calculation formula is as follows: actual tablet weight (g) is 13.0% of theoretical content per tablet x 0.3 g/tablet divided by the content of intermediate product particles, the tablet press is installed, and the tablet weight control range is as follows: the upper limit is marked weight multiplied by 104.5%; the lower limit is marked tablet weight x 95.5%, hoof nail polypeptide tablet particles are added into a tablet press, the tablet press is used for tabletting, and 10 tablets are sampled every 30 minutes for inspection;
step eleven, coating, namely preparing a coating solution, namely pouring diluted ethanol (80%) into a solution preparation container; secondly, stretching the stirrer into 2/3 below the liquid level, starting the stirrer, wherein the stirring speed is required to ensure that the liquid in the container is completely stirred, and the liquid level is just formed into a vortex; thirdly, continuously scattering the medicinal film coating premix powder on the liquid level of the vortex at a stable speed, wherein the adding speed is that the powder is rapidly stirred into the vortex, and the feeding process is finished within 5-10 minutes; and fourthly, after the feeding is finished, slowing down the stirring speed to enable the vortex of the liquid level to just disappear, and continuously stirring for 45 minutes until the medicinal film coating premix powder is completely dissolved.
Installing a peristaltic pump of a coating machine and a film coating spray gun, weighing a proper amount of plain tablets from a plain tablet container according to the weight range (100kg +/-20 kg) of a single-pot base tablet, wherein the weight of each pot of plain tablets is kept consistent, directly transferring the hoof nail polypeptide plain tablets weighed by the weight into a coating pot through a charging hole, and setting parameters of the coating machine as the temperature of a tablet bed: 40 +/-2 ℃; air inlet temperature: 75-80 ℃; rotating speed of the pot body: 2-7 revolutions per minute; atomization pressure: 3.5kg/cm 2; air intake: 3000m 2/h; flow rate of coating liquid: 180-260 ml/min, carrying out film preheating and edge grinding, adjusting the rotating speed parameter of the pot body to be 3-5 revolutions/min, starting the coating pot, introducing hot air into the coating pot, preheating the tablet bed, simultaneously carrying out edge grinding treatment on plain tablets in the pot through uniform-speed rotation of the coating pot, and carrying out spraying operation after the temperature in the pot meets the requirement and the edge grinding of the film meets the requirement.
After the bottom sheet is uniformly coated with a layer of film coating, the rotating speed of the coating pan and the spraying speed of the peristaltic pump are gradually increased according to the flowing state of the sheet in the pan, and finally the pan speed is generally increased to 6-7 revolutions per minute, and the spraying speed is about 180-260 ml per minute.
During spraying, the appearance of the tablets should be observed at any time, when the coating liquid is sprayed, the peristaltic pump is closed, the spraying is stopped, the steam valve is closed, the rotating speed of the coating pan is reduced, and the tablets are taken out of the pan after being dried in the pan for 30 minutes by cold air.
The coated tablets are transported to a drying room for drying for more than eight hours (pollution and cross contamination are prevented during drying).
The dried tablets were transferred to a pill bucket which had been weighed beforehand and lined with a pharmaceutical low density polyethylene bag.
Step twelve, packaging, namely packaging the hoof nail polypeptide sheets subjected to coating, wherein the packaging comprises an inner package and an outer package, the inner package is subjected to inner packaging by using aluminum plastic, and the inner package is subjected to inner packaging by using a multifunctional automatic aluminum plastic packaging machine, and is DPB-250F; the extranal packing is packed with the packing carton to use the shrink film to seal the membrane to a plurality of packing carton, the extranal packing uses far infrared heat shrink packagine machine when packing.
Wherein the pulverizer is a universal pulverizer with the model of WF-40B; the mixer for granulating is a groove mixer with the model of CH-200; the granulator is a swing granulator with model number YK-160A; the drier is a boiling drier with model number of FG-300; the tablet press is a rotary tablet press, and the model is ZPW-21B; the mixer used for the total mixing is a double cone mixer with the model number of SH 1500; the model of the coating machine is BG-150D.
Example two differs from example one only in that hoof nail polypeptide tablets were made from 40 parts hoof nail polypeptide, 10 parts corn starch, 20 parts sucrose, 10 parts sodium starch glycolate, 0.4 parts magnesium stearate, 0.8 parts silicon dioxide, 12 parts ethanol (60%) and 25 parts ethanol (80%), with 4.5 parts of a pharmaceutical film coating premix added at the time of making the coating.
