CN111000819A - Fukean film-coated tablet and preparation process thereof - Google Patents

Fukean film-coated tablet and preparation process thereof Download PDF

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Publication number
CN111000819A
CN111000819A CN202010011196.XA CN202010011196A CN111000819A CN 111000819 A CN111000819 A CN 111000819A CN 202010011196 A CN202010011196 A CN 202010011196A CN 111000819 A CN111000819 A CN 111000819A
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parts
film
tablet
coating
fukean
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张�浩
罗运樟
李霞
黄灿林
于海翠
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Yili Pharmaceutical Co Ltd
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Yili Pharmaceutical Co Ltd
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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
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
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    • A61K9/2004—Excipients; Inactive ingredients
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61K9/2893—Tablet coating processes
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Abstract

The invention belongs to the technical field of medicine coating, and particularly relates to a Fukean film-coated tablet and a preparation process thereof, wherein the Fukean film-coated tablet consists of a tablet core and a film coating layer, and the tablet core comprises the following preparation raw materials: jasminum Amplexicaule, herb Polygoni chinensis, cortex Ilicis Rotundae, herba plantaginis, pericarpium Granati, corn starch, sugar powder and magnesium stearate; the film coating layer comprises the following preparation raw materials: mannitol, acetyl triethyl citrate, titanium dioxide, wheat gluten, polysorbate-80 and propylene glycol. The Fukean film-coated tablet has the characteristics of high yield, good stability and low water absorption rate, and is suitable for industrial mass production.

Description

Fukean film-coated tablet and preparation process thereof
Technical Field
The invention belongs to the technical field of medicine coating, and particularly relates to a Fukean film-coated tablet and a preparation process thereof.
Background
Fukean tablet has effects of clearing heat, promoting diuresis, astringing and relieving pain, and can be used for treating acute gastroenteritis, and abdominal pain, diarrhea and emesis caused by dyspepsia. The traditional Fukean sugar-coated tablet has long coating operation time, considerable water in syrup permeates a tablet core to influence the quality of the medicine, a large amount of talcum powder is used during coating of the Fukean sugar-coated tablet to cause the defects of powder flying, poor operation environment and the like, and the defects can be overcome by using a film coating.
The traditional Chinese patent medicine tablets are coated by sugar coating, not only have the defects of easy moisture absorption, fading, cracking and the like, but also have the weight increased by 70 percent and high water absorption rate after the sugar coating is carried out on one tablet. In addition, the sugar powder and talcum powder contained in the sugar coating are not beneficial to the middle-aged and the elderly and diabetes. Meanwhile, the results of experimental production of film coating are greatly different from those of actual production because the specifications of experimental production are mostly thousands or tens of thousands of tablets, and the specifications of actual production are over a million tablets, the increase of production capacity causes that equipment needs higher pressure, concentration needs more cycle times or more production time to achieve the results of experimental production, and the increase of the conditions causes the cost increase and the production efficiency reduction of enterprises, thereby causing the burden of the enterprises. Therefore, on the basis of the prior art, the research and development of the high-efficiency and low-water absorption scale-available Fukean film-coated tablet has important significance.
Disclosure of Invention
The invention discloses a Fukean film-coated tablet, which not only has the performance of the conventional film-coated tablet, but also has the characteristics of high yield, good stability and low water absorption rate, and is also suitable for industrial mass production.
In order to achieve the purpose, the invention adopts the following technical scheme:
a Fukean film-coated tablet consists of a tablet core and a film coating layer, wherein the tablet core comprises the following preparation raw materials in parts by weight: 1000-3000 parts of Jasminum Amplexicaule, 1000-3000 parts of Chinese knotweed herb, 670-800 parts of ovate leaf holly bark, 330-600 parts of plantain herb, 330-600 parts of pomegranate bark, 28.7-50.3 parts of corn starch, 61-125 parts of powdered sugar and 3.3-6.5 parts of magnesium stearate; the film coating layer comprises the following preparation raw materials in parts by weight: 6.45-12.9 parts of mannitol, 1.93-5.03 parts of acetyl triethyl citrate, 2.55-5.10 parts of titanium dioxide, 0.77-1.54 parts of wheat gluten, 0.51-1.03 parts of polysorbate-800.51 and 0.51-1.03 parts of propylene glycol.
