CN111803461A - Promethazine tablet and processing technology thereof - Google Patents
Promethazine tablet and processing technology thereof Download PDFInfo
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- CN111803461A CN111803461A CN202010700670.XA CN202010700670A CN111803461A CN 111803461 A CN111803461 A CN 111803461A CN 202010700670 A CN202010700670 A CN 202010700670A CN 111803461 A CN111803461 A CN 111803461A
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- PWWVAXIEGOYWEE-UHFFFAOYSA-N Isophenergan Chemical compound C1=CC=C2N(CC(C)N(C)C)C3=CC=CC=C3SC2=C1 PWWVAXIEGOYWEE-UHFFFAOYSA-N 0.000 title claims abstract description 28
- 229960003910 promethazine Drugs 0.000 title claims abstract description 28
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 72
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 42
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- XXPDBLUZJRXNNZ-UHFFFAOYSA-N promethazine hydrochloride Chemical compound Cl.C1=CC=C2N(CC(C)N(C)C)C3=CC=CC=C3SC2=C1 XXPDBLUZJRXNNZ-UHFFFAOYSA-N 0.000 claims abstract description 25
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Images
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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
- A61K9/2095—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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
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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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/2013—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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- 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
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
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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
- A61K9/2893—Tablet coating processes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
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Abstract
The invention discloses promethazine tablets and a processing technology thereof, wherein the promethazine tablets comprise the following raw materials in parts by weight: 11.5-13.50 parts of promethazine hydrochloride, 16.72-18.72 parts of lactose, 2.89-3.09 parts of corn starch, 1.34-1.54 parts of pregelatinized starch, 7-9 parts of absolute ethyl alcohol, 0.25-0.45 part of magnesium stearate, 0.15-0.35 part of shellac, 1.58-1.78 parts of 96% ethanol, 32.475-34.475 parts of sucrose, 4.655-6.655 parts of talcum powder, 0.518-0.718 parts of titanium dioxide, 0.42-0.62 part of povidone, 1.07-1.27 parts of blue protein coating pulp, 13.35-15.35 parts of purified water, 0.18-0.38 part of yellow beeswax and 0.18-0.38 part of carnauba wax, wherein the raw materials comprise the following components in parts by weight: the invention relates to the technical field of promethazine tablets, and discloses the promethazine tablet, which comprises 12.50 parts of promethazine hydrochloride, 17.72 parts of lactose, 2.99 parts of corn starch, 1.44 parts of pregelatinized starch, 8 parts of absolute ethyl alcohol, 0.35 part of magnesium stearate and 0.25 part of shellac. The promethazine tablet and the processing technology thereof ensure that the promethazine tablet has stable and lasting drug effect and quick response when being used for stopping vomiting and resisting dizziness by adding the promethazine hydrochloride, the lactose, the corn starch, the pregelatinized starch, the absolute ethyl alcohol and the magnesium stearate.
Description
Technical Field
The invention relates to the technical field of promethazine tablets, in particular to promethazine tablets and a processing technology thereof.
Background
Allergies of the skin mucosa, such as chronic, seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis caused by exposure to allergens or food, urticaria, angioneurotic edema, allergic reactions to blood or plasma products, dermabrasion requiring corresponding medication, motion sickness, such as car sickness, sea sickness, aeroplanes requiring preventive medication, preoperative, postoperative and obstetrical medications frequently requiring sedation and hypnosis, furthermore, fear of adults and children, light sleep states, medications requiring relief, some narcotics and post-operative nausea, vomiting, radiation-or drug-induced nausea, vomiting requiring preventive medication.
Promethazine is a phenothiazine derivative, belongs to an antihistamine and has the following effects: 1. the antihistaminic effect competes with histamine released by tissues for H1 receptor, and can antagonize contraction or contracture of histamine on gastrointestinal tract, trachea, bronchus or bronchiole smooth muscle, and relieve spasmolytic and hyperemic effects of histamine on bronchial smooth muscle. 2. May act on vestibular and vomiting centers and mesencephalon medullary receptors through central anticholinergic performance, and mainly block the excitation of cholinergic synaptic maze impulse in vestibular nucleus area. 3. The mechanism for inhibiting the central nervous system is not exactly clarified, and the irritability of the brain stem network structure activation system is reduced indirectly, so that the invention provides the promethazine tablet and the processing technology thereof.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides an promethazine tablet and a processing technology thereof.