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 (10)
1. A hoof nail polypeptide tablet, which is characterized in that: is prepared from 35-40 parts of hoof nail polypeptide, 5-10 parts of corn starch, 15-20 parts of cane sugar, 5-10 parts of sodium carboxymethyl starch, 0.2-0.4 part of magnesium stearate, 0.5-0.8 part of silicon dioxide, 8-12 parts of ethanol (60%) and 20-25 parts of ethanol (80%), wherein 2.5-4.5 parts of medicinal film coating premix is added during coating.
2. A hoof nail polypeptide tablet preparation technology is characterized in that: comprises the following steps of (a) carrying out,
removing an outer package of a hoof nail polypeptide raw material;
step two, preparing materials, namely preparing 35-40 parts of hoof nail polypeptide, 5-10 parts of corn starch, 15-20 parts of cane sugar, 5-10 parts of sodium carboxymethyl starch, 0.2-0.4 part of magnesium stearate, 0.5-0.8 part of silicon dioxide, 8-12 parts of ethanol (60%) and 20-25 parts of ethanol (80%), and adding three quarters of water into 95% ethanol (60%) and ethanol (80%) for dilution;
crushing, namely crushing the prepared sucrose and hoof nail polypeptide raw materials by using a crusher, wherein the crushing amount and the crushing time of the crusher are 168-800 kg/h;
step four, batching, namely weighing the materials by using an electronic platform scale, performing different preparations on the materials required during granulation and the materials required during total mixing, using corn starch, sucrose powder, carboxymethyl starch sodium, hoof nail polypeptide powder and ethanol for the preparation of granulation, and using the carboxymethyl starch sodium, magnesium stearate and silicon dioxide for the preparation of total mixing;
step five, granulating, namely putting corn starch, sucrose powder, sodium carboxymethyl starch and hoof nail polypeptide powder into a mixer, mixing for 10 minutes, adding diluted ethanol (60%), mixing for 10 minutes, making into a soft material which is held by a hand to be agglomerated and dispersed by light pressure, transferring the prepared soft material to a granulator by using a clean stainless steel barrel, making wet granules by using a screen with 16 meshes, and containing the prepared wet granules by using a clean stainless steel tank car;
drying, namely feeding the prepared wet particles into a dryer through a feeder, wherein the drying temperature is 70-80 ℃, the drying time is 60-80 minutes, and after drying is finished, collecting the particles by using a clean stainless steel barrel;
step seven, finishing, namely properly finishing the dried granules by using a granulator to disperse the agglomerated and adhered granules, and finishing the granules by using a sieve with 14 meshes to obtain granules with uniform size;
step eight, total mixing, namely putting the granules prepared in the step seven and the prepared carboxymethyl starch sodium, magnesium stearate and silicon dioxide in the step four into a mixer, mixing for 40 minutes, and filling the total mixed hoof nail polypeptide tablet granules into a medical low-density polyethylene bag after mixing;
step nine, transferring the particles, and transferring the particles to an intermediate station for storage;
step ten, tabletting, namely adding hoof nail polypeptide tablet particles into a tabletting machine, tabletting by using the tabletting machine, and sampling 10 tablets every 30 minutes for inspection;
step eleven, coating, namely mixing diluted ethanol (80%) and medicinal film coating premix powder to prepare a coating solution, putting the coating solution into a film coating spray gun, putting the pressed hoof nail polypeptide tablets into a coating machine, setting machine parameters, coating the hoof nail polypeptide tablets, drying after the treatment is finished, wherein the drying time is 8-15 hours, and putting the dried hoof nail polypeptide tablets into a medicine barrel sleeved with a medicinal low-density polyethylene bag;
and step twelve, packaging, namely packaging the hoof nail polypeptide tablets after coating.
3. The hoof nail polypeptide tablet of claim 1, wherein: is prepared from 35 parts of hoof nail polypeptide, 5 parts of corn starch, 15 parts of cane sugar, 5 parts of sodium starch glycolate, 0.2 part of magnesium stearate, 0.5 part of silicon dioxide, 8 parts of ethanol (60%) and 20 parts of ethanol (80%), wherein 2.5 parts of medicinal film coating premix is added during coating preparation.