Preferably, the tablet core comprises the following preparation raw materials in parts by weight: 1000 parts of Jasminum Amplexicaule, 1000 parts of Chinese knotweed herb, 670 parts of ovate leaf holly bark, 330 parts of plantain herb and 330 parts of pomegranate bark; 28.7 parts of corn starch, 61 parts of powdered sugar and 3.3 parts of magnesium stearate; the film coating layer comprises the following preparation raw materials in parts by weight: 6.45 parts of hydroxypropyl methylcellulose, 1.93 parts of acetyl triethyl citrate, 2.55 parts of titanium dioxide, 0.77 part of wheat gluten, 800.51 parts of polysorbate and 0.51 part of propylene glycol.
Preferably, the preparation process of the tablet core comprises the following steps:
(1) weighing the medicinal materials, adding water for decocting, adding 6 times of drinking water, decocting for 2 hours, filtering to collect supernatant, adding 4 times of drinking water into filter residue, decocting for 2 hours for the second time, filtering the 2 times of extractive liquid medicines respectively through 80 mesh sieves, pumping into a liquid medicine temporary storage tank, mixing to obtain liquid medicine A, and standing at room temperature;
(2) pumping the liquid medicine A in the liquid medicine tank into a double-effect vacuum concentrator, heating and concentrating, measuring the specific gravity by a specific gravity meter at any time, concentrating to obtain clear paste with the relative density of 1.18-1.20, and collecting the paste;
(3) adding high-concentration ethanol into the clear paste, stirring for 15min to enable the ethanol content to reach 65%, standing for 24 hours, pumping supernatant into a liquid medicine storage tank, washing residues with 65% ethanol for one time, standing for 12 hours, filtering, combining secondary filtrate, recovering ethanol, pumping into a spherical concentration tank for concentration, concentrating into thick paste with the relative density of 1.30-1.40, drying at low temperature, and crushing;
(4) adding corn starch and sugar powder, granulating, drying, grading, adding magnesium stearate, mixing, and tabletting to obtain tablet core.
Further, the invention provides a preparation process of the Fukean film-coated tablet, which comprises the following steps:
s1 pretreatment of materials: weighing required film coating solid powder, sieving, adding water to dissolve wheat gluten, adding papain, adjusting the pH to 4.5 by using acetic acid, placing the mixture into a 50 ℃ reaction tank, filling nitrogen for reacting for 8 hours, heating the reacted product to 95 ℃ for 10min, cooling the temperature to 4 ℃, freeze-drying the freeze-dried product, putting the frozen product, mannitol, triethyl acetylcitrate, titanium dioxide, polysorbate-80 and propylene glycol into a full-automatic colloid mill, and pre-milling to 0.05-0.015 mm;
s2 mixing: adding a required amount of purified water into a stirring cylinder, starting stirring slurry to enable the purified water to form a vortex, uniformly adding the film-coated solid powder obtained in the step S1 into the vortex, and uniformly stirring; reducing stirring speed to eliminate vortex, stirring for 45min, filtering with 100 mesh stainless steel sieve, and checking the coating liquid to be uniform, free of precipitate and bubble to obtain film coating liquid;
s3 preheating of tablet cores: putting the tablet core into a high-efficiency coating cylinder, inching a high-efficiency coating machine, rotating for half a circle at an interval of 2min, blowing hot air and simultaneously exhausting air, and preheating the tablet core;
s4 coating: adding the film coating liquid prepared in advance in the step S1 into a high-efficiency coating cylinder, adjusting the rotating speed of a nozzle and a coating machine, coating until the coating liquid is coated, blowing hot air for drying, and stopping the machine to obtain the Fukean film coated tablet.
Preferably, the temperature of the hot air in the step S3 is 65-70 ℃, and the temperature of the air exhaust is 40-45 ℃.
Preferably, the temperature for preheating the tablet core in the step S3 is 55 +/-2 ℃.