In order to achieve the purpose, the invention is realized by the following technical scheme: the promethazine tablet and the processing technology thereof comprise the following raw materials in parts by weight: 11.5-13.50 parts of promethazine hydrochloride, 16.72-18.72 parts of lactose, 2.89-3.09 parts of corn starch, 1.34-1.54 parts of pregelatinized starch, 7-9 parts of absolute ethyl alcohol, 0.25-0.45 part of magnesium stearate, 0.15-0.35 part of shellac, 1.58-1.78 parts of 96% ethanol, 32.475-34.475 parts of sucrose, 4.655-6.655 parts of talcum powder, 0.518-0.718 part of titanium dioxide, 0.42-0.62 part of povidone, 1.07-1.27 parts of blue protein coating pulp, 13.35-15.35 parts of purified water, 0.18-0.38 part of yellow beeswax and 0.18-0.38 part of carnauba wax.
Preferably, the raw materials comprise the following components in parts by weight: 12.50 parts of promethazine hydrochloride, 17.72 parts of lactose, 2.99 parts of corn starch, 1.44 parts of pregelatinized starch, 8 parts of absolute ethyl alcohol, 0.35 part of magnesium stearate, 0.25 part of shellac, 1.68 parts of 96% ethanol, 33.475 parts of cane sugar, 5.655 parts of talcum powder, 0.618 part of titanium dioxide, 0.52 part of povidone, 1.17 parts of blue protein coating, 14.35 parts of purified water, 0.28 part of yellow beeswax and 0.28 part of carnauba wax.
Preferably, the raw materials comprise the following components in parts by weight: 11.5 parts of promethazine hydrochloride, 16.72 parts of lactose, 2.89 parts of corn starch, 1.34 parts of pregelatinized starch, 7 parts of absolute ethyl alcohol, 0.25 part of magnesium stearate, 0.15 part of shellac, 1.58 parts of 96% ethanol, 32.475 parts of cane sugar, 4.655 parts of talcum powder, 0.518 part of titanium dioxide, 0.42 part of povidone, 1.07 part of blue protein coating, 13.35 parts of purified water, 0.18 part of yellow beeswax and 0.18 part of carnauba wax.
Preferably, the raw materials comprise the following components in parts by weight: 13.50 parts of promethazine hydrochloride, 18.72 parts of lactose, 3.09 parts of corn starch, 1.54 parts of pregelatinized starch, 9 parts of absolute ethyl alcohol, 0.45 part of magnesium stearate, 0.35 part of shellac, 1.78 parts of 96% ethanol, 34.475 parts of sucrose, 6.655 parts of talcum powder, 0.718 part of titanium dioxide, 0.62 part of povidone, 1.27 parts of blue protein coating pulp, 15.35 parts of purified water, 0.38 part of yellow beeswax and 0.38 part of carnauba wax.
Preferably, the type of the pregelatinized starch is PGS type, the specification of the povidone is K30, and the type of the Blue protein coating slurry is OPALUX Blue AS-205001.
The invention also discloses a processing technology of the promethazine tablet, and the preparation method specifically comprises the following steps:
uniformly putting promethazine hydrochloride, lactose, corn starch and pregelatinized starch into a hopper mixer for dry mixing for 5-10min, taking out after uniform mixing, putting into a boiling drying granulator, adding absolute ethyl alcohol for drying granulation, wherein the reaction temperature in the boiling drying granulator is 40-42 ℃;
step two, sieving the prepared granules by a sieve with the aperture of 1.5mm, putting the granules into a hopper mixer, adding magnesium stearate for mixing, reacting for 3-5min, taking out, and putting the mixture into a high-speed rotary tablet machine for tabletting;
dissolving shellac in 96% ethanol, placing the tabletted tablets and the prepared solution into a water chestnut type sugar coating machine for isolated coating, then mixing sucrose, talcum powder, titanium dioxide, povidone and purified water, continuing placing the prepared solution into the water chestnut type sugar coating machine for coating a powder coating layer, then mixing the blue protein coating pulp, sucrose and purified water, and placing the prepared solution into the water chestnut type sugar coating machine for color coating;
and step four, putting the coated tablet into polishing equipment, then mixing the yellow beeswax and the carnauba wax, putting the mixture into the polishing equipment, and polishing the coated tablet to obtain the compound propolis tablet.
The invention provides promethazine tablets and a processing technology thereof. Compared with the prior art, the method has the following beneficial effects:
(1) the promethazine tablet and the processing technology thereof lead the promethazine tablet to have stable and lasting efficacy and quick response when being used for stopping vomiting and resisting dizziness by adding the promethazine hydrochloride, the lactose, the corn starch, the pregelatinized starch, the absolute ethyl alcohol and the magnesium stearate.