4. The hoof nail polypeptide tablet of claim 1, wherein: is prepared from 40 parts of hoof nail polypeptide, 10 parts of corn starch, 20 parts of cane sugar, 10 parts of sodium starch glycolate, 0.4 part of magnesium stearate, 0.8 part of silicon dioxide, 12 parts of ethanol (60%) and 25 parts of ethanol (80%), wherein 4.5 parts of medicinal film coating premix is added during coating preparation.
5. The process for preparing hoof nail polypeptide tablets of claim 2, wherein: the pulverizer is a universal pulverizer, and the model of the pulverizer is WF-40B; the mixer for granulating is a groove mixer with the model of CH-200; the granulator is a swing granulator with the model of YK-160A; the dryer is a boiling dryer with the model number of FG-300; the tablet press is a rotary tablet press, and the model is ZPW-21B; the mixer used for the total mixing is a double cone mixer with the model number of SH 1500; the model of the coating machine is BG-150D.
6. The process for preparing hoof nail polypeptide tablets of claim 2, wherein: step twelve, packaging comprises inner packaging and outer packaging, wherein the inner packaging is carried out by using aluminum plastic, and the inner packaging is carried out by using a multifunctional automatic aluminum plastic packaging machine with the model of DPB-250F; the extranal packing is packed with the packing carton to use the shrink film to seal the membrane to a plurality of packing carton, the extranal packing uses far infrared heat shrink packagine machine when packing.
7. The process for preparing hoof nail polypeptide tablets of claim 2, wherein: in the step four, when the weighed material is less than 5.0kg, weighing by using an electronic platform scale with the specification of 5.0 kg; when the material to be weighed is greater than or equal to 5.0kg, the material is weighed by using an electronic platform scale with the specification of 50.0 kg.
8. The process for preparing hoof nail polypeptide tablets of claim 2, wherein: and the screen in the fifth step and the screen in the seventh step are both stainless steel screens.
9. The process for preparing hoof nail polypeptide tablets of claim 2, wherein: step eleven, coating solution preparation is carried out, specifically, in the first step, diluted ethanol (80%) is poured into a solution preparation container; secondly, stretching the stirrer into 2/3 below the liquid level, starting the stirrer, wherein the stirring speed is required to ensure that the liquid in the container is completely stirred, and the liquid level is just formed into a vortex; thirdly, continuously scattering the medicinal film coating premix powder on the liquid level of the vortex at a stable speed, wherein the adding speed is that the powder is rapidly stirred into the vortex, and the feeding process is finished within 5-10 minutes; and fourthly, after the feeding is finished, slowing down the stirring speed to enable the vortex of the liquid level to just disappear, and continuously stirring for 45 minutes until the medicinal film coating premix powder is completely dissolved.
10. The process for preparing hoof nail polypeptide tablets of claim 2, wherein: in the eleventh step, the parameters of the coating machine are set as follows, and the temperature of a slice bed is set as follows: 40 +/-2 ℃; air inlet temperature: 75-80 ℃; rotating speed of the pot body: 2-7 revolutions per minute; atomization pressure: 3.5kg/cm 2; air intake: 3000m 2/h; flow rate of coating liquid: 180-260 ml/min.
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| CN201911398377.6A CN111000816A (en) | 2019-12-30 | 2019-12-30 | Hoof nail polypeptide tablet and preparation process thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN301175786S (en) * | 2009-07-10 | 2010-04-21 | 山东鲁北药业有限公司 | Packing box (hoof nail peptide tablets) |
| CN102018726A (en) * | 2009-09-18 | 2011-04-20 | 广州加原医药科技有限公司 | Method for preparing animal hoof nail extract |
| CN108504711A (en) * | 2018-04-08 | 2018-09-07 | 山东鲁北药业有限公司 | The preparation method of hoof nail polypeptide |
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2019
- 2019-12-30 CN CN201911398377.6A patent/CN111000816A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN301175786S (en) * | 2009-07-10 | 2010-04-21 | 山东鲁北药业有限公司 | Packing box (hoof nail peptide tablets) |
| CN102018726A (en) * | 2009-09-18 | 2011-04-20 | 广州加原医药科技有限公司 | Method for preparing animal hoof nail extract |
| CN108504711A (en) * | 2018-04-08 | 2018-09-07 | 山东鲁北药业有限公司 | The preparation method of hoof nail polypeptide |
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