Preferably, the coating rotation speed in the step S4 is 5 revolutions per minute for the first 5 minutes, and then the rotation speed is adjusted to 8 revolutions per minute, and the distance between the nozzle and the tablet surface is 25-30 cm.
The invention provides a Fukean film-coated tablet and a preparation process thereof, which improves a coating layer in the technical process of film coating, and gluten is modified and added with mannitol, triethyl acetyl citrate, titanium dioxide, polysorbate-80 and propylene glycol for pre-grinding, so that the film coating has strong binding power, high toughness and bright color. After the wheat gluten is subjected to enzymolysis, hydrophobic groups and sulfhydryl groups in molecules are exposed, hydrophobic bonds in protein molecules can be combined with disulfide bonds to form a new three-dimensional network structure, and the protein molecules are combined with mannitol and acetyl triethyl citrate, so that the coating liquid has good hydrophobicity and film-forming property, raw materials are easy to obtain, the price is low, and the product quality is improved.
Aiming at the research of improving the stability, water absorption and industrial yield of the prior film technology, the invention improves the coating premix liquid in the film coating technical process, reduces the cost, improves the economic benefit and is suitable for industrial large-scale production.
Detailed Description
The present invention will be described in further detail with reference to the following examples. It should not be understood that the scope of the above-described subject matter of the present invention is limited to the following examples.
EXAMPLES 1-3 preparation of samples
Examples 1-3 provide the tablet core formulations shown in table 1.
Figure BDA0002357212090000031
Figure BDA0002357212090000041
The preparation process of the tablet core comprises the following steps:
(1) weighing and cleaning Jasminum Amplexicaule, herba plantaginis, pericarpium Granati, herb Polygoni chinensis and cortex Ilicis Rotundae, decocting with water, adding 6 times of drinking water, decocting for 2 hr, filtering to obtain supernatant, adding 4 times of drinking water into the residue, decocting for 2 hr for the second time, filtering the 2 extractive liquids with 80 mesh sieve, pumping into a liquid medicine temporary storage tank, mixing to obtain liquid medicine A, and standing at room temperature;
(2) pumping the liquid medicine A in the liquid medicine tank into a double-effect vacuum concentrator, heating and concentrating, measuring the specific gravity by a specific gravity meter at any time, concentrating to obtain clear paste with the relative density of 1.18-1.20, and collecting the paste;
(3) adding high-concentration ethanol into the clear paste, stirring for 15min to enable the ethanol content to reach 65%, standing for 24 hours, pumping supernatant into a liquid medicine storage tank, washing residues with 65% ethanol for one time, standing for 12 hours, filtering, combining secondary filtrate, recovering ethanol, pumping into a spherical concentration tank for concentration, concentrating into thick paste with the relative density of 1.30-1.40, drying at low temperature, and crushing;
(4) adding corn starch and sugar powder, granulating, drying, grading, adding magnesium stearate, mixing, and tabletting to obtain 20000 tablet core.
The tablet cores of examples 1-3 were subjected to film coating experiments, and the tablet core film coating formulations are given in table 2.
TABLE 2 tablet core film coating recipe
Figure BDA0002357212090000042
Figure BDA0002357212090000051
The preparation process of the Fukean film-coated tablet comprises the following steps:
s1 pretreatment of materials: weighing required film coating solid powder, sieving, adding water to dissolve wheat gluten, adding papain, adjusting the pH to 4.5 by using acetic acid, placing the mixture into a 50 ℃ reaction tank, filling nitrogen for reacting for 8 hours, heating the reacted product to 95 ℃ for 10min, cooling the temperature to 4 ℃, freeze-drying the freeze-dried product, putting the frozen product, mannitol, triethyl acetylcitrate, titanium dioxide, polysorbate-80 and propylene glycol into a full-automatic colloid mill, and pre-milling to 0.05-0.015 mm;
s2 mixing: adding a required amount of purified water into a stirring cylinder, starting stirring slurry to enable the purified water to form a vortex, uniformly adding the film-coated solid powder obtained in the step S1 into the vortex, and uniformly stirring; reducing stirring speed to eliminate vortex, stirring for 45min, filtering with 100 mesh stainless steel sieve, and checking the coating liquid to be uniform, free of precipitate and bubble to obtain film coating liquid;
s3 preheating of tablet cores: putting the core tablet obtained in claim 3 into a high-efficiency coating cylinder, inching a high-efficiency coating machine, rotating for half a circle at an interval of 2min, blowing hot air and simultaneously exhausting air, and preheating the core tablet;
s4 coating: adding the film coating solution prepared in advance in the step S1 into a high-efficiency coating cylinder, adjusting the rotating speed of a nozzle and a coating machine, coating until the coating solution is coated, blowing hot air for drying for 15min, and stopping the machine to obtain the Fukean film coated tablet.