(2) The promethazine tablet and the processing technology thereof are characterized in that promethazine hydrochloride, lactose, corn starch, pregelatinized starch, absolute ethyl alcohol and magnesium stearate are mixed and tabletted, so that the promethazine tablet is more stable to mix, the promethazine hydrochloride content is high, and the tablet inner core is prevented from oxidative deterioration, moisture or volatilization through later-stage coating and polishing, and the concealed cover chip has uncomfortable taste for taking.
Drawings
FIG. 1 is a statistical table of comparative experimental data according to the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. 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.
Referring to fig. 1, the embodiment of the present invention provides three technical solutions: the promethazine tablet and the processing technology thereof specifically comprise the following embodiments:
example 1
The raw materials comprise the following components in parts by weight: 12.50 parts of promethazine hydrochloride, 17.72 parts of lactose, 2.99 parts of corn starch, 1.44 parts of pregelatinized starch, 8 parts of absolute ethyl alcohol, 0.35 part of magnesium stearate, 0.25 part of shellac, 1.68 parts of 96% ethanol, 33.475 parts of cane sugar, 5.655 parts of talcum powder, 0.618 part of titanium dioxide, 0.52 part of povidone, 1.17 parts of blue protein coating, 14.35 parts of purified water, 0.28 part of yellow beeswax and 0.28 part of carnauba wax.
The preparation method specifically comprises the following steps:
uniformly putting 12.50 parts of promethazine hydrochloride, 17.72 parts of lactose, 2.99 parts of corn starch and 1.44 parts of pregelatinized starch into a hopper mixer for dry mixing for 5-10min, taking out after uniform mixing, putting into a boiling drying granulator, adding 8 parts of absolute ethyl alcohol for drying and granulating, wherein the reaction temperature in the boiling drying granulator is 40-42 ℃;
step two, sieving the prepared granules by a sieve with the aperture of 1.5mm, putting the granules into a hopper mixer, adding 0.35 part of magnesium stearate, mixing, reacting for 3-5min, taking out, and putting the mixture into a high-speed rotary tabletting machine for tabletting;
step three, dissolving 0.25 part of shellac in 1.68 parts of 96% ethanol, then putting the tabletted tablets and the prepared solution into a water chestnut type sugar coating machine for isolated coating, then mixing 16.475 parts of sucrose, 5.655 parts of talcum powder, 0.618 parts of titanium dioxide, 0.52 parts of povidone and 7.125 parts of purified water, continuously putting the prepared solution into the water chestnut type sugar coating machine for coating a powder coating layer, then mixing 1.17 parts of blue protein slurry, 17 parts of sucrose and 7.125 parts of purified water, and putting the prepared solution into the water chestnut type sugar coating machine for colored coating;
and step four, putting the coated tablet into polishing equipment, mixing 0.28 part of yellow beeswax and 0.28 part of carnauba wax, putting the mixture into the polishing equipment, and polishing the coated tablet to obtain the compound propolis tablet.
Example 2
The raw materials comprise the following components in parts by weight: 11.5 parts of promethazine hydrochloride, 16.72 parts of lactose, 2.89 parts of corn starch, 1.34 parts of pregelatinized starch, 7 parts of absolute ethyl alcohol, 0.25 part of magnesium stearate, 0.15 part of shellac, 1.58 parts of 96% ethanol, 32.475 parts of cane sugar, 4.655 parts of talcum powder, 0.518 part of titanium dioxide, 0.42 part of povidone, 1.07 part of blue protein coating, 13.35 parts of purified water, 0.18 part of yellow beeswax and 0.18 part of carnauba wax.
The preparation method specifically comprises the following steps:
uniformly putting 11.5 parts of promethazine hydrochloride, 16.72 parts of lactose, 2.89 parts of corn starch and 1.34 parts of pregelatinized starch into a hopper mixer for dry mixing for 5-10min, taking out after uniform mixing, putting into a fluidized drying granulator, adding 7 parts of absolute ethyl alcohol for drying and granulating, wherein the reaction temperature in the fluidized drying granulator is 40-42 ℃;
step two, sieving the prepared granules by a sieve with the aperture of 1.5mm, putting the granules into a hopper mixer, adding 0.25 part of magnesium stearate, mixing, reacting for 3-5min, taking out, and putting the mixture into a high-speed rotary tabletting machine for tabletting;
step three, dissolving 0.15 part of shellac in 1.58 parts of 96% ethanol, then putting the tabletted tablets and the prepared solution into a water chestnut type sugar coating machine for isolated coating, then mixing 16.475 parts of sucrose, 4.655 parts of talcum powder, 0.518 parts of titanium dioxide, 0.42 parts of povidone and 6.675 parts of purified water, continuously putting the prepared solution into the water chestnut type sugar coating machine for coating a powder coating layer, then mixing 1.07 parts of blue protein slurry, 16 parts of sucrose and 6.675 parts of purified water, and putting the prepared solution into the water chestnut type sugar coating machine for colored coating;
and step four, putting the coated tablet into polishing equipment, mixing 0.18 part of yellow beeswax and 0.18 part of carnauba wax, putting the mixture into the polishing equipment, and polishing the coated tablet to obtain the compound propolis tablet.
Example 3
The raw materials comprise the following components in parts by weight: 13.50 parts of promethazine hydrochloride, 18.72 parts of lactose, 3.09 parts of corn starch, 1.54 parts of pregelatinized starch, 9 parts of absolute ethyl alcohol, 0.45 part of magnesium stearate, 0.35 part of shellac, 1.78 parts of 96% ethanol, 34.475 parts of sucrose, 6.655 parts of talcum powder, 0.718 part of titanium dioxide, 0.62 part of povidone, 1.27 parts of blue protein coating pulp, 15.35 parts of purified water, 0.38 part of yellow beeswax and 0.38 part of carnauba wax.
The preparation method specifically comprises the following steps:
uniformly putting 13.5 parts of promethazine hydrochloride, 18.72 parts of lactose, 3.09 parts of corn starch and 1.54 parts of pregelatinized starch into a hopper mixer for dry mixing for 5-10min, taking out after uniform mixing, putting into a fluidized drying granulator, adding 9 parts of absolute ethyl alcohol for drying and granulating, wherein the reaction temperature in the fluidized drying granulator is 40-42 ℃;
step two, sieving the prepared granules by a sieve with the aperture of 1.5mm, putting the granules into a hopper mixer, adding 0.45 part of magnesium stearate, mixing, reacting for 3-5min, taking out, and putting the mixture into a high-speed rotary tabletting machine for tabletting;
step three, dissolving 0.35 part of shellac in 1.78 parts of 96% ethanol, then putting the tabletted tablets and the prepared solution into a water chestnut type sugar coating machine for isolated coating, then mixing 17.475 parts of sucrose, 6.655 parts of talcum powder, 0.718 parts of titanium dioxide, 0.62 parts of povidone and 7.675 parts of purified water, continuously putting the prepared solution into the water chestnut type sugar coating machine for coating a powder coating layer, then mixing 1.27 parts of blue protein slurry, 17 parts of sucrose and 7.675 parts of purified water, and putting the prepared solution into the water chestnut type sugar coating machine for color coating;
and step four, putting the coated tablet into polishing equipment, mixing 0.38 part of yellow beeswax and 0.38 part of carnauba wax, putting the mixture into the polishing equipment, and polishing the coated tablet to obtain the compound propolis tablet.
Comparative experiment
In a medical laboratory, the promethazine hydrochloride content of example 1, example 2 and example 3 is measured, each example is 6 groups of experiments, the statistics of the value, the average value, the maximum value, the minimum value and the relative standard deviation of the promethazine hydrochloride content are made, the promethazine hydrochloride content takes 95.0-105.0% as a standard range, and the relative standard deviation takes not more than 5% as a standard;
as can be seen from the table of FIG. 1, the promethazine tablets in all three examples meet the standard, with example 1 having a smaller relative standard deviation being the most preferred.
And those not described in detail in this specification are well within the skill of those in the art.
It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (6)
1. An promethazine tablet characterized by: the raw materials comprise the following components in parts by weight: 11.5-13.50 parts of promethazine hydrochloride, 16.72-18.72 parts of lactose, 2.89-3.09 parts of corn starch, 1.34-1.54 parts of pregelatinized starch, 7-9 parts of absolute ethyl alcohol, 0.25-0.45 part of magnesium stearate, 0.15-0.35 part of shellac, 1.58-1.78 parts of 96% ethanol, 32.475-34.475 parts of sucrose, 4.655-6.655 parts of talcum powder, 0.518-0.718 part of titanium dioxide, 0.42-0.62 part of povidone, 1.07-1.27 parts of blue protein coating pulp, 13.35-15.35 parts of purified water, 0.18-0.38 part of yellow beeswax and 0.18-0.38 part of carnauba wax.