Comparative example 1
Similar to example 2, except that: other parameters for the conversion of mannitol to hypromellose were the same as in example 2.
Comparative example 2
Similar to example 2, except that: the acetyl triethyl citrate was exchanged for diethyl phthalate with the same other parameters as in example 2.
Comparative example 3
Similar to example 2, except that: gluten was changed to zein, and the other parameters were the same as in example 2.
Comparative example 4
The tablet core is the same as example 2, except that: the film coating excipients were replaced with commercially available sugar coating excipients, and the other parameters were the same as in example 2.
Test example 1 test results of film-coated tablets
Test samples: coated tablets prepared according to examples 1 to 3 and comparative examples 1 to 4
Observing the above samples, and performing identification, examination, tablet weight gain rate measurement and content measurement (based on the total flavone and rutin (C)27H30O16) Meter), the coating time was recorded and the results are shown in table 3.
The inspection results of the film-coated tablets show that all the inspection items in the examples 1 to 3 meet the standard specification, the yield can reach more than 97%, the weight gain of the film-coated tablets is only about 3.47% of that of the tablet cores, the weight gain of the sugar-coated tablets in the comparative example 4 is about 85.9% of that of the tablet cores, the coating weight gains of the comparative examples 1 to 3 are heavier, the coating time is longer, and the equipment cost and the auxiliary material consumption are higher.
Table 3 inspection results of film coated tablets
Figure BDA0002357212090000061
Test example 2 high temperature and high humidity accelerated test
Taking 20 tablets respectively, placing at 60 deg.C and relative humidity of 75% and 92.5%, examining water absorption rate, standing for 10 days and 30 days, comparing water absorption, and performing friability measurement and content measurement.
TABLE 4 Water absorption results of high temperature and high humidity accelerated test
Figure BDA0002357212090000071
TABLE 5 determination of contents and variation of friability
Figure BDA0002357212090000072
The results in the above table show that under the same storage conditions, examples 1 to 3 are superior to comparative examples 1 to 4 in water absorption, content change and coarse degree, wherein example 2 has the lowest water absorption and small content change under the relative humidity of 92.5%.
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims (7)

1. The Fukean film-coated tablet consists of a tablet core and a film coating layer, and is characterized in that the tablet core comprises the following preparation raw materials in parts by weight: 1000-3000 parts of Jasminum Amplexicaule, 1000-3000 parts of Chinese knotweed herb, 670-800 parts of ovate leaf holly bark, 330-600 parts of plantain herb, 330-600 parts of pomegranate bark, 28.7-50.3 parts of corn starch, 61-125 parts of powdered sugar and 3.3-6.5 parts of magnesium stearate; the film coating layer comprises the following preparation raw materials in parts by weight: 6.45-12.9 parts of mannitol, 1.93-5.03 parts of acetyl triethyl citrate, 2.55-5.10 parts of titanium dioxide, 0.77-1.54 parts of wheat gluten, 0.51-1.03 parts of polysorbate-800.51 and 0.51-1.03 parts of propylene glycol.
2. The abdomen-cotine film coated tablet according to claim 1, wherein the tablet core comprises the following preparation raw materials in parts by weight: 1000 parts of Jasminum Amplexicaule, 1000 parts of Chinese knotweed herb, 670 parts of ovate leaf holly bark, 330 parts of plantain herb and 330 parts of pomegranate bark; 28.7 parts of corn starch, 61 parts of powdered sugar and 3.3 parts of magnesium stearate; the film coating layer comprises the following preparation raw materials in parts by weight: 6.45 parts of hydroxypropyl methylcellulose, 1.93 parts of acetyl triethyl citrate, 2.55 parts of titanium dioxide, 0.77 part of wheat gluten, 800.51 parts of polysorbate and 0.51 part of propylene glycol.
3. The abdomen-attachable film coated tablet according to claim 1 or 2, wherein the process for preparing the tablet core comprises the steps of:
(1) weighing the medicinal materials, adding water for decocting, adding 6 times of drinking water, decocting for 2 hours, filtering to collect supernatant, adding 4 times of drinking water into filter residue, decocting for 2 hours for the second time, filtering the 2 times of extractive liquid medicines respectively through 80 mesh sieves, pumping into a liquid medicine temporary storage tank, mixing to obtain liquid medicine A, and standing at room temperature;
(2) pumping the liquid medicine A in the liquid medicine tank into a double-effect vacuum concentrator, heating and concentrating, measuring the specific gravity by a specific gravity meter at any time, concentrating to obtain clear paste with the relative density of 1.18-1.20, and collecting the paste;
(3) adding high-concentration ethanol into the clear paste, stirring for 15min to enable the ethanol content to reach 65%, standing for 24 hours, pumping supernatant into a liquid medicine storage tank, washing residues with 65% ethanol for one time, standing for 12 hours, filtering, combining secondary filtrate, recovering ethanol, pumping into a spherical concentration tank for concentration, concentrating into thick paste with the relative density of 1.30-1.40, drying at low temperature, and crushing;
(4) adding corn starch and sugar powder, granulating, drying, grading, adding magnesium stearate, mixing, and tabletting to obtain tablet core.
4. A process for the preparation of a film coated tablet according to claim 1 or 2, comprising the steps of:
s1 pretreatment of materials: weighing required film coating solid powder, sieving, adding water to dissolve wheat gluten, adding papain, adjusting the pH to 4.5 by using acetic acid, placing the mixture into a 50 ℃ reaction tank, filling nitrogen for reacting for 8 hours, heating the reacted product to 95 ℃ for 10min, cooling the temperature to 4 ℃, freeze-drying the freeze-dried product, putting the frozen product, mannitol, triethyl acetylcitrate, titanium dioxide, polysorbate-80 and propylene glycol into a full-automatic colloid mill, and pre-milling to 0.05-0.015 mm;
s2 mixing: adding a required amount of purified water into a stirring cylinder, starting stirring slurry to enable the purified water to form a vortex, uniformly adding the film-coated solid powder obtained in the step S1 into the vortex, and uniformly stirring; reducing stirring speed to eliminate vortex, stirring for 45min, filtering with 100 mesh stainless steel sieve, and checking the coating liquid to be uniform, free of precipitate and bubble to obtain film coating liquid;
s3 preheating of tablet cores: putting the core tablet obtained in claim 3 into a high-efficiency coating cylinder, inching a high-efficiency coating machine, rotating for half a circle at an interval of 2min, blowing hot air and simultaneously exhausting air, and preheating the core tablet;
s4 coating: adding the film coating liquid prepared in advance in the step S1 into a high-efficiency coating cylinder, adjusting the rotating speed of a nozzle and a coating machine, coating until the coating liquid is coated, blowing hot air for drying, and stopping the machine to obtain the Fukean film coated tablet.
5. Process for the preparation of a Fukean film coated tablet according to claim 4, characterized in that said step
The temperature of the hot air in the S3 is 65-70 ℃, and the temperature of the exhaust air is 40-45 ℃.
6. Process for the preparation of a Fukean film coated tablet according to claim 4, characterized in that said step
The pre-heating temperature of the core in S3 was 55 ± 2 ℃.
7. The process for preparing a belly-mountable film-coated tablet according to claim 4, wherein the coating speed in the step S4 is 5 rpm for the first 5min, and is adjusted to 8 rpm with the nozzle being 25 to 30cm from the tablet surface.
CN202010011196.XA 2020-01-06 2020-01-06 Fukean film-coated tablet and preparation process thereof Withdrawn CN111000819A (en)

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Application publication date: 20200414