2. The promethazine tablet of claim 1, wherein: the raw materials comprise the following components in parts by weight: 12.50 parts of promethazine hydrochloride, 17.72 parts of lactose, 2.99 parts of corn starch, 1.44 parts of pregelatinized starch, 8 parts of absolute ethyl alcohol, 0.35 part of magnesium stearate, 0.25 part of shellac, 1.68 parts of 96% ethanol, 33.475 parts of cane sugar, 5.655 parts of talcum powder, 0.618 part of titanium dioxide, 0.52 part of povidone, 1.17 parts of blue protein coating, 14.35 parts of purified water, 0.28 part of yellow beeswax and 0.28 part of carnauba wax.
3. The promethazine tablet of claim 1, wherein: the raw materials comprise the following components in parts by weight: 11.5 parts of promethazine hydrochloride, 16.72 parts of lactose, 2.89 parts of corn starch, 1.34 parts of pregelatinized starch, 7 parts of absolute ethyl alcohol, 0.25 part of magnesium stearate, 0.15 part of shellac, 1.58 parts of 96% ethanol, 32.475 parts of cane sugar, 4.655 parts of talcum powder, 0.518 part of titanium dioxide, 0.42 part of povidone, 1.07 part of blue protein coating, 13.35 parts of purified water, 0.18 part of yellow beeswax and 0.18 part of carnauba wax.
4. The promethazine tablet of claim 1, wherein: the raw materials comprise the following components in parts by weight: 13.50 parts of promethazine hydrochloride, 18.72 parts of lactose, 3.09 parts of corn starch, 1.54 parts of pregelatinized starch, 9 parts of absolute ethyl alcohol, 0.45 part of magnesium stearate, 0.35 part of shellac, 1.78 parts of 96% ethanol, 34.475 parts of sucrose, 6.655 parts of talcum powder, 0.718 part of titanium dioxide, 0.62 part of povidone, 1.27 parts of blue protein coating pulp, 15.35 parts of purified water, 0.38 part of yellow beeswax and 0.38 part of carnauba wax.
5. The promethazine tablet of claim 1, wherein: the type of the pregelatinized starch is PGS type, the specification of the povidone is K30, and the type of the Blue protein coating pulp is OPALUX Blue AS-205001.
6. The promethazine tablet of any one of claims 1 to 5, wherein: the preparation method specifically comprises the following steps:
uniformly putting promethazine hydrochloride, lactose, corn starch and pregelatinized starch into a hopper mixer for dry mixing for 5-10min, taking out after uniform mixing, putting into a boiling drying granulator, adding absolute ethyl alcohol for drying granulation, wherein the reaction temperature in the boiling drying granulator is 40-42 ℃;
step two, sieving the prepared granules by a sieve with the aperture of 1.5mm, putting the granules into a hopper mixer, adding magnesium stearate for mixing, reacting for 3-5min, taking out, and putting the mixture into a high-speed rotary tablet machine for tabletting;
dissolving shellac in 96% ethanol, placing the tabletted tablets and the prepared solution into a water chestnut type sugar coating machine for isolated coating, then mixing sucrose, talcum powder, titanium dioxide, povidone and purified water, continuing placing the prepared solution into the water chestnut type sugar coating machine for coating a powder coating layer, then mixing the blue protein coating pulp, sucrose and purified water, and placing the prepared solution into the water chestnut type sugar coating machine for color coating;
and step four, putting the coated tablet into polishing equipment, then mixing the yellow beeswax and the carnauba wax, putting the mixture into the polishing equipment, and polishing the coated tablet to obtain the compound propolis tablet.
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| CN202010700670.XA CN111803461A (en) | 2020-07-20 | 2020-07-20 | Promethazine tablet and processing technology thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116172968A (en) * | 2022-12-30 | 2023-05-30 | 山东中健康桥制药有限公司 | Alolol hydrochloride preparation and preparation method thereof |
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| CN104666265A (en) * | 2015-03-17 | 2015-06-03 | 常州康普药业有限公司 | Promethazine hydrochloride tablet and preparation method thereof |
| CN108096203A (en) * | 2018-02-09 | 2018-06-01 | 常州康普药业有限公司 | A kind of promethazine hydrochloride piece and preparation method thereof |
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| CN104666265A (en) * | 2015-03-17 | 2015-06-03 | 常州康普药业有限公司 | Promethazine hydrochloride tablet and preparation method thereof |
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Application publication date: 20201023